anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Valomaciclovir
Trial phase: Phase 1 | Phase 2
SMILES: CC(C)[C@H](N)C(=O)OCC[C@@H](CO)Cn1cnc2c(=O)[nH]c(N)nc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Valomaciclovir 2 grams orally twice daily for 21 days

Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.
Eligibility criteria:
Inclusion Criteria:

Age 15 years or older
Within 14 days of initial symptoms of present illness diagnosed by a health care provider as infectious mononucleosis and confirmed to be due to primary EBV by antibody profile. The criteria for antibody confirmation of primary EBV at the screening visit are: 1)Positive for anti-EBV VCA IgM antibody and negative for anti-EBV EBNA1 IgG antibody; 2)EBV antibody testing will be done in the Clinical Virology Research Laboratory using commercial ELISA kits (Diamedix Corporation, Miami, FL).
Willingness to sign the Informed Consent Form (ICF)
Willingness to contribute samples of blood and oral washings at regular intervals
Males and females must use effective contraception during treatment and for at least 90 days following treatment
Negative pregnancy test result at the Screening Visit for females of childbearing potential (including females who have had a bilateral tubal ligation). Female patients of childbearing potential must be willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 90 days after completion of dosing and male patients with female partners of childbearing potential must be willing to use a condom. Patients who are sterile or infertile (defined as those who are postmenopausal or have undergone a complete hysterectomy) are eligible.
Estimated creatinine clearance (Cockcroft and Gault method) ≥ 60 ml/min
Absolute neutrophil count ≥ 1000 cells/microliter
Platelets ≥ 100,000/microliter
Hemoglobin ≥ 9.5 g/dL

Exclusion Criteria:

Previous history of infectious mononucleosis-like illness
Immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications (e.g., corticosteroids prior to enrollment, cytotoxic drugs, interferons)
Another intercurrent viral infection (including HIV), based on history or referring physician medical evaluation
More than 7 days elapsed since onset of illness (including screening time)
The following concomitant medications are prohibited: probenecid, trimethoprim, myelosuppressive therapies, and medications known to be nephrotoxic
Breast feeding during the study
Corticosteroids are not permitted. If they are prescribed by the subject's primary physician for treatment of this acute disease after the subject has enrolled, the subject will be replaced.
Intervention: Temozolomide
Trial phase: Phase 2
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.

Number of cycles: Until progression or unacceptable toxicity
Eligibility criteria:
Inclusion Criteria:

Patient age >18 years old
Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)
Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging
Karnofsky Performance Status scale >/=50 (due to brain pathology)
Adequate hematological, renal and hepatic function
Patients willing to participate in the study and signing the informed consent

Exclusion Criteria:

Karnofsky Performance Status scale <50
Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study
Patients not suitable for follow-up
Intervention: Simvastatin
Trial phase: Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Clinicopathological diagnosis of Waldenstrom's macroglobulinemia
Measurable disease
Slowly progressing disease not requiring therapy for at least 3-6 months and who do not meet consensus panel criteria for initiation of therapy
ECOG Performance status of 0 or 1
Adequate organ function as defined in the protocol
Patients should agree to avoid grapefruit juice which is a major inhibitor of CYP 3A4

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than four weeks earlier
Patients who have had rituximab within 3 months prior to entering the study
Patients who have taken any Statin in the past
Patients who take cyclosporin, danazol, or gemfibrozil will be excluded
Prior history of rhabdomyolysis
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
Pregnant or breastfeeding women
HIV-positive
Patients who take verapamil will be excluded
Patients with active or history of liver disease
Patients who consume more than three alcoholic beverages per day
Intervention: Atorvastatin
Trial phase: Not Applicable
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: All patients in this arm are given atorvastatin therapy.

Atorvastatin : Atorvastatin 80 mg a day
Eligibility criteria:
Inclusion Criteria:

The patients are eligible if they are undergoing catheterization for stable angina or acute coronary syndromes
At the time of catheterization the patient has a "moderate coronary" lesion in the proximal 60mm of an epicardial coronary artery
"Moderate lesion" is defined as a lesion deemed significant enough to warrant further evaluation using coronary flow reserve (CFR) and fractional flow reserve (FFR) by the treating physician
Patient must have decision making capacity and consented prior to the catheterization
Ages: All ages
Performance Status: all levels

Exclusion Criteria:

1. Screening Exclusion Criteria:

Patients with coronary bypass grafts
Severe valvular heart disease
Patients presenting with a ST segment elevation myocardial infarction (STEMI)
Inability to provide informed consent prior to randomization
Creatinine >1.5
Patients who are on a statin with an LDL < 130.
Any patient on a maximum dose of statin (atorvastatin 80mg, simvastatin 80mg, rosuvastatin 20mg, pravastatin 80mg, or fluvastatin 80mg)
Uncontrolled diabetes requiring intensification of therapy
Uncontrolled hypertension requiring the addition of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker

2. Angiographic Ineligibility Criteria:

A Left Main lesion greater than 50% stenosis
The moderate lesion is located beyond 60mm
Collaterals
Coronary Anatomy requiring coronary artery bypass grafting (CABG)
Intervention: Ramelteon
Trial phase: Phase 4
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 79
Group description: 6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
Eligibility criteria:
Inclusion Criteria:

After initial screening and consenting, subjects with a 5-night average baseline sleep efficiency of less than or equal to 75% will be included

Exclusion Criteria:

Less than 65 yrs old
Bedbound
Resided in NH for less than two months
Patients on Medicare Part A skilled Benefit(anticipated short length stay) - Terminal Illness
Unstable psychotropic drug regimen (addition, discontinuation, or change of dosage of any psychotropic drug in the prior two weeks) - Use of hypnotic, antihistamine, or benzodiazepine more than once per week during the two weeks before screening
Use of drugs that could potentially inhibit the metabolism of Ramelteon (ie: fluvoxamine, ketoconazole, fluconazole)
Use of Drugs that induce the metabolism of Ramelteon (ie: rifampin)
Intervention: Docetaxel
Trial phase: Phase 2
ATC code: L01CD02
SMILES: CC(=O)OC12COC1CC(O)C1(C)C(=O)C(O)C3=C(C)C(OC(=O)C(O)C(NC(=O)OC(C)(C)C)c4ccccc4)CC(O)(C(OC(=O)c4ccccc4)C21)C3(C)C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
Eligibility criteria:
Inclusion Criteria:

Patients must have clinical stage 1-3 disease and no radiographic evidence of metastatic disease
Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of <60%.

