bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People
Condition: Obesity; Insulin Resistance; Inflammation; Blood Glucose, High
MeSH terms: Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      This study evaluates the effect of balanced and sustainable diet application on fat
      composition, insulin resistance and inflammation marker in obese people.

      Intervention: Obese subject will receive intervention on balanced and sustainable diet
      application Control: Obese subject will receive a balanced diet application only
    

Detailed description: 
      Maintaining the adherence of weight loss programme while selecting healthy and sustainable
      foods will become a worldwide future challenge in nutrition. Therefore, we investigated the
      suitable content, graphic, and flow in developing a mobile application as an alternative
      solution for enhancing the compliance of weight control and selecting healthy food with the
      least environmental impact.

      The treatment for obesity consists of dieting, physical exercise, pharmacology, and surgery.
      Restricted balanced diet is a well known diet recommendation for people with obesity.
      Sustainable diet is an alternative form of diet which contributes to healthy life and is
      protective of biodiversity.

      The main challenge in obesity management is the sustainability of weight loss programme.
      Mobile apps are an alternative solution for enhancing compliance.
    

Intervention name(s): balanced and sustainable diet
Intervention type(s): Other
Intervention description(s): the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.
the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group balance diet One group balance and sustainable diet
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity
The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      Exposure to air pollution has been linked to increased cardiorespiratory morbidity and
      mortality. The exact component of air pollution that mediates this effect is unknown, but the
      link is strongest for fine combustion derived particulate matter derived from traffic
      sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs
      vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these
      detrimental vascular is unclear, but is thought to be via oxidative stress and altered
      bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of
      endogenous nitric oxide synthase isoforms (NO) in the adverse vascular responses observed
      following exposure to diesel exhaust.
    


Intervention name(s): Forearm vascular study
Intervention type(s): Procedure
Intervention description(s): Forearm venous occlusion plethysmography to measure forearm blood flow during intrabrachial infusion of nitric oxide synthase inhibitors L-NMMA (2-8 µg/min), S-methionyl-L-citrulline (25-200 nmol/min) and 1400W (100-1000 nmol/min) and positive control norepinephrine (60-540 pmol/min)
Other intervention name(s): 1400W; SMTC; L-NMMA; Noreadrenaline; NorAd
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Air Pollution; Nitric Oxide; Nitric Oxide Synthase; Diesel exhaust; endothelial dysfunction
Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates
Condition: Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might
      yield functional results comparable to OP but with lower perioperative morbidity, and have
      equivalent long-term efficacy with OP for large prostates. The first objective was to
      demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year
      postoperatively.

      To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP
      with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up
      period of 6 years.
    


Intervention name(s): PkEP; OP
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"Mobile Stroke Unit"-Concept for Delivery of Specialized Acute Stroke Care to Patients in Remote Areas
Condition: Acute Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety
      and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site
      for hyperacute treatment and transfer to the most appropriate target hospital. The effects on
      reduction delays until different stroke treatments will be assessed. First estimations of
      cost-effectiveness will also be performed.
    

Detailed description: 
      Stroke is a medical emergency for which "time-is-brain". Indeed, a huge body of animal
      experimental and clinical evidence exists that demonstrates that reducing the time to
      thrombolytic therapy is the most important variable in prevention of the disability. However,
      most stroke patients arrive to hospital too late for any type of acute stroke treatment: Only
      an estimated 19-60% of stroke patients present within 3 hours after symptom onset. Today, for
      stroke patients 3 different treatment options exist.

        1. Thrombolysis with recombinant tissue plasminogen activator (rt-PA) is an effective
           treatment for many acute stroke patients as evidenced by several large randomized
           trials.

        2. More recently, mechanical clot removal via catheters has been developed. There is
           currently increasing evidence that in obstruction of large brain vessels such
           endovascular treatment is superior to systemic thrombolysis in regard to recanalization
           rates and outcome.

        3. Patients with intracranial hemorrhage can profit if transferred to hospitals with
           neurosurgical treatment options such as ventricular drainage or hematoma removal.

      However, each of these treatment are highly time sensitive and due the availability of
      endovascular and neurosurgical treatment options only in very few highly specialized
      neurovascular centres decision in which institution the patient should be transported is of
      high medical and financial relevance. The aim of this trial is to show feasibility, safety
      and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site
      and its role in decision regarding transfer to appropriate target institution, thus
      potentially allowing reduction of time until treatment and delays until specialized treatment
      also in remote regions. First estimations of cost-effectiveness will also be performed.
    

Intervention name(s): MSU-based stroke management; Control stroke management
Intervention type(s): Device; Device
Intervention description(s): Prehospital stroke treatment with a mobile stroke unit; Conventional stroke management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: acute stroke; prehospital; treatment
Weight Loss Study for People With Type 2 Diabetes
Condition: Type 2 Diabetes; Overweight; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the Weight Watchers program modified for
      use by people with Type 2 diabetes results in more improvements in blood glucose control
      relative to a control group receiving standard diabetes counseling.
    


Intervention name(s): Weight Watchers modified program; Standard Care group
Intervention type(s): Behavioral; Other
Intervention description(s): Weight Watchers: For people with Type 2 diabetes including (1) weekly standard in-person Weight Watchers meetings, (2) use of the standard Weight Watchers online program and tools, and (3) two scheduled telephone consultations with a Certified Diabetes Educator (CDE) who will assist the participant in tailoring the standard Weight Watchers program to accommodate the participant's diabetes-related status, with additional unlimited phone and email access to CDEs at the participant's request; One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; HbA1c; Overweight; Obesity
A Study of LY2605541 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at the amount of LY2605541 in the body after it is injected under the skin.
      The study has 3 periods, each lasting 10 days. Each participant will receive one injection in
      each period. At least 14 days will pass between each injection.
    


Intervention name(s): LY2605541
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the
      Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).
    


Intervention name(s): V710 (30 µg) with MAA; V710 (30 µg) without MAA
Intervention type(s): Biological; Biological
Intervention description(s): Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly; Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Bacterial Vaccines; Staphylococcus Aureus; Adjuvanted Vaccine
Diet, Imaging and Energy Balance Trial (DIET)
Condition: Obesity
Study type: Interventional

Summary: 
      To evaluate whether changes in macronutrient consumption (i.e., switching to a diet low in
      carbohydrates) can change brain responses to cues depicting foods representing that
      macronutrient. In addition to answering specific questions regarding the effects of an LCKD,
      the study will provide general information about relations between brain responses to food
      cues and a broad arrive of factors including typical diet, food preferences, weight control
      history and genes.
    

Detailed description: 
      We propose a parallel arm randomized clinical trial of two diets-a low carbohydrate ketogenic
      diet (LCKD) and a low fat diet (LFD). Following screening, eligible participants will undergo
      a six week dietary intervention that will include 7 clinic visits at the Duke Lifestyle
      Medicine Clinic (Director: Dr. Westman). In addition to the dietary intervention,
      participants will undergo fMRI scanning on two occasions: once in the week prior to
      randomization to a diet (Baseline Scan) and after three weeks of following a diet (Post-Diet
      Scan). During scanning participants will view food cues in order to assess the effects of
      diet on brain responses to different macronutrient content categories (e.g., High vs. Low
      Complex Carbohydrate). In addition to scanning measures, we will also record information
      regarding dietary intake, food preferences, weight, mood, and diet adherence.
    

Intervention name(s): Low Carbohydrate Ketogenic Diet (LCKD); Low Fat Diet (LFD)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): participants will follow a low carbohydrate ketogenic diet for six weeks; particpants will follow a low fat diet for six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obese; overweight; fMRI; Diet
The Oxford Optimisation of PCI Study (OXOPT-PCI Study)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The OxOPT-PCI study addresses patients with coronary artery disease who are referred to the
      John Radcliffe Hospital because of the need for treatment with an intra-coronary stent (metal
      scaffold) for clinical reasons. Although, this has become a highly standardised procedure it
      is still challenging for the clinician to assess the final success of this procedure at the
      end of intervention with conventional methods. This shortcoming can potentially translate
      into a worse clinical outcome for approximately 10 percent of all patients treated with an
      intra-coronary stent for this type of disease.

      This study (OxOPT-PCI) investigates if the use of blood flow measurements (namely measurement
      of fractional flow reserve (FFR)) and intravascular imaging (namely optical coherence
      tomography (OCT)) after the implantation of a stent can improve the treatment result for
      these patients. Both, FFR and OCT are being used already in daily clinical routing but their
      usefulness especially in combination is not clear. In order to standardise the optimisation
      procedure we developed a specific algorithm to make sure that all patients receive the same
      optimisation measures based on the assessment of FFR and OCT.

