anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lemborexant
Trial phase: Phase 1
ATC code: N05CJ02 | N05CM21
SMILES: Cc1ncc(OC[C@@]2(c3cccc(F)c3)C[C@H]2C(=O)Nc2ccc(F)cn2)c(C)n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Healthy Subjects:

With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800
Who report typical sleep latency of </= 30 minutes
With typical total sleep time (TST) >/= 420 minutes

Primary Insomnia Subjects:

Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months
With a score of > 15 on the Insomnia Severity Index (ISI) at Screening
Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the past month
Who report 6.5 hours sleep or less on at least 3 nights per week for the past month
With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes with neither night < 15 minutes
With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with neither night < 15 minutes or mean TST > 420 minutes

Key Exclusion Criteria:

With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B)
Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment
All females must be of non-childbearing potential
With a known history of significant neurological or serious psychiatric illness
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 4
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 184
Group description: Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)
Eligibility criteria:
Inclusion Criteria:

Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment
Planning to deliver at Magee-Womens Hospital and to breastfeed
Plans to use DMPA for postpartum contraception for at least 6 months
Willing and able to provide informed consent in English and to comply with study protocol

Exclusion Criteria:

Intolerance of irregular vaginal bleeding
Severe coagulation disorder
Severe liver disease (LFTs >2x upper limits of normal at time of randomization)
Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia
History of breast cancer, reduction or augmentation surgery
History of severe clinical depression
Multiple gestation
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 4
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 184
Group description: Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)
Eligibility criteria:
Inclusion Criteria:

Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment
Planning to deliver at Magee-Womens Hospital and to breastfeed
Plans to use DMPA for postpartum contraception for at least 6 months
Willing and able to provide informed consent in English and to comply with study protocol

Exclusion Criteria:

Intolerance of irregular vaginal bleeding
Severe coagulation disorder
Severe liver disease (LFTs >2x upper limits of normal at time of randomization)
Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia
History of breast cancer, reduction or augmentation surgery
History of severe clinical depression
Multiple gestation
Intervention: 1-[(3R)-3-[2-[4-hydroxy-1-[(2R,3S)-2-propyl-1-[3-(trifluoromethyl)pyridine-2-carbonyl]-3-[5-(trifluoromethyl)thiophen-3-yl]oxypiperidine-3-carbonyl]piperidin-4-yl]phenoxy]butyl]cyclobutane-1-carboxylic acid
Trial phase: Phase 1
SMILES: CCCC1N(C(=O)c2ncccc2C(F)(F)F)CCCC1(Oc1csc(C(F)(F)F)c1)C(=O)N1CCC(O)(c2ccccc2OC(C)CCC2(C(=O)O)CCC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
Eligibility criteria:
Inclusion criteria:

Histologically confirmed advanced solid tumor for which there are no effective standard therapy options
Willing to provide tumor tissue for p53 wild type gene analysis
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Adequate organ function
Female participants and male participants and their partners who are of childbearing potential must agree to abstain from sexual intercourse or to use an acceptable method of contraception during the study and for 90 days following the last dose of study drug
At least one measurable lesion
In Part 2, participants with liposarcoma must have a confirmed well-differentiated or de-differentiated histology

Exclusion criteria:

Known treated or untreated leptomeningeal metastases, or metastatic central nervous system disease
History of recent myocardial infarction (within the past year); or with unstable or uncontrolled angina, New York Heart Association (NYHA) Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality
Uncontrolled active infection on optimal systemic treatment
Clinically significant hepatitis or hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive
Persistent, unresolved common terminology criteria for adverse events (CTCAE v4.0) ≥Grade 2 drug-related toxicity associated with previous treatment except for alopecia
Radiation therapy or other loco-regional therapy within 2 weeks prior to study
Use of moderate and strong cytochrome P450 inhibitors or inducers within 1 week prior to study
Chemotherapy or any investigational drug(s) within 4 weeks prior to study
Known hypersensitivity to MK-8242 or its components
Nursing, pregnant, or intention to become pregnant during the study
Initiating bisphosphonate therapy or adjusting the bisphosphonate dose or regimen within 30 days of Cycle 1 Day 1
Intervention: 1-[(3R)-3-[2-[4-hydroxy-1-[(2R,3S)-2-propyl-1-[3-(trifluoromethyl)pyridine-2-carbonyl]-3-[5-(trifluoromethyl)thiophen-3-yl]oxypiperidine-3-carbonyl]piperidin-4-yl]phenoxy]butyl]cyclobutane-1-carboxylic acid
Trial phase: Phase 1
SMILES: CCCC1N(C(=O)c2ncccc2C(F)(F)F)CCCC1(Oc1csc(C(F)(F)F)c1)C(=O)N1CCC(O)(c2ccccc2OC(C)CCC2(C(=O)O)CCC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
Eligibility criteria:
Inclusion criteria:

Histologically confirmed advanced solid tumor for which there are no effective standard therapy options
Willing to provide tumor tissue for p53 wild type gene analysis
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Adequate organ function
Female participants and male participants and their partners who are of childbearing potential must agree to abstain from sexual intercourse or to use an acceptable method of contraception during the study and for 90 days following the last dose of study drug
At least one measurable lesion
In Part 2, participants with liposarcoma must have a confirmed well-differentiated or de-differentiated histology

Exclusion criteria:

Known treated or untreated leptomeningeal metastases, or metastatic central nervous system disease
History of recent myocardial infarction (within the past year); or with unstable or uncontrolled angina, New York Heart Association (NYHA) Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality
Uncontrolled active infection on optimal systemic treatment
Clinically significant hepatitis or hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive
Persistent, unresolved common terminology criteria for adverse events (CTCAE v4.0) ≥Grade 2 drug-related toxicity associated with previous treatment except for alopecia
Radiation therapy or other loco-regional therapy within 2 weeks prior to study
Use of moderate and strong cytochrome P450 inhibitors or inducers within 1 week prior to study
Chemotherapy or any investigational drug(s) within 4 weeks prior to study
Known hypersensitivity to MK-8242 or its components
Nursing, pregnant, or intention to become pregnant during the study
Initiating bisphosphonate therapy or adjusting the bisphosphonate dose or regimen within 30 days of Cycle 1 Day 1
Intervention: 1-[(3R)-3-[2-[4-hydroxy-1-[(2R,3S)-2-propyl-1-[3-(trifluoromethyl)pyridine-2-carbonyl]-3-[5-(trifluoromethyl)thiophen-3-yl]oxypiperidine-3-carbonyl]piperidin-4-yl]phenoxy]butyl]cyclobutane-1-carboxylic acid
Trial phase: Phase 1
SMILES: CCCC1N(C(=O)c2ncccc2C(F)(F)F)CCCC1(Oc1csc(C(F)(F)F)c1)C(=O)N1CCC(O)(c2ccccc2OC(C)CCC2(C(=O)O)CCC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
Eligibility criteria:
Inclusion criteria:

Histologically confirmed advanced solid tumor for which there are no effective standard therapy options
Willing to provide tumor tissue for p53 wild type gene analysis
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Adequate organ function
Female participants and male participants and their partners who are of childbearing potential must agree to abstain from sexual intercourse or to use an acceptable method of contraception during the study and for 90 days following the last dose of study drug
At least one measurable lesion
In Part 2, participants with liposarcoma must have a confirmed well-differentiated or de-differentiated histology

Exclusion criteria:

Known treated or untreated leptomeningeal metastases, or metastatic central nervous system disease
History of recent myocardial infarction (within the past year); or with unstable or uncontrolled angina, New York Heart Association (NYHA) Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality
Uncontrolled active infection on optimal systemic treatment
Clinically significant hepatitis or hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive
Persistent, unresolved common terminology criteria for adverse events (CTCAE v4.0) ≥Grade 2 drug-related toxicity associated with previous treatment except for alopecia
Radiation therapy or other loco-regional therapy within 2 weeks prior to study
Use of moderate and strong cytochrome P450 inhibitors or inducers within 1 week prior to study
Chemotherapy or any investigational drug(s) within 4 weeks prior to study
Known hypersensitivity to MK-8242 or its components
Nursing, pregnant, or intention to become pregnant during the study
Initiating bisphosphonate therapy or adjusting the bisphosphonate dose or regimen within 30 days of Cycle 1 Day 1
Intervention: 6-Acryloyloxyhexyl phosphate
Trial phase: Phase 3
SMILES: C=CC(=O)OCCCCCCO.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 391
Group description: PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Eligibility criteria:
Inclusion Criteria:

Subjects who have completed treatment in Protocol PA-CL-05A
Written Informed Consent

Exclusion Criteria:

Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
Other significant medical conditions
Pregnancy
Intervention: CID 11593706
Trial phase: Phase 3
SMILES: C=CCN.ClCC1CO1.O=C(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 267
Group description: Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
Eligibility criteria:
Inclusion Criteria:

Subjects who have completed treatment in Protocol PA-CL-05A
Written Informed Consent

Exclusion Criteria:

Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
Other significant medical conditions
Pregnancy
Intervention: Progesterone
Trial phase: Phase 3
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: No
Participants at risk: 93
Group description: Oral micronized progesterone is Prometrium 300 mg at bedtime daily

Oral micronized progesterone: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Between 35-58 years of age
At least 4 vasomotor symptoms (VMS) per day, on average, for at least 2/4 weeks or at least 56 over a four-week period. In addition, women should report having VMS of moderate or severe rather than mild intensity. Women reporting fewer VMS than this, but who report night sweats that awaken them from sleep on two or more nights per week will also be included.
Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
At least one menstrual period within 12 months of study enrollment
Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
Ability to understand, speak, read and write English.
Women who are at high risk for breast cancer (ie first degree relative with breast cancer, known/suspected history of breast cancer) will be required to have a normal mammogram and clinical breast examination within 12 months of study enrollment.

Exclusion Criteria:

VMS without perimenopausal etiology.
Women who have had a hysterectomy and/or ovariectomy.
Peanut allergy (because peanut oil is used in the progesterone formulation.)
Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period. Two exceptions: women using progestin-releasing intrauterine device (IUD) will not be excluded as it is felt that level of hormone released will not have an effect on VMS and women taking very low-dose transdermal progesterone therapies who have VMS and meet inclusion criteria will be considered on a case-by-case basis. If enrolled, women with these exclusion exceptions will be required to continue and document use of these therapies throughout the entire trial.
Planned pregnancy or fertility treatment during the study period.
Women who are breastfeeding.
Participants with a score greater or equal to 15 on the Personal Health Questionnaire (PHQ-9) will be assessed on a case-by-case basis. Women assessed as needing further investigation and/or treatment for depression will be excluded.
Intervention: Testosterone
Trial phase: Phase 2
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: 20
Group description: Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
Eligibility criteria:
Inclusion Criteria:

Ages 18-75
History of hypogonadism
In good health based on medical history, physical examination, and clinical laboratory tests
Serum testosterone deficiency
One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
Body mass index (BMI) between 18 and 35 kg/m^2
All screening lab tests within 20% of the normal range (exceptions are liver function tests)
HIV, Hepatitis B and C negative

Exclusion Criteria:

Previous use of FE 999303
Prostate cancer
Breast carcinoma, patient or partner
Palpable prostatic mass(es)
Serum PSA levels ≥3 ng/dL
Chronic use of any drug of abuse
Lower urinary tract obstruction
Clinically significant anemia or renal dysfunction
Cardiovascular disease
Hyperparathyroidism or uncontrolled diabetes
Generalized skin irritation or significant skin disease
Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
Sleep apnea
Untreated depression
Subject with a partner who is pregnant or will not use contraception
Intervention: Testosterone
Trial phase: Phase 2
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: 20
Group description: Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
Eligibility criteria:
Inclusion Criteria:

Ages 18-75
History of hypogonadism
In good health based on medical history, physical examination, and clinical laboratory tests
Serum testosterone deficiency
One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
Body mass index (BMI) between 18 and 35 kg/m^2
All screening lab tests within 20% of the normal range (exceptions are liver function tests)
HIV, Hepatitis B and C negative

Exclusion Criteria:

Previous use of FE 999303
Prostate cancer
Breast carcinoma, patient or partner
Palpable prostatic mass(es)
Serum PSA levels ≥3 ng/dL
Chronic use of any drug of abuse
Lower urinary tract obstruction
Clinically significant anemia or renal dysfunction
Cardiovascular disease
Hyperparathyroidism or uncontrolled diabetes
Generalized skin irritation or significant skin disease
Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
Sleep apnea
Untreated depression
Subject with a partner who is pregnant or will not use contraception
Intervention: Testosterone
Trial phase: Phase 2
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: 20
Group description: Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
Eligibility criteria:
Inclusion Criteria:

Ages 18-75
History of hypogonadism
In good health based on medical history, physical examination, and clinical laboratory tests
Serum testosterone deficiency
One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
Body mass index (BMI) between 18 and 35 kg/m^2
All screening lab tests within 20% of the normal range (exceptions are liver function tests)
HIV, Hepatitis B and C negative

Exclusion Criteria:

Previous use of FE 999303
Prostate cancer
Breast carcinoma, patient or partner
Palpable prostatic mass(es)
Serum PSA levels ≥3 ng/dL
Chronic use of any drug of abuse
Lower urinary tract obstruction
Clinically significant anemia or renal dysfunction
Cardiovascular disease
Hyperparathyroidism or uncontrolled diabetes
Generalized skin irritation or significant skin disease
Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
Sleep apnea
Untreated depression
Subject with a partner who is pregnant or will not use contraception