anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Suvorexant
Trial phase: Phase 4
ATC code: N05CJ01 | N05CM19
SMILES: [H][C@@]1(C)CCN(c2nc3cc(Cl)ccc3o2)CCN1C(=O)c1cc(C)ccc1-n1nccn1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity

Suvorexant
Eligibility criteria:
Inclusion Criteria:

Aged 20-60 (older individuals excluded due to altered sleep-related circadian signaling)
Males and females

Shift worker

Minimum of three months of prior shift work
Will work minimum of four nights per week or 32 hours of night shift per week during study
"Night work" defined as having at least six hours of work occurring between 8 PM and 8 AM and no longer than 12 hours on shift

Presence of DSM-5 defined Circadian Rhythm Sleep-Wake Disorder: Shift Work Type

Insomnia (SE < 88%) during attempted daytime sleep or excessive sleepiness during nocturnal wake

Exclusion Criteria:

Currently or planning to become pregnant
Currently breastfeeding
Inadequate opportunity (<7 hours) for daytime sleep after shift work
Use of sleep aids during the study period. Includes as needed or continuous use of prescription, non-prescription, and naturopathic pharmacotherapies
Diagnosis or detection (during study) of sleep disordered breathing (AHI>10) on home sleep testing; referral to clinical sleep program will be offered
Diagnosis of narcolepsy
Restless Legs Syndrome
>600 mg caffeine intake per night shift or use of prescription stimulant medication during night shift
Rotational or irregular work shifts during study
Use of digoxin for six months prior to or during study
Use of strong (e.g., etoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan) or moderate (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) CYP3A inhibitors or CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin) for six months prior to or during study
Severe hepatic impairment
Unstable or severe medical or psychiatric condition
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Propofol is administered intravenously as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 ("light sedation - awakens to voice <10 seconds") to RASS target of -3 ("moderate sedation - movement or eye opening without eye contact") for 15 minutes.
Eligibility criteria:
Inclusion Criteria:

Age between 18 and 65
Chief complaint consistent with the diagnosis of headache that meets 2 of the 4 following criteria (check all that apply):
Unilateral Headache
Pulsatile Sensation
Moderate to Severe pain intensity
Aggravation by physical activity or causing avoidance of physical activity (i.e. climbing stairs, walking)
Headache is associated with at least one of the following symptoms (check all that apply):
Nausea and/or vomiting
Photophobia and/or phonophobia
History of at least 5 similar headaches

Within 6 hours of screening has received BOTH (via IV or PO):

A Non-Steroidal Anti-Inflammatory Drug (NSAID):

Ibuprofen / "Motrin" Naproxen / "Aleve" Ketorolac / "Toradol"

A Dopamine-Antagonist:

Metoclopramide / "Reglan" Prochlorperazine / "Compazine"

Persists with 6/10 or greater pain at one hour after above treatment
Emergency Department attending feels patient appropriate for propofol treatment

Exclusion Criteria:

Allergy to the study medication / eggs / soy (medication components)
Inability to provide written, informed consent
Employee or in police custody
Pregnant or breast-feeding
Medical concerns: Chronic obstructive pulmonary disease, active asthma exacerbation, obstructive sleep apnea, morbid obesity (Body Mass Index > 40), American Society of Anaesthesiologists class 3 or greater, actively intoxicated, Blood Pressure < 110/70
Meal or heavy snack within 3 hours of sedation time
Will be driving themselves home from Emergency Department
Opioid use within the last 6 hours
Previously enrolled in this study
Intervention: Progesterone
Trial phase: Not Applicable
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 118
Group description: Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
Eligibility criteria:
Inclusion Criteria:

Patients are undergone intrauterine insemination with gonadotropin stimulation
Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy
After semen preparation for intrauterine insemination, total progressive sperm count > 5 million

Exclusion Criteria:

endocrin or metabolic disorders,
uterine factor,
pelvic inflammatory disease,
women with basal follicle-stimulating hormone (FSH) level >15 IU/mL,
body mass index (BMI) ≥ 35 kg/m2,
age ≥ 40 and < 18 years,
Intervention: CALCIUM HYDROXIDE
Trial phase: Phase 2 | Phase 3
SMILES: [Ca+2].[OH-].[OH-]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 169
Group description: -material for pulp capping

Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
Eligibility criteria:
Inclusion Criteria:

Systemically healthy patients
Patients with at least one full or partial tooth root development
Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis
Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration
Teeth that have pulp exposure not exceeding 1 mm in size.

Exclusion Criteria:

Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic
Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .
Intervention: Tricalcium silicate
Trial phase: Phase 2 | Phase 3
SMILES: O=[Ca].[Ca+2].[Ca+2].[O-][Si]([O-])([O-])[O-]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 169
Group description: Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping

Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Eligibility criteria:
Inclusion Criteria:

Systemically healthy patients
Patients with at least one full or partial tooth root development
Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis
Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration
Teeth that have pulp exposure not exceeding 1 mm in size.

Exclusion Criteria:

Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic
Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .
Intervention: Capsaicin
Trial phase: Phase 2
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: The capsaicin solution will be prepared by using the formula previously reported by Van Rijswijk et al; (0.1mmol/l) diluted in ethanol and 0.9% normal saline (19). Using the MAD, 0.8mL will be delivered to each nasal cavity for a total of 24.4 ug per nasal cavity. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.

Capsaicin
Eligibility criteria:
Inclusion criteria:

Non-allergic irritant rhinitis (NAIR) patients as defined by history (symptoms of nasal congestion, rhinorrhea, nasal itching or sneezing upon exposure to nasal irritants)
Patients with positive optical rhinometer (ORM) response with intranasal challenge with 0.5 millimolar (mM) capsaicin as described by Lambert et al 2012
Confirmed negative skin prick test to common allergens (which rules out allergic rhinitis)

Exclusion Criteria:

History of sinonasal surgery
Chronic rhinosinusitis
Inflammatory or granulomatous diseases
Asthma
Allergic rhinitis
Immunocompromised state
Radiation to the head and neck
Intranasal steroid use >4 wks
Intranasal or systemic antihistamine x 3 days
Intranasal or systemic decongestants x 3 days
Intervention: Plecanatide
Trial phase: Phase 3
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 375
Group description: Plecanatide 3.0 mg Tablets dosed once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

• Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

Refusal or inability to sign informed consent for the trial
Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
BMI ≥ 40 or < 18
Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
Women who are pregnant or lactating
Diagnosis of IBS-D or IBS-M
Organic or obstructive disease of the small or large intestine
Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
Unstable medical illness
Bilirubin > 3X ULN in the absence of a conjugation defect
Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
Intervention: Plecanatide
Trial phase: Phase 3
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 379
Group description: Plecanatide 6.0 mg Tablets dosed once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

• Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

Refusal or inability to sign informed consent for the trial
Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
BMI ≥ 40 or < 18
Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
Women who are pregnant or lactating
Diagnosis of IBS-D or IBS-M
Organic or obstructive disease of the small or large intestine
Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
Unstable medical illness
Bilirubin > 3X ULN in the absence of a conjugation defect
Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery

Modafinil: Atypical Psychomotor stimulant
Eligibility criteria:
Inclusion Criteria:

18 years or older
Meets diagnostic criteria for obstructive sleep apnea
Willing and able to comply with study procedures
Willing and able to provide informed consent
If female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) for one month after surgery and discontinuation of study medication (modafinil may reduce the effectiveness of steroidal contraception for one month after discontinuation)

Exclusion Criteria:

Have a medical condition that, in the study physician's judgment, may interfere with safe participation (active cardiac conditions such as angina, recent myocardial infarction w/in 6 months, severe renal or liver disease, unstable diabetes, or elevated liver enzymes greater than twice normal).
Have a current neurological disorder (e.g. organic brain disease, dementia) or major psychiatric condition that would impair the collection of data (schizophrenia, bipolar illness).
Currently on prescription medication that is known to interact with the study drug. (ethinylestradiol and triazolam).
Have current dependence on cocaine, methamphetamine, alcohol or benzodiazepines (DSM-IV criteria).
Have a history of severe valvular heart disease, severe left ventricular hypertrophy, cardiac arrhythmias, angina, cardiac syncope, or pre-syncope or myocardial infarction <6 months.
Have a history of uncontrolled or poorly controlled essential hypertension, or a heart rate greater than 70% of the maximum heart rate expected for their age (Formula: 0.70(220 - age).
Any condition, in the opinion of the principal investigators that would compromise patient safety.
A documented history of sensitivity to modafinil.
Current Modafinil use for daytime somnolence associated with obstructive sleep apnea.
Intervention: Curcumin
Trial phase: Phase 4
SMILES: COc1cc(/C=C/C(=O)CC(=O)/C=C/c2ccc(O)c(OC)c2)ccc1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 34
Group description: 25/mg/kg per day for 1 year.

Curcumin: Dietary Supplement
Eligibility criteria:
Inclusion Criteria:

ADPKD diagnosis
Normal renal function (estimated glomerular filtration rate >80 mL/min/1.73m^2)
Ability to provide informed consent

Exclusion Criteria:

Currently taking a curcumin supplement
Current smoking or history of smoking in the past 12 months
Marijuana use within 2 weeks prior to FMDBA and aPWV testing
Antioxidantand/or omega-3 fatty acid use within the past 4 weeks prior to FMDBA and aPWV testing and for the duration of the study
Alcohol dependence and abuse
History of hospitalization within the last 3 months
Active infection or antibiotic therapy
Pregnancy, lactation, or unwillingness to use adequate birth control
Body-mass index >95th percentile in ages 6-17 or >40 kg/m2 in ages 18-25
Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Intervention: Pridopidine
Trial phase: Phase 2
SMILES: CCCN1CCC(c2cccc(S(C)(=O)=O)c2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 248
Group description: Pridopidine (45 mg) administered as oral capsules, taken twice daily (bid)
Eligibility criteria:
Inclusion Criteria:

Pride HD completion within the last 6 months, including 2 week follow up period or patients who transitioned from the Open HART study or patients who complete future safety and efficacy clinical trials of pridopidine. In addition, patients who have already completed their defined study period under Open PRIDE HD global or local amendments and have discontinued treatment with pridopidine will be allowed to re enter the Open PRIDE HD study.
Women of child bearing potential or male participants: Adequate contraception and birth control

Good general health

other criteria apply, please contact the investigator for more information

Exclusion Criteria:

Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal function to PRIDE HD;

Similar concomitant medication restrictions to PRIDE HD.

other criteria apply, please contact the investigator for more information
Intervention: Mirabegron
Trial phase: Phase 4
ATC code: G04BD12
SMILES: Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: This arm comprises women who received mirabegron
Eligibility criteria:
Inclusion Criteria:

Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥ 5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary incontinence or mixed urinary incontinence-urgency predominant)
No contraindications to taking mirabegron
Patients on current OAB therapy will undergo a two-week drug washout period prior to baseline assessment

Exclusion Criteria:

Neurologic disease known to affect the lower urinary tract
Systemic immunologic deficiency
Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent culture-proven UTIs
History or current pelvic malignancy or radiation
Untreated symptomatic pelvic organ prolapse (POP) > POP-Q Stage II
A contraindication to receiving mirabegron
Women of childbearing potential who are pregnant or nursing or intend to become pregnant during the study, or who are not practicing a reliable method of contraception
Must not have taken any antibiotics in the 4 weeks prior to enrollment
Intervention: Tenofovir
Trial phase: Not Applicable
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence

emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks.

CBT-based counseling: Brief CBT-based counseling to promote adherence
Eligibility criteria:
Inclusion Criteria:

Self-identify as MSM: (1) born male who (2) has sex with men
Age: 18 or older
Sexual Risk: has had condomless anal sex with 2 or more men or any transactional sex with a man within the past 12-months.
Vacation: identified an upcoming period of episodic risk away (i.e. vacation) from their home city that will last at least 7 but not more than 14 days during which they anticipate having at least one high-risk sexual event.
Able and willing to provide informed consent

Exclusion Criteria:

HIV positive
Glomerular filtration rate < 60 mL/min (calculated using the Cockcroft-Gault formula)
Hepatitis B surface antigen positive
Symptoms suggestive of acute HIV seroconversion at screening or enrollment
Have used PrEP or PEP within the previous 3 months
Currently enrolled in another study involving medications, investigational drug, or medical device
Has other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures
Intervention: Rifaximin
Trial phase: Phase 3
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 246
Group description: Participants received a generic rifaximin 200 mg tablet 3 times daily orally for 3 days.
Eligibility criteria:
Inclusion Criteria:

Adult male or nonpregnant female aged ≥18 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal.
At least 3 unformed stools recorded within the 24 hours immediately preceding randomization.

At least 1 of the following signs and symptoms of enteric infection:

abdominal pain or cramps
nausea
vomiting
fecal urgency
excessive gas/flatulence
tenesmus
Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.

Exclusion Criteria:

Pregnant, breast feeding, or planning a pregnancy.
Immediately prior to randomization, acute diarrhea for >72 hours.

Presence of:

fever (≥100 degrees fahrenheit [°F] or ≥37.8 degrees celsius [°C]), or
hematochezia (blood in stool), or
clinical findings suggesting moderate or severe dehydration.
Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (GI) tract (other than infectious diarrhea in travelers), or central nervous system.

Administration of any of the following:

any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization
more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization
Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.