bioihbjkbjnl/mcl2 huggingface dataset:
Outpatient Treatment of Patients With Morbid Obesity - a Two-year Follow up
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      This study is a pilot project to investigate any effect on these markers in conjunction with
      lifestyle changes / conservative treatment. Useful and significant information in this pilot
      project is intended to be used as background for further research on this issue in connection
      with a doctorate.

      What is the effect of two years of outpatient treatment for lifestyle change for weight
      markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults
      with morbid obesity?
    


Intervention name(s): lifestyle advice
Intervention type(s): Device
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: obesity; adults; lifestyle intervention; effect after two years treatment for lifestyle change - morbid obesity adults
Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes and Ultrasound Changes in Non-Diabetic Non-Alcoholic Fatty Liver
Condition: NAFLD
Study type: Interventional
Phase: Phase 3

Summary: 
      BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of hepatic disease
      ranging from fat accumulation in liver to fibrosis and cirrhosis. It affects 25% of the world
      population on average. Objective of this study is to compare the effect of metformin (1000
      milligrams daily) versus pioglitazone (30 milligrams daily) in improving liver transaminases
      and ultrasound changes in non-diabetic patients of NAFLD when given for six months.

      METHODS: A Quasi-experimental study was conducted in Mayo Hospital Lahore from October 2019
      to November 2020.Out of 96 half Patients were assigned randomly to Group-A (metformin) or
      Group-B (pioglitazone). Demographic history, abdominal ultrasound & liver enzymes were
      recorded on Proforma monthly till 6 months. Data was put into and analyzed by SPSS version
      26; t-test was used to compare the mean liver transaminases between the two groups.
      Ultrasound findings were compared by Chi square. The P value of less than 0.05 was counted as
      significant.
    


Intervention name(s): Metformin and Pioglitazone
Intervention type(s): Drug
Intervention description(s): Every participant in Group-A took tablet metformin 500 mg daily and every participant in Group-B took tablet pioglitazone 30 mg daily.
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Electromyography Evaluation of the Impacts of Different Insoles in the Activity Patterns of the Lower Limb Muscles
Condition: Electromyography; Muscles; Foot Orthoses
Study type: Interventional

Summary: 
      The main objective of this research is to demonstrate that the use of insoles of different
      hardness in motorcycle riders may cause variations in the electromyographic activity of the
      lower limb muscles during the race. This study is a cross-over quasi-experimental study. Nine
      motorcycle riders were recruited. Electromyographic activity of the lower limb muscles is
      recorded under different insole types.
    


Intervention name(s): Foot insoles
Intervention type(s): Other
Intervention description(s): Different foot insoles of different hardness
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with
      relapsing multiple sclerosis (RMS) in Japan and the other countries
    

Detailed description: 
      This study had 2 parts: A controlled Core and an open-label Extension.

        -  Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group,
           multicenter study evaluated the efficacy, safety and tolerability and PK of ofatumumab
           in patients with RMS.

        -  Extension part: The Core part was followed by an Extension part in which all patients
           received open-label ofatumumab. In the Extension part, patients were treated for at
           least 24 weeks and no longer than 48 weeks.

      Sixty-four patients were randomized in a 2:1 ratio to ofatumumab or placebo in the Core part;
      half of the study patients were from Japan and the other half from the other countries.
    

Intervention name(s): Ofatumumab; Matching placebo of ofatumumab
Intervention type(s): Drug; Drug
Intervention description(s): Provided in pre-filled syringes for subcutaneous injection (s.c.) administration containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content); Matching placebo in pre-filled syringes
Intervention MeSH terms: Ofatumumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: double-blind; placebo controlled; ofatumumab; relapsing multiple sclerosis; Japanese patients; MS; RMS; adult; OMB157
Rural Interventions for Screening Effectiveness
Condition: Breast, Cervical or Colorectal Cancer Screening Needed
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This randomized clinical trial studies how well a tailored interactive digital versatile disc
      (DVD) with or without patient navigation works in improving screening rates in rural women
      for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and
      patient navigation may help rural women to learn more about cancer screening and to better
      understand the results.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Compare the effectiveness of a tailored and interactive DVD (TIDVD) versus (vs.) TIDVD +
      telephone-based patient navigation (PN) intervention (TIDVD + PN) vs. usual care (UC), to
      increase guideline-based cancer screening rates at 12 months post randomization for breast
      cancer (BC), cervical cancer (CC), and colorectal cancer (CRC) among 1058 women age 50 to 74
      living in rural northwest Ohio and northeast Indiana.

