anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Chloroprocaine
Trial phase: Early Phase 1
ATC code: N01BA04
SMILES: CCN(CC)CCOC(=O)c1ccc(N)cc1Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
Eligibility criteria:
Inclusion Criteria:

≥ 18 years of age for the mother
Singleton pregnancy
Gestation > 36 weeks
American Society of Anesthesiologist (ASA) class II
Provides written consent
Infant of mother

Exclusion Criteria:

Patient refusal
Non-elective or urgent/emergent cesarean sections
ASA class III or above
Unable to understand English
Significant back surgery or scoliosis
Known fetal abnormality
Weight > 120 kg
Height < 150 cm
Allergy to local anesthetics
Concurrent use of sulfonamides
Intervention: Indinavir
Trial phase: Phase 2
ATC code: J05AE02
SMILES: CC(C)(C)NC(=O)[C@@H]1CN(Cc2cccnc2)CCN1C[C@@H](O)C[C@@H](Cc1ccccc1)C(=O)N[C@H]1c2ccccc2C[C@H]1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.

Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients both sexes
Age between 30 and 60 years
Mild to moderate physical activity
Stable body weight for at least 12 weeks prior to the study
BMI 25.0 - 34.9 kg/m2
Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl
Informed consent signed

Exclusion Criteria:

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Previous treatment for glucose
Fasting glucose ≥250 mg/dL
Known uncontrolled renal, hepatic, heart or thyroid diseased
Hypersensibility to ingredients of intervention
Known allergies to bee stings or their derived products
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Intervention: Fitusiran
Trial phase: Phase 3
SMILES: CC(=O)NC1C(OCCCCC(=O)NCCCNC(=O)CCOCC(COCCC(=O)NCCCNC(=O)CCCCOC2OC(CO)C(O)C(O)C2NC(C)=O)(COCCC(=O)NCCCNC(=O)CCCCOC2OC(CO)C(O)C(O)C2NC(C)=O)NC(=O)CCCCCCCCCCC(=O)N2CC(O)CC2C)OC(CO)C(O)C1O
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Participants received Fitusiran 80 mg subcutaneously (SC) as prophylaxis once monthly from Day 1, along with the on-demand BPAs (per investigator's discretion and within bleeding dosing guidelines) for treatment of breakthrough bleeding episodes, up to a total of 9 months.
Eligibility criteria:
Inclusion Criteria:

Males, greater than or equal to (>=) 12 years of age.

Severe hemophilia A or B with inhibitors.

(Severity confirmed by a central laboratory where coagulation factor VIII (FVIII) level was less than (<)1% or factor IX (FIX) level was less than or equal to [<=]2% at Screening; Inhibitors defined as inhibitor titer of >=0.6 Bethesda units per milliliter [BU/mL] or as evidenced by medical records).
A minimum of 6 bleeding episodes requiring BPA treatment within the last 6 months prior to screening.
Willing and able to comply with the study requirements and to provide written informed consent and assent.

Exclusion Criteria:

Known co-existing bleeding disorders other than hemophilia A or B.
Antithrombin (AT) activity <60% at Screening.
Co-existing thrombophilic disorder.
Clinically significant liver disease.
Active hepatitis C virus infection.
HIV positive with a cluster of differentiation-4 count of <200 cells/microliter.
History of arterial or venous thromboembolism.
Inadequate renal function.
History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine.
History of intolerance to SC injection(s).
Any other conditions or comorbidities that would make the participant unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement.
Intervention: Mechlorethamine hydrochloride
Trial phase: Phase 2
SMILES: CN(CCCl)CCCl.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.

Valchlor: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Eligibility criteria:
Inclusion Criteria:

Male and female patients 18 years or older.
Biopsy proven diagnosis of Lichen Planopilaris
Biopsy proven diagnosis of Fontal Fibrosing Alopecia (a clinical variant of LPP restricted to frontal scalp)
Good general health as confirmed by medical history
Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
Patients who read and sign an approved informed consent for this study

Exclusion Criteria:

Vulnerable study population
Pregnant or nursing women
Women planning a pregnancy within the study period
Active smokers
Known history of adverse reaction to mechlorethamine
Use of systemic immunosuppressive
Presence of ulcerated scalp lesions
Intervention: NIACINAMIDE
Trial phase: Phase 2
ATC code: A11HA01
SMILES: NC(=O)c1cccnc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 23
Group description: All participants will receive study agent

nicotinamide: 2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday
Eligibility criteria:
Diagnosis and Inclusion Criteria

Maternal age 18-55 years
Singleton pregnancy with no known fetal anomalies

Early-onset preeclampsia OR early-onset severe gestational hypertension defined as:

Early-onset: between 24 weeks 0 days and -33 weeks 3 days, based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
Preeclampsia:
New onset hypertension and proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and > 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio >0.3;
New onset hypertension and NO proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and one or more of the following: serum creatinine >1.1 mg/dL or doubling from baseline ,or central nervous system symptoms or visual changes

