bioihbjkbjnl/mcl2 huggingface dataset:
Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer
Condition: Breast Cancer; Nutrition Related Cancer; Physical Activity; Mindfulness
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      ABSTRACT

      BACKGROUND:

      Breast Cancer (BC) is one of the leading causes of death among women around the world.
      Integrative oncology, together with conventional medical treatment, has proven to be an
      important support for the control of cancer symptoms, improvement of quality of life, and
      contribution to the overall patient health, providing an integrated patient care both
      physically and emotionally.

      METHODS:

      75 stage II-III breast cancer survivors were randomized (according to age, tumor stage and
      receptor status) into 2 groups: intervention and control. Within the intervention group (IG)
      a diet, exercise and mindfulness intervention was performed, while the control group (CG) did
      not receive any sort of treatment, during 6 months. Passed (at the beginning and end of the
      research) questionnaires concerning general health, quality of life (EORTC QLQ-C30 and BR23),
      and diet (Mediterranean diet adherence test and 24-h-recall) and a blood and urine sample was
      collected to analyze general biochemical variables.

      RESULTS:
    


Intervention name(s): Mediterranean diet, physical exercise and mindfulness workshops
Intervention type(s): Other
Intervention description(s): a group of dietary intervention, physical exercise and mindfulness and another control group, and a longitudinal follow-up was carried out for 6 months from the beginning of the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients between 18 and 70 years of age with breast cancer II-III operable in follow-up, seen in the Oncology service of the Virgen de las Nieves Hospital in Granada and residents in the city or metropolitan area of Granada, which had completed, in the 12 months prior to its inclusion, treatment with surgery, radiotherapy and / or systemic chemotherapy treatment (including biological treatment).
Randomized assignment was made based on age, stage, hormone receptor and her2 status, establishing two groups: a group of dietary intervention, physical exercise and mindfulness and another control group. A longitudinal follow-up was carried out for 6 months from the beginning of the intervention.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer survival; mediterranean diet; physical activity; mindfulness
Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
Condition: Foot Drop
MeSH terms: Peroneal Neuropathies
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effects of personalized, adaptive,
      current-steering functional electrical stimulation (FES) of the lower leg to improve gait in
      people with foot drop.
    

Detailed description: 
      Adaptive, current-steering FES enables precise control over dorsiflexor and evertor muscles,
      allowing for personalized treatment to correct key foot drop characteristics including
      dorsiflexion at heel strike and ankle inversion during swing phase. All participants will
      receive adaptive FES of the dorsiflexors and evertors during back-to-back walking sets.
      Participants completed up to three walking sets of unstimulated walking (pre-test) followed
      by lower-leg stimulated walking (post-test). The primary outcome measures include ankle
      dorsiflexion at heel strike and mean ankle inversion during swing phase. Secondary outcome
      measures include foot angle at heel strike and single-side heel strike to toe strike time
      (heel-toe time).
    

Intervention name(s): Cionic Neural Sleeve
Intervention type(s): Device
Intervention description(s): Adaptive, functional electrical stimulation
Intervention model: Single Group Assignment
Intervention model description: A one-group, pre-test post-test study.
Masking: None (Open Label)
Primary purpose: Treatment
Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is carried out in order to determine the relationship between AZD2066 exposure and
      mGluR5 receptor occupancy in the brain and to demonstrate that AZD2066 can displace
      [11C]AZ12713580 from mGluR5 binding-sites in the Central Nervous System
    


Intervention name(s): AZD2066; radioligand [11C] AZ12713580
Intervention type(s): Drug; Drug
Intervention description(s): single dose of oral dose, 3 times per subject; single dose of iv administered 4 times per subject (3 times together with AZD2066)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pain; PET; Phase 1; Analgesia; Positron Emission Tomography; mGlu5 receptor; Dose finding; Analgesia/Pain
Effects of Food Cooking on Diabetes-2 Risk Factors
Condition: Obesity; Type 2 Diabetes; Insulin Resistance; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Insulin Resistance
Study type: Interventional

Summary: 
      The aim of the project is to investigate the effects of advanced glycation end products
      (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the
      human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is
      that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii)
      AGEs formation in the body is lower at low dietary intake of certain sugar forms.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: advanced glycation end products; insulin sensitivity; obesity; inflammation; metabolomics; appetite; CVD
Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes
Condition: Diabetes Mellitus; Periodontitis
MeSH terms: Periodontitis; Diabetes Mellitus
Study type: Interventional

Summary: 
      To evaluate the effectiveness of non surgical periodontal therapy in addition to
      antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease
    

Detailed description: 
      A total of 40 patients with diabetes and chronic periodontitis attending the department of
      periodontics will be recruited in the study. 40 subjects will be randomly divided into two
      groups(control group and test group with 20 subjects in each group). Clinical parameters such
      as gingival index, periodontal index, random blood sugar levels(RBS) and glycosylated
      hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and 2ml of blood
      sample will be collected by venepuncture ( baseline and after 3 months) and stored in
      Ethylenediaminetetraacetic acid containing vials to identify the levels of resistin in the
      patients by Enzyme linked immunosorbent assay. Group A will receive Alpha lipoic acid at
      baseline for a period of 3 months. Both the groups will receive scaling and rootplaning at
      baseline.
    

Intervention name(s): Alpha lipoic acid; Scaling and Root planing
Intervention type(s): Other; Procedure
Intervention description(s): Scaling and root planing will be done at baseline and systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months.; Scaling and root planing will be done at baseline.
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Concomitant Treatment of Permanent Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched
      concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
    


Intervention name(s): Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Intervention type(s): Device
Intervention description(s): Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AF; Atrial Fibrillation; afib; racing heart; cabg; valve; ablation; bipolar; radiofrequency; rf
Perioperative Effects of Operating Room Virtual Tour
Condition: Preoperative Care; Anxiety; Emergence Delirium; Postoperative Complications
MeSH terms: Delirium; Emergence Delirium; Postoperative Complications
Study type: Interventional

Summary: 
      Preoperative anxiety is associated with adverse consequences such as emergence delirium, and
      postoperative behavioral changes. According to previous studies, providing information of
      anesthetic procedures helps to lessen preoperative anxiety. However, verbal explanation alone
      provides the limited effect, and the tour program of the operating room prior to surgery may
      not be possible for a number of hospitals due to organizational and financial reasons.
      Therefore, the virtual reality (VR) tour of the operating room may be an innovative and novel
      method to give children information about the preoperative process and to alleviate the
      preoperative anxiety. In this study, we intend to evaluate the effects of the operating room
      virtual tour on preoperative anxiety as well as emergence delirium and postoperative
      behavioral changes, in pediatric patients.
    


Intervention name(s): a 360-degree VR video tour
Intervention type(s): Behavioral
Intervention description(s): At operation day, pediatric patients of the VR group and their parents are educated using virtual tour program explaining preoperative procedures and showing environment of the operating room. A 360-degree virtual reality (VR) video for the tour program was filmed in advance and is provided using a head mount device into which a smartphone is installed, at 30 minutes before the induction of anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New LDL-C Target Goal
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Observational

Summary: 
      The purpose of this study is to determine the efficacy of Crestor in high risk patients
      switched from higher doses of other statins in obtaining the new European Atherosclerosis
      Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care
      
Keywords: High risk patients; Crestor; Rosuvastatin; LDL cholesterol; observational
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional
      therapy using digital subtraction angiography（DSA）for lung cancer.
    

Detailed description: 
      By enrolling patients with lung cancer adapted to enrolled criteria, this study will document
      for the first time the safety and the short and long term efficacy of HepaSphere
      interventional therapy using digital subtraction angiography（DSA）for lung cancer.
    

Intervention name(s): interventional therapy
Intervention type(s): Procedure
Intervention description(s): lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Cancer; HepaSphere
Long-term Safety Extension to Study TRCA-301
Condition: Metabolic Acidosis
MeSH terms: Acidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301
      (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301
      have the option to participate in this extension study evaluating the long-term safety and
      durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease
      and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily
      (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive
      the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.
    


Intervention name(s): TRC101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral suspension; Oral suspension
Other intervention name(s): Veverimer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: blood bicarbonate, kidney disease
Effect Evaluation of Early Exercise Training After Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the effect of early onset of exercise training (ET) after
      myocardial infarction (MI) in a randomized controlled trial. Usual care is to wait 4-6 weeks
      after onset of MI, and our hypotheses are that early ET will prevent a fall in VO2peak and
      contribute to better quality of life.
    

Detailed description: 
      Exercise training is well documented as effective treatment for myocardial infarction(MI)
      patients. However, the long time effect of early onset is more unclear, and it is needed to
      provide knowledge about to which extend early onset of ET contribute to reduce risk factors,
      increase oxygen consumption and influence on quality of life.

      A RCT is conducted, 60 persons with recently MI is invited to participate. The subjects
      participating is hospitalised in St. Olavs Hospital. The participants are randomised to
      either a training group or a control group. The training group will be offered hospital
      out-patient group exercise training of moderate intensity twice a week for four weeks. The
      training is leaded by a physiotherapist. The control group will wait four weeks before both
      groups continue ET twice a week for 12 weeks (high intensity training).
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
Condition: Facial Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial
      inflammatory acne vulgaris.
    


Intervention name(s): Sebacia Microparticles
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne
Impact of School-based Delivery of Long Lasting Insecticide Nets
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Insecticide-treated nets (ITNs), and more recently long lasting insecticide nets (LLINs),
      have been shown to effectively protect those groups most biologically vulnerable to the
      burden of malaria across Africa. However, achieving universal coverage, especially in poor
      and remote areas, has proved a particular challenge and there remains a need to explore
      alternative delivery mechanisms. The recent introduction of universal primary education in
      Kenya has meant that even the poorest households are sending at least one child to school,
      providing a complementary, potentially equitable, mechanism through which to distribute
      LLINs. The delivery of LLINs through schools will be piloted by Population Services
      International in schools situated along the Tana River in North Eastern Kenya. This proposal
      seeks to evaluate the impact of this programme on both household use of school donated, free
      LLINs and the health of schoolchildren. The study hypothesis is that the free delivery of
      long lasting insecticide nets (LLINs) through schools will increase household LLIN coverage
      among younger siblings not enrolled in school and will reduce rates of malaria infection and
      anaemia among school children. The study will be an impact evaluation of a programme
      delivering LLINs through schools, which is to be implemented by Population Services
      International (PSI)-Kenya. The programme will be implemented in 50 schools and due to
      PSI-Kenya's roll out, the programme will be phased in over two years. will be phased in over
      two years. The 50 schools will be randomly divided into two groups, the first 25 schools will
      receive LLINs in 2009 and the second group will receive them in 2010. In each school, five
      households will be randomly selected and household surveys will be conducted to collect
      information on household net use and household demographic and socio-economic status. School
      health surveys will be completed at the end of the programme to assess programme impact on
      malaria infection and anaemia.
    


Intervention name(s): School-based delivery of long lasting insecticide nets
Intervention type(s): Device
Intervention description(s): Free distribution of long lasting insecticide nets to school children and their younger siblings
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: malaria; long lasting insecticide nets; anaemia; schools
A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to assess the single-dose relative bioavailability of Actavis Group
      hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg
      venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study
      of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals
      (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets in Healthy Adult Volunteers under Fed
      Conditions.

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): VENLAFAXINE TABLETS 50 mg , single dose; Effexor® Tablets equivalent to 50 mg venlafaxine
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions; B: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions
Other intervention name(s): venlafaxine; venlafaxine
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; venlafaxine; Healthy subjects
Evaluation of Bariatric Surgery Patients Before and After Sleeve Gastrectomy in Terms of Nutritional Status
Condition: Obesity; Bariatric Surgery Candidate; Healthy Eating Index
Study type: Observational

Summary: 
      Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative
      surgical method for the treatment of obesity and is progressively applied worldwide. However,
      data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies
      and body composition are limited. The purpose of this study is to search nutritional status,
      body composition and biochemical parameters following LSG.

      Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included.
      Macro-micronutrient intake analysis, biochemical blood parameters, and anthropometric
      measures were performed before and 1, 3 and 6 months after LSG.
    

Detailed description: 
      Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative
      surgical method for the treatment of obesity and is progressively applied worldwide.
      Nutritional deficiencies are identified as the possible complications of bariatric surgery.
      However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient
      deficiencies and body composition are limited. The purpose of this study is to search
      nutritional status, body composition and biochemical parameters following LSG.

      Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included in this study.
      Preoperative and postoperative (1, 3 and 6th months) protein-energy and other nutrient
      consumptions, eating habits, food consumption diversity were evaluated with food frequency
      questionnaire, 3-days food diary record, three-factor eating scale and healthy eating index.
      Also in the pre- and postoperative period; anthropometric (weight, height, waist, hip, fat
      free mass) values measured and biochemical blood parameters were collected.
    

Intervention name(s): Pre-operative LSG patients; Post-operative patients 1st month; Post-operative patients 3rd month; Post-operative patients 6th month
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Baseline; 1 month after surgery; 3 months after surgery; 6 months after surgery
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population of the study consists of patients who received LSG surgery approval which
        was conducted in a special obesity clinic, Obezite Cerrahi Ankara Merkezi in Ankara,
        Turkey.

        The decision for surgery was taken after a multidisciplinary meeting, following
        recommendations of international consensus conferences or expert panels American Society
        for Metabolic and Bariatric Surgery (ASMBS).