bioihbjkbjnl/mcl2 huggingface dataset:
Vacant Lot Greening and Violence-Related Outcomes
Condition: Violence Prevention; Built Environment
Study type: Observational

Summary: 
      The purpose of this study is to determine the impact of vacant lot greening on perceptions of
      safety and violence for residents living around the lots. We hypothesize that people living
      around lots that are greened will have improved perception of safety.
    

Detailed description: 
      Violence is a serious health problem in the US, and especially in Philadelphia, as the city
      ranks first in violent crime amongst the ten largest US cities. The determinants of violent
      crime range from individual to community level factors. In this study, we focus on physical
      incivilities in the built environment, specifically vacant lots, as they have been associated
      with violent crime. Physical incivilities are also associated with individual perceptions of
      crime and safety, and subsequently, negative health outcomes. However, prior research has
      been observational and retrospective. We aim to expand this body of work through a randomized
      community intervention trial of vacant lot greening to explore causal mechanisms between
      vacant lots and violent crime outcomes. This pilot study, in partnership with the
      Pennsylvania Horticultural Society, will investigate the feasibility of a vacant lot greening
      intervention, and explore how vacant lot greening changes resident perception about violence,
      fear, stress, and neighborhood disorder, as well as violent crime in the surrounding area. We
      will interview residents living around the greened and non-greened lots during a joint walk
      around a pre-determined route, which will ensure exposure to our intervention. We will also
      use violent crime data (homicide, aggravated assault, robbery, and rape) from the
      Philadelphia Police Department. Results of this pilot trial will be used to develop a full
      scale vacant lot greening grant to be submitted to the National Institutes of Health or the
      National Institute of Justice.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Residents living around two seperate sites (one site where vacant lots are greened and a
        control site where vacant lots are not greened).
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults
      with genotype 2 chronic hepatitis C virus (HCV) infection.
    


Intervention name(s): ABT-493/ABT-530; Placebo for ABT-493/ABT-530
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; ABT-493 coformulated with ABT-530; tablet
Other intervention name(s): ABT-493 also known as glecaprevir; ABT-530 also known as pibrentasvir; MAVYRET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment-Naive; Hepatitis C Virus Genotype 2; Sofosbuvir (SOF)-Experienced; Treatment-Experienced; Non-cirrhotic
Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography
Condition: Infertility; Pain
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the analgetic effects of the fast-release orodispersible tramadol
      tablet.

      Tramadol acts through a weak affinity for μ receptors and secondly by inhibiting
      noradrenaline and serotonin neuronal reuptake. It has been used since the 1970s by over 50
      million people for the treatment of acute and chronic pain. The orodispersible Tramadol
      tablet is a new galenic form and is available on the Belgian market for the last three years.
      Pregastric absorption leads to a quicker onset of action.

      So far, evidence shows that pain during and immediately after the Hysterosalpingography (HSG)
      procedure is only significantly reduced by IV opioid analgesia. This study evaluates the
      analgetic potential of an orodispersible opioid tablet. This tablet disintegrates rapidly (in
      around 20-30 seconds) and may be taken without water. Its abuse potential is very low and its
      respiratory depressant effect is negligible.
    

Detailed description: 
      Four arm prospective randomized double blinded trial

      Patients that need a HSG as part of their diagnostic work-up and are eligible for
      randomization are counseled about possible participation. After signing the informed consent
      patients will be randomized in one of the following four groups:

      Group 1: Fast-release Orodispersible Tramadol Tablet + metal cannula Group 2: Placebo + metal
      cannula Group 3: Fast-release Orodispersible Tramadol Tablet + balloon catheter Group 4:
      Placebo + balloon catheter

      Tablets are administered 30 min before the procedure

      Primary Endpoint:

        -  VAS at the six different assessment points

      Secondary Endpoint

        -  adverse effects and complications such as: nausea, vomiting, constipation, drowsiness,
           respiratory depression, hypotension, allergic reaction and infection
    

Intervention name(s): Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); Hysterosalpingography (HSG); Placebo
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): 1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Other intervention name(s): Tradonal odis®; HSG
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HSG; analgesia; tramadol; metal cannula; balloon catheter
"Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"
Condition: Human Nutrition, Omega-3 Fatty Acids, Microalgae; Micronutrients
Study type: Interventional

Summary: 
      The aim of the research project is to investigate the uptake of omega-3 fatty acids into the
      blood plasma through the consumption of the microalgae Phaeodactylum tricornutum (PT) in a
      human study. In an open, crossover study, the volunteers will receive a drink enriched with
      the microalgae P. tricornutum or an omega-3 fatty acid preparation or (optionally) pollock
      for 14 days each. Since the microalgae P. tricornutum is rich in omega-3 fatty acids, the
      target parameter chosen is the uptake of omega-3 fatty acids in the blood plasma
    

Detailed description: 
      A large number of diet-related diseases, such as obesity, are characterized by subclinical
      inflammation of the body. For this reason, anti-inflammatory foods such as omega-3 fatty
      acids, which are found in fish and nuts, are used. However, the disadvantage of fish as a
      resource is its limited availability. Therefore, it is of great interest to provide a
      resource-saving diet that still supplies us with all macro and micro nutrients. For this
      reason, microalgae have become the focus of science in recent years. Microalgae not only
      serve as a source of protein, but also contain a large number of nutrients that could have
      possible physiological and preventive effects in human nutrition. These include substances
      from the group of carotenoids and the various polyunsaturated FS found in microalgae.

      The microalgae PT is rich in omega-3 FS eicosapentaenoic acid (EPA), which is otherwise found
      mainly in fatty fish, and could therefore be an alternative or vegetarian source of
      polyunsaturated fatty acids.

      Previous work by U. Neumann has shown that the microalgae P. tricornutum could be used for
      human nutrition. No toxic effects could be observed in vivo and the bioavailability of fatty
      acids and proteins could also be successfully demonstrated. In vitro experiments also showed
      a more anti-inflammatory, anti-oxidative and anti-proliferative effect on human blood cells.
      For this reason, a health-promoting effect is also possible in human nutrition, but this must
      be proven in human studies.
    

Intervention name(s): Microalgae; Omega-3-fatty acid capsule; sea fish
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Open, monocentric intervention study in crossover design; Open, monocentric intervention study in crossover design; Open, monocentric intervention study in crossover design
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: eicosapentaenoic acid, Nutrition, micronutrients, anti-inflammatory foods, omega-3 fatty acids, microalgae
Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetic effect of a vaginally administered antimycotic
      (miconazole), antibiotic (clindamycin), spermicide (nonoxynol-9) or the concomitant use of
      tampons during the use of an intravaginal ring releasing anastrozole and levonorgestrel
    


Intervention name(s): Anastrozole / Levonorgestrel (BAY98-7196); Gyno-Daktarin; Sobelin vaginal creme; Patentex oval; Tampon
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG; 400 mg miconazole nitrate per day for 3 consecutive days; 100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days; 75 mg Nonoxynol-9 per day for 3 consecutive days
Other intervention name(s): Tampons (3 changes per day) for 3 consecutive days
Intervention MeSH terms: Anastrozole; Levonorgestrel; Nonoxynol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      Specific subgroups of children who survive treatment for childhood malignancies have been
      shown to develop relative osteopenia following chemotherapy and are felt to be at risk for
      developing osteoporosis later in life due to their inability to reach peak bone mass during
      childhood. Based upon an earlier study in our department, the investigators reported
      conclusive evidence that approximately half of survivors of pediatric solid malignancies are
      at risk for these problems. However, the proportion of patients in our population that showed
      osteopenia/osteoporosis was lower than that in other similar cross-sectional studies in solid
      tumors such as osteosarcoma. The main difference between our report and the osteosarcoma
      study was duration of follow-up, with ours being shorter. Longer follow-up may prove that a
      larger proportion of our patients are affected. The purpose is to perform a longitudinal
      follow-up study of bone mineral density using dual-energy X-ray absorptiometry (DXA) in adult
      survivors of solid pediatric tumors that were previously studied as subjects in our original
      cross-sectional study. The primary hypothesis is that the proportion of pediatric solid
      cancer survivors with significantly lower bone mineral density (BMD) compared to established
      age group controls will be increased with the additional time that has elapsed since the
      original study despite the fact that the patients are young and would not normally be
      expected to have osteopenia/osteoporosis at this age.
    

Detailed description: 
      AS ABOVE
    

Sampling method: Non-Probability Sample
Study population: 
        The 38 patients from the SUNY Upstate Medical Center (Syracuse, NY) Pediatric Oncology
        Long-term Survivor Clinic who were subjects in the original Georg Fund supported study will
        comprise the patient population if they are locatable and willing to participate. Patients
        must be less than 40 years of age to participate.
      
Biospecimen description: 
      bone specific alkaline phosphatase n-telopeptide
    
Keywords: Examine the risk of osteoporosis in survivors of solid pediatric cancers
NFAT-Dependent Cytokine Gene Expression for Immune Monitoring in Kidney Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different ways of monitoring the immune system to
      determine how to manage the doses of anti-rejection medications.
    

Detailed description: 
      This is a single center randomized controlled trial investigating the efficacy and safety of
      adjusting calcineurin inhibitor (CNI) dosing based on Nuclear Factor of Activating T Cells
      (NFAT)-dependent cytokine gene expression as compared to standard of care adjustments based
      on trough level. Before any study-related evaluations are performed, the patient must give
      written informed consent. Once consent is obtained, a patient's eligibility to participate in
      the study will be assessed within 4 weeks of their 6 month management biopsy. Approximately
      40 patients who meet inclusion criteria will be randomized at University of California, San
      Francisco (UCSF). Eligible patients include any patient maintained on triple therapy with
      tacrolimus, mycophenolate mofetil ,and prednisone who has had no prior rejection episodes and
      who has undergone a 6 month management kidney biopsy that shows no evidence of acute cellular
      rejection or antibody mediated rejection.
    

Intervention name(s): Dose adjust group (NFAT)
Intervention type(s): Other
Intervention description(s): If the average residual expression of the 3 cytokines is <20%, the CNI daily dose will be reduced by 15%. If the average residual gene expression of the 3 cytokines is > 60% the CNI daily dose will be increased by 15%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Transplantation; Kidney; calcineurin inhibitor; NFAT; tacrolimus
The Efficacy of Mobile Video Counseling for Employees With Emotional Labor
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effectiveness of mobile video counseling for
      workers. Subjects who can participate in the screening evaluation are assigned to one of
      face-to-face counseling group, mobile counseling group, and self-treatment group. The mobile
      counseling group and the face-to-face counseling group counseld with a total of 4 times, 50
      minutes at a time, once a week, and the self-treatment group provides self-education by
      providing the stress education kit.
    

Detailed description: 
      After screening, Pre-evaluation is conducted on the subjects who agreed to participate in the
      study. Pre-assessment includes questionnaires related to stress, emotional labor, resilience,
      sleep, etc., and includes stress-related physiological measures using HRV, 2 lead EEG. After
      the pre-evaluation, the test group will conduct a counseling program with a psychologist for
      50 minutes at a time, once a week, for a total of 4 sessions (one month for a period). The
      place should be placed in a quiet place where the subject thinks comfortably and is
      designated as the same place to exclude the influence by the place, but the subject does not
      have to visit the hospital. In the offline counseling group, four counseling sessions are
      held with the psychologist off-line for a total of 4 counseling sessions, 50 minutes at a
      time, once a week after the same pre-evaluation. As a self-care control, counseling is not
      provided and self-learning materials are provided once a week.

      Mobile counseling group and offline counseling group visit the hospital within one week after
      termination and within 4 to 5 weeks after pre-evaluation in self-care control group. Also, to
      see if the effect of mobile counseling is continued even after counseling is completed, visit
      the counseling clinic one month after counseling is over and conduct the same test. The data
      obtained from this study showed that the mobile counseling program measured the change in the
      clinical scale and heart rate variability and EEG such as the stress and resilience of the
      subjects, and the self-care group using the offline counseling group and stress data and
      stress related psychological and physiological And compare the effects on the improvement of
      the indicator.
    

Intervention name(s): Stress management counseling
Intervention type(s): Behavioral
Intervention description(s): stress management counseling based on CBT and relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy individuals recruited through advertisement
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Resilience; Mobile video counseling; Emotiona labor
Clinical Trial for Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome
Condition: X Fragile Syndrome
MeSH terms: Fragile X Syndrome; Syndrome; Mental Disorders; Child Behavior Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine vitamin C and vitamin E in combination are
      effective in the treatment of cognitive and behavior disorder in children with fragile X
      syndrome.
    

Detailed description: 
      The combination of vitamin E and vitamin C supplementation has been associated with a lower
      prevalence (-78%) and incidence (-64%) of Alzheimer's disease in the elderly population. It
      has recently been shown that dietary vitamin E supplementation reduces the production of free
      radicals inhibiting NADPH oxidase activity in circulating neutrophils. Another work describes
      the inhibition of glutamate release by activated microglia in cell cultures incubated with
      vitamin E, effect that can prevent excitotoxicity.

      The investigators propose to evaluate the effectiveness of treatment in neurodevelopmental
      disorders affected by fragile X syndrome (FXS) with lipophilic compounds antioxidants such as
      tocopherol and hydrophilic compounds antioxidants such as ascorbic acid, which regulate
      oxidative stress and improve learning and behavioral mouse model and humans.

      Our group has positive results in the use of this combination of antioxidants as a treatment
      for fragile X syndrome in adolescents. This disease has developed previous clinical trials
      with EUDRACT codes: 2009-017837-23 and 2013-004276-35.

      The use of the combination of vitamin C and E in the treatment of cognitive and behavioral
      disorder in FXS, is patented PCT-050 187 with reference number 2011070875

      This combination will be administered as a single oral dose with a total dose of 10mg / kg /
      day for each of the vitamins. This dose is maintained within the therapeutic range of both
      antioxidants.
    

Intervention name(s): Vitamin C 10mg/Kg Vitamin E 10 mg/Kg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo
Intervention MeSH terms: Vitamins; Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: behavior, cognitive
Detection of Visual-Auditory Reaction Rates in Individuals With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Cognitive Dysfunction; Nerve Damage
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Cognitive Dysfunction
Study type: Observational

Summary: 
      Background: The primary purpose of our study was to understand the damage in the peripheral
      nerves of patients with diabetes and to determine the change in patients' reaction rates and
      perceptions by the age groups, duration of diabetes, fasting plasma glucose and HbA1c values,
      and compare these with those of the healthy individuals.

      Methods: This study was carried out at the Baskent University Hospital Endocrinology and
      Metabolic Diseases Outpatient Clinic. A total of 64 patients diagnosed with type 2 diabetes
      and 64 healthy controls were included in the study. Finger tapping, visual, and auditory
      reaction time tests were performed on the subjects, respectively. The subjects' fasting
      plasma glucose and HbA1c levels, and the duration of their diabetes were recorded. Analyses
      were performed using the SPSS version 25. Differences were considered statistically
      significant when the p-value is <0.05.
    


Intervention name(s): recation time test
Intervention type(s): Device
Intervention description(s): visual-finger tapping and auditory reaction time tests
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population consisted of healthy individuals aged between 18-64 years, diagnosed
        with type 2 diabetes, and resided in Ankara. The sample comprised 128 volunteers, 64 of
        whom were patients and 64 were controls.