bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Rescue Therapies for Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional

Summary: 
      From the profiles of antibiotic susceptibility data following eradication therapy,
      tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the
      rescue treatment.
    

Detailed description: 
      The H pylori-infected adult patients with failure of standard triple therapy and H
      pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly
      assigned to either EALT (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500
      mg o.d., and tetracycline 500 mg q.d.s.) therapy or EAL (esomeprazole 40 mg b.d., amoxicillin
      500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. Repeated endoscopy with rapid
      urease test, histological examination and culture or urea breath tests is performed at six
      weeks after the end of anti-H pylori therapy.
    

Intervention name(s): esomeprazole+amox+levo+tetra; esomeprazole+amox+levo
Intervention type(s): Drug; Drug
Intervention description(s): esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.; esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,
Other intervention name(s): esomeprazole 40mg; amoxicillin 500 mg; levofloxacin 500 mg; tetracycline 500 mg; esomeprazole 40 mg; amoxicillin 500 mg; levofloxacin 500 mg
Intervention MeSH terms: Amoxicillin; Levofloxacin; Ofloxacin; Tetracycline; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Eradication rate; Rescue treatment
Evaluation of the Static Stability of Footwear
Condition: Postural; Strain
Study type: Interventional

Summary: 
      Introduction: Postural control is a crucial factor for maintaining balance while standing and
      walking. The shoe has a role to play in postural stability.

      Objectives: To evaluate the static balance of subjects when barefoot and when using three
      types of footwear with their eyes closed or open.

      Material and methods:
    

Detailed description: 
      Each participant was asked to focus on a white mark 2 cm in diameter, positioned on a screen
      2 m in front of them at eye level. This was done to standardize the data collection and
      minimize any variation in postural stability caused by changes in the visual field. Each
      participant was asked to remain in this position for a period of 30 seconds, while the data
      was collected. Three repetitions were made for each condition to obtain an average value. The
      condition on footwear and open / closed eyes was randomized to reduce the learning effect. On
      the other hand to reduce fatigue, each participant was allowed to rest for 5 minutes between
      shoe changes.

      The size of the sample was calculated with the software of the Clinical Epidemiology and
      Biostatistics Unit. Complexo Hospitalario Universitario de A Coruña. University of A Coruña
      (www.fisterra.com). The estimated sample size estimated was calculated to be at least 16
      subjects.
    

Intervention name(s): Stabilometry
Intervention type(s): Device
Intervention description(s): To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Other intervention name(s): Eyes open and eyes closed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Footwear; Barefoot
Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to use Cabozantinib to treat those with Metastatic Colorectal Cancer who
      have not previously responded to treatment.
    

Detailed description: 
      This is a phase II clinical trial that seeks to use Cabozantinib to treat those with
      Metastatic Colorectal Cancer who have not previously responded to treatment. This study is a
      two stage study that will first measure (up to) 16 patients' progression free survival (PFS).
      Stage two will, again, measure PFS, but in a population (up to) 28 patients.
    

Intervention name(s): Oral Tablet: Cabozantinib
Intervention type(s): Drug
Intervention description(s): Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
Other intervention name(s): Cometriq; Cabometyx
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cabozantinib; Progression Free Survival; Metastatic Colorectal Cancer; Tumor
A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
Condition: Contraception; Female Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, single treatment study. All subjects will receive 12 months of oral
      contraceptive therapy with DR-102. Study participants will receive physical and gynecological
      exams, including Pap smear. During the study, all participants will be required to complete a
      daily diary.
    


Intervention name(s): DR-102
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy Prevention; Oral Contraceptives
Comparison of in Vitro Fertilization Rates of Oocytes and Embryo Development Using Two Techniques of Semen Processing
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      The investigators propose to assess one method of sperm selection based on the
      characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a
      gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better
      quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional
      technique of swin up) as well as embryo development.
    

Detailed description: 
      The project is a RCT follow the orientation of CONSORT. The investigators propose to assess
      one method of sperm selection based on the characteristics of spermatozoa recently
      introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to
      act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization
      with two techniques (SSSA versus traditional technique of swin up) as well as embryo
      development.
    

Intervention name(s): SSA sperm selection
Intervention type(s): Other
Intervention description(s): The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
Masking: Single (Participant)
Primary purpose: Treatment
The Pacing (Guided Vs Unguided) Strategies Study
Condition: Body Temperature Changes
MeSH terms: Body Temperature Changes
Study type: Interventional

Summary: 
      The objectives of this study are to demonstrate that real time physiological status
      monitoring and the use of optimization techniques during exercise can have a positive impact
      on physiological status, and to collect metabolic flexibility profiles of young fit adults
      during rest and exercise.
    

Detailed description: 
      This experiment aims to accomplish two goals: collect additional metabolic flexibility data
      with young fit adults in response to exercise; and demonstrate that automated pace guidance
      generated from real-time thermal-work strain monitoring and an optimized pacing policy will
      allow less stressful completion of a timed (60 minute) treadmill exercise of 5 miles. Each
      participant will undergo two treatments of first UNGUIDED followed by GUIDED exercise. The
      two exercise sessions will be conducted as part of a ~24 hour stay in an indirect calorimetry
      chamber.
    

Intervention name(s): Guided Exercise Session; Unguided Exercise Session
Intervention type(s): Other; Other
Intervention description(s): Participants will be provided a pace based upon their current (estimated) physiological strain index (PSI) - a measure of thermal work strain, the time, and the distance completed already.; Participants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find an optimal dose to determine the safety and tolerability
      of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular
      injection in subjects with glabellar lines compared with the standard dose of BOTOX®
    


Intervention name(s): MT10109
Intervention type(s): Biological
Intervention description(s): Single dose intramuscular injection MT10109 vs Botox®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Healthy Participants
Condition: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of D-4517.2
      after single subcutaneous (SC) doses in healthy participants.
    


Intervention name(s): D-4517.2
Intervention type(s): Drug
Intervention description(s): Subcutaneous (SC) injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: D-4517.2; Neovascular Age-related Macular Degeneration; Diabetic Macular Edema
Glulisine Pre- and Postmeal
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and
      RHI (HOE31HPR100) injected subcutaneously before and after a standard meal
    


Intervention name(s): Insulin glulisine
Intervention type(s): Drug
Intervention MeSH terms: Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin glulisine; Diabetes mellitus Type 1; Postprandial Period; Pharmacokinetics; Glucodynamics
Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison
      with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.
    


Intervention name(s): generic clopidogrel (Plavitor® ); original clopidogrel (Plavix® )
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiplatelet; clopidogrel; acute coronary syndrome
Comparison Between Two Operational Techniques for Total Knee Replacement
Condition: Gait, Unsteady; Knee Arthropathy; Surgery
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973
      there has been continuous advance in implant technology as well as operative technique, yet
      current patient satisfaction after the procedure is accepted to be about 80%.

      There are a few operative techniques to perform TKR. Until recently the most common technique
      is the anterior approach to the knee and then using mechanical instrumentation to make the
      bone cuts for the femur and tibia. A second popular technique is the anterior approach to the
      knee and then using a kinematic alignment to make the bone cuts.

      The investigators wish to compare short term results of the two operative techniques as
      evidenced in patient objective functional scores and also by evaluating the gait of the
      patients by using the REHAGAIT ANALYZER PRO by HASOMED inc. Magdeburg Germany.
    


Intervention name(s): REHAGAIT ANYLIZER
Intervention type(s): Diagnostic Test
Intervention description(s): Gait analysis instrumentation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: total knee replacement; gait analysis; PROMS; mechanical aligment; kinematic alignment
The Effects of a Train High, Sleep Low Strategy
Condition: Cycling Performance; Muscular Adaptations; Substrate Utilization
Study type: Interventional

Summary: 
      The investigators will examine the long-term effects of a combined training and diet
      intervention that, acutely, increases fat oxidation during exercise. This is done with a 4
      week intervention study with moderately trained cyclists. Performance is tested pre and post
      intervention and muscle biopsies are obtained.
    


Intervention name(s): Combined exercise and diet intervention
Intervention type(s): Other
Intervention description(s): Both groups exercise 6 times per week in 4 weeks conducted as 3 evening and 3 morning sessions per week. Both groups receive dietary products to be consumed immediately before and after each evening and morning session, respectively. One group conduct morning sessions in a fasted state, the other conduct the morning sessions in a fed state. Performance pre and post is measured, and muscle biopsies are obtained.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease
Condition: Idiopathic Interstitial Pneumonia; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis
MeSH terms: Pneumonia; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Idiopathic Interstitial Pneumonias; Hamman-Rich Syndrome; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study evaluates the safety and the efficacy of the addition of intravenous
      transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic
      interstitial pneumonia or connective tissue disease associated with interstitial lung
      disease, which have actively progressing disease with rapid loss of pulmonary function on the
      background of routine treatment.
    

Detailed description: 
      Despite significant progress in the treatment of interstitial lung disease, achieved thanks
      to new drugs, such as pirfenidone and nintedanib, there are many patients for whom these
      drugs are not available or poorly tolerated. In addition significant evidence of their
      effectiveness and safety is valid only for idiopathic pulmonary fibrosis. The transplantation
      of allogeneic stem cells is a promising direction in the modern medicine with the proven
      safety for different diseases. But the effectiveness of this therapy is still under research.
      We believe that in most severe cases of a rapidly progressive interstitial lung disease the
      transplantation of mesenchymal stem cells may be an effective technology due to their
      immunomodulatory properties.
    

Intervention name(s): Bone marrow mesenchymal stem cells; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bone marrow will be harvested in healthy donors followed by separation and cultivation of MSCs. Before infusion cells will be suspended in 400 mL saline; intravenous infusion of 400 mL saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interstitial lung disease; idiopathic interstitial pneumonia; idiopathic pulmonary fibrosis; stem cells
Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity
Condition: Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs
Study type: Interventional
Phase: Phase 1

Summary: 
      High-potency benzodiazepines have strong anxiolytic effects accompanied by significant
      adverse effects including impaired cognitive function, drowsiness, dizziness and impaired
      motoric abilities. Importantly, the long-term use of benzodiazepines may produce dependence
      and withdrawal. Therefore, there is considerable scientific and public interest in
      identifying new anxiolytic agents.

      The hypothalamic peptide oxytocin (OXT) has anxiolytic effects both in healthy participants
      and patients with anxiety disorders by decreasing fear-associated amygdala activity. However,
      so far no human study has directly compared the underlying anxiolytic mechanisms of OXT and
      established anxiolytic agents on amygdala activity. Importantly, the amygdala is not a
      homogenous structure but rather consists of several subdivisions with structural and
      functional differences.

      Therefore, the rationale of the present project is to determine the effects of intranasal OXT
      and the high-potency benzodiazepine lorazepam on fear-associated responses in intra-amygdalar
      subregions.
    


Intervention name(s): Oxytocin; Lorazepam 1 mg; Placebo nasalspray; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intranasal administration, 24 international units (IU) oxytocin; Oral administration of 1mg lorazepam; The placebo nasalspray contain identical ingredients except for the active agent itself.; The placebo pill contain identical ingredients except for the active agent itself.
Other intervention name(s): syntocinon; Tavor
Intervention MeSH terms: Lorazepam; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Amygdala, anxiety, benzodiazepines, fear, fMRI, lorazepam, oxytocin, 7 Tesla
"Visiobiane Anti-age" Effects on Vision Parameters
Condition: Macular Pigment Optical Density
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary
      supplement on macular pigment optical density, contrast sensibility and visual acuity.
      Additionally, the study would like to evaluate seric variations of carotenoids and the total
      antioxydant capacity.
    

Detailed description: 
      Visiobiane study is a randomized trial of 30 participants designed to assess the effects of
      oral supplementation of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs for
      the eyes protection. The study will enroll healthy participants aged 45 to 55 years. 15
      subjects will be assigned in placebo group and 15 in experimetal group (Visiobiane anti-age).
      They will be supplemented for 24 weeks
    

Intervention name(s): lutein; DHA; vitamins
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: visual caracteristics; macular pigment optical density; visual acuity; contrast sensibility; lutein; docosahexaenoic acid (DHA)
sPLA2 in EBC During Acute Chest Syndrome
Condition: Sickle Cell Disease; Acute Chest Syndrome
MeSH terms: Acute Chest Syndrome; Anemia, Sickle Cell; Syndrome
Study type: Observational

Summary: 
      Secretory phosholipases A2 (sPLA2) are significantly elevated in the plasma of sickle cell
      disease patients with acute chest syndrome (ACS), and similar enzymes have been measured in
      exhaled breath condensate (EBC), which is collected easily and non-invasively. The
      investigators hypothesize that sPLA2 will be measurable in EBC samples from sickle cell
      patients with acute chest syndrome.
    

Detailed description: 
      The purpose of this research study is to test the ease and effectiveness of collecting
      exhaled breath condensate (liquid) to measure levels of a biomarker, secretory phospholipases
      A2 (sPLA2) in people with sickle cell disease during an attack of acute chest syndrome. sPLA2
      levels have been reported to be much higher in persons with acute chest syndrome and might be
      useful to diagnose and to evaluate the effects of therapy.

      Serial monitoring of plasma sPLA2 levels might lead to earlier or more accurate detection of
      acute chest syndrome and monitoring of its progression or improvement in patients with sickle
      cell disease. However, there is a significant inherent risk of frequent blood collection
      further dropping the blood (hemoglobin) levels of an already anemic patient. If sPLA2 can be
      measured in exhaled breath condensate, this non-invasive and well-tolerated sample collection
      might allow for serial monitoring of the enzyme without depleting the patient's already
      diminished blood supply.
    

Intervention name(s): Exhaled Breath Condensate (EBC); Plasma Sample
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Serial EBC samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up; Serial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sickle cell patients with acute chest syndrome
      
Keywords: acute chest syndrome; secretory phospholipases A2; exhaled breath condensate; sickle cell disease