bioihbjkbjnl/mcl2 huggingface dataset:
RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe
Condition: Carcinoma; Renal Cell; Non Clear Cell Renal Carcinoma; Papillary Cell Renal Carcinoma; Adenocarcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: RAD001
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal cell carcinoma; non clear cell carcinoma; papillary cell renal carcinoma; adults; everolimus

Summary:

      To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line
      treatment of patients with metastatic papillary carcinoma of the kidney.
    

Eligibility criteria:

        Inclusion criteria:

          1. ≥ 18 years old.

          2. Patients with metastatic papillary renal cell carcinoma, type I or II.

          3. Patients with at least one measurable lesion.

          4. Patients with an ECOG Performance Status ≤1.

          5. Adequate bone marrow function.

          6. Adequate liver function.

          7. Adequate renal function.

          8. Adequate lipid profile.

        Exclusion criteria:

          1. Patients who had radiation therapy within 28 days prior to start of study.

          2. Patients who have received prior systemic treatment for their metastatic RCC.

          3. Patients who received prior therapy with VEGF pathway inhibitor.

          4. Patients who have previously received systemic mTOR inhibitors.

          5. Patients with a known hypersensitivity everolimus or other rapamycins or to its
             excipients.

          6. Patients with uncontrolled central nervous system (CNS) metastases.

          7. Patients receiving chronic systemic treatment with corticosteroids or another
             immunosuppressive agent.

          8. Patients with a known history of HIV seropositivity.

          9. Patients with autoimmune hepatitis.

         10. Patients with an active, bleeding diathesis.

         11. Patients who have any severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study.

         12. Patients who have a history of another primary malignancy and off treatment ≤ 3 years,
             with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine
             cervix.

         13. Female patients who are pregnant or breast feeding, or adults of reproductive
             potential who are not using effective birth control methods.

         14. Patients who are using other investigational agents or who had received
             investigational drugs ≤ 4 weeks prior to study treatment start.

         15. Patients unwilling to or unable to comply with the protocol.
Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: D-cycloserine; Placebo
Intervention description: Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10); Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: cognitive-behavior therapy; d-cycloserine; cognitive enhancer; drug dependence; opiate dependence; exposure; isolated doses of d-cycloserine; isolated doses of matching pill placebo; DCS

Summary:

      This study examines whether isolated doses of d-cycloserine enhance the efficacy of an
      exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance
      dependence.
    

Eligibility criteria:

        Inclusion criteria:

        The primary selection criteria include women and men between the ages of 18 and 65 who:

          1. Meet DSM-IV criteria for opiate dependence,

          2. Maintain a stable dose of methadone for two weeks prior to recruitment and:

               -  fail to achieve "take-home" status for methadone dosing during at least the first
                  four months of methadone treatment,

               -  test positive on at least two toxicology screens for illicit drugs during the
                  month prior to recruitment

               -  have never achieved two consecutive toxicology screens free of illicit substances
                  since entering the current treatment episode.

          3. Meet study criteria for chronic stress:

               -  unemployment criteria, and

               -  affective disorder criteria.

        Exclusion Criteria:

          1. Patients with significantly unstable or uncontrolled medical illness which may
             interfere with participation in treatment (e.g., patients likely to require
             hospitalization during the study period).

          2. Patients with a psychotic or organic mental disorder according to DSM-IV criteria.

          3. Patients receiving medication affecting methadone metabolism (e.g. rifampin).

          4. Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria
             for mania or hypomania or meeting criteria for rapid cycling in the last year (as
             indicated by structured questioning of all patients meeting criteria for bipolar
             disorder).

          5. Patients unable to complete the informed consent or unable to understand study
             procedures in the informed consent process.

          6. Pregnancy or current alcohol use.
Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Proellex 25 mg; Placebo; Proellex 50 mg
Intervention description: 1 capsule daily for 4 months; 1 capsule daily for 4 months; 2 capsules daily for 4 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Endometriosis; Pelvic pain; Oral progesterone blocker

Summary:

      The purpose of this study is to determine whether Proellex is safe and effective for the
      treatment of symptomatic endometriosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women aged 18-48 inclusive

          -  Endometriosis documented by laparoscopic or surgical assessment within the past ten
             (10) years

          -  Clinical symptoms of endometriosis for at least the past three (3) months

          -  Endometriosis symptoms

          -  Must be sexually active unless sexually inactive for endometriosis-related dyspareunia

          -  Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a
             detectable ovulation during the baseline period using an ovulation monitoring kit (for
             timing of endometrial biopsy)

          -  Other inclusion criteria may apply

        Exclusion Criteria:

          -  Six (6) months or more without a menstrual period, or

          -  Prior hysterectomy or

          -  Prior bilateral oophorectomy

          -  Diagnosis of osteopenia

          -  Present history or condition that causes non-endometriosis-related dyspareunia

          -  Presence of excessive bleeding or menorrhagia

          -  Abnormal screening endometrial biopsy

          -  Other exclusion criteria may apply
An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
Condition: Compensated Cirrhosis and Portal Hypertension
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Intervention: Terlipressin acetate; Serelaxin (RLX030)
Intervention description: IV bolus injection; Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours
Intervention MeSH terms: Terlipressin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Portal hypertension, cirrhosis, TIPSS, MRI, MRA, portal pressure, portal pressure gradient

Summary:

      The main purpose of this exploratory study was to investigate the effect of serelaxin
      (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis
      and portal hypertension. Measurements were acquired non-invasively using magnetic resonance
      angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein
      during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study
      part B), to determine the acute haemodynamic response to serelaxin (RLX030).
    

Eligibility criteria:

        Inclusion Criteria:

        Study Parts A and B:

        -Cirrhosis of alcohol aetiology according to physician's assessment prior to screening.

        Part A:

        -Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g.
        oesophageal varices).

        Part B:

          -  Cirrhosis with TIPSS in situ and PPG>5mmHg.

          -  Fully functioning TIPSS without variceal filling as confirmed by portography.

        Exclusion Criteria:

        Study Parts A and B:

          -  Use of any drug to treat portal hypertension (e.g. vasodilators such as non-selective
             beta blockers or nitrates) within 1 month prior to screening.

          -  Decompensated cirrhosis (Child-Pugh score >9 points, and/or ascites requiring
             diuretics, and/or hepatic encephalopathy) at visit 1.

          -  Presence of any non-controlled and clinically significant disease that could affect
             the study outcome or that would place the patient at undue risk.

        Part A:

          -  BMI (weight[kg] / height[m^2]) > 40 kg/m^2.

          -  Any contraindication to having an MRI scan

        Part B:

        -Contraindication to catheterization
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
Condition: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Intervention: Concizumab; Eptacog alfa
Intervention description: A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase; A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to
      assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once
      daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial
        related activities are any procedures that are carried out as part of the trial, including
        activities to determine the suitability for the trial - Male haemophilia A or B patients
        with inhibitors aged 18 years or older at the time of signing informed consent - Patients
        currently in need of treatment with bypassing agents Exclusion Criteria: - Known or
        suspected hypersensitivity to trial product(s) or related products - Known inherited or
        acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance
        induction therapy or prophylaxis with FVIII or FIX
A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: CP-690,550; CP-690,550; CP-690,550; Placebo
Intervention description: administration via oral route twice daily; administration via oral route twice daily; administration via oral route twice daily; administration via oral route twice daily
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to
      severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be
      tested will be more effective than placebo (inactive drug).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be at least 18 years of age at screening

          -  Males and females with clinical evidence of Crohn's disease for at least 3 months
             duration at screening

          -  Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's
             Disease Activity Index (CDAI) score of 220-450 inclusive

        Exclusion Criteria:

          -  Subjects currently receiving immunosuppressants, interferon, anti-TNFa

          -  Subjects with evidence of hematopoietic disorders

          -  Subjects with evidence of active or latent TB
A School Program for Children Exposed to Violence
Condition: Stress Disorders, Post-Traumatic; Depression
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: School-based cognitive behavioral support group
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 10 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: Trauma; Violence; Adolescent; Schools; Cognitive behavioral therapy

Summary:

      This study will develop a program to help school children deal with violence-related trauma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Students in 6th and 7th grade in two participating Los Angeles area schools

          -  Exposure to severe violence, as either a victim or witness, within 1 year prior to
             study entry

          -  Have symptoms of post-traumatic stress disorder at study entry

          -  Able to speak and understand English

          -  Parent or guardian willing to give informed consent

        Exclusion Criteria:

          -  Post-traumatic stress disorder symptoms that are not related to a traumatic event

          -  Mental retardation

          -  Conduct disorder that would interfere with the participant's ability to engage in
             group therapy
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: H.pylori eradication
Intervention description: The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Steatohepatitis,; Helicobacter pylori,; Insulin resistance,; Alanine aminotransferase,; Aspartate aminotransferase,

Summary:

      The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat
      content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)
      index, and anthropometric measurements (body mass index and waist circumference)in diabetic
      subjects with non-alcoholic fatty liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetic dyspeptic patients with positive antibody to H.pylori and persistent elevated
             aminotransferase levels with the evidence of fatty liver in ultrasonography, who were
             referred to a gastroenterology clinic

        Exclusion Criteria:

          -  Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
             heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune
             hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum
             creatinine concentration of > 1.5 mg/dl), any severe systemic co-morbidities,
             neoplasm, using any hepatotoxic medication during the past 3 months, previous history
             of peptic ulcer, previous history of H.pylori eradication, existence of alarm signs
             (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal
             cancers), and pregnant or lactating women.
A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: placebo; ibuprofen; acetominophen; telcagepant
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 683.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will test the safety and how effective telcagepant is when taken with ibuprofen or
      acetaminophen in participants with migraine with or without aura. The primary study
      hypothesis is that at least one drug combination is superior to telecagepant alone in the
      treatment of acute migraines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 18 years of age or older

          -  History of migraine with or without aura for more than 1 year with 1-8 moderate or
             severe migraine attacks per month in the 2 months prior to starting in the study

          -  Willing to stay awake for at least 2 hours after taking study drug

          -  Able to read, understand and complete questionnaires and diaries

        Exclusion Criteria:

          -  Breast-feeding, pregnant, or plan to become pregnant during the study

          -  Not able to tell migraine attack from other headaches

          -  Older than 50 years of age at migraine onset

          -  Have more than 15 headache days per month or have taken medication for acute headache
             on more than 10 days per month in any of the 3 months before starting in the study

          -  History of gastric or small intestinal surgery

          -  History of heart attack, stroke, unstable angina, coronary artery bypass surgery or
             transient ischemic attack in the 3 months before starting in the study

          -  Currently participating or have participated in a study with in investigational
             compound or device in the last 30 days
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: NYX-2925; Placebo
Intervention description: NYX-2925 administered orally; Placebo administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed consent

          -  Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening
             and reports at least moderate pain over the last week

          -  Stable protocol allowed medication and other therapies during the study

          -  Agrees to use highly effective birth control during the study

          -  Has not participated in an interventional study for at least 30 days and agrees not to
             participate in another interventional study during the study

        Exclusion Criteria:

          -  Pain due to other conditions or diseases that would complicate participation in the
             study or pain reporting

          -  Current or historical serious medical conditions

          -  Prior participation in NYX-2925 clinical trial
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide Acetate; Matching placebo
Intervention description: Oral, once daily; Oral, once daily
Intervention MeSH terms: Linaclotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome with Constipation; IBS; Irritable Bowel Syndrome; linaclotide acetate; linaclotide; MD-1100

Summary:

      The purpose of this study is to determine the safety, efficacy, and dose response of a range
      of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must not be pregnant or breastfeeding and agree to use birth control;

          -  Completion of a negative colonoscopy as per American Gastroenterology Association
             (AGA) criteria and no clinically-significant laboratory or physical examination
             findings;

          -  Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool
             consistency, abdominal pain, and abdominal discomfort criteria;

          -  Demonstrates English fluency and has access to a touch-tone telephone.

        Exclusion Criteria:

          -  Recent history of mushy or watery stools;

          -  Various medical conditions, medical histories, or family medical histories that would
             not make the patient a good candidate for the study;

          -  Clinically-significant alarm symptoms;

          -  Secondary causes of constipation or evacuation disorders;

          -  Surgery to the gastrointestinal tract;

          -  Usage of prohibited medications.