anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 4
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Lisdexamfetamine Dimesylate 30, 50, or 70 mg
Eligibility criteria:
Inclusion Criteria:

BRIEF-A Global Executive Composite score (GEC) ≥ 65, or Behavioral Regulation Index score (BRI) ≥ 65, or Metacognition Index score (MI) ≥ 65.
Subjects must meet consensus criteria for chronic fatigue syndrome.
Provide written informed consent for participation in the trial before completing any study-related procedures.
18-60 years at time of consent
Male or non-pregnant females who are not breastfeeding.
Females of reproductive potential must agree to use a medically accepted means of contraception when engaging in sexual intercourse at any time during the study.
Are able to swallow study medication.

Exclusion Criteria:

CFS and executive functioning impairment are not present or not diagnosable
Serious comorbid psychiatric condition
Subjects who were pregnant, nursing, or intended to become pregnant
Subjects who had been on a psychostimulant regimen in the last six months
Subjects who had a medical condition that would have been affected by psychostimulant medication
Subjects who were of low intelligence, or who were unable to communicate effectively with the study team
Intervention: Paricalcitol
Trial phase: Phase 3
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Eligibility criteria:
Inclusion Criteria:

Subject is a Chinese male or female greater than or equal to 20 years old.
Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.

For entry into the Treatment Phase, the subject must have:

Intact parathyroid hormone greater than or equal to 300 pg/mL
Serum calcium less than 10.2 mg/dL (2.55 mmol/L)
Calcium-phosphorus product less than 65 mg^2/dL^2

Exclusion Criteria:

Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
Subject with New York Heart Association (NYHA) Class III or IV.
Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.
Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.
Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
Subject is known to be human immunodeficiency virus (HIV) positive.
Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.
Intervention: Paricalcitol
Trial phase: Phase 3
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Eligibility criteria:
Inclusion Criteria:

Subject is a Chinese male or female greater than or equal to 20 years old.
Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.

For entry into the Treatment Phase, the subject must have:

Intact parathyroid hormone greater than or equal to 300 pg/mL
Serum calcium less than 10.2 mg/dL (2.55 mmol/L)
Calcium-phosphorus product less than 65 mg^2/dL^2

Exclusion Criteria:

Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
Subject with New York Heart Association (NYHA) Class III or IV.
Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.
Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.
Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
Subject is known to be human immunodeficiency virus (HIV) positive.
Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.
Intervention: Amantadine
Trial phase: Phase 4
ATC code: N04BB01
SMILES: NC12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
Eligibility criteria:
Inclusion Criteria:

Parkinson's disease patient, defined by United Kingdom Brain Bank criteria
Current age between 30-90
Clinically pertinent dyskinesias defined by Clinical Gl;obal Impression-severity score (see attachment) > 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. *
Documentation of creatinine level at screening evaluation that is within the normal range for the local university laboratory.
Stable doses of all antiparkinsonian medications for at least 4 weeks
No treatment with amantadine for at least 3 months.
Presence of a caregiver willing to participate in the study
Subjects/caregivers must demonstrate the capacity to complete an accurate home diary based on training and evaluation during the screening period (see attached training rules).
Subjects must be able to provide written informed consent.
If the subject received amantadine in the past, the drug was stopped for reason other than adverse events.
In the opinion of the enrolling investigator, the subject will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
The subject must be willing to participate in all study related activities and visits.

Exclusion Criteria:

Subjects who have had prior brain surgery.
Subjects with other major illnesses that could be complicated by amantadine exposure, including glaucoma, current hallucinations, urinary retention.
Subjects with dementia, depression and psychosis as determined by clinical examination.
Intervention: Buprenorphine
Trial phase: Phase 2
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.
Eligibility criteria:
Inclusion Criteria:

Age >/= 50 years
Major depressive disorder
Non-responder to at least 2 FDA-approved antidepressants prescribed at a therapeutic dose, each for at least 6 weeks, or is a depression non-responder from an ongoing study of late-life depression at our research clinic.

