bioihbjkbjnl/mcl2 huggingface dataset:
SWISS_EVIDENCE - Compartment Compressibility Monitoring Using CPM#1
Condition: Compartment Syndromes
MeSH terms: Compartment Syndromes
Study type: Interventional

Summary: 
      Compartment syndrome is a very serious musculoskeletal disorder, which can lead to
      potentially devastating consequences, such as limb amputation and life-threatening
      conditions. It is a well described medical condition considered to be an orthopaedic
      emergency affecting all ages.

      Even though compartment syndrome is a well described medical condition, the appropriate
      treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own
      risks. Furthermore, and of most critical importance is the timing for the intervention of a
      fasciotomy. The concerned limb may already have had severe, sometimes even irreversible,
      tissue damage due to high intra-compartmental pressure within 6 to 10 hours.

      The standard diagnostic method for compartment syndrome is an invasive intra-compartmental
      pressure measurement via insertion of a pressure monitoring device into the muscle
      compartment. Commercially available intra compartmental pressure monitors have a highly
      variable intra-observer reproducibility and user errors are common.

      Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring
      System (CPM#1) shows promising advantages for the clinical application. Not only is the
      technology used for the CPM#1 device safe and non-invasive for the patient with minimal
      training required for the healthcare professionals, but it has also demonstrated high intra-
      and inter-observer reproducibility (as per bench tests and clinical settings with prototypes,
      to be confirmed in clinical studies like this one). The use of the CPM#1 device therefore
      facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids
      any further risks to the patients compared to invasive compartmental pressure diagnosis
      methods.
    


Intervention name(s): Measurement of compartment compressibility
Intervention type(s): Device
Intervention description(s): Application of the CPM#1 device for compartment compressibility ratio measurement - 4 measurements on both legs of each healthy volunteer will be performed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of nocturnal administration of
      Anti-hypertensive medications in Non-dippers.

      Efficacy variables.

        1. ECHO

        2. 24hr. horter

        3. IMT

        4. BUN/crea, urine analysis (microalbulinuria

        5. Cardio vascular event. "
    


Intervention name(s): Valsaltan, amlodipine
Intervention type(s): Drug
Intervention description(s): nti hypertensive medication time (nocturnal administration vs morning administration
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-dipper HTN patient
Carboplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer
Condition: Head and Neck Cancer
MeSH terms: Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating
      patients with locally recurrent or metastatic nasopharyngeal cancer.
    

Detailed description: 
      OBJECTIVES: I. Estimate the response and toxicity of carboplatin in combination with
      paclitaxel in patients with locally recurrent or metastatic nasopharyngeal carcinoma.

      OUTLINE: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30
      minutes. This cycle is repeated every 3 weeks. Patients may receive 6-8 cycles of therapy in
      the absence of toxicity and disease progression. Patients are followed every 3 months for the
      first 2 years, every 6 months for the next 3 years, and yearly thereafter.

      PROJECTED ACCRUAL: 30 eligible patients will be accrued in approximately 18 months.
    

Intervention name(s): carboplatin; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin
Primary purpose: Treatment
Keywords: stage IV nasopharyngeal cancer; recurrent nasopharyngeal cancer
Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of
      function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat
      meniscal tears. Improvements have been reported both after arthroscopy and with conservative
      treatment, however no direct comparison exist. Accordingly, the aim of this study is to
      assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative
      tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised
      trial.
    

Detailed description: 
      Middle-aged men and women with degenerative meniscal tears constitute a large group of
      patients presenting with knee pain, sometimes accompanied with swelling and loss of function.
      Many meniscal tears occur without a trauma in physically active individuals as well as in
      older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy
      is the most common orthopaedic procedure and is used to treat patients with meniscal tears.
      Many patients report improvement after arthroscopy referring especially to reduced knee pain,
      better knee function and improved quality of life. However, similar results have also been
      obtained with conservative treatment (physical therapy) of patients with degenerative
      meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic
      partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee
      using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic
      partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at
      rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the
      functional outcome is assessed using the WOMET knee score (a disease-specific quality of life
      -knee score development on the assessment of meniscal pathology), the general quality of life
      score (15-D), and cost-effectiveness analysis.
    

Intervention name(s): Operative (partial arthroscopy); Conservative (diagnostic arthroscopy)
Intervention type(s): Procedure; Procedure
Intervention description(s): Partial arthroscopic resection of degenerative rupture of the medial meniscus; Diagnostic arthroscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Arthroscopic Surgery; Menisci, Medial; Placebo Effect; Treatment Efficacy
Ultrastructure of Atrial Myocytes in Patients in Sinus Rhythm and With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The aim of this work is to study the prevalence of T-tubular system in left and right
      myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and
      permanent atrial fibrillation. Furthermore, since current information is lacking on the key
      Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it
      will be investigated whether a regulation of these proteins could be an underlying cause of
      the disease. Mitochondrial function will also studied.

        1. The investigators hypothesize that both structure of sarcolemma and localization of key
           Ca2+-handling proteins are altered in patients with atrial fibrillation compared with
           patients in sinus rhythm.

        2. The investigators hypothesize that mitochondrial function is altered in patients with
           atrial fibrillation compared with patients in sinus rhythm.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        selected for open heart surgery in St Olavs Hospital, Trondheim University Hospital, Norway
      
Biospecimen description: 
      Myocardial tissue from the right and left atrial appendage.
    
Keywords: atrial fibrillation; atrial cells; myocardial tissue; t-tubules; immunofluorescence
Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies
Condition: Twin Pregnancy With Antenatal Problem
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9
      fold higher compared to singletons, and progesterone supplementation can decrease the
      incidence of preterm labor in singleton pregnancy.

      There were studies that used 200mg vaginal progesterone with no effect on the result So this
      study aims To examine the effect of prophylactic vaginal progesterone 400mg v.s 200mg for
      prevention of preterm birth in twin pregnancies
    


Intervention name(s): Progesterone
Intervention type(s): Drug
Intervention description(s): Taking prontogest vaginally
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Progesterone; Twin pregnancy; Preterm labor
A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma
Condition: Lymphoma, B-Cell; Lymphoma, Large-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18
      to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted
      IPI. The consolidation treatment is allocated according to the response to induction
      treatment assessed by PET after the 2nd and 4th induction cycles.
    

Detailed description: 
      1) Induction Arm A: 4 cycles of R-ACVBP, 2 weeks interval. After the 3rd cycle, if PET 2+
      (fixing), collection of peripheral blood stem cell progenitors will be organized at the time
      of hematological recovery under support with G-CSF.

      The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and
      cycle 4 (PET4).

        -  Consolidation 1A (in case of PET 2- PET 4 -):

             -  High-dose Methotrexate with folinic acid rescue; 2 cycles spaced out 14 days.

             -  Rituximab-Ifosfamide-Etoposide : 4 cycles spaced out 14 days

             -  Cytarabine sub-cutaneous, during 4 days; 2 cycles spaced out 14 days.

        -  Consolidation 2 A (in case of PET 2+ PET4 -):

             -  2 cycles high-dose Methotrexate with folinic acid rescue

             -  High dose with Z- BEAM conditioning regimen followed by autologous transplant.

        -  Salvage(in case of PET 4 +):

      The patient will be treated with a salvage regimen, after a biopsy of the residual mass
      whenever possible.

      2) Induction arm B: 4 cycles of R-CHOP, 2 weeks interval. After the 3rd cycle, if PET 2+
      (fixing), collection of peripheral blood stem cell progenitors will be organized at the time
      of hematological recovery under support with G-CSF.

      The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and
      cycle 4 (PET4).

        -  Consolidation 1B(in case of PET 2- PET 4 -):

           4 additional cycles of R-CHOP, 2-weeks interval

        -  Consolidation 2 B(in case of PET 2+ PET 4 -):

             -  2 cycles high-dose Methotrexate with folinic acid rescue

             -  High dose with Z- BEAM conditioning regimen followed by autologous transplant

        -  Salvage(in case of PET 4 +):

      The patient will be treated with a salvage regimen, after a biopsy of the residual mass
      whenever possible
    

Intervention name(s): R-CHOP14 induction regimen; R-ACVBP14 induction regimen
Intervention type(s): Drug; Drug
Intervention description(s): R-CHOP14 induction regimen; R-ACVBP14 induction regimen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; PET; Chemotherapy; Rituximab
Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers
Condition: Qt Interval, Variation in
Study type: Interventional
Phase: Phase 1

Summary: 
      The study designed to determine the effect induced by WCK 2349 on the QT interval.

      The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2)
      to assess the safety of high doses of single-dose administration of WCK 2349 on the QT
      interval.
    

Detailed description: 
      Part 1 of this study will determine the supratherapeutic dose to be used in Part 2. Part
      1will enroll 8 subjects at each of 4 dose levels (up to 32 subjects). Cohorts will be
      staggered so that appropriate safety monitoring and follow-up can be performed for each
      subject at each dose level.

      Safety monitoring will be based upon review of AEs, ECGs and clinical laboratory test results
      prior to escalation to the next dose level.

      At the first dose level, 6 subjects will be randomly assigned to receive a single dose of WCK
      2349 at 1800 mg and 2 subjects will be randomly assigned to placebo. If this dose is
      tolerated by subjects, and safety data allows, the next group will be initiated in the same
      fashion at a dose of 2200 mg. If this dose is tolerated by subjects, and safety data allows,
      the next group will be initiated in the same fashion at a dose of 2600 mg. If this dose is
      tolerated by subjects, and safety data allows, the next group will be initiated in the same
      fashion at a dose of 3000 mg. Based upon safety data, the highest safely tolerated dose in
      Part 1 will be utilized as the supratherapeutic dose in Part 2.
    

Intervention name(s): WCK 2349; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Levonadifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: TQT
A Study of GLWL-01 in Patients With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate efficacy, safety, and pharmacokinetics of GLWL-01 in the
      treatment of patients with Prader-Willi Syndrome (PWS).
    

Detailed description: 
      Participants will be assigned to one of two treatment sequences (GLWL-01/Placebo or
      Placebo/GLWL-01), with each sequence consisting of two treatment periods separated by a
      washout period
    

Intervention name(s): GLWL-01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of 3 capsules, twice a day; Oral administration of 3 capsules, twice a day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)
Condition: Critical Illness; Epidural Analgesia
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the
      intensive care unit settings, EA should be proposed in critically ill patients, such as
      postoperative or trauma patients, typically. Recent findings also support anti-inflammatory,
      vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA
      safety and feasibility in the intensive care unit settings are still lacking. The purpose of
      this observational prospective study is to describe the safety and feasibility of this
      analgesia technique in ICU patients.
    

Detailed description: 
      BACKGROUND:

      Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the
      intensive care unit settings, EA should be proposed in critically ill patients, such as
      postoperative or trauma patients, typically. Recent findings also support anti-inflammatory,
      vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA
      safety and feasibility in the intensive care unit settings are still lacking.

      DESIGN NARRATIVE:

      This observational multicenter prospective clinical study will report the incidence of
      EA-related complications, such as infectious or neurologic complications, and the mean
      duration of EA in the ICU settings.

      Patients admitted in three intensive care units (two from an University Hospital and one from
      a local hospital) and receiving EA will be included in the study, whether the EA catheter is
      inserted in the ICU or outside the ICU, e.g. in the operating room. Demographics, clinical
      and biological data will be recorded prospectively. The main goal is to evaluate the safety
      and feasibility of EA in critically ill patients, being assumed this technique is currently
      and routinely used in our intensive care units, in accordance with national and international
      guidelines on epidural analgesia practice.
    

Intervention name(s): Epidural analgesia
Intervention type(s): Other
Intervention description(s): The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients requiring epidural analgesia, whether the epidural analgesia catheter is inserted
        in the ICU or outside the ICU, e.g. in the operating room
      
Keywords: Epidural catheter; Epidural analgesia; Intensive care unit; Safety
A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of Antioxidants
Condition: Adrenomyeloneuropathy
MeSH terms: Adrenoleukodystrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      X-linked adrenoleukodystrophy is a rare, demyelinating and neurodegenerative disorder, due to
      a loss of function of a fatty acid transporter, the peroxisomal ABCD1protein. Its more
      frequent phenotype, the adrenomyeloneuropathy in adults, is characterized by axonal
      degeneration in spinal cord, spastic paraparesis and a disabling peripheral neuropathy.
      Actually, there is no efficient treatment for the disease. Our work in the last twelve years
      dissecting the physiopathological basis of the disorder has uncovered an involvement of the
      oxidative stress early in the neurodegenerative cascade. In a preclinical trial we have
      identified an antioxidant cocktail that efficiently reverse the clinical symptoms and the
      axonal degeneration in the mouse model for the disease. We propose the translation of the
      results to an open trial to test the tolerance and effectiveness of these drugs in the
      correction of the previously identified oxidative lesion biomarkers, as a first step to a
      randomized versus placebo, multicentric and international trial. You will be clinically
      explored and assessed in the Hospital Universitari of Bellvitge (HUB) using clinical scales
      for spasticity, disability, electroneurogram and cranial and spinal Nuclear Magnetic
      resonance (NMR). The information will be collected in a data base that will be of great value
      to improve the present attention and the future follow-up to facilitate your inclusion in
      therapeutic randomized, double blind, against placebo clinical trials.
    


Intervention name(s): N-acetylcysteine; lipoic acid; vitamin E
Intervention type(s): Drug; Drug; Drug
Intervention description(s): N-acetylcysteine, 800-2400 mg daily for 2 months; lipoic acid, 300-600 mg daily for 2 months; vitamin E, 150-300 mg daily for 2 months
Intervention MeSH terms: Vitamin E; Thioctic Acid; Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: XALD; AMN
'Fitness To Fly' Tests In Children With Type II Respiratory Failure
Condition: Neuromuscular Diseases; Central Hypoventilation
MeSH terms: Hypoventilation; Neuromuscular Diseases
Study type: Interventional

Summary: 
      The conventional hypoxic challenge test might not predict 'fitness-to-fly' equally well in
      all patients. Patients at risk of hypercapnia with supplemental oxygen are not well studied.
      Th investigators will study children who have either neuromuscular weakness or central
      hypoventilation and who require nocturnal or intermittent daytime ventilator support.

      The study also aims to assess feasibility of a randomised controlled trial (RCT) comparing
      the standard hypoxic standard test to a modified test designed to better suit children with
      type two respiratory failure.
    

Detailed description: 
      This study will assess feasibility of pulse oximetry (SpO2), end tidal carbon dioxide (ETCO2)
      and transcutaneous carbon dioxide partial pressure (TcCO2) measurement during a modified
      Hypoxic challenge test (HCT) in 12 children with neuromuscular weakness and 12 with central
      hypoventilation.
    

Intervention name(s): Hypoxic challenge test
Intervention type(s): Diagnostic Test
Intervention description(s): Physiological response to 15% ambient oxygen monitored.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants randomised to uniform balanced crossover (new/old or old/new hypoxic challenge test components).
Masking: None (Open Label)
Primary purpose: Other
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Condition: Chronic Hepatitis; Chronic Hepatitis C; Chronic Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Hepatitis, Alcoholic
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis
      patients whose serum liver enzymes are elevated more than upper limit.
    

Detailed description: 
      The changes of laboratory findings including serum transaminase levels, serum albumin levels,
      Child-Pugh score, MELD score, and APRI score will be evaluated.
    

Intervention name(s): High dose vitamin C
Intervention type(s): Drug
Intervention description(s): Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Other intervention name(s): Koreaeundan Vitamin C 1000
Intervention MeSH terms: Vitamins; Ascorbic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment