bioihbjkbjnl/mcl2 huggingface dataset:
Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This study is designed to test a standard mailed intervention (SI) versus a novel decision
      support and navigation intervention (DSNI). Working with patients and stakeholders, this
      randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age,
      patients in community based primary care practices, and are eligible for CRC screening. We
      will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI
      Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on
      overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC
      screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific
      CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and
      knowledge and perceptions.
    


Intervention name(s): Decision Support & Navigation; Standard
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Colorectal Cancer; Cancer Screening; Decision Support; Navigation
Estimating EC95 of Remifentanil for Cough Prevention During Emergence From Total Intravenous Anesthesia With Propofol and Remifentanil in Patients Undergoing Transsphenoidal Hypophysectomy
Condition: Hypophysectomy
Study type: Interventional

Summary: 
      In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough
      during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage.
      Previous reports demonstrated that administration of remifentanil during anesthetic emergence
      could reduce the incidence and severity of cough during anesthetic emergence. Therefore, the
      objective of this study is to determine EC95 of remifentanil for preventing cough during
      anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.
    


Intervention name(s): Administration of remifentanil with TCI system
Intervention type(s): Drug
Intervention description(s): A given effect site concentration of remifentanil would be administered to subjects using TCI system. According to biased coin design, the given concentration of remifentanil is determined according to success or failure of just previously enrolled patient. If the former patient did not cough during anesthetic emergence at a given concentration (success), the next patient will be randomly allocated into the same concentration of remifentanil with 18/19 of probability or the lower concentration of remifentanil by 0.4 ng/ml with 1/19 of probability. If the former patient coughed during anesthetic emergence (failure), the next will be automatically allocated into the higher concentration of remifentanil by 0.4 ng/ml.
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: EC95, effective concentration in 95% of subjects
Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome
Condition: Weight Loss; Insulin Resistance; Adipokines
MeSH terms: Metabolic Syndrome; Insulin Resistance; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers
      associated with insulin resistance, metabolic profile and body composition in women with
      Metabolic Syndrome.
    


Intervention name(s): Low-calorie diet
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement
Condition: Acne Scars - Mixed Atrophic and Hypertrophic
MeSH terms: Acne Vulgaris; Hypertrophy
Study type: Interventional

Summary: 
      Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with
      masked evaluation.
    

Detailed description: 
      Eligible patients will receive 3 treatments (4-6 weeks apart) on the facial acne scars using
      Sofwave System.

      Treatment may be administered after the enrollment and screening at the first visit, or it
      may occur later following the enrollment and screening activities based on site scheduling
      availabilities.

      All patients will return to the clinic for one follow up visit at 3 months ± 3 weeks post
      last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety
      of treatments will be carried out at each visit at the clinic.
    

Intervention name(s): Sofwave
Intervention type(s): Device
Intervention description(s): The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Other intervention name(s): SUPERB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne Scars
An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis
Condition: Non-alcoholic Steatohepatitis; Fatty Liver; Fibrosis, Liver; Compensated Cirrhosis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after
      24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis
    

Detailed description: 
      Based on the anti-fibrotic properties demonstrated in the animal models of fibrosis, this
      proof of concept clinical study aims at evaluating NTZ in patients with non-alcoholic
      steatohepatitis (NASH) and fibrosis stage 2 and 3. Although NTZ has been evaluated in liver
      disease populations up to 60 weeks, this is the first study evaluating NTZ treatment in a
      population with NASH induced stage 2 and 3 fibrosis. The aim of this study is to evaluate the
      safety and tolerability of NTZ 500 mg BID after 24 weeks of treatment in this population.

      This proof of concept study will also evaluate the anti-fibrotic effect of NTZ as a secondary
      objective.

      The methods of evaluation of fibrosis will include an innovative method of metabolic
      labeling.This approach is based on the concept that liver status can be determined by
      measuring the ratio of newly synthesized/pre-existing proteins.The turn-over rate of newly
      synthesized collagen and proteins represents the hepatic fibrogenic disease activity.
      Patients will be given "heavy water" to drink. Heavy water contains D20, deuterium being a
      stable isotope of hydrogen. Mass spectrometry is used to identify individual proteins and to
      quantify the ratio of labeled protein to total protein. The results are expressed as
      fractional synthesis rate of these proteins (FSR). This method has been previously published
      (Decaris et al, 2017).

