bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      AC-1202 (Ketasyn) is a nutritional beverage currently being studied in neurodegenerative
      conditions including Alzheimer's disease. The current study is a randomized, open-label trial
      to compare the safety, tolerability, and PK profiles of 3 formulations of Ketasyn
      administered on a daily basis for 14 days, with and without a 7-day titration period, in
      normal, healthy elderly volunteers.
    

Detailed description: 
      Sixty healthy, elderly volunteers between the ages of 55 and 85 will be enrolled at one of
      four clinical sites in the Tampa/St. Petersburg area. Subjects with a history of GI
      inflammatory conditions (e.g., IBS or diverticulitis) or other clinically significant
      abnormalities will be excluded from enrollment. Subjects will be randomized to one of two
      dosing regimens (with or without a 7-day titration period) and to one of three formulations
      of Ketasyn containing the identical amount of active ingredient, but different amounts of
      proteins and carbohydrates. Subjects assigned to Group 1 will receive 10 grams active
      ingredient daily on Days 1-7, followed by a daily dose of 20 grams active ingredient on Days
      8-14. Subjects assigned to Group 2 will receive 20 grams active ingredient on Days 1-14. All
      subjects will have clinic visits on Day 1 and 14; subjects assigned to Group 1 will also have
      a clinic visit on Day 8. Subjects will fast prior to each clinic visit and have vital signs
      and routine lab tests performed prior to dosing. A standard breakfast will be served along
      with the study product, following which blood samples will be collected for product
      concentration levels.
    

Intervention name(s): Ketasyn
Intervention type(s): Other
Intervention description(s): 10g for 7 days, 20g for 7 or 14 days
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy elderly male and female subjects 55 - 85 years of age
      
Biospecimen description: 
      plasma beta-hydroxybutyrate
Effect of LANCONONE in Weight-bearing Joint Pain
Condition: Osteo Arthritis Knee
MeSH terms: Arthralgia; Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The current study has been designed to primarily assess the effect of Lanconone® in
      comparison to placebo on pain in weight bearing joints.
    


Intervention name(s): Lanconone®; Methyl crystalline cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules; 2 Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This clinical trial investigated the combined effects of Semaglutide and a fiber supplement
      (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity.
      Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two
      groups: one receiving Semaglutide with active fiber supplements and the other with
      Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in
      body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating
      the additive effects of dietary fibers in enhancing Semaglutide's efficacy.
    


Intervention name(s): Fiber Supplement Group; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Semaglutide (2.4 mg weekly). Three daily packets of active fiber supplement (each containing 1g of glucomannan, 1g of inulin, and 3g of psyllium), taken 30 minutes before each main meal. The supplement is provided by S.Lab (Soloways), LLC.; Semaglutide (2.4 mg weekly). Three daily packets of placebo powder, taken 30 minutes before each main meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Semaglutide; Weight Loss; Obesity; Appetite Suppression
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
Condition: Regurgitation, Gastric; Diarrhea
MeSH terms: Laryngopharyngeal Reflux; Diarrhea
Study type: Interventional

Summary: 
      A randomized, controlled study to evaluate the safety and tolerance of an infant formula with
      locust bean gum in infants with regurgitation. (Solar)
    


Intervention name(s): milk based anti-regurgitation infant formula; Milk based infant formula
Intervention type(s): Other; Other
Intervention description(s): Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.; Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Relationship of Aerobic Capacity With Agility, Core Muscle Endurance and Peripheral Muscle Strength in Adolescent Basketball Players
Condition: Sports Physical Therapy
Study type: Observational

Summary: 
      The aim of this study is to investigate the relationship of aerobic capacity with agility,
      core muscle endurance and peripheral muscle strength in adolescent basketball players.
    

Detailed description: 
      A basketball player must have good physical condition to contribute to the team. In this
      physical condition, especially cardiorespiratory endurance (aerobic and anaerobic capacity),
      agility, muscle endurance and strength are important for basketball.

      Revealing the interaction of aerobic capacity, which is critical for basketball, with other
      physical fitness components such as agility, core muscle endurance and peripheral muscle
      strength may shed light on the shaping of basketball players' exercise programs.
    

Intervention name(s): Multi-Stage 20 m Shuttle Run Test
Intervention type(s): Other
Intervention description(s): The aerobic capacities of the participants will be evaluated with the Multi-Stage 20 m Shuttle Run Test, their agility levels with the Pro Agility Test, their core muscle endurance with the McGill Trunk Extensor and Flexor Endurance test and their peripheral muscle strength with the MicroFET® 2" handheld dynamometer.
Other intervention name(s): Pro Agility Test; McGill Trunk Extensor and Flexor Endurance test; MicroFET® 2" handheld dynamometer
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adolescent Male Basketball Players
      
Keywords: Basketball; Aerobic Capacity; Agility; Core Muscle Endurance; Peripheral Muscle Strength
Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia
Condition: Cervical Persistent High Risk HPV Infection; Cervical Intraepithelial Neoplasia
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections; Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of
      cervical precancerous lesions in women.
    


Intervention name(s): Aminolaevulinic acid photodynamic therapy
Intervention type(s): Drug
Intervention description(s): Aminolaevulinic acid mediated photodynamic therapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the use of a new vapocoolant spray, Pain Ease, to
      reduce intravenous (IV) insertion pain in school-aged children receiving treatment in the
      Emergency Department.
    

Detailed description: 
      Inserting a needle into a child's vein is a distressing experience for children. Reducing the
      pain of injection and avoiding the child's discomfort remains an important aim for both
      parents and health care workers. Withdrawing blood and intravenous insertion (IV) in children
      is also time consuming, especially when the child is uncooperative and stressed.

      We, the researchers at Children's Hospital of Eastern Ontario, have been searching for an
      effective, rapid and inexpensive method to alleviate the distress associated with
      venipuncture and IV insertion.

      Medications by mouth, such as anti-anxiety drugs, are helpful but usually do not
      significantly reduce the pain. The most commonly used anti-anxiety drug at our institution is
      midazolam, but unfortunately onset of action takes 20-30 minutes. There are various forms of
      topical creams that can numb the skin. EMLA, a mixture of two local anesthetics (Lidocaine
      2.5% and Prilocaine 2.5%), is applied as a topical cream and is covered with an occlusive
      dressing. It requires at least 1 hour to be effective. It is not only time consuming but
      expensive (~$1.30 per application). Ametop (Tetracaine PH. Eur.4%w/w) is another effective
      topical cream, which works in 30 minutes, but it is more expensive than EMLA (~$3.00 per
      application). Vapocoolant sprays applied for ~10 seconds immediately before injection have
      been shown to be faster, less expensive and as effective as EMLA in reducing pain at the site
      of injection during immunization.

      The current investigation will evaluate the quality, efficacy and costs associated with the
      use of a new vapocoolant spray, Pain Ease, in reducing pain associated with IV insertion for
      school age children.
    

Intervention name(s): Pain Ease
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IV; cannulation; Injections, Intravenous
A Comparison Between the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training Early After Stroke
Condition: Stroke; Gait, Hemiplegic; Ambulation Difficulty; Hemiparesis
MeSH terms: Stroke; Paresis; Gait Disorders, Neurologic; Mobility Limitation
Study type: Interventional

Summary: 
      Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on
      short- and long-term functioning, disability and health compared to conventional gait
      training as part of an inpatient rehabilitation program early after stroke.
    

Detailed description: 
      To compare outcome after 4 weeks of gait training with HAL vs. 4 weeks of conventional gait
      training as part of a regular inpatient rehabilitation program for hemiparetic patients with
      severely limited mobility early after stroke.

      Study design: Randomized, controlled study with blinded outcome assessment.

      Conventional gait training is individualized and performed according to current practice
      (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight
      shifting, stepping, over ground walking with assistance and/or assistant devices as well as
      the use of a treadmill and body weight support. Conventional gait training is offered to both
      study groups.

      Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for
      each session is individualised but does not exceed 60 minutes/session (effective time).
      Training with HAL is performed in combination with body-weight support system and on a
      treadmill. The training program is performed by 2 physiotherapists, who have been trained in
      the HAL method.
    

Intervention name(s): Hybrid Assistive Limb (HAL); gait training; Control Group; Conventional gait training
Intervention type(s): Device; Other
Intervention description(s): Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.; Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.
Other intervention name(s): Hybrid Assistive Limb (HAL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Robotics
Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)
Condition: Aortic Valve Disease
MeSH terms: Aortic Valve Disease
Study type: Observational

Summary: 
      The overall project aim is to study outcomes following aortic valve replacement with either
      mechanical valves or bioprostheses by retrieving data from the main social security carriers
      in Austria for the years 2010-2020 in under 50 year old patients.
    

Detailed description: 
      The purpose of this research project is to evaluate mortality (primary outcome) and incidence
      of heart attack, stroke, reoperation and first diagnosis of heart insufficiency, MACE
      (secondary outcomes) after aortic valve replacement in under 50 year olds. We aim to compare
      those outcomes between mechanical valves and bioprostheses.

      Data will be retrieved from the main social security carriers in Austria (covering 98% of its
      population) from 2010-2020.
    

Intervention name(s): Aortic Valve Replacement
Intervention type(s): Device
Intervention description(s): Surgical replacement of aortic valves
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who underwent isolated surgical aortic valve replacement in Austria above 18
        years and below 50 years of age with no other concomitant heart surgery were included.
Breakfast for Young Females
Condition: Overweight and Obesity; Overweight Adolescents; Metabolic Disease
MeSH terms: Overweight; Metabolic Diseases
Study type: Interventional

Summary: 
      Investigators will test the health effects of eating a dairy-based protein-rich breakfast or
      isocaloric breakfast and performing regular physical exercise training for 12 weeks in young
      overweight women (2 x 2 factorial design). Measurements of body composition, physical
      fitness, metabolic health parameters, faeces and urine metabolites, and food diary will be
      collected.
    

Detailed description: 
      The study is a 2×2-factorial randomized controlled trial with 4 study arms. One-hundred (100)
      subjects will be randomly allocated to eat breakfast consisting of high-protein yoghurt
      (300g/day) with oats or an isocaloric breakfast consisting of bread, jam and juice matched
      for fat and fiber content and to either exercise 3x per week or maintain habitual physical
      activity for 12 weeks. Measurements and biological sampling will be performed at baseline,
      half way (some parameters only) and at the end of the intervention period.

      The primary outcome will be fat mass and fat free mass determined by DXA. The investigators
      will also measure effects on weight, waist, health-related blood parameters, muscle function,
      physical activity, habitual food intake and metabolites in faeces, urine and blood.
    

Intervention name(s): Low protein breakfast; High protein breakfast; Exercise training
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume ~60 g bread, 20 g jam and 250 ml juice for breakfast.; High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats for breakfast.; Participants will be asked to participate in organized exercise training 3 times per week.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dairy protein; Breakfast content; body composition; Muscle strength; Gut microbiota/microflora; Dietary recommendations; Exercise training
A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy Adults
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of a low-fat and high-fat meal on the
      medicine called PF-07284890 following three single doses PF-07284890. The study will include
      male participants and female participants of non-childbearing potential who are healthy.
      Participants will be required to stay in the clinical research unit for 15 days and 14
      nights.
    


Intervention name(s): PF-07284890 Treatment A; PF-07284890 Treatment B; PF-07284890 Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF-07284890 tablet by mouth while fasting; PF-07284890 tablet after low fat meal; PF-07284890 tablet after high fat meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food effect study
Acu-TENS for Pain Relief During Colonoscopy
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Background:

      Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric
      Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used
      successfully to treat pain of various origins, but few good-quality studies have evaluated
      its role in treating pain and anxiety during colonoscopy.

      Objective:

      To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the
      consumption of sedatives/analgesics during colonoscopy.

      Design:

      Prospective, randomized, placebo-controlled study.

      Subjects:

      One hundred and twenty eight consecutive patients undergoing first-time elective day-case
      colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.

      Interventions:

      Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before
      colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension,
      including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS
      group, a non-conductive plastic film will be placed between the acupoint and the electrode so
      that no current will be transmitted. Acu-TENS and placebo-TENS will be continued throughout
      colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe
      pump, will be used for sedation/analgesia in both groups.

      Outcome measures:

      Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes:
      pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time,
      and episodes of hypotension/desaturation.
    


Intervention name(s): Acu-TENS; Placebo-TENS
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients randomized to the experimental group will receive Acu-TENS on acupoints relevant to the treatment of abdominal pain and distension, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), Neiguan (pericardium meridian PC-6), Tianshu (stomach meridian ST-25), and Dachangshu (bladder meridian BL-25).; Patients randomized to the control group will receive placebo-TENS at the same acupoints.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Pilates in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence
Condition: Prostate Cancer; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy between a Pilates exercise program and a
      Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES)
      in muscular pressure strength of the pelvic floor as conservative treatment of urinary
      incontinence after prostatectomy.
    

Detailed description: 
      This randomized clinical trial includes 115 individuals with urinary incontinence one month
      after radical prostatectomy. One physiotherapist, with experience in urogynecology, was
      responsible for all the assessments. muscular pressure strength of the pelvic floor, 24-hour
      pad test and the International Consultation on Incontinence Questionnaire - Short Form
      (ICIQ-SF) were the variables evaluated.

      The subjects were allocated in one of three treatment groups (G1: Pilates; G2: anal
      electrical stimulation combined with pelvic floor muscle training and G3: Control Group).
    

Intervention name(s): Pilates; PFMT and AES; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Pilates exercises; conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment