bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This research study is determined to see the effects of low-impact elliptical training on
      knee osteoarthritis outcomes.
    

Detailed description: 
      This study is designed to reduce the load of knee osteoarthritis patients in society so that
      the individual lives a healthy life without getting caught in any form of disability. Knee
      osteoarthritis is a progressive and degenerative disease of a joint that includes focal
      cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of
      periarticular ligaments and peripheral muscles.

      There are several techniques used to overcome the individual's pain, for instance, the
      mobilization of the joint, prolotherapy, and the use of different electrical modalities.
      meanwhile, an elliptical workout provides a positive result in reducing the progression of
      overall knee joint and cartilage defects. elliptical training is included in low-impact
      activities which are proven joint-friendly activities for the better improvement of the knee
      joint.

      This activity works on a similar principle of cyclic compressive loading as occurs in the
      manual mobilization of the knee joint. This activity brings out the fluid from the synovial
      membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and
      nutrients, which crosses the synovial barrier into the synovial fluid through a double
      diffusion system in the joint. The fluid then reaches the extra-cellular matrix that moves to
      the multiple layers of chondrocytes for the growth of the cartilage in OA.
    

Intervention name(s): experimental and conventional group
Intervention type(s): Other
Intervention description(s): Static stretchings of the lower limb, Ultrasound 1 MHz 1.5W/cm2 7 mins, knee isometrics, open chain activities, knee mobilizations grade 1 and 2, and home care plan.
Other intervention name(s): Conventional group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Knee osteoarthritis
HeartHab, Can a Patient-tailored Application Support Coronary Artery Disease Patients During Rehabilitation?
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The HeartHab study is a pilot trial in which coronary artery disease patients (n = 15-30) are
      given the HeartHab application. The HeartHab application is a smarthphone based mobile
      application that serves as a secondary prevention tool, to support cardiac patients after
      their phase II cardiac rehabilitation program. During study period (4-6 weeks), participating
      patients will be asked to use the application. HeartHab includes a module devoted to therapy
      compliance, one to exercise training prescription and one to risk factor control. HeartHab
      aims to motivate the patient to improve his/her self-management skills and hence decrease
      cardiovascular morbidity (and mortality).

      Motivational aspects and usability data will be collected during study period by means of app
      logs and/or questionnaires/interviews.
    


Intervention name(s): HeartHab application intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention patients will use the HeartHab application on a smartphone. During the study, the patients will use the HeartHab application for 4-6 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated
      t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation
    

Detailed description: 
      AML patients displaying t(8;21) have a relatively favourable outcome. Nevertheless, only
      approximately 50% of patients carrying this cytogenetic aberration are alive at 5 years. This
      suggests that some patients have more aggressive leukemic phenotypes and indicates the need
      for treatment optimization with novel therapies.

      The mutated KIT gene as well as the FLT3-ITD mutation have recently been identified as
      factors most likely to explain the heterogeneous clinical outcomes within the group of
      t(8;21) AML. The FLT3 and c-KIT genes encode type III receptor tyrosine kinases (RTK) with
      important and partly redundant functions in early hematopoietic stem cells. Various
      activating mutations have been described for both genes. For c-KIT, the incidence ranges from
      17 to 48% depending on the source population and type of mutations determined. It has been
      consistently shown that in AMLs with t(8;21), mutated c-KIT is associated with a dramatically
      increased risk of relapse and reduced overall survival compared to their unmutated
      counterparts. The FLT3-ITD mutation has a similar negative effect on prognosis in the patient
      group of t(8;21) mutated AMLs as c-KIT.

      PKC412 (midostaurin) is known to inhibit the c-KIT RTK activity as well as the FLT3 kinase,
      both in patients with ITD and TKD mutations. It should therefore be possible to abrogate the
      negative impact of pathologically increased c-KIT or FLT3-ITD activity on relapse and overall
      survival by using midostaurin in this patient population. Aim of the proposed clinical trial
      is to prove the efficacy of midostaurin in c-KIT or FLT3-ITD mutated t(8;21)- AMLs in an
      open-label one-arm design.
    

Intervention name(s): midostaurin (PKC412)
Intervention type(s): Drug
Intervention description(s): Midostaurin 50 mg (2 capsules) twice daily days 8-21 in induction II + consolidation I-III; maintenance treatment twice daily continuously for 12 months
Other intervention name(s): Rydapt
Intervention MeSH terms: Midostaurin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; Acute Myeloid Leukemia; c-KIT; FLT3-ITD; t(8;21); chemotherapy; midostaurin
Biological Therapy in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
      tumor cells from growing. Treating a person's white blood cells in the laboratory and
      reinfusing them may cause a stronger immune response and kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients
      who have metastatic melanoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of autologous CD4+ antigen-specific T-cells for
           cellular adoptive immunotherapy in patients with metastatic melanoma.

