anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pretomanid
Trial phase: Phase 2
ATC code: J04AK08
SMILES: O=[N+]([O-])c1cn2c(n1)OC[C@@H](OCc1ccc(OC(F)(F)F)cc1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: PA-824 : 150 mg oral tablet
Eligibility criteria:
Inclusion Criteria:

Informed Consent
Body weight between 40 and 90 kg, inclusive.
Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB.
A chest X-ray compatible with TB.
Sputum positive
Adequate volume of sputum
Female participants of childbearing potential negative serum pregnancy and agree to use birth control
Male participants must agree to use contraception throughout participation in the trial and for 12 weeks after last dose.

Exclusion Criteria:

Poor general condition
Rifampicin-resistant and/or Isoniazid-resistant
MTB Treatment received within the 3 months prior
Allergy to the IMP or related substances
Evidence of extrathoracic TB
A history of previous TB
Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease
History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination
Any evidence of renal impairment
For males, any evidence or history of abnormality in the reproductive system
History and/or presence (or evidence) of neuropathy or epilepsy.
Clinically relevant changes in the ECG
A history of or current clinically relevant cardiovascular disorder
Concomitant use of any drug known to prolong QTc interval
Diabetics using insulin
Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).
Any diseases or conditions in which the use of the standard TB drugs or any of their components is contra-indicated, including but not limited to allergy to any TB drug, their component or to the IMP.
Any disease or conditions in which any of the medicinal products listed in the section pertaining to prohibited medication is used.
alcohol or drug abuse
Administration of an IMP prior to Visit 1, within 5 half-lives for that IMP if known. If the half-life of the IMP is unknown within 1 month.
Pregnant, breast-feeding, or planning to conceive or father a child within twelve weeks of cessation of treatment for males and within one week of cessation of treatment for females.
Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes
Any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing.
glucocorticoids within one year prior to dosing.
HIV infection with helper/inducer T lymphocyte (CD4 cell) count of less than or equal to 300x10-6/L.
Receiving antiretroviral therapy (ART).
Intervention: Pretomanid
Trial phase: Phase 2
ATC code: J04AK08
SMILES: O=[N+]([O-])c1cn2c(n1)OC[C@@H](OCc1ccc(OC(F)(F)F)cc1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: PA-824 : 200 mg oral tablet
Eligibility criteria:
Inclusion Criteria:

Informed Consent
Body weight between 40 and 90 kg, inclusive.
Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB.
A chest X-ray compatible with TB.
Sputum positive
Adequate volume of sputum
Female participants of childbearing potential negative serum pregnancy and agree to use birth control
Male participants must agree to use contraception throughout participation in the trial and for 12 weeks after last dose.

Exclusion Criteria:

Poor general condition
Rifampicin-resistant and/or Isoniazid-resistant
MTB Treatment received within the 3 months prior
Allergy to the IMP or related substances
Evidence of extrathoracic TB
A history of previous TB
Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease
History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination
Any evidence of renal impairment
For males, any evidence or history of abnormality in the reproductive system
History and/or presence (or evidence) of neuropathy or epilepsy.
Clinically relevant changes in the ECG
A history of or current clinically relevant cardiovascular disorder
Concomitant use of any drug known to prolong QTc interval
Diabetics using insulin
Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).
Any diseases or conditions in which the use of the standard TB drugs or any of their components is contra-indicated, including but not limited to allergy to any TB drug, their component or to the IMP.
Any disease or conditions in which any of the medicinal products listed in the section pertaining to prohibited medication is used.
alcohol or drug abuse
Administration of an IMP prior to Visit 1, within 5 half-lives for that IMP if known. If the half-life of the IMP is unknown within 1 month.
Pregnant, breast-feeding, or planning to conceive or father a child within twelve weeks of cessation of treatment for males and within one week of cessation of treatment for females.
Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes
Any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing.
glucocorticoids within one year prior to dosing.
HIV infection with helper/inducer T lymphocyte (CD4 cell) count of less than or equal to 300x10-6/L.
Receiving antiretroviral therapy (ART).
Intervention: Pyrazinamide
Trial phase: Phase 2
ATC code: J04AK01 | J04AM05 | J04AM06
SMILES: NC(=O)c1cnccn1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
Eligibility criteria:
Inclusion Criteria:

Informed Consent
Body weight between 40 and 90 kg, inclusive.
Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB.
A chest X-ray compatible with TB.
Sputum positive
Adequate volume of sputum
Female participants of childbearing potential negative serum pregnancy and agree to use birth control
Male participants must agree to use contraception throughout participation in the trial and for 12 weeks after last dose.

Exclusion Criteria:

Poor general condition
Rifampicin-resistant and/or Isoniazid-resistant
MTB Treatment received within the 3 months prior
Allergy to the IMP or related substances
Evidence of extrathoracic TB
A history of previous TB
Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease
History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination
Any evidence of renal impairment
For males, any evidence or history of abnormality in the reproductive system
History and/or presence (or evidence) of neuropathy or epilepsy.
Clinically relevant changes in the ECG
A history of or current clinically relevant cardiovascular disorder
Concomitant use of any drug known to prolong QTc interval
Diabetics using insulin
Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).
Any diseases or conditions in which the use of the standard TB drugs or any of their components is contra-indicated, including but not limited to allergy to any TB drug, their component or to the IMP.
Any disease or conditions in which any of the medicinal products listed in the section pertaining to prohibited medication is used.
alcohol or drug abuse
Administration of an IMP prior to Visit 1, within 5 half-lives for that IMP if known. If the half-life of the IMP is unknown within 1 month.
Pregnant, breast-feeding, or planning to conceive or father a child within twelve weeks of cessation of treatment for males and within one week of cessation of treatment for females.
Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes
Any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing.
glucocorticoids within one year prior to dosing.
HIV infection with helper/inducer T lymphocyte (CD4 cell) count of less than or equal to 300x10-6/L.
Receiving antiretroviral therapy (ART).
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 104
Group description: Experimental group given varenicline dosing.

Varenicline: Varenicline and placebo given twice a day or five weeks.
Eligibility criteria:
Inclusion Criteria:

Age 18-75 years old
Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake
Contemplating a smoking cessation attempt in the near future
Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion
Able to give informed consent

Exclusion Criteria:

Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia
History of attempted suicide or expresses any current suicidal ideation
Pregnant, breast feeding, or planning to become pregnant within the next 3 months
Reports desire for immediate treatment of tobacco/nicotine dependence
Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)
Intervention: Atropine
Trial phase: Phase 3
ATC code: A03BA01 | A03BA03 | A03CB03 | A03CB31 | S01FA01
SMILES: CN1C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Weekend atropine 1%

Atropine: Weekend atropine 1%
Eligibility criteria:
Inclusion Criteria:

Major Eligibility Criteria for Run-in Phase

Age 3 to < 8 years
Amblyopia associated with strabismus, anisometropia, or both
Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines

Amblyopia treatment within the past 6 months subject to the following stipulations:

No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with atropine who are entering the study on treatment)
No simultaneous treatment with patching and atropine
No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D

Maximum level of treatment within the past 6 months:

Patching: up to 2 hours daily
Atropine: up to once daily
Wearing spectacles with optimal correction (if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses; if amblyopic eye acuity is 20/100 or worse, then spectacles and atropine can be initiated simultaneously).
Hypermetropia and spectacle correction in sound eye of +1.50 D or more

Eligibility Criteria for Randomization:

Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
Compliance with weekend atropine treatment based on investigator judgment.

Exclusion Criteria:

Currently using vision therapy or orthoptics
Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
Prior intraocular or refractive surgery
Known allergy to atropine or other cycloplegic drugs
Down Syndrome present
Intervention: Nitric Oxide
Trial phase: Phase 2 | Phase 3
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: Prospective group who received iNO.

inhaled nitric oxide: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
Eligibility criteria:
Inclusion Criteria:

Male/female patients
Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children
Written parental permission to participate in this research study

Exclusion Criteria:

Any condition which the PI feels will interfere with the patient's safe and effective participation
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: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Progesterone 400mg per vagina qhs.
Eligibility criteria:
Inclusion Criteria:1. Pregnant women with arrested preterm labor between 24+0 to 33+6 weeks pregnant.

2. Intact membranes 3. Singleton pregnancy 4. Greater than or equal to 18 years of age 5. Cervical dilation less than or equal to 4cm Exclusion Criteria:1. Any contraindication to on-going pregnancy 2. Placental abruption 3. Placenta previa 4. Lethal fetal anomalies 5. Premature rupture of membranes 6. Multiple gestation 7. Less than 18 years old 8. Known allergy to any component of the study medication or placebo 9. Severe maternal medical illness
Intervention: Desogestrel and ethinyl estradiol
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCC4=CCCCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: One pill containing estrogen and progesterone taken daily for 21 days followed by placebo pills only for 7 days; regimen repeated for 12 months.

Ethinyl Estradiol + Desogestrel: Oral ethinyl estradiol (0.03 mg) + desogestrel (0.15 mg) + Elemental calcium 1200 mg and Vit D 400 IU taken once daily
Eligibility criteria:
Inclusion Criteria:

Females 14-21 years old Note: Our pilot data are reassuring in that young women 18-25 years old with hypothalamic amenorrhea are not adversely affected with estrogen use. In fact, in our prospective study, beneficial effects were observed both in young women 18-25 years old using oral estrogen, and in 14-18 year old adolescent girls using transdermal estrogen. We therefore feel that including girls in the 14-21 year age range will not be hazardous to their bone health. In fact, given the lack of data in this age group, it is important to study younger women and teenagers rather than extrapolate data from studies in adults to this younger population. Hormone dynamics differ in teenagers compared with adults, and bone mass accrual is even more dependent on estrogen and IGF-1 in younger than older women who have already achieved peak bone mass.
Bone age (BA) >15 years Note: 99% of adult height is achieved at a BA of 15 years, thus estrogen replacement will not result in stunting of height potential after this age. Although we could have chosen to include girls with a BA >14 in this study, we are limiting this to girls with a BA of >15 years. This is because 2% of growth potential persists at a BA of 14 years, versus only 1% at a BA of 15 years (~0.6" of potential height (130)). Thus, to avoid potential stunting of growth potential with estrogen replacement, we have chosen to include girls with BA of > 15 years.
BMI between 10th-90th percentiles for age.
Amenorrhea (for AA): absence of menses for > three months (74) within a period of oligomenorrhea (cycle length > six weeks) for >six months, or absence of menarche at >16 years.
Eumenorrhea (EA and controls): > nine menses (cycle length 21-35 days) in preceding year.
Non-athlete healthy controls will be eligible if weight bearing exercise activity is less than two hours a week and if they are not participating in organized team sports.
Endurance athletes Note: severity of low BMD and menstrual dysfunction differ by kind of exercise and activity. For example, runners have a higher prevalence of menstrual irregularity than swimmers and cyclists (131). By limiting enrollment to endurance athletes, we will eliminate variability from the type of activity. Endurance training is defined as > 4 h of aerobic weight-bearing training of the legs or specific endurance training weekly, or > 20 miles of running weekly for a period of > 6 months in the last year.

Exclusion Criteria:

Other conditions that may affect bone metabolism
Intervention: Potassium Iodide
Trial phase: Phase 4
ATC code: R05CA02 | S01XA04 | V03AB21
SMILES: [I-].[K+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: 8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.

Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
Eligibility criteria:
Inclusion Criteria:

Adult patients with a clinical diagnosis of Graves Disease
Patients who have selected surgical resection as treatment of their Graves Disease
Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid

Exclusion Criteria:

Patients deemed unfit for surgery by operating surgeon or anesthesist
Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal
Intervention: Dronabinol
Trial phase: Phase 1
ATC code: A04AD10
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)Oc1cc(CCCCC)cc(O)c12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Dronabinol 15 mg
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria for study subjects (dual diagnosis patients):

Age 18-50;
Diagnosis of schizophrenia or schizoaffective disorder (by SCID)
Diagnosis of current cannabis abuse or dependence (by SCID);
Recent use of cannabis (within the past month on Timeline Follow-Back);
Stability on antipsychotic medication for past 1 month);
Outpatient status for past 3 months;
Willing and able to participate as demonstrated by a signed informed consent document.

Inclusion criteria for normal control subjects:

Age 18-50;
Willing to participate as demonstrated by a signed informed consent document

Exclusion Criteria:

Exclusion criteria for study subjects (dual diagnosis patients):

PANSS subscale for positive symptoms of psychosis item > 3 [moderate] on Day 15 (once they are abstinent from cannabis);
Cocaine/stimulant use disorder;
Pharmacological treatment for addiction (e.g., disulfiram, naltrexone, acamprosate, topiramate); Mental retardation;
Pregnancy or currently nursing;
Uncontrolled serious medical condition;
Seizure disorder
Seeking treatment to limit their cannabis use
Taking clozapine

Additional Exclusion criteria for Main Study patients only:

Claustrophobia prohibiting scanning
History of head injury with period of unconsciousness;
Metal objects within the body;
Taking antipsychotic other than risperidone or first generation antipsychotic as main treatment
Previous participation in the Pilot Dose Finding Study

Exclusion criteria for normal control subjects:

Axis I or Axis II psychiatric diagnosis (including substance use disorder) based on SCID
Mental retardation;
History of head injury with period of unconsciousness;
Metal objects within the body;
Pregnancy or currently nursing;
Uncontrolled serious medical condition;
Current tobacco smokers. Note: We exclude current tobacco smoking (but not a history of smoking) in the normal control subjects since the fact of cigarette smoking could select subjects with a dysregulated BRC as a basis for their continued cigarette smoking in the face of social conventions toward non-smoking.
Intervention: Humulene
Trial phase: Phase 1
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Cannabis cigarette (3.6% THC)
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria for study subjects (dual diagnosis patients):

Age 18-50;
Diagnosis of schizophrenia or schizoaffective disorder (by SCID)
Diagnosis of current cannabis abuse or dependence (by SCID);
Recent use of cannabis (within the past month on Timeline Follow-Back);
Stability on antipsychotic medication for past 1 month);
Outpatient status for past 3 months;
Willing and able to participate as demonstrated by a signed informed consent document.

Inclusion criteria for normal control subjects:

Age 18-50;
Willing to participate as demonstrated by a signed informed consent document

Exclusion Criteria:

Exclusion criteria for study subjects (dual diagnosis patients):

PANSS subscale for positive symptoms of psychosis item > 3 [moderate] on Day 15 (once they are abstinent from cannabis);
Cocaine/stimulant use disorder;
Pharmacological treatment for addiction (e.g., disulfiram, naltrexone, acamprosate, topiramate); Mental retardation;
Pregnancy or currently nursing;
Uncontrolled serious medical condition;
Seizure disorder
Seeking treatment to limit their cannabis use
Taking clozapine

Additional Exclusion criteria for Main Study patients only:

Claustrophobia prohibiting scanning
History of head injury with period of unconsciousness;
Metal objects within the body;
Taking antipsychotic other than risperidone or first generation antipsychotic as main treatment
Previous participation in the Pilot Dose Finding Study

Exclusion criteria for normal control subjects:

Axis I or Axis II psychiatric diagnosis (including substance use disorder) based on SCID
Mental retardation;
History of head injury with period of unconsciousness;
Metal objects within the body;
Pregnancy or currently nursing;
Uncontrolled serious medical condition;
Current tobacco smokers. Note: We exclude current tobacco smoking (but not a history of smoking) in the normal control subjects since the fact of cigarette smoking could select subjects with a dysregulated BRC as a basis for their continued cigarette smoking in the face of social conventions toward non-smoking.