bioihbjkbjnl/mcl2 huggingface dataset:
Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients
Condition: Chronic Kidney Diseases; Hemodialysis; Physical Rehabilitation
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Hemodialysis patients display among the lowest level of daily activities and decline of
      functional abilities is highly correlated with mortality. Perdialytic exercise during
      hemodialysis procedure is now part of the patients' routine care and appears to be a solution
      to struggle against the functional skills decrease. Our team was able to demonstrate that
      beyond muscle mass, muscle strength and physical activity were essential determinants of
      morbidity and mortality of dialysis patients. The AIDER Santé medical team has set up an
      assessment of physical activities and muscle strength in the Montpellier and Nimes centers.
      In order to rehabilitate muscle strength and endurance, perdialytic exercise may be
      prescribed. Its effectiveness can be appreciated by measuring the SPPB score (Short Physical
      Performance Battery). Recent studies established that combined training including resistance
      and endurance exercises was the most effective to improve functional performance. In AIDER
      Santé dialysis centers, the two mainly used exercise approaches are distinguished by the time
      distribution of the two types of exercise: the first plans to practice both types of exercise
      at each session (continuous program), the second plans to alternate a week of resistance
      exercise with a week of endurance exercise (discontinuous program). It is established that
      the rehabilitation of the hemodialysis patient must include both resistance and endurance
      exercises, but the combination of these exercises during the same session is potentially at
      the origin of an interference phenomenon, limiting neuromuscular adaptations specific to each
      effort. Therefore, the main hypothesis of the project is that the temporal separation of
      resistance and endurance exercises in a discontinuous program could optimize the functional
      gains of combined rehabilitation and therefore be more effective than a continuous program
      generating a phenomenon of interference.
    


Intervention name(s): Combined rehabilitation during hemodialysis
Intervention type(s): Other
Intervention description(s): Combined rehabilitation during hemodialysis
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hemodialysis patients of Montpellier AIDER Santé dialysis center
      
Keywords: Perdialytic exercise; Combined rehabilitation; Functional abilities; Interference effect
A Nicotine Pharmacokinetics and Smoking Behaviour Study Examining Cigarette Ingredients
Condition: Healthy Volunteers; Smoking
Study type: Interventional

Summary: 
      This study will compare nicotine delivery and smoking behaviour in healthy subjects using
      several combustible cigarette prototypes containing different ingredients which are commonly
      used in the European Union.
    


Intervention name(s): Reference cigarette; Cigarette with carob bean extract; Cigarette with cocoa powder; Cigarette with fenugreek extract; Cigarette with fig juice; Cigarette with glycerol; Cigarette with guaiacol; Cigarette with liquorice extract powder; Cigarette plus I-menthol; Cigarette with propylene glycol; Cigarette with sorbitol; Cigarette with multiple ingredients
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): The reference product is based on a commercially-available king-size cigarette design (length 83 mm, circumference 24.6 mm) with a single segment cellulose acetate filter and tobacco blend recipe without ingredients.; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette with added ingredient; Based on reference cigarette plus propylene glycol, glycerol, liquorice extract powder, cocoa powder, carob bean extract, fig juice concentrate, maltol, guaiacol, geraniol, fenugreek extract.
Intervention MeSH terms: Fenugreek seed meal; Menthol; Sorbitol; Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Assessment of Orthopedic Care of the Z-shaped Foot in Infant
Condition: Foot Deformities
MeSH terms: Foot Deformities; Foot Deformities, Congenital
Study type: Observational

Summary: 
      Real-life, observational, monocentric, ambispective study, carried out in France. The aim of
      the study is to evaluate the success rate of orthopedic management of the Z-foot after at
      least 9 months of follow-up.
    

Detailed description: 
      The study will include a single prospective data collection, which will make it possible to
      obtain prospective clinical data at the longest follow-up after treatment, with a minimum
      follow-up of 9 months. This collection will be done during a visit to the office or a phone
      call, depending on the preference of patients and their parents.

      Early data (before the intervention, immediately after, and at 3 months of follow-up) will be
      collected retrospectively in medical records.
    

Intervention name(s): Orthopedic management of the Z-foot
Intervention type(s): Procedure
Intervention description(s): Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children who suffered from a congenital idiopathic Z-foot deformation, aged 6 months to 2
        years at the time of orthopedic treatment.
Predicting and Addressing Colonoscopy in Safety Net Settings
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The prospective cohort study will evaluate the effectiveness of patient navigation in
      community health center settings. The investigators will collaborate with the advisory board,
      composed of key clinicians and patients, researchers, and policymakers, to establish a
      procedure to conduct and evaluate a patient navigation program that aims to increase rates of
      follow-up colonoscopy among diverse patient populations served by safety net clinics. Phase 1
      will be a milestone-driven planning process in which the investigators will validate the risk
      prediction model and apply the risk prediction model to stratify the patients and adapt
      patient navigation materials for the local context. Phase II will be a large-scale, patient
      randomized-controlled trial that will include 1200 patients at a large 34-clinic community
      health center in Washington State.
    

Detailed description: 
      The study will fulfill the following aims:

      Aim 1: Validate externally the predictive risk score using Sea Mar CHC's robust data
      including 29,000 patients age-eligible for colorectal cancer screening; stratify patients
      according to risk of non-adherence to follow-up colonoscopy; and adapt patient navigation
      program for the local context.

      Aim 2: Assess the effectiveness, costs, and cost-effectiveness of a centralized, phone-based
      patient navigation program for follow-up colonoscopy receipt for patients at moderate risk or
      high risk for non-adherence.

      Aim 3: Assess differences in the intervention arms in secondary outcomes (e.g. time to
      colonoscopy receipt, no-show/canceled appointments, colonoscopy quality) and moderators of
      intervention effectiveness (e.g. probability level, intervention dose, and patient age,
      ethnicity, and sex)
    

Intervention name(s): Patient navigation
Intervention type(s): Behavioral
Intervention description(s): Receive up to 6 live phone calls with a patient navigator for education, barrier assessment, and barrier resolution to follow up colonoscopy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colorectal cancer screening; Cancer screening; Risk prediction model; Patient navigation; Colonoscopy
MyT1DHero: an mHealth Intervention for Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The overall objective of the proposed research is to improve HbA1c, adherence to treatment
      plans, and family communication surrounding adolescents' self-management of T1D. The
      investigators will test the efficacy of the MyT1DHero app against an attention control group.
      This will allow investigators to better understand the health and psychosocial improvements
      being made through the app.
    

Detailed description: 
      This research seeks to realize the potential and test the efficacy of MyT1DHero to improve
      adolescent users' glycemic control and adherence to blood glucose monitoring. The
      investigators' goal is to help families receive more social support, and to improve diabetes
      knowledge, self-efficacy, family communication, and quality of life. The investigators
      further seek to decrease family conflict among children with T1D and their parents. In a
      12-month RCT, investigators will randomize 166 adolescents and their parents to one of two
      groups: (1) attention control, or (2) the MyT1DHero app. Adolescents enrolled in the study
      will be 10-15 years old, and will have been living with T1D for <1 year or >5 years at the
      start of the study. The primary outcome will be a change in the participants' HbA1C from
      baseline levels at the start of the study, to levels measured after 12 months.
    

Intervention name(s): MyT1DHero; Other T1D Mobile App
Intervention type(s): Device; Device
Intervention description(s): MyT1DHero is an app with two separate interfaces, one for the parent and one for the child, that work together to help them communicate about diabetes management. The child receives system reminders to enter their blood glucose numbers, and parents receive a notification about each blood glucose test their child enters. Parents are also able to use the app to communicate with their child about their plan for care. The app has customizable blood glucose reminders and ranges, videos of support from other adolescents with T1D, snack lists, and other educational information on T1D.; A mobile app will be used in this control/comparison group that only has blood sugar testing reminders and logging capabilities. There will be no other components of the app.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mHealth; Adolescent
Using Parkinson's Disease to Study the Role of the Substantia Nigra Pars Reticulata
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,
      slowness of movement, slowness of initiation of movement or rigidity of muscles. Deep Brain
      Stimulation (DBS) is the FDA-approved method for patients who no longer get effective
      treatment from the best available medication. The location in the brain where the electrode
      is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. This study aims
      to investigate another location in the brain, the Substantia nigra pars reticulata or SNr.
      The SNr is also known to be involved in motor control of muscles and may be involved in the
      process by which the initiation of movement occurs.
    

Detailed description: 
      Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,
      slowness of movement, slowness of initiation of movement or rigidity of muscles. One method
      of easing PD symptoms is the FDA-approved method of Deep Brain Stimulation (DBS) for patients
      who no longer get effective treatment from the best available medication. The location in the
      brain where the electrode is placed during DBS surgery for PD is called the Subthalamic
      Nucleus or STN. During placement of the DBS electrode, the patient is awake and is asked to
      do motor tasks to determine the correct placement in the STN and proper functioning of the
      DBS electrode. This study aims to investigate another location in the brain, the Substantia
      nigra pars reticulata or SNr, during the normal placement of the DBS electrode. This location
      is also known to be involved in motor control of muscles and may be involved in the process
      by which the initiation of movement occurs. The path through the brain to the STN used for
      DBS surgery goes into the SNr but currently, no testing of the SNr is performed. We will
      conduct a simple and well documented visual motor test to document the patient's stimulus
      perception and motor intention both at rest and during neural stimulation of the SNr.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinson's disease who are candidates for Deep Brain Stimulation surgery.
SHR-1210 in Combination With GEMOX in Patients With Advanced BTC
Condition: Biliary Tract Cancer; Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma; Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody
      SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of
      advanced biliary malignancies.

      In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined
      with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects
      with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma,
      extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.

      28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered
      IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W
      (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6
      cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease
      progression or un-tolerable toxicity.
    


Intervention name(s): SHR-1210+GEMOX
Intervention type(s): Drug
Intervention description(s): 28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BTC; PD-1 antibody
Acute Health Effects of Short-term Use of E-cigarettes on Pulmonary and Cardiovascular System
Condition: E-cigarette
Study type: Interventional

Summary: 
      The goal of our study was to assess acute, short term respiratory (airflow, FeNO, O2
      saturation, exhaled air temperature) and cardiovascular (heart rate, blood pressure)
      responses to smoking an e-cigarette in exclusive e-smokers and dual users and to compare
      these effects with responses to smoking a tobacco-cigarette in exclusive tobacco smokers.
    


Intervention name(s): Cigarette smoking; E-cigarette use; Simulation of the use of e-cigarette
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): T-smokers were asked to smoke a cigarette of one of the popular brands (0.6mg nicotine per one cigarette) according to their everyday habits.; E-smokers and dual users were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.; The control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled).
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This was a laboratory-based intervention study: pre-post-post
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: e-cigarette; health effects; cigarette smoking; exhaled nitric oxide; pulmonary function tests
A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene
      Cream 0.1% and Tazorac® (tazarotene cream 0.1%).
    

Detailed description: 
      The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene
      Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to
      demonstrate the superiority of the test and reference products over the placebo control.
    

Intervention name(s): Tazarotene Cream 0.1%; Tazorac®; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.; Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.; Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
Other intervention name(s): Tazarotene; Tazarotene; Vehicle
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Consumption of a Food Supplement in a Group of Healthy People
Condition: Immune System and Related Disorders
Study type: Interventional

Summary: 
      Bioactive supplements might display relevant therapeutic properties according to validated
      molecular effects. Herein, the effect of a supplement based on diterpenes from Rosmarinus
      Officinalis L. and alkylglycerols with proven properties against signaling pathways involved
      in tumorigenesis is evaluated. The biological and molecular effects of this supplement,
      mainly based on expected effects on immune and genetic modulatory properties is investigated.
      For this purpose, 60 healthy volunteers were enrolled in a six week, double-blind, randomized
      and parallel pilot study with two study arms -rosemary and alkylglycerol containing capsules
      and control capsules. The study includes the analysis of (1) immunological parameters (ex
      vivo cytokine profile of LPS stimulated PBMC and PBMC phenotyping by cluster differentiation
      (CD) markers), (2) regulation of the expression of genes linked to immuno-modulation,
      inflammation, oxidative stress response and cancer, and (3) the analysis of correlation of
      selected genetic variants (SNPs) with the differential responses among individuals.
    


Intervention name(s): Dietary supplementation with capsules containing rosemary and alkylglycerol; Dietary supplementation with control capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rosmarinus officinalis L; alkylglycerols; immuno-nutrition; colon cancer
Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children: A Randomised Controlled Trial
Condition: Pain, Procedural; Child; Phlebotomy; Venipuncture
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The aim of the study was to determine the effects of providing procedural informational
      animation, Buzzy application during the procedure, the combination of both interventions
      (Animated video and Buzzy), and standard care on pain management during venipuncture in
      children aged 6-12 years.
    

Detailed description: 
      A prospective randomized controlled trial design was used to determine the effects of Buzzy,
      procedural informational animation, multiple interventions (Buzzy and Animated video), and
      standard care on the pain level of 6-12 years aged children during venıpunctrue. The study
      was conducted in the territory hospital pediatric blood collection unit The sample size was
      determined by power analysis and 45 child-parent pairs were included in each group. The
      patients who met the sample selection criteria were randomly and equally assigned into 4
      groups using a computer-based program. As a data collection tools, Data Collection Form and
      Wong-Baker have been used. Venipuncture-related pain was self-reported by each child, as well
      as through parents and nurse. Children in the multiple interventions group were shown
      procedural informative animation and the venipunctıre procedure was performed with buzzy®.
      Standard care was applied to the control group, in which no local anesthetic was used and
      families could accompany the bloodletting process. The pain responses of the children were
      evaluated twice, immediately after the procedure (while the child was sitting in the blood
      collection chair) and 2-3 minutes after the procedure, both by the children's self-reports
      and by the parents and the nurse.
    

Intervention name(s): Providing procedural informational animation video; Buzzy; Multiple interventions
Intervention type(s): Other; Device; Combination Product
Intervention description(s): Children and parents have watched procedural informational animation before venipuncture. Afterward, the children and their parents entered the blood drawn unit, and the procedure was performed as in standard care.; Buzzy® was placed on the injection site and it was turned on 60 s before the procedure. Then, the nurse moved Buzzy® about 3-5 cm above the injection site. The procedure was performed with buzzy®. The Buzzy® intervention and phlebotomy were terminated at the same time.; Watching procedural informational animation video prior to venipuncture, and Buzzy application during venipuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: procedural pain; child; phlebotomy; venipunctur; animation; nursing practice; Non-pharmacological method