bioihbjkbjnl/mcl2 huggingface dataset:
Oversewing Staple Line of The Gastric Remnant
Condition: Gastric Bypass; Obesity
MeSH terms: Obesity
Study type: Observational [Patient Registry]

Summary: 
      Background: Roux-en-Y gastric bypass (RYGB) is a surgery with low rate complications.
      However, it is not exempt from them, and 1-6% suffer complications such as postoperative
      bleeding. Many intraoperative techniques have been evaluated to reduce postoperative
      bleeding, like the oversewing or reinforcement of the staple line. This study aims to
      evaluate the rate of postoperative bleeding in the oversewing of the staple line of the
      gastric remnant group versus the stapling only group.

      Methods: This is a 2-center, case-control study. The investigators randomly selected two
      groups who underwent RYGB or OAGB: group A (n=225) with oversewing from 2019-2020 and group B
      (n=225) with stapling only between the period of 2017-2018; both groups with similar
      demographic characteristics.
    

Detailed description: 
      This case-control study was conducted in the International Unit of Bariatric and Metabolic
      Surgery of "Clinica La Sagrada Familia" located in Maracaibo, Venezuela, and in "Grupo Medico
      Santa Paula" Caracas, Venezuela. All procedures were performed by a single experienced
      bariatric surgeon during the period 2017-2020. The Ethics committees of Clinica "La Sagrada
      Familia" and "Grupo Medico Santa Paula" approved this study. The investigators selected 225
      patients (group A) from the period 2019-2020 where the stapling line of the gastric remnant
      was oversewn and another group of 225 patients (group B) from the period of 2017-2018 with
      stapling alone.
    

Intervention name(s): Oversewing
Intervention type(s): Procedure
Intervention description(s): Oversewing of the gastric remnant
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients older than 18 years, body mass index (BMI) > 30kg/m2 with or without comorbidities
        that underwent RYGB or one anastomosis gastric bypass (OAGB).
      
Keywords: Obesity
Safety, Tolerability and Immunogenicity of a Plant-Made H1 VLP Influenza Vaccine in Adults
Condition: Flu
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter,
      dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single
      non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.
    


Intervention name(s): Dose given at Day 0
Intervention type(s): Biological
Intervention description(s): Dose given by intramuscular administration (0.5 mL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Respiratory disease; Prevention
SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and
      cognition in patients with mild to moderate Alzheimer's disease.
    

Detailed description: 
      SGS742 is a GABA(B) receptor antagonist. It is an orally active drug and possesses
      neurochemical and psychopharmacologic features that suggest it could improve memory and
      cognition in humans. The primary objective of the SGS742 clinical trial will be to determine
      the effect of SGS742 on memory and cognition in individuals diagnosed with mild to moderate
      Alzheimer's disease. The duration of the study is 3 months with 5 clinic visits.
    

Intervention name(s): SGS742
Intervention type(s): Drug
Intervention MeSH terms: (3-aminopropyl)(n-butyl)phosphinic acid
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer disease; memory; cognition; GABA(B)receptor antagonist
The Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients
Condition: Alzheimer's Type Dementia; Cognitive Decline; Postural; Strain
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This research study is developed on an experimental design with randomized controlled
      intervention were participated 135 subjects with AD including 45 of the control group. It
      lasted 6 months with pre-post tests (T0-T1) executed before and after six months of
      treatment. By having in focus the evaluation of GPR therapy effects on cognitive,
      proprioceptive, depressive, autonomy, gait and life quality of the above mentioned subjects.
    

Detailed description: 
      In order to assess the cognitive abilities of the patients a cognitive test was administered
      which acts through a scale concerning depression and mood evaluation as well as a
      questionnaire was developed aiming to evaluate the examined subjects' functional abilities:
      Mini Mental State Examination (MMSE), Quality of Life in Alzheimer Disease (QoL-AD),
      geriatric Depression Scale (GDS), Barthel Index (BI), Neuropsychiatric Inventory (NPI),
      Tinetti Scale (TS).
    

Intervention name(s): GPR Intervention Research group
Intervention type(s): Other
Intervention description(s): The research intervention consisted in the reappointment of three GPR therapeutic postures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Total Disc Replacement Versus Anterior Cervical Decompression and Fusion
Condition: Cervical Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      Background : Cervical degenerative disc disease is frequent and the consequence of aging.
      Degeneration may lead to disc herniation. Surgery is indicated in the presence of root
      compression with cervicobrachial neuralgia and/or myelopathy.

      Purpose: The main objective of the study is the comparison of efficacy between total disc
      replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical treatment
      of symptomatic cervical degenerative disc disease in term of "Success" rate, defined as
      preservation of adjacent segments, 24 months after surgery.

      In our knowledge, there are no published data about randomized clinical trials comparing
      these radiological parameters (worsening of degeneration signs on static cervical spine
      radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery,
      between these 2 surgical approaches in patients suffering from cervical degenerative disc
      disease.
    

Detailed description: 
      Surgical treatment of cervical degenerative disc disease usually consists in neural
      decompression followed by intervertebral space reconstruction.

      ACDF consists in interbody fusion by replacing disc space with a cage packed with bone
      substitute, and inserted into the anterior portion of the interspace. Fusion is successful in
      approximately 95% of patients with good to excellent clinical results in most of them.
      Unfortunately, up to 25% of these patients will develop degenerative changes at adjacent
      levels after surgery.

      TDR consists in total disc replacement with preserved segmental motion decreasing load on
      adjacent levels.

      Worsening of radiological degeneration signs at adjacent levels seems to be an important long
      term prognostic factor for reoperation.

      In this trial, included patients will be randomly assigned to undergo either TDR or ACDF Six
      visits are planned during the study: pre inclusion visit within 3 months before surgery,
      inclusion/randomisation the day before surgery, 3 follow up visits (45 days, 6, and 12 months
      after surgery) and an end of study visit 24 months after surgery (or at time of withdrawal if
      relevant).
    

Intervention name(s): Surgical treatment of cervical degenerative disc disease (CP ESP®); Surgical treatment of cervical degenerative disc disease (Axelle®)
Intervention type(s): Device; Device
Intervention description(s): Axelle®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Total Disc Replacement; Anterior Cervical Decompression and Fusion
Toric Orthokeratology - Slowing Eye Elongation
Condition: Myopia; Astigmatism
MeSH terms: Myopia; Astigmatism
Study type: Interventional

Summary: 
      The aims of this study are to investigate the effects of ortho-k for astigmatic and myopic
      reduction and myopic control in children, and the long term effects on corneal curvatures and
      biomechanics.
    

Detailed description: 
      Ortho-k has been shown to be effective in correcting low myopia but relatively ineffective
      for astigmatism, using spherical reverse geometry lens designs. Toric ortho-k lenses have
      been introduced in recent years but the efficacy for astigmatic reduction and for myopic
      control in children have not been confirmed. The mechanism of myopic reduction in ortho-k
      cannot be fully explained by changes to the anterior corneal curvatures. It is therefore
      possible that other corneal parameters such as posterior corneal curvature and corneal
      biomechanics may contribute to the mechanism.

      The current study aims at investigating the efficacy of toric ortho-k lenses for correcting
      myopic astigmatism and for retarding myopic progression in children compared to children
      wearing single-vision spectacles. Long term changes to other corneal parameters such as
      posterior cornea curvatures, topographical corneal thickness, corneal hysteresis, corneal
      resistance factor, with and without ortho-k lens wear will also be investigated.
    

Intervention name(s): Toric Orthokeratology lenses; Single-vision spectacles
Intervention type(s): Device; Device
Intervention description(s): Children wearing toric orthokeratology at night for correcting astigmatism and myopia will be the study group; Children wearing single-vision spectacles in the daytime for correcting the refractive errors will serve as the control group
Other intervention name(s): corneal reshaping therapy; glasses
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Myopia; Astigmatism; Orthokeratology; Corneal thickness; Corneal curvatures; Corneal biomechanics
A Pharmacokinetic Interaction Study Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how taking JNJ-54861911 every day will effect the
      amount of rosuvastatin or metformin in your blood after taking only a single dose of either
      one.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      fixed sequence, 2-panel study in a total of 32 healthy adult participants (16 participants
      per panel). The study consists of 3 phases: a Screening Phase of approximately 3 weeks (Days
      -22 to -2), an Open-Label Treatment Phase consisting of a single 19 day Treatment Period for
      Panel 1 (Days -1 to 18) or a single 18 day Treatment Period for Panel 2 (Days -1 to 17) and a
      Follow-up Phase of 5 to 7 days. In Panel 1, each participant will be administered a single
      oral dose of 10 milligram (mg) rosuvastatin on Day 1 and Day 14. Participants will receive
      JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 17. In Panel 2, each
      participant will be administered a single oral dose of 500 mg metformin on Day 1 and Day 14.
      Participants will receive JNJ-54861911 at a dose of 25 mg once daily from Day 8 until Day 16.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Rosuvastatin; JNJ-54861911; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 14.; JNJ-54861911 will be administered at a dose of 25 mg once daily from Day 8 to Day 17 (in panel 1), Day 8 to 16 (in panel 2).; Metformin will be administered as a single oral 500 mg on Day 1 and Day 14.
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-54861911; Rosuvastatin; Metformin
An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg
      Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people
      with symptoms of Gastroesophageal Reflux Disease (GERD)
    


Intervention name(s): Esomeprazole; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 20mg oral; 15 minute intravenous infusion
Other intervention name(s): Nexium; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium
Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass
Condition: Coronary Artery Disease
MeSH terms: Respiratory Aspiration; Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital
      cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential
      association with improved functional capacity after coronary artery bypass grafting surgery.
    

Detailed description: 
      Eligible patients were randomized to a cardiopulmonary rehabilitation program (Rehab; n = 10)
      or to usual care (Control; n = 10). The randomization was done by the Graphpad StatMate
      computerized program. Those patients assigned to Control were followed by their own
      physicians, received routine nursing assistance, were visited daily by the one of the
      investigators (CPM), but were not exposed to any specific respiratory or motor physical
      intervention. Those randomized to Rehab received the same medical and nursing care, but
      followed a structured physical therapy program twice a day.
    

Intervention name(s): In Hospital Cardiopulmonary Rehabilitation
Intervention type(s): Other
Intervention description(s): The program consisted of bronchial hygiene characterized by detachment and removal of secretions and respiratory exercises which were applied in the respiratory muscles in order to strengthen and increase the resistance. Patients were instructed to maintain diaphragmatic breathing, at a rate of 12 to 18 breaths per minute during EPAP mask use, and the expiratory pressure was increased progressively in the following fashion: 3-8 cm H2O during 3-12 minutes. Also, they performed flexion/extension of hip and knee, active free exercises for upper limbs, ambulation exercise and ascent/descend of stairs
Other intervention name(s): Cardiac rehabilitation; Phase one cardiac rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Physical therapy; Inspiratory muscles; Exercise
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 4

Summary: 
      This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group,
      single-dose study will assess the efficacy and tolerability of the active tablets versus
      placebo in participants suffering from cold and influenza. Eligible participants will be
      randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a
      four-hour (hr) treatment phase. Each participant will be administered only once during each
      study period. Participants will use a questionnaire to record the symptom severity scores as
      described, as well as time.
    


Intervention name(s): Test tablet; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity; The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
D2560C00015 FluMist Annual Safety Study 2018
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective annual release study is designed to evaluate the safety of 2 new influenza
      virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza
      season.
    

Detailed description: 
      This prospective. randomized, double-blind. placebo-controlled release study will enroll
      approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday).
      Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of
      bivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site.
      This study will be conducted at 2 sites in the United States of America. Each subject will
      receive 1 dose of investigational product on Day 1. The duration of study participation for
      each subject is the time from study vaccination through 180 days after study vaccination.
    

Intervention name(s): Bivalent influenza vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.; A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bivalent.; Influenza.; FluMist Quadrivalent.; Vaccine Prevention in Healthy Adults.
Accelerated Transcranial Magnetic Stimulation (TMS) for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determinate if accelerated rTMS treatment over 1.5 days is
      effective for ameliorating depression in Parkinson's disease.
    

Detailed description: 
      Objective: The goal of this study is to investigate a new approach to administering
      repetitive transcranial magnetic stimulation (rTMS) in patients with refractory depression.
      (Please Note: The original requirement for comorbid Parkinson's disease has been dropped from
      this study).

      Research Plan: This inpatient study will provide an initial test for the hypothesis that
      accelerated rTMS is an effective treatment for depression. Followup testing will help
      delineate the time course of response.

      Methods: The rTMS treatment site over left dorsolateral prefrontal cortex will be 5.5cm
      anterior to the hand motor area. Treatments consisting of 1000 total pulses at 10 Hz and 100%
      motor threshold will be administered hourly for 1.5 days, totaling 15 sessions. A
      comprehensive test battery will be administered just before and after treatment, at 3 weeks,
      and at 6 weeks after treatment.

      Clinical Relevance: We expect that accelerated rTMS treatments will lessen the degree of
      depression to the same extent as rTMS treatments of longer duration, but far more rapidly. A
      much shorter hospitalization would be more easily tolerated. In addition, reducing the
      duration of hospitalization substantially reduces burdens and costs to hospital, staff, and
      caregivers, while more rapidly enhancing function and quality of life.
    

Intervention name(s): Transcranial magnetic Stimulator
Intervention type(s): Device
Intervention description(s): a device which produces intense magnetic fields in the brain and activates cerebral neurons
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Parkinson Disease; Transcranial Magnetic Stimulation
A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12)
Condition: Heartburn
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the bioequivalence of omeprazole administered as either Zegerid® powder
      for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.
    


Intervention name(s): omeprazole/sodium bicarbonate; omeprazole magnesium
Intervention type(s): Drug; Drug
Intervention description(s): Single 20 mg dose of omeprazole/sodium bicarbonate powder for oral suspension; Single 40 mg capsule of omeprazole given orally
Other intervention name(s): Zegerid Powder for Oral Suspension; Prilosec
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This study is designed to evaluate complications, specificity, diagnostic yield of radial
      endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy
      with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between
      non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in
      the cancer microenvironment.
    


Intervention name(s): Transbronchial forceps biopsy; Transbronchial forceps biopsy+Transbronchial cryobiopsy
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and mini probe endobronchial ultrasound (RP-EBUS) scans were enrolled. Transbronchial forceps biopsy (TBFB) was performed for all these patients.; All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans were enrolled. TBFB was performed for all these patients. In addition, all of these patients, with no contraindications, underwent transbronchial cryobiopsy (TBCB)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: cryobiopsy; lung cancer; gut-lung microbiota; immune system