anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Estradiol
Trial phase: Phase 4
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump

100mcg estradiol cream: Use of study drug nightly
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women aged 40 to 70 years old.

Postmenopausal, demonstrated by at least one of the following:

i. Cessation of menses for ≥1 years if age is >50 ii. Bilateral oophorectomy iii. A history of climacteric symptoms if below age 50, having an ovary and scarred or absent uterus.

Onset of dyspareunia after menopause.*
Stable heterosexual partnership ≥2 years (or by investigator discretion if less than 2 years) and both partners want to have more satisfying penetrative intimacy.
No estrogen product use, local or systemic, for 6 months.*
More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).*
Willingness to enter a study where she will receive low-dose local estrogen.*
Willingness to enter a study that requires application of cream on a frequent schedule for 3 months. *

Willingness to evaluate the progress of therapies by use of the Tampon Test as many as 2 times per week, and willingness to attempt intercourse if the Tampon Test indicates tolerable penetrative pain.*

n/a for reference group

Exclusion Criteria:

Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
Negative cotton-swab touch test in the vulvar vestibule or vestibular tenderness that is not extinguishable by application of lidocaine 4% topical solution applied for 3 minutes.
Partner with sexual dysfunction limiting his performance or making it inconsistent. (The use of male therapy for erectile dysfunction is acceptable.)
Diagnosis by a physical therapist or clinician of significant pelvic floor muscle tension causing pain (pelvic floor myalgia) or has been found on screening examination to have pelvic floor tenderness or bladder tenderness.
Constant burning pain localized to the vulva.
Allergy to local estrogen products or lidocaine numbing agents.
Previous estrogen receptor positive breast cancer or endometrial cancer.
Endometrial thickness ≥5mm on screening via transvaginal ultrasound.
Intervention: Sotagliflozin
Trial phase: Phase 3
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56.1 weeks.
Eligibility criteria:
Inclusion criteria :

Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and <30 milliliter per minute (mL/min)/1.73 per meter square (m^2).
Signed written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

At the time of screening, age <18 years.
Hemoglobin A1c (HbA1c) <7% or >11%.
Type 1 diabetes.
Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
Treatment with an sodium-glucose cotransporter type 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Sotagliflozin
Trial phase: Phase 3
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 260
Group description: Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.
Eligibility criteria:
Inclusion criteria :

Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and <60 milliliter per minute (mL/min)/1.73 meter square (m^2) (chronic kidney disease [CKD] 3A, 3B).
Participants has given written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

Hemoglobin A1c (HbA1c) of <7.0% or >11.0%.
Type 1 diabetes.
Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
Treatment with a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin, Dapagliflozin, Empagliflozin) during the last 12 months.
Uncontrolled high blood pressure.
Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Testosterone
Trial phase: Phase 3
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day

LPCN 1021: Oral testosterone undecanoate
Eligibility criteria:
Inclusion Criteria:

Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy.
Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.

Exclusion Criteria:

History of significant sensitivity or allergy to androgens, or product excipients.
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).
Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis
Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
History of stroke or myocardial infarction within the past 5 years.
History of or current or suspected prostate or breast cancer.
History of untreated and severe obstructive sleep apnea.
History of long QT syndrome (QTc > 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).
Intervention: Testosterone
Trial phase: Phase 3
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day.

LPCN 1021: Oral testosterone undecanoate
Eligibility criteria:
Inclusion Criteria:

Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy.
Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.

Exclusion Criteria:

History of significant sensitivity or allergy to androgens, or product excipients.
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).
Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis
Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
History of stroke or myocardial infarction within the past 5 years.
History of or current or suspected prostate or breast cancer.
History of untreated and severe obstructive sleep apnea.
History of long QT syndrome (QTc > 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).
Intervention: Fluorodopa F-18
Trial phase: Phase 2
ATC code: V09IX05
SMILES: NC(Cc1cc(O)c(O)cc1F)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test
Eligibility criteria:
Inclusion Criteria

Age > or equal to 18 years
ECOG PS < or equal to 3
Histologically confirmed or radiographic evidence of recurrent/progressive glioma.
History of radiation therapy to the brain for prior diagnosis of glioma
Planned radiation treatments at Mayo Clinic Rochester
Provide informed written consent
Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136 (blood draw optional)
Willing to return to enrolling institution for follow-up during Active Monitoring Phase of the study.

Exclusion Criteria

More than one prior course of radiotherapy or prior prescription doses exceeding 60 Gy to re-irradiation target volumes
Unable to undergo MRI scans with contrast
Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking anti dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists.)

Note: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline). If a patient is on any of these drugs, list which ones on the On-Study form.

