anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Clopidogrel
Trial phase: Phase 1
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 82
Group description: Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
Eligibility criteria:
Inclusion Criteria:

Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture.

Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating and

• if of non child-bearing potential, confirmed at screening by fulfilling one of the following criteria:

Post-menopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post-menopausal range.

Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

• if of child-bearing potential and are sexually active must use, with their partner, 2 approved methods of highly effective contraception from the time of IMP administration until 3 months after the last dose of IMP.

Have a body mass index between 18,5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Be able to understand, read and speak the German language.

Exclusion criteria

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.
Current smokers or those who have smoked or used nicotine products within the previous 3 months.
History of haemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the Investigator.
Use of aspirin, ibuprofen, NSAIDS, or any other drug known to increase the propensity for bleeding for 2 weeks before randomisation.
Intervention: Daptomycin
Trial phase: Not Applicable
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 190
Group description: Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline

Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age and older;
Open pancreatoduodenectomy for any diagnosis

Exclusion Criteria:

Pregnant;
Prisoners;
Patients undergoing concomitant colectomy;
Antibiotic allergy to study medication;
Serum creatinine > 2.0;
Unable to provide informed consent
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: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Calcitriol 3 mcg/g Ointment
Eligibility criteria:
Inclusion Criteria:

Male or female 2 to 12 years of age
Clinical diagnosis of stable mild to moderate plaque psoriasis

Exclusion Criteria:

Other forms of psoriasis
Hypercalcemia
Past history of kidney stones
Vitamin D deficiency
Other concomitant dermatological disease
Intervention: Buprenorphine
Trial phase: Phase 3
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.

Buprenorphine
Eligibility criteria:
Inclusion Criteria:

Males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates;
willingness to be detoxified from opioids for buprenorphine maintenance ;
for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation.

Exclusion Criteria:

use of heroin for more than 4 days in the past month;
lifetime history of opioid dependence due to heroin alone;
ever used heroin intravenously;
requirement for current ongoing opioid treatment for adequate pain management;
current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical,
serious unstable medical illness including bradycardia or other arrhythmias, major cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine treatment is contraindicated or which at the determination of the MD is medically dangerous;
serious psychiatric illness including psychosis, bipolar disorder with psychosis:
or significant current suicidal or homicidal thoughts necessitating a higher level or care;
known allergy or intolerance to buprenorphine.
Intervention: Buprenorphine
Trial phase: Phase 3
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.

Buprenorphine
Eligibility criteria:
Inclusion Criteria:

Males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates;
willingness to be detoxified from opioids for buprenorphine maintenance ;
for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation.

Exclusion Criteria:

use of heroin for more than 4 days in the past month;
lifetime history of opioid dependence due to heroin alone;
ever used heroin intravenously;
requirement for current ongoing opioid treatment for adequate pain management;
current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical,
serious unstable medical illness including bradycardia or other arrhythmias, major cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine treatment is contraindicated or which at the determination of the MD is medically dangerous;
serious psychiatric illness including psychosis, bipolar disorder with psychosis:
or significant current suicidal or homicidal thoughts necessitating a higher level or care;
known allergy or intolerance to buprenorphine.
Intervention: Progesterone
Trial phase: Phase 2 | Phase 3
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=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
Healthy volunteers: No
Participants at risk: 13
Group description: For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)

Progesterone
Eligibility criteria:
Inclusion Criteria:

Men and women ages 21 to 60;
Current diagnosis of AD and PTSD;
Drink regularly are not in an active phase of alcohol withdrawal;
Not at risk for suicide;
Not taking regularly psychoactive drugs including anxiolytics and antidepressants;
For women, have regular menses every 25-35 days.

Exclusion Criteria:

Current SCID diagnosis of any psychotic disorder;
Substance dependence (other than alcohol and nicotine) in the past 30 days;
Current unstable medical condition;
Positive test results at more than one baseline appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines, and barbiturates; for women, amenorrhea, use of oral contraceptives;
Known allergy to progesterone or peanuts (vehicle for micronized progesterone);
History of thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or Bleeding disorders, heart disease, diabetes or history of stroke.
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: 10
Group description: A single 2000 mg dose of deferiprone sustained-release under fasting conditions.

Deferiprone sustained-release: Deferiprone sustained-release tablets
Eligibility criteria:
Main Inclusion Criteria:

Meeting the age, body mass index (BMI) and weight requirements.
Signing the Informed Consent Form.
Acceptable alcohol and/or drug screen at check-in of each period.
Acceptable health, blood pressure, pulse rate and temperature at check-in.
Being a non-smoker.
Female subjects of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study and throughout the study, and for 30 days after completion of the study, or be using an acceptable method of birth control.

Exclusion Criteria:

A history of presence of significant asthma, chronic bronchitis, seizure, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological conditions, psychiatric conditions, hepatic, renal, hematopoietic or gastrointestinal diseases or ongoing infectious diseases, or any other significant abnormality as evidenced by a medical history and physical examination.
Blood chemistry, hematology, international normalized ratio, partial thromboplastin time and urinalysis values outside clinically acceptable limits.
A positive screen for Hepatitis B surface antigens, Hepatitis C antibodies or HIV.
Significant abnormality found on ECG.
Known sensitivity to deferiprone or any components of the Ferriprox tablets.
Requiring other medication at the time of the study. Oral, injectable or topical contraceptives, and contraceptive implants are permitted as they are acceptable methods of contraception.
Acetaminophen use within 2 weeks prior to dosing and for the duration of the study.
History of drug or alcohol abuse within the last 6 months.
Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
History of long QT syndrome, cardiac arrhythmias.
Infection within two weeks prior to dosing.
Participation in an investigational drug study within 30 days prior to first dosing in this study.
Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
Positive test for pregnancy at medical screening or prior to dosing in either period.
Female subjects who are breast-feeding.
Absolute neutrophil count (ANC) <= 1.0 x 10E9 cells/L prior to dosing for each period.
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: 11
Group description: A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.

