bioihbjkbjnl/mcl2 huggingface dataset:
Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the feasibility of cholecystectomy made by a
      transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic
      surgery).
    

Detailed description: 
      Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform
      intraperitoneal surgical procedures with a minimal number of access points in the abdominal
      wall. At the present time these procedures are hybrids. It is expected a better cosmetic
      result and lower incidence in parietal complications in front of laparoscopic
      cholecystectomy, but is necessary to investigate that these benefits should not be associated
      with complications of the new access to abdominal cavity.

      Methods. Prospective randomized clinical series of 60 female patients with gallstones that
      underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20
      by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach.
      Variables as surgical wound infection, urinary tract infection, evisceration, hernia,
      mortality and other complications will be analyzed.
    

Intervention name(s): Transvaginal hybrid NOTES cholecystectomy; Cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Cholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope.; Extirpation of the gallbladder by a surgical procedure
Other intervention name(s): NOTES cholecystectomy; Transvaginal cholecystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transvaginal cholecystectomy; NOTES; Minilaparoscopy; Endoscopic surgery; Cholecystectomy; Surgical translumenal endoscopic surgery; Transvaginal translumenal endoscopic surgery
Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients
Condition: Chest X-ray for Clinical Evaluation
Study type: Observational

Summary: 
      The purpose of this study is to compare X-ray images obtained using the GM85 digital
      radiography machine at the standard full dose to X-ray images obtained using the GM85 digital
      radiography machine along with the Samsung S-Vue system, which is a image post-processing
      engine that allows images to be obtained using a lower dose. The study also aims to determine
      the lowest dose of radiation that can be used to get a good, readable x-ray of the chest in
      pediatric patients using Samsung S-Vue system.
    


Intervention name(s): Full Dose Chest X-Ray; Low Dose Chest X-Ray
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Full dose X ray at Day 1; Low dose X ray within 3 months from full dose
Other intervention name(s): GM85; GM85
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seen in clinic.
Non-surgical Intervention for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome, Susceptibility to
MeSH terms: Carpal Tunnel Syndrome; Syndrome; Disease Susceptibility
Study type: Interventional

Summary: 
      This randomized controlled trial graduate student research study will explore the effect of
      non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel
      syndrome, and forearm wrist hand pain.
    

Detailed description: 
      This randomized controlled trial graduate student research study will explore the effect of
      non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel
      syndrome, and forearm wrist hand pain. Little evidence exists for an effective non-surgical
      intervention. Semi-structured interviews will be conducted to explore changes in occupational
      performance and compliance in order to understand if Kinesio Tape contributed to results and
      if so, how the participants perceived the interventions.
    

Intervention name(s): Kinesio 12 inch Tape; Kinesio 4 inch Tape; Cock up Splint and Lumbrical exercises
Intervention type(s): Device; Device; Device
Intervention description(s): Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study.; Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study.; A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled trial
Masking: Single (Participant)
Primary purpose: Other
Keywords: carpal tunnel syndrome, pain, numbness, kinesio tape
The Effect of Dynamic Tape ® on Plantar Fascitis
Condition: Fasciitis, Plantar; Foot Tapping
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      The Dynamic Tape ® (DT) is a new Tape (2009). Dynamic tape ® is a visco-elastic nylon tape
      material , greater than 200% elastic has manufactured in Asia. The material and adhesive
      arefast drying and breathable meaning that the tape, if it is correctly applied may stay on
      for up to 5 days, bearingin mind that if any discomfort, itching, burning, stinging
      orirritation is felt immediate removal is strongly advised.

      Usually tapes are applied in plantar fasciitis to improve the symptoms. The fasciitis plantar
      is an pain that sometimes incapacitates the physical activity of the patients.
    

Detailed description: 
      Objective: To evaluate the evolution of this symptomatology prior to and thereafter the
      application of Dynamic Tape® bandage in a sample of 15 amateur athletes affected by plantar
      fasciitis. The assessment will be performed using an analogue visual scale (EVA). Material
      and methods: the aim of the study is to evaluate a group of 15 amateur athletic subjects ,
      all individuals suffering plantar fasciitis without any previous or current treatment. The
      age, from 18 to 65 years old. Samplings will be performed intentionally without a control
      group.

      The control group will use a Low-dye tape and will be evaluated before and after a week
    

Intervention name(s): Dynamic Tape® (Tape)
Intervention type(s): Other
Intervention description(s): To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage affected by plantar fasciitis during a week the Outcome Measure, pain is evaluate with a VAS (visual pain scale).
Intervention model: Single Group Assignment
Intervention model description: Patients with fasciitis plantar pain
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: foot; fasciitis; tapping
Ultrasonic Wound Debridement vs. Standard Sharp Debridement
Condition: Chronic Skin Ulcers
MeSH terms: Skin Ulcer
Study type: Interventional

Summary: 
      A single center, randomized, parallel, clinical outcome trial to compare the rate of healing
      in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation)
      or standard of care sharp debridement.
    


Intervention name(s): Contact ultrasonic debridement device
Intervention type(s): Device
Intervention description(s): Cavitational ultrasound wound debridement device
Other intervention name(s): SonicOne, Misonix Inc, Farmingdale NY
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: wound debridement; requiring debridement
To Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      CitruSlim® can promote healthy weight loss by promoting anabolic state during weight loss
      programs, prevent the body from storing fat, reduce appetites and maintain healthy
      cholesterol and blood glucose level during weight loss program.

      This study focuses to prove the efficacy and safety of the product in a population of
      overweight and obese individual.
    


Intervention name(s): Citrus flavonone-O-glycosides- LD; Citrus flavonone-O-glycosides- HD; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Low Dose of 200 mg; High Dose of 400 mg; Placebo (Microcrystalline Cellulose) of 400 mg
Intervention MeSH terms: Cardiac Glycosides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Textured Food Introduction Information and Parental Feeding Practices
Condition: Feeding Practices; Food Acceptance
Study type: Interventional

Summary: 
      The purpose of this study is to conduct an intervention with 60 parents of 8 months old
      children to test the effect of recommendations, compared to usual care, promoting the
      introduction of textured foods between 8 and 15 months on parental practices of use of
      textured foods and the effect of such practices on children acceptance for a variety of
      textured foods.
    

Detailed description: 
      The intervention tests the effect of providing parents with recommendations on textured food
      introduction between 8 and 15 months on their practices of offering of textured foods and
      their child's acceptance of textured foods. The intervention consists of advice and tips on
      the why and how introducing textured food during complementary feeding, which were not
      address in French national guidelines (Programme National Nutrition Santé (PNNS)) at the
      start of the study. Advise were developped from current literature knowledge and
      recommendations in other countries. They are accompanied with monthly counselling via phone
      calls by dietician and two baskets containing food preparation utensils and commercial
      textured foods. The intervention group (n=30) benefits from this intervention. The control
      group (n=30) receive general information on healthy eating provided by the food guides of the
      PNNS, phone calls collecting general information and 2 baskets containing baby gifts.

      Acceptance is evaluated experimentally pre and post intervention in a laboratory setting
      evaluating children swallowing foods of different textures.
    

Intervention name(s): Counselling on textured food introduction between 8 and 15 months
Intervention type(s): Behavioral
Intervention description(s): Intervention program : Advice and tips on the why and how introducing textured food during complementary feeding are grouped in a booklet and provided to participants. Monthly counselling via phone call by a dietician (at 9, 10, 11,12, 13, 14 months) and two baskets containing food preparation utensils and commercial textured foods provided at 8 and 12 months.
Usual care : reflects the standard information provided within French national guidelines (PNNS). Two phone calls at 9 and 13 months. If questions are raised by parents, dieticians will restrict their responses based on the food guides of the PNNS. Two gift boxes containing presents for the child of same financial value as those provided to intervention group, provided at 8 and 12 months.
Other intervention name(s): Food provision
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention run between 8 and 15 months of the children, randomisation of children within a control (n=30) or intervention group (n=30).
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: children; parental feeding practices; food texture; food oral processing; complementary feeding; recommendation
Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic
      patients on two different treatment regimens: insulin and metformin versus glyburide,
      metformin and pioglitazone.
    

Detailed description: 
      This is a 72 months long randomized clinical trial longitudinally evaluating beta-cell
      function, as well as glycemic control and inflammatory markers in newly diagnosed type 2
      diabetic patients on two different treatment regimens: insulin and metformin versus
      glyburide, metformin and pioglitazone.
    

Intervention name(s): Metformin; Insulin; Metfomin; Pioglitazone; glyburide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Metformin 1000mg/BID; Insulin Novolg 70/30 per protocol titration; Metformin 1000mg/BID; Pioglitazone 45mg; Glyburide per protocol titration
Intervention MeSH terms: Metformin; Pioglitazone; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TYpe 2 diabetes mellitus; Newly diagnosed; Beta-cell function
Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia
Condition: Acute Myeloid Leukaemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an
      uncontrolled proliferation of immature hematopoietic cells. Over the last two decades,
      clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive
      induction plus more potent intensification programs with chemotherapy alone or chemotherapy
      plus stem cell transplantation (SCT) has improved treatment results. Advances in
      understanding disease biology, improvements in induction and consolidation program, and
      better supportive care have also all contributed. A number of clinical and laboratory
      characteristics influence the response to treatment and, thus, the survival of patients with
      AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable.
      However, other factors may have a prognostic value and may influence patient's outcome.

      Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it
      has become apparent that the frequency of allogeneic blood transfusions can modify host
      immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic
      factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood
      cell (RBC) transfusion need was identified as a strong and independent risk factor for
      survival in MDS, for which the presence and severity of anaemia were attributed to a clonally
      advanced and biologically more aggressive disease.

      Based on these data, the investigators retrospectively assessed the prognostic value of RBC
      and platelet transfusions at the time of diagnosis and the frequency of transfusions during
      the first induction course of chemotherapy in a large unselected group of patients with
      previously untreated AML.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Acute myeloid leukaemia (AML)
      
Keywords: Acute myeloid leukaemia; Transfusion dependency; Transfusion intensity; Prognosis; Chemotherapy
Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children
Condition: Laparoscopic Cholecystectomy
Study type: Interventional

Summary: 
      The objective of this study is to compare transversus abdominis plane (TAP) blocks to local
      wound infiltration (LWI) in terms of postoperative pain control in pediatric patients
      undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be
      superior to LWI for postoperative pain control resulting in decreased use of opioid /
      narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative
      period. The rationale is that determining the effect of analgesia in this pediatric
      population is important to optimize clinical care.
    

Detailed description: 
      In this study, patients ages 8 through 17 years scheduled for elective laparoscopic
      cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy
      procedures will also be eligible. The da Vinci System is a minimally invasive option
      utilizing robotic technology. Once randomized, the patient will undergo either ultrasound
      guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective
      data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will
      be collected for both groups. Due to the nature of the study, it will not be possible to
      blind the investigators to the randomly selected method of injecting local anesthesia;
      however the personnel involved in the post-anesthetic and post-operative assessment will be
      blinded to the intervention, as well as the subjects themselves.
    

Intervention name(s): TAP Blocks; local wound infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine; local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
Other intervention name(s): nerve block; transversus abdominis plane block; local wound injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Pediatric; post-operative pain prevention; Anesthesia, Infiltration; Nerve Blockade
Home-based Arm and Hand Exercise to Improve Upper Limb Function After Traumatic Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether the Home-based Arm and Hand Exercise (HAHE)
      program improves functions of the upper limb that is affected after traumatic brain injury.
      HAHE is made up of exercises that simulate real-life tasks.
    

Detailed description: 
      Arm and hand dysfunction, although not widely recognized, is a common and devastating
      consequence of traumatic brain injury (TBI). Recommendations have been published that
      encourage clinicians to include upper extremity retraining within the TBI population;
      however, very little research exists that will help inform treatments for this population.
      There is urgency to broaden the scientific evidence critical to informing upper limb
      rehabilitation for TBI survivors. The proposed study will do just that by using a
      task-specific visuomotor exercise protocol that emphasizes upper limb movements which can be
      practiced by patients in their homes. This new home-based arm and hand exercise (HAHE)
      protocol is expected to improve functional recovery and quality of life among individuals
      with chronic upper limb impairment after moderate-to-severe TBI.
    

Intervention name(s): Wrist Alarm; Home-based Arm and Hand Exercise
Intervention type(s): Other; Behavioral
Intervention description(s): Wrist device with alarm timer; Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Oscillations in Reward-guided Behavior
Condition: Reward-guided Behaviour
Study type: Interventional

Summary: 
      While people are reading, talking or playing computer games, their brain cells elicit
      electrical signals so they could perform these actions. The firing of these cells is not
      random but is organized in a temporal pattern, such that a group of cells are simultaneously
      active at a particular frequency. The researchers can read the frequency of brain signals and
      identify their location using different brain-imaging tools like EEG and fMRI. These methods
      are applied to healthy individuals and do not pose any danger.

      The investigators of this project would like to use these techniques to study the brain
      signals, while healthy participants are making the decisions choosing between 2 rewards,
      e.g., 2 food items. Participants who have depression show different behavior while performing
      decision-making tasks and the investigation of processes that underlie them will lead to a
      better understanding of this disease.

      Furthermore, there is another category of tools, which help to study the brain. This category
      includes electrical stimulation, which mimics the electrical pattern that brain cells elicit.
      Application of external electrical stimulation can enhance this pattern or disrupt it and
      this process will affect the behavior of a person. Recent investigations have led to the
      development of a new stimulation technique that allows targeting deep brain regions. The
      investigators of this project want to apply this method to change the performance of healthy
      participants in the tasks on decision-making. If this experiment is successful, then
      stimulation can be used as a therapy for participants with depression.
    


Intervention name(s): TI transcranial electrical stimulation
Intervention type(s): Device
Intervention description(s): Participants will undergo transcranial electrical stimulation, which will be delivered with low current amplitudes (<= 2 mA) established with international safety guidelines for electrical stimulation. Threshold for the current amplitude will be established by participants themselves, such that they cannot distinguish when stimulation is applied and not applied.
Duration of stimulation will not last longer than 30 minutes.
Intervention model: Single Group Assignment
Intervention model description: The same participants receive placebo/sham stimulation and active stimulation on different sessions separated with 1 week or within the same session.
The sequence of sham/placebo and active stimulation will be randomized.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Brain oscillations; Neural oscillations; Transcranial electrical stimulation tCS; Temporal Interference stimulation TI; Decision-making