anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Clobazam
Trial phase: Phase 3
ATC code: N05BA09
SMILES: CN1C(=O)CC(=O)N(c2ccccc2)c2cc(Cl)ccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 3
Group description: A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally

Clobazam
Eligibility criteria:
The inclusion and exclusion criteria for the patients who participated in lead-in Study 14362A will be transferred from the 14362A study and for the patients who did not participate in lead-in Study 14362A the inclusion/exclusion is separately listed below.

Inclusion Criteria:

The patient has a diagnosis of Dravet Syndrome supported by:

onset of seizures in the first year of life

history of fever-induced prolonged seizures as determined by the Investigator

these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures

multiple seizure types which may include:

generalised tonic-clonic (required for inclusion)
clonic (required for inclusion)
myoclonic jerks/seizures
history of normal development prior to seizure onset followed by development delay or regression after seizure onset
abnormal EEG consistent with Dravet Syndrome
The patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day (maximum 20 mg/day) for at least 3 months

Other protocol-defined inclusion and exclusion criteria may apply.
Intervention: DCFBC F-18
Trial phase: Early Phase 1
SMILES: O=C(O)CC[C@H](NC(=O)N[C@@H](CSCc1ccc([18F])cc1)C(=O)O)C(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Eligibility criteria:
INCLUSION CRITERIA:
Subject is greater than or equal to18 years old
Platelet count > 50,000/mm^3
Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.

Categories

ARM 1 only

---For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging.

ARM 2 only:

For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir
OR
For patients status post prostatectomy, a PSA >/=0.2 ng/ml
Nonspecific or no evidence for disease on standard imaging modality

ARM 3 only:

Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality. If only soft tissue metastasis, one lesion must measure at least 6mm or greater. Patients must have confirmation of prostate cancer prior to 18FDCFBC imaging

Note: A patient who is eligible for one arm, subsequently may cross-over into a different arm.

EXCLUSION CRITERIA:

Subjects for whom participating would significantly delay the scheduled standard of care therapy
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
Serum creatinine > 2 times the upper limit of normal
Total bilirubin > 2 times the upper limit of normal
Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal
Intervention: DCFBC F-18
Trial phase: Early Phase 1
SMILES: O=C(O)CC[C@H](NC(=O)N[C@@H](CSCc1ccc([18F])cc1)C(=O)O)C(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Eligibility criteria:
INCLUSION CRITERIA:
Subject is greater than or equal to18 years old
Platelet count > 50,000/mm^3
Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.

Categories

ARM 1 only

---For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging.

ARM 2 only:

For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir
OR
For patients status post prostatectomy, a PSA >/=0.2 ng/ml
Nonspecific or no evidence for disease on standard imaging modality

ARM 3 only:

Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality. If only soft tissue metastasis, one lesion must measure at least 6mm or greater. Patients must have confirmation of prostate cancer prior to 18FDCFBC imaging

Note: A patient who is eligible for one arm, subsequently may cross-over into a different arm.

EXCLUSION CRITERIA:

Subjects for whom participating would significantly delay the scheduled standard of care therapy
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
Serum creatinine > 2 times the upper limit of normal
Total bilirubin > 2 times the upper limit of normal
Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal
Intervention: Sucrose
Trial phase: Phase 1 | Phase 2
SMILES: OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: DNase 0.1% eye drops four times a day for 8 weeks

DNase: DNase 0.1% eye drops four times a day for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Aged 18 years or older.
Capable of giving informed consent and does provide informed consent.
Documented Dry Eye Disease for at least 6 months.
Schirmer I <10
Corneal/ conjunctival (Rose Bengal) staining ≥1
Ocular symptoms must be considered as annoying or activity limiting (OSDI ≥13; mild).
Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study.

Exclusion Criteria:

Allergic to Deoxyribonuclease eye drops or any similar products, or excipients of Deoxyribonuclease eye drops 0.1%.
Receiving or have received within 30 days any experimental systemic medication.
Active ocular infection or ocular allergies.
Any history of eyelid surgery or ocular surgery within the past 3 months.
Corneal epithelial defect larger than 1 mm2 in either eye.
The use of topical cyclosporine or corticosteroids within 2 weeks of enrollment
Have active drug/alcohol dependence or abuse history
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 35
Group description: Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
Eligibility criteria:
Inclusion Criteria:

Participant with a clinical diagnosis of new-onset or recent-onset epilepsy characterized by partial-onset seizures (POS) (with or without secondary generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance with criteria of the International League Against Epilepsy. The epilepsy diagnosis must be within the previous 2 years before screening
Caregivers (parents or legally acceptable representatives) of the participant must be able to accurately maintain the participant take-home record and seizure diary
At screening, participant must have weight and height values within the 5th to 95th percentile for chronological age (based on standard Child Height and Weight Charts from the Centers for Disease Control [CDC])
Participant must never have been treated for epilepsy (treatment-naïve) or have been treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment
Parents (or legally acceptable representatives) of the participant must sign an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation

Exclusion Criteria:

Participant has a surgically implanted and functioning vagus nerve stimulator
Participant has a history of seizures as a result of a correctable medical condition, such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2 weeks prior to the first day of Screening
Participant has had uncontrolled seizures while previously taking either topiramate or levetiracetam
Participant has a history of non-epileptic seizures within 2 weeks prior to the first day of Screening
Participant has myoclonic or absence seizures
Intervention: Povidone iodine
Trial phase: Not Applicable
SMILES: C=CN1CCCC1=O.II
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 932
Group description: Pre-operative skin preparation with Povidone-Iodine Scrub and Paint

Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Eligibility criteria:
Inclusion Criteria:

cesarean delivery
age 18-65
ability to consent in English or Spanish

Exclusion Criteria:

inability or unwillingness to consent to study participation in English or Spanish
current incarceration
pre-operative diagnosis of chorioamnionitis
perceived inability to complete follow up for data collection
any prior known allergy or adverse reaction to either study preparation
Intervention: Hexose
Trial phase: Not Applicable
ATC code: V04CE01 | V06DC01
SMILES: OCC1OC(O)C(O)C(O)C1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Healthy adult volunteers will recieve Dextrose (placebo).

dextrose: We are administering dextrose to healthy volunteers for our placebo group.
Eligibility criteria:
Inclusion Criteria:

Healthy adult volunteers

Exclusion Criteria:

any current medical condition requiring medication or abnormal electrocardiogram
current or past medical condition considered to be a contraindication for the study conditions
any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
less than high school education
lack of fluency in English
night shift work
Pregnancy, lactation or plans to become pregnant.
Use of hormonal contraception.
Daily cigarette smokers i.e., >7 cigarettes per week
Intervention: Ketamine Hydrochloride
Trial phase: Phase 2
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1
Group description: A single dose of intranasal ketamine up to 50 mg

Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg
Eligibility criteria:
Inclusion Criteria:

Age 18-55
Physically healthy and not currently pregnant
Primary diagnosis of OCD
Sufficient severity of symptoms
For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses.
Able to provide consent

Exclusion Criteria:

First degree relative with schizophrenia
Psychiatric conditions that would make participation unsafe determined by study doctor
Female patients who are either pregnant or nursing
Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
Nasal obstruction or history of nasal surgery
Currently on psychotropic medication or other medication likely to interact with the glutamate system
Medical conditions that make participation unsafe
Allergy or intolerance to ketamine or midazolam
Intervention: Misoprostol
Trial phase: Phase 4
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 47
Group description: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.

Misoprostol: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
Eligibility criteria:
Inclusion Criteria:

Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
Age ≥ 18 years and ≤ 50 years
Pre-operative hemoglobin >8 g/dl
Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.
Ability to understand and the willingness to sign a written informed consent.
Admissible medical/surgical history
Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
Intraoperative use of vasopressin and uterine tourniquet is permissible
Can have had prior Cesarean delivery

Exclusion Criteria:

Patients who have had a prior abdominal myomectomy
Post-menopausal women
Patients with known bleeding/clotting disorders
Patients with a history of gynecologic malignancy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol
Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Intervention: Selinexor
Trial phase: Phase 2
ATC code: L01XX66
SMILES: O=C(/C=C\n1cnc(-c2cc(C(F)(F)F)cc(C(F)(F)F)c2)n1)NNc1cnccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Participants with advanced SCC of lungs, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
confirmed SCC of the head and neck, lung, or esophagus
1 to 2 prior therapies
measurable disease at screening and documented progression within the past 6 weeks

Exclusion Criteria:

patients requiring total parenteral nutrition
unstable cardiovascular function
substantially impaired gastrointestinal function
Symptomatic brain metastases
another malignancy within 3 years except adequately treated in situ carcinoma of any type, basal or non-melanomatous skin cancer
Intervention: Osoresnontrine
Trial phase: Phase 1
SMILES: O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.
Eligibility criteria:
Inclusion criteria:

Healthy male and female volunteers
Age 18 (incl.) to 50 (incl.) years
Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria:

Any evidence of a clinically relevant concomitant disease
Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
Positive pregnancy test
No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
Intervention: Osoresnontrine
Trial phase: Phase 1
SMILES: O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.
Eligibility criteria:
Inclusion criteria:

Healthy male and female volunteers
Age 18 (incl.) to 50 (incl.) years
Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria:

Any evidence of a clinically relevant concomitant disease
Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
Positive pregnancy test
No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
Intervention: Osoresnontrine
Trial phase: Phase 1
SMILES: O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time
Eligibility criteria:
Inclusion criteria:

Healthy male and female volunteers
Age 18 (incl.) to 50 (incl.) years
Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria:

Any evidence of a clinically relevant concomitant disease
Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
Positive pregnancy test
No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)