bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of a Commercial Program on Weight Loss and Health Outcomes 2
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      There is a body of evidence that has evaluated the effect of Weight Watchers, a commercially
      available weight loss program, on changes in body weight. The current investigation aims to
      add to this body of evidence by providing additional data on changes in body weight and
      enhance the current evidence-base in regards to evaluating other health-related outcomes.

      There is little evidence that demonstrates whether or not the weight loss as a result of the
      Weight Watchers program elicits changes in health-related functional outcomes such as aerobic
      capacity, flexibility, sleep, and other psychological measures. Additionally, within a
      scientific research protocol, measures of adherence and satisfaction will also be evaluated
      evaluated. This study will evaluate these outcomes beyond weight changes achieved across the
      24-week program.
    


Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Weight Watchers Intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of Nurse Navigators in Cancer Care
Condition: Neoplasms; Nurse-Patient Relations; Psychiatric Disorder
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      Cancer patients will be recruited from the Taipei Cancer Center of Taipei Medical University.
      This study was divided into two phases. The first phase adopted cross-sectional study design
      with questionnaires to analyze the potential predictors of depressive symptoms among cancer
      patients. The second stage was adopted experimental study design to explore the effectiveness
      of nurse navigators in cancer care.
    

Detailed description: 
      The first phase analyze the potential predictors include the following: socio-demographic
      characteristics, disease characteristics, lifestyle, perceived benefits, cancer patient'
      experience with medical service, emotional distress, anxiety, and demoralization.

      The second phase will be experimental study.Thus, subjects were randomly sampled and divided
      into 2 groups: experimental group and control group. Subjects in the experimental group will
      receive oncology case manager care combined with cancer nurse navigator care, while subjects
      in the control group will be designed as regular care, which only care with cancer case
      managers. Both groups will receive long-term follow-up analysis (pre-intervention,
      post-intervention - 3 months, and 6 months). Outcome measures include the following:
      perceived benefits, emotional distress, depression and anxiety, demoralization, cancer
      patient' experience with medical service, and medical report indicators (retention rate,
      completion rate, survival rate, mortality rate, untreated cancer within 3 months).
    

Intervention name(s): cancer nurse navigator care; case manager care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): oncology case manager care combined with cancer nurse navigator care; case manager care (usual care)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Navigator
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir with or without
      dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)
      has been shown to be safe and effective in randomized controlled clinical trials with strict
      inclusion and exclusion criteria under well-controlled conditions.

      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±
      RBV, used according to the local label, under real-world conditions in Greece in a clinical
      practice patient population.
    

Detailed description: 
      This was a prospective, multi-center observational study in participants receiving the
      interferon-free ABBVIE REGIMEN ± RBV. The prescription of a treatment regimen was at the
      discretion of the physician in accordance with local clinical practice and label, was made
      independently from this observational study and preceded the decision to offer the
      participant the opportunity to participate in this study. Adults chronically infected with
      hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN, were offered the
      opportunity to participate in this study during a routine clinical visit at the participating
      sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians'
      routine clinical practice. Data were collected at the following time windows: baseline, early
      on-treatment visit, mid-treatment visit (for participants with treatment duration of 24
      weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of
      treatment (representing sustained virologic response 12 weeks after the end of treatment
      [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).
    

Intervention name(s): Paritaprevir/ritonavir/ombitasvir; Dasabuvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Co-formulated tablet; Tablet; Tablet
Other intervention name(s): Paritaprevir also known as ABT-450; Ombitasvir also known as ABT-267; ABT-333
Intervention MeSH terms: Ritonavir; Ribavirin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving
        combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin.
      
Keywords: Observational Study; Sustained Virological Response; Chronic Hepatitis C genotype 1; Chronic Hepatitis C; Ombitasvir/paritaprevir/ritonavir ± dasabuvir; Chronic Hepatitis C genotype 4
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the safety, tolerability, and immunogenicity of measles, mumps,
      rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with
      those of the 2006 process
    


Intervention name(s): MMRV (AMP); MMRV (2006 process)
Intervention type(s): Biological; Biological
Intervention description(s): Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.; Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
Other intervention name(s): ProQuad™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Research of Prevention and Intervention of Mental Health Problems
Condition: Anxiety; Depression; Alcohol-abuse
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The purpose of this research is to establish a suitable community-based model for Chinese
      culture,to improve the community recognition of common mental disorders,as well as its
      treatment and control.
    

Detailed description: 
      The project will select seven metropolis,through multi-center collaborative research,use of
      interdisciplinary methods and combining qualitative and quantitative research
      methods.Community resources will be integrated so as to build the Chinese model of community
      mental health services and to establish the routine for common mental disorders. Evaluation
      criteria for community mental health needs to be developed for the process of health
      education and intervention techniques.
    

Intervention name(s): regular intervention; community intervention
Intervention type(s): Other; Other
Intervention description(s): the subjects in the control group live in the used model; in addition to regular intervention, those subjects in the intervention group will be given education intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: mental health education; community-based
Trial of a Decision Support Intervention for Adolescents and Young Adults With Ulcerative Colitis
Condition: Ulcerative Colitis, Pediatric
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      A web application decision support tool has been developed for adolescents and young adults
      (AYAs). The purpose of this pilot trial is to test the web application for adolescent and
      young adults (AYAs) with Ulcerative Colitis (UC). This research will assess acceptability,
      feasibility of the decision support intervention for AYA UC patients. Participants will be
      randomized to usual care or usual care plus the web application prior to an upcoming clinic
      visit in Gastroenterology. Participants will complete surveys one week after their clinic
      visit about decision making preferences and, for those in the intervention group, usability
      and acceptability of the web application.
    

Detailed description: 
      The iBDecide app provides participants with electronic tools to learn more about UC, track
      symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well
      as learn more about treatment options and compare UC medications.

      Participants will be provided instructions over the phone or via email to download the
      iBDecide app on their personal smartphone approximately two weeks prior to the scheduled
      clinic visit. When possible they will download the app during the consent call and the
      research staff member will review features of the app with the participant. For those unable
      to download it while talking on the phone, a follow-up phone call will be scheduled to review
      the features. During the consenting phone call or at the clinic visit, a time will be
      scheduled to collect additional information via a brief telephone survey approximately one
      week after the clinic visit. Participants will be sent emails and an electronic calendar
      invitation to confirm their scheduled telephone interview.
    

Intervention name(s): iBDecide Decision Support Application
Intervention type(s): Other
Intervention description(s): The iBDecide app provides an electronic tools to learn more about UC, track symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well as learn more about treatment options and compare UC medications.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adolescents and young adults; decision making
Effect of Resistant Starch (Type-4) on Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Metabolic syndrome is a condition characterized by excess body weight, large waist
      circumference, high cholesterol and glucose in the blood, and hypertension. People with
      metabolic syndrome are at increased risk for heart diseases. Research shows benefits of
      regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the
      high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients.
      This study is designed to find if blinded-substitution of regular wheat flour in domestic
      kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4),
      minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from
      wheat.
    


Intervention name(s): RS4 enriched flour; Control flour
Intervention type(s): Other; Other
Intervention description(s): Wheat flour with 30% resistant starch (type-4); Wheat flour without resistant starch (type-4)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Diabetes; Obesity; Cardiovascular disease; Metabolic syndrome
Use of Ziv Aflibercept in Different Retinal Diseases
Condition: Central Retinal Vein Occlusion With Macular Edema
MeSH terms: Macular Edema; Retinal Vein Occlusion; Choroidal Neovascularization
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A prospective interventional case series study was conducted on 20 eyes of 20 patients with
      active myopic choroidal neovascularisation (CNV) ,20 eyes with resistant diabetic macular
      edema and 15 eyes with non ischaemic central retinal vein occlusion(CRVO) after approval of
      the Ethical Committee of the Faculty of Medicine, Tanta University . All procedures were
      carried out under the tenets of the Helsinki Declaration. Written consent was provided by all
      participants after discussing the procedure, alternative treatment plans, follow-up
      schedules, and possible benefits and risks.
    

Detailed description: 
      Intravitreal injection of 1.25 mg of ziv aflibercept was done in different retinal diseases
      including myopic CVN,resistant diabetic macular edema to previous ranibizumab injection and
      non ischaemic CRVO .Thorough ophthalmic evaluation was done including BCVA(best corrected
      visual acuity) ,anterior and posterior segment examination ,fundus fluorescein angiography
      and OCT(optical coherence tomography) were performed for all patients .Injection was repeated
      as PRN(pro re nata) method after one month if persistent intraretinal or subretinal fluid was
      found.
    

Intervention name(s): Ziv-Aflibercept 25 MG/ML [Zaltrap]
Intervention type(s): Drug
Intervention description(s): Intravitreal injection of 1.25 mg of ziv aflibercept in patients
Other intervention name(s): zaltrap
Intervention MeSH terms: Aflibercept
Intervention model: Single Group Assignment
Intervention model description: Resistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myopic choroidal neovascularisation
Tantrum Tamers 2.0: The Role of Emotion
Condition: Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Problem Behavior
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      This study aims to better understand how to best help parents of young children with problem
      behavior. Problem behaviors vary between and within children, but can include
      inattention/hyperactivity, tantrums, and/or noncompliance.
    

Detailed description: 
      If eligible and choose to participate, this study includes:

      A baseline assessment which will include asking a series of questions about parent, child and
      family, as well as parent-child observations.

      If eligible for treatment, sessions occur once per week for approximately 8 to 12 weeks.
      Sessions include new information and lots of practice and discussion about how to make the
      skills work best for specific families.

      After finishing treatment a post-assessment (similar to BL) conducted.

      All of the assessments (i.e., video-and audio-recorded), as well as the sessions with a
      therapist will be recorded (i.e., video recorded).
    

Intervention name(s): Helping the Noncompliant Child (HNC)
Intervention type(s): Behavioral
Intervention description(s): HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.
Intervention model: Single Group Assignment
Intervention model description: All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tantrums; Inattentive; Noncompliance
Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often
      have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an
      evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients
      with primary hypercholesterolemia where the combination therapy with statins
      (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should
      be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total
      cholesterol levels compared to monotherapy.
    

Detailed description: 
      Ezetimibe, a cholesterol-absorption inhibitor, significantly lowers low-density lipoprotein
      cholesterol (LDL-C) when administered in addition to statin treatment. The effect of
      ezetimibe on the incidence and progression of vascular disease is elusive. Therefore, our
      objective was to examine the effects of fluvastatin and fluvastatin plus ezetimibe on
      lipoprotein subfractions in patients with diabetes mellitus and/or coronary heart disease.
    

Intervention name(s): fluvastatin; Fluvastatin plus ezetimibe
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg MR, 12 weeks; fluvastatin 80 mg MR plus ezetimibe 10 mg
Other intervention name(s): Lescol; Lescol, Ezetrol
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer
Condition: Severe Acute Mucositis; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis
Study type: Interventional

Summary: 
      This randomised, double-blind study will compare an oral immunomodulatory solution to a
      placebo for the prevention of acute severe mucositis in head and neck cancer patients treated
      surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of
      25% of severe acute mucositis in experimental arm.
    


Intervention name(s): Oral Impact; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The patients will benefit in each case from a similar energy supplement (either Oral Impact or placebo) during the 5 days preceding the course of chemotherapy. They will receive the supplement 3 times per day at 10am, 3pm and 5pm outside of their meals. In total, the patients will take the supplements for 15 days (3 courses of 5 days). If the patient has difficulty taking the treatment orally, it can be given via an enteral tube (nasogastric tube or percutaneous gastrostomy). All patients in the protocol will systematically receive a dietetic consultation.
This consultation by a dietician will detect malnutrition and result in nutritional counsel if necessary (advice re. enrichment of diet, CNO without immunonutrients, artificial nutrition). Follow-up appointments with a dietician will be organised every 3 weeks to maintain adherence to the suggested dietary changes.; The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
Condition: Body Mass Index Quantitative Trait Locus 7 Disorder; Tangier Disease
MeSH terms: Tangier Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators aimed to determine the effects of HP diet on CVD risk factors among
      overweight and obese children.
    

Detailed description: 
      Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD)
      risk factors have reported contradictory results.

      Objective: In present study, the investigators aimed to determine the effects of HP diet on
      CVD risk factors among overweight and obese children.

      Design: In this randomized controlled trial, the investigators recruited 50 overweight and
      obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (protein,
      carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount,
      divided to animal and plant sources in 50%-50% and animal sources distributed (half/half)
      between meats and dairy products. Fasting blood samples, lipid profile, systolic and
      diastolic blood pressure and anthropometric measurements were measured based on the standard
      guidelines.
    

Intervention name(s): nutrition intervention
Intervention type(s): Other
Intervention description(s): high protein diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research