bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery
Condition: To Prevent Scar Formation for Patients Underwent Surgery
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The centella asiatica cream applied to the wrist after the CTR surgery was found to be
      beneficial in preventing the scar tenderness in the thenar and hypothenar regions of the
      hand.
    

Detailed description: 
      Aim: This study was performed to evaluate the efficacy of centella asiatica extract in a
      cream preparation for the prevention of scar tenderness formation in patients who underwent
      conventional open carpal tunnel release surgery.
    

Intervention name(s): undefinedCentella Asiatica Extract
Intervention type(s): Drug
Intervention description(s): All patients were asked about scar hypertrophy, scar tenderness, and pillar pain.
The scar assessment was performed using the Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery.
Patients were asked to complete pre- and postoperative functional evaluations. The VAS score and QuickDASH test was used
Other intervention name(s): centella asiatica extract
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 280 operated patient with carpal tunnel release surgery.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: carpal tunnel syndrome; centella asiatica; surgery; cosmetic outcome; wound healing
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
Condition: Critical Limb Ischemia; Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      The study is intended to evaluate the safety and feasibility of using the Intact Vascular
      (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System)
      in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.
    

Detailed description: 
      The primary objective of the study is to evaluate the safety of delivery and placement of the
      Innovasc Tack Intravascular Staple System on vascular flaps in the SFA, created by
      percutaneous transluminal balloon angioplasty

      Safety will be evaluated as the 30-day (or hospital discharge date, whichever is longer) rate
      of major adverse events defined as the composite endpoint of death, device embolization, the
      occurrence of surgery related to the device, device related occlusion of the artery, or major
      unplanned amputation of the ipsilateral lower extremity.

      The secondary objective is to evaluate the feasibility of using the Innovasc Tack
      Intravascular Staple System to permanently secure vascular flaps.

      Secondary Evaluation of Feasibility (technical success) of the Innovasc Tack Intravascular
      Staple System (procedure and device) will be evaluated acutely by the following:

        -  Feasibility is defined as the ability to accurately place the Plaque Tacks and resolve
           post-PTA dissection flaps prior to the conclusion of the procedure, as demonstrated by
           angiography

        -  Acute technical success: Acute luminal patency during the revascularization procedure
           using standard angiography which demonstrates that the lumen of the artery at the
           location of tack implant remains patent at the conclusion of the procedure.

      The additional objectives of the study are to assess additional parameters as follows:

        -  Long term success will be assessed at one (1) month and three (3) months by evaluation
           of post-implant stability of the Plaque Tack relative to vascular or external landmarks
           at 30 days and 3 months via standard x-ray.

        -  Patency at 30 days and 3 months via duplex scanning or angiography, whichever deemed
           most appropriate for follow up of each individual patient by the principal investigator.
    

Intervention name(s): Innovasc Tack Intravascular Staple System (Tack)
Intervention type(s): Device
Intervention description(s): Tack-It Dissection repair
Other intervention name(s): Intact Vascular Tack-It; Tack-It Endovascular Dissection Repair System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: angioplasty; dissections
Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens
Condition: Pneumonia, Bacterial; Pneumonia, Viral; Pneumonia Fungal; Pneumonia Cavitary; Immunocompromised Host
MeSH terms: Pneumonia; Pneumonia, Viral; Pneumonia, Bacterial
Study type: Observational

Summary: 
      Given the need for a more sensitive pathogen detection test in patients with
      immunocompromised pneumonia, this study will evaluate the performance of the Karius Test, a
      novel NGS blood test for the diagnosis of infectious diseases. We will compare the
      performance of the Karius Test to the results of microbiologic tests obtained as part of
      usual care for immunocompromised patients undergoing evaluation for suspected pneumonia.
    

Detailed description: 
      Pneumonia is a major cause of morbidity and mortality in highly immunocompromised individuals
      such as patients with hematologic malignancies and/or hematopoietic stem cell transplant.
      These patients can be infected by a broad range of potential pathogens, including viral,
      bacterial, and fungal etiologies and sometimes with multiple pathogens simultaneously.
      Diagnostic testing often fails to identify a microbial etiology for lower respiratory illness
      even with bronchoalveolar lavage (BAL). In fact, culture methods, PCR, and antigen testing on
      BAL samples yields a positive result only 30-67% of the time. Additionally, Idiopathic
      Pulmonary Syndrome (IPS), a non-infectious pulmonary complication of transplant, can have
      many overlapping symptoms with infectious pneumonia. Treatment for IPS is administration of
      steroids which can exacerbate infections. Given these reasons, there is a need for better
      diagnostics to aid in the management of immunocompromised patients with pneumonia.

      Karius has developed a microbial cell-free plasma next-generation sequencing test for
      pathogen detection capable of detecting >1,000 organisms including DNA viruses, bacteria,
      yeasts, molds, and other eukaryotic pathogens. The test is performed in a
      CLIA-certified/CAP-accredited laboratory with results typically provided within one day from
      sample receipt. Given the need for a more sensitive diagnostic test for pneumonia in this
      population, we are evaluating the performance of the Karius Test for pathogen detection.
    

Intervention name(s): Karius Test
Intervention type(s): Diagnostic Test
Intervention description(s): Karius Test for detection of microbial cell free DNA (mcfDNA) in plasma
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Immunocompromised adult patients being evaluated for pneumonia who have undergone
        hematopoietic stem cell transplantation for any clinical indication or are receiving active
        chemotherapy for treatment of a hematologic malignancy.
      
Biospecimen description: 
      Blood
    
Keywords: Pneumonia; NGS; cell free DNA; microbial cell free DNA; immunocompromised
Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones
Condition: Obesity; Kidney Stones
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the influence of low-calorie diet on serum and
      urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic
      abnormalities.
    

Detailed description: 
      Objective: to evaluate the influence of low-calorie diet on serum and urinary metabolic
      parameters of obese adults with urinary calculi and lithogenic metabolic abnormalities.

      Method: prospective study of 50 patients, aged over 18 years, with a body mass index above 30
      kg/m2, urinary calculi and lithogenic metabolic abnormalities. Will be excluded from the
      study patients with psychiatric diagnoses other than depression, patients with inability to
      attend to clinical follow-up, patients with nephrocalcinosis, patients with urinary tract
      infection, patients with cystinuria and patients subjected to previous surgeries to treat
      obesity. Each patient will be evaluated monthly on the same day by urologist and
      nutritionist. On the first evaluation, will be done anamnesis, anthropometric measurements of
      weight, height, waist, bioimpedance and requested total serum calcium, phosphate, sodium,
      potassium, urea, creatinine, uric acid, and PTH, pH venous blood, urine tests type I, culture
      of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate,
      magnesium, creatinine, uric acid, cystine and computed tomography for evaluation of urinary
      calculus. In the second evaluation, 30 days after, anthropometric measures will be repeated,
      bioimpedance and nutritional assessment will be made with recommendation of daily ingestion
      of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day and requested total serum
      calcium, phosphate, sodium, potassium, urea, creatinine, uric acid, and PTH, pH venous blood,
      urine tests type I, culture of urine and urine tests of calcium, oxalate, phosphate, sodium,
      potassium, citrate, magnesium, creatinine, uric acid, cystine. Patients will be monitored
      monthly for 3 months with anthropometric measurements, bioimpedance and strengthening of
      nutritional recommendations. By the end of the third month, patients will be submitted to two
      series of serum and urine tests as before the diet. The results of serum and urine tests from
      the beginning of dietary treatment will be compared to those of the end of the treatment with
      Student T test. P<0.05 are considered significant.
    

Intervention name(s): Hypocaloric diet
Intervention type(s): Behavioral
Intervention description(s): recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Kidney stones; Diet
Inhibition of Non-histaminergic Pruritus Applied Using 3 Different Pruritogens
Condition: Itch
Study type: Interventional

Summary: 
      With this experiment, we want to use to investigate whether repeated application of EMLA
      cream as a tool to modulate non-histaminergic itching, which is produced using small needles
      from the plant mucuna pruriens (it is known that antihistamine does not attenuate this form
      of itch) and we want to compare the effect of short (1 hour) and prolonged (3 hours)
      application of EMLA. The sub-project takes place in 3 sessions over a period of 3 consecutive
      days (24 hours apart). All sessions will be identical.
    


Intervention name(s): Emla 1 hour; EMLA 3 hours; Vehicle cream for 1 hour; Vehicle cream for 3 hours; Cowhage
Intervention type(s): Drug; Drug; Other; Other; Other
Intervention description(s): At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then one area will be pre-treated with cutaneous 2.5% lidocaine/2.5% prilocaine cream (EMLA cream) for 1 hour.; At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then one area will be pre-treated with cutaneous 2.5% lidocaine/2.5% prilocaine cream (EMLA cream) for 3 hours.; At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then two area will be pre-treated with a vehicle cream for 1 h.; At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then two area will be pre-treated with a vehicle cream for 3 h.; Cowhage spicules are 1-2 mm in length and have a diameter of 1-3 μm. The spicules are inserted by gently rubbing 30-35 spicules into a 1 cm diameter skin area.
Intervention MeSH terms: Lidocaine, Prilocaine Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin
Condition: Gonorrhoea
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal
      pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary
      objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical,
      seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose.
    

Detailed description: 
      This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal
      pharmacokinetics of a single 1000mg oral dose of solithromycin. A total of 28 subjects (14
      male, 14 female) will be enrolled and will receive a single 1000mg dose of solithromycin
      after a 12 hour overnight fast (water permitted). Solithromycin is a fluoroketolide
      antibiotic under investigation for oral and parenteral use and will be administered orally.
      The study duration is approximately 18 months. Study Objectives: The primary objective is to
      determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical, seminal,
      rectal, and pharyngeal fluid samples after a single 1000mg oral dose. The secondary objective
      is to determine the safety and tolerability of a single 1000 mg oral dose of solithromycin in
      healthy adult subjects.
    

Intervention name(s): Solithromycin
Intervention type(s): Drug
Intervention description(s): Cohorts 1 and 2 will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted). Solithromycin is a fluoroketolide antibiotic under investigation for oral and parenteral use and will be administered orally.
Intervention MeSH terms: Solithromycin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: genitourinary; Neisseriaceae; pharyngeal; Solithromycin
Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1
      (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by
      boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly
      controlled Type 2 diabetes patients. This study is designed to understand the pharmacological
      effects and genetic variation of incretin based therapy on type 2 diabetes.
    

Detailed description: 
      Background:

      Since GLP-1 receptor is encoded by GLP1R ( glucagon-like peptide-1 receptor) gene,
      individuals may veritably respond to incretion based treatment, depending on the presence or
      absence of minor alleles characterized by single nucleotide polymorphisms. The genotyping of
      patients will be performed to compare the genetic factors and the pharmacological effects.

      Expected Results: How to select a anti-diabetic drug tailored to the individual becomes more
      and more important because the enormously increasing classes of treatment modality. This
      study could be of great help in recommending the best possible agent for an individual,
      improving the possibility of treatment success, and justifying if the need of expensive drugs
      in a given patient.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Poorly Controlled Type 2 Diabetic Patients
      
Biospecimen description: 
      DNA for sequencing
Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate the improved ablation and procedure times of the
      HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial
      fibrillation.
    


Intervention name(s): HeartLight X3
Intervention type(s): Device
Intervention description(s): Pulmonary vein isolation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Local Culture-Based Nutrition Education Intervention on Iron Supplement Tablets (IST) Consumption Compliance in Female Adolescents at Ogan Komering Ilir Regency: A Quasi-Experimental Protocol Study
Condition: Anemia; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to test the impact of a local culture-based nutritional
      education intervention on IST consumption compliance among female adolescents in the Ogan
      Komering Ilir Regency. The main questions it aims to answer are:

      a To identify information for the development of a local culture-based nutrition education
      model and to build a ready-to-implement local culture-based nutrition education model.

      b. To evaluate the implementation of the Anemia Prevention and Control Program among female
      adolescents in Ogan Komering Ilir Regency.

      c. To test the impact of the local culture-based nutrition education model on the improvement
      of knowledge, attitude, and IST consumption compliance among female adolescents.

      Participants will received IST and local culture-based nutrition education. Researchers will
      compare control group received IST as the Ministry of Health's program for the prevention of
      anemia with a subsidy for providing IST
    


Intervention name(s): Iron Supplement Tablets
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention group received IST and local culture-based nutrition education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: anemia; Iron Supplement Tablets
Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)
Condition: Post-Polio Syndrome
MeSH terms: Postpoliomyelitis Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness,
      fatigue and pain experienced by patients with post-polio syndrome. Intravenousimmunoglobulin
      (IvIg) reduces this inflammation. The purpose of this study is to investigate the clinical
      effect of IvIg in post-polio syndrome.
    

Detailed description: 
      Post-polio syndrome (PPS) is characterised by new muscle weakness, pain, and fatigue several
      years after the attack of acute polio. This leads to increased disability, and up to now only
      supportive therapy is available.

      Patients with PPS lose more motor neurons than expected and surviving neurons fail to
      maintain neurogenic supply to enlarged motor units. New data report an increased level of
      inflammatory cytokines in the cerebrospinal fluid (CSF). Immune modulating therapy like IvIg
      could be an option and this pilot study is the first to investigate the clinical effect of
      IvIg in PPS. In addition, levels of cytokines in CSF and serum before and after treatment
      will be investigated.
    

Intervention name(s): IvIg
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Post-polio syndrome; IvIg
The Comparison Between the PVAM and CPVI for the Patients of PAF
Condition: Atrial Fibrillation; Pulmonary Vein Isolation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      To compare the efficacy and safety of circumferential pulmonary vein isolation without
      contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial
      fibrillation.
    

Detailed description: 
      This is a single centre, prospective control study. The study will enroll 180 patients with
      2:1 grouped.
    

Intervention name(s): pulmonary vein antrum modification
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: atrial fibrillation; pulmonary vein isolation; Contact Force; antrum
Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      A case-control study will evaluate the clinical utility of the Congo Red test GV-005 in
      following women with a clinical diagnosis of preeclampsia and clinically healthy women in the
      postpartum period
    

Detailed description: 
      A case-control study (n=150) will evaluate the clinical utility of the Congo Red test GV-005
      in following women with a clinical diagnosis of preeclampsia and clinically healthy women in
      the postpartum period. Women with preeclampsia (n=100) (cases) and clinically healthy women
      (n=50)(controls) who are hospitalized postpartum will be recruited for the trial. All women
      will be asked to provide a urine sample. Samples will be collected daily during a woman's
      hospitalization. The Congo Red test GV-005 and a standard urine dipstick proteinuria test
      will be performed by a lab technician within 72 hours of sample collection. The purpose of
      this research is to evaluate progression of urine congophilia postpartum by following
      patients diagnosed with preeclampsia and clinically healthy women.
    

Intervention name(s): Congo Red test GV-005
Intervention type(s): Device
Intervention description(s): Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women attending Dhaka Medical College (Dhaka) with clinically confirmed cases of
        preeclampsia and clinically healthy women who deliver at term will be eligible for the
        study.
      
Biospecimen description: 
      urine samples collected
    
Keywords: Congo Red test GV-005