bioihbjkbjnl/mcl2 huggingface dataset:
Daily Undulating Periodization Methods With Parkinson's Disease
Condition: Parkinson Disease; Weight-Lifting Exercise Program
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Compare periodized (cyclic) resistance training with and without motor training specific to
      activities of daily living.
    

Detailed description: 
      This study will look at how well two different daily undulating training programs
      (hypertrophy-strength-power training, versus strength-power-functional training) improve
      participants' physical functions. All testing procedures will take place at the Max Orovitz
      Laboratory on the Coral Gables campus. This study will involve a 1-week baseline testing
      phase, a 2-week familiarization phase, a 9-week intervention phase, and a 1-week post-testing
      window where subjects must report to the lab for 2 sessions.
    

Intervention name(s): Periodized training with motor practice; Simple Periodized Training
Intervention type(s): Other; Other
Intervention description(s): Exercises at 75-80% of the subject's maximum for strength exercise using contractions with 2 second concentric and 3 second eccentric for the strength day. 30-80% of subjects' maximal strength for the power day with high-speed concentric and 2 second eccentric contractions, and exercises that simulate activities of daily living for the motor practice day. All resistance-training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for 12 consecutive weeks, for a total of 36 visits. Each visit will be approximately 60 minutes long and will consist of 5 minutes warm-up, 50 minutes of training and five minutes of cool-down.; Exercises at 75-80% of the subject's maximum for strength using contractions with 2 second concentric and 3 second eccentric for the strength day. 30-80% of subjects' maximal strength for the power day, with high speed concentric and 2 second eccentric contractions, and for hypertrophy day at 60-75% of subjects' maximum strength. All resistance-training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for 12 consecutive weeks, for a total of 36 visits. Each visit will be approximately 60 minutes long and will consist of 5 minutes exercise using contractions warm-up, 50 minutes of training and five minutes of cool-down.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals'
      10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.
    

Detailed description: 
      Test groups: 4 (400 subjects/group). 3 groups receiving 10-valent pneumococcal conjugate
      vaccine (3 different lots) as follows: - 10-valent vaccine (lot 1, 2 or 3) + DTPa combined
      vaccine; Control group receiving Prevenar + DTPa combined vaccine
    

Intervention name(s): Pneumococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
Condition: Bipolar I
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be an open-label uncontrolled trial to evaluate the safety and tolerability of
      aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar
      I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects
      not participating in Trial 31-08-250.
    

Detailed description: 
      This will be an open-label, uncontrolled study which will enroll subjects completing Study
      31-08-250 and new subjects. The treatment history of subjects prior to enrollment in the
      open-label study will vary according to the design of the pivotal double-blind study (i.e
      31-08-250).

      This open-label study will be comprised of phases similar to the pivotal double-blind study
      (i.e. Study 250): a screening phase (if applicable), a conversion phase (Phase A, if
      applicable), an oral stabilization phase (Phase B, if applicable), and an IM depot open-label
      maintenance phase (Phase C). Phase C will be a minimum of 28 weeks up to a 52-week treatment
      period with a 4 week follow up period.

      During Phase C (the open-label maintenance phase) rescue medication will be allowed for
      subjects who do not meet stability criteria. This analysis focuses on Phase C due to
      ClinicalTrials.gov system limitations.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): 400mg or 300mg, intramuscular injections every 4 weeks.
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aripiprazole, Intramuscular (IM) Depot, Bipolar
Effects of TOT on Walking in Children With CP
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of the study was to determine the effects of task oriented training (TOT) on
      walking and balance in children with spastic Cerebral Palsy (CP).
    

Detailed description: 
      The aim of study is to evaluate the effectiveness of task-oriented training on the walking in
      Cerebral Palsy children and compare its results with that of the conservative rehabilitation
      treatment. By training children to walk using task oriented training not only improves their
      walk and balance but also encourage them to actively participate in their own treatment
      process. Task oriented training approach can prove to be an effective technique for those CP
      children who can perform ambulation and have defined targets for gross motor activities
    

Intervention name(s): Task oriented training; Conventional rehabilitation treatment
Intervention type(s): Other; Other
Intervention description(s): Task oriented training consisted of different functional tasks for lower limbs to improve balance and walk. Each task was given 5 minutes Tasks were progressed according to each child's performance. These progressions included increase of repetitions, speed and switching between the tasks. One hour practice of these tasks was advised for home plan; Conventional rehabilitation treatment includes mat activities and ROM of all limbs, Lower limb strengthening and stretching, walking, cycling.
Each exercise was performed for 5 minutes. One hour practice of above exercises and thermotherapy for the spastic muscles advised for 10 minutes once a day at home was advised.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Walking; Task oriented training; Conventional therapy; Balance
Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?
Condition: Dietary Proteins
Study type: Interventional

Summary: 
      The primary objective is to determine whether meat interacts positively with calcium to
      improve calcium retention. The secondary objective is to determine whether any interaction
      between dietary protein and calcium affects biomarkers of bone metabolism.
    

Detailed description: 
      This study tests the effects of dietary protein and calcium on calcium retention and indices
      of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2
      Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass
      Index (weight in kilograms divided by height in meters squared)and randomly assigned to a
      high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group,
      and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7
      weeks each. There is a 3-week "washout" between dietary periods, during which the subjects
      consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu
      is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days
      by whole body scintillation counting. In addition to Calcium retention, other endpoints
      include urinary indices of acid excretion and urine serum indices of bone resorption.
    

Intervention name(s): High Protein Diet; Low Protein Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm; High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Calcium retention; dietary protein; dietary calcium
Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin
      sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
    

Detailed description: 
      1. Test the hypothesis that nebivolol treatment decreases PAI-1 antigen and activity and
           improves fibrinolytic balance compared to metoprolol treatment in individuals with
           metabolic syndrome.

        2. Test the hypothesis that nebivolol treatment improves insulin sensitivity compared to
           metoprolol treatment in individuals with metabolic syndrome.
    

Intervention name(s): placebo; Nebivolol; Metoprolol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo pill by mouth daily for 21 days followed by either Nebivolol 5 mg by mouth daily or metoprolol ER 100mg by mouth daily for 12 weeks.; Nebivolol 5 mg by mouth daily for 12 weeks.; Metoprolol ER 100mg by mouth daily for 12 weeks.
Intervention MeSH terms: Metoprolol; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a multicenter, case-control phase IV clinical trial to evaluate the
      effectiveness of the EV71 vaccine. About 40000 children in the town aged 6-35 months will be
      recruited and vaccinated with EV71 vaccines, which account for 20-40% of the children aged
      6-35 months in the areas. The subjects will be vaccinated with EV71 vaccine at day 0 and day
      28. Other children of appropriate age in the town will choose voluntarily whether or not to
      be vaccinated with EV71 vaccine. All children's vaccination of EV71 vaccines will be recorded
      in the study areas and the coverage rate of EV71 vaccine in the town will be calculated. The
      vaccination is expected to complete before the epidemic peak of HFMD.

      Surveillance of HFMD cases caused by EV71 will be conducted in hospitals of the study areas
      for 10-12 months, which cover a whole HFMD epidemic period. Throat and anal swabs will be
      collected from children with a clinically diagnosed HFMD for typing of human enteroviruses
      tested by PCR. The HFMD cases with EV71 positive will be recruited as cases, while those with
      EV71 negative will be recruited as test-negative controls. Besides, for each EV71-associated
      HFMD cases, the investigators will select 4 community controls mateced with each case for
      age, sex and residence.
    


Intervention name(s): EV71 vaccine
Intervention type(s): Biological
Intervention description(s): EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Group Hypnosis for Stress Reduction
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This prospective feasibility study aims to test a 5 week group hypnosis training as
      intervention to reduce perceived psychological stress in healthy subjects.
    

Detailed description: 
      In a pre- post comparison the feasibility of a standardized weekly 90 minutes group hypnosis
      training including CDs/MP3 recordings as homework to reduce perceived psychological stress in
      healthy subjects is investigated. Outcomes are measured quantitatively and qualitatively.
    

Intervention name(s): Group hypnosis
Intervention type(s): Behavioral
Intervention description(s): 5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation. Additional auditapes of hypnosis sessions as hoemwork
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Effects of Telmisartan and Valsartan on Neointima Volume in Diabetes
Condition: Hypertension; Diabetes; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      People with diabetes mellitus are more prone to coronary heart disease, stroke, and
      peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk
      factor for the progression of coronary artery disease. Several studies have been reported
      that diabetes increased the risk of cardiovascular mortality in both men and women. With the
      introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later
      months have reduced dramatically in several studies. However, even with DESs, diabetic
      patients showed increased rates of restenosis and late loss index compared with nondiabetic
      patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous
      coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes
      after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been
      demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era
      of DESs, no study has compared the effects of telmisartan and valsartan on neointima volume
      with intravascular ultrasound (IVUS) at 8 months after zotarolimus-eluting stent implantation
      in hypertensive type 2 diabetic patients. Telmisartan, which is well-known for its selective
      peroxisome proliferator-activated receptor (PPAR)-γ activity with its anti-inflammatory and
      antiproliferative properties, could be an appropriate therapeutic option for treating
      hypertensive diabetic patients with significant coronary artery diseases requiring stent
      implantation. In contrast, valsartan is an angiotensin receptor blocker with negligible
      PPAR-γ activity. Increasing interest remains in the identification of systemic
      pharmacological therapies to prevent coronary restenosis especially in diabetic patients.
    


Intervention name(s): telmisartan; valsartan
Intervention type(s): Drug; Drug
Intervention description(s): telmisartan 40-80mg once per day for 8 months; valsartan 80-160mg once per day for 8 months
Intervention MeSH terms: Valsartan; Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Exploring the Influence of Clinical Factors on the Prognosis of Papillary Renal Cell Carcinoma
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Observational

Summary: 
      Patients with renal cell carcinoma who were admitted to the First Affiliated Hospital of Sun
      Yat-sen University from February 1, 2021, to February 1, 2022, and met the following
      inclusion and exclusion criteria were collected. Clinical factors influencing the prognosis
      of enrolled patients were retrospectively analyzed, and a predictive system was established
      based on this.

      (Inclusion criteria: pathology of the surgical specimen confirmed the diagnosis of pRCC,b:
      age 18 years or older, c: localized RCC underwent radical nephrectomy or partial nephrectomy
      in our center.

      Exclusion criteria:a: lack of original CT images, b: patients with malignant tumors of other
      systems, c: patients who lost follow-up.)
    


Intervention name(s): We do not have any interventions. This study is based on obseravation.
Intervention type(s): Other
Intervention description(s): observational retrospective study without any interventions
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All the enrolled patients were Asian(we are a affiliated hospital of a university based in
        Mailand china ).
Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy
Condition: Hemiplegia and Hemiparesis; Cerebral Palsy Infantile
MeSH terms: Paralysis; Cerebral Palsy; Hemiplegia; Paresis
Study type: Interventional

Summary: 
      The main objective:

      To determine the effectiveness of a treatment that combines the application of a functional
      upper limb orthosis together with a home-based program of specific tasks in children with
      unilateral cerebral palsy versus a home-based program of specific tasks in improving
      structure and function, activity and participation.

      Hypothesis:

      The application of a functional upper limb orthosis together with a home-based program of
      specific tasks in children with unilateral cerebral palsy results in a greater improvement in
      structure and function, activity and participation compared to the implementation of a
      home-based specific task program.
    

Detailed description: 
      Randomized clinical trial with blinding of the evaluator and the person analyzing the data.

      A home-based protocol of specific tasks will be performed in both groups and one of the
      groups will also receive a treatment with upper limb splinting. The assessment will be made
      by a single evaluator with 10 years of experience in the treatment of children with motor
      disabilities.
    

Intervention name(s): Home-based protocol in specific tasks; Upper-limb splint
Intervention type(s): Device; Device
Intervention description(s): The home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow.; In the case that treatment with splint is also received, a researcher of this study will take measurements of the hand and will provide the appropriate splint. The intensity of the application will be 5 days a week from monday to friday, for 6 hours a day, for a period of 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; Hemiplegia; Upper-limb splint; Home-based; Social Participation
The Study of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases
Condition: Obstructive Sleep Apnea-hypopnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      This was a cross-sectional observational study to evaluate the prevalence and predictive
      factors of SDB in ILD and to analyze the relationship between polysomnography (PSG) findings,
      pulmonary function, disease severity, parenchymal involvement, and sleep questionnaires ESS
      and SBQ. This study included 69 patients who were diagnosed with diffuse parenchymal lung
      diseases by high-resolution computed tomography (HRCT) chest. All patients were subjected to
      clinical examination, HRCT, spirometry, full-night polysomnography, and echocardiography.
    


Intervention name(s): Polysomnography
Intervention type(s): Diagnostic Test
Intervention description(s): Polysomnography is done for patients to find any sleep disordered breathing
Other intervention name(s): Sleep study
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        69 patients with interstitial lung diseases of both sexs and older than 18 years
Mirror Therapy in Complex Regional Pain Syndrome Type I
Condition: Complex Regional Pain Syndrome Type I
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The aim is to evaluate the efficacy of Mirror Therapy on pain reduction and hand function in
      subjects with unilateral upper extremity Complex Regional Pain Syndrome Type I.
    

Detailed description: 
      Subjects were randomly divided into two groups. Group A carried out a ten-minute Mirror
      Therapy exercise daily, for a total duration of six weeks. Group B acted as a control group
      for six weeks followed by six weeks of Mirror Therapy with the same characteristics as Group
      A. Upper extremity active range of motion, strength, dexterity, limb volume, right-left
      temperature difference, and health-related quality of life were evaluated before and after
      each period. Daily records on the visual analogue scale were used for pain evaluation.
      Effectiveness was calculated using mixed-effects modelling for between-group comparisons and
      within-group variability and identifying significant predictors.
    

Intervention name(s): Mirror Therapy exercise
Intervention type(s): Other
Intervention description(s): Mirror Therapy for the upper limb involves the use of a mirror to create a reflected image of the unaffected arm, making it appear as if both arms are moving symmetrically. During the therapy, the patient places their affected arm behind the mirror and their unaffected arm in front. While focusing on the mirror reflection, the patient performs various movements with the unaffected arm, giving the illusion that the affected arm is moving normally.
Other intervention name(s): Mirror visual feedback exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Specifically, the study employs a half cross-over design. Group A begins with the intervention, while Group B starts with a control period of equal length, followed by the intervention. This design facilitates comparisons both between the groups and within Group B across the two periods.
Masking: None (Open Label)
Primary purpose: Treatment