bioihbjkbjnl/mcl2 huggingface dataset:
Mulligan Rotational Movement Versus Medial Gapping Technique in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis is a progressive degenerative and non-inflammatory joint disorder. Due to
      the extensive use and stress placed on knee joint, it is a common site for painful disorders
      such as knee osteoarthritis. It is seen that medial side of knee is most commonly affected
      because of weight bearing on medial side. Symptomatically, the knee joint is most commonly
      affected in osteoarthritis because it requires support, high mobility, and insufficient
      internal stability. Osteoarthritis of the knee joint affects three parts of the knee joint
      (medial, lateral, and patellar-femoral joints) and develops slowly, usually over 10-15 years,
      interfering with daily activities Slow and gentle movements like Tai Chi, Isometric,
      iso-kinetic and isotonic exercises are considered helpful in increasing joint range of motion
      and physical function. Stretching and aquatic therapy can also decrease pain and enhance
      joint flexibility. The aim of this study is to compare the effects of Mulligan rotational
      movement vs Medial gapping technique on pain, range of motion and disability in knee
      osteoarthritis.

      This study will be a randomized control trial and will be conducted in Riphah clinics and
      LGH. The study will be completed within the time duration of six months. Non-probability
      convenient sampling technique will be used to collect the data. Those who will meet the
      inclusion criteria will be recruited in the group. The sample size of patients with knee
      osteoarthritis will be taken in this study to find the effects of Mulligan Rotational
      movements vs. Medial gap technique, aged between 20-40 years, will be allocated to an
      intervention or control group. The scales used for recording findings will be goniometer,
      visual analogue scale and modified disability index. Subjects will randomly divide into
      control group called group A Taking Mulligan therapy and Interventional group called group B
      taking Median Gapping Technique. 12 sessions over 6 weeks were performed on both groups. Data
      analysis will be done by SPSS version 25.
    


Intervention name(s): MULLIGAN ROTATIONAL MOVEMENT; Medial gapping technique
Intervention type(s): Other; Other
Intervention description(s): 12 sessions over 6 weeks; 12 sessions over 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mulligan Rotational Movement; Medial Gapping Technique; Pain; Range of Motion; Knee Osteoarthritis
A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety and pharmacokinetics of
      linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin
      and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer
      (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in
      the subjects as first-line treatment.
    


Intervention name(s): Linifanib; Linifanib; Carboplatin; Paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Low dose linifanib (once a day); High dose linifanib (once a day); Given on Day 1 of every 21-day cycle; Given on Day 1 of every 21-day cycle
Other intervention name(s): ABT-869; ABT-869; Paraplatin; Taxol
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of High and Low Roasted Coffee on Vascular Response
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular
      effects. Coffee is a good source of phenolic compounds called chlorogenic acids (CGA),
      however the level of CGA is reduced during the roasting process.

      The aim of this study is to investigate the effect of coffee roasting on vascular response.
      The investigators hypothesize that coffee roasted to a lesser extent will exert a favourable
      vascular response over more heavily roasted coffee due to the higher levels of CGA.
    


Intervention name(s): Low roast coffee; High roast coffee; Control (Caffeine dissolved in water)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Instant coffee; Instant coffee; Caffeine dissolved in water
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
To Evaluate if Multiple Doses of Ketoconazole Change the Blood Concentration of YM150 (Darexaban)
Condition: Pharmacokinetics of Darexaban and Metabolites; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the effect of ketoconazole on the blood
      concentrations of darexaban and its metabolites (drug degradation products). The secondary
      objective of the study is to evaluate the safety and tolerability of a single dose of
      darexaban alone and when administered together with ketoconazole.
    

Detailed description: 
      This is an open-label, 2-period crossover study in young healthy male subjects to evaluate
      the effect of multiple once daily doses of ketoconazole on the pharmacokinetics (PK) of
      darexaban and metabolites after a single dose of darexaban. In addition, safety and
      tolerability of darexaban administered alone and in combination with ketoconazole, is
      evaluated. Eligible subjects are admitted to the clinical unit in the morning of Day -1. The
      subjects are randomized to receive either first darexaban plus ketaconazole and then
      darexaban alone, or first darexaban alone followed by darexaban plus ketoconazole.
    

Intervention name(s): darexaban; ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): YM150; Nizoral
Intervention MeSH terms: Ketoconazole; Darexaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; darexaban; ketoconazole; Phase 1
Effect of Exercise on Metabolic Health
Condition: Obesity
Study type: Interventional

Summary: 
      One of the main objectives of this study will be to assess potential differences in important
      risk factors associated with Metabolic Syndrome in overweight adults who do not participate
      in a regular exercise program compared with overweight individuals who do exercise regularly.
      In addition, we will determine the effects of a single, modest session of exercise on the
      body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults
      vs. obese adults who live a physically active lifestyle. Our study focuses on identifying
      mechanisms responsible for improved insulin action related to regular exercise and to provide
      novel targets for preventing and treating type 2 diabetes.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): single session of exercise
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin Sensitivity; Exercise; Metabolism
A Comparison Chocolate With and Without High Cocoa Solids in Patients With Type 2 Diabetes in a Randomised Clinical Trial
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 diabetes is being acknowledged as a potential public health time bomb, whose incidence
      is predicted to double over the next 10 years in the UK, associated with the rise in obesity
      and increasing sedentary lifestyles. Increased insulin resistance has been shown to be an
      important feature of type 2 diabetes (especially in those presenting with obesity and in
      particular visceral or abdominal obesity). Insulin resistance is implicated as a risk factor
      of cardiovascular disease and may lead to pancreatic dysfunction through increased β-cell
      stress in the pancreas. A combination of insulin resistance and pancreatic beta cell failure
      then leads to type 2 diabetes. The main cause of morbidity and mortality in type 2 diabetes
      is cardiovascular disease as the condition is associated with impaired vascular functioning
      and increased levels of oxidation markers.

      Epidemiological studies suggest dietary flavonoids decrease the risk of death from coronary
      heart disease, cancer, and stroke. Flavonoid-rich foods include fruits and vegetables as well
      as tea, red wine, and chocolate. In a cohort of elderly men, cocoa intake was inversely
      associated with blood pressure and 15-year cardiovascular and all-cause mortality. It has
      been reported that in healthy humans, consumption of flavanol-rich dark chocolate decreased
      daytime and night time blood pressure, reduced insulin resistance, and improved nitric oxide
      dependent vaso-relaxation. Another trial found that cocoa powder increased postprandial
      insulinaemia in lean young adults. These research papers have led to the hypothesis that
      chocolate containing high cocoa liquor may help to reduce the risk of developing type 2
      diabetes.

      This study is design as a double-blind, controlled, single center, randomized, parallel
      design clinical trial. The primary outcome measure is to compare parameters of insulin
      resistance and glycaemic control in volunteers with type 2 diabetes after consumption of 3
      different chocolates (one dark and two milk chocolates) with a secondary outcome of
      endothelial function, cholesterol profile and oxidative stress. Subjects will undergo medical
      screening, anthropometry, physical activity and dietary assessments before randomization.
    


Intervention name(s): Cocoa Polyphenols
Intervention type(s): Other
Intervention description(s): 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: diabetes type 2; insulin resistance; glycaemic control; Endothelial function; Cocoa Polyphenols
Effect of Phytosterols on Nonalcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Phytosterols are plant sterols . Phytosterols have anti-inflammation effect. Investigators
      have a hypothesis: phytosterols reduce oxidative stress , enhance Insulin-like growth
      factor-1(IGF-1) and endothelial progenitor cells(EPCs). Therefore, phytosterols has novel
      role in cardiovascular protection.
    

Detailed description: 
      Fatty liver is the hepatic feature of metabolic syndrome. Metabolic syndrome increase the
      risk of atherosclerosis and cardiovascular disease. Adipose tissue secrete adipocytes
      accumulate in the liver result in fatty liver. Excess fat become low density
      lipoprotein-cholesterol(LDL-C) from liver. Oxidized- LDL-C adherence in the vessel result in
      atherosclerosis via inflammation and immune response.

      Phytosterols are present in the nuts, plant oil, broccoli and so on. The structure of
      phytosterols are similar with cholesterols. After the competition, the smaller absorption of
      cholesterols. Studies showed the average consumptions of phytosterols were 200mg daily but
      the enough amount for cardiovascular protection of phytosterols were 2000mg daily.

      Daily 2000mg phytosterols inhibit the absorption of intestine, reduce the LDL-C about 7-10%.
      Besides, phytosterols have the effect of anti-inflammation and anti-immune response. The
      anti-inflammation effect obvious inhibit the monocyte to transform to macrophage, inhibit the
      formation of foam cell.

      Clinical studies divided into two groups: 20/20 patients and 4 weeks follow up with
      cross-over test.First group A: Phytosterols 1800mg/day for 4 weeks ,washout 2 weeks, then
      placebo 4 weeks. Another group B: placebo 4 weeks, washout 2 weeks, then phytosterols 4
      weeks.Cross-over, double blind study was designed.

      Investigators check the possible benefits of LDL-C, Total -cholesterol,anti-oxidant
      capacity,C reactive protein,insulin-like growth factor-1, endothelial progenitor cells ; the
      possible side effect including liver function,muscle enzyme .
    

Intervention name(s): Phytosterols & placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Phytosterols; Endothelial progenitor cells
Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)
Condition: Influenza; Pandemic Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to assess the dose-related safety and immunogenicity of six
      different dose levels of inactivated, Vero cell-derived reverse genetic reassortant
      A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will
      receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be
      drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body
      temperature will be measured daily for 6 days following vaccination. Injection site reactions
      and systemic reactions will be monitored throughout the entire 180 days of the study. Safety
      data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be
      reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to
      proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.
    


Intervention name(s): H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)
Intervention type(s): Biological
Intervention description(s): 2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant)
Intervention MeSH terms: Hemagglutinins; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Lexaptepid Pegol (NOX-H94) in ESA-hyporesponsive Anemia in Dialysis Patients
Condition: Anemia; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Dialysis patients regularly suffer from anemia which may be caused by various contributing
      factors, alone or in combination, including blood loss, low erythropoietin and iron
      sequestration. In most patients, the anemia is responsive to treatment with erythropoietin or
      other erythropoiesis stimulating agents (ESA) alone or in combination with intravenous (i.v.)
      iron. In about 10% of patients however, the anaemia does not respond appropriately to this
      standard treatment and high to very high doses of ESA and i.v. iron are used to maintain
      acceptable hemoglobin concentrations. In these patients, hepcidin was identified as a
      causative factor leading to anemia of chronic disease with functional iron deficiency and
      ESA-hyporesponsiveness.

      The Spiegelmer lexaptepid pegol (NOX-H94) offers a hepcidin-specific approach to the
      treatment of anemia of chronic disease. The safety and the activity of lexaptepid pegol are
      supported by data from healthy subjects and patients with multiple myeloma or lymphoma. The
      present study in dialysis patients with functional iron deficiency and ESA-hyporesponsiveness
      is conducted to demonstrate the safety of lexaptepid pegol in this population, to investigate
      its pharmacokinetic (PK) and pharmacodynamic (PD) profiles and its efficacy in increasing
      haemoglobin (Hb) in dialysis patients.
    


Intervention name(s): Lexaptepid pegol (NOX-H94); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): anti-hepcidin L-RNA-aptamer (Spiegelmer)
Other intervention name(s): NOX-H94
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dialysis
The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.
Condition: Nephrectomy
Study type: Interventional

Summary: 
      The main purpose of this study is to evaluate the postoperative effect of erector spinae
      block in patients undergoing nephrectomy that causes both visceral and somatic pain.
    

Detailed description: 
      After being informed and potential risks about the study, all patients have given written
      consent will undergo 24 hours screening for the analgesic effect of erector spinae block
      after nephrectomy. Patients meeting the criteria were randomly selected in double-blind
      manner 1:1 ratio to erector spiane block or not.
    

Intervention name(s): erector spinae block (ESP)
Intervention type(s): Procedure
Intervention description(s): Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: It is a single centre, randomized, prospective method comparison study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: erector spinae block; nephrectomy; ultrasound
A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
Condition: Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome; Weight Loss
Study type: Interventional

Summary: 
      The present study is designed to examine the effect of changes in body weight and related
      parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter
      proposed to be studied here is the impact of fructose restriction and weight loss on serum
      uric acid concentrations and arterial stiffness.
    

Detailed description: 
      It is well know that consumption of a calorically-restricted diet helps people lose weight.
      Such a diet with low carbohydrate lowers the serum uric acid concentration which is a factor
      associated with obesity and also represents a particular metabolic risk in women compared to
      men. The present weight loss study will determine whether women benefit more than men to
      short-term weight loss occurring during restriction of simple sugars.

      Specifically, this study is designed to cause weight loss acutely through consumption of a
      diet that is restricted in calorie and simple sugars. Both men and women will be studied and
      their results compared to determine whether women benefit more with respect to arterial
      stiffness. Upon finishing the four-week diet intervention, body weight and blood lipids will
      be assessed two and four weeks later to compare the longer term effect on blood pressure.
    

Intervention name(s): "Grab-and-Go" meal plan; "Jump-Start" meal plan
Intervention type(s): Other; Other
Intervention description(s): The "Grab-and-Go" meal plan will provide Atkins shakes and bars for breakfast, lunch, and snacks. For dinner, the participant will receive a freshly-prepared meal. There will be no difference in terms of calories or nutrient composition between "Grab-and-Go" meal plan versus "Jump-Start" meal plan.
The amount of weight loss caused by these two meal plans is not expected to differ.; The "Jump-Start" plan will provide Atkins frozen meals at breakfast, lunch and dinner and these meals will be supplemented with fresh salads and vegetables. There will be no difference in terms of calories or nutrient composition between "Grab-and-Go" meal plan versus "Jump-Start" meal plan. The amount of weight loss caused by these two meal plans is not expected to differ.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gender; arterial stiffness; blood pressure; weight loss; uric acid
A Pilot Study To Evaluate the Effects of Lactobacillus Supplements
Condition: Feasibility Studies
Study type: Interventional

Summary: 
      This is a feasibility study to evaluate a decentralized (remote) clinical trial in Korea. In
      this study, an open-label, randomized, remote clinical trial to evaluate the effects of
      lactobacillus supplements on alleviating functional constipation symptoms in poor-health
      volunteers will be conducted.
    

Detailed description: 
      This study was designed for the purpose of confirming the feasibility of conducting a
      distributed clinical trial in the domestic medical environment and practically checking the
      considerations during implementation. This clinical trial aims to evaluate the effectiveness
      of interventions for functional constipation, a chronic disease, through the design of a
      fully distributed clinical trial, which is the most advanced form of distributed clinical
      trial. There are many patients with functional constipation around the world, and the need
      for a comparative randomized clinical trial for new treatments is being emphasized. It is
      expected to have a high potential for use in that it can be evaluated as In particular,
      health functional food preparations such as lactobacillus preparations have been reported to
      have effects on functional constipation, but it is difficult to prove their effectiveness due
      to the heterogeneity of clinical trial design5, so it can be considered as an application
      field for distributed clinical trials.

      For this purpose, we intend to try an exploratory clinical trial to evaluate the
      effectiveness of lactic acid bacteria preparations in a distributed environment. In this
      clinical trial, patients are recruited remotely through a website, and visits to medical
      institutions are minimized by delivering lactic acid bacteria to home delivery and evaluating
      symptom improvement through self-recording symptoms. In addition, it is intended to ensure
      the accuracy of the collected data by having the urine vitamin C test be performed by oneself
      to check whether the drug is administered or not. Through this, it is expected that issues
      and considerations that may arise when designing distributed clinical trials in the future
      can be derived.
    

Intervention name(s): Lactobacillus plantarum; Vitamin C
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus product 1 pack daily; Vitamin C tablet 1 pack daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other