Exclusion Criteria:

Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for prostate cancer, prior hormonal therapy (except finasteride or dutasteride for obstructive voiding symptoms)
Male patients unwilling to use effective means of contraception are excluded. Contraception should be continued for 3 months after treatment.
Prior malignancy will not exclude the patient. (Patients can not have active cancer or be undergoing active treatment). The Principal Investigator will make final decision regarding eligibility since the end point is pathological complete response.
Intervention: RISEDRONIC ACID
Trial phase: Phase 4
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: one 150 mg risedronate once a month, orally
Eligibility criteria:
Inclusion Criteria:

Female: 40 and 57 years of age inclusive
cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment
have osteopenia defines as having the following: have osteopenia defined as having the following:
Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR
Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;
have a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria:

history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
hypocalcemia or hypercalcemia of any cause
Intervention: Naltrexone
Trial phase: Phase 3
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
Eligibility criteria:
Inclusion Criteria:

Age 18-60.
Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. If participating as an outpatient only, recent opiate dependence must be confirmed by clinical history and/or communication with former treatment provider.
Seeking treatment for heroin dependence.
Able to give informed consent.

Exclusion Criteria:

Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
Active medical illness which might make participation hazardous, such as untreated hypertension, hepatitis with SGOT or SGPT > 3 times normal, unstable diabetes.
Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year.
Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary. Multiple substance use is common in this population, and such an exclusion would rule out a large proportion of the population and limit the generalizability of the study.
History of allergic reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
Chronic organic mental disorder (e.g. AIDS dementia).
History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
Currently receiving any other investigational drug, or has used any other investigational drug within 30 days of study entry.
Currently prescribed or regularly taking opiates for chronic pain or medical illness or those individuals anticipating surgical procedures which will necessitate opioid medications.
Intervention: Naltrexone
Trial phase: Phase 3
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).

Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
Eligibility criteria:
Inclusion Criteria:

Age 18-60.
Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. If participating as an outpatient only, recent opiate dependence must be confirmed by clinical history and/or communication with former treatment provider.
Seeking treatment for heroin dependence.
Able to give informed consent.

Exclusion Criteria:

Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
Active medical illness which might make participation hazardous, such as untreated hypertension, hepatitis with SGOT or SGPT > 3 times normal, unstable diabetes.
Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year.
Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary. Multiple substance use is common in this population, and such an exclusion would rule out a large proportion of the population and limit the generalizability of the study.
History of allergic reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
Chronic organic mental disorder (e.g. AIDS dementia).
History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
Currently receiving any other investigational drug, or has used any other investigational drug within 30 days of study entry.
Currently prescribed or regularly taking opiates for chronic pain or medical illness or those individuals anticipating surgical procedures which will necessitate opioid medications.
Intervention: RISEDRONIC ACID
Trial phase: Phase 2
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 37
Group description: 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
Eligibility criteria:
Inclusion Criteria:

In generally good health, as determined by medical history, physical examination, and laboratory test results
Postmenopausal greater than 2 years, naturally or surgically based on medical history.

Exclusion Criteria:

Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:

oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
anabolic steroids
estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
progestins
calcitonin
vitamin D supplements
calcitriol, calcidiol, or alfacalcidol at any dose
any bisphosphonate
fluoride
strontium
parathyroid hormone, including teriparatide
Intervention: RISEDRONIC ACID
Trial phase: Phase 2
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
Eligibility criteria:
Inclusion Criteria:

In generally good health, as determined by medical history, physical examination, and laboratory test results
Postmenopausal greater than 2 years, naturally or surgically based on medical history.

Exclusion Criteria:

Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:

oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
anabolic steroids
estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
progestins
calcitonin
vitamin D supplements
calcitriol, calcidiol, or alfacalcidol at any dose
any bisphosphonate
fluoride
strontium
parathyroid hormone, including teriparatide
Intervention: RISEDRONIC ACID
Trial phase: Phase 2
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
Eligibility criteria:
Inclusion Criteria:

In generally good health, as determined by medical history, physical examination, and laboratory test results
Postmenopausal greater than 2 years, naturally or surgically based on medical history.

Exclusion Criteria:

Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:

oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
anabolic steroids
estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
progestins
calcitonin
vitamin D supplements
calcitriol, calcidiol, or alfacalcidol at any dose
any bisphosphonate
fluoride
strontium
parathyroid hormone, including teriparatide
Intervention: RISEDRONIC ACID
Trial phase: Phase 2
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
Eligibility criteria:
Inclusion Criteria:

In generally good health, as determined by medical history, physical examination, and laboratory test results
Postmenopausal greater than 2 years, naturally or surgically based on medical history.

Exclusion Criteria:

Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:

oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
anabolic steroids
estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
progestins
calcitonin
vitamin D supplements
calcitriol, calcidiol, or alfacalcidol at any dose
any bisphosphonate
fluoride
strontium
parathyroid hormone, including teriparatide