bioihbjkbjnl/mcl2 huggingface dataset:
Modified Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection
Condition: Cirrhosis; Hypertension; Splenectomy; Laparoscopy
MeSH terms: Hypertension; Fibrosis
Study type: Interventional

Summary: 
      This study aimed to evaluate whether vagus nerve-preserving laparoscopic splenectomy and
      azygoportal disconnection is effective and safe, and to determine whether a reduction in the
      incidence of postoperative complications of the digestive system improves postoperative
      quality of life compared with conventional laparoscopic splenectomy and azygoportal
      disconnection.
    

Detailed description: 
      After successful screening the cases of cirrhosis of liver irrespective of the etiology who
      have non tumor portal vein thrombosis will be enrolled. The baseline parameter will be
      recorded and the patient will be randomized into either interventional (vagus
      nerve-preserving laparoscopic splenectomy and azygoportal disconnection) or control
      (conventional laparoscopic splenectomy and azygoportal disconnection) group. From
      postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets
      (Bayer, Leverkusen, Germany) once daily for 1 year, low-molecular-weight heparin (CS Bio,
      Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan
      Furen, Henan, China) thrice daily for 3 months. At months 3, 9, and 12 after operation,
      electron gastroscopy examination for delayed gastric emptying will be done for all patients.
      Postoperative complications of the digestive system (including diarrhea, epigastric fullness,
      bloating, nausea, and vomiting), liver and renal function, and body weight will be recorded
      at the seventh day, months 1, 3, 6, 9, and 12 after operation. Then one year monitoring will
      be done in the both groups as per the primary or secondary outcome.
    

Intervention name(s): Vagus nerve-preserving group
Intervention type(s): Procedure
Intervention description(s): The modified vagus nerve-preserving procedure was performed in the following order: (1) left gastroepiploic vein along greater curvature; (2) the posterior surface of stomach, including the posterior gastric veins; (3) the left lateral surface of the distal esophagus; (4) the left inferior phrenic veins; (5) the posterior surface of the distal esophagus;(6) the anterior surface of the distal esophagus; and (7) the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved. the adherent junction between visceral peritoneum and the right crural diaphragm, and divided it into the lesser omental sac. The left gastric artery and vein and the posterior gastric veins were transected en bloc using a linear laparoscopic vascular stapler.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vagus nerve; Delayed gastric emptying; Cirrhosis; Hypertension; laparoscopy
Insertion Depth Comparison of Tracheal Tubes
Condition: Intubation
Study type: Observational

Summary: 
      There will be a difference of the insertion depth between the types of the endotracheal tube.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        American Society of Anesthesiologists physical status I, II patients scheduled for elective
        surgery with general anesthesia
Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the
      effectiveness of the Strongest Families distance intervention compared to usual or standard
      care that is typically provided to children with mild to moderate Attention
      Deficit/Hyperactivity Disorder. This is a single-centre trial based at the IWK Health Centre.
      The primary outcome is change in diagnosis.
    

Detailed description: 
      The purpose of the Strongest Families (formerly Family Help Program): is to deliver, primary
      care mental health services to children and their families in the comfort and privacy of
      their own home. Approximately 60 children (8-12 years of age)suffering from mild to moderate
      (but clinically significant) symptoms of pediatric Attention Deficit/Hyperactivity Disorder
      will be randomized.

      The intervention is delivered from a distance, using educational materials (manuals,
      video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach"
      who is supervised by a licensed health care professional. The telephone coach delivers
      consistent care based on written protocols, with on-going evaluation by a professional team.

      Fifty percent of the eligible participants will receive Strongest Families (formerly Family
      Help Program): telephone-based treatment and 50% will be referred back to their family
      physician to receive standard care as determined by that physician. Those receiving standard
      care will be evaluated for outcome results and then compared to the Strongest Families
      treated participants. It is anticipated that Strongest Families treatment will be proven to
      be as or more effective than standard care.
    

