anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Plecanatide
Trial phase: Phase 2 | Phase 3
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 237
Group description: Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18-75, inclusive
Body Mass Index = 18-35 kg/m2, inclusive
Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation.
Less than 3 CSBMs per week at baseline and during pretreatment
Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
Willing to maintain a stable diet during the study.
Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Exclusion Criteria:

Loose stool (mushy) or watery (Bristol score- 6 or 7) stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day treatment period
Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
Active peptic ulcer disease not adequately treated or not stable
History of cathartic colon, laxative, enema abuse, or ischemic colitis.
Fecal impaction within 3 months of screening
Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
Major surgery within 60 days of screening.
Intervention: Plecanatide
Trial phase: Phase 2 | Phase 3
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 238
Group description: Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18-75, inclusive
Body Mass Index = 18-35 kg/m2, inclusive
Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation.
Less than 3 CSBMs per week at baseline and during pretreatment
Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
Willing to maintain a stable diet during the study.
Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Exclusion Criteria:

Loose stool (mushy) or watery (Bristol score- 6 or 7) stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day treatment period
Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
Active peptic ulcer disease not adequately treated or not stable
History of cathartic colon, laxative, enema abuse, or ischemic colitis.
Fecal impaction within 3 months of screening
Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
Major surgery within 60 days of screening.
Intervention: Plecanatide
Trial phase: Phase 2 | Phase 3
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 237
Group description: Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18-75, inclusive
Body Mass Index = 18-35 kg/m2, inclusive
Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation.
Less than 3 CSBMs per week at baseline and during pretreatment
Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
Willing to maintain a stable diet during the study.
Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Exclusion Criteria:

Loose stool (mushy) or watery (Bristol score- 6 or 7) stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day treatment period
Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
Active peptic ulcer disease not adequately treated or not stable
History of cathartic colon, laxative, enema abuse, or ischemic colitis.
Fecal impaction within 3 months of screening
Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
Major surgery within 60 days of screening.
Intervention: Dimboa
Trial phase: Not Applicable
SMILES: COc1ccc2c(c1)OC(O)C(=O)N2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion

Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
Eligibility criteria:
Inclusion Criteria:

Adult, age 18 - 65 years
Completion of medical history questionnaire without concerns identified for exposure to increased pressure
Familiarity with atmospheric pressure change:
Experienced and active hyperbaric chamber inside attendant: more than 50 hyperbaric compressions, with more than 4 have been in the last 4 months; or
Experienced and active SCUBA diver: more than 20 lifetime compressed gas open water (not swimming pool) dives, with more than 10 in the last 12 months
Able to equalize middle ear pressure easily

Exclusion Criteria:

Pregnancy
Known risk for barotrauma, as identified on the medical history questionnaire, such as:
Recent (within 12 months) inner ear or sinus surgery
Spontaneous pneumothorax
Pulmonary cysts
Emphysema
Bullous lung disease
Chronic obstructive pulmonary disease needing chronic active therapy
Inability to tolerate chamber confinement or pressure
Presence of heart failure
Presence of any implanted electrical device, except hyperbaric-approved pacemakers
Presence of middle-ear tympanostomy tubes
Intervention: Dimboa
Trial phase: Not Applicable
SMILES: COc1ccc2c(c1)OC(O)C(=O)N2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion

Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
Eligibility criteria:
Inclusion Criteria:

Adult, age 18 - 65 years
Completion of medical history questionnaire without concerns identified for exposure to increased pressure
Familiarity with atmospheric pressure change:
Experienced and active hyperbaric chamber inside attendant: more than 50 hyperbaric compressions, with more than 4 have been in the last 4 months; or
Experienced and active SCUBA diver: more than 20 lifetime compressed gas open water (not swimming pool) dives, with more than 10 in the last 12 months
Able to equalize middle ear pressure easily

Exclusion Criteria:

Pregnancy
Known risk for barotrauma, as identified on the medical history questionnaire, such as:
Recent (within 12 months) inner ear or sinus surgery
Spontaneous pneumothorax
Pulmonary cysts
Emphysema
Bullous lung disease
Chronic obstructive pulmonary disease needing chronic active therapy
Inability to tolerate chamber confinement or pressure
Presence of heart failure
Presence of any implanted electrical device, except hyperbaric-approved pacemakers
Presence of middle-ear tympanostomy tubes
Intervention: Atorvastatin
Trial phase: Phase 1 | Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 34
Group description: Atorvastatin dose titration to maximum tolerated dose

Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Eligibility criteria:
Inclusion criteria:

Age ≥ 2 years to 17 years old
Meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries
Patient presents within the first 20 days after fever onset
Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
Males engaging in sexual activity that could lead to pregnancy must use a condom.

Exclusion Criteria:

Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age
Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days
Patient has a history of allergy to atorvastatin or its derivatives
Intervention: Pioglitazone Hydrochloride
Trial phase: Phase 1
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants will receive oral doses of pioglitazone hydrochloride 30 mg once daily for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Females must be of non-childbearing potential
Body mass index (BMI) ≥32.0 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
No clinically significant abnormality on electrocardiogram
Has documented hepatic fat content ≥10% within 6 months of enrollment
Maintained stable weight (by history) for at least 4 weeks
Agrees not to initiate a weight loss program and agrees to maintain consistent dietary habits and exercise routines for the duration of the study
Has a rating of 'moderate' or 'severe' steatosis on ultrasound at the prestudy (screening) visit

Exclusion Criteria:

Change in weight greater than 4% between prestudy visit and randomization into the study
History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant
Liver disease other than fatty liver or non-alcoholic steatohepatitis (NASH)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x the upper limit of normal range
Serum triglyceride level >600 mg/dL
History of stroke, chronic seizures, or major neurological disorder
History of clinically significant endocrine, gastrointestinal, cardiovascular (including congestive heart failure), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Had abdominal surgery, gastric bypass, bowel resection, recent liver biopsy, or any other procedure within a minimum of 4 weeks
History of neoplastic disease
Claustrophobia or other contraindication to magnetic resonance imaging (MRI)
Have not washed off agents associated with changes in hepatic fat or used for treatment of Non-alcoholic fatty liver disease (NAFLD) or NASH for a minimum of 3 months prior
Consumes excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks
Significant multiple and/or severe allergies
Intolerance or hypersensitivity to pioglitazone hydrochloride or any inactive ingredients
Regular user of any illicit drugs or has a history of drug (including alcohol) abuse.
Intervention: Lithium
Trial phase: Not Applicable
ATC code: N05AN01
SMILES: [Li]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Bipolar patients must take lithium; others do not take lithium
all patients are hospitalized for a week during which they do not sleep on alternating nights
for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations

Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.

light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire

Lithium: For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)
Eligibility criteria:
Inclusion Criteria:

current major depressive episode (MDD, BP-I or BP-II)
if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms
If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate
physically healthy
age 18-75
not taking current antidepressants(antidepressants deemed effective will not be discontinued

Exclusion Criteria:

medically unstable condition
past intolerance of lithium (bipolar only)
history of (or current) psychosis or epilepsy
current (past six months) drug or alcohol abuse/dependence
pregnancy
contraindication to lithium (bipolar only)
significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration)
currently taking effective antidepressant
cognitive dysfunction
Parkinson's Disease
Thyroid Stimulating Hormone > 5 milli International Units/Liter
left ventricular hypertrophy
symptomatic mitral valve prolapse
abnormal creatinine
Intervention: Pioglitazone
Trial phase: Phase 4
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: No
Participants at risk: 24
Group description: Pioglitazone 45 mg daily orally for 12 months

Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.
Eligibility criteria:
Inclusion Criteria:

Patients must range in age from 30 to 70 years.
Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Patients may be of either sex. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions or be surgically sterilized.
Patients must meet the American Diabetes Association Criteria for diagnosis of type 2 diabetes mellitus.
Patients must be on diet therapy alone and/or metformin treatment (stable dose) and have a fasting plasma glucose concentration between 126 and 260 mg/dl.
Patients must have Hematocrit greater than 34%.
Subjects whose body weight has been stable (±1 Kg) over the three months prior to study will be included.

Exclusion Criteria:

1, Type 1 diabetes.

2. Fasting plasma glucose greater than 260 mg/dl.

3. Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.

4. Patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. Patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.

5. Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.

6. Patients taking medications that affect gastrointestinal motility will be excluded

7. Patients with a history of Congestive Heart failure (CHF), or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).
Intervention: Cysteamine
Trial phase: Not Applicable
ATC code: A16AA04 | S01XA21
SMILES: NCCS
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Cysteamine bitartrate, 500mg once a day, three days.

Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period.
Eligibility criteria:
Inclusion Criteria:

Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI > 18 and < 30.0.
Females of childbearing potential who are sexually active must be willing to use two forms of contraceptive methods throughout the study and for 14days after the last study drug administration.
Minimum weight of 50 kg.
Good health, defined as not having history of any chronic illness and not requiring any regular medication/therapy.
Must swallow tablets on a regular basis.

Exclusion Criteria:

Evidence of Helicobacter pylori infection, presently, or within the last year.
Subjects with known hypersensitivity to cysteamine.

History, currently or within the past 3 months, of the following conditions:

Pancreatitis
Inflammatory bowel disease
Malabsorption
Severe liver disease
Unstable heart disease, e.g., myocardial infarction, heart failure, arrhythmias.
Unstable diabetes mellitus
Any bleeding disorder.
Zollinger-Ellison syndrome
Malignant disease
Subjects whom may be pregnant or have health issues that make it unsafe for them participate, or whose concomitant medical problems preclude them from committing to the study schedule.
Use of an investigational drug within 30 days (or 90 days for biologics) prior to dosing.
Use of prescription medication within 14 days prior to the first dosing;
Use over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing.
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
Hemoglobin <13.5 g/dL (males) and <12.0 g/dL (females) and hematocrit <41.0% (males) and <36.0% (females) at screening.
Breast-feeding subject.
Immunization with a live attenuated vaccine 1 month prior to dosing or planned vaccination during the course of the study.

Presence of fever (body temperature >37.6°C) (e.g. a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.

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Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks
Eligibility criteria:
Inclusion Criteria:

History of cough for more than 8 weeks
Normal chest radiograph
Idiopathic or treatment resistant cough (idiopathic defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip [treatment-resistant]).

Exclusion Criteria:

Current smoker
Individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
Treatment with an angiotensin-converting-enzyme inhibitor (ACE-inhibitor) as the potential cause of a participant's cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to Day 0
Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <60%