Severe preeclampsia defined as new onset systolic BP > 160 mm Hg and/or diastolic BP > 105 with proteinuria as above or or without proteinuria and one or more of the following criteria listed above

Candidate for expectant management for at least 48 hours
Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery) for at least 48 hours;
Maternal liver function tests < 2x ULN
Maternal platelet count > 100,000 mm³
Planned expectant management
Pre-existing medical diseases such as hypertension, diabetes, endocrine disorders, gastrointestinal diseases, are well controlled
Fetal well-being established by estimated fetal weight > 5th %tile; normal amniotic fluid volume (MVP > 2 cm); normal Umbilical Artery (UA) Dopplers; or reactive Non Stress Test (NST) or Biophysical Profile (BPP) > 6
Delivery not anticipated within 48 hours of enrollment

Exclusion Criteria

Pre-existing renal disease (creatinine > 1.5 mg/dL)
Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV; Isoniazid (INH) use)
Eclampsia; cerebral edema on CT/MRI; headache unrelieved by analgesics
Evidence of liver dysfunction (LFTs > 2x ULN)
Thrombocytopenia (platelets < 100,000 mm³)
Pulmonary edema
HELLP syndrome
Evidence of fetal compromise: Estimated Fetal Weight (EFW) < 5th percentile; or BPP < 6; or absent or reverse diastolic UA blood flow; or oligohydramnios (MVP < 2 cm)
Placental abruption defined as unexplained vaginal bleeding
Preterm labor defined as regular contractions and cervical change
Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study
Any condition deemed by the investigator to require delivery within 48 hours
Intervention: NIACINAMIDE
Trial phase: Phase 2
ATC code: A11HA01
SMILES: NC(=O)c1cccnc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 23
Group description: All participants will receive study agent 1000 mg in single dose

nicotinamide: 1000 mg nicotinamide in morning
Eligibility criteria:
Diagnosis and Inclusion Criteria

Maternal age 18-55 years
Singleton pregnancy with no known fetal anomalies

Early-onset preeclampsia OR early-onset severe gestational hypertension defined as:

Early-onset: between 24 weeks 0 days and -33 weeks 3 days, based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
Preeclampsia:
New onset hypertension and proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and > 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio >0.3;
New onset hypertension and NO proteinuria, with systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart and one or more of the following: serum creatinine >1.1 mg/dL or doubling from baseline ,or central nervous system symptoms or visual changes

Severe preeclampsia defined as new onset systolic BP > 160 mm Hg and/or diastolic BP > 105 with proteinuria as above or or without proteinuria and one or more of the following criteria listed above

Candidate for expectant management for at least 48 hours
Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery) for at least 48 hours;
Maternal liver function tests < 2x ULN
Maternal platelet count > 100,000 mm³
Planned expectant management
Pre-existing medical diseases such as hypertension, diabetes, endocrine disorders, gastrointestinal diseases, are well controlled
Fetal well-being established by estimated fetal weight > 5th %tile; normal amniotic fluid volume (MVP > 2 cm); normal Umbilical Artery (UA) Dopplers; or reactive Non Stress Test (NST) or Biophysical Profile (BPP) > 6
Delivery not anticipated within 48 hours of enrollment

Exclusion Criteria

Pre-existing renal disease (creatinine > 1.5 mg/dL)
Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV; Isoniazid (INH) use)
Eclampsia; cerebral edema on CT/MRI; headache unrelieved by analgesics
Evidence of liver dysfunction (LFTs > 2x ULN)
Thrombocytopenia (platelets < 100,000 mm³)
Pulmonary edema
HELLP syndrome
Evidence of fetal compromise: Estimated Fetal Weight (EFW) < 5th percentile; or BPP < 6; or absent or reverse diastolic UA blood flow; or oligohydramnios (MVP < 2 cm)
Placental abruption defined as unexplained vaginal bleeding
Preterm labor defined as regular contractions and cervical change
Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study
Any condition deemed by the investigator to require delivery within 48 hours
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Participants received AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants received AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version
At least 3 IED days (at least 1 IED episode each day, as recorded by the participant) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator
Score ≥ 12 on the Life History of Aggression scale at screening
Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and baseline
Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening and baseline

Exclusion Criteria:

Diagnosis of major depressive disorder within 6 months of screening
Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 score ≥ 10 at screening
Met only the DSM-5 A2 criterion for IED
Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)
Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)
Intervention: Zepatier
Trial phase: Phase 4
ATC code: J05AP54
SMILES: C=CC1CC1(NC(=O)C1CC2CN1C(=O)C(C(C)(C)C)NC(=O)OC1CC1CCCCCc1nc3ccc(OC)cc3nc1O2)C(=O)NS(=O)(=O)C1CC1.COC(=O)NC(C(=O)N1CCCC1c1ncc(-c2ccc3c(c2)cc2n3C(c3ccccc3)Oc3cc(C4=NC(C5CCCN5C(=O)C(NC(=O)OC)C(C)C)N=C4)ccc3-2)[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks

EBR/GZR: Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

20 yeas or more
Male or female
Body mass index (BMI) 18.5-35.0 kg/m2

Chronic HCV infection, defined as patients who meet as least one of the two following criteria:

Anti-HCV antibody (Abbott HCV EIA 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) or HCV RNA > 1,000 IU/mL for at least 6 months before screening
Positive HCV RNA > 1,0000 IU/mL (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, low limit of quantification (LLOQ): 25 IU/mL) at the time of screening with a liver biopsy consistent with chronic HCV infection
HCV genotype 1 (HCV GT-1b) infection (Abbott RealTime HCV genotype II, Abbott Molecular Inc. Illinois, USA)
Treatment-naïve or treatment-experienced (including patients who relapsed, who had virological breakthrough, or who were null-responsive to IFN-based therapies)
HCV RNA > 10,000 IU/mL at screening
Estimated glomerular filtration (eGFR) rate < 15 mL/min/1.73m2 as assessed by modified of diet in renal disease (MDRD) equation, and receiving regular hemodialysis

Exclusion Criteria:

HCV infection other than HCV GT-1b
HBV or HIV coinfection
Presence of decompensated cirrhosis (Child-Pugh class B or C)

Any primary cause of liver disease other than chronic HCV infection, including but not limited to the following

Hemochromatosis
Alfa-1 antitrypsin deficiency
Wilson's disease
Autoimmune hepatitis
Alcoholic liver disease
Drug-induced hepatitis

Screening laboratory analyses showing any of the following results

Hemoglobin (Hb) level < 10 g/dL
Absolute neutrophil count (ANC) < 1,500 cells/μL
Platelet count < 70,000 cells/mm3
International normalized ratio (INR) > 2.0
Albumin (Alb)< 3.0 g/dL
Bilirubin (Bil) > 2.0 mg/dL
Alanine aminotransferase (ALT) > 10X upper limit of normal (ULN)
Aspartate aminotransferase (AST) > 10X upper limit of normal (ULN)
Serum alfa-fetoprotein (AFP) > 100 ng/mL
Presence of hepatocellular carcinoma (HCC) on imaging studies such as computed tomography (CT) scan or magnetic resonance imaging (MRI)
History of malignancy (except cutaneous melanoma) within 5 years at the screening
Organ transplantation other than cornea and hair (prior renal transplantation with graft failure not included)
Prior exposure to investigational agents for HCV (direct acting antiviral agents, host-targeting agents, or therapeutic vaccines)
Pregnancy
Unwilling to have contraception during the study period
Unwilling to provide informed consent
Intervention: Relamorelin
Trial phase: Phase 3
SMILES: NC(=O)C1(NC(=O)[C@H](Cc2ccccc2)NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@@H](Cc2csc3ccccc23)NC(=O)C2CCNCC2)CCNCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 231
Group description: Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks.
Eligibility criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:
Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:
Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease
Intervention: Relamorelin
Trial phase: Phase 3
SMILES: NC(=O)C1(NC(=O)[C@H](Cc2ccccc2)NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@@H](Cc2csc3ccccc23)NC(=O)C2CCNCC2)CCNCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
Eligibility criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:
Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:
Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease
Intervention: TEPILAMIDE FUMARATE
Trial phase: Phase 2
SMILES: CCN(CC)C(=O)COC(=O)/C=C/C(=O)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Tepilamide Fumarate 600 mg twice per day

PPC-06 600 mg: Tepilamide Fumarate tablets 600 mg twice per day
Eligibility criteria:
Inclusion Criteria:

Generally healthy males or non-pregnant females age ≥18 years at the time of screening (or who have reached the state minimum legal age of consent).
Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator or as reported by the subject).

Severity of disease meeting all 3 of the following criteria prior to randomization (at the Baseline [Day 0] visit):

PASI score of ≥12
Total body surface area (BSA) affected by plaque psoriasis of ≥10%
IGA score of >3
Must be a candidate for phototherapy and/or systemic therapy for psoriasis.

Exclusion Criteria:

Subjects with non-plaque psoriasis (ie, predominantly inverse, erythrodermic, predominantly guttate, or pustular psoriasis).
Subjects with drug-induced psoriasis or subjects with drug-exacerbated psoriasis that has not resolved within 4 weeks prior to screening.
Subjects who have received systemic non-biologic psoriasis therapy or phototherapy (including either oral and topical psoralen and ultraviolet A (PUVA) light therapy, ultraviolet B, or self-treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to the Baseline Visit.
Subjects who had topical psoriasis treatment within the previous 2 weeks prior to the Baseline Visit.

Subjects with history of concurrent or recent use of any biologic agent within the following washout periods prior to baseline visit:

Etanercept - 35 days
Infliximab, adalimumab - 12 weeks
Ustekinumab - 24 weeks
Any other biologic agent <5 half-lives prior to the Baseline Visit
Subjects with history of use of any investigational drug within 28 days prior to randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives (whichever is longer).