anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Propranolol
Trial phase: Phase 2
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).

Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
Eligibility criteria:
Inclusion:

Diagnostic criteria for TMD: Group II, Masticatory Muscle Disorders, Myalgia
Facial pain for at least 3 months (and at least 10 of the last 30 days at Visit 0)
Average pain intensity rating ≥30 (0-100 numeric rating scale) over the past week or average daily pain intensity rating ≥30 on the same scale on at least 3 days over the past week
Agrees to terms for continuing/discontinuing certain prescription/over-the-counter pain medications throughout participation
Agrees to not commence new prescription medication, injection therapy, occlusal splint therapy or certain other pain management techniques throughout participation
Agrees to limit consumption of alcohol to no more than 7 drinks/week (females) and no more than 14 drinks/week (males) throughout participation
If a female of childbearing potential, agrees to use of contraception (licensed hormonal method, intrauterine device, condoms with contraceptive foam, abstinence, or partner vasectomy) throughout participation
Able to understand and comply with study procedures and provide written informed consent

Exclusion:

History of congestive heart failure or certain cardiac conditions including coronary artery disease, uncontrolled hypertension, or hypotension
Bronchial asthma, nonallergic bronchospasm, renal failure or dialysis, diabetes mellitus, hyperthyroidism, fibromyalgia, or uncontrolled seizures
Currently taking a β-blocker or certain other medications including haloperidol, intravenous verapamil, or reserpine
Currently taking an opioid medication
Daily prescription medication, occlusal splint therapy, or an investigational drug or treatment for pain management within past 30 days
Injection therapy or certain other pain management techniques within last 2 weeks
Facial trauma or orofacial surgery within past 6 weeks
Active orthodontic treatment
History of major depression or other psychiatric disorder requiring hospitalization within past 6 months
Treatment for drug or alcohol abuse within the last year
Smokes 25 or more cigarettes/day
Currently receiving chemotherapy or radiation therapy
Pregnant or breastfeeding
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.

Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
Eligibility criteria:
Inclusion Criteria:

Age between 18-60 year-old
American Society of Anesthesiology(ASA) status I~II
Elective craniotomy patients with supratentorial eloquent glioma diagnosed by MRI (In control group: volunteers without neuro-diseases)

Exclusion Criteria:

Unable to comprehend and cooperate with the neurologic examination
Impaired mental status
Taking sedative drugs in the past 24 hours
Taking pain reliever in the past 24 hours
Drug and/or alcohol abuse
Pregnant and/o lactating women
Recurrent brain tumors
Multiple brain tumors
Accepting radiotherapy or chemotherapy
Complicated with intracranial trauma and vascular diseases
Complicated with grand mal epilepsy ( in midazolam group)
Complicated with neuromuscular diseases
Complicated with cutaneous paresthesia
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.

Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
Eligibility criteria:
Inclusion Criteria:

Age between 18-60 year-old
American Society of Anesthesiology(ASA) status I~II
Elective craniotomy patients with supratentorial eloquent glioma diagnosed by MRI (In control group: volunteers without neuro-diseases)

Exclusion Criteria:

Unable to comprehend and cooperate with the neurologic examination
Impaired mental status
Taking sedative drugs in the past 24 hours
Taking pain reliever in the past 24 hours
Drug and/or alcohol abuse
Pregnant and/o lactating women
Recurrent brain tumors
Multiple brain tumors
Accepting radiotherapy or chemotherapy
Complicated with intracranial trauma and vascular diseases
Complicated with grand mal epilepsy ( in midazolam group)
Complicated with neuromuscular diseases
Complicated with cutaneous paresthesia
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 50
Group description: Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
Eligibility criteria:
Inclusion Criteria:

age 10-17 years
scheduled for elective laparoscopic appendectomy
weight >/=34kg
complete postoperative questionnaires.

Exclusion Criteria:

patients younger than 10 years and 18 years or older
weight < 34 kg
weight >/=100 kg
patient and family refusal
non-English-speaking patients and families
cognitive impairment
developmental delay
allergies to medications used in the study (hydromorphone, oxycodone, acetaminophen, ketorolac, ropivacaine, and clonidine)
need for opioids via patient controlled analgesia device
patients with a positive pregnancy test
local infection at planned injection sites
patients with failed rectus sheath blocks
patients that require opioids via patient controlled analgesia device
patients with laparoscopic procedure converted to open
patients that will not be able to place the time of return to normal sensation within 1 hour of its occurrence
patients with no follow up possible
the patients that will be discharged home before the resolution on paresthesia will be excluded from analysis of the first aim.
Intervention: Pregnenolone
Trial phase: Phase 2
SMILES: [H][C@@]12CC=C3C[C@@H](O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication
Eligibility criteria:
General Inclusion / Exclusion Criteria Inclusion Criteria

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must meet DSM-5 criteria for current cannabis use disorder (within the past three months). While individuals may endorse use of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for any other substance use disorder (except nicotine) within the last 60 days. Due to the high comorbidity of marijuana and alcohol use disorder, subjects who meet criteria for mild alcohol use disorder will be included.
Subjects must consent to remain abstinent from alcohol for 24 hours and other drugs of abuse (except nicotine and marijuana) for three days immediately prior to the study visit. Subjects must abstain from marijuana for 24 hours prior to the study visit. By restricting marijuana use as proposed, subjects should not be under the acute effects of marijuana.
Subjects must consent to random assignment.

Exclusion Criteria

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Individuals taking exogenous gonadal steroids including estrogens, progestins and testosterone. This includes hormonal contraception and replacement therapy.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, neurological disease including diabetes or cancer, as these conditions may affect study outcomes.
Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
Subjects taking any psychotropic medications, including SRI's or other antidepressants, opiates or opiate antagonists because these may affect test response. Individuals who take stimulants for treatment of ADHD will be allowed to participate.
Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
Subjects who are unwilling or unable to maintain abstinence from alcohol and marijuana for 24 hours and other drugs of abuse (except nicotine) for three days prior to the study visit.
Subjects meeting DSM-5 criteria for a substance use disorder (other than nicotine, marijuana, or alcohol) within the past 60 days.
Intervention: Bombesin (68Ga)
Trial phase: Phase 2
SMILES: CC(C)CC(NC(=O)CC(O)C(CC(C)C)NC(=O)C(Cc1cnc[nH]1)NC(=O)CNC(=O)C(NC(=O)C(C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(Cc1ccccc1)NC(=O)CN1CCC(NC(=O)CN2CCN(CC(=O)[O-])CCN(CC(=O)[O-])CCN(CC(=O)[O-])CC2)CC1)C(C)C)C(N)=O.[Ga+3]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Eligibility criteria:
INCLUSION CRITERIA

Provides written informed consent
Known diagnosis of prostate cancer
Patient has suspected recurrence based on biochemical data [prostate-specific antigen (PSA) > 2 ng/mL]
Able to remain still for duration of each imaging procedure (about one hour)

EXCLUSION CRITERIA

Unable to provide informed consent
Inability to lie still for the entire imaging time
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Metallic implants
Intervention: ALENDRONIC ACID
Trial phase: Not Applicable
ATC code: M05BA04 | M05BB03 | M05BB05 | M05BB06
SMILES: NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: High turnover osteoporosis group treated with alendronate.

Alendronate
Eligibility criteria:
Inclusion Criteria:

Aged 21 years or older;
Chronic maintenance dialysis of at least 3 months' duration;
Osteoporotic by DXA of either spine or total hip (Women: post-menopausal or age ≥ 50 with T-score ≤ -2.5; Men: age ≥ 50 with T-score ≤ -2.5; All others, Z-score ≤ -2.5);
Mental competence;
Willingness to participate in the study;
Normal serum calcium.

Exclusion Criteria:

Pregnancy or breast feeding;
Incarceration;
Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
Chronic alcoholism and/or drug addiction;
Known Paget 's disease of bone;
Prior external beam or implant radiation therapy involving the skeleton;
More than 3 computed tomography (CT) scans in the prior 12 months (to avoid excessive radiation exposure);
Participation in a study of an investigational drug during the past 90 days;
Planning to move out of the area within 1 year of the study;
On active transplant list;
BMD t-score of the radius less than -3.5 by DXA (to avoid the known potential negative effects of teriparatide treatment on BMD of the radius);
Planned or anticipated oral surgery within the next 12 months;
Inability to stand or sit upright for at least 30 minutes;
Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia;
Treatment within last 6 months with drugs that may affect bone metabolism including bisphosphonates and teriparatide (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics);
Current treatment with medicines containing digoxin or warfarin;
Calcidiol level below the normal range. (The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.)
Intervention: Deferiprone
Trial phase: Phase 1
ATC code: V03AC02
SMILES: Cc1c(O)c(=O)ccn1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast

Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation
Eligibility criteria:
Inclusion Criteria:

Male or female aged ≥18 to <50 years
A female volunteer of childbearing potential must agree to use an accepted contraceptive regimen from at least 28 days prior to the first administration of the study drug until at least 30 days after the last dose of the study drug
A sexually active male must agree that he and/or his female partner will use a medically acceptable method of contraception throughout the study and for at least 30 days following drug administration
Body mass index (BMI) greater than or equal to 18.5 kg/m^2 and below 30.0 kg/m^2
Non- or ex smoker
Clinical laboratory values within the laboratory's stated normal range; if not within this range, an abnormal value must be without any clinical significance
Have no clinically significant diseases captured in the medical history, or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, coagulation, ECG, and urinalysis)

Exclusion Criteria:

Pregnant or breastfeeding
Absolute neutrophil count (ANC) < 1.8 x 109/L at screening (no repeat can be performed)
History of significant hypersensitivity to deferiprone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (such as angioedema) to any drugs
History or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
Presence of out-of-range cardiac interval (PR < 110 msec, PR > 220 msec, QRS < 60 msec, QRS >119 msec and QTcF > 450 msec for males and > 460 msec for females) on the screening ECG or other clinically significant ECG abnormalities
Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Any clinically significant illness in the previous 28 days before Day 1 of this study
Serum ferritin value below the normal limit of the reference laboratory at screening
Positive urine screening of alcohol and/or drugs of abuse
Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
Intervention: Deferiprone
Trial phase: Phase 1
ATC code: V03AC02
SMILES: Cc1c(O)c(=O)ccn1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast

Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation
Eligibility criteria:
Inclusion Criteria:

Male or female aged ≥18 to <50 years
A female volunteer of childbearing potential must agree to use an accepted contraceptive regimen from at least 28 days prior to the first administration of the study drug until at least 30 days after the last dose of the study drug
A sexually active male must agree that he and/or his female partner will use a medically acceptable method of contraception throughout the study and for at least 30 days following drug administration
Body mass index (BMI) greater than or equal to 18.5 kg/m^2 and below 30.0 kg/m^2
Non- or ex smoker
Clinical laboratory values within the laboratory's stated normal range; if not within this range, an abnormal value must be without any clinical significance
Have no clinically significant diseases captured in the medical history, or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, coagulation, ECG, and urinalysis)

Exclusion Criteria:

Pregnant or breastfeeding
Absolute neutrophil count (ANC) < 1.8 x 109/L at screening (no repeat can be performed)
History of significant hypersensitivity to deferiprone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (such as angioedema) to any drugs
History or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
Presence of out-of-range cardiac interval (PR < 110 msec, PR > 220 msec, QRS < 60 msec, QRS >119 msec and QTcF > 450 msec for males and > 460 msec for females) on the screening ECG or other clinically significant ECG abnormalities
Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Any clinically significant illness in the previous 28 days before Day 1 of this study
Serum ferritin value below the normal limit of the reference laboratory at screening
Positive urine screening of alcohol and/or drugs of abuse
Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
Intervention: Deferiprone
Trial phase: Phase 1
ATC code: V03AC02
SMILES: Cc1c(O)c(=O)ccn1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast

Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation
Eligibility criteria:
Inclusion Criteria:

Male or female aged ≥18 to <50 years
A female volunteer of childbearing potential must agree to use an accepted contraceptive regimen from at least 28 days prior to the first administration of the study drug until at least 30 days after the last dose of the study drug
A sexually active male must agree that he and/or his female partner will use a medically acceptable method of contraception throughout the study and for at least 30 days following drug administration
Body mass index (BMI) greater than or equal to 18.5 kg/m^2 and below 30.0 kg/m^2
Non- or ex smoker
Clinical laboratory values within the laboratory's stated normal range; if not within this range, an abnormal value must be without any clinical significance
Have no clinically significant diseases captured in the medical history, or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, coagulation, ECG, and urinalysis)

Exclusion Criteria:

Pregnant or breastfeeding
Absolute neutrophil count (ANC) < 1.8 x 109/L at screening (no repeat can be performed)
History of significant hypersensitivity to deferiprone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (such as angioedema) to any drugs
History or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
Presence of out-of-range cardiac interval (PR < 110 msec, PR > 220 msec, QRS < 60 msec, QRS >119 msec and QTcF > 450 msec for males and > 460 msec for females) on the screening ECG or other clinically significant ECG abnormalities
Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Any clinically significant illness in the previous 28 days before Day 1 of this study
Serum ferritin value below the normal limit of the reference laboratory at screening
Positive urine screening of alcohol and/or drugs of abuse
Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
Intervention: Pitavastatin
Trial phase: Phase 4
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Treatment A = administration pitavastatin for 12 weeks
Eligibility criteria:
Inclusion Criteria:

aged ≥18 years
able to provide informed consent
had confirmed HIV infection
on ART including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that were not changed within 12 weeks before the randomization
patients who had cholesterol level between 200 and 500 and LDL between 130 and 400 mg/dL without any lipid-lowering agent or discontinued the lipid-lowering agent at least 1 month prior to randomization

Exclusion Criteria:

had the history of pitavastatin and/or the constituent of the drugs allergy
known history of myocardial infarction and/or ischemic stroke within 1 month prior to the randomization that would be endangered if we stopped the previous lipid-lowering agent before the enrollment
abnormal AST and ALT with level ≥5 times in asymptomatic patients or ≥3 times of upper normal limit (UNL) in symptomatic patients
pregnancy or breastfeeding
on cyclosporine which had major drug interactions with pitavastatin
patients who denied to join the study