bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
Condition: Hepatocellular Cancer
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular
Intervention: Tivozanib
Intervention description: Oral medication given daily. No placebo.
Intervention MeSH terms: Tivozanib
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: Tivozanib; Advanced hepatocellular cancer; Angiogenesis

Summary:

      The purpose of this study is to learn about the effect of the investigational agent tivozanib
      on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also
      plan to collect information on the likelihood to develop side effects while on this
      treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is
      designed to stop the tumor from developing new blood vessels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with measurable, histological diagnosis of hepatocellular carcinoma (HCC) and
             whose disease is not amenable to surgical or regional therapy.

          2. Prior allowed therapy:

               -  Surgery including hepatic resection

                    1. Minimum of 4 weeks since any surgical procedure.

                    2. Patients must have adequately recovered from surgery.

               -  Regional therapy

                    1. Includes transarterial chemoembolization (TACE), drug-eluting bead
                       [DEB]-TACE, percutaneous ethanol injection, radiofrequency/cryo ablation,
                       Yttrium-90 radioembolization.

                    2. More than 2 weeks must have lapsed from therapy.

                    3. There must be an indicator lesion outside the treated area or clear evidence
                       of progression in the treated lesion, not amenable for further local
                       therapies.

                    4. Concomitant sorafenib with regional therapy is allowed as long as no
                       evidence of progression on sorafenib.

               -  Prior adjuvant sorafenib is allowed, if completed more than 6 months prior to
                  disease recurrence.

          3. Adequate hematological, liver and metabolic organ function.

          4. Signed informed consent.

        Exclusion Criteria:

          1. Patients with mixed histology or fibrolamellar variant.

          2. Prior systemic therapy for metastatic disease.

          3. Uncontrolled hypertension (HTN).

          4. Symptomatic heart failure.
Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Intervention: Photobiomodulation; Manual Therapy (MT)
Intervention description: PBM was applied, three times a week for four consecutive weeks at 5 points in the TMJ region: superior, anterior, lateral, posterior and postero inferior to the condyle. In addition, all patients received laser application in the temporal muscle (anterior, middle and posterior), in the masseter (upper, middle and lower portion) and insertion of the medial pterygoid.; Patients were submitted to MT at temporal, masseter and pterygoid medial from both sides, during 3 minutes each muscle group (Extraoral) and at masseter and lateral pterygoid (Intraoral) for 3 minutes, each total 21 minutes. MT on the TMJ region was performed for 1 minute and 3 repetitions during three times a week .
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Temporomandibular Diseases; Photobiomodulation; Low level laser; Treatment; Manual Therapy

Summary:

      The aim of the present study was to investigate the effect of photobiomodulation (PBM) and
      manual therapy (MT) isolated or combined in the reduce of pain, the improve of mandibular
      movements, the psychosocial aspects and the anxiety symptoms of patients with TMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  TMD myogenic and arthrogenic diagnosis based in RDC/TMD Axis I analysis

          -  Pain in temporomandibular joint (TMJ)

          -  Limitation in mouth opening.

        Exclusion Criteria:

          -  Current dental or physical treatment

          -  Polyarthritis and other rheumatic diseases

          -  Use of anti-inflammatory and muscle relaxant
Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation
Condition: Anxiety
MeSH terms: Anxiety Disorders
Intervention: Anxiety Self-Management, Patient preferred relaxing music; Control 1: Noise-cancelling headphones; Control 2: Standard of Care
Intervention description: Experimental group randomized to patient-directed music intervention where subjects listened to tailored, self-selected music as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.; Control group: noise-canceling headphones only where subjects wear headphones as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.; Usual ICU nursing care.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 364.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventilator; chronic obstructive pulmonary disease; Anxiety

Summary:

      The purpose of this study is to test whether patients who are receiving mechanical
      ventilation in the ICU who listened to preferred, relaxing music whenever they desire for as
      long as they desire will have less anxiety, receive fewer medications, stay in the ICU for a
      shorter time, and experience less stress than patients who do not listen to music.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient who is alert, on the ventilator because there is some condition involving
             the lungs preventing him/her from breathing on his/her own and willing and able to
             provide own consent.

        Exclusion Criteria:

          -  On the ventilator because of a surgical procedure, not alert and unable to provide own
             consent.
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Stanford V Chemotherapy; Radiation Therapy
Intervention description: The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone; Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Hodgkin Lymphoma

Summary:

      This phase II trial is studying how well combination chemotherapy with or without radiation
      therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in
      chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride,
      vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving
      more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy
      uses high-energy x-rays to kill cancer cells for those patients that still had residual
      cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may
      kill more cancer cells and allow doctors to save the part of the body where the cancer
      started.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, previously untreated Hodgkin lymphoma.

          -  Age: Participants must be 21 years of age or younger

          -  Stage must be classified as one of the following:

        Ann Arbor stage IA or IIA with:

          -  Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on CXR)

          -  < 3 nodal regions involved on the same side of the diaphragm

          -  No "E" lesion

          -  Female patients who are post-menarchal must have a negative pregnancy test. Patients
             of reproductive potential must agree to use an effective contraceptive method.

          -  Signed informed consent

          -  If re-evaluation of a patient's disease shows intermediate risk features, the patient
             will be removed from the HOD08.

        Exclusion Criteria:

          -  Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with
             "E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy
Long-Term Study of the Effects of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe COPD (MK-7123-019)
Condition: COPD
Intervention: Navarixin; Placebo; Rescue medication
Intervention description: Navarixin 10 mg and 30 mg capsules; Placebo to navarixin capsules; Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 616.0
Sex: All
Minimum age: 41 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Neutrophils are thought to play an important role in the pathophysiology of chronic
      obstructive pulmonary disease (COPD). Navarixin (SCH 527123, MK-7123) is an antagonist of the
      cysteine-X-cysteine chemokine receptor 2 (CXCR2) and is thought to reduce neutrophil
      migration to the diseased lung. It is theorized that reducing neutrophil migration to the
      diseased lung will improve a participant's symptoms and the natural history of the disease.

      The study will consist of a 2-week screening period followed by a 2-year (104-week)
      double-blind treatment period. The 2-year Treatment Period will be made up of two phases: a
      26-week (6-month) dose range-finding phase with 3 active arms and 1 placebo arm (Period 1),
      followed by a 78-week (18-month) long-term safety and efficacy phase (Period 2). Participants
      participating in the original 6-month study (Period 1) may elect not to continue into the
      18-month extension study (Period 2).

      Hypothesis: navarixin, 50 mg, or the highest remaining dose if the 50-mg dose is
      discontinued, is superior to placebo with respect to improving airflow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD for at least 2 years based on American Thoracic Society/European
             Respiratory Society (ATS/ERS) current guidelines or symptoms consistent with COPD for
             at least 2 years.

          -  >40 to <=75 years of age, of either sex, and of any race.

          -  No exacerbation or respiratory infection in the past 6 weeks.

          -  Smoker or ex-smoker with more than 10 pack-year history.

        Exclusion Criteria:

          -  Diagnosis of asthma or other clinically relevant lung disease (other than COPD), i.e.,
             sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer.

          -  Significant X-ray findings.

          -  Use of supplemental oxygen for >12 hours/day.
Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Metformin; Placebo
Intervention description: Monitoring of tolerability and symptoms.; Monitoring of tolerability and symptoms.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: kidney disease; polycystic kidney disease; autosomal dominant kidney disease; kidney cysts; PKD

Summary:

      This study will test to see if metformin is safe and if it is tolerated compared to placebo
      in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages
      of chronic kidney disease. We will also measure its effect on progression of kidney disease
      as reflected in the kidney size and the kidney function, along with its effect on kidney pain
      and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject has Autosomal Dominant Polycystic Kidney Disease; Subject is fluent in English

        Exclusion Criteria:

        Subject is not on active military duty; Subject is not currently participating in another
        clinical trial; Subject's current GFR is not <50 cc/min/1.73m2; Subject does not have
        diabetes; Subject does not have a systemic disease other than hypertension and PKD; Subject
        does not have a solitary kidney; Subject does not have an allergy or intolerance to
        metformin; Subject is not pregnant or lactating or intending to become pregnant within the
        next three years; Subject does not have an unstable or unclipped cerebral aneurysm; Subject
        does not have active coronary artery disease; Subject does not have an MRI incompatible
        device/implant; Subject does not have severe claustrophobia; Subject has not had any solid
        organ transplant; Subject does not have a Vitamin B12 deficiency; Subject does not
        currently take any medications that interact with metformin, such as nifedipine,
        furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide,
        quinidine, vancomycin, trimethoprim); Subject does not currently take nor has taken (within
        2 weeks) the drug tolvaptan (Jynarque or Samsca)
Multi-Center Pre-Bariatric Weight Loss Study
Condition: Obesity
MeSH terms: Weight Loss
Intervention: GI Sleeve Implantable weight loss device (EndoBarrier); Sham Procedure
Intervention description: device for weight loss; Weight loss
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Weight Reduction

Summary:

      The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients
      who require weight loss prior to their Bariatric surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI > 35 with a significant comorbid condition or BMI 40-60

          -  Candidate for Bariatric Surgery

        Exclusion Criteria:

          -  No pathologies of the GI Tract

          -  No anti-coagulant or non-steroidal anti-inflammatory medications
Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: SU011248/Trastuzumab
Intervention description: SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
Intervention MeSH terms: Trastuzumab; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer Metastatic

Summary:

      The current study is to evaluate: Overall response rate for the combination of trastuzumab
      and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and
      tolerability of the combination; measure duration of tumor control and survival; assess
      patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and
      safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or
             2) metastatic disease.

          -  HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)

          -  Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/
             lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted.
             Treatment with hormone therapy in the adjuvant and/or advanced disease setting is
             permitted.

        Exclusion Criteria:

          -  Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting.
             Adjuvant chemotherapy is permitted

          -  Prior exposure to trastuzumab if the patient had developed severe hypersensitivity
             reactions.

          -  Prior treatment on a SU11248 clinical trial.

          -  Uncontrolled brain metastases.
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome; Hyperphagia
MeSH terms: Prader-Willi Syndrome; Syndrome; Hyperphagia
Intervention: Intranasal Oxytocin (IN-OXT); Matched Placebo
Intervention description: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).; Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Prader-Willi Syndrome (PWS); Hyperphagia

Summary:

      The investigators propose a randomized double-blind 8 week treatment trial of intranasal
      oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess
      IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3)
      Salivary OXT levels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female child outpatients aged 5 to 18 years

          2. Diagnosis of PWS confirmed by genetic testing and patient medical records and history

          3. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks
             prior to the study start, and for the duration of the study.

          4. Have a physical exam and laboratory results that are within the norms for PWS

          5. Have a parent/caregiver/guardian that is able to consent for their participation and
             complete assessments regarding the child's development and behavior improvement
             throughout the study.

        Exclusion Criteria:

          1. Exposure to any investigational agent in the 30 days prior to randomization

          2. Prior chronic treatment with oxytocin.

          3. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis,
             schizophrenia, PTSD or major depressive disorder. These patients will be excluded due
             to potential confounding results.

          4. Pregnant or lactating patients. IN-OXT has not been studied in pregnant or lactating
             women.

          5. A medical condition that might interfere with the conduct of the study, confound
             interpretation of study results or endanger their own well-being.

          6. Plan to initiate or change nonpharmacologic or pharmacologic interventions during the
             course of the study.

          7. Females using an estrogen-based contraceptive. As an alternative to an estrogen based
             contraceptive, subjects will be counseled to use progesterone-based contraceptives;
             cervical caps; cervical sponges; or spermicidal foam in combination with a condom.
             Subjects will need to use a double barrier method to be in the study.
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
Condition: Epilepsy, Complex Partial
MeSH terms: Epilepsy, Complex Partial
Intervention: ganaxolone
Intervention description: liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Epileptic Seizures; Seizure Disorder; Seizures; Convulsions; Anticonvulsant; Anticonvulsive; Antiepileptic; Ganaxolone

Summary:

      This study is designed to provide ganaxolone to those patients deriving significant benefit
      from current treatment in protocol 1042-0601.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects who have completed all study visits from previous protocol 1042-0601 and have
             been deemed eligible by the Investigator as:

          -  having had no major adverse events thought to be drug related

          -  deriving benefit from ganaxolone treatment

          -  be properly informed of the nature and risks of the study and give written informed
             consent prior to study entry

          -  must be willing to use a medically acceptable method of birth control and if female of
             child-bearing potential, have a negative qualitative serum pregnancy test

        Exclusion Criteria:

          -  significant medical or surgical condition at screening or that develops during
             protocol participation that might compromise hematologic, cardiovascular, pulmonary,
             renal, gastrointestinal, or hepatic systems, or other conditions that would place the
             subject under increased risk

          -  unwilling to use a double-barrier method of birth control or submit to a serum
             pregnancy test

          -  history of chronic non-compliance with drug regimens

          -  females currently breastfeeding

          -  AST or ALT levels greater than 3 times the upper limit of normal at screen

          -  Inability to withhold grapefruit or grapefruit products during the study