bioihbjkbjnl/mcl2 huggingface dataset:
Study of TNF-Antagonism in the Metabolic Syndrome (II)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study will investigate whether etanercept will result in improved inflammatory indices,
      glucose tolerance and endothelial function in patients with the metabolic syndrome.
    

Detailed description: 
      Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of
      type II DM (diabetes mellitus) and cardiovascular morbidity and mortality. A subclinical
      inflammatory state is thought to contribute to the pathophysiology of metabolic syndrome,
      insulin resistance, and coronary artery disease (CAD). Tumor Necrosis Factor (TNF) -alpha is
      an inflammatory cytokine that is increased in a spectrum of inflammatory diseases as well as
      in insulin resistance. TNF-alpha antagonists are clinically effective in the inflammation of
      arthritides, and have recently been shown by our group to decrease inflammatory
      cardiovascular risk markers in metabolic syndrome. Data suggests that adiponectin, a recently
      discovered adipocytokine that may protect against the development of insulin resistance and
      atherosclerosis, may be downregulated by TNF-alpha. In addition, population based studies
      have shown that those with the highest levels of TNF-alpha have an increased relative risk of
      cardiovascular morbidity while rheumatoid arthritis patients treated with TNF-alpha blockade
      appear protected from cardiovascular disease. We will perform a 6-month study in which we
      will administer etanercept, a TNF-alpha receptor fusion protein, to subjects with metabolic
      syndrome to investigate its effect on surrogate markers of cardiovascular disease, including
      inflammatory markers, adiponectin and glucose tolerance and endothelial function. The results
      of the proposed study will have broad implications regarding the physiological role of
      TNF-alpha on the inflammatory cascade, cardiovascular indices and endothelial function.
    

Intervention name(s): Etanercept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg one syringe sc 2X per week for three months followed by 50 mg one syringe sc 1X per week for three months; 50 mg one syringe sc 2x per week for three months followed by 50 mg one syringe sc 1X per week for three months
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inflammation; Visceral adiposity; TNF; Adiponectin; glucose tolerance; endothelial function; metabolic syndrome
Routine Nasobiliary Insertion During ERCP in High Risk Patients.
Condition: Gallstones Complicated by CBD Stones
MeSH terms: Gallstones
Study type: Interventional

Summary: 
      110 patients with common bile duct (CBD) stones and had one or more anther preoperative
      predictors for high risk for difficult cholecystectomy admitted to departement of surgery of
      Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient
      divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP
      after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done
      within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and
      methylene blue injected at the end of the procedure to detected any leak in NB group
    

Detailed description: 
      110 patients with common bile duct (CBD) stones and had one or more anther preoperative
      predictors for high risk for difficult cholecystectomy as , age > 65 , male sex, obesity,
      acute cholecystitis, previous upper abdominal surgery, and certain ultrasonographic findings
      i.e. distended gall bladder (GB), thickened GB wall, pericholecystic fluid collection and
      impacted stone etc. these patients admitted to department of surgery of Minia university
      hospital for ERCP followed with laparoscopic cholecystectomy (LC). the patient divided into 2
      equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP to settle high up
      in the intrahepatic biliary tree after complete CBD clearance. In group 2, only CBD clearance
      was done. In all patients LC was done within the same week of ERCP. sequential, multiple,
      step after step, tans-nasobiliary Intraoperative cholangiography was done during every step
      in cholecystectomy especially during dissection of calot's triangle and just before clipping
      of supposed cystic duct (CD) to make sure that the structure supposed to be CD was not the
      CBD. after the end of procedure methylene blue is injected from the the NB to detected any
      leak and if present
    

Intervention name(s): ERCP with NB; ERCP alone
Intervention type(s): Procedure; Procedure
Intervention description(s): ERCP with NB catheter for introperative tans-nasobiliary cholangiography; ERCP alone followed with standard laparoscopic cholecystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Effect of Skate Skin Extract on Cognitive Function in Adults
Condition: Subjective Memory Impairment
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of Skate Skin extract on cognitive function in adults with subjective memory
      impairment for 12 weeks.
    

Detailed description: 
      Previous animal studies have indicated that Skate Skin extract may have the ability to
      improve cognitive function. Therefore, the investigators conduct a randomized, double-blind,
      placebo-controlled study to investigate the effects of Skate Skin extract on cognitive
      function in adults with subjective memory impairment for 12 weeks; the safety of the compound
      are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive
      function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults
      were administered either 500 mg of Skate Skin extract or a placebo each day for 12 weeks;
    

Intervention name(s): Skate group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This group takes 500 mg/day Skate Skin extract for 12 weeks; This group takes 500 mg/day Placebo for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Effect of GS-6615 in Subjects With LQT-3
Condition: Long QT Syndrome
MeSH terms: Long QT Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval
      in participants with Long QT-3 syndrome. This study will be performed in six cohorts of
      participants in a sequential manner, four single-dose cohorts followed by two multiple-dose
      cohorts. Duration of treatment for the single-dose cohorts and multiple-dose cohorts will be
      1 day and 7 days, respectively. Participants will be confined at the study center from
      check-in until completion of assessments at discharge.

      Participants will be continuously monitored using real-time telemetry throughout the
      in-clinic confinement. Physical examinations including vital signs, laboratory analysis,
      electrocardiograms (ECGs), Holter recordings and echocardiography (ECHO) will be performed at
      defined time points throughout the study period. Assessment of adverse events and concomitant
      medications will continue throughout the duration of the study.
    


Intervention name(s): GS-6615
Intervention type(s): Drug
Intervention description(s): GS-6615 tablet(s) administered orally
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Long QT Syndrome; LQTS; Long QT-3 Syndrome; LQT-3; prolonged QT interval; GS-6615; late sodium current inhibitor
Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Aim: Steroid injections are remarkably effective as a treatment for carpal tunnel syndrome
      (CTS) in the short term. The aim of this study was to determine whether hydrodissection would
      provide an additional clinical effect when used along with a corticosteroid in the short
      term.

      Methods: A prospective cohort of patients with CTS were retrospectively evaluated. 28
      patients were selected randomly who received ultrasound (US)-guided triamcinolone
      hydrodissection (3 mL) as intervention group and received US-guided triamcinolone injection
      (1 mL) as control group, from the data (case-control ratio 1:1). Outcome measures were the
      Boston Carpal Tunnel Questionnaire (BCTQ), hand grip strength (HGS), fhe cross-sectional area
      (CSA) of the median nerve and Short Form 12 (SF-12). Assessments were recorded at baseline, 1
      and 4 weeks after injection.
    

Detailed description: 
      Background: Steroid injections are remarkably effective as a treatment for carpal tunnel
      syndrome (CTS) in the short term.

      Aim: To determine whether hydrodissection would provide an additional clinical effect when
      used along with a corticosteroid in the short term.

      Methods: A prospective cohort of patients with CTS were retrospectively evaluated. 28
      patients were selected randomly who received ultrasound (US)-guided triamcinolone
      hydrodissection (3 mL) as intervention group and received US-guided triamcinolone injection
      (1 mL) as control group, from the data (case-control ratio 1:1). Outcome measures were the
      Boston Carpal Tunnel Questionnaire (BCTQ), hand grip strength (HGS), fhe cross-sectional area
      (CSA) of the median nerve and Short Form 12 (SF-12). Assessments were recorded at baseline, 1
      and 4 weeks after injection.
    

Intervention name(s): Corticosteroid Hydrodissection; Corticosteroid Injection
Intervention type(s): Other; Other
Intervention description(s): The median nerve was examined by US at the scaphoid-pisiform level of the inlet of carpal tunnel. The hydrodissection was achieved by a total volume of 3 mL (1 mL of triamcinolone and 2 mL of saline) in the intervention group based on a study identifying median nerve hydrodissection with this volume. Half of the total volume (1.5 mL ) was delivered via the in-plane ulnar approach and the other half (1.5 mL) via the in-plane median approach to create a fluid plane along the nerve.; 1 mL of triamcinolone was delivered via the in-plane ulnar approach
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carpal tunnel syndrome; ultrasonography; hydrodissection; steroid injection
A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure (MK-8141-006)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood
      pressure in patients who have hypertension (high blood pressure).
    


Intervention name(s): MK8141; Comparator: placebo (unspecified); Enalapril
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period; MK8141 Pbo tablet once daily. 4 week treatment period.; Enalapril 20 mg tablet once daily. 4 week treatment period.
Other intervention name(s): Vasotec®
Intervention MeSH terms: Enalapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was designed to determine if Androxal® would affect sperm parameters (count,
      concentration, volume) in men with secondary hypogonadism who have been previously treated
      with topical testosterone.
    

Detailed description: 
      The study was designed to determine if Androxal® would affect sperm parameters (count,
      concentration, volume) in men with secondary hypogonadism who have been previously treated
      with topical testosterone. A maximum of twelve subjects per group were randomized to daily
      treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was
      later amended to include a treatment group who received Androxal after a 3 month wash out
      period.
    

Intervention name(s): 25 mg Androxal; Testim 1%
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg Androxal capsules, 1 capsule daily for 6 months; Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
Other intervention name(s): Enclomiphene citrate; Topical testosterone
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH); Secondary hypogonadism; Semen volume; Sperm count; Sperm motility
Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee
Condition: Articular Cartilage Disorder of Knee; Articular Cartilage; Degeneration
MeSH terms: Cartilage Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled,
      parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage
      lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy
      of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic
      acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC
      therapy can improve functional outcome and reduce pain of the knee joint better than a
      standard treatment (HA injections and physiotherapy regimen).
    

Detailed description: 
      This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled,
      parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage
      lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy
      of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic
      acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC
      therapy can improve functional outcome and reduce pain of the knee joint better than a
      standard treatment (HA injections and physiotherapy regimen).
    

Intervention name(s): Autologous peripheral blood stem cells and hyaluronic acid; Hyaluronic acid
Intervention type(s): Biological; Other
Intervention description(s): Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy; Regimen of intra-articular HA injections and postoperative physiotherapy
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Trial to Test a Nutrition Application for Making Smart and Healthy Choices
Condition: Diet Modification; Obesity
Study type: Interventional

Summary: 
      An innovative nutritional application (App) entitled "MyNutriCart" was developed to create a
      list of foods and beverages to help individuals make smart and healthy choices when
      purchasing foods at grocery stores based on the Dietary Guidelines for Americans. This App
      was tested in a pilot trial to evaluate its feasibility, usability, and acceptability for
      making smart and healthy choices when purchasing food in grocery stores and test its
      effectiveness in improving food selection, dietary patterns, and weight status compared with
      the traditional nutritional counseling.
    

Detailed description: 
      An innovative nutritional application (App) entitled "MyNutriCart" was developed to create a
      list of foods and beverages to help individuals make smart and healthy choices when
      purchasing foods at grocery stores based on the Dietary Guidelines for Americans. A pilot
      randomized clinical trial was done to test the effectiveness of this App on food selection
      and purchase, dietary patterns, and weight loss during two months of intervention. We also
      assessed feasibility, usability, satisfaction and acceptability of the App. A total of 138
      overweight and obese adults aged 21-45 years old who own a Smartphone were invited to
      participate in this study. Participants were randomized into two groups; (1) the intervention
      group used the App, which generated a healthy grocery list to use when purchasing foods in in
      the supermarket; (2) the control group had a traditional intervention with a nutritionist. To
      assess the impact of the intervention on dietary patterns, participants completed three
      24-hour dietary recalls, a short food frequency questionnaire (FFQ) and provided grocery
      receipts at baseline and at the end of the study (8 weeks later). Weight and height were also
      performed before and after the intervention. Feasibility, usability, satisfaction, and
      acceptability of the nutrition App were assessed at the end of the study using a
      questionnaire.
    

Intervention name(s): Smartphone Application; Traditional Nutritional Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The smartphone Application generates a shopping list for participants, based on a low caloric diet (energy requirements minus 500 kcals), taking into consideration the Dietary Guidelines for Americans' recommendations and also considering the available budget for each shopping event and the weekly discounts from major supermarkets.; Participants will have a face-to-face counseling session with a registered dietitian, who will provide recommendations for a low caloric diet (energy requirements minus 500 kcals) using the food group sheets from the Dietary Guidelines for Americans.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.
Condition: Fever; Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the acceptability over 24 hours of a new paracetamol formulation 4.8% paediatric
      oral suspension in children weighing between 3 and 26 kg including limits
    


Intervention name(s): paracetamol 4.8% paediatric oral suspension
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Does Consuming Modified Plant Seed Oil Containing Fish Oil Fatty Acids Act in the Same Way as Consuming Fish Oil?
Condition: Healthy
Study type: Interventional

Summary: 
      Fish oil and oily fish contain omega 3 long chain polyunsaturated fatty acids known to be
      beneficial to health. Many people consume little, despite UK government recommendations to
      eat at least one portion of oily fish per week. Furthermore, despite modest consumption, fish
      stocks are declining due to over fishing. Therefore, there is a need for an alternative,
      sustainable and cost efficiently produced dietary source. A seed oil source of these fish
      oil-type fatty acids has been achieved by adding genes from other plant sources to the oil
      seed plant Camelina sativa. Camelina sativa, related to mustard and cabbage, has provided
      seed oil for human consumption for thousands of years. It was the most important oil seed
      plant in Europe until the 1900's. This research is being done to see if consuming fish
      oil-type fatty acids in Camelina seed oil allows the body to take up and use the fish oil
      fatty acids in the same way as it does from fish oil.
    

Detailed description: 
      This research is being done to see if consuming fish oil-type omega 3 long chain
      polyunsaturated fatty acids in Camelina seed oil allows the body to take up the fish oil
      fatty acids in the same way as it does from fish oil.

      In the first study (A) the Camelina oil will be used in a meal. The volunteers (healthy men
      and women) will be asked to consume the meal and provide blood samples in the following 6
      hours to look at immediate uptake of the fish oil fatty acids. This will be repeated (for
      comparison) with fish oil.

      The second study (B) will look at consumption over a longer period. Volunteers will be asked
      to consume the Camelina oil daily for 8 weeks and provide blood samples at the visits at the
      start and end of that period. This will be repeated (for comparison) with fish oil.
    

Intervention name(s): Single dose fish oil; Repeated dose fish oil; single dose Camelina seed oil; repeated dose camelina seed oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fish oil consumed within a single high fat test meal; Fish oil consumed daily for 8 weeks; camelina seed oil consumed within a single high fat test meal; camelina seed oil consumed daily for 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: omega 3 polyunsaturated fatty acid; camelina sativa; fatty acid composition; immune modulation
A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects
Condition: Relapsing Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary objective is to determine adherence to Rebif® New Formulation administered by
      RebiSmart during 12 weeks of therapy in patients with RRMS.
    


Intervention name(s): RebiSmart
Intervention type(s): Device
Intervention description(s): Treatment with Rebif New Formulation using RebiSmart.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neurology Clinics at Danish and Norwegian hospitals (single treatment group)
      
Keywords: Relapsing Remitting Multiple Sclerosis; RebiSmart; Rebif; Adherence