Intervention name(s): FHPADHD; ADHD Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Evidence-based psychological and behavioural distance intervention
Other intervention name(s): Strongest Families (formerly Family Help Program):
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety of "Ticagrelor+ Warfarin"in Comparison With "Clopidogrel+Aspirin+Warfarin"
Condition: Atrial Fibrillation; Coronary Artery Disease
MeSH terms: Atrial Fibrillation; Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to assess safety of antithrombotic drug ticagrelor plus oral
      anticoagulation adopted in persistent or permanent AF(Atrial fibrillation)
      patients（CHA2DS2VASc≥2） after PCI-S with specially regard to the occurrence of major bleeding
      complications. We hypothesized that baseline characteristics (ie age, anemia, previous major
      bleeding) and type of antithrombotic regimen could influence any bleeding events and the time
      of bleeding occurrence. We will test this hypothesis by comparing those AF patients who
      subsequently received double antithrombotic therapy (Ticagrelor + Warfarin) vs. triple
      antithrombotic therapy (Clopidogrel + Aspirin + Warfarin) after undergoing PCI-S.
    

Detailed description: 
      Currently, the optimal antithrombotic treatment of AF patients with indication for long-term
      oral anticoagulation undergoing PCI-S is unknown. The randomized trials to assess the best
      antithrombotic regimen in this setting and the management of this population are challenging.
      It poses imperative demands for future prospective randomized studies to define the optimal
      antithrombotic regimen in patients requiring chronic anticoagulation undergoing coronary
      stenting. Additionally, the vast majority of current clinical studies about antithrombotic
      therapy for atrial fibrillation together with PCI were retrospectively analysis to date
      ,whereas the prospective studies are rare and urgently needed
    

Intervention name(s): Ticagrelor+Warfarin; Clopidogrel+Aspirin+Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor 90mg/bid + Warfarin (maintain INR 2.0-2.5); Clopidogrel 75mg/day + Aspirin 100mg/day + Warfarin(maintain INR 2.0-2.5)
Other intervention name(s): Double antithrombotic therapy; Triple antithrombotic therapy
Intervention MeSH terms: Aspirin; Warfarin; Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is Double-Blind, Placebo-Controlled Multicentre Clinical Phase III Study conducted in 10
      medical facilities. The objective of the study is to evaluate efficacy and safety of the drug
      Drug RADAMIN®VIRO, Lyophilisate for Preparation of Solution for Intramuscular and
      Subcutaneous Administration for COVID-19 Postexposure Prophylaxis
    

Detailed description: 
      Upon signing the informed consent form and screening, 800 eligible subjects resides with a
      person with confirmed COVID-19 were randomized at a 1:1 ratio to receive either RADAMIN®VIRO
      once intramuscularly 5 mg (1 vial) or 1 vial of placebo once intramuscularly
    

Intervention name(s): Double-Stranded RNA sodium salt; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once intramuscular injection 5 mg (1 vial); Once intramuscular injection (1 vial)
Other intervention name(s): RADAMIN®VIRO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SARS-CoV-2; RADAMIN®VIRO; Double-stranded RNA sodium salt
Validity and Reliability of Perceived Exertion Rating Scale in Children With Brain Damage
Condition: Traumatic Brain Injury; Cerebral Palsy
MeSH terms: Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The purpose of this study is to examine the reliability and validity of the rating of
      perceived exertion scale in children post severe traumatic brain injury during treadmill
      exercise.
    

Detailed description: 
      walking on a treadmill twice- one weeks interval five intensity level in each session
    

Intervention name(s): Walking on treadmill, different velocities and incline
Intervention type(s): Other
Intervention description(s): Walking on treadmill twice, with one week interval in each session the child will walk in different velocities and incline
Other intervention name(s): RPE
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children post severe TBI Children with CP TD control
How Reducing Anxiety in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Health care that addresses the emotional regulation capacity of patients with
      schizophrenia confronted with daily stress may contribute to a less anxious life. A
      psycho-physiological training (cardiac coherence training; CCT) focusing on emotion
      regulation is known to decrease anxiety for non-clinical individuals.

      Methods: the investigators performed a pilot cross sectional survey to explore the benefits
      of CCT for clinically stable patients with schizophrenia. Ten patients were enrolled in the
      program consisting in height to twelve weekly one hour session program during a 2-month
      follow-up. Standardised questionnaires were used before and after the intervention assessing
      anxiety, well-being outcomes, and how patients deal with stress and stressors.
    

Detailed description: 
      Ten subjects, five women and five men, all volunteers, were included in the study. The
      patients were all clients of the rehabilitation center for psychotic disorders (Le Vinatier
      hospital) situated in Lyon, France. Criteria for entry into the study included: a Diagnostic
      and Statistical Manual of Mental Disorder-4 diagnosis of schizophrenia as confirmed by the
      Mini International Neuropsychiatric Interview for DSM-IV (MINI); age between 18 and 65; being
      clinically stable (i.e. not having required hospitalization or increases in medication as a
      result of an exacerbation of acute symptoms over the previous three months.

      All subjects completed a set of "paper and pencil" standardized assessments at
      pre-intervention and immediately after the end of the intervention.

      Trait and State anxiety was assessed using the French version of the Spielberger
      State-Trait-Anxiety Inventory (S-STAI).

      Three questionnaires were used in order to evaluate the outcomes quality of life of patients.
      1/ The Positive And Negative Syndrome Scale (PANSS); 2/ Patient's body/mind perceptions were
      assessed using mindfulness concept (Freiburg Mindfulness Inventory, FMI), and 3/ Patients'
      quality of life was evaluated using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).

      One questionnaire was used to assess how patients deal with stress and stressors (the
      Derogatis Stress Profile, DSP).
    

Intervention name(s): emotion focused therapy training
Intervention type(s): Other
Intervention description(s): The Cardiac Coherence Training (CCT) incorporates a series of emotion-refocusing and restructuring techniques involving the use of biofeedback to control heart rate variability
Other intervention name(s): Cardiac Coherence Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Experience With a Tensor Fasciae Latae Perforator Flap Based on Septocutaneous Perforators
Condition: Soft Tissue Defect
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the possible harvest of a tensor fasciae latae flap
      based on septocutaneous perforators.This study should further confirm our data from an
      anatomical study concerning location, distribution, diameter and differentiation of the
      perforators.
    


Intervention name(s): septocutaneous perforator flap
Intervention type(s): Other
Intervention description(s): Perforator flaps can be based on septocutaneous or musculocutaneous perforators. If septocutaneous perforators are present, the harvest of these flaps is more straight forward and the dissection of the pedicle is easy.
Other intervention name(s): fasciocutaneous flaps; perforator flap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tensor fasciae latae; septocutaneous perforators
A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to
      investigate the safety and efficacy of MIN-117 in male and female patients with Major
      Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly
      assigned to 1 of 3 treatment arms, including placebo, 2.5 mg MIN-117, or 5.0 mg MIN-117, in a
      2:1:1 ratio.
    


Intervention name(s): MIN-117 5.0 mg; MIN-117 2.5 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5.0 mg MIN-117 administered as two MIN-117 2.5 mg capsules as a single dose once daily; 2.5 mg MIN-117 administered as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily; Placebo administered as two Placebo capsules as a single dose once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MIN-117
Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus
Condition: Cutaneous Lupus
Study type: Interventional
Phase: Phase 4

Summary: 
      Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous
      involvement at some point during course of their disease. In spite of the esthetic
      consequence during the acute phase, the main problem is still related to its disfiguring and
      incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the
      conventional therapy. Unfortunately, approximately 30% will be refractory to these measures.
      For those patients, immunosuppressive therapy can be an alternative with controversial
      results. Several series have shown a 90% of clinical efficacy in patients treated with
      Thalidomide. Unfortunately, the main drawback has been the serious described side effects
      such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide
      analogue, more potent, efficient and with better safety profile has been discovered. The main
      objective of the study is to evaluate the efficacy and safety of Lenalidomide for patients
      with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect of this
      drug on the systemic manifestations of lupus disease, the adverse effects, frequency of flare
      after withdrawal, the sequela and the effect on the seric parameters. Methods: Twelve
      patients with refractory cutaneous lupus will be included. Lenalidomide will be started at
      5mg/day and tapered progressively. Blood test and EMG will be performed at onset and at the
      end of follow up.
    


Intervention name(s): Lenalidomide
Intervention type(s): Drug
Intervention description(s): 5 mg daily will be administered until the achievement of complete response, and then tapered progressively according to clinical response
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lenalidomide; Refractory Cutaneous Lupus
Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control
Condition: Gingival Diseases
MeSH terms: Gingival Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the adjunctive use of Centella Asiatica (gotukola) to scaling in the
      reduction of plaque and gingival inflammation. Patients were divided into three groups of
      which group 1 received scaling and gotukola mouthwash, group 2 received scaling only and
      group 3 received gotukola mouthwash only.
    

Detailed description: 
      Mechanical plaque control by tooth brushing is considered to be the ideal way of preventing
      plaque associated gingivitis. However due to various factors individuals fail to perform an
      adequate quality of self performed plaque control. Centella Asiatica (gotukola) possess wide
      range of biological activities like anti-inflammatory, anti-psoriatic, anti-ulcer,
      hepato-protective, anticonvulsant, immunostimulant, cardioprotective, antidiabetic,
      antiviral, antibacterial, antifungal, etc. So, it could be used as adjunctive to mechanical
      periodontal therapy.
    

Intervention name(s): Gotukola; Scaling
Intervention type(s): Drug; Procedure
Intervention description(s): 10 ml of mouthwash to be rinsed for duration of 60 seconds; Ultrasonic scaling was performed in one visit on both upper and lower arches.
Other intervention name(s): Centella Asiatica
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antiplaque; antigingivitis
Purge Vs no Purge in Living Donor Liver Transplantation Recipients
Condition: Ischemia Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      The investigators tested the impact of purging the graft contents and mesenteric blood into
      the systemic circulation versus washing out this volume out of the circulation in living
      donor liver transplantation recipients.
    

Detailed description: 
      All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4
      Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg)
      (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml
      per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg)
      (n=40) where graft fluid contents were washed into the systemic circulation by the patient's
      portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes
      after portal declamping. Secondary objectives included hemodynamic and oxygenation.
    

Intervention name(s): Purge
Intervention type(s): Procedure
Intervention description(s): In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Liver transplantation; Graft rinse; Ischemia reperfusion injury
To Evaluate the Safety and Tolerability, Pharmacokinetics, Food-effect and Pharmacodynamics of EHP-101 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the safety and tolerability, pharmacodynamic, pharmacokinetic profiles,
      and food effect of single ascending doses and multiple ascending doses (7 consecutive days)
      after daily oral administration in healthy male and female subjects.
    

Detailed description: 
      This Phase 1, single center, randomized, double-blind, placebo-controlled study will be
      conducted in 2 parts: the single ascending dosing (SAD) will constitute Part 1 and the
      multiple ascending dosing (MAD) will constitute Part 2. In Part 1 (ie, SAD) of the study, up
      to 64 eligible subjects will be randomized with an allocation ratio of 3:1 to receive EHP-101
      Liquid or matching placebo within one of up to 8 sequential cohorts; Sentinel subjects (1
      receiving EHP-101 Liquid and 1 receiving placebo) will be dosed prior to dosing the remaining
      6 subjects to allow for observation of adverse reactions before exposing the Investigational
      Product (IP) to a greater number of subjects, in the SAD cohorts. In Part 2 of the study, up
      to 40 eligible subjects will be randomized with an allocation ratio of 4:1 to receive EHP 101
      Liquid or matching placebo within one of up to 4 cohorts. Dose-escalations, initiation of a
      single-dose food effect cross-over investigation and the start of the MAD part of the study
      will be coordinated by a Safety Review Committee (SRC) following review of available safety
      data.
    

Intervention name(s): EHP-101 Liquid single dose; EHP-101 Liquid multiple doses; Matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single oral administration with EHP-101 liquid formulation. The doses will be ascending per cohort from 0.91 mg to 200 mg. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day).; One single daily administration with EHP-101 liquid formulation during 7 consecutive days. The doses will be ascending per cohort. Each ascending level will not exceed the tested dose levels in the single dose part of the study. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day); Oral liquid administration daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment