anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Prednisone
Trial phase: Phase 2
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Prednisone 5 mg once daily
Eligibility criteria:
Inclusion Criteria:

Meet the ACR / EULAR criteria for classification of RA
Have moderate to severe RA, defined as involving a minimum (≥6 total swollen and ≥6 total tender) of the 28 joints assessed
Have screening CRP levels of at least 0.6 mg/dl and a DAS28-CRP score ≥4.5
Have been on a stable dose of conventional DMARD therapy for at least 90 days without dosage adjustment or modification and should be able to maintain the same dose of conventional DMARD therapy during study participation (with or without glucocorticoid therapy

Exclusion Criteria:

Treatment-refractory patients are excluded
Has active cardiovascular disease, unless well controlled by appropriate treatment for a minimum of 3 months prior to screening
Is taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg
Is currently taking steroids at a daily prednisone dose, or the equivalent, of >10 mg
Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study
The need to continue the use of one or multiple NSAID's at the same time, or the use of acetaminophen on a chronic basis
All opiate use is prohibited
Use of any other medications or herbs used for the treatment of pain is prohibited
Patients with a history of or currently active tuberculosis as per specific country guidelines are excluded
Has uncontrolled diabetes mellitus as defined by a serum glucose >126 mg/dl
Knowingly has HIV infection or hepatitis
Has undergone administration of any investigational drug within 30 days of study initiation
All biologic agents are excluded for 90 days prior to Screening and throughout the study.
Has undergone administration of rituximab or any B-cell depleting investigational drugs within 6 months of study initiation
Has had a history of alcohol or drug abuse within the past 2 years
Has a history of hypersensitivity to glucocorticoids and/or dipyridamole
Intervention: Ethyl 2-(4-fluoro-7-methylsulfonyloxy-6,7,8,9-tetrahydropyrido[1,2-a]indol-10-yl)acetate
Trial phase: Phase 1
SMILES: CCOC(=O)Cc1c2n(c3c(F)cccc13)CC(OS(C)(=O)=O)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
Eligibility criteria:
Inclusion Criteria:

If female, must be of non-childbearing potential
Have a history of mild to moderate asthma for at least 6 months
Other than asthma, in general good health
Able to perform reproducible pulmonary function testing
Is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 12 months
Have body mass index (BMI) ≥17 kg/m^2, but ≤35 kg/m^2

Exclusion Criteria:

Demonstrate a decrease in absolute forced expiratory volume in 1 second (FEV1) of >20% from the Screening Visit to the Baseline Visit
Experience a decrease in AM or PM peak expiratory flow (PEF) below the Stability Limit on any 2 consecutive days prior to the Baseline Visit
Require the use of >8 inhalations per day of short-acting beta2-agonist metered dose inhaler (MDI) or >2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the Screening Visit up to the Baseline Visit
Experience an exacerbation defined as a clinical deterioration of asthma, as judged by the clinical investigator, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded medication (other than short-acting beta agonists [SABA]) at any time from the Screening Visit up to the Baseline Visit
Have been hospitalized for treatment of asthma or required oral corticosteroids for treatment of asthma within the past 6 months, or has ever required ventilator support for respiratory failure secondary to asthma
Require the chronic use of high-dose inhaled corticosteroids
Have been diagnosed with chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease, other than asthma
Have a history of any illness that might confound the results of the study or poses additional risk to the participant
Have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory tract infection
Is nursing
Have a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
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: 20
Group description: Subjects received testosterone gel 2% at dose of 1.25 mL (1 stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
Eligibility criteria:
Inclusion Criteria:

Ages 18-65
History of hypogonadism
In good health based on medical history, physical examination and clinical laboratory tests
Screening morning serum testosterone ≤ 297 ng/dL
One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
Body mass index (BMI) between 18 and 31

Exclusion Criteria:

Prostate cancer
Palpable prostatic mass(es)
Generalized skin irritation or significant skin disease
Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride, ketoconazole)
Clinically significant anemia or renal dysfunction
Hyperparathyroidism or uncontrolled diabetes
Serum PSA Levels; ≥ 4ng/mL
History of cardiovascular disease
Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)
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: 20
Group description: Subjects received testosterone gel 2% at dose of 2.50 mL (2 strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
Eligibility criteria:
Inclusion Criteria:

Ages 18-65
History of hypogonadism
In good health based on medical history, physical examination and clinical laboratory tests
Screening morning serum testosterone ≤ 297 ng/dL
One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
Body mass index (BMI) between 18 and 31

Exclusion Criteria:

Prostate cancer
Palpable prostatic mass(es)
Generalized skin irritation or significant skin disease
Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride, ketoconazole)
Clinically significant anemia or renal dysfunction
Hyperparathyroidism or uncontrolled diabetes
Serum PSA Levels; ≥ 4ng/mL
History of cardiovascular disease
Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)
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: 20
Group description: Subjects received testosterone gel 2% at dose of 3.75 mL (3 strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
Eligibility criteria:
Inclusion Criteria:

Ages 18-65
History of hypogonadism
In good health based on medical history, physical examination and clinical laboratory tests
Screening morning serum testosterone ≤ 297 ng/dL
One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
Body mass index (BMI) between 18 and 31

Exclusion Criteria:

Prostate cancer
Palpable prostatic mass(es)
Generalized skin irritation or significant skin disease
Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride, ketoconazole)
Clinically significant anemia or renal dysfunction
Hyperparathyroidism or uncontrolled diabetes
Serum PSA Levels; ≥ 4ng/mL
History of cardiovascular disease
Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)
Intervention: Omeprazole
Trial phase: Phase 3
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: Placebo for Esomeprazole
Eligibility criteria:
Inclusion Criteria:

Males and non-pregnant ,non-lactating females 18 years or older
Experience heartburn at least 2 days a week
Having heartburn that has responded to heartburn medication
Must discontinue any current heartburn medications

Exclusion Criteria:

Having a history of erosive esophagitis verified by endoscopy
Having a history of GERD which was diagnosed by a physician
Inability to take study medication or complete the study and all study procedures
Subjects that have required more than one 14-day course of PPI treatment within the past 4 months
Intervention: Omeprazole
Trial phase: Phase 3
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 158
Group description: Placebo for Esomeprazole
Eligibility criteria:
Inclusion Criteria:

Males and non-pregnant ,non-lactating females 18 years or older
Experience heartburn at least 2 days a week
Having heartburn that has responded to heartburn medication
Must discontinue any current heartburn medications

Exclusion Criteria:

Having a history of erosive esophagitis verified by endoscopy
Having a history of GERD which was diagnosed by a physician
Inability to take study medication or complete the study and all study procedures
Subjects that have required more than one 14-day course of PPI treatment within the past 4 months
Intervention: Revexepride
Trial phase: Phase 2
SMILES: COCCCN1CCC(CNC(=O)c2cc(Cl)c(N)c3c2OC(C)(C)C3)C(O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: 0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
Eligibility criteria:
Inclusion criteria:

Written ICF signed voluntarily before the first trial related activity.
Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation) during the last 6 months
Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.
≥3 days per week with heartburn and/or regurgitation symptoms of at least moderate severity and a minimum of 25 liquid containing reflux events over 24h (pH/MII monitoring).

Exclusion criteria:

Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic, cancer or AIDS.
Alarm symptoms suggestive of malignancies or organic disease.
Intervention: Ketamine
Trial phase: Phase 1 | Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride

Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.
Eligibility criteria:
Inclusion Criteria:

Male or female patients, 21-65 years
Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
Primary diagnosis of Obsessive-Compulsive Disorder as assessed by the SCID-P, with symptoms for at least 1 year (Patients who meet criteria for OCD will be required to be medication free or have all psychotropics aside from SSRIs and as needed benzodiazepines tapered. Prior to study entry, proscribed psychotropics are tapered, and subjects must be on the same SSRI for at least 8 weeks with no change in dose for at least 4 weeks and throughout the study. However, subjects will be allowed to use benzodiazepines as needed throughout the study.)
History of a failure to respond to at least two (2) adequate pharmacotherapy trials and CBT for OCD
Subjects must have scored ≥ 21 on the Y-BOCS at Screening, and to not be in remission on Treatment Day #1, and Treatment Day #2
Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria:

Women who plan to become pregnant within the next six months, are pregnant or are breast-feeding
Non-English speakers
Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG
Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, or pervasive developmental disorders
Current evidence of psychotic or manic symptoms
Drug or alcohol abuse or dependence within the preceding 6 months
Lifetime abuse or dependence on ketamine or phencyclidine
Patients judged by study investigator to be at high risk for suicide
Current use of psychotropics other than SSRIs
Intervention: Midazolam
Trial phase: Phase 1 | Phase 2
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam

Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.
Eligibility criteria:
Inclusion Criteria:

Male or female patients, 21-65 years
Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
Primary diagnosis of Obsessive-Compulsive Disorder as assessed by the SCID-P, with symptoms for at least 1 year (Patients who meet criteria for OCD will be required to be medication free or have all psychotropics aside from SSRIs and as needed benzodiazepines tapered. Prior to study entry, proscribed psychotropics are tapered, and subjects must be on the same SSRI for at least 8 weeks with no change in dose for at least 4 weeks and throughout the study. However, subjects will be allowed to use benzodiazepines as needed throughout the study.)
History of a failure to respond to at least two (2) adequate pharmacotherapy trials and CBT for OCD
Subjects must have scored ≥ 21 on the Y-BOCS at Screening, and to not be in remission on Treatment Day #1, and Treatment Day #2
Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria:

Women who plan to become pregnant within the next six months, are pregnant or are breast-feeding
Non-English speakers
Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG
Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, or pervasive developmental disorders
Current evidence of psychotic or manic symptoms
Drug or alcohol abuse or dependence within the preceding 6 months
Lifetime abuse or dependence on ketamine or phencyclidine
Patients judged by study investigator to be at high risk for suicide
Current use of psychotropics other than SSRIs
Intervention: Sandostatine
Trial phase: Phase 4
SMILES: CC(=O)O.CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery

Octreotide LAR
Eligibility criteria:
Inclusion Criteria:

Carry a diagnosis of de novo acromegaly with an elevated age and sex matched IGF-I and GH >1ng/ml at all time points during OGTT
Have a pituitary macroadenoma
Have clinical changes consistent with acromegaly
Have a single random serum hGH of 12.5 ng/ml or greater
Both the endocrinologist and surgeon must agree that the patient's health would not be compromised by a three-month period during which time Octreotide LAR is administered.
Patients currently on dopamine agonist who agree to discontinue medication (2-6 week washout required)

Exclusion Criteria:

Pregnant or breastfeeding
Documented loss of vision due to pituitary tumor
Prior treatment for acromegaly other than dopamine agonists
Inability to complete the protocol
Intolerance to octreotide
Intervention: Solifenacin Succinate
Trial phase: Phase 4
SMILES: O=C(O)CCC(=O)O.O=C(OC1CN2CCC1CC2)N1CCc2ccccc2C1c1ccccc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 313
Group description: Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
Eligibility criteria:
Inclusion Criteria:

Ambulatory
Willing and able to complete the daily pad use diary,

American Urology Association Symptom Score (AUASS) with Bother Score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and the Work Productivity and Activity Impairment Questionnaire (WPAI)

Has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment
Diagnosed with prostate cancer, treated by Robotic Assisted Radical Prostatectomy, is voiding spontaneously and has urinary incontinence one week after removal of the indwelling catheter which requires management with 2 to 10 pads inclusive per day (24 hour days) for 7 consecutive days

Exclusion Criteria:

Evidence of severe neurologic damage post-prostatectomy
Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder
Symptomatic for urinary tract infection or has a urine culture result which requires treatment as determined by the investigator.
Clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine clearance < 30 ml/min)
History of diagnosed gastrointestinal obstruction disease
Any prior history of local radiation therapy to the prostate or rectum or any prior hormonal therapy or has planned such therapy during study conduct
Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
Treated with any investigational drug within last 30 days
History of a clinically significant illness or medical condition that would preclude participation in the study
Diagnosed with New York Heart Association Class III and IV heart failure
Any of the following peri-operative laboratory results: ALT > 2.0 ULN, AST > 2.0 ULN, serum creatinine > 1.5 mg/L, blood glucose > 130 mg/dL, blood urea nitrogen (BUN) > 23 mg/dL.
Severe hypertension on peri-operative evaluation which is defined as a sitting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, and which is not corrected
Electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Can be eligible if electrolytes are corrected to within normal range prior to randomization
Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of Screening.
Intervention: Intralipid
Trial phase: Phase 4
SMILES: CCCCCC=CCC=CCCCCCCCC(=O)O.CCCCCCCCC=CCCCCCCCC(=O)OC(COC(=O)CCCCCCCCCCCCCCC)COP(=O)(O)OCC[N+](C)(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).

Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.
Eligibility criteria:
Inclusion Criteria:

congenital or acquired gastrointestinal disorder
age less than 5 days of life

Exclusion Criteria:

congenital intrauterine infection know to be associated with liver involvement
known structural liver abnormalities
known genetic disorders (trisomy 21, 13, and 18)
inborn errors of metabolism
infants meeting the criteria for terminal illness (ph:6.8>2 hours)
Intervention: Intralipid
Trial phase: Phase 4
SMILES: CCCCCC=CCC=CCCCCCCCC(=O)O.CCCCCCCCC=CCCCCCCCC(=O)OC(COC(=O)CCCCCCCCCCCCCCC)COP(=O)(O)OCC[N+](C)(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).

Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.
Eligibility criteria:
Inclusion Criteria:

congenital or acquired gastrointestinal disorder
age less than 5 days of life

Exclusion Criteria:

congenital intrauterine infection know to be associated with liver involvement
known structural liver abnormalities
known genetic disorders (trisomy 21, 13, and 18)
inborn errors of metabolism
infants meeting the criteria for terminal illness (ph:6.8>2 hours)