anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lovenox
Trial phase: Phase 2
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
Eligibility criteria:
Inclusion Criteria:

Documented HgbSS or HgbS-beta0 thalassemia by previous hemoglobin electrophoresis,
age greater than 18 years old, and
admit diagnosis of vaso-occlusive crisis.

Labs must be drawn within 36 hours of admission and randomization to treatment arm must occur during this time.

Exclusion Criteria:

End stage renal disease (creatinine >3.0 mg/dL),
use of antiplatelet or anticoagulation medication for an alternative indication,
use of steroids or immunosuppressive medications,
platelet count less than 100 X 109/L,
history or development of heparin induced thrombocytopenia, packed red blood cell transfusion in the past one month, or
recent hospitalization with discharge within the past 1 week.

Patients with re-admissions will not be enrolled again and will have no further samples drawn.
Intervention: Vytorin
Trial phase: Not Applicable
ATC code: C10BA02
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21.O=C1C(CCC(O)c2ccc(F)cc2)C(c2ccc(O)cc2)N1c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: No adverse events
Eligibility criteria:
Inclusion Criteria:

Age 18-65years.
Obese BMI >30kg/m2
LDL cholesterol >100 mg/dl
Written and informed consent signed and dated 5. Not on any vitamin/antioxidants

Exclusion Criteria:

On any antilipid agents.
Triglyceride >500mg/dl
Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery in the past 6 months
Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids
Hepatic disease
Renal impairment
History of drug or alcohol abuse
Participation in any other concurrent clinical trial
Use of an investigational agent or therapeutic regimen within 30 days of study.
Smoker
Pregnancy
Premenopausal women who are not on birth control pills and have not had a hysterectomy or tubal ligation 13. Anemia with hemoglobin <12 g/dl
Intervention: Ibuprofen
Trial phase: Phase 3
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 112
Group description: Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally

Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
Eligibility criteria:
Inclusion Criteria:

Provides written informed consent before initiation of any study-related procedures.
Males and females aged at least 10 years and not more than 60 years old on the day of consent.
Undergoing dental surgery for the extraction of at least 2 impacted third molar teeth.
A resting VAS pain intensity score at baseline (within 6 hours after the completion of surgery) of greater than or equal to 40 mm on a 100 mm VAS scale with 0 = no pain and 100 = worst pain imaginable.

Exclusion Criteria:

Has taken any NSAID or acetaminophen within 12 hours prior to the stat of surgery other than asprin less than or equal to 150 mg/day
Subjects who have received any anaesthetics within 24 hours prior to surgery
Hypersensitivity to opioids
Known to be pregnant or possibly pregnant
Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A women of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral oophorectomy.
Women of childbearing potential who are unwilling to undergo an urine pregnancy test.
Suffering from a neurological disorder relating to pain perception or any acute or chronic condition that, in the opinion of the investigator, makes the subject unsuitable from an efficacy or safety perspective.
In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
Currently, or in the last 30 days, has been in a clinical trial involving another study drug.
Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids or topical steroids with the approval of the investigator) cyclosporin, tacrolimus or methotrexate, or any other medication felt by the investigator to interfere with safety or efficacy evaluations.
Participant weight < 50 kg or > 120 kg.
Has a history of drug or alcohol abuse.
Suffering from any other disease or condition which, in the opinion of the investigator, means that it would not be in the participants best interests to participant in the study.
Intervention: Atazanavir
Trial phase: Phase 1
ATC code: J05AE08 | J05AR15 | J05AR23
SMILES: COC(=O)N[C@H](C(=O)N[C@@H](Cc1ccccc1)[C@@H](O)CN(Cc1ccc(-c2ccccn2)cc1)NC(=O)[C@@H](NC(=O)OC)C(C)(C)C)C(C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Atazanavir 300 mg BID for 4 days.

Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug.
Eligibility criteria:
Inclusion Criteria:

Symptoms of diabetes plus casual plasma glucose concentration ≥ 200 mg/dl (11.1 mmol/l), or;
FPG ≥ 126 mg/dl (7.0 mmol/l), or;

2-h postload glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT. In addition, subjects would be required to be at increased risk of cardiovascular events, defined as:

microalbuminuria, or;
T1DM duration of > 20 years.

Exclusion Criteria:

HIV infection
Gilbert's syndrome
Hepatic failure or active hepatitis,
Unstable cardiovascular disease, including angina, heart failure or arrhythmia
drug abuse including alcoholism or addiction to cocaine, heroin or amphetamines
Use of medications that significantly with atazanavir
Pregnancy, or inability to practice adequate contraception
Intervention: Linezolid
Trial phase: Phase 3
ATC code: J01XX08
SMILES: CC(=O)NC[C@H]1CN(c2ccc(N3CCOCC3)c(F)c2)C(=O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 327
Group description: IV to oral linezolid 600 mg twice daily for 10 days.
Eligibility criteria:
Inclusion Criteria:

Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI.
Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

Uncomplicated skin infections
Severe sepsis or septic shock
ABSSSI solely due to gram-negative pathogens
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Eligibility criteria:
Inclusion Criteria:

Generally healthy women
Age 18 and over
Indication for endometrial biopsy or IUD placement

Exclusion Criteria:

Allergy to lidocaine or other local anesthetic
Pregnancy, known or suspected
Patients who are premedicated with misoprostol
Patients with a chronic pain condition for which the patient takes daily pain medication
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.

Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.

The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
Eligibility criteria:
Inclusion Criteria:

Ability to follow study instructions and likely to complete all required visits
Ability to comply with the therapy protocol as assessed by the investigator
3 months post first-time unilateral stroke with right or left hemiparesis and complaints of unilateral hand dysfunction
Must have ability to grasp and lift the test object
Subjects must have upper extremity motor impairment

Exclusion Criteria:

Known allergy or sensitivity to botulinum toxin type A (BOTOX).
Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
Concurrent participation in another investigational drug or device study or participation in another Botulinum toxin study in the 6 months prior to study.
Treatment with botulinum toxin of any serotype in the 3 months prior to study enrollment
Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition.
Infection or skin disorder at an anticipated injection site.
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
Current treatment with intrathecal baclofen.
Intervention: Alseroxylon
Trial phase: Phase 2 | Phase 3
SMILES: ClCC1CO1.NCCNCCNCCNCCN
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: gram morning and bedtime for 90 days; then
grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concentrations were determined monthly.
Eligibility criteria:
Inclusion Criteria:

Adult over age 21
healthy

Exclusion Criteria:

Intercurrent illness
pregnancy
Intervention: Acetylcysteine
Trial phase: Phase 2 | Phase 3
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: This is an open label trial, all patient will be entered into one treatment arm.

N-Acetylcysteine: 600mg by mouth, three times daily for 12 months
Eligibility criteria:
Inclusion:

Subject gives voluntary written informed consent to participate in the study.
Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by computed tomography of the lungs along with symptoms of cough and/or shortness of breath.
Males and females age greater than 18 years at time of screening.
Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least two years are not considered to be of child-bearing potential.

Exclusion:

History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.
Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Intervention: IC Green
Trial phase: Not Applicable
ATC code: V04CX01
SMILES: CC1(C)C(=CC=CC=CC=CC2=[N+](CCCCS(=O)(=O)[O-])c3ccc4ccccc4c3C2(C)C)N(CCCCS(=O)(=O)[O-])c2ccc3ccccc3c21.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Indocyanine Green (ICG)

Indocyanine Green (ICG): Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)
Eligibility criteria:
Inclusion Criteria:

Subject is willing and able to provide an informed consent
Subject is willing and able to comply with the study procedures
Subject speaks English and is able to understand the study procedures
A pregnancy test for women of childbearing potential prior to surgery
Subject is scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

Subject has uremia, serum creatinine >2.5 mg/dl
Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
Subject is a pregnant or lactating female
Subject is actively participating in another drug, biologic and/or device protocol
Intervention: Prucalopride
Trial phase: Phase 4
ATC code: A06AX05
SMILES: COCCCN1CCC(NC(=O)c2cc(Cl)c(N)c3c2OCC3)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 181
Group description: 1 mg or 2 mg tablet once daily before breakfast
Eligibility criteria:
Inclusion Criteria:

Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl/enemas].

Exclusion Criteria:

Subjects in whom constipation is thought to be drug-induced
Subjects using any disallowed medication.
Subjects who previously used prucalopride.
Subjects suffering from secondary causes of chronic constipation.
Intervention: Boceprevir
Trial phase: Phase 1
ATC code: J05AP03
SMILES: [H][C@@]12[C@@H](C(=O)NC(CC3CCC3)C(=O)C(N)=O)N(C(=O)[C@@H](NC(=O)NC(C)(C)C)C(C)(C)C)C[C@]1([H])C2(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
Eligibility criteria:
Inclusion Criteria:

Documented chronic hepatitis C (CHC) genotype 1 infection
Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study

Exclusion Criteria:

Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
Discontinued from interferon treatment due to adverse events
Currently receiving antiviral/immunomodulating therapy for hepatitis C
Prior treatment with an HCV protease inhibitor
Prior treatment with any known hepatotoxic agent (including herbal remedies)
Use of investigational drugs within 30 days of enrollment into study
Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
Substance abuse (including but not limited to alcohol abuse, illicit drugs,

inhalational drugs, marijuana use, etc) any time prior to entry into the study

Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
Pregnant or breastfeeding female
Meeting any of the laboratory exclusion criteria
Intervention: Bepotastine besilate
Trial phase: Phase 3
SMILES: O=C(O)CCCN1CCC(OC(c2ccc(Cl)cc2)c2ccccn2)CC1.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 161
Group description: TAU-284 5mg twice daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Patients aged between 7 and 15 years
Patients with a weight of at least 20 kg
Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period

Exclusion Criteria:

Patients with vasomotor rhinitis or eosinophilic rhinitis
Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
Patients with a history of any of the nasal surgical procedures
Patients who have a positive result for pollen antigens which are dispersed during the study period
Patients who have a positive result for dog dander or cat dander antigen
Patients with current or previous history of drug allergy
Patients who concurrently have renal function abnormalities that may cause safety problems
Intervention: Bepotastine besilate
Trial phase: Phase 3
SMILES: O=C(O)CCCN1CCC(OC(c2ccc(Cl)cc2)c2ccccn2)CC1.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 166
Group description: TAU-284 10mg twice daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Patients aged between 7 and 15 years
Patients with a weight of at least 20 kg
Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period

Exclusion Criteria:

Patients with vasomotor rhinitis or eosinophilic rhinitis
Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
Patients with a history of any of the nasal surgical procedures
Patients who have a positive result for pollen antigens which are dispersed during the study period
Patients who have a positive result for dog dander or cat dander antigen
Patients with current or previous history of drug allergy
Patients who concurrently have renal function abnormalities that may cause safety problems
Intervention: Celecoxib
Trial phase: Phase 4
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 299
Group description: Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.

Celecoxib
Eligibility criteria:
Inclusion Criteria:

At least 40 years of age
Primary OA of the knee according to the American College of Rheumatology (ACR) criteria
OA of radiological stages II or III according to Kellgren and Lawrence
Patients with moderate-severe knee pain

Exclusion Criteria:

Subjects with active malignancy of any type or history of a malignancy within the last five years
Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
Pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint
Patients with fibromyalgia
Subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart
Subjects with high risk of cardiovascular (CV) events
Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections
Subjects with a history of recurrent Upper Gastrointestinal (UGI) ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect
Subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
Washout period for OA treatments before beginning the study.
Intervention: Ipratropii bromidum
Trial phase: Phase 2
ATC code: R03BB01
SMILES: CC(C)[N+]1(C)C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Ipratropium bromide Inhalation Solution via Handihaler® DPI

Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
Eligibility criteria:
Inclusion Criteria:

40-75 years of age
Clinical diagnosis of moderate to severe COPD
Current/ex-smokers with at least 10 pack-year smoking history
Post-bronchodilator FEV1 ≥ 30% and ≤ 70% predicted normal values
Post-bronchodilator FEV1/FVC ratio of ≤ 0.70
Post-bronchodilator improvement in FEV1 ≥ 12% and ≤ 30%, and a minimum of 100 mL
Willing and able to remain at the study site for at least 24 hours at each study visit
Signed written informed consent

Exclusion Criteria:

Current evidence or recent history of any clinically significant and unstable disease or abnormality (e.g., myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes)
Primary diagnosis of asthma
History of malignancy within the past 5 years
History of COPD exacerbation within 6 weeks of Screening
Daily oxygen therapy > 10 hours per day
Systemic steroids use within 6 weeks of Screening
Respiratory tract infection within 6 weeks of Screening
History of tuberculosis, bronchiectasis
History of urinary retention or bladder neck obstruction type symptoms
History of glaucoma
Prolonged QTc interval (>460msec) or history of long QT syndrome
Recent history of alcohol or drug abuse
Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable birth control methods
History of hypersensitivity or intolerance to aerosol medications
Participation in another investigational drug study within 30 days of Screening