      Other non-invasive methods will be used to evaluate the liver stiffness changes after NTZ
      treatment: Magnetic Resonance Elastography (MRE) and FibroScan®.
    

Intervention name(s): Nitazoxanide 500mg BID
Intervention type(s): Drug
Intervention description(s): Patients will receive 500mg of Nitazoxanide BID daily for 24 weeks
Other intervention name(s): NTZ
Intervention MeSH terms: Nitazoxanide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Macronutrients and Gut Hormone Secretion
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Study hypothesis is to examine the relative contribution of macronutrients for gut hormone
      secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes.
      Individual macronutrients or a mixed meal will therefore be served and gut hormones are
      measured during the following 300 min.
    

Detailed description: 
      In healthy volunteers and subjects with dietary regulated diabetes mellitus, glucose, protein
      mixture or fat emulsion will be served individually and on a separate occasions a mixed meal
      will be served. Samples will be taken during the following 300 min. Concentrations of the gut
      hormones glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1, insulin
      and glucagon will be determined.
    

Intervention name(s): Macronutrients
Intervention type(s): Other
Intervention description(s): Glucose 330 kcal Protein 110 kcal Fat emulsion 110 kcal Mixed meal 550 kcal
Other intervention name(s): Glucose; Protein mixture; Fat emulsion; Mixed meal
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: Gut hormones; Insulin secretion
Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a stepped glucose clamp study designed to investigate the effect of treatment with
      albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in
      subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given
      prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate
      that albiglutide increases insulin secretion and decreases glucagon levels in a
      glucose-dependent manner.
    

Detailed description: 
      This is a Phase II, single-site, randomized, double-blind, parallel-group,
      placebo-controlled, stepped glucose clamp study designed to investigate the effect of
      treatment with albiglutide on counter-regulatory hormone responses and recovery from
      hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or
      placebo will be given 3 days before employing a stepped hyper- and hypoglycemic clamp. The
      goal of this study is to demonstrate that albiglutide increases insulin secretion and
      decreases glucagon levels in a glucose-dependent manner. In particular, this study is being
      conducted to ensure that albiglutide does not impair counter-regulatory responses during
      hypoglycemia.
    

Intervention name(s): albiglutide; placebo
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous injection; subcutaneous injection
Intervention MeSH terms: rGLP-1 protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glucose clamp; hypoglycemia
Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate a reduction in the proportion of new
      vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment
      with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and
      vitamin D alone.
    


Intervention name(s): teriparatide; teriparatide; Placebo; Calcium Supplement; Vitamin D Supplement
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase; 20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase; Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.; Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement; Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Other intervention name(s): LY333334; Forteo; Forsteo; LY333334; Forteo; Forsteo
Intervention MeSH terms: Vitamin D; Teriparatide; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress in Healthy Adults
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and efficacy of VR-3 Herbal Blend and
      its effects on acute and chronic stress responses.
    


Intervention name(s): VR-3 Herbal Blend; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This is a liquid blend of various reputed adaptogenic herbs. The dosage will be 2ml of liquid per day.; The placebo will be a similar tasting liquid as VR-3 Herbal blend. The dosage will be 2ml of liquid per day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section
Condition: Obstetric Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for
      cesarean section with spinal anesthesia but it was limited for cesarean section with general
      anesthesia. The hypothesis that this technique has effect to postoperative analgesia for
      cesarean section with general anesthesia and it could reduce 50% of total morphine
      consumption during 24 hours after surgery.
    

Detailed description: 
      This is a randomized, controlled, no-blind clinical trial. The investigators selected 60
      cases, who were cesarean section under general anesthesia, age from18 years, and American
      Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal
      impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal
      failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two
      groups: the TAP block group (T group) and controlled group (C group). Each group has 30
      cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20
      ml each side. The both groups was treated postoperative analgesia with intravenous morphine
      to patients controlled analgesia (PCA). The primary outcome was total morphine consumption
      during 24 hours after surgery. The secondary outcomes were the time of required the first
      dose of morphine, pain score, the complications of TAP block, the side effects of morphine,
      and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The
      sample size was calculated with the hypothesis that TAP block could reduce 50% of dose
      morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.
    

Intervention name(s): TAP block; Morphine; Ropivacaine
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.; Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.; Ropivacaine 0.25% 20 ml each side
Other intervention name(s): Transversus abdominis plane block; Opioids; Anaropin
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Transversus abdominis plane block under the ultrasound guidance
Masking: None (Open Label)
Primary purpose: Other
Keywords: transversus abdominis plane block (TAP block); postoperative analgesia; cesarean section
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
Condition: Femur Fracture
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Observational

Summary: 
      The purpose of this multi-center prospective clinical outcomes study is to determine validity
      and safety of the pediatric locking nail for femoral fracture management in children with
      open physes.
    


Intervention name(s): Pediatric Locking Nail
Intervention type(s): Device
Intervention description(s): The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and tolerability of repeated subcutaneous injections of
      CAD106 in patients with Alzheimer's disease.
    


Intervention name(s): CAD106
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Active immunization; Alzheimer disease; Antibody; Central Nervous System Diseases; Neurodegenerative diseases; Vaccine
Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Suicidal Ideation
Study type: Observational

Summary: 
      This study will develop a new methodology to evaluate any treatment-emergent suicidal
      ideation that might occur when an antidepressant treatment has been started and/or during
      times when doses are increased in patients with major depressive disorder.
    

Detailed description: 
      This is a pilot study to begin to develop a measurement procedure to help guide the clinical
      management of suicide risk in people beginning a type of antidepressant medication called a
      selective serotonin reuptake inhibitor (SSRI). The goals of the study are: 1) to identify the
      best method and assessment measures to evaluate the severity of suicidal ideation, 2) to
      determine the appropriate frequency and duration of assessment required to adequately
      evaluate this suicidal ideation, 3) to evaluate the presence of symptoms that are associated
      with suicidal ideation (such as anxiety, panic attacks, difficulty in sleeping) and 4) to
      identify the most critical time periods during which suicidal ideation appears or worsens
      (such as how long after initiation of treatment or dosage increase).

      In all, 300 adult participants with major depressive disorder (MDD), between the ages of 18
      and 75, may be enrolled at primary and psychiatric care sites across the US. All patients
      will be treated with an SSRI for eight weeks. The choice of SSRI used in treatment will be
      chosen by the study physician at each site. For this study, physicians will choose from the
      following six SSRIs: citalopram, escitalopram, sertraline, paroxetine, paroxetine-CR, and
      fluoxetine.

      Patients beginning an SSRI for MDD in "real world" psychiatric and primary care settings,
      will have clinic visits and receive evaluations of their symptoms of depression, side
      effects, suicidal thinking and symptoms that are thought to be associated with suicidal risk,
      every other week for eight weeks. They will be evaluated by phone for symptoms and side
      effects each week they do not come to the clinic. They will also receive phone calls three
      times a week for the first two weeks of the study, after beginning the antidepressant, and
      after a dose increase to evaluate suicide risk.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fifteen primary care and specialty care clinics across the country.
      
Keywords: Suicidal Ideation; Major Depressive Disorder; Suicide Risk; Antidepressant Medication
Safety Study of Multiple Peptide Vaccine to Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients
      with esophageal cancer.
    

Detailed description: 
      LY6K (lymphocyte antigen 6 complex, locus K) was identified as a new target of tumor
      associated antigen using cDNA microarray technologies combined with the expression profiles
      of normal and cancer tissues. On the other hand, anti-angiogenic therapy is now considered to
      be one of promising approaches to treat of cancer. In this clinical trial, we evaluate the
      safety and immune responses of multiple peptide cocktail including LY6K and vascular
      endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor
      2 (VEGFR2) together with IFA and GM-CSF as immunoadjuvants in patients who had LY6K expressed
      primary esophageal cancer. Toxicity profiles will be monitored, and antigen specific T cell
      responses will be described.
    

Intervention name(s): LY6K, VEGFR1, VEGFR2
Intervention type(s): Biological
Intervention description(s): 1 mg/body every two week with GM-CSF, 4 cycles
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment