anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Methylnaltrexone
Trial phase: Phase 3
ATC code: A06AH01
SMILES: C[N@+]1(CC2CC2)CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Participants received MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
Eligibility criteria:
Key Inclusion Criteria:

History of chronic non-malignant pain (originating from a non-malignant source) with condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months' duration before the screening visit.
Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic non-malignant pain for ≥1 month.
No known history of chronic constipation prior to the initiation of opioid therapy.
Currently taking laxative therapy for ≥30 days and willing to discontinue all laxative therapy at the start of screening period and use only study-permitted rescue laxatives throughout the screening and double-blind treatment periods..

Key Exclusion Criteria:

Prior treatment with oral MNTX.
Prior treatment with SC MNTX within 30 days of screening.
Women who are pregnant, breastfeeding, or plan to become pregnant during the study.
Fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant gastrointestinal disorders such as inflammatory bowel disease or clinically significant irritable bowel syndrome that would have made bowel movement assessment inaccurate.
Current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists.
Intervention: Telapristone acetate
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 1 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Eligibility criteria:
Inclusion Criteria:

Ability to understand and provide a written informed consent.

Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:

Excessive menstrual bleeding;
Menstrual pain;
Confirmed uterine fibroids; and
Confirmed endometriosis
Normal menstrual cycle of 26-32 days
Agree not to attempt to become pregnant
Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
Ability to swallow gelatin capsules Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits

Exclusion Criteria:

Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period
Women with abnormal liver enzymes or liver disease.
Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
Received an investigational drug in the 30 days prior to the screening for this study
Women with a history of PCOS
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
Women currently using narcotics
Women currently taking cimetidine or spironolactone
Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intervention: Telapristone acetate
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: 3 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Eligibility criteria:
Inclusion Criteria:

Ability to understand and provide a written informed consent.

Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:

Excessive menstrual bleeding;
Menstrual pain;
Confirmed uterine fibroids; and
Confirmed endometriosis
Normal menstrual cycle of 26-32 days
Agree not to attempt to become pregnant
Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
Ability to swallow gelatin capsules Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits

Exclusion Criteria:

Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period
Women with abnormal liver enzymes or liver disease.
Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
Received an investigational drug in the 30 days prior to the screening for this study
Women with a history of PCOS
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
Women currently using narcotics
Women currently taking cimetidine or spironolactone
Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intervention: Telapristone acetate
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 6 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Eligibility criteria:
Inclusion Criteria:

Ability to understand and provide a written informed consent.

Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:

Excessive menstrual bleeding;
Menstrual pain;
Confirmed uterine fibroids; and
Confirmed endometriosis
Normal menstrual cycle of 26-32 days
Agree not to attempt to become pregnant
Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
Ability to swallow gelatin capsules Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits

Exclusion Criteria:

Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period
Women with abnormal liver enzymes or liver disease.
Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
Received an investigational drug in the 30 days prior to the screening for this study
Women with a history of PCOS
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
Women currently using narcotics
Women currently taking cimetidine or spironolactone
Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intervention: Telapristone acetate
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 9 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Eligibility criteria:
Inclusion Criteria:

Ability to understand and provide a written informed consent.

Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:

Excessive menstrual bleeding;
Menstrual pain;
Confirmed uterine fibroids; and
Confirmed endometriosis
Normal menstrual cycle of 26-32 days
Agree not to attempt to become pregnant
Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
Ability to swallow gelatin capsules Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits

Exclusion Criteria:

Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period
Women with abnormal liver enzymes or liver disease.
Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
Received an investigational drug in the 30 days prior to the screening for this study
Women with a history of PCOS
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
Women currently using narcotics
Women currently taking cimetidine or spironolactone
Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intervention: Telapristone acetate
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 12 mg proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Eligibility criteria:
Inclusion Criteria:

Ability to understand and provide a written informed consent.

Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:

Excessive menstrual bleeding;
Menstrual pain;
Confirmed uterine fibroids; and
Confirmed endometriosis
Normal menstrual cycle of 26-32 days
Agree not to attempt to become pregnant
Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
Ability to swallow gelatin capsules Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits

Exclusion Criteria:

Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period
Women with abnormal liver enzymes or liver disease.
Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
Received an investigational drug in the 30 days prior to the screening for this study
Women with a history of PCOS
Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
Women currently using narcotics
Women currently taking cimetidine or spironolactone
Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intervention: Levosimendan
Trial phase: Phase 4
ATC code: C01CX08
SMILES: C[C@@H]1CC(=O)NN=C1c1ccc(NN=C(C#N)C#N)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation

levosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.
Eligibility criteria:
Inclusion Criteria:

Eligible for aortic valve replacement
EF > 45%
Left ventricular posterior wall > 12mm
Sinus rhythm

Exclusion Criteria:

Concomitant bypass operation
Severe mitral insufficiency
Active endocarditis
Insufficient ultrasound opportunity
Systolic blood pressure < 100 mmHg
moderate-severe renal failure
allergy to levosimendan
lack of patient consent Pregnancy or status of lactating
Fertile women who do not use relevant anticonception
Intervention: Diquafosol tetrasodium
Trial phase: Phase 2
SMILES: O=c1ccn(C2OC(COP(=O)([O-])OP(=O)([O-])OP(=O)([O-])OP(=O)([O-])OCC3OC(n4ccc(=O)[nH]c4=O)C(O)C3O)C(O)C2O)c(=O)[nH]1.[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Participants at risk: 96
Group description: 1% DE-089 ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Those who show:

Keratoconjunctival disorder confirmed with vital dye staining
Abnormal Schirmer score results

Exclusion Criteria:

Eye disease that needs therapy other than that for dry eye
Those who need to wear contact lenses during the clinical study
Intervention: Diquafosol tetrasodium
Trial phase: Phase 2
SMILES: O=c1ccn(C2OC(COP(=O)([O-])OP(=O)([O-])OP(=O)([O-])OP(=O)([O-])OCC3OC(n4ccc(=O)[nH]c4=O)C(O)C3O)C(O)C2O)c(=O)[nH]1.[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Participants at risk: 96
Group description: 3% DE-089 ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Those who show:

Keratoconjunctival disorder confirmed with vital dye staining
Abnormal Schirmer score results

Exclusion Criteria:

Eye disease that needs therapy other than that for dry eye
Those who need to wear contact lenses during the clinical study
Intervention: Darifenacin
Trial phase: Not Applicable
ATC code: G04BD10
SMILES: NC(=O)C(c1ccccc1)(c1ccccc1)[C@@H]1CCN(CCc2ccc3c(c2)CCO3)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: 3 days of preoperative darifenacin anticholinergic medication

Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery.
Eligibility criteria:
Inclusion Criteria:

Participants will be included in the study if they are undergoing a procedure that a stent will likely be required. This will include participants who will have ureteroscopy or extracorporeal shock wave lithotripsy and a stone 1 cm or larger.
Also participants with stones smaller than 1 cm who due to anatomy of the ureter or kidney will likely need a stent on preoperative evaluation will also be included in the study.
Included as well in the study are participants who will undergo renal or ureteral surgery that a ureteral stent will be utilized.

Exclusion Criteria:

Those who do not meet inclusion criteria-
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)

Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
Eligibility criteria:
Inclusion Criteria:

Age > 18
Planned partial or total thyroidectomy

Exclusion Criteria:

History of adverse effects to dexamethasone or propyleneglycol or di-natrium-EDTA
Patients with chronic pain
Necessity for opioids-application in the postoperative course
Not possible administration of a cervical block (0.5% bupivacaine at a dose of 20ml)
Patients with Diabetes mellitus
Pregnancy (test in young women)
Glaucoma
Patients who received antiemetic therapy within 48h before surgery
Patients with acute pain requiring painkillers others than paracetamol or more than single dose NSAR treatment within 48h before surgery
Use of psychotropic drugs
Incompliant patients
Preoperatively high suspicion of malignancy
Re-operations
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.

erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
Eligibility criteria:
Inclusion Criteria:

A history of stage I-IIIB NSCLC
Previously underdone definitive surgery or radiation
Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time
Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence
Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor
Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible)
Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field
Signed informed consent
Age > or = to 21 years old
Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped

Exclusion Criteria:

Prior progressive disease while receiving erlotinib or gefitinib therapy
Patients with known pre-existing interstitial lung disease
Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome
AST or ALT greater than five times the upper limit of normal
Pregnant or lactating women
Medically unfit for erlotinib therapy as determined by treating oncologist
Intervention: Ampicillin/sulbactam
Trial phase: Phase 3
SMILES: CC1(C)C(C(=O)[O-])C2C(=O)CC2S1(=O)=O.CC1(C)SC2C(NC(=O)C(N)c3ccccc3)C(=O)N2C1C(=O)[O-].[Na+].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
Eligibility criteria:
Inclusion Criteria:

16 years of age or older.
Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.

Exclusion Criteria:

Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam sodium, other penicillins, or cephems.
Hepatic dysfunction [Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin > 3 times upper limit of normal range values].
Severe renal dysfunction (creatinine clearance < 30 ml/min).
Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.