bioihbjkbjnl/mcl2 huggingface dataset:
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
Condition: Pregnancy - Labor Monitoring
Study type: Observational

Summary: 
      This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG
      Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the
      performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
    

Detailed description: 
      The SureCALL® EMG Labor Monitor® (SureCALL®)is a transabdominal electromyography monitor
      intended to measure intrapartum uterine activity. It is intended for use on term pregnant
      women who are in labor, with singleton pregnancies, using surface electrodes on the maternal
      abdomen. The device is intended for use by healthcare professionals in a clinical setting.

      This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to
      the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure
      Catheter device (IUPC) as the "gold standard".

      This study involved 20 women at term, in labor, at three clinical sites. Each study subject
      was instrumented with three technologies for measuring uterine activity:

        1. a tocodynamometer attached to the maternal abdomen

        2. a set of abdominal surface electrodes for uterine electromyography, and

        3. an intrauterine pressure catheter.

      An assessment was obtained and quantified from masked, qualified clinical obstetrician
      readers for the evaluation of the equivalence of the three independent labor monitor devices
      by identifying in isolation the individual uterine contraction signals and the peak of each
      contraction signal produced by a full-term patient in term labor as independently collected
      by each labor monitor device.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes
        ruptured and sufficient cervical dilation.
Pulsed Electro Magnetic Fields (PEMF) in Depression
Condition: Depression, Unipolar
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      PEMF (Pulsed Electro Magnetic Fields) therapy has been used to stimulate bone repair in
      non-union since the 1970s. This is an accepted use, which has been approved by the Food and
      Drug Administration in the US. The mode of action of PEMF is based on creating small
      electrical fields in tissue and thereby promoting healing. Besides it has been shown that
      PEMF enhance regeneration of nerve fibers exposed to a lesion For treatment of depression the
      PEMF equipment, which are provided by the company Re5 A/S, consists of a 220 V impulse
      generator that creates electrical impulses and an applicator which consists of an electrical
      cable connected to a helmet on which there are 7 electrical coils on the inside. In
      comparison with the rTMS (Transcranial Magnetic Stimulation) equipment, which uses stimuli
      approaching neuronal firing level, the PEMF fields in human is very much lower.
    

Detailed description: 
      Applied to cells PEMF have a stimulatory effect on intracellular tyrosine kinase activity,
      especially the Src family. The Src family upregulate NMDAR (N-methyl-D-aspartate) subtype of
      glutamate receptor thereby gating the production of NMDAR-dependent synaptic potentiation
      that are vital for processes that underlie physiological and pathological plasticity in the
      brain. Dysregulation of fibroblast growth factor receptors in frontal cortical regions of the
      brain seem to be associated with depression. The fibroblast growth factors are highly
      dependent on the activity of the Src family.

      For treatment of depression the PEMF equipment, which are provided by the company Re5 A/S,
      consists of a 220 V impulse generator that creates electrical impulses and an applicator
      which consists of an electrical cable connected to a helmet on which there are 7 electrical
      coils on the inside. In comparison with the rTMS equipment, which uses stimuli approaching
      neuronal firing level, the PEMF fields in human are very much lower.

      PEMF treatment involves placing the treatment helmet on the head and connecting it to a power
      source (220 V), which leads to induction of a pulsating magnetic field. The treatment was
      given for 30 min once or twice daily for 8 weeks. Participants are awake during these
      treatments and sit in a chair where they can read or eat. Pilot data demonstrates that the
      treatment can give mild transient nausea. No other side effects have been observed.
    

Intervention name(s): Treatment with PEMF equipment
Intervention type(s): Device
Intervention description(s): Treatment with PEMF in 8 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression, unipolar; Treatment resistant; PEMF
A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of
      asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg
      twice daily improves therapeutic response compared to placebo in participants with a
      diagnosis of asymptomatic chronic Chagas disease.
    


Intervention name(s): Posaconazole; Placebo for posaconazole; Benznidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): POS 40 mg/mL oral suspension; Placebo oral suspension; BNZ 100 mg oral tablet
Other intervention name(s): SCH 056592, MK-5592
Intervention MeSH terms: Posaconazole; Benzonidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of daily consumption of eggs or egg
      substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in
      participants with clinically established coronary heart disease (CHD).
    

Detailed description: 
      Restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is
      routinely recommended to patients with coronary disease. However, the relative importance of
      dietary cholesterol to serum lipids has become a subject of active debate. Eggs provide a
      complete array of amino acids and an array of micronutrients, and are low in total fat.
      Epidemiological and clinical studies have showed that dietary intake of omega-3 fatty acids
      decreases the risk of coronary heart disease (CHD). Endothelial function testing represents a
      uniquely valuable means of assessing aggregated influences on cardiac risk by gauging
      physiologic responses of the vascular endothelium. In prior studies the investigators have
      shown that daily egg ingestion for 6 weeks did not adversely affect endothelial function in
      healthy adults or in hyperlipidemic adults. The investigators now propose a prospective,
      randomized, single-blind crossover study to assess the effects of eggs, egg substitute and
      high-carbohydrate American breakfast on endothelial responses and serum lipids in
      participants with clinically established CHD.
    

Intervention name(s): Egg supplementation; Egg substitute; Control diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of 2 eggs for breakfast for 6 weeks; Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks; Daily consumption of high carbohydrate breakfast diet for 6 weeks, consisting of any of the following choices during each day of the treatment period: bagel, waffles, pancakes, or cereal and milk
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Coronary Artery Disease; Egg Consumption; Endothelial Function
A Trial of SB-061 in Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.
      Half of the patients will receive the agent via intra-articular injection and half will
      receive a placebo injection.
    

Detailed description: 
      The treatment of pain associated with osteoarthritis may include periodic intra-articular
      injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is
      anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing
      a lubricating coating of the cartilage. Subjects will receive 2 intra-articular injections of
      either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects
      and Investigators are blinded to treatment allocation.
    

Intervention name(s): SB-061; Placebo
Intervention type(s): Device; Other
Intervention description(s): delivered via intra-articular injection; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee
Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS
Condition: Pancreatic Masses; Lymph Nodes
Study type: Interventional

Summary: 
      The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue
      acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G
      Echotip ProCore Fine Needle Biopsy (FNB) device.
    

Detailed description: 
      Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to
      diagnose and stage malignancies. During Endoscopic Ultrasound (EUS), tissue samples can be
      obtained for pathological evaluation with different devices. Fine needle aspiration (FNA)
      provides a cytological specimen. Unfortunately, in a cytological specimen, inflammatory
      changes may be undistinguishable from well-differentiated dysplasia. Moreover, for neoplasms
      such as lymphomas and stromal tumors, tissue architecture and cell morphology are essential
      for accurate pathological assessment. Therefore, pathologists generally prefer a histological
      specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen,
      which may lead to better diagnostic performance. However, FNB needles are stiffer and more
      difficult to handle, which can complicate tissue acquisition. In addition, the superiority of
      histology over cytology in EUS-guided tissue sampling has not been proven yet. For instance,
      tissue, obtained by FNA and processed with the new cell-block technique, may equal the
      diagnostic yield of histological tissue cores.

      A recent meta-analysis suggested that 25G is the optimal FNA needle size to obtain an
      adequate cytological specimen. In this study, we aim to compare the properties and merits of
      a newly designed, more flexible, 20G EUS ProCore FNB device to a conventional 25G EUS-FNA
      device.
    

Intervention name(s): 25G FNA needle; 20G ProCore FNB needle
Intervention type(s): Device; Device
Other intervention name(s): 25G Echotip Ultra Fine Needle Aspiration (FNA) device; 20G Echotip ProCore Fine Needle Biopsy (FNB) device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Diagnostic accuracy; Endoscopic Ultrasound-Guided Fine Needle Aspiration; EUS-FNA; Endoscopic Ultrasound-Guided Fine Needle Biopsy; EUS-FNB; Pancreatic mass; Lymph node
Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of the study is to explore the concept of GnRH-agonist triggering in combination with
      elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting.
      The question asked is: "Does GnRH-agonist triggering and cryopreservation work", in terms of
      efficacy and safety, when applied to a larger cohort of patients, and by a number of
      different centres with different clinical routines.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IVF patients
      
Keywords: frozen-thawed embryo replacement; GnRH agonist; GnRH antagonist; ovarian hyperstimulation
Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy
Condition: Nonrevascularizable Critical Ischemia of the Lower Limbs
MeSH terms: Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells
      derived from lipoaspirate for treating various pathologies fistula. With this project we will
      address a study population with critical ischemia of lower limbs without possibility of
      revascularization, either by technical criteria (no intervention possible to compensate for
      the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for
      the type of intervention required). It will almost always elderly patients with multiple
      comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with
      very high probability of major amputation in the short term or immediate.

      Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable
      of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable
      a safe manner
    

Detailed description: 
      The primary endpoint of safety and feasibility study will be done when the patient has
      received treatment at 12 months after implantation. It defines that the process is safe when
      in the development and monitoring of the trial there has been no adverse events that may be
      related to the proposed therapy in the trial. All adverse events will be collected during the
      same time monitoring the clinical evaluation. The main objective will be assessed the
      cumulative incidence of adverse effects attributed to the study therapy.

      Secondary endpoints: As part of the evaluation of the quality of life of patients and
      clinical evaluation of the treatment will be at 6, 9 and 12 months after implantation a Test
      SF-12, a magnetic resonance angiography, and tissue oximetry records ankle-brachial index
    

Intervention name(s): Intramuscular injection of a suspension of adult mesenchymal stem cells derived
Intervention type(s): Other
Intervention description(s): Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Critical Ischemia; Amputation
Prevalence and Risk Factor of NP in Women With LUTS
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the
      treatment of women with lower urinary tract symptoms (LUTS). Thus, our aim is to describe the
      prevalence and risk factors of nocturnal polyuria in women with LUTS.
    

Detailed description: 
      Between September 2010 and January 2019, all women with LUTS visiting urogynecological
      department of a medical center for urodynamic evaluation were reviewed. Nocturnal polyuria
      was defined when the proportion of night-time voided volume over 24-hour voided volume was
      greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume
      over 24-hour voided volume was greater than 20% for <65 year-old women. Backward stepwise
      multivariable logistic regression analysis was performed using all statistical variables in
      the univariate logistic regression analysis. P < 0.05 was considered as statistical
      significant.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with lower urinary tract symptoms
      
Keywords: Nocturnal polyuria; Bladder diary
Protect - The Impact of a High Protein Diet on Preservation of Muscle Mass
Condition: Obesity
Study type: Interventional

Summary: 
      The present study is designed to investigate whether a high protein diet will preserve muscle
      mass during caloric restriction in older adults.
    


Intervention name(s): High protein diet; standard protein diet
Intervention type(s): Other; Other
Intervention description(s): controlled feeding trail. Both arms are caloric restricted
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Muscle; Physical performance; Protein; Diet; Caloric restriction
The Pharmacokinetics (PK), Pharmacodynamics(PD), Safety, Tolerability of SR1375 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled phase I bridging study to evaluate the
      PK, PD, safety and tolerability of SR1375 in healthy subjects.
    

Detailed description: 
      The study is a Phase I study to evaluate the PK, PD, safety, and tolerability of SR1375 in
      healthy volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 1
      multiple-dose cohorts (Part A and part B respectively), a total of 4 cohorts, and each cohort
      includes 3 stages: screening and baseline, treatment and safety monitoring, and safety
      follow-up.
    

Intervention name(s): SR1375 capsules; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Ascending single and multiple doses of SR1375 orally; Ascending single and multiple doses of Placebo orally
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
RELATIONSHIP BETWEEN INITIAL PROBING DEPTH AND CHANGES IN CLINICAL PARAMETERS FOLLOWING NON-SURGICAL PERIODONTAL TREATMENT IN CHRONIC PERIODONTITIS PATIENTS
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Aim: The aim of this study was to evaluate the relationship between initial probing depth
      (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT)
      in chronic periodontitis patients.

      Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic
      periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling
      and root planing was applied in two sessions. Probing depth (PD), clinical attachment level,
      gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites
      were grouped according to their IPD and root number of teeth as single- or multi-rooted.
    


Intervention name(s): Gracey Curettes
Intervention type(s): Device
Other intervention name(s): Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic periodontitis, dental scaling, periodontal pockets
A Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets
      (Pharmacare, Palestine) and Exforge 10/160 film coated tablets (Novartis Pharma, USA).
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary
      Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for
      transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and
      AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of
      logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within
      80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Amlodipine/Valsartan; Exforge
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains Amlodipine 10 mg &valsartan 160 mg; 1 tablet contains Amlodipine 10 mg &valsartan 160 mg
Other intervention name(s): Exforge
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

        -  To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg
           tablets in healthy, adult, human subjects under fasting conditions with a washout period
           of 14 days.

        -  To monitor adverse events and ensure the safety of subjects.
    

Detailed description: 
      A randomized, open label, two treatment, two period, two sequence, single dose crossover,
      bioequivalence study of nabumetone 750 mg tablets of Dr. Reddy's Laboratories Limited and
      Relafen® 750 mg tablets of Glaxosmithkline research triangle park, in healthy, adult, human
      subjects under fasting conditions.
    

Intervention name(s): Nabumetone; Relafen
Intervention type(s): Drug; Drug
Intervention description(s): Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited; Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
Other intervention name(s): Relafen® 750 mg Tablets
Intervention MeSH terms: Nabumetone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Nabumetone
Reversal of Obesity Cardiomyopathy
Condition: Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Observational

Summary: 
      The overall purpose of this study is to determine if weight loss is beneficial for obese
      patients with diastolic heart failure.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who are obese with heart failure and will undergo gastric bypass surgery or who
        have already had gastric bypass surgery.
      
Biospecimen description: 
      Blood Samples