anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pituitrin
Trial phase: Not Applicable
SMILES: NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.

Vasopressors
Eligibility criteria:
Inclusion Criteria:

Who are receiving vasopressors for distributive shock
Who are older than 16 years of age at the time of eligibility.
Who are under the direct care of the ICU team regardless of location.
Who have received a minimum of 30 mL/kg of intravenous fluids (2100 mL for a 70 kg patient) before enrolment OR the most responsible physician has good reasons to believe that more fluid resuscitation is no longer required and could be harmful.
Who the treating physician believes will need vasopressors for at least 6 hours once enrolled.

Exclusion Criteria:

Have received vasopressors for more than 24 consecutive hours; if vasopressors are discontinued for >= 2 hours then restarting vasopressors will constitute a distinct vasopressor episode and the clock will be reset.
Are judged by the treating physician to be in obvious cardiogenic shock after an acute myocardial infarction (based on new ST segment elevations on ECG or obvious echocardiographic findings).
Have obvious haemorrhagic shock as a consequence of a clearly identified source of blood loss.
Require vasopressors after cardiac surgery as a result of cardiopulmonary bypass-induced hypotension.
Who have a specific indication for catecholamine therapy other than shock (i.e. angioedema or intracranial hypertension).
If the attending team has agreed to withhold or withdraw life sustaining care.
Concurrent enrollment in interventional trials that do not meet guidelines (see ccctg.ca) for co-enrollment (co-enrollment is permissible if there is no potential interaction between the protocols; this will be addressed case by case).
Prior randomization in this study.
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: No
Participants at risk: 13
Group description: Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
Eligibility criteria:
Inclusion Criteria:

Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.
Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
Abdominal incision length of 3-12 cm.
Subjects must be physically and mentally able to participate in the study and complete all study assessments.
Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.
Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
Any female subject who is currently pregnant.
Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Single, 300 mg pre-operative oral dose of Pregabalin.

Pregabalin: One 300 mg oral dose of Pregabalin given before surgery.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.

Exclusion Criteria:

-
Intervention: Fluocinonide
Trial phase: Early Phase 1
ATC code: C05AA11 | D07AC08 | D07CC05
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.

fluocinonide 0.05% ointment
Eligibility criteria:
Inclusion Criteria:

Any male or female 18 years or older of age with a diagnosis of mild to moderate psoriasis by a dermatologist will be eligible for participation.
Less than 20% of body surface involvement for psoriasis.
Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
The subject is able to complete the study and comply with study instructions, including attending all study visits.
In general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase health risk by study participation

Exclusion Criteria:

Individuals younger than 18 years of age.
Known allergy or sensitivity to topical fluocinonide.
Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
Introduction of any other prescription medication, topical or systemic, for psoriasis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for psoriasis must be on a stable dose for at least 3 months prior to enrollment.
Any skin condition or disease that may require concurrent therapy or may confound evaluations
Current enrollment in any research study involving an investigational drug
Intervention: Odanacatib
Trial phase: Phase 3
SMILES: CC(C)(F)C[C@H](N[C@@H](c1ccc(-c2ccc(S(C)(=O)=O)cc2)cc1)C(F)(F)F)C(=O)NC1(C#N)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5 years post bilateral oophorectomy).
Prior or current treatment with oral bisphosphonate therapy (i.e., alendronate, risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years.
BMD T-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and >-3.5 as assessed by dual-energy X-ray absorptiometry (DXA) without a history of a prior fragility fracture. For participants with a history of a prior fragility fracture (except hip fracture), BMD T-score can be ≤-1.5 and >-3.5 at any hip site.
Serum 25-hydroxyvitamin D level of ≥20 and ≤60 ng/mL within 90 days of the time of randomization.

Exclusion Criteria:

Evidence of a metabolic bone disorder other than osteopenia or osteoporosis
History or current evidence of hip fracture.
History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Active parathyroid disease. Participant with a documented history of parathyroid disease can be considered for inclusion if she has normal parathyroid hormone (PTH) at screening.
History of thyroid disease not adequately controlled by medication.
Current treatment with anti-seizure medication, with indices of calcium metabolism not within normal limits.
Prior treatment with strontium-containing products; intravenous bisphosphonates; cathepsin K inhibitors; RANK ligand inhibitors; fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks.
Use of following medications within the 6 months prior to the screening visit: activated vitamin D; estrogen, with or without progestin, at a dose high enough to have systemic effects; raloxifene or other selective estrogen receptor modulator (SERM), tibolone or any aromatase inhibitor; sub-cutaneous calcitonin (Note: use of intranasal calcitonin is allowed at any time); anabolic steroid; PTH (1-34 or 1-84); growth hormone; systemic glucocorticoids (≥5 mg/day of prednisone or equivalent) for more than 2 weeks; cyclosporine for more than 2 weeks.
Concurrent use of cancer chemotherapy or heparin; protease inhibitors for human immunodeficiency virus (HIV) treatment; and vitamin A (excluding beta carotene) >10,000 IU daily, unless willing to discontinue this dose during the study.
Current treatment with cytochrome P450 3A4 (CYP3A4) inducers or treatment with CYP3A4 inducer within 4 weeks of screening.
Intervention: Desvenlafaxine
Trial phase: Phase 2 | Phase 3
ATC code: N06AX23
SMILES: CN(C)CC(c1ccc(O)cc1)C1(O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Desvenlafaxine

Omega 3 Fatty acids

2 subjects were randomized to this group
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Diagnosed with depression and have cardiovascular disease, diabetes or cancer.
Able to provide written informed consent prior to initiation of any study-related procedures.
Able to understand and comply with the requirements of the study.

Exclusion Criteria:

Hospitalized patients or psychotherapy for depression begun within 4 weeks.
Patients with medically reversible causes of depression (e.g. hypothyroidism).
Patients with significant comorbid symptoms (e.g. pain, insomnia) that have a direct causal relation to depressive and anxiety symptoms with these comorbid symptoms dominating the clinical scenario. Patients will be enrolled in the study if these comorbid symptoms merely coexist with depressive and anxiety symptoms and are not dominating the clinical scenario as judged by the study investigator
Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.
Patients with any clinically significant unstable or inadequately treated co-morbid medical condition which, in the opinion of the investigator, would make the patient unsuited for the study
Patients with currently active or with significant history of other clinically significant psychiatric disorders such as bipolar disorder, schizophrenia etc.
Pregnant patients, breastfeeding or those planning to become pregnant during the study.
Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment in the study, including known or suspect history of allergy to fish oil, fish or desvenlafaxine.
Intervention: Zolpidem
Trial phase: Phase 2 | Phase 3
ATC code: N05CF02
SMILES: Cc1ccc(-c2nc3ccc(C)cn3c2CC(=O)N(C)C)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 72
Group description: A three week treatment of Zolpidem

Zolpidem:

Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.
Eligibility criteria:
Inclusion Criteria:

primary insomnia
secondary insomnia
requiring sleep medication (Zolpidem) for a three-week trial.
active duty military service member stationed at Fort Carson.

Exclusion Criteria:

secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication.
treated for sleep problems using sleep medications which include Lunesta, Ambien, Ambien Controlled Release (CR), Seroquel, Trazodone or Remeron
major psychopathology (i.e., schizophrenia)
severe depression within the past 90 days
suicidal ideation within the past 90 days
psychiatrically hospitalized within the past 90 days
uncontrolled hypertension or diabetes
pregnancy
previous use of Zolpidem proved to be ineffective or to cause other unwanted side effects
actively abusing controlled substances
enrolled in another study
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 31
Group description: Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:

NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose

Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)
Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.
If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.

Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
Eligibility criteria:
Inclusion Criteria:

i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores > 8 in an 8 hour time period, AND

ii. Gestation => 35 weeks at entry defined by best obstetrical and physical exam criteria, AND

iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND

iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.

Exclusion Criteria:

i. Gestation < 35 weeks at entry defined by best obstetrical and physical exam criteria.

ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,

iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.

iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course

v. Mother consistently taking prescribed benzodiazepine at the time of delivery
Intervention: Melatonin
Trial phase: Early Phase 1
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Taken orally, once per day, at/around 9:00pm

Placebo
Eligibility criteria:
Inclusion Criteria:

History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer
Not currently receiving chemotherapy or hormonal therapy
Postmenopausal

Exclusion Criteria:

Stage IV breast cancer or systemic recurrences
Prior malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, lutenizing hormone releasing hormone agonists currently or within the past 60 days
Concomitant use of beta-blockers
Concomitant nightly use of sleep aids at bedtime
Working more than one overnight shift per month on a regular basis
Concomitant use of postmenopausal hormone replacement therapy
Concomitant use of black cohosh, flaxseed or soy in pill or supplement form
Use of any type of oral melatonin supplementation within the past 30 days
Use of warfarin (coumadin) within the past 30 days
Active seizure disorder requiring the use of daily anti-epileptic medication
Intervention: Uridine
Trial phase: Not Applicable
SMILES: O=c1ccn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c(=O)[nH]1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks.

Uridine: Uridine is the active treatment in this clinical trial.
Eligibility criteria:
Inclusion Criteria For Bipolar Disorder Participants:

Participants under 18 years of age must be able to provide assent, and have the permission of a parent or guardian. Participants 18 years of age or older must be able to provide informed consent.
Participants must be between the ages of 13 and 21 years.
Participants must meet DSM criteria for Bipolar Disorder (Type I, II, or NOS), with current mood state depressed for at least 2 weeks.
Participants must have a current Children's Depression Rating Scale-Revised (CDRS-R) score of 45 or greater, and/or a Montgomery/Asberg Depression Rating Scale (MADRS) score of 25 or greater.

Inclusion Criteria For Healthy Comparison Participants:

Participants under 18 years of age must be able to provide assent, and have the permission of a parent or guardian. Participants 18 years of age or older must be able to provide informed consent.
Participants must be between the ages of 13 and 21 years.
Participants must not meet any DSM-IV criteria for a psychiatric illness or substance use disorder

Exclusion Criteria:

Participants must not meet DSM criteria for a primary psychotic disorder, a developmental disorder or substance use disorder.
Participants must not be at high risk for suicidal or homicidal actions.
Participants must not be pregnant or breastfeeding.
Participants must not have a contraindication to magnetic resonance imaging (e.g. ferromagnetic implant, or claustrophobic anxiety).
Incarcerated persons are excluded, because this study is not approved for Research Involving Prisoners.
Intervention: Minocycline
Trial phase: Phase 1 | Phase 2
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.

Minocycline: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older.
Intracerebral hemorrhage documented by CT scan
The first dose of the drug can be administered within 12 hours of time last known to be at baseline

Exclusion Criteria:

Allergy to tetracycline antibiotics
Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
Hepatic and/or renal insufficiency (LFT's >3x upper limit of normal; Creatinine >2mg/dL)
History of intolerance to minocycline
National Institutes of Health Stroke Scale score of 4 or less
Glasgow Coma Scale score of 5 or less
Surgical evacuation of hematoma planned within 24 hours
Secondary intracerebral hemorrhage resulting from trauma, arteriovenous malformation, aneurysm, tumor or other causes
Thrombocytopenia (platelet count <75,000/mm3) or coagulopathy (INR >1.4)
Previously not independent (prestroke modified Rankin scale score >2)
Suspected of not being able to comply with the study protocol
Unlikely to be available for 90 day follow-up
Pre-existing Do Not Resuscitate (DNR) order or indication that a new DNR order will be implemented within the first 48 hours of hospitalization
Intervention: Sapropterin Dihydrochloride
Trial phase: Not Applicable
SMILES: CC(O)C(O)C1CNc2nc(N)[nH]c(=O)c2N1.Cl.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Subjects will be administered Kuvan once daily.
They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).

Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

PKU PARTICIPANTS (ARM 1):

Subject has a confirmed diagnosis of PKU with hyperphenylalaninemia documented by a fasting Phenylalanine level of at least 360 umol/L (6 mg/dL)
Patient is at least 4 years old (there is no upper age limit for this study)
Willing and able to provide written authorization or, if under the age of 18 years, provide written assent (if required) and written patient authorization by a parent or legal guardian
Willing to undergo study related procedures including commencing Kuvan treatment for patient not currently on treatment; temporary discontinuation of Kuvan for patient on treatment; and completing the 24-Hour Blood Assessment
Authorized to provide personal health information
Subjects should not be pregnant and willing to use appropriate birth control during the study

CONTROL GROUP (ARM 2):

Healthy, non-PKU individuals. They will be age-sex matched to the PKU group. They may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.
Individual is at least 4 years old (there is no upper age limit)
Willing and able to provide written consent or, if under the age of 18 years, provide written assent and written participant authorization by a parent or legal guardian
Authorized to provide personal health information

Exclusion Criteria (BOTH ARMS):

Subjects who do not meet all the inclusion criteria
Age < 4 years
Concomitant medical problems or medications which at the discretion of the principal investigator would put participant at health risk or prevent them from completing study.
If female, unwillingness to use birth control during the period of the study drug administration (this doesn't apply to Arm 2)
Intervention: Fluconazole
Trial phase: Phase 3
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 157
Group description: Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Eligibility criteria:
Inclusion Criteria:

Patients with clinical symptoms and signs of vulvovaginal candidiasis.
Patients tested positive for Candida by fungal culture.
Patients who can agree not to have intercourse up to 28 days after dosing.

Exclusion Criteria:

Patients with a history of hypersensitivity to fluconazole.
Patients with severe renal dysfunction.
Patients with liver disorder.