bioihbjkbjnl/mcl2 huggingface dataset:
Does Mechanical Correction Reduce Muscle Stiffness in People With Rounded Shoulder?
Condition: Posture
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the effect of mechanical correction taping on
      the stiffness of the upper trapezius and pectoralis minor muscles in patients with rounded
      shoulder deformity. The secondary aim of our study was to see whether different tape
      materials affect the application results.
    

Detailed description: 
      Mechanical correction technique is a highly preferred method among users. Besides its
      tactical stimulation it serves like a tool helping to reposition the joints.

      Here in this study, the investigators aimed to see the secondary effect of the technique on
      posture. İt is already known that mechanical correction supports the joints and posture but,
      the question is; by supporting the upright position does it help the extra loaded muscles to
      release? As the best way to measure the stiffness of the muscles is Elastography, this study
      will highlight an important issue about correcting posture and regulate muscle loading.
    

Intervention name(s): kinesio tape; exercise
Intervention type(s): Other; Other
Intervention description(s): This is a taping method used for correction of rounded shoulders.; Exercises include basic postural exercises.
Other intervention name(s): exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: kinesio tape; posture; elastography
Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age
Condition: Obesity; Neural Tube Defects
MeSH terms: Neural Tube Defects; Spinal Dysraphism
Study type: Observational

Summary: 
      The purpose of this study is to determine if there is a difference in the short term response
      in serum folate after a single dose of folic acid in normal weight and obese women of
      childbearing age.
    

Detailed description: 
      Current recommendations established in 1998, specify that all women capable of becoming
      pregnant consume 400 micrograms of folate daily from supplements, fortified foods, or both,
      in addition to consuming food folate from a varied diet. Despite this recommendation, obese
      women have a lower folate status than women of normal weight which suggests that obesity may
      have a negative impact on folate metabolism. Therefore, the objective of this study is to
      determine if there are differences in the metabolic response to a single dose of folate
      between normal weight and obese women of child bearing age. The two groups of women will be
      given the currently recommended amount of folic acid, 400 micrograms, and blood samples will
      be taken before the vitamin is given and at various points afterwards to determine serum
      folate response to the folate dose. Results of this research should help determine if folate
      requirements are higher for obese than for non-obese women. The long-term goal of this and
      follow-up studies is to generate data that will contribute to the evidence base used by
      scientific advisory panels to determine whether dietary folate intake recommendations should
      be based on body weight.
    

Sampling method: Non-Probability Sample
Study population: 
        Community sample from Athens, GA and surrounding area
      
Biospecimen description: 
      Buffy Coat Serum samples Plasma samples
    
Keywords: Folic acid; Folate; Pharmacokinetics; Women of Child Bearing Age
Actigraphy Improvement With Voxelotor (ActIVe) Study
Condition: Sickle Cell Disease; Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to evaluate the effect of voxelotor on daily physical activity and sleep
      quality, as measured by a wrist-worn device in participants with sickle cell disease (SCD)
      and chronic moderate anemia.
    

Detailed description: 
      All participants will receive Voxelotor as treatment. There will be approximately 13 sites in
      the US.

      Participant safety and tolerability will be monitored during the study using standard
      measures, including physical examinations, vital signs (including temperature, blood
      pressure, pulse rate, respiratory rate and peripheral oxygen saturation [SpO2]), clinical
      laboratory tests, and adverse event (AE) monitoring.

      Screening Period (up to 4 weeks in duration): During this period, participants will sign the
      informed consent form (ICF), after which they will complete the screening assessments as
      detailed in the Schedule of Assessments (SOA).

      Run-in Period (2 weeks in duration): During this period, participants will enter a 2-week
      run-in period (Day -14 to Day -1) during which baseline actigraphy measures of physical
      activity and sleep quality, overnight pulse oximetry assessments of oxygen saturation, and
      Patient-Reported Outcome (PRO) assessments will be collected before initiating treatment with
      voxelotor.

      Treatment Period (24 weeks in duration): After completion of the 14-day Run-in Period,
      participants will enter the open label treatment period and receive voxelotor 1500 mg once
      daily for 24 weeks. Repeat actigraphy assessments of physical activity and sleep quality, and
      overnight pulse oximetry will be performed during the treatment period (Weeks 10 to 12 and
      Weeks 22 to 24). PRO and Clinical Global Impression (CGI) assessments will be completed at
      scheduled study visits. The open-label treatment period is considered the continuous 24 weeks
      of voxelotor treatment from date of first dose (Day 1).

      Follow-up Period (4 weeks in duration): Immediately following the 24-week treatment period,
      participants will enter a 4-week Follow-up Period.
    

Intervention name(s): Voxelotor
Intervention type(s): Drug
Intervention description(s): 500 mg Tablet, Oral, With or Without Food
Other intervention name(s): GBT440; Oxbryta
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
P53 in Differentiated Thyroid Cancer
Condition: Thyroid Neoplasms
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Observational

Summary: 
      In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is
      considered as radioiodine resistant or in another words in the process of dedifferentiation.
      The aim of the present study was to search a simple blood test that could lead to early
      identification of patients with dedifferentiation. In this respect, we investigate whether
      the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients
      with high levels of thyroglobulin (tg) and negative I-131 scan.
    

Detailed description: 
      In the present study enrolled were 171 patients with mean age of 47.7±13.5 yrs (range;
      16-80yrs) and 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs). 134
      (78.4%) patients were female and 37 (21.6%) patients were male.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 171 patients with an age range of 16-80 yrs (mean: 47.7±13.5 yrs) and a total of
        28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs) were included in
        this study.
      
Biospecimen description: 
      Serum
    
Keywords: Tumor Suppressor Protein p53,; Iodine Radioisotopes
Effects of School Gardens on Children's Diet, Nutritional Knowledge, Etc.
Condition: Dietary Habits
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether school gardens influence children's dietary
      intake, nutritional knowledge, and other outcomes.
    

Detailed description: 
      Schools in New York, Washington State, Iowa, and Arkansas were randomly assigned to receive
      school gardens and associated curriculum or to serve on the wait list control group that
      received gardens and curriculum at the end of the 2-year study. Baseline data were collected
      in Fall 2011. Garden interventions began in Spring 2012. Follow-up data were collected at 6,
      12, 18 months following baseline data collection.
    

Intervention name(s): garden intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention includes raised bed garden kits for participating classes as well as access to garden-based curriculum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: children; fruit; vegetable; diet; school; garden
The Effect of Virtual Reality Glasses on Dental Anxiety Control
Condition: Periodontitis; Dental Anxiety; Dental Fear; Gingivitis; Calculus, Dental
MeSH terms: Gingivitis; Periodontitis; Dental Calculus; Calculi; Anxiety Disorders
Study type: Interventional

Summary: 
      In this clinical study, it was aimed to evaluate whether there is a decrease in patient
      anxiety by applying virtual reality glasses, which are the product of new technology, during
      scaling and root planing treatment.

      Patients who required scaling and root planing treatment and also scored 9 or above according
      to the Dental Anxiety Scale were included in our study. Scaling and root planing was
      performed in a randomly selected intraoral quadrant of the patients, in the same way, with or
      without the use of virtual reality glasses. In the virtual reality glasses application, a
      video consisting of images of nature landscapes developed for patient rehabilitation was
      projected onto the screen in front of the patient's eyes. The Dental Anxiety Scale was
      reapplied after the completion of the treatment.

      In the intraoral quadrant where virtual reality glasses were used, it is expected that lower
      Corah Dental Anxiety Scale scores may be obtained after the treatment is completed, compared
      to the intraoral quadrant where the treatment is performed without glasses, thus reducing
      anxiety.
    


Intervention name(s): Scaling and root planing
Intervention type(s): Procedure
Intervention description(s): Phase 1 periodontal therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hydration and Exercise Performance in Cycling
Condition: Healthy
Study type: Interventional

Summary: 
      This study will evaluate the effects manipulating ingested fluids can have on hydration
      status and cycling performance. There will be 4 different conditions.
    

Detailed description: 
      Being dehydrated can decrease endurance exercise performance. The investigators wish to test
      which of three drinks is most effective at re-hydrating cyclists and if this affects
      performance. Subjects will undertake 4 tests: once dehydrated, once hydrated with water, once
      hydrated with a sports-specific drink, and once with an altered sports drink. Blood samples
      will be taken and expired gasses will be sampled at various time points throughout the tests
      for later analysis. A small amount of labelled water will be consumed with each drink, a
      technique which will allow us to quantify the absorption of each of the drinks.
    

Intervention name(s): Hypotonic; Isotonic; Placebo; Dehydrated
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): N/A: see arm description; N/A: see arm description; N/A: see arm description; N/A: see arm description
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine
      for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the
      early post-deployment period; and 2) To determine the potential efficacy of paroxetine in
      preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and
      improving overall veteran function.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Paroxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.; Placebo: same as paroxetine (active comparator)
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: PTSD; Paroxetine; Subthreshold
GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis
Condition: Rectal Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective, open, multicenter, randomized III trial with two arms:

        -  Arm A: Primary tumor resection , followed by chemotherapy

        -  Arm B: Chemotherapy alone. Compare overall 2-year survival rates in patients treated for
           resectable rectal adenocarcinoma with unresectable metastasis, treated either with the
           primary tumor resection with chemotherapy +/- target therapy, or with chemotherapy (+/-
           target therapy) alone.
    


Intervention name(s): Primary tumor resection + chemotherapy; Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab
Intervention type(s): Procedure; Drug
Intervention description(s): Step 1: Primary Tumor (PT) resection
Within 3 weeks after randomization
Immunonutrition given 7 days prior to PT resection
Mechanical bowel preparation performed before surgery according to the local practices
Performed by laparoscopy (recommended) or by laparotomy (at the investigator's discretion)
Step 2: postoperative CT-scan
Must be performed within 4 weeks after surgery
CT-scan/MRI with the same criteria as pre-treatment evaluation
Step 3: Chemotherapy +/- target therapy
Within 4 weeks after the surgery
Chemotherapy administered according to the usual scheme for the chosen protocol
All validated and/or registered perioperative rectal cancer treatments authorized
The duration of one treatment cycle depending on the type of treatment administered
Radiotherapy is allowed after randomization if indicated; Treatment will start within 3 weeks after randomization; Chemotherapy will be administered according to the regimen in the chosen protocol and validated by the MDOC of each center.
If complications occur, emergency surgery can be performed according to the local practices of each investigator center.
Radiotherapy is allowed after randomization if indicated (MDOC).
Other intervention name(s): EGFR antibodies panitumumad and cetuxiamb in case of KRAS wild-type tumors.
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Rectal adenocarcinoma; unresectable; surgery; chemotherapy
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
Condition: Moderate to Severe Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the rapidity of onset of clinical response to
      adalimumab therapy in patients with luminal Crohn's disease.
    


Intervention name(s): adalimumab
Intervention type(s): Biological
Intervention description(s): Adalimumab pre-filled syringe, administered by subcutaneous injection
Other intervention name(s): Humira, ABT-D2E7
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease
Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors
Condition: Alcohols; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor
      liquor may be beneficial to CVD risk factors postprandially.

      Design: three-way crossover design with one week wash time.16 young men were included to
      consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45%
      alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours
      postprandially.

      Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.
    


Intervention name(s): Chinese tea flavor liquor; Chinese Meijiao liquor; Water control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chinese tea flavor liquor; postprandial; uric acid; high-sensitive C-reactive protein
Dexmed/Buspirone Synergism on Shivering
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to determine if the combination of buspirone and
      dexmedetomidine are effective as a treatment to induce therapeutic hypothermia.

      The design of the study includes four study days done in random order. The days are as
      follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a
      computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the
      combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6
      ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic
      technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted
      into the other arm for drug administration.

      Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting
      the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air
      warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and
      lower-body will individually be maintained at the designated skin temperature. Lactated
      Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to
      decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen
      consumption or electromyographic intensity (see below) continues to increase or a total of 5
      liters of fluid is given. Heart rate will be measured continuously using an
      electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at
      the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of
      the baseline), the study will stop and the volunteer will be re-warmed immediately.
    


Intervention name(s): dexmedetomidine; buspirone; Bus and Dex; Control
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dexmedetomidine (delivered by a computer-controlled IV infusion to target a plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia; Buspirone, 60 mg orally, will be given during controlled hypothermia.; the combination of 60 mg buspirone and dexmedetomidine (target plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia; No drugs given during controlled hypothermia
Intervention MeSH terms: Dexmedetomidine; Buspirone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly.BAC.U
Condition: Healthy
Study type: Interventional

Summary: 
      This usability study is to test the basic functionality of the BrightArm Compact (BAC)
      system. The BAC is a motorized rehabilitation platform to offer gravity bearing for weak
      upper extremity. It has a medical grade PC which hosts numerous interactive, adaptable
      computer games, played using BrightBrainer Grasp (BBG) controllers. The device is passive, in
      that no actuators apply forces on the patient. Further, the patient is free to lift that arm,
      nothing restricts the arms movement away from the BAC table.
    

Detailed description: 
      Healthy, age matched participants are invited to test the BAC at Bright Cloud Int Corporate
      Labs (675 US Hwy 1 south, B203, North Brunswick, NJ 08902, USA).

      At the beginning of the usability training, participants will be required to sign a consent
      form, and BCI research staff will go over the details of the study and check inclusion
      criteria (generally healthy individual, age 50 ~ 85, English speaker, cognitively normal).

      Subjects participate in 4 study sessions over approximately 1 month, each session lasting
      about an hour. The BAC table will have a different configuration each session. In the first
      session the table will have 0 tilt (flat). In session 2 it will be tilted 10 degrees
      downwards, in session 3 the table will be tilted up 10 degrees and in Session 4 the BAC table
      will be tilted up 20 degrees.

      The difficulty of the games will also vary from session to session, progressing from the
      lowest difficulty in Session 1 to the highest difficulty in Session 4. Thus a given game will
      not be exactly the same, when played in a subsequent session, so to allow varying interaction
      scenarios.

      At the end of each session, participants will be asked to fill up a custom feedback form. The
      custom form has questions on the system, the rehabilitation table, the controller, the
      therapeutic games they tested, and their overall impression of the experimental device. Each
      question on the custom form is answered on a 5-point Liker Scale.

      At the end of the last session they will fill a standardized USE form, with questions rated
      on a 7-point Likert scale.

      Feedback from participant will be used to improve the device as well as the therapeutic
      games.
    

Intervention name(s): usability evaluation of medical device
Intervention type(s): Device
Intervention description(s): participants interact with medical device and rate it for usability
Intervention model: Single Group Assignment
Intervention model description: Device usability single group
Masking: None (Open Label)
Primary purpose: Other
Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients
      with drug refractory atrial fibrillation are not inferior to manual radiofrequency current
      ablation.
    


Intervention name(s): Pulmonary vein isolation with radiofrequency current
Intervention type(s): Procedure
Intervention description(s): Pulmonary vein isolation with radiofrequency current
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary vein isolation; robotic navigation; atrial fibrillation