bioihbjkbjnl/mcl2 huggingface dataset:
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-200,201) in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and
      subtropical regions of the world. The purpose of this study is to test the safety of and
      immune response to a new dengue virus vaccine in healthy adults.
    

Detailed description: 
      Dengue viruses cause dengue fever and the more severe dengue hemorrhagic fever/shock
      syndrome. More than 2 billion people living in tropical and subtropical regions of the world
      are at risk of dengue virus infection, which is the leading cause of hospitalization and
      death in children in several tropical Asian countries. This study will evaluate the safety
      and immunogenicity of a live attenuated dengue virus vaccine called rDEN4delta30-200,201.
      This vaccine is derived from rDEN4delta30, another dengue virus vaccine candidate that has
      been shown to be safe and immunogenic in Phase I and II trials in healthy adults.

      This study will last 180 days. There will be three cohorts in this dose de-escalation study.
      Participants in Cohort 1 will be randomly assigned to receive the highest dose of
      rDEN4delta30-200,201 or placebo at study entry. Cohort 2 will begin only after safety review
      of all participants in Cohort 1. Participants in Cohort 2 will receive a lower dose of
      rDEN4delta30-200,201 or placebo. Cohort 3 will begin only after safety review of all
      participants in Cohort 2. Participants in Cohort 3 will receive the lowest dose of
      rDEN4delta30-200,201 or placebo.

      After vaccination, participants will be asked to monitor their temperatures every day for 16
      days. Study visits will occur every other day after vaccination until Day 16, followed by
      four additional visits at selected days through Day 180. Blood collection, vital signs
      measurement, and a targeted physical exam will occur at each study visit. Some participants
      will be asked to undergo a skin biopsy or additional blood collection at selected visits.
    

Intervention name(s): rDEN4delta30-200,201; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated dengue 4 vaccine (one of three doses); Placebo for rDEN4delta30-200,201
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue Vaccine; Dengue Virus; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
Predicting Patients' Response to Spinal Manipulation
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical effectiveness of two types of
      chiropractic spinal manipulation to conservative medical care for patients at least 55 years
      old with sub-acute or chronic LBP.
    

Detailed description: 
      Despite the high prevalence of LBP and the associated economic costs, disability, and lost
      productivity, and despite the development of several treatment guidelines, one of which
      recommends chiropractic spinal manipulation for some subgroups of patients with back pain,
      the management of LBP remains controversial and highly variable across professions and
      geographic regions. Although one recent publication describes the design of chiropractic and
      exercise for seniors with low back or neck pain, no published studies, to our knowledge, have
      assessed the effectiveness of chiropractic manipulation compared to medical care for older
      adults with sub-acute or chronic low back pain.
    

Intervention name(s): HVLA-SM; LVVA-SM; Usual Medical Care
Intervention type(s): Other; Other; Other
Intervention description(s): HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation; LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation; Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Spinal Manipulation
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Condition: Labor Fetal Anoxia
MeSH terms: Fetal Hypoxia
Study type: Interventional

Summary: 
      This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing
      in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii
      (a newer device also created by Monica Healthcare) using the same technology with different
      monitor placement.
    

Detailed description: 
      This study has one arm, in which Both the FDA - Approved AN24 (Fetal Monitoring device
      marketed by Monica Healthcare) and the new device (Novii, being investigated in this clinical
      trial) will be placed on the patient's abdomen. After delivery of the patient's infant, the
      data will be abstracted from the second device. This data will be compared to the data from
      the first device for accuracy.
    

Intervention name(s): Novii; AN24
Intervention type(s): Device; Device
Intervention description(s): The Novii is a modified device with similar technology to the AN24 device already being used in the USA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Fetal monitoring; ECG
Curcumin in Treating Patients With Familial Adenomatous Polyposis
Condition: Familial Adenomatous Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized phase II trial studies curcumin in treating patients with familial
      adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of
      rectal polyps or colorectal neoplasia.
    

Detailed description: 
      Specific Aims:

      I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability
      and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and
      colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients with
      intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir) surgery.

      II. To measure markers of cell proliferation including colorectal mucosal levels of ornithine
      decarboxylase (ODC), polyamines, mucosal deoxyribonucleic acid (DNA) methylation,
      proliferative index (Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular
      density, mucosal prostaglandin, leukotriene levels, and activation of the nuclear factor
      kappa B (NFKB), and v-akt murine thymoma viral oncogene homolog 1 (Akt) survival pathways.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      Arm I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.

      Arm II: Patients receive placebo PO BID for 12 months.

      After completion of study treatment, patients are followed up at 4 months.
    

Intervention name(s): Curcumin; Laboratory Biomarker Analysis; Placebo
Intervention type(s): Drug; Other; Other
Intervention description(s): Given PO; Correlative studies; Given PO
Other intervention name(s): C.I. 75300; C.I. Natural Yellow 3; Diferuloylmethane; Turmeric Yellow; placebo therapy; sham therapy
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparing Between Two Different Restoration
Condition: Dental Restoration Failure
Study type: Interventional

Summary: 
      Clinical performance of two different ceramic restoration in patient mouth after 3 years
      follow up
    

Detailed description: 
      Comparing two different dental restoration in patient mouth after 3 years follow up by using
      USPHS criteria
    

Intervention name(s): Full Ceramic restoration; Hybrid resin Ceramic restoration
Intervention type(s): Other; Other
Intervention description(s): Two different dental restoration inserted in patient mouth ( split mouth); Hybrid resin Ceramic restoration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two different restorations in patient mouth
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic
      nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the
      first morning void urine sample as an indicator.
    


Intervention name(s): MT-3995 Low; MT-3995 Middle; MT-3995 High; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Nephropathy
Genetic Information as a Life Style Change Motivator
Condition: Health Behavior; Alzheimer Disease, Protection Against
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The study investigates whether information on having a risk genotype (ApoE4) and life style
      advisory information affects lifestyle changes and sensory preferences. The project studies
      also the ethic aspects of giving the information of risk genotype.
    

Detailed description: 
      We will run intervention based on our earlier pilot study. It includes intensive intervention
      and a modification of our earlier pilot intervention. Our intervention methods are general
      lectures of the effects of healthy diet (Finnish Nutrition Recommendations 2014) and healthy
      lifestyle for all participants. Effects on motivation, attitudes and preferences will be
      studied and verified by questionnaires and risk factors of cardiovascular disease and
      Alzheimer disease by analyzing clinical markers of lipid metabolism, general phenotype
      markers and profiles of nutritional markers. Nutritional biomarkers will verify also the
      self-reported changes of diet in the questionnaires and in digital food diaries.
    

Intervention name(s): information on the risk gene status; life style advise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): information on risk gene status (APOE4 allele or not) was given before intervention; all test persons were given information on healthy diet and life style
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy
Condition: Pancreatic Cancer; Pancreatic Surgery
Study type: Interventional

Summary: 
      The independent impact of surgeon volume on outcome of patients undergoing
      pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of
      pancreatic fistula rate was found in the high-volume surgeon group in comparison with
      low-volume surgeon group. However, no difference between groups was found in mortality, major
      complications, and hospital stay.
    

Detailed description: 
      Objectives: To define the independent impact of surgeon volume on outcome after
      pancreaticoduodenectomy (PD) in a single high-volume institution.

      Summary Background Data: The impact of surgeon volume on PD outcome is still controversial.
      So far, data available are from retrospective multi-institutional reviews, considering
      in-hospital mortality as the only outcome variable.

      Methods: Prospectively collected data on 610 patients who underwent PD from August 2001 to
      August 2009 were analyzed. Cut-off value to categorize high and low-volume surgeons (HVS and
      LVS, respectively) was 18 PD/year. Primary endpoint was operative mortality (death within
      30-day post-discharge). Secondary endpoints were morbidity, pancreatic fistula (PF) and
      length of stay. Demographic, clinical, and surgical variables were recorded.
    

Intervention name(s): Pancreaticoduodenectomy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of an Ascensia Blood Glucose Meter and App System
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to assess the usability of the Onyx system in the hands of
      subjects with Insulin Dependent Diabetes Mellitus (IDDM) or insulin-using subjects with
      Non-IDDM.
    


Intervention name(s): Onyx BG Meter / App System
Intervention type(s): Device
Intervention description(s): Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Acne vulgaris is a common cutaneous inflammatory condition of sebaceous follicles that can
      profoundly affect patients' quality of life, especially at a young age. In this context the
      use of teledermatology can potentially reduce the healthcare costs associated to traditional
      consultations as well as the costs related to travel and loss of school/working time for the
      patient, with a clear benefit for the whole community. Since 2016, the Department of
      Dermatology at Inselspital Hospital in Bern has a portal and a smartphone app for online
      advice service.

      Hereby the investigators propose to explicitly investigate the efficacy of this system in
      reducing healthcare costs as compared to traditional face-to-face consultations, in a cohort
      of patients with mild-to-moderate acne vulgaris.
    


Intervention name(s): Teledermatology; Face-to-face consultation
Intervention type(s): Device; Other
Intervention description(s): Patients will be assessed and followed-up by trained physicians through a store-and-forward system (teledermatology online service - Evita® app), which allows patients to upload pictures of skin areas affected by acne as well as their symptoms or questions related to their disease.; Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 stratified random allocation
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: acne; telemedicine; teledermatology
Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
Condition: Osteopenia, Generalized
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of
      Lifenol® in Improving Bone Status in Postmenopausal Osteopenic Women. 100 postmenopausal
      women will be enrolled to investigate the effect of a 12 month supplementation with Lifenol®
      on bone density DXA parameters and plasma bone biomarkers.
    

Detailed description: 
      Osteoporosis is a skeletal disorder characterized by reduced bone mass and deterioration in
      bone architecture leading to an increased bone fragility and fracture risk. Postmenopausal
      women are a particularly at-risk population as the maintenance of bone homeostasis is
      influenced by estrogens. Recently, phytoestrogens have drawn attention as an interesting
      natural way to prevent oestrogen-deficient osteoporosis. Hops contain one of the most potent
      phytoestrogen known to date: 8-prenylnaringenin (8-PN). Lifenol® is a polyphenolic powdered
      extract obtained by a patented process from the female hop flowers (Humulus lupulus L.),
      standardized in 8-PN content.

      Therefore, the present clinical trial aims to determine whether long-term consumption of
      Lifenol® can reduce bone mineral density loss in postmenopausal women with osteopenia taking
      traditional recommended calcium and vitamin D supplementation (1000 mg of calcium and 800 IU
      of vitamin D per day).

      100 postmenopausal women (>1 year post-menopause) will be enrolled to consume during 12
      months either Lifenol® (dose of 100µg of 8-PN per day) or a placebo. Effect of
      investigational product will be measured notably on bone density DXA parameters and plasma
      bone biomarkers.
    

Intervention name(s): Lifenol®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lifenol®, powdered extract obtained from female hops flowers (Humulus lupulus L.) standardized in 8-PN content (100 µg /day) + maltodextrin = 500 mg/capsule
+ 1000 mg of calcium and 800 IU of vitamin D per day; Maltodextrin = 500 mg/capsule
+ 1000 mg of calcium and 800 IU of vitamin D per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: osteopenia; phytoestrogen; hop; menopause
Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study assessed and compared the effects of clinic-based and telemonitored home-based
      interventions on pain intensity, function and quality of life in patients with knee
      osteoarthritis (KOA). This was with a view to providing evidence for the validation of the
      effectiveness of home-based intervention on knee osteoarthritis
    

Detailed description: 
      This study was a quasi-experiment involving forty two patients with KOA. They were randomly
      allocated into two groups equally; clinic-based group (CBG) and telemonitored home-based
      group (THG).

      The CBG received exercises to strengthen the quadriceps and hamstring muscles using thera
      band while THG received same treatment regimen but at home and were monitored on phone by the
      researcher. The subjects performed four sets of eight repetitions for each of the exercises
      three days in a week for eight weeks. Pain intensity was assessed with Quadruple Visual
      Analog Scale, function was assessed with the Western Ontario and McMaster University
      Osteoarthritis Index and quality of life was assessed with WHO Quality of Life-BREF at
      pretreatment, 3rd week, 6th week and 8th week of intervention. Data was analysed with
      descriptive and inferential statistics. Repeated measure ANOVA was used to compare the mean
      value of variables within the group and between the groups. Alpha level was set at 0.05.
    

Intervention name(s): Clinical Based Isometric contraction strengthening Exercises using Thera band; Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band
Intervention type(s): Other; Other
Intervention description(s): Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone; Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks
Other intervention name(s): Clinical Based intervention; Telemonitores Home based Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were two groups, one with clinical based and the other with telemonitored home based. The two groups received thera band exercises of isometric contractions. The clinical based at the hospital, and the home based at home but being monitored by researcher with phone call.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Knee osteoarthritis; Pain intensity; Functioning; Health Related Quality of Life; Tele-monitoring
Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles
Condition: Diabetes and Healthy Control; FTO Gene Expression; Aerobic Exercise Intervention or Home Exercise; Pre-training and Post-training
Study type: Interventional

Summary: 
      The aim of the first year of this three-year plan is to analyze and compare the muscle
      quality of lower limb muscle (microcirculation, muscle performance and mechanical
      characteristics) and maximal aerobic exercise capacity in treadmill exercise tests for
      diabetic and non-diabetic cases. The hypotheses are:1) the muscle quality of lower limb
      muscle and maximal aerobic exercise capacity are different between participate with diabetic
      and non-diabetic, 2) the effect of the three-month aerobic exercise intervention or home
      exercise on the characteristics of the muscle quality are different , and 3) intrinsic
      factors (such as age, BMI, and HDL) and characteristics of specific FTO genes are influenced
      the training outcomes.
    

Detailed description: 
      Participants with diabetes will attend an 12-week aerobic exercise intervention or home
      exercise if the exercise test result of the maximum rate of oxygen consumption is fair or
      poor. Assessments will be taken before and after the training program, which including muscle
      strength, stiffness, quality, microcirculation and exercise capacity. Comparisons between the
      pre-training and post-training condition will be made for each groups. And the assessments
      also compare with the healthy control group.
    

Intervention name(s): supervised aerobic exercise or home-based aerobic exercise
Intervention type(s): Behavioral
Intervention description(s): The aerobic exercise and home exercise programs are consisted of 50 minutes per time, 3 times per weeks and totally 3 months.
The aerobic exercise group will perform the exercise program under one physical therapy and one aerobic dance teacher supervised. The home exercise group will do the exercise program based on ACSM's aerobic exercise recommend, and will used the home exercise record form to make sure their cooperation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: his study is going to recruit subjects with and without type 2 diabetes and age between 30 and 70 years old. This study will be focused on the effects of diabetes on maximum aerobic exercise intensity (VO2max) and muscle quality including microcirculation (by NIRS), mechanical properties (by elastography) and isometric strength in different age groups, and observe whether these results are related to the clinically relevant findings of diabetes. This study will recruit qualified diabetic subjects according to their results of maximal aerobic exercise capacity (VO2max) and assign them into two groups; aerobic exercise or home exercise intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; muscle quality; aerobic exercise; FTO gene