Deferiprone immediate-release: Deferiprone immediate-release tablets
Eligibility criteria:
Main Inclusion Criteria:

Meeting the age, body mass index (BMI) and weight requirements.
Signing the Informed Consent Form.
Acceptable alcohol and/or drug screen at check-in of each period.
Acceptable health, blood pressure, pulse rate and temperature at check-in.
Being a non-smoker.
Female subjects of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study and throughout the study, and for 30 days after completion of the study, or be using an acceptable method of birth control.

Exclusion Criteria:

A history of presence of significant asthma, chronic bronchitis, seizure, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological conditions, psychiatric conditions, hepatic, renal, hematopoietic or gastrointestinal diseases or ongoing infectious diseases, or any other significant abnormality as evidenced by a medical history and physical examination.
Blood chemistry, hematology, international normalized ratio, partial thromboplastin time and urinalysis values outside clinically acceptable limits.
A positive screen for Hepatitis B surface antigens, Hepatitis C antibodies or HIV.
Significant abnormality found on ECG.
Known sensitivity to deferiprone or any components of the Ferriprox tablets.
Requiring other medication at the time of the study. Oral, injectable or topical contraceptives, and contraceptive implants are permitted as they are acceptable methods of contraception.
Acetaminophen use within 2 weeks prior to dosing and for the duration of the study.
History of drug or alcohol abuse within the last 6 months.
Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
History of long QT syndrome, cardiac arrhythmias.
Infection within two weeks prior to dosing.
Participation in an investigational drug study within 30 days prior to first dosing in this study.
Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
Positive test for pregnancy at medical screening or prior to dosing in either period.
Female subjects who are breast-feeding.
Absolute neutrophil count (ANC) <= 1.0 x 10E9 cells/L prior to dosing for each period.
Intervention: Pioglitazone
Trial phase: Not Applicable
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: pioglitazone 45 mg, oral, daily

Pioglitazone: 45 mg daily Insulin sensitizing
Eligibility criteria:
Inclusion Criteria:

Healthy Individuals
Age 30-70 years old
BMI- 25-40 kg/m2
Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography

Exclusion Criteria:

Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer.
Must not have previously received treatment for OSA, including CPAP.
Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity.
Pregnancy/lactation is also an exclusion.
Intervention: Spinraza
Trial phase: Phase 3
SMILES: COCCOC1C(OP(O)(=S)OCC2OC(n3cnc4c(N)ncnc43)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(N)nc3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(=O)[nH]c3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(=O)[nH]c3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(=O)[nH]c3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(N)nc3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cnc4c(N)ncnc43)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(=O)[nH]c3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cnc4c(N)ncnc43)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cnc4c(N)ncnc43)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(=O)[nH]c3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cnc4c(=O)[nH]c(N)nc43)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(N)nc3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cc(C)c(=O)[nH]c3=O)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cnc4c(=O)[nH]c(N)nc43)C(OCCOC)C2OP(O)(=S)OCC2OC(n3cnc4c(=O)[nH]c(N)nc43)C(OCCOC)C2O)C(COP(O)(=S)OC2C(CO)OC(n3cc(C)c(=O)[nH]c3=O)C2OCCOC)OC1n1cc(C)c(N)nc1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 80
Group description: Nusinersen (2.4 mg/mL) administered as an IT lumbar puncture injection on Study Days 1, 15, 29, 64, 183, and 302.
Eligibility criteria:
Key Inclusion Criteria:

Be born (gestational age) between 37 and 42 weeks
Be medically diagnosed with spinal muscular atrophy (SMA)
Have Survival Motor Neuron2 (SMN2) Copy number = 2
Body weight equal to or greater than 3rd percentile for age using appropriate country-specific guidelines
Be able to follow all study procedures
Reside within approximately 9 hours ground-travel distance from a participating study center, for the duration of the study

Key Exclusion Criteria:

Hypoxemia (oxygen [O2] saturation awake less than 96% or O2 saturation asleep less than 96%, without ventilation support) during screening evaluation
Clinically significant abnormalities in hematology or clinical chemistry parameters or Electrocardiogram (ECG), as assessed by the Site Investigator, at the Screening visit that would render the participant unsuitable for participation in the study
Participant's parent or legal guardian is not willing to meet standard of care guidelines (including vaccinations and respiratory syncytial virus prophylaxis if available), nor provide nutritional and respiratory support throughout the study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: SODIUM FLUORIDE
Trial phase: Not Applicable
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 59
Group description: Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
Eligibility criteria:
Inclusion Criteria:

Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
Participants with maxillary dental arch suitable for the retention of the palatal appliance

Exclusion Criteria:

Participants taking fluoride supplement
Pregnant or breast-feeding women
Intervention: SODIUM FLUORIDE
Trial phase: Not Applicable
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 57
Group description: Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
Eligibility criteria:
Inclusion Criteria:

Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
Participants with maxillary dental arch suitable for the retention of the palatal appliance

Exclusion Criteria:

Participants taking fluoride supplement
Pregnant or breast-feeding women
Intervention: SODIUM FLUORIDE
Trial phase: Not Applicable
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 55
Group description: Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
Eligibility criteria:
Inclusion Criteria:

Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
Participants with maxillary dental arch suitable for the retention of the palatal appliance

Exclusion Criteria:

Participants taking fluoride supplement
Pregnant or breast-feeding women
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 417
Group description: Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Eligibility criteria:
Inclusion Criteria:

-Moderate to severe Crow's Feet Lines.

Exclusion Criteria:

Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
Any medium-depth or deep facial peels within 5 years
Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.