bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia
      who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone,
      paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms.
      After a 4 week run in period on their current anti psychotic treatment, patients will be
      randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on
      therapy. The anticipated time o n study treatment is <3 months, and the target sample size is
      100-500 individual s.
    


Intervention name(s): RO4917838; RO4917838; RO4917838; Placebo; Standard antipsychotic therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10mg po daily; 30mg po daily; 60mg po daily; po daily; As prescribed
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

Summary: 
      Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This
      disease is usually thought to spare central nervous system. However, neuropsychiatric
      manifestations like depression and cognitive functions impairment seem to be frequent.
      Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter
      hyperintensities have been reported suggested CNS vascular manifestations in systemic
      sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric
      manifestations in systemic sclerosis is unknown. The primary objective of this prospective
      and multicentre study is to assess a link between neuropsychiatric manifestations and CNS
      involvement in systemic sclerosis. Secondary objectives are to assess the frequency of
      neuropsychiatric manifestations, to compare central nervous system abnormality between
      scleroderma patient and healthy subjects. Central nervous system involvement and
      neuropsychiatric manifestations will be systematically assessed through central nervous
      system imaging and questionnaires.
    


Intervention name(s): Magnetic resonance Imaging
Intervention type(s): Other
Intervention description(s): Magnetic resonance Imaging Assessment
Other intervention name(s): Cognitive, psychiatric and neurological evaluation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Systemic Sclerosis; neuropsychiatric manifestations; magnetic resonance imaging
Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects
      with methamphetamine dependence who report using methamphetamine 29 or less days during the
      30 days prior to the start of signing consent.
    

Detailed description: 
      The primary objective of this study is to assess the efficacy of bupropion in reducing
      methamphetamine use in subjects with methamphetamine dependence who report using
      methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary
      objectives included but were not limited to: assessing the success or failure to achieve
      abstinence (confirmed by at least two methamphetaminenegative urines and no
      methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for
      subjects using methamphetamine 18 or less days during the 30 days prior to signing consent,
      assessing the safety of bupropion in this study population, assessing other measures of
      efficacy of bupropion in reducing methamphetamine use or craving, and other psychological
      assessments of methamphetamine dependence.

      It is hypothesized that bupropion, compared to placebo, would be associated with an increase
      in the proportion of subjects who achieved abstinence (confirmed by at least two
      methamphetamine-negative urines and no methamphetaminepositive urines) each week during the
      last two weeks (Weeks 11 and 12) for non-daily users.
    

Intervention name(s): Bupropion; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.; Placebo
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Dynamic Hyperinflation and Tiotropium
Condition: COPD
Study type: Interventional
Phase: Phase 4

Summary: 
      We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease)
      patients with moderately severe disease using metronome paced hyperventilation (MPH) with
      inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung
      volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized
      crossover double blinded study.
    

Detailed description: 
      Study completed with 29 patients studied. Data is being analyzed to evaluate trough and peak
      effect of 18 µg tiotropium vs placebo on FEV 1 (L)(forced expiratory capacity in one second),
      inspiratory capacity and functional residual volume. In addition, we will study the effect of
      18 µg tiotropium vs placebo on metronome paced hyperventilation induced dynamic
      hyperinflation. We will also evaluate the effect of tiotropium induced increase in IC
      (inspiratory capacity) vs extent of emphysema as evaluated on high resolution thin section CT
      lung
    

Intervention name(s): Placebo
Intervention type(s): Drug
Intervention description(s): Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      We aim to optimize the radiological selection and the transfer model in patients with a 6-24h
      stroke for a fairer and broader access to a reperfusion treatment. The specific objectives
      are:

        1. To confirm that the selection of patients for reperfusion therapies in the late window
           is safe by applying the same clinical and imaging criteria recommended by clinical
           guidelines for the early window treatment selection.

        2. To evaluate the performance of non-contrast CT by applying immediate post-processing
           software for the selection of patients for reperfusion treatment in the late window.

        3. To analyze the prehospital and arrival variables at the primary stroke center to
           generate decision trees that optimize the transfer decision in patients with activation
           of the stroke code in >6h from the onset of symptoms.

      METHODOLOGY: Study based on a mandatory, prospective, multicenter registry (CICAT registry)
      consisting of two phases

        1. retrospective analysis with a detailed evaluation of the images of the included patients
           and generation of "machine learning" models that accurately predict the probability of
           receiving reperfusion treatment in the late window.

        2. validation of the models in a prospective study. Clinical, radiological and transport
           variables will be studied.

      Response variables: rate of patients receiving reperfusion treatment in the late window,
      functional prognosis at 90 days, hemorrhagic transformation, and mortality.
    


Intervention name(s): Multiparametric imaging; Non contrast CT+CT angiography
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): MR perfusion or multiparametric CT including NCCT, CTA and CTP; NCCT+CTA
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with stroke suspiction in Catalonia included in the CICAT registry
Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      -  Selection of patient and preparation of questionnaires

        -  Presentation of the study by the doctor

        -  Verbal consent of participants (patient and Partner)

        -  Delivery of booklets

        -  Response to documents (questionnaires and written consent) at home, send by mail
    

Detailed description: 
      1. Before consultation :

           Selection of patients according to inclusion criteria by persons in charge and
           preparation of inclusion file

        2. During the consultation :

             -  Presentation of the study by the investigator

             -  The investigator signs the information note and give two file to the patient (1 for
                her and 1 for her Partner : both contains 1 information note signed by the
                investigator, 1 questionnaire and 2 stamped envelopes

             -  Finally, the investigator fill-in the medical form and send the original to the
                university (université de Lille 3)

        3. At home :

             -  Signature of the information note and the participation consent form

             -  Patients and Partner responds to their questionnaire (including socio-demographique
                questionnaire)

             -  They send the documents thanks to stamped envelopes:

                  1. They send information note to the medical center

                  2. They send the questionnaires to the university
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young women (<45 years old)treated or previously treated by chemotherapy for a non
        metastatic breast cancer, in Relationship for at least 6 months
      
Keywords: Breast cancer; Quality Of Life; Women; Partner
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
Condition: Cervical Radiculopathy; Myelopathy
MeSH terms: Radiculopathy; Spinal Cord Diseases; Bone Marrow Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated
      allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion
      of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or
      myelopathy.

      Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after
      surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after
      surgery, the implanted bone dowels will be assessed for fusion. Patients will complete
      questionnaires and x-rays taken at each visit.

      The degree of subsidence and rate of fusion will be assessed based on the evaluation of the
      x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the
      type of treatment that each patient has received.
    


Intervention name(s): Anterior Cervical Discectomy and Fusion
Intervention type(s): Procedure
Intervention description(s): 1,2,3,or 4 level surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical fusion; Anterior Cervical Discectomy and Fusion; ACDF
The Effects of β-Hydroxy-β-methylbutyrate Free Acid and High-Intensity Interval Training
Condition: Exercise
Study type: Interventional

Summary: 
      Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT) and
      free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold, critical
      power, anaerobic working capacity and neuromuscular economy in a population of endurance
      trained individuals. 2) Determine the effect of 4-weeks of HIIT and HMB-FA on changes in
      skeletal muscle physiological cross-sectional area (PCSA=Volume/Fascicle length) and muscle
      quality (MQ=echo intensity) in the rectus femoris and vastus lateralis.

      Subjects: Fifty males and females between the ages of 18 - 35 will be recruited to
      participate in this study. Subject will be randomized to one of three groups: a control group
      (CTL), an HIIT only group (HIIT) or a group which will take the amino acid metabolite HMB and
      perform HIIT (HMB-HIIT). Individuals assigned to CTL will undergo baseline testing. They will
      then be asked to continue their normal exercise routine for 4 weeks and will undergo
      post-testing after this time period.

      Study Protocol: Two testing sessions, on nonconsecutive days, will occur at least 72 hours
      prior to the start of the training period. The same testing protocols will be repeated at the
      end of the 4-week training period. Testing protocols include performance testing (VO2peak,
      lactate threshold, critical power, anaerobic working capacity and neuromuscular economy) and
      anthropometric measures (physiological cross-sectional area and muscle quality). The training
      protocol for individuals in the experimental groups will consist of 4-weeks of high intensity
      interval training with three sessions per week on an electronically braked cycle ergometer.
      Individual work -loads will be calculated based on the outcomes from each participant's
      preliminary testing.
    


Intervention name(s): Placebo; HMB-FA; High Intensity Interval Training
Intervention type(s): Dietary Supplement; Dietary Supplement; Procedure
Other intervention name(s): beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Performance; Aerobic Exercise
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label, non randomized Phase I study is being conducted to
      investigate the pharmacokinetics, mass balance and metabolite profiling and identification
      after a single oral dose of 100mg of [14C]-MD1003 in 6 healthy males subjects. The
      radioactivity will be followed in the blood, urine and faeces to study MD1003 metabolism.
    


Intervention name(s): [14C]-MD1003
Intervention type(s): Drug
Intervention description(s): single oral dose of 100mg [14C]-MD1003
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Infant Pulse Oximetry in Pakistan Study
Condition: Hypoxemia; Neonatal Sepsis; Pneumonia
MeSH terms: Pneumonia; Neonatal Sepsis; Hypoxia
Study type: Observational

Summary: 
      Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign
      of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid,
      portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation
      (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting.
      In this research study, we propose to test the hypothesis that the use of pulse oximetry to
      detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible
      for the identification of the infants most urgently in need of medical care. We will enroll
      1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi.
      Infants will undergo brief clinical assessment by a community health worker (CHW) based on
      the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm,
      assessment by two pulse oximetry devices, and examination by a physician. The primary
      outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain
      measurement, number of infants for who repeat measurements are required), and concordance
      between paired measurements on separate devices.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young infants, aged 0-59 days.
      
Keywords: Pulse Oximetry; Pediatrics; Pakistan; Hypoxemia; Neonatal Sepsis; Pneumonia
Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effects on heart function of ivabradine administered to patients with severe
      chronic heart failure
    


Intervention name(s): Ivabradine
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Study to Investigate the Glucose Lowering Effects of Dextromethorphan Alone or in Combination With Sitagliptin in Subjects With Type 2 Diabetes Mellitus (T2DM) After an Oral Glucose Tolerance Test
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The study has a randomized, double-blind, placebo-controlled, double dummy and eight-way
      cross-over design. Males with T2DM on a stable metformin monotherapy will be screened for
      participation in the study. Eligible subjects will be randomized to receive DXM 30 mg, DXM 60
      mg, DXM 90 mg alone or in combination with sitagliptin 100 mg, sitagliptin 100 mg alone, or
      placebo (for DXM and sitagliptin) on in total eight treatment days. An OGTT will be started 1
      hour after study drug administration and blood glucose will be measured over the next 4
      hours. There will be a 3 to 14-day washout period between doses.
    

Detailed description: 
      This study is performed to determine the optimal dose of DXM that, compared to placebo,
      decreases glucose excursions following an OGTT. Doses of 30 mg, 60 mg and 90 mg DXM were
      chosen. Since DXM 60 mg was effective in the previous study in increasing insulin secretion,
      this dose will be kept. A lower dose (30 mg) will be given to see whether effects on insulin
      secretion are present also at lower doses and then translate into a BG lowering action. A
      higher dose (90 mg) will be added to see whether this way an effect on glucose excursion
      reduction occurs following an OGTT, (like previously demonstrated with 270 mg DXM) that can
      be related to an increase of insulin secretion.
    

Intervention name(s): Dextromethorphan; Sitagliptin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate; Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes mellitus
CNAP Accuracy Dependent on Hemodynamic Variables
Condition: Accuracy and Precision of Noninvasive Measurement
Study type: Observational

Summary: 
      Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic
      variables achieved by a PICCO monitor.

      Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the
      accuracy of CNAP.
    

Detailed description: 
      Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic
      variables achieved by a PICCO monitor.

      Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the
      accuracy of CNAP. Body mass index and age may have impact on the accuracy of PPV measured
      non-invasively on the basis of volume-clamp technique.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing major surgery under general anaesthesia
A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and effectiveness of treatment with ribavirin (RBV) plus isoprinosine
      (INPX) in preventing the development of AIDS in patients infected with the AIDS virus (HIV).
      Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when
      RBV is given with INPX. The patients may or may not have generalized lymphadenopathy syndrome
      (LAS). RBV has prevented the development of AIDS in some HIV-infected patients with LAS and
      INPX has stimulated the immune system of patients infected with HIV. The immune system fights
      infections in the human body, and the HIV attacks T cells that are an important part of the
      immune system. Reports from individual cases treated with both RBV and INPX suggest that
      clinical improvements occurred in HIV-infected patients, but there is no reliable information
      on the safety and effectiveness of this drug combination in such patients.
    

Detailed description: 
      RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has
      stimulated the immune system of patients infected with HIV. The immune system fights
      infections in the human body, and the HIV attacks T cells that are an important part of the
      immune system. Reports from individual cases treated with both RBV and INPX suggest that
      clinical improvements occurred in HIV-infected patients, but there is no reliable information
      on the safety and effectiveness of this drug combination in such patients.

      All patients take INPX capsules 4 times a day and RBV capsules 2 or 3 times a day. The first
      group of patients take the dose of RBV shown to be effective in an earlier trial and
      subsequent groups take higher doses until toxic effects occur. The planned treatment period
      is 3 months, but further treatment may be allowed for patients showing improvement. Blood
      samples are taken from an arm vein and used to evaluate possible changes in the patient's
      immune system, any toxic effects that might be detected in the blood and possible changes in
      the presence of HIV in the blood.
    

Intervention name(s): Inosine pranobex; Ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin; Inosine Pranobex
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ribavirin; Inosine Pranobex; Dose-Response Relationship, Drug; Drug Evaluation; Drug Therapy, Combination; AIDS-Related Complex