bioihbjkbjnl/mcl2 huggingface dataset:
Syndecan-1 a Surrogate Marker for IBD
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Syndecan-1 is a protein on the surface intestinal cells. previous studies proved low levels
      of mucosal syndecan-1 levels on the surface of intestinal cells is patients with acute and
      chronic inflammation due to inflammatory bowel disease.

      this protein might shed from cell surface to the serum. The investigators wish to prove that
      elevated serum levels of syndecan-1 may be predictive of disease presence, extent and
      severity, that buy taking a simple blood sample from patients diagnosed with inflammatory
      bowel disease and comparing to normal subjects and to other markers.
    

Detailed description: 
      One of the main hypothesis for the etiology of Inflammatory bowel disease (IBD) is an
      inappropriate and ongoing activation of the mucosal immune system in response to the presence
      of normal luminal flora. This aberrant response is most likely facilitated by defects in both
      the barrier function and the mucosal immune system of the intestinal epithelium. Syndecans
      are a class proteoglycans that take part in both cell adhesion and growth factor binding. Of
      the four known syndecan core proteins, syndecan-1 (CD138) and one of the best studied of this
      group and is also the relevant to the this study as it is expressed on the basolateral
      surface of columnar epithelial cells of the colon. Syndecan-1 functions as an integral
      membrane protein that participates in cell proliferation, cell migration and cell matrix
      interactions in the GI tract. Evidence for a reduction of syndecan-1 expression in the
      regenerating epithelium that overlies inflamed tissue was reported in both acute and chronic
      inflammation. This protein that is lost from the inflamed mucosal membrane might shed to the
      serum. Elevated serum levels of syndecan-1 may be predictive of disease presence and extent.
    

Intervention name(s): blood sample; Blood sample - venous blood 10 ml.
Intervention type(s): Procedure; Procedure
Intervention description(s): Blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1; venous blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1
Other intervention name(s): Syndecan-1; Syndecan-1
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Normal population, having no known inflammatory disease
      
Biospecimen description: 
      Venous blood sample for syndecan-1 levels, blood count, CRP levels,serum albumin and total
      protein
    
Keywords: Crohn's disease; ulcerative colitis; Syndecan-1
Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection
Condition: Lumbar Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The study is conducted to compare pain relief, accuracy and safety and radiation exposure of
      selective lumbar nerve root injection for lumbar radicular pain using ultrasound guidance
      versus fluoroscopy guidance
    

Detailed description: 
      Radicular pain is believed to be induced by irritation or inflammation of a nerve root caused
      by mechanical pressure or chemical irritation from degeneration herniation or rupture of
      intervertebral disc .Nerve root steroid injection is the most commonly performed minimally
      invasive technique for treatment of radicular pain in lumbar spine.The mechanism of action of
      steroids is to reduce inflammation by reduction in proinflammatory mediators around the nerve
      root, causing reduction in pain levels . Although Fluoroscopy guided technique is the most
      widely accepted method in lumbar selective nerve root injection, but recently ultrasound
      technique has gained acceptance among physicians due its reliability, efficacy, real-time
      guidance of injection and reduction of radiation exposure. Real-time guidance of injection
      provided by ultrasonography allows for good identification of the spinous process and
      adjacent structures such as lamina, zygapophyseal articulations and transverse process
      allowing for safer and potentially equally effective injection technique. The patients are
      randomly allocated into two groups; one group will receive injection under fluoroscopy
      guidance and the other group will receive injection under ultrasound guidance. The two groups
      are compared in terms of pain relief, accuracy and safety and radiation exposure.
    

Intervention name(s): selective lumbar nerve root injection
Intervention type(s): Procedure
Intervention description(s): selective lumbar nerve root steroid injection for treatment of radicular pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lumbar radicular pain; selective nerve root injection; ultrasound selective lumbar nerve root injection
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of Brotizolam in the treatment of patients with
      insomnia in comparison with that of Estazolam
    

Detailed description: 
      It is intended to recruit 240 insomnia outpatients in this study, 120 patients receiving
      Brotizolam + Estazolam placebo (Test Group) and 120 patients given Estazolam + Brotizolam
      placebo (Control Group).

      Study Hypothesis:

      Brotizolam can be safely used in insomnia patients in China. And Brotizolam 0.25mg is
      non-inferior with Estazolam 1-2mg in treatment of insomnia patients in China

      Comparison(s):

      Estazolam 1-2mg
    

Intervention name(s): Brotizolam; Estazolam
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estazolam; Brotizolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection
Condition: Thoracic Diseases; Thoracic Surgery
MeSH terms: Thoracic Diseases
Study type: Observational

Summary: 
      Exploring the optimal interval time in patients with the clinical diagnosis of lung cancer or
      mediastinal tumors indicated for thoracic surgeries after SARS-CoV-2 infection by comparing
      30-day mortality and 30-day morbidity.
    


Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Observe the 30-day mortality and 30-day morbidity.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who undergo thoracic surgery for the clinical diagnosis of lung cancer or
        mediastinal tumors with or without SARS-CoV-2 infection.
Effects of Plasmapheresis on Aging Biomarkers
Condition: Aging; Plasmapheresis
Study type: Observational

Summary: 
      The aim of the study is to evaluate the effect of plasmapheresis (repeated plasma
      withdrawals) on selected health indicators (hematological, biochemical, immunological and
      indicators of biological age) of plasma donors.
    


Intervention name(s): Plasmapheresis
Intervention type(s): Procedure
Intervention description(s): Procedure whereby plasma is separated and extracted from anticoagulated whole blood and the red cells retransfused to the donor.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        41 donors are welcomed to begin with the study. The participants are divided into 2 groups
        (Group 1 = therapeutic, Group 2 = half control) using stratified randomization, major
        criteria being chronological age and BMI, minor criteria being illness/medication, smoking,
        COVID in past 3 months, covid vaccination.

        Group 1 consists of 28 participants (14 female, 14 male). Group 2 consists of 13
        participants (7 female, 6 male). We suppose that the number of participants will decline
        during each phase of the study, approx. 10% before it even starts, 10% in the middle, 10%
        in the end. The goal is to have more than 30 participants finishing the study.
      
Keywords: Aging; Plasmapeheresis
Pneumoperitoneum Management With SurgiQuest AirSeal at Low vs. Higher Pressure ( PRESSURE )
Condition: Shoulder Pain
MeSH terms: Shoulder Pain; Pneumoperitoneum
Study type: Interventional

Summary: 
      This study is designed to evaluate physician preference related to the use of the SURGIQUEST
      AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of
      pneumoperitoneum.
    

Detailed description: 
      The objective of this study is to evaluate physician preferences related to use of the
      SurgiQuest AirSeal Insufflation System (AIS) used at low vs. higher pressures for maintaining
      pneumoperitoneum during laparoscopic/robotic surgical procedures.

      The study is designed and powered to demonstrate superiority of the AIS used at low
      insufflation pressure (9±mmHg ±1mmHg) vs higher pressure (15mmHg ±1mmHg) in relation to a
      single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1
      to either AIS with an insufflation pressure target of 9±1mmHg) or to AIS with an insufflation
      target pressure of 15±1mmHg.

      Secondary outcome measures include severity of shoulder pain measured using a VAS scale and
      medication use, procedure time, the number of procedure interruptions, length of hospital
      stay, aspects of anesthesia management including end tidal CO2 and the frequency of adverse
      events. These outcomes will be evaluated in a controlled population undergoing
      laparoscopic/robotic surgery.
    

Intervention name(s): SurgiQuest AIRSEAL® Insufflation System (AIS)
Intervention type(s): Device
Intervention description(s): The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas (establish and maintain pneumoperitoneum), to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
Other intervention name(s): AIS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer
      cells. Peripheral stem cell transplantation may allow doctors to give higher doses of
      chemotherapy and radiation therapy and kill more cancer cells.

      PURPOSE: Phase I/II trial to study the effectiveness of etoposide plus radiation therapy
      followed by peripheral stem cell transplantation in treating patients who have non-Hodgkin's
      lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the overall and progression-free survival of patients with selected
      poor-prognosis non-Hodgkin's lymphomas treated with high-dose etoposide and total-body
      irradiation followed by rescue with peripheral blood stem cells. II. Determine the toxicity
      of this regimen. III. Evaluate the short-term and long-term engraftment characteristics of
      patients treated on this regimen.

      OUTLINE: Patients who respond on Regimen A and who have no bulk disease greater than 5 cm are
      treated on Regimen B. Regimen A: Single-Agent Chemotherapy/Stem Cell Mobilization with
      Urothelial Protection and Growth Factor Therapy. Cyclophosphamide, CTX, NSC-26271; with
      Mesna, NSC-113891; and Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629.
      Regimen B: Sequential Radiotherapy, Single-Agent Chemotherapy, and Stem Cell Rescue.
      Total-body irradiation, TBI (equipment not specified); Etoposide, VP-16, NSC-141540; and
      Peripheral Blood Stem Cells, PBSC.

      PROJECTED ACCRUAL: 20 patients will be studied.
    

Intervention name(s): filgrastim; cyclophosphamide; etoposide; mesna; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Etoposide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Waldenstrom macroglobulinemia; recurrent small lymphocytic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma
A Phase I Pharmacokinetic Study of Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 Microgram [mcg]) After Single and Repeat Dose Administration From a Dry Powder Inhaler in Healthy Chinese Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to evaluate the PK of FF/UMEC/VI in dose combinations of
      100/62.5/25 mcg after single and repeat dose administration from a DPI in healthy Chinese
      subjects. This study will evaluate the systemic pharmacokinetics (PK), of FF/UMEC/VI in
      Chinese healthy population when administered using dry powder inhaler (DPI)as a blended
      combination of UMEC/VI in one strip and FF in the second strip in dose combinations of
      100/62.5/25 mcg. The triple, fixed dose combination product Fluticasone furoate(FF)/
      Vilanterol (VI) /Umeclidinium bromide (UMEC) with new configuration enables the delivery of
      inhaled long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA) and
      inhaled corticosteroid (ICS) from a single device. Approximately 16 subjects will be enrolled
      in the study. After taking into account the allowable time windows for screening, treatment
      and follow-up, a subject will be in the study for a maximum duration of 6-7 weeks.
    


Intervention name(s): FF; VI/UMEC
Intervention type(s): Drug; Drug
Intervention description(s): FF is a dry white powder blended with lactose. It is the first strip of DPI. Per blister contains 100 mcg of dose; VI and UMEC bromide combination is a dry white powder blended with lactose and magnesium stearate. It is the second strip of DPI. Per blister contains 25 mcg/62.5 mcg of VI/UMEC dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Long-acting muscarinic antagonist; Long-acting beta2 agonist; Dry powder inhaler; Inhaled corticosteroid
Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      study effects of rosuvastatin on markers of atherosclerosis, thrombosis, in diabetic patients
      treated with glimepiride/metformin without coronary artery disease.

      This effect will be investigated especially on sortilin ,fetuin-A
    

Detailed description: 
      A randomized controlled trial on 70 patients with DM type 2 will be recruited from Damanhour
      national medical institute.

        -  Subjects will be divided into two group (one arm is DM-type 2 patients who will receive
           rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type
           2 patient who will receive glimepiride-metformin combination (30 patients).

        -  Determination of serum levels of fetuin A and Sortilin

        -  Blood samples will be collected after 3-month after active treatment.

        -  Outcomes measurement : Sortilin ,fetuinA, Atherogenic index (AI) and coronary risk index
           (CRI) .

      Methodology

        -  Sortilin, fetuinA will be determined by ELISA.

        -  Lipid profile.

        -  FBG and Hb A1C will be measured.

        -  Atherogenic index (AI = LDL-C/HDL-C) and CRI (CRI = TC/HDL-C) will be calculated for all
           subjects.
    

Intervention name(s): Rosuvastatin10 mg tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral; Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Other intervention name(s): Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral; Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Intervention MeSH terms: Metformin; Glimepiride; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: T2DM.
Functional Neuroimaging Effects of Cognitive Remediation Training
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine behavioral and functional brain changes occuring as a
      result of cognitive remediation training in patients with schizophrenia. Extension and
      specificity of related changes will also be examined.
    


Intervention name(s): Cognitive Remediation; Cognitive Behavioral Social Skills Training; Retest in Health Controls
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Pre/Post test performance and neuroimaging only
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, single-blind. An untreated healthy control group was also included to examine simple retest effects.
Masking: Single (Participant)
Primary purpose: Basic Science
Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms
Condition: Disintegration; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to find out how different types of capsules or tablets containing EDP1815 move
      through the GI tract and release the drug after being swallowed. The capsules and tablets
      also contain a very small dose of a commonly used radioactive label called technetium-99m
      which is released in the GI tract to be seen on pictures taken by a scanner (gamma
      scintigraphy).
    

Detailed description: 
      This is a Phase I single centre, crossover, gamma scintigraphy study to investigate the
      gastrointestinal transit and disintegration kinetics of capsule and tablet formulations of
      EDP1815 (which contains a specific pure strain of Prevotella histicola, a natural human
      commensal organism).

      In Part 1, up to 12 healthy male volunteers will receive single doses of EDP1815 administered
      either as capsules or tablets in 4 treatment periods.

      The data generated in Part 1 will be assessed prior to progressing to Part 2 to select
      formulations and doses to be studied. Part 2 will include gamma scintigraphy in up to 12
      healthy volunteers receiving single doses of EDP1815 capsules over up to 4 treatment periods.

      The data generated in Part 2 will be assessed prior to progressing to Part 3 to select
      formulations and doses to be studied. Part 3 will include gamma scintigraphy in up to 12
      healthy volunteers receiving single doses of EDP1815 capsules or tablets over up to 4
      treatment periods.

      The data generated in Part 3 will be assessed prior to progressing to Part 4 to select
      formulations and doses to be studied. Part 4 will include gamma scintigraphy in up to 12
      healthy volunteers receiving single doses of EDP1815 tablets over up to 4 treatment periods.

      Each capsule or tablet will contain the radio-isotope technetium-99m complexed to DTPA;
      99mTc-DTPA, does not enter the systemic circulation and is routinely used for investigations
      of this type. Imaging via gamma scintigraphy will be used to assess the gut transit time and
      disintegration location/rate of the capsules/tablets. The drug will be given fasted or fed.
    

Intervention name(s): EDP1815 capsule A; EDP1815 capsule B; EDP1815 tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): EDP1815 capsule A is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The capsule is radio-labeled with approximately 4 MBq 99mTc-DTPA; EDP1815 capsule B is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The capsule is radio-labeled with approximately 4 MBq 99mTc-DTPA; EDP1815 tablet is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The tablet is radio-labeled with approximately 4 MBq 99mTc-DTPA
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this proof of principle study is to evaluate efficacy and safety of the sequential
      application of two marketed products for the treatment of acne vulgaris, using the Split-Face
      model
    


Intervention name(s): marketed topical retinoid; marketed topical NSAID; vehicle gel; marketed topical retinoid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once daily application, 4 weeks; once daily application, 4 weeks; once daily application, 4 weeks; once daily application, 4 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment