bioihbjkbjnl/mcl2 huggingface dataset:
Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The aim is to study the effect of a dietary supplement on stress and pain through
      questionnaires and follow-up of physiological parameters, and functional Magnetic Resonance
      Imaging (fMRI) in stressed healthy subjects versus stressed healthy subjects without
      treatment.
    

Detailed description: 
      The MAGRITTE monocentric study conducted at Clermont-Ferrand University Hospital is a
      parallel, randomized, and controlled versus placebo performed in stressed subjects.

      The main outcome of this study is to demonstrate on stress the effectiveness of a dietary
      supplement based on magnesium (Mg), vitamins, rhodiola and L-Theanine, compared to placebo,
      in subjects with chronic stress and free from other pathologies.

      The secondary objectives are to evaluate the action of Mg dietary supplement on:

        1. pain by the Numerical Scale and fMRI,

        2. stress by the Numerical Scale and fMRI,

        3. anxiety, depression and sleep with questionnaires,

        4. selected biological parameters,

        5. heart rate variability,

        6. microbiota,

        7. safety of the product.
    

Intervention name(s): Stress Resist® (oral dietary supplement)
Intervention type(s): Dietary Supplement
Intervention description(s): Stress Resist® (dietary supplement) is composed of Mg (150 mg), Vitamin B6 (0.7 mg), Vitamin B9 (100µg), Vitamin B12 (1.25 µg), rhodiola (222mg), and green tea/L-théanine (125 mg). Oral supplementation. All subjects in the MAGRITTE study will receive either a dietary supplement or a placebo for 28 days (morning intake). The effects on stress will be studied both with questionnaires, biological samples (blood, urine and stool), with a Heart Rate Variability test. 40 subjects (20 subjects per group) will have an fMRI exam.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After pre-selection (Day-14 to Day 0), participants will receive one of the two products in random order (Mg or placebo).
Treatment allocation will follow a randomization plan and will be carried out by a Clinical Research Associate totally independent from the protocol. The randomization list and a copy will be edited, placed in a sealed envelope, and submitted to the Pharmacy of the University Hospital of Clermont-Ferrand and the Clinical Pharmacology Centre of Clermont-Ferrand which is the coordinating centre.
For a 5% risk of bilateral species error and a 90% power, it is necessary to include 50 subjects per group to highlight such an effect size. In addition, fMRI examinations will be offered to the first 20 subjects included per group, i.e. 40 subjects, an usual and relatively consensual number for fMRI work.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stressed individuals; Dietary supplement; Magnesium; fMRI
The Social Media and Activity Research in Teens Trial
Condition: Physical Activity
Study type: Interventional

Summary: 
      In an effort to address the physical inactivity crisis among adolescents, the present study
      will examine the efficacy of using an already established Web-based social networking
      platform (i.e., Facebook) to deliver a physical activity intervention to adolescents.
    

Detailed description: 
      In an effort to address the physical inactivity crisis among adolescents, the present study
      will examine the efficacy of using an already established Web-based social networking
      platform (i.e., Facebook) to deliver a physical activity intervention to adolescents. The
      primary objectives of this trial are to 1) test the efficacy of a social media-delivered
      physical activity program for increasing lifestyle physical activity in adolescents, and 2)
      determine the effectiveness of a physical activity intervention based on social cognitive
      principles in comparison to a simple information-based physical activity condition.
      Additional objectives include an examination of how program participation may influence
      psychosocial health and how these changes affect physical activity patterns in youth.
    

Intervention name(s): SMART Behavioral Group; SMART Informational Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Test the efficacy of using social media to deliver a physical activity intervention based on social cognitive principles to increase lifestyle physical activity in low-active adolescents (i.e., access to regularly posted physical activity content on a study-specific, restricted access Facebook Group, as well as receipt of weekly video-based behavioral modules).; Test the efficacy of using social media to deliver a physical activity intervention to increase lifestyle physical activity in low-active adolescents (i.e., access to regularly posted physical activity content on a study-specific, restricted access Facebook Group, but does not receive the weekly video-based behavioral modules).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Stockholm Obesity Prevention Program
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      To study whether a targeted intervention can prevent the development of overweight and
      obesity among pre-school children in families with either one obese or two overweight
      parents.
    

Detailed description: 
      Early STOPP project wants to promote good health in children from early age by supporting
      good habits for the whole family. Our aim is to see if we can prevent overweight and obesity
      in children in families where parents are overweight or obese. Normal weight parents will
      also be needed in this study.

      Background Life is in constant change and affects our habits. In many ways this is positive
      but it also contributes to less favorable health factors. For example, take the car instead
      of cycling, take the lift instead of the stairs. This makes us less active in everyday life.
      Individuals also eat more unhealthy foods in larger portions. In combination with genetics,
      social in heritage and surrounding factors this contributes to increase overweight and
      obesity among children not only in adults but also in children.

      Good treatment methods for childhood obesity are lacking, making prevention very important.
      The earlier good habits are introduced to a child the better it is.

      In Early STOPP project we study food, physical activity and sleep habits in the families with
      a little child. The height, weight, waist circumference and blood pressure will be recorded
      in both child and parents. The parents will answer questionnaires about food, physical
      activity and sleeping habits for both the child and themselves. During the study, the child's
      physical activity will be measured.
    

Intervention name(s): Dietary, physical activity and sleeping
Intervention type(s): Behavioral
Intervention description(s): The intervention in the present study will be delivered through sessions aiming at developing healthy lifestyle habits regarding physical activity, food intake and regular sleeping habits for parents and children. These sessions will be performed face to face by trained health care workers and carried out in the welfare centres with the parent/s. Children will not be approached directly in the present study. All families will meet with their coach/facilitator during at least 12 times (including start and final evaluation meeting) until the children reach 6 years of age (such as school age). However extra effort (as boosting sessions) will be made if growth records show an increased BMI (weight induced meetings). The parents are also encouraged to keep contact with their coach either by phone or e-mail as often as they feel needed.
The Low intensity arm will only receive written information and no direct face to face support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: child overweight; child obesity; prevention; targeted intervention; development of overweight
The Effects of Restricted Dietary of AGEs on the Glycemic Control, Oxidative Stress and Inflammation
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Inflammation
Study type: Interventional

Summary: 
      To evaluate the effects of dietary restriction of advanced glycated end products (AGEs) on
      glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects
      with metabolic syndrome for 8 weeks.Both groups will be advised to follow same low energy
      diet and no changing in physical activity pattern.Parameters related to metabolic syndrome,
      anthropocentric factors, oxidative stress(Malondialdehyde), CML(AGEs factor in blood) and
      systemic inflammation factors (hs-CRP وTNF-α ) will be measured at the baseline and at the
      end of the study.
    

Detailed description: 
      Metabolic syndrome (MS) is a cluster of cardiovascular risk factor abnormalities associated
      with increased risk of type 2 diabetes mellitus, cardiovascular disease, and all-cause
      mortality. Non-enzymatic glycation plays an important role in the development of
      physiological and pathophysiological processes such as aging, diabetes, atherosclerosis, and
      chronic renal failure. Preventing glycation can minimize diabetic complications. Advanced
      glycation end products (AGEs) are formed endogenously when the carbonyl groups of reducing
      sugars nonenzymatically react with the free amino groups on proteins. AGEs are generated in
      vivo as a normal consequence of metabolism, but their formation is accelerated under
      conditions of hyperglycemia, hyperlipidemia and increased oxidative stress. It can also form
      in food processing and the variety and the amount of dietary AGEs (dAGE) depend on food
      nutrients, the heating used in food processing, pH conditions, presence of some metal ions
      (Cu++, Fe++) and water content. In this study 2 groups of metabolic syndrome patients(22 in
      each group) will receive same low calorie diet and one of the groups plus restricted dietary
      AGEs according to the international references.Along 8 weeks the investigators will talk to
      each patient by phone and every months the participants will come and the investigators will
      take anthropocentric measurements and the recommendations for diets will review. The
      three-day 24-hour recall food questionnaire will take at first,middle and the end of program.
    

Intervention name(s): AGEs restricted diet
Intervention type(s): Other
Intervention description(s): Diet modification to reduce advanced glycation end products in diet. for example to change ways of cooking, time of cooking and also omit some foods.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AGEs( Advanced glycation end products)
Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
Condition: Skin Lesion; Skin Abnormalities; Sebaceous Hyperplasia
MeSH terms: Skin Abnormalities; Hyperplasia
Study type: Interventional

Summary: 
      This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation
      (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.
    

Detailed description: 
      The study is designed with each subject serving as his or her own control. A total of up to
      75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm
      x 1.5-mm or 2.5-mm x 2.5-mm tip. One lesion will be randomized as a untreated control and no
      NPS energy will be delivered. All treated lesions will receive at least one NPS treatment and
      evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially
      Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at
      60 days post-primary or secondary treatment.
    

Intervention name(s): Nano-Pulse Stimulation Device
Intervention type(s): Device
Intervention description(s): NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nano-Pulse Stimulation; NPS
Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A new approach to HIV prevention currently being studied includes the use of microbicides,
      substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved,
      anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is
      to determine the adherence and acceptability to and blood levels of three daily regimens of
      tenofovir in both oral and gel form.
    

Detailed description: 
      It is necessary to monitor both the adherence and blood levels of microbicides in order to
      gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir
      gel) and an anti-HIV drug (TDF), this study will measure the adherence and acceptability to
      and blood levels of the two interventions in three separate regimens given to HIV-uninfected
      women.

      The expected duration of participation for each participant is 21 weeks. Study participants
      will be randomly assigned into one of six study groups, each with a different regimen
      sequence. Each sequence will consist of three study periods and three wash-out periods. Each
      study period lasts 6 weeks, followed by a 1 week wash-out period. The regimen assigned for a
      given study period will include either oral TDF, tenofovir vaginal gel, or both. All
      participants will be prescribed all three regimens in the order designated by their
      randomized assignment.

      Study visits will occur at Weeks 1, 3, 6, 7, 10, 13, 14, 17, 20, and 21. Medical history, a
      physical exam, behavioral assessment, and urine, blood, pelvic sample collection, and
      counseling will occur at all visits. At some study sites rectal swabs may be performed.
      Counseling will include information regarding contraception, protocol adherence, HIV,
      HIV/Sexually Transmitted Infection risk reduction, and male condom use. Pharmacokinetic (PK)
      studies, to be determined by the study site, will occur during all three study periods. These
      studies may involve additional procedures.
    

Intervention name(s): Tenofovir disoproxil fumarate; Tenofovir gel
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg tablet daily; 1 gm/100 ml of 1% gel vaginally daily
Other intervention name(s): TDF; TFV; 9-[2-(Phosphonomethoxy)propyl]adenine
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Microbicide; HIV Seronegativity
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules
Condition: HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope
      glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody
      response and its relationship to the dose and frequency of inoculation.

      Although recent advances have been made in antiviral therapy against AIDS, there is currently
      no cure for AIDS. It is likely that ultimate control of the disease depends on the
      development of safe and effective vaccines against HIV.
    

Detailed description: 
      Although recent advances have been made in antiviral therapy against AIDS, there is currently
      no cure for AIDS. It is likely that ultimate control of the disease depends on the
      development of safe and effective vaccines against HIV.

      Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are
      randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the
      following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days
      84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140.
      Subjects are followed for 1 year after the last injection. Per 05/13/94 amendment, 10
      subjects at the St. Louis University site receive an additional boost 18-24 months after the
      last injection.
    

Intervention name(s): gp160 Vaccine (Immuno-AG)
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; Drug Evaluation; HIV Envelope Protein gp160; Drug Administration Schedule; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Effect of Evidence Based Teamwork System on Patient Safety Culture
Condition: Safety Issues
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of evidence-based teamwork system on patient safety
      culture among newly graduate nurses at Main Mansoura University Hospital
    

Detailed description: 
      Developing a patient safety culture was one of the recommendations made by the Institute of
      Medicine to assist hospitals in improving patient safety and crucial for healthcare quality.
      Newly graduated nurses with lower levels of work experience, education, and work as part of a
      team in the healthcare setting are needed to develop communication and teamwork skill to
      improve patient safety culture . Ineffective communication and teamwork skill among newly
      graduated nurses are associated with negative patient safety culture outcomes, such as
      increased error rates, increased length of hospital stay, medication errors, pressure ulcers,
      and death. The implementation of modified TeamSTEPPS is highly expected to promote better
      interprofessional communication and teamwork skill between newly graduate nurses as well as
      improve patient safety culture. So that, this study aims to evaluate the effect of
      evidence-based teamwork system on patient safety culture among newly graduate nurses at Main
      Mansoura University Hospital.
    

Intervention name(s): TeamSTEPPS
Intervention type(s): Other
Intervention description(s): Team Tools and Strategies to Enhance Performance and Patient Safety (TeamSTEPPS®) is an evidence-based framework that has been used in interprofessional education programs to develop and train newly graduate nurses to deal with difficult clinical situations.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, multicentric, comparative, non-randomized interventional study in
      which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were
      treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.
    

Detailed description: 
      740 girls with CPP and EP participated in this study, all participates were divided into
      GnRHa group, traditional chinese medicines group and blank group. After at least six months
      therapy with GnRHa or traditional Chinese medicines, the investigators compare clinical
      parameters, sex hormone, bone age and ovarian ultrasound in three groups.
    

Intervention name(s): Triptorlin or Leuprorelin; Zhibo dihuang pills; Dabu ying pills
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Gonadotrophin releasing hormone agonists (GnRHa); Traditional Chinese Medicine; Traditional Chinese Medicine
Other intervention name(s): Triptorlin; Leuprorelin
Intervention MeSH terms: Leuprolide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epidemiology; treatment; molecular pathological mechanism; environmental disrupting chemicals
Effects of Mobile Game on Life Quality of Cancer Patients
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether functional games can be used to improve the
      adherence and quality of life of breast cancer patients with chemotherapy.
    


Intervention name(s): Functional mobile game
Intervention type(s): Device
Intervention description(s): Functional mobile game for chemotherapy side effect education
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast Cancer; chemotherapy side effect; mobile game
A Prospective Study of Application of Platelet Mapping in Chronic Liver Disease Complicated With ALI and/or AD in China
Condition: Thrombelastography, Acute Liver Injury, Acute Decompensation, Platelet
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease
      (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin
      production and provides a global assessment of coagulation incorporating the cumulative
      effect of the interactions at various levels between plasma components and cellular component
      of coagulation. Through the previous studies(NCT03281278 and NCT04119973), we found that ACLF
      patients with high ADP inhibition rate had high 28-day mortality.This study aims to validate
      that high ADP inhibition rate only occurs in patients with liver failure and is related to
      the severity of the disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        chronic liver disease patients（with liver dysfunction more than 6 months） with acute liver
        injury[with ALT>3 ULN),AST>3NL or TB>2 ULN within 1 week before enrollment] or acute
        decompensation[having ascites, hepatic encephalopathy and/or bacterial infection within 1
        month before enrollment].