bioihbjkbjnl/mcl2 huggingface dataset:
Free Gingival Graft Adjunct With Low Level Laser Therapy
Condition: Wounds and Injuries; Transplants; Gingival Recession, Localized; Low-Level Light Therapy
MeSH terms: Gingival Recession; Wounds and Injuries
Study type: Interventional

Summary: 
      The present placebo-controlled parallel design clinical study was planned to determine the
      effect of low level laser therapy on clinical periodontal conditions and dimensions of free
      gingival graft as well as postoperative pain levels in the surgical area.
    

Detailed description: 
      Background: Shrinkage of the free gingival graft (FGG) and patient's discomfort during
      healing period are important concerns. Therefore, this study aimed to evaluate the effect of
      low level laser therapy (LLLT) in terms of enhancing wound healing, reducing graft shrinkage
      and postoperative pain.

      Methods: Thirty patients were randomly assigned to receive either FGG+ LLLT (test, n = 15) or
      FGG + placebo LLLT (control, n = 15). In the test group, a diode laser
      (aluminum-gallium-arsenide, 810 nm, 0.1 W, continuous mode, time of irradiation:60 s, energy
      density: 6 J/cm2, spot size:0.5 cm) was applied immediately after the FGG surgery and 1,3,7,
      and 14 days later. The control group received the same sequence of irradiation with the
      laser-off. Comparison of the graft surface areas between groups at 1st, 3rd and 6th months
      were made with an image-analyzing software. Complete wound epithelization, visual analogue
      scale (VAS) pain score of recipient site and the number of analgesic used were evaluated
      after the surgery.
    

Intervention name(s): CheseeTM Diode Laser; Clinical examination
Intervention type(s): Device; Other
Intervention description(s): low level laser therapy was utilized adjunct with free gingival graft.; The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.
Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2) at 7, 14, 21, and 28 days after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo-controlled parallel design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Free gingival graft, Low level laser therapy, Shrinkage
Nudging Nutrition With Monetary Incentives Environmental Cues
Condition: Obesity; Food Labeling; Health Behavior; Diet
Study type: Interventional

Summary: 
      The investigators hypothesize that monetary incentives and messaging, such as making
      nutritious foods relatively less expensive than less nutritious foods and framing the price
      difference in a positive or negative way, will influence purchasing behavior of households.
    

Detailed description: 
      In this study, 239 loyalty card shoppers were recruited at Hannaford grocery stores to
      participate in a study in which a 10% price difference between nutritious and less nutritious
      foods was introduced. and then framed as a subsidy, tax, or a combination of a tax and
      subsidy. To determine whether or not the framing of the price difference influenced
      purchasing behavior, the difference was framed as a subsidy on nutritious foods, a tax on
      less nutritious foods, and a combination of a tax and subsidy on less nutritious and
      nutritious foods, respectively. The purpose of this study was to examine the general impact
      of this price difference on purchases of nutritious and less nutritious foods, and whether or
      not the framing of the price difference had a differential effect on behavior.
    

Intervention name(s): Subsidy; Tax; Tax and subsidy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Frame the price difference as a 10% subsidy on nutritious food items.; Frame the price difference as a 10% tax on less nutritious food items.; Frame the price difference as a 5% tax on less nutritious food items and a 5% subsidy on nutritious food items, creating a 10% relative price difference between the types of foods.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Keywords: Public policy; Food choice; Nutrition labeling; Fat tax; Vegetable subsidy; Behavioral economics; Health behavior
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether protective anti-HB serum levels are
      maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific
      hepatitis B immune globulin, in patients having previously undergone liver transplantation.
    


Intervention name(s): Specific intravenous anti-hepatitis B immunoglobulin
Intervention type(s): Drug
Intervention description(s): Monthly doses of 5000 IU administered intravenously during 6 consecutive months
Other intervention name(s): Niuliva
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; HBV; Anti-hepatitis B antibodies; Immunoglobulins; liver transplantation; Protective levels; Recurrence; Intravenous
Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism
Condition: Morbid Obesity; Hypogonadism
MeSH terms: Obesity; Obesity, Morbid; Hypogonadism
Study type: Observational

Summary: 
      The purpose of this study is to determine the natural course of the androgen profile after
      bariatric surgery in men with obesity related hypogonadotropic hypogonadism.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men with planned bariatric surgery
      
Biospecimen description: 
      serum
    
Keywords: hypogonadotropic hypogonadism; bariatric surgery; serum androgen levels; bone density
A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.
Condition: Dyslipidaemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first study in humans to assess the safety and tolerability of various
      doses of GSK1292263 alone, and taken with sitigliptan.
    


Intervention name(s): an undetermined dose of GSK1292263; ascending dose of GSK1292263; ascending dose of GSK1292263; ascending dose of GSK1292263; ascending dose of GSK1292263
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): GSK investigational product or placebo; Ascending dose based on target exposures or placebo; An ascending dose based on target exposure; An ascending dose based on target exposures.; An ascending dose based on target exposure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: tolerability; pharmacodynamics; pharmacokinetics; safety
The Knowledge Levels and Attitudes of the People Living in Nevşehir on Organ Donation and Transplantation
Condition: Organ Finding
Study type: Interventional

Summary: 
      In this descriptive study, the purpose was to determine the knowledge levels and attitudes of
      the people in Nevsehir, Turkey on organ donation.

      It has been determined that the people living in Nevsehir do not have sufficient knowledge on
      organ donation, they had various concerns on the issue, and they wanted to receive
      information from Organ Donation Units. It can be used the exemplification and internalization
      in educational curricula about increasing the organ donation.
    

Detailed description: 
      Purpose

      In this descriptive study,the purpose was to determine the knowledge levels and attitudes of
      the people in Nevsehir on organ donation.

      Methods

      The data of the study were collected with the questionnaire applied to 414 people residing in
      Nevşehir between February and May 2016. In evaluating the data, the numbers, percentage
      calculations, Chi-Square Test,t-test, and One-Way tests were used.
    

Intervention name(s): Nevsehir
Intervention type(s): Behavioral
Intervention description(s): The data of the study were collected with the questionnaire
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Organ donation; brain death; public opinion
Effect of Genetic Variants on Fat-soluble Vitamin Bioavailability
Condition: Biological Availability of Vitamins and Micronutrients
Study type: Observational

Summary: 
      The aim was to identify minor genetic variations (single nucleotide polymorphisms) that
      explain the interindividual variability in bioavailability of fat soluble micronutrients (fat
      soluble vitamins and carotenoids).
    

Detailed description: 
      Healthy male volunteers were genotyped and submitted to 5 test-meals containing either no
      micronutrient of interest, 100 g tomato puree as a source of carotenoids, a lutein
      supplement, a vitamin E supplement or a vitamin D supplement. Blood samples were taken in the
      postprandial period (up to 8 hours after the test-meals intake) and the concentration of the
      studied micronutrients were measured in the chylomicrons. Multivariate analysis were then
      performed to identify single nucleotide polymorphisms that best explained the variance in the
      interindividual response (0 to 8 h area under the curve) in micronutrients.
    

Sampling method: Non-Probability Sample
Study population: 
        healthy male adults.
      
Biospecimen description: 
      blood, adipose tissue
    
Keywords: bioavailability; postprandial period; genetic variants; single nucleotide polymorphisms; vitamin; carotenoid; lutein; lycopene; tocopherol; cholecalciferol
Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)
Condition: Visual Impairment
MeSH terms: Optic Nerve Diseases; Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      Non-invasive brain stimulation can increase cortical excitability in the visual system, but
      it is not known if this is of clinical value. The investigators now assessed if repetitive,
      transcranial alternating current stimulation (rtACS) can improve visual field size in
      patients with optic nerve damage. The investigators hypothesized that rtACS would improve
      visual functions with the defective visual field sectors of the visual field (primary outcome
      measure).
    

Detailed description: 
      exploratory, randomized, controlled study
    

Intervention name(s): rtACS (verum condition); placebo stimulation
Intervention type(s): Device; Device
Intervention description(s): Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000 microA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.; a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).
Other intervention name(s): Device for electrical stimulation "Brainstim"; Hersteller: "ELSTIM", St. Petersburg, Russland; Device number: "07062006"; Classification: Class II, Type BF; SLG device marking: "5016-07-P/001"; Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"; Device for electrical stimulation "Brainstim"; Hersteller: "ELSTIM", St. Petersburg, Russland; Device number: "07062006"; Classification: Class II, Type BF; SLG device marking: "5016-07-P/001"; Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biological Therapy in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to
      stimulate the immune system and stop cancer cells from growing. Treating a person's white
      blood cells in the laboratory and then reinfusing them may cause a stronger immune response
      and kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients
      who have metastatic melanoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety and toxicity of cellular adoptive immunotherapy comprising
           autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in
           patients with metastatic melanoma.

        -  Determine the duration of in vivo persistence of this therapy in these patients.

      Secondary

        -  Evaluate the antitumor effects of this therapy in these patients.

      OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then
      CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive cellular
      adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer testis antigens
      IV over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12
      hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks for 4 courses in the
      absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinical
      response after completion of the fourth course are eligible to receive additional T-cell
      infusions.

      Patients are followed for 9 months.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.
    

Intervention name(s): aldesleukin; therapeutic tumor infiltrating lymphocytes
Intervention type(s): Biological; Biological
Intervention MeSH terms: Aldesleukin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent melanoma; stage IV melanoma
Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms
      associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of
      schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized
      that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving
      signal to noise ratio and thereby improving cognitive symptoms.
    


Intervention name(s): memantine HCl
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: memantine; adjunctive therapy; schizophrenia
Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      Epithelial ovarian cancer constitutes one of the most common gynecological
      malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients
      are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer
      patients often bears similar genetic and epigenetic features to the related tumor DNA.This
      study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.
    

Detailed description: 
      Epithelial ovarian cancer constitutes one of the most common gynecological malignancies, with
      an incidence rate of 3-12/100 000 woman per year. Because the ovaries lie in the deep pelvic
      cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed
      at an advanced stage. Liquid biopsy, which is meant to detect cancers by sequencing the DNA
      in a few drops of a person's blood. It may detect cancers early, even before symptoms arise,
      when there is just a few cells in the blood circulation.

      ctDNA in cancer patients often bears similar genetic and epigenetic features to the related
      tumor DNA. There is evidence that some of the ctDNA originates from tumor tissue. This, and
      the fact that ctDNA can easily be isolated from the circulation and other body fluids of
      patients, makes it a promising candidate as a non-invasive biomarker of cancer.

      This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.
    

Intervention name(s): methylation markers screening
Intervention type(s): Diagnostic Test
Intervention description(s): ctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive colletion of patinets with ovarian cancer treatment at our clinical centre
      
Biospecimen description: 
      blood samples
Yoga@Work for Reducing Musculoskeletal Pain in Neck and Shoulder
Condition: Neck Pain; Shoulder Pain; Musculoskeletal Pain
MeSH terms: Shoulder Pain; Musculoskeletal Pain; Neck Pain
Study type: Interventional

Summary: 
      Work-related musculoskeletal disorders (MSDs) are disorders of muscles, tendons, joints and
      nerves which can affect all body parts, although the neck, upper limb and back are the most
      common areas.

      The peer-reviewed literature about workplace prevention describes a variety of interventions
      that have been implemented and evaluated.but only few studies show sustainable positive
      effects on symptom outcomes.

      Yoga@Work program was developed to self manage pain around neck and shoulder areas among
      office workers.
    


Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Yoga sessions includes sukshma vyayama (strengthening yoga expertise), stretching and relaxing postures (asana) on chair or standing, breathing and meditation practices.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the effect of selpercatinib on the levels of
      rosuvastatin in the blood stream in healthy participants. This study will also evaluate the
      safety and tolerability of rosuvastatin when administered in combination with selpercatinib
      in healthy participants. This study will last up to approximately 26 days excluding screening
      period.
    


Intervention name(s): Rosuvastatin; Selpercatinib
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LY3527723; LOXO-292; Retevmo®
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug Drug Interaction Trial; Selpercatinib (Retevmo®)
Diabetes Outcomes and Unmet Resources
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study will refine and test the effectiveness of CareAvenue, an automated e-health tool
      that informs and activates patients with uncontrolled diabetes to take steps in accessing
      resources and engaging in self-care. Our central hypothesis is that activating patients with
      uncontrolled diabetes and linking them to resources to address financial burden and unmet
      social risk factors will improve both intermediate outcomes and measures of disease control
      above and beyond existing services, especially for high need patients.
    


Intervention name(s): CareAvenue; Guest Assistance Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.; The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diabetes; Self-management; Adherence; Social determinants of health; Social risk factors
Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
Condition: Hypertension; Prehypertension; Aging
MeSH terms: Respiratory Aspiration; Prehypertension
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of inspiratory muscle strength training
      for lowering blood pressure and improving physiological function (vascular, motor, and
      cognitive) in middle-aged and older adults with elevated systolic blood pressure.
    

Detailed description: 
      Over, the proposed research project has the long-term potential to influence clinical
      practice by establishing a novel lifestyle intervention for treating multiple domains of age-
      and hypertension-associated physiological dysfunction and thereby reducing the risk of
      clinical disease and disability.
    

Intervention name(s): Inspiratory muscle strength training; Sham training
Intervention type(s): Other; Other
Intervention description(s): Subjects will perform inspiratory muscle strength training for 6 weeks.; Subjects will perform sham training for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inspiratory muscle strength training