bioihbjkbjnl/mcl2 huggingface dataset:
Remote Exercise Programs and Preventive Training in Asymptomatic Individuals
Condition: Healthy People
Study type: Interventional

Summary: 
      In recent years, it has been emphasized that preventive approaches are a less costly and more
      effective way to treat a pathology. Primary preventive approaches should become widespread,
      especially in problems with changeable risk factors such as spine health. Various preventive
      approaches and exercise training seem to be an effective way to prevent the development of
      back and neck pain. Again, in recent years, the pandemic process has increased the interest
      and need for tele-rehabilitation. As a result, scientific research results on
      tele-rehabilitation are needed as a necessity to adapt to the Covid-19 epidemic and the
      globalizing world. The aim of the thesis study planned in this context is to investigate the
      effectiveness of remote exercise applications on lumbar and cervical region muscle
      architecture and functionality in asymptomatic individuals.Another aim of this study is to
      investigate the remote applicability of functional level, quality of life, kinesophobia and
      cognitive assessment.
    


Intervention name(s): Exercise; Remotely and face to face evaluation of Functional Capacity Level
Intervention type(s): Other; Other
Intervention description(s): Spinal stabilization exercise; Quality of life assessment (SF-36), and cognitive assessment ((Montreal Cognitive Assessment Scale (MOCA)) will be administered face to face. Functional capacity assessment tests will be administered both face-to-face and remotely. All participants will be administered both remotely and face-to-face. The order of the remote and face-to-face evaluations will be determined by the closed envelope randomization method. The remote evaluation will be done by video interview method under the direction of the researcher. During the remote evaluation, the necessary equipment for the participant will be prepared in the unit in advance. There will be a 10-30 minute rest interval between each evaluation.This application will only be applied at the beginning of the exercise program.After the 8-week program, only face-to-face evaluation will be made.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: spinal stabilization exercise; tele-rehabilitation; muscle architecture; functional level
Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia
Condition: ESOPHAGEAL SQUAMOUS CELL CARCINOMA
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional

Summary: 
      Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month
      intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse
      in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after
      baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.
    

Detailed description: 
      A patient population with a histopathological diagnosis of moderate-grade intra-epithelial
      neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of
      the esophagus, in lesions measuring 3 to 12cm in length, will be treated with radiofrequency
      ablation (RFA) using the HALO ablation system. Additional RFA sessions will be performed on 3
      month intervals until complete response (CR; no MGIN or worse in biopsies) will be achieved.
      All patients will then undergo an endoscopy at 12 months after baseline. Patients with CR at
      12 months will be followed-up for 5 years with annual endoscopy and biopsies, and additional
      treatment if necessary. Patients with no CR at 12 months are considered failures.
    

Intervention name(s): Radiofrequency Ablation
Intervention type(s): Device
Intervention description(s): Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.
Other intervention name(s): RFA; Barrx ablation system; HALO ablation system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ESCN; RFA
BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      To explore the efficacy and safety of four BAY1003803 formulations by means of a within
      subject comparison in an open Psoriasis Plaque Test
    


Intervention name(s): BAY1003803; Clobetasol propionate; Betamethasone/calcipotriene
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect; Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect; Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
Intervention MeSH terms: Betamethasone; Clobetasol; Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Plaque form psoriasis vulgaris
AlmegaPL CV Health Open Label Study
Condition: Cholesterol; Triglycerides; Omega-3; Eicosapentaenoic Acid
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the effectiveness of Almega PL, a Nannochloropsis
      algae-derived extract rich in eicosapentaenoic acid (EPA), on improving blood markers
      associated with heart health of iwi customers.
    

Detailed description: 
      The investigational product iwi/Cholesterol is a commercially available capsule-form herbal
      (algae) supplement containing Almega®PL, a Nannochloropsis algae-derived extract rich in
      eicosapentaenoic acid (EPA). EPA is a type of omega-3 essential fatty acid known to play a
      beneficial role in protection against cardiovascular disease.The aim of this study is to
      assess the effectiveness of AlmegaPL on improving blood markers associated with heart health
      of iwi customers.The study will involve over 200 male and female new consumers of this
      product and monitor their blood markers during 6 months of supplementation.
    

Intervention name(s): AlmegaPL (FDA NDIN # 826)
Intervention type(s): Dietary Supplement
Intervention description(s): The investigational product iwi/Cholesterol is a commercially available capsule-form herbal (algae) supplement containing Almega®PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA). EPA is a type of omega-3 essential fatty acid known to play a beneficial role in protection against cardiovascular disease. Iwi/Cholesterol is the only source of long chain omega-3 that does not contain the DHA that is present in other omega-3 sources (fish oil, krill oil, other algal oils). Almega®PL was registered at the Food and Drug Administration (FDA) as a New Dietary Ingredient (NDIN) in 2014.
Other intervention name(s): iwi Algal Oil; Nannochloropsis Oil Extract
Intervention model: Single Group Assignment
Intervention model description: Self elected consumers who choose to purchase this iwi EPA andiwi Heart product containing 1000-1100 mg of AlmegaPLR
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Microalgae; Nannochloropsis; AlmegaPL
Bioavailability and Pharmacokinetics of BI 10773 Tablet in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a
      single dose BI 10773 tablet in healthy subjects
    


Intervention name(s): BI 10773
Intervention type(s): Drug
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients
Condition: HIV Infections; Leukoencephalopathy, Progressive Multifocal
MeSH terms: Leukoencephalopathy, Progressive Multifocal; Leukoencephalopathies
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either
      didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine
      (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or
      improvement of neurological function over 6 months in HIV-infected individuals who have
      developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these
      three treatment regimens on Karnofsky score and MRI studies.

      The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus
      (designated JC virus) infection, has not been determined, although the most encouraging
      results have occurred with intrathecal administration of the drug.
    

Detailed description: 
      The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus
      (designated JC virus) infection, has not been determined, although the most encouraging
      results have occurred with intrathecal administration of the drug.

      Patients are randomized to receive antiretroviral therapy alone (AZT plus ddI or ddC),
      antiretroviral therapy plus intravenous Ara-C, or antiretroviral therapy plus intrathecal
      Ara-C. All patients receive 24 weeks of antiretroviral therapy. Beginning at week 2, patients
      on the intravenous Ara-C arm receive daily infusions of Ara-C over 5 days, with cycles
      repeating every 21 days. Patients on the intrathecal Ara-C arm receive single administrations
      of Ara-C at weeks 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, and 24. A brain biopsy confirmation or in
      situ hybridization will be required within 7 days after study entry. Patients are followed
      every 4 weeks.
    

Intervention name(s): Filgrastim; Cytarabine; Zidovudine; Zalcitabine; Didanosine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cytarabine; Zidovudine; Didanosine; Zalcitabine
Primary purpose: Treatment
Keywords: Leukoencephalopathy, Progressive Multifocal; Infusions, Intravenous; Cytarabine; Zalcitabine; Didanosine; Drug Therapy, Combination; Granulocyte Colony-Stimulating Factor; Acquired Immunodeficiency Syndrome; Zidovudine; Injections, Spinal
Study of SHEN26 Capsule in Patients With Mild to Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II
      clinical trial. It is designed to evaluate the efficacy, safety, tolerability, and
      pharmacokinetic (PK) profile of SHEN26 capsules in Chinese patients with mild to moderate
      COVID-19.
    

Detailed description: 
      Eligible patients with mild to moderate COVID-19 will be randomized in a 1:1:1 ratio to
      SHEN26 low dose group (200 mg), SHEN26 high dose group (400 mg), and placebo group, with 30
      patients in each group.
    

Intervention name(s): SHEN26 dose 1; SHEN26 dose 2; SHEN26 placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specification: 200mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).; Specification: 400mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).; Placebo matching the SHEN26 capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Remote Exercise Programs in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is a common problem that affects many people at some point in their lives.
      These people constitute a big part of the disease burden due to their recurrent complaints.
      About 45% of individuals with chronic low back pain seek medical attention. This situation
      makes chronic low back pain the second reason for individuals to apply to the hospital.

      Exercise therapy is the first option that comes to mind in the management of low back pain.
      It is seen that exercise therapy both reduces the intensity of pain and reduces the
      recurrence rate of complaints. When the literature is examined, it is observed that among the
      exercise models, stabilization exercises can provide more benefits than general exercises in
      reducing pain and improving disability. The COVID-19 pandemic causes disruptions in
      face-to-face rehabilitation services. The development of telemedicine and telerehabilitation
      services, whose popularity is increasing with the advancing technology, gained momentum with
      these disruptions. With telerehabilitation, long-term treatments tailored to the needs of the
      patients can be offered, the cost is low, and the patients can exercise at home, on their
      own, at their own pace, whenever they want. These reasons make telerehabilitation stand out
      especially during the pandemic period. The aim of the study planned in this context is to
      investigate short and long-term results of remote and face-to-face exercise training on
      function and disease symptoms for individuals with chronic low back pain.
    


Intervention name(s): Face to Face Exercise; Telerehabilitation
Intervention type(s): Other; Other
Intervention description(s): Face to face (in clinic) progressive spinal stabilization exercises.; Remotely (with video) progressive spinal stabilization exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: spinal stabilization exercise; tele-rehabilitation; low back pain
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether moxonidine is effective in reducing urine
      albumin levels in patients with diabetic kidney disease.
    

