anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Quetiapine
Trial phase: Phase 2 | Phase 3
ATC code: N05AH04
SMILES: OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)

Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day

Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.

This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.

Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule.
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV Criteria for Bipolar Disorder, Type II, currently depressed;
HRSD-25 ≥15
Age 18-65 years;
Able to give informed consent;
Women of child bearing potential will be included if they agree to use adequate contraception for the duration of the study.

Exclusion Criteria:

Not competent to give informed consent in the opinion of the investigator (e.g., psychotic at time of evaluation);
Unwilling or unable to comply with study requirements;
Meets DSM-IV criteria for borderline personality disorder or antisocial personality disorder;
Active substance abuse within the past 6 months(episodic abuse related to mood episodes will not exclude a subject);
Currently a high suicide risk, as assessed by an active plan and intent to behave in a way that risks ending ones life;
Non-English speaking;
Significant, unstable, medical illness that might confound symptom scores or preclude treatment with pharmacotherapy
Currently applying for disability because of psychiatric illness (we have found that these individuals have a vested interested in appearing to remain ill which potentially confounds outcome scores).
Women who are pregnant, lactating or plan to become pregnant during their study participation.
Intervention: Sitagliptin Phosphate
Trial phase: Phase 3
SMILES: NC(CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
Eligibility criteria:
Inclusion Criteria:

Patients have type 2 diabetes mellitus on diet/exercise therapy

Exclusion Criteria:

Patients have type 1 diabetes mellitus
Intervention: Voglibose
Trial phase: Phase 3
ATC code: A10BF03
SMILES: OCC(CO)N[C@H]1C[C@](O)(CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 156
Group description: The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Eligibility criteria:
Inclusion Criteria:

Patients have type 2 diabetes mellitus on diet/exercise therapy

Exclusion Criteria:

Patients have type 1 diabetes mellitus
Intervention: Everolimus
Trial phase: Phase 1 | Phase 2
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
Eligibility criteria:
Inclusion Criteria:

Age three years and older
If female and of child bearing potential, documentation of negative pregnancy test prior to enrollment. In the extension phase, all females of child bearing potential will be required to take monthly home pregnancy tests and record results on a provided diary card.
Clinically definite diagnosis of tuberous sclerosis (modified Gomez criteria or positive genetic test)
Presence of giant cell astrocytoma as defined by imaging characteristics and serial increase in size of lesion on 2 or more MRI scans
Adequate renal function (creatinine < 1.5 mg/dl)

Exclusion Criteria:

Serious intercurrent medical illness or other uncontrolled medical disease which could compromise participation in the study
Significant hematologic or hepatic abnormality
Continuous requirement for supplemental oxygen
Intercurrent infection at initiation of everolimus
Embolization of angiomyolipoma within one month; any other recent surgery within 2 months of initiation of everolimus
Pregnant or lactating women
Use of an investigational drug within the last 30 days
Must be adequately recovered from the acute toxicities of any prior therapy
Clinical evidence of impending herniation or focal neurologic deficit related to the subject's astrocytoma
Unwilling or unable to use highly effective contraception
Intervention: ULIPRISTAL ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1533
Group description: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse

CDB-2914
Eligibility criteria:
Inclusion Criteria:

Aged 18 years or more
Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure
No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception
For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses)
Willing to not use hormonal methods of contraception until study completion
At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
Able to provide informed consent in English
Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks)
Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained

Exclusion Criteria:

One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
Currently pregnant as confirmed by positive HSUP test performed at screening
Currently breast-feeding
Current use of hormonal contraception
Use of hormonal emergency contraception since last menstrual period
Current use of IUD
Tubal ligation
Partner with a vasectomy
Unsure about the date of the last menstrual period
Severe asthma insufficiently controlled by oral glucocorticoid
Currently enrolled in any other trial of an investigational medicine
Intervention: Fondaparinux
Trial phase: Phase 1
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: Child | Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Single arm group receiving fondaparinux 0.1 mg/kg.
Eligibility criteria:
Inclusion Criteria:

Children between 1 year and 18 years of age.
The presence of documented venous or arterial thrombosis confirmed by diagnostic imaging.
Weight greater than 8.3 kg.
Signed informed consent/assent.

Exclusion Criteria:

Patients with active bleeding.
Patients with planned invasive procedures less than 2 weeks from the time of enrollment.
Patients with a contraindication to anticoagulation.
Patients receiving thrombolytic agents.
Patients with an INR>1.5 or an activated partial thromboplastin time (PTT)>40 seconds.
Patients with a creatinine level above 1.2 times the upper limit of normal expected for age.
Children <1 year of age.
Intervention: Thymidine
Trial phase: Phase 3
ATC code: J05AF11
SMILES: Cc1cn([C@@H]2C[C@@H](O)[C@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Telbivudine 600 mg once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B
Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

Pregnant or breastfeeding
Unwilling to use double barrier method of contraception
Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
Received Hepatitis B therapy in the past
Use of immunomodulatory therapy in past 12 months
History of or symptoms of hepatic decompensation or pancreatitis
Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
Concurrent medication likely to preclude compliance with schedule of evaluations
Use of other investigational drugs within 30 days of enrollment
Abnormal laboratory values during screening

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Entecavir
Trial phase: Phase 3
ATC code: J05AF10
SMILES: C=C1[C@H](CO)[C@@H](O)C[C@@H]1n1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Entecavir 0.5 mg once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B
Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

Pregnant or breastfeeding
Unwilling to use double barrier method of contraception
Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
Received Hepatitis B therapy in the past
Use of immunomodulatory therapy in past 12 months
History of or symptoms of hepatic decompensation or pancreatitis
Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
Concurrent medication likely to preclude compliance with schedule of evaluations
Use of other investigational drugs within 30 days of enrollment
Abnormal laboratory values during screening

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Oseltamivir
Trial phase: Phase 4
ATC code: J05AH02
SMILES: CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 238
Group description: Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Negative rapid diagnostic test for influenza at baseline;
Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).

Exclusion Criteria:

Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
Influenza vaccination in 6 weeks prior to randomization;
Positive rapid diagnostic test for influenza;
Solid organ transplant within 6 months of randomization;
Antiviral treatment for influenza in 2 weeks prior to randomization.
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Atorvastatin 40mg
Eligibility criteria:
Inclusion Criteria:

All individuals must fulfill 4 of the revised criteria of the American College of Rheumatology for SLE
Patient started on corticosteroids at a dose of at least .5mg/kg for an interval greater than two weeks
To be able to come for all follow-up visits for nine months
No contraindications to undergoing MRI
Age 18-75 years

Exclusion Criteria:

Evidence of liver disease, not secondary to active lupus, or liver enzyme greater than 2x normal
Elevated CPK at baseline
Pregnancy or Lactating
Allergy to a statin
Current or recent use of a statin within 3 months
Intervention: BI 2536
Trial phase: Phase 2
SMILES: CC[C@@H]1C(=O)N(C)c2cnc(Nc3ccc(C(=O)NC4CCN(C)CC4)cc3OC)nc2N1C1CCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course.
Eligibility criteria:
Inclusion Criteria:

Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.
Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater.
Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines.

Exclusion Criteria:

More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
Symptomatic brain metastases or leptomeningeal disease
Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer)
Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin <9 mg/dl
Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine >2.0 mg/dl (>176 µmol/L, SI Unit equivalent)
Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug
Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug
Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection
Known or suspected active drug or alcohol abuse
Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug
Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin ®)
Patients with neuropathy (sensory or motor) CTCAE 3
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 180
Group description: Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
Eligibility criteria:
Inclusion Criteria:

Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by the MINI structured interview.
Historical failure to respond optimally to a GAD treatment

Exclusion Criteria:

Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th edition) diagnosis of major depressive disorder with or without seasonal pattern, dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder, dissociative disorder, borderline personality disorder, obsessive-compulsive disorder, antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision).
Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).
Intervention: Zoely
Trial phase: Phase 3
SMILES: CC(=O)OC1(C(C)=O)CCC2C3C=C(C)C4=CC(=O)CCC4C3CCC21C.CC12CCC3c4ccc(O)cc4CCC3C1CCC2O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1666
Group description: Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
Eligibility criteria:
Inclusion Criteria:

Sexually active women, at risk for pregnancy and not planning to use condoms;
Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles);
At least 18 but not older than 50 years of age at the time of screening;
Body mass index >=17 and <=35;
Good physical and mental health;
Willing to give informed consent in writing.

Exclusion Criteria:

Contraindications for contraceptive steroids
In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
Renal insufficiency;
Hepatic dysfunction;
Adrenal insufficiency.
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], squamous intraepithelial lesion [SIL], carcinoma in situ, invasive carcinoma) at screening;
Clinically relevant abnormal laboratory result at screening as judged by the investigator;
Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
Before spontaneous menstruation has occurred following a delivery or abortion;
Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).
Intervention: Lopinavir
Trial phase: Not Applicable
ATC code: J05AR10
SMILES: Cc1cccc(C)c1OCC(=O)N[C@@H](Cc1ccccc1)[C@@H](O)C[C@H](Cc1ccccc1)NC(=O)[C@H](C(C)C)N1CCCNC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Kaletra (pre-study dose)
Eligibility criteria:
Inclusion Criteria:

Previously diagnosed HIV infection
Age between 18-65 years
Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
CD4 count > 400 cell/mm3
Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin >= 15 mIU/ml), hypercholesteremia (fasting total cholesterol >= 200 mg/dL), hypertriglyceridemia (fasting triglycerides >= 150 mg/dL), or treatment with a lipid lowering medication.

Exclusion Criteria:

Hemoglobin < 11.0 g/dL
History of Diabetes Mellitus
Currently on medication for Diabetes
Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
Current substance abuse, including alcohol, cocaine and/or heroin
Any contraindication to ATV/r or known allergy to ATV
Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam
New or serious opportunistic infection in the past 3 months
Pregnancy
Intervention: Rosiglitazone
Trial phase: Not Applicable
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.

Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months
Eligibility criteria:
Inclusion Criteria:

Good general health
Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size>6ml)
IGT based on 2-hr plasma glucose>140mg/dl and <200mg/dl during an OGTT.

Exclusion Criteria:

Baseline creatinine>1.0mg
AST and ALT>2.5 ULN
Anemia (Hct<30)
Pregnancy (females must have a negative urine pregnancy test during the study)
Cardiac or pulmonary or other significant chronic illness
Plans to increase the frequency or intensity of a regular exercise program
Psychiatric disorder or substance abuse of anorexic agents.