anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ataluren
Trial phase: Phase 3
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Participants received ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 192 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Ability to provide written informed consent (parental/guardian consent and participant assent if less than [<] 18 years of age).
Evidence of completed participation in the double-blind study, PTC124-GD-009-CF (Study 009).
Body weight greater than or equal to (≥) 16 kilograms (kg).
Performance of a valid, reproducible spirometry test using the study-specific spirometer during the screening period.
Confirmed laboratory values within the central laboratory ranges at screening.
In male and female participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration and 60-day follow-up period.
Willingness and ability to comply with all study procedures and assessments, including scheduled visits, drug administration plan, laboratory tests, and study restrictions.

Key Exclusion Criteria:

Chronic use of systemic tobramycin within 4 weeks prior to screening.
Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to screening or between screening and randomization.
Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 4 weeks prior to screening and randomization.
Known hypersensitivity to any of the ingredients or excipients of the study drug.
Exposure to another investigational drug within 4 weeks prior to screening.
Treatment with intravenous antibiotics within 3 weeks prior to screening.
History of solid organ or hematological transplantation.
Ongoing immunosuppressive therapy (other than corticosteroids).
Positive hepatitis B surface antigen, hepatitis C antibody test or human immunodeficiency virus (HIV) test.
Known portal hypertension.
Pregnancy or breast-feeding.
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: 20
Group description: Nilotinib was administered orally at 300 mg BD at approximately 12 hour intervals which had to be taken without food. The capsules were to be swallowed whole with water and no food should have been consumed for at least 2 hours before and at least 1 hour after the dose was taken. Prior to the first dose of nilotinib, patients were required to have an imatinib or dasatinib washout period of at least 3 days. Therapy with nilotinib was to be continued for up to 24 months while on study
Eligibility criteria:
Inclusion Criteria:

Written informed consent prior to screening procedures
Eastern Cooperative Oncology Grou (ECOG) Performance Status of 0, 1, or 2.
Patient with diagnosis of Ph+ CML-CP associated with BCR-ABL quantifiable by RQ-PCR (IS).
Patient has received a minimum of 3 months of imatinib or dasatinib treatment (any dose) since initial diagnosis with a documented response.
Patient is eligible for Pharmaceutical Benefits Scheme (PBS) reimbursed 1st line TKI treatment.
Patient has experienced non-hematological Adverse Events (AE(s)) of any grade, which persisted for at least 1 month despite supportive care or recurred at any grade at least once. Patients who, at the Investigator's discretion, require immediate discontinuation due to the severity of the adverse event are also eligible.
No other current or planned anti-leukemia therapies.
Adequate organ function.
Potassium, Magnesium and Total Calcium above Lower limit of normal.
life expectancy of more than 12 months in the absence of any intervention

Key Exclusion Criteria:

Prior treatment with nilotinib.
Prior Accelerated Phase (AP), Blast Crisis (BC) or allogeneic-transplant (unless the patient received an autologous transplant and was in Chrionic Phase (CP) prior to transplant and never in AP or BC).
Patient has documented Molecular Response (MR) 4.5 at the time of study entry
Patients with atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.
Known impaired cardiac function.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
Pregnant or breast feeding (lactating) women.
Women of child-bearing potential unwilling or unable to use highly effective contraception.
Intervention: Revefenacin
Trial phase: Phase 2
ATC code: R03BB08
SMILES: CN(CCN1CCC(OC(=O)Nc2ccccc2-c2ccccc2)CC1)C(=O)c1ccc(CN2CCC(C(N)=O)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: TD-4208 inhalation solution 44 mcg twice daily for 7 days
Eligibility criteria:
Inclusion Criteria:

Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
Subject is capable of performing reproducible spirometry maneuvers
Subject has post-bronchodilator FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) ratio <0.7
Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines)
Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
Subject demonstrates a post-ipratropium FEV1 response ≥ 12% and ≥ 200 mL of pre-ipratropium FEV1 response
Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria:

Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
Subject has a history of reactions or hypersensitivity to inhaled anticholinergic or beta-agonist agents
Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
Subject has been hospitalized for COPD or pneumonia within 12 weeks.
Subject requires long-term oxygen therapy (>15 hours a day)
Intervention: PBT-1033
Trial phase: Phase 1
SMILES: CN(C)Cc1ccc2c(Cl)cc(Cl)c(O)c2n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Single dose of caffeine 100 mg administered on Day 1 and Day 12

PBT2: PBT2 250 mg administered is Day 8 to 12.
Eligibility criteria:
Inclusion Criteria:

Healthy males or females with a BMI between 19 and 30kg/m2
No clinically significant abnormalities

Exclusion Criteria:

Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2
Use of caffeine-containing beverages, supplements or alcohol
Significant history of depression or other psychiatric illness
Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
Unable to swallow capsules or tablets
Intervention: Uridine triacetate
Trial phase: Phase 3
ATC code: A16AX13
SMILES: CC(=O)OC[C@H]1O[C@@H](n2ccc(=O)[nH]c2=O)[C@H](OC(C)=O)[C@@H]1OC(C)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: All patients were treated with uridine triacetate oral granules.
Eligibility criteria:
Inclusion Criteria (Main Study):

Patients with diagnosed hereditary orotic aciduria
Judged by the investigator to have the initiative and means to be compliant with the protocol
Able to take oral medications
Able to provide written informed consent (patient or legally authorized representative)
Females of childbearing potential must have a negative pregnancy test at screening
Females of childbearing potential or males with partners of childbearing potential are to use one of the following acceptable birth control methods:
Surgically sterile or partner is surgically sterile
Using adequate contraception (hormonal contraceptives, double barrier methods, or intra-uterine devices)
Patients who claim to be sexually inactive agree to use an acceptable method of contraception should she or he become sexually active from 14 days prior to first dosing, throughout the study and for 14 days after the last dose administration

Exclusion Criteria (Main Study):

Has a known allergy to uridine triacetate or any of its excipients
Known to have ornithine transcarbamoylase deficiency
Unable to have the initiative and means to be compliant with the protocol
Unable to be compliant with taking oral medications
Unable to provide written informed consent (patient or legally authorized representative)
Female who is pregnant or lactating

Inclusion Criteria (Treatment Extension)

Patient successfully completed the Main Study

Exclusion Criteria (Treatment Extension)

Patient did not successfully complete the Main Study
Intervention: Propranolol
Trial phase: Phase 4
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of essential voice tremor
Patients who have received or are planning to receive botulinum toxin injections for essential voice tremor
Patients who give informed consent to be contacted for research

Exclusion Criteria:

Patients who are already on a beta blocker
Patients who suffer from hypotension, bradycardia, or otherwise have a medical contraindication to beta blocker therapy (eg. moderate to severe bronchial asthma)

If the patient has received botulinum toxin injections for EVT previously, a three-month washout period is necessary before participation.
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: After securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia.

Propofol: Propofol infusion with nasal oxygen

Propofol: Propofol infusion with an LMA
Eligibility criteria:
Inclusion Criteria:

Age 2-12yrs,
ASA Class I-II,
Fasting,
Unmedicated,
Elective MRI scan

Exclusion Criteria:

Cognitive impairment,
On psychotropic medications,
Taking multiple (>2) antiepileptic medications,
Requiring endotracheal intubation for GA
Intervention: Sevoflurane
Trial phase: Phase 4
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: After securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed.

Sevoflurane: Sevoflurane with an LMA
Eligibility criteria:
Inclusion Criteria:

Age 2-12yrs,
ASA Class I-II,
Fasting,
Unmedicated,
Elective MRI scan

Exclusion Criteria:

Cognitive impairment,
On psychotropic medications,
Taking multiple (>2) antiepileptic medications,
Requiring endotracheal intubation for GA
Intervention: Welchol
Trial phase: Phase 4
SMILES: C=CCN.C=CCNCCCCCCCCCC.C=CCNCCCCCC[N+](C)(C)C.Cl.ClCC1CO1.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 1875 mg of Colesevelam orally twice daily for 10 days
Eligibility criteria:
Patients with IBS-diarrhea with prior evidence of increased fecal 48 hour total bile acid and increased fasting serum 7alphaC4 who meet the following:

INCLUSION CRITERIA

Bowel disease questionnaire (BDQ) - IBS symptoms: Positive by Rome lll criteria
No restrictions on Hospital Anxiety/Depression Score (HADS).
Gender: Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication.

EXCLUSION CRITERIA

Use of drugs or agents within the past 1 week or planned use in the subsequent 2 weeks during the study period (Birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible exceptions):

Agents that alter GI transit including opioids, narcotics, anticholinergics, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRI) antidepressants.
Analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAID), cyclooxygenase-2 (COX 2) inhibitors
Intake of medication that could interfere with the interpretation of the study.
Female subjects who are pregnant or breast-feeding. Females must be either surgically sterilized, postmenopausal (>12 months since last menses), or, if of childbearing potential, using reliable methods of contraception as determined by the physician.
Abdominal surgery (except Appendectomy)

Patients with known chronic liver disease or history of elevated aspartate aminotransferase (AST)/ alanine transaminase (ALT) 2.0 X upper limit of normal.

Bile acid (BA) synthesis and possible false positive or negative fecal bile acid or serum 7alpha-hydroxy-4-cholesten-3-one (7alphaC4) result. If there is no AST or ALT values in the medical record, the study physicians will determine if the tests need to be run.
Intervention: Betamethasone
Trial phase: Phase 2 | Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Dexamethasone
Eligibility criteria:
Inclusion Criteria:

Male or female subject aged 18 years of age or older
Informed consent obtained from a patient or a legal representative before enrollment
Enrollment into the study within 12 hours of detection of chronic subdural hematoma on cranial imaging
Presence of symptoms referable to chronic subdural hematoma, including one or more of the following: Headache; altered mental status, limb weakness, dysphasia, or focal neurological deficit
Demonstration of unilateral chronic subdural hematoma on cranial imaging, including the following features: On computed tomography imaging, iso- or hypo-intensity extra-axial collection with or without presence of acute component; radiologic interpretation of magnetic resonance imaging consistent with subacute or chronic SDH; with or without evidence of acute hemorrhagic component
Maximum depth of subdural hematoma of less than 20mm, with less than 10mm of midline shift, as measured on axial CT or MR imaging
Absence of skull fracture over the subdural hematoma
Able to receive the drug treatment

Exclusion Criteria:

Presence of skull fracture over the subdural hematoma, or other specific etiology for cSDH not suitable for drainage by burr hole craniostomy, such as presence of a ventriculoperitoneal shunt
Extent of subdural hematoma > 20mm in maximal depth, or > 10mm of midline shift, as measured on axial CT or MR imaging
GCS <8 or cSDH of an extent or size for which craniotomy, rather than burr hole drainage alone, is judged necessary by the neurosurgery attending on call
Prior diagnosis of dementia
Presence of symptomatic peptic ulcer, psychosis, active or suspected TB, acute infection, or documented hypersensitivity or allergy to dexamethasone
Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding
Intervention: Betamethasone
Trial phase: Phase 2 | Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Observational cohort of patients treated with dexamethasone protocol

Dexamethasone
Eligibility criteria:
Inclusion Criteria:

Male or female subject aged 18 years of age or older
Informed consent obtained from a patient or a legal representative before enrollment
Enrollment into the study within 12 hours of detection of chronic subdural hematoma on cranial imaging
Presence of symptoms referable to chronic subdural hematoma, including one or more of the following: Headache; altered mental status, limb weakness, dysphasia, or focal neurological deficit
Demonstration of unilateral chronic subdural hematoma on cranial imaging, including the following features: On computed tomography imaging, iso- or hypo-intensity extra-axial collection with or without presence of acute component; radiologic interpretation of magnetic resonance imaging consistent with subacute or chronic SDH; with or without evidence of acute hemorrhagic component
Maximum depth of subdural hematoma of less than 20mm, with less than 10mm of midline shift, as measured on axial CT or MR imaging
Absence of skull fracture over the subdural hematoma
Able to receive the drug treatment

Exclusion Criteria:

Presence of skull fracture over the subdural hematoma, or other specific etiology for cSDH not suitable for drainage by burr hole craniostomy, such as presence of a ventriculoperitoneal shunt
Extent of subdural hematoma > 20mm in maximal depth, or > 10mm of midline shift, as measured on axial CT or MR imaging
GCS <8 or cSDH of an extent or size for which craniotomy, rather than burr hole drainage alone, is judged necessary by the neurosurgery attending on call
Prior diagnosis of dementia
Presence of symptomatic peptic ulcer, psychosis, active or suspected TB, acute infection, or documented hypersensitivity or allergy to dexamethasone
Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding
Intervention: Fostamatinib
Trial phase: Phase 2
ATC code: B02BX09
SMILES: COc1cc(Nc2ncc(F)c(Nc3ccc4c(n3)N(COP(=O)(O)O)C(=O)C(C)(C)O4)n2)cc(OC)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks

Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Eligibility criteria:
Inclusion Criteria:

Renal biopsy findings consistent with IgA nephropathy
Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose
Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day at the second Screening Visit
Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents

Exclusion Criteria:

Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
Use of > 15 mg/day prednisone (or other corticosteroid equivalent).
Intervention: Fostamatinib
Trial phase: Phase 2
ATC code: B02BX09
SMILES: COc1cc(Nc2ncc(F)c(Nc3ccc4c(n3)N(COP(=O)(O)O)C(=O)C(C)(C)O4)n2)cc(OC)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks

Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Eligibility criteria:
Inclusion Criteria:

Renal biopsy findings consistent with IgA nephropathy
Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose
Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day at the second Screening Visit
Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents

Exclusion Criteria:

Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
Use of > 15 mg/day prednisone (or other corticosteroid equivalent).
Intervention: Dapagliflozin
Trial phase: Phase 2 | Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.

Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Eligibility criteria:
Inclusion Criteria:

Patients both sexes
Age between 30 and 60 years
Metabolic Syndrome according to the IDF criteria
Waist circumference
Man ≥90 cm
Woman ≥80 cm
And two of the following criteria
High density lipoprotein
Man ≤40 mg/dL
Woman ≤50 mg/dL
Fasting glucose ≥100 mg/dL
Triglycerides ≥150 mg/dL
Blood pressure ≥130/85 mmHg
Informed consent signed

Exclusion Criteria:

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to SGLT2 inhibitors
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased
Previous treatment for the metabolic syndrome components
Body Mass Index ≥39.9 kg/m2
Fasting glucose ≥126 mg/dL
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Low density lipoprotein (c-LDL) ≥190 mg/dL
Blood Pressure ≥140/90 mmHg