Exclusion Criteria:

Concomitant use of strong or moderate CYP3A4 inhibitor.
Refusal to stop all opioids.
Refusal to discontinue all alcohol.
Refusal to discontinue benzodiazepines other than the equivalent of lorazepam 2 mg/day prescribed at a stable dose for at least the past 2 weeks.
Hepatic impairment (AST/ALT > 1.5 times upper normal.
Lung disease requiring supplemental oxygen.
Estimated creatinine clearance <30 mL/min.
Inability to provide informed consent.
Depressive symptoms not severe enough (i.e., MADRS < 10) at the baseline assessment.
Dementia.
Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
Abuse of or dependence on alcohol or other substances within the past 3 months.
Meets criteria for history of abuse or dependence upon opioids.
High risk for suicide.
Contraindication to buprenorphine.
Inability to communicate in English.
Non-correctable clinically significant sensory impairment.
Unstable medical illness.
Subjects taking psychotropic medications that cannot be safely tapered and discontinued prior to study initiation.
Intervention: Atorvastatin
Trial phase: Not Applicable
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Eligibility criteria:
Inclusion Criteria:

Adults > 18 years of age
undergoing coronary or peripheral angiography with or without intervention
Cr > 1.3 mg/dL or GFR < 60 mL/min

Exclusion Criteria:

end-stage renal disease on dialysis
acute renal failure
previous iodinated contrast media exposure within 7 days of study entry
history of hypersensitivity to statins
pregnancy or lactation
emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock
prisoners
patients already on maximum dose of statins
patient receiving N-acetylcysteine or sodium bicarbonate
Intervention: Fluoride Ion
Trial phase: Phase 3
SMILES: [F-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: sodium fluoride control (placebo)
Eligibility criteria:
Inclusion Criteria:

Male and female subjects, ages 30-70.
Availability for the six-month duration of the clinical research study.
Good general health.
Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.
Minimum of 5 remaining teeth and a minimum of 2 implants.
Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing.
Initial plaque evaluation by determining full mouth presence/absence of plaque.
Signed Informed Consent Form.

Exclusion Criteria:

Tumor(s) of the soft or hard tissues of the oral cavity.
Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).
Carious lesions requiring immediate restorative treatment.
Uncontrolled Diabetes
Use of antibiotics any time during the one month prior to entry into the study.
Untreated peri-implantitis.
Participation in any other clinical research study or test panel within the three months prior to entry into the study.
Pregnant women or women who are breast feeding.
History of allergies to personal care/consumer products or their ingredients.
Medical condition which prohibits not eating/drinking for up to 2 hours.
Current alcohol or drug abuse.
Systemic or local disease conditions that would compromise post-operative healing.
Regular use of anti-inflammatory drugs.
Intervention: Apigenin
Trial phase: Phase 3
SMILES: O=c1cc(-c2ccc(O)cc2)oc2cc(O)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Pharmaceutical grade oral chamomile extract.

Chamomile (Matricaria recutita): 500 mg 3 times daily
Eligibility criteria:
Inclusion Criteria:

Men and women at least 18 years old (all races and ethnicity)
DSM IV diagnosis of GAD as the primary anxiety disorder
Baseline GAD-7 score ≥ 10
Baseline CGI/S score at least 4
Not taking anti-anxiety medication (e.g., Benzodiazepines, buspirone, antidepressants)
Not taking antidepressant, mood stabilizer, or tranquilizer therapy for a prior DSM IV Axis I mood disorder that is in remission
Able to understand and provide informed consent
Able to participate in a 38-week study

Exclusion Criteria:

Patients < 18 years old
Primary DSM IV Axis I anxiety disorder other than GAD (e.g., panic disorder with or without agoraphobia, phobia disorder, acute stress disorder, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, substance-induced anxiety disorder)
Current DSM IV Axis I psychotic disorder
Substance abuse or dependence within the prior 3 months
Current DSM IV Axis I bipolar or major depressive disorder [Note: Patients with co-morbid depressive disorder NOS (e.g., minor depression, recurrent brief depressive disorder, or premenstrual dysphoric disorder (PMDD)] will not be excluded
Unstable medical condition
Allergy to chamomile
Documented allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)
Allergic to mugwort or birch pollen
Concurrent anti-anxiety tranquilizer, antidepressant or mood stabilizer therapy
Concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., chamomile, St. John's Wort, kava kava)
Concurrent use of established antidepressant, mood stabilizer, or tranquilizer therapy for pre-existing affective disorder. [Note: Patients with a history of affective disorder (in remission) who are not currently taking antidepressant, mood stabilizer, or tranquilizer therapy are not excluded from the trial]
Women of child-bearing potential not willing to use a medically proven form of contraception
Positive pregnancy test
Actively suicidal or suicide attempt within the preceding 12 months
Intervention: Apigenin
Trial phase: Phase 3
SMILES: O=c1cc(-c2ccc(O)cc2)oc2cc(O)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Pharmaceutical grade lactose monohydrate.

Chamomile (Matricaria recutita): 500 mg 3 times daily
Eligibility criteria:
Inclusion Criteria:

Men and women at least 18 years old (all races and ethnicity)
DSM IV diagnosis of GAD as the primary anxiety disorder
Baseline GAD-7 score ≥ 10
Baseline CGI/S score at least 4
Not taking anti-anxiety medication (e.g., Benzodiazepines, buspirone, antidepressants)
Not taking antidepressant, mood stabilizer, or tranquilizer therapy for a prior DSM IV Axis I mood disorder that is in remission
Able to understand and provide informed consent
Able to participate in a 38-week study

Exclusion Criteria:

Patients < 18 years old
Primary DSM IV Axis I anxiety disorder other than GAD (e.g., panic disorder with or without agoraphobia, phobia disorder, acute stress disorder, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, substance-induced anxiety disorder)
Current DSM IV Axis I psychotic disorder
Substance abuse or dependence within the prior 3 months
Current DSM IV Axis I bipolar or major depressive disorder [Note: Patients with co-morbid depressive disorder NOS (e.g., minor depression, recurrent brief depressive disorder, or premenstrual dysphoric disorder (PMDD)] will not be excluded
Unstable medical condition
Allergy to chamomile
Documented allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)
Allergic to mugwort or birch pollen
Concurrent anti-anxiety tranquilizer, antidepressant or mood stabilizer therapy
Concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., chamomile, St. John's Wort, kava kava)
Concurrent use of established antidepressant, mood stabilizer, or tranquilizer therapy for pre-existing affective disorder. [Note: Patients with a history of affective disorder (in remission) who are not currently taking antidepressant, mood stabilizer, or tranquilizer therapy are not excluded from the trial]
Women of child-bearing potential not willing to use a medically proven form of contraception
Positive pregnancy test
Actively suicidal or suicide attempt within the preceding 12 months
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.

The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.

0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Patient or legally authorized representative willing and able to provide written informed consent
Willing and able to comply with study assessments for the full duration of the study
High-risk characteristics for penetrating keratoplasty: Either presence of 1.) Corneal NV in one or more quadrants (≥ 3 clock hours NV ≥ 2mm from the limbus) OR 2.) Extension of corneal NV to graft-host junction in a previous failed graft
In generally good stable overall health

Exclusion Criteria:

History of Stevens-Johnson syndrome or ocular pemphigoid
Ocular or periocular malignancy
Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
Uncontrolled glaucoma
Currently on dialysis
Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
Concurrent use of systemic anti-VEGF agents
Change in topical corticosteroid regimen within 14 days of transplantation
Use of systemic immunosuppressive for indication other than corneal graft rejection
Pregnancy (positive pregnancy test) or lactating
Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
Uncontrolled hypertension defined as systolic blood pressure (BP) ≥150 or diastolic BP ≥90 mmHg
History of thromboembolic event within 12 months prior to study entry
Participation in another simultaneous medical investigation or trial
Intervention: Tiotropium
Trial phase: Phase 4
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 121
Group description: Patients who received tiotropium in period one or period two
Eligibility criteria:
Inclusion criteria:

For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion criteria:

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.

Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.
Intervention: Ambrisentan
Trial phase: Not Applicable
ATC code: C02KX02 | C02KX52
SMILES: COC(c1ccccc1)(c1ccccc1)[C@H](Oc1nc(C)cc(C)n1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: drug arm

use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow
Eligibility criteria:
Inclusion Criteria:

Subjects should have limited scleroderma with disease duration <7 years and should satisfy American College of Rheumatology criteria for diagnosis.9;

10 Raynaud's phenomenon would be defined as episodic, bilateral, digital color changes (at least 2 out of 3 possible phases:

pallor, cyanosis, rubor),
provoked by cold or emotional stress.
Subjects should be between 18 and 70 years of age and be able to give informed consent.

Exclusion Criteria:

(a) current tobacco users,
(b) advanced cardiopulmonary disease,
(c) clinically unstable patient,
(d) presence of active digital ulcers or prior history of digital ulcers which led to scarring or significant pitting of digits in the area of interest(presence of ulcers or pits would interfere with measurement of blood flow by LDPI),
(e) pregnancy (class X in pregnancy) or unable to use two reliable forms of contraception during the study if patient is of child bearing age,
(f) patients with moderate or severe hepatic impairment
(g) hemoglobin values less than 10% of the lower limit of normal per laboratory standards
(h) inability to discontinue vasodilator treatment including calcium channel blockers, nitrates, alpha blockers, PDE-5 inhibitors, ACE inhibitors and angiotensin receptor blockers at least one week prior to the study,
(i) echocardiographic evidence of pulmonary arterial hypertension [estimated right ventricular systolic pressure <35 mm Hg],
(j) based on section 7.3 of the full prescribing information booklet- patients on cyclosporine, rifampin or ritonavir should be excluded,
(k) patients with diffuse disease,
(l) disease duration > 7 years