anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Iopamidol
Trial phase: Phase 4
ATC code: V08AB04
SMILES: C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 327
Group description: Iopamidol 300 mg I/mL

Iopamidol 300-Arm 2
Eligibility criteria:
Inclusion Criteria:

Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination.

Exclusion Criteria:

Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not permitted.
Patients undergoing dialysis or kidney transplantation will not be included.
Intervention: Imatinib Mesylate
Trial phase: Phase 2
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.

Glivec
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria: at registration· Chronic myeloid leukaemia Ph+ confirmed by cytogenetic analysis or BCR-ABL translocation by molecular biology· Chronic phase:-<15% blast cells in blood and 5% in bone marrow-<30% blast cells+promyelocyte cells in blood and bone marrow-<20% basophils in blood->100.000 platelets· Without extra medullar attempt excepted hepatosplenomagalia· First line of treatment· Biology and biochemistry with normal levels· Male or female>18 years old· Signed written consent· ECOG<3At inclusion· Chronic myeloid leukaemia with cytogenetic response without molecular response after one year of treatment by imatinib and BCR-ABL transcript detected by RT-PCR

Exclusion Criteria:

· Other cancer excepted basocellular or cervix carcinoma · Major surgery in last 2 weeks previous inclusion· Women who are pregnant or breastfeeding (are unable to use an acceptable method to avoid pregnancy of his partner for the entire study period)· Dementia or altered mental status that would prohibit the understanding or rendering of informed consent · Abnormal renal function with creatinine clearance < 30 ml/ minuteAccording to Cockcroft-Gault : CrCl= [[140-age (years)] x weight (kg)]/ [72 x serum creatinine (mg/dL)] {x 0.85 for women}· Chronic myeloid leukaemia in acute phase or in pass to be in acute phase · Treatment with bisphosphonates in last 6 months previous inclusion · Intolerance to bisphosphonates: hypersensitivity, on course dental problem, including tooth or mandibular infection; dental traumatism or recent diagnosis or previous mandibular osteonecrosis, or dental extraction with cicatrisation delay or necessity to set bone evidence · Mandibular surgery in last 6 weeks or planned in the future during treatment (tooth extraction)· Serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy: diabetes, thyroid pathology, neuropsychiatric illness, myocardial infarction or congestive heart failure grade 3-4 according to " New York Heart association"· History of psychiatric or depressive pathology · HIV positivity known · Inclusion in other study investigating antineoplastic molecule in last 30 days previous inclusion
Intervention: Chlorambucil
Trial phase: Phase 3
ATC code: L01AA02
SMILES: O=C(O)CCCc1ccc(N(CCCl)CCCl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 131
Group description: chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)

chlorambucil (drug): chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
Eligibility criteria:
Inclusion Criteria:

histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
any stage (Ann Arbor I-IV)
either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
no evidence of histologic transformation to a high grade lymphoma
measurable or evaluable disease
age > 18
life expectancy of at least 1 year
ECOG performance status 0-2
no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
no prior chemotherapy
no prior immunotherapy with any anti-CD20 monoclonal antibody
no prior radiotherapy in the last 6 weeks
no corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
no evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
no evidence of symptomatic central nervous system (CNS) disease
no impairment of bone marrow function (WBC >3.0x109/L, ANC >1.5x109/L, PLT >100x109/L), unless due to lymphoma involvement
no major impairment of renal function (serum creatinine <1,5x upper normal) or liver function (ASAT/ALAT <2,5 upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement
no evidence of active opportunistic infections
no known HIV infection
no active HBV and/or HCV infection
no pregnant or lactating status
appropriate contraceptive method in women of childbearing potential or men
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
informed consent must be given according to national/local regulations before randomization
Intervention: Tenofovir
Trial phase: Phase 2
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Monotherapy tenofovir (300mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
Antiretroviral naïve defined as no prior therapy.
CD4+ cell count > than 200 cells/ mm3 determined by site clinical laboratory within 90 days of screening.
HIV-1 RNA level > 5000 copies/mL obtained by site clinical laboratory within 90 days of screening.

Laboratory values obtained by screening laboratories within 30 days of entry:

Absolute neutrophil count (ANC) ≥ 750/mm3.
Hemoglobin ≥ 8.0 g/dL.
Platelet count ≥ 50,000/mm3.
Calculated creatinine clearance (CrCl) > 50 mL/min as estimated by the
AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 5 x ULN.
Total bilirubin ≤ 2.5 x ULN.
Negative serum or urine pregnancy test within 30 days of study entry.
Karnofsky performance score ≥ 70.
Men and women age ≥ 18 years.
Ability and willingness of subject to give written informed consent.

Exclusion Criteria:

Any NRTI or NNRTI-associated resistance mutations as defined by the updated International AIDS Society-USA (IAS-USA) mutation list.
Pregnancy and breast-feeding.
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Urgent need to initiate antiretroviral therapy, as determined by the patient's primary provider.
Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
Use of human growth hormone within 30 days prior to study entry.
Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed)
Intervention: Abacavir
Trial phase: Phase 2
ATC code: J05AF06 | J05AR02 | J05AR04 | J05AR13
SMILES: Nc1nc(NC2CC2)c2ncn([C@H]3C=C[C@@H](CO)C3)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Monotherapy abacavir (600mg) for 7 days followed by a 35-day washout period then 7 days of ABC + TDF dual therapy
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
Antiretroviral naïve defined as no prior therapy.
CD4+ cell count > than 200 cells/ mm3 determined by site clinical laboratory within 90 days of screening.
HIV-1 RNA level > 5000 copies/mL obtained by site clinical laboratory within 90 days of screening.

Laboratory values obtained by screening laboratories within 30 days of entry:

Absolute neutrophil count (ANC) ≥ 750/mm3.
Hemoglobin ≥ 8.0 g/dL.
Platelet count ≥ 50,000/mm3.
Calculated creatinine clearance (CrCl) > 50 mL/min as estimated by the
AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 5 x ULN.
Total bilirubin ≤ 2.5 x ULN.
Negative serum or urine pregnancy test within 30 days of study entry.
Karnofsky performance score ≥ 70.
Men and women age ≥ 18 years.
Ability and willingness of subject to give written informed consent.

Exclusion Criteria:

Any NRTI or NNRTI-associated resistance mutations as defined by the updated International AIDS Society-USA (IAS-USA) mutation list.
Pregnancy and breast-feeding.
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Urgent need to initiate antiretroviral therapy, as determined by the patient's primary provider.
Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
Use of human growth hormone within 30 days prior to study entry.
Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed)
Intervention: Citalopram
Trial phase: Phase 2
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of OCD
A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits

Exclusion Criteria:

Lifetime history of psychosis or cognitive dysfunction due to a general medical condition or substance use
A primary diagnosis of another Axis I psychiatric disorder
Alcohol or other substance abuse or dependence within the last 6 months
Unstable medical condition
Clinically significant laboratory abnormality
Failure of a previous 10-week trial of citalopram of at least 40 mg/day or escitalopram 20 mg/day
Active suicidality
History of violent behavior in the past year or current risk of serious violence
A history of sensitivity to citalopram or escitalopram
Use of other investigational drugs within 30 days of baseline or other psychotropic drugs or herbs within 14 days of baseline (28 days for fluoxetine)
Need for concurrent psychotherapeutic intervention
Pregnant or lactating females.
Intervention: Palmitic Acid
Trial phase: Phase 2
SMILES: CCCCCCCCCCCCCCCC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 47
Group description: SURFAXIN (lucinactant) at 90 mg/kg
Eligibility criteria:
Inclusion Criteria:

Premature infants between 600 and 900 grams birth weight
Intubated and on mechanical ventilation
Sustained (>= 30 minutes) fraction of inspired oxygen (FiO₂) >= 0.30 within 8 hours prior to randomization

Exclusion Criteria:

Mother has prolonged rupture of membranes ≥ 2 weeks
Culture-proven sepsis
High grade intraventricular hemorrhage (IVH)
Congenital heart disease
Congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints
FiO₂≥ 0.80 and mean airway pressure (MAP) ≥ 12 cmH2O at day of life (DOL) 3
FiO₂< 0.25 at any time between meeting the entry criteria to immediately prior to randomization
Concomitant use of any other surfactant within the first 48 hours of life
Prior use of nitric oxide
Prior use of steroids
Current participation in any other clinical trial or has received an experimental drug or used an experimental device
Intervention: Lansoprazole
Trial phase: Not Applicable
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Lansoprazole 30mg BID for one year
Eligibility criteria:
Inclusion Criteria:

Subjects will:

Be adults with nasal polyposis
recruited from the PI's private practice
Not be currently taking a PPI
Be able and willing to undergo a noninvasive 24 hour pH probe study; and
Take a PPI.

Exclusion Criteria:

Patients who:

Are pregnant
Have a history of surgical treatment for reflux disease
History of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period; and
Do not meet inclusion criteria.
Intervention: Budesonide
Trial phase: Phase 2 | Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: 9 mg daily
Eligibility criteria:
Inclusion Criteria:

Diarrhea, defined as greater than 4 bowel movements per day and greater than "mild"; currently on no treatment or active despite treatment.
Lymphocytic colitis confirmed histologically within one year of enrollment

Exclusion Criteria:

Previous unsuccessful treatment with corticosteroids or immunosuppressive drugs
History of severe corticosteroid side effects
Corticosteroid, ticlopidine, or flutamide use within the previous 4 weeks
Antibiotic, mesalamine or bismuth subsalicylate use within two weeks
Current use of anticholinergics, cholestyramine, narcotics, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or grapefruit juice
Known active medical conditions, including cancer, infection, uncontrolled hypertension or diabetes, osteoporosis, peptic ulcer disease, glaucoma, cataracts, liver cirrhosis or history of tuberculosis
Other diarrheal conditions (sprue, infection, hyperthyroidism, lactose intolerance)
Pregnant or nursing females
Patients without a telephone or unable to communicate in English over the telephone, or unable or unwilling to give consent
Known hypersensitivity to or intolerance of budesonide.
Intervention: Dronabinol
Trial phase: Phase 2
ATC code: A04AD10
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)Oc1cc(CCCCC)cc(O)c12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 79
Group description: Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Eligibility criteria:
Inclusion Criteria:

men and women between the ages of 18-60
Meets DSM-IV criteria for current marijuana dependence and reports marijuana as primary drug of abuse
Individuals must report using marijuana at least 5 days a week and have a marijuana positive urine drug screen on the day of study entry
Individuals must be capable of giving informed consent and capable of complying with study procedures.
Women of child-bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.

Exclusion Criteria:

Meets criteria for current psychiatric disorder requiring psychiatric intervention. Disorders that are stable on psychotherapy or pharmacotherapy will not be exclusionary. Individuals will be permitted to take prescribed zolpidem and zaleplon if there is no evidence of dependence on these substances.
History of seizures
Known sensitivity to dronabinol
Unstable medical conditions
Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
Pregnant or breast-feeding
Individuals who have exhibited suicidal or homicidal behavior within the past two years or who have current active suicidal ideation.
Individuals with coronary vascular disease as indicated by history of abnormal ECG or history of cardiac symptoms.
Unstable physical disorder which might make participation hazardous such as uncontrolled hypertension (SBP > 150, DBP> 90, or HR > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 2-3X upper limit of normal are acceptable), or medically unstable diabetes.
Subjects in professions in which even mild intoxication would be hazardous (e.g., police officer, bus driver, firefighter).
Individuals who are court-mandated to treatment.
Intervention: Progesterone
Trial phase: Not Applicable
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Progesterone (200mg given twice daily)
Eligibility criteria:
Inclusion Criteria:

Smoked at least 1 gram of cocaine each week for the 6 months prior to study entry
Agrees to use an adequate method of contraception for the duration of the study
If female, current regular menses

Exclusion Criteria:

Major psychiatric illnesses, including psychotic mood and anxiety disorders
Current dependence on alcohol or drugs other that cocaine or nicotine
History of major medical illnesses, including liver disease, abnormal vaginal bleeding, suspected or known breast cancer, thrombophlebitis, or other medical conditions
Current use of oral contraceptives or other types of hormonal contraceptives
Amenorrhea
Currently on parole or probation
Received treatment for chemical dependency within the 6 months prior to study entry
Known allergy to progesterone or peanuts
Intervention: Modafinil
Trial phase: Phase 2
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: 200mg Modafinil

Modafinil: 200mg Modafinil
Eligibility criteria:
Inclusion Criteria:

Seeking treatment for cocaine dependence
Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview
If female, willing to use effective contraception throughout the study
Lives within 50 miles of the research center and has reliable transportation

Exclusion criteria:

Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana
Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis
Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis
Recent suicidal or homicidal attempts within 60 days of study entry
Suicidal or homicidal ideation within 30 days of study entry
Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders section of Mini-SCID for a history of psychotic symptoms during a period of cocaine use (e.g., persistent hallucinations and delusions)
Serious medical illness, including left ventricular hypertrophy, mitral valve prolapse, left bundle branch block, heart attack, angina, serious liver disease (transaminase levels four times greater than normal), and kidney, neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
Required by the court to obtain treatment for cocaine dependence
Not seeking treatment for cocaine dependence
Participated in cocaine treatment (clinical or research) within 30 days of study entry
Anticipating elective surgery or hospitalization within 20 weeks of study entry
Known or suspected hypersensitivity to modafinil
Use of any of the following medications within 14 days of study entry: selective serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine agonists, and other psychotropic medications, including anticonvulsants, antipsychotics, anxiolytics, or psychostimulants
Currently taking medications that could adversely interact with study medications, including azole-type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine
Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways
Pregnant or breastfeeding