bioihbjkbjnl/mcl2 huggingface dataset:
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release
      formulation of gabapentin that is being studied for the treatment of hot flashes in
      postmenopausal women.
    

Detailed description: 
      The primary study objective is to assess the efficacy of G-ER dosed in either of the
      following regimens:

        -  G-ER 1200 mg daily (single evening dose)

        -  G-ER 1800 mg daily (dosed asymmetrically; 600 mg in AM/1200 mg in PM) compared to
           placebo in reducing the average daily frequency and severity score of moderate to severe
           hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a
           stable dose, compared with the baseline week.
    

Intervention name(s): Gabapentin Extended-Release (G-ER) 1200 mg; Gabapentin Extended-Release (G-ER) 1800 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): G-ER 1200 mg daily dosage given as two 600-mg tablets.; G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.; Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).
Other intervention name(s): Gabapentin; Gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hot flashes; Hot flushes; Postmenopausal symptoms; Vasomotor symptoms
Study of Tissue and Blood Samples From Patients With Recurrent Prostate Cancer Who Received Lapatinib on Clinical Trial ECOG-E5803
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with
      cancer may help doctors learn more about changes that occur in DNA and identify biomarkers
      related to cancer. It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This research study is looking at tissue and blood samples from patients with
      recurrent prostate cancer who received lapatinib on clinical trial ECOG-E5803.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the association between polymorphisms in drug metabolizing enzymes and
           lapatinib ditosylate-associated toxicity in patients with hormone-sensitive recurrent
           prostate cancer receiving lapatinib ditosylate on clinical trial ECOG-E5803.

        -  To determine the association between mutations in EGFR, HER-2 and Kras; protein
           expression of HER2, EGFR, MAPK and AKT; polymorphism controlling androgen synthesis; and
           progression-free survival.

      OUTLINE: Tissue and blood samples collected from patients enrolled on clinical trial
      ECOG-E5803 are analyzed for correlative studies. Samples are assessed for HER2, EGFR, MAPK,
      and Akt; EGFR mutations and polymorphisms in CYP3A4; Ras mutations; recently identified
      mutations in HER2-neu and Kras; and additional polymorphisms in the lapatinib ditosylate
      metabolic pathway by automated quantitative IHC. Predictors of efficacy and toxicity are
      analyzed, including markers in the EGFR pathway as predictors of progression-free survival.
    

Intervention name(s): mutation analysis; polymorphism analysis; protein expression analysis; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients enrolled on E5803
      
Keywords: recurrent prostate cancer
Anakinra in Myositis
Condition: Polymyositis; Dermatomyositis; Inclusion Body Myositis
MeSH terms: Dermatomyositis; Myositis; Polymyositis; Myositis, Inclusion Body
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients
      with treatment-resistant inflammatory myopathies.

      Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis
      (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per
      day during 12 months. Outcome measures included myositis disease activity score with
      improvement defined according to The International Myositis Assessment and Clinical Studies
      Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition
      repeat muscle biopsies were performed
    


Intervention name(s): Anakinra
Intervention type(s): Drug
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Intervention model: Single Group Assignment
Primary purpose: Treatment
Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Directly reinforcing abstinence from alcohol with monetary incentives is an effective
      treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical
      measures of abstinence limit the dissemination of this treatment approach. The goal of this
      feasibility study is to use a breathalyzer and cost-controlling deposit contracts to
      facilitate a contingency-management intervention to reduce alcohol use that requires no
      in-person contact between the participants and the study staff during the intervention phase.
    


Intervention name(s): Contingency management: Contingent incentives; Contingency management: Noncontingent incentives
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Monetary incentives are delivered to participants contingent upon on- time breathalyzer submissions and verified abstinence from alcohol.; Monetary incentives are delivered to participants contingent upon on- time breathalyzer submissions only with no contingency on alcohol use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deep Brain Stimulation and Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      -  Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective
           treatment for a large variety of movement disorders. However, the efficacy of STN-DBS
           relies on unclear mechanisms.

        -  Purpose: In this study, using optical imaging, the investigators will evaluate the
           cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor
           task and delay discounting task. the investigators will perform an optical imaging study
           using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The
           investigators will measure bilateral local cortical hemodynamic changes under "On" and
           "Off" stimulation conditions and during a motor task (left hand movement) and delay
           discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will
           be continuously analyze.

        -  Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total
           Hb) under " on " and " off " stimulation during a motor task.
    


Intervention name(s): NIRS EEG HR recording
Intervention type(s): Device
Intervention description(s): NIRS EEG HR recording
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Near-InfraRed Spectroscopy (NIRS); Deep brain stimulation of SubThalamic Nucleus (DBS)
A Study of L-735,524 in HIV-Positive Children and Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate
      ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the
      plasma concentration profile after the initial dose with data from a historical group of
      adults. To obtain preliminary data on antiviral activity of MK-639.
    

Detailed description: 
      Patients receive MK-639 for 14 and one-third days. Repeat plasma samples are collected up to
      8 hours following the first and last dose. Urine samples are collected on days 1 and 5.
    

Intervention name(s): Indinavir sulfate
Intervention type(s): Drug
Intervention MeSH terms: Indinavir
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; HIV Protease Inhibitors; Indinavir
Use of Oxybutynin to Treat Axillary Hyperhidrosis
Condition: Axillary Hyperhidrosis; Osmidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      The objective of this study was to evaluate the effectiveness and patient satisfaction with
      the use of oxybutynin at low doses for treating axillary hyperhidrosis in a large series of
      patients.
    


Intervention name(s): Oxybutynin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.; Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
Intervention MeSH terms: Oxybutynin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperhidrosis; axillary; osmidrosis; oxybutynin
The Influence of Fasting on Selected Hemodynamic Parameters Measured in a Non-invasive Way
Condition: Perioperative Complication; Hemodynamic Instability
Study type: Interventional

Summary: 
      Preoperative fasting is considered to be refraining from taking meals for at least 6 hours
      and clear fluids for at least 2 hours before anesthesia. On the one hand, it is a procedure
      that reduces the risk of aspiration of chyme and the occurrence of Mendelson's syndrome, and
      on the other hand, it is one of the causes of water and carbohydrate disturbances in patients
      undergoing general anesthesia. Most of them experience some degree of dehydration in the
      preoperative period. It is associated with a worse prognosis. Due to the negative impact of
      fasting on homeostasis, as well as significant changes in heart rate in participants in the
      previous study, we decided to measure the hemodynamic parameters during fasting. The
      development of impedance cardiography techniques enables the measurement of these parameters
      by a non-invasive method.

      After obtaining the participant's written consent to participate in the study, the first
      measurement of body weight, blood pressure using a non-invasive method and hemodynamic
      parameters using a non-invasive impedance cardiography method using the Niccomo ™ device
      (Medizinische Messtechnik GmbH) will be performed in the evening. The subject will then be
      asked to refrain from food for at least 10 hours and fluid for 6 hours before the next
      measurement. The next morning, another measurement will be made and the participant will be
      randomly assigned to one of two groups: subjects in the first group will be asked to refrain
      from eating and drinking for another 2 hours, while subjects in the second group per os will
      receive 400 milliliters of PreOp® (Nutricia ™ preparation intended for preoperative dietary
      management in surgical patients, containing carbohydrates and electrolytes). After another
      two hours, the third measurement of the tested parameters will be performed. The obtained
      results will be subjected to statistical analysis consisting in comparing the values of
      hemodynamic parameters between the studied groups at appropriate measurement points.
    


Intervention name(s): Nutricia Pre-op, 400 milliliters, per os
Intervention type(s): Dietary Supplement
Intervention description(s): After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers
Condition: Crohn Disease; Mycobacterium Avium Subspecies Paratuberculosis
MeSH terms: Mycobacterium Infections; Mycobacterium avium-intracellulare Infection; Paratuberculosis; Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I dose escalation study to assess the safety and immunogenicity of the candidate
      vaccines ChAdOx2 HAV and MVA HAV in healthy volunteers.

      Volunteers will be recruited and vaccinated in Oxford, England.

      All vaccinations will be administered intramuscularly. Three different doses of the ChAdOx2
      HAV will be tested (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp). MVA HAV will be assessed at 2
      different doses (5x10^7 and 2x10^8 pfu)

      The total duration of the study will be 52 weeks from the day of enrolment for volunteers
      receiving ChAdOx2 HAV only, 12 weeks for volunteers receiving MVA HAV only and 20 weeks for
      volunteers receiving ChAdOx2 HAV and MVA HAV.
    

Detailed description: 
      This is a phase I, open label, dose escalation trial to assess the safety and immunogenicity
      of the ChAdOx2 and MVA HAV vaccines against Mycobacterium avium subspecies paratuberculosis
      (MAP) in healthy volunteers

      There will be 5 study groups with a total of 28 volunteers. ChAdOx2 HAV will be administered
      intramuscularly as a single vaccination at 3 different doses: 5x10^9 vp (group 1), 2.5x10^10
      (group 2) and 5x10^10 vp (group 3) and as a prime vaccine in group 6 (prime/boost group). MVA
      HAV will be administered intramuscularly as a single vaccination at 2 different doses: 5x10^7
      pfu (group 4), 2x10^8 pfu (group 5) and as a boost vaccine in group 6 (prime/boost group)

      Vaccination of groups will be sequential from Group 1 to Group 6 with interim safety reviews
      prior to dose escalation

      Volunteers will be recruited and undergo screening visits, vaccination and clinic visits
      post-vaccination at the trial site. Blood samples for safety and immunology purposes will be
      performed on the visit time points indicated in the schedule of attendances.

      Safety will be assessed by the frequency, incidence and nature of adverse events and serious
      adverse events arising during the study.
    

Intervention name(s): ChAdOx2 HAV; MVA HAV
Intervention type(s): Biological; Biological
Intervention description(s): The ChAdOx2 HAV vaccine consists of the replication-deficient simian adenovirus vector ChAdOx2, containing the Mycobacterium avium subspecies paratuberculosis (MAP) antigens; The MVA HAV vaccine consists of the replication deficient modified vaccinia virus Ankara (MVA) containing the Mycobacterium avium subspecies paratuberculosis (MAP) antigens.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaccine; MAP
Dance Dance Revolution (DDR) in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Regular physical activity is important for the treatment of type 2 diabetes, but it is often
      not sustained for many reasons, including lack of interest. New video games that involve
      physical movement ("exergames") may help in this regard. This study will compare the
      "exergame" "Dance Dance Revolution" (DDR) with traditional treadmill exercise on blood sugar
      control among sedentary, overweight or obese adults with type 2 diabetes.
    

Detailed description: 
      This study is a randomized, controlled trial of a 3-month ad libitum program of the
      "exergame" "Dance Dance Revolution" (DDR) versus traditional treadmill exercise. Each group
      of subjects will be assessed at baseline, and then assigned exclusively to one of the two
      exercise modalities. Subjects will be free to attend exercise sessions in their assigned
      exercise modality at the exercise facility, at a frequency, duration and intensity of their
      own choosing with minimal staff supervision, for a period of exactly 90 days; adoption of new
      exercise programs outside of the study will be prohibited. Dosages of any concurrent
      medications will be maintained constant, and all subjects will receive standardized nutrition
      counseling.
    

Intervention name(s): DDR; Treadmill
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ad libitum attendance to engage in "Dance Dance Revolution" (DDR) Exergaming, for a 3-month period; Ad libitum attendance to engage in treadmill exercise, for a 3-month period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Video game; Type 2 diabetes; Dance
A Study in People With Abnormal Fat Levels in the Blood
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purposes of this study are to determine:

        -  The safety of the study medication and any side effects that might be associated with
           it;

        -  Whether the study medication can help patients with low levels of 'good' cholesterol
           (HDL-C) and high blood fats or triglycerides (TG);

        -  How much of the study medication should be given to patients;

        -  How the study medication compares to fenofibrate (Lofibra), a drug used for people with
           low levels of HDL-C and high levels of TG.
    


Intervention name(s): PPAR alpha; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Safety of Bevacizumab for the Treatment Hemorrhagic Hereditary Telangiectasia (HHT) Associated With Severe Hepatic Vascular Malformations. Phase II Study
Condition: Hemorrhagic Hereditary Telangiectasia
MeSH terms: Telangiectasis; Vascular Malformations
Study type: Interventional
Phase: Phase 2

Summary: 
      The efficacy of anti-VEGF treatments such as Bevacizumab in cases of HHT can be considered
      because of the molecular mechanisms implied in angiogenesis and HHT, as well as the
      mechanisms of action of this type of treatment. Two articles that have recently reported
      spectacular improvement thanks to Bevacizumab in patients with HHT complicated with severe
      liver involvement and cardiac effects support us in this sense.

      Up to now, the only treatment recommended in the severe hepatic forms of HHT is a liver
      transplant, the disadvantages of which are both multiple and well known: long waiting lists,
      surgical morbidity and mortality, immunosuppressive treatment for life. Furthermore,
      treatment with Bevacizumab is not a contraindication, should the drug be ineffective, for a
      subsequent liver transplant if necessary.
    


Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): 5 mg / kg every 14 days with a total of 6 injections.A two-phase Gehan method will be used with a first phase designed to eliminate a non effective treatment quickly and a second phase allowing assessment of efficacy.
Other intervention name(s): AVASTIN
Intervention MeSH terms: Bevacizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiangiogenic therapies; Bevacuzimab; Hemorrhagic Hereditary Telangiectasia (HHT) with severe liver involvement
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers
      (DFU) and venous stasis ulcers (VSU).
    

Detailed description: 
      This study is designed to demonstrate the effectiveness of DermACELL in the treatment of
      chronic wounds of the lower extremities. DermACELL will be compared to conventional care in
      both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU).
      In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects
      with diabetic foot ulcers.

      DermACELL and GraftJacket are both made from donated human skin (dermis). These products have
      been processed so that cells are removed and bacteria and viruses are destroyed. This
      processing provided a supporting structure, an acellular dermal matrix, into which cells can
      migrate and divide during the wound healing process.
    

Intervention name(s): DermACELL; GraftJacket; Conventional Care Dressings
Intervention type(s): Other; Other; Other
Intervention description(s): Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).; Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).; Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing:
If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound.
Hydrogels can also be used if the wound is in need of moisture.
For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration.
A secondary dressing may be desired to add either loft or cushion.
Other intervention name(s): LifeNet Health Product Code: DCELL112; KCI Product Code: GJ44
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic foot ulcer; Venous stasis ulcer; Wound of the lower extremity; Skin substitute; Acellular Dermal Matrix