bioihbjkbjnl/mcl2 huggingface dataset:
SLMAP and EPO Genetic Polymorphism in Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Observational

Summary: 
      A case-control study to assess the association between the risk of diabetic retinopathy in
      Egyptians and genetic polymorphism of both EPO and SLMAP genes.
    

Detailed description: 
      Traditional environmental risk factors, such as glycemic control and duration of diabetes,
      failed to fully explain why some individuals remain protected while others progress to severe
      diabetic retinopathy.

      Several studies suggest variations in diabetic retinopathy prevalence depending on racial
      background and genetic polymorphism.
    

Intervention name(s): SLMAP and EPO genetic polymorphism
Intervention type(s): Genetic
Intervention description(s): Presence of EPO gene SNP rs551238 and SLMAP rs17058639 gene polymorphisms
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All diabetic patients registered to the outpatient clinic of the Endocrinology Unit will be
        assessed for eligibility followed by screening for diabetic retinopathy by fundoscopic
        examination Those with diabetic retinopathy will be assigned to the case group while
        matched diabetic patients free from diabetic retinopathy will be assigned to the control
        group.
Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The investigators recently found a positive effect of omega-3 supplements on cognitive
      function in healthy individuals after 4 weeks (J of Psychopharmacology 2009, 23: 831-840).
      The investigators hypothesize that 4 weeks consumption of omega-3 supplements in previously
      depressed individuals will positively affect their cognitive functions.

      Secondly, low Heart Rate Variability (HRV) is a risk factor for cardiovascular disease. Some
      studies have found low HRV in patients with depression. No studies have investigated the
      effects of omega-3 fatty acid supplements on Heart Rate Variability in individuals with a
      history of depression. The investigators will test the hypotheses that omega-3 supplements
      lead to an improvement of heart rate variability indices in healthy volunteers with a history
      of depression.
    


Intervention name(s): omega-3 fatty acids supplements (fish oil); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA); softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; cognition; heart rate variability; omega-3 fatty acids; Depression (in remission) (vulnerability to depression)
Cranberry Juice in the Prevention of Urinary Tract Infections in Children
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      The objective of the study is to determine whether recurrences of urinary tract infection in
      children can be prevented with cranberry juice.
    

Detailed description: 
      Five percent of children have at least one UTI episode and 30% of these episodes recur.
      Recurrences and the risk of renal damage are indications for long term antimicrobial
      prophylaxis, but emerging antimicrobial resistance underlines the need for alternatives. The
      bacteria causing urinary tract infection arise from the stools. Dietary changes can alter the
      balance of faecal bacteria. Vaccinium berries and products containing lactobacilli have been
      shown to act against the coliform bacteria that cause most urinary tract infections. In our
      previous study cranberry juice was effective in preventing symptomatic recurrences of urinary
      tract infections in women. The objective of our study is to determine whether recurrences of
      urinary tract infection in children can be prevented with cranberry juice.
    

Intervention name(s): Cranberry juice; Placebo juice
Intervention type(s): Biological; Biological
Intervention description(s): 5 ml/kg up to 300 ml, 1-2 doses daily for six months; 5 ml/kg up to 300 ml, 1-2 doses daily for six months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Urinary Tract Infections; Cranberry; Prevention
A 14 Day Early Bactericidal Activity Study of Nitazoxanide for the Treatment of Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to determine if Nitazoxanide (NTZ) will cause a significant
      decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment. The
      study is being conducted at the GHESKIO Centers in Port au Prince Haiti
    

Detailed description: 
      This is a prospective randomized two-arm 14-day, early bactericidal activity study in
      treatment-naive, drug-susceptible patients with uncomplicated pulmonary tuberculosis (TB).
      The study will be conducted at the GHESKIO Centers in Port au Prince Haiti. Twenty patients
      will be randomized to receive NTZ 1 gram orally twice daily for 14 days. Ten patients will be
      randomized as positive controls to receive standard 4 drug tuberculosis therapy with
      isoniazid (H), rifampin (R), ethambutol (E), and pyrazinamide (PZA). Patients' sputum will be
      collected before and then every two days during 14 days of treatment, and the primary
      endpoint will be the change in the number of M. tuberculosis in patients' sputum. Our primary
      hypothesis is that NTZ will result in a significant decrease in the number of M. tuberculosis
      in sputum during14 days of treatment. The number of M. tuberculosis will be quantified by the
      time to positive (TTP) signal in hours in an automated liquid media culture system (BACTEC
      MGIT 960, Becton Dickinson).
    

Intervention name(s): Nitazoxanide; Control
Intervention type(s): Drug; Other
Intervention description(s): nitazoxanide 1000 mg orally twice daily with food for 14 days; The control arm will receive WHO standard therapy for tuberculosis with isoniazid, rifampin, pyrazinamide, and ethambutol
Other intervention name(s): Nizonide; Alinia
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Isotretinoin for Proliferative Vitreoretinopathy
Condition: Proliferative Vitreoretinopathy
MeSH terms: Vitreoretinopathy, Proliferative
Study type: Interventional
Phase: Phase 4

Summary: 
      Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an
      important cause of retinal re-detachment. The purpose of this study is to evaluate the effect
      of oral isotretinoin, which inhibits the growth of cells responsible for proliferative
      vitreoretinopathy (PVR), on recurrent retinal detachment.
    

Detailed description: 
      Small retrospective studies have shown isotretinoin to be effective in reducing the rate of
      recurrent retinal detachment in patients with or at high risk for developing PVR. This is a
      prospective study to evaluate a low dose of oral isotretinoin in this regard. There are two
      arms to the study: 1) eyes with recurrent retinal detachment due to existing PVR, and 2) eyes
      with primary detachment and features associated with a high risk of PVR formation. Eligible
      and willing patients will receive a 12-week course of isotretinoin, and will be followed for
      retinal attachment rate, and PVR and/or ERM (epiretinal membrane) formation.
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): Isotretinoin 20mg daily for 12 weeks
Intervention MeSH terms: Isotretinoin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Oral Hygiene Products in an In Situ Caries Model
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The study will evaluate and compare the potential anti-caries efficacy of a test regimen:
      placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily
      use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to
      remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness
      Recovery (%SMHR).

      This will be a single center, randomized, laboratory analyst blinded, placebo, four
      treatment, cross-over study in healthy participants. Participants will be assessed at
      baseline and at the beginning and end of each treatment visit to monitor clinical efficacy
      and safety.
    


Intervention name(s): Fluoride free toothpaste; Fluoride toothpaste; Fluoride mouthwash
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brushing with fluoride free toothpaste; Brushing with fluoride containing toothpaste; Fluoride mouth wash to be followed after brushing with fluoride free toothpaste in "Placebo dentifrice/Fluoride rinse" arm and in "Fluoride dentifrice/Fluoride rinse" arm
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus
      Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not
      Adequately Controlled on Atorvastatin 40 mg.
    


Intervention name(s): atorvastatin; atorvastatin; ezetimibe
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks; Atorvastatin 40 mg by mouth, once a day for 6 weeks; Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Iyengar Yoga for Young People With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this study is to compare a standardized 6 week Iyengar Yoga program (IYP) for
      adolescents and young adults with rheumatoid arthritis to a standard care wait-list
      condition. In addition to effects on function and pain, this study will explore intervention
      effects on disease activity, immune response, HRQOL, functionality, and mood. Results will
      shed light on the feasibility and potential efficacy of a novel intervention (Iyengar yoga)
      for rheumatoid arthritis symptoms.

      The hypotheses are:

        1. The IYP will be safe, acceptable and feasible: at least 80% of subjects will complete
           the IYP.

        2. Following the IYP, participants will show significantly improved disease status, general
           functioning, arthritis-functioning and HRQOL relative to controls. The benefits will be
           apparent post-treatment and at two-month follow-up.

        3. Following the IYP, participants will report significantly improved pain, immune response
           and mood compared to controls. These improvements will be evident at both post-treatment
           and at two-month follow-up.
    


Intervention name(s): Iyengar Yoga
Intervention type(s): Behavioral
Intervention description(s): Iyengar Yoga classes twice a week for six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Yoga; Adolescents; Young Adults
Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design
Condition: Adolescent - Emotional Problem; Adolescent Problem Behavior; Nonsuicidal Self Injury; Depressive Symptoms; Anxiety; Self-Criticism
MeSH terms: Depression; Self-Injurious Behavior; Problem Behavior
Study type: Interventional

Summary: 
      In this pilot study, the effect of a group intervention targeting self-criticism in
      adolescents in a clinical child- and adolescent psychiatric outpatient setting will be
      examined using a single-case experimental design (AB). Participants will be randomized to
      multiple baseline with weekly measures. Our primary outcomes, measured weekly, are
      self-criticism, nonsuicidal self-injury and symptoms of depression and anxiety, as well as an
      individually chosen behavior driven by self-criticism. Secondary outcomes are
      self-compassion, psychological flexibility, quality of life and functioning. In addition to
      the weekly administered questionnaires, before and after measures, and 3- and 6-month
      follow-up will be collected. After the treatment, participants will also be interviewed about
      their experiences of targeting self-criticism.
    


Intervention name(s): Treating self-criticism
Intervention type(s): Behavioral
Intervention description(s): A psychological treatment given i a group format targeting self-criticism. The treatment is based on treatment principles from Cognitive behavior therapy, Self-compassion, Acceptance and Commitment Therapy and also contains psychoeducation. The group treatment consists of 8 sessions delivered once a week for 2 hrs during 8 weeks in a child- and adolescent psychiatric outpatient setting.
Intervention model: Single Group Assignment
Intervention model description: Single-case experimental design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: self-criticism; adolescents; group intervention; single-case experimental design
Dietary Nitrate Intake in Vegetarians and Omnivores
Condition: Blood Pressure
Study type: Interventional

Summary: 
      Vegetarian diets are commonly associated with lower blood pressure levels. This has been
      related to greater consumption of inorganic nitrate, since vegetables are the main source of
      this anion. Dietary nitrate is reduced to nitrite by commensal bacteria in the mouth, which
      in turn leads to increased circulatory nitrite availability. Nitrite can form nitric oxide by
      several pathways promoting a reduction in the vascular tone and lower blood pressure.
    


Intervention name(s): Placebo mouthwash; Chlorhexidine mouthwash
Intervention type(s): Other; Other
Intervention description(s): Participants received placebo mouthwash (ultrapure unflavoured water) with which they rinsed their mouth for one minute, twice a day for 7 days. Resting metabolic rate and blood pressure were measured on day eight. Additionally, blood and saliva samples were taken from all the participants. Dietary records of seven days were also collected in order to confirm the foods and portion sizes consumed, preparation methods, recipes and any brand names.; After using placebo and complete all the physiological measurements, participants were given a further one-week supply of antibacterial mouthwash containing 0.2% chlorhexidine (Corsodyl, GlaxoSmithKline, UK), encouraged to rinse their mouth for one minute, twice a day for 7 more days. They returned to the laboratory in 7 days to repeat all measurements in the same order.
Intervention MeSH terms: Chlorhexidine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: nitrate; vegetarian; nitrite; oral microbiome
Effectiveness of Dance on Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of the present study is to assess the effectiveness of belly dance as a treatment for
      pain and improving the quality of life of patients with fibromyalgia.

      Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a
      dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks
      of belly dance twice a week, while the patients in the control group remained on a waiting
      list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute
      walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck
      Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder
      Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and
      after 32 weeks.
    


Intervention name(s): Dance; Control Group
Intervention type(s): Behavioral; Other
Intervention description(s): Belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.; The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Treatment; Dance; Randomized controlled study; Exercise
Cognitive Behavioral Aggression Treatment
Condition: Aggression
MeSH terms: Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      Aggressive behavior is a leading worldwide public health problem. Despite this, relatively
      little is known about how to best treat individuals who are highly angry and aggressive. A
      rich literature suggests that aggression is associated with a tendency to interpret
      situations as threatening or hostile even when they are not. This process is governed by a
      prefrontal-limbic circuit in the brain. A goal of cognitive behavioral therapy is to reduce
      these kinds of hostile biases. Preliminary data by the PI suggests a 12- session cognitive
      behavioral aggression treatment (CBAT) may help reduce aggressive behavior and underlying
      hostile biases associated with affective aggression. To assess the efficacy of this
      treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of
      either CBAT or supportive psychotherapy. All subjects will monitor their anger and aggressive
      behavior throughout the treatment electronic diaries. Subjects will also complete
      questionnaires and computer tasks to assess anger, hostile biases and related processes
      1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends.
      In addition, to understand the effects of CBAT on the brain, subjects will have their brains
      scanned (functional Magnetic Resonance Imaging) while they look at emotional pictures and
      complete computer tasks. The brain scans will occur once before treatment starts and once
      after treatment ends.

      Our hypotheses are:

        1. CBAT will reduce anger, aggression and hostile biases more than supportive therapy.

        2. CBAT will decrease limbic activation and increase prefrontal activation to emotional
           pictures more than supportive therapy.
    


Intervention name(s): Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment or supportive psychotherapy
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychotherapy; Cognitive Behavioral Therapy; Aggression; fMRI; Behavioral Intervention
Standardized Patients to Measure and Address Intersectional Stigma
Condition: Hiv; HIV Infections; AIDS
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study aims to develop and evaluate an intervention to reduce enacted stigma in
      healthcare settings aimed at people living with HIV (PLWH) and men who have sex with men
      (MSM) in China. Enacted stigma will be measured using a quality of care score collected
      through unannounced standardized patient (SP) visits to consenting providers in sexual health
      clinics.
    

Detailed description: 
      Standardized patients, or trained actors from the community, will conduct a baseline round of
      unannounced clinic visits with consenting providers for the purposes of observing their
      clinical performance. SPs will present clinically standardized case scenarios, but the HIV
      status and sexual orientation of each case will be randomly varied in order to quantify the
      extent to which HIV stigma and/or homophobia contribute to the deterioration of care quality.
      Care quality will be calculated using a global score based on a standard checklist
      administered to SPs following each visit. Results of the baseline visit will inform the
      development of a stigma reduction intervention for consenting providers employed at clinics
      randomized to the treatment arm of the study. Design of this intervention has been informed
      by results of the baseline study and incorporates expert input from members of community
      advisory boards (CAB), one made up of community members and the other of providers. The
      intervention will consist of both didactic and skills-building methods and will be delivered
      both in-person and through follow-up modules online. Didactic portions will include content
      on topics including clinical management of common STIs, shared decision making, sexual
      history taking, and working with marginalized populations. Skills-building sessions will
      include group-based discussion and medical simulation and feedback with trained standardized
      patients. Follow-up data collection will begin within 2 months of completing the stigma
      reduction intervention using the same approach as for the baseline data collection. All
      research activities will take place in Guangzhou, China.
    

Intervention name(s): Stigma Reduction Intervention
Intervention type(s): Behavioral
Intervention description(s): Care providers will complete the Stigma Reduction Intervention curriculum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stigma