anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Prednisolone
Trial phase: Not Applicable
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
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)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF
Fill out the case report form
Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis
Drug administration:

The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose.
Eligibility criteria:
Inclusion Criteria:

Male or female patient with clinical and pathological diagnoses of severe cutaneous adverse drug reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or Durg reaction with eosinophilia and systemic symptoms.
Male or female patient aged more than 4 years.
Inform consent obtained.

Exclusion Criteria:

Pregnant or breastfeeding female.
Allergic to any anti-TNF-α biological product.
Active or latent tuberculosis confirmed with Chest X-ray.
Severe active infection and septicemia.
Active Hepatitis B or C carrier.
Suspected HIV carrier with CD4 count less than 200.
Patient with poor compliance or with safety concerns judged by investigator.
Intervention: Cholecalciferol
Trial phase: Phase 1 | Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Vitamin D3: Oral vitamin D3 100,000 IU administered monthly for six months in children and adolescents with sickle cell disease
Eligibility criteria:
Inclusion Criteria:

patients with sickle cell disease
3 to 20 years old
pregnant females with sickle cell disease are eligible

Exclusion Criteria:

no informed consent or assent
unable or unwilling to comply with requirements of the clinical trial
participation in another clinical trial
history of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, such as primary hyperparathyroidism, malignancy, familial hypocalciuric hypercalcemia, William's syndrome and other rare causes
therapy with thiazide diuretics or lithium carbonate
known renal or liver disease
known malabsorption syndrome and inflammatory bowel disease
chronic use of corticosteroids, excluding inhaled steroids
current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine)
current intake of vitamin D and calcium supplements
initiation of hydroxyurea or iron chelation therapy within the past 3 months
serum 25hydroxyvitamin D >60 ng/mL
Intervention: Remifentanil
Trial phase: Phase 4
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days).

TDF 300 mg tablet once daily for up to 120 weeks
Eligibility criteria:
Inclusion Criteria:

Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline
Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
Positive or negative for hepatitis B e antigen (HBeAg)
HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants)
Alanine aminotransferase (ALT) > 54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300 U/L for women
Creatinine clearance ≥ 70 mL/min
Negative serum pregnancy test for females of childbearing potential
Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication
Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product

Exclusion Criteria:

Known bridging fibrosis or cirrhosis and/or decompensated liver disease
Evidence of hepatocellular carcinoma
Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
History of severe depression or severe psychiatric disease
Thyroid dysfunction
Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
Pregnant
Intervention: Sandostatine
Trial phase: Phase 4
SMILES: CC(=O)O.CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months
Eligibility criteria:
Inclusion Criteria:

• Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)

Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level
Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion

Exclusion Criteria:

Newly diagnosed or previously medically untreated acromegalic patient
Concomitant treatment with GH-receptor antagonist
Concomitant treatment with dopamine-agonist
Symptomatic cholelithiasis or choledocolithiasis
Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according to local laboratory)
Previous gamma-knife radiotherapy for treatment of acromegaly
Compression of the optic chiasm causing visual field defect
Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Donepezil
Trial phase: Phase 3
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
Eligibility criteria:
Inclusion Criteria

Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
Clinical Dementia Rating (CDR) score ≥ 0.5
Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

Patients diagnosed with Parkinson's disease with dementia (PDD)
Patients who received anti-dementia drug therapy at the same institution
Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening
Intervention: Donepezil
Trial phase: Phase 3
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
Eligibility criteria:
Inclusion Criteria

Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
Clinical Dementia Rating (CDR) score ≥ 0.5
Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

Patients diagnosed with Parkinson's disease with dementia (PDD)
Patients who received anti-dementia drug therapy at the same institution
Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening
Intervention: Donepezil
Trial phase: Phase 3
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
Eligibility criteria:
Inclusion Criteria

Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
Clinical Dementia Rating (CDR) score ≥ 0.5
Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

Patients diagnosed with Parkinson's disease with dementia (PDD)
Patients who received anti-dementia drug therapy at the same institution
Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: A sham infrapatellar block performed under US guidance with normal saline

Normal Saline: 10cc, single dose, US guided injection
Eligibility criteria:
Inclusion Criteria:

planned knee arthroscopy with soft tissue intervention
age 18+
English speaking

Exclusion Criteria:

contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy
knee arthroscopy with planned bony intervention
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine

0.25% Bupivacaine: 10cc, single dose, US guided injection
Eligibility criteria:
Inclusion Criteria:

planned knee arthroscopy with soft tissue intervention
age 18+
English speaking

Exclusion Criteria:

contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy
knee arthroscopy with planned bony intervention
Intervention: Famciclovir
Trial phase: Phase 3
ATC code: J05AB09 | S01AD07
SMILES: CC(=O)OCC(CCn1cnc2cnc(N)nc21)COC(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: 1 tablet every 12 hours for 5 days

Famciclovir: Famciclovir 125 mg every 12 hours for 5 days
Eligibility criteria:
Inclusion criteria:

Patients must be able to understand the study procedures agree to participate and give written consent.
Patients with clinical diagnosis of recurrent genital herpes;
Score symptoms higher than 4;
Negative pregnant urine test.

Exclusion criteria:

Pregnancy or risk of pregnancy.
Lactation
Any pathology or past medical condition that can interfere with this protocol.
Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
Patients with immunodeficiency and/or immunosuppressive disease;
Hypersensitivity to components of the formula;
Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Intervention: Acyclovir
Trial phase: Phase 3
ATC code: D06BB03 | D06BB53 | J05AB01 | S01AD03
SMILES: Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: 1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days
Eligibility criteria:
Inclusion criteria:

Patients must be able to understand the study procedures agree to participate and give written consent.
Patients with clinical diagnosis of recurrent genital herpes;
Score symptoms higher than 4;
Negative pregnant urine test.

Exclusion criteria:

Pregnancy or risk of pregnancy.
Lactation
Any pathology or past medical condition that can interfere with this protocol.
Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
Patients with immunodeficiency and/or immunosuppressive disease;
Hypersensitivity to components of the formula;
Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Intervention: Vigabatrin
Trial phase: Phase 2 | Phase 3
ATC code: N03AG04
SMILES: C=CC(N)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
Eligibility criteria:
Inclusion Criteria:

Able to understand the study and provide written informed consent.
Male or female at least 18 years of age.
Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual-IV (DSM-IV) module.
Have a verifiable place of primary residence.
Seeking treatment for cocaine dependence.
Be in generally good health based on history, physical examination, electrocardiogram, eye exam and laboratory findings.
If female of childbearing potential, use acceptable contraceptive methods (oral contraceptives (the pill), intrauterine device (IUD), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable.

Exclusion Criteria:

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Intervention: Valsartan
Trial phase: Phase 2
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 143
Group description: Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
Eligibility criteria:
Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.

Exclusion Criteria:

Severe hypertension
History of angioedema, drug-related or otherwise, as reported by the patient.
Pregnant or nursing (lactating) women.
Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
History or evidence of a secondary form of hypertension.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Olopatadine
Trial phase: Phase 4
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Eligibility criteria:
Inclusion Criteria:

History of allergic conjunctivitis;
Active signs and symptoms of ocular allergies;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

History of dry eye;
Presence of ocular infection;
Presence of severe or serious ocular conditions;
Symptoms of allergic conjunctivitis;
Use of topical or systemic ocular medications as specified in protocol;
Ocular surgery or laser surgery within 6 months of study start;
Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
Other protocol-defined exclusion criteria may apply.
Intervention: Lactulose
Trial phase: Not Applicable
ATC code: A06AD11 | A06AD61
SMILES: OCC1OC(OC2C(CO)OC(O)(CO)C2O)C(O)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Per standard of care

Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care
Eligibility criteria:
Inclusion Criteria:

Ages 18-80
Male and female subjects of all races and ethnicities including Spanish speaking subjects
Cirrhosis of any cause
Any grade of hepatic encephalopathy (1-4)
A legally authorized representative has to be able and willing to comply with all protocol procedures and to understand, sign and date an informed consent document, and authorize access to protected health information on the subjects behalf

Exclusion Criteria:

Acute liver failure
Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam)
Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy)
Previous use of rifaximin or neomycin in past 7 days
Prisoners
Pregnancy
<18 years old
Serum sodium <125 mEq/L
Receiving > 1 dose of lactulose prior to enrollment
Uncontrolled infection with hemodynamic instability requiring vasopressors
Intervention: Clopidogrel
Trial phase: Phase 4
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
Eligibility criteria:
Inclusion Criteria:

Male or females without child bearing potential aged 21-80 years
Known coronary artery disease by angiogram or documented myocardial infarction.
Able to provide written informed consent

Exclusion Criteria:

Treated with clopidogrel or ticlodipine in the previous 3 months
Age < 21 or >80 years
Premenopausal females with potential for pregnancy
Allergy to clopidogrel or aspirin
Initiation or change in dose of any concomitant medical therapy within 2 months before the study
Uncontrolled hypertension with BP>180 mmHg systolic and >120 mmHg diastolic
Treated with coumadin therapy
Intolerance or allergy to statins
Acute infection in previous 4 weeks
History of substance abuse
Uninterpretable PAT test
Current neoplasm
Chronic renal failure [creatinine > 2.5 mg/dL] or liver failure (Liver enzymes >2X normal)
Acute coronary syndrome, heart failure, CVA, coronary intervention within 3 months
Known aortic stenosis, hypertrophic cardiomyopathy, symptomatic heart failure.
Inability to give informed consent
Inability to return to Emory for follow-up
Intervention: RETINOL
Trial phase: Phase 2
ATC code: A11CA01 | D10AD02 | R01AX02 | S01XA02 | V04CB01
SMILES: CC1=C(/C=C/C(C)=C/C=C/C(C)=C/CO)C(C)(C)CCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Retinol 1.0% cream
Eligibility criteria:
Inclusion Criteria:

Age 35 or over
Moderate to severe photodamage

Exclusion Criteria:

History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or facial fillers
History of keloids or hypertrophic scars
Use of oral steroids or oral retinoids (such as Accutane) in past 6 months