bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.
Condition: Caffeine; Cellulitis
MeSH terms: Cellulitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Introduction: Gynoid hydrolipodystrophy (HLDG) or cellulitis is a subcutaneous tissue
      disorder, with several strategies for its treatment, such as caffeine and iontophoresis.
      Objective: To evaluate the effects of caffeine-associated iontophoresis for the treatment of
      HLDG. Methods: In a longitudinal study, participants will be evaluated for: photographic
      documentation, ultrasound imaging, thermography and quality of life questionnaire. If
      included, they will be separated into 3 randomized groups (n = 30). G1: use of base gel (n =
      10); G2: use of iontophoresis and gel with caffeine (n = 10) and G3: use of iontophoresis
      alone (n = 10). The groups will be treated with 10 sessions, 2 times per week. After that
      they will be reevaluated. Statistical analysis: The software used will be the SPSS
      StatisticalPackage (IBM SPSS Statistics, Chicago, IL, USA). The data distribution will be
      analyzed by the Shapiro-Wilk test. In case of normal distribution, the data will be described
      as mean ± standard deviation; otherwise, as median [interquartile range 25-75%]. For
      comparison of the data, we will use ANOVA and for comparison of means the Tukey test and case
      not normal distribution, krulskal-Wallis test and the Dunns test. The level of statistical
      significance adopted will be P <0.05. Expected contributions: It is expected that
      investigators can contribute to the treatment of patients with HLDG and analyze the effects
      of iontophoresis with caffeine, both in clinical and scientific practice, providing a method
      that is valid and reliable for this purpose; multidisciplinary training of highly qualified
      human resources and the strengthening and consolidation of a research team.
    


Intervention name(s): iontophoresis + caffeine
Intervention type(s): Combination Product
Intervention description(s): we will use cafeislaine c (caffeine) +galvanic current
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: It is a longitudinal and randomized
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Cerebral Edema in Children Having Diabetic Ketoacidosis
Condition: Cerebral Edema
MeSH terms: Brain Edema; Ketosis; Diabetic Ketoacidosis; Edema
Study type: Observational

Summary: 
      The purpose of this study is to determine cerebral edema with evaluation of measurement of
      diameter of optic nerve sheath.
    

Detailed description: 
      The purpose of this study is to determine cerebral edema with evaluation of measurement of
      diameter of optic nerve sheath. For that, If patients have Fluid treatment shall be started
      in 4 hours in our or other Emergency Care, they will be included our study. If not, they will
      be out of our study.

      How we measure;

        1. First measurement shall be taken in 4 hours.

        2. Second measurement shall be taken at 12 hours in mild and 12-18 hours measurement shall
           be taken for severe diabetic ketoacidosis,

        3. Third measurement shall be taken after fluid treatment.

        4. Fourth measurement shall be taken at polyclinic control. So, after all measurements will
           be hand and all data will be analyzed with statistical program. After that all outcome
           will be discussed and compared with patient at normal conditions at their polyclinic
           visit.
    

Intervention name(s): Ultrasonic Measurement
Intervention type(s): Other
Intervention description(s): How we measure;
First measurement shall be taken in 4 hours.
Second measurement shall be taken at 12 hours in mild and 12-18 hours measurement shall be taken for severe diabetic ketoacidosis,
Third measurement shall be taken after fluid treatment.
Fourth measurement shall be taken at patients polyclinic control.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        General
      
Keywords: C10.228.140.187
Dynamic and Static Stretching on Postural Stability, Reaction Time and Countermovement Jump of Sprinters
Condition: Postural Stability
Study type: Interventional

Summary: 
      All the athletes should perform a warm-up consisting of five minutes of jogging and static
      stretching (Experimental Group 1) or dynamic stretching (Experimental Group 2). Before the
      beginning of the study and right after performing the stretching protocol, the investigators
      evaluated the unipedal postural stability, the acustic reaction time, the joint position
      sense of the knee and the countermovement jump of the athletes.
    


Intervention name(s): Static Stretching; Dynamic Stretching
Intervention type(s): Procedure; Procedure
Intervention description(s): To analyze the immediate effects of static stretching on performance of sprinters; To analyze the immediate effects of dynamic stretching on performance of sprinters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: proprioception; countermovement jump; postural balance
Nobori Dual Antiplatelet Therapy as Appropriate Duration
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet
      Therapy (DAPT) following Nobori stent deployment.
    


Intervention name(s): Aspirin or thienopyridine; Aspirin and thienopyridine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized 6 month DAPT will be prescribed either aspirin or thienopyridine (clopidogrel or ticlopidine) following 6 months DAPT for the duration of study, which is left on the physician's discretion.; Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Function Following Thumb MP Fusion and IP Fusion
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study is to determine function following simulated thumb metacarpophalangeal (MP) and
      thumb interphalangeal (IP) joint fusion. The investigators want to determine the functional
      limitation created by MP and IP joint fusion. 20-30 volunteers will be fitted for custom
      molded orthoplast splints immobilizing either the MP or IP joint. The volunteers will then be
      taken through multiple tests including lateral pinch strength, tip pinch, grip strength,
      grooved pegboard test time, and Jebson Taylor test. Each patient will be tested without a
      splint, with their MP joint immobilized and with their IP joint immobilized. The results of
      this study can be used for patient education before surgery in order to help them make
      informed decisions as well as manage expectations. It can also serve as a decision aid in
      pinch restoration in the context of ulnar nerve palsy.
    


Intervention name(s): Jebsen Taylor Hand function test; Pinch strength; Grooved pegboard test
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): consists of seven test items, which are felt to represent various hand activities. These test items include: writing a short sentence; turning over 365 inch cards; picking up small objects and placing in a container; stacking checkers; simulated eating; moving empty large cans; and moving weighted large cans.; Measured in every splint position using a standard dynamometer; Time will be measured and compared between control, MP splint and IP splint
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gastric Acid Suppression and Probiotic Colonization
Condition: Probiotics
Study type: Interventional
Phase: Phase 4

Summary: 
      Probiotics are over-the-counter dietary products with microorganisms that are generally
      consumed for health benefit. However, the durability of these microorganisms is unclear,
      particularly when they pass through the highly acidic environment of the stomach. We will
      test the colonization of these microorganisms among individuals who consume probiotics with
      and without acid suppression therapy.
    

Detailed description: 
      All activities will be related to research. Participants will be randomized to receive either
      over-the-counter acid suppression medication or placebo from weeks -2 through week 4. All
      participants will receive VSL #3 (over-the-counter probiotic) from weeks 0 through 4. Survey
      data, serum, and stool samples will be collected at weeks -2, 0, and 4.

      The intervention medication and probiotics have a very low side effect profile and are
      available over the counter. All data collection methods are non-invasive.

      Elucidation of the effects of acid suppression on probiotic colonization will allow us to
      better understand the utility of probiotics use by individuals on acid suppression
      medications.
    

Intervention name(s): Omeprazole; VSL #3; Placebo
Intervention type(s): Drug; Dietary Supplement; Drug
Intervention description(s): Proton pump inhibitor (PPI) that suppresses gastric acid secretion; Probiotics; Placebo to match omeprazole
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets
      500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy
      subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, bioequivalence study of Divalproex sodium DR 500 mg tablets of Dr.Reddy's
      Laboratories Limited, Generics, India comparing with that of Depakote® DR (containing
      Divalproex sodium) 500 mg tablets of Abbott Laboratories PR Ltd., Barceloneta, PR, in
      healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Divalproex Sodium
Intervention type(s): Drug
Intervention description(s): Divalproex Sodium DR Tablets 500 mg
Other intervention name(s): Depakote DR 500 mg Tablets
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Divalproex Sodium
Oral Bioavailability of Pterostilbene Cocrystal Compared to Its Free Form (BIOPTERO)
Condition: Biological Availability
Study type: Interventional

Summary: 
      Oxidative stress and reactive oxygen species (ROS) can seriously affect cells, tissues and
      organs. The human body is capable of counteracting ROS production by stimulating antioxidant
      defense systems and consequently adapting to the oxidative challenge.

      Several transcription factors are involved in the induction of antioxidant genes. Activators
      of nuclear factor derived from erythroid 2 (NRF2), a protein that controls the expression of
      certain genes, are considered agents capable of inducing antioxidant capacity and to
      alleviate ROS. There are some food bioactive compounds, including polyphenols, capable of
      activating NRF2.

      Pterostilbene (PT) is a stilbenoid found in many natural sources, and is emerging as an
      antioxidant due to its potential preventive and therapeutic properties in a long list of
      diseases. Despite its apparent properties, the water solubility and bioavailability of PT are
      low.

      The co-crystallization of nutraceuticals is a recent strategy based on crystal engineering to
      overcome their low solubility and, therefore, their low oral bioavailability. It has been
      identified and characterized a cocrystal of pterostilbene that can increase oral
      bioavailability in animals by up to 10 times compared to the commercial free base PT.

      The main objective of the study is to evaluate the oral bioavailability of the crystallized
      form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT).

      The secondary objectives of the study are to determine the pharmacokinetic parameters:

        -  Relative oral bioavailability (Frel)

        -  Maximum concentration (Cmax).

        -  Maximum time (Tmax).

        -  Half life time (T1/2).

      During the study there will be 3 visits: a preselection visit (V0), a visit for the first
      postprandial study (V1) and after one week washing period, a visit for the second
      postprandial study (V2).
    


Intervention name(s): Pterostilbene cocrystal; Pterostilbene free form
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One capsule with Pterostilbene cocrystal; One capsule with Pterostilbene free form
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Polyphenols; Antioxidant activity; Co-crystallization; Pterostilbene
Urine Metabolomics and Colorectal Cancer Screening
Condition: Colorectal Cancer; Colorectal Polyps
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      This is a prospective, multi-centered study to assess whether urine metabolomics can play a
      role in the screening of colorectal cancer (CRC). Urine samples will be collected from 1000
      patients going through an established CRC screening program, and from a further 500 patients
      who already have a diagnosis of CRC. Using nuclear magnetic resonance (NMR) spectroscopy, the
      1H NMR spectrum of urine samples will be analyzed for specific metabolites, and establish the
      metabolomic signature of colorectal cancer. The results from metabolomic urinalysis of this
      screening cohort will be compared with results from colonoscopy, histological descriptions,
      fecal occult blood testing (FOBT), and fecal immune testing (FIT) to assess the accuracy of
      urine metabolomics in identifying patients with polyps and malignancies. The urine
      metabolomic results from the colorectal cancer group will be correlated with operative,
      histological and clinical staging to define the role of urine metabolomics in assessing
      colorectal cancer type, location and stage. Additionally approximately 300 urine samples from
      breast cancer patients and 300 from prostate cancer patients will be collected to validate
      that the colorectal cancer signature is unique.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects undergoing colorectal cancer screening Patients with diagnosis of colorectal
        cancer
      
Biospecimen description: 
      Urine sample
Interventions and Viscoelasticity of Hamstring
Condition: Injury; Back, Lower, Superficial; Hamstring Injury; Sport Injury; Sports Physical Therapy
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      The study aims to investigate acute effects of ballistic hamstring stretching, hamstring
      extender exercise, and kinesiotaping application on viscoelasticity of hamstrings and
      standing long jump performance on rowers.
    

Detailed description: 
      The study aims to investigate acute effects of ballistic hamstring stretching, hamstring
      extender exercise, and kinesiotaping application on viscoelasticity of hamstrings and
      standing long jump performance on rowers. A total of 60 professional rowing athletes were
      included. Viscoelasticity of hamstrings were assessed by MyotonPRO, Tallinn, Estonia.
      Athletic performance was assessed by Standing Long Jump Test (SLJT). The athletes were
      randomly divided into Ballistic Hamstring Stretching Group (n= 20), Hamstring Extender
      Exercise Group (n= 20), and Kinesiotape Group (n= 20). For balistic hamstring stretching,
      athletes were asked to reach the floor in the BS group by leaning over in the standing
      posture without knee flexion. When they feel the tension in hamstring muscle groups, athletes
      were requested to make small rebounding motion at degrees between 3°-5° for half a minute.
      For hamstring extender exercise, athletes were asked to apply the exercise 12 repetitions and
      3 sets. Kinesiotaping was applied on the hamstring muscle with Y shape and 25% tension force.
    

Intervention name(s): Ballistic Hamstring Stretching; Hamstring Extender Exercise; Kinesiotape
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Athletes were asked to reach the floor in the BS group by leaning over in the standing posture without knee flexion. When they feel the tension in hamstring muscle groups, athletes were requested to make small rebounding motion at degrees between 3°-5° for half a minute.; Athletes were asked to applied 12 repetitions and 3 sets of hamstring extender exercise. Firstly athlete lies on his/her back. Then, athlete is asked to do 90 degrees of knee and hip flexion at the same time. Finally, the person is expected to perform slow repetitive knee extension to the point of maximal possible extension.; Kinesio tape is applied on the hamstring muscle with a Y shape and %25 tension force.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study is designed as Randomized Uncontrolled Trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ballistic Stretching; Eccentric exercise; Kinesiotaping; Viscoelasticity; Hamstrings; Athletic Performance; Rowers
Comparative Effectiveness of Acute Low Back Pain Management
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped
      care approach with initial treatment of education and advice to remain active. Referral to
      physical therapy is considered only when patients fail to recover after a few weeks. Recent
      research has led to the identification a subgroup of patients likely to experience rapid,
      pronounced, and sustained decreases in disability and pain with a brief manipulation and
      exercise intervention, suggesting it may be more cost-effective to manage this sub-group with
      early referral to physical therapy instead of the usual care approach. The integration of
      this evidence into routine practice has not been evaluated. We will assess the outcomes of
      integrating this evidence into the management of patients with low back pain. The study is a
      randomized trial, comparing management with early manipulation with the current care process
      model. Patients fitting the inclusion criteria will be randomized into one of two groups. One
      group will be managed with the current care process model. The other group will be managed
      consistent with the decision rule recommending early referral for a brief manipulation and
      exercise intervention during the first 4 weeks. Patients will be followed over 1 year.
      Outcomes will include measures of disability, pain, satisfaction, and direct medical costs.
      The study will examine the costs and effectiveness of integrating the alternative care model
      into practice.
    


Intervention name(s): Early Physical Therapy with Usual Care; Usual Care
Intervention type(s): Other; Other
Intervention description(s): The early physical therapy arm includes 4 total sessions. The first 2 sessions include use of thrust spinal manipulation with exercises for range of motion and strengthening of the spine. The final 2 sessions include the exercise component only.; The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Primary Care; Physical Therapy
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients
Condition: Low Back Pain; Radiating Pain
MeSH terms: Neuralgia; Back Pain; Low Back Pain; Pain
Study type: Interventional

Summary: 
      Epidural injection will be completed under fluoroscopy and all patients will receive 1-4 mg
      of Midazolam for relaxation before procedure and, if needed, 50-100 mcg of Fentanyl
      intravenous (IV). Radiopaque contrast (Omnipaque 300), for confirming the epidural position
      of the needle, steroids and local anesthetic agents will be used according to the physician
      performing the block and will not be controlled by the study. Patients will be randomly
      assigned to receive either inhaled Entonox along with the interventional block they are
      scheduled for or oxygen. They will be blinded about the treatment they are receiving. Those
      randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and
      also continue to receive it for a total of 4 hours in the recovery. Those randomized to the
      oxygen group will receive oxygen through a similar mouthpiece for the entire duration of the
      procedure and recovery for 4 hours. Following completion of procedure the patient will be
      transferred to recovery and monitored for 3-5 hours then discharged home with instructions.
      Possible side effects will be monitored and recorded, pain score of patient will be recorded
      before discharge. All the patients will receive standard instructions regarding physical back
      exercises. This will be repeated for every procedure up to maximum of three blocks.

      The patients will be followed during each block and over a period of 1, 3, 6 and 12 months
      and on each follow-up visit will complete computerized set of questionnaires as they did
      before the procedure. The patients charts will be then reviewed for one year after the
      initial procedure to determine if further epidural steroid injections or surgery for the
      presenting problem were required. It is anticipated that the appropriate number of patients
      will be enrolled within six months of study initiation.
    


Intervention name(s): Entonox; Oxygen
Intervention type(s): Other; Other
Intervention description(s): Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery.; Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery.
Other intervention name(s): Nitrous Oxide
Intervention MeSH terms: Nitrous Oxide; Entonox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: radiating back pain; epidural block; steroid; recurrent low back pain; Lumbar Epidural Steroid Block with 3 injections