-Any of the following:

Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Intervention: Mavoglurant
Trial phase: Phase 2
SMILES: COC(=O)N1CC[C@@H]2[C@H]1CCC[C@@]2(O)C#Cc1cccc(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Mavoglurant was up titrated on a bid regimen followed by fixed-dose bid regimen: 50 mg bid from Day 1 to Day 7, 100 mg bid from Day 8 to Day 14, and then fixed-dose 200 mg bid for 84 days
Eligibility criteria:
Inclusion Criteria:

Understand the study procedures and provide written informed consent before any assessment is performed.
Subjects diagnosed with Cocaine Use Disorder according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Ed.).
Must use cocaine through snorting (intranasally) as primary route of administration.
Recent cocaine use confirmed by positive urine screen for 1 or more benzoylecgonine (BE).
Must be seeking treatment for cocaine dependence and have a desire to reduce or cease cocaine use.

Exclusion Criteria:

Has current diagnosis of Substance Use Disorder (according to the DSM 5) on alcohol, cannabis or other stimulants, except cocaine.
Meets current or lifetime DSM 5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
Have current treatment for Substance Use Disorder (e.g.: disulfiram, acamprosate, methyl phenidate, modafinil, topiramate, immediate release dexamfetamine,or baclofen).
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
Have a history of any illness, condition, and use of medications that in the opinion of the investigator or designee might confound the results of the study or pose additional risk in administering the investigational agents to the subject or preclude successful completion of the study
Current or/and previous treatment with concomitant medications that are strong or moderate inducers/inhibitors of CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, etc.)
History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the CSSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
Controlled hypertension
Intervention: OXYTOCIN
Trial phase: Phase 1 | Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 15
Group description: Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.

Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning.
Eligibility criteria:
Inclusion Criteria:

Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI
Physical exam and laboratory results that are within the normal range.
Presence of a parent/caregiver/guardian that is able to consent for their participation.

Exclusion Criteria:

Exposure to any investigational agent in the 30 days prior to randomization.
Prior chronic treatment with oxytocin.
A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.
Intervention: Enclomiphene
Trial phase: Phase 2
ATC code: G03GB02
SMILES: CCN(CC)CCOc1ccc(C(=C(Cl)c2ccccc2)c2ccccc2)cc1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Subjects will be randomized to receive clomiphene capsules

Clomiphene: clomiphene capsule 25mg twice a week
Eligibility criteria:
Inclusion Criteria:

Males
Age 18-30 years inclusive will be recruited.

A total of 90 males will be recruited:-

30 obese males (defined as BMI ≥30 kg/m2) with HH,
30 obese males with normal FT concentrations and
30 lean males (defined as BMI <25 kg/m2) with normal FT concentrations.

Exclusion Criteria:

Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months
Hematocrit > 50%
Congestive heart failure
currently suffering from depression
type 1 diabetes
Hepatic disease (transaminase > 3 times normal) or cirrhosis
Renal impairment (eGFR<30 ml/min/1.73m2)
HIV or Hepatitis C positive status
Participation in any other concurrent clinical trial
currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
Intervention: Cangrelor
Trial phase: Phase 4
ATC code: B01AC25
SMILES: CSCCNc1nc(SCCC(F)(F)F)nc2c1ncn2[C@@H]1O[C@H](COP(=O)(O)OP(=O)(O)C(Cl)(Cl)P(=O)(O)O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours

Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.
Eligibility criteria:
Inclusion criteria:

Patients with STEMI undergoing primary PPCI
Age > 18 years old

Exclusion criteria:

Inability to provide written informed consent
Known history of prior intracranial bleeding
On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in the prior 10 days
Known allergies to aspirin, ticagrelor or cangrelor
On treatment with oral anticoagulant
Treatment with glycoprotein IIb/IIIa inhibitors
Fibrinolytics within 24 hours
Active bleeding
High risk of bleeding
Known platelet count <80x106/mL
Known hemoglobin <10 g/dL
Intubated patients (prior to randomization)
Known creatinine clearance <30 mL/minute or on hemodialysis.
Known severe hepatic dysfunction
Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection
Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
Pregnant or lactating females.
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during migraine attack.
Eligibility criteria:
Inclusion Criteria:

Males or females with history of migraine with or without aura, as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for at least 1 year, based on medical history
Have a body mass index (BMI) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion Criteria:

Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan
Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
Have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (≤) 90 or greater than (>) 155 millimeters of mercury (mmHg) or diastolic blood pressure ≤ to 50 or >95 mmHg
Have clinically significant electrocardiogram (ECG) findings, including a QT interval corrected for heart rate using QT interval corrected for heart rate using Fridericia's formula (QTcF) value >450 milliseconds (ms) (males) or >470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias
Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder)
Have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
Have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit