bioihbjkbjnl/mcl2 huggingface dataset:
Validity and Reliability of the Dual-task Questionnaire
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      It is important to increase the independence of Multiple Sclerosis (MS) patients in
      activities of daily living. Almost all activities of daily living require managing many
      activities at the same time. For example, walking or standing while talking on the phone.
      There is a need for easily applicable, reliable and valid scales to evaluate dual-task
      performance in MS patients. Therefore, the aim of this study is to establish the Turkish
      cultural adaptation, validity and reliability of the Dual-Task Questionnaire scale in MS
      patients. This study included a total of 50 patients with MS [age (18-65) years]. Dual-task
      Questionnaire (DTQ), Timed Up and Go test (TUG) with dual-task and Nine Hole Peg test (9-HPT)
      with dual-task were applied to the patients. The second evaluation (retest) was carried out
      by the same physiotherapist one week following the first evaluation (test) in order to
      measure test-retest reliability.
    

Detailed description: 
      This study included patients with MS between 0-5,5 score according to the Extended Disability
      Status Scale (EDSS). DTQ was used to assess the frequency of difficulties associated with
      daily tasks involving the dual-task. Additionally TUG with dual-task and 9-HPT with dual-task
      were applied to the patients. An experienced physiotherapist applied all these tests. In
      order to measure test-retest reliability, a retest was carried out by the same
      physiotherapist one week following the first evaluation. The construct validity of DTQ was
      tested by Pearson's correlation coefficient.
    

Intervention name(s): validity and reliability study
Intervention type(s): Procedure
Intervention description(s): Validity and reliability assessment of the Dual-task Questionnaire
Intervention model: Single Group Assignment
Intervention model description: Cross-Sectional
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Multiple Sclerosis; Dual-Task; Validity; Reliability
A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of Continuous Diffusion
      of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers. The primary objective of
      this study is to evaluate the effectiveness of CDO in combination with standard moist wound
      therapy (MWT) on wound healing as compared to standard MWT alone.
    


Intervention name(s): CDO electrochemical tissue oxygenation system; Moist Wound Therapy
Intervention type(s): Device; Device
Intervention description(s): The TransCu O2® device is a non-invasive, electrochemical tissue oxygenation system intended for use with lower-cost wound dressings for the treatment of chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers and other skin wounds through the continuous diffusion of oxygen (CDO). The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing; Moist Wound Therapy in combination with sham or deactivated device
Other intervention name(s): TransCu O2® device; CDO Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Foot Ulcer
A Trial of SHR0410 Injection in Hemodialysis Participants.
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of
      IV SHR0410 in participants who are undergoing hemodialysis.
    

Detailed description: 
      This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of
      IV SHR0410 in participants who are undergoing hemodialysis. Twenty-four eligible participants
      will be enrolled into 3 dose cohorts. SHR0410 will be administered after dialysis session.
      Safety assessments, PK assessments and efficacy evaluations will be performed.
    

Intervention name(s): SHR0410; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): drug will be dosed repeatedly; Placebo will be dosed repeatedly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This Clinical Trial is being conducted to study how patients with peripheral arterial disease
      (a condition in which the blood vessels of the extremities are affected) respond to a dietary
      regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed
      have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of
      dietary flaxseed on exercise tolerance will be assessed.
    

Detailed description: 
      The proposed trial is a one year, double blinded, placebo controlled study designed to
      examine and compare the effects of dietary ground flaxseed supplementation in volunteers with
      claudication secondary to lower extremity atherosclerotic arterial disease (peripheral
      arterial disease). The original proposal was for a two year study duration but this was
      truncated at one year to insure patient compliance remained high. This patient population is
      likely to benefit from flaxseed because there is a high prevalence of accelerated
      atherosclerosis and a higher than normal incidence of arrhythmias, myocardial infarctions and
      stroke. This study will be focus on whether dietary flaxseed can reduce clinical
      manifestations of peripheral arterial disease and increase exercise capacity in these
      patients. Two general hypotheses will be tested in this proposal. First, we hypothesize that
      fewer primary and secondary events (all-cause mortality, cardiovascular mortality, stroke,
      myocardial infarctions, angina, arrhythmias) will occur in patients who ingest flaxseed in
      their diet. Secondly, we hypothesize that dietary flaxseed supplementation will be associated
      with beneficial effects on exercise performance, blood pressure and circulating lipid levels.
      This trial will generate data on the safety, tolerability, cardiovascular efficacy and
      genomic response to a diet rich in flaxseed in patients with peripheral arterial disease
      (PAD).
    

