bioihbjkbjnl/mcl2 huggingface dataset:
Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease
Condition: Liver Fibrosis
MeSH terms: Liver Diseases; Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      The aim of this prospective study was to compare the 5-year prognostic value of transient
      elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting
      survival and complications of cirrhosis in patients with chronic liver diseases.
    

Detailed description: 
      A total of 1616 patients with chronic hepatitis C was included. At 5 years, 79 patients were
      dead (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival
      was 91.7% and survival without liver-related death 94.4%. Survival was significantly
      decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used.
      All these methods were able to predict a shorter survival in this large population. Patients
      had their prognosis decreased as liver stiffness increased. By multivariate analysis, only
      FibroTest > 0.74 (OR 4.41, 95%CI 1.62-12.01, p=0.004) was associated with overall survival,
      and liver stiffness > 9.5 kPa (OR 4.71, 95%CI 1.06-21.01, p=0.04) associated with
      liver-related death.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We included all consecutive patients with an age over eighteen and a chronic hepatitis C of
        any severity. The determination of chronic hepatitis C was made using standard diagnostic
        criteria: serological detection of hepatitis C antibodies and positive serum HCV-RNA by PCR
        for more than 6 months. Exclusion criteria were chronic hepatitis B virus infection and all
        other causes of chronic liver disease. Patients with HIV infection were included.
      
Keywords: liver fibrosis; survival; transient elastography
Tablet-based Patient Reported Outcome
Condition: Antineoplastic Agents
Study type: Interventional

Summary: 
      This study is a single arm feasibility study. Patients that have been diagnosed with
      carcinoma and are undergoing chemotherapy have to document chemotherapy associated side
      effects on a regular basis by means of a tablet-based online questionnaire. Goal of the study
      is to find out if patients that are undergoing chemotherapy are willing to document
      chemotherapy associated side effects by means of a tablet-based online questionnaire.
    


Intervention name(s): Tablet-based questionnaire
Intervention type(s): Device
Intervention description(s): tablet-based patient reported outcomes (TabPRO)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Antineoplastic Agents
Prevention of Diabetes Progression Trial (PDPT)
Condition: Newly Diagnosed With Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine the efficacy and safety of daclizumab in
      preventing the progression of diabetes in children who have just been diagnosed with type I
      diabetes. Additional purposes of the study are to investigate the amount of drug in the
      children, how quickly it is eliminated from the blood, and analyze the effect of the drug on
      the immune reaction to diabetes.
    


Intervention name(s): Zenapax
Intervention type(s): Drug
Intervention MeSH terms: Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians
Condition: Strength Training; Dietary Proteins; Muscle Strength; Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      A strength training session promotes increased muscle sensitivity to protein synthesis, which
      lasts for 24 hours after its closure. Recent studies have shown that the subsequent intake to
      the training session of approximately 20g or 0.24g / kg of high-quality protein in the same
      meal induces a plateau in this synthesis. Thus, this study aims to compare the muscular
      strength between vegetarian and omnivorous athletes with adequate protein intake to reach
      this plateau. It will recruit 64 university sportsmen who have maintained vegetarian or
      omnivorous diet for at least 6 months, totalizing 32 individuals per group. After signing the
      Term of Consent, participants will be submitted to anthropometric and body composition
      assessment (via DEXA), neuromuscular tests [(ie, muscle strength - 1RM, peak torque of knee
      extensors (JE), muscle thickness of JE and cohort analysis (ANCOVA) will be used in order to
      compare the results of the study, and to compare the results of the covariance analysis
      (ANCOVA). the levels of the neuromuscular parameters between the groups, considering the
      initial values of the force and the initial muscular thickness as covariables, the other
      parameters will be presented in the form of mean and standard deviation or median, the
      differences will be considered significant for values of p <0, 05. Expected to find no
      differences in strength and muscle thickness between vegetarians and omnivores after adequate
      protein intake.
    


Intervention name(s): Strength training; Protein intake
Intervention type(s): Other; Other
Intervention description(s): 24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week; Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Laser Spot Treatment of Perioral Rhytids
Condition: Facial Aging
Study type: Interventional

Summary: 
      Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be
      addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable
      scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing,
      usually with laser treatment. Often the peri-oral area is treated with additional spot
      treatments with an ablative laser to cause a more robust healing response and better aesthtic
      result. To date, no studies have specifically shown efficacy of additional spot treatment
      over full facial laser alone.

      This study is designed as a split-face study, to compare the aesthetic results of full field
      laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on
      the other half.

      To clarify further to the IRB board, this is not an experimental treatment. Spot treatment is
      used by many surgeons/laser proceduralists for addressing specific areas of the face. This is
      an FDA indicated use of the laser for facial resurfacing. Due to the many genetic and
      enviromental factors that can effect the results the best design for the study to is have
      each patient serve as their own control with a split-face study.
    

Detailed description: 
      Cohort Study, with Split Face treatment

      Methods:

      Patients will be evaluated in the office for possible inclusion. Those who agree to partipate
      will receive preoperative photos.

      On the day of the procedure patients will have a topical anesthestic applied for 30 minutes,
      then patients will recieve a 20um laser resurfacing of the entire face to remove dead skin
      and debris. After that, patients will have reapplication of a topical anesthetic for an
      additional 10 minutes. They will then undergo a 50 um peel to one side of the face and a
      patient tailored spot treatment of perioral wrinkles to the other side of the face. The depth
      of this may vary from 100 to 400um.

      Patients will return to clinic at 1 week, 2 weeks, and 3 weeks post-procedure and fill out a
      short survey and have medical photography done. Patients will return at 3 and 6 month
      follow-up for additional photography and surveys. These visits will typically take 10 to 20
      minutes.

      Preoperative and post-operative photos will be analyzed by 2 independent plastic surgeons for
      post-operative changes and improvements.
    

Intervention name(s): Laser Treatment
Intervention type(s): Procedure
Intervention description(s): Patient will have split face laser resurfacing as per standard of care. One side of the face will be treated with a standardized single depth laser peel. The other side of the perioral area will be treated with variant, deeper treatment to perioral rhytids.
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser Resurfacing; Rhytids; Perioral
Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China
Condition: Iron Metabolic Homeostasis
Study type: Interventional

Summary: 
      The investigators plan to perform a randomized, mutual-control and double-blinded cohort
      study to further exploit the vitamin A supplementation on iron metabolic homeostasis
      (including iron reserve, mobilization and absorption status in the same population) compared
      with solely iron and vitamin A plus iron.
    


Intervention name(s): iron and vitamin a
Intervention type(s): Drug
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin a; preschool children; iron metabolic homeostasis; supplementation effect
A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
Condition: Ventral Hernia
MeSH terms: Hernia; Incisional Hernia; Hernia, Ventral
Study type: Observational

Summary: 
      The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh
      in ventral and incisional repair procedures by evaluating the following:

        1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh
           for up to 12 months post surgery.

        2. Perioperative, short-term and long-term procedural and/or device related complications.

        3. Abdominal Wall Function and mobility.
    


Intervention name(s): Phasix mesh implant
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patents with ventral hernias that meet eligibility criteria.
      
Keywords: Resorbable mesh; Phasix mesh
Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy
Condition: FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65
      weeks in participants with Familial Amyloid Polyneuropathy (FAP).
    

Detailed description: 
      FAP is a rare, hereditary disease caused by mutations in the transthyretin (TTR) protein. TTR
      is made by the liver and secreted into the blood. TTR mutations cause it to misfold and
      deposit in multiple organs causing FAP.

      Inotersen (also known as ISIS 420915) is an antisense drug that was designed to decrease the
      amount of mutant and normal TTR made by the liver. It is predicted that decreasing the amount
      of TTR protein would result in a decrease in the formation of TTR deposits, and thus slow or
      stop disease progression.

      The purpose of this study is to determine if inotersen can slow or stop the nerve damage
      caused by TTR deposits. This study will enroll late Stage 1 and early Stage 2 FAP
      participants. Participants will receive either inotersen or placebo for 65 weeks.
    

Intervention name(s): Inotersen; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): TEGSEDI; IONIS-TTR Rx; ISIS 420915
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis
Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns
Condition: Preterm Birth; Postpartum Women
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effect of banana blossom in increasing breast milk
      volume
    


Intervention name(s): Banana Blossom; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Banana Blossom 225 mg tablet orally four times per day for 14 days; Placebo tablet orally four times per day for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Combination Chemotherapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known whether combination chemotherapy with or without epirubicin and cyclophosphamide is
      more effective in treating patients with extensive stage small cell lung cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      with or without epirubicin and cyclophosphamide in treating patients who have extensive stage
      small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the overall survival and survival without recurrence of patients with
      extensive stage small cell lung cancer after receiving cisplatin and etoposide with or
      without epirubicin and cyclophosphamide. II. Compare the relative dose and intensity of
      cisplatin and etoposide between the two groups of patients. III. Compare the complete and
      objective response rate and quality of life of these patients. IV. Compare the toxic effects
      of these 2 regimens in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
      treatment arms. Arm I: Patients receive etoposide IV on days 1 and 3 and cisplatin IV on day
      2. Arm II: Patients receive etoposide and cisplatin as in arm I, plus epirubicin IV on day 1
      and cyclophosphamide IV on days 1 and 3. Treatment is repeated in both arms every 28 days for
      up to 6 courses. Patients who achieve a partial or complete response receive cerebral and/or
      thoracic radiotherapy. Patients with residual tumor may receive oral etoposide for 3 of every
      4 weeks. Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 2.5 years.
    

Intervention name(s): cisplatin; cyclophosphamide; epirubicin hydrochloride; etoposide; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Cyclophosphamide; Etoposide; Epirubicin
Allocation: Randomized
Primary purpose: Treatment
Keywords: extensive stage small cell lung cancer
A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of three doses of
      vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose
      levels in people with type 2 diabetes who have not been previously treated with drug therapy
      to lower their blood sugar.
    


Intervention name(s): vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
Effects of TRF on Obese Patients With CKD Stage 3-4
Condition: Time Restricted Feeding; Renal Insufficiency, Chronic; Obesity
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Obesity is associated with glomerular hyperfiltration leading to renal impairment and is a
      risk factor for the progression of kidney disease.Weight loss can reduce proteinuria and
      improve eGFR.Intermittent fasting is safe and effective, and in addition to improving body
      shape and weight in obese patients, it can also improve glucolipid metabolism, reduce
      proteinuria, improve kidney function and delay the progression of kidney disease.
    

Detailed description: 
      KDOQI clinical practice guideline for nutrition in chronic kidney disease (CKD) uses a
      low-protein diet to reduce renal impairment and delay progression. The current research
      hotspot is dietary intervention. Time-restricted feeding was used to intervene in the
      progression of CKD. It restrict the time of eating but not the eaten calories, which have a
      higher compliance and safety. Studies have shown that intermittent fasting in obese patients
      with CKD is not only reduce body weight, but also improves glycolipid metabolism, reduces
      proteinuria and delays the progression of kidney disease. Intermittent fasting is currently a
      scientific research hotspot, and there are few international studies on the implementation of
      intermittent fasting to delay the deterioration of renal function in obese CKD patients, and
      lack of data on Chinese patients, which has great research potential. Based on the above
      background, this study was conducted as an pilot clinical trial to explore the effects of
      intermittent fasting on obese patients with CKD and to observe its effectiveness, safety and
      compliance.
    

Intervention name(s): Time-restricted feeding(TRF)
Intervention type(s): Behavioral
Intervention description(s): The TRF group was asked to restrict the eating window to 8 hours a day, during waking hours and also continue a low-protein diet.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: It was non-randomized trial study design, two parallel groups were assigned to time-restricted feeding(TRF) and control group and to do the intervention for 12 weeks.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: time-restricted feeding; chronic kidney disease; obesity
Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer.
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor
      of prostate-specific membrane antigen (PSMA), [18F]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging
      if available) for detection of metastatic prostate cancer. PSMA is a well characterized
      histological marker of prostate cancer tumor aggressiveness and metastatic potential.
      Preliminary first-in-human studies demonstrate high specific uptake of a first generation
      less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for
      prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL
      PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis.
      Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive
      but less specific [18F]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.
    


Intervention name(s): 18F-DCFPyL Injection; 18F-NaF
Intervention type(s): Drug; Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Caffeinated Gum on a Basketball-specific Tests in Trained University Male Basketball Players: a Crossover Trial
Condition: Caffeine
Study type: Interventional

Summary: 
      This study investigated the effects of chewing 3 mg/kg of caffeinated gum on basketball free
      throw accuracy and basketball -specific performance. Fourteen trained basketball players with
      at least a top 8 national ranking were recruited to be participants in this study. After 2
      simulation tests to familiarize the experimental procedure, we employed a double blind,
      randomized crossover design to divide participants into caffeine trial (CAF) and placebo
      trial (PL). The CAF trial chewed caffeine gum containing 3 mg/kg for 10 minutes, whereas the
      PL trial chewed a placebo gum without caffeine. After 15 minutes rest, the stationary free
      throw shooting test, countermovement jump, t-test, 20-meter segmented dash test, squat in the
      flywheel device and running based anaerobic sprint test were conducted.
    


Intervention name(s): caffeine gum
Intervention type(s): Dietary Supplement
Intervention description(s): This study investigated the effects of chewing 3 mg/kg of caffeinated gum on basketball free throw accuracy and basketball -specific performance.
Other intervention name(s): plocabo gum
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Eccentric exercise; basketball
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized double-blind vehicle-controlled Phase 3 study to evaluate the efficacy
      and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in
      adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to
      receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.
    

Detailed description: 
      This study is a 12-week double-blind, vehicle-controlled treatment study in which subjects
      will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 12 weeks.
      At the end of the 12-week study treatment, qualified subjects completing the study will have
      the option to enter a separate open-label, long-term safety and efficacy study for an
      additional 40 weeks of treatment with tapinarof cream, 1%. Subjects who do not enroll in the
      open-label long-term study will complete a follow-up visit approximately 4 weeks after end of
      treatment in this study (at Week 16).
    

Intervention name(s): Tapinarof; Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): Tapinarof cream, 1%, applied once daily; Vehicle cream applied once daily
Other intervention name(s): DMVT-505
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following a 34-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive once daily treatment with tapinarof cream, 1% or vehicle cream.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tapinarof; plaque psoriasis; adult; phase 3; topical; double-blind; efficacy; safety; psoriasis