bioihbjkbjnl/mcl2 huggingface dataset:
Phototherapy in Association to Resistance Training in the Elderly: the Effect on Muscle Strength, Muscle Mass and Functional Capacity
Condition: Elderly Men
Study type: Interventional

Summary: 
      Phototherapy has been largely used in rehabilitation programs due to its analgesic,
      antiinflammatory and healing effects. Lately, its effects of optimizing the results of
      resistance training on young individuals have been studied. However, there is a lack of
      studies on its effect on the elderly population. The objective of the present study is to
      verify the effect of Low-Level Laser Therapy (LLLT) on the results of resistance training in
      the elderly. The study will be a randomized doubled-blinded controlled trial. 30 elderly men
      with age ranging from 60 to 80 years will be included and randomized between Placebo Group
      (placebo LLLT + Resistance Training) and LLLT Group (active LLLT + Resistance Training). All
      volunteers will be submitted to a control period of four weeks before the beginning of the
      resistance training, which will have 12 weeks of duration. The assessments will be done at
      baseline, after the control period and after the training period. The training sessions will
      be performed twice a week and the training protocol will be performed with repetition maximum
      periodization. The LLLT will be applied before the training sessions on eight points of the
      quadriceps muscles, leading to a total of 240 Joules on each leg. The placebo LLLT will be
      applied on the same way, but with the equipment turned off. The assessments will include
      muscle architecture by ultrasonography, muscle strength by isokinetic dynamometer and 1
      Repetition Maximum test of leg-extension and leg-press exercises, and functional capacity by
      the 6-Minute Walking Test, 30s Sit to Stand Test, Timed Up-and-Go Test and Stair Ascent Test.
    


Intervention name(s): Active Low Level Laser Therapy; Resistance Training; Placebo Low Level Laser Therapy
Intervention type(s): Device; Behavioral; Device
Intervention description(s): Active application of Low Level Laser Therapy with a dose of 240 Joules; Resistance Training; Placebo application of Low Level Laser Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
The Value of EMDR in the Treatment of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and
      EMDR as a treatment for tinnitus.
    

Detailed description: 
      Patients with subjective, chronic, non-pulsatile tinnitus will be randomized in two treatment
      groups: TRT and CBT versus TRT and EMDR. Evaluations will take place at baseline before
      therapy starts, at the end of the treatment, after 3 months (10 treatment sessions) and 3
      months after therapy ends. The Tinnitus Functional Index (TFI) will be used as the primary
      outcome measurement. Secondary outcome measurements will be the Visual Analogue Scale of
      Loudness (VAS), Tinnitus Questionnaire (TQ), Hospital Anxiety and Depression Scale (HADS),
      Hyperacusis Questionnaire (HQ), psychoacoustic measurements and Event-related potentials
      (ERP). The objective is to evaluate whether the bimodal therapy TRT and EMDR can provide
      faster and/or more relief from the annoyance experienced in chronic tinnitus patients' daily
      lives compared to the bimodal therapy TRT and CBT.
    

Intervention name(s): TRT / EMDR; TRT / CBT
Intervention type(s): Other; Behavioral
Intervention description(s): Tinnitus Retraining Therapy:
TRT is a therapy developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell. During the counseling, the patient is educated about the work mechanism of tinnitus and how to deal with the emotional and physical responses. The main goal is to habituate to the sound of the ringing in the ears.
Eye Movement Desensitization and Reprocessing:
This is a scientifically, psychotherapeutic approach, developed in 1987 by Francine Shapiro. EMDR represents a specific method within a wider theoretical model called 'Adaptive Information Processing (AIP)'. Within the treatment bilateral stimulation is used i.e. visual, auditory and tactile stimuli can be used to stimulate both the left - and the right hemisphere.; Tinnitus Retraining Therapy:
TRT is a therapy developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell. During the counseling, the patient is educated about the work mechanism of tinnitus and how to deal with the emotional and physical responses. The main goal is to habituate to the sound of the ringing in the ears.
Cognitive Behavioral Therapy:
CBT is the combination of behavioral therapy with interventions that have been developed from cognitive psychology. The founders of CBT are Aaron Beck and Albert Ellis. The core idea is the assumption that so-called negative cognitions are responsible for dysfunctional behavior. The techniques used in the cognitive behavioral therapy focus on changing the content of these irrational cognitions.
Other intervention name(s): TRT / Eye Movement Desensitization Reprocessing; TRT / Cognitive Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke (REVISE-1)
Condition: Acute Stroke
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Currently, early reperfusion is considered as the most effective therapy for the treatment of
      acute ischemic stroke (AIS). Over the past 20 years, intravenous tissue plasminogen activator
      (IV tPA) has been demonstrated to be the only effective therapy for AIS. More recently,
      several large randomized clinical trials have concluded the superiority of endovascular
      mechanical thrombectomy for AIS. Furthermore, with the development of materials and
      techniques, the occluded artery can be recanalized with high percentage (60%-90%), and the
      rate of recanalization is still being improved. A great number of AIS patients are now
      eligible for revascularization therapy and there should be a good prognosis of AIS after
      recanalizing the occluded artery using mechanical thrombectomy. However, things are never as
      simple as wished to be. The rate of patients with functional independence is less than 50%
      and over 15% patients died at 3 months post thrombectomy. The discrepancy between the
      functional outcome and recanalization rates encourage researchers to explore strategies that
      further improving the functional outcome of AIS patients.

      Remote ischemic conditioning has been demonstrated to reduce cerebral infarct size in mouse
      model of focal cerebral ischemia. And clinical researches demonstrated the protective effects
      of remote ischemic conditioning in AIS patient treated with IV tPA,. However, whether remote
      ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic
      stroke and undergoing endovascular treatment is still unknown.
    

Detailed description: 
      In the present study, the investigators will assess the safety and feasibility of remote
      ischemic condition paired with endovascular treatment for AIS. A single arm of AIS patients
      treated with endovascular therapy will be recruited, and remote ischemic conditioning will be
      applied prior to reperfusion therapy and in combination with post reperfusion therapy.
    

Intervention name(s): Remote ischemic conditioning; Endovascular treatment
Intervention type(s): Device; Procedure
Intervention description(s): RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.; Endovascular treatment include strategies that used to recanalize the occluded artery. Strategies often used include thrombectomy, intra-arterial thrombolysis, stenting and balloon angiography.
Other intervention name(s): RIC; ET
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Acute ischemic stroke; Endovascular treatment; Remote ischemic conditioning; Reperfusion therapy; Neuroprotection
A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects
Condition: Infections, Urinary Tract
MeSH terms: Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, randomized, single dose, two-sequence two-period crossover study,
      separated by 7 days washout interval from the first Study Drug Administration. This study is
      conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets
      manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and
      cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &amp;Chem .Ind.
      Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy
      adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive
      cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days,
      subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not
      receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a
      trademark of Sandoz.
    


Intervention name(s): Cefadroxil tablets manufactured by GSK; Cefadroxil tablets manufactured by NP
Intervention type(s): Drug; Drug
Intervention description(s): Cefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil; Cefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil
Intervention MeSH terms: Cefadroxil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; film coated tablets; cefadroxil
Fuchs' Torsional Phaco Study
Condition: Fuchs' Endothelial Dystrophy; Phacoemulsification
MeSH terms: Fuchs' Endothelial Dystrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to compare the effect of torsional phacoemulsification and
      longitudinal phacoemulsification on central and peripheral corneal thickness/volume after
      cataract surgery in patients with Fuchs' endothelial dystrophy.
    

Detailed description: 
      Fuchs' endothelial dystrophy is a progressive, bilateral disease of the corneal endothelium,
      which eventually leads to corneal decompensation. In the early stage, some patients develop
      visually significant cataract. During cataract surgery ultrasound (US) power is used to
      emulsify the lens, which leads to endothelial cell loss and tissue damage. The reduction of
      US power has become the primary surgical goal in cataract surgery, which is especially
      important in patients with Fuchs' endothelial dystrophy to limit endothelial cell loss.

      In 2006, Alcon Surgical introduced a torsional mode in its phacoemulsification system
      (Infiniti Vision System). It includes a handpiece that produces rotary oscillations of the
      phacoemulsification tip and is suggested to reduce the amount of US power required to remove
      the cataractous nucleus, because it does not produce repulsion and breaks up the cataract by
      shearing and not by the conventional jackhammer effect. This reduction in US power, could
      lead to less endothelial cell damage than the conventional (longitudinal) mode, which is
      reported recently for patients with hard cataract. It is important to investigate patients
      with Fuchs' endothelial dystrophy, because patients with a compromised endothelial cell layer
      will benefit the most from less endothelial cell damage. Consequently, this lower level of
      endothelial damage may postpone the date of keratoplasty.
    

Intervention name(s): Phacoemulsification
Intervention type(s): Procedure
Intervention description(s): Comparison of longitudinal phacoemulsification and torsional phacoemulsification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Natalizumab for thE Relief of MS Associated FatiGue
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Fatigue
Study type: Observational

Summary: 
      This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in
      patients with relapsing forms of MS.
    

Detailed description: 
      TYSABRI® treatment has already demonstrated significant improvement in the quality of life
      (QoL) of patients with MS. In particular, TYSABRI® add-on treatment to interferon beta-1a has
      demonstrated improvement in fatigue as measured by the Modified Fatigue Impact Scale (MFIS).
      Both patients and neurologists report that patients have experienced significant improvements
      in fatigue shortly after initiating TYSABRI® treatment. Fatigue is both a common and a
      disabling symptom of MS. Further, there is evidence that fatigue contributes to cognitive
      difficulties in patients with MS. This study aims to study the effects of TYSABRI® treatment
      on fatigue and cognition in patients with relapsing forms of MS.

      The primary objective of this study is to determine the effects of TYSABRI® treatment on
      fatigue in subjects with relapsing forms of MS as measured by changes in patient-reported
      Visual Analog Scale for Fatigue (VAS-F).

      Primary endpoint is the change in the following:

      1. Visual Analog Scale for Fatigue (VAS-F) at three months after initiating treatment with
      TYSABRI®.

      Secondary objectives are to measure changes in patient-reported Modified Fatigue Impact Scale
      (MFIS) and Fatigue Severity Scale (FSS).

      Secondary endpoints are changes in the following:

        1. Modified Fatigue Impact Scale (MFIS)

        2. Fatigue Severity Scale (FSS)

      The tertiary objective of this study is to explore for any effects of TYSABRI® treatment on
      cognition by assessing changes in the Automated Neuropsychology Assessment Metrics (ANAM).

      Tertiary endpoints are changes in the Automated Neuropsychology Assessment Metrics (ANAM)
      consisting of:

        -  Traditional Continuous Performance Test

        -  Running Memory Continuous Performance Test

        -  Simple Response Time

        -  Procedural Response Time

        -  Coding Substitution

        -  Mathematics

        -  Logical Relations

        -  Matching-to-Sample

        -  Stanford Sleepiness Scale
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        multicenter clinic patients
      
Keywords: fatigue; Tysabri; cognition
Evaluate the Efficacy and Safety of Pletaal (Cilostazol) in Subjects With Vasospastic Angina
Condition: Variant Angina
MeSH terms: Angina Pectoris; Angina Pectoris, Variant
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol)
      in comparison with placebo for 4 weeks in vasospastic angina patients who have an
      insufficient response to Amlodipine (Calcium channel blocker).
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic
      exploratory Study.

      The subject who has at least an episode of chest pain weekly despite Amlodipine 5mg once a
      day (qd) taking during 2 weeks will have treatment of Pletaal (Cilostazol) or Placebo for 4
      weeks. Pletaal (Cilostazol) is taken 100mg oral tablets two times a day (bid) during 2 weeks
      after dosing of Pletaal (Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal
      (Cilostazol) is used as the control medication.
    

Intervention name(s): Placebo
Intervention type(s): Drug
Intervention description(s): 2 weeks treatment of Cilostazol 100mg, or placebo oral tablets bid after 2 weeks treatment of Cilostazol 50mg, or placebo oral tablets bid (Total 4 weeks)
Other intervention name(s): Amlodipine; Nitroglycerin
Intervention MeSH terms: Amlodipine; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Variant angina; Cilostazol
Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      An early stage trial to check how safe and tolerable, as well as how the body handles
      continuous daily use of Active IMP over 28 days in healthy volunteers.
    

Detailed description: 
      Detailed information restricted because this is a Phase 1 clinical trial.
    

Intervention name(s): Ivermectin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study; Matching Placebo to the Active IMP.
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study is a placebo-controlled, double-blinded exploratory study to investigate safety, Pk and tolerability of a continuous daily dosing of the active drugs (at 3 different doses) in healthy participants.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Location Specific Differences in Intestinal Brake Activation
Condition: Ileal Brake; Satiety; Overweight; Obesity; Overeating
MeSH terms: Overweight; Hyperphagia
Study type: Interventional

Summary: 
      The appearance of intact macronutrients in the small intestine can result in the activation
      of an intestinal brake; a negative feedback mechanism from different parts of the intestine
      to the stomach, the small intestine and to the central nervous system. These processes
      inhibit food processing, appetite sensations and food intake, and furthermore they increase
      feelings of satiety and satiation. The researchers will investigate the effects of
      intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food
      intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and
      glucose and insulin.
    


Intervention name(s): placebo; Casein (in duodenum); Casein (in jejunum); Casein (in ileum)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): infusion of tap water in all regions (duodenum, jejunum and ileum); infusion of protein in duodenum; infusion of protein in jejunum; infusion of protein in ileum
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the effect of light therapy using a narrow
      467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It
      is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm
      light.
    

Detailed description: 
      Participants will be randomly assigned to receive either a 467nm light or a 580nm light.
      Participants will use the light every day for six weeks for 30 minutes. Multiple assessments
      and questionnaires will be given weekly to assess the efficacy of the treatment.
    

Intervention name(s): goLITE; Control
Intervention type(s): Device; Device
Intervention description(s): goLITE at 30 minutes per day, within 30 minutes of waking in the morning; light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
Other intervention name(s): Light device; Blue Light
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SAD; Seasonal Affective Disorder; Winter Blues; Seasonal Depression
Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303
      in subjects with Crohn's disease.
    

Detailed description: 
      This is a Phase I, open-label, non-randomised, multicenter single-dose study to evaluate PK,
      PD, and safety of a single oral dose of MT-1303 in subjects with moderate to severe active
      Crohn's disease (ileal and ileo-colonic type).
    

Intervention name(s): MT-1303
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's disease
A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients
Condition: Trientine Treatment for Wilson's Disease
MeSH terms: Hepatolenticular Degeneration
Study type: Observational

Summary: 
      This is a retrospective study to assess the clinical efficacy and safety of trientine in
      Wilson's disease patients
    

Detailed description: 
      In this retrospective study, the investigators will collect and analyze data from reviewing
      medical history files of larger and long-term follow-up cohorts with Wilson's disease in
      Taiwan to assess the efficacy and safety of Trientine in Taiwanese Wilson's Disease patients.
    

Intervention name(s): Trientine
Intervention type(s): Drug
Intervention description(s): Trientine is a chelating agent for removing the copper from the body
Intervention MeSH terms: Trientine
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had the diagnosis of Wilson's disease
      
Keywords: trientine; Wilson's disease