bioihbjkbjnl/mcl2 huggingface dataset:
COMPARİSON OF HEART FAİLURE PATİENTS AND HEALTHY PEOPLE İN BALANCE AND GAİT PARAMETERS
Condition: Heart Failure,Balance
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      We aimed to show the difference between balance and gait parameters in heart failure and
      healthy individuals.
    

Detailed description: 
      Heart failure is the inability of the heart to pump a sufficient amount of blood into our
      body. The reason is usually the decrease in the contractile capacity of myocardium due to
      decreased coronary blood flow. Symptoms and symptoms may be quite diverse in the underlying
      pathophysiology of heart failure, which is usually the only type. As a result of heart
      failure; problems such as dyspnoea, anemia, peripheral edema, peripheral muscle involvement
      and decreased muscle mass, confusion, sleep disorder, dementia, various cardiac symptoms and
      renal failure can be seen.

      Balance body with minimal muscle activity in static or dynamic position on the support base
      is to maintain the center of gravity. Patients with heart failure may have decreased postural
      control, exercise intolerance, breathing problems, and decreased cognitive function.

      Gait analysis, evaluation of neuro musculoskeletal system functions and interpretation of
      results with numbers and graphs. Gait analysis is an analysis method that plays a role in
      many cases of clinical diagnosis and follow-up. Heart failure is characterized by a
      significant reduction in walking distance, which leads to reduced quality of life. In a study
      conducted in heart failure, it is stated that gait velocity is a determinant of one year
      mortality and hospitalization, and should be considered for clinical evaluations and
      prognosis. All these causes of heart failure in chronic disease groups defined considering it
      is important to investigate the balance and gait parameters.

      This study will show the difference between the balance and walking parameters in heart
      failure according to the healthy participants.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        İndividuals who are diagnosed with Heart Failure at Hacettepe University and who reffered
        to the Cardiopulmonary Rehabilitation Unit for Physiotherapy also who are willing to
        participate in the study will be include in the study.
      
Keywords: Gait Parameters, Heart Failure,Balance,Gait,Cognition,Functional Capacity,Muscle Strength
Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage
Condition: Missed Abortion
MeSH terms: Abortion, Spontaneous; Abortion, Missed
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this work is to compare the effectiveness of vaginal versus sub-lingual
      misoprostol for medical treatment of first trimester missed miscarriage.
    

Detailed description: 
      In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal
      misoprostol in achievement of successful miscarriage so our aim was to compare the
      effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first
      trimester missed miscarriage.
    

Intervention name(s): sublingual misoprostol; vaginal misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.
Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose).
Paracetamol, eight hourly, will be provided as analgesic or antipyretic.
A specimen bottle to collect the POC if passed out.
Two pairs of disposable gloves.
Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception; All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.
Paracetamol, eight hourly, will be provided as analgesic or antipyretic
Other intervention name(s): Misotac; Misotac
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of an Oral Contraceptive in Healthy Females
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the study drug is safe and effective in the
      prevention of pregnancies in a large group of volunteers.
    

Detailed description: 
      This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
      HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the
      trial.
    

Intervention name(s): EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Intervention type(s): Drug
Intervention description(s): GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy of the Therapy With BRAINMAX® for the Treatment of Patients With Asthenia After COVID-19
Condition: Asthenia; COVID-19
MeSH terms: COVID-19; Asthenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is prospective multicentre comparative randomized double blind placebo controlled study
      conducted in 6 medical facilities.The objective of the study is to assess the safety and
      efficacy of the sequential therapy with BRAINMAX®, solution for intravenous infusion and
      intramuscular injection, and BRAINMAX®, capsules for the treatment of patients with asthenia
      after having the novel coronavirus infection (COVID-19)
    

Detailed description: 
      Upon signing the informed consent form and screening, 160 eligible patients from 18 to 65
      years of age with asthenia after having the novel coronavirus infection (COVID-19) were
      randomized at a 1:1 ratio. First group received intramuscularly with the dosage regimen of 5
      mL of solution (500 mg of ethyl methyl hydroxypyridine succinate + 500 mg of meldonium) once
      per day for 10 days; total number of injections for the treatment course is 10 and then
      orally with the dosage regimen of 2 capsules (500 mg of ethyl methyl hydroxypyridine
      succinate + 500 mg of meldonium) twice per day for 30 days; total number of capsules for the
      treatment course is 120. Second group received Placebo in the same way.
    

Intervention name(s): Ethyl methyl hydroxypyridine succinate + Meldonium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ethyl methyl hydroxypyridine succinate 100.0 mg/mL, meldonium dihydrate - 100.0 mg/mL (Solution for intravenous and intramuscular administration), then Ethyl methyl hydroxypyridine succinate - 250.0 mg, meldonium dihydrate based on dihydrate without adsorption moisture - 250.0 mg (oral capsules); Placebo was used in the same way
Other intervention name(s): BRAINMAX®
Intervention MeSH terms: 3-(2,2,2-trimethylhydrazine)propionate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
Condition: Opioid-related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the presence, degree, time course and profile of
      opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine
      or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome
      measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal
      Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate
      an opioid withdrawal syndrome.
    

Detailed description: 
      Buprenorphine sublingual and buccal soluble films are being developed to be used for the same
      indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual
      tablets in the treatment of opioid dependence. However, only films administered by the
      sublingual route were evaluated in this study.

      The soluble film dosage is expected to provide the following enhancements and potential
      advantages over the current Subutex and Suboxone product:

        -  Mitigation against unintentional pediatric exposure by providing child-resistant
           packaging in unit dose format.

        -  Improvement in subject convenience and compliance by ensuring rapid disintegration.

        -  Protection against diversion by providing a dosage form that is very difficult for the
           subject to remove from the sublingual or buccal mucosa after administration. This
           provides assurance to the caregiver that the dose has actually been taken appropriately
           in a supervised setting.

        -  Provision of a unit dose product format for hospital and institutional use.

        -  Decreased product damage during shipping as compared to Subutex and Suboxone tablets.
    

Intervention name(s): Buprenorphine soluble film; Buprenorphine/naloxone film strip; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment.; Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment.; Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.
Other intervention name(s): Subutex; Suboxone
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid dependence; Opioid withdrawal symptoms
Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human
      Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, study to evaluate the safety and
      tolerability of Nexvax2 preceded by dose titration period in patients with celiac disease
      currently on a gluten-free diet. The study will consist of a Screening Period, a Treatment
      Period, and a Follow-up Period. Eligible subjects will be enrolled in one of three cohorts
      according to whether they are homozygous or not homozygous for both genes coding for
      HLA-DQ2.5.
    

Intervention name(s): Nexvax2; Nexvax2 placebo
Intervention type(s): Biological; Biological
Intervention description(s): Nexvax2 intra-dermal injections twice weekly; Sodium chloride 0.9% intra-dermal injections twice weekly
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to see if an investigational drug known as the lidocaine 5%
      patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how
      topical lidocaine affects the nerve endings, and to determine whether treatment with the
      lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in
      subjects who did not report pain at the start of the study.
    


Intervention name(s): Skin biopsy; Lidocaine 5% patches
Intervention type(s): Procedure; Drug
Intervention description(s): Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.; Subject will apply patches to affected area QD for 12 hours then remove.
Intervention MeSH terms: Lidocaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare the fit of two pediatric face masks in children.
    

Detailed description: 
      This is a prospective, randomized, open-label comparative observational study to be conducted
      in up to two (2) facilities with the healthy and non-healthy Subjects (4-12 years of age).
      The usage of face masks is common practice within hospitals, and masks may be evaluated
      outside of clinical facilities as well.
    

Intervention name(s): Medline Pediatric Face Masks; KC Childs Mask
Intervention type(s): Device; Device
Intervention description(s): Medline Face Masks, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.; KC Childs Mask, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pediatric Face Masks; children
Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      Therapeutic equivalence and safety study
    

Detailed description: 
      To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference
      Listed Drug (RLD).

      To demonstrate the superiority of efficacy of the Test and Reference products over the
      placebo control in the treatment.

      To compare the safety of Test, Reference and Placebo treatments.
    

Intervention name(s): Test.; Aczone Gel 5%; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): gel; gel; gel
Other intervention name(s): dapsone; dapsone; Vehicle
Intervention MeSH terms: Dapsone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia
Condition: Pathologic Myopia
MeSH terms: Myopia; Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of antiangiogenic therapy to
      choroidal neovascularization secondary to pathologic myopia.
    

Detailed description: 
      The purpose of this study is to determine the effectiveness of antiangiogenic therapy to
      choroidal neovascularization secondary to pathologic myopia.

      This study is planned as a follow-up. Patients with myopia included in it will receive
      antiangiogenic therapy in accordance with the approved indications for use indicated in the
      instructions for the use of drugs in Ukraine.

      The treatment proposed in this study is based on the world experience and scientific
      developments of the Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of
      Ukraine ". Therefore, it is expected that the benefit / risk ratio in relation to the
      participation in this study should not be different from that described in the scientific
      literature and the benefits outweigh the risk. It is known that the absence of treatment in
      these diseases leads to an irreparable loss of central vision.

      Patients with a pathologic myopia with CNV (native) will be treated with antiangiogenic drugs
      according to the regimen pro re nata.
    

Intervention name(s): Intravitreal injection
Intervention type(s): Procedure
Intervention description(s): Intravitreal injection to the regimen pro re nata.
Other intervention name(s): Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescence angiography) receive an injection according to the regimen pro re nata.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fundus diseases; antiangiogenic therapy; choroidal neovascularization; pathologyc myopia; intravitreal injection; anti-VEGF
Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, double-blinded, placebo-controlled, randomized, cross-over Study designed
      to determine the efficacy of multiple intrathecal administrations of autologous mesenchymal
      stem cell-derived neural progenitor cells (MSC-NP) compared to placebo in patients with
      progressive multiple sclerosis. Efficacy will be measured through assessment of disability
      outcomes. Study participants will receive six intrathecal injections of culture-expanded
      autologous MSC-NPs at two month intervals in one year and six lumbar punctures as placebo
      treatments in a second year.
    

Detailed description: 
      The IT-MSC-NP treatments and all clinical assessments will take place at a single center
      (Tisch MSRCNY). Study subjects will be assigned to blocks stratified by baseline EDSS score
      (3.0-4.0, 4.5-5.5, 6.0, and 6.5) and disease subtype (SPMS or PPMS). Study subjects are
      randomized in an equal fashion (1:1) to study treatment and placebo at initial randomization.
      Subjects in each block will be randomized into placebo or treatment group. In the second
      year, treated subjects will cross over to the placebo group and placebo subjects will cross
      over to the treated group.

      The total study duration will be 3 years upon enrollment. Each study subject will be required
      to attend up to 18 study visits, to include 1 screening visit, 1 bone marrow visit, 1
      baseline visit, followed by study visits every 2 months during the treatment period of two
      years (12 treatment/LP procedure visits and 2 outcome visits), and an additional follow-up
      visit at the end of year 3.
    

Intervention name(s): Intrathecal MSC-NP injection; Intrathecal saline injection
Intervention type(s): Biological; Other
Intervention description(s): MSC-NPs represent a neural subpopulation of MSCs from bone marrow with reduced pluripotency and minimized risk of ectopic differentiation, thus are likely to be more suitable for CNS delivery. Importantly, characterization of MSC-NPs demonstrated their immunoregulatory and trophic properties, and MSC-NPs derived from MS and non-MS patients alike were therapeutically viable.; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Compassionate crossover design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mesenchymal Stem Cells; Neural Progenitors; Autologous; Bone Marrow; Multiple Sclerosis
Memory Consolidation in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The overarching goal of the research proposed here is to test the hypothesis (i) that the
      pathophysiological mechanisms of OSA lead to deterioration in sleep-dependent memory
      consolidation across memory systems, with the genetic marker APOε4 as a modulator, and (ii)
      that CPAP can reverse some or all of these measured memory deficits.

      In addition, we are exploring which aspects of OSA (e.g., changes in sleep architecture,
      measures of hypoxemia, or the EEG power spectrum) most likely impact sleep-dependent memory
      processing.To this end, we are using specific cognitive tasks for which sleep-dependent
      memory consolidation processes have previously been demonstrated by our group and others. In
      addition, we are carrying out quantitative EEG power spectral analyses, to delineate abnormal
      functioning of brain regions with more precision.
    


Intervention name(s): CPAP
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science