anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.

Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
Eligibility criteria:
Inclusion Criteria:

Cervical Pain at least six weeks
At least 40 mm in the VAS
They cannot been received treatment like physical therapy or analgesics
Maximum score of PHQ 16 points

Exclusion Criteria:

Depression
Fibromyalgia
Cervical Radiculopathy
Intervention: Aminophylline
Trial phase: Phase 4
ATC code: R03DA05 | R03DA20 | R03DA55 | R03DB05
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O.Cn1c(=O)c2[nH]cnc2n(C)c1=O.NCCN
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: 75 mg of intravenous aminophylline.
Eligibility criteria:
Inclusion Criteria:

Adult patients referred to undergo a clinically-indicated regadenoson-stress myocardial perfusion imaging at Rush University Medical Center

Exclusion Criteria:

Patient refusal to participate
Known allergic reaction to aminophylline.
Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea, abdominal discomfort, nausea or vomiting.
Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and acute coronary symptoms.
Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12 months or any seizure in the past week.
Pregnant or breast-feeding women.
Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).
Intervention: Atenolol
Trial phase: Phase 4
ATC code: C07AB03 | C07BB03 | C07CB03 | C07CB53 | C07DB01 | C07FB03
SMILES: CC(C)NCC(O)COc1ccc(CC(N)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Eligibility criteria:
Inclusion Criteria:

Subjects aged between 25-65 years
Subjects with essential hypertension (EH)
Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
Subjects with normal sinus rhythm
Subjects with resting heart rate (RHR) greater than 70 bpm
Subjects who give written informed consent

Exclusion Criteria:

Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
Subjects with bradyarrhythmia/hypotension
Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association [NYHA] Class III - IV)
Subjects with uncontrolled diabetes mellitus (DM)
Subjects with bronchial asthma
Subjects with gastro-intestinal ulcer or skin ulcer
Subjects with liver dysfunction/renal impairment
Subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers.
Subjects with glaucoma
Subjects with known allergic/intolerance to beta-blocker
Pregnant or lactating women
Subjects who had participated in another clinical study within the last 3 months
Subjects who have legal incapacity or limited legal capacity
Intervention: Biperiden
Trial phase: Phase 3
ATC code: N04AA02
SMILES: OC(CCN1CCCCC1)(c1ccccc1)C1CC2C=CC1C2
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 56
Group description: No adverse event
Eligibility criteria:
Inclusion Criteria:

Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)

Exclusion Criteria:

Being under treatment with psychoactive drugs
Have been diagnosed for other Psychiatric Disorders
Have dependence diagnosis for other drugs, except for tabacco
Intervention: Ruxolitinib
Trial phase: Phase 1 | Phase 2
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
Eligibility criteria:
Inclusion Criteria:

Must be >14 years of age
Must be diagnosed with refractory or relapsed AML or ALL.
Must have adequate organ function as demonstrated by the following: o Alanine Aminotransferase (ALT) (SGOT) and/or Aspartate Aminotransferase (AST) (SGPT) equal to or less than 1.5x upper limit of normal o Serum creatinine equal to or less than 2.5 mg/dL
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
At least 2 weeks from prior leukemia-directed treatment to starting treatment drug (except for hydroxyurea, which is allowed if clinically indicated but should be stopped after 2 weeks of receiving study drug, and glucocorticoids, which are allowed but should be stopped upon starting treatment drug).
Treatment-related toxicities from prior therapies must have resolved to Grade equal to or less than 1 (except for peripheral neuropathy, which should resolve to grade equal to or less than 2)
No active malignancies with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
Females of childbearing potential (FCBP)(A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) must have negative pregnancy test. FCBP and males participating in the study must agree to use a reliable form of contraception or to practice complete abstinence from heterosexual intercourse while participating in the study and for at least 28 days after discontinuation from the study. If pregnancy or a positive pregnancy test does occur in a study subject, treatment with the study drug must be immediately discontinued.

Exclusion Criteria:

Known positive status for HIV, or known active hepatitis A, B, or C infection.
Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Pregnant or lactating females.
Acute promyelocytic leukemia
Concurrent use of strong inducers or strong inhibitors of cytochrome P450 3A4 (CYP3A4). Strong inducers are rifampin and St. John's Worth. Strong inhibitors are HIV-antivirals, clarythromycin, itraconazole, ketoconazole, nefazodone, and telithromycin.
Participating in any other research trial.
Intervention: ETHINYL ESTRADIOL
Trial phase: Phase 2
ATC code: G03AA07 | G03CA01 | L02AA03
SMILES: C#C[C@]1(O)CC[C@H]2[C@@H]3CCc4cc(O)ccc4[C@H]3CC[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 83
Group description: Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
Eligibility criteria:
Inclusion Criteria:

Premenopausal, non-pregnant, non-lactating women age 18-40 years old
Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
Regular spontaneous menstrual cycle
Others as dictated by FDA-approved protocol

Exclusion Criteria:

Any condition which contraindicates the use of combination oral contraceptives
Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
Others as dictated by FDA-approved protocol
Intervention: Ovral
Trial phase: Phase 2
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 89
Group description: Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
Eligibility criteria:
Inclusion Criteria:

Premenopausal, non-pregnant, non-lactating women age 18-40 years old
Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
Regular spontaneous menstrual cycle
Others as dictated by FDA-approved protocol

Exclusion Criteria:

Any condition which contraindicates the use of combination oral contraceptives
Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
Others as dictated by FDA-approved protocol
Intervention: Desogestrel and ethinyl estradiol
Trial phase: Phase 2
SMILES: C#CC1(O)CCC2C3CCC4=CCCCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
Eligibility criteria:
Inclusion Criteria:

Premenopausal, non-pregnant, non-lactating women age 18-40 years old
Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
Regular spontaneous menstrual cycle
Others as dictated by FDA-approved protocol

Exclusion Criteria:

Any condition which contraindicates the use of combination oral contraceptives
Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
Others as dictated by FDA-approved protocol
Intervention: Aliskiren
Trial phase: Not Applicable
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Men and women, 18-70 years old
BMI =/< 35
BP: BP > 145/95 on no BP medication or on 3 or less BP medications
HOMA =>2.5
Any race

Exclusion Criteria:

4 or more BP medications
Intolerance or known prior adverse history from taking the medications amlodipine, aliskiren or valsartan
BP >170/110 on screening exam
Alcohol intake >12 oz per week
Current smoking
Recreational drug use
Known or suspected secondary hypertension
Known history of coronary artery disease, cerebrovascular disease or congestive heart failure
History or known kidney disease (eGFR <50cc/min)
Diabetes or current metformin use, or HbA1c >=6.5% on screen
Steroid use (oral or inhaled, chronic or within the past 6 months)
Clinically significant screening lab abnormalities (See attached "Screening Labs Acceptable Ranges")
Evidence of ischemia or heart block on screening electrocardiogram (greater than type I-second degree heart block, left bundle branch block, or ST-T wave changes in 2 or more contiguous leads).
Acute hospitalizations including surgery in the past 6 months
Chronic use of non-steroidal anti-inflammatory or narcotic medications
Women who are pregnant or nursing, or wish to become pregnant and/or who can not agree or tolerate two forms of birth control during the study period:

Acceptable birth control methods for use in this study are:

hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
intrauterine device (IUD)
abstinence (no sex)
Significant concomitant medical illnesses (cancer, chronic active immunological conditions, etc.)
Intervention: Amlodipine
Trial phase: Not Applicable
ATC code: C07FB07 | C07FB12 | C07FB13 | C08CA01 | C08CA17 | C08CA51 | C08GA02 | C09BB03 | C09BB04 | C09BB07 | C09BB13 | C09BX01 | C09BX03 | C09BX04 | C09DB01 | C09DB02 | C09DB04 | C09DB05 | C09DB06 | C09DB07 | C09DB09 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA53 | C09XA54 | C10BX03 | C10BX07 | C10BX09 | C10BX11 | C10BX14 | C10BX18 | C10BX19
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Only taking Amlodipine

Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure.
Eligibility criteria:
Inclusion Criteria:

Men and women, 18-70 years old
BMI =/< 35
BP: BP > 145/95 on no BP medication or on 3 or less BP medications
HOMA =>2.5
Any race

Exclusion Criteria:

4 or more BP medications
Intolerance or known prior adverse history from taking the medications amlodipine, aliskiren or valsartan
BP >170/110 on screening exam
Alcohol intake >12 oz per week
Current smoking
Recreational drug use
Known or suspected secondary hypertension
Known history of coronary artery disease, cerebrovascular disease or congestive heart failure
History or known kidney disease (eGFR <50cc/min)
Diabetes or current metformin use, or HbA1c >=6.5% on screen
Steroid use (oral or inhaled, chronic or within the past 6 months)
Clinically significant screening lab abnormalities (See attached "Screening Labs Acceptable Ranges")
Evidence of ischemia or heart block on screening electrocardiogram (greater than type I-second degree heart block, left bundle branch block, or ST-T wave changes in 2 or more contiguous leads).
Acute hospitalizations including surgery in the past 6 months
Chronic use of non-steroidal anti-inflammatory or narcotic medications
Women who are pregnant or nursing, or wish to become pregnant and/or who can not agree or tolerate two forms of birth control during the study period:

Acceptable birth control methods for use in this study are:

hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
intrauterine device (IUD)
abstinence (no sex)
Significant concomitant medical illnesses (cancer, chronic active immunological conditions, etc.)
Intervention: Levomefolic acid
Trial phase: Phase 1
SMILES: CN1c2c(nc(N)[nH]c2=O)NCC1CNc1ccc(C(=O)NC(CCC(=O)O)C(=O)O)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
Eligibility criteria:
Inclusion Criteria:

Healthy female volunteer
Age: 18 - 38 years inclusive
Body mass index (BMI)1: ≥ 19 and < 28 kg/m²
Regular cyclic menstrual periods at screening OR when using combined oral contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior to their use
Willingness to use non-hormonal methods of contraception during the complete trial OR previous tubal ligation

Exclusion Criteria:

incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal
known or suspected sex-steroid influenced malignancies
endometrial hyperplasia; genital bleeding of unknown origin; uterus myomatosus
known or suspected tumors of the liver and pituitary
presence or history of severe hepatic disease as long as liver function values have not returned to normal
severe renal insufficiency or acute renal failure
thrombophlebitis, venous / arterial thromboembolic diseases; presence or history of prodromi of a thrombosis
other conditions that increase susceptibility to thromboembolic diseases
known neuropsychiatric diseases, especially known or suspected epilepsy, and/ or deficient status of folate or vitamin B12
use of any other medication within 2 cycles before first study drug administration which could affect the study aim
use of potassium sparing drugs; use of folic acid containing supplements or medicines or use of any medication within 2 cycles before first study drug administration known to interfere with folate metabolism
inadequate folate and/or Vitamin B12 status, clinically relevant deviations in red cell folate concentrations
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
Best corrected visual acuity score of 20/100 or better in both eyes
Females on birth control pills must be on same type of pill and dose for at least 3 month

Exclusion Criteria:

Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
History of or active ocular infection/inflammation (eg, uveitis)
Punctal plug use
Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
Planned contact lens wear during study
Intervention: Amoxicillin
Trial phase: Not Applicable
ATC code: A02BD01 | A02BD03 | A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD10 | A02BD11 | A02BD12 | A02BD13 | A02BD14 | A02BD15 | A02BD16 | J01CA04 | J01CR50
SMILES: [H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 74
Group description: Amoxicillin 20-30mg per kg 8 hourly for 5 days
Eligibility criteria:
Inclusion Criteria:

Ingestion in the preceding 24 hours
Presence of respiratory symptoms and/or signs at presentation
Informed consent obtained from parent or legal guardian
Resident within the Red Cross Hospital drainage area and able to come for two follow-up appointments

Exclusion Criteria:

Asymptomatic and no clinical signs

Too ill to be excluded from receiving an antibiotic as judged by:

Requiring more than 2L/min nasal-prong oxygen
Requiring continuous or intermittent positive airway pressure ventilation
Fever > 40˚C
Needing an antibiotic for another reason e.g. otitis media, tonsillitis
Current antibiotic use, prior to kerosene ingestion
Allergic to amoxicillin
Intervention: Nilotinib
Trial phase: Phase 3
ATC code: L01EA03 | L01XE08
SMILES: Cc1cn(-c2cc(NC(=O)c3ccc(C)c(Nc4nccc(-c5cccnc5)n4)c3)cc(C(F)(F)F)c2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 421
Group description: Nilotinib 300 mg BID
Eligibility criteria:
Inclusion Criteria:

-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry

Exclusion Criteria:

Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
Uncontrolled congestive heart failure or hypertension
Myocardial infarction or unstable angina pectoris within past 12 months
Known T315I mutations
QTcF >450 msec
Significant arrhythmias

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Ondansetron
Trial phase: Phase 2
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Eligibility criteria:
Inclusion Criteria:

Subjects will be at least 18 years old and HIV-infected
All subjects will be actively drinking at hazardous levels (1) AUDIT score => 4 for women or =>8 for men, or 2) => 2 binge drinking episodes/month, or 3) >7 drinks/week for women or >14 drinks/week for men)

Exclusion Criteria:

Liver Function Tests (LFTs) > 5 X normal
Magnesium or potassium > 3 X normal
Qtc => .460 and or a family history of long QT syndrome (LQT)
Inability to read and comprehend English
Actively psychotic or other severe mental health symptoms that would prevent appropriate participation
Current enrollment in alcoholism treatment program
Pregnancy; Ondansetron is currently a category B drug. While animal data have not identified any harmful effects to mother or fetus, there have not been adequate human controlled trials to recommend routine use in this population
Intervention: ALBUTEROL
Trial phase: Not Applicable
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: All subjects underwent an acute bronchodilation with albuterol by inhaling four consecutive doses (100 mcg each)of the drug through a valved-holding chamber
Eligibility criteria:
Inclusion Criteria:

consecutive, clinically-stable, outpatients undergoing allogeneic HSCT (sourcing from bone marrow) for hematological malignancies
values of standard PFTs within normal range before HSCT
good collaboration during the maneuvers

Exclusion Criteria:

patients showing any spirometric and/or volumetric abnormality before HSCT
poor collaboration and/or coordination during the maneuvers
any clinically-significant respiratory disease (bronchial asthma, COPD, cystic fibrosis, etc.) before HSCT