Datasets:

anthonyyazdaniml

/

CT-ADE-SOC

like 1

NCT05419908

NCT05419908_EG001

No

Female

Adult | Older Adult

Phase 2

Inclusion Criteria: Spontaneous amenorrhea for at least 12 consecutive months; or spontaneous amenorrhea for at least 6 months with biochemical criteria of menopause (FSH >40 IU/L); or spontaneous amenorrhea for at least 3 months with biochemical/physical criteria of menopause (FSH >40 IU/L and E2 <0.21 nmol/); or having had bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy); At least 49 moderate or severe hot flashes or night sweats over a period of 7 consecutive days, as recorded in the daily diary during the screening period, with at least 4 of those days with 7 or more moderate or severe hot flashes per day; In good general health as determined on the basis of medical history and general physical examination performed at screening; hematology and chemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations; Negative urine test for selected drugs of abuse (amphetamines, tricyclic antidepressants, cannabinoids, cocaine, tetrahydrocannabinol, or opiates) at screening; Negative serology panel (including hepatitis B surface antigen [HBsAg], antihepatitis C virus [HCV] and human immunodeficiency virus (HIV) antibody screens); Negative urine pregnancy test at screening; Exclusion Criteria: Use of a prohibited therapy or not willing to wash-out drugs considered prohibited therapies; History (in the past year) or presence of drug or alcohol abuse; Suicide attempt in the past 3 years; Previous or current history of a malignant tumor (except basal cell carcinoma); Active liver disease or jaundice, or out-of-range values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST); or total bilirubin >1.3 times the upper limit of normal (ULN); or creatinine >1.5 times the ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula <60 mL/min/1.73 m2 at screening; Medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], or endocrine disease) or malignancy that could confound interpretation of the study outcome; Any psychological disorder according to the criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders (DSM, 4th edition) within one year prior to screening. Such disorders include but are not limited to current major depression, alcohol (more than 3 glasses of wine, beer, or equivalent/day) or substance abuse/dependence; Unsuited to participate in the study, based on findings observed during physical examination, vital sign assessment, or 12-lead ECG; History of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients; Presence or sequellae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution, metabolism, or excretion (ADME) mechanisms of drugs; Concurrent participation in another interventional study (or participation within 3 months prior to screening in this study); History of poor compliance in clinical studies; Unable or unwilling to complete the study procedures; Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.

Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.

Fezolinetant

Cc1nsc(-c2nnc3n2CCN(C(=O)c2ccc(F)cc2)[C@@H]3C)n1

G02CX06

NCT05438277

NCT05438277_EG000

Accepts Healthy Volunteers

All

Adult | Older Adult

Phase 4

Inclusion Criteria: Subacromial or glenohumeral shoulder pain to be treated with steroid injection Fluent in written and oral English Willing and able to provide written consent Willing to complete follow up pain scores (visual analog score) Exclusion Criteria: Unable to provide written consent Chronic pain syndrome Unwilling to complete follow up pain scores (visual analog score)

subacromial or glenohumeral shoulder injection Methylprednisolone (MPA): injection into subacromial or glenohumeral space with MPA

Methylprednisolone

[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C

D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07

NCT05438277

NCT05438277_EG001

Accepts Healthy Volunteers

All

Adult | Older Adult

Phase 4

Inclusion Criteria: Subacromial or glenohumeral shoulder pain to be treated with steroid injection Fluent in written and oral English Willing and able to provide written consent Willing to complete follow up pain scores (visual analog score) Exclusion Criteria: Unable to provide written consent Chronic pain syndrome Unwilling to complete follow up pain scores (visual analog score)

subacromial or glenohumeral shoulder injection Triamcinolone Acetonide (TA): injection into subacromial or glenohumeral space with TA

Kenalog

CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1

NCT05439460

NCT05439460_EG000

No

All

Child | Adult

Phase 4

Inclusion Criteria: Patients presenting for cardiac catheterization procedure with a diagnosis of PAH either by previous cardiac catheterization or echocardiography Exclusion Criteria: Children presenting for cardiac catheterization who do not have PAH; Children with PAH but with intracardiac shunts

Phenylephrine (1ug/kg) administered once the child is under anesthesia.

Phenylephrine

CNC[C@H](O)c1cccc(O)c1

C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55

NCT05439460

NCT05439460_EG001

No

All

Child | Adult

Phase 4

Inclusion Criteria: Patients presenting for cardiac catheterization procedure with a diagnosis of PAH either by previous cardiac catheterization or echocardiography Exclusion Criteria: Children presenting for cardiac catheterization who do not have PAH; Children with PAH but with intracardiac shunts

Arginine Vasopressin (1ug/kg) administered once the child is under anesthesia.

Pituitrin

NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O

NCT05439460

NCT05439460_EG002

No

All

Child | Adult

Phase 4

Inclusion Criteria: Patients presenting for cardiac catheterization procedure with a diagnosis of PAH either by previous cardiac catheterization or echocardiography Exclusion Criteria: Children presenting for cardiac catheterization who do not have PAH; Children with PAH but with intracardiac shunts

Epinephrine (0.5-1ug/kg) administered once the child is under anesthesia.

Epinephrine

CNCC(O)c1ccc(O)c(O)c1

A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51

NCT05460871

NCT05460871_EG001

Accepts Healthy Volunteers

All

Adult | Older Adult

Phase 4

Inclusion Criteria: Patients undergoing native joint unilateral TKA due to Grade 3-4 primary osteoarthritis Patients with score of at least 40 on Central Sensitization Inventory Patients who will complete PT within the U of Iowa Health Care system Patients who have been nonsmokers for > 2 years Patients between the ages of 50 and 85 Exclusion Criteria: Patients already taking pregabalin or had an adverse effect with pregabalin in the past Patients indicated for joint revision surgery Patients taking at least 30 morphine milligram equivalents per day for the past 1 month Patients with an estimate GFR < 30 ml/min Patients who do not have an understanding of English Patients who are pregnant or women of child-bearing years Patients who are prisoners Patients who score < 40 on the CSI Patients who answer Yes to any questions on the Columbia Suicide Severity Rating Scale or express suicidal ideation

Participants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days. Then Stop.

Flutamide

CC(C)C(=O)Nc1ccc([N+](=O)[O-])c(C(F)(F)F)c1

L02BB01

NCT05502081

NCT05502081_EG001

Accepts Healthy Volunteers

All

Child | Adult | Older Adult

Phase 4

Inclusion Criteria: age more than 12 years old. weight not less than 40 kg. Moderate, sever or critical COVID-19 disease as defined by WHO. PCR- confirmed patients to be Positive before inclusion. Exclusion Criteria: history of hypersensitivity or infusion related reactions after administration of monoclonal antibodies. prior use of standard antiviral therapy (remedsvir or favipravir). Current use of controversial antiviral therapy (hydroxychloroquine, ivermectin, nitazoxanide, oseltemavir, acyclovir, ribavirine, lopinvir/rotinvir, sofosfbuvir, decltasevir, semipirvir, azithromycin). patients expected to die within 48 hours.

Remdesivir, vials Day1 (loading dose): 200 mg (two 100mg vials) diluted in 500ml 0.9% sodium chloride solution infused I.V over 60 minutes Day 2-5 or Day 2-10 (maintenance dose): 100 mg (one 100mg vial) in 250 ml 0.9% sodium chloride solution infused I.V over 30 minutes Remdesivir: antiviral drug

Remdesivir

CCC(CC)COC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@](C#N)(c2ccc3c(N)ncnn23)[C@H](O)[C@@H]1O)Oc1ccccc1

J05AB16

NCT05502081

NCT05502081_EG002

Accepts Healthy Volunteers

All

Child | Adult | Older Adult

Phase 4

Inclusion Criteria: age more than 12 years old. weight not less than 40 kg. Moderate, sever or critical COVID-19 disease as defined by WHO. PCR- confirmed patients to be Positive before inclusion. Exclusion Criteria: history of hypersensitivity or infusion related reactions after administration of monoclonal antibodies. prior use of standard antiviral therapy (remedsvir or favipravir). Current use of controversial antiviral therapy (hydroxychloroquine, ivermectin, nitazoxanide, oseltemavir, acyclovir, ribavirine, lopinvir/rotinvir, sofosfbuvir, decltasevir, semipirvir, azithromycin). patients expected to die within 48 hours.

Favipravir, tablets Day 1 (loading dose): 1600 mg (8 tablets) orally or in Ryle tube / 12 hours day 2-10 (maintenance dose): 800 mg (4 tablets) orally or in Ryle tube / 12 hours Favipiravir: antiviral drug

Favipiravir

NC(=O)c1nc(F)cnc1O

J05AX27

NCT05513625

NCT05513625_EG000

Accepts Healthy Volunteers

All

Adult

Phase 1

Inclusion Criteria: Subjects had to have the ability to understand and sign written informed consent, which had to be obtained prior to any trial-related procedures being completed; Healthy male and female subjects of any ethnic origin, aged between 18 and 45 years (inclusive) assessed as healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, electrocardiogram (ECG) assessment, and clinical laboratory results. Female subjects of non-childbearing potential had to be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks prior to Screening) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at Screening based on the central laboratory's ranges. Female subjects of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) and all male subjects had to use a medically accepted contraceptive regimen during their participation in the trial and for 90 days after the last administration of trial drug. Medically accepted contraceptive methods were defined as those with 90% or greater efficacy. Acceptable methods of contraception for male subjects enrolled in the trial included the following: Condoms with spermicide. Surgical sterilization of the subject at least 26 weeks prior to Screening (vasectomy). Acceptable methods of contraception for female subjects enrolled in the trial included the following, (the subject had to choose two of the following [a single barrier method alone or abstinence alone was not acceptable]): Condoms with spermicide. Intrauterine device for at least 12 weeks prior to Screening. Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks prior to Screening. Diaphragm used in combination with spermicide. Male subjects had to agree to abstain from sperm donation and not plan to father a child (including sperm donation) through 90 days after administration of the last dose of trial drug. In women: a negative serum beta-human chorionic gonadotropin (β-HCG) test at Screening and negative urine β-HCG test at Admission in each Treatment Period. Subject agreed to pharmacogenetic blood sampling. Normal body weight as evidenced by a Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2, and a body weight ≥50.0 kg at Screening. Subjects had to have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), and human immunodeficiency virus (HIV) at Screening; Subjects had to have negative urine tests for drugs of abuse (metamphetamines, amphetamines, 3,4-Methylendioxyamphetamin (MDMA), barbiturates, benzodiazepines, cannabinoids, opioids, cocaine and tricyclic antidepressants) and negative breath alcohol tests at Screening and Admission in each Treatment Period. Exclusion criteria: History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food History of allergic reactions to any active or inactive ingredient(s) of the trial medication(s) History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease suspected to influence pharmacokinetics or safety of PTV History of malignancy Resting pulse rate after 5 minutes in supine position at Screening and Day -1 of Treatment Period 1: <45 or >100 beats per minute (bpm), if out of range, up to one repeat assessment was allowed Resting blood pressure after 5 minutes in supine position at Screening and Day -1 of Treatment Period 1: systolic blood pressure <90 or >145 mmHg diastolic blood pressure <40 or >95 mmHg, if out of range, up to one repeat assessment was allowed ECG abnormalities of clinical relevance (eg, QTc according to Fridericia: QTc >450 ms in males and >470 ms in females; PR ≥220 ms) Febrile or infectious illness within 5 days prior to administration of Investigational Medicinal Product Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables Chronic or clinically relevant acute infections Diagnosed to be COVID-19 positive by polymerase chain reaction (PCR) testing (SARS-CoV-2 RT-PCR positive) of a respiratory specimen (preferably a nasopharyngeal swab) on Day -2 of Treatment Period 1 Subject was lactating or breastfeeding Use of any medication (incl. over-the-counter [OTC] medication) within 2 weeks before first drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment periods. Use of hormonal contraceptives was allowed. Single intake of a drug may have been accepted if judged by the Investigators to have no clinical relevance and no relevance for the trial objectives. Limited amounts of acetaminophen were allowed to treat painful intercurrent adverse events (eg, headache, migraine). Consumption of any (eg, CYP1A2, CYP3A4) enzyme inducing or inhibiting aliments and beverages (eg, but not limited to broccoli, Brussels sprout, grapefruit, grapefruit juice, Seville orange, star fruit, tonic water, bitter lemon etc.) within 2 weeks prior to the Screening (Pre-trial examination) Consumption of methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks") from 24 hours before PTV dosing on Day 1 until release from the clinic on Day 5 of each period Consumption of alcohol and tobacco products within 48 hours prior to admission to the clinic until discharge of each period Vegetarian diet or other dietary habits which would have precluded the subject's acceptance of standardized meals Diseases or surgery of the gastrointestinal tract which may have interfered with drug absorption (note: this was not applicable for minor abdominal surgery such as eg, appendectomy and herniotomy) Receipt of any Investigational Medicinal Product (IMP) within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to trial drug administration. Blood donation or loss of 550 mL or more within the last 30 days before start of Screening (Pre-trial examination) Smoking of more than 10 cigarettes/cigars/pipes per Day and/or inability to refrain from smoking during confinement Intake of more than 12 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) Had any finding that, in the view of the Investigator, would have compromised the subject's safety requirements

Single dose 100 mg pritelivir (PTV) administered day 1 Pritelivir: oral administration

Pritelivir

Cc1nc(N(C)C(=O)Cc2ccc(-c3ccccn3)cc2)sc1S(N)(=O)=O

NCT05641311

NCT05641311_EG000

Accepts Healthy Volunteers

All

Adult

Phase 1

Key Inclusion Criteria: - Body weight ≤80 kilograms (kg) and body mass index (BMI) within the range 18-25 kg/m^2, inclusive, at screening. - Negative serum pregnancy test. - Female participants of childbearing potential and male participants with a female spouse or partner of childbearing potential must be willing to follow protocol-specified contraception guidance starting at least one menstrual cycle before first study drug administration and continuing for up to 3 months after the end of systemic exposure of the study drug (that is, 3 months after end of study visit). Key Exclusion Criteria: - Current or recurrent/chronic disease (for example, cardiovascular, hematological, neurological, endocrine, immunological, rheumatological, renal, hepatic, or gastrointestinal (GI) or other conditions) that or could affect clinical assessments or clinical laboratory evaluations. - Current or relevant history of physical or psychiatric illness that are not stable or may require a change in treatment, use of prohibited therapies during the study or make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the study drug or study procedures. - Any other significant disease or disorder which, in the opinion of the Investigator, may put the participant at risk. - History of significant allergic reaction (for example, anaphylaxis or angioedema) to any product (for example, food, pharmaceutical). - Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of Alexion. - Use of non-prescription/ over-the-counter medications including vitamins and dietary or herbal supplements, within 7 days prior to dosing on Day 1. - Donated or lost 400 milliliters (mL) blood or more within the last 16 weeks preceding the first day of dosing.

All Japanese participants received a single dose of ALXN1840 15 mg in Dosing Period 1 and received a single dose of ALXN1840 60 mg in Dosing Period 2.

Bis(choline)tetrathiomolybdate

C[N+](C)(C)CCO.C[N+](C)(C)CCO.S=[Mo]=S.[SH-].[SH-]

NCT05736874

NCT05736874_EG000

No

All

Adult | Older Adult

Phase 3

Inclusion Criteria: Completed Informed Consent Age ≥ 30 years old Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell Exclusion Criteria: Prior diagnosis of COVID-19 infection (> 10 days from screening) Current or recent (within 10 days of screening) hospitalization Current use of study drug or study drug/device combination* Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo* Known contraindication(s) to study drug including prohibited concomitant medications* [*If only one study drug appendix is open at the time of enrollment. If multiple study drug appendices are open, a participant may opt-out of any study drug appendix or be excluded from any study drug appendix based on contraindications listed in the study drug appendix, current use of study drug, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study drug appendices.] Arm-specific exclusion criteria Severe hypersensitivity to milk proteins Currently prescribed or use within 30 days of inhaled or systemic steroids Moderate to severe hepatic impairment, defined as Child-Pugh B or C Nursing mothers Pregnancy

Fluticasone is a self-administered inhaled drug. Participants will self-administer 200 µg (1 blister) of fluticasone once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the study drug through the mouthpiece. Fluticasone: Fluticasone furoate is an inhaled powder drug product composed of fluticasone furoate. It is a synthetic trifluorinated corticosteroid that is insoluble in water. Fluticasone furoate is a white powder and will be provided in a two tone grey inhaler with a mouthpiece cover and separate foil blister strips. The inhaler will be packaged in a moisture-protective foil tray with a desiccant and a peelable lid.All packaging will be labeled to indicate that the product is for investigational use. Participants will self-administer 200 µg (1 blister) of fluticasone furoate once daily for 14 days.

FLUTICASONE FUROATE

[H][C@@]12C[C@@H](C)[C@](OC(=O)c3ccco3)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C

R01AD12 | R03AK10 | R03AL08 | R03BA09

NCT05740371

NCT05740371_EG000

No

All

Adult | Older Adult

Phase 4

Inclusion Criteria: Diagnosis of stable CAD or unstable angina (troponin negative, i.e. within the normal range for the study site) with low to moderate anatomic risk. Patient required elective percutaneous coronary angioplasty or stent insertion with an approved device in one or more de novo-treated or re-stenotic lesions in native vessels. Patient was on adequate platelet inhibition therapy after having received a loading dose with ASA and clopidogrel before start of intervention (this additional inclusion criterion was introduced with study protocol version 1.6, dated 14.12.2018) Willingness to give written informed consent, written consent for data protection (legal requirement in Germany "datenschutzrechtliche Einwilligung") and willingness to participate and to comply with the requirements of the study protocol. The patient (female/male) was at least 18 years of age. Baseline ECG without changes that impair assessment of QTc interval. Exclusion Criteria: Patient was indicated for highly complex 3-vessel intervention. The female patient was pregnant (exclusion by routine urine test) or was nursing during therapy period. Patients who were currently participating in another clinical trial or patients who participated in another clinical trial during the last 3 months prior to study start (date of treatment visit). History of drug, alcohol or chemical abuse within 6 months prior to study start. Planned surgical intervention other than study procedure within 7 days after study start. Any condition, which contraindicated the use of argatroban, or endangered the patient if he/she participated in this study. Factors influencing QTc interval: Marked baseline prolongation of QTc interval (repeated demonstration of a QTc interval > 450 ms at baseline ECG). A history of risk factors of Torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome). Known intraventricular conduction disturbance. Bradycardia: heart rate < 45 min-1. Electrolyte level outside normal range (according to laboratory's reference values). The use of concomitant medications that interfered with the QTc interval. Intake of digitalis within the last 2 weeks before study start. Acute myocardial infarction or troponin-positive unstable angina. Factors inhibiting use of argatroban in this study: Intolerance to ingredients of Argatra® (sorbitol). Known cirrhosis, hepatitis, clinically significant hepatic disorder at study start and/or history of clinically relevant hepatic disorder. Current hepatic disorder indicated by laboratory liver profile at screening: Bilirubin, AST/SGOT, ALT/SGPT, gammaGT > 3.0 times upper limit of the normal (ULN). Renal insufficiency indicated by laboratory renal profile at study start: GFR < 35 ml/min. Uncontrolled hypertension (defined as blood pressure >180/120 mmHg). If any form of heparin was taken prior to study start and aPTT ≥ 35 s. Intake of direct oral anticoagulants (DOAC) within 1 month prior to study start. If anticoagulants of type of vitamin K antagonists (VKA) were taken prior to study start and INR >1.2. Platelet count <125 x 109/l. Documented coagulation disorder or bleeding diathesis. Uncontrolled haemorrhage within the past 3 months. Uncontrolled peptic ulcer disease or gastrointestinal bleeding within the past 3 months. Cerebral aneurysm. Haemorrhagic stroke or ischaemic stroke in the past 6 months.

i.v. bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure.

Argatroban

CC1CNc2c(cccc2S(=O)(=O)N[C@@H](CCCNC(=N)N)C(=O)N2CC[C@@H](C)C[C@@H]2C(=O)O)C1

B01AE03

NCT05742841

NCT05742841_EG000

No

All

Adult | Older Adult

Phase 4

Inclusion Criteria: Emergency Department (ED) patients with chest pain 40-75 years old a low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL on an ED lipid panel or have known diabetes or Atherosclerotic Cardiovascular Disease (ASCVD) Exclusion Criteria: Subject unwilling to take study medication Pregnancy or breastfeeding Inability to take study medication or, in the opinion of the Investigators/subject's doctors unsuitable for study participation ST-Segment Elevation Myocardial Infarction (STEMI) Activation ST-Segment Depression >1 mm On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran) Unstable Vitals (Blood Pressure (BP) <90, Heart Rate (HR) >120 or <50, O2 sat <90%) Statin Intolerance High-sensitivity Troponin I ≥100 ng/L End-Stage Renal Disease (ESRD) and/or glomerular filtration rate (GFR) <30 mL/min/1.73 m2 Liver Cirrhosis Hospitalization Life Expectancy <1 Year Transfer from Another Hospital Prisoner Non-English Speaking

1) ordering a lipid panel during the index ED encounter and 30-days (+/- 5 business days) after ED discharge, 2) completion of the Pooled Cohort Equations by the patient's ED provider at the index visit, and 3) starting medical therapy (moderate- or high-intensity statin/ rosuvastatin) in the ED moderate- or high-intensity statin/ rosuvastatin: moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)

Rosuvastatin Calcium

CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1C=CC(O)CC(O)CC(=O)[O-].CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1C=CC(O)CC(O)CC(=O)[O-].[Ca+2]

NCT05780541

NCT05780541_EG000

No

All

Adult | Older Adult

Phase 3

Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Exclusion Criteria: Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure. Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (see Section H6.3.4). Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine. Pregnant women Nursing mothers Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 5 weeks of the study. Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 5 weeks of the study. Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism*. Prior to the initial futility assessment, which is performed when approximately 150 patients have been enrolled on PF-07304814 and 150 on placebo, patients with a history of deep vein thrombosis or pulmonary embolism will be excluded. These patients will be eligible for the trial if the initial futility assessment is passed by this agent, and if risk-benefit is favorable based on an assessment of available data that is reviewed by the independent DSMB. These data will include treatment comparisons of thromboembolic events and coagulation markers, and any additional data from studies carried out by Pfizer.

PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro. Remdesivir: Antiviral agent

PF-07304814

[H][C@@]1(C[C@H](NC(=O)[C@H](CC(C)C)NC(=O)c2cc3c(OC)cccc3[nH]2)C(=O)COP(=O)(O)O)CCNC1=O

NCT05803096

NCT05803096_EG000

Accepts Healthy Volunteers

Male

Adult | Older Adult

Phase 4

Inclusion Criteria: Biological male Aged 18 to 85 years Scheduled for clinically-indicated prostate needle biopsy Suitable for nitrous oxide/oxygen with willingness to be randomized to inhaled SANO or inhaled oxygen during the procedure Access to an email and computer Exclusion Criteria: Perioral facial hair impeding good mask seal Learning disabilities and/or inability to cognitively complete survey questions Taken a pre-procedure benzodiazepine or narcotic. Has any of the following medical conditions: Inner ear, bariatric or eye surgery within the last 2 weeks, Current emphysematous blebs, Severe B-12 deficiency. Bleomycin chemotherapy within the past year. Class III or higher heart failure. Undergoing novel therapy for prostate cancer

Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy. After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question "are you feeling the nitrous" and "are you happy at this level". The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.

NITROUS OXIDE

[N-]=[N+]=O

N01AX13 | N01AX63

NCT05890586

NCT05890586_EG000

No

All

Adult | Older Adult

Phase 3

Inclusion Criteria: Completed Informed Consent Age ≥ 30 years old Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell Exclusion Criteria: Prior diagnosis of COVID-19 infection (> 10 days from screening) Current or recent (within 10 days of screening) hospitalization Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo Known contraindication(s) to study drug including prohibited concomitant medications

Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days. Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.

Fluvoxamine

COCCCC/C(=N\OCCN)c1ccc(C(F)(F)F)cc1

N06AB08

NCT05894564

NCT05894564_EG000

No

All

Adult | Older Adult

Phase 3

Inclusion Criteria: Completed Informed Consent Age ≥ 30 years old Confirmed SARS-CoV-2 infection (or reinfection) by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell Exclusion Criteria: Prior diagnosis of COVID-19 infection (> 10 days from screening) Current or recent (within 10 days of screening) hospitalization Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo Known contraindication(s) to study drug including prohibited concomitant medications Additional Appendix-Level Exclusion Criteria Use of selective serotonin (or norepinephrine) reuptake inhibitors (SSRIs/SNRIs), including fluvoxamine, or monoamine oxidase inhibitors (MAOIs) within 2 weeks of consent including triptans and tryptophan. Use of fluoxetine within 45 days of consent. Co-administration of tizanidine, thioridazine, alosetron, pimozide, diazepam, ramelteon, linezolid Bipolar Disorder Nursing mothers Pregnancy

Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days. Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.

Fluvoxamine

COCCCC/C(=N\OCCN)c1ccc(C(F)(F)F)cc1

N06AB08

NCT06097676

NCT06097676_EG001

Accepts Healthy Volunteers

All

Adult

Phase 4

Inclusion Criteria: Provision of signed and dated informed consent form (ICF), Stated willingness to comply with all study procedures and availability for the duration of the study, Male or female, between 18 and 55 years of age, inclusive, Current nondependent, recreational drug user who has used sedative drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the subject's lifetime and at least once in the 12 weeks before screening, Body mass index (BMI) within 18.0 kg/m^2 to 36.0 kg/m^2, inclusive, If female, meets 1 of the following criteria: If of childbearing potential agrees to use 1 of the accepted contraceptive regimens from at least 30 days prior to the first study drug administration, during the study, and for at least 30 days after the last dose of the study drug. An acceptable method of contraception includes 1 of the following: Abstinence from heterosexual intercourse, Hormonal contraceptives (birth control pills, injectable/implantable/insertable hormonal birth control products, transdermal patch), Intrauterine device (IUD; with or without hormones), Or If of childbearing potential agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of study drug. Or If of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e., at least 1 year without menses without an alternative medical condition and confirmed follicle stimulating hormone (FSH) ≥ 40 milli-International unit/mL (mIU/mL) prior to the first study drug administration), If male and engaging in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication, a male who has a pregnant partner shall be excluded, Healthy, as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs or clinical laboratory (including hematology, clinical chemistry, urinalysis, and serology [screening visit only]) at screening visit and admission, as applicable, in the opinion of an investigator, Negative Coronavirus disease 2019 (Covid-19) test prior to each admission, as applicable. Exclusion Criteria: History of significant hepatic, renal, cardiovascular, pulmonary, hematologic, neurological, psychiatric, gastrointestinal, endocrine, immunologic, ophthalmologic, or dermatologic disease of any etiology (including infections), Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability with the exception that cholecystectomy is permitted at the discretion of an investigator, Presence of any significant respiratory illness or presence or history of chronic respiratory disease (e.g., upper respiratory illness, sleep apnea, emphysema, asthma) at screening (subjects with acute respiratory illness may be rescheduled upon resolution at the discretion of an investigator), Personal or family history (first degree relatives) of allergy, hypersensitivity, or drug rash with eosinophilia and systemic symptoms (DRESS) syndrome to gabapentin enacarbil, gabapentin or any drug product including anti-convulsants (e.g., alprazolam, carbamazepine) or related drugs (e.g., other benzodiazepines) or known excipients of any of the drug products in this study (e.g., lactose), History of sensitivity to or poor tolerance of gabapentin enacarbil, gabapentin, pregabalin, or alprazolam, Female who is lactating at screening, Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration or planning to become pregnant within 30 days following the last study drug administration, History of substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), and/or subject has been in a drug or alcohol rehabilitation program within the last 2 years, Subjects with positive urine drug screen (UDS) results at screening and admission will be assessed for inclusion at the discretion of an Investigator. If tetrahydrocannabinol (THC) is positive at admission to the Qualification phase and Treatment phase, as applicable, a cannabis intoxication evaluation will be done by an investigator and subjects may be permitted to continue in the study, rescheduled, or discontinued at the discretion of an investigator. Other positive test results should be reviewed to determine if the subject may be rescheduled, in the opinion of the investigator, Is a heavy smoker (>20 cigarettes per day or nicotine-equivalent) and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine-containing products for at least 1 hour before and 6 hours after study drug administration (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges), Regularly consumes excessive amounts of caffeine or xanthines within 30 days prior to screening, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day, History of suicidal ideation within 24 months or suicidal behaviour within 2 years of screening, showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS) administered at screening, or is currently at risk of suicide in the opinion of an investigator, Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment, Note: QT corrected according to Fridericia's formula (QTcF) interval of >450 msec in male subjects or >470 msec in female subjects will be exclusionary. The ECG may be repeated once for confirmatory purposes if the initial value obtained exceeds the limits specified, Has creatinine clearance ≤60 ml/min as calculated by the Cockcroft-Gault equation, Any history of tuberculosis, Positive screening results to human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) tests, Intake of an investigational product (IP) within 30 days or 5 times the half-life (whichever is longer) prior to screening, Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 30 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the subject as healthy, Use of over-the-counter (OTC) products (including herbal preparations and supplements) within 7 days prior to the first study drug administration, with the exception of ibuprofen or acetaminophen, Donation of plasma in the 7 days prior to screening, Blood donation (excluding plasma) of approximately 500 mL of blood in the 56 days prior to screening, Is, in the opinion of an investigator or designee, considered unsuitable or unlikely to comply with the study protocol for any reason, Poor venous access at screening, as judged by an investigator.

Alprazolam 2 mg: Oral dose of alprazolam 2 mg

Alprazolam

Cc1nnc2n1-c1ccc(Cl)cc1C(c1ccccc1)=NC2

N05BA12