bioihbjkbjnl/mcl2 huggingface dataset:
Neo-angiogenesis in Inguinal Henia Implant ProFlor
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal; Neovascularization, Pathologic
Study type: Observational

Summary: 
      The investigation is aimed at specifically demonstrating the ingrowth of newly formed
      vascular elements within ProFlor, a 3D dynamic responsive implant for inguinal hernia repair
    

Detailed description: 
      Biopsy specimen were excised at defined postoperative stages from patients who underwent
      hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the
      presence, quantity and quality of the vascular elements ingrowth within the implant fabric.
      Histology revealed the presence of multiple angiogenetic clusters that, starting from the
      early stage post-implantation, increased in number and degree of maturation. In the long
      term, the detected vascular components assumed the typical aspect of mature veins and
      arteries complete in all components. The development of fully developed vascular structures,
      ingrowing together with other components of the abdominal wall already described in
      literature, seems to finalize a regenerative response. This kind of behavior, being the
      expected result from a device intended for the cure of inguinal hernia and its degenerative
      source, seems to be coherent with the pathogenesis of the disease.
    

Intervention name(s): ProFlor inguinal hernia device
Intervention type(s): Device
Intervention description(s): Inguinal hernia repair
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
      
Biospecimen description: 
      Tissue specimens excised from ProFlor prosthesis implanted in patients who underwent inguinal
      hernia repair
    
Keywords: Hernia implants; Biologic response; Neo-angiogenesis; Regenerative scaffolds
Sedation and Pain (The Effect of IV Sedation on Pain Perception)
Condition: Pain
Study type: Interventional

Summary: 
      The investigators propose to evaluate the potential effect of sedation on pain perception in
      two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's
      brain activation using fMRI(objective).
    

Detailed description: 
      We propose to contrast and compare the effect of propofol and midazolam, two GABA-related
      sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in
      human volunteers by asking a participant to rate their pain and by evaluating a subject's
      brain activation using fMRI.
    

Intervention name(s): dexmedetomidine; midazolam; propofol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Midazolam; Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pain; Propofol; Dexmedetomidine; Midazolam; Effects of sedation on pain perception.
Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This investigation is intended to provide clinical information about alignment using
      TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will
      be compared to a historical control study, which compares alignment results of computer aided
      surgery (CAS) and conventional surgical techniques.

      The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior
      to alignment achieved with conventional instrumentation. This investigation will compare long
      leg alignment in total knee replacement achieved by the two types of procedures. Radiographic
      analysis will be performed by the same independent radiographic reviewer as the historical
      control study.
    

Detailed description: 
      The study is designed as a prospective, multi-center, non-randomized, clinical investigation
      to determine whether TruMatch™ alignment is non-inferior to alignment achieved in a recently
      completed study (historical control) with conventional instrumentation.

      Each enrolled Subject will undergo a total knee replacement using the TruMatch™ surgical
      technique. This investigation will require the Subject to be followed once postoperatively to
      collect radiographs. Follow-up will occur typically 2 to 12 weeks after surgery and when the
      Subject can achieve full leg extension (+/-5 degrees) and can tolerate weight-bearing.
    

Intervention name(s): TruMatch™ Personalized Solutions; Total Knee Arthroplasty with Conventional Instrumentation.
Intervention type(s): Other; Device
Intervention description(s): TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.; Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthroplasties, Knee Replacement; Arthroplasties, Replacement, Knee; Arthroplasty, Knee Replacement; Knee Replacement Arthroplasties; Knee Replacement Arthroplasty; Knee Replacement, Total; Replacement Arthroplasties, Knee; Replacement Arthroplasty, Knee; Replacement, Total Knee; Total Knee Replacement
An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
Condition: Normal Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different
      liposomal amphotericin B injections after single IV infusion at the same dose in normal
      healthy subjects.
    


Intervention name(s): Liposomal Amphotericin B; AmBisome
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of treatment withdrawal compared to
      continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the
      incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The
      primary hypothesis is that continued treatment with golimumab is superior to treatment
      withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of
      blinded therapy.
    


Intervention name(s): Golimumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.; Injections of matching placebo for golimumab.
Other intervention name(s): MK-8259; Simponi®
Intervention MeSH terms: Golimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (either every month [QM] or every 2 months [Q2M]) on the incidence of a "flare" during up to 12 months in Period 2 (blinded therapy).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Renal Denervation in Hypertension
Condition: Hypertension, Resistant to Conventional Therapy; Renal Denervation
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the
      effectiveness and costs of renal denervation in addition to standardized medical treatment
      compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal
      denervation will be performed using the Symplicity Catheter - a percutaneous system that
      delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
    

Detailed description: 
      The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the
      efficacy and cost-effectiveness of renal denervation plus standardized optimal
      antihypertensive treatment compared to standardized optimal antihypertensive treatment alone
      in patients with proven resistant hypertension. Patients with essential resistant
      hypertension will first enter a 4-week run-in period during which they will receive a
      standardized triple combination therapy (diuretic+ ACE inhibitor+ CCB at maximal dose). After
      4 weeks of standardized triple therapy patients will be randomized to renal denervation +
      optimal antihypertensive treatment compared to standardized optimal antihypertensive
      treatment if daytime ambulatory BP remains ≥ 135 and/or 85 mmHg. Bilateral renal denervation
      will be performed using the Symplicity Catheter (Medtronic ®) - a percutaneous system that
      delivers radiofrequency (RF) energy through the luminal surface of the renal artery. Study
      amendment: Extended follow-up of 48 months for all randomized patients.
    

Intervention name(s): renal denervation and optimized medication regimen; optimized medication regimen
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients are treated with the renal denervation plus a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.; Patients are treated with a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.
Other intervention name(s): TMAOS + DR; TMAOS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resistant hypertension; Renal denervation; Standardized medication regimen; Endovascular; Primary hypertension; Cardiovascular diseases; Vascular diseases
Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion
Condition: Pain; Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo
      for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks,
      in regard to the effect on pain relief and the overall procedure success.

      expected results:

      The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction in
      the need for additional pain relievers compared to the placebo, without interfering with the
      outcome of medical abortion
    


Intervention name(s): ibuprofen
Intervention type(s): Drug
Intervention description(s): The most common side effect observed during medical abortion using mifepristone together with misoprostol is abdominal pain. The use of ibuprofen was not shown to interfere with the action of misoprostol to induce uterine contractions and pregnancy expulsion.
Other intervention name(s): ibuprofen - Nonsteroidal anti-inflammatory drugs (NSAIDs)
Intervention MeSH terms: Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pain after abortion; abortion
Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the
      hypothesis that nutritional supplementation with whey protein, essential amino acids and
      vitamin D concurrent with regular, controlled physical activity would increase muscle mass,
      strength, physical functional, quality of life, and decrease the risk of malnutrition and
      inflammation in sarcopenic elderly.
    

Detailed description: 
      This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the
      hypothesis that nutritional supplementation (32 g) with whey protein, essential amino acids
      and vitamin D concurrent with regular, controlled physical activity would increase muscle
      mass (assessed by DXA), strength (assessed by handgrip dynamometer), physical functional
      (assessed by ADL), quality of life (assessed by SF-36), and decrease the risk of malnutrition
      (assessed by MNA and IGF-I) and inflammation (assessed by C-reactive protein) in sarcopenic
      elderly.
    

Intervention name(s): dietary supplement; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): oral essential amino acid (EAA), whey protein and vitamin D mixture; placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Several properties of VT-1161 suggest that it might be a safer and more effective treatment
      for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal
      medicines.

      This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail
      onychomycosis and consists of a screening phase, a 24-week treatment phase in which the
      patient will take either active drug, placebo or a combination of the 2 (according to random
      assignment), an initial observational phase of 36 weeks and an additional observational study
      extension of 9 months.

      The additional 9-month observational study extension was added with a protocol amendment and
      patient participation was optional.
    


Intervention name(s): VT-1161; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intestinal Microbiota Composition in Patients With Chronic Pancreatitis and Pancreatic Exocrine Insufficiency
Condition: Chronic Pancreatitis; Pancreatic Exocrine Insufficiency
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency
Study type: Observational

Summary: 
      Assessment of qualitative and quantitative composition of the intestinal microbiota in
      patients with CP; in patients with CP and PEI complication of mild to severe degree; patients
      with CP and PEI who underwent surgical intervention on the pancreas. Intergroup comparison of
      the microbial compositional characteristics and their analysis. Correction of enzyme
      replacement therapy in selected groups of patients with regard to the identified microbial
      characteristics. Assessment of the intestinal microbiota composition in dynamics after 6 (+1)
      months on the background of allocated therapy
    


Intervention name(s): enzyme replacement therapy
Intervention type(s): Combination Product
Intervention description(s): Correction of the previously prescribed dose of enzyme replacement therapy (ERT)/first time selection of ERT according to the severity of pancreatic exocrine insufficiency
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The investigator will set up a study evaluating vocal biomarkers in people with MS in order
      to identify persons with non-motor symptoms: depression, cognitive deterioration, and
      fatigue. Up to now, to the best of the investigator's knowledge, there is no study reporting
      the use of vocal biomarkers to predict these three non-motor symptoms in people with MS.
    


Intervention name(s): Voice analysis
Intervention type(s): Other
Intervention description(s): Voice analysis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapsing MS and healthy controls
      
Keywords: Multiple Sclerosis; Digital Biomarker; Non-Motor symptoms; Fatigue; Cognition; Depression; Voice Analysis
Effect of Folate on DNA in Colon Tissue and Blood Samples From Patients at Increased Risk of Developing Colorectal Neoplasia
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Studying samples of blood and tissue from patients at risk of cancer in the
      laboratory may help doctors learn more about the effect of folate on DNA and identify
      biomarkers related to cancer.

      PURPOSE: This phase I trial is studying the effect of folate on DNA in colon tissue and
      peripheral blood samples from patients at increased risk of developing colorectal neoplasia.
    

Detailed description: 
      OBJECTIVES:

        -  To analyze the effects of changes in levels of dietary folate intake on damage to DNA
           and repair capacity, mRNA expression, and DNA uracil incorporation in peripheral blood
           mononuclear cell and rectal biopsy cell samples from patients at increased risk for
           developing colorectal neoplasia.

      OUTLINE: Patients are enrolled into 1 of 2 intervention groups..

        -  Group I (folate depletion [in-patient]): Patients consume a weight-maintaining, average
           folate diet with no high folate-containing foods for 8 weeks. Patients are then admitted
           to The Rockefeller University Hospital and placed on a weight-maintaining, low-folate
           diet for 12 weeks. During the last 4 weeks of the in-patient period, patients receive
           oral folic acid supplementation once daily for 4 weeks.

        -  Group II (folate supplementation [out-patient]): Patients consume a weight-maintaining,
           average folate diet with no high folate-containing foods for 16 weeks as an out-patient.
           After the first 8 weeks of the diet, patients also receive oral folic acid
           supplementation once daily for 8 weeks.

      Patients undergo blood sample collection periodically for biomarker correlative studies.
      Samples are analyzed for serum and red cell folate and homocystine levels to assess folate
      depletion; methylentetrahydrofolate reductase (MTHFR) polymorphism to test for inherited
      alterations of folate metabolism; serum and plasma biomarkers; and DNA studies. Patients also
      undergo tissue sample collection by sigmoidoscopy and rectal biopsy periodically. Tissue
      samples are assessed for mucosal folate concentration and mucosal folic acid metabolites; DNA
      methylation; and gene assays by microarray analysis.

      After completion of study intervention, patients are followed at 4 weeks.
    

Intervention name(s): folic acid; DNA methylation analysis; gene expression analysis; microarray analysis; polymorphism analysis; laboratory biomarker analysis
Intervention type(s): Dietary Supplement; Genetic; Genetic; Genetic; Genetic; Other
Intervention MeSH terms: Folic Acid
Masking: Single
Primary purpose: Prevention
Keywords: colon cancer; rectal cancer
Preventing Age-Related Weight Gain in the Workplace With Daily Weighing
Condition: Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional

Summary: 
      To examine the effectiveness of daily weighing to prevent age-related weight gain.
    

Detailed description: 
      Cornell employee's were recruited for a two-year weight gain prevention study. Height and
      weights were taken in our metabolic center. They were randomized into two group. The
      experimental group was given an internet based scale and asked to weigh themselves every
      morning immediately after rising. The other group was asked to return at the end of the study
      when they height and weight will again be measured.
    

Intervention name(s): Daily Weighing Group; Control group
Intervention type(s): Device; Device
Intervention description(s): The Experimental group will weigh themselves everyday; This group will be weighed and measured at the beginning and end of the study and will not be weighing themselves daily
Other intervention name(s): Daily weighing; Not weighing daily
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Effect of self-weighing to prevent age-related weight gain
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors
Condition: Leukapheresis
Study type: Observational

Summary: 
      The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra
      Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of
      differentiation 34 (CD34) positive cells from healthy nonmobilized blood donors and healthy
      G-CSF (granulocyte colony stimulating factor) mobilized blood donors, respectively.
    


Intervention name(s): Mononuclear cell collection.
Intervention type(s): Device
Intervention description(s): Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Community Volunteers
      
Keywords: Leukapheresis; Hematopoetic Stem Cell Mobilization