bioihbjkbjnl/mcl2 huggingface dataset:
Thermic Effect of Three Different Meals in Healthy Women
Condition: Weight Loss; Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study will investigate the acute effect of three isocaloric meals varying in level of
      food processing, including a whole foods, gluten-free, and highly processed meal on energy
      metabolism and blood glucose in 8-12 young adult, normal weight females. A secondary aim of
      this proposed study is to compare palatability, satiety, and perceived energy ratings among
      highly processed, unrefined, and gluten-free unrefined isocaloric meals.
    

Detailed description: 
      A shift towards a diet containing large quantities of highly processed foods is believed to
      be a major contributor to the trends in obesity. The degree of processing of foods often
      affects the nutritional content of the constituents. A reduction in macromolecular complexity
      allows for an increased rate of digestion, meaning that the body does not have to work as
      hard to metabolize high processed food products. Thus, the purpose of this study is to
      investigate the effect on energy metabolism and blood glucose after the consumption of an
      unrefined, whole foods meal versus two highly processed food meals, including a common
      Western style meal and gluten-free meal in 8-12 young adult, normal weight females. A
      secondary aim of this proposed study is to compare palatability, satiety, and perceived
      energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.
      It is hypothesized that an unrefined meal will induce a greater postprandial thermogenic
      response and a smaller blood glucose response than a highly processed or gluten-free meal.
      Additionally, it is hypothesized that a highly processed foods meal will be considered more
      palatable than an unrefined or gluten-free meal.
    

Intervention name(s): Whole Food Meal; Processed Food Meal; Gluten-free and lactose-free
Intervention type(s): Other; Other; Other
Intervention description(s): Whole foods meal; Processed food meal; Gluten-free and lactose-free food meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Preconception Women's Health in Pediatric Practice Intervention
Condition: Preconception Care; Women's Health
Study type: Interventional

Summary: 
      The aims of the intervention are:

        1. Assess the feasibility and effectiveness of preconception health care initiated by
           pediatric clinicians on outcomes including women's access to primary care and
           contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy
           interval; and women's immunization rate, control of chronic illnesses, nutritional
           status, smoking and substance use, mental health and violence exposure; child and family
           health.

        2. Assess the cost-effectiveness of preconception health care initiated in pediatric
           practices.

      The investigators will evaluate these outcomes with a clinic based trial comparing usual care
      to preconception care intervention.
    


Intervention name(s): Preconception Care Screener
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: preconception care; women's health
Hypoglycemia and the Mineralocorticoid Receptor
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to look at whether blockade of the mineralocorticoid receptor
      will result in changes in the cardiovascular and inflammatory response to hypoglycemia.
    

Detailed description: 
      The effect of ongoing hypoglycemia on cardiovascular autonomic function is unclear and the
      focus of this protocol. In our preliminary studies, the investigators demonstrated that
      baroreflex sensitivity is impaired during hypoglycemia in healthy individuals. Treatment with
      eplerenone (200mg total administered in two doses in the 15 hours prior to the hypoglycemic
      clamp) prevented this impairment.

      The study is based on the overarching hypothesis that hypoglycemia leads to increases in
      aldosterone/mineralocorticoid receptor (MR) activity and increased cardiovascular injury.

      This study will address the following Specific Aims:

      To test the hypothesis that MR blockade will reduce the adverse effects of hypoglycemia on
      inflammation and on autonomic control of cardiovascular function.

      The investigators will determine the effects of hypoglycemia (50 mg/dl for 2.0 hours) on the
      blood inflammatory factor interleukin-6 levels, and on cardiovascular autonomic function
      (baroreflex sensitivity) in each subject under two conditions - pretreatment with MR blockade
      (eplerenone) and pretreatment with placebo.
    

Intervention name(s): Eplerenone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg x 2
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as
      an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.
    


Intervention name(s): efgartigimod IV; efgartigimod PH20 SC
Intervention type(s): Biological; Biological
Intervention description(s): intravenous infusions of efgartigimod; subcutaneous injections of efgartigimod PH20 SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population
Condition: Partially Edentulous Jaw
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm
      diameter implant in a Chinese population by evaluation of marginal bone level alteration,
      implant stability and implant survival in the posterior maxilla up to 3 years after loading.
      Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
    


Intervention name(s): OsseoSpeed™ TX
Intervention type(s): Device
Intervention description(s): OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Naltrexone for Early Problem Drinkers
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      Early problem drinkers are prevalent in the United States. Recent controlled trials have
      shown that brief interventions in the primary care setting can reduce drinking and
      alcohol-related problems in patients who lack evidence of alcohol dependence.

      Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few
      pharmacotherapy studies have been undertaken with early problem drinkers. This study is an
      8-week trial of naltrexone versus placebo, combined with coping skills treatment that either
      focuses on targeted use of medication or serves as background to daily use of the medication.
      A total of 160 early problem drinkers recruited through screening in primary care medical
      settings will be randomly assigned to one of four treatment groups. Followup evaluations will
      be conducted at the end of treatment and again 3, 6, and 12 months.
    


Intervention name(s): naltrexone
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Primary purpose: Treatment
Retrospective Analysis of Anesthesia Procedure in Orthognathic Surgery
Condition: Orthognathic Surgery
Study type: Observational

Summary: 
      Using retrospective medical records to analyze the difference between the analysis of the
      correlation between operation time, blood loss, anesthesia methods, anesthesia medication,
      and postoperative recovery time
    

Detailed description: 
      In Orthognathic surgery, facial bones involved in the operation site are more likely to
      bleed. In order to reduce the amount of bleeding during the operation, intentional
      hypotensive anesthesia is executed during the operation.

      Because the amount of bleeding is controlled within a reasonable range, the surgical field of
      vision is naturally clear, which can also make the operation go smoothly, shorten the
      operation time, and increase the postoperative comfort. Therefore, for orthognathic surgery,
      the maintenance of intraoperative blood pressure is very important. Using inhaled anesthetics
      can easily achieve deeper anesthesia, but may increase postoperative nausea and vomiting.
      Generally speaking, these patients will be fixed with steel wires between the upper and lower
      jaws after the operation. Postoperative nausea and vomiting will increase the risk of
      aspiration pneumonia, but intravenous anesthesia can reduce postoperative nausea and
      vomiting.

      This research is a retrospective investigation of medical records. The purpose of this study
      is to understand the differences in the analysis of the correlation between the operation
      time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery of
      patients undergoing surgery during orthognathic surgery. In the future, orthognathic surgery
      (Orthognathic surgery) anesthesia policy and anesthesia target process guidelines can be
      formulated, and it can help remind medical staff to make an early and appropriate treatment
      at any time.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Review the operation time, blood loss, anesthesia method, anesthesia medication, and
        postoperative recovery evaluation of the operation record sheet and anesthesia-related
        record sheet (including the recovery room and postoperative visit record sheet) in the
        patient's medical record.
      
Keywords: orthognathic surgery; anesthesia; retrospective analysis
Comparison of Clinical Outcomes of Distal Radius Fractures Treated Surgically With WALANT and Peripheral Nerve Block
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Observational

Summary: 
      WALANT anesthesia technique has been frequently preferred in hand and upper extremity surgery
      in recent years. WALANT technique; It stands out with its advantages such as lack of
      pre-operative anesthesia preparation process, reduction in test and examination requests,
      reduction in unnecessary hospitalizations and high patient satisfaction. There are studies
      with a high level of evidence showing that the WALANT technique has such advantages in soft
      tissue and smallmedium bone fracture surgery. In large bone fractures (radius, etc.),
      surgical treatment is performed with the WALANT technique and positive results have been
      reported. Although there is a study comparing WALANT and general anesthesia in the surgical
      treatment of distal radius fractures, there is no study comparing the peripheral nerve block
      technique.
    


Intervention name(s): Open reduction and internal fixation (under WALANT); Open reduction and internal fixation (under peripheral nerve block)
Intervention type(s): Procedure; Procedure
Intervention description(s): Open reduction and internal fixation with volar Henry approach under WALANT.; Open reduction and internal fixation with volar Henry approach under peripheral nerve block.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 50 patients are planned to be included in the study.
      
Keywords: WALANT; Distal Radius Fracture; Peripheral nerve block
A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate the relative bioavailabilities of
      rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and
      together with BI 1323495 (Test 1, Test 2) following oral administration.
    


Intervention name(s): Rosuvastatin; Rosuvastatin + BI 1323495; Dabigatran etexilate; Dabigatran etexilate + BI 1323495
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Tablets; Capsule; Capsule and tablets
Intervention MeSH terms: Dabigatran; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MOTIVATE Weight Loss Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of minor variations in Incisionless
      Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety,
      and weight loss in the treatment of primary obesity. It will confirm, in an open prospective
      study, the action mechanisms for the "POSE" endoscopic treatment technique for obesity, and
      it will help determine if they are maintained at least 6 months following the procedure.
      Durability of weight loss will be tracked through post-POSE visits up to 18 months following
      the procedure.
    


Intervention name(s): Using The IOP system from USGI to place suture anchors
Intervention type(s): Device
Intervention description(s): Sutures are placed in the distal body in one of three randomized techniques:
"A" = reduction in "ring" opening to antrum using plications "B" = continuous horizontal row, running from distal body into proximal antrum "C" = Control. Current V shape as Control
Other intervention name(s): The g-Cath EZ Suture Anchor Delivery Catheter
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Using POSE as a treatment for Obesity
Pilates Method and Therapeutic Exercise in Children That Play String Instruments
Condition: Postural Kyphosis; Postural Lordosis; Postural Low Back Pain
MeSH terms: Kyphosis; Lordosis; Low Back Pain
Study type: Interventional

Summary: 
      Introduction: An inappropriate posture in children for a while kept playing some instrument
      of the group of the rubbed string, can cause pain and alterations of the spine, as it
      continues to consolidate.

      Objective: To study the benefits acquired during the application of the Pilates Method
      combined with therapeutic exercise against the Therapeutic Exercise to reduce alterations of
      the vertebral rachis in children from 10 to 14 years old who play instruments of rubbed
      strings.
    

Detailed description: 
      Material and methods: A pilot study designed by a randomized controlled trial in two parallel
      intervention groups was carried out; 9 children performed the combination of the Pilates
      Method and Therapeutic Exercise (experimental) and 7 children performed the Therapeutic
      Exercise (control). At the beginning and at the end of the study, pain measurements have been
      made through the Visual Analogue Scale (EVA), and the Kinovea programme for the alignment of
      shoulder, scapula and hip postures.
    

Intervention name(s): Pilates Method combined with Therapeutic exercice.; Therapeutic exercise
Intervention type(s): Other; Other
Intervention description(s): Children must perform specific exercices in this combined method with the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.; Children must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot study designed by a randomized controlled trial in two parallel intervention groups
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pilates; Therapeutic Exercise; Children; String instruments; Vertebral column
What do Stroke Survivors Actually Learn When Regaining Walking Ability After Stroke? The TARGET Phase I Study
Condition: Stroke; Paresis; Gait, Hemiplegic
MeSH terms: Stroke; Paresis; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      Phase I: Exploring what stroke survivors exactly learn when recovering the ability to stand
      and walk.
    

Detailed description: 
      GENERAL:

      Pre-clinical research has pointed towards a time window of enhanced responsiveness to therapy
      early after stroke. For example, training has led to substantial recovery if initiated 5 or
      14, but not 30 days post-stroke in a rodent model (Biernaski 2004). It is suggested that this
      early period is characterized by heightened levels of plasticity and that training can
      exploit this leading to improved outcome. The typically observed non-linear recovery pattern
      in stroke survivors (Kwakkel 2004) might suggest that similar mechanisms are induced in the
      human brain, however clinical research on this is disappointingly sparse.

      In two closely inter-related phases, we aim to examine the biomechanical changes related to
      walking recovery in general (Phase I) and the specific effects of robot-assisted training
      (Phase II). By that, we aim to detect a time window in stroke survivors which resembles the
      same characteristics as observed in animal models. To initiate gait training at an early
      stage, when patients usually present severe weakness and balance deficits, a mobile
      exoskeleton is used which is developed to provide intensive walking practice.

      OBJECTIVES:

      (I.a) Is there a distinct time window of behavioral restitution (i.e., returning towards
      pre-stroke movement patterns) underlying early walking recovery?

      (I.b) Are improvements in standing and walking throughout the first 6 months post-stroke
      explained by behavioral restitution or learning to use compensation strategies?
    

Intervention name(s): conventional rehabilitation
Intervention type(s): Behavioral
Intervention description(s): The investigated cohort will be exposed to 'standard care' including conventional rehabilitation therapy.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to the neurology department of the Antwerp University Hospital after
        acute stroke will be contacted and asked to participate. Information about the study's aim
        will be provided with a clear understanding of what is expected from the participant. If
        the patient express willingness to enter the study, the examination on in- and exclusion
        criteria will be performed. If the patient is considered eligible, an informed consent will
        be signed.
      
Keywords: walking; recovery; compensation
The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less
      invasive treatment for Achalasia has been developed.

      The purpose of this study is to decide the role this less invasive treatment (Peroral
      Endoscopic Myotomy) has in the treatment of patient's with achalasia.
    


Intervention name(s): Peroral Endoscopic Myotomy a less invasive treatment for Achalasia
Intervention type(s): Procedure
Intervention description(s): In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit
Other intervention name(s): Achalasia; Heller myotomy; Dysphagia; Peroral Endoscopic Myotomy; Disease of the muscle of the esophagus.; Disorder of the swallowing tube.; Esophageal Motility Disorders; Esophageal Achalasia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Less invasive treatment for Achalasia
The Digital Wellbeing Project
Condition: Mental Health
Study type: Interventional

Summary: 
      This goal of this randomized control trial is to test whether a web application that provides
      sexual and gender minority youth ages 13-19 (N=200) with tools for affirming their identities
      and coping with minority stress can affect key psychosocial outcomes, such as coping
      self-efficacy and symptoms of anxiety and depression.
    


Intervention name(s): immi; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).; The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Sexual and Gender Minorities
Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study will evaluate immunological memory to hepatitis B antigen in subjects who
      received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in
      the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values
      at the previous long-term time point. All participating subjects will receive a challenge
      dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of
      this study. No new subjects will be recruited in this long-term follow-up study. Blood
      sampling will be done one month after the administration of the challenge dose. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): Engerix™-B
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, 1 dose
Other intervention name(s): Hepatitis B vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B vaccine; Challenge dose