bioihbjkbjnl/mcl2 huggingface dataset:
Prebiotic in Preterm Infants
Condition: Preterm Infant; Development, Infant; Nutrition
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This is a double blinded, randomized, controlled trial of prebiotic in infants born between
      26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in
      total and for the study to be completed in 18 months. The investigators anticipate collecting
      clinical data, anthropometrics, stool samples (requiring appropriate storage through
      analysis), salivary samples from mother and infant, discarded blood samples from baby after
      the standard care lab tests are done, a single, optional blood draw at the conclusion of the
      study, and subjecting infants to a neurodevelopmental survey at study completion.

      The overall goal of this study is to test prebiotic administration to human milk-fed infants
      who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through
      one primary aim, a secondary aim, and exploratory aims, indicated below:

      Primary aim: Compare weight, length, and head circumference Z-score growth between the study
      and placebo groups.

      Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more)
      between the study and placebo groups.

      Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive
      care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.

      Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of
      supplementation on reducing intestinal inflammation between the study and placebo groups.

      Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to
      determine whether there is a shift in microbial composition towards bifidobacteria and other
      microbes that are capable of metabolizing prebiotic.
    


Intervention name(s): Prebiotic; Dextrose Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Prebiotic experimental group; Dextrose Control
Other intervention name(s): Study product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration
Study type: Interventional

Summary: 
      The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep
      quality, disease severity, and airway muscle tone have been investigated in several studies.
      IMT and OE exercise modalities for patients and practitioners have advantages and
      disadvantages. It is recommended to compare exercise modalities in the studies. Whether OE or
      IMT exercise type is more effective on disease severity, sleep quality and snoring has not
      been investigated. The aim of this study was to compare the effectiveness of inspiratory
      muscle training and oropharyngeal exercises in patients with OSAS in terms of disease
      severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.
    


Intervention name(s): respiratory muscle strengthening exercise; oropharyngeal muscles strengthening exercise
Intervention type(s): Other; Other
Intervention description(s): These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.; These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; oropharyngeal exercises; inspiratory muscle training; sleep quality
Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing
      hormone-releasing hormone agonists may lessen the amount of androgens made by the body.
      Internal radiation uses radioactive material placed directly into or near a tumor to kill
      tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I
      125 implant may be an effective treatment for patients with prostate cancer.

      PURPOSE: This randomized phase III trial is studying how well giving luteinizing
      hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or
      without additional luteinizing hormone-releasing hormone agonist therapy in treating patients
      with previously untreated prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To evaluate the biochemical progression-free survival (PFS), overall survival, clinical
           PFS, and disease-free survival of patients with previously untreated intermediate-risk
           prostate cancer treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)
           agonist therapy and permanent iodine I 125 implantation with vs without adjuvant LHRH
           agonist therapy.

        -  To determine the non-adaptive interval to salvage therapy in patients treated with these
           regimens.

        -  To determine the safety of these regimens in these patients.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive neoadjuvant luteinizing hormone-releasing hormone (LHRH) agonist
           therapy for up to 3 months and undergo permanent iodine I 125 implantation. Patients
           then receive adjuvant LHRH agonist therapy for up to 9 months.

        -  Arm II: Patients receive neoadjuvant LHRH agonist therapy and undergo permanent iodine I
           125 implantation as in arm I.
    

Intervention name(s): Adjuvant therapy; Neoadjuvant therapy; Brachytherapy（iodine I 125）
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): AHT group receives 9 cycle of LHRH-A (goserelin acetate 3.6 mg/4 weeks or leuprorelin acetate 3.75 mg/4 weeks) after Iodine I-125 implantation (TPPB).; 3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).; Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIB prostate cancer; stage IIA prostate cancer; stage I prostate cancer
Nutraceutical on Hyperuricemia
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin,
      bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values
      between ≥ 6 and < 7 mg/dl after 3 months of therapy.
    

Detailed description: 
      The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin,
      bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values
      between ≥ 6 and < 7 mg/dl after 3 months of therapy.

      Patients will be randomized to Uricemin® or placebo for three months. We will evaluate body
      weight, fasting plasma glucose (FPG), lipid profile, uricemia (UA), high-sensitivity
      C-reactive protein (Hs-CRP) at baseline and after 3 months since the study start. Treatment
      tolerability will be assessed evaluating transaminases, and creatinine, and all adverse
      events will be recorded.
    

Intervention name(s): Uricemin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position
Condition: Intraocular Pressure
Study type: Observational

Summary: 
      This study analyse the rise in Intraocular Pressure while patient is in surgery in head low
      position.
    

Detailed description: 
      Patient undergoing robotic surgeries requires steep trendelenburg position (upto 60 degrees)
      along with pneumoperitoneum. These both can cause a significant rise in intraocular pressure.
      Significant rise of pressure for prolonged period can cause post operative visual
      disturbances, which can be of medicolegal importance. Thus studying the quantitative rise and
      thus trend of intraocular pressure is first step in managing ophthalmic changes during
      robotic surgeries.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing robotic surgeries in steep trendelenburg position
      
Keywords: Intraocular Pressure, Trendelenburg position
Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI)
Condition: Covid19; Corona Virus Infection; Vaccine Effectiveness
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      Although clinical trials for approved COVID-19 vaccines demonstrated efficacy of the vaccine
      in preventing symptomatic infection, many questions about vaccine effectiveness, such as the
      effectiveness of COVID-19 vaccine in preventing asymptomatic infection, a surrogate for
      transmission, and duration of protection, can only be evaluated in real-world trials. The
      objective of the study is to evaluate COVID-19 vaccine effectiveness (Pfizer vaccine, and, if
      available, Moderna vaccine) in preventing infection in healthcare personnel in Israel. HCP
      who are Clalit members and working in Soroka, Beilinson, Meir, Haemek, Kaplan and Schneider
      hospitals, 18 years or older, and eligible to get COVID-19 vaccine according to Ministry of
      Health guidelines, will be recruited, regardless of their intention to get the COVID-19
      vaccine. A baseline serology sample and respiratory sample will be collected. Participants
      will be asked to provide a respiratory sample weekly for 3 months, and then monthly for the
      remainder of the study. Participants will also have blood drawn at 1 month, 3 months, 6
      months, 9 months and 12 months. Respiratory samples will be tested for SARS-CoV-2 by RT-PCR;
      serology will be tested for SARS-CoV-2 antibodies. The study will last for 12 months. For
      each participant, data will be extracted from the Electronic Medical Record for the period of
      the study and retrospectively from 2010.
    


Intervention name(s): Serologic test; Respiratory swabs
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): A blood test to check antibodies type and amount; PCR test to Covid-19
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthcare workers who work in 6 Clalit hospitals in Israel (Soroka, Kaplan, Meir,
        Beilinson, HaEmek, and Schneider)
Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort
Condition: Gut Health
Study type: Interventional

Summary: 
      Dietary fibres are complex carbohydrates present in fruit, vegetables, grains, and beans
      which are broken down into smaller molecules (short-chain fatty acids) in the colon by the
      gut microbiota. Increased intake of dietary fibres is associated with a lower risk of type 2
      diabetes, obesity, or heart disease. Despite their health benefits, most people consume half
      of the daily recommended intake (30 grams) of dietary fibres. This trend has become more
      apparent in the past few decades with the advent of ultra-processed foods which are poor in
      dietary fibres. Since this change in dietary habits is more recent, the research team
      hypothesizes that older generations have a more diverse and better adapted gut microbiota at
      breaking down dietary fibres compared to younger generations.

      The aims of this study are to examine the effects of the daily intake over four weeks of a
      dietary fibres supplement on the gut microbiota, metabolic profiles, and general health in a
      transgenerational cohort (grandmother, mother and daughter OR mother and daughter) compared
      to placebo.
    

Detailed description: 
      Eligible participants will need to take daily for 14 days a dietary fibre supplement or
      placebo (depending on the randomisation) followed by wash-out period of 14 days and then
      followed by taking daily for 14 days the opposite arm of intervention (placebo or dietary
      fibre supplement). During the study period, participants will come to the research facility
      to assess the impact of these supplements on their gut microbiota, metabolic profiles and
      blood glucose, insulin and gut hormone levels.
    

Intervention name(s): Dietary Fibres Mix; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The Fibre Mix, which comprises of a mix of dietary fibres (inulin, pectin and oat beta-glucan) will need to be taken by participants twice daily for 2 weeks with their usual food.; The placebo, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blinded, randomised, cross-over
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: dietary fibres; gut microbiota; generation; metabolic profiles
Prevention of Early Postoperative Decline
Condition: Delirium; Postoperative Cognitive Dysfunction
MeSH terms: Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this trial is to determine whether using a brain training program in the time
      leading up to as well as after heart surgery will reduce confusion and cognitive loss that
      can occur after surgery.
    

Detailed description: 
      Randomized, controlled pilot study with a convenience sample of 45 adult cardiac surgical
      patients. The main intervention to be studied will be the use of a neurocognitive training
      program (Lumosity) for 10 days preoperatively, and then for four weeks postoperatively. The
      prescribed regimen of training will focus on the areas of cognitive function most commonly
      affected in the postoperative period, including working memory, attention, and processing
      speed. Patients in the control arm will undergo current standard cardiac surgical
      postoperative care and will be asked to refrain from obtaining a Lumosity account.
    

Intervention name(s): Lumosity
Intervention type(s): Device
Intervention description(s): A neurocognitive training program designed to enhance cognitive abilities
Other intervention name(s): Brain Games
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiac Surgery; Delirium; Postoperative Cognitive Dysfunction
Humidity Under Continuous Positive Airway Pressure
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Heated humidification in CPAP therapy is often not enough to prevent side effects like
      dryness of nasal mucosa and xerostomia, especially in cases of mouth breathing or mask
      leakage. Additionally a higher level of humidification in lower ambient room temperature can
      lead to condensation and irritating noises. Compliance of affected patients decreases
      considerably. Regarding this, devices with humidifier and additional heated tubing are
      developed to automatically regulate optimal humidification and temperature right up to the
      mask. The efficacy of a system with controlled heated humidification and heated tubing in
      nasal masks under various conditions like leakage and different pressure levels is object of
      this study.
    

Detailed description: 
      Participants will breath 3 hours during daytime with a nasal mask under three different
      humidity modes (No humidity, controlled heated humidification, controlled heated
      humidification with heated tubing) with CPAP 8 and 12 mmHg and with and without leakage. The
      ambient room temperature is controlled with air conditioning. Changes in temperature and
      humidity is measured inside of the mask with a humidity sensor and recorded. After each phase
      the participants subjective opinion about humidity and temperature is asked.
    

Intervention name(s): RESMed S9 with humidifier H5i and heated tube Climate Line; CPAP without humidification; CPAP with heated humidification
Intervention type(s): Device; Device; Device
Intervention description(s): At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. Controlled heated humidification with heated tubing (Climate Line).; At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. Without any humidification.; At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. With controlled heated humidification and standard tubing.
Other intervention name(s): ResMed S9 without humidifier; RESMed S9 with humidifier H5i
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; humidification; mask; heated tubing
Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney
      disease.
    


Intervention name(s): Open; Nifedipine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sitaxsentan sodium 100 mg orally administered once daily (double blind arm); Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm); Placebo for sitaxsentan, orally administered once daily (double blind arm)
Other intervention name(s): Sitaxsentan
Intervention MeSH terms: Nifedipine; Sitaxsentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease; Sitaxsentan
Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Transcranial direct current stimulation (tDCS) has shown promising results in the modulation
      of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose
      of this study was to compare the effectiveness of three different montages of tDCS (anodal,
      cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in
      acute stroke patients.
    

Detailed description: 
      This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines.
      The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study
      design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham
      stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.
    

Intervention name(s): Anodal transcranial direct current stimulation; Cathodal transcranial direct current stimulation; Bilateral transcranial direct current stimulation; Sham transcranial direct current stimulation
Intervention type(s): Device; Device; Device; Device
Intervention description(s): The active electrode is placed on the affected hemisphere; The active electrode is placed on the unaffected hemisphere; The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.; Placebo stimulation, with emission current by only 30 seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT
Condition: Weight Loss; Breast Cancer Risk Factors
MeSH terms: Breast Neoplasms; Weight Loss
Study type: Interventional

Summary: 
      The objective of this protocol is to adapt and pilot test an existing lifestyle modification
      intervention for weight loss for women with overweight or obesity who have had a recent false
      positive mammography screen. The purpose of this pilot trial is to establish feasibility of
      Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased
      physical activity and diet change.
    


Intervention name(s): CONECT
Intervention type(s): Behavioral
Intervention description(s): 1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical activity; Diet; Nutrition; Breast cancer prevention; Mammography screening
Pioglitazone on Pancreatic Steatosis and Bone Health
Condition: Obesity; Type 2 Diabetes
MeSH terms: Fatty Liver; Obesity
Study type: Interventional

Summary: 
      Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on
      pancreatic fat content and bone turnover markers.
    


Intervention name(s): pioglitazone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): pioglitazone 45 mg daily; one daily
Other intervention name(s): Actos; Placebo tablet resembling pioglitazone 45 mg.
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pioglitazone; prediabetes; diabetes; obesity; Pancreatic fat