bioihbjkbjnl/mcl2 huggingface dataset:
Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial
Condition: Health Behaviour
Study type: Interventional

Summary: 
      A randomised controlled trial to test if offering three visits to a dietician + two visits to
      a physiotherapist over six months + a home sphygmomanometer, will result in a reduction in
      sodium intake and an increase in fitness in people over 75yrs. Volunteers were enrolled from
      Oct 2008 to July 2009.
    

Detailed description: 
      There is evidence that both sedentary lifestyle and high sodium diets contribute to
      cardiovascular disease and possibly dementia among the elderly. There is a need to show that
      minimal intervention can reduce sodium intake and increase fitness in the elderly. Finland
      has shown that five dietician visits/year could change diet in respect to fat and fibre. In
      Australia the National Health Insurer (Medicare) funds five allied health visits/year for
      those with chronic disease, hence our use of this model. This is consistent with WHO
      guidelines for a national approach using existing health infrastructure. The elderly
      (75-95yrs) were chosen as this group is thought most difficult to change behaviour and has a
      higher incidence of dementia.
    

Intervention name(s): Lifestyle counselling
Intervention type(s): Behavioral
Intervention description(s): as in Arm Description
Other intervention name(s): salt reduction in the elderly; increased fitness in the elderly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Elderly; Sodium reduction; Fitness increase; Primary Care
Determination of Protein Requirement in Elderly Male Subjects 65-75 Yrs Old.
Condition: Healthy Males 65-75 Yrs Old
Study type: Interventional

Summary: 
      Minimal data are available on protein requirements throughout the lifespan. Currently
      available recommendations are based on nitrogen balance data. The limitations of the nitrogen
      balance method have been well described. Importantly, nitrogen balanced underestimates
      requirements.

      The current dietary reference intakes (DRI) requirement for healthy adult males is based on
      the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was
      reanalyzed statistically by Rand et al. and he concluded that the protein requirement of
      healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using
      indicator amino acid oxidation (IAAO), our group estimated the protein requirement of young
      men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).

      Currently there are no studies on protein requirement in the elderly. In a recent nutrition
      survey conducted by national health and nutrition examination survey (NHANES), the authors
      concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0
      g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on
      the calculations used for ideal body weight some older adults could be getting higher or
      lower than requirement. There is no scientifically derived protein estimate for older adults.
      Therefore there is a need to measurer protein requirement in that population.

      The goal of this study therefore is to measure the protein requirement of male elderly
      subjects between the ages of 65 - 75 years using the IAAO technique.
    


Intervention name(s): protein intake
Intervention type(s): Dietary Supplement
Intervention description(s): on the study day, the diet will be provided as free amino acids,with calories made up by a liquid diet and protein free cookies. Protein intake will be varied at 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8, and 2.0 g.kg/day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Radial Extracorpeal Shock Wave on Pain and Function
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      The purpose of the current study will be focused on the following issues. Evaluation of the
      effect of radial extracorporeal shock wave on the pressure pain threshold and disability in
      stroke hemiplegic shoulder.
    

Detailed description: 
      Further understanding of rotator cuff tendon impairment and other shoulder soft tissue
      structural abnormalities in stroke patients may help clinicians in assigning more complete
      therapeutic plans to hemiplegic patients. The radial extra-corporeal shock-wave therapy has
      promising results in patients with musculoskeletal problems and in those with various causes
      of HSP, including spasticity, rotator cuff problems, adhesive capsulitis, and complex
      regional pain syndrome.
    

Intervention name(s): radial extracorpeal shock wave
Intervention type(s): Device
Intervention description(s): Swiss DolorClast® Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The selected patients will be randomly assigned to two equal groups (study group (GI), and control group (GII).
The study group (GI) will be treated by the radial extracorporeal shock wave in addition to design physical therapy program.
The control group (GII) will be treated by sham radial extracorporeal shock wave in addition to the same design physical therapy program of (GI).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pain thrshold; ROM
Evaluation of Short Implants' Success for Teeth Replacement in Atrophic Posterior Mandibular Ridge
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The aim of this study was to evaluate clinically and radiographically the splinted short
      implants' and single short implants' stability and bone condition before and after loading,
      in atrophic posterior mandibular alveolar ridges.
    

