bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to get information about absorption, distribution, metabolism and
      excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.
    


Intervention name(s): AZD1386
Intervention type(s): Drug
Intervention description(s): 1 dose of oral solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pain
Can A Nutrition Education Immersion Program Foster Sustainable Improvements in Clinical Parameters Over Time?
Condition: Behavior
Study type: Interventional

Summary: 
      Nutrition and Education Immersion program sponsored by WholeFoods, Inc. for their employees.
    

Detailed description: 
      An ongoing Nutrition and Education Immersion program is currently ongoing that is supported
      by Whole Foods, Inc. for their employees. Eighty employees have previously agreed to attend a
      one week nutrition education and immersion program October 14-21, 2017. This program will
      involve nutrition education seminars, exercise and support classes that they are scheduled to
      attend. All meals are provided. They will all be 100% plant based with low oil. All employees
      will complete a dietary survey at the beginning of the study. Clinical parameters will be
      tested at start and end of the program. The majority of the lectures are CME certified by
      Rush University.

      All participants will be approached for participation on day one to allow for the collection
      of the data being obtained as part of the existing project. In addition to the data from the
      program, this project will include a lab draw for nutritional markers at baseline and at the
      end of the immersion program, a dietary survey, SF-36, and DASI at baseline. Participants
      will be contacted by phone at months 3 and 6 and will be asked to complete the dietary
      survey, SF-36, and DASI. In addition, self-reported weight will be collected, and occurrence
      of health events (hospitalizations, new diagnoses). This will end their participation.
    

Intervention name(s): Immersion program
Intervention type(s): Behavioral
Intervention description(s): Evaluate the impact of an already established one week long lifestyle immersion program sponsored by Whole Foods, Inc for their employees on anthropomorphic, clinical labs such as lipid levels, blood sugar and other markers of nutrition, quality of life and activity levels at baseline, at the end of the program and at 3 and 6 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Education
The Analgesic Effect of QLB II After Robotic Prostatectomy. (QLB II: Quadratus Lomborum Block II Type)
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The analgesic effects of Quadratus Lomborum Block II type after robotic-assisted laparoscopic
      radical prostatectomy, will be assessed.
    

Detailed description: 
      Quadratus Lomborum Block II type will be performed before performing robotic-assisted
      laparoscopic radical prostatectomy.

      The post-operative analgesic effect will be assessed, by using Numeric Rate Scale for pain.

      The pain assessment will be evaluated during the first 24 hours from surgery. The opioids
      requirement and side effects will be also assessed.
    

Intervention name(s): Levobupivacaine in QLB II
Intervention type(s): Other
Intervention description(s): Quadratus Lomborum Block II type will be performed by injecting levobupivacaine 0.375% 20 ml between latissimus dorsi and quadratus lomborum muscle.
Other intervention name(s): Quadratus Lomborum Block II type
Intervention MeSH terms: Levobupivacaine
Intervention model: Single Group Assignment
Intervention model description: Simon's Two-Stage single arm study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain, radical prostatectomy, QLB II type
Human Islet Transplantation in Brittle Type 1 Diabetes Mellitus. The GRAGIL 2 Study.
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research project is supported by a multicentric network of collaborators whose goal is
      to assess the efficacy of transplanting allogenic pancreas islets to restore insulin
      secretion in patients with brittle type 1, insulin-dependent diabetes mellitus and to improve
      their metabolic control.
    

Detailed description: 
      The general objective is to demonstrate the beneficial effect of islet allotransplantation in
      patients with brittle type 1 diabetes with no endogenous insulin secretion, for whom the risk
      of the spontaneous course of the disease is judged to be worse than the
      transplantation-related risk. The specific objective is to establish reference data for islet
      transplantation in non-uremic patients with brittle diabetes, in a multicentric network
      setting, using the Edmonton protocol.
    

Intervention name(s): human pancreatic islet transplantation
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: islet transplantation; brittle diabetes; severe hypoglycemia; type 1 diabetes mellitus
Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study will follow subjects for 28 days while using an DUO extended infusion set combined
      with glucose sensor. the objective is to evaluate saftey and efficacy of the set in adult
      patient with type 1 diabetes.
    


Intervention name(s): DUO Extended Set
Intervention type(s): Device
Intervention description(s): to evaluate saftey and efficacy of DUO extended set combined with glucose sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state concentrations of
      odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the
      single-dose pharmacokinetics of dabigatran etexilate in healthy participants.
    


Intervention name(s): Dabigatran etexilate mesylate; Odalasvir (ODV); Simeprevir (SMV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive dabigatran etexilate mesylate 75 mg, orally.; Participants will receive ODV 25 mg, orally.; Participants will receive SMV 75 mg, orally.
Intervention MeSH terms: Simeprevir; Odalasvir; Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Graduated Embryo Score (GES) in the Fresh Cycle Predicts Outcome From Frozen Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Evaluation of embryo quality in the fresh cycle as a predictor of outcome from frozen embryo
      transfer.
    

Detailed description: 
      Outcomes from frozen embryo transfer reviewed based on the quality of the embryos in the
      ftresh cycle as assessed by the Graduatede embryo score.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All IVF patients at our center between 2002 and 2007 with at least 2 frozen blastocysts
        undergoing frozen embryo transfer.
      
Keywords: Cryopreservation; Frozen embryo transfer; Graduated Embryo Score
A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal
      women
    


Intervention name(s): Progesterone vaginal ring,
Intervention type(s): Drug
Intervention description(s): Participants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA)
Other intervention name(s): Treatment A - DR-201, progesterone vaginal ring, 20% (w/w),; 11 mg/day, produced from the NEW process and; Treatment B - DR-201, progesterone vaginal ring, 20% (w/w),; 11 mg/day, produced from the LEGACY process
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
Condition: Acute Gastritis; Chronic Gastritis
MeSH terms: Gastritis; Gastritis, Atrophic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID
      compared to placebo in patients with Acute or Chronic Gastritis
    

Detailed description: 
      This study was designed as a multi-center, randomized, double-blind, placebo-controlled,
      parallel-group, phase 3 study to assess the efficacy and safety of oral administration of
      DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic
      gastritis.
    

Intervention name(s): DWP14012 X mg; DWP14012 X mg placebo; DWP14012 Y mg; DWP14012 Y mg placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): DWP14012 X mg, tablet, orally, once daily for 2 weeks; DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks; DWP14012 Y mg, tablet, orally, twice daily for 2 weeks; DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks
Intervention MeSH terms: Fexuprazan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.
Condition: Patients With Grade II Ankle Sprain
MeSH terms: Ankle Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Generating critical levels of power is a prerequisite for performing simple daily activities,
      such as rising from a chair or climbing stairs. For a young healthy person these activities
      can be performed easily, however after a prolonged period of forced inactivity (such as
      during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss of muscle
      mass occurs. It has been suggested that this loss may be triggered by oxidative stress. An
      enzyme involved in the production of free radicals in various experimental models, including
      immobilization, is xanthine oxidase (XO). Although allopurinol is an inhibitor of XO widely
      used in clinical practice, its effect on the maintenance of muscle mass after an
      immobilization protocol is unknown. Thus, the major aim of this clinical trial is to
      determine the effect of allopurinol administration on the prevention of muscle mass loss in
      immobilized subjects.

      This is a prospective, randomized study in which fifty young male subjects (aged between 25
      and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization
      the patients will be assigned randomly to one of two experimental groups, one treated with
      allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the
      same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization
      period, which will last fifteen days. This medication will be delivered to the patients when
      they agree to participate in the clinical trial. They will be immobilized by posterior knee
      splint, preventing use of that leg.

      We will determine muscle mass loss by performing two magnetic resonances of both legs before
      and after the immobilization period. We will also take two blood samples (before and after
      immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls,
      and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin),
      as well as vitamin D levels.
    


Intervention name(s): Allopurinol; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): 1H-pirazolo (3,4-d)pirimidina-4-ol; Zyloric
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Xanthine oxidase; Magnetic resonance; Oxidative stress; Inflammation
Providing Peer Mother Support Through Cell Phone and Group Meetings to Increase Exclusive Breastfeeding in Kenya
Condition: Breastfeeding
Study type: Interventional

Summary: 
      This behavioural support intervention trial will investigate the potential to increase
      exclusive breastfeeding rates in an urban Kenyan community through peer mother support
      delivered either by cell phone or through group meetings. It will follow a cohort of more
      than 800 women attending antenatal care at a large public hospital, and compare indicators of
      breastfeeding and infant and maternal health between groups receiving one or other type of
      peer mother support. The main part of the study will test the primary hypothesis that peer
      group and cell phone based support can both increase rates of EBF at 3 months by 20% relative
      to a control group.
    

Detailed description: 
      The general objective was to assess whether participation from late pregnancy through to 3
      months postpartum in bi-weekly cell phone based peer support (CPS) or monthly peer-led
      support groups (PSG) can increase adoption and duration of EBF amongst low-income women in
      Kenya served by a nationalized BFHI certified hospital above benchmarks achieved with current
      approaches and standard of care by existing facility-based support (SOC).

      The study aimed to reach the following specific objectives related to message delivery on
      EBF:

      assess the feasibility of two innovative approaches (CPS and PSG) to deliver extended
      postnatal peer support for EBF by women in an urban, low-income country setting; compare the
      effectiveness of these two innovative approaches to existing facility-based support; and
      compare the relative effectiveness of each type of peer support intervention.
    

Intervention name(s): Peer mother support for continued exclusive breastfeeding
Intervention type(s): Behavioral
Intervention description(s): Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: breastfeeding exclusively
Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Open label extension study of Ziprasidone, evaluation of safety of long term use of
      ziprasidone
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
Condition: Hepatic Impairment; Healthy Participants
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the effect of hepatic impairment on the
      pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses
      of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this
      study.
    


Intervention name(s): PF-06651600 30 mg
Intervention type(s): Drug
Intervention description(s): PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06651600; Pharmacokinetics; Hepatic impairment
A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
Condition: Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses; Rheumatic Diseases; Collagen Diseases; Necrosis; Fractures, Bone; Femoral Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the performance and compare the wear characteristics
      of two polyethylene cup liners, Marathon™ and Enduron™, in the treatment of patients with hip
      joint disease requiring a total hip replacement. Patients who enter the study will be
      randomly allocated to one of the polyethylene cup liners, Marathon™ or Enduron™ and will be
      evaluated at regular intervals using clinical and x-ray assessments.
    

Detailed description: 
      The original protocol intended to perform clinical assessment using the Harris Hip Score,
      Merle D'Aubigne score and UCLA Activity Level Rating at 6 months, 1 year, 2 years, 3 years, 4
      years, 5 years and 10 years post-operative. Merle D'Aubigne score evaluation was removed per
      Amendment 2.

      However, protocol-specified data collected included only the linear and volumetric wear and
      incidence and pattern of radiological signs at 10 years post surgery. Data collected outside
      of the protocol included Oxford Hip Score and SF-12 for mental and physical well-being at 10
      years post surgery and revision for any reason.
    

Intervention name(s): Marathon™; Enduron
Intervention type(s): Device; Device
Intervention description(s): Moderately cross-linked polyethylene liner in a modular acetabular component; Standard polyethylene liner in a modular acetabular component
Intervention MeSH terms: Methyclothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip; Cemented
Transcranial Magnetic Stimulation For Visual Snow Syndrome
Condition: Visual Snow Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      This study aims to investigate the feasibility of the use of repetitive transcranial magnetic
      stimulation (rTMS) for symptoms associated with Visual Snow syndrome (VS).
    

Detailed description: 
      The study will gather information about the treatment of up to 10 people with VS using rTMS.
      Treated participants will undergo 10 sessions of rTMS administered 5 times a week over 2
      weeks. All visits will take place in the University of Colorado School of Medicine
      NeuroMag/Transcranial Magnetic Stimulation laboratory on University of Colorado Anschutz
      Medical Campus.

      The specific aims for this feasibility study include:

        1. Determine whether any participant experiences untoward effects of rTMS in the setting of
           visual snow syndrome and determine the potential drop-out rate of larger study.

        2. Determine the performance of a novel scale (Colorado Visual Snow Scale) and two three
           psychophysical visual processing tasks

             1. Determine the standard deviation and test-retest reliability for the novel scale
                and two visual processing tasks

             2. Determine whether the visual processing tasks perform similar to performance found
                by the developer

        3. Describe changes in outcome measures between pre- and post-treatment with rTMS
    

Intervention name(s): Transcranial Magnetic Stimulation device
Intervention type(s): Device
Intervention description(s): Five days a week for 2 consecutive weeks, participants will have repetitive TMS at specific paramaters
Other intervention name(s): TMS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: repetitive Transcranial Magnetic Stimulation
Activation Innate Immune System in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Cardiovascular Diseases; Innate Immune System; Inflammation; Metabolism Disorder, Glucose
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Diseases; Glucose Metabolism Disorders; Inflammation
Study type: Observational

Summary: 
      Hyperglycemia is a well-known cardiovascular risk factor. It has also been shown that
      episodes of hyperglycemia increase the risk for cardiovascular diseases despite return to
      normoglycemia, a phenomenon termed 'glycemic or metabolic memory'. The molecular mechanism
      underlying this phenomenon remains unclear.

      Cardiovascular events, such as myocardial infarction and stroke are caused by
      atherosclerosis, which is characterized by low grade inflammation of the vascular wall,
      including accumulation of innate immune cells such as monocytes and macrophages.

      The investigators hypothesize that chronic hyperglycemia shifts intracellular metabolism of
      innate immune cells towards glycolysis and changes the epigenetic state of (progenitors of)
      innate immune cells (monocytes and macrophages), which reprograms these cells towards a more
      aggressive, pro-atherogenic phenotype, thereby accelerating atherosclerosis.

      In this study, the investigators aim to test this hypothesis. This research will reveal
      whether the innate immune cells of patients with chronic hyperglycemia show a durable shift
      in intracellular metabolism and epigenetic changes and whether this associates with vascular
      inflammation.
    


Intervention name(s): PET-CT (positron emission tomography - computer tomography); Blood drawn
Intervention type(s): Radiation; Diagnostic Test
Intervention description(s): PET-CT to determine vascular inflammation; Blood drawn
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 diabetes patients, without macrovascular complications. Minimum diabetes duration 10
        years.

        Patients are recruited at university hospital.