anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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 in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
Eligibility criteria:
Inclusion Criteria:

Ages 18-75
History of hypogonadism
In good health based on medical history, physical examination, and clinical laboratory tests
Serum testosterone deficiency
One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
Body mass index (BMI) between 18 and 35 kg/m^2
All screening lab tests within 20% of the normal range (exceptions are liver function tests)
HIV, Hepatitis B and C negative

Exclusion Criteria:

Previous use of FE 999303
Prostate cancer
Breast carcinoma, patient or partner
Palpable prostatic mass(es)
Serum PSA levels ≥3 ng/dL
Chronic use of any drug of abuse
Lower urinary tract obstruction
Clinically significant anemia or renal dysfunction
Cardiovascular disease
Hyperparathyroidism or uncontrolled diabetes
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, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
Sleep apnea
Untreated depression
Subject with a partner who is pregnant or will not use contraception
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 169
Group description: Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section

Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section

After interim analysis, the genetics part of the analysis was dropped and the study completed and analyzed with 54 in this group
Eligibility criteria:
Inclusion Criteria:

healthy women undergoing elective cesarean

Exclusion Criteria:

cardiovascular disease
analgesic medications
complications of pregnancy
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 169
Group description: Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section

Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section

After interim analysis, the genetics part of the analysis was dropped and the study completed and analyzed with 43 in this group
Eligibility criteria:
Inclusion Criteria:

healthy women undergoing elective cesarean

Exclusion Criteria:

cardiovascular disease
analgesic medications
complications of pregnancy
Intervention: Preladenant
Trial phase: Phase 1
SMILES: COCCOc1ccc(N2CCN(CCn3ncc4c3nc(N)n3nc(-c5ccco5)nc43)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
Eligibility criteria:
Key Inclusion Criteria for Healthy Participants Groups:

Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.

Key Inclusion Criteria for Hepatic Impaired Groups:

Must have mild or moderate hepatic impairment.
Must have a diagnosis of chronic liver disease for >6 months.
Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.

Key Exclusion Criteria

Must not be on any prohibited medications for entry into the trial.
Intervention: Preladenant
Trial phase: Phase 1
SMILES: COCCOc1ccc(N2CCN(CCn3ncc4c3nc(N)n3nc(-c5ccco5)nc43)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
Eligibility criteria:
Key Inclusion Criteria for Healthy Participants Groups:

Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.

Key Inclusion Criteria for Hepatic Impaired Groups:

Must have mild or moderate hepatic impairment.
Must have a diagnosis of chronic liver disease for >6 months.
Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.

Key Exclusion Criteria

Must not be on any prohibited medications for entry into the trial.
Intervention: Preladenant
Trial phase: Phase 1
SMILES: COCCOc1ccc(N2CCN(CCn3ncc4c3nc(N)n3nc(-c5ccco5)nc43)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
Eligibility criteria:
Key Inclusion Criteria for Healthy Participants Groups:

Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.

Key Inclusion Criteria for Hepatic Impaired Groups:

Must have mild or moderate hepatic impairment.
Must have a diagnosis of chronic liver disease for >6 months.
Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.

Key Exclusion Criteria

Must not be on any prohibited medications for entry into the trial.
Intervention: Preladenant
Trial phase: Phase 1
SMILES: COCCOc1ccc(N2CCN(CCn3ncc4c3nc(N)n3nc(-c5ccco5)nc43)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
Eligibility criteria:
Key Inclusion Criteria for Healthy Participants Groups:

Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.

Key Inclusion Criteria for Hepatic Impaired Groups:

Must have mild or moderate hepatic impairment.
Must have a diagnosis of chronic liver disease for >6 months.
Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.

Key Exclusion Criteria

Must not be on any prohibited medications for entry into the trial.
Intervention: Tofacitinib
Trial phase: Phase 3
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 476
Group description: Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
Eligibility criteria:
Inclusion Criteria:

Subject must be at least 18 years of age.
Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
Subjects with moderately to severely active UC based on Mayo score criteria.

Subjects must have failed or be intolerant of at least one of the following treatments for UC:

Corticosteroids (oral or intravenous).
Azathioprine or 6 mercaptopurine (6 MP).
Anti TNF-alpha therapy.

Exclusion Criteria:

Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
Subjects with disease limited to distal 15 cm.
Subjects without previous treatment for UC (ie, treatment naïve).
Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Liquid intranasal oxytocin administered in a nasal spray.

Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
Eligibility criteria:
Inclusion Criteria:

Men or women 18 to 65 years of age
Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (SCID) completed within the past 4 months.
Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures.
Subjects must be able to give informed consent and be willing and able to comply with study procedures.

Exclusion Criteria:

Presence of a current DSM-IV Axis I diagnosis as measured by the SCID.
A serious medical condition or other condition deemed likely to result in surgery or hospitalization, or which would make participation in the study difficult.
Patients with a history of trauma resulting in head injury related seizures or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
Use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics.
Pregnant or lactating women.
Women of childbearing potential not using medically accepted forms of contraception.
Current use of the excluded psychiatric medications.
Known hypersensitivity to oxytocin
Known hyponatremia.
Intervention: Fondaparinux
Trial phase: Phase 4
ATC code: B01AX05
SMILES: CO[C@H]1O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]2O[C@@H](C(=O)O)[C@@H](O[C@H]3O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]4O[C@H](C(=O)O)[C@@H](O[C@H]5O[C@H](COS(=O)(=O)O)[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)O)[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)O)[C@H]3NS(=O)(=O)O)[C@H](O)[C@H]2OS(=O)(=O)O)[C@H](O)[C@H]1NS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: These are patients with acute kidney injury not yet on dialysis

Fondaparinux: 2.5 mg every 48 hours
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years old and ≤ 89 years old
Body weight ≥ 50 kg or ≤ 150 kg
Estimated creatinine clearance of < 30 mL/min
Predicted ICU stay of more than 72 hours.

Exclusion Criteria:

Pregnant women
Infective Endocarditis
Neuraxial anesthesia or spinal puncture
Active bleeding
Treatment with vitamin K antagonists or therapeutic doses of unfractionated heparin
Signs of disseminated intravascular coagulation
Severe liver failure (serum bilirubin > 5 mg/dL)
Surgery planned within 24 hours of ICU admission
Latex allergy
Intervention: Triptorelin
Trial phase: Phase 3
ATC code: L02AE04
SMILES: CC(C)C[C@H](NC(=O)[C@@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 44
Group description: All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
Eligibility criteria:
Inclusion criteria:

Onset of development of sex characteristics before 8 and 9 years in girls and boys, respectively (breast development in girls or testicular enlargement in boys according to the Tanner method), and candidate to receive at least 12 months of GnRH agonist therapy after study entry.
Aged 2-8 years inclusive (i.e. < 9 years) for girls and 2-9 years inclusive (i.e. < 10 years) for boys at initiation of triptorelin treatment.
Initiation of triptorelin treatment at the latest 18 months after onset of the first signs of precocious puberty.
Difference (Δ) bone age (Greulich and Pyle method) - chronological age ≥ 1 year.
Pubertal-type LH response 30 minutes following a GnRH agonist stimulation test before treatment initiation (leuprolide acetate 20 μg/kg SC) ≥ 6 IU/L.
Clinical evidence of puberty, defined as Tanner Staging ≥ 2 for breast development for girls and testicular volume ≥ 4 mL (cc) for boys.
Informed consent signed by one parent or both parents (as per local requirements), by the liable parent or by the legal guardian (when applicable); assent signed by the child if ≥ 7 years.

Non-inclusion criteria:

Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion.
Non-progressing isolated premature thelarche.
Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Patients with hamartomas not requiring surgery are eligible.
Evidence of renal (creatinine > 2 x ULN) or hepatic impairment (bilirubin or ASAT > 3 x ULN).
Any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use [except mild topical steroids], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumour).
Prior or current therapy with a GnRH agonist, medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF 1).
Major medical or psychiatric illness that could interfere with study visits.
Diagnosis of short stature, i.e. > 2.25 SD below the mean height for age.
Positive pregnancy test.
Known hypersensibility to any of the test materials or related compounds.
Use of anticoagulants (heparin and coumarin derivatives).
Intervention: Doxycycline
Trial phase: Not Applicable
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.

Doxycycline: 40 mg orally at the start of cycle 3 (study day 57) for 28 days.
Eligibility criteria:
Inclusion Criteria:

Women between the ages 18 and 45 who are ovulatory as demonstrated by a pre-treatment Progesterone (P) greater than or equal to 3.0 ng/mL prior to oral contraceptive use

Exclusion Criteria:

Women with any absolute contraindications to ethinyl estradiol and levonorgestrel;
Women who are pregnant or breastfeeding
Use of oral contraceptives, patch, ring, intrauterine or implantable hormonal contraception within 4-weeks;
Medroxyprogesterone acetate use within six months;
Current use of drugs that interfere with sex steroid metabolism.
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: 44
Group description: 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
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 sulfamethoxazole/trimethoprim, closely related compounds, or any of the stated ingredients
A history of, or current, pancreatitis
Intervention: Fluocinonide
Trial phase: Phase 2
ATC code: C05AA11 | D07AC08 | D07CC05
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.
Eligibility criteria:
Inclusion Criteria:

Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (parent permission and assent if applicable).
Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4 in the Investigator Global Assessment).
Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a 100-point scale.
Percentage of overall body surface area of involvement (BSA) must be ≥2%.
Women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.

Exclusion Criteria:

Use within four weeks from Baseline any systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
Application or use within two weeks of Baseline topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.
Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
Use of anti-histamines while participating in the study will not be permitted unless the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.
Amount of disease involvement that would require >60 gm of cream in a 1 week period.
Subjects with known allergy or sensitivity to topical Vanos® cream or components.
Pregnant women
Women who are breastfeeding
Intervention: Solifenacin
Trial phase: Not Applicable
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 58
Group description: patients in this arm will receive drug

solifenacin: patient will receive solifenacin 5mg daily or placebo daily
Eligibility criteria:
Inclusion Criteria:

Women between the ages of 18 and 89
Incontinence in the form of post void dribbling that occurs at least twice weekly.

Exclusion Criteria:

Severe renal or hepatic disease.
Active urinary tract infection.
Glaucoma.
Stress incontinence as the only incontinence symptom
Urge incontinence as the only incontinence symptom
Chronic severe constipation.
History of bladder cancer.
Known or suspected hypersensitivity to anticholinergics.
Any clinical condition that would not allow safe completion of the study.
Pregnancy or lactation, intention to become pregnant during the study, or use of an unreliable birth control method in women of childbearing potential. Reliable forms of contraception include: permanent sterilization of either partner, hormonal contraception (oral contraceptive, Nuva ring, contraceptive patch, depoprovera, implants), intrauterine device (IUD), and condoms. Abstinence is considered a reliable form of contraception, but abstinent subjects will be informed that they need to use condoms or other form of birth control mentioned above if they become sexually active during the study.
Presently on systemic anti-cholinergic therapy or who have been on therapy within the last 4 weeks. Anti-cholinergic drugs include; darifenacin, fesoterodine, hyoscyamine, oxybutynin, solifenacin, tolterodine, and trospium.
Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.