anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ALENDRONIC ACID
Trial phase: Phase 2 | Phase 3
ATC code: M05BA04 | M05BB03 | M05BB05 | M05BB06
SMILES: NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Alendronate in 10mg capsules taken once daily

Alendronate
Eligibility criteria:
Inclusion Criteria:

Clinical history consistent with moderate asthma for >1 year
Asthma is controlled with ICS, with an FP dose ≤ 1000mcg/day and >100mcg/day (or equivalent)
Able to perform reproducible spirometry according to ATS criteria
Baseline FEV1 ≥ 50% of predicted and ≥1L.
If FEV1 <80%, a minimum 12% increase in FEV1 post-bronchodilator or a MCh PC20 ≤ 8 mg/mL
If FEV1 ≥80%, a MCh PC20 ≤ 8 mg/mL
Salmeterol protected MCh ≤ 16 mg/mL

Exclusion Criteria:

Uncontrolled asthma, as suggested by an ACT score <18 while on high-dose ICS (FP daily dose >500mcg or equivalent)
Non-ICS controller medication or LABA use within 4 weeks of study entry.
Contraindications to use of bisphosphonates: history of intolerance to bisphosphonates, history of esophageal ulcers, history of hematemesis, uncontrolled gastro-esophageal reflux disease, inability to stay erect for 30 minutes after oral drug, history of osteonecrosis of the jaw, dental extraction or root canal in prior 8 weeks, or anticipated during the study
Calculated GFR of less than 35 mL/min
History of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or > 10 pack-years total if ≥ 18 years of age
Systemic corticosteroid treatment for any condition within 4 weeks of enrollment at Visit 1, history of significant asthma exacerbation requiring systemic corticosteroids within 4 weeks of Visit 1 or more than five courses of systemic corticosteroids in the past year, history of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years
History of a respiratory tract infection within 4 weeks of Visit 1
Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment
Intervention: Clopidogrel
Trial phase: Phase 2 | Phase 3
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Clopidogrel 75mg by mouth daily

Clopidogrel: 75mg once a day by mouth
Eligibility criteria:
Inclusion Criteria:

Adults age 18-100 years with Rutherford Classification Stage IV through VI PAD with a recent percutaneous lower extremity arterial angiography with arterial intervention in the past 2 weeks
Willingness to sign informed consent
Ability to return for follow up visits
A female patient of childbearing potential who is sexually active must agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug. Women not of childbearing potential are defined as those who have surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are post menopausal (defined as at least 2 years since last regular menses). The female patient should not be lactating and must have a negative pregnancy test at screening.

Exclusion Criteria:

Patients will be ineligible for this study if they meet any one of the following criteria:

Intolerance to thienopyridines
Hypersensitivity to ticagrelor or any component of the product.
Concomitant use of oral anticoagulation with vitamin K antagonist, factor Xa inhibitor, or direct thrombin inhibitor
History of intracranial hemorrhage
History of severe hepatic impairment defined by baseline transaminase greater than or equal to 3x ULN or any elevation in bilirubin
Active bleeding
Allergy to aspirin
Baseline TcPO2 < 10 mmHg post angiography
Resting, pre- procedure heart rate <50 beats-per-minute without a permanent pacemaker and not on an atrioventricular nodal blocking agent
Severe COPD on home oxygen therapy -
Intervention: Ticagrelor
Trial phase: Phase 2 | Phase 3
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Ticagrelor 90mg by mouth twice daily

Ticagrelor: 90mg twice a day by mouth
Eligibility criteria:
Inclusion Criteria:

Adults age 18-100 years with Rutherford Classification Stage IV through VI PAD with a recent percutaneous lower extremity arterial angiography with arterial intervention in the past 2 weeks
Willingness to sign informed consent
Ability to return for follow up visits
A female patient of childbearing potential who is sexually active must agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug. Women not of childbearing potential are defined as those who have surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are post menopausal (defined as at least 2 years since last regular menses). The female patient should not be lactating and must have a negative pregnancy test at screening.

Exclusion Criteria:

Patients will be ineligible for this study if they meet any one of the following criteria:

Intolerance to thienopyridines
Hypersensitivity to ticagrelor or any component of the product.
Concomitant use of oral anticoagulation with vitamin K antagonist, factor Xa inhibitor, or direct thrombin inhibitor
History of intracranial hemorrhage
History of severe hepatic impairment defined by baseline transaminase greater than or equal to 3x ULN or any elevation in bilirubin
Active bleeding
Allergy to aspirin
Baseline TcPO2 < 10 mmHg post angiography
Resting, pre- procedure heart rate <50 beats-per-minute without a permanent pacemaker and not on an atrioventricular nodal blocking agent
Severe COPD on home oxygen therapy -
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
Eligibility criteria:
Inclusion Criteria:

Painful osteoarthritis
Able to discontinue anti-inflammatory drugs and analgesics
Must be ambulatory without assistive walking devices

Exclusion Criteria:

Chronic pain conditions other than knee osteoarthritis
Treatment with corticosteroids in the study knee within 12 weeks
Treatment with hyaluronic acid in the study knee within 24 weeks
Previous treatment with any botulinum toxin for any reason
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 2
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Bupivacaine HCl

150mg Bupivacaine HCl injection
Eligibility criteria:
Inclusion Criteria:

Man or woman who is ≥ 18 years of age
Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique)
If female, is nonpregnant

Exclusion Criteria:

Scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedures
Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively
Has any clinically significant unstable cardiac, neurological, immunological, renal, hepatic or hematological disease or any other condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff or otherwise contraindicate study participation
Intervention: Levosimendan
Trial phase: Phase 2
ATC code: C01CX08
SMILES: C[C@@H]1CC(=O)NN=C1c1ccc(NN=C(C#N)C#N)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Patients who received levosimendan
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Female and male children between 1 and 12 months of age
Non-restrictive VSD (corrective surgery)
Complete AVSD (biventricular repair)
Tetralogy of Fallot

Exclusion Criteria:

Unbalanced AtrioVentricular Septal Defect or AVSD with cyanosis
Age less than one month and more than one year
Acute operation that is unscheduled operation during the first 24 hours after presentation to the department for thoracic surgery
Mild, moderate, or severe kidney dysfunction and known anatomical anomalies of kidneys
Liver impairment or disease
Ongoing infection
Use of nephrotoxic drugs (like ibuprofen, angiotensin-converting-enzyme inhibitors, gentamicin, vancomycin) preoperative or postoperative until first post operative day. Contrast agents whithin 24 hours before operation.
Use of inhibitors of membrane transport proteins (cimetidine, cetirizine, trimethoprim, probenecid, rifampin and gemfibrosil).
Allergy to Levosimendan or substance included in the preparation or previous use of Levosimendan.
Severe arrhythmias needing pace-maker treatment prior to the operation
Severe cardiac dysfunction needing for treatment with extracorporeal membrane oxygenation (ECMO) prior to the operation.
Preoperative need for mechanical ventilation and/or inotropic agents.
Re-operation (open heart surgery). Earlier surgical closure of the arterial duct does not count as an exclusion criteria.
Prematurity: Gestational age < 30 weeks, irrespective of postpartum age. Gestational age 30-34 weeks if patient is included at postpartum age under 3 months.
Intervention: Lovenox
Trial phase: Phase 1
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 46
Group description: Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.

Enoxaparin Sodium: comparison of bioavailability of generic Enoxaparin Sodium and Clexane
Eligibility criteria:
Inclusion Criteria:

Healthy male or female volunteer between 18 and 55 years of age.
Subject with a BMI of 18-30 (Body Mass Index = Body weight (kg) / [Height (m)]2)
Subject with no clinically significant abnormal serum biochemistry, haematology, coagulation factors and urine examination values within 14 days of the first dose.
Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) and vital signs determined within 14 days of the first dose.
Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (HbsAg) and hepatitis C virus antibody (HCV) results.

Exclusion Criteria:

Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low molecular weight heparins, and/or pork products.
Subject with a relevant history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. Or with history or presence of alcoholism or drug abuse;
Subject with clinically relevant abnormal physical findings or clinically relevant abnormal laboratory values indicative of physical illness;
Female subject who is pregnant or lactating
Female subject with weight < 45 kg or male subject with weight < 57 kg.
Intervention: Lovenox
Trial phase: Phase 1
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 45
Group description: Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.

Enoxaparin Sodium: comparison of bioavailability of generic Enoxaparin Sodium and Clexane
Eligibility criteria:
Inclusion Criteria:

Healthy male or female volunteer between 18 and 55 years of age.
Subject with a BMI of 18-30 (Body Mass Index = Body weight (kg) / [Height (m)]2)
Subject with no clinically significant abnormal serum biochemistry, haematology, coagulation factors and urine examination values within 14 days of the first dose.
Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) and vital signs determined within 14 days of the first dose.
Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (HbsAg) and hepatitis C virus antibody (HCV) results.

Exclusion Criteria:

Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low molecular weight heparins, and/or pork products.
Subject with a relevant history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. Or with history or presence of alcoholism or drug abuse;
Subject with clinically relevant abnormal physical findings or clinically relevant abnormal laboratory values indicative of physical illness;
Female subject who is pregnant or lactating
Female subject with weight < 45 kg or male subject with weight < 57 kg.
Intervention: Tranexamic acid
Trial phase: Not Applicable
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Patients will receive either oral or intravenous Tranexamic Acid

Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement
Eligibility criteria:
Inclusion Criteria:

Any patient scheduled for a primary TKA or cementless THA with epidural/spinal anesthesia

Exclusion Criteria:

Allergy to TXA, acquired disturbances of color vision, refusal of blood products, pre-op use of anticoagulant therapy within five days before surgery, a history of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA), pregnancy, breastfeeding, major comorbidities (such as severe ischemic heart disease [New York Heart Association Class III or IV], previous myocardial infarction, severe pulmonary disease, renal impairment, or hepatic failure), patients who decline to participate, any patient undergoing a revision TKA, THA or BHR
Intervention: Tranexamic acid
Trial phase: Not Applicable
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Patients will receive either oral or intravenous Tranexamic Acid

Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative
Eligibility criteria:
Inclusion Criteria:

Any patient scheduled for a primary TKA or cementless THA with epidural/spinal anesthesia

Exclusion Criteria:

Allergy to TXA, acquired disturbances of color vision, refusal of blood products, pre-op use of anticoagulant therapy within five days before surgery, a history of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA), pregnancy, breastfeeding, major comorbidities (such as severe ischemic heart disease [New York Heart Association Class III or IV], previous myocardial infarction, severe pulmonary disease, renal impairment, or hepatic failure), patients who decline to participate, any patient undergoing a revision TKA, THA or BHR
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 64
Group description: Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.

0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
Eligibility criteria:
Inclusion Criteria:

All pediatric patients aged 2 months to 24 months of age, both genders attending the pediatric emergency service.
With first episode of wheezing associated with respiratory distress and a history of upper respiratory tract infection.
You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu (HSJD) from 6 to 16 at entry points (moderate and severe degree).

Exclusion Criteria:

Subjects with a history of previous wheezing, asthma, or who have received bronchodilator treatment before the present illness.
Subjects with chronic lung disease, with heart disease, with congenital or acquired anatomic abnormalities of the airway.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 64
Group description: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.

3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
Eligibility criteria:
Inclusion Criteria:

All pediatric patients aged 2 months to 24 months of age, both genders attending the pediatric emergency service.
With first episode of wheezing associated with respiratory distress and a history of upper respiratory tract infection.
You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu (HSJD) from 6 to 16 at entry points (moderate and severe degree).

Exclusion Criteria:

Subjects with a history of previous wheezing, asthma, or who have received bronchodilator treatment before the present illness.
Subjects with chronic lung disease, with heart disease, with congenital or acquired anatomic abnormalities of the airway.
Intervention: ASPIRIN
Trial phase: Phase 4
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Aspirin: 2-week aspirin therapy (81mg/day)
Eligibility criteria:
Inclusion Criteria:

45-75 years
GeneSTAR participant
No personal History of Coronary Artery Disease
Women who are post-menopausal
Women who are using a reliable method of contraception, such as history of tubal ligation, IUD or taking OCP

Exclusion Criteria:

Taking aspirin prescribed by physician
weight < 60 kg
History of recent or current bleeding
allergy to aspirin or history of adverse events to aspirin
serious comorbid conditions (such as AIDS, active cancer)
high blood pressure (>160/95)
History of gastrointestinal ulcer/bleeding
Mental incompetence to make decision to participate.
Intervention: Pomaglumetad methionil
Trial phase: Phase 1
SMILES: CSCCC(N)C(=O)NC1(C(=O)O)CS(=O)(=O)C2C(C(=O)O)C21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Pomaglumetad Methionil 160mg, one dose, one time
Eligibility criteria:
Inclusion Criteria:

Men and women between 18 and 60 years of age, any race
Primary, current Axis I diagnosis of post traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria
Able to provide written informed consent

Exclusion Criteria:

Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia, schizoaffective disorder, bipolar disorder
History of moderate or severe traumatic brain injury (TBI) with loss of consciousness
Lifetime history of seizure disorder
Current diagnosis of obsessive-compulsive disorder (OCD)
Current diagnosis of bulimia nervosa or anorexia nervosa; or substance use disorder
Alcohol or drug abuse in the past 90 days, or dependence in the past year.
Individuals with a cumulative lifetime history of intravenous substance abuse longer than 1 year.
Severe dissociation, defined as a Clinician Administered Dissociative States Scale (CADSS) score greater than 60 at baseline
Patients with creatinine clearance <60 milliliters (mL)/min (moderate renal impairment)
Current pregnancy or breast feeding; medical conditions that could interfere with correct interpretation of study data, i.e., individuals with the following medical conditions will be excluded: cancer in the past year, stroke, heart attack, angina, neurological disease (multiple sclerosis, epilepsy, Parkinson's disease), central nervous system (CNS) lesions including TBI with loss of consciousness, dementing illness, and/or liver or kidney disease. Patients with QT interval >450 msec (males) and >470 msec (females).
Participants who have started new medication regimen for PTSD within 3 months prior to study start and subjects taking fluoxetine
Current suicidality defined by emergent Columbia Suicide Severity Rating Scale (CSSRS)-defined suicidal behavior, a suicidal ideation score of 5 (indicating active suicidal ideation with specific plan and some level of intent) or 4 (indicating active suicidal ideation with some intent to act, without specific plan) on the CSSRS or in the absence of a CSSRS suicidal ideation score of 5 or 4 or CSSRS-defined suicidal behavior, if the investigator determines the patient to have a significant short-term risk for a suicide attempt.
Individuals with active suicidal risk, active self-mutilation or aggressive behavior with threatening behavior toward others within the past year, as judged by the Principal Investigator
Pregnant or lactating women
Legal and Financial: Current legal proceedings resulting from the traumatic events. People whose continued receipt of financial benefits is contingent upon maintaining PTSD symptoms or who are waiting for a decision concerning the receipt of financial benefits based upon PTSD symptoms