      The benefit of this specific optimisation algorithm will be assessed by measuring 1) indices
      of coronary blood flow, 2) intravascular imaging at the end of the procedure, and 3) by
      contacting the patients 12 months after stenting to verify the clinical mid-term success.
    


Intervention name(s): Optimisation of the result of intracoronary stenting according to specific algorithm
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis
Condition: Tennis Elbow; Lateral Epicondylitis; Tendinopathy
MeSH terms: Tendinopathy; Tennis Elbow
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of Radial Extracorporeal Shockwave Therapy
      (rESWT) treatment and Deep Friction Massage (DFM) treatment on pain, functionality, grip
      strength (GS), edema, range of motion (ROM) of the elbow and quality of life in individuals
      with chronic lateral epicondylitis (CLE).

      36 individuals diagnosed with CLE will be randomly divided into two equal groups. rESWT
      treatment will be applied to Group 1 and DFM treatment to Group 2. Visual analogue scale will
      be used to assess pain severity, functionality with Patient-Rated Elbow Evaluation Turkish
      version (PRTEE-T), GS with digital dynamometer, ROM of the elbow joint with goniometer, edema
      with environmental measurement, and quality of life with Short Form 36 (SF-36).
    


Intervention name(s): Radial Extracorporeal Shock Wave Therapy; Deep Friction Massage
Intervention type(s): Other; Other
Intervention description(s): Radial Extracorporeal Shock Wave Therapy will given for 3 weeks, 1 days in a week. moreover 10-12 minutes cold pack will apply for every session; Deep Friction Massage will given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block
Condition: Atrioventricular Nodal Disease
Study type: Interventional

Summary: 
      Recently, the concept of physiological pacing has emerged in the clinical practice, in an
      attempt to prevent the deteriorating effects of right ventricular pacing in the long-term.
      Left bundle branch pacing seems to be a safe procedure with promising results that may
      prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.
    

Detailed description: 
      In this prospective, randomized study the outcomes regarding echocardiographic indices of
      dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients
      with atrioventricular node disease will be compared In recent years, His pacing has
      demonstrated better results regarding resynchronization compared to conventional
      biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to
      unstable lead positioning or inability in succeeding low pacing threshold have led to low
      success rates. An alternative site of physiological pacing that could possibly overcome these
      issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead
      implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead
      is screwed into the interventricular septum, until left bundle branch pacing is achieved. The
      randomized patients 24 hours after the procedure are echocardiographically evaluated and
      indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months
      and one year post-procedure.
    

Intervention name(s): Left bundle branch pacing lead (Select Secure 3830 lead); Right ventricular active fixation lead
Intervention type(s): Device; Device
Intervention description(s): Implantation of a left bundle branch pacing lead via sheath; Active fixation lead (standard)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the absorption of four different inhalation products
      with the reference product in healthy volunteers.
    

Detailed description: 
      Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products
      and two reference inhalation products according to a five-period cross-over design. Plasma
      tiotropium levels will be measured pre-dose and over 48 hours post-dose.
    

Intervention name(s): Tiotropium
Intervention type(s): Drug
Other intervention name(s): Spiriva
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inhalation; anticholinergic
A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine
      type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.
    

Detailed description: 
      Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE
      recommendations at the time of writing this protocol. After this cessation of OPV2,
      stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future
      outbreak. However, there is a risk of cVDPV2 from Sabin 2 in settings of low population
      immunity. Research is ongoing to develop vaccines that are genetically more stable than the
      currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and
      genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio
      vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is
      performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability
      endpoints of mOPV2 in children aged 1 to 5 years for better understanding of the stockpile
      use of this vaccine, and any potential new polio vaccine with a type 2 component in the
      future.
    

Intervention name(s): Sabin mOPV2
Intervention type(s): Biological
Intervention description(s): Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate.
One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine.
Other intervention name(s): mOPV2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Diet and Nutritional Status of Adolescent Girls in Zambézia, Mozambique
Condition: Nutritional Status; Diet
Study type: Observational

Summary: 
      Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique
      was collected. A cross-sectional study was carried out in 2010 in two seasons,
      January-February and May-June. Participants (total n=551) were recruited from Quelimane (the
      provincial capital), Maganja da Costa district and Morrumbala district.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adolescent girls living in Quelimane city, Maganja da Costa district and Morrumbala
        district.
      
Biospecimen description: 
      Blood, urine, buccal cells
    
Keywords: Adolescent girls; Mozambique; Diet; Anthropometrics; Serum biomarkers