bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Severe Hypoglycemia in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Severe hypoglycaemia leading to collapse without warning is one of the most-feared
      complications for those with Type 1 diabetes. The aim of this study is to determine whether
      detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous
      insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1
      diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants
      will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current
      insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia;
      or continuous subcutaneous insulin infusion. Symptomatic experience and severity of
      hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals,
      response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It
      is envisaged that successful prevention of hypoglycaemia by one or more interventions may
      reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.
    

Detailed description: 
      The unifying objective of the proposed unblinded randomized prospective study is to determine
      whether hypoglycaemia awareness in Type 1 diabetes can be restored by rigorous avoidance of
      hypoglycaemia addressed by one of the following interventions:

        1. A non-targeted approach whereby pre-prandial glycaemic targets are raised from
           4.5-7mmol/L to 7.2-8.3mmol/L and hypoglycaemia is rigorously avoided without specific
           alterations in subcutaneous insulin regime5

        2. Optimisation of subcutaneous insulin regime employing pre-prandial short-acting insulin
           analogue in combination with once daily insulin Glargine targeted to prevent periods of
           hypoglycaemia identified by 24 hour glucose profiles

        3. Insulin delivery by external pump (continuous subcutaneous insulin infusion) targeted to
           prevent periods of hypoglycaemia identified by 24 hour glucose profiles
    

Intervention name(s): insulin glargine; continuous subcutaneous insulin infusion
Intervention type(s): Drug; Device
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CSII; insulin analog; severe hypoglycaemia; altered hypoglycaemia awareness; diabetes quality of life; CGMS
Endocrine and Nutritional Assessment in B Thalassemia Major
Condition: Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional

Summary: 
      B Thalassemia patients developed short stature and low weight in spite no evident endocrine
      abnormalities. One hypothesis is that they developed some degree of malnutrition,then the
      purpose of this study is to assess the nutritional status before nutritional intervention and
      after one year. Siblings of the patients will serve as a control group.

      BMI, lipid and endocrine profile and leptin levels will be analysed in the study group only.
    

Detailed description: 
      The nutritionist will advice the patients about calories requirement and intake, balance diet
      and follow up the patients during the study period of one year. No special medicaments or
      drug therapy will be provided as part of the study protocol
    

Intervention name(s): Nutritional recommendations
Intervention type(s): Other
Intervention description(s): Nutritional status assessment including complete endocrine and lipid laboratory profile and after one year of nutritional follow up a secondary assessment will be done
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Thalassemia; Nutrition; Endocrine; BMI
Stretching and Pain Sensitivity
Condition: Stretching
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and
      to prevent sports injuries. It is not known if stretching affects pain sensitivity. The
      purpose of this study is to investigate if a 4 week daily stretching protocol alters pain
      sensitivity.

      The investigators hypothesize that stretching reduces pain sensitivity.
    


Intervention name(s): Calf muscle stretching
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in
      comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether
      KamRAB interferes with the development of self active antibodies when given simultaneously
      with active rabies vaccine, as compared to the HRIG comparator product, also given in
      conjunction with the active rabies vaccine.
    

Detailed description: 
      This is a prospective, randomized, double-blind, and single period non-inferiority and safety
      study conducted at a single study site. Subjects were randomized into the following two
      groups:

      Group A: KamRAB (20 IU/kg by weight [bw]) intramuscular (IM), rabies vaccine (1.0 mL; ≥2.5
      IU/mL) IM Group B: Human rabies immune globulin (HRIG) Comparator product (20 IU/kg bw) IM,
      rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM The primary endpoint was a dichotomous (0-1) variable,
      defined by reaching an anti-rabies immunoglobulin G (IgG) concentration ≥0.5 IU/mL on Day 14.
      The primary hypothesis was that the proportion of KamRAB + vaccine recipients with
      anti-rabies concentration ≥0.5 IU/mL on Day 14 would not be less than the corresponding
      proportion of HRIG Comparator subjects by as much as 0.1.

      The safety and tolerability of the study treatments was assessed based on: vital signs and
      physical examination findings, electrocardiogram (ECG), laboratory findings (hematology,
      clinical chemistry, and urinalysis) and the occurrence of adverse events (AEs) after drug
      administration
    

Intervention name(s): Active rabies vaccine (US-FDA approved)
Intervention type(s): Drug
Intervention description(s): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG.
Other intervention name(s): RabAvert®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Pii Ngima: Consequences of Water Insecurity for Maternal and Child Health
Condition: Maternal and Child Health; HIV
Study type: Observational

Summary: 
      This study will implement the validated household-level water insecurity scale developed by
      study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a
      range of outcomes linked to water insecurity, such as viral load, hydration status, maternal
      depression, stress, food insecurity, and cognitive development.
    

Detailed description: 
      This study will develop the first well-known household water insecurity scale. Currently,
      water insecurity cannot be measured at the level of the household or individual, i.e. at the
      endpoint of water use. Although there are myriad national, regional, community, and
      hydrological indexes of water availability, to the investigators' knowledge, there is no way
      of measuring water access at the household or individual levels. Without a comprehensive,
      validated scale to measure household water insecurity, the scientific, programmatic, and
      public health communities cannot empirically test the prevalence of household water
      insecurity access and its potential impacts on economic, nutrition, disease, and psychosocial
      health pathways and outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort of postpartum HIV-infected and -uninfected women (ratio 1:1) who were previously
        enrolled into the Pith Moromo (clinical trials ID: NCT02974972) research study in Nyanza,
        Kenya.
      
Keywords: Water insecurity
Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule
Condition: Proof of Concept; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Prospective, open label trial to establish the ability of the SIMBA Capsule to accurately
      obtain a sample from the small bowel of participants with IBS (10 constipation-predominant
      (IBS-C) and 10 diarrhea-predominant (IBS-D)) and healthy participants (n=10). The accuracy of
      targeting the small bowel will be established by visual confirmation via X-ray. The clinical
      utility of the collected sample will be evaluated by analysis with samples obtained by the
      current gold standard (duodenal aspirate), as well as stool analysis and LBT.
    


Intervention name(s): Ingestible capsule; Sedated EGD; Lactulose Breath Test
Intervention type(s): Device; Procedure; Diagnostic Test
Intervention description(s): Participants will swallow capsules and collect in stool concurrent with stool samples; Participants will undergo sedated esophagogastroduodenoscopy (EGD) for collection of small intestine aspirate and simultaneous saliva sample.; Hydrogen and methane breath test with lactulose substrate
Intervention MeSH terms: Lactulose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and
      oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or
      die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy as first-line
      therapy in treating patients who have metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the tumor response rate in patients with metastatic colorectal cancer treated
           with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line
           treatment.

      Secondary

        -  Determine the time to tumor progression, time to treatment failure, and overall survival
           of patients treated with this regimen.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the quality of life of patients treated with this regimen.

        -  Determine whether UGT1A1 polymorphism is related to toxicity (especially leukopenia,
           diarrhea, or neutropenia) or response in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and
      leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3
      weeks in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline, before each chemotherapy course, and at the end of
      treatment.

      Patients are followed every 3 months until 5 years after registration.
    

Intervention name(s): fluorouracil; irinotecan hydrochloride; leucovorin calcium; oxaliplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum
A Study With an Open-Label Active Control to Evaluate the Potential of Nestorone® to Delay Cardiac Repolarization in Healthy Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an
      bolus injection on the corrected QT interval using Fridericia's formula (QTcF).
    


Intervention name(s): Supratherapuetic dose of Nestorone; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; ST 1435
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nestorone use as an IV solution on heart rate;; Abnormality in Heart Rate or Rhythm, Unspecified as to Time of Onset
Wiser Choices in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Patients who are hospitalized because of a heart attack are prescribed a number of medicines
      to help the heart heal. The investigators will examine different ways in which clinicians
      share information about those treatment options with patients and the impact that this can
      have on patients' choices and health.
    


Intervention name(s): AMI Choice Decision Aid; Usual Care
Intervention type(s): Other; Other
Intervention description(s): The decision aid describes the risk of dying in the first six months following a heart attack without and with taking a bundle of medications to help the heart heal.; Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Decision aid; Heart attack; myocardial infarction
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy
Condition: Partial Epilepsy; Surgery
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the study is twofold:

        1. Assess the clinical efficacy of DBS on epilepsy according to their number and severity
           at 1 year follow up.

        2. Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.

      The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the
      thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe
      crises) of the most severe seizures, in at least 50% of patients who have drug-resistant
      partial epilepsy; and should also improve significantly the quality of life through a gain of
      independence in activities of daily life, the possible recovery of functional abilities,
      recovery of social or professional activities.
    


