anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: LEVONORGESTREL
Trial phase: Phase 1 | Phase 2
ATC code: G03AA07 | G03AB03 | G03AC03 | G03AD01 | G03FA11 | G03FB09
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3([H])[C@@]1([H])CC[C@@]1(CC)[C@@]2([H])CC[C@@]1(O)C#C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Evaluate levonorgestrel delivery in AG890-6.5

levonorgestrel: transdermal contraceptive delivery system
Eligibility criteria:
Inclusion Criteria:

Body mass index (BMI) greater than or equal to 18.
Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy
Willing to refrain from excessive use of alcohol from 48 hours prior to patch application through completion of the study.

Exclusion Criteria:

Known or suspected pregnancy
Lactating women
Status post-partum or post-abortion within a period of 2 months prior to the start of study medication
A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater
Smoking
Hypertension (blood pressure >140 mm Hg systolic and/or >90 mm Hg diastolic)
Valvular heart disease with complications
ECG (in women with BMI ≥35 kg/m2) with clinically significant findings
Diabetes Mellitus
History of headaches with focal neurological symptoms
Uncontrolled thyroid disorder
Sickle cell anemia
Current or history of clinically significant depression in the last year
Known disturbance of lipid metabolism
Acute or chronic hepatocellular disease with abnormal liver function
Hepatic adenoma or carcinoma
Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
Plans for major surgery
History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
Undiagnosed abnormal genital bleeding
Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia
History or presence of dermal hypersensitivity in response to topical applications (bandages, surgical tape, etc.)
Use of an injectable hormonal contraceptive within the past 10 months prior to the screening visit
Use of a contraceptive implant or hormone-medicated intrauterine device (IUD) within 1 month prior to the screening visit
Use of oral contraceptives or other sex steroid hormones within 2 months prior to the screening visit
Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit
A recent history (within prior 2 years ) of drug or alcohol abuse
Intervention: LEVONORGESTREL
Trial phase: Phase 1 | Phase 2
ATC code: G03AA07 | G03AB03 | G03AC03 | G03AD01 | G03FA11 | G03FB09
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3([H])[C@@]1([H])CC[C@@]1(CC)[C@@]2([H])CC[C@@]1(O)C#C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Evaluate levonorgestrel delivery in AG890-12.5

levonorgestrel: transdermal contraceptive delivery system
Eligibility criteria:
Inclusion Criteria:

Body mass index (BMI) greater than or equal to 18.
Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy
Willing to refrain from excessive use of alcohol from 48 hours prior to patch application through completion of the study.

Exclusion Criteria:

Known or suspected pregnancy
Lactating women
Status post-partum or post-abortion within a period of 2 months prior to the start of study medication
A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater
Smoking
Hypertension (blood pressure >140 mm Hg systolic and/or >90 mm Hg diastolic)
Valvular heart disease with complications
ECG (in women with BMI ≥35 kg/m2) with clinically significant findings
Diabetes Mellitus
History of headaches with focal neurological symptoms
Uncontrolled thyroid disorder
Sickle cell anemia
Current or history of clinically significant depression in the last year
Known disturbance of lipid metabolism
Acute or chronic hepatocellular disease with abnormal liver function
Hepatic adenoma or carcinoma
Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
Plans for major surgery
History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
Undiagnosed abnormal genital bleeding
Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia
History or presence of dermal hypersensitivity in response to topical applications (bandages, surgical tape, etc.)
Use of an injectable hormonal contraceptive within the past 10 months prior to the screening visit
Use of a contraceptive implant or hormone-medicated intrauterine device (IUD) within 1 month prior to the screening visit
Use of oral contraceptives or other sex steroid hormones within 2 months prior to the screening visit
Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit
A recent history (within prior 2 years ) of drug or alcohol abuse
Intervention: Risperidone
Trial phase: Phase 2 | Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
Eligibility criteria:
Inclusion Criteria:

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Intervention: Risperidone
Trial phase: Phase 2 | Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
Eligibility criteria:
Inclusion Criteria:

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia

Patients who meet at least one of the following:

current diagnosis of schizophrenia of chronic phase
between 65 and 74 years of age
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: Indomethacin Nanoformulation Capsules 40 mg TID
Eligibility criteria:
Inclusion Criteria:

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Indomethacin Nanoformulation Capsules 40 mg BID
Eligibility criteria:
Inclusion Criteria:

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Indomethacin Nanoformulation Capsules 20 mg TID
Eligibility criteria:
Inclusion Criteria:

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening
Intervention: Caffeine
Trial phase: Phase 4
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline.

Aspirin, Acetaminophen, Caffeine pills: One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV)
Eligibility criteria:
Inclusion Criteria:

18 years or older

Headache must meet the IHS criteria for migraine or probable migraine

2 out of 4 of following:

Unilateral location
Throbbing (pulsating) quality
Moderate to severe intensity (inhibits/prohibits daily activities)
Exacerbation with moderate activity or mild activity

During HA, at least 1 out of 3 of following:

Nausea and/or vomiting
Photophobia
Phonophobia

Exclusion Criteria:

Known allergy to study medications
Pregnancy
< 18 years old
Inability to provide written, informed consent
Patients with positive lumbar puncture or positive CT scan for suspected secondary headache
History of peptic ulcer disease
History of liver failure
History of coagulopathy
Gastrointestinal bleeding within the last 3 months
Previous gastrointestinal bleeding with non-steroidal anti-inflammatory medications
Ingestion of other pain medications within the previous six hours deemed to put the patient at risk of exceeding a toxic dose of ASA or acetaminophen (> 100mg/kg for ASA or acetaminophen)
Vomiting within one hour of receiving oral study medications.
Intervention: Rivaroxaban
Trial phase: Phase 2
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Oral Rivaroxaban 10 mg od for 7 days Rivaroxaban: 10 mg os once daily for 1 week
Eligibility criteria:
Inclusion Criteria:

Adult patient (18 years and older)
Knee arthroscopy not combined with open surgery.
Patients eligible for surgical treatment.
Patients are willing and able to continue study participation to ensure completion of all procedures and observations required by the study.
Written informed consent

Exclusion Criteria:

Diagnostic arthroscopy
Patients concomitantly treated systemically with strong concurrent CYP3A4 and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors.
Hypersensitivity to the active substance or to any of the excipients of study drug
Pregnant women or breast-feeding.
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
Known thrombophilia (hereditary or acquired)
Mandatory anticoagulation.
Known severe bleeding tendency
Clinically significant active bleeding.
Severe renal failure (GFR<30mL/min/1.73m2)
Patients participating in another clinical trial.
Recent mayor surgery (6 to 12 weeks)
Intervention: ULIPRISTAL ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 221
Group description: PGL4001 10 mg: PGL4001 10mg daily administration
Eligibility criteria:
Inclusion Criteria:

Be a pre-menopausal woman between 18 and 50 years inclusive.
Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
Have FSH levels ≤ 20 mIU/mL
Have excessive uterine bleeding due to myoma.
Have regular menstrual cycles
Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Exclusion Criteria:

Has a history of or current uterine, cervical, ovarian or breast cancer.
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
Has a known severe coagulation disorder.
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
Has abnormal hepatic function at study entry.
Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study.
Has a current (within twelve months) problem with alcohol or drug abuse.
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Intervention: Vilazodone
Trial phase: Phase 3
ATC code: N06AX24
SMILES: N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 227
Group description: Vilazodone 20mg once per day, oral administration.
Eligibility criteria:
Inclusion Criteria:

Male and female, 18 - 70 years of age
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)
Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control

History of meeting DSM-IV-TR criteria for any of the following:

Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
Any depressive episode with psychotic or catatonic features
Panic disorder with or without agoraphobia
Obsessive-compulsive disorder
Schizophrenia, schizoaffective, or other psychotic disorder
Bulimia or anorexia nervosa
Presence of borderline personality disorder or antisocial personality disorder
Mental retardation, dementia, amnesia, or other significant cognitive disorders
Patients who are considered a suicide risk
Intervention: Vilazodone
Trial phase: Phase 3
ATC code: N06AX24
SMILES: N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: Vilazodone 40mg once per day, oral administration
Eligibility criteria:
Inclusion Criteria:

Male and female, 18 - 70 years of age
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)
Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control

History of meeting DSM-IV-TR criteria for any of the following:

Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
Any depressive episode with psychotic or catatonic features
Panic disorder with or without agoraphobia
Obsessive-compulsive disorder
Schizophrenia, schizoaffective, or other psychotic disorder
Bulimia or anorexia nervosa
Presence of borderline personality disorder or antisocial personality disorder
Mental retardation, dementia, amnesia, or other significant cognitive disorders
Patients who are considered a suicide risk
Intervention: Metoclopramide
Trial phase: Phase 4
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Pro-motility agent
Eligibility criteria:
Inclusion Criteria:

Men and women over the age of 18 undergoing pill capsule endoscopy to investigate unexplained rectal bleeding, anemia, iron deficiency, abdominal pain, altered bowel habits, and/or weight loss.

Exclusion Criteria:

Inability to sign consent for research participation
Inability to swallow PillCam™, placebo, or metoclopramide capsule
Known hypersensitivity/allergy to metoclopramide
Active congestive heart failure or respiratory failure requiring ventilator assistance
Presence of cardiac pacemaker or implanted electromedical device
Known bowel obstruction/stricture/fistula or intrauterine pregnancy
Known history of Whipple procedure (pancreaticoduodenectomy), Billroth II surgery (partial gastrectomy with gastrojejunostomy), or gastric bypass surgery due to risk of capsule retention in a blind intestinal limb necessitating surgical retrieval
Known history of seizure disorder, renal failure requiring dialysis, or pheochromocytoma
Lactating women
Intervention: FLUTICASONE FUROATE
Trial phase: Phase 3
ATC code: R01AD12 | R03AK10 | R03AL08 | R03BA09
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)c3ccco3)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 131
Group description: Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Informed Consent
6 to <15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.
Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.
ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN
Average of 3TNSS is >= 4.0 in the last consecutive 4 days prior to Visit 2.
Completion of the patient diary on >= 3 days of the last consecutive 4 days prior to Visit 2

Exclusion Criteria:

Has a seasonal pollen as an allergen
A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)
Bacterial or viral infection of upper respiratory tract or eye
Concurrent disease/abnormalities: Clinically significant uncontrolled disease
Known hypersensitivity to corticosteroids or any excipients in the investigational product
Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1
Use of the following medication and/or its combination drug within the specified time:

Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1

Affiliation with Investigator's Site: Relative or employee
History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.
Average of 3TNSS is >= 8.0 in the last consecutive 4 days prior to Visit 2.
Bacterial or viral infection of upper respiratory tract or eye during the screening period.