      II. Compare the cost effectiveness of the TIDVD and the TIDVD + PN intervention vs. UC, for
      adherence to each screening outcome or combination of screening tests.

      OUTLINE: Patients are randomized to 1 of 3 arms.

      Arm I: Patients watch a tailored interactive DVD program and answer questions posed by the
      DVD program.

      Arm II: Patients engage in TIDVD and PN.

      Arm III: Patients receive brochures that explain and provide encouragement for cancer
      screening.

      After completion of the study, patients are followed up at 2 and 12 months.
    

Intervention name(s): Educational Intervention via brochure; Educational Intervention via DVD; Educational Intervention-DVD & Telephone Based Navigation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Educational Intervention via brochure:
In this arm of the educational intervention the participant receives brochures; Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch; Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator
Other intervention name(s): Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: RISE
A Study of Qishenyiqi Dripping Pills in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of Qishenyiqi Dripping Pills in healthy
      participants, following oral administration with multiple escalating dose of it.
    

Detailed description: 
      Qishenyiqi dripping pills, which are made of Huangqi, Danshen, Sanqi, active ingredients of
      Jiangxiang, have the efficacy of beneficial effects of qi and pulse, blood circulation and
      pain relief.

      This study is a randomized, double-blind, placebo-controlled, dose-escalation design study,
      including three cohorts and 36 healthy participants. Within each cohort, participant will
      receive Qishenyiqi dripping pills at the selected dose level by oral administration three
      times a day for 28 consecutive days.
    

Intervention name(s): Qishenyiqi dripping pills, 6 bags; Qishenyiqi dripping pills, 9 bags; Qishenyiqi dripping pills, 12 bags; Qishenyiqi dripping pills placebo, 6 bags; Qishenyiqi dripping pills placebo, 9 bags; Qishenyiqi dripping pills placebo, 12 bags
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 28 consecutive days; 28 consecutive days; 28 consecutive days; 28 consecutive days; 28 consecutive days; 28 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Qishenyiqi Dripping Pills
Human Phototoxicity Test (823/2016)
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Phototoxic
Study type: Interventional

Summary: 
      To determine the phototoxic potential of a topically applied article in human subjects
    


Intervention name(s): BAY987517; Untreated Skin
Intervention type(s): Drug; Other
Intervention description(s): 50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. (Formulation: Z43-078); This site is patched without treatment as irradiated control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study
Condition: Facial Nerve Palsy; Bell's Palsy
MeSH terms: Bell Palsy; Facial Paralysis; Facial Nerve Diseases; Paralysis
Study type: Interventional

Summary: 
      To investigate the Effect of Kabat motor control re-education therapy on facial nerve Electro
      physiological responses and facial muscles function in bell's palsy.

      BACKGROUND: facial nerve recovery in children could be improved through facilitation of nerve
      regeneration which can be enhanced through Kabat motor control re-education therapy.
    

Detailed description: 
      Thirty children with bell's palsy will participate in this study. The patients will randomly
      be divided into two equal groups; the control group received the conventional selected
      program, and the study group received the same exercise training program in addition to Kabat
      motor control re-education therapy. The program of treatment will be three times per week for
      six weeks.

      The evaluation methods: Facial nerve distal latency, amplitude, and percentage of
      degenerations via the Neuropack S1 MEB9004 EMG device, the Facial Disability Index, and
      Sunnybrook facial grading system (SBFGS) all the assessment methods before the program and
      after finishing the program
    

Intervention name(s): Kabat motor control re-education therapy; conventional selected program
Intervention type(s): Other; Other
Intervention description(s): Kabat motor control re-education therapy that includes specific movements with predefined patterns of facial muscles exercises, which is spiral and diagonal movements involve the facial muscles, which are brought to train in global patterns. The program of treatment for three times per week for six weeks.; the conventional selected program in the form of electrical stimulation (Faradic current) of affected muscles, facial muscle exercise program in front of the mirror, and home advices.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control group which received conventional selected program, and study group received the same exercise training program in addition to Kabat motor control re-education therapy
Masking: None (Open Label)
Primary purpose: Treatment
A Novel Smartphone Application for "Smart" Trials
Condition: Healthy
Study type: Observational

Summary: 
      The overarching goal is to develop a mHealth App that can use smartphone embedded sensors to
      objectively collect physical function data in healthy individuals in the context of daily
      life.
    

Detailed description: 
      The goal is to develop a mHealth App using smartphone embedded sensors to objectively collect
      physical function data in healthy individuals in the context of daily life. The investigators
      will perform technical development of an internet-interactive App to collect, analyze and
      transfer the subjects' data. As a proof-of-concept, the mHealth App will execute algorithms
      that automate deployment of three well-established physical function tests. In a laboratory
      setting, it will be evaluated usability, acceptability and reliability of the mHealth App
      compared with traditional performance tests among focus groups. The investigators will then
      evaluate its usability and acceptability when used in the participants' home environments.
    

Intervention name(s): Mobile Health App
Intervention type(s): Device
Intervention description(s): There is no intervention
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study includes healthy subjects who are equal or greater than 50 years old.
      
Keywords: Technology; Physical Function
Temporary Biventricular Pacing
Condition: Right Ventricular (RV) Dysfunction
Study type: Interventional

Summary: 
      The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic
      performance in patients with right ventricular dysfunction after open cardiac chamber cardiac
      surgery.
    


Intervention name(s): left ventricular epicardial pacing lead
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: after open cardiac chamber cardiac surgery
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to
      assess the effects of varying doses and schedules of oral insulin on immunological and
      metabolic markers in relatives at risk for type 1 diabetes (T1D).
    

Detailed description: 
      A minimum of 40 eligible participants will be identified for study participation from the
      TrialNet Pathway to Prevention study. Participants must have a relative with type 1 diabetes
      and be positive for insulin autoantibodies and at least one other autoantibody. All
      participants will receive active treatment of recombinant insulin treatment in capsules of
      either 67.5 mg daily or 500mg every other week. Participants will need to visit the study
      site up to eleven times over one year for blood tests and other study procedures. During the
      beginning treatment phase there are two visits one month apart for those given the 67.5 mg
      dose, and three visits two weeks apart to titrate the dose for those in the 500mg treatment
      group. There are three additional treatment visits at months 2, 3, and 6 and 4 additional
      visits for follow-up at months 7, 8, 9 and 12. The primary outcome is the change in immune
      function as assessed by change in level or quality of T lymphocyte or autoantibody biomarkers
      measured between 13 and 26 weeks compared to baseline. .
    

Intervention name(s): 67.5 mg oral insulin crystals daily; 500mg oral insulin crystals every other week
Intervention type(s): Drug; Drug
Intervention description(s): human insulin crystals in capsules; human insulin crystals in capsules
Other intervention name(s): Humulin R crystals; Humulin R crystals
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: oral insulin
Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.
    


Intervention name(s): Fostamatinib; Fostamatinib; Fostamatinib; Fostamatinib; Fostamatinib
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablets, 50 mg x 2, single dose; Oral tablets, 50 mg x 3, single dose; Oral tablets, 100 mg, single dose; Oral tablets, 150 mg, single dose; Oral tablets, 50 mg x 2, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy male volunteers; pharmacokinetics; fostamatinib; Scientific Terminology: Bioavailability, R406 plasma AUC and C_maxR406 plasma AUC0-t, t1/2λz and t_max; Laymen Terminology: Amount of R406 in blood
Clinical Value of Self-assessment Risk of Osteoporosis in Chinese
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      This cross-sectional study aimed to validate the effectiveness of the combined use of the
      Osteoporosis Self-Assessment Tool for Asians (OSTA) and the One-Minute Osteoporosis Risk Test
      (IOF test) in a population from Wuhan, China.
    

Detailed description: 
      This cross-sectional study was a field investigation. A total of 400 Wuhan residents who
      visited the Health Examination Department at our hospital were invited to participate in this
      study. Potential participants were informed of the aim and procedures and were asked to sign
      an informed consent form before participation. Inclusion criteria were as follows: age of at
      least 20 years, able to read and fill out the questionnaire, and willingness to participate.
      Exclusion criteria were as follows: severe liver, heart, or kidney impairment, and tumor.
      Procedures of the study were in accordance with the Declaration of Helsinki and were approved
      by the local ethics committee.

      The study population was divided into four groups according to age and sex: Younger Women
      (age ≤ 55 years), Younger Men (age ≤ 55 years), Older Women (age > 55 years), and Older Men
      (age > 55 years). A research assistant and a nurse distributed the Chinese version of the IOF
      test to participants. The Chinese version of the IOF test includes 10 questions, two of which
      are specific to women and one to men. The maximum number of risk factors is 8 for women and 9
      for men. Individuals were regarded as susceptible to osteoporosis risk if they answered "yes"
      to any of the 10 questions.

      To assess the grade of osteoporosis risk, the OSTA index was calculated by the equation (body
      weight (kg) - age (years))*0.2. An OSTA index of -1 to -4 is regarded as medium risk, greater
      than -1 as low risk, and less than -4 as high risk.
    

Intervention name(s): questionaire
Intervention type(s): Other
Intervention description(s): Arm: Experimental :questionaire medium risk, and high risk.(more than one positive answer about questionaire) Arm:Active Comparator: questionaire low risk (none of positive answer about questionaire)
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        age of at least 20 years, able to read and fill out the questionnaire, and willingness to
        participate.
      
Keywords: Osteoporosis; Osteoporosis Self-Assessment Tool; One-Minute Osteoporosis Risk Test; Asians
Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy
Condition: Glomerulonephritis, IGA; Nephropathy, IGA; IGA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA; Glomerulonephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus
      oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.
    


Intervention name(s): ACE inhibitor + statin; Sirolimus (study drug)+ACE inhibitor + statin
Intervention type(s): Drug; Drug
Intervention description(s): sirolimus starting at 1 mg/d (target 3-6 ng/ml) plus enalapril starting at 5 mg/d to control blood pressure plus atorvastatin starting at 10 mg/d; enalapril starting at 5 mg/d in order to control blood pressure. Atorvastatin starting at 10 mg/d
Intervention MeSH terms: Sirolimus; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nephropathy, IGA; Pilot trial; Sirolimus; Rapamune
Neurorehabilitation of the Hand
Condition: Stroke
Study type: Interventional

Summary: 
      Stroke is the number one cause of adult disability in the world. Due to the neurological
      damage from stroke, a vast majority of individuals suffer from hand function disability
      (~70%). To improve hand function and overcome challenges from this disability, IRegained has
      developed the MyHandTM system, a connected mechatronic device with programmed proprietary
      hand function training protocols developed through deep research in neuroplasticity that
      provide targeted hand function therapy. When these therapeutic protocols are provided in a
      gamified format, it enhances the patient engagement and motivation, thereby enabling
      effective therapy administration with the required intensity and repetition to improve hand
      function. Participants who have sustained a stroke 6 months or earlier will be eligible to
      participate in this study, and will undergo hand function therapy for one 1-hour/session, 5
      times/week, over a 3-week duration, for a total of 15 sessions. Therapy will be administered
      through with specific hand functions in a gamified format to enhance greater function in the
      hand and thereby help patients gain greater independence in performing activities of daily
      living. This research project will aim to understand the extent to which this approach to
      therapy impacts patient motivation and engagement in order to develop the most efficient and
      effective mode of therapy.
    


Intervention name(s): MyHand System Hand Rehabilitation
Intervention type(s): Device
Intervention description(s): 15 1-hour patient specific sessions using the MyHand System to help improve Hand function in the affected hand of stroke survivors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hand Function; Rehabilitation; Engagement; Motor control