Detailed description: 
      This study will investigate the effect of moxonidine in lowering urine albumin excretion and
      limiting further damage to the kidneys in patients with diabetic nephropathy. Reducing urine
      albumin excretion in type 2 diabetic patients is an indicator of successful treatment.
      Previous studies have shown that drugs that work in a similar fashion to moxonidine
      (intervene with the sympathetic nervous system)have been very effective in reducing the
      amount of albumin in the urine and are associated with long term renal and cardiovascular
      protection.
    

Intervention name(s): Moxonidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive moxonidine treatment for 12 weeks, at a dose of 0.4mg/d for the first 6 weeks of treatment followed by up-titration of the dose to 0.6 mg/d for the final 6 weeks.; lactose capsule taken once daily
Other intervention name(s): Physiotens; sugar pill
Intervention MeSH terms: Moxonidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ultrasound Imaging Measurements of the Thoracolumbar Fascia
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      In this prospective study, eligible subjects with chronic non specific low back pain and
      asymptomatic volunteers will undergo a research dynamic ultrasound exam of the lower back
      before and after a massage technique.

      The overall aim of the present research is to develop ultrasonographic parameters that
      characterize the geometrical, the mechanical and tissue characteristic properties of the
      thoracolumbar fascia, and to explore the effect of a massage therapy technique on these
      parameters.
    

Detailed description: 
      In this prospective proof of concept study, eligible subjects with chronic non specific low
      back pain and asymptomatic volunteers will undergo a research dynamic ultrasound (US) exam of
      the thoracolumbar fascia (TLF) of the lower back. A musculoskeletal radiologist will perform
      the US exams consisting of a series of 5 dynamic scans of both the right and left paraspinal
      muscles, obtained during 15 degrees of passive flexion of the lower body using a motorized
      table.

      Following the US exam, the group of patients and the group of volunteers will be respectively
      randomized to receive either a standardized massage technique intervention or a sham
      technique. The US exam will be repeated after the intervention.

      Ultrasound image segmentation will be performed by two independent observers and inter-rater
      variability will be assessed. Post-processing of the US recordings will include assessment of
      geometrical (thickness), mechanical (percent shear strain between the TLF and the
      epimysium-muscle complex) and tissue ultrastructure features (the mean intensity μ, the
      scatterer clustering parameter α and the structure parameter κ of the echo envelope). These
      features will be compared between patients and volunteers and between the intervention
      groups.
    

Intervention name(s): Massage therapy technique; Sham massage technique
Intervention type(s): Other; Other
Intervention description(s): The massage therapy technique consists of manual deep and slow compression and shearing forces applied on the lumbar spine muscles and thoracolumbar fascia in a distal to proximal direction.; For the sham massage technique the massage therapist will put the right palm at the participant's right lower back along erector spinae and likewise left palm at left lower back without applying force, holding the palm during 2 minutes and half.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Fascia; Quantitative ultrasound; Elastography; Massage therapy
Effects of Scapular Therapeutic Exercise on Essential Biomechanical and Neurophysiological Parameters in Shoulder Pain Conditions With Scapular Impairments
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Shoulder pain is a prevalent and recurrent condition. After a period of shoulder pain, some
      adaptations could be found, as in scapular muscles and kinematics and/or in nervous system.

      It seems important to assess several biomechanical and neurophysiological outcomes to better
      characterize shoulder pain conditions and to program an intervention plane.

      Therapeutic exercise is one of the treatments used for shoulder pain, however there are still
      doubts and controversial findings regarding exercise focusing the scapular musculature. Thus,
      the present study aims to assess the effects of an intervention protocol based on scapular
      therapeutic exercise.
    


Intervention name(s): Experimental Scapular Therapeutic Exercise Group
Intervention type(s): Other
Intervention description(s): All subjects will perform a program of scapular therapeutic exercises including: neuromuscular control/strength - scapular therapeutic exercises that leads to, at least, moderate muscular activity levels; and stretching exercises.
The intervention period will be of 8 weeks, considering in-person and/or home sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shoulder pain; Scapular muscles; Scapular kinematics; Therapeutic exercise
Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS
Condition: Lumbar Foraminal Stenosis
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws
      providing initial stability have been developed to correct deformity, improve the rate of
      fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw
      fixation is a standard approach. Recently, studies have revealed that unilateral pedicle
      screw fixation provides equivalent clinical outcomes and fusion rates as compared with
      bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can
      reduce intraoperative blood loss and operating time. To our knowledge, few randomized
      controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar
      degenerative diseases have been reported. The purpose of this study is to compare clinical
      and radiographic outcomes in a series of patients with lumbar foraminal stenosis using
      instrumented TLIF with unilateral or bilateral pedicle screw fixation.
    


Intervention name(s): TLIF and unilateral pedicle screw fixation; TLIF and bilateral pedicle screw fixation; Pedicle screw and cage
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): TLIF combined with posterior unilateral pedicle screw fixation; TLIF combined with posterior bilateral pedicle screw fixation; Pedicle screw and cage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment