bioihbjkbjnl/mcl2 huggingface dataset:
Using Mobilization Exercises on Total Knee Arthroplasty Rehabilitation
Condition: Total Knee Arthroplasty; Total Knee Replacement
Study type: Interventional

Summary: 
      There is no definite evidence about the most effective treatment approach in early-stage
      rehabilitation after total knee arthroplasty surgery. The purpose of this study is to
      investigate the effects of mobilization exercises applied with classical exercises on pain,
      joint range of motion, edema, function, quality of life and patient satisfaction in early
      stage rehabilitation after total knee arthroplasty surgery.
    

Detailed description: 
      There is no definite evidence about the most effective treatment approach in early-stage
      rehabilitation after total knee arthroplasty surgery. The purpose of this study is to
      investigate the effects of mobilization exercises applied with classical exercises on pain,
      joint range of motion, edema, function, quality of life and patient satisfaction in early
      stage rehabilitation after total knee arthroplasty surgery. Patients with bicompartmental
      total knee arthroplasty operation due to knee osteoarthritis will randomly assign to 2
      groups. Patients in group 1 will treat with mobilization exercises in addition to classical
      exercises performed in the early post-op period; patients in group 2 will treat only with
      classical exercises.
    

Intervention name(s): Exercises
Intervention type(s): Behavioral
Intervention description(s): mobilization exercises (Patellofemoral joint, Tibiofemoral joint, Soft tissue) and classical exercises performed in the early post-op period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mobilization; Manual Therapies; Exercise
Platelets in Cystic Fibrosis Lung Inflammation
Condition: Platelet Levels and Mean Platelet Volume in Patients With CF
MeSH terms: Pneumonia; Cystic Fibrosis; Pulmonary Fibrosis; Fibrosis; Inflammation
Study type: Observational

Summary: 
      Cystic fibrosis (CF) is a chronic multiorgan disorder caused by mutations in the CFTR (cystic
      fibrosis transmembrane conductance regulator) gene. Chronic airway infection by bacterial
      pathogens accounts for the progressive, suppurative pulmonary disease that leads to
      significant morbidity and mortality in patients with CF. Neutrophil recruitment to the lungs
      accounts the most important contributor to pulmonary destruction. However, there is evidence
      that platelets may also have an important role in the pathogenesis of inflammation. To our
      knowledge, there is few information in platelet levels in patients with cystic fibrosis
      during pulmonary exacerbation, chronic airway colonization and when stable.
    

Detailed description: 
      Airway inflammation in CF is predominantly neutrophilic in nature with increased
      concentrations of pro-inflammatory mediators include TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-33,
      GM-CSF and G-CSF. In addition, other cell types including macrophages and T-lymphocytes are
      expressed by CFTR and contribute to the CF inflammatory response.

      Researches have indicated that platelets may also have a significant contribution to the
      inflammation. Platelet depletion or antiplatelet therapies attenuate injury and mortality in
      animal models of acute lung injury. More importantly, CFTR expression has been shown on human
      platelets. Recent data suggests that CF patients have an increase in circulating activated
      platelets and platelet reactivity.

      Taken together, these observations support a potentially important role of platelets in
      regulating lung inflammation in CF. However, there are few studies examine platelet and lung
      inflammation interraction in patients with CF. Therefore we aimed to investigate platelet
      count (PC) and mean platelet volume (MPV) levels in various conditions in our CF patients.
    

Intervention name(s): platelet count and mean platelet volume are obtained from whole blood count
Intervention type(s): Other
Intervention description(s): The records of cystic fibrosis patients will be retrospectively evaluated for acute pulmonary exacerbation, chronic airway colonization for bacteria, clinical stable status. PC and MPV will be obtained and matched in 6 groups (described above). Then, PC and MPV will be compared among the groups.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Cystic fibrosis patients
      
Keywords: cystic fibrosis, platelet count, mean platelet volume
Simplified Negative Pressure Wound Therapy
Condition: Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to implement a simplified Negative Pressure Wound Therapy
      (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device
      is at least equivalent to commercially available NPWT devices. Therefore, the specific aims
      of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the
      adverse events associated with the sNPWT device.
    


Intervention name(s): simplified negative pressure wound therapy device (Wound Pump device)
Intervention type(s): Device
Intervention description(s): A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.
Other intervention name(s): Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wound; negative pressure wound therapy; non-powered negative pressure wound therapy
Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives

      1.Evaluation of safety and tolerability after repeated administration of injectable
      Lipivirtide in HIV-infected patients not receiving antiretroviral therapy

      Secondary Objectives

        1. Evaluation of the pharmacokinetic properties of injectable Lipovirtide after multiple
           administrations in HIV-infected patients not receiving antiretroviral therapy, to obtain
           pharmacokinetic parameters.

        2. Evaluation of the efficacy of injectable Lipovirtide for HIV in HIV-infected patients
           not receiving antiretroviral therapy.

        3. Evaluation of the immunogenicity of lipovirtide for injection.
    

Detailed description: 
      PK parameters were calculated by Phoenix WinNonlin 8.2 (or higher) and other data were
      analyzed using SAS 9.4 (or higher) software.

      Full analysis set: will be used for efficacy analysis. Descriptive statistics of HIV viral
      load and CD4+ T-cell count at each time point, calculation of subject means, standard
      deviations, quartiles, minimum and maximum values, and comparison of changes from baseline at
      each time point.

      Safety analysis set: calculation of the incidence of adverse events and systematic
      categorization. Calculate the incidence of adverse events and systematically categorize them.
      Cross tabulation of clinical determination before and after drug administration for
      laboratory tests, ECG tests, and physical examination. Changes in measured values of vital
      signs over time. The actual measured values of the vital signs varied over time.

      Immunogenicity analysis: statistics of the results of each indicators (including the positive
      incidence and titer) over time, and a detailed list of the results of each visit.

      Pharmacokinetic analysis: individual and mean c-t curves were plotted; mean, standard
      deviation, interquartile, maximum, minimum and coefficient of variation of blood
      concentrations at each time point were listed. Pharmacokinetic parameters were calculated for
      each subject from the non-compartment model. and the arithmetic mean, standard deviation,
      quartiles, maximum value, minimum value and geometric mean and coefficient of variation were
      also calculated for each parameter.
    

Intervention name(s): Lipovirtide for injection
Intervention type(s): Drug
Intervention description(s): Multiple dosing of Lipovirtide
Other intervention name(s): nothing
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy of Microneedling as a Stand-alone Treatment for Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional

Summary: 
      This is a study that is being conducted in order to assess the efficacy of microneedling as a
      stand-alone treatment for vitiligo. Vitiligo is an autoimmune depigmentation disease of the
      skin that is characterized by the destruction of epidermal melanocytes by CD8+ T cells. The
      pathogenesis of Vitiligo has been linked to autoimmunity, oxidative stress, and genetic
      susceptibility.
    

Detailed description: 
      Microneedling is a minimally invasive technique developed for skin rejuvenation. In the
      treatment for vitiligo, the procedure causes micro-inflammations on the epidermis and
      enhances melanocytes and keratinocytes migration. This process leads to the stimulation and
      repigmentation of vitiligo areas. Several topical therapies such as Tacrolimus and
      5-Fluorouracilused in conjunction with microneedling have yielded favorable repigmentation
      results. This study aims to evaluate the repigmentation rates of microneedled vitiligo
      patches without any topical medications other than sunscreen.

      There will be a total of 8 -12 treatments over the course of 244 days, with subjects
      receiving a treatment every 2 weeks.
    

Intervention name(s): Skinpen Precision System
Intervention type(s): Device
Intervention description(s): Subjects will receive a total of 8-12 treatments with the Skinpen Precision system targeting their Vitiligo lesions.
Intervention model: Single Group Assignment
Intervention model description: A proof of concept study to determine the safety and efficacy of Microneedling in patients with stable Vitiligo.
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to support the optimal use of rivastigmine patch in long-term
      treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline
      at the target maintenance dose of rivastigmine patch 10 cm^2.
    


Intervention name(s): Rivastigmine 5 cm^2; Rivastigmine 10 cm^2; Rivastigmine 15 cm^2; Placebo to 15 cm^2 patch; Placebo to 10 cm^2 patch
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 cm^2 transdermal patch; 10 cm^2 transdermal patch.; 15 cm^2 transdermal patch.; Placebo of rivastigmine transdermal patch 15 cm^2.; Placebo of rivastigmine transdermal patch 10 cm^2.
Other intervention name(s): Exelon®; Exelon®; Exelon®
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's; Patch; Cognitive; Decline
Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees
Condition: Amputation
Study type: Interventional

Summary: 
      The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to
      improve signal quality and consistency of myoelectric signals for prosthetic control in
      individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up
      myoelectric signals intramuscularly and therefore signal quality is not affected from
      electrode replacement, perspiration, or artefacts.
    

Detailed description: 
      Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external
      equipment used to control an electromechanical prosthetic device, together comprise the IMES
      System (investigational product, medical device).

      Each IMES acts as an independent differential amplifier consisting of custom electronics
      housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The
      end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse
      telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and
      forward telemetry is used to transmit power and configuration settings to the sensors. The
      coil and associated electronics are housed within the frame of a prosthesis. A control system
      that sends data associated with muscle contraction to the motors of the prosthetic joints is
      housed in a belt-worn, battery-powered device. A cable attaches the control unit to the
      prosthetic frame.

      An IMES is implanted into each targeted muscle that will be used to control a function of the
      prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would
      control fingers opening and another device would control fingers closing.
    

Intervention name(s): Implantation of IMES sensors
Intervention type(s): Device
Intervention description(s): Surgical implantation of IMES sensors during routine surgery to improve prosthetic control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Dutasteride Treatment for the Reduction of Heavy Drinking in Men
Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the safety and potential benefit of the medication dutasteride to
      help men reduce or stop drinking alcohol.
    

Detailed description: 
      Extensive preclinical studies indicate that neuroactive steroids medicate important effects
      of alcohol and support the examination of neuroactive steroid modulators as treatment options
      for alcohol use problems. Dutasteride, a widely prescribed medication for benign prostatic
      hypertrophy, blocks a key step in the production of neuroactive steroids and represents a
      promising candidate for treatment of alcohol use disorders. This study will use a 12-week
      randomized placebo controlled design to examine the safety and efficacy of dutasteride to
      reduce drinking among a sample of 160 men with hazardous levels of alcohol use. It will
      additionally examine the potential moderation of dutasteride treatment effects by a common
      missense polymorphism in a neuroactive steroid biosynthetic enzyme that we have previously
      reported to be associated with alcohol dependence. Identification of genetic predictors of
      medication response offers the potential for matching alcohol treatment medications with
      those most likely to respond.
    

Intervention name(s): Dutasteride; sugar pill
Intervention type(s): Drug; Drug
Other intervention name(s): Avodart; placebo
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuroactive steroids
Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary endpoint of this trial will be to evaluate if a single administration in human of
      a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce
      postprandial glycemia and insulinemia.
    


Intervention name(s): Reduction of glycemic index of ingested foods
Intervention type(s): Dietary Supplement
Intervention description(s): Oral administration of the experimental lemon tea powder(56.1 g) and the placebo lemon tea powder (55.6 g) dissolved in water. Each participant will receive both treatment in a cross-over protocol design during 2 visits separated by a 2-weeks period. The day before both intervention, participants will consume a standardised meal for the supper.
Other intervention name(s): InSea2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Amylase; Glucosidase; Glycemic response; Sucrose; Seaweed
Cycloplegic Refraction Among Children
Condition: Cycloplegia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for
      cycloplegic refractions in pediatric populations. This will be a prospective double-blinded
      randomized clinical trial (RCT), multi center, with randomized sequencing of cycloplegic
      agent; each patient received one agent at one visit, and the other agent in the next visit (2
      different visits ≥ 1 week apart) within 3 months.
    

Detailed description: 
      Refractive errors assessment especially in pediatric populations is usually affected by the
      accommodative spasm and possibly a myopic shift in the results. Spasm of accommodation become
      evident as pesudomyopia or latent hyperopia. Therefore, cycloplegic refraction using
      cycloplegic drugs is an effective way to reduce fluctuation in accommodation or spasm of
      ciliary muscle. The drug of choice should have a rapid onset, appropriate cyclopegic effect
      and minimum side effects. Cyclopentolate and Tropicamide are well known drugs used for
      accommodation relaxation. Cyclopentolate is widely accepted drug of first choice for patients
      of all ages. Its cycloplegic effects begins at 25-75 min after administration of the drop and
      recovery appears through 6-24 h later.6 Ocular side effects may include irritation,
      lacrimation, allergic blepharoconjunctivitis, conjunctival hyperemia, and increase in
      intraocular pressure. Some of its systemic side effects are drowsiness, ataxia,
      disorientation, incoherent speech, restlessness, and visual hallucinations. Tropicamide, as
      an alternative, is a synthetic analog of tropic acid and is known as a safe agent for
      cycloplegic refraction. It characterized by a rapid onset and the cycloplegia effect appears
      20-30 min after administration. Its recovery appears 6 h later with safer profile compared to
      cyclopentolate. Several studies have been conducted to compare the cycloplegic effect of
      these two agents and different results have been reported. Because of inconsistencies in the
      previous reported results, this randomized clinical trial was conducted to compare the
      cycloplegic effect between cyclopentolate and tropicamide among pediatric populations (aged
      between 3 and 16).
    

Intervention name(s): Cyclopentolate; Tropicamide
Intervention type(s): Drug; Drug
Intervention description(s): Well known eye drop used for cycloplegic refraction among children.; Well known eye drop used for cycloplegic refraction among children.
Other intervention name(s): Cyclogel; Mydriacil
Intervention MeSH terms: Tropicamide; Cyclopentolate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: vision; cycloplegia; cycloplegic refraction; cyclopentolate; cyclogyl; tropicamide; mydriacil; refractive errors; latent hyperopia
Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia
Condition: Strabismus
MeSH terms: Strabismus; Esotropia
Study type: Observational

Summary: 
      Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus
      muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the
      lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized
      prospective study.
    

Detailed description: 
      We randomly assigned 124 patients (average age 5.8) from twelve participating clinics in
      Germany and the Netherlands to either BR or RR. Patients did not have demonstrable binocular
      vision at baseline. The angle of strabismus was measured pre- and postoperatively in a
      standardized fashion. The primary parameter to assess difference between BR and RR was the
      variation of the latent angle of strabismus at distance at three months postoperatively,
      secondary outcomes were reduction of convergence excess and binocular vision.
    

Intervention name(s): Bilateral recession; Unilateral recession and resection
Intervention type(s): Procedure; Procedure
Observational model: Defined Population
Time perspective: Prospective
Keywords: Strabismus; Esotropia; Surgical techniques
Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for
      CD patients. Studies are now required to determine if repeated FMT can overcome the apparent
      immune response to FMT thereby maintaining sustained clinical improvement and remission.
      Prior to a large randomized controlled trial of FMT in CD we will carry out a feasibility
      study to determine if serial FMTs can sustain a clinical response and maintain stability of
      transplanted microbiota.
    

Detailed description: 
      Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6.
      Assessments include HBI score, SES-CD score, and serum CRP levels.
    

Intervention name(s): Fecal Microbiota Transplant
Intervention type(s): Biological
Intervention description(s): Fecal transplant processed from routinely screened universal donor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment