bioihbjkbjnl/mcl2 huggingface dataset:
Kori-tofu Proteins and Blood Glucose Response
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The study is a randomized, cross-over, double blind, controlled trial in which study
      participants will visit the research facility on two occasions under fasting conditions with
      a minimum of 1 week between visits. During each visit, participants will receive a
      carbohydrate rich test-meal with Kori-tofu (protein) or whey protein. The two meals will be
      given in randomized order and blood will be collected via a catheter before and up to 3 hours
      after consumption of the test-meal. Study participants will also wear continuous glucose
      meters during the trial. They will receive a standardized evening meal prior to each study
      day and are asked not to drink alcohol or perform heavy exercise the day before. After each
      test day participants are offered a meal.
    

Detailed description: 
      There are several types of tofu, an example of a specific type of tofu is called Kori-tofu.
      Kori-tofu literally means frozen tofu. The production process of Kori-tofu leads to the
      formation of a higher high molecular weight fraction (HMF) content of the soy proteins.
      Several clinical studies describe the effects of Kofi-tofu on health. In this study, the aim
      is to investigate whether Kori-tofu protein affects postprandial blood glucose concentrations
      in participants with an impaired glucose tolerance.

      The primary objective is to investigate whether Kori-tofu protein affects postprandial blood
      glucose concentrations, when administered as a part of an ordinary high carbohydrate meal.
      The secondary objective is to investigate whether Kori-tofu protein affects postprandial
      insulin concentrations.

      The study is a randomized, cross-over, double blind, controlled trial in which study
      participants will visit the research facility on two occasions under fasting conditions.
      Subjects will receive two different carbohydrate-rich meals, either with added Kori-tofu or
      whey protein, with a washout period of one week. Blood will be collected via a catheter
      before and up-to 3 hours after consumption of the test-meal.
    

Intervention name(s): Kori tofu; Whey protein
Intervention type(s): Other; Other
Intervention description(s): 16.5 gram Kori-tofu mixed in a high carbohydrate test meal; high carbohydrate test meal with whey protein, matched in macronutrient content
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Kori tofu; Glucose response; Pre-diabetics
Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess if oral nizatidine or lisinopril alone and in combination will increase heme
      oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy
      subjects.
    

Detailed description: 
      Current therapeutic options for gastroparesis are limited to dietary modifications and
      pharmacological (i.e., prokinetic and symptomatic) agents. Exciting and novel preliminary
      data from our programs demonstrate that (i) reduced expression of heme oxygenase 1 (HO-1) is
      responsible for loss of interstitial cells of Cajal and delayed gastric emptying in non-obese
      diabetic (NOD) mice, (ii) upregulation of (HO-1) reverses delayed gastric emptying in this
      model, perhaps by generating carbon monoxide (CO), which has anti-apoptotic and
      cytoprotective actions, and may relax smooth muscle, and (iii) hemin upregulates HO-1 in
      humans. However, hemin is exorbitant and can only be administered intravenously. A large
      throughput screening assay uncovered that the histamine H2 receptor antagonist nizatidine and
      the ACE inhibitor lisinopril upregulate HO-1 in Human Embryonic Kidney (HEK) cells. Hence,
      this double-blind placebo-controlled study will randomly assign 24 healthy subjects to one of
      4 arms, and HO-1 protein activity and concentration will be assessed.
    

Intervention name(s): Nizatidine; Lisinopril; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nizatidine (150 mg) will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.; Lisinopril (10 mg) will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.; Placebo capsules to match active drug will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.
Other intervention name(s): Axid; Zestril; Prinivil
Intervention MeSH terms: Lisinopril; Nizatidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Women's Post Traumatic Stress Disorder (PTSD) Research Study
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The purpose of this study is to examine the relationship between trauma and startle. The
      investigators are also looking at the effect of menstrual phase on this relationship.
    

Detailed description: 
      The investigators are trying to understand if there is a relationship between the experience
      of traumatic events such as those experienced by people with post traumatic stress disorder
      and reactivity to startling noises or mild threats. So, the investigators are looking at
      startle reflex, heart rate, and stress hormone responses to short noises and small shocks in
      people exposed to trauma and who either do or do not have PTSD. Additionally, the
      investigators will be looking at how the menstrual cycle impacts these processes. The
      investigators know that women have twice the risk for developing PTSD and some research
      suggests that stress hormones change during the menstrual cycle and may have an effect on
      risk.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women, ages 18-55.
      
Biospecimen description: 
      Urine, blood and saliva samples are taken. Only blood and saliva samples are retained and
      used to measure stress hormone levels.
    
Keywords: Stress; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic
Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, beginning
      most often in subjects aged 20-40 years. In France, thanks to recent studies reported during
      general states of MS in 2006, the prevalence is estimated at 65.5 / 100,000 population (96.3
      / 100,000 women and 41.9 / 100,000 men) and incidence at 7.91 per 100,000. In Lower Normandy,
      the incidence of MS is estimated to 4.45 / 100,000 inhabitants or 60 new cases per year.

      The primary objective of this pilot study is to assess the levels of glutamate and aspartate
      (excitotoxicity markers) and their repercussions on the clinical and radiological outcome in
      40 patients experiencing an event demyelinating central nervous system.
    


Intervention name(s): glutamate and aspartate
Intervention type(s): Biological
Intervention MeSH terms: N-Methylaspartate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Use of Local Hemostatic in Patients With Large Incisional Hernias
Condition: Hernia, Ventral
MeSH terms: Hernia; Incisional Hernia; Hernia, Ventral
Study type: Interventional

Summary: 
      Design of a simple blind randomized controlled trial study. Large incisional hernia repair
      with use of local hemostatic Hemoblock
    

Detailed description: 
      Design of a simple blind randomized controlled trial study. The total number of subjects was
      66. In the main group (A) - 33, in the other group (B) - 33. Operation - sublay retromuscular
      using prolene mesh implant. In group A Hemoblock 15 ml in the retromuscular and 15 ml in the
      subcutaneous spaces were used. Wounds were drained by vacuum-suction drainage. Postoperative
      monitoring of early ultrasound examinations on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st,
      25th, 28th, 30th days after drainage removal.

      In group B were used a standard intervention (sublay retromuscular).
    

Intervention name(s): Incisional hernia repair by the mesh implant in sublay retromusuclar position; Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock
Intervention type(s): Procedure; Procedure
Intervention description(s): Incisional hernia repair using mesh prolene implant in sublay retromuscular position. Dissect the posterior rectus sheets, suture them continuously, formed a retromuscular space in which the standard prolene mesh implant is installed. Perform hemostasis. Install the drainage tube into the retromuscular space.
After that, the anterior rectus sheets were sutured, hemostasis was performed, a drainage tube was installed in the subcutaneous tissue. Drainage tubes were connected to the UnoVac vacuum aspiration system (Unomedical, Denmark).; Incisional hernia repair using mesh prolene implant in sublay retromuscular position. Dissect the posterior rectus sheets, suture them continuously, formed a retromuscular space in which the standard prolene mesh implant is installed. Perform hemostasis. Install the drainage tube into the retromuscular space. Used a local hemostatic Hemoblock 15 ml in this space.
After that, the anterior rectus sheets were sutured, hemostasis was performed, a drainage tube was installed in the subcutaneous tissue. Used a local hemostatic Hemoblock 15 ml in subcutaneus space. Drainage tubes were connected to the UnoVac vacuum aspiration system (Unomedical, Denmark).
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: hernia
Immediate Effect of Subliminal Priming With Subliminal Reward Stimuli on Standing Balance in Healthy Young Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the study was to examine the immediate effect of subliminal priming with
      subliminal reward stimuli on standing balance in healthy young adults. The study also
      compared the outcomes with the immediate effects of subliminal priming with supraliminal
      reward stimuli.
    


Intervention name(s): Subliminal priming with subliminal reward stimuli; Subliminal priming with supraliminal reward stimuli
Intervention type(s): Other; Other
Intervention description(s): Positive words as subliminal reward (displayed for 17 ms).; Positive words as supraliminal reward (displayed for 150 ms).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized
      study.
    

Detailed description: 
      Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein
      Reflux
    

Intervention name(s): radiofrequency
Intervention type(s): Other
Intervention description(s): ClosureFAST
Other intervention name(s): ClosureFAST
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Urdu Version of Arthritis Impact Measurement Scales 2 Short Form:Reliability and Validity Study
Condition: Quality of Life
Study type: Observational

Summary: 
      In this study ,Investigators will observe the Reliability and Validity of Arthritis Impact
      Measurement Scale 2 Short Form translated in Urdu language in Pakistani population to check
      quality of life in patients suffering from Osteoarthritis.
    

Detailed description: 
      The main aim of this study is to translate and culturally adapt AIMS2 SF into Urdu language
      and to investigate the reliability and validity of AIMS2 SF in Osteoarthritis patients among
      Urdu speaking Pakistani population.

      The study will be completed in 5 steps such as translation ,synthesis ,back translation
      ,expert committee review and pre testing. The study will be a cross sectional survey .The
      result of the study helps to know the validity and reliability of AIMS2 SF in Urdu Version to
      check the quality of life .The reliability of the scale will be checked through internal
      consistency and test retest method .Internal consistency will be analyzed through Cronbach's
      alpha value to estimate whether each item of a scale is appropriate for assessing the
      underlying concept of its scale with 165 patients will be used.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Osteoarthritis is the leading cause of pain and disability and the most common joint
        disorder in our general population .According to high prevalence due to increasing age it
        is also increasing in the upcoming years .It causes narrow joint space and degeneration of
        cartilage
      
Keywords: AIMS2 SF; Urdu; OA; ACR
A Study to Assess the New Candidate Rift Valley Fever Virus Vaccine in Healthy Adults
Condition: RVF; Rift Valley Fever
MeSH terms: Coccidioidomycosis; Coccidiosis; Rift Valley Fever; Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomised, single blind, placebo - controlled, dose-escalation, phase I clinical trial
      recruiting healthy adults aged 18-50 years
    

Detailed description: 
      This is a randomised, single blind, placebo-controlled, dose escalation, phase I clinical
      trial to assess the safety and immunogenicity of the candidate ChAdOx1 RVF vaccine in healthy
      Ugandan volunteers aged 18-50. The vaccine will be administered intramuscularly.

      This study will run concurrently with the first-in-human ChAdOx1 RVF trial in Oxford.
      Vaccination at the MRC/UVRI and LSHTM Uganda Research Unit, Masaka will only begin upon
      receiving a favourable opinion of Uganda's trial DSMB of the 7-day post-vaccination safety
      analysis of the first two lowest dose groups (ChAdOx1 RVF 5 x 10^9vp and ChAdOx1 RVF 2.5 x
      10^10vp) of the trial in Oxford.

      Volunteers will be recruited and vaccinated at the MRC/UVRI and LSHTM Uganda Research Unit
      Clinical Research Centre in Masaka. There will be three study groups and a total of 30
      volunteers will be enrolled (table 3). Volunteers will be recruited sequentially into Groups
      1,2 and 3. Within each group, eligible volunteers will be randomly allocated to receive
      either ChAdOx1 RVF or placebo of 0.9% Normal Saline in a ratio of 2:1 in group 1 and 5:1 in
      groups 2 and 3. The DSMB will analyse the 7-day post-vaccination safety data in each group
      and advise on whether to proceed to the next group with a higher dose .
    

Intervention name(s): ChAdOx1 RVF; Saline
Intervention type(s): Biological; Other
Intervention description(s): Single dose ChAdOx1 vectored vaccine; 0.5ml saline placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Rift Valley Fever; Vaccine; ChAdOx1
Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a brief (12 week) psychological treatment
      program, based in primary care, can help youths struggling with anxiety and/or depression.
      This brief cognitive behavioral therapy program will be compared to enhanced referral to
      specialty mental health care.
    

Detailed description: 
      Mood and anxiety disorders in childhood and adolescence are disabling, distressing, and
      prevalent and produce added costs to health systems. This two-site randomized controlled
      trial will test the effects of a brief cognitive behavioral therapy (BCBT) protocol (8-12
      sessions) in a large sample (N=210) of children and adolescents (age 8-16) presenting with
      anxiety and/or depression in primary care. Clinical and cost-effectiveness of BCBT will be
      compared to a plausible public health alternative - enhanced referral to specialty mental
      health care (SMHC). This investigation is noteworthy in adopting a deployment-focused model
      and testing this intervention early in its development within a real world context (primary
      care) and against a plausible public health comparison condition (SMHC) relevant for future
      treatment dissemination.
    

Intervention name(s): Brief Cognitive Behavioral Therapy (BCBT); Specialty mental health care referral (SMHC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting; SMHC: specialty mental health care referrals provided
Other intervention name(s): BCBT; SMHC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child; adolescent; anxiety; depression; internalizing; cognitive behavioral therapy; pediatric primary care
Analysis of the Biomechanics of Walking
Condition: Elderly People; Falls
Study type: Observational

Summary: 
      The proportion of people aged 60 and over in the French population has increased from 18% in
      1970 to over 22% in 2010.

      One major problem in the elderly is falling. About half of these falls cause a minor injury
      and between 5% and 25% will cause a more serious injury such as a fracture or a sprain
      (Alexander et al., 1992; Nevitt et al., 1991).

      It therefore seems essential to study the locomotion of seniors to limit the maximum risk of
      falling into a public health measure.

      Two factors may be involved:

        1. The first corresponds to factors related to natural aging topics

        2. The second is the environment that is a real problem for seniors (Rolling showers,
           presence of works ....) And especially the port of inappropriate footwear.

      Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this
      parameter that will be highlighted in our study.
    

Detailed description: 
      The subjects will test different characteristics on the same shoe. A single parameter vary
      for each condition (Different insole, heel height, stem length ...) For each condition,
      analysis of locomotion on treadmill ADAL be performed as well as tests on postural balance
      platform. Kinematic measurements, accelerometer and postural will be performed for each
      subject.
    

Intervention name(s): Shoes characteristics
Intervention type(s): Other
Intervention description(s): A single parameter of shoe vary for each test (Different insole, heel height, stem length ...)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Elderly people
      
Keywords: biomechanics of walking; footwear
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia
Condition: Type 2 Diabetes; Stroke; Myocardial Infarction
MeSH terms: Myocardial Infarction; Diabetes Mellitus, Type 2; Hypoglycemia; Infarction
Study type: Interventional

Summary: 
      Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence
      world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing
      effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New
      animal studies indicate a protective effect of GLP-1 in the brain and the heart. The
      mechanism behind this is yet not known.

      The study hypothesis is that during hypoglycaemia GLP-1 will stimulate glucose-uptake in the
      brain and heart independent of insulin and thereby exert protective effects in the brain.
    

Detailed description: 
      Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence
      world wide. T2D is associated with a three-fold increase in cardiovascular complications
      (myocardial infarction and stroke) leading to significantly higher morbidity and mortality in
      this group of patients. The prospective British Diabetes Study (UKPDS) showed that neither
      diet alone nor the pharmaceutical treatment utilized (Sulphonylurea, Metformin, Insulin) were
      able to reduce these macrovascular complications. GLP-1 (glucagon-like-peptide-1)is an
      incretin with convincing effects on glycaemia in type 2 diabetic patients with little or no
      risk of hypoglycaemia. New research in animal models has shown a potential protective effect
      in the brain and heart in association with ischaemic damage. The mechanism behind this
      protective effect is not known. During hypoglycaemia the brain lacks glucose which is the
      main fuel for sufficient brain function. The brain will compensate by increasing glucose
      uptake across the blood brain barrier and similarly in the heart.

      The effect of native GLP-1 on glucose uptake in the brain and heart will by visualized by
      fluoro-deoxy-glucose FDG-PET-scan during hypoglycaemia in healthy men. At the same time a
      pancreatic/pituitary clamp will be performed. The hypothesis is that GLP-1 directly will
      stimulate glucose uptake independent of the pancreatic hormones and through this mechanism
      exert neuro- and cardioprotective actions.

      Comparisons: FDG-uptake in the brain and heart with GLP-1 infusion compared to placebo.
    

Intervention name(s): glucagon-like-peptide-1; placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusion of 1.2pmol/kg/min for 7 hours; intravenous infusion of 1.2pmol/kg/min
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GLP-1; glucose metabolism; Type 2 diabetes; brain; PET