bioihbjkbjnl/mcl2 huggingface dataset:
Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Sensory and motor cueing have been demonstrated as useful ambulation training techniques for
      Parkinson's disease (PD). This study is aimed to evaluate the effectiveness of treadmill
      training program with music cueing for mild to moderate PD patients.
    


Intervention name(s): Music and treadmill walking program; Treadmill walking program; Home program
Intervention type(s): Other; Other; Other
Intervention description(s): Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks; Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks; Home walking program 6 days/wk x 4 weeks
Other intervention name(s): Music cueing; Treadmill
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Cueing training; Treadmill training; Music
Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailability of BI
      1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This
      assessment will be performed under fasted conditions. Furthermore, the effect of food on
      relative bioavailability of the tablet formulation of BI 1467335 will be investigated.
    


Intervention name(s): BI 1467335 (Treatment A); BI 1467335 (Treatment B); BI 1467335 (Treatment C)
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to assess safety and tolerability of ASP1941 compared to placebo in
      adult subjects with type 2 diabetes mellitus
    

Detailed description: 
      Trial includes a two week washout period before entering the treatment period for subjects on
      oral anti-diabetic medication.
    

Intervention name(s): ASP1941; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ASP1941; Type 2 Diabetes Mellitus
Natural Cycle In Vitro Fertilization
Condition: Natural Cycle in Vitro Fertilization (IVF)
Study type: Observational

Summary: 
      Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron & hCG.
      Patients will not be given any other stimulating medications during the cycle. They will have
      2 uterine aspirations and an endometrial biopsy at designated times. The first uterine
      aspiration will be randomized to one of four days (day before retrieval, day of retrieval,
      day after retrieval or 2 days after retrieval). The second uterine aspiration and endometrial
      biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be biopsied for
      Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent thaw cycle.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile patients
      
Biospecimen description: 
      serum samples
    
Keywords: Natural; IVF Cycle
Gait Evaluation of Experienced Below Knee Amputees
Condition: Amputations, Traumatic
MeSH terms: Amputation, Traumatic
Study type: Observational

Summary: 
      Post traumatic amputees with an experience of over 3 months of prosthesis use at home,
      without any known difficulty using the prosthesis and without stump pathology, using no
      assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and
      kinetic parameters of gait will be obtained.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Trans tibial amputees without pain or complaints about stump or prosthesis,using their
        prosthesis more than 3 months.
      
Keywords: Amputation; trans tibial; prosthesis; motion analysis
A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma
Condition: Trauma Chest
MeSH terms: Wounds and Injuries; Thoracic Injuries
Study type: Interventional

Summary: 
      Chest trauma (CT) patients with 3 or more ribs fractures with or without pleuropulmonary
      injury are an indicator of severity. Chest physiotherapy (CP) and analgesia is the first line
      treatment in these patients.

      The aim study is to evaluate the effect of positive expiratory pressure (PEP) breathing
      compared to the incentive spirometry in terms of pain control in the recent phase of CT.
    

Detailed description: 
      After acceptance to participate in the study, patients will be computerized randomized into 2
      groups:

        -  PEP group: positive expiratory pressure (PEP) breathing.

        -  INS group: inspiratory incentive spirometry breathing. The period between day 0 and 20
           days post-trauma is considered an immediate phase of TT.

      Once admitted, an initial evaluation by the doctor will be performed, and pleuro-pulmonary
      complications, the presence of respiratory failure, and pain control will be evaluated. The
      CP will perform a clinical, pain control, secretion and a dynamic costal examination. The
      medical treatment of pain control will begin, and the treatment of CP will begin, where it
      will be randomized in 2 groups: 1- PEP group: positive expiratory pressure (PEP) breathing
      the help of a PEP bottle device. 2- INS group: inspiratory incentive spirometry device
      (Coach®). Will be daily FR sessions, on weekdays. Upon admission, hospital discharge and
      post-discharge, radiological checks (simple radiography) will be performed and forced vital
      capacity will be measured with forced spirometry.
    

Intervention name(s): PEP bottle
Intervention type(s): Device
Intervention description(s): PEP bottle: it will be performed with a bottle of distilled water and a plastic tube, where the patient breathes against a resistance during expiration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: aleatorizado 1:1
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
Condition: Aging
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of supplementation with the Nicotinamide
      Adenine Dinucleotide (NAD+) precursor compound, Nicotinamide Riboside (NR), for improving
      physiological function (vascular, motor, and cognitive) in healthy middle-aged and older
      adults.
    

Detailed description: 
      Overall, the proposed research project has the long-term potential to influence clinical
      practice by establishing novel therapies for treating multiple domains of age-associated
      physiological dysfunction and thereby reducing the risk of clinical disease and disability.
    

Intervention name(s): Niagen™; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): nicotinamide riboside chloride, 250mg capsules; silicified microcrystalline cellulose, vegetarian capsule
Other intervention name(s): Nicotinamide Riboside
Intervention MeSH terms: Niacinamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nicotinamide riboside; aging; arterial stiffness; endothelial dysfunction
High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of High Intensity Interval Training
      (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.
    

Detailed description: 
      Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in
      individuals with type 2 diabetes, but implies a considerable time commitment. High intensity
      interval training (HIT) is time-efficient exercise consisting of repeated bouts of short
      duration high intensive workloads. The aim of this study is to determine the effect of HIT in
      patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of
      HIT.

      Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg
      serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be
      measured after completion of the overall training program by euglycemic hyperinsulinemic
      clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during
      training period for measuring of muscle glycogen content, and muscle biopsies for further
      analysis obtained during the experimental day.
    

Intervention name(s): High intensity interval training
Intervention type(s): Behavioral
Intervention description(s): HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.
Other intervention name(s): High intense interval training; HIT; HIIT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Insulin sensitivity; High intensity interval training
Clinical Rescue Protocol - 2
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to detect increasing medication dose results in heroin cessation
      for patients still using, to determine if decreasing medication dose in patients unable to
      tolerate medication dose increases retention, and to determine if blood levels of methadone
      or buprenorphine correlate with clinical response.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Masking: Double
Primary purpose: Treatment
Keywords: Opioid
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg
      metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt
      Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured
      in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in
      Evansville, Indiana) in the fed state in healthy subjects.
    

Detailed description: 
      This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/1000 mg metformin
      extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered
      5 mg saxagliptin tablet plus 2 x 500 mg Glucophage XR tablets (manufactured in Evansville,
      Indiana)
    

Intervention name(s): saxagliptin; Glucophage XR; saxagliptin + metformin XR (FDC tablet)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 5 mg, once daily, Single dose; Tablets, Oral, 500 mg, once daily, Single dose; Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days
Other intervention name(s): Onglyza; Onglyza
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Beverages and Societal Health
Condition: Cardiovascular Disease, Obesity
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The overall aim of the study is to compare the effects of three types of beverages -
      sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on
      cardiovascular disease (CVD) risk factors and body weight among young adults.
    

Detailed description: 
      Consumption of sugar sweetened beverages (SSB) has been linked to obesity and, independent of
      body weight, risk for diabetes and cardiovascular disease. With rising public health
      awareness of these potential adverse effects, consumption of artificially sweetened beverages
      (ASB) has increased dramatically. These low-calorie products are marketed as "diet," with the
      implication that they promote weight loss and improved health. However, there are no
      long-term experimental studies of ASB and body weight or any other health outcome. Several
      recent prospective observational studies have linked intake of ASB to increased risk of the
      metabolic syndrome, type 2 diabetes, and obesity. In the proposed clinical trial, 270 young
      adults who habitually consume SSB will be randomly assigned to one of three groups: 1) to
      continue consuming habitual levels of SSB; 2) to substitute ASB for SSB; or 3) to substitute
      unsweetened beverages for SSB. Each group will receive home delivery of the targeted beverage
      for 1 year, using methods that build upon previous successful work. Careful attention will be
      given to assuring treatment fidelity, equivalence of treatment intensity, and avoidance of
      experimental confounders. The primary study endpoint will be the ratio of serum triglyceride
      to HDL-cholesterol concentrations. Secondary endpoints will include changes in other
      cardiovascular disease risk factors, body weight, dietary quality, and taste preferences.
    

Intervention name(s): Provision of beverages
Intervention type(s): Behavioral
Intervention description(s): Home delivery of specified beverage type
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Does the Menstrual Phase Affect Gastric Emptying? Prospective, Observational Study
Condition: Gastric Contents
Study type: Observational

Summary: 
      This prospective observational study aimed to evaluate the relationship between menstrual
      phase cycles and gastric emptying in female volunteers of reproductive age.
    

Detailed description: 
      Volunteers included in the study will be evaluated for gastric emptying with USG in both
      phases of the menstrual phase. In each phase, volunteers will be evaluated for gastric
      emptying of both liquid food intake and a light meal. At first, 400 ml of water will be drunk
      after 10 hours of fasting, and gastric content will be evaluated with USG after 2 hours.

      Secondly, after 10 hours of fasting, solid food intake will be evaluated. Then, after taking
      a light meal (toast and 200 ml tea), the volunteers will be evaluated by USG at the 6th hour.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        24 healthy female volunteers who are of the reproductive age and have had a regular
        menstrual cycle for at least six
Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      This study partially replicates two previous studies with normal weight women, and overweight
      women. Both found that women could compensate for sucrose added to the diet in carbonated
      soft drinks (4 x250ml total1800 kJ per day) when it was given blind over a period of 4 weeks.
      The hypothesis is that this applies also to obese women, who will not gain weight, increase
      overall energy intake in the diet, or eat differently whilst consuming sucrose. 42
      participants shall be randomly assigned to either be given carbonated drinks that contain
      sucrose, or drinks that are artificially sweetened.
    


Intervention name(s): Sucrose; Aspartame
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day); Intensely sweetened soft drink (no energy content)
Other intervention name(s): Irn Bru; Diet Irn Bru
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      The Vibrant capsule is a novel vibrating device for the treatment of gastrointestinal
      disorders. The effect of different vibrations on the motor functions of the gastrointestinal
      tract are unclear. The study will focus on the stomach in healthy volunteers.

      The study will compare the effects of Vibrant capsule treatment and Sham capsule treatment on
      gastric emptying and gastric motility in healthy volunteers.
    


Intervention name(s): Sham vibrating capsule; Vibrant Capsule (1 vibration); Vibrant Capsule (3 vibration); Vibrant Capsule (5 vibration)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Sham device without vibration; 1 vibration/min; 3 vibration/min; 5 vibration/min
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the safety and efficacy of flexibly dosed
      paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder
      with symptoms of emotional instability, detachment from reality, often with delusions and
      hallucinations, and withdrawal into the self).
    

Detailed description: 
      This is an open-label, prospective (study following participants forward in time), single
      arm, and non-comparative study of paliperidone Extended Release(ER) in participants with
      schizophrenia (after switching from the existing drug to paliperidone ER). The total study
      duration will be approximately of 48 weeks per participant. The study consists of 2 parts:
      Screening (that is, 14 days before study commences on Day 1); Treatment (single-oral dose of
      paliperidone for 48 weeks, dose ranging from 3 to 12 milligram). Efficacy of the participants
      will primarily be evaluated by Positive and Negative Syndrome Scale. Participants' safety
      will be monitored throughout the study.
    

Intervention name(s): Paliperidone
Intervention type(s): Drug
Intervention description(s): Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
Other intervention name(s): R076477; Invega Slow-Release Tablet
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone; Antipsychotics Agents
Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles
Condition: Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to confirm the functional improvement obtained through treatment of
      spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both
      muscles gives a better and longer functional improvement than treatment of only one muscle.
      The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum
      toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level,
      functional scales and subjective feeling) and gait analysis data (kinematics and kinetics
      data) are collected. Evaluations take place before treatment, 2 months and 6 months after
      treatment.
    


Intervention name(s): Botulinum toxin
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy children; Botulinum toxin
Pilot Study for the NorCAPITAL Trial
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic
Study type: Interventional

Summary: 
      The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and
      safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the
      investigators wanted to assess appropriate dosage in relation to a) plasma concentration
      levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure
      responses when rising up), and c) reports of possible adverse effects.

      A possible beneficial effect of clonidine in adolescent CFS will be investigated in
      NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.
    


Intervention name(s): Clonidine
Intervention type(s): Drug
Intervention description(s): 50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.
Intervention MeSH terms: Clonidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: adolescents