anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ACARBOSE
Trial phase: Phase 4
ATC code: A10BD17 | A10BF01
SMILES: [H]C(=O)[C@H](O)[C@@H](O)[C@]([H])(O[C@@]1([H])O[C@H](CO)[C@@]([H])(O[C@H]2O[C@H](C)[C@@H](N[C@@]3([H])C=C(CO)[C@@H](O)[C@H](O)[C@H]3O)[C@H](O)[C@H]2O)[C@H](O)[C@H]1O)[C@H](O)CO
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
Eligibility criteria:
Obese Subjects:

Inclusion Criteria:

Obesity (BMI > 97%tile for age and sex matched normative data)
Good general health, taking no medication on a chronic basis
Age 12-19 yrs, in puberty (girls: breast: Tanner stage II to V, boys: testicular volume >6ml)
Girls who are sexually active must use adequate birth control methods(such as barrier method or oral contraception) and must have a negative pregnancy test
Normal liver function tests

Exclusion Criteria:

Raynaud's syndrome
Pregnancy or breastfeeding mothers
Smokers
Anemia (Hct < 35)
Baseline creatinine > 1.0 mg
Abnormal liver transaminases > 1.5X the upper limit of normal
Presence of endocrinopathies (Cushing syndrome, hypothyroidism)
Presence or history of gastrointestinal disorders (Inflammatory bowl disease, irritable bowl disease, hernia, ileus)
Presence of significant chronic illness of any kind
Drug therapy (examples of commonly occurring drug therapy include any drugs to treat asthma, hypertension, dyslipidemia, insulin resistance, depression)
Psychiatric disorders
History of substance abuse (including anorexic agents)

Control Subjects:

Inclusion Criteria:

Lean (BMI < 85%tile for age and sex matched normative data)
Good general health, taking no medication on a chronic basis
Age 12-25 yrs, in puberty (girls: breast: Tanner stage II to V, boys: testicular volume >6ml)
Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test

Exclusion Criteria:

Raynaud's syndrome
Pregnancy or breastfeeding mothers
Smokers
Presence of endocrinopathies (Cushing syndrome, hypothyroidism Presence of significant chronic illness of any kind
Drug therapy (examples of commonly occurring drug therapy include any drugs to treat asthma, dyslipidemia, hypertension, depression)
Psychiatric disorders
History of substance abuse
First degree relative with either T1DM or T2DM
Presence of acanthosis nigricans
Intervention: Baclofen
Trial phase: Phase 2
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Eligibility criteria:
Inclusion Criteria:

Male or female subjects 6 to 17 years of age, inclusive.
Diagnosis of Autistic spectrum disorders
Clinical Global Impression - Severity (CGI-S) rating for aberrant behavior of moderate or higher at screening and at Visit 1 (Day 1).
An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score ≥16 at screening and at Visit 1 (Day 1).
If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 3 months prior to Screening (Visit 1) and subjects and their parent/caregiver/legally authorized representative (LAR) will not electively initiate new or modify ongoing interventions for the duration of the study.
Exclusion Criteria:
Subjects with known genetic disorders associated with PDD such as fragile X syndrome.
Subjects with a history of a seizure disorder who are not currently receiving treatment with antiepileptic medication.
Subjects with any medical condition, including alcohol and drug abuse that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
Subjects currently treated or have been treated in the last 2 weeks with any psychotropic medication except anti-epileptics or who have been treated with fluoxetine in the last 4 weeks.
Subjects currently treated with vigabatrin or tiagabine.
Subjects taking another investigational drug currently or within the last 30 days.
Subjects who have a history of hypersensitivity to racemic baclofen.
Intervention: (4aR,5aR)-4,4a,5,5a-Tetrahydro-1H-cyclopropa(4,5)cyclopenta(1,2-C)pyrazole-3-carboxylic acid
Trial phase: Phase 2
SMILES: O=C(O)c1n[nH]c2c1CC1CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Eligibility criteria:
Inclusion Criteria:

Participant is not on a statin or other lipid-modifying therapy
Low or moderate risk participant
Male participants, and female participants not of reproductive potential

Exclusion Criteria:

Female participant of reproductive potential
Participant is pregnant, breastfeeding, or expecting to conceive during the study
Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer)
Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse
Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study
Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week
Participant is currently experiencing menopausal hot flashes
Participant currently engages in vigorous exercise or an aggressive diet regimen
Participant is at high risk for heart conditions
Participant has Type 1 or Type 2 diabetes mellitus
Participant has poorly controlled cardiac arrhythmias
Participant has a history of stroke or other hemorrhage
Participant has poorly controlled high blood pressure
Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids
Participant has a disease of the kidney or liver
Participant has an ulcer within 3 months of screening
Participant is Human Immunodeficiency Virus (HIV) positive
Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy
Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening
Participant has taken an anti-obesity medication within 3 months of screening
Participant is taking coumarins
Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed)
Participant is taking more than 100 mg aspirin per day
Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents
Intervention: Alovudine
Trial phase: Not Applicable
SMILES: Cc1cn([C@H]2C[C@H](F)[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
Eligibility criteria:
Inclusion Criteria:

Patient provides written Informed Consent and is willing to comply with protocol requirements
Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
Patient has a diagnosis of one of the following malignancies using the TNM Staging System:
Lung cancer (T3 grade up, node positive, but no metastatic disease)
Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18]FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan
Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic agent)
Patient has a score of greater than or equal to (>/=) 60% on the Karnofsky Performance Status Scale

Exclusion Criteria:

Patient is a pregnant or lactating female. Exclude the possibility of pregnancy:
by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration
by surgical history (eg, tubal ligation or hysterectomy)
by patient's history of being post menopausal with a minimum 1 year without menses
Patient is undergoing treatment with palliative intent
Patient has received an investigational compound and/or medical device within 14 days before admission into this study
Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
Intervention: TEPROTIDE
Trial phase: Not Applicable
SMILES: CCC(C)C(NC(=O)C(CCC(N)=O)NC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C1CCCN1C(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C1CCC(=O)N1)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: Patients already on an ACE inhibitor will continue it until the day of surgery

Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
Eligibility criteria:
Inclusion Criteria:

Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
Patients must be taking an ACE inhibitor prior to their operation

Exclusion Criteria:

Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
Pregnancy as ruled out by standard of care screening procedures.
Individuals whose weight is less than 3.5 kg at the time of enrollment.
Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.
Intervention: Sapropterin
Trial phase: Phase 2
ATC code: A16AX07
SMILES: CC(O)C(O)C1CNc2nc(N)[nH]c(=O)c2N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 23
Group description: sapropterin 20 mg/kg/day
Eligibility criteria:
Inclusion Criteria:

Parents sign informed consent
Child meets criteria for autistic disorder (based on score on the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS), given by a certified administrator, research reliable)
Child has a Developmental Quotient (DQ) ≥ 50 (Vineland Adaptive Scales, Interview Edition)
Parents agree to delay initiation of other treatments during double-blind trial

Exclusion Criteria:

Child has had seizures in past 6 months or a change in seizure medications in past 4 weeks.
Child has > 18 points on subscale of (Autism Behavior Checklist) ABC-I
Child is taking any psychoactive medication other than supplements, anticonvulsants, or soporifics (melatonin, diphenhydramine)
Child has had any change in standing medications in the past 4 weeks.
Child has known genetic disorders
Child has known severe neurological disorders, including cerebral palsy
Intervention: Egrifta
Trial phase: Not Applicable
ATC code: H01AC06
SMILES: CCC=CCC(=O)NC(Cc1ccc(O)cc1)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(CO)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NCC(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CO)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC(C(=O)NC(CCSC)C(=O)NC(CO)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(N)=O)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(CC(N)=O)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CC(C)C)C(N)=O)C(C)CC)C(C)C)C(C)O)C(C)CC
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Eligibility criteria:
Inclusion Criteria:

Men aged 18-60 years
BMI > 20kg/m2 and <35kg/m2

Exclusion Criteria:

Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study
Use of GH or growth hormone stimulating peptides within six months of starting the study
Change in lipid lowering or antihypertensive regimen within 3 months of screening
Fasting blood sugar > 126 mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL
Carpal tunnel syndrome
Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5 ng/mL
Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
Weight < 110 lbs.
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Group A will serve as a control and will receive only injections of saline as a placebo.
Eligibility criteria:
Inclusion Criteria:

Age 25 and over
BMI of 18.5-29.99
Two localized areas of fat deposition on the upper and lower torso that have failed on self-reported diet and exercise
The subject is in good health
The subject has the willingness and the ability to understand and provide informed consent

Exclusion Criteria:

Under 25 years of age
Pregnancy or Lactation
BMI≥ 30
Subjects with known eating disorders or a history of weight loss/gain of 5 pounds or more within the past 6 months
Subjects with hepatrophy, nephopathy, diabetes, hyperthyroidism, neoplasias, AIDS or other immuno-compromised illness, allergies to eggs or soy, poorly controlled hypertension, or autoimmune disease
Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
Subjects with an open, non-healing sore or infection near site of injection
Subjects with active eczema or psoriasis
Subjects who are unable to understand the protocol or to give informed consent
Subjects with mental illness
Intervention: Duo-cotecxin
Trial phase: Phase 3
SMILES: CC1CCC2C(C)C(O)OC3OC4(C)CCC1C32OO4.Clc1ccc2c(N3CCN(CCCN4CCN(c5ccnc6cc(Cl)ccc56)CC4)CC3)ccnc2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 198
Group description: Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)

dihydroartemisinin-piperaquine: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)
Eligibility criteria:
Inclusion Criteria:

Age ≥ 8 to < 14 years (boys), ≥ 8 to < 12 years (girls)
Student enrolled at participating school in classes 3-7
Provision of informed consent from parent or guardian
Provision of assent by student

Exclusion Criteria:

Known allergy or history of adverse reaction to study medications
Onset of menstruation (girls)
Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours
Evidence of severe malaria or danger signs
Haemoglobin < 7.0 gm/dL
Parasite density > 10,000/ul
Intervention: Suldox
Trial phase: Phase 3
SMILES: CCc1nc(N)nc(N)c1-c1ccc(Cl)cc1.COc1ncnc(NS(=O)(=O)c2ccc(N)cc2)c1OC
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 186
Group description: sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets

sulfadoxine-pyrimethamine: 25 mg/kg po once on day 0
Eligibility criteria:
Inclusion Criteria:

Age ≥ 8 to < 14 years (boys), ≥ 8 to < 12 years (girls)
Student enrolled at participating school in classes 3-7
Provision of informed consent from parent or guardian
Provision of assent by student

Exclusion Criteria:

Known allergy or history of adverse reaction to study medications
Onset of menstruation (girls)
Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours
Evidence of severe malaria or danger signs
Haemoglobin < 7.0 gm/dL
Parasite density > 10,000/ul
Intervention: Solifenacin
Trial phase: Not Applicable
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: 1 subject enrolled, unknown patient assignment because this study was double blinded.
Eligibility criteria:
Inclusion Criteria:

Age >/= 18
Patient is appropriate for sub-urethral sling procedure
Mixed urinary incontinence
No antimuscarinic therapy for previous 30 days

Exclusion Criteria:

Uncontrolled narrow angle glaucoma
Acute cystitis
Unevaluated hematuria
Currently using anti-muscarinic therapy
Unable to complete pre-operative urodynamics
Contraindication to anti-cholinergic therapy
Unable or unwilling to complete diaries or quality of life questionaire
Significant (exteriorized) Pelvic Organ Prolapse
Intervention: CLOBETASOL PROPIONATE
Trial phase: Phase 4
ATC code: D07AD01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Olux-E (clobetasol propionate 0.05%) foam
Eligibility criteria:
Inclusion Criteria:

Body surface area (BSA) affected with psoriasis between 4% and 20% .
Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
Male or female, 18 years of age or older at the time that the consent form was signed.
Able to complete the study and comply with study instructions.
Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.

Exclusion Criteria:

Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
Other serious skin disorder or any chronic medical condition that is not well controlled.
Female subjects who are pregnant, trying to become pregnant or lactating.
Any major illness within 30 days prior to the baseline visit.
Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.
Intervention: CLOBETASOL PROPIONATE
Trial phase: Phase 4
ATC code: D07AD01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Clobex (clobetasol propionate 0.05%) lotion.
Eligibility criteria:
Inclusion Criteria:

Body surface area (BSA) affected with psoriasis between 4% and 20% .
Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
Male or female, 18 years of age or older at the time that the consent form was signed.
Able to complete the study and comply with study instructions.
Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.

Exclusion Criteria:

Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
Other serious skin disorder or any chronic medical condition that is not well controlled.
Female subjects who are pregnant, trying to become pregnant or lactating.
Any major illness within 30 days prior to the baseline visit.
Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.
Intervention: NIACIN
Trial phase: Phase 4
ATC code: C04AC01 | C10AD02 | C10AD52 | C10BA01
SMILES: O=C(O)c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Niacin : 1000 mg tablets once per day
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CKD Stage 2 (GFR >60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30)
HDL-cholesterol <50 for men and <55 for women
If taking a statin, stable dose for past one month
Glucose <200 mg/dL and HbA1c <9%
Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry

Exclusion Criteria:

Hospitalization within prior 3 months

Any of the following conditions:

uncontrolled peptic ulcer disease
active liver disease OR abnormal SGOT/SGPT
history of adverse reaction to niacin
contra-indication to aspirin
concurrent fibrate therapy
history of gout
serum phosphorus levels below 2.7mg/dl
Nursing
Pregnancy