Detailed description: 
      A prospective study was conducted on 16 Patients with missing posterior molars. Group A: 8
      patients had 2 short implants placed in atrophic posterior mandibular alveolar ridge. Group
      B: 8 patients had a single short implant placed in atrophic posterior mandibular alveolar
      ridge.
    

Intervention name(s): Double short implant; Single short implant
Intervention type(s): Other; Other
Intervention description(s): Patients receives 2 short implants to restore missing posterior teeth, loaded with splinted screw retained crowns.; Patients receives single short implants, loaded with single screw retained crowns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Short implant; Splinted short implant
Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the relative bioavailability (rate and extent of absorption) of 180
      mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.
      with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral
      dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Fexofenadine 180 mg tablets; ALLEGRA® 180 mg tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 180 mg; 1 x 180 mg
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will be conducted in compliance with the International Council for Harmonisation
      (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
      Clinical Practice (GCP) and applicable regulatory requirements.

      This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with
      Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and
      efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as
      lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm
      A) or to receive JCAR017 (Arm B).

      All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP,
      RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT)
      and Hematopoietic stem cell transplant (HSCT).

      Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an
      EFS event.

      Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by
      JCAR017 infusion.
    


Intervention name(s): Standard of Care; JCAR017
Intervention type(s): Drug; Genetic
Intervention description(s): Standard of Care; JCAR017
Other intervention name(s): lisocabtagene maraleucel or liso-cel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Hodgkin Lymphomas; DLBCL; Efficacy; Safety; JCAR017; Liso-cel; High-Risk; Relapsed; Refractory; B-cell NHL
Physiotherapist Led Group-exercise Compared Physical Activity on Prescription, a 3 Months Follow-up
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      To investigate the effect of exercise or PAP prescription 3 months after completion of the
      study "Should elderly patients with atrial fibrillation be offered physiotherapist group
      exercise or can physical activity on prescription (PAP) be used as an alternative?" regarding
      level of physical fitness, physical activity, heart rate and health related quality of life
      (HR-QoL). Also if any of the investigated variables can predict the possible change in
      physical fitness.
    

Detailed description: 
      Patients who have completed study will be offered a follow-up after 3 months regarding
      physical fitness, physical activity, heart rate and HR-QoL. Physical fitness will be measured
      by a symptom limited bicycle test and a muscle endurance test. Physical activity will be
      measured by accelerometer and the International Physical Activity Questionnaire (IPAQ) and a
      physical activity diary, HR-QoL will be measured by short form (SF-36).
    

Intervention name(s): No intervention in the follow up study.
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have completed the primary study will be offered a follow-up after 3 months
      
Keywords: Follow up; Exercise; Rehabilitation
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Condition: Diarrhea-Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      New and effective treatments are needed for patients with post-infectious irritable bowel
      syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy
      and safety of glutamine, an abundant amino acid in the body and the principal fuel for
      enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with
      increased intestinal permeability following an enteric infection.
    

Detailed description: 
      In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal
      permeability were randomly assigned to receive either glutamine (5 g three times daily) or
      placebo for eight weeks. The primary end point was the proportion of patients who had a
      reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).
    

Intervention name(s): Glutamine
Intervention type(s): Drug
Intervention description(s): Drug
Other intervention name(s): L-Glutamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Glutamine; Intestinal Permeability
A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function
Condition: Moderate Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to compare the pharmacokinetics (PK) of a single oral
      dose of mitapivat in participants with moderate hepatic impairment to that in matched healthy
      control participants with normal hepatic function.
    


Intervention name(s): Mitapivat
Intervention type(s): Drug
Intervention description(s): Mitapivat tablets
Other intervention name(s): AG-348; AG-348 sulfate hydrate; Mitapivat sulfate
Intervention MeSH terms: Mitapivat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AG-348; Healthy Volunteer; Hepatic Impairment; pharmacokinetic
Regulation of Intestinal and Hepatic Lipoprotein Particle Production by Blood Glucose in Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of study is to examine whether raised blood glucose enhances lipid particle
      production independent of effects on gastric emptying and pancreatic/ gastrointestinal
      hormone production.
    

Detailed description: 
      This study will be performed on healthy, lean, non-diabetic males and females who will
      participate two studies each in random order, 4 to 6 weeks apart. Study A: lipoprotein
      turnover with intravenous infusion of normal saline. Study B: lipoprotein turnover i.v
      infusion of glucose. In both studies, subjects will drink a liquid formula every hour to
      remain in a constant fed state and will be under conditions of pancreatic clamp (with the
      infusion of hormones somatostatin, insulin, glucagon, growth hormone). Subjects will be
      blinded with regard to the treatments.
    

Intervention name(s): glucose or normal saline
Intervention type(s): Biological
Intervention description(s): 20% glucose solution or normal saline, intravenous infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: lipid handling by the gut and liver
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis
Condition: Renal Impairment; Hemodialysis
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928
      in participants with varying level of renal function or impairment.
    


Intervention name(s): INCB000928
Intervention type(s): Drug
Intervention description(s): INCB000928 200 mg will be administered on Day 1 of each treatment period.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal impairment; hemodialysis; Kidney failure; end-stage renal disease; Fibrodysplasia ossificans progressiva
Auricular Stimulation vs. Relaxation for Pre-exam Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Title of the study: Auricular acupuncture (AA) vs. progressive muscle relaxation for pre-exam
      anxiety - a randomised crossover study

      Study period: 04 / 2015 - 07 / 2015

      Principal Investigator: PD Dr. T. Usichenko Department of Anaesthesiology and Intensive Care,
      University Medicine of Greifswald

      Aim of the study: To investigate the anxiolytic effect of AA vs. progressive muscle
      relaxation and vs. no intervention in students, passing the oral exams in anatomy at the
      University of Greifswald

      Design: Prospective randomised crossover trial

      Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Progressive
      muscle relaxation

      Number of volunteers: N = 30

      Healthy medical students at the University of Greifswald Participants of the oral anatomy
      exams in spring/summer 2015 Without previous anxiolytic, sedative and analgesic medication No
      pregnancy or lactating Informed consent

      Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase
    


Intervention name(s): Auricular stimulation; Relaxation
Intervention type(s): Device; Behavioral
Intervention description(s): Auricular stimulation with indwelling fixed needles; Progressive muscle relaxation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Inspiratory Muscle Training in Children With Chest Burn
Condition: Burns; Respiratory Function Impaired; Children
MeSH terms: Respiratory Insufficiency; Burns
Study type: Interventional

Summary: 
      8 weeks of inspiratory muscle training combined with a pulmonary rehabilitation program
      increases respiratory muscle strength, pulmonary function, functional capacity, and quality
      of life in chest burned children.
    

Detailed description: 
      The primary purpose of this study is to see how an inspiratory muscle training program along
      with a pulmonary rehabilitation program improved respiratory muscle strength, respiratory
      function and quality of life after children with chest burns were discharged from the
      hospital.
    

Intervention name(s): inspiratory muscle training; pulmonary rehabilitation
Intervention type(s): Other; Other
Intervention description(s): training done with a pressure threshold-loading device; Circuit training of aerobic and resistive exercise
Other intervention name(s): inspiratory resistance; Aerobic and resistance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chest burn; respiratory muscle strength; lung function
Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of dietary supplement with Camel Milk
      containing Bifidobacterium animalis A6 on the plasma glucose and other related cytokines in
      patients with type 2 diabetes mellitus. 45 patients with type 2 diabetes mellitus were
      recruited, and a Double Blind Randomized Parallel Controlled Trial was performed. The fasting
      glycaemia, 2 hour postprandial glycaemia, insulin, uric acid and serum lipid (total
      cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density
      lipoprotein cholesterol ) were measured as Primary Outcome. The Fecal microbiome, fecal
      metabolites, gut hormones (amylin, ghrelin, glucagon-like peptide 1, pancreatic polypeptide),
      inflammation cytokines (TNF-α, IL-6, MCP-1), myokines (FGF-21, irisin, osteocrin/musclin,
      osteonectin) and adipokines (adiponectin, resistin, lipocalin-2, adipsin) and body
      composition analysis were also assessed.
    


Intervention name(s): Camel milk containing Bifidobacterium animalis A6; Camel milk; Bifidobacterium animalis A6; Cow milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.; Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.; Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.; Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Camel Milk; Probiotics; Gut Microbiome
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity in terms of antibody response and
      the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse
      events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine
      GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined
      vaccine and rotavirus vaccine in children during the first 6 months of life.
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Synflorix; Infanrix hexa; Rotarix
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses.; Intramuscular injection, 3 doses.; Oral, 2 doses.
Other intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; DTPa-HBV-IPV/Hib; HRV vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine.; Pneumococcal disease; Safety; Immunogenicity; Primary vaccination