bioihbjkbjnl/mcl2 huggingface dataset:
Study to Determine the Effectiveness of the Probiotic E. Coli Strain M17 in Treating Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the tolerance and efficacy of the probiotic E. Coli
      Strain M17 on symptoms and Quality of Life in Individuals with Irritable Bowel Syndrome
      (IBS).
    

Detailed description: 
      IBS is characterized by abdominal discomfort and altered bowel function, without identifiable
      structural or biochemical abnormalities. Current management approaches are not satisfactory
      for many individuals, who continue to have intermittent constipation or diarrhea, associated
      with abdominal discomfort.

      Probiotics, or "friendly bacteria", is the name given to a new category of products that show
      promise for managing the symptoms of IBS. In the intestine they are believed to compete with
      other bacteria, to product substances that interfere with other bacteria, and to improve the
      function of the mucous lining and immune function of the gastrointestinal tract. A common
      source of probiotics is in cultured dairy products,m such as yogurt or cheese. E. coli Strain
      M17 is not regulated vy the Food and Drug Administration. It is considered to be a health
      food supplement.

      E. coli strain M17 was identified in Russia more than 70 years ago. It became widely used in
      countries of the former Soviet Union for a variety of gastrointestinal problems, including
      IBS, inflammatory bowel disease (ulcerative colitis or Crohn's disease), and diarrhea,
      including infants and children. It continues to be produced and marketed under government
      control in the Russian Federation. E. coli strain M17 was brought to Israel in the early
      1990's by two Russian scientists. It was developed for human use and animal feed and approved
      for use by the Israeli health authorities. A special liquid formulation was developed and
      sold as a nutritional supplement in pharmacies in Israel until 2002 when the product was
      acquired by a U.S. company, the BioBalance Corporation, for the purpose of introducing it
      outside Israel as a medical food and nutritional supplement in the U.S. and other countries.

      The purpose of this research study is to compare the tolerability and effectiveness of E.
      coli strain M17 to placebo in the treatment of Irritable Bowel Syndrome (IBS).
    

Intervention name(s): E. Coli Strain M17 Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): 30 ml PO BID for 12 weeks
Other intervention name(s): ProBactrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Functional Capacity and Quality of Life Following Septal Myectomy in Patients With HCM
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Observational

Summary: 
      Investigators aim to assess changes in exercise capacity and quality of life after septal
      myectomy in patient with hypertrophic cardiomyopathy.
    

Detailed description: 
      The objective of this study is to examine change in quality of life and functional capacity
      as respectively measured by, Quality of Life Questionnaires and six-minute walk test
      distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy,
      as compared to prior to surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18-65 with an established diagnosis of obstructive hypertrophic
        cardiomyopathy and scheduled for septal Myectomy surgery
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops
Condition: Corneal Epithelium Defect
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A
      total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye
      drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects
      in each group.
    

Detailed description: 
      Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end
      of the study on D7.

      Statistical analysis was performed using SAS9.4 or above software. All statistical tests were
      two-sided, and P less than or equal to 0.05 was considered statistically significant for the
      difference being tested unless specified.
    

Intervention name(s): lowe-dose ZKY001 eye drops; Medium-dose ZKY001 eye drops; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): eye drops; eye drops; eye drops
Other intervention name(s): ZKY001; ZKY001; Simulated eye drops
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vilazodone for Corticosteroid-Induced Memory Impairment
Condition: Memory Impairment
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine whether vilazodone attenuates the memory and mood
      effects of corticosteroids on the human hippocampus in 24 healthy controls.
    

Detailed description: 
      In animals and humans, stress and corticosteroid excess are associated with changes in
      hippocampal structure and functioning. These findings have important implications to the
      millions of patients taking prescription corticosteroids and to patients with major
      depressive disorder or bipolar disorder who have elevated cortisol levels and memory
      impairment. The investigators believe that vilazodone may be a medication that can block the
      effects of hydrocortisone on the human hippocampus. The investigators propose to examine
      whether vilazodone attenuates the effects of corticosteroids in a randomized, double-blind,
      placebo-controlled pilot study using a within-subject crossover design.
    

Intervention name(s): Vilazodone; Placebo; Hydrocortisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be randomized to either vilazodone or placebo titrated as follows: 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days.; Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment
Other intervention name(s): Viibryd
Intervention MeSH terms: Hydrocortisone; Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Distal Renal Denervation to Prevent Renal Function Decline in Patients With T2DM and Hypertension
Condition: Type 2 Diabetes Mellitus; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to test the hypothesis that distal renal denervation (RDN) may delay
      or prevent the progressive decline of renal function in patients with type 2 diabetes
      mellitus and hypertension
    

Detailed description: 
      Detailed Description: Diabetes mellitus and hypertension are two major causes of chronic
      kidney disease (CKD) that starts as subclinical decline in renal function that silently
      progresses to symptomatic advanced stages associated with irreversible significant damage of
      the kidney structure. Recent major improvements in pharmacotherapy of hypertension and
      diabetes have substantially reduced the prevalence of cardiovascular complications, yet, the
      frequency of CKD remains largely unchanged. Renal denervation is a new minimally invasive
      method to create regional blockade of the renal sympathetic nerves that is currently used as
      non-pharmacological therapy of hypertension. The CKD is likewise mediated by overactivity of
      renal sympathetic system so that RDN has strong potential to prevent development or
      progression of CKD. The new anatomically optimized distal RDN may have additional benefit in
      this regard. Denervation of the distal vessels involved in tonic regulation of renal blood
      should cause a significant drop in renal vascular resistance and proportional increase in
      blood and oxygen supply to the kidney preventing/reducing chronic hypoxia of renal tissue
      that is major mechanism of CKD. The aim of this study is to prove the aforementioned concept.
      For this purpose the eligible patients with type 2 diabetes mellitus and hypertension will
      undergo distal renal denervation performed using dedicated radiofrequency catheter Symplicity
      Spyral. The changes in the kidney function and structure as well as BPs (office and
      ambulatory) will be assessed at baseline, 6 and 12 months post-procedure
    

Intervention name(s): Anatomically optimized distal renal denervation
Intervention type(s): Procedure
Intervention description(s): Bilateral radiofrequency renal denervation will be performed using Symplicity Spyral renal denervation system. Generally, at least two separate applications of radiofrequency energy will be performed in each segmental branch of renal artery. Each application will be done through 4 electrodes deployed in helical manner according to the design of the catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; diabetes mellitus; kidney; renal function; denervation; blood pressure
Gastric Assessment Ambulatory Surgery
Condition: Full Stomach
Study type: Observational

Summary: 
      The surgical procedures in outpatient surgery are in perpetual increase. However, the peri
      operative stress can reduce the gastric emptying. A patient's compliance for following the
      fasting rules cannot be controlled at home. Ambulatory surgery is currently proposed to
      fragile patients with many comorbidities known to slow gastric emptying. In day case surgery
      the airway management are often managed with supraglottic device ( laryngeal mask). This
      device does not protect the respiratory tract and may expose the patient to a risk of
      inhalation of gastric content (if not empty).

      This study aim to mesure the prevalence of full stomachs in outpatient surgery and to observe
      any changes in anesthetic management secondary to the ultrasound assessment of gastric
      content. It will confront theoretical full stomach risk factors with ultrasound findings. The
      practical and clinical relevance of such a technique in the context of outpatient surgery
      will be assessed in this study. The ultimate goal is to improve the safety of the patient's
      anesthetic management by controlling the risk of pulmonary aspiration.
    

Detailed description: 
      Patients will be included during the pre-anesthetic evaluation. The theoretical full stomach
      risk factors and the anesthetic management will be recorded in the computerized
      pre-anesthetic evaluation.

      A qualitative and quantitative ultrasound evaluation will be performed when the patient
      arrives in the pre-anesthesia room. The examination will be performed in the right lateral
      decubitus with a low frequency convex ultrasound probe.

      The main objective is to measure the prevalence of patients with a "full stomach" based on
      ultrasound criteria.

      The primary endpoint is the presence of solid or fluid greater than 1.5 ml / kg of the
      predicted ideal body weight during ultrasonographic evaluation of gastric contents. In this
      situation, the patient will be considered at high risk of inhalation (considered full
      stomach).

      This study will observe and record any anesthetic changes (ie : airway management) secondary
      to this ultrasouund assessment of gastric contents.
    

Intervention name(s): Ultrasouund assessment of gastric contents
Intervention type(s): Other
Intervention description(s): A qualitative and quantitative ultrasound evaluationof the stomach will be performed when the patient arrives in the pre-anesthesia room. The examination will be held in the right lateral decubitus with a low frequency convex ultrasound probe.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ultrasouund assessment of gastric contents : prevalence of patients with a "full stomach"
        based on ultrasound criteria.
      
Keywords: Pulmonary aspiration, full stomach, gastric content inhalation, Mendelson syndrom
Health Mobile Cognitive Stimulation in Alcohol Use Disorder
Condition: Alcohol-Induced Disorders, Nervous System; Alcohol Dependence
MeSH terms: Nervous System Diseases; Alcohol-Induced Disorders, Nervous System; Alcoholism; Alcohol-Induced Disorders
Study type: Interventional

Summary: 
      The consequences of alcohol dependence are severe and may range from physical diseases to
      neuropsychological deficits in several cognitive domains. Alcohol abuse has also been related
      to brain dysfunction specifically in the prefrontal cortex. To assess these deficits and the
      application of a novel approach of cognitive stimulation to alcoholics, we have carried out a
      neuropsychological intervention program with mobile health technology. Patients diagnosed
      with alcohol dependence syndrome were submitted to cognitive stimulation during four weeks in
      a three-day/week basis.
    


Intervention name(s): Mobile health cognitive stimulation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Cognitive Therapy; Executive Function; Mobile Health; Recovery of Function; Rehabilitation
A Novel Clinically Usable Point Score To Prejudge The Complexity Of Colonoscopy
Condition: Insertion Time
Study type: Observational [Patient Registry]

Summary: 
      Colonoscopy is the current common method for management of colorectal diseases, and
      effectiveness of colonoscopy associate with complication rate. A lot of patients were failed
      because of technical difficulty, those required more than 10 min to intubate the cecum are
      consider as difficult colonoscopy, in such condition, specialized equipment or maneuvers may
      be required for a successful colonoscopy. Thus, it is important to set up a clinical model to
      predict the technical difficulty of the examination in preoperational stage.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective study involving only one tertiary center in China. The patients were
        enrolled from the Endoscopy Center of Xi jing Hospital of Digestive Diseases in China.
      
Keywords: insertion time
Assessing a Length Artificial Intelligence Algorithm to Estimate Length of Children
Condition: Growth; Stunting, Nutritional
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      An exploratory study to explore the possibility of using computer vision algorithms to
      estimate a child's length using images taken by a healthcare professional or parents.
    

Detailed description: 
      This is an exploratory, observational, pilot study that aims to evaluate the performance of a
      Length Artificial Intelligence (LAI) algorithm in a real world setting. Images will be
      collected by parents or healthcare professionals, together with physical length measurements.
      This data will be used to evaluate the accuracy of the algorithm and to explore potential
      improvements. Data on the acceptance and experience of the using the algorithm will be
      collected for improvements.
    

Intervention name(s): Physical length measurement
Intervention type(s): Other
Intervention description(s): Physical length will be measured and images will be collected for AI to estimate the length
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between 0-18 months of age with no physical deformities.
      
Keywords: growth; length; artificial intelligence; algorithm
Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if administration of RM-131 is effective in
      improving appetite and gastrointestinal symptoms leading to the recovery of patients with
      anorexia nervosa in the outpatient setting.
    


Intervention name(s): RM-131; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anorexia nervosa; Anorexia; Eating disorders
Efficacy and Safety of Ingavirin®, 90 mg Capsules in Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to investigate the efficacy of Ingavirin®, 90 mg
      capsules in achieving clinical improvement of novel coronavirus disease (COVID-19) symptoms.
      A secondary goal of this study is to evaluate the safety of Ingavirin®, 90 mg capsules in
      patients with COVID-19 infection.
    


Intervention name(s): Ingavirin®, 90 mg capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 90-180 mg/day for 7 days on top of standard therapy; 1-2 capsules for 7 days on top of standard therapy
Intervention MeSH terms: Pentanedioic acid imidazolyl ethanamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oncological and Functional Outcomes in Lower Limb Osteosarcoma Pediatric Patient
Condition: Osteosarcoma; Pediatric; Lower Limb Injury; Outcome
MeSH terms: Osteosarcoma; Leg Injuries
Study type: Observational

Summary: 
      Retrospective analysis of specific characteristics of complications and long-term oncological
      and function outcomes in lower-limb osteosarcoma pediatric patients.
    

Detailed description: 
      Clinical and functional outcomes were compared based on age groups, surgical methods, type of
      prosthesis, and primary tumor location. Patients were divided into the Low-age group (≤10
      years old) and the High-age group (>10 years old). Overall Survival rate (OS),
      Progression-Free Survival rate (PFS), and prosthesis survival rate were assessed using
      Kaplan-Meier curves, and non-parametric survival analysis (log-rank test) was used for
      comparison. The incidence of complications, local relapse rate (LRR), metastasis rate, final
      limb-salvage and amputation rate, and Musculoskeletal Tumor Society (MSTS) score of different
      independent groups were further evaluated using χ2 test or Fisher's exact test, and t-test
      was employed to evaluate the measurement data.
    

Intervention name(s): Retrospective analysis
Intervention type(s): Other
Intervention description(s): Retrospective analysis
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A retrospective analysis of 345 pediatric patients with lower-limb osteosarcoma admitted to
        our department between 2000 and 2019 was conducted.
Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the extent of effect of gemfibrozil on
      the pharmacokinetics and pharmacodynamics of mitiglinide.
    


Intervention name(s): placebo for gemfibrozil; gemfibrozil
Intervention type(s): Drug; Drug
Intervention description(s): mitiglinide + placebo for gemfibrozil 600 mg bid; Mitiglinide + 600 mg gemfibrozil bid
Intervention MeSH terms: Gemfibrozil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Participants With Mild or Moderate Hepatic Impairment Compared With Participants With Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in
      participants with mild and moderate hepatic impairment.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-dose,
      single-center, non-randomized study of JNJ-56021927 in participants who either have hepatic
      impairment or qualify for the control group. The study consists of 3 Phases: Screening Phase
      (21 Days), open-label treatment Phase (8 Days) and follow up Phase (49 Days). The duration of
      participation in the study for each participant is approximately 78 Days. Primarily the
      pharmacokinetics of JNJ-56021927 will be measured. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): JNJ-56021927
Intervention type(s): Drug
Intervention description(s): Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; JNJ-56021927
The Effect of Various External Pressure on Blood
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid
      infusion, external pressure can be used. The investigators will study correlation between
      external pressure and hemolysis and deformability of red blood cell.
    

Detailed description: 
      Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid
      infusion, external pressure can be used which cause hemolysis and alteration of red blood
      cell. The investigators will study correlation between variable external pressure and
      hemolysis and deformability of red blood cell. Differ from previous study, the investigator
      will use scanning electron microscope for observation red blood cell.
    

Intervention name(s): Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control); Auto PC(Acemedical, Goyang-si, Korea) - 150mmHg; Auto PC(Acemedical, Goyang-si, Korea) - 200mmHg; Auto PC(Acemedical, Goyang-si, Korea) - 250mmHg; Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Blood pass through infusion set without external pressure.; Blood pass through infusion set under external pressure (150mmHg); Blood pass through infusion set under external pressure (200mmHg); Blood pass through infusion set under external pressure (250mmHg); Blood pass through infusion set under external pressure (300mmHg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care