anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 3
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 410
Group description: Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Eligibility criteria:
Key Inclusion Criteria:

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Key Exclusion Criteria:

Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Pregnant or nursing women.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 3
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 416
Group description: Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Eligibility criteria:
Key Inclusion Criteria:

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Key Exclusion Criteria:

Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Pregnant or nursing women.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Ergocalciferol
Trial phase: Phase 4
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
Eligibility criteria:
Inclusion Criteria:

Fragility hip fracture patient
Previous Vitamin D supplementation is okay.

Exclusion Criteria:

Patients with pathological fracture secondary to malignancy or intrinsic bone disease (eg. Paget's disease)
Cancer in the past 10 years likely to metastasize to bone
Renal insufficiency (creatinine <30 mls/min)
Hypercalcemia (primary hyperparathyroidism; granulomatous diseases; drug-induced such as lithium, thiazides), hypocalcemia, hypercalciuria, fracture or stroke within the last 3 months
Hormone replacement therapy, calcitonin, fluoride, or bisphosphonates during the previous 24 months
Pre-existing bone abnormality
Renal stones in past 10 years
Intervention: Ergocalciferol
Trial phase: Phase 4
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
Eligibility criteria:
Inclusion Criteria:

Fragility hip fracture patient
Previous Vitamin D supplementation is okay.

Exclusion Criteria:

Patients with pathological fracture secondary to malignancy or intrinsic bone disease (eg. Paget's disease)
Cancer in the past 10 years likely to metastasize to bone
Renal insufficiency (creatinine <30 mls/min)
Hypercalcemia (primary hyperparathyroidism; granulomatous diseases; drug-induced such as lithium, thiazides), hypocalcemia, hypercalciuria, fracture or stroke within the last 3 months
Hormone replacement therapy, calcitonin, fluoride, or bisphosphonates during the previous 24 months
Pre-existing bone abnormality
Renal stones in past 10 years
Intervention: Midodrine Hydrochloride
Trial phase: Phase 2
SMILES: COc1ccc(OC)c(C(O)CNC(=O)CN)c1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
Eligibility criteria:
Inclusion Criteria:

This study will be performed on subjects 18 to 65 years old, with chronic SCI (> 1 year), who are neurologically stable and have demonstrated significant hypotension (total time [proportion 50%] spent with hypotension [systolic BP below 110 mmHg for males and 100 mmHg for females] during a 24-hour observation.

Exclusion Criteria:

hypertension
diabetes
vascular disease
cardiac disease
cardiovascular medication
pregnancy
Intervention: Raloxifene
Trial phase: Phase 3
ATC code: G03XC01
SMILES: O=C(c1ccc(OCCN2CCCCC2)cc1)c1c(-c2ccc(O)cc2)sc2cc(O)ccc12
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: Use of 100mg of raloxifene during days 5-9 of the menstrual cycle

raloxifene: 100mg PO on days 5-9 of the menstrual cycle

Two cases: one woman had nausea, and the other woman had nausea, headache, and pelvic pain. All mild
Eligibility criteria:
Inclusion Criteria:

All patients with polycystic ovarian syndrome will be invited to participate in the study. The PCOS criteria are according to modified Rotterdam criteria (7); i.e., oligoovulation defined as < 6 menstrual periods per year, signs of clinical hyperandrogenism (Ferriman and Gallwey >8) or laboratorial (total Testosterone >=0.81 ng/dL) or polycystic ovary > 10cm3.

Furthermore, all patients with infertility diagnosis based solely on ovulation factor will included in the protocol

Age >18 years old and <= 38 years old.
No endometriosis on laparoscopy

Exclusion Criteria:

Not willing to participate in the study
use of IUD or contraceptive pill within 2 months before the study.
Hyperprolactinemia (>20ng/mL)
Abnormal serum levels of TSH(normal range:0.4-40 mUI/mL).
High 17-OH progesterone (>=4.9ng/mL)
Endometriosis
Known allergy to clomiphene or raloxifene
Intervention: Afegostat tartrate
Trial phase: Phase 2
SMILES: O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Afegostat tartrate was administered orally during the 4-week treatment period.
Eligibility criteria:
Inclusion Criteria:

Had a confirmed diagnosis of type 1 Gaucher disease with a known documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase alleles
Clinically stable
Male or female participants, 18 to 74 years old inclusive
All participants of childbearing potential used adequate birth control
Provided written informed consent to participate in the study

Exclusion Criteria:

Clinically significant disease, severe complications from Gaucher disease, or serious illness that precluded participation in the study in the opinion of the Investigator that compromised the safety of the participant or precluded the participant from completing the study
During the screening period, any clinically significant findings, as deemed by the Investigator
Partial or total splenectomy (removal of spleen) within the 2 years prior to study entry
History of pulmonary hypertension or Gaucher related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious adverse reaction to iminosugars (for example, N-butyldeoxynojirimycin or miglustat)
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence or symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Intervention: Afegostat tartrate
Trial phase: Phase 2
SMILES: O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Afegostat tartrate was administered orally once per day during the 4-week treatment period.
Eligibility criteria:
Inclusion Criteria:

Had a confirmed diagnosis of type 1 Gaucher disease with a known documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase alleles
Clinically stable
Male or female participants, 18 to 74 years old inclusive
All participants of childbearing potential used adequate birth control
Provided written informed consent to participate in the study

Exclusion Criteria:

Clinically significant disease, severe complications from Gaucher disease, or serious illness that precluded participation in the study in the opinion of the Investigator that compromised the safety of the participant or precluded the participant from completing the study
During the screening period, any clinically significant findings, as deemed by the Investigator
Partial or total splenectomy (removal of spleen) within the 2 years prior to study entry
History of pulmonary hypertension or Gaucher related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious adverse reaction to iminosugars (for example, N-butyldeoxynojirimycin or miglustat)
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence or symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Intervention: Afegostat tartrate
Trial phase: Phase 2
SMILES: O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Afegostat tartrate was administered orally once every 7 days during the 4-week treatment period.
Eligibility criteria:
Inclusion Criteria:

Had a confirmed diagnosis of type 1 Gaucher disease with a known documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase alleles
Clinically stable
Male or female participants, 18 to 74 years old inclusive
All participants of childbearing potential used adequate birth control
Provided written informed consent to participate in the study

Exclusion Criteria:

Clinically significant disease, severe complications from Gaucher disease, or serious illness that precluded participation in the study in the opinion of the Investigator that compromised the safety of the participant or precluded the participant from completing the study
During the screening period, any clinically significant findings, as deemed by the Investigator
Partial or total splenectomy (removal of spleen) within the 2 years prior to study entry
History of pulmonary hypertension or Gaucher related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious adverse reaction to iminosugars (for example, N-butyldeoxynojirimycin or miglustat)
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence or symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Intervention: MYCOPHENOLIC ACID
Trial phase: Phase 4
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Participants at risk: 5
Group description: The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
Eligibility criteria:
Inclusion criteria:

Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
Age > 18 yrs
Adequate and stable renal function
Informed consent.

Exclusion criteria:

Kidney transplant combined with other organs;
Significant proteinuria
Severe ongoing infections;
Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
Relapse of the end-stage renal disease on the transplanted kidney;
Leucopenia, thrombocytopenia or severe anemia;

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Quetiapine Fumarate
Trial phase: Phase 3
SMILES: O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Quetiapine XR
Eligibility criteria:
Inclusion Criteria: subjects between the ages of 18-65 years, with a DSM-IV diagnosis of current alcohol dependence (past year), can speak, understand, and print in English, and is capable of giving written informed consent

Exclusion Criteria: Positive urine drug screen for opioids, cocaine, or amphetamine (excluding THC), dependence on other drugs excluding alcohol/nicotine/cannabis over the past year, unstable psychiatric, medical disorders, cataracts [posterior capsular/ nuclear (grade NS3 or more), currently on any maintenance psychotropic medications affecting sleep, currently pregnant, nursing, or not using a reliable method of contraception; history of hypersensitivity to antipsychotic drugs, including quetiapine, severe cognitive impairment, severe untreated obstructive sleep apnea, and inadequately controlled diabetes mellitus.
Intervention: Chlordiazepoxide
Trial phase: Phase 3
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).
Eligibility criteria:
Inclusion Criteria:

A candidate for unilateral treatment of osteoarthritis of the shoulder
Have failed conservative treatment

Exclusion Criteria:

Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function
No active instability or acute dislocation episodes within the previous 12 months
Known allergy to hyaluronate preparations
Pregnant or breast feeding
Is receiving prescription pain medication for conditions unrelated to the index shoulder condition
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ

Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:

Whole breast (as part of breast-conservation therapy)

Chest wall (as part of post-mastectomy irradiation)

Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed

Must meet the following criteria for planned radiotherapy:

Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy
No planned split-course radiotherapy
No partial breast treatment, defined as treatment of < 75% of the breast parenchyma
Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed

Must be entered on study within 7 days prior to beginning radiotherapy

Must start study drug prior to receiving the third radiotherapy fraction
No preexisting skin breakdown within the planned radiotherapy field at the time of study entry
No bilateral breast cancer treatment
No inflammatory carcinoma of the breast
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Male or female
Menopausal status not specified
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to complete questionnaires independently or with assistance
No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior radiotherapy to the planned radiotherapy treatment area

No concurrent or planned leukotriene inhibitors, including the following:

Zafirleukast
Monteleukast
Zileuton

No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:

Cortaid®
Cortizone 10®
Tucks®
Preparation H®
No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment
Intervention: Frovatriptan
Trial phase: Not Applicable
ATC code: N02CC07
SMILES: CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: 5.0 mg of Frovatriptan given as single dose
Eligibility criteria:
Inclusion Criteria:

Male and female subjects between the ages of 18 and 65, inclusive
Subjects diagnosed with episodic migraine, with or without aura according to IHS criteria for at least one-year prior to screening
Subjects who experience between 1 and 6 migraine attacks per month inclusive (during the previous 6 months) with no more than 15 days of headache per month.
Subject reports hunger or fasting as a known trigger for migraine
Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
Subjects who are able to understand and comply with all study procedures.
Subject is willing to complete one 20-hour fast, starting between 5:00 and 8:00 P.M., with no food or drink (except water needed to take routine medication)
Subject provides written informed consent prior to any screening procedures being conducted
If subject is taking a preventive migraine medication for migraine or any other reason, that medication must have been a stable dose for at least 4 weeks prior to screening, and must remain stable throughout the duration of the study.

EXCLUSION CRITERIA

Pregnant and/or lactating women
Subjects who have a history of clinically relevant allergy to frovatriptan or like compounds
Subjects who, in the investigators opinion, have a history or have evidence of any other medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
Subjects who currently have or have a history of significant cerebrovascular disease including basilar or hemiplegic migraine
Subjects who have a history of non-response to triptans, as determined by investigator
Subjects with uncontrolled hypertension
Subjects with diabetes mellitus who require insulin or oral anti-hyperglycemic agents will be excluded. (Subjects with Type II diabetes who are well controlled with diet and exercise alone may be included.)
Subjects who currently have or who have a history of ischemia and/or vasospastic coronary artery disease
Subjects who, in the investigators opinion, have significant risk factors of coronary artery disease
Intervention: Gemcitabine Hydrochloride
Trial phase: Phase 3
SMILES: Cl.Nc1ccn(C2OC(CO)C(O)C2(F)F)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 165
Group description: Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of newly diagnosed or recurrent transitional cell bladder cancer meeting the following criteria:

Ta or T1 primary tumor
Grade 1 or 2 disease

No more than 2 recurrences (except for index tumor) within the 18 months prior to the index tumor's transurethral resection of the bladder tumor (TURBT)

Index tumor post-TURBT must meet the following criteria:

Ta or T1 tumor without any prior tumor in situ, grade 3 (high grade) disease within 2 years prior to index tumor TURBT, or invasion of the muscularis propria (stage ≥ T2)
Grade 1 or 2 disease (similar to papillary urothelial neoplasm of low malignant potential and low-grade bladder cancer)
Not a candidate for a therapy other than TURBT (e.g., a series of instillations of intravesical immunotherapy [e.g., BCG] or intravesical chemotherapy, or cystectomy or partial cystectomy)

Negative upper tract imaging studies within 1 year (365 days) prior to study entry

Imaging studies may be performed after registration provided it is done prior to TURBT on the day of treatment
No urothelial cancer of the prostate or more distal urethra (or urethra at all in women) as assessed by endoscopy
Must have a negative urine culture (less than or equal to 10,000 col/mL, mixed flora-likely contamination) OR negative urine analysis for infection AND negative nitrates on reagent strip, ≤ 10 white blood cell count (WBC)/high-power field, and no rods or organisms on examination of spun urine sediment OR an automated or visual reagent strip urinalysis that is negative for leukocytes and nitrates within the past 28 days
TURBT planned within the next 28 days and planned treatment within 3 hours after TURBT

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
Not pregnant or nursing
Fertile patients must use effective contraception

No other prior malignancy except for any of the following:

Adequately treated basal cell or squamous cell skin cancer
In situ cervical cancer
Adequately treated stage I or II cancer from which patient is in complete remission
Any other cancer from which patient has been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 145 days since prior intravesical therapy