bioihbjkbjnl/mcl2 huggingface dataset:
Impedance Spectroscopy in Esophageal Cancer
Condition: Cancer of Esophagus
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      Detection of early esophageal cancer in surrounding normal tissue can be challenging even for
      experienced examiners. The early detection is essential to determine the following treatment.
      Early stages of esophageal cancers can be treated by endoscopic resection whereas advanced
      neoplasia might lead to an Operation of the esophagus. Diagnosis is made usually by biopsies
      of suspicious lesions or untargeted quadrant biopsies. The electrical properties in
      inflammatory tissue and cancer can be sensed by electrical bioimpedance technique.

      The aim of this study is to compare the impedance probe with the histological result and to
      investigate the feasibility of the new technique in detection of esophageal cancer.
    

Detailed description: 
      Detection of early esophageal cancer in surrounding normal tissue can be challenging even for
      experienced examiners. The early detection is essential to determine the following treatment.
      Early stages of esophageal cancers can be treated by endoscopic resection (ER) whereas
      advanced neoplasia might lead to esophagectomy. Diagnosis is made usually by biopsies of
      suspicious lesions or untargeted quadrant biopsies. The electrical properties in inflammatory
      tissue and dysplasia can be sensed by electrical bioimpedance technique. The aim of this
      study is to compare the impedance probe with the histological result and to investigate the
      feasibility of the new technique in detection of esophageal cancer.
    

Intervention name(s): impedance
Intervention type(s): Device
Intervention description(s): After endoscopic resection of early esophageal cancer, the tissue will be measured by an impedance probe between 10Hz-1000000Hz, 20mV. 8 gold electrodes have been integrated to the probe. The impedance will be measured in different ways between the elctrodes. There will be 10 measurements in total for each specimen.
Intervention model: Single Group Assignment
Intervention model description: Observation group: patient who are planned for endoscopic resection because of known esophageal cancer. Immediately after retrieval the resected specimens will be investigated for their electrical impedance properties. The results of the impedance measurement are compared to the histological results.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: impedance, Barrett´s cancer, early detection of cancer
Value of Manual Therapy Specificity Referred to Pain Intensity in Patients With Subacute and Unspecified Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Pain
Study type: Interventional

Summary: 
      This study proves the specificity of manual therapy in unspecified an subacute low back pain
    

Detailed description: 
      The purpose of the study is to determine the importance of manual therapy specificity in
      relation to subacute low back pain.

      In order to do this, it will be selected a sample of at least 48 people who suffer low back
      pain whose duration has not exceeded 12 weeks. Patients will be divided into two groups and a
      different physiotherapist from the one who will subsequently perform the intervention, will
      assess and determine which is the most painful segment in each of them.

      In the first group, the intervention to be carried out will be through posteroanterior (PA)
      vertebral mobilizations in the most painful lumbar segment. The members of the second group
      will undergo this same technique on a painful segment of the region adjacent to the one they
      have referred as the main source of pain.

      Each of these sessions will continue until the patient's symptoms have decreased two points
      on the numerical scale of pain. There will be one session per week, for six weeks.

      To determine the differences between the two groups, there will be carried out 4 measurements
      of pain, functional disability, quality of life and kinesiophobia, and 3 measurements of
      pressure pain threshold were performed. Each one of them will be carried out in the first
      session, in the third week of treatment, in the last session of the treatment and one month
      after the end of the treatment. The last measeurement will be executed online and that is why
      the pressure pain threshold will be measured three times while the rest will be do it.

      The hypothesis is that it won´t be differences in the amount of pain between the tratment on
      the main painful segment and the treatment on his adyacent segment.
    

Intervention name(s): PA vertebral mobilization
Intervention type(s): Other
Intervention description(s): A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention will assess and determine which is the most painful segment in each of them.
In the first of the groups, the intervention to be carried out will be through posteroanterior vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: low back pain; subacute; manual therapy; PA; mobilization; manipulation
Efficacy Study of Protein Supplementation in Attenuating the Decline in Performance After Strenuous Concurrent Exercise
Condition: Sports Nutritional Sciences
Study type: Interventional

Summary: 
      This study is designed to investigate whether protein supplementation can improve recovery of
      muscle function following a strenuous combination of both endurance and resistance exercise.
      It will specifically investigate the effect of protein supplementation on the recovery of
      strength, power and endurance exercise performance, along with measures of damage and
      inflammation of the muscle.
    


Intervention name(s): Test product; Reference product 1; Reference product 2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Whey protein hydrolysate (20 g); Iso-energetic carbohydrate (20 g); Negligible energy placebo (20 g)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse
Condition: Body Composition
Study type: Observational

Summary: 
      Body composition measurement is an important tool for assessing the physical condition of
      sick or healthy people, as well as for monitoring changes in body composition and physical
      performance during diet and/or training. Many people self-monitor their body composition
      using portable and inexpensive assessment tools, but most of them have not been tested for
      accuracy and precision.

      This study aims to assess the accuracy and precision of a new portable impedancemeter scale
      to measure body composition in comparison with proven techniques, such as 4-electrode
      electrical bioimpedance analysis and dual X-ray absorptiometry.
    

Detailed description: 
      This is an observational, prospective, cross-sectional study to evaluate the accuracy and
      precision of the new HAG-B19 in healthy Western adults. A stratified sampling method is used
      to recruit a heterogeneous sample of 160 subjects, covering a wide range of ages and body
      compositions according to gender specific BMI distributions in the population. Volunteers who
      signed the informed consent form are included in the study. A financial compensation of 50.-
      CHF is given to each participant (100.- to the 16 participants subjected to the DEXA
      measurements).

      The body composition of each subject (FM, LBM and FM%) is assessed with sequential
      measurements using 3 HAG-B19 and 3 Nutriguard-M® devices (Data Input, Germany). FM% values
      measured by HAG-B19 are compared to values by Nutriguard-M® to assess the accuracy and
      precision of HAG-B19 (main objective). Intra- and inter-device variability are obtained by
      comparing the 3 repeated measurements and the 3 HAG-B19 devices (secondary objective). In a
      subgroup of 16 individuals, the FM% values measured by HAG-B19 are compared to DEXA
      measurements (secondary objective). Pearson correlations and Bland-Altman graphs are
      performed to assess the agreement of the measurements between the devices and paired t-tests
      are used to determine if there is a bias between the devices. The significance of the
      statistical analysis is fixed at p <0.05.
    

Intervention name(s): Body composition measurement with HAG-BIA scale
Intervention type(s): Device
Intervention description(s): Bio-impendance analysis
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Caucasians/Hispanics adults
      
Keywords: Body composition; Bioimpendance analysis; Physical activity; Nutrition
An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study was designed to demonstrate that a single, intravenous dose of
      palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed
      CINV and was also well tolerated in the Chinese cancer patients.
    


Intervention name(s): palonosetron; Granisetron
Intervention type(s): Drug; Drug
Intervention description(s): receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.; receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.
Intervention MeSH terms: Palonosetron; Granisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Supportive Care
Cardiac AResT And GENEtic
Condition: Out-of-hospital Cardiac Arrest
MeSH terms: Out-of-Hospital Cardiac Arrest
Study type: Observational

Summary: 
      Sudden death is a major problem in industrially developed countries. Despite a decline in
      ischemic heart disease mortality and the progress has been made in resuscitation, treatment
      of sudden death victims is frequently unsuccessful. the ideal solution would be to prevent
      the disease process that causes the initial episode of cardiac arrest. Parental sudden death
      is an independent risk factor for sudden death. So, detect a gene predisposing to sudden
      death may help provide better identification of subjects at high risk of cardiac arrest. This
      research is a genetic study of sudden cardiac death, recruited 2000 subjects in
      out-of-hospital cardiac arrest.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all subjects in out-of-hospital cardiac arrest and treated by medical mobil emergency
        medical care
      
Biospecimen description: 
      whole blood to obtain DNA
Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response
      Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451)
      with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic
      Genotype 1 Hepatitis C Virus (HCV) Infection.
    

Detailed description: 
      In September 2011, the FDA requested that Gilead make several major changes to this study
      because of side effects experienced by two patients in other Gilead studies.

      In 2 HCV-infected people that were given tegobuvir with another experimental medication plus
      interferon and ribavirin, big reductions in the number of white blood cells, red blood cells
      and platelets were seen. Because these cases might have been related to tegobuvir when given
      with interferon, ribavirin and another direct antiviral agent, tegobuvir is no longer being
      given to people with these other medications in this study.

      As a result, the study is now open label which means both you and your study doctor will know
      the medication you will be receiving and Arms 1 and 3 have been discontinued from the study.

      All subjects enrolled in the study as of September 2nd 2011 will receive Response Guided
      Therapy (RGT) with both GS-5885 and GS-9451 plus PEG and RBV.
    

Intervention name(s): GS-5885 tablet; GS-9451 tablet; peginterferon alfa-2a; ribavirin tablet
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): 30 mg active tablet; two active 100 mg tablets; peginterferon alfa-2a (solution for injection) 180 µg/week; ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Ledipasvir
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Rapid Virologic Response; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy HCV RNA; Polymerase inhibitor; Protease inhibitor; Treatment naïve; GS-5885; GS-9190; Tegobuvir; GS-9451
Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome
Condition: Idiopathic Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Nephrosis, Lipoid; Syndrome
Study type: Observational

Summary: 
      The primary purpose of the study is to identify the factors of steroid dependency in
      childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of
      nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the
      first manifestation. Different clinical and biological factors will be analyzed: age of first
      manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization
      in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes
      involved in the response to steroid therapy.
    

Detailed description: 
      Patients with a steroid dependent nephrotic syndrome will be compared to those with a non
      steroid dependent form of nephrotic syndrome at the end of the first manifestation. An
      additional blood volume will be sampled in patients and controls during a scheduled
      biological check-up for the initial disease. Genetics factors will be checked using a DNA
      chips devoted to the response to steroid therapy and viral genome of EBV, CMV, HHV7 will be
      searched for using PCR reaction in total blood DNA extract.
    

Intervention name(s): DNA chip dedicated to the pharmacogenetic of steroids
Intervention type(s): Genetic
Intervention description(s): direct DNA extraction from peripheral blood cells
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Any children below 16 years of age with a first manifestation of idiopathic nephrotic
        syndrome commencing or having commenced in the Paris area
      
Biospecimen description: 
      DNA Peripheral Blood Mononuclear Cells Plasma
    
Keywords: Proteinuria; idiopathic; nephrotic syndrome; herpesvirus; epidemiology; immune response; interferon; steroid dependency; nephrotic disease: Idiopathic nephrotic syndrome
Translation of the Sydney Swallow Questionnaire and Validation of the German Version
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      Translation of a validated questionnaire (SSQ) from english to german and validation of the
      german version. The SSQ consists of 17 well-structured questions for the assessment and
      quantification of patient reported difficulties in swallowing function. The tool is
      specifically designed to evaluate important aspects of swallowing function The questions
      cover the symptoms related to combinations of variables like the anatomic region, type of
      dysfunction, and the consistency of swallowed bolus.
    


Intervention name(s): Questionnaire
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from Dysphagia for at least half a year
      
Keywords: Dysphagia, Swallowing functions, Questionnaire in German
Evaluation of Fiit-ns® in Health-related Quality of Life Improvement in Overweight and Obese Subjects
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a 16-week supplementation with a
      polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL)
      of overweight and obese volunteers, as compared to placebo. Previous beneficial results from
      a pilot study showed that the supplementation may improve quality of life as well as body
      composition. Based on such results, this pivotal study is statistically powered to detect
      significant differences in HR-QOL assessed with the Short Form-36 Health survey (SF-36)
      between baseline (Week 1, W1) and end of the supplementation period (Week 16, W16).
    


Intervention name(s): Fiit-ns®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fiit-ns® is a blend of polyphenol-rich extracts from grapefruit, grape, green tea, guarana and black carrot. It also provides Vitamin B3. Daily dosage is 900 mg in two 450 mg-capsules for 16 weeks.; Placebo product is 100% maltodextrin. Daily dosage is 900 mg in two 450 mg-capsules of identical appearance than the supplement capsule for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
A Study of Baricitinib (LY3009104) in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to investigate the safety and tolerability of the study
      drug known as baricitinib in healthy Chinese participants. The study will measure how the
      body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not
      including screening. This study is for research purposes only, and is not intended to treat
      any medical condition.
    


Intervention name(s): Baricitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LY3009104
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and tolerability of levalbuterol HFA
      metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years
      of age with asthma
    

Detailed description: 
      A randomized, double-blind, active-controlled multicenter, two-way crossover study of HFA
      levalbuterol (with and without a spacer) in subjects 4-11 years of age with asthma. This
      study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by
      Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion
      Pharmaceuticals Inc.
    

Intervention name(s): Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI; Racemic Albuterol followed by levalbuterol HFA MDI
Intervention type(s): Drug; Drug
Intervention description(s): (a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses); (a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)
Other intervention name(s): Xopenex HFA MDI; albuterol HFA MDI; albuterol HFA MDI; Xopenex HFA MDI
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Levalbuterol; Racemic Albuterol
Safety and Efficacy of IBI306 in HeFH Patients
Condition: Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      IBI306 is a fully human monoclonal antibody that binds proprotein convertase
      substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density
      lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and
      low-density lipoprotein cholesterol (LDL-C) uptake. In the phase I study, IBI306 was shown to
      be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and
      lipoprotein (a) in healthy subjects. This study is a randomized, double-blind,
      placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy
      and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous
      familial hypercholesterolemia.
    

Detailed description: 
      The study plans to enroll 148 patients with heterozygous familial hypercholesterolemia.
      Subjects will maintain a low-fat diet and stable current lipid-lowering therapy for at least
      4 weeks and will be randomized into different dose groups at a 1:1 ratio, followed by a 2:1
      randomization double-blind treatment with subcutaneous IBI306 150 mg (n=49) or placebo (n=25)
      every two weeks; or subcutaneous injection of IBI306 450mg (n=49) or placebo (n=25) every
      four weeks. Treatment lasts for 12 weeks. After 12 weeks, each group enters a 12-week
      open-label treatment, in which IBI306 subjects continue to receive IBI306, and placebo
      subjects shift to receive IBI306. The primary endpoint is the percent change in LDL-C levels
      relative to baseline at 12 weeks. Secondary endpoints include changes in baseline lipid
      levels, drug safety, and immunogenicity at 12 weeks and 24 weeks. The exploratory endpoint is
      the population pharmacokinetic profile of IBI306 in Chinese subjects with heterozygous
      familial hypercholesterolemia. If necessary, the dose of IBI306 will be adjusted accordingly
      based on the results of the ongoing multi-dose escalation study. After the open period, the
      subjects will be given a safety visit for 8 weeks.
    

Intervention name(s): IBI306; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment