bioihbjkbjnl/mcl2 huggingface dataset:
A Postoperative Sore Throat After Thyroidectomy
Condition: Post Operative Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      This study was performed to compare the effect on of a postoperative sore throat between
      dexmedetomidine and remifentanil in patients undergoing thyroidectomy.
    


Intervention name(s): dexmedetomidine infusion group; remifentanil infusion group
Intervention type(s): Drug; Drug
Intervention description(s): dexmedetomidine as anaesthetic adjuvant; remifentanil as anaesthetic adjuvant
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: postoperative sore throat; dexmedetomidine; remifentanil; thyroidectomy
Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia
Condition: Surgical Procedures, Operative
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not a new brain function monitor can
      distinguish between anesthetized and awake patients. The device implemented utilizes
      functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to
      stimuli during surgical procedure.

      After obtaining consent the device is placed across the forehead of the patient. A baseline
      signal is obtained prior to induction. The fNIR signal is continuously recorded throughout
      the procedure. Key events as well as administration of drug are recorded in order to observe
      changes in the signal trend. Neither the device nor the light emitted is hazardous to the
      patient - no risks or discomforts are involved.
    


Intervention name(s): fNIR light emitting and sensing device
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: No specific disease is being studied, few procedures are excluded.; The focus of the study is to rule out the efficacy of the device, so the aim is to include as wide a variety of procedures as possible.
Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women
Condition: Placental Vascular Pathologies; Venous Thromboembolism Diseases
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only
      a few recommendations were available on the optimal use of antithrombotic therapy as a
      preventive measure against thromboembolism in pregnant women. In this study, we propose :

        1. To gather the experts who took part in the French consensus conference and the local
           experts to create a score in accordance with the national and international consensus
           and to give some precise therapeutic strategies.

        2. To evaluate the discriminant, feasible and useful character of this new score by a
           prospective multicentric study including 2000 pregnant women with a risk of
           thromboembolism or placental vascular pathology who will benefit from therapeutic
           strategies defined by the new score.

           .
    

Detailed description: 
      Purpose : To create a score inspired by our first experience i.e. simple, standardized and
      quickly usable in day-to-day practice to individualize antithrombotics prescription to women
      at risk.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Keywords: venous thromboembolism diseases; placental vascular pathologies; antithrombotic treatment; symptomatic thromboembolic events; pregnant women; score; therapeutic strategies; heparin; aspirin; pregnancy pathology
FAsenra Safety Trial in India
Condition: In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Benralizumab is a humanised, afucosylated, monoclonal antibody that binds specifically to the
      human interlukin-5 (IL-5) receptor alpha subunit (IL-5Rα) of target cells such as eosinophils
      and basophils (Takatsu et al, 1994; Toba et al, 1999; Pelaia et al, 2020).

      Benralizumab was generally well tolerated by patients in clinical trials, with no apparent
      safety concerns.

      This study shall be conducted at 10 centers across India. The primary outcome measures will
      be

        -  Percentage of AEs a, SAEs, and TEAEs

        -  Nature, incidence, and severity of AEs including unexpected adverse drug reactions

        -  Percentage of patients with AEs that lead to study treatment discontinuations.
    

Detailed description: 
      Fasenra (benralizumab) has been recently approved in India with the condition to conduct a
      Phase 4 postmarketing study in the Indian population, as previous studies did not include
      patients from India. This prospective postmarketing safety study is planned to meet the
      regulatory mandate and assess the safety of benralizumab treatment in adult patients of
      severe asthma with eosinophilic phenotype over a period of 24 weeks. This interventional
      study will provide insights into the potential risks of eosinophil-lowering therapies when
      used in routine clinical care in India. The study will also evaluate the effectiveness of
      benralizumab in reducing asthma exacerbations.

      This is a prospective, single-arm, multicentre, interventional, Phase 4 study investigating
      the safety, tolerability, and effectiveness of Fasenra (benralizumab) in adult patients of
      severe asthma with eosinophilic phenotype over a period of 24 weeks.
    

Intervention name(s): Benralizumab
Intervention type(s): Biological
Intervention description(s): Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India
Intervention MeSH terms: Benralizumab
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, single-arm, multicentre, interventional, Phase 4 study investigating the safety, tolerability, and effectiveness of Fasenra (benralizumab) in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia
Condition: Community-Acquired Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: To compare the clinical effectiveness and hospital costs, the initial empirical
      treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community
      Acquired Pneumonia (CAP) severe.

      Methods: Clinical prospective randomized study in children aged two months to five years of
      age with a diagnosis of severe CAP, according to criteria of World Health Organization (WHO),
      admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu- UNESP. We
      excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute
      or chronic kidney disease, referred patients receiving antibiotics proposal and history of
      allergy to antibiotics proposed. We included 104 children who were randomized into two groups
      to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin / Clavulanate IV (GAA, n
      = 56). Patients of the GAA, after clinical improvement, has been receiving the same oral
      antibiotic, and maintaining clinical stability, were discharged from hospital, the GOC
      received any IV treatment. The outcomes analyzed were time to clinical improvement (fever and
      tachypnea), duration of oxygen therapy, hospitalization time, need to expand the
      antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and hospital costs.
      Treatment failure was determined by the need to expand the antimicrobial spectrum after 48
      hours of hospitalization.
    

Detailed description: 
      eligibility: Children aged two months to five years with diagnosis of severe community
      acquired pneumonia, requiring hospitalization.

      Outcomes measures: time to clinical improvement (respiratory rate and fever), duration of
      oxygen therapy, length of stay in the Division of Pediatrics, evolution with clinical
      complications, need for broadening the spectrum antimicrobials.
    

Intervention name(s): Amoxycillin/clavulanic acid; ceftriaxone/oxacillin
Intervention type(s): Drug; Drug
Intervention description(s): 100mg/Kg/day/10 days.; 75 mg/Kg/day/10 days.
Intervention MeSH terms: Amoxicillin; Ceftriaxone; Clavulanic Acids; Clavulanic Acid; Oxacillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: pneumonia; children; antibiotics
Ultrasound Guidance Vs. Electrical Nerve Stimulation for Infraclavicular Brachial Plexus Block
Condition: Hand Surgery; Brachial Plexus Block
Study type: Interventional

Summary: 
      In an observer-blinded study ultrasound guidance and electrical nerve stimulation will be
      compared for lateral sagital infraclavicular blocks (LSIB). Block effectiveness, time
      consumption and patient acceptance will be registered in 80 patients. Ultrasound guidance may
      cause less discomfort and could be less time consuming than electrical nerve stimulation.
    


Intervention name(s): brachial plexus block; ultrasound guidance; electrical nerve stimulation
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study that will follow transplant patients from Study A3921030 to monitor for long
      term safety, tolerability and efficacy for 5 additional years, except in Portugal where the
      study will follow transplant patients through Month 36 posttransplant. Patients will continue
      their study medications that were previously assigned.
    


Intervention name(s): Cyclosporine; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Standard of care; CP-690,550 tablets dosed BID Months 12-72; CP-690,550 tablets dosed BID Months 12-72
Intervention MeSH terms: Cyclosporine; Cyclosporins; Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunosuppression; JAK inhibitor; kidney transplantation
Oral Immunotherapy for Wheat Allergy
Condition: Wheat Allergy
MeSH terms: Hypersensitivity; Wheat Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being done to learn about the medical effects, the safety, and the immunologic
      effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out
      whether subjects can develop the ability to eat wheat (the food allergen) regularly without
      allergic symptoms after stopping the study treatment.
    

Detailed description: 
      Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight
      most common foods inducing allergic reactions in the US. Current treatment for food allergy
      is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine
      if an accidental reaction occurs. However, accidental exposure to allergens in processed
      foods may be difficult to avoid. Currently, several therapeutic strategies are being
      investigated to prevent and treat food allergies. Since immunotherapy injections for food
      allergy are associated with a high rate of allergic reactions, alternate approaches to
      treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried
      in some studies in the treatment of food allergies. The intent of the study is to examine the
      clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects
      will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital
      wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects
      will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year
      time point. At selected visits, blood and urine collection, physical examination, prick skin
      tests, and atopic dermatitis and asthma evaluations will occur.
    

Intervention name(s): Wheat OIT
Intervention type(s): Drug
Intervention description(s): Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.
Other intervention name(s): Vital Wheat Gluten
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Food Allergy; Wheat Allergy; Oral Immunotherapy
A Single Dose PK Study of SENS-218 in Healthy Volunteers
Condition: Inner Ear Diseases
MeSH terms: Ear Diseases; Labyrinth Diseases; Labyrinthitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to aid the development for the use of SENS-218 outside its marketed therapeutic
      indications. SENS-218 is available in Asia and is marketed as an anti-emetic (Anti-sickness)
      drug often prescribed after exposure to chemotherapy. Chemotherapy exposure can often induce
      nausea and/or vomiting.

      The study only involves the one drug, referred to as SENS-218 in this study. The purpose of
      the study is to support the development of use of SENS-218 in non-Asian population.

      The key objective of this study is to identify the pharmacokinetic (PK) parameters of the
      drug in healthy Caucasian population. The PK refers to what the body does to the body, for
      example, how quickly the drug is absorbed into the blood stream.

      The population who are eligible to take part in the study are healthy male and female,
      non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at
      Simbec.

      Participation in the trial will last for about 3 weeks (from first screening visit to final
      end of study visit).
    

Detailed description: 
      This study consists of a screening visit, 1 treatment period and a post study visit.

      These are outlined below:

      Screening visit ( Day -14 to Day -1)

      - Ensure subjects are eligible for the study.

      Treatment period 1 -If all screening assessments are satisfactory, subjects will be invited
      to attend Simbec to take part in the study. The treatment period consists of 2 overnight
      stays (Day -1 until the morning of Day 2). One return visit is required at the 48 hour point
      post dose on Day 3.

      Post study visit

      -Subjects will be asked to attend Simbec 5-7 days after administration of the last dose for a
      post study visit. If you are withdrawn from the study, you will still be asked to attend for
      an end of study assessment.

      Subjects may be asked to return again if we need to follow you up.
    

Intervention name(s): SENS-218
Intervention type(s): Drug
Intervention description(s): Oral Administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Healthy Volunteer Study
Role of Allopurinol on Oxidative Stress and Mitochondrial Alterations in Skeletal Muscle of Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Our recent data in mice have demonstrated a key role of xanthine oxidase in
      hyperglycemia-induced by Reactive oxygen species production, and a preventive role of
      allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and
      structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical
      trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial
      alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2
      diabetic patients.
    


Intervention name(s): 2 capsules of allopurinol 150 mg daily for 3 month; 2 capsules of lactose daily for 3 month
Intervention type(s): Drug; Drug
Intervention description(s): 2 capsules of allopurinol 150 mg daily for 3 month; 2 capsules of lactose daily for 3 month
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Type 2 diabetes mellitus, oxidative stress; insulin sensitivity; insulin resistance; mitochondrial dysfunction; skeletal muscle; xanthine oxidase; allopurinol
Effects of Beef Protein Consumption on Energy Intake
Condition: Obesity; Severe Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine ad libitum daily energy intake, body weight changes
      and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive
      days, and in relation to age, gender, body mass index (BMI) and fat mass and
      obesity-associated (FTO) gene alleles.
    

Detailed description: 
      The protein leverage hypothesis requires specific evidence whether energy intake would depend
      on a possible protein intake target in humans. Meat protein as complete protein may show most
      beneficial effects on variables regarding food intake regulation.
    

Intervention name(s): Differences in protein content (En%) of meals
Intervention type(s): Dietary Supplement
Intervention description(s): The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content.
Other intervention name(s): All food items will be commercial available.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Energy intake; Beef protein; Satiety; Protein leverage hypothesis
Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice:Evaluation of Perioperative Opioid Use
Condition: Pain; Anesthesia
Study type: Interventional

Summary: 
      This study compares two groups of patients undergoing a gynecological surgey under general
      anesthesia: one group in which intraoperative analgesia is guided by the
      Analgesia-nociception index, and another group in which intraoperative analgesia is managed
      as in standard practice. The objective is to assess if the Analgesia Nociception Index may
      result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain
      and in chronic pain development.
    


Intervention name(s): Analgesia Nociception Index; Remifentanil
Intervention type(s): Device; Drug
Intervention description(s): : Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity; intravenous short-acting opioid routinely administered during general anesthesia
Other intervention name(s): ANI
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Analgesia-Nociception Index (ANI); General anesthesia; Opioids; Remifentanil; Pain; Monitoring
Web-based Oncofertility Support Tool for Reproductive-age Women With Breast Cancer
Condition: Breast Neoplasm Female; Fertility Preservation
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of this study was to develop electronic systems (e-systems) for oncofertility
      support, and to examine the comprehensibility, feasibility, usability, and effects on social
      support and preparation for decision-making.
    

Detailed description: 
      Background: When reproductive-aged women with breast cancer lack support in making decisions
      about fertility, this results in conflicts in decision-making with negative effects on their
      mental health.

      Objective: The aim of this study was to develop electronic systems (e-systems) for
      oncofertility support, and to examine the comprehensibility, feasibility, usability, and
      effects on social support and preparation for decision-making.

      Methods: The study steps were guided, tested, and utilized to (a) identify the requirements
      of a patient, (b) guide the development of support interventions, and (c) evaluate the
      quality of web-based oncofertility support. Both qualitative and quantitative data were
      collected to explore supportive requirements related to oncofertility care, and an initial
      website concerning oncofertility was developed based on the resulting requirements and system
      review regarding social support. Alpha testing and beta testing were used to ensure the
      quality of the web-based oncofertility support tool. The effectiveness was evaluated using
      the Preparation for Decision-Making Scale and Social Support Questionnaire.
    

Intervention name(s): Web-based oncofertility support tool
Intervention type(s): Device
Intervention description(s): The website structure was developed to satisfy the needs of reproductive-age women was investigated based on four domains of social support, as developed by Cohen and Syme (1985). The important needs of patients can be classified as emotional, informational, appraisal, and instrumental support.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer; fertility preservation; social support; Ottawa Decision Support Framework; website