anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cetirizine
Trial phase: Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Eligibility criteria:
Inclusion Criteria:

positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

known contraindications or sensitivities to the study medication or its components
any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Participants will be randomized 1:1 to either Ketamine (experimental condition) or Methohexital anesthesia (active comparator)

Ketamine: Ketamine 1-2 mgr/ kg IV
Eligibility criteria:
Inclusion Criteria:

Male or female subjects 18 to 70 years of age
Diagnostic Statistical Manual (DSM) IV diagnosis of Major Depression (296.3), unipolar without psychotic features or Bipolar I or Bipolar II Depression without psychotic features confirmed by Structured Clinical Interview for DSM-IV (SCID-IV) interview
Pretreatment 24-item Hamilton Rating Scale for Depression score > 21
Subjects must have an initial score of at least 20 on the Montgomery-Asbergers Depression Rating Scale (MADRS) at screen
ECT is clinically indicated
Patient is competent to provide informed consent

Exclusion Criteria:

Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the DSM-IV
Current (within the last year) diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression
Current diagnosis of delirium, dementia, or amnestic amnesiac disorder
Diagnosis of Mental Retardation
Baseline Mini Mental State Exam (MMSE) score < 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less
Any active general medical condition or central nervous system (CNS) disease which can affect cognition or response to treatment
Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
Lifetime history of ketamine or phencyclidine (PCP) abuse or dependence
ECT within three months
The presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension, arrhythmia, severe coronary artery disease and porphyria
Pregnancy
Status 4 or greater according to the criteria of the American Society of Anesthesiologists
MRI contraindications
Intervention: Methohexital
Trial phase: Phase 4
ATC code: N01AF01 | N05CA15 | N05CB01
SMILES: C=CCC1(C(C)C#CCC)C(=O)NC(=O)N(C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Participants will be randomized 1:1 to either Ketamine (experimental condition) or Methohexital anesthesia (active comparator)

Methohexital: Methohexital 0.5-1mg/kg IV
Eligibility criteria:
Inclusion Criteria:

Male or female subjects 18 to 70 years of age
Diagnostic Statistical Manual (DSM) IV diagnosis of Major Depression (296.3), unipolar without psychotic features or Bipolar I or Bipolar II Depression without psychotic features confirmed by Structured Clinical Interview for DSM-IV (SCID-IV) interview
Pretreatment 24-item Hamilton Rating Scale for Depression score > 21
Subjects must have an initial score of at least 20 on the Montgomery-Asbergers Depression Rating Scale (MADRS) at screen
ECT is clinically indicated
Patient is competent to provide informed consent

Exclusion Criteria:

Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the DSM-IV
Current (within the last year) diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression
Current diagnosis of delirium, dementia, or amnestic amnesiac disorder
Diagnosis of Mental Retardation
Baseline Mini Mental State Exam (MMSE) score < 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less
Any active general medical condition or central nervous system (CNS) disease which can affect cognition or response to treatment
Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
Lifetime history of ketamine or phencyclidine (PCP) abuse or dependence
ECT within three months
The presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension, arrhythmia, severe coronary artery disease and porphyria
Pregnancy
Status 4 or greater according to the criteria of the American Society of Anesthesiologists
MRI contraindications
Intervention: GLYCEROL PHENYLBUTYRATE
Trial phase: Phase 1
ATC code: A16AX09
SMILES: O=C(CCCc1ccccc1)OCC(COC(=O)CCCc1ccccc1)OC(=O)CCCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Open Label Study

Ravicti: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day
Eligibility criteria:
Inclusion Criteria:

confirmation of a diagnosis of MCAD deficiency
at least one copy of 985A>G MCAD mutation
ability to follow protocol

Exclusion Criteria:

positive pregnancy test
currently breastfeeding
currently taking any medication for which there is a potential drug interaction with Ravicti, includes corticosteroids, valproic acid, haloperidol, and probenecid
liver or kidney insufficiency
Intervention: Tritriacontanoic acid
Trial phase: Phase 4
SMILES: CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal

Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of non-erosive form of Gastroesophageal Reflux disease
Dietary fiber deficiency by dietary questionnaire
pathological gastroesophageal reflux by 24-hours esophageal pH-impedance examination
willingness to participate (signed informed consent)

Exclusion Criteria:

presence of esophageal mucosal damages (esophagitis) by endoscopic evaluation
gastrointestinal surgery in anamnesis
current pregnancy or breast-feeding
known hypersensitivity to Mucofalk or its components
Intervention: AQX-1125
Trial phase: Phase 2
SMILES: C=C1CC[C@H]2[C@H](CN)[C@@H]([C@@]3(C)CC[C@H](O)C[C@@H]3CO)CC[C@]12C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: 1 x AQX-1125 Capsule daily

AQX-1125: Synthetic SHIP1 activator
Eligibility criteria:
Inclusion Criteria:

Be females, ≥18 and ≤75 years of age, who have consistently had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 12 months
Have had the diagnosis of interstitial cystitis for > 6 months (pain for at least 12 months) but ≤15 years
Have average daily pain score of at least 5 out of 10 on the 11-point Numerical Rating Scale [NRS] pain scale in the 9 days prior to baseline
Have undergone a cystoscopy and have documented visible signs of bladder bleeding, lesions or glomerulation within the last 36 months prior to baseline.
Subjects if of child bearing potential, must agree to avoid pregnancy and use medically acceptable method of contraception from screening visit and throughout the study.
Must be capable of voiding independently

Exclusion Criteria:

Pelvic floor pain (>5 out of 10 on the 11-point NRS pain scale following a pelvic pain assessment)
Have a body mass index [BMI] of <18 kg/m2 or >39 kg/m2
Have had a urinary tract infection including bacterial cystitis within the past 30 days.
Have greater than 1+ hematuria on dipstick test at screening from an unknown cause
History of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis) that has affected bladder function
Intervention: Vildagliptin
Trial phase: Phase 4
ATC code: A10BD08 | A10BH02
SMILES: N#C[C@@H]1CCCN1C(=O)CNC12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy

vildagliptin: vildagliptin 50mg bid for 16 weeks
Eligibility criteria:
Inclusion Criteria:

Age in the range of 18 to 80 years
HbA1c 7 to 11%
FPG < 270 mg/dL (15 mmol/L);
Agreement to maintain prior diet & exercise
Written informed consent to participate in the study

Exclusion criteria:

Type 1 diabetes or Any kind of secondary diabetes
Pregnant or lactating women
Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
Significant diabetes complications e.g., symptomatic autonomic neuropathy or gastroparesis

Previous history of severe cardiovascular disease such as

Torsades de Pointes, sustained and clinically relevant ventricular tachycardia, or ventricular fibrillation
Percutaneous coronary intervention within the past 3 months

Any of the following within the past 6 months

Myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with an MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor)
Coronary artery bypass surgery
Unstable angina
Stroke
Congestive heart failure (NYHA class I to IV)
Liver disease such as cirrhosis or chronic active hepatitis
Known sensitivity to pioglitazone, rosiglitazone, or similar drugs
Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months
Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1

Any of the following laboratory abnormalities

Alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 times the upper limit of the normal range at visit 1
Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1
Serum creatinine levels > 2.5 mg/dL (220 μmol/L) at visit 1
Clinically significant thyroid-stimulating hormone (TSH) outside normal range at visit 1
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: 111
Group description: Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy

Pioglitazone: Pioglitazone 15mg bid for 16 weeks
Eligibility criteria:
Inclusion Criteria:

Age in the range of 18 to 80 years
HbA1c 7 to 11%
FPG < 270 mg/dL (15 mmol/L);
Agreement to maintain prior diet & exercise
Written informed consent to participate in the study

Exclusion criteria:

Type 1 diabetes or Any kind of secondary diabetes
Pregnant or lactating women
Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
Significant diabetes complications e.g., symptomatic autonomic neuropathy or gastroparesis

Previous history of severe cardiovascular disease such as

Torsades de Pointes, sustained and clinically relevant ventricular tachycardia, or ventricular fibrillation
Percutaneous coronary intervention within the past 3 months

Any of the following within the past 6 months

Myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with an MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor)
Coronary artery bypass surgery
Unstable angina
Stroke
Congestive heart failure (NYHA class I to IV)
Liver disease such as cirrhosis or chronic active hepatitis
Known sensitivity to pioglitazone, rosiglitazone, or similar drugs
Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months
Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1

Any of the following laboratory abnormalities

Alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 times the upper limit of the normal range at visit 1
Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1
Serum creatinine levels > 2.5 mg/dL (220 μmol/L) at visit 1
Clinically significant thyroid-stimulating hormone (TSH) outside normal range at visit 1
Intervention: Methyldopa
Trial phase: Not Applicable
ATC code: C02AB01
SMILES: C[C@](N)(Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: All participants selected to continue with Methyldopa administration.

Methyldopa: 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Type 1 Diabetes Mellitus
18-46 years of age
Residual C-peptide production during screening
Positive for at least one islet autoantibody: insulin (if only insulin autoantibody positive, determination must be within two weeks of insulin initiation), GAD-65, IA-2 or ZnT8
Positive for at least one gene encoding HLA-DQ8 (DQB*0302)
No history of difficult to control hypertension (defined as requiring > 2 anti-hypertensive medications)
Agree to intensive management of diabetes with an HgbA1c goal of < 8.0%
If female: (a) surgically sterile or (b) postmenopausal or (c) if of reproductive potential, willing to use medically acceptable birth control (e.g. female hormonal contraception, barrier methods or sterilization.) until study completion
If male and of reproductive potential, willing to use medically acceptable birth control until study completion, unless the female partner is postmenopausal or surgically sterile

Exclusion Criteria:

Unable or unwilling to comply with the requirements of the study protocol
No HLA-DQ8 gene (DQB*0302)
Difficult to control hypertension (defined as requiring > 2 anti-hypertensive medications)
History of postural hypotension or Addison's disease
Body Mass Index (BMI) > 30 kg/m2
Unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days
Administration of an experimental agent for T1D at any time or use of an experimental device for T1D within 30 days of screening, unless approved by the study PI
History of any organ transplant, including islet cell transplant
Active autoimmune or immune deficiency disorder (e.g. sarcoidosis, rheumatoid arthritis)
Anticipated pregnancy during the 12 week study period
Any social or medical condition that would, in the opinion of the investigator, prevent complete participation in the study or that would pose a significant hazard to the subjects' participation
History of active substance abuse within 12 months of screening
A psychiatric or medical disorder that would prevent giving informed consent
Intervention: Doconexent
Trial phase: Phase 3
SMILES: CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 30
Group description: Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 12 weeks

DHA Omega-3: Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 12 weeks
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent/assent
Ages 5-15 years old
Meets DSM-IV-TR criteria for ADHD as determined by the KSADS

Exclusion Criteria:

Contraindication to an MRI scan (i.e., braces, claustrophobia)
A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy)
Greater than 1 year outside appropriate age/grade level
A history of intolerance or hypersensitivity to omega-3 fatty acids
Currently taking omega-3 supplements
Not proficient in English language
Any history of a hematological disorder or concomitant use of anticoagulant medications
Personal history of an Axis I psychiatric disorder other than ADHD
Inability to swallow capsules
Intervention: Baricitinib
Trial phase: Phase 3
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 592
Group description: 2 mg Baricitinib administered orally once daily throughout the 96-week step-down period.
Eligibility criteria:
Inclusion Criteria:

Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)

Exclusion Criteria:

Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
Have a known hypersensitivity to baricitinib or any component of this investigational product
Had investigational product permanently discontinued at any time during a previous baricitinib study
Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
Intervention: Baricitinib
Trial phase: Phase 3
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 594
Group description: 4 mg Baricitinib administered orally once daily throughout the 96-week step-down period.
Eligibility criteria:
Inclusion Criteria:

Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)

Exclusion Criteria:

Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
Have a known hypersensitivity to baricitinib or any component of this investigational product
Had investigational product permanently discontinued at any time during a previous baricitinib study
Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
Intervention: Phentermine
Trial phase: Phase 4
ATC code: A08AA01 | A08AA51
SMILES: CC(C)(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 13
Group description: This describes all participants who received 37.5mg phentermine for one week.

Other names for phentermine:

adipex ionamin
Eligibility criteria:
Inclusion Criteria:

BMI between 30-40kg/m2
Stable weight (+5 lbs) for a minimum of 3 months
Systolic Blood Pressure <140mm Hg
Diastolic Blood Pressure <90 mm Hg
Pulse <95 beats per minute
English language proficiency

Exclusion Criteria:

Previous unsuccessful trial of phentermine
Prior adverse reaction to phentermine
On any antidepressant medications,especially monoamine oxidase inhibitors(MAOI)
History of neurological disorder (e.g. dementia)
History of moderate or severe head injury
Current or past history of coronary artery disease
Current or past history of stroke or transient ischemic attack
Current or past history of heart arrhythmias
Current of past history of congestive heart failure
Current or past history of peripheral artery disease
Current or past history of liver disease
Current or past history of kidney disease
Uncontrolled diabetes mellitus (type I or II)
Narrow-angle glaucoma
Hypo- or hyper-thyroidism not adequately treated
On medications (prescribed or OTC) known to affect appetite (e.g. diet pills), weight, or metabolism
Current or past history (within the past 12 months) of major depression
Current or past history (past 12 months) of alcohol or drug abuse or dependence
Current or past history (lifetime) of amphetamine abuse or dependence
Known history of learning disorder or developmental disability
Current or past Attention Deficit Hyperactivity Disorder (ADHD)
Pregnancy, planning to become pregnant, or lactation within the previous 6 months
Waist circumference greater than 188cm
Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo
Significant claustrophobia
Current or past history of anorexia nervosa,bulimia nervosa (within the past 12 months) or binge eating disorder (within the previous 6 months)