bioihbjkbjnl/mcl2 huggingface dataset:
BI 2536 Second Line Monotherapy in SCLC
Condition: Carcinoma, Small Cell
MeSH terms: Carcinoma, Small Cell
Intervention: BI 2536
Intervention description: Intravenous Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in
      second line treatment in sensitive-relapse SCLC patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC
             defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.

          -  Patients with at least one measurable lesion, with longest diameter to be recorded as
             20 mm or greater.

          -  Life expectancy of at least three months and ECOG performance score of 2 or less and
             written informed consent that must be consistent with ICH-GCP Guidelines.

        Exclusion Criteria:

          -  More than one prior regimen of chemotherapy, mixed small cell/large cell or combined
             small cell histology.

          -  Symptomatic brain metastases or leptomeningeal disease

          -  Patients with ascites, patients who have any other life-threatening illness or organ
             system dysfunction, or other malignancies diagnosed within the past five (5) years
             (other than non melanomatous skin cancer)

          -  Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin
             <9 mg/dl

          -  Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino
             transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine
             amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine
             >2.0 mg/dl (>176 µmol/L, SI Unit equivalent)

          -  Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or
             within less than 4 half-life times of the previous drug prior to treatment with the
             trial drug

          -  Radiation therapy within the past 2 weeks prior to or during treatment with the trial
             drug

          -  Patients with any serious active infection (i.e., requiring an IV antibiotic,
             antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection

          -  Known or suspected active drug or alcohol abuse

          -  Treatment with any other investigational drug within the past 4 weeks or within less
             than 4 half-life times of the investigational drug

          -  Patients with a known pre-existing coagulopathy or requiring therapeutic
             anticoagulation with warfarin (Coumadin ®)

          -  Patients with neuropathy (sensory or motor) CTCAE 3
Glenohumeral Cortisone Injection
Condition: Humeral Fractures
MeSH terms: Humeral Fractures
Intervention: kenalog; Lidocaine
Intervention description: Cortisone injection into shoulder; Lidocaine injection into shoulder
Intervention MeSH terms: Triamcinolone Acetonide; Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The objective of this project is to determine if giving a cortisone injection to patients
      with proximal humerus fractures who have stiff shoulders recover their range of motion.
    

Eligibility criteria:

        Inclusion Criteria:

        1.18-90

        2. Proximal Humerus Fracture

        3. Decreased range of motion at 6 wk follow-up

        4. Likely to be available for follow up for 26 wks

        Exclusion Criteria:

          1. Known drug allergy to kenalog or lidocaine

          2. Unable to complete functional outcome

          3. Pregnant Women
Efficacy of an Intranasal Testosterone Product
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: 10.0 mg of Testosterone, 4.0% TID; 13.5 mg of Testosterone, 4.5% B.I.D; 11.25 mg of Testosterone, 4.5% T.I.D
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This clinical trial will compare the pharmacokinetic profile of testosterone after repeated
      intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes)
             testosterone levels >100 ng/dl and ≤ 300 ng/dL.

          -  Normal Otolaryngological nasal endoscopy examination.

          -  Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.

        Exclusion Criteria:

          -  Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex
             hormones

          -  Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12
             months

          -  History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or
             sinus surgery.

          -  History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per
             month, abuse of nasal decongestants) or sleep apnea.
Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: GM-CSF (Sargramostim); Rituximab
Intervention description: 250 mcg injection under the skin, three times a week for eight weeks.; 375 mg/m^2 administered intravenously once weekly for four weeks
Intervention MeSH terms: Rituximab; Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Rituximab; Leukemia; Sargramostim; GM-CSF

Summary:

      The goal of this clinical research study is to learn if giving granulocyte-macrophage
      colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of
      rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of
      this combination treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Group 1. Diagnosis of previously treated B-CLL Rai III-IV or earlier stage disease
             with evidence of "active disease" as defined by the NCI-sponsored working group 1)
             weight loss of >10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats
             without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive
             lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia
             or paraproteinemia, 7) lymphadenopathy >5 cm in diameter.

          2. Group 2. Diagnosis of previously untreated B-CLL with Rai stage 0-II disease but high
             risk for progression based on B2-microglobulin >3.0 mg/mL, or with symptoms or
             significant fatigue.

          3. Group 3. Patients age 70 years of age and older with previously untreated B-CLL and
             Rai stage III-IV or earlier stage disease with indication for treatment who refused
             chemotherapy.

          4. Age 15 years or above.

          5. Adequate renal and hepatic functions (creatinine <2.5 mg/dL, bilirubin <2 mg/dL).
             Patients with renal or liver dysfunction due to organ infiltration by lymphocytes are
             eligible, as are patients with elevated bilirubin and history consistent with
             Gilbert's disease.

          6. Performance status <3 (Zubrod Scale).

          7. No active viral hepatitis

        Exclusion Criteria:

        1) None.
Orlistat for the Treatment of Type I Hyperlipoproteinemia
Condition: Hyperlipoproteinemia Type I; Hypertriglyceridemia
MeSH terms: Hyperlipoproteinemia Type I; Hypertriglyceridemia; Hyperlipoproteinemias; Hyperlipidemias
Intervention: Orlistat
Intervention description: Orlistat is a gastric and pancreatic lipase inhibitor that is approved by the FDA for weight loss. It is available over-the-counter as 60 mg tablets under the trade name Alli, and available by prescription as 120 mg capsules under the trade name Xenical.
Intervention MeSH terms: Orlistat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with Type I Hyperlipoproteinemia (T1HLP) have a rare form of hypertriglyceridemia
      marked by significant chylomicronemia and recurrent episodes of acute pancreatitis. T1HLP is
      caused by a deficiency of lipoprotein lipase or one of its cofactors. Many patients are a
      challenge to treat, as the only effective therapy available is an extremely low fat diet.
      This diet is exceedingly difficult to follow, and despite adherence, many patients still have
      chylomicronemia and develop acute pancreatitis.

      Specific Aim: To determine the efficacy of a gastric and pancreatic lipase inhibitor,
      Orlistat, in reducing serum triglyceride levels in patients with T1HLP.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type I hyperlipoproteinemia

          2. Fasting serum triglyceride levels of greater than 1000 mg/dL

          3. Age > 8 years

        Exclusion Criteria:

          1. Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism,
             alcoholism and drug therapy such as estrogens and estrogen analogues, steroids,
             HIVprotease inhibitors, retinoic acid derivatives and interferons

          2. Pregnant or lactating women

          3. Significant liver disease (elevated transaminases > 2 times upper limit of normal)
             Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks or 168 g per week
             for men)

          4. Severe anemia (hematocrit < 24%)

          5. Drug use (cocaine, marijuana, LSD, etc.)

          6. Major surgery in the past three months

          7. Congestive heart failure

          8. Serum creatinine greater than 2.5 mg/dL

          9. Cancer within the past five years

         10. Gastrointestinal surgery in the past

         11. Current therapy with anti-coagulants, digoxin, and anti-arrhythmics

         12. Current therapy with cyclosporine

         13. Chronic malabsorption syndromes

         14. Cholestasis

         15. Acute illnesses such as acute pancreatitis in the last 8 weeks
A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome With Diarrhea (IBS-D)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea; Abdominal Pain
Intervention: MD-7246; Placebo
Intervention description: Oral tablet; Matching oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 515.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abdominal pain; Diarrhea; Irritable Bowel Syndrome

Summary:

      To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose
      response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel
      syndrome (IBS-D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets the Rome IV criteria for diagnosis of IBS-D

          -  Patient maintains a minimum level of compliance with daily diary

          -  Female patients of childbearing potential must agree to use one of the following
             methods of birth control:

               1. Hormonal contraception

               2. Double-barrier method

               3. Maintenance of a monogamous relationship with a male partner who has been
                  surgically sterilized by vasectomy

        Exclusion Criteria:

          -  Patient has clinically significant findings on a physical examination and/or clinical
             laboratory tests

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments

        NOTE: Additional inclusion/exclusion criteria may apply
A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide
Intervention description: Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bone turnover; hormone-naïve; prostate specific antigen; Prostate Cancer

Summary:

      To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with
      prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed prostate cancer (all stages) for whom androgen deprivation
             therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)

          -  Asymptomatic from prostate cancer

          -  Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening

          -  PSA ≥ 2 ng/mL at screening

        Exclusion Criteria:

        Has previously or is currently receiving:

          -  Hormonal therapy with intent to treat prostate cancer

          -  Systemic glucocorticoids

          -  Chemotherapy with the intent to treat prostate cancer

          -  Opiate analgesics for pain from prostate cancer

          -  Radiation therapy for treatment of the primary tumor or metastases

          -  Has history of known or suspected brain or skull metastases or leptomeningeal disease

          -  Has history of seizure including febrile seizure or any condition that may predispose
             to seizure or history of loss of consciousness or transient ischemic attack

          -  Clinically significant cardiovascular disease
A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: BAY94-9343 (Anetumab ravtansine)
Intervention description: BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies
Intervention MeSH terms: Maytansine; Tubulin Modulators; Anetumab ravtansine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid tumors; Mesothelin; Mesothelioma

Summary:

      The purpose of this study is to enable patients with solid tumors, who received anetumab
      ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective
      study has been closed. The patients will be observed to collect information on how safe and
      efficient the drug is.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants ongoing in an applicable Bayer-sponsored anetumab ravtansine parent study
             at the time of its planned study closure.

          -  For on-treatment participants: participant is eligible to receive the next dose of
             study intervention per the parent study protocol.

          -  For on-treatment participants: any ongoing adverse events that require temporary
             treatment interruption must be resolved to baseline grade or assessed as stable and
             not requiring further treatment interruption. For applicable studies: should treatment
             be permanently interrupted in the parent study, participants may be enrolled in the
             follow-up portion of the rollover study.

        Exclusion Criteria:

          -  For on-treatment participants: a positive serum pregnancy test.

          -  For on-treatment participants: use of one or more of the prohibited medications listed
             in the respective parent study protocol.

          -  Participants who are receiving standard-of-care agent(s) but not anetumab ravtansine
             in the parent study, and are able to receive standard-of-care agent outside of the
             clinical study.
Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
Condition: Intestinal Obstruction
MeSH terms: Intestinal Obstruction
Intervention: Lanreotide Autogel
Intervention description: 120mg administered via deep subcutaneous injection at Day 0 and Day 28.
Intervention MeSH terms: Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to
      inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to
      assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without the
      recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a
      nasogastric tube.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent before any study related procedure

          -  Male and female patients age 18 years or older at time of enrollment

          -  Diagnosis of intestinal obstruction of malignant origin

          -  In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3
             months preceding the inclusion in the study

          -  Confirmed as inoperable after surgical advice

          -  Patient with a nasogastric tube OR presenting with 3 or more episodes of vomiting /
             24h in the last 48 hours

          -  Estimated life expectancy 1 month or more

        Exclusion Criteria:

          -  Operable obstruction or subobstruction

          -  Bowel obstruction due to a non-malignant cause

          -  Signs of bowel perforation

          -  Prior treatment with somatostatin or any other analogue within the previous 60 days

          -  A known hypersensitivity to any of the study treatments or related compounds

          -  Previous participation in this study

          -  Is likely to require treatment during the study with drugs that are not permitted by
             the study protocol

          -  Has abnormal baseline findings, any other medical condition(s) or laboratory findings
             that, in the opinion of the Investigator, might jeopardise the subject's safety
Interleukin-2 in Metastatic Kidney Cancer
Condition: Renal Cell Cancer Metastatic; Kidney Cancer Metastatic
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms; Neoplasms
Intervention: Interleukin-2
Intervention description: Interleukin-2
Intervention MeSH terms: Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Renal Cell; Metastatic Kidney Cancer

Summary:

      The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used
      in this study will help increase tumor shrinkage.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a histologic diagnosis of metastatic kidney cancer. Patients may
             have received prior systemic therapy or may be previously untreated

          2. Patients must have bi-dimensional measurable disease on physical exam or radiologic
             studies.

          3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.

          4. White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl;
             bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.

          5. Patients must undergo a low-level cardiac stress test as a screen for possible
             atherosclerotic heart disease. Patients with a positive stress test would be excluded
             from this trial.

          6. Patients with elevated temperatures > 100.5 F must have sources of occult infection
             excluded.

          7. Patients must be felt to have recovered from effects of prior therapy, such as > 2
             weeks after prior chemotherapy.

          8. Patient consent must be obtained prior to entrance onto study.

          9. Women of childbearing potential must have a negative pregnancy test and must take
             adequate precautions to prevent pregnancy during treatment

        Exclusion Criteria:

          1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as
             cyclosporin or methotrexate.

          2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by
             immune-based therapy.

          3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.

          4. Lactation or pregnancy.

          5. Evidence of significant cardiovascular disease including history of recent (< 6 months
             prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias
             (not due to electrolyte disorder or drug toxicity, for example) beyond occasional
             PVC's, angina, positive low-level stress test, or cerebrovascular accident.

          6. Current brain metastasis.