        -  Determine the safety and toxicity of this regimen in these patients.

        -  Determine the duration of in vivo persistence of adoptively transferred CD4+
           antigen-specific T-cell clones in these patients.

      Secondary

        -  Determine the antitumor effects of this regimen in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients undergo leukapheresis to collect peripheral blood mononuclear cells. CD4+
      antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic
      peptides MART1, tyrosinase, or gp100.

      Patients receive autologous CD4+ antigen-specific T-cells IV over 30 minutes.

      Cohorts of 3-6 patients receive escalating doses of autologous CD4+ antigen-specific T-cells
      until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

      Patients are followed on days 1 and 3 post T-cell infusion, and then once weekly for 12
      weeks.

      PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
    

Intervention name(s): therapeutic autologous lymphocytes
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: recurrent melanoma; stage IV melanoma
Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE)
      levels and antigen consumption in two distinct food allergies.
    

Detailed description: 
      In subjects with mammalian meat allergy, the effect of daily oral cow's milk on immune
      parameters and desensitization will be assessed. Similarly, in subjects with a peanut allergy
      the effects of low dose peanut flour will be assessed and comparisons between two distinct
      food allergies.
    

Intervention name(s): cow's milk; peanut powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): daily consumption of cow's milk; peanut oral immunotherapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and
      tirabrutinib in adults with active Sjogren's Syndrome (SjS).
    


Intervention name(s): Lanraplenib; Filgotinib; Tirabrutinib; Lanraplenib placebo; Filgotinib placebo; Tirabrutinib placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 x 30 mg tablet administered orally once daily; 1 x 200 mg tablet administered orally once daily; 1 x 40 mg tablet administered orally once daily; 1 x tablet administered orally once daily; 1 x tablet administered orally once daily; 1 x tablet administered orally once daily
Other intervention name(s): GS-9876; GS-6034; GS-4059
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
LP0058-1005 - A Open-Label, Four-Way Crossover and Food-Effect Study of LEO 32731 in Healthy Subjects
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      LEO 32731 ("Study Drug") is an investigational drug which is being developed by LEO Pharma
      A/S ("the Sponsor"), with an aim to help people with skin conditions called psoriasis. The
      aim (s) of this Study are to determine:

        -  The effects of the Study Drug when given as different formulations intended for oral
           administration (tablets and capsules)

        -  The safety of the Study Drug and any side effects that might be associated with it

        -  The effect of food on the Study Drug

        -  The Study will also measure how much of the Study Drug gets into the blood stream and
           how long it takes the body to remove it and what affect the Study Drug has on the body.
    


Intervention name(s): LEO32731
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Inspiratory Resistive Loading and Proprioceptive Postural Control
Condition: Low Back Pain; Respiratory Loading; Proprioceptive Impairment
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Proprioceptive weighting changes may explain differences in postural control performance. In
      addition, the respiratory movement has a disturbing effect on postural balance. Postural
      balance seems to be impaired in individuals with respiratory disorders. Besides the essential
      role of respiration, the diaphragm may also play an important role in the control of the
      trunk and postural balance. Deficits in proprioception are found in a subgroup of patients
      with low back pain. In addition, disorders of respiration have been identified as strongly
      related to low back pain.

      The aim of the study is to clarify whether loading of the inspiratory muscles has a negative
      effect upon proprioceptive postural control in healthy individuals and individuals with
      recurrent low back pain.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        young flemish volunteers
Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
Condition: Physical Activity; Muscle Recovery
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of NMN supplementation (250 and 500
      mg/day over 38 days) compared to placebo in healthy volunteers with moderate physical
      activity on muscle recovery, physical capacity, cardiorespiratory recovery, the perception of
      the arduousness of the effort, the variation in blood lactate levels before and after
      physical exercise, the perception of the intensity of post-exercise muscle pain (cramps), the
      body composition and Nicotinamide-Adenine Mononucleotide (NAD+) level in blood.
    


Intervention name(s): Nicotinamide mononucleotide; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Daily supplementation with NMN at 250 and 500 mg for 38 days in total; Daily supplementation with placebo for 38 days in total
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Nicotinamide mononucleotide; Muscle pain
Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission
Condition: Fatigue; Leukemia; Long-term Effects Secondary to Cancer Therapy in Children
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Metabolic Syndrome; Fatigue
Study type: Observational

Summary: 
      RATIONALE: Gathering information about metabolic syndrome from young patients with acute
      lymphoblastic leukemia may help doctors learn more about the disease.

      PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute
      lymphoblastic leukemia in remission.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the incidence and prevalence of the components of metabolic syndrome (e.g.,
           obesity, hypertension, dyslipidemia, and insulin resistance) in pediatric patients with
           acute lymphoblastic leukemia in remission.

        -  To determine the trajectory of the onset of these components over a 1-year period in
           patients undergoing maintenance therapy.

      Secondary

        -  To identify potential associations between components of metabolic syndrome and fatigue,
           health-related quality of life, family history, nutrition, and physical activity.

        -  To identify potential biomarkers that are associated with clinical features of metabolic
           syndrome.

        -  To evaluate whether patients will show a decrease in IGF-1 levels.

      OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.

        -  Part 1: Patients undergo physical exam measurements (e.g., body mass index, waist
           circumference, and blood pressure) at baseline (during maintenance course 1) and at 12
           months (during maintenance course 5). Patients also undergo blood sample collection at
           baseline and at 12 months to measure laboratory markers (e.g., fasting lipid profile,
           fasting insulin and glucose, IGF-1, leptin, and adiponectin levels). Patients or their
           parents complete a family history questionnaire at baseline and questionnaires to assess
           physical activity, quality of life, nutritional intake, and fatigue at baseline and at 6
           and 12 months.

        -  Part 2: Patients or their parents complete a family history questionnaire at baseline.
    

Intervention name(s): laboratory biomarker analysis; metabolic assessment; questionnaire administration; assessment of therapy complications; fatigue assessment and management; quality-of-life assessment
Intervention type(s): Other; Other; Other; Procedure; Procedure; Procedure
Keywords: fatigue; long-term effects secondary to cancer therapy in children; childhood acute lymphoblastic leukemia in remission; B-cell childhood acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia
Mass in Motion Kids in the Clinical Setting
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Mass in Motion Kids is a whole-of-community intervention in Fitchburg and New Bedford,
      Massachusetts that incorporates evidence-based interventions across multiple sectors and at
      multiple levels. The overall goal of the study is to examine the extent to which the
      comprehensive, systematic intervention reduces childhood obesity among underserved children.

      The clinical intervention implements evidence-based interventions each city's
      federally-qualified community health center. Intervention components aim to improve primary
      and secondary prevention of childhood obesity and implement changes at four levels:
      clinician; parent-family; organizational; and environmental. We additionally provide training
      and educational materials to other pediatric clinicians in the two communities. The clinical
      intervention components include (1) advanced training on clinical quality improvement and
      obesity prevention, assessment, management; (2) computerized, point-of-care decision support
      tools for clinicians; (3) implementation of multi-disciplinary weight management programs
      within the community health centers, e.g. Healthy Weight Clinics (HWC); (4) integrating
      community health workers into the primary care and HWC teams; and (5) health center
      environmental changes to support behavior change modification.
    


Intervention name(s): Primary Care Practice Changes
Intervention type(s): Other
Intervention description(s): The clinical intervention components included (1) advanced training on clinical quality improvement and obesity prevention, assessment, management; (2) computerized, point-of-care decision support tools for clinicians; (3) implementation of multi-disciplinary weight management programs within the community health centers, e.g. Healthy Weight Clinics (HWC); (4) integrating community health workers into the primary care and HWC teams; and (5) health center environmental changes to support behavior change modification.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study in Healthy Men to Test How BI 690517 is Taken up and Handled by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is intended to investigate the basic pharmacokinetics, excretion pathways and
      metabolism of BI 690517 and its metabolites.
    


Intervention name(s): BI 690517 (C-14); BI 690517
Intervention type(s): Drug; Drug
Intervention description(s): BI 690517 (C-14); BI 690517
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time
      contact lens wearers.
    


Intervention name(s): Delefilcon A contact lens
Intervention type(s): Device
Intervention description(s): Silicone hydrogel contact lens CE-marked for single use, daily disposable wear
Other intervention name(s): DAILIES® TOTAL1™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DAILIES TOTAL1; Alcon; contact lens
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is the comparative evaluation of the pharmacokinetics and
      pharmacodynamics of two recombinant regular human insulin injections administered
      subcutaneously in healthy volunteers under the conditions of euglycemic clamp.
    

Detailed description: 
      A comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant
      regular human insulin injections administered subcutaneously in healthy volunteers. It is a
      crossover study. The subjects shall be administered single doses of each insulin during two
      separate visits under the conditions of euglycemic clamp.
    

Intervention name(s): Wosulin R; Novolin R
Intervention type(s): Biological; Biological
Intervention description(s): Penfill cartridges; Single Dose, 0.2 IU/ kg;; Penfill cartridges; Single Dose, 0.2 IU/ kg;
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics; pharmacodynamics; recombinant human insulin; healthy volunteers