bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      BACKGROUND: Bathing in sweet or mineral water can induce significant physiological changes in
      several body systems including the endocrine system. To date, there have only been a small
      number of reports that balneology can reduce blood sugar Levels in patients with type 2
      diabetes mellitus (DM].

      OBJECTIVE: To compare the effects of a immersion in sweet or mineral water on blood glucose
      levels in patients with type 2 DM.

      METHODS: Forty patients with type 2 DM will immerse in either sweet or mineral water twice
      daily. In both cases the water will be warmed to a temperature of 35 degrees C and the bath
      continue for 20 minutes.
    


Intervention name(s): Dead Sea water; Pool water
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days; Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity Resp Insufficiency
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      The purpose for the investigators study is to investigate the severity and incidence of
      respiratory insufficiency using transcutaneous carbon dioxide (TcPCO2) monitoring as an
      adjunct to the current standard of care for early detection of inadequate ventilation in
      post-operative surgical in-patients undergoing cardiac surgery after discharge from intensive
      care unit (ICU) or post anesthesia recovery unit (PACU).
    

Detailed description: 
      This observational study is to determine the baseline carbon dioxide and severity of
      respiratory distress and acute respiratory failure (ARF)/respiratory arrest in the post
      cardiac surgery patients in the first 24 hours on a monitored telemetry floor.
    

Intervention name(s): TOSCA 500 monitor
Intervention type(s): Device
Intervention description(s): transcutaneous ear lobe probe that monitors pulse rate, oxygen saturation and carbon dioxide levels
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cardiovascular surgical patients at Baylor University Medical Center
      
Keywords: Post operative Respiratory insufficiency
Study of Chemoembolisation Using Irinotecan Bead Prior to Surgery in Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the
      neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of
      resectable liver metastases from colorectal cancer.
    

Detailed description: 
      The Primary Endpoint of this study is Tumour resectability at surgery. Secondary Endpoints:

        1. Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0)

        2. Tumour response assessed by imaging (RECIST and necrosis)

        3. Viable residual tumour assessed by pathological evaluation of resected liver tissue.

        4. Recurrence (time and site) following resection

        5. Correlation of tumour response by imaging and pathology
    

Intervention name(s): Irinotecan Bead
Intervention type(s): Device
Intervention description(s): Irinotecan eluting bead
Other intervention name(s): Irinotecan Bead, PARAGON Bead
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
Condition: Chronic Total Occlusion of Coronary Artery
Study type: Interventional

Summary: 
      This is a prospective, non-randomized, first-in-man investigational study, to assess the
      safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™
      micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO
      penetration rate.

      Each study subject/patient will have a total of one (1) procedure performed for this study.
    

Detailed description: 
      To be filled later
    

Intervention name(s): NovaCross, CTO
Intervention type(s): Device
Intervention description(s): evaluate the safety and performance of the NovaCross™ micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CABG Coronary artery bypass grafting; CTO Chronic Total Occlusion; PCI Percutaneous coronary intervention; MACE Major adverse cardiovascular event(s); MI Myocardial infarction
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Condition: Colorectal Neoplasms; Digestive System Diseases; Colonic Diseases; Colorectal Cancer
MeSH terms: Neoplasms; Colorectal Neoplasms; Adenomatous Polyps; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases
Study type: Observational

Summary: 
      The primary objective is to determine the sensitivity and specificity of the Exact Colorectal
      Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method.
      Lesions will be confirmed as malignant by histopathologic examination.

      The secondary objective is to compare the performance of the Exact CRC screening test to a
      commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions
      will be confirmed as malignant or precancerous by colonoscopy and histopathologic
      examination.
    

Detailed description: 
      Patients who are at average risk of developing colorectal cancer who are eligible for
      colorectal cancer screening will be asked to collect a single stool sample for the Exact CRC
      screening test and for the commercially available FIT assay. Subjects will undergo
      colonoscopy within 90 days of enrollment. Representative histopathology slides from tissue
      biopsied or excised during colonoscopy and representative histopathology slides resulting
      from subsequent definitive surgery may be retrieved in order to be evaluated by central
      pathology to confirm diagnosis and staging.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at average risk of developing colorectal cancer.
      
Biospecimen description: 
      Residual stool samples may be archived for further research. Clinical data and samples will
      be kept in a manner that preserves anonymity of the subjects, using the subject ID as the
      only tracking information. Specimens will be stored in a commercial biorepository contracted
      by Exact Sciences or at Exact Sciences and may be used for future research.
    
Keywords: Cancer; Colorectal Cancer; Neoplasm; Colorectal Neoplasm; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases
Rituximab for Obsessive-compulsive Disorder. (RITS-PO-2019)
Condition: Obsessive-Compulsive Disorder; Treatment Resistant Disorders
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the addition of rituximab to 12 patients diagnosed with treatment
      resistant obsessive-compulsive disorder in an open trial.
    

Detailed description: 
      Immunological factors may be determinants for some psychiatric disorders, thus
      immunomodulation may be helpful. Rituximab (antibodies against CD20, cluster of
      differentiation), a standard treatment for multiple sclerosis, is an anti-inflammatory drug,
      hitherto not tested for psychiatric disorders.

      The aim of this study is to investigate whether the psychiatric symptoms of
      treatment-resistant adult psychiatric patients, diagnosed with obsessive-compulsive disorder
      (OCD), are significantly improved after treatment with rituximab. The investigator's purpose
      is to implement recent insights from "Immunopsychiatry" to find efficacious, but still
      tolerable treatment for these patients.

      This is a single-site, 20-week, open pilot, add-on treatment as usual, trial, where the
      patients will be followed for 1 year.

      Rituximab will be administered with one single dose of 1000 mg. Investigators will analyse
      inflammatory and metabolic biomarkers in relation to the primary outcome, treatment response
      (defined as clinically relevant reduction in the validated measure Y-BOCS). Other outcomes
      are "much" or "very much improved" on Clinical Global Impression - Improvement scale (CGI-I)
      and change in Personal and Social Performance Scale measuring overall disability.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Infusion
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immunopsychiatry; pediatric acute-onset neuropsychiatric syndrome
The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of L-arabinose and D-xylose in a
      sugar-rich drink on intestinal sucrase activity in healthy volunteers by measuring
      postprandial blood glucose and insulin, and selected intestinal hormonal responses to
      increasing doses of L-arabinose and D-xylose.
    

Detailed description: 
      Based on previous scientific results we hypotesize, that pentoses decreases the demand for
      insulin in metabolizing a given dose of sucrose.
    

Intervention name(s): Placebo comparator: 0% pentose; Active comparator: 4% D-xylose; Active comparator: 8% D-xylose; Active comparator: 8% L-arabinose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 14 healthy subjects participated in a randomized double-blinded cross-over study based on four single tests. Sucrose containing drinks were supplemented with two different doses of D-xylose and in addition one dose of L-arabinose was included for comparison with earlier studies. Blood was collected fasting and for 3-h postprandially. Appetite sensations and energy intake were registered. Gastrointestinal symptoms were monitored for 24 hours
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: L-arabinose; D-xylose; sucrose; glucose; insulin; C-peptide; GLP-1
Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled
      trial to evaluate an active choice intervention with and without social comparison feedback
      to increase physician statin prescribing rates for eligible patients.
    

Detailed description: 
      Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United
      States. Strong evidence indicates that statin medications can reduce the risk of CVD and for
      those with CVD statins have been shown to reduce mortality. Despite this evidence, statins
      are under-prescribed. In this study, the investigators will test the effectiveness of nudges
      targeted to physicians using active choice and social comparisons feedback to increasing the
      rate at which statin medications are prescribed to patients eligible based on national
      practice guidelines.
    

Intervention name(s): Active choice; Social comparison feedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin; Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Montreal Heart Attack Readjustment Trial (M-HART)
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine the impact of a monitoring and social support intervention upon survival of
      myocardial infarction patients.
    

Detailed description: 
      BACKGROUND:

      Despite evidence that social support and various aspects of negative affect may influence
      prognosis after a myocardial infarction, the impact of psychosocial supportive interventions
      had not been demonstrated. Further, little was known about the impact of psychosocial and/or
      interventions among women patients. Previous work by Nancy Frasure-Smith and colleagues
      suggested that a one-year post-myocardial infarction program of monthly telephone monitoring
      of psychological stress symptoms, coupled with home nursing visits for patients reporting
      high stress levels, had an impact on one-year cardiac mortality and long-term myocardial
      infarction recurrences among men. However, methodological difficulties prevented drawing firm
      conclusions. A trial which corrected for these difficulties was conducted involving 948
      post-myocardial infarction patients. However, the project was too small to study enough
      patients to assess program impact separately for men and women. The trial was supported by
      Canadian sources. The NHLBI supplemented the study in order to expand the sample size from
      948 patients to 1,376 patients to allow gender analysis.

      DESIGN NARRATIVE:

      Randomized, with a multi-hospital design. At the time of discharge from the hospital
      following a documented myocardial infarction, patients were randomized to treatment and
      control groups. The control group received usual care from their physicians. In addition to
      usual care, treatment patients were phoned monthly and responded to a standardized index of
      psychological symptoms of stress. Those with high stress levels received home nursing visits
      to reduce their stress. Patients in both groups took part in three interviews: in the
      hospital, at three months, and at one year post-discharge. Interviews assessed depression,
      anxiety, anger, self-perceived stress, social support, medication compliance, and cardiac
      risk factors. Salivary cortisol, a physiological indicator of stress, was assessed on the
      evening following each interview. Indicators of residual myocardial infarction, ischemia, and
      arrhythmias were obtained from hospital charts. Outcome data were obtained from hospital
      charts, death certificates, and Quebec Medicare data and were blindly classified by study
      cardiologists.
    

Intervention name(s): social support
Intervention type(s): Behavioral
Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500
Condition: HIV-infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500
      given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel
      design is used due to the long half life for VM-1500.
    

Detailed description: 
      This drug-drug interaction study will not be done as a cross-over study due to the extreme
      long half life of the drug. The 24 healthy subjects participating will be randomized to
      VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir in parallel arms.

      For the cohort taking VM-1500 40 mg only just 4 subject will be enrolled as 6 subjects have
      been already on the same regimen in the trial before. Based on the parallel design it seems
      appropriate not to expose more healthy subjects than necessary. This means the available data
      of 6 subjects dosed with 40 mg VM-1500 alone will be matched.

      Three groups of healthy subjects will be randomized to VM-1500 alone or VM-1500 in
      combination with Raltegravir or Darunavir (4:10:10). The healthy subjects will stay at the
      unit and receive 40 mg VM-1500 alone or VM1500 in combination with Raltegravir or Darunavir
      one time and PK blood samples at several time points will be collected. PK (trough level)
      blood samples will also be collected at visits on Days 2, 4,7, 14, 21, and on Day 36.
    

Intervention name(s): VM-1500; Darunavir; Ritonavir; Raltegravir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): VM-1500 40 mg; Darunavir 600 mg; Ritonavir 100 mg; 400 mg Raltegravir
Intervention MeSH terms: Ritonavir; Darunavir; Raltegravir Potassium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sub-clinical Inflammation and Iron Supplementation
Condition: Anemia
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also in
      Myanmar. Both nutrient deficiencies result from interaction of several causal factors, and a
      better understanding of the etiology to interpret the prevalence and to formulate appropriate
      measures to reduce these deficiencies is necessary. There is a growing concern on the role of
      sub-clinical inflammation on the nutritional status indicators during the nutritional status
      assessment. However, there is lack of information on the role of inflammation on the iron
      supplementation. The adolescent period is a window of opportunity to improve the
      preconceptional iron status of the girls and recently gained much attention. The purpose of
      the study is to understand the role of inflammation on iron and vitamin A status during iron
      and vitamin A supplementation. The findings will show the extent to which iron
      supplementation has been hampered by inflammation and to formulate the necessary measures to
      overcome the interference.
    


Intervention name(s): Iron group; Vitamin A group; Iron and vitamin A group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Ferrous fumarate, 60 mg, weekly dose; Retinol, weekly dose, 15,000 IU; Ferrous fumarate, Retinol combination group, weekly dose; folic acid only as placebo group
Other intervention name(s): Iron supplement; Vitamin A supplement; Iron and Vitamin A supplement; Placebo group, folic acid only
Intervention MeSH terms: Vitamins; Folic Acid; Vitamin A; Iron; Retinol palmitate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: anemia; iron supplementation; sub-clinical inflammation; adolescents
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
Condition: Diabetes Mellitus, Type 1; Type 1 Diabetes; Type 1 Diabetes Mellitus; Diabetes Mellitus, Insulin-Dependent, 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using
      continuous subcutaneous insulin infusion with an infusion set that needs to be changed every
      3 days. This study will assess the feasibility and device performance of the study device,
      the Achilles infusion set over three periods during routine insulin infusion.

      This study will include 20 participants and has 3 periods:

      Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7
      days): participants will manage their blood glucose solely with their insulin pump and the
      Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose
      monitoring (CGM) device.

      Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles
      infusion set and continue blood glucose management at home until infusion set failure or 7
      days.
    

Detailed description: 
      This is a prospective, non-randomized, home-use feasibility study of device performance,
      usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles
      infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in
      up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).

      The CapBio Achilles infusion set is a sterile single use device designed to be used with
      commercially available infusion pumps (e.g., Medtronic MiniMed). The investigational Achilles
      infusion set contains a coil reinforced soft polymer indwelling cannula with one distal and
      three proximal holes.

      The primary objective of this study is to determine feasibility and device performance of the
      CapBio Achilles infusion set over 2 extended home use wear periods of up to 7 days each
      during routine therapeutic insulin infusion. Feasibility is evidenced by the absence of
      uncontrolled hyperglycemia and/or suspected infusion set cannula occlusion.
    

Intervention name(s): coil-reinforced soft polymer indwelling cannula
Intervention type(s): Device
Intervention description(s): This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).
Intervention model: Single Group Assignment
Intervention model description: This study is designed as a single arm device feasibility evaluation
Masking: None (Open Label)
Primary purpose: Device Feasibility