bioihbjkbjnl/mcl2 huggingface dataset:
First Time in Man Study of Finafloxacin Hydrochloride
Condition: Helicobacter Infections; Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Helicobacter Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the safety of single doses and multiple doses of
      Finafloxacin hydrochloride in healthy volunteers. The level of Finafloxacin hydrochloride
      will be measured in the subjects blood and urine. One part of the study will assess if
      Finafloxacin hydrochloride eradicates Helicobacter pylori, a stomach bacteria. Another part
      of the study will assess the activity of the drug in urine.
    

Detailed description: 
      New antibiotics are needed due to the increasing resistance of bacteria to existing
      antibiotics. Helicobacter pylori (H. pylori) is a bacteria of the stomach and has been shown
      to cause peptic ulcers and is implicated in gastric cancer. Up to 40% of the population has
      H. pylori. Current treatments used to eradicate H. pylori are a combination of a number of
      drugs including antibiotics and drugs which reduce the acid in the stomach. These treatments
      are complicated and some H. pylori is resistant to the antibiotics used.

      This study is the first use of Finafloxacin hydrochloride in man and will examine its safety
      and make a preliminary study of its effectiveness as a single agent in eradicating H. pylori.
      The urine of subjects will also be used to test its effectiveness in killing the bacteria
      which cause urinary tract infections.
    

Intervention name(s): Finafloxacin hydrochloride
Intervention type(s): Drug
Intervention description(s): Tablets, oral single dose and multiple dose once daily for 7d
Intervention MeSH terms: Finafloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Fluoroquinolones; First in Man
The Angioshield Study Feasibility II
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical
      Support for Vein Grafts Used in CABG Surgery.
    

Detailed description: 
      The study is designed to investigate the feasibility of using an applied support
      (Angioshield) to a saphenous vein to be used in Coronary Artery Bypass Surgery. It is a
      feasibility to determine safety prior to launching a larger pivotal study. The primary
      endpoint, 30-day safety, will be assessed by recording and reporting of adverse events during
      surgery and throughout the investigation until the 30-day follow-up visit. The secondary
      endpoints, long term safety and patency, will be assessed by recording and reporting of
      adverse events and graft patency (via serial CT angiograms) at the 30, 90, and 365 day
      follow-up visits.
    

Intervention name(s): Angioshield
Intervention type(s): Device
Intervention description(s): Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate of absorption and oral bioavailability of a test formulation of
      Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral
      dose of the commercially available reference product Atlace® manufactured by Monarch
      Pharmaceuticals Inc. administrated to healthy subjects after a 10-hour overnight fast
      followed by a high-calorie, high-fat breakfast meal.
    

Detailed description: 
      Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period
      crossover study

      Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of
      Ramipril10 mg Capsules Under Fed Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Ramipril10 mg Capsules, single dose; Atlace® 10 mg capsules, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Purepac formulated products under fed conditions; B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products under fed conditions
Other intervention name(s): Ramipril; Ramipril
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Ramipril; Healthy subjects
Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
Condition: Minimal Change Disease
MeSH terms: Nephrosis, Lipoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with
      minimal change nephritic syndrome.
    

Detailed description: 
      A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf
      cap®) in adult patient with minimal change nephritic syndrome.
    

Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd
Other intervention name(s): Prograf
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: minimal change disease; tacrolimus; corticosteroid
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section
Condition: Caesarean Section; Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative pain management is critical for the fulfillment of the maternal duties. The
      transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12
      and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on
      postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS)
      under spinal anesthesia.
    


Intervention name(s): Bupivacaine Hcl 0.25% Inj; saline 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine; ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study
Condition: Tooth Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      The study is intended to verify through clinical measurement that the NUPRO Sensodyne
      Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended
      relief up to 28 days.
    

Detailed description: 
      It is hypothesized that the prophy paste with Novamin will give patients immediate
      sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
    

Intervention name(s): Group C; Group A; Group B
Intervention type(s): Device; Device; Device
Intervention description(s): Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.; Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.; Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Other intervention name(s): NUPRO Classic Prophy Paste; NUPRO Sensodyne Prophy Paste with NovaMin with Fluoride.; NUPRO Sensodyne Prophy Paste with NovaMin without Fluoride.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Two Sub-occipital Techniques on Limited Mobility According to the Flexion-rotation Test
Condition: Upper Cervical Spine Rotational Hypomobility
Study type: Interventional

Summary: 
      The cervical spine should work as a functional unit. If hypomobility should exist in any of
      the segments it would limit the mobility of the spine as a whole. Although it is frequent
      that certain cervical segments present hypomobility, they are not always related to
      symptomatology. The effects of inhibition sub-occipital techniques on cervical mobility have
      not been evaluated.

      The objetive of this trials is to assess and compare the effects on cervical mobility, of the
      manual technique of sub-occipital inhibition by applying pressure and self-treatment by way
      of Occipivot® cushion, in subjects with no cervical symptomatology but with limited mobility
      assessed by the flexion-rotation test.
    


Intervention name(s): Manual technique of sub-occipital inhibition; Self-treatment by way of Occipivot®
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Physiotherapy; Range of motion; Inhibition sub-occipital techniques
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center open label randomized 4-period 2-sequence replicated crossover design
      study. A total of 52 healthy subjects will be randomized.
    

Detailed description: 
      Serial blood samples will be obtained for PK evaluation.
    

Intervention name(s): Betrixaban
Intervention type(s): Drug
Intervention MeSH terms: Betrixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Condition: Malaria; Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of
      America.
    

Detailed description: 
      -  Controlled challenge, Phase I/IIa WRAIR study.

        -  Healthy, malaria-naive adults aged 18 - 50 years.

        -  2 groups, 5 subjects in group A (10µg dose) and 15 subjects in group B (50µg dose).

        -  Control: none for immunization phase; infectivity controls for challenge and rechallenge
           phases. Six infectivity controls per day of challenge will be enrolled for the challenge
           phases, with 3 alternates available for challenge if needed.

        -  Vaccination schedule of 0, 1 months.

        -  Challenge of up to 15 subjects in Group B.

        -  Contingent upon short term efficacy, rechallenge of initially protected subjects 6
           months (+/- 2 months) after second dose of vaccine.

        -  Self-contained study.

        -  Duration of the study, per subject: approximately 15 months (screening, enrollment,
           vaccination, challenge and rechallenge).

        -  Data collection will be by done at the site.
    

Intervention name(s): Falciparum Malaria Protein 11 with AS02A adjuvant
Intervention type(s): Biological
Intervention description(s): vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Malaria; Liver Stage Antigen-1; Falciparum Malaria Protein-11; AS02A; adjuvant
Clinical Efficacy of Diazepam After Whiplash : A Randomized Controlled Study
Condition: Whiplash Injuries; Whiplash Injury of Cervical Spine
MeSH terms: Wounds and Injuries; Whiplash Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Whiplash injury is very common and lot of patients which suffered the injury have chronic
      symptoms despite different treatment options. One of main symptoms include muscle spasm and
      pain caused by neck movement. Diazepam is a well known drug which can be used to treat muscle
      spasms. The aim of this study is to determine whether short term Diazepam therapy can have
      positive effect on long term outcomes after whiplash injury.
    

Detailed description: 
      This randomized, assessor-blinded study was conducted on patients presented due to a cervical
      spine injury caused by a traffic accident in the previous 48 hours from 1st January 2020 to
      31st December 2020. All the patient which were included in this study were divided into 2
      groups: group A, the Test group, and group B, the control group. All patients signed the
      consent to participate in the study prior to randomization. During the initial examination a
      detailed history was taken and it included Visual Analog Pain Scale (VAS). On follow up
      examinations 7 days, 6 weeks and 6 months after the injury, all patients completed Neck
      disability index (NDI), Whiplash disability questionnaire (WDQ) as well as Visual Analog Pain
      Scale (VAS). Any patient which didn't complete all the follow up examination was excluded
      from the study.
    

Intervention name(s): Diazepam Tablets
Intervention type(s): Drug
Intervention description(s): Diazepam 5 mg tablet once per day (bedtime) for 7 days
Intervention MeSH terms: Diazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study group will get the recommendation to use one Diazepam 5 mg pill per day (bedtime) for 7 days after whiplash injury.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: whiplash; cervical spine; neck; whiplash injury; muscle spasm; diazepam; muscle strain
Comparison of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Overweight; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of this study are to determine:

        -  The effectiveness of olanzapine as compared to quetiapine in treating and preventing the
           recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in
           patients who are obese or overweight.

        -  The safety of olanzapine as compared to quetiapine.
    


Intervention name(s): Olanzapine; Quetiapine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Football 4 Health in Middle-aged to Older Adults
Condition: Exercise Training
Study type: Interventional

Summary: 
      Ageing in humans is accompanied by a progressive decline in lower-limb muscle power
      production. In addition to a decline in musculoskeletal fitness, ageing is associated with a
      reduction in cardiovascular and metabolic fitness. Therefore, if exercise interventions aim
      for a high impact on the overall health status of middle-aged and older adults, they should
      combine endurance, high-intensity interval training and muscular strengthening activities.
      Recreational football training combines all these training components, which implies that it
      could constitute an adequate training modality for participants of all ages. What remains to
      be investigated in more detail, is whether recreational football training can improve muscle
      power production in middle-aged to older adults and whether this potential improvement is
      present across the full force-velocity (F-V) profile. Next to a detailed analysis of the
      leg-extensor F-V profile as primary outcome, simultaneous effects on functional capacity,
      body composition and endurance exercise capacity were investigated. In addition, feasibility
      and the physical demands (internal and external load indicators) of the training program were
      tracked throughout the intervention period.
    


Intervention name(s): Football training
Intervention type(s): Other
Intervention description(s): 10-week progressive football training with small-sided games, 2x/week, 45min-1h sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil
Condition: Maintenance Kidney Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the quality of life in renal transplant recipients who require a
      reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and
      will also access the relationship between mycophenolic acid (MPA) dose in those patients
      receiving enteric-coated mycophenolate sodium formulation(EC-MPS).

      Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then
      again at 12 weeks post-conversion.
    


Intervention name(s): Enteric-coated Mycophenolate sodium (EC-MPS); Mycophenolate mofetil
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: kidney transplant; enteric-coated mycophenolate sodium; quality of life; gastrointestinal symptoms
The Association Between Different Monocyte Subsets and Coronary Collateral Development
Condition: Coronary Artery Disease; Coronary Ischemia
MeSH terms: Coronary Artery Disease; Ischemia
Study type: Observational

Summary: 
      Collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia.
      Collateralization helps to restore blood flow and as a result salvages myocardium in severely
      ischemic myocardial regions. Thus, good collateral development in patients with severe
      coronary artery disease (CAD) improves ventricular function and prognosis (1-3).

      However, coronary collateral development is different among patients even with similar
      degrees of coronary artery stenosis. Several factors, such as diabetes mellitus (4) and
      duration of myocardial ischemic symptoms (5) have been reported to effect coronary collateral
      development. At the cellular level, inflammatory cells, especially monocytes have an
      important role in collateralization. In a series of experimental studies with animals, it has
      been shown that monocytes are important elements for development of collateral vessels (6-7).
      In a recent study, it has been demonstrated that increased circulating monocyte count is
      related to good collateral development in patients with stable coronary artery disease (8).

      Monocytes in human blood are heterogeneous and can be classified into two subsets according
      to the presence or absence of the FcγRIII receptor CD16 (9): CD14++CD16- monocytes
      characterized by high level expression of the CD14 cell surface receptor but no expression of
      CD16 receptor, and CD14+CD16+ monocytes characterized by the co-expression of CD16 receptor
      with either high or low level expression of the CD14 receptor. These subsets differ in
      function and response to several cytokines.

      Our aim in this study was to find out any possible relationship between the levels of
      circulating monocyte subsets and coronary collateral development.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients who were found to have >95% stenosis of at least one major coronary
        artery in their first coronary angiogram were included in this study.
      
Keywords: Coronary collateral development; monocyte subsets; collateralization
Mechanochemical Ablation vs Thermal Ablation
Condition: Varicose Veins of Lower Limb
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with
      laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one
      year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with
      laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one
      and three years.
    

Detailed description: 
      During 2014-2015, all patients referred to our vascular surgery clinic by their general
      practitioners due to varicose veins were screened for GSV insufficiency. We invited all
      patients filling the inclusion criteria to participate in this study.

      Included patients were randomized to receive either thermal ablation (laser ablation or
      radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the
      refluxing GSV.

      The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We
      recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal
      20 centimetres, and the mean overall diameter at the thigh.

      During the procedure, before discharge, and a week after, the patients reported pain scores
      using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we
      recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status
      of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to
      determine what would have been the optimal sick leave after the procedure.

      At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded,
      as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the
      AVVQ questionnaire.
    

Intervention name(s): MOCA; EVLA; RFA
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.; Great saphenous vein occlusion with a thermal laser chateter; Great saphenous vein occlusion with a thermal radiofrequency chateter
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Our study aim was to assess the applicability and safety of MOCA in short term as well as occlusion rate and disease specific quality of life one year after the procedure, and compare it with currently used thermal ablation methods of laser ablation (EVLA) and radiofrequency ablation (RFA) in a randomized controlled trial.
Randomization took place by a study nurse after the appointment, using block randomization with sealed envelopes into EVLA, RFA, or MOCA in ratio 1:1:2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Great saphenous vein; Thermal ablation; Mechanochemical ablation; Randomized controlled trial