Intervention name(s): AN-DBS; Usual treatment
Intervention type(s): Procedure; Drug
Intervention description(s): Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment; usual treatment of epilepsy Vagus nerve stimulation: maintained
Other intervention name(s): Deep Brain Stimulation; Treatment of epilepsy including vagus nerve stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep Brain Stimulation; Anterior Nucleus of thalamus; Treatment refractory; Pharmacoresistant partial epilepsy; vagus nerve stimulation therapy
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is not being conducted in the United States. Many people with type 2 diabetes
      cannot maintain target blood glucose levels when taking a single oral drug. The purpose of
      this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug,
      compared to that of gliclazide in lowering overall blood glucose levels when added to
      metformin in people with type 2 diabetes not at target blood glucose levels on metformin
      alone.
    


Intervention name(s): vildagliptin; Gliclazide; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Vildagliptin; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial; Pilot Study)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      "Translation" of the current "basic science" information related to physical activity into
      patient intervention programs is needed. This translation is critical to providing benefit to
      the maximum number of patients. Little is known about the determinants of physical activity
      among breast cancer patients undergoing hormonal therapy and few studies have attempted to
      evaluate an exercise behavior change program aimed to improve exercise adherence among such
      patients. The proposed project will evaluate use of an innovative behavioral and psychosocial
      intervention to increase physical activity among breast cancer patients.
    


Intervention name(s): Exercise Behavior Change
Intervention type(s): Behavioral
Intervention description(s): attend 12 supervised exercise sessions, attend 6 group sessions with psychologist, attend 3 counseling sessions with exercise specialist
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Exercise; Social Cognitive Theory; Adherence; Symptoms; Body Composition
A Study of LY3526318 in Healthy Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about how LY3526318 affects blood flow to the
      skin in healthy women. For each participant, the study will last up to 28 days and Part B
      will last up to 78 days, including screening and follow-up.
    


Intervention name(s): LY3526318; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to develop, evaluate, and optimize "MigraineManager", the first
      web-based comprehensive self-management tool for adolescents with migraine, their parents,
      and clinicians.
    


Intervention name(s): MigraineManager: Individualized Self-Management Tool
Intervention type(s): Behavioral
Intervention description(s): Answers provided during the online assessment will result in certain intervention recommendations. Once assessments are completed, a treatment plan will be automatically generated for patient and parent guidance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine
Dexamethasone for Pain After Shoulder Surgery
Condition: Shoulder Impingement Syndrome; Arthritis
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective
      as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.
    


Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): Singe dose preoperatively in 100 ml saline intravenously
Other intervention name(s): Fortecortin
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fully Disposable Patient-Specific Instrumentation
Condition: Osteoarthritis,Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with
      fully disposable patient-specific instrumentation versus conventional, versus patient
      specific instrumentation.
    

Detailed description: 
      The investigators performed a controlled multicenter trial comparing the clinical and
      radiologic results and resources consumption of primary TKA using patient-specific cutting
      guides (PSCG) versus conventional instrumentation (CI), and compared the results to those
      obtained with a fully disposable patient-specific instrumentation (PSCG-D).
    

Intervention name(s): GMK Medacta Total Knee arthroplasty
Intervention type(s): Device
Intervention description(s): Total Knee arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Current Scope of Practice of Today's Hepatopancreatobiliary Surgeons: A Survey of AHPBA Members
Condition: Scope of Practice of Today's Hepatopancreatobiliary Surgeons
Study type: Observational

Summary: 
      The development of multiple training pathways to foster competent hepatopancreatobiliary
      (HPB) surgeons has led to a diverse group of surgical subspecialists. The objective of our
      study was to determine the current scope of practice of today's HPB surgeons. An online
      survey was sent to all the Americas Hepato-Pancreato-Biliary Association's members to assess
      the current scope of practice of today's HPB surgeons. We found very few surgeons run a solo
      HPB practice, so changes may be needed in HPB training to provide uniformity and enhance the
      scope of practice for future HPB surgeons.
    


Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Survey was sent to all the Americas Hepato-Pancreato-Biliary Association's members
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Member of Americas Hepato-Pancreato-Biliary Association
      
Keywords: survey; AHPBA