bioihbjkbjnl/mcl2 huggingface dataset:
High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity,
      and respiratory muscle strength has been previously investigated in OSA syndrom. Only the
      effects of the high-intensity short-term EMST study in moderate OSAS patients were studied.
      High intensity and low intensity EMST has advantages and disadvantages.The study aims to
      compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training
      (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life
      in severe OSAS patients.
    

Detailed description: 
      Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab,
      polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS
      patients. Patients will be divided into two groups by block randomization method. The study
      was planned as double-blind. Patients will not know what treatment they are receiving, the
      doctor does not know what treatment the patient is receiving, and technicians who take and
      analyze polysomnography will not know what treatment the patients are receiving.

      Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high
      intensity) to the second group with expiratory muscle training device, 7 days / week, 25
      breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will
      take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP
      measurements will be repeated every 2 weeks in the hospital and the new training workload
      will be calculated.
    

Intervention name(s): Expiratory muscle trainig
Intervention type(s): Other
Intervention description(s): This exercise will be used to strengthen forced expiratory muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Expiratory muscle strength training; Snoring; Sleep quality; EMST
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients
Condition: Cancer-related Problem/Condition
MeSH terms: Anorexia
Study type: Interventional

Summary: 
      To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from
      anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per
      day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test
      such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.
    


Intervention name(s): SJDBT; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sipjeondaebo-tang; Placebo
Other intervention name(s): Sipjeondaebotang; Placebo control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Optimizing Vitamin D Status During Initial Military Training
Condition: Bone Health; Nutrition Status
Study type: Interventional

Summary: 
      The primary objective of this randomized, double-blind, placebo-controlled trial is to
      determine the effect of vitamin D and calcium supplementation (800IU and 2000mg,
      respectively) on biochemical indicators of nutritional status and bone health in military
      personnel during Army basic combat training (BCT) and Air Force basic military training
      (BMT).

      The investigators hypothesize that daily supplementation with vitamin D and calcium during
      military training will improve vitamin D status, stabilize PTH levels, and result in
      improvements in markers of bone health. As a result of the investigators study design, the
      findings will provide critically important data regarding the concentration of vitamin D in
      blood necessary to stabilize PTH levels and to optimize bone formation during initial
      military training.
    

Detailed description: 
      Vitamin D is an essential nutrient for maintaining bone health. Previous work from our
      laboratory indicates that vitamin D status may decline in Soldiers during BCT, even during
      the summer months in the Southeastern United States. Stress fractures may affect up to 5% of
      male and 21% of female Soldiers during training, resulting in attrition in up to 60% of
      affected personnel, but a recent report indicates that vitamin D and calcium supplementation
      may attenuate stress fracture risk by up to 20% in female Navy recruits. However, biochemical
      measures of nutritional status and associated markers of bone health were not collected in
      that study, leaving questions regarding the vitamin D and calcium requirements for military
      personnel during periods of elevated bone turnover.
    

Intervention name(s): Ca/Vit D; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars; administered as 5 pills daily or as 2 snack bars
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Calcium; Parathyroid hormone; Bone; Bone formation; Bone resorption; Micronutrients; Trace Elements
Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells.
      Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18
      that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped
      that taking this drug will reduce the symptoms of rheumatoid arthritis
    


Intervention name(s): CE-224,535; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg po BID; no active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rheumatoid arthritis DMARD methotrexate
A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy
Condition: Depressive Disorder, Major; Suicidal Ideation
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Suicidal Ideation
Study type: Observational

Summary: 
      The purpose of the study is to describe the pharmacological and non-pharmacological treatment
      utilization pathways in Italian routine clinical practice of participants with Major
      Depressive Disorder (MDD) and active suicidal ideation with intent.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No intervention will be administered as a part of this study. Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population consists of participants with confirmed Major Depressive Disorder (MDD)
        and active suicidal ideation with intent as per physician's opinion.
A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with
      an alcohol containing essential oil mouth rinse; brushing and flossing; versus brushing and
      rinsing with an alcohol containing essential oil mouth rinse; and brushing only for the
      prevention and reduction of plaque and gingivitis.
    


Intervention name(s): Listerine Cool Mint; Colgate Cavity Protection Toothpaste; Reach Unflavored Waxed Dental Floss; American Dental Association (ADA) Ref Toothbrush
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.; Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.; Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.; Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Intervention MeSH terms: Listerine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will
      be provided information about the trial. If interested and if eligible, they will then be
      asked to provide signed informed consent. The initial study visit can occur immediately after
      signed informed consent has been obtained. Approximately 135 subjects will be enrolled to
      receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.
    


Intervention name(s): MenACWY
Intervention type(s): Biological
Intervention description(s): Four Intramuscular doses of MenACWY vaccine at 2, 4, 6 and 12 months of age followed by two blood samples at 13 and 24 months of age.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Objective of this study is the comparative assessment of the beneficial impact of the Viscoat
      viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema following
      torsional-ip cataract extraction surgery.

      Participants will be recruited from the Cataract Service of the University Hospital of
      Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include
      diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities
      Classification System III (LOCS-3) grading scale. By means of a custom computer randomization
      program all participants will randomly populate two study groups according to the OVD used
      (ie. viscoat or visthesia).
    


Intervention name(s): Viscoat; Visthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision 3% Sodium Hyaluronate, 4% Chondroitin Sulfate (Viscoat, Alcon, Greece) was injected in the anterior chamber; Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision sodium hyaluronate 1.5% and lidocaine hydrochloride 1% ophthalmic viscosurgical device (OVD) (Visthesia, Carl Zeiss, Germany) was injected in the anterior chamber
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: cataract; viscoelastic (OVD) technology; endothelial cell count; endothelial cell pattern; central corneal edema
Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on Plasma Zinc Concentration
Condition: Zinc Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, randomized controlled trial conducted in men 19-65 years of age who
      will receive daily zinc supplements (10 or 20 mg zinc/d as zinc sulfate) or placebo for 21
      days. Blood samples for plasma zinc and CRP concentrations will be drawn at baseline and days
      1, 2, 5, 9, 14, and 21 during supplementation and days 1, 2, 5, 9, and 14 after
      discontinuation of supplementation.
    

Detailed description: 
      The study will be a double blind, randomized, placebo controlled trial conducted in men 19-65
      years of age. Participants will receive daily zinc or placebo liquid supplements for 21 days.
      Supplemental zinc will be given as zinc sulfate; the lower dose zinc supplement will contain
      10 mg/d elemental zinc, and the higher dose zinc supplement will contain 20 mg/d elemental
      zinc. The placebo will contain the same excipients expect for zinc sulfate.

      Multiple blood draws will be performed throughout the course of the study, to determine the
      responsiveness of plasma zinc concentrations to zinc supplementation. Two baseline blood
      draws will occur prior to the start of supplementation (study days -7 and 0). Blood draws
      will be performed on days 1, 2, 5, 9, 14 and 21 of the 21 day supplementation period. Upon
      termination of supplementation (day 21), blood draws will be performed on days 1, 2, 5, 9, 14
      and 21 post-supplementation (study days 22, 23, 26, 30, 35 and 42).

      The major outcomes of interest are the magnitude and velocity of change in plasma zinc
      concentration. Other outcomes to be assessed are plasma concentrations of the acute phase
      proteins CRP and AGP, as well as reported morbidity, because of their potential roles as
      confounding variables. Anthropometric variables will be assessed at baseline.
    

Intervention name(s): zinc sulfate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20 or 10 mg zinc per day for 3 weeks; Daily placebo for 3 weeks
Other intervention name(s): Producer: UCD pharmacy; Producer: UCD pharmacy
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Plasm zinc concentration; Zinc supplementation; Assessment of zinc status; Plasma zinc concentration
Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the gene expression of the endometrium after an
      endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.
    

Detailed description: 
      An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day
      LH+7.

      Tissue is analysed and compared for changes in gene expression profile using Seq RNA
    

Intervention name(s): endometrial biopsy
Intervention type(s): Procedure
Other intervention name(s): Pipelle de Cornier
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Endometrium; Endometrial biopsy; Gene expression
Preoperative Intravenous Omega 3 Fatty Acids Administration in Valvular Surgery Patients
Condition: Valvular Surgery; Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The perioperative administration of n-3 fatty acids has been shown to lead to favorable
      effects on outcome in patients with severe surgical interventions by lowering the magnitude
      of inflammatory response and by modulating the immune response. To the investigators'
      knowledge, no study with preoperative administration of intravenous (IV) omega 3 fatty acids
      as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its
      effects on inflammatory and immune response has been conducted. So, this study has been
      planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty
      acids in elderly patients undergoing valvular surgery considering the hyperinflammation
      associated with this type of surgery in elderly patients.
    


Intervention name(s): Omegaven-IV FO
Intervention type(s): Dietary Supplement
Intervention description(s): will receive IV Omega 3 fatty acids (Omegaven®) for 3 pre operative days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: IVFO; Inflammation; Valvular surgery; Inflammatory status; Infectious complications
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Condition: Clostridium Difficile Associated Disease
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85
      years, who will each receive 3 doses of vaccine. The study will assess the safety and
      tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
    


Intervention name(s): Clostridium difficile vaccine; Clostridium difficile vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL intramuscular injection on day 1, day 8, and day 30.; 0.5 mL intramuscular injection on day 1, day 8, and day 30.; Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Clostridium difficile; vaccine
Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
Condition: Schizophrenia; Central Nervous System Diseases; Cognition
MeSH terms: Nervous System Diseases; Central Nervous System Diseases; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to determine the safety and effect on cognitive function of two
      different doses of an investigational medication, EVP-6124, in individuals with schizophrenia
      who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and
      psychotic symptoms will be evaluated.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in
      which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients
      who meet clinical criteria for schizophrenia and who are taking chronic atypical
      anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of
      EVP-6124 when administered concomitantly with anti-psychotic medication.

      Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or
      placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be
      orally administered once daily for a total of 84 days.
    

Intervention name(s): EVP-6124; Placebo; EVP-6124
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Arms: 1; Arm: 3; Arms: 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Central nervous System Diseases; Cognition
An Exploration of Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to explore the potential efficacy and safety of low-dose Apatinib combined with
      S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with
      oral apatinib and S-1 after treatment failure of standard regimen.
    

Detailed description: 
      Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial
      growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved
      in preclinical tests. Phase II study has showed an improvement of progression free survival
      in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with
      mild side effect in patients failed to standard treatments. The purpose of this study is to
      evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily
      pretreated patients with advanced lung cancer. And to explore the biomarkers of
      antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of
      next generation sequencing.
    

Intervention name(s): Apatinib Mesylate tablet combined with S-1 capsules
Intervention type(s): Drug
Intervention description(s): Oral use with low-dose Apatinib combined with S-1 until disease progression
Other intervention name(s): Ai Tan combined with S-1; Apatinib combined with S-1
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-small cell lung cancer; Apatinib; S1
A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study
      evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid
      arthritis (RA) who are receiving Methotrexate (MTX).
    


Intervention name(s): placebo; rituximab; methotrexate; folate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous repeating dose; Intravenous repeating dose; Oral or parenteral repeating dose; Intravenous repeating dose
Intervention MeSH terms: Rituximab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment