bioihbjkbjnl/mcl2 huggingface dataset:
Improved Diagnostics of Celiac Disease in Children
Condition: Celiac Disease; Eosinophilic Esophagitis
MeSH terms: Esophagitis; Celiac Disease; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      The main purpose of this study is to improve the diagnostics of celiac disease and reduce the
      need for invasive endoscopic studies in children. Further, the investigators aim to
      investigate the natural history and risk of complications in children with celiac disease or
      gluten sensitivity and to create a large scientific database.
    

Detailed description: 
      Prevalence of celiac disease is on a steep rise in Western countries, but due to difficult
      diagnosis the majority of patients remain unrecognized. Undiagnosed celiac disease causes
      incremental burden to the health care and predisposes to severe complications. On the other
      hand, increasing screening in at-risk groups of celiac disease frequently detects
      seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal
      morphology. At present the natural history and benefits of an early diagnosis in such
      individuals is poorly known. Further, the endoscopic demonstration of the small-intestinal
      damage required for the diagnosis is unpleasant, expensive and often misleading. New
      serology-based diagnostic criteria have been suggested but prospective data is lacking. Aims
      of the present study are to improve the diagnostic yield and accuracy of the current
      diagnostic methods and to develop novel non-invasive methods and biomarkers for early
      detection of celiac disease. In addition, the investigators will evaluate natural history of
      celiac disease in screening-detected asymptomatic children and in those with positive
      serology but normal histology, and form a large database for future clinical and
      translational studies. The study and patient collection are to be conducted at the pediatric
      clinics in Finland and in Romania. All children referred due to suspicion of celiac disease
      or gluten sensitivity will be asked to participate to the study. Patient samples and clinical
      information are collected during the routine visits and the study does not include any
      additional visits or endoscopies. The total duration of the study is 10 years but data will
      be analyzed on-line.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital clinic; secondary and tertiary centers
      
Biospecimen description: 
      Whole blood, serum, intestinal mucosal biopsies
    
Keywords: Celiac disease; Eosinophilic esophagitis; Endomysial antibodies; Transglutaminase antibodies; Small-bowel
Multimodal Prehabilitation for Colorectal Surgery
Condition: Colorectal Cancer; Colorectal Cancer Stage III
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite advances in surgical care, the incidence of postoperative complications and prolonged
      recovery following colorectal surgery remains high. Efforts to improve the recovery process
      have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural
      blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. The
      pre-operative period may in fact be a better time to intervene in the factors that contribute
      to recovery. The process of enhancing functional capacity of the individual in anticipation
      of an upcoming stressor has been termed "prehabilitation". Based on the notion that
      preoperative exercise would have an impact on recovery of functional capacity after
      colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup
      analysis identified that patients whose functional exercise capacity improved preoperatively,
      regardless of exercise technique, recovered well in the postoperative period. However,
      one-third of patients deteriorated preoperatively despite the exercise regimen, and these
      patients were also at greater risk for prolonged recovery after surgery. These results
      suggested that exercise alone is not sufficient to attenuate the stress response in all
      patients. In the present trial, the impact of a multimodal prehabilitation intervention
      composed of exercise, nutritional supplement and psychological well-being begun in the
      preoperative period will be compared to one begun in the postoperative period.
    


Intervention name(s): multimodal prehabilitation; multimodal prehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support starting 3-5 weeks before surgery and continuing postoperative for up to 8 weeks; multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: colorectal cancer; colorectal surgery; prehabilitation; surgical recovery; exercise; referred for scheduled resection
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
Condition: Obesity; Cardiovascular Disease; Type 2 Diabetes
MeSH terms: Cardiovascular Diseases; Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The major objective of this study is to conduct a double-blind, placebo-controlled,
      randomized clinical trial to assess whether oral alpha lipoic acid supplementation will
      decrease cardiovascular disease and type 2 diabetes risk in obese subjects.
    


Intervention name(s): Alpha Lipoic Acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1200 mg/day; 1200 mg/day
Other intervention name(s): Lipoic acid
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Antioxidant; Obesity
The Relationship of Rehabilitation Therapy Time To The Prevention of Burn Scar Contracture
Condition: Burns
MeSH terms: Contracture; Burns
Study type: Observational

Summary: 
      This project will develop a descriptive database of patient information and patient outcomes.
      This database will be used to determine the association of time spent in rehabilitation and
      patient outcomes, to relate patient acuity to burn scar contracture development and to
      establish minimal time requirement guidelines for various rehabilitation patient outcomes.
    


Intervention name(s): Routine post burn rehabilitation therapy
Intervention type(s): Other
Intervention description(s): No testing outside of routine clinical rehabilitation will be performed
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary diagnosis of acute burn injury
      
Keywords: Burn; Rehabilitation
Relative Bioavailability of Phase II and Phase III Formulations of AZD0530
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to compare how different formulations of AZD0530 are absorbed by the
      body. As for all clinical trials, safety and tolerability of the drug will be evaluated.
    


Intervention name(s): AZD0530; AZD0530
Intervention type(s): Drug; Drug
Intervention description(s): of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.; Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.
Intervention MeSH terms: Saracatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Relative Bioavailability
Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
Condition: Hookworm Infections
MeSH terms: Infections; Hookworm Infections; Ancylostomiasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The rational of this study is to provide evidence on the safety and efficacy of a new
      chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged
      children infected with hookworm.
    


Intervention name(s): Mebendazole
Intervention type(s): Drug
Intervention description(s): Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mebendazole; Chewable tablet; Hookworm; Soil-transmitted helminths; Efficacy; Safety; Acceptability
Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Hypothermia
Study type: Interventional
Phase: Phase 4

Summary: 
      Controlled therapeutic hypothermia is a method of preserving neurological function
      post-resuscitation.It has been associated with improved functional recovery and reduced
      histological deficits in animal models of cardiac arrest.
    

Detailed description: 
      Three randomized clinical studies have been reported showing improved neurological outcome
      and reduced mortality in post-resuscitation patients treated with hypothermia compared to
      controls. Of the various methods of inducing hypothermia, internal cooling using an
      endovascular catheter and external cooling using gel pads with a water based circulating
      system have shown the most promise. There have not been any studies looking at outcomes
      between the two methods of cooling.
    

Intervention name(s): Internal Cooling; External Cooling
Intervention type(s): Device; Device
Intervention description(s): The intravascular cooling system uses a single lumen (8.5 Fr,38 cm) central venous catheter inserted into the inferior vena cava via the left or right femoral vein. Normal saline is pumped through three balloons mounted on the catheter and returned to a central system in a closed loop. The saline flow within the balloons is in close contact with the patient's blood flow and serves as a heat exchange system. An automatic temperature control device adjusts the temperature of the circulating saline (4°C to 42°C) based on the patient's core temperature.; The gel-coated external cooling device consists of four water circulating gel coated energy transfer pads, and is placed on the patient's back, abdomen, and both thighs. Depending on the size used, the total surface area ranges between 0.60 and 0.77 m2. It is connected to an automatic thermostat controlling the temperature of the circulating water (4°C to 42°C) based on the patient's core temperature.
Other intervention name(s): Alsius Thermogard; Arctic Sun
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypothermia; Internal cooling; External cooling; Cardiac arrest
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and antiviral activity of
      ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267
      also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin
      (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without
      cirrhosis.
    

Detailed description: 
      A randomized, double-blind, multicenter study to evaluate the safety and antiviral activity
      of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and
      without ribavirin (RBV) in treatment-naïve, noncirrhotic participants with chronic hepatitis
      C virus genotype 1b (HCV GT1b) infection.
    

Intervention name(s): ABT-450/r/ABT-267, ABT-333; Ribavirin; Placebo for ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Capsule; Capsule
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ABT-333 also known as dasabuvir; Viekira PAK
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Interferon-Free; Hepatitis C Genotype 1b; Chronic Hepatitis C; Hepatitis C Virus; Hepatitis C; Treatment-Naive; Paritaprevir; Ombitasvir; Dasabuvir; Viekira PAK; Ribavirin
Treatment Effect of Tamoxifen on Patients With DMD
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      Duchenne muscular dystrophy (DMD) is a progressive devastating disease that affects mainly
      boys, with an incidence of about 1:3,500 live births. The pathology of DMD is a result of
      non-repaired muscle damage that leads to muscle-tissue replacement by scar tissue, a process
      known as fibrosis. Currently, there is no effective treatment for the disease. The only
      therapy offered to these boys are steroids which slightly delayed the disease progression.
      The boys lose their ability to walk at around the age of 12, and die in the 4th decade of
      life from severe heart and lung problems.

      In this study investigators will test the efficacy of Tamoxifen treatment in ambulatory DMD
      boys. Tamoxifen is a drug used for palliative treatment of breast cancer patients and has an
      outstanding safety profile. In addition, Tamoxifen was tested in the past in boys, for other
      pediatric indications, and showed an excellent safety with no side effects.

      Tamoxifen is being tested in this study, as a therapy for DMD, for the following reasons:

      (i) it was shown to have anti-fibrotic effect in multiple in-vivo systems; (ii) it assists in
      the repair of damaged muscles.

      In other words, Tamoxifen is expected to have a synergistic effect on DMD patients, due to
      its dual mechanism of action. Indeed, Tamoxifen was shown to have significant beneficial
      effects in the mdx mouse model of DMD. Also, a small compassionate cohort of 3 boys, treated
      for 6 months with Tamoxifen, yielded very encouraging results.
    


Intervention name(s): Tamoxifen
Intervention type(s): Drug
Intervention MeSH terms: Tamoxifen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duchenne Tamoxifen
A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effect of itraconazole (a potent
      cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics of IW-1973.
    


Intervention name(s): IW-1973; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Oral Capsule
Intervention MeSH terms: Itraconazole; Praliciguat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of a Psychiatric Intensive Care Unit
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to compare the effects of using or not using a Psychiatric
      Intensive Care Unit (PICU) in an acute psychiatric department.
    

Detailed description: 
      The main aim of the study is to compare the effects of using or not using a Psychiatric
      Intensive Care Unit (PICU) in an acute psychiatric department.The acute ward of Østmarka
      psychiatric department, St. Olavs Hospital has a PICU separated from the rest of the ward.
      The PICU is separated with a locked door. Under two different conditions at different times
      all patients evaluated to be in need of PICU were admitted to the PICU. In the first
      condition the doors inside the PICU and between the rest of the acute ward and PICU were
      closed or locked. In the second condition the doors inside the PICU and the door between the
      PICU and the rest of the acute ward were either removed or held permanently open. In the
      second condition the patients thus were admitted to a PICU unit not using PICU principles.

      The patients were evaluated with different rating scales at admittance, day three and at
      discharge from PICU.
    

Intervention name(s): Psychiatric Intensive Care Unit; Care in whole acute unit
Intervention type(s): Procedure; Procedure
Intervention description(s): psychiatric acute care as usual
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emergency services, psychiatric; Intensive care units; Hospitals, psychiatric; Aggression; Violence
Acute Effects of Fruit Juices Consumption on Postprandial Glycemic Responses and Satiety
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the acute effects of two fruit juices on postprandial glycemic
      responses and satiety in healthy individuals
    

Detailed description: 
      This study aimed to 1. Determine the glycemic index and glycemic load of two types of fruit
      juices (orange juice and mixed fruit juice consisted of apple, orange, grape, and
      pomegranate) and 2. Investigate the effects of these two fruit juices on postprandial
      glycemic responses and satiety in healthy individuals
    

Intervention name(s): Glucose as reference food; Orange juice; Mixed fruit juice
Intervention type(s): Other; Other; Other
Intervention description(s): Ten healthy, normal-weight subjects after 10-14 hours of fasting, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Ten healthy, normal-weight subjects after 10-14 hours of fasting, consumed 50g available carbohydrates from orange juice, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Ten healthy, normal-weight subjects after 10-14 hours of fasting, consumed 50g available carbohydrates from mixed fruit juice (consisted of apple, orange, grape, and pomegranate), tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: blood glucose; fruit juice; glycemic index; glycemic load; satiety
Resistant Starch and Satiety
Condition: Healthy Adults
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Dietary fiber consumption may contribute to weight regulation by improving satiety. In an
      earlier study the investigators found that a muffin containing resistant starch was more
      effective than other fibers in altering satiety. The objective of this study is to determine
      if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant
      starches is more effective than either alone in enhancing satiety.
    


Intervention name(s): Placebo- Fiber free control; Hi-maize resistant starch 9g; Novalose 330 resistant starch 9g; 4.5g Hi-maize resistant starch and 4.5g Novalose 330
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dextrin control administered in a muffin treatment.; 9g Hi-maize resistant starch administered in a muffin treatment.; 9g Novalose 330 resistant starch administered in a muffin treatment.; 4.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: satiety, dietary fiber
Evaluation of a Binaural Spatialization Method for Hearing Aids
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study investigates the possible benefits of using binaural spatialization techniques in
      digital wireless microphone systems for hearing aids. Speech intelligibility tests, speaker
      localization tests and preference tests are performed. The results of a diotic (current
      rendering) and a binaural (suggested rendering) rendering are compared.
    

Detailed description: 
      The signal processing laboratory (LTS2) of the Swiss Federal Institute of Technology (EPFL)
      has developed a new feature of sound rendering in hearing aids. This is a collaboration
      between EPFL and the Swiss company Phonak Communications AG. The new functionality works with
      the range of Roger products from Phonak, a new generation of FM systems that use a digital
      transmission.

      FM technology refers to a type of wireless system that helps people better understand speech
      in noisy situations. FM systems commonly work together with a user's hearing aids, although
      systems are also available for those with otherwise normal hearing (such as people who suffer
      from APD, ADHD etc.). An FM system works like this: the person speaking wears or holds a
      transmitter microphone, or the transmitter is placed in the middle of the group (picking up
      speech from all around). Using harmless radio waves, the FM system sends speech signal(s) to
      the listener, who wears a tiny FM receiver behind the ear.

      The new feature of such systems performs processing of the speaker's speech signal so that it
      renders information related to their spatial location. This so-called sound "spatialization"
      is a natural property of the human binaural auditory system, which allows us to localize
      sounds. However, this sound spatialization is not delivered by the current FM systems. Thanks
      to the new technology from EPFL and Phonak, it is now possible to include a binaural
      spatialization of the speech signal in the Roger product of Phonak hearing devices.
    

Intervention name(s): Hearing Aids
Intervention type(s): Device
Intervention description(s): The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment.
Other intervention name(s): Hearing instruments
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care