anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
Eligibility criteria:
Inclusion Criteria:

Subjects, 18 to 80 years of age, scheduled for elective cardiac surgery requiring CPB
For female subjects, the following conditions must be met:

postmenopausal for at least 1 year, or status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and a negative urine beta-hcg prior to drug treatment

Exclusion Criteria:

Allergic reaction to ApAP (acetaminophen)
Evidence of severe hepatic impairment (history of liver cirrhosis or total bilirubin >2.0mg/dl)
Impaired renal function (serum creatinine >2.0 mg/dl)
Emergency surgery
Pregnancy
Breast-feeding
Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
History of alcohol or drug abuse
Treatment with any investigational drug in the 1 month preceding the study
Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
History or evidence of active asthma
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Saline infusion
Eligibility criteria:
Inclusion Criteria:

Subjects, 18 to 80 years of age, scheduled for elective cardiac surgery requiring CPB
For female subjects, the following conditions must be met:

postmenopausal for at least 1 year, or status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and a negative urine beta-hcg prior to drug treatment

Exclusion Criteria:

Allergic reaction to ApAP (acetaminophen)
Evidence of severe hepatic impairment (history of liver cirrhosis or total bilirubin >2.0mg/dl)
Impaired renal function (serum creatinine >2.0 mg/dl)
Emergency surgery
Pregnancy
Breast-feeding
Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
History of alcohol or drug abuse
Treatment with any investigational drug in the 1 month preceding the study
Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
History or evidence of active asthma
Intervention: Fesoterodine
Trial phase: Not Applicable
ATC code: G04BD11
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.

Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks
Eligibility criteria:
Inclusion Criteria:

For healthy volunteers the inclusion criteria are:

Females ≥ 18 years old
Not experiencing overactive bladder symptoms
Not experiencing frequency or urgency

For overactive bladder patients the inclusion criteria are

Females ≥ 18 years old
Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) > 3/year

Exclusion Criteria:

For healthy volunteers the exclusion criteria are:

Overactive bladder symptoms, such as frequency and urgency
Intermittent/unstable use of bladder medications
Pregnant women or women unwilling to use contraceptives
Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
Lower urinary tract surgery within past 6 months
Known history of IC or pain associated with OAB
Urinary retention requiring catheterization, indwelling catheter of Self-cath
Recurrent UTIS > 3/year

For overactive bladder patients the exclusion criteria are:

Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma
Intermittent/unstable use of bladder medications
Pregnant women or women unwilling to use contraceptives
Neurological conditions: stroke, MS, Parkinson's, spinal cord injury
Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
Lower urinary tract surgery within past 6 months
Known history of Interstitial Cystitis (IC) or pain associated with OAB
Urinary retention requiring catheterization, indwelling catheter of Self-cath
Recurrent urinary tract infections (UTIS) > 3/year

Deferral Criteria:

Treatment with OAB medications within 2 weeks before baseline visit. If patient is currently on OAB medications the patient will be asked to stop OAB medication for 2 weeks and return for baseline visit.
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed

Saline: 2 ml at induction 1-2 ml boluses as needed
Eligibility criteria:
Inclusion Criteria

Patients scheduled to undergo outpatient arthroscopic surgery procedures
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
18 - 80 years of age
American Society of Anesthesiologists (ASA) Class I - III adults of either sex
Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test

Exclusion Criteria

Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Any other conditions or use of any medication which may interfere with the conduct of the study (e.g., asthmatic patients history of asthma, chronic cough, or upper respiratory tract infection during the previous 2 wk or recent treatment with angiotensin-converting enzyme inhibitors, bronchodilators, or steroids.
Intervention: Fluoxetine
Trial phase: Phase 3
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 112
Group description: Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
Eligibility criteria:
Inclusion Criteria:

Age >=7 and <18 years of age
Primary diagnosis of major depressive disorder (MDD)
CDRS-R score >40

Exclusion Criteria:

History of suicidal behaviour, or requires precaution against suicide
Not in generally healthy medical condition
History of psychosis or bipolar disorder
Seizure disorder
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.
Eligibility criteria:
Inclusion Criteria:

Patients aged between 18 and 60 years old
Subacute low back pain -evolution time more than 4 weeks and less than 3 months.
That have social security system
Live in the metropolitan area

Exclusion Criteria:

Antecedents of spinal, pelvis or abdominal trauma
Cancer
Diabetes mellitus
Steroids use
Men and Women over 60 years
Cauda equine syndrome
Women and men with osteoporosis or compression fractures
Suspicion of infection.
Insidious onset, constitutional symptoms
Intravenous drugs abuse
HIV
Immunosuppression or previous surgery
Rheumatic diseases
Urinary tract infections
Neurological symptoms in lower limbs
Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
Deformities in the spine (scoliosis greater than 15º)
History of peptic acid disease
Renal failure
Intake of anticoagulants or antiplatelet drugs
Allergy to NSAIDs.
Intervention: Lenalidomide
Trial phase: Phase 2
ATC code: L04AX04
SMILES: Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.

Lenalidomide and azacitidine combination: lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.

Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy.
Eligibility criteria:
Inclusion Criteria: Patients with low to Int-1 risk MDS

ECOG performance status of < 2 at study entry (see Appendix II).
Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
Serum bilirubin levels < 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN.
Serum creatinine levels 1.5 x ULN
Absolute neutrophil count > 1000/mm³
Platelet count > 30,000/mm³
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Females of childbearing potential (FCBP)† must have a negative serum or urine

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking Revlimid® (lenalidomide).
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.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to lenalidomide, azacitidine, or mannitol.
Any prior use of Vidaza® (azacitidine).
Prior use of Revlimid® (lenalidomide) for more than 84 days (three 28 day cycles).
Concurrent use of other anti-cancer agents or treatments.
Known positive for HIV or infectious hepatitis, type B or C.
Intervention: Cyclohexylamine
Trial phase: Phase 2
SMILES: NC1CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Eligibility criteria:
Inclusion Criteria:• Informed consent

Age > 18 years
Performance status 0-1; expected survival ≥ 3 months
Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast
Liver metastases not suitable for local treatment
Extrahepatic disease should be determined by PET-CT-scan.
No progression on treatment with capecitabine.
Prior treatment with taxane (adjuvant or for metastatic disease)
Metastases < 70 % of the liver
Neutrophile granulocytes > 1.5 x 109/l og thrombocytes > 100 x 109/l
Bilirubin < 2.0 x UNL (upper normal limit).
Creatinine-clearance > 30 ml/min.
INR < 1.6.
If the patient is HER2-positive:Baseline LVEF ≥ 50 %

Exclusion Criteria:

History of chemotherapy within the 4-week period prior to the start of trial medication
Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
Previous treatment with oxaliplatin
Cytotoxic or experimental treatment within a 14 days period before start of trial medication
The patient is not allowed to participate in other clinical trials.
Any clinical symptoms suggesting peripheral neuropathy < or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion
Other severe medical conditions e.g. severe cardial disease or AMI < 1 year
Presence of diseases which prevent oral therapy.
Patients with uncontrolled infection
Pregnant or lactating women
Women capable of childbearing not using a sufficient non-hormonal method of birth control
Patients not able to understand the treatment or to collaborate.
Prior serious or unsuspected reaction after treatment with fluoropyrimidine
Known prior hypersensitivity reactions to the agents

If the patient is HER2-positive:

Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.
Intervention: Nacom
Trial phase: Phase 2
SMILES: CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: levodopa/carbidopa 800/200 mg/d
Eligibility criteria:
Inclusion Criteria:

meet criteria for cocaine dependence
seeking treatment for cocaine dependence
be in acceptable health based on medical history and physical exam

Exclusion Criteria:

dependent on drugs other than cocaine, nicotine, marijuana
have a medical condition contraindicating treatment with study medications
having conditions of probation or parole requiring reports of drug use to officers of the court
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.
Eligibility criteria:
Inclusion Criteria:

Subjects 10-18 years who are status post anterior or posterior spine fusion surgery

Exclusion Criteria:

All patients requiring mechanical ventilation post-operatively, continuous infusions of sedative, or continuous infusions of alternate opiates (i.e. fentanyl)
Patients with hepatic dysfunction
Patients with chronic opiate requirements
Pregnant or lactating females
Patients placed on opiates other than morphine or hydromorphone
Patients with opiate or acetaminophen allergies
Patients placed on alternate analgesic adjuncts (i.e. ketamine, etc)
Patients who receive intrathecal opiates
Intervention: Perflutren
Trial phase: Phase 2
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Eligibility criteria:
Inclusion Criteria:

The subject is is greater than or equal to 18 years of age.
The subjects has highly suspected or established carotid artery disease.
The subject has undergone or been referred for either unilateral or bilateral intra-arterial X-ray carotid angiography for the determination of subject management (within 30 days before or after the U/S procedure).
The subject has non-diagnostic U/S of the carotids as defined by institutional standards.

Exclusion Criteria:

The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
The subject has a history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent.
The subject has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin.
The subject has right to left, bi-directional or transient right to left cardiac shunts.
Intervention: Rabeprazole
Trial phase: Phase 2 | Phase 3
ATC code: A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03
SMILES: COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 201
Group description: Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
Eligibility criteria:
Inclusion Criteria

Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308.
Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study.

Exclusion Criteria

-Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.
Intervention: Riboflavin
Trial phase: Phase 3
ATC code: A11HA04 | S01XA26
SMILES: Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Riboflavin : Both treatment and sham groups will receive riboflavin
Eligibility criteria:
Inclusion Criteria:

18 Years of age or older
Diagnosis of Ectasia
Presence of central or inferior steepening
Topography consistent with ectasia
BSCVA 20/20 or worse
If contact lens wearer; removal of contact lenses for required period of time
Signed informed consent
Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
History of chemical injury or delayed epithelial healing
A known sensitivity to study medications
Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
A condition that would interfere with or prolong epithelial healing
Presence or history of any other condition or finding that makes the patient unsuitable for treatment
Intervention: Riboflavin
Trial phase: Phase 3
ATC code: A11HA04 | S01XA26
SMILES: Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 500
Group description: All eyes to be treated with riboflavin and UV light
Eligibility criteria:
Inclusion Criteria:

12 years of age or older
Diagnosis of Keratoconus or Ectasia
Central or Inferior steepening on the Pentacam map
Topography consistent with Keratoconus or Ectasia
BSCVA 20/20 or worse
Removal of contact lenses for required period of time
Signed written informed consent
Willingness and ability to comply with schedule for follow up visits

Exclusion Criteria

For Keratoconus, a history of previous corneal surgery
Corneal pachymentry equal to or greater and 400
Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
A history of chemical injury or delayed healing
Pregnancy
A known sensitivity to the study medications
Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
Presence or history of any other condition or finding that makes the patient unsuitable as a candidate
Intervention: Hydrocortisone
Trial phase: Phase 4
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Hydrocortisone 100 mg IV Q 8hrs x3

Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for bilateral total knee replacement
Between 50-90 years of age

Exclusion Criteria:

Patients on steroid therapy
Patients that require stress-dose steroid pre-operatively
Patients that smoke
Patients that are diabetic
Patients younger than 50 or older than 90 years
Intervention: Ampicillin
Trial phase: Phase 3
ATC code: J01CA01 | J01CA51 | J01CR50 | S01AA19
SMILES: [H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 263
Group description: Benzyl Penicillin 50,000IU/kg 6 hourly
Eligibility criteria:
Inclusion Criteria:

Clinical signs of WHO-defined severe pneumonia
Age 2 months to 59 months

Exclusion Criteria:

Clinical signs of WHO-defined very severe pneumonia
Clinical or laboratory diagnosis of meningitis
Clinical diagnosis of severe malnutrition (marasmus/kwashiorkor)
Clinical or laboratory diagnosis of severe anaemia requiring transfusion
HIV-exposure on rapid HIV antibody test (only observational data will be collected from these patients)
Elimination of signs of severe pneumonia in a child with wheeze after outpatient bronchodilator therapy
Chronic condition that may underlie or contribute to a presentation with respiratory distress such as: known chronic renal or cardiac disease, presence of cerebral palsy predisposing child to aspiration/hypostatic pneumonia
Established bronchiectasis or congenital abnormality of the lower respiratory tract
Upper airway obstruction producing stridor
Admission from outpatient clinic specifically for treatment of TB
Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the initial regimen is considered to have failed
Documented history of >48hours treatment with oral amoxicillin
Failure to obtain informed consent
Penicillin allergy