Intervention name(s): Flaxseed; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30 grams of milled flaxseed per day in food products or on its own.; Wheat and Mixed Dietary Oils
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: PAD; Peripheral Arterial Disease; Diabetes; Atherosclerosis; Flax; Flaxseeds; Functional Foods; Essential Fatty Acids; Winnipeg
Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
Condition: Intestinal Barrier Function; Chronic Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The main objective of this work is to conduct a clinical trial in obese and non-obese
      individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health
      and reduce chronic inflammation. Our central hypothesis is that short and long-term
      consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese
      individuals by improving intestinal barrier function.
    


Intervention name(s): Low fat dairy yogurt; Soy pudding
Intervention type(s): Other; Other
Intervention description(s): Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks; Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Yogurt; Intestine; Inflammation; Obese
Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Observational

Summary: 
      This study, which was designed as a prospective observational study, was planned to enroll 75
      female patients with postmenopausal osteoporosis who had been using bisphosphonates for more
      than two years and did not respond to treatment. 2 doses of denosumab were administered to
      the patients every 6 months. Bone mineral density of patients were measured with DEXA at the
      beginning and end of the study. A total of 66 patients completed the study.

      At the end of the study, there was a significant improvement in the femur and lumbar total
      bone mineral density of the patients compared to the baseline. However, no statistically
      significant difference was found in terms of the frequency of new fractures.
    


Intervention name(s): Denosumab 60 MG/ML
Intervention type(s): Drug
Intervention description(s): Denosumab, another antiresorptive agent, is a fully human monoclonal IgG2 antibody that binds to the receptor activator of the nuclear factor-kB ligand (RANKL) with high specificity and affinity. Denosumab inhibits bone resorption by affecting the development, activation, and survival of osteoclasts.
Denosumab 60 mg subcutaneously was administered to the patients whose consent forms were obtained, once every 6 months.
Intervention MeSH terms: Denosumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study, which was designed as a prospective observational study, was planned to enroll
        75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for
        more than two years and did not respond to treatment.
Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
Condition: Rotavirus Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      Assess the immunological behavior of children from 2 months of age that receive one out of
      seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 -
      Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq)
      versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine),
      Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group
      5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one
      dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of
      pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of
      pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.

      Secondary objectives

        -  To describe number and features of acute diarrheal disease (ADD) due to rotavirus
           displayed in the seven prevention schedules.

        -  To describe the adverse events temporarily associated with the seven prevention
           schedules.

      Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus
      antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages
      and the GMTs induced in subjects that received the routine vaccination schedules with two
      doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).
    

Detailed description: 
      In this protocol we included 1498 at 6 to 8 weeks of age with a second visit at 2 months, a
      third visit at 4months four visit at 5 months after the first vaccination, ( 1st, second and
      3erd visits for vaccine administration) phone calls every month and not schedule visits at
      the center when parents required and the last protocol visit was at one year of age This
      follow up to one year was to access security.
    

Intervention name(s): Rotarix; RotaTeq
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Rotavirus; immunological behavior; Rotarix; RotaTeq; vaccine interchangeability
Screening Hepatitis Positive Women for Congenital Anomalies
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Congenital Abnormalities
Study type: Observational

Summary: 
      Hepatitis C virus is one of the virulent viruses
    

Detailed description: 
      Hepatitius positive women should be screened for congenital anomalies
    

Intervention name(s): ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): screening of pregnant women with hepatitis c virus received treatment in first trimester for congenital anomalies
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with hepatitis C virus received treatment during first trimester
Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure Compared to Electrical Stimulation and Cold Water.
Condition: Healthy
Study type: Interventional

Summary: 
      The objective is to estimate the effects on pain thresholds of a painful mechanical stimulus
      on the upper trapezius compared to a painful electrical stimulus and a diffuse noxious
      stimulus using the cold water hand immersion test.
    

Detailed description: 
      The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological
      responses within the peripheral and central nervous system responsible for pain inhibition.
      Almost all types of MT elicit a neurophysiological response that is associated with the
      descending pain modulation circuit. But it has not been demonstrated whether this inhibition
      occurs through a conditioned pain modulation mechanism induced by painful mechanical
      stimulation that is carried out with manual therapy techniques.
    

Intervention name(s): Conditioning stimulus
Intervention type(s): Other
Intervention description(s): Pain stimulus on non-dominant side
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Conditioned Pain Modulation; Manual Therapy; Physiotherapy; Physical therapy
Defense Health Agency- Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      PainQx, with the support of the Department of Defense (Contract #W81XWH-21-C-0034), is
      conducting a study to collect electroencephalography (EEG) data from people with chronic pain
      in order to develop algorithms than will objectively assess the pain a person is
      experiencing. EEG is a monitoring method that records electrical activity in the brain. If
      enrolled in the study, subjects will be asked to answer a series of questions regarding their
      level of chronic pain, level of functionality, symptoms, behavioral health information, and
      medications, and subsequently have a 15 minute, non-invasive EEG recording taken by placing
      electrodes along the scalp. Through participation, chronic pain subjects will provide data
      needed to further develop this technology.
    


Intervention name(s): Zeto WR19 EEG Recording
Intervention type(s): Device
Intervention description(s): 15 minutes of EEG recording to be obtained from eligible participants
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A minimum of two hundred twenty-five (225) male and female chronic pain patients between
        the ages of 18-85 years will be enrolled in the study. A minimum of seventy-five (75)
        healthy normal subjects between the ages of 18-85 years will also be enrolled. The normal
        subjects are added to assure that the study spans the entire pain scale including those
        with a self-reported pain score of 0. Subjects who meet inclusion/exclusion criteria will
        be asked to participate and to provide informed consent. The study will enroll up to 350
        patients.
Use of a GLP-1R Agonist to Treat Opioid Use Disorder
Condition: Opiate Substitution Treatment; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research is being done to find out if liraglutide (brand name is Saxenda®) can safely
      and effectively reduce craving for opioids in patients with opioid use disorder, a primary
      factor contributing to early relapse.
    

Detailed description: 
      The rationale for the proposed research is to develop an acute intervention that can improve
      treatment outcomes in opioid use disorder (OUD) by reducing craving, a primary factor
      contributing to early relapse. Although liraglutide was approved for human use in 2010, there
      are no data testing the effectiveness in patients with an OUD. The objective of the proposed
      research is to test whether treatment with a GLP-1R agonist can reduce craving in humans with
      OUD. Understanding how a 'satiety' agent may affect craving and brain responses to drug cues
      in an OUD population would provide entirely novel information. If liraglutide shows a trend
      towards efficacy, and safety of the GLP-1R agonist is demonstrated in this population, it
      would provide an indication to run the second phase, multi-center clinical trial of GLP-1R
      agonist in OUD patients.
    

Intervention name(s): Liraglutide Pen Injector; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide will be provided using an injection pen provided by the manufacturer; Placebo injection pen
Other intervention name(s): Saxenda
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opiate treatment; Opioid treatment; Glucagon-Like Peptide-1 Agonist; Opioid use disorder; Liraglutide
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Condition: End-Stage Renal Disease; Hemodialysis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered
      approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the
      drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a
      second period (Period 2) will be conducted. In Period 2, a single dose of drug will be
      administered approximately 4 hours prior to hemodialysis.
    


Intervention name(s): CP-690,550
Intervention type(s): Drug
Intervention description(s): CP-690,550 10 mg oral powder for constitution
Intervention MeSH terms: Tofacitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CP-690; 550; pharmacokinetics; end-stage renal disease
Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if there are any clinical or radiographic
      differences in non-posterior stabilized rotating mobile bearing design versus a posterior
      stabilized rotating mobile bearing designs.
    

Detailed description: 
      Out comes measures were to determine

        1. whether the knee and function scores and the radiographic results of the knees with a
           PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis.

        2. whether the patients with a PFC RP knee prosthesis would have a better range of knee
           motion than those with an LCS RP prosthesis.

        3. whether patient satisfaction and preference would be better in the patients having a PFC
           Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis

        4. whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis
           than in the knees with an LCS RP prosthesis.
    

Intervention name(s): PFC-Sigma RP; LPS RP
Intervention type(s): Device; Device
Intervention description(s): Posterior stabilizing rotating platform total knee components; non-posterior stabilized rotating platform design
Other intervention name(s): PFC sigma RP; LCS RP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rotating platform; posterior stabilized; non-posterior stabilized
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Disease; Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness
      in Assessing the Risk Factors of Atherosclerosis.
    


Intervention name(s): Ateronon
Intervention type(s): Drug
Intervention description(s): Ateronon daily for 3 months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asymptomatic Myocardial Ischemic patients