anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Clascoterone
Trial phase: Phase 2
ATC code: D10AX06
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(=O)CC)C(=O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: high dose of CB-03-01, 1% applied twice a day

CB-03-01: Topical cream, applied twice a day
Eligibility criteria:
Inclusion Criteria:

Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
Subject has provided written and verbal informed consent/assent.
Subject has facial acne vulgaris (including the nose).
Subject is willing to comply with study instructions and return to the clinic for required visits.
Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial

Subject has used any of the following topical anti-acne preparations or procedures on the face:

Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.

Subject has used the following systemic anti-acne medications:

Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
Retinoid therapy within six months of the initiation of treatment.
Intervention: Propranolol
Trial phase: Phase 4
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation

Propranolol: 40mg single pill
Eligibility criteria:
Inclusion Criteria:

Age 18-35
Top half of the normal human distribution of the Spider Phobia Questionnaire-15

Exclusion Criteria:'

Any criteria for diagnosable spider phobia
Any current Axis I mental disorder on the Structured Clinical Interview for DSM-IV (SCID)
Presence of drugs of abuse (e.g. opiates, marijuana, cocaine, or amphetamines) per urine screen
Non-English speaking (due to lack of validated questionnaires/instruments in other languages)
Intervention: OXYTOCIN
Trial phase: Phase 4
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.

Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril
Eligibility criteria:
Inclusion Criteria:

Age 18-35
Top half of the normal human distribution of the Spider Phobia Questionnaire-15

Exclusion Criteria:'

Any criteria for diagnosable spider phobia
Any current Axis I mental disorder on the Structured Clinical Interview for DSM-IV (SCID)
Presence of drugs of abuse (e.g. opiates, marijuana, cocaine, or amphetamines) per urine screen
Non-English speaking (due to lack of validated questionnaires/instruments in other languages)
Intervention: Metoclopramide
Trial phase: Not Applicable
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.

metoclopramide: 1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.
Eligibility criteria:
Inclusion Criteria:

Patients 18 years - 70 years old, male or female, belonging to any race or ethnic origin.
Patients necessitating video capsule endoscopy.
Patients who are willing and competent to sign an informed consent and to comply with study related visits and procedures.

Exclusion Criteria:

Patients below the age of 18 or greater than 70 years old.
Pregnant patients
Patients with a documented history of Parkinson's Disease or Parkinsonian Symptoms, Tardive Dyskinesia, history of neuroleptic malignant syndrome, history or seizure disorder.
Patients who are currently taking antipsychotic medications including typical and atypical antipsychotics.
Patients taking other drugs that may cause extrapyramidal reactions.
Patients with a history of cirrhosis or congestive heart failure.
Patients with a history of depression.
Patients with uncontrolled hypertension.
Patients with renal impairment, creatinine clearance < 40ml/minute.
Patients who have massive gastrointestinal hemorrhage, mechanical obstruction, or perforation.
Patients with a known history of pheochromocytoma, as this may precipitate hypertensive crisis.
Patients with a known sensitivity or intolerance to metoclopramide.
Patients who, in the investigator's opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study.
Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest.
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Gabapentine

Gabapentine: Gabapentine 600 mg 01 dose
Eligibility criteria:
Inclusion Criteria:

carpal tunnel syndrome

Exclusion Criteria:

disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant
Intervention: Calcitriol
Trial phase: Phase 4
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.

1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
Eligibility criteria:
Inclusion Criteria:

Patients with age between 18-75 years.
Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder.

Exclusion Criteria:

Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
New fracture in last 3 months.
Active system immunity diseases.
History of liver failure
History of intestinal malabsorption or chronic diarrhea
Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
Primary hyperparathyroidism
Treatment with cinacalcet or other calcimimetic within the past 6 months
Anticipated dialysis within 6 months after randomization
Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
Current treatment with vitamin D 50,000 IU
Using glucocorticoid or immunosuppressive agents.
Acute renal dysfunction.
The expected live time is less than 2 years.
Pregnant or lactating woman.
Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Intervention: Apremilast
Trial phase: Phase 1
ATC code: L04AA32
SMILES: CCOc1cc([C@@H](CS(C)(=O)=O)N2C(=O)c3cccc(NC(C)=O)c3C2=O)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.
Eligibility criteria:
Inclusion Criteria:

Inclusion Criteria for elderly group

Healthy male or female subjects of any ethnic origin between ages of 65 and 85 inclusive with a body mass index (BMI) between 18 and 35.
Females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).
Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
Elderly subjects with stable, chronic medical condition may be eligible if the condition is well-controlled and medications do not interfere with study procedures or pharmacokinetic interpretation

Inclusion Criteria for younger group:

Healthy male or female of any ethnic origin between the ages of 18 and 55 inclusive with a BMI between 18 and 35.
Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.

Females who are able to become pregnant have a negative pregnancy test at screening and baseline, and must agree to use one of the following:

a highly effective form of contraception (ex. Non-oral hormonal, intrauterine device) OR
oral hormonal contraceptive plus one additional form of barrier contraception OR
two forms of barrier contraception These must be effective by the time of screening. For younger females who are not able to become pregnant, the conditions for the elderly females will apply.

Exclusion Criteria:

Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent form, places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Subjects with known serum hepatitis, is a known carrier of hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
Subjects who have used prescription systemic or topical medications within 30 days of dosing, unless it is being used to treat a stable, chronic medical condition. This includes medication that is an inhibitor or inducer of P-glycoprotein transporter and CYP-3A4/5 used within 14 days of dosing.
Intervention: Apremilast
Trial phase: Phase 1
ATC code: L04AA32
SMILES: CCOc1cc([C@@H](CS(C)(=O)=O)N2C(=O)c3cccc(NC(C)=O)c3C2=O)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
Eligibility criteria:
Inclusion Criteria:

Inclusion Criteria for elderly group

Healthy male or female subjects of any ethnic origin between ages of 65 and 85 inclusive with a body mass index (BMI) between 18 and 35.
Females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).
Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
Elderly subjects with stable, chronic medical condition may be eligible if the condition is well-controlled and medications do not interfere with study procedures or pharmacokinetic interpretation

Inclusion Criteria for younger group:

Healthy male or female of any ethnic origin between the ages of 18 and 55 inclusive with a BMI between 18 and 35.
Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.

Females who are able to become pregnant have a negative pregnancy test at screening and baseline, and must agree to use one of the following:

a highly effective form of contraception (ex. Non-oral hormonal, intrauterine device) OR
oral hormonal contraceptive plus one additional form of barrier contraception OR
two forms of barrier contraception These must be effective by the time of screening. For younger females who are not able to become pregnant, the conditions for the elderly females will apply.

Exclusion Criteria:

Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent form, places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Subjects with known serum hepatitis, is a known carrier of hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
Subjects who have used prescription systemic or topical medications within 30 days of dosing, unless it is being used to treat a stable, chronic medical condition. This includes medication that is an inhibitor or inducer of P-glycoprotein transporter and CYP-3A4/5 used within 14 days of dosing.
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 130
Group description: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.

Route of administration: intravenous

Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.

Route of administration: intravenous
Eligibility criteria:
Inclusion Criteria:

Clinical candidate for labor induction utilizing either misoprostol or oxytocin
Greater than or equal to 18 years of age
Multiparous
Singleton gestation;
Greater than 37 weeks gestation;
Cephalic presentation

Exclusion Criteria:

Any clinical contraindication to misoprostol as induction drug
Age less than 18 years
Contraindication to vaginal birth
Nonreassuring fetal heart rate tracing
Prior uterine surgery
Active labor
Active maternal bleeding
Chorioamnionitis (infection)
Intervention: Calcitriol
Trial phase: Not Applicable
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.

Calcitriol: Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Type-Two Diabetes (treated with diet alone, with oral hypoglycemic agents, or with a single injection of basal insulin daily)
Normal blood pressure, or Mild (Stage 1) Hypertension that is either untreated, or adequately treated with a single anti-hypertensive drug.
Age >18 years and <70 years
Estimated GFR > 60ml/min
Normal laboratory values for: Complete blood count, sodium, potassium, glucose, liver enzymes, urinalysis
Electrocardiogram without any signs of prior infarction, ventricular conduction abnormality, or supraventricular arrhythmia.

Exclusion Criteria:

Chronic Kidney Disease or eGFR<60
History of nephrolithiasis (kidney stones)
Multiple (more than one) insulin injections daily (since insulin can alter the RAS)
Poorly controlled type 2 diabetes (That may require more aggressive therapy) as defined by an HbA1c>8.5%
Type 1 diabetes
Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs by a physician.
The use of prescribed doses of potassium supplements.
History of liver failure
History of parathyroid or granulomatous disorders
History of heart failure, cerebrovascular disease or coronary heart disease
History of known microvascular complications of diabetes (including retinopathy, neuropathy, nephropathy)
Illness requiring overnight hospitalization in the past 6 months
Active tobacco or recreational drug use
Pregnancy or current breast feeding
Intervention: Dinoprostone
Trial phase: Phase 3
ATC code: G02AD02
SMILES: CCCCC[C@H](O)/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1C/C=C\CCCC(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
Eligibility criteria:
Inclusion Criteria:

Gestational age 37 weeks or more
Singleton pregnancy
Cephalic presentation.

Exclusion Criteria:

Previous cesarean section
Any contraindication for vaginal delivery
Suspected Cephalo-Pelvic Disproportion
Unexplained antepartum Hemorrhage
Intervention: Dinoprostone
Trial phase: Phase 3
ATC code: G02AD02
SMILES: CCCCC[C@H](O)/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1C/C=C\CCCC(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 100
Group description: PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Eligibility criteria:
Inclusion Criteria:

Gestational age 37 weeks or more
Singleton pregnancy
Cephalic presentation.

Exclusion Criteria:

Previous cesarean section
Any contraindication for vaginal delivery
Suspected Cephalo-Pelvic Disproportion
Unexplained antepartum Hemorrhage
Intervention: Mifepristone
Trial phase: Not Applicable
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion

Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure
Eligibility criteria:
Inclusion Criteria:

Age greater or equal to 18 years
Fluency in English or Spanish
Intrauterine pregnancy between 11 0/7 and 15 0/7 on the day of the abortion procedure
Desire for pregnancy termination
Ability to return for abortion procedure 24-48 hours after the preoperative visit

Exclusion Criteria:

Allergy or contraindication to study agents
Requirement of general anesthesia to perform the abortion
Diagnosis of missed abortion, spontaneous abortion, incomplete abortion, or threatened abortion at time of initial preoperative evaluation
Intervention: Everolimus
Trial phase: Phase 3
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
Eligibility criteria:
Inclusion Criteria:

recipient of deceased or living donor kidney transplant
Age 18-75 years (inclusive)
Male or female
renal allograft dysfunction/deterioration evidenced by glomerular filtration rate (GFR) less than or equal to 35
Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 5 years of enrollment
Willing and able to provide informed consent for study participation

Exclusion Criteria:

Prior solid organ transplant (other than kidney)
History of donor-specific antibody
History of biopsy-proven acute rejection within 1 year prior to enrollment
Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio
Evidence of Hepatitis C virus infection (antibody positive or polymerase chain reaction(PCR) positive)
Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment
Subjects receiving belatacept (Nulojix)
Pregnant or nursing (lactating) women
Women of child-bearing potential (WOCBP) who are unwilling or unable to use two birth-control methods throughout participation in the study