bioihbjkbjnl/mcl2 huggingface dataset:
Traumatic Ulnar Translocation of the Carpus
Condition: Traumatic Ulnar Translocation of the Carpus
Study type: Observational

Summary: 
      Ulnar translocation of the carpus is a form of wrist instability where the small bones of the
      wrist shift out of position. It is well recognized in patients with rheumatoid arthritis, but
      can also occur after a traumatic event, such as a violent football tackle or a fall from a
      height. The treatment options vary considerably, and there is no consensus of how to best
      address this injury pattern.

      Because traumatic ulnar translocation is relatively rare, the diagnosis may be missed or
      delayed, causing problems for the patient such as persistent pain and loss of function. The
      investigators present 11 cases of this injury, discuss how to recognize it, and report our
      results after different treatment methods.
    

Detailed description: 
      Ulnar translocation of the carpus is a form of wrist instability where the entire carpus
      translates medially along the inclined plane of the distal radius. This pattern of
      instability has been well recognized in patients with rheumatoid arthritis as a result of
      articular erosions and attenuation of wrist ligaments. In contrast, ulnar translocation of
      the carpus following trauma is seemingly rare, with published accounts limited to case
      reports and small case series.

      The radiographic features of traumatic ulnocarpal translocation have been described and the
      instability pattern has been reproduced in cadaveric models. However, the recognition of
      radiocarpal malalignment may be unintentionally missed or delayed owing due to the uncommon
      nature of the this injury. The investigators present 11 cases of posttraumatic ulnar
      translocation of the carpus and review criteria for early recognition of the injury and the
      results following varying treatment methods.
    

Intervention name(s): Surgery or immobilization
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who suffered traumatic ulnar translocation of the carpus
Evaluation of Education for Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      Prospective observational cohort study of women with gestational diabetes (GDM) based on the
      'International Association of Pregnancy Study Groups' (IADPSG) criteria. The overall aim is
      to evaluate the knowledge regarding GDM of women with GDM and to evaluate the satisfaction of
      women with GDM about the education they receive (given in group or individually). Normal
      routine care is followed and evaluated.
    


Intervention name(s): education
Intervention type(s): Behavioral
Intervention description(s): Evaluation of education for GDM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women diagnosed with GDM based on the IADPSG criteria
      
Keywords: gestational diabetes; education
Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women
Condition: Healthy Subjects
MeSH terms: Obesity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Liposuction is the most popular aesthetic surgery in Brasil and worldwide. Evidence showing
      that adipose tissue is a metabolically active tissue led to the suggestion that liposuction
      could be a viable method for the improvement of metabolic profile through the immediate loss
      of adipose tissue. Studies about the effects of liposuction on metabolic profile are
      conflicting. A few studies report the improvement of insulin sensitivity, inflammatory
      markers and lipid profile, others observe no changes and a few report the worsening of
      metabolic profile. In addition, animal studies show a compensatory growth of intact adipose
      tissue in response to lipectomy. Physical exercise improves insulin sensitivity, lipid
      profile, inflammatory balance, adipose tissue distribution and increases or preserves free
      fat mass. Therefore, liposuction and physical exercise seem to act on similar tissues of the
      body. To the investigators knowledge, there are no studies about the associated effects of
      liposuction and exercise in humans. However, one can suggest that exercise training
      associated with liposuction could: [1] attenuate or block the possible fat recovery or
      compensatory growth; [2] block or reverse the possible harmful effects of liposuction; or [3]
      exert an additive or synergistic effect to the possible beneficial effects induced by
      liposuction on metabolic and hormonal profile and inflammatory balance.
    


Intervention name(s): exercise
Intervention type(s): Procedure
Intervention description(s): combined resistance and aerobic training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Liposuction; exercise; metabolism; adiposity
Apatinib Combined With Oral Etoposide in Metastatic HER2 Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral
      Etoposide can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.
    

Detailed description: 
      Apatinib is an orally administered second-generation blocker of the phosphorylation of the
      tyrosine residues within the intracellular domain of VEGF receptor 2 (VEGFR2). A prospective,
      open label, phase II multicenter trial of apatinib in heavily pretreated patients with
      metastatic triple-negative breast cancer demonstrated that the daily dose of apatinib 500
      mg/day is active in pretreated metastatic TNBC with encouraging rates of disease
      stabilization and PFS.

      Etoposide is a highly active drug in the treatment of MBC, both as a single agent or in
      combination regimens, and is well tolerated, with a low incidence of severe toxicity.
      Clinical trials demonstrated oral Etoposide provided comparable effectiveness to iv
      Etoposide. and oral availability allows using different schedules.

      The NCCN guideline introduces that combination chemotherapy is one of the standard treatment
      options in metastatic breast cancer, especially in patients with visceral metastases and/or
      need of rapid symptom or disease control.

      Theoretically, anti-angiogenesis regimen combined with chemotherapy may present increasing
      therapeutic effect. Related researches are urgently needed to find optimal combined therapy.

      The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral
      Etoposide can shrink or slow the growth of pretreated HER2 negative breast cancer. The safety
      of the combination will also be studied. Patients physical state, symptoms, changes in the
      size of the tumor, and laboratory findings obtained while on-study will help the research
      team decide if this combination is safe and effective in pretreated HER2 negative metastatic
      breast cancer patients.
    

Intervention name(s): apatinib+oral etoposide
Intervention type(s): Drug
Intervention description(s): apatinib 425/500mg qd, 21days/cycle oral etoposide 50mgmg/m2 d1-10 21days/cycle
Intervention MeSH terms: Etoposide; Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Intestinal Microbiota on Uremic Toxins Productions
Condition: CKD; Uremia
MeSH terms: Uremia
Study type: Interventional

Summary: 
      Chronic renal failure (CKD) affects 3 million people in France and is characterized by the
      accumulation of uremic toxins (UTs) such as p-cresyl sulfate (PCS) and indoxyl sulfate (IS)
      which participate in cardiovascular complications and disturbance of the carbohydrate
      metabolism associated with CKD. These UTs are not eliminated by dialysis due to their high
      affinity for albumin and alternative strategies to dialysis must be developed to decrease the
      production of TUs in patients not yet in dialysis. The dysregulation of the intestinal
      microbiota observed during CKD increases the generation of UTs in the intestine, by the
      transformation of amino acids derived from proteins (such as tyrosine and tryptophan
      transformed respectively into PCS and, IS). Thus, modulation of the intestinal microbiota
      seems to be an attractive target for reducing the production of UTs and the comorbidities
      associated with CKD. Some studies have demonstrated the potential interest of probiotics in
      lowering the plasma concentration of UTs, but the effects remain unclear. In order to test
      the interest of probiotics during CKD, the investigators have, in collaboration with the
      Nestlé laboratory and the ProDigest platform, the possibility of testing probiotics using a
      human intestine simulator before the investigation of experimental and human models. For this
      the investigators would need a collection of fresh stools. The fresh stools will be instilled
      in artificial intestine to test the efficacy of selected probiotics on UTs production.
    


Intervention name(s): Ex vivo exploration of the effect of a probiotic over precursor indole production
Intervention type(s): Other
Intervention description(s): Fresh feces in chronic kidney patients and healthy volunteers will be collected. The feces will be instilled in artificial intestine with and without selected probiotics and production of uremic toxins will be measured.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: CKD; uremic toxin; probiotics; intestinal microbiota; artificial intestine
Hypnosis vs Midazolam for Sedation for TEE
Condition: Clinical Indications for Transesophageal Echocardiography
Study type: Observational

Summary: 
      Most of the reports on hypnosis in the literature have focused on pain control during minor
      operations. With this study we aimed to evaluate the role of hypnosis on sedation for
      transesophageal echocardiography and compare it with commonly used sedative midazolam.
    


Intervention name(s): Midazolam; hypnotherapy
Intervention type(s): Drug; Other
Intervention description(s): The patients will be given 0.05mg/kg iv midazolam just before monitorization. During probing, in case of intolerance to the insertion of the probe, the increments of midazolam with 0.005mg/kg doses will be given.; A first hypnotic induction will be carried out the day before the procedure, next day, fifteen minutes before the procedure, a new induction will be performed.
Intervention MeSH terms: Midazolam
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients admitting to cardiology department for transesophageal echocardiography (TEE)
Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)
Condition: Somatoform Disorders
MeSH terms: Somatoform Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare cognitive behavior therapy (CBT) to medical
      care-as-usual for the treatment of patients with high levels of medically unexplained
      physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of
      CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.
    

Detailed description: 
      Patients with Somatization Disorder suffer from medically unexplained physical ailments and
      experience significant distress and disability. This disorder is an important problem for the
      primary health care system because patients with Somatization Disorder use health care
      resources extensively but receive little benefit. To date, no medical or psychiatric
      intervention has been demonstrated in controlled trials to produce clinically significant and
      lasting symptom relief or improved functional status in Somatization Disorder patients.

      Patients in primary care settings with multiple unexplained symptoms are treated with 10
      weekly sessions of CBT or "treatment as usual." Physical symptoms, comorbid psychiatric
      symptoms, disability, and health care utilization are measured and assessed through a
      combination of structured interviews and self-reports. Assessments are performed at study
      start, mid-treatment, end of treatment, and at a 6-month follow-up.
    

Intervention name(s): Cognitive Behavioral Therapy; CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ten Weekly Sessions of Manualized CBT; Cognitive Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Drug Interaction Study Between Simvastatin and GSK376501
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a 3-period crossover drug interaction study between GSK376501 and simvastatin
      in healthy adult subjects. This study will examine if repeat doses of GSK376501 affects the
      pharmacokinetics of simvastatin and if repeat doses of simvastatin affects the
      pharmacokinetics of GSK375601.
    


Intervention name(s): GSK376501
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK376501; Simvastatin; Healthy Subjects; Repeat Dose; Drug Interaction; Randomized; Pharmacokinetics
Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso
Condition: Breast Cancer; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to develop, implement and evaluate a comprehensive breast and
      cervical cancer screening program designed to increase uptake of breast and cervical cancer
      screening among rarely and never-screened low-income women in El Paso County and to increase
      repeat screening among those currently overdue.
    


Intervention name(s): Unidas por Vida y Salud prevention program
Intervention type(s): Behavioral
Intervention description(s): The Unidas por Vida y Salud (United for Life and Health) prevention program is led by the El Paso Cancer and Chronic Disease Consortium (CCDC), the only Breast and Cervical Cancer Services (BCCS) provider in El Paso. This prevention program will use a well-integrated network of community organizations and health service providers to connect medically underserved women to services. To reach the most underserved women and increase preventive cancer screening and timely follow-up, diagnosis, and treatment, the multi-method approach uses evidence-based strategies, including face-to-face educational sessions led by promotoras (community health workers), client reminders, and provision of community-based navigation services to affordable and free screening services. The program also includes clinic-based navigation for those requiring diagnostics or treatment delivered by trained nurses and case workers.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mammogram; Pap test
A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This is a 26 week randomized controlled study. The study consists of, in order, an enrollment
      visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be
      telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve comprehensive
      assessments of the patients lung condition, including post-bronchodilator spirometry, Shuttle
      walk distance, BODE index, health status (SGRQ) and symptoms (CCQ). Sputum and serum samples
      will also be collected at these visits for microbiological and inflammation analysis. Sputum
      will be obtained with the Lung Flute as an induction device and Pulse Oximetry will be
      assessed prior to and after use of the Lung Flute. Clinic and telephonic visits will collect
      information regarding compliance with the use of the Lung Flute, adverse events and
      exacerbation history.
    


Intervention name(s): Lung Flute
Intervention type(s): Device
Intervention description(s): Used twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Positive Pressure Treatment of Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Six month at home positive pressure therapy study; which mode of therapy will lead to better
      adherence and patient outcomes?
    

Detailed description: 
      Three arm randomized controlled trial evaluating therapy titration methodologies and device
      comfort.
    

Intervention name(s): Auto AFlex; Auto CPAP; CPAP
Intervention type(s): Device; Device; Device
Intervention description(s): Positive pressure therapy treatment; Positive pressure therapy treatment; Positive pressure therapy treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Protectivity and Safety Following Recombinant Hepatitis B Vaccine
Condition: Immunogenicity
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of
      Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population
    

Detailed description: 
      Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of
      Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population.

      Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency
      study.
    

Intervention name(s): Recombinant Hepatitis B vaccine; Recombinant Hepatitis B (Bio Farma)
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.; Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental, randomized, double blind, four arm parallel group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Healthy Children 2021 Study in Childcare Centers
Condition: Family Health; Child Health; Sleep; Child; Executive Function; Pediatric Obesity; Dietary Habits
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      In Portugal, 17.3% of children under 10 years old are overweight and 7.7% are obese. Research
      has shown the implementation of healthy lifestyle promotion programs and obesity prevention,
      however "best practices" are far from being defined. Also, the first five years of life are
      important for the executive functions development, namely memory, inhibition (including
      self-regulation) and flexibility, which includes creative thinking, thinking "outside of the
      box", important in problem solving. The importance of social and emotional dimensions, as
      well as physical health for the development of cognitive health is consensual, as sleep
      deprivation, low physical activity, unhealthy food may inhibit the proper development of
      executive functions.

      This project aims to evaluate the effectiveness of a healthy lifestyle promotion program on
      emotional, social and cognitive development and eating habits, sleep and physical activity in
      children between 12 and 42 months of age.

      A cluster randomised trial will be developed and 300 children, from 16 childcare centres will
      be invited to participate. Half of the childcare centres will be allocated to the control
      group and the other half to the intervention group. Data collection will occur before
      randomisation (at baseline) and after intervention. A feasibility study will be undertaken
      prior to the experimental study, in accordance with internationally accepted procedures.

      The investigators intend to implement the concept that the development of executive functions
      requires the combination of healthy eating, physical activity and sleep.

      The project will contribute with evidence-based to the cognitive, social and emotional
      development in children.
    


Intervention name(s): The education and training of early childhood educators and their intervention on children
Intervention type(s): Behavioral
Intervention description(s): A 24-week cluster randomized trial will be developed, with the childcare being the randomization unit. Training sessions will be conducted for all early childhood educators in the intervention group. The control group will receive the Portuguese "standard" education and at the end of the intervention this group will also receive the initial training given to the intervention group, so that they can later also implement the intervention. At the end of the intervention, all early childhood educators and parents/guardians will have access to the intervention outcomes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of
      MK-3682B, a fixed dose combination (FDC) tablet containing uprifosbuvir (MK-3682) +
      grazoprevir (MK-5172) + ruzasvir (MK-8408) in participants with moderate (Part 1) and severe
      (Part 2) renal insufficiency (RI) to plasma PK in healthy participants.
    


Intervention name(s): MK-3682B
Intervention type(s): Drug
Intervention description(s): FDC oral tablet containing 225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir.
Intervention MeSH terms: Uprifosbuvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment