bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project. Randomized Study.
Condition: To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional

Summary: 
      Background To evaluate clinical results, insulin resistance and inflammatory response to
      trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received
      either traditional preoperative care or treatment following the ACERTO protocol.
    

Detailed description: 
      Methods The population of the study consisted of morbidly obese patients, who were operated
      on with the Sleeve procedure, from Cuiaba, MT, between April and October 2012. We studied the
      inflammatory response and insulin resistance by measuring levels of glucose, insulin, Homa
      IR, reactive C protein, albumin, pre-albumin, alpha 1 acid glicoprotein, interleukin 6 and
      glycosylated hemoglobin. We also studied hydration, nausea and vomiting, hypertension, and
      length of hospital stay.
    

Intervention name(s): ACERTO protocol vs Traditional care
Intervention type(s): Other
Intervention description(s): Three sample blood collections were performed, being one in the anesthesic induction and the others in the next 24 to 48 hours. The blood was sent to the laboratory for dosages of glucose, insulin, C-reactive protein, albumin, prealbumin, alpha 1 acid glycoprotein and interleukin 6. During the anesthesic induction we also collected blood for analize glycosylated hemoglobin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Obesity, Morbid; Insulin Resistance; Acute-Phase Reaction; Gastroplasty; Length of Stay; Protocols; Randomized Controlled Trial.
Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions
Condition: Pseudoarthrosis of Bone; Implant Breakage
MeSH terms: Hypertrophy; Pseudarthrosis
Study type: Interventional

Summary: 
      In 12 patients with corticalization and hypertrophic pseudarthrosis were present after
      dynamization, the old nail was removed and nail exchange was performed with a longer and
      larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior
      from the old nail.
    

Detailed description: 
      Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the
      early sign of dynamization treatment failure in hypertrophic nonunion after femoral
      transverse diaphyseal fractures. When corticalization is seen during follow-up after
      dynamization is performed because of non-union of a femoral transverse fracture, nail
      exchange should be performed without further delay. More rigid fixation should be applied
      with a longer and thicker nail crossing the area of corticalization.
    

Intervention name(s): exchange nailing with larger, thicker nail crossing corticalization
Intervention type(s): Procedure
Intervention description(s): exchange nailing with larger, thicker nail crossing corticalization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertrophic pseudarthrosis; dynamization; corticalisation
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the contrast agent is effective and safe in the
      Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the
      trial.
    

Intervention name(s): Gadobutrol (Gadavist, Gadovist, BAY86-4875); Gadopentate dimeglumine (Magnevist, BAY86-4882)
Intervention type(s): Drug; Drug
Intervention description(s): Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Gadovist; Gadavist; MRI Imaging; vascular diseases; Chinese
A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Participants With Transfusion-Dependent β-Thalassemia
Condition: Beta-Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 18 participants
      less than or equal to (<=) 50 years of age with transfusion-dependent β-thalassemia (TDT),
      who have a β0/β0, β0/IVS-I-110, or IVS-I-110/IVS-I-110 genotype. The study will evaluate the
      efficacy and safety of autologous hematopoietic stem cell transplantation (HSCT) using
      LentiGlobin BB305 Drug Product.
    


Intervention name(s): LentiGlobin BB305 Drug Product
Intervention type(s): Genetic
Intervention description(s): LentiGlobin BB305 Drug Product is administered by IV infusion following myeloablative conditioning with busulfan.
Other intervention name(s): betibeglogene autotemcel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Baseline V-RESOLVE Score Guided Versus Angiography Guided Stent Implantation in Coronary Bifurcation Lesions (CIT-RESOLVE II)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether baseline V-RESOLVE score guided
      intervention is associated with significant reduction of side branch occlusion rates compared
      to angiography guided intervention in patients with coronary bifurcation lesions.
    

Detailed description: 
      A number of 1104 patients scheduled for elective percutaneous coronary intervention (PCI)
      with native coronary bifurcation lesions suitable for stent implantation are included in the
      present study. This study will be conducted in two stages with 552 patients each. In the
      first stage, all patients receive angiography-guided PCI. In the second stage, all patients
      receive PCI under the guidance of baseline V-RESOLVE score.
    

Intervention name(s): Baseline V-RESOLVE score-guided PCI; Angiography-guided PCI
Intervention type(s): Procedure; Procedure
Intervention description(s): Jailed wire technique (JWT): Both main vessel (MV) and side branch (SB) are wired. The MV is stented with wire protection in SB. If suboptimal results exist, the SB would be rewired and a kissing balloon inflation (KBI) is undertaken.
Jailed balloon technique: A monorail balloon is advanced into the SB. If there is TIMI flow grade decrease in the SB after MV stenting, the SB balloon is inflated to simulate attempt to reopen the SB.
Provisional two-stent strategy: Lesion preparation and MV stenting are consistent with JWT. Provisional SB stenting could be undertaken when suboptimal results occur after SB rewiring and a KBI is undertaken.
Elective two-stent strategy: Patients in this subgroup would undergo crush procedure or any other elective two-stent strategy which usually stenting SB before MV stenting.; The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Percutaneous Coronary Intervention; Coronary Bifurcation Intervention
Couples Dynamics and Smoking Cessation
Condition: Smoking; Smoking Cessation; Cessation, Smoking; Smoking Behaviors; Smoking, Cigarette
Study type: Observational

Summary: 
      This study is about investigating smoking and attempts to quit smoking in couples.
      Participation will help determine better treatment efforts for couples who want to quit
      smoking. All study procedures will be conducted remotely, allowing couples to interact with
      study personnel through zoom.
    


Intervention name(s): No Interventions
Intervention type(s): Other
Intervention description(s): There are no interventions in this study. Participants are observed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants may live through the United States.
Red Cell Distribution Width Versus Presepsin (Soluble CD14) as a Prognostic Marker in Critically-ill Sepsis Patients
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting
      its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher
      Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels
      correlates well with sepsis severity. Red cell distribution width variations are increased in
      a variety of medical conditions such as congestive heart failure, acute myocardial
      infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a
      predictor of mortality in the general population. we aim to compare between Presepsin
      (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.
    


Intervention name(s): Red Cell Distribution Width (RDW); Presepsin (sCD14-ST)
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker.; : A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the general ICU with sepsis or septic shock of both sexes between 18
        and 65 years of age.
      
Keywords: sepsis; presepsin; red cell distribution width
Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial
Condition: Disc Degeneration of Pfirrmann Grade III or Greater; Degenerative Spondylolisthesis; Isthmic Spondylolisthesis of Grade I or II
MeSH terms: Spondylolisthesis; Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into
      two groups: one to receive a new ceramic implant and a control group with a more traditional
      PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will
      measure and compare pain and disability improvement with the two implanted devices over a
      period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
    


Intervention name(s): Posterior lumbar interbody fusion with a PEEK cage; Posterior lumbar interbody fusion with a Valeo OL cage
Intervention type(s): Device; Device
Intervention description(s): PEEK cage suitable for oblique placement in the lumbar spine; Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.
Other intervention name(s): Amedica Phantom Plus or Pioneer Bullet-Tip cage; Valeo OL; silicon nitride ceramic
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spondylolisthesis; disc degeneration; lumbar interbody fusion; randomized controlled trial; ceramic interbody spacer
Bioequivalence Study of Nitrofurantoin 100 mg Capsules Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      An open label, randomised, two-treatment, four-period, two-sequence, single-dose, crossover,
      fully replicated bioavailability study on Nitrofurantoin formulations comparing
      Nitrofurantoin 100 mg capsules of Ranbaxy Laboratories with Macrobid 100 mg capsules in
      healthy, adult, human subjects under fed conditions
    

Detailed description: 
      This was an open-label, randomized, single-dose, four period fully replicate crossover,
      relative bioavailability study performed on 40 healthy adult male and. A total of 35
      completed the clinical phase of the study.
    

Intervention name(s): Nitrofurantoin 100 mg capsules
Intervention type(s): Drug
Intervention MeSH terms: Nitrofurantoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence Nitrofurantoin capsules
Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis
Condition: Hypersensitivity; Allergic Rhinitis; Allergic Conjunctivitis; Seasonal Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of
      300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior
      to the birch pollen season and continuing over the birch pollen season compared with placebo
      for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.
    


Intervention name(s): Placebo; Birch pollen allergen extract
Intervention type(s): Biological; Biological
Intervention description(s): 10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years; Sublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years
Other intervention name(s): Staloral Birch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Birch pollen extract solution; Allergic rhinoconjunctivitis
Teach-Back Method on Quality of Life in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study determines effect of education with Teach-Back method in patients with Heart
      failure. In this randomized clinical trial, 70 patients with Heart failure hospitalized in
      year 2016-17 were selected and they were randomly divided into control group and test
      group.Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on
      the case group, and control group received routine treatment. Information have collected whit
      Demographic questionnaire and SF36 questionnaire before and after training. Data were
      analyzed by Spss version18 And there were analyzed by descriptive statistics and Chi-square,
      Independent T-test, Paired T-test and Co-variance tests.
    


Intervention name(s): Education with Teach-Back method; Received routine treatment
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Self Care; Heart Failure; Quality of Life; Teach-Back
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to determine which maintenance immunosuppressive agent, rapamycin or
      mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal
      failure, who presented for a kidney-pancreas transplant.
    

Detailed description: 
      This is a randomized, prospective single center study evaluating the two maintenance drugs
      above.
    

Intervention name(s): Rapamycin; Mycophenolate Mofetil; Tacrolimus; Steroids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.; MMF 1 gm BID beginning 1st day postoperative day; Part of standard maintenance.; Part of standard maintenance
Other intervention name(s): Rapamune® (sirolimus); Cellcept; MMF; TAC; Corticosteroids
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Tacrolimus
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rapamycin; Mycophenolate Mofetil (MMF); Kidney-Pancreas Transplant
Infrared Thermography for the Diagnosis of Musculoskeletal Pain
Condition: Healthy; Pain; Temperature Change, Body
MeSH terms: Musculoskeletal Pain; Body Temperature Changes
Study type: Observational [Patient Registry]

Summary: 
      This study sought to evaluate the vasomotor response in the pain referral area of healthy
      individuals, performing the same procedure with and without the experience of delayed onset
      muscle soreness.
    

Detailed description: 
      Validity of infrared thermography for properly diagnosing musculoskeletal pain and their
      clinical applicability is lacking. This study investigates temperature changes on the upper
      extremity before and after a suprathreshold stimulation (painful stimulus) with a digital
      algometer over the infraspinatus muscle. The same procedure is performed in two consecutive
      days, 24 hours apart (Day-1 and Day-2). At the end of Day-1, an eccentric exercise is
      performed in order to to induce delayed onset muscle soreness on the external rotators of the
      shoulder.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants with no acute pain, chronic pain or other medical disorders relevant to this
        study.
      
Keywords: Musculoskeletal pain; Delayed Onset Muscle Soreness; Pain sensitivity; Infrared thermography; Referred pain
Synbiotic Approach to Immunity and Metabolism in the Elderly Study
Condition: Healthy
Study type: Interventional

Summary: 
      The aging process leads to a marked decline in immune function (immunosenescence), causing a
      significant reduction in immune response after vaccination or infections. Dietary
      intervention is an attractive, safe and non-invasive way to impact on gut bacteria and
      subsequently the functioning of the immune system. The ability of the dietary supplementation
      to alter these functions can be of particular importance in those groups that have an
      underdeveloped, poorly functioning immune system such as infants, immuno-compromised subjects
      or elderly. Research over the past two decades has provided evidence that administration of
      probiotics (live microorganisms which, when administered in adequate amounts, confer a health
      benefit on the host) could enhance immune function. Lactobacilli and bifidobacteria are the
      most common probiotics used in humans and various strains have been shown to have
      immunostimulatory properties in vitro and in experimental models, these properties include
      modulation of cytokine production. evidence exists of the immunostimulating effects of
      certain probiotics and the potential to use prebiotics to increase the levels of beneficial
      bacteria (which are known to be reduced in elderly population). Furthermore, by providing a
      probiotic at the same time as a prebiotic conditions for survival are enhanced. To date, only
      a small number of studies conducted have been randomised and/or placebo controlled to
      unequivocally demonstrate efficacies.
    

Detailed description: 
      The aim of this study is to investigate the effect of probiotic Lactobacillus rhamnosus GG
      (commercialised as LGG), a pilus-less derivative L. rhamnosus GG (LGG-PB12)combined with a
      putative prebiotic PromitorTM (soluble corn fiber) i.e. a synbiotics and PromitorTM (SCF
      alone) on the faecal microbiota composition, metabolism and immunity in healthy individuals
      aged 60-80 years.

      It consists of a 3 week randomised intervention treatment periods with the synbiotics,
      prebiotic and placebo control. Any adverse medical events which occur during the trial (e.g.
      headache, gut symptoms) should be recorded in a diary along with medication taken.
    

Intervention name(s): LGG+Promitor™; Promitor™; LGG-PB12+Promitor™; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): synbiotic; Soluble Corn Fiber; synbiotic; Control
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome
Condition: PCOS; Obesity
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether combined treatment with
      phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than
      metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome
      (PCOS) who had been previously poor responders regarding weight reduction on metformin
      monotherapy. The investigators anticipated greater changes in body weight in patients on
      combined treatment than in those on monotherapy with metformin.
    


Intervention name(s): metformin; metformin and roflumilast
Intervention type(s): Drug; Drug
Other intervention name(s): Glucophage tablets; Glucophage tablets and Daxas 500 micrograms film-coated tablets
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; PDE-4 inhibitor; roflumilast; metformin; obesity
Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery
Condition: Nerve Block
Study type: Interventional

Summary: 
      Analgesia following video-assisted thoracoscopic surgery (VATS) is important for the
      prevention of postoperative pulmonary complications.Various regional methods of anesthesia
      are currently being used to achieve this goal. The aim of the study was to assess the
      effectiveness of SAPB on postoperative VATS analgesia.
    


Intervention name(s): Serratus Anterior Plane Block; IV patient-controlled analgesia (PCA) tramadol
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, controlled, single-blind
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment