bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation
      (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1
      includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending
      dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation.
      Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under
      fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2
      of the study to explore additional dose levels, solid oral dosage formulations, or for cohort
      expansion.
    


Intervention name(s): ABI-H3733 Liquid Oral Dosage Form; ABI-H3733 Solid Oral Dosage Form; Placebo to ABI-H3733 Liquid Oral Dosage Form; Placebo to ABI-H3733 Solid Oral Dosage Form
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ABI-H3733 liquid oral dosage form; ABI-H3733 solid oral dosage form; Placebo to ABI-H3733 liquid oral dosage form; Placebo to ABI-H3733 solid oral dosage form
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Sleep Study Results After Partial Intracapsular Tonsillectomy Versus Total Tonsillectomy
Condition: Sleep-disordered Breathing; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate similar improvements in sleep-disordered
      breathing as determined by sleep study with microdebrider-assisted partial intracapsular
      tonsillectomy and adenoidectomy versus total Bovie electrocautery tonsillectomy and
      adenoidectomy.
    

Detailed description: 
      Objectives: To demonstrate similar improvement in sleep-disordered breathing as determined by
      polysomnography (PSG) with microdebrider-assisted partial intracapsular tonsillectomy and
      adenoidectomy (PITA) versus Bovie electrocautery complete tonsillectomy and adenoidectomy
      (T&A).

      Methods: In a retrospective cohort study children found to have Obstructive Sleep Apnea (OSA)
      by PSG who have undergone either PITA or T&A as treatment will be evaluated with repeat PSG.
      The groups will be matched by age, sex, and severity of pre-operative Apnea-Hypopnea Indices
      (AHI). The investigators performing and evaluating the PSG will be blinded to type of
      procedure and preoperative AHI. Change scores will be computed for each participant and the
      change scores of the groups compared.
    

Intervention name(s): PITA or T&A
Intervention type(s): Procedure
Intervention description(s): PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy
Other intervention name(s): PITA = Partial Intracapsular Tonsillectomy and Adenoidectomy; T&A = Tonsillectomy and Adenoidectomy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children treated at the SUNY Downstate Medical Center or the Long Island College Hospital
        in Brooklyn, NY for sleep-disordered breathing documented by positive polysomnography by
        either Partial Intracapsular Tonsillectomy and Adenoidectomy or complete Tonsillectomy and
        Adenoidectomy between 2003 and 2008.
      
Keywords: Sleep-disordered breathing; Obstructive sleep apnea; Polysomnography; Tonsillectomy; Microdebrider assisted partial intracapsular tonsillectomy
Trace Element Repletion Following Severe Burn Injury
Condition: Critical Illness; Nutritional Deficiency; Trace Element Deficiency; Burn Injury
MeSH terms: Malnutrition; Critical Illness; Wounds and Injuries; Burns
Study type: Observational

Summary: 
      Major burn patients are characterized by large exudative losses of Cu, Se and Zn. Trace
      element (TE) repletion has been shown to improve clinical outcome. The study aimed to check
      if our repletion protocols were achieving normalization of TE plasma concentrations of major
      burn patients and if the necessity for continuous renal replacement therapy (CRRT) might
      increase the needs.
    

Detailed description: 
      Retrospective analysis of prospectively collected data in burn patients requiring intensive
      care (ICU) between 1999 and 2015. The cohort was divided into 4 groups according to the
      protocol changes. Period 1 (P1): 1999-2000, P2: 2001-2005, P3: 2006-2010, P4: 2011-2015.
      Changes consisted mainly in increasing TE repletion doses and duration. Demographic data,
      daily TE intakes and weekly plasma concentrations were retrieved for the first 21 ICU-days.
    

Intervention name(s): Trace elements replacement
Intervention type(s): Other
Intervention MeSH terms: Trace Elements; Micronutrients
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive burns admissions to the ICU, between June 1st, 1999 and December 31st, 2015 in
        a Swiss quaternary care hospital (Lausanne University Hospital, Centre Hospitalier
        Universitaire Vaudois).
      
Keywords: Copper; Selenium; Zinc; Continuous renal replacement therapy
Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery
Condition: Abdominal Surgery; Obese Patients
MeSH terms: Obesity
Study type: Interventional

Summary: 
      the purpose of this study is to compare open lung approach versus conventional protective
      ventilation in obese patients undergoing open abdominal surgery
    

Detailed description: 
      after being informed about the study and potential risks. All patients giving written consent
      will be randomized by double blind manner into 2 groups each one containing 24 patients Group
      SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with
      addition of 5 cm H₂O fixed PEEP till the end of the surgery .

      Group OLA: The patients will undergo ARM followed by personalized PEEP.
    

Intervention name(s): ARM; spontanous ventilation
Intervention type(s): Other; Other
Intervention description(s): The ARM is performed by setting the peak inspiratory pressure to 45 cmH₂O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH₂O. The PEEP level is then increased in 5 cmH₂O steps every minute till it reaches 20 cmH₂O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH₂O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH₂O.
The titration of individualized PEEP is done by decremental reduction of the 20 cmH₂O PEEP level in 2 cmH₂O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step.; volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
Other intervention name(s): followed by personalized PEEP.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: Open lung approach; conventional ventilation
Low Dose Radiation Therapy for Glioblastoma Multiforme
Condition: High Grade Glioma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and effectiveness of low dose rate radiation therapy plus
      temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic
      Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery
      followed by radiation surgical resection followed by adjuvant radiation therapy plus
      temozolomide.
    

Detailed description: 
      In vitro and in vivo studies have suggested that low dose fractionated radiation therapy
      (LDFRT) may be used to potentiate full dose chemotherapy, decreasing the development of
      resistance found with standard doses of radiation and chemotherapy. This is a nonrandomized,
      open label, single institution phase II trial with a safety run-in to evaluate the safety and
      efficacy of LDFRT plus temozolomide in patients with High Grade Glioma (to only include
      Anaplastic Astrocytoma or Glioblastoma Multiforme) previously treated with surgical resection
      followed by adjuvant radiation therapy plus temozolomide. The primary objective of the phase
      II study is to estimate response rate in patients treated with twice daily fractions of low
      dose radiation plus temozolomide chemotherapy.
    

Intervention name(s): Low Dose Fractionated Radiation Therapy (LDFRT); Temozolomide
Intervention type(s): Radiation; Drug
Intervention description(s): All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below.; All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression.
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent Glioblastoma Multiforme; Recurrent Anaplastic Astrocytoma; Surgery; Adjuvant Radiation; Adjuvant Temozolomide
Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People
Condition: Balance
Study type: Interventional

Summary: 
      Aim: To compare the effect of different type of shoes (unstable or stable) combined with a
      whole body vibration training on balance.

      Design: Randomized controlled trial.

      Setting: Laboratory of biomechanics.

      Population: Healthy young people.
    

Detailed description: 
      Background: The use of whole body vibration to train strength and balance has increased in
      the last years. Last studies have shown that adding an unstable device increased
      electromyographic activity of the lower limb and the trunk muscles. However, no studies have
      investigated the effects of wearing unstable shoes during a whole-body vibration training on
      balance in healthy young people.

      Aim: To compare the effects of different type of shoes (unstable [Intervention group] or
      stable [Control group]) combined with a 12-weeks whole body vibration training on balance.

      Setting: Laboratory of biomechanics.
    

Intervention name(s): Unstable shoes plus Whole-body vibration; Stable shoes plus Whole-body vibration
Intervention type(s): Other; Other
Intervention description(s): Wearing unstable shoes during the whole-body vibration training; Wearing stable shoes during the whole-body vibration training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unstable Shoes; Whole Body Vibration
A Study of NKTR-358 (LY3471851) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of a study drug
      known as LY3471851 in healthy participants. The study will last about 50 days for each
      participant.
    

Detailed description: 
      LY3471851 is a potential first-in-class therapeutic that may address an underlying immune
      system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2)
      receptor complex in the body in order to stimulate proliferation of inhibitory immune cells
      known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune
      system back into balance.
    

Intervention name(s): LY3471851; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LY3471851 drug product is a sterile liquid for SC injection that may be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration.; The placebo dosing solution is 0.9% sodium chloride for injection (USP).
Other intervention name(s): NKTR-358
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy
Condition: Diabetic Polyneuropathy
MeSH terms: Polyneuropathies; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are to evaluate the efficacy and safety of three doses of
      MCC-257 in patients with mild to moderate diabetic polyneuropathy
    

Detailed description: 
      The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group
      design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg,
      MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will
      consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a
      formal screening visit; and 2) a 24-week treatment period, during which patients will take
      the study treatment, and have various assessments performed during 4 visits.
    

Intervention name(s): Placebo; MCC-257; MCC-257; MCC-257
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once daily for 24 weeks; 20mg, once daily for 24 weeks; 40mg, once daily for 24 weeks; 80mg, once daily for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathy; Nerve Conduction
Impact of Fruit and Vegetables in PKU
Condition: Phenylketonurias
MeSH terms: Phenylketonurias
Study type: Interventional

Summary: 
      In the UK, some fruits and vegetables are permitted without measurement in the diets of
      people with phenylketonuria (PKU). It is proven that fruits and vegetables containing
      phenylalanine (Phe) up to 75mg/100g (e.g. carrots, sweet potato, tomatoes) do not affect
      blood Phe control but it is unknown to what extent fruits and vegetables containing Phe from
      76-100mg/100g (e.g. cauliflower, broccoli, beansprouts and asparagus) increase blood Phe
      levels. In addition, there is very little information about how differently animal and
      vegetable protein affect blood Phe levels. It is believed that plant protein may have less
      bioavailability and therefore have less impact on blood Phe control. The investigators aim is
      to perform a randomized controlled study over 21 weeks in children (5-12y) with PKU. Children
      will be studied during five different time periods, examining the effect on blood Phe control
      when increasing Phe intake from vegetables/fruits containing Phe from 76-100 mg/100g vs.
      animal sources. At the end of the study, fruits and vegetables containing 76- 100mg Phe/100g
      will continue to be given as "exchange-free" for 6 months. This is a practical, cost
      effective study and should bring benefit to all people with PKU following a very restrictive
      diet both within the UK and throughout the world.
    


Intervention name(s): Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g; Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g; Phase D - Extra 1 Phe exchange from milk or yoghurt; Phase E - Extra 2 Phe exchanges from milk or yoghurt
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Usual low Phe diet + 60g fruits/vegetables containing Phe from 76-100mg/100g; Usual low Phe diet + 120g fruits/vegetables containing Phe from 76-100mg/100g; Usual low Phe diet but 1 x 50 mg extra Phe exchange from milk or yoghurt; Usual low Phe diet but 2 x 50 mg extra Phe exchange from milk or yoghurt eaten daily
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a prospective, randomised controlled study over 21 weeks in children to assess how Phe intake from fruits and vegetables (containing 76-100 mg Phe/100g) vs. animal sources will impact on blood Phe control. This will be followed by a 6 months extension study examining the 'unlimited' use of fruits and vegetables containing Phe 76-100 mg/100g on blood Phe control.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fruit and vegetables; Phenylalanine; Animal protein; Vegetable protein
Nutrition and Soccer for Pediatric Overweight and Obesity
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine whether two months of youth soccer, combined with a single brief
      behavioral/nutritional intervention, can reduce BMI in 5th grade overweight or obese females.
    

Detailed description: 
      Female overweight and obese public school students will be recruited during the summer of
      2006 based on FitnessGram testing done by graduate students at MSU during their prior (4th
      grade) school year. After receiving informed consent from parent/child, the subjects will be
      checked for height/weight and other screening criteria, then exposed to 2005 My Pyramid for
      Kids, "Tips for Families" information, and watch a short 8 minute DVD that discusses the
      importance of exercise and fitness by way of interviewing two club level female soccer
      players of equivalent age. Subjects will then be randomly assigned to fall youth soccer in
      Starkville, or spring youth soccer, after first phase data collection occurs in November,
      2006.
    

Intervention name(s): Youth Soccer
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: obesity; overweight
Clinical Performance Comparison of Several Different Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the possible benefits of second generation silicone
      hydrogel contact lenses.
    


Intervention name(s): senofilcon A; lotrafilcon B; balafilcon A; methafilcon A; vifilcon A
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): contact lens; contact lens; contact lens; contact lens; contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Protective Immunity Project 02
Condition: Kidney Transplant; Immunology; Immunosuppression
Study type: Observational

Summary: 
      Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6
      months post-transplant. The influenza vaccine stimulates the immune system to builds
      protective antibodies against the flu virus.

      Previous research has shown that adult kidney transplant patients are not able to form as
      much of these protective antibodies as compared to healthy volunteers. Research has also
      suggested that different immunosuppressive medicines may have different effects on antibody
      formation. In this study, we hope to evaluate these differences in more detail.

      In recent years, increasingly effective, but also increasingly complex, immunosuppressive
      regimens have been developed, however, there has been little detailed systematic study of the
      immune changes that occur in response to vaccination with these newer immunosuppressive
      regimens.Current policies on vaccination of transplant recipients are generic and continue to
      be based on old concepts rather than on any new understanding of the effects of these newer
      therapies on the immune system.

      We hope to improve our understanding of the effects of the immunosuppressive regimens in use
      today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu
      vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting
      desirable immune responses while not causing rejection.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult (ages 18-59) recipients of deceased or living donor renal transplants
      
Biospecimen description: 
      serum, PBMCs
    
Keywords: Transplant; Immunology; Immunosuppression
Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-arm, double blind randomized 12-week study to supplement omega-3
      (Eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) among 100 adults (age 18+) who had
      coronavirus-19 (covid-19) and are experiencing possible after-effects from post-acute
      sequelae of covid-19 (also called post-covid syndrome or long covid syndrome).
    

Detailed description: 
      This is a double-blind, randomized controlled trial (RCT) with two treatment arms:

      Arm 1 - Omega-3 (Eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) - Dose is 2,100mg
      per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has
      252mg of EPA and 102mg of DHA.

      Support for dosing:

        -  The American Heart Association (AHA) says taking up to 3 grams of fish oil daily in
           supplement form is considered safe;

        -  Up to 5,000mg of omega-3 fatty acids per day is considered safe;

        -  The U.S. Food and Drug Administration recommends consuming no more than 3 g/day of EPA
           and DHA combined, including up to 2 g/day from dietary supplements.

      Arm 2 - Placebo - made from soybean oil (same dosing schedule as intervention arm)
    

Intervention name(s): Omega-3 (EPA+DHA); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.; 3 Soybean Oil Placebo capsules
Other intervention name(s): fish oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-acute sequelae of covid-19; post- covid syndrome; long covid syndrome; healthcare workers; post-covid symptoms; quality of life; omega-3