bioihbjkbjnl/mcl2 huggingface dataset:
Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery
Condition: Laparoscopic Sleeve Gastrectomy; Subcostal Transversus Abdominis Plane Block
Study type: Interventional
Phase: Phase 4

Summary: 
      The study team will be assessing if the unilateral subcostal transversus abdominis plane
      (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy
      surgeries.
    

Detailed description: 
      This study will be a double-blinded randomized control trial. Patients will be randomized
      into one of two groups. Patients in Group 1 will undergo general anesthesia with a
      post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25%
      bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo
      general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block
      with 40 mL sterile normal saline on the ipsilateral side as the extraction site.
      Investigators will be blinded to the randomization of these patients. Following performance
      of these blocks, patients will receive standard care for the surgery as well as during the
      postoperative recovery period. Data will be obtained from the EPIC electronic medical record,
      and from the anesthesia computer record. Patients will be asked postoperatively to assess
      items such as their nausea and pain scores. Patients will also be contacted by phone within
      1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on
      the Redcap server.
    

Intervention name(s): Saline; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 40 mL sterile normal saline; 40 mL 0.25% bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consists of two study arms. Patients will be getting a subcostal transversus abdominis plane block with either bupivacaine or saline.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Randomized control trial; Subcostal transversus abdominis plane block; Laparoscopic sleeve gastrectomy; Regional anesthesia; Opioid consumption; Bariatrics
The Effectiveness of the Water Jet Device in Removing Dental Plaque Around Orthodontic Braces in Adolescents
Condition: Plaque, Dental
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effectiveness of the water jet in removing dental
      plaque around the orthodontic braces in adolescents.
    

Detailed description: 
      The aim of this randomized controlled trial was to evaluate the effectiveness of the water
      jet in removing dental plaque around the orthodontic braces compared to manual toothbrush in
      adolescents. The null hypothesis was that no significant difference would be noted between
      the Water Jet and manual toothbrush in removing dental plaque around the orthodontic braces.
      Such studies provide another dental care tools for maintaining oral hygiene among orthodontic
      patients.
    

Intervention name(s): Water Jet; Manual toothbrush
Intervention type(s): Device; Device
Intervention description(s): The water jet works by directing a stream of water towards the gap between your teeth. The stream of water helps to loosen and remove plaque and food particles stuck in this area.; Manual toothbrush: The patients were taught to use the modified vertical method, and the patient brushed the teeth of the upper and lower jaws using traditional toothbrushes (Diamond, JolleyDent, Damascus, Syria), and anti-plaque toothpaste (Elgydium, UniPharma Co., Ltd, Ashrafiyat Sahnaya, Syria).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Regulation of FGF21 by Nutritional Challenges
Condition: Fasting; Non-alcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The purpose of this study is to examine how acute nutritional challenges affect levels of
      several proteins involved in metabolism. These proteins will be measured in blood and fat
      tissue.

      This study will have several aims.

      One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21
      (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at
      the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken.
      Two fat samples will be taken prior to and at the end of the fast. A subset of participants
      will also have two MRIs, one prior to and one at the end of the fast. We will study healthy
      adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease
      (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING

      Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will
      follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll
      participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will
      report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for
      weight measurements. Blood will be drawn before and after the weight loss. Participants will
      also have an MRI before and after the weight loss.

      THIS ARM IS CURRENTLY NOT RECRUITING

      Another aim of the study is to examine the effect of acute ingestion of glucose, fructose,
      and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and
      individuals with metabolic syndrome.

      THIS ARM IS CURRENTLY RECRUITING
    

Detailed description: 
      Participation in this study involves fasting overnight, drinking a sweet beverage, and
      several blood draws through an IV line. Each subject may drink up to 5 different sweet
      beverages, separated by 2 weeks.
    

Intervention name(s): Fasting; Fasting; Diet; oral carbohydrate challenge
Intervention type(s): Behavioral; Behavioral; Behavioral; Dietary Supplement
Intervention description(s): Participants will fast for 72 hours and may consume only water and vitamins.; Participants will fast for 72 hours and may consume only water and vitamins.; Participants will follow a low-calorie diet until they lose 3-5% of their body weight.; Participants will fast for 16 hours and then drink a beverage containing glucose, fructose or a mixture of both
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fasting; Fast; healthy; diet; study; manipulation; dietary; FGF21; Fibroblast growth factor; PTRF; Polymerase 1 and transcript release factor; adipose; fat; blood; inpatient; outpatient; NAFLD; metabolism
The TISA Trial - Senegal
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      This study evaluates the addition of a simple, scalable "WASH kit", including household water
      treatment products, a safe water storage container, and hygiene promotion, to the standard
      national protocol for outpatient treatment of uncomplicated severe acute malnutrition among
      children aged 6-59 months of age in northern Senegal.
    

Detailed description: 
      Severe acute malnutrition (SAM) is defined as a weight-for-height z-score (WHZ) below -3 of
      the World Health Organisation growth standards. It is a short-term acute condition with a
      high case-fatality rate that increases both the susceptibility of children to infection and
      the risk of mortality. The global prevalence of SAM in children is estimated to be over 17
      million with most of those affected living in sub-Saharan Africa and Asia.

      Community-Based Management of Acute Malnutrition (CMAM) has significantly changed standard
      practice for the treatment of SAM. Uncomplicated SAM cases are now predominantly managed on
      an outpatient basis and Action Contre la Faim (ACF) supports outpatient treatment programs
      (OTP) across the globe, particularly in Africa and Asia. This innovation has increased
      coverage, and reduced the cost of treatment for both the health system and individuals.
      However, under CMAM, the treatment context has moved from a more controlled health facility
      setting to the generally less controlled household setting where the risk of infection due to
      environmental hazards, such as contaminated water, may be higher.

      The TISA trial described here will evaluate the effectiveness of combining a simple, scalable
      "WASH kit" with OTP on the recovery rate among uncomplicated SAM cases aged 6-59 compared to
      the national standard OTP. The WASH kit includes a plastic container, a supply of Aquatabs®
      (effervescent chlorine tablets), and training in their use and associated hygiene practices.
      The study is a cluster randomized controlled trial (cRCT), with health centres constituting
      the clusters. Clusters are randomly allocated to either a control group receiving the
      standard OTP or an intervention group receiving OTP plus the WASH kit. The primary outcome of
      the trial is the recovery rate and the secondary outcomes are weight gain, referral rate,
      longitudinal prevalence of diarrhoea, prevalence of enteric pathogen detection and all-cause
      mortality.
    

Intervention name(s): WASH kit; Standard treatment
Intervention type(s): Other; Other
Intervention description(s): WASH kit containing a plastic container and a supply of Aquatabs® (effervescent chlorine tablets) and training in their use and associated hygiene practices.; National standard outpatient treatment for uncomplicated severe acute malnutrition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 1

Summary: 
      ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic
      equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD,
      Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing
      spondylitis.
    

Detailed description: 
      ASART-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured
      by JSC BIOCAD, Russia.The aim of this study is to establish that BCD-055 is equivalent to
      Remicade in terms of pharmacokinetics and safety when used by the standard regimen in
      patients with ankylosing spondylitis (AS).

      The study will enroll 90 patients with active AS, who will be randomized into 2 groups (1:1
      ratio): patients from the first group will receive BCD-055 IV at a dose 5 mg/kg on week 0, 2,
      6, 14 and 22; patients from the second group will receive Remicade at the same regimen.
    

Intervention name(s): Infliximab (BCD-055); Infliximab (Remicade)
Intervention type(s): Drug; Drug
Intervention description(s): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
Other intervention name(s): Remicade; BCD-055
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.
    


Intervention name(s): Pasireotide (SOM230), Octreotide (Sandostatin)
Intervention type(s): Drug
Intervention MeSH terms: Octreotide; Pasireotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly; SOM230; Sandostatin
Prospective Observational Study for Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen (Equinoxe 2)
Condition: Allergic Rhinitis Due to Grass Pollen
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      Prospective multi-center study carried out in France involving patients with allergic
      rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is
      required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.
    


Intervention name(s): Allergic rhinitis
Intervention type(s): Other
Intervention description(s): Questionnaire
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with allergic rhinitis due to grass pollen
Effects of Dietary Nitrate Supplementation on Cardiorespiratory Control in Chronic Heart Failure
Condition: Heart Failure, Systolic
MeSH terms: Heart Failure; Heart Failure, Systolic
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to determine whether dietary nitrate supplementation via
      concentrated beetroot juice improves central and peripheral cardiovascular control and
      physical capacity in patients with systolic heart failure.
    

Detailed description: 
      Chronic heart failure (CHF) is a leading cause of morbidity and mortality worldwide. Although
      affecting the heart at first, it is now recognized that disability is largely due to impaired
      cerebral and skeletal muscle blood flow and consequently microvascular oxygenation. Reduced
      muscle oxygenation compromises oxidative metabolism and thus contractile performance.
      Impaired cerebral oxygenation not only reduces motor output (thus exacerbating muscle
      fatigue) but also constitutes a predictor of cerebral ischemic events and an independent
      prognostic risk factor.

      Reduced levels of the vasodilator nitric oxide (NO) contribute to impaired blood flow and
      oxygenation in CHF. Development of new effective therapeutic strategies is therefore crucial
      given that current pharmacological treatment has failed to abrogate oxygenation deficits in
      CHF patients. Emerging evidence shows that nitrate serves as an alternative source for NO and
      improves muscle blood flow and oxygenation in health. Another striking feature of nitrate is
      that it can improve muscle work efficiency, a tenet of physiology that was once considered
      immutable.

      Objective: To investigate systematically the role of dietary nitrate supplementation on
      central and peripheral cardiovascular function in CHF patients.
    

Intervention name(s): Nitrate supplementation; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nitrate supplementation: concentrated nitrate-rich beetroot juice (2 x 70 ml/day; approximately 10 mmol nitrate/day; Beet It, James White Drinks, Ipswich, UK) for 8 consecutive days.; Placebo: nitrate-depleted beetroot juice (2 x 70 ml/day; approximately 0.01 mmol nitrate/day; Beet It, James White Drinks, Ipswich, UK) for 8 consecutive days. The placebo juice is similar to the concentrated beetroot juice in appearance, texture, smell and taste and is obtained by removing nitrate ions from the latter.
Other intervention name(s): Concentrated nitrate-rich beetroot juice; Nitrate-depleted beetroot juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 SAD/MAD Study of RLS-0071 in Healthy Volunteers in Support of a COVID-19 Development Program
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, randomized, double-blind, placebo-controlled,
      adaptive-design study to assess the safety, tolerability, PK, and PD of single- and
      multiple-ascending doses of RLS-0071 in healthy adult subjects.
    

Detailed description: 
      The present study is a single-ascending dose (SAD) and multiple-ascending dose (MAD)
      evaluation of RLS-0071 in healthy volunteers. This study is designed to evaluate the safety
      and tolerability of RLS-0071 administered by the intravenous (IV) route to healthy subjects
      as single- and multiple-ascending doses. Importantly, a SAD/MAD study in healthy subjects is
      critical to generate robust pharmacokinetic (PK) data using intensified PK sample collection,
      not feasible in a patient study.
    

Intervention name(s): RLS-0071; Saline Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RLS-0071 is administered as an IV infusion; Placebo is administered as an IV infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Each cohort will include 8 subjects randomized to receive either RLS-0071 (6 subjects) or placebo (2 subjects). Up to 7 cohorts (4 single-ascending dose [SAD] and 3 multiple-ascending dose [MAD]) enrolling up to 56 subjects are planned for the study. Subjects enrolled in a SAD cohort will receive a single infusion of RLS-0071. Subjects enrolled in a MAD cohort will receive a RLS-0071 infusion every (q) 8 hours for a total of 9 doses, with the ninth infusion occurring in the morning on Day 4. Dose escalation will depend on the Safety Review Committee (SRC) review of available blinded safety and PK data through the observation period of the previous cohort (ie, 48 hours after the last dose of study intervention).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALS
Condition: Amyotrophic Lateral Sclerosis; ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, off label study, to provide interested ALS patients with
      Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability and
      routine disease progression measures (ALSFRS-R and Vital Capacity).
    

Detailed description: 
      Patients will be prescribed a fixed dose combination of Ciprofloxacin and Celecoxib to be
      taken thrice daily, and will be monitored for safety and tolerability. Additionally, routine
      disease progression measures will be assessed.
    

Intervention name(s): Fixed dose combination Ciprofloxacin/Celecoxib
Intervention type(s): Drug
Intervention description(s): Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day
Other intervention name(s): PrimeC
Intervention MeSH terms: Ciprofloxacin; Celecoxib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Intervention Detection in the Small Intestine
Condition: Proof of Concept
Study type: Interventional

Summary: 
      Proof of concept study to validate the ability of a capsule device to gather samples from the
      small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous
      ingestion of a probiotic.
    


Intervention name(s): Ingestible Capsule; Probiotic
Intervention type(s): Device; Dietary Supplement
Intervention description(s): Participants will swallow capsule and undergo X-rays to establish transit; Participants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Conquering Feared Foods Study
Condition: Eating Disorder Symptom; Fear
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to use ecological momentary assessment (EMA) data and
      physiological data to asses a client's eating disorder symptoms and behaviors before and
      after a meal with a feared food. The investigators are conducting a pilot clinical
      measurement study. Participants will be screened for eating disorder symptoms via a
      structured clinical interview. Participants with or without eating disorders will also
      complete self-reported measures of eating disorder symptoms and anxiety. Participants with
      eating disorders will complete assessments on their phone and will wear a sensor band to
      assess heart rate and galvanic skin response.
    

Detailed description: 
      Exposure therapy has been used in the treatment of Anorexia Nervosa (AN), as seen in mirror
      exposure to address body image and anxiety, as well as food exposure to address avoidant
      eating behavior. In food exposure therapy, individuals are exposed to feared foods in a
      clinical and/or non-clinical setting. Food exposure therapy has been effective in alleviating
      some anxiety in individuals with eating disorder behaviors and symptoms. However, the
      investigators do not yet know what characteristics predict response in food exposure therapy.
      The purpose of this study is to use EMA data and physiological data to asses a client's
      eating disorder symptoms and behaviors before and after a meal with a feared food.

      Lastly, the study would like to utilize individuals who do not meet criteria for an eating
      disorder (ED) and will act as controls in this study to address the research question: is
      there a difference between individuals with EDs and without EDs as they complete the entirety
      of the study, specifically in regards to physiological data? These controls will not complete
      the EMA data aspect of the study.

      The investigators are conducting a pilot clinical measurement study. Participants will be
      screened for eating disorder symptoms via a structured clinical interview or determined to
      not have eating disorder symptoms and will act as controls in the study. Both groups will
      also complete self-reported measures of eating disorder symptoms and anxiety. Participants
      will also complete assessments on their phone and will wear a sensor band to assess heart
      rate and galvanic skin response. However, control participants will not complete assessments
      on their phone. Both groups will wear the health-sensor band to assess heart rate and
      galvanic skin response.
    

Intervention name(s): Food Exposure
Intervention type(s): Behavioral
Intervention description(s): Participants will complete a meal exposure using one of their feared foods.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eating disorder; food exposure; feared food
Bifeprunox in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.
    


Intervention name(s): bifeprunox
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: double-blind study in the treatment of schizophrenia