bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to determine the safety and effectiveness of 3 asoprisnil doses
      compared to placebo, taken for 12 weeks by women with uterine fibroids.
    

Detailed description: 
      No medical therapy is currently available for the long-term treatment of uterine fibroids.
      The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg
      and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine
      fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be
      allowed to enter an open-label extension study
    

Intervention name(s): Asoprisnil; Asoprisnil; Asoprisnil; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mg Tablet, oral Daily for 12 weeks; 10 mg Tablet, oral Daily for 12 weeks; 25 mg Tablet, oral Daily for 12 weeks; Tablet, oral Daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibroid Uterus; Leiomyoma; Uterine Fibroids; asoprisnil
Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to investigate whether secretion of incretin hormones is intact
      and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose
      excursions in patients with type-1 diabetes mellitus.
    

Detailed description: 
      GLP-1 and GIP are incretin hormones secreted from specific endocrine celles in the gut.
      Stimulus for secretion is prescence of carbohydrates, fat and protein in the gut. The
      incretin hormones controls postprandial glucose excursions through stimulation of
      insulinsecretion as well as inhibition of glucagon and gastric emptying.The effects of GLP-1
      on insulin secretion and glucagon inhibition are glucose dependent and the risc of
      hypoglycemia is therefore negligible when the hormone is administered in supra physiological
      concentrations.Furthermore, some animal studies suggest that GLP-1 has a trofic effect on the
      betacells and the hormone has been shown to replenish intracellular stores of insulin.
      Because the main bloodglucose lowering effect of GLP-1 has been thought to be due to
      increased insulin secretion, analouges of the hormone has been developed for the treatment of
      type-2 diabetes. So far, relatively little is known about the effect of GLP-1 in type-1
      diabetes.It possible, that GLP-1 in combination with insulin (possibly mainly through its
      effect on glucagon inhibition and gastric emptying) could reduce the need for exogenous
      insulin with a concomitant reduced risc of hypoglycemia. Without compromising the target
      glucemic control. This study focuses of the postprandial bloodglucose lowering effects of
      endogenous as well as exogenous GLP-1 in patients with type-1 diabetes according to residual
      betacell function and glycemic control.Furthermore, the endogenous secretion of incretin
      hormones in patients with type-1 diabetes mellitus will be compared to that of matched normal
      controls.
    

Sampling method: Non-Probability Sample
Study population: 
        primary care clinic patients and community population(control subjects)
      
Biospecimen description: 
      whole blood, plasma
    
Keywords: GLP-1; Type 1 diabetes; Glycemic control; Incretin hormone
Impedance Cardiography During Major Abdominal Surgery
Condition: Abdominal Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators validated ICG's(impedance cardiography) usefulness during the abdominal
      surgery, by comparing it with FloTrac/Vigileo™ (Edwards Lifesciences,Irvine, CA, USA)
    

Detailed description: 
      Intrathoracic structures have relatively constant resistance except the influence of changing
      diameter of aorta. Great vessels in thorax has the lowest resistance, and their diameter
      changes by the beats of the heart. As their diameter increases, their resistance decreases.
      ICG measures the difference between the resistances caused by heartbeats, and calculates
      cardiac output.

      But during the surgery, there are many interfering electrical currents made by electro
      cautery, patient positioning, and internal organ handling. Therefore, it has been thought
      that ICG is not a valid tool for measuring cardiac output during the surgery.

      The investigators validated ICG's usefulness during the surgery, by comparing it with
      Floctac/Vigileo.
    

Intervention name(s): Niccomo™ (Medis, Ilmenau, Germany) impedance cardiography
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: impedance cardiography; Flotrac/Vigileo; cardiac output
Cassia Cinnamon for Glucose Uptake in Young Women
Condition: Insulin Resistance; Impaired Glucose Tolerance; Prediabetes
MeSH terms: Insulin Resistance; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study was to compare the acute effects of 5g of Cassia cinnamon, 50
      minutes of endurance exercise performed at 70% of the heart rate reserve (correlated to
      VO2max), and 5g of cellulose placebo on blood glucose, serum insulin and insulin sensitivity
      following an oral glucose tolerance test 3 hours after administration of each intervention.
    


Intervention name(s): Cassia cinnamon; 50 minutes exercise; Cellulose Powder
Intervention type(s): Dietary Supplement; Procedure; Dietary Supplement
Intervention description(s): 5g encapsulated ground bark administered once in experimental session; 50 minutes treadmill endurance exercise at 70% of the heart rate reserve (correlated to VO2max); 5g encapsulated powder administered during placebo experimental session
Other intervention name(s): Brand: Nature's Bounty
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Cassia; Cinnamon; Blood Glucose; Endurance exercise; Acute exercise; Overweight; Obesity; Women
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
Condition: Central Nervous System Diseases; Central Nervous System Neoplasms
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Nervous System Diseases; Central Nervous System Diseases
Study type: Observational

Summary: 
      Safety and Efficacy Study in pediatric subjects <2 years of age who have undergone Brain or
      Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent
      those in routine clinical practice. Retrospective enrolment with a prospective blinded read.
    

Detailed description: 
      The purpose of this study is to retrospectively enroll children younger than 2 years of age
      who have undergone brain or spine MRI with 0.1 mmol/kg PROHANCE and to gather safety data as
      well as to collect MR images for a prospective blinded read to evaluate the efficacy of
      PROHANCE in terms of visualization and enhancing properties.

      The study will be conducted in 4-8 sites in the United States and Europe. It is estimated
      that 120 patients will be enrolled to provide 108 evaluable patients.

      Three radiologists unaffiliated with enrolling centers (blinded readers), blinded to the
      patient's identity and clinical profile will independently evaluate the MRI images. The
      efficacy analysis will be primarily based on the blinded reader evaluations.

      Imaging conditions will represent those in routine clinical practice, inclusive of pre and
      post-contrast images.
    

Intervention name(s): ProHance
Intervention type(s): Drug
Intervention description(s): 0.1 mmol/kg ProHance intravenous injection
Other intervention name(s): Gadoteridol
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include patients younger than 2 years of age who have previously undergone
        MRI of the CNS (brain or spine) with PROHANCE at the dose of 0.1 mmol/kg as part of their
        clinical work-up.
      
Keywords: CNS; MRI; ProHance; Gadoteridol
Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in
      conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from
      buprenorphine maintenance prior to the first dose of VIVITROL.
    


Intervention name(s): Naltrexone; Placebo; Buprenorphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): daily dosing; daily dosing; daily dosing
Intervention MeSH terms: Naltrexone; Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: naltrexone; VIVITROL; buprenorphine; opioid; addiction
Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
Condition: Knee Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      Assess the safety and functionality of the Freedom Knee® system through a multi-center
      clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data
      for:

        1. Range of Motion

        2. Quality of Life measurements using Knee Society Scale (KSS)

        3. Survivorship as defined by 'No Revision' of baseline implant

        4. Quality of Life measurements using the WOMAC Score
    

Detailed description: 
      The clinical study will involve a series of evaluations performed by your surgeon. These
      examinations are consistent with the normal surgeon care as part of Total Knee Replacement
      surgery. The study objective is to assess the safety, functionality, and survivorship of the
      Freedom Knee System through a multi-center clinical trial. Study endpoints include a
      comparison of Pre-Surgery (baseline) versus Post-Surgery data for Range of Motion and
      Flexion, Quality of Life (KSS), and survivorship (defined by 'no revisions'). Additionally,
      the structural integrity will be evaluated based on the x-ray performed 36-months after knee
      replacement.
    

Intervention name(s): Freedom Total Knee; Total Knee Replacement; Freedom Total Knee System
Intervention type(s): Device; Device; Device
Intervention description(s): The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement; total Knee replacement implant; Total Knee replacement implant
Other intervention name(s): Freedom Total Knee System; Freedom Knee; Freedom Knee
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Obesity; Overweight; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      This study evaluates the effects of an ad libitum addition of a high fiber product to the
      regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first
      6 weeks half of the participants will receive the high fiber test product and half a
      reference product without fiber. After the first 6 weeks both groups will be switched to the
      high fiber product.
    

Detailed description: 
      It has previously been shown that an increase in the consumption of fiber improves glucose
      control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely
      based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled
      type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized
      by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran
      high in fiber will be studied in type 2 diabetes patients with inadequate glucose control
      that are treated with oral medication or with additional once-daily insulin only against a
      reference product. 30 patients will be treated with the oat bran product or reference product
      over a period of 6 weeks in a double blinded approach, hereafter all participants will be
      switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks.
      Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented
      glucose as well as the body weight and body mass index.
    

Intervention name(s): active product; reference product
Intervention type(s): Other; Other
Intervention description(s): Once daily consumption over the period of the study; Once daily consumption over the period of the study
Other intervention name(s): LOB; Liquid Oat Bran; High fiber product; placebo food product
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First 6 weeks double blinded vs. a reference product and second 6 weeks open label both groups receive the test product in the second 6 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fiber; type 2 diabetes; dietary intervention; weight loss; glucose control; obesity; overweight; metabolic syndrome; oats
Relationships Between Exercise and Emotion Regulation on Physical Activity in Frail Older Adults
Condition: Mobility Limitation; Sedentary Lifestyle; Older Adults
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      Frailty in older adults is a consequence of physical inactivity, which leads to poor physical
      function, disability and poor health outcomes. Nearly 60% of older adults report inactivity.
      Emotion regulation strategies have affective, cognitive and social consequences. Positive
      emotions are significantly associated with a higher ability to perform activities of daily
      living. There is a gap in the understanding of how exercise influences the selection of
      emotion regulation strategies (avoidant vs. adaptive) in frail older adults. The
      investigators propose to examine the interactions between regular exercise, selection of
      emotional regulation strategies, and daily physical activity in frail sedentary older adults.
    

Detailed description: 
      1. Determine the choice of emotion regulation strategies used by frail sedentary older
           adults (60+ years; n=24). Frailty will be defined as a gait speed <0.8 m/sec.

           Hypothesis: Frail sedentary older adults will choose avoidant emotion regulation
           strategies.

        2. Examine whether a peer-led, community-based, group-exercise program lasting 12-weeks
           improves the selection of emotion regulation strategies in frail sedentary older adults
           as compared to those receiving support services (12/group).

           Hypothesis: Exercise will result in higher use of adaptive emotion regulation strategies
           than support services.

        3. Examine if improved selection of emotional regulation strategies with exercise
           translates into increased daily physical activity and reduced sedentary behavior by
           frail older adults as compared to those receiving support services.

           Hypothesis: Exercise will significantly increase daily physical activity and decrease
           sedentary behavior than support services.

        4. Determine if improvements in emotional regulation strategy selection and daily physical
           activity levels positively influence health and well-being (i.e. health status, physical
           function, mood, depressive symptoms, anxiety, and sense of loneliness and isolation).

      Hypothesis: Exercise-induced improvements in emotion regulation and increased daily physical
      activity will be associated with improved overall health and well-being as compared to
      support services.
    

Intervention name(s): Group exercise
Intervention type(s): Behavioral
Intervention description(s): Group exercise based on the American College of Sports Medicine guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization to group exercise or an attention-control group for 12 weeks (2:1 ratio). Group exercise sessions took place once per week at a community center.
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians
Condition: Medical Abortion
Study type: Interventional
Phase: Phase 3

Summary: 
      The physical examination before an abortion is usually performed by a physician. However, in
      many countries access to physicians is limited. To increase access to safe abortion this
      study wishes to examine if midlevel providers such as specially trained midwives can provide
      safe abortion services. Midwives in study were specially trained to perform early pregnancy
      ultrasound and if needed to consult a physician. The midwife then provided the abortion
      service as well as the contraceptive advice. Women were randomized to receive the service
      from a midwife or a physician.
    


Intervention name(s): Midwife
Intervention type(s): Other
Intervention description(s): gynecological exam and ultrasound and contraceptive advice provided by midwife
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: abortion; medical abortion
Registry Study - Whipple at the Splenic Artery
Condition: Pancreas Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to determine how effective Whipple at the Splenic Artery
      (WATSA).
    

Detailed description: 
      Primary

      The primary objective of this registry study is to collect clinical data from patients who
      undergo the WATSA procedure. Specific hypotheses to be tested are

        -  To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors
           with negative microscopic margins (R0) at the resection line on the pancreas and at the
           tangential posterior, uncinate, and venous margins.

        -  To determine if WATSA can be performed within the usual range of morbidity and mortality
           (30 day postoperative mortality) for a standard a Whipple procedure.

      Secondary

      The secondary objectives of this registry study are to

        -  To determine the survival/recurrence rates at 2 years.

        -  To determine the effect of occlusion of the splenic vein at the confluence.
    

Intervention name(s): Whipple at the Splenic Artery (WATSA)
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Participants will be identified from PI's patient population or referrals from colleagues.
Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin
Condition: Gastrointestinal Hemorrhage
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      To compare the diagnostic yield of mesenteric angiogram with CE in patients with active
      obscure GIB.
    

Detailed description: 
      Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in
      recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the
      standard radiological investigations for GIB of obscure origin, and its diagnostic yield
      ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel
      examination, especially in bleeding of obscure origin. The diagnostic yield is particularly
      high in patients with ongoing bleeding. This is a prospective randomized study to compare the
      diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure
      origin. The results will help to define the optimal management strategy for this group of
      patients.
    

Intervention name(s): capsule endoscopy; Mesenteric Angiogram
Intervention type(s): Procedure; Procedure
Intervention description(s): capsule endoscopy of small intestine; Mesenteric Angiogram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Capsule Endoscopy; Mesenteric angiogram
Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects
Condition: Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The goal is to investigate the 180 min postprandial response on blood glucose and insulin
      levels after intake of Pep2Dia® in two different dosages compared to placebo in the context
      of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15
      min prior to a standardized challenge meal.
    

Detailed description: 
      From a previous pilot study (BTS1130/17) there is first evidence that the native whey product
      with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate
      postprandial hyperglycaemia in prediabetic subjects.

      Thereby, incremental areas under the curve (iAUC) of glucose as the primary outcome were
      significantly reduced by a single dosage of 1400 mg Pep2Dia® compared to placebo the second
      study is to investigate the 180 min postprandial response on blood glucose and insulin levels
      after intake of Pep2Dia® in two different dosages compared to placebo in the context of a
      meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min
      prior to a standardized challenge meal. Furthermore, the 120 min postprandial incretin
      response in terms of Glucagon-like Peptide-1 (GLP-1) will be determined. Changes in insulin
      sensitivity will be determined by the Matsuda-index as appropriate outcome measure.
    

Intervention name(s): Pep2dia; maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): what is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g); maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be performed as a multicentric, randomized, double-blind, and placebo-controlled in a 3-way cross-over design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention