anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: GLUTAMINE
Trial phase: Phase 2
ATC code: A16AA03
SMILES: NC(=O)CCC(N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Oral Whey Protein Powder
Eligibility criteria:
Inclusion Criteria:

men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS)
increased intestinal permeability on Lactulose/Mannitol permeability test
able and willing to cooperate with the study
*absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and throughout the study duration

Exclusion Criteria:

current participation in another research protocol or unable to give informed consent
women with a positive urine pregnancy test or breastfeeding
history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue
+ hydrogen breath test for bacterial overgrowth
+ antiendomysial antibody titer
use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study
known allergy to glutamine
abdominal surgery except for removal of gallbladder, uterus, or appendix
Abnormal blood urea nitrogen(BUN) and/or creatinine
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 427
Group description: Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients, of age 18 - 54 years
Patients diagnosed with stage 1 or stage 2 essential hypertension
Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

Secondary hypertension or severe hypertension
History of Type 1 diabetes mellitus
A medical contraindication to discontinuing a current antihypertensive therapy
Clinically significant respiratory disease that prohibit use of a beta blocker
Intervention: Betamethasone
Trial phase: Not Applicable
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 314
Group description: Dexamethasone: 0.5mg/kg (max dose 20mg)
Eligibility criteria:
Inclusion Criteria:

Patients ages 3 to 18 undergoing tonsillectomy or adenotonsillectomy by electrocautery alone for the indication of sleep disordered breathing or infectious tonsillitis.
Patients with complex medical conditions or craniofacial abnormalities will be included.
Informed consent and child assent are required for enrollment.
Eligibility will be determined by the principal investigator, associate investigator or research nurse.

Exclusion Criteria:

Subjects with a known personal or family history of any bleeding disorder will be excluded.
Subjects currently on oral corticosteroids for other medical conditions or have recently taken any oral corticosteroid within two weeks of surgery.
Patients with tonsillectomy performed using a cold knife technique, microdebrider, coblation or plasma knife due to surgeon or parent preference.
Where appropriate subjects who do not have informed consent or child assent signed will be excluded
Children less than three years old will be excluded due to the fact the majority of these children at the collaborating centers have an adenotonsillectomy using the microdebrider for pain control purposes.
Intervention: Pyridostigmine Bromide
Trial phase: Phase 2
SMILES: CN(C)C(=O)Oc1ccc[n+](C)c1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Forced titration protocol 15-60 mg every 8 hours as tolerated

Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue.
Eligibility criteria:
Inclusion Criteria:

Age 21-75 years
Symptomatic NYHA Class II-III heart failure >6 months
Left ventricular ejection fraction <35%
Previous implantation of implantable cardiovertor defibrillator or pacemaker
Guideline-recommended heart failure treatment for > 3 months
Able and willing to provide written informed consent

Exclusion Criteria:

Contraindications to cholinergic stimulation
Heart failure primarily attributable to genetic, valvular, infiltrative diseases
Persistent atrial fibrillation
Sick sinus syndrome
Pacemaker dependency during exercise
Severe chronotropic incompetence with peak exercise heart rate < 100 min-1
Severe exercise intolerance (unable to complete first stage of Bruce Protocol)
Coronary or cerebral atherothrombotic events within the past year
Hospitalization of emergency room visit for heart failure within last 3 months
ICD shock in last 6 months
Diabetes mellitus with peripheral neuropathy
Autonomic or peripheral neuropathy of any cause
Systolic blood pressure <90 or >160 mmHg
Resting heart rate <60 or >100 min-1
Serum sodium < 132 mmol/L
Serum creatinine >2.5 mg/dl
Liver function tests >3 times upper limit of normal
Severe anemia (Hemoglobin <10 gm/dl)
FEV1.0 < 60% of predicted or FEV1.0/FVC ratio <70%
PR interval >240 msec or second or third degree heart block on electrocardiogram
Exercise limited primarily by angina or non-cardiac co-morbid condition
Pregnant or breast-feeding women
Current treatment with medications known to interact with pyridostigmine
Known intolerance of oral preparations containing bromides
Any condition (e.g., psychiatric illness or active substance abuse) or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's ability to adhere with study procedures.
Intervention: Pyridostigmine Bromide
Trial phase: Phase 2
SMILES: CN(C)C(=O)Oc1ccc[n+](C)c1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Matching placebo forced titration 15-60 mg as tolerated

Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue.
Eligibility criteria:
Inclusion Criteria:

Age 21-75 years
Symptomatic NYHA Class II-III heart failure >6 months
Left ventricular ejection fraction <35%
Previous implantation of implantable cardiovertor defibrillator or pacemaker
Guideline-recommended heart failure treatment for > 3 months
Able and willing to provide written informed consent

Exclusion Criteria:

Contraindications to cholinergic stimulation
Heart failure primarily attributable to genetic, valvular, infiltrative diseases
Persistent atrial fibrillation
Sick sinus syndrome
Pacemaker dependency during exercise
Severe chronotropic incompetence with peak exercise heart rate < 100 min-1
Severe exercise intolerance (unable to complete first stage of Bruce Protocol)
Coronary or cerebral atherothrombotic events within the past year
Hospitalization of emergency room visit for heart failure within last 3 months
ICD shock in last 6 months
Diabetes mellitus with peripheral neuropathy
Autonomic or peripheral neuropathy of any cause
Systolic blood pressure <90 or >160 mmHg
Resting heart rate <60 or >100 min-1
Serum sodium < 132 mmol/L
Serum creatinine >2.5 mg/dl
Liver function tests >3 times upper limit of normal
Severe anemia (Hemoglobin <10 gm/dl)
FEV1.0 < 60% of predicted or FEV1.0/FVC ratio <70%
PR interval >240 msec or second or third degree heart block on electrocardiogram
Exercise limited primarily by angina or non-cardiac co-morbid condition
Pregnant or breast-feeding women
Current treatment with medications known to interact with pyridostigmine
Known intolerance of oral preparations containing bromides
Any condition (e.g., psychiatric illness or active substance abuse) or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's ability to adhere with study procedures.
Intervention: Voriconazole
Trial phase: Phase 4
ATC code: J02AC03
SMILES: C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Voriconazole dose will be adjusted based on per protocol obtained TDM levels

Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels
Eligibility criteria:
Inclusion Criteria:

Indication for voriconazole administration: proven, probable, or possible IMI, excluding zygomycosis (based on the revised EORTC/MSG consensus definitions) [De Pauw, Clin Infect Dis. 2008; 46:1813].
Male or female ≥12 years of age.
Evidence of a personally signed and dated informed consent document in accordance with local regulatory and legal requirements indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Known history of allergy, hypersensitivity or serious reaction to azole antifungals.
Patients with aspergilloma or allergic bronchopulmonary aspergillosis (ABPA).
Patients with chronic invasive aspergillosis with duration of symptoms or radiological finding for more than 4 weeks prior to study entry.
Patients who are receiving and cannot discontinue the following drugs at least 24 hours prior to randomization: terfenadine, pimozide or quinidine (because of the possibility of QT prolongation), St John's wort preparation.
Patients receiving any of the following medications: sirolimus, rifampin, rifabutin, carbamazepine, long acting barbiturates (e.g., phenobarbital, mephobarbital), ritonavir, efavirenz, or ergot alkaloids (e.g., ergotamine, dihydroergotamine).
Receipt of more than 5 days of voriconazole as treatment prior to enrollment.
Receipt of 7 days or more of systemic antifungal treatment for the current episode of IMI.
Severe liver dysfunction (defined as total bilirubin, AST, ALT, or alkaline phosphatase >5x upper limit of normal). Local laboratory results may be used to qualify individuals for enrollment.
Patients with any condition which, in the opinion of the investigator, could affect patient safety, preclude evaluation of response, or make it unlikely that the proposed course of therapy can be completed.
Patients who have already participated in this trial within the last 30 days.
Patients with a high likelihood of death due to factors unrelated to IA (e.g., due to relapsed malignancy, severe GVHD, other underlying diseases, etc.) within 30 days following planned enrollment (investigator's discretion).
Patients that weigh <45 and >120 kg, respectively, upon enrollment. If patients' weight is beyond those limits upon serial assessments during the study period, the study monitor should be contacted and decisions to keep or withdraw subject from the study will be made.
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 170
Group description: Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability.
Eligibility criteria:
Inclusion Criteria:

The participants successfully completed the final assessment visit in either Study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352). The participants completed all required assessments for the Week 8/Early Termination Visit to be eligible for rollover in to this open-label trial.
Written informed consent form (ICF) obtained from a legally acceptable representative & informed assent at Baseline as applicable by trial center's Institutional review board/independent ethics committee (IRB/IEC).
The participant, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.

Exclusion Criteria:

The participants experienced adverse events (AEs) during the double-blind study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
The participants had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the participant a poor candidate for the trial.
A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which will result in early termination at Week 1.
Sexually active patients who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 and 30 days following the last dose of study drug for male and female respectively.
Participants representing Risk of committing suicide.
Body weight lower than 16 kg.
Abnormal laboratory test results (Platelet, Hemoglobin, Neutrophils, Aspartate aminotransferase, Alanine aminotransferase, Creatinine) vital signs and Electrocardiogram (ECG) results.
Intervention: Diazepam
Trial phase: Phase 2
ATC code: N05BA01
SMILES: CN1C(=O)CN=C(c2ccccc2)c2cc(Cl)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Diazepam: single-dose; dosage in mg, based on patient body weight
Eligibility criteria:
Inclusion Criteria:

Provide signed informed consent for study participation.
General good health with no clinically significant unstable abnormalities.
Diagnosis of epilepsy.

Exclusion Criteria:

Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®).
Use of any investigational drug within 30 days.
Blood or plasma donation within 30 days.
Not willing or unable to tolerate blood draws.
Intervention: Aliskiren
Trial phase: Phase 2 | Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
Eligibility criteria:
Inclusion Criteria: Patients, both males and females, were eligible if they were ≥ 45 years of age, with previously documented cardiovascular disease, defined as at least one of the following: myocardial infarction (MI), cerebrovascular accident (CVA), coronary bypass surgery and/or percutaneous intervention, peripheral arterial disease (PAD), defined as ankle brachial index (ABI) <0.9 and/or prior peripheral intervention/surgery. Subjects on angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB) therapy were eligible to participate, provided no dose adjustments were made during the course of the study.

Exclusion Criteria: Contraindications to the MRI exam (pacemakers, metallic implants, severe claustrophobia); diagnosis of Type II Diabetes or use of hypoglycemic drugs; uncontrolled hypertension (>145/90 mm Hg); low density lipoprotein (LDL) of ≥ 130mg/dL; renal insufficiency defined as glomerular filtration rate (GFR) ≤ 40 ml/minute (derived by the Modified Diet in Renal Disease (MDRD) equation); initiation of new therapy with statins, ACEI/ARBs, anti-oxidants, calcium channel blockers, diuretics, β blockers; transient ischemic cerebral attack during the prior 6 months; history of allergy to renin inhibitors; unstable cardiac syndromes; symptomatic arrhythmias; history of malignancy including leukemia and lymphoma (but not basal cell skin cancer, cured squamous cell cancer and localized prostate cancer) and history of allergy to renin inhibitors.
Intervention: Human Menopausal Gonadotrophin
Trial phase: Phase 4
ATC code: G03GA02
SMILES: CC(C)(C)CCCCC=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 62
Group description: The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
Eligibility criteria:
Main Inclusion Criteria:

Infertile pre-menopausal female subjects
Documented history of infertility (eg., unable to conceive for at least 1 year, or 6 months for women ≥36 years of age, or women with bilateral tubal occlusion or absence, or subjects who require donor sperm).
Subject's male partner with semen analysis that was at least adequate for intracytoplasmic sperm injection (ICSI) within 6 months prior to the subjects beginning down-regulation with gonadotropin-releasing hormone (GnRH)-agonist. Partners with severe male factor requiring invasive or surgical sperm retrieval or donor sperm could have been used.
Anti-mullerian hormone (AMH) > 1 ng/mL and < 3 ng/mL at screening.
Eligible for in-vitro fertilisation (IVF) or ICSI treatment.

Main Exclusion Criteria:

Oocyte donor or embryo recipient; gestational or surrogate carrier
Previous IVF or assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response was defined as development of ≤ 2 mature follicles or history of 2 previous failed cycle cancellations prior to oocyte retrieval due to poor response.
Inadequate number of oocytes, defined as fewer than 5 oocytes retrieved in previous ART attempts.
Subject's male partners with obvious leukospermia (>2 million white blood cells [WBC]/mL) or signs of infection in semen sample within 2 months of the start of subject's pituitary down-regulation. If either of these conditions existed, the male was to be treated with antibiotics and retested prior to subject's pituitary down-regulation.
Undergoing blastomere biopsy and other experimental ART procedures.
Body mass index (BMI) of ≤18 and ≥32 kg/m^2
Intervention: MESALAMINE
Trial phase: Phase 1
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
Eligibility criteria:
Inclusion Criteria

Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period.

Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:

Male, or
Non-pregnant, non-lactating female
Females must be at least 90 days post-partum or nulliparous.

Exclusion Criteria

A history of current or recurrent disease that could affect the colon. This includes gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel Syndrome. Subjects who have a history of chronic constipation, which is physician diagnosed and treated, will also be excluded from the study (frequency of bowel movements >48 hours between samples).
A history of current or relevant serious, severe, or unstable (acute or progressive) physical or psychiatric illness.
A history of gastrointestinal surgery performed within the past 12 months prior to the first dose of investigational product, with the exception of an appendectomy.
A history of or current clinically relevant moderate or severe renal or hepatic impairment.
A history of asthma or bronchospasm associated with the use of 5-ASA or other non-steroidal anti-inflammatory drugs.
Known or suspected intolerance or hypersensitivity to the investigational product or metronidazole, closely related compounds, or any of the stated ingredients
A history of, or current, pancreatitis.
Intervention: Testosterone
Trial phase: Phase 2
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Total testosterone level <10.4 nanomoles per liter (nmol/L) [300 nanograms per deciliter (ng/dL)] at screening
Presents with 1 or more of the following symptom(s) of ejaculatory dysfunction: delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased ejaculatory volume, as determined by investigator assessment
Prostate-Specific Antigen (PSA) <4 nanograms per milliliter (ng/mL) at screening

Exclusion Criteria:

Sexual partner who is or becomes pregnant at any time during the study
Premature ejaculation as determined by investigator assessment
Currently receiving testosterone replacement therapy or have a history of insufficient response to testosterone replacement therapy for ejaculatory dysfunction symptoms
Currently receiving treatment with cancer chemotherapy or antiandrogens
History of use of estrogenizing agents
Current use of warfarin
History of selective serotonin reuptake inhibitor (SSRI) and/or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in the 6 months prior to screening
History of frequent opioid use within 30 days prior to screening, with exception of treatment for chronic pain as determined by investigator.
Body Mass Index (BMI) >35 kilograms per square meter (kg/m^2) at screening
Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic function
Hematocrit ≥50% at screening
Exhibit systolic blood pressure >170 millimeters of mercury (mm Hg) or <90 mm Hg or diastolic blood pressure >100 mm Hg or <50 mm Hg at screening (if stress is suspected, retest under basal conditions at screening), or have history of malignant hypertension
History of any of the following coronary conditions within 90 days of screening: myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (for example, angioplasty or stent placement)
Known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious nodules on digital rectal exam at screening
Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)