bioihbjkbjnl/mcl2 huggingface dataset:
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional

Summary: 
      To non-invasively estimate the alveolar surface area of the lungs of prematurely born infants
      by taking measurements of oxygen and carbon dioxide and utilizing functional morphometry.
    


Intervention name(s): Calculation of ventilation-perfusion ratio
Intervention type(s): Other
Intervention description(s): Three to five paired measurements of fraction of inspired oxygen and peripheral oxygen saturations.
Insertion of mainstream capnograph with combined pressure and flow sensor to perform end-tidal capnography measurement.
Echocardiogram to assess intra-cardiac shunting.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Telerehabilitation vs Supervised Exercises in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS
      (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a
      safe and effective rehabilitation tool for PwMS. A structured and personalized exercise
      program can improve physical fitness, functional capacity, quality of life and modifiable
      disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation
      method in PwMS. The purpose of this study is to investigate the effectiveness of exercise
      programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised
      exercise and home-based exercise programs for the PwMS.
    

Detailed description: 
      Participants are randomly assigned to the structured supervised exercise or structured
      home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a
      week over a 12-weeks structured exercise program under the supervision of a physical
      therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked
      and controlled through telerehabilitation three times a week. All measurements pre-post
      intervention.
    

Intervention name(s): Structured Supervised Exercise; Structured telerehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Structured Exercise Program under the supervision of Physical Therapist; Structured Exercise Program checked and controlled through telerehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Telerehabilitation; Supervised exercises; Structured exercise; Quality of Life; Activities of Daily Living
Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Observational

Summary: 
      Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold
      raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery
      disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been proved
      to be a reliable method to decrease LDL-C concentrations and therefore decrease
      cardiovascular disease risk in HoFH. The objective of this crossover study was to compare
      efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran
      sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and
      LDL particles size in a cohort of HoFH subjects.
    


Intervention name(s): heparin-induced extracorporeal LDL precipitation; dextran sulfate adsorption
Intervention type(s): Device; Device
Intervention description(s): Lipid apheresis for 3 hours; Lipid apheresis for 3 hours
Other intervention name(s): Futura; Kaneka
Intervention MeSH terms: Heparin; Dextrans
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with homozygous familial hypercholesterolemia already treated with LDL apheresis
        using both systems being compared (HELP vs Dextran)
Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities
Condition: Tooth Diseases
MeSH terms: Tooth Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate long-term clinical performance of a self-adhering
      flowable resin composite in comparison with a conventional flowable resin composite used with
      an etch&rinse adhesive system in minimally invasive class I cavities. Twenty-five patients
      will receive at least one pair of class I restorations. After class I cavities were prepared
      they were restored either with a self-adhering flowable resin composite (VertiseFlow/Kerr-VR)
      or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch&rinse
      adhesive (Teco/DMG) [according to the manufacturers' instructions. Restorations will be
      evaluated at baseline and yearly according to FDI criteria by two evaluaters. Statistical
      analysis will be carried out with Pearson Chi-Square test and Cochran Q-test followed by Mc
      Nemar's.
    


Intervention name(s): Vertise Flow; LuxaFlow; Teco Adhesive
Intervention type(s): Device; Device; Device
Intervention description(s): Composite resin; Composite resin; Adhesive system
Other intervention name(s): Self-adhering flowable composite; Flowable composite with Teco adhesive system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: composite resin; occlusal caries
A Combined Single and Multiple Ascending Dose Study of ASP6858 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is evaluate the safety and tolerability of single and multiple
      ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of
      ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. The study
      will also evaluate the pharmacodynamics of ASP6858.
    

Detailed description: 
      This study has 2 parts: Part 1 is a placebo-controlled, single ascending dose study where
      male only subjects will be residential for 5-8 days (Part 1 will also include an open-label,
      food effect section); and Part 2 is a placebo-controlled, randomized, 2-way crossover,
      multiple ascending dose study where male and female subjects will be residential for 14-17
      days for each treatment period. There will be a washout period between the 2 periods in Part
      2.
    

Intervention name(s): ASP6858; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy subjects; Pharmacokinetics of ASP6858; ASP6858; Pharmacodynamics of ASP6858
Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      This study aims to evaluate the 12 month outcome of the mono- or combination therapy with
      iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial
      occlusive disease, presenting with critical limb ischemia.
    

Detailed description: 
      Extensive arterial occlusions significantly reduces distal arterial perfusion, and may
      eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as
      ischemic pain, slow healing wounds at lower extremity and gangrene. It places patients with
      multi-segment occlusion at high risks of amputations and mortality.

      The treatment methods for such long occlusive lesions are limited. Traditionally, the
      standard of care would be surgical revascularization. This is because lesion length have been
      identified in several studies as an independent risk factor for the development of restenosis
      after angioplasty and/or stenting. However, thanks to recent advances in endovascular
      techniques, such as the utilization of subintimal technique for crossing long segment
      occlusions, it is now possible to employ endovascular techniques for suitable patients.

      The re-establishment of an in-line flow, even if only temporary, can allow tissue healing,
      which is vital in achieving limb salvage. In addition, the use of Drug Coated Balloons (DCB)
      and Drug Eluting Stents (DES) can potentially reduce restenosis rate.

      To date, there are few studies that have evaluated the performance of DCB in lesions that are
      longer than 10cm. We hope to evaluate the performance of iVascular Luminor DCB and Angiolite
      DES when used in the treatment of such lesions.
    

Intervention name(s): Luminor DCB and Angiolite DES
Intervention type(s): Device
Intervention description(s): Patient to undergo angioplasty with Luminor DCB and Angiolite DES
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angioplasty; Drug Coated Balloon; Drug Coated Stents
Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled
Condition: Edema; Arthroplasty, Replacement, Knee
MeSH terms: Edema
Study type: Interventional

Summary: 
      We hypothesize that the use of MOBIDERM® after total knee prosthesis allows a greater and
      faster resorption of periarticular edema:

        -  improvement of knee flexion;

        -  faster functional gain;

        -  faster decrease in postoperative pain by decreasing tissue tension.
    


Intervention name(s): MOBIDERM
Intervention type(s): Device
Intervention description(s): Use of a MOBIDERM mobilizing band after total knee prosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Safety Study of LY3462817 in Healthy Japanese and Non-Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3462817 in
      healthy Japanese and non-Japanese participants. The study will also assess how fast LY3462817
      gets into the blood stream and how long it takes the body to remove it. The study is open to
      healthy participants. The study will last up to approximately 12 weeks.
    


Intervention name(s): LY3462817 (SC); Placebo (SC); LY3462817 (IV); Placebo (IV)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC.; Administered SC.; Administered IV.; Administered IV.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced
      dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with
      levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the
      modified AIMS.
    

Detailed description: 
      The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on
      levodopa-induced dyskinesias in advanced Parkinson's disease.

      The design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase
      IV study design.

      The hypothesis is that levetiracetam is able to reduce duration and severity of
      levodopa-induced dyskinesias in Parkinson's disease.

      The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo
      for 13 weeks. Efficacy measure is the modified AIMS.

      Main inclusion criteria are:

        -  Advanced Parkinson's disease (Hoehn & Yahr II-IV)

        -  Age of 30 to 80 years

        -  Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate
           disability

        -  Stable dosage of antiparkinson medication and/or stable deep brain stimulation
           parameters for at least 4 week prior inclusion

        -  Written informed consent

      Main exclusion criteria are:

        -  Atypical parkinsonian syndromes

        -  Treatment with antipsychotics

        -  Epilepsia or seizure in the history

        -  Deep brain stimulation other than DBS in STN

        -  Pregnant or lactating women

        -  Severe dementia

      Methods:

        -  Primary outcome measure is the modified AIMS

        -  Secondary outcome measures include UPDRS, safety, patient day record

      Study medication:

        -  Levetiracetam (upt to 2000 mg / day)

        -  Matched Placebo
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): up to 200 mg per day in two dosages per day.
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dyskinesias; Parkinson's disease; Levetiracetam; Treatment
Coronavirus Associated Pneumomediastinum and Pneumothorax
Condition: Pneumothorax; Pneumomediastinum; COVID-19 Pneumonia
MeSH terms: Pneumothorax; Mediastinal Emphysema
Study type: Observational

Summary: 
      Spontaneous pneumomediastinum (PMS) is defined as free air within the mediastinum.
      Spontaneous pneumothorax (PNX) consists of the presence of air inside the pleural space. PMS
      and PNX may sometimes occur secondly to an underlying pathology, or deriving from a sudden
      increase in intra-alveolar pressure such as functional alteration such as airway
      hyperactivity, Valsalva maneuver, cough, barotrauma, and/or volutrauma with consequent
      rupture of the alveoli and subsequent leakage of air into the mediastinum due to the Macklin
      effect. The escaping air can then spread inside the pericardium, the peritoneum, the muscles,
      and subcutaneous tissues, hence causing subcutaneous emphysema.

      PMS and PNX are rare complications of several lung infections such as Pneumocystis Jirovecii
      pneumonia, tuberculosis, bacterial necrotizing pneumonia, and herpes pneumonia.

      However, an increasing number of PMS and PNX has been described in patients with SARS-CoV2
      interstitial pneumonia. PMS and PNX can either present as the onset manifestation of COVID-19
      disease, or occur as complications of non-invasive and/or invasive ventilation, or following
      to cystic and/or fibrotic evolution of the pathology.

      The frequency of PMS and PNX during COVID-19 is not well defined, as the available data are
      limited to case collections and single reports. According to currently available scientific
      literature, PNX in COVID-19 occurs with frequency rates of 1-3%, up to 6% in patients
      undergoing non-invasive ventilation (NIV) and mechanical artificial ventilation (VAM). In
      McGuinness's analysis, which compared the complications of barotrauma in patients with acute
      respiratory distress syndrome (ARDS) in VAM, PNX and PMS occurred with frequency rates of 9%
      and 10%, respectively, while in non-COVID-19 population, PNX and PMS frequency rates were 12%
      and 3%, respectively.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized patients with SARS-COV2 infection
The Effect of a Short-term Very Low Calorie Diet on Heart Rate Variability in Obese Individuals
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether short-term adherence to a very low calorie
      diet is effective in improving heart rate variability in obese individuals.
    


Intervention name(s): Very low calorie diet; Standard weight loss diet
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): Lighterlife Total
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
Condition: Pulmonary Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs
      mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who
      often have a PDA and have received surfactant. Although not clear, the cause of PH is thought
      to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right
      shunting across a patent ductus arteriosus and an increase in pulmonary blood flow.
      Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising
      results in treating PH.In this study we aimed to evaluate the effect of two different natural
      surfactants in neonates with pulmonary hemorrhage.
    

Detailed description: 
      The incidence of PH was about 1.3 per 1,000 live births. Formerly,the risk factors associated
      with PH included the severity of the associated illness, intrauterine growth restriction,
      patent ductus arteriosus (PDA), coagulopathy, and the need for assisted ventilation.
      Currently, PH occurs mainly in preterm ventilated infants with severe respiratory distress
      syndrome (RDS) who often have a PDA and have received surfactant. Currently, PH complicates
      the hospital course of 3-5% of preterm infants with RDS. The cause of PH is thought to be due
      to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting
      across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective
      uncontrolled studies that used surfactant for PH in neonates have shown promising results in
      treating PH.In this study we aimed to evaluate the effect of two different natural
      surfactants in neonates with pulmonary hemorrhage.
    

Intervention name(s): Poractant alfa; Beractant
Intervention type(s): Drug; Drug
Intervention description(s): Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage; Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Other intervention name(s): Curosurf; Survanta
Intervention MeSH terms: Poractant alfa; Beractant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary hemorrhage; Mortality; Newborn
Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for
      their growth.

      PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients
      who have metastatic or recurrent prostate cancer that has not responded to previous hormone
      therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of sorafenib, as measured by prostate-specific antigen response,
           in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the
           prostate.

      Secondary

        -  Determine the objective response rate and duration of response in patients treated with
           this drug.

        -  Determine the tolerability and toxicity of this drug in these patients.

        -  Determine time to treatment failure and overall survival in patients treated with this
           drug.

        -  Explore the relationship between measures of ras/raf pathway activation (pERK) and
           response to treatment in these patients.

      OUTLINE: This is a non-randomized, multicenter study.

      Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the
      absence of disease progression or unacceptable toxicity.

      Patients are followed at 4 weeks after going off study treatment and then periodically for
      survival. Patients with stable or responding disease, when they go off study treatment, are
      followed every 3 months until relapse or progression.

      PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18
      months.
    

Intervention name(s): sorafenib tosylate
Intervention type(s): Drug
Intervention description(s): BAY 43-9006 given orally at 400 mg BID in a 28 day cycle
Intervention MeSH terms: Sorafenib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate
Assessing Cervical Dystonia
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional

Summary: 
      The study involves the use of a novel, non-invasive, monitoring device to measure the
      response to treatment with botulinum toxin injections in 24 (16 Intervention and 8 control)
      patients with cervical dystonia. A baseline assessment, prior to botulinum treatment,will be
      structured around validated clinical rating scales for cervical dystonia and questionnaires
      and the performance of simple neck movements, and will be undertaken while the patient wears
      a movement sensor attached to the head with an elastic strap. The same assessments will be
      undertaken at 0, 3, 6, 9 and 12 weeks following treatment to assess response. The patients'
      treatment will not be affected by their participation in the research. The device readings
      will then be compared with the clinical ratings to establish whether it might be used as a
      more sensitive measure of treatment response than clinical assessment alone. This will help
      clinicians to plan and execute botulinum injections more effectively in future
    


Intervention name(s): Shimmer monitoring
Intervention type(s): Device
Intervention description(s): The shimmer monitor, monitors movement and the range of movement.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science