bioihbjkbjnl/mcl2 huggingface dataset:
Sexual Functions and Covid-19
Condition: Covid19; Sexual Behavior
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Sexual health is one the important components of life quality. The aim of this study is to
      compare sexual dysfunction of women who survived Covid-19 and who didn't undergo Covid-19.
    

Detailed description: 
      With identifying a new type of coronavirus, the infection disease known as Coronavirus
      disease-2019 (Covid-19) is still effective worldwide. Within the frame of the description
      that the health is "a complete physical, mental and social welfare," many physical and mental
      modality may be expected due to the pandemic and the measures against pandemic. Among them,
      sexual health is one of the basic indicative factors of human welfare. There are few data on
      sexual dysfunctions from the previous clinic pandemic experiences. From the very early stages
      of Covid-19 pandemic, health systems and researches focused on mortalities and short-term
      morbidities. Although there are similar studies about effects of pandemic on sexual behaviors
      of general community, there is no comparative study about the effects on sexual functions of
      women survived from Covid-19 and women having no Covid-19 history, yet. This study aims to
      compare women survived from Covid-19 and women having no Covid-19 history and having similar
      characteristics in terms of sexual dysfunctions.
    

Intervention name(s): Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
Intervention type(s): Behavioral
Intervention description(s): sexual dysfunction assesment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Application of ROTEM Technology in Aortic Surgery
Condition: Aortic Surgery; Coagulation Management
Study type: Observational

Summary: 
      Comparison of the diagnostic capabilities of rotational thromboelastometry (ROTEM) and
      standard coagulogram in the detection of disorder and correction of the hemostasis system in
      the perioperative period in patients who underwent surgical intervention on the aorta under
      cardiopulmonary bypass and or circulatory arrest.
    

Detailed description: 
      The patient is monitored in the intensive care unit according to the following scheme: ROTEM
      (NATEM, INTEM, EXTEM, FIBTEM; with high clotting time (CT) values in INTEM - HEPTEM is done)
      and a coagulogram (activated coagulation time (ACT), activated partial thromboplastin time
      (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen, antithrombin III, platelet
      aggregation) are done on admission and after 6 hours - with a smooth course of the
      perioperative period. If it is necessary or the development of disorders in the form of
      bleeding or thrombosis that require correction, ROTEM and a coagulogram are done, treatment
      is carried out, and after elimination of the causes, ROTEM and a coagulogram are examined in
      dynamics to assess the effectiveness of the therapy.
    

Intervention name(s): ROTEM and standard coagulation tests
Intervention type(s): Device
Intervention description(s): ROTEM and standard coagulation tests assessment
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or
        circulatory arrest.
      
Keywords: ROTEM; coagulation tests; coagulation disorders; aortic surgery
Blood Pressure Lowering in Dialysis (BOLD) Trial
Condition: Blood Pressure; End Stage Renal Disease on Dialysis (Diagnosis); Chronic Kidney Diseases; Chronic Kidney Disease Stage 5
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Blood pressure may be one of the most important modifiable risk factors for cardiovascular
      disease in patients with end-stage-renal-disease undergoing maintenance hemodialysis.
      Although a systolic blood pressure <140 mmHg treatment target has been recommended, there
      remains uncertainty on which blood pressure should be targeted, more specifically that
      measured in the dialysis unit or at home. Observational studies have reported a paradoxical
      U-shaped associated with dialysis unit (pre-dialysis) systolic blood pressure and
      cardiovascular events and death (where blood pressure below 140 mmHg is actually linked with
      poor outcomes). Conversely, the same studies have reported a linear association between
      higher home systolic blood pressure and worse clinical outcomes, where blood pressure below
      140 mmHg is associated with better outcomes. This pilot clinical trial aims to address this
      important question.
    

Detailed description: 
      Blood Pressure Lowering in Dialysis (BOLD) is a pilot randomized controlled trial of 50
      maintenance hemodialysis patients in San Francisco and Seattle to test whether targeting a
      home systolic blood pressure <140 mmHg (versus a pre-dialysis systolic blood pressure <140
      mmHg) is feasible and safe. The study duration is 4 months and blood pressure targets will be
      achieved through dry weight adjustment and adjustment of standard anti-hypertensive therapies
      by the study team. The primary outcomes are focused on feasibility and safety. The home blood
      pressure treatment arm will also have the opportunity to utilize a blood pressure monitor
      with Bluetooth capabilities. The rates of utilization of mobile health technology in this
      population will also be assessed as an outcome. This pilot trial will provide key data to
      design a larger trial focused on clinical outcomes.
    

Intervention name(s): Anti-Hypertensive medications; Dry Weight Adjustment
Intervention type(s): Drug; Procedure
Intervention description(s): Use of standard Anti-Hypertensive medications; The participant's target post-dialysis dry weight is adjusted
Other intervention name(s): anti-hypertensive
Intervention MeSH terms: Antihypertensive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood pressure; Hemodialysis; End-stage-renal-disease; Chronic kidney disease
Dementia Care Training With Virtual Reality and Support for Home Care Staff
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      This study aims to evaluate a dementia care training with virtual reality and peer support
      program on dementia care knowledge, attitude, care competence, work stress, and empathy of
      home care staff.
    

Detailed description: 
      Home care staff often have insufficient knowledge and skills of caring people with dementia
      at home. Many lack empathy for those with dementia. Training courses for home care staff
      often are not developed according to their educational background and workplace needs.

      This two-group cluster randomised controlled trial aims to evaluate a dementia care training
      with virtual reality and peer support program on dementia care knowledge, attitude, care
      competence, work stress, and empathy of home care staff.

      The dementia care training consists of dementia care e-books, dementia virtual reality
      activity and peer support program.

      The interventional group will receive a dementia care training using dementia care e-books,
      dementia virtual reality activity and peer support program.

      The control group will only receive dementia care e-books and peer support with no dementia
      virtual reality activity.

      Both groups will be assessed for their dementia care knowledge, attitudes, care competence,
      work stress and empathy at baseline, month 3, and 6.
    

Intervention name(s): Intervention group; Control group
Intervention type(s): Other; Other
Intervention description(s): Dementia care training consists of dementia care e-books, dementia virtual reality activity and peer support program.; Dementia care training consists of dementia care e-books and peer support program without dementia virtual reality activity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two-group cluster randomised controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Home care staff; dementia care; virtual reality
Evaluation of Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX)
Condition: Appetite and Hunger, Suppression; Blood Glucose, Postprandial
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to compare subjective appetite ratings and after-meal and 24
      hour blood glucose levels within overweight and obese female subjects consuming either a
      standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX
      (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length
      and separated by 3 week washout phase, so subjects will also be acting as their own control.
      Subjects will be randomized to either start with the low calorie diet with PGX or the low
      calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will
      elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour
      placebo control.
    


Intervention name(s): PolyGlycopleX (PGX)
Intervention type(s): Dietary Supplement
Intervention description(s): powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: viscous; fibre; polysaccharide; blood glucose; postprandial; appetite; hunger; satiety
Diastolic Dysfunction During Conservative Lifestyle Treatment
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The Purpose of this study is to 1) investigate prevalence of diastolic dysfunction in
      patients with morbid obesity attending a conservative lifestyle change program, 2)
      investigate effects on cardiac function, cardiorespiratory Fitness, body composition, quality
      of life and cardiovascular risk through the program, 3) investigate feasibility of
      introducing two different activity monitors throughout the program, and 4) comparing
      compliance to activity sensor market leader FitBit Application versus Mio Pai Application
    


Intervention name(s): Pai APP; FitBit APP
Intervention type(s): Device; Device
Intervention description(s): Prescription: Target 100 PAI Points per week; Prescription: Target daily 10.000 steps
Other intervention name(s): Personal Activity Intelligence (PAI) application; MIO Fuse Wristband; FitBit Zip
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
Condition: Sprain of Ankle
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine the efficacy of Traumeel S (both ointment and
      gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained
      ankle.
    

Detailed description: 
      Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both
      ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain.
      In addition tolerability/safety of both drug preparations is to be compared, so that the
      benefit-risk relation can be determined.
    

Intervention name(s): Traumeel S ointment; Traumeel S gel; Diclofenac gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 g, 3 times daily topical during 14 days; 2 g, 3 times daily topical during 14 days; 2 g, 3 times daily topical during 14 days
Other intervention name(s): Traumeel S ointment, Traumeel S gel, Diclofenac gel
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ankle sprain; traumeel; diclofenac; antiinflammatory; time to normal function
Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
Condition: Gastroparesis; Diabetic Gastroparesis; Diabetes; Diabetes Mellitus; Delayed Gastric Emptying
MeSH terms: Gastroparesis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray
      solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic
      gastroparesis.
    


Intervention name(s): metoclopramide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 minutes before meals and at bedtime for 4 weeks; 30 minutes before meals and at bedtime
Other intervention name(s): Reglan
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastroparesis; Diabetic Gastroparesis; Diabetes; Diabetes Mellitus; Delayed Gastric Emptying
Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines
      administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian
      children. The Protocol Posting has been updated in order to comply with the FDA Amendment
      Act, Sep 2007.
    

Detailed description: 
      This study will be conducted in a partially blind fashion: it will be observer-blind as to
      which vaccine was administered, and open as to the vaccination schedule. One group of
      children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the
      same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.
    

Intervention name(s): GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049; Rabipur
Intervention type(s): Biological; Biological
Intervention description(s): 2 different formulations are tested. For each formulation, 3 different dosing schedules are tested; 3-dose intramuscular injection.
Other intervention name(s): RTS; S vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Prophylaxis Plasmodium falciparum malaria; Plasmodium falciparum; Malaria
Evaluation of Common Bean Baked Snack Consumption on Blood Lipids in Overweight People With Altered Blood Lipid Levels
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      Introduction: The Mexican population consumes vegetables and snacks with the same frequency.
      Besides, most of the snacks available on the market contain high fat, sodium and calorie, and
      low protein levels. Regular consumption of these snacks and low physical activity could
      promote the development of noncommunicable diseases. Common bean-based snacks are potential
      healthier alternatives to replace conventional snacks.

      Hypothesis: The consumption of a common bean baked snack (Phaseolus vulgaris L.) reduces
      blood lipid levels in overweight people with altered blood lipid levels.

      Objectives: Evaluate the effect of common bean baked snack consumption on blood lipid levels
      in overweight people with altered blood lipid levels.

      Material and Methods: Randomized crossover clinical trial, 28 patients with altered blood
      lipid levels, 18-40 years old, snack supplementation for four weeks, clinical and laboratory
      determinations, such as total cholesterol, triglycerides, LDL, HDL, among others.

        -  Intervention phase: Common bean baked snack intervention.

        -  Control phase B: No intervention.
    


Intervention name(s): Snack
Intervention type(s): Other
Intervention description(s): Participants will consume 32 g of a common bean baked snack per day for 28 days during the intervention stage.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional food; Common bean; Snack
Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
Condition: Gastric Ulcer
MeSH terms: Stomach Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta
      (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.
    


Intervention name(s): Rebamipide and Omeprazole; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks; open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks
Other intervention name(s): Mucosta; Omeprazole
Intervention MeSH terms: Omeprazole; Rebamipide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis
Condition: Glomerulonephritis, Membranous
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 4

Summary: 
      Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of
      membranous glomerulonephritis it is likely to improve the initial response to treatment and
      reduce the risk of relapse on stopping therapy.
    

Detailed description: 
      Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to
      treat and if persistent leads to end stage renal failure in a significant number of patients.
      It is currently treated in this institution with tacrolimus monotherapy. This is effective in
      the majority of patients in reducing proteinuria but the remissions are often partial and
      patients tend to relapse when the tacrolimus treatment is stopped. We propose to use
      mycophenolate mofetil in combination with tacrolimus with the aim of obtaining a more
      complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy
      and less progression of renal failure. This will be a randomised control trial, patients will
      be randomised to receive treatment with tacrolimus alone (our current standard therapy)or
      treatment with tacrolimus and mycophenolate mofetil. Participants will receive treatment for
      up to 2 years and then be monitored for relapse of their nephrotic syndrome.
    

Intervention name(s): tacrolimus; tacrolimus and mycophenolate mofetil
Intervention type(s): Drug; Drug
Intervention description(s): tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml; tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Other intervention name(s): prograff; prograf; cellcept
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glomerulonephritis
Physical Activity in Postmenopausal Women
Condition: Postmenopausal Disorder
Study type: Interventional

Summary: 
      The study is designed to investigate the physical activity and its dose-response relationship
      in postmenopausal women on the cardiovascular risks and cardiac function.
    


Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): Different dose of exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Postmenopausal women; Physical activity; Cardiovascular risks; Cardiac function; Dose-response
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
Condition: Cold Urticaria; Cold Contact Urticaria; Symptomatic Dermographism; Symptomatic Dermatographism; Cholinergic Urticaria
MeSH terms: Urticaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria,
      Symptomatic Dermographism, or Cholinergic Urticaria.
    

Detailed description: 
      This study is an open label Phase 1 study evaluating the safety, pharmacokinetics, and
      pharmacodynamics of a single dose of CDX-0159 in patients with Cold Contact Urticaria,
      Symptomatic Dermographism, or Cholinergic Urticaria who remain symptomatic despite treatment
      with antihistamines. Twenty patients with Cold Contact Urticaria, ten patients with
      Symptomatic Dermographism, and ten patients with Cholinergic Urticaria will be enrolled in
      four separate cohorts for a total of 40 patients.

      Prospective patients will be screened with tests in clinic as well as daily at home diaries
      for 2 weeks prior to enrollment. CDX-0159 will be administered intravenously on Day 1.
      Post-treatment, patients will be followed for 12 weeks with an optional longer term follow up
      period.
    

Intervention name(s): CDX-0159
Intervention type(s): Drug
Intervention description(s): Administered intravenously
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This trial will be designed as a multi-center randomized non-inferiority clinical trial to
      demonstrate safety and efficacy of the FEMTO LDV Z8 laser for cataract surgery in a Chinese
      population in China compared to the conventional technique.
    

Detailed description: 
      In this three center, prospective, interventional, randomized controlled study we aim to
      determine safety and efficacy of the FEMTO LDV Z8 laser as compared to conventional technique
      in Chinese patients diagnosed with cataract of any severity grade that are eligible to
      undergo cataract surgery with age 50 years and a maximum age of 80 years in China.
    

Intervention name(s): Femtosecond Laser Assissted Cataract Surgery
Intervention type(s): Device
Intervention description(s): During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Femto Cataract Surgery