bioihbjkbjnl/mcl2 huggingface dataset:
Nutributter Programming to Prevent Undernutrition: an Evaluation
Condition: Undernutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This randomized, controlled effectiveness study examines Nutributter programming within an
      integrated package of maternal and child health services offered by Haiti's Ministry of
      Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process
      evaluation is to better understand the uptake of Nutributter® as a complementary food in the
      diets of young children and its feasibility and acceptability as part of MSPP's package of
      services. This project is being carried out at a public hospital in Fort San Michel, an
      impoverished community outside of Cap Haitien, Haiti.
    


Intervention name(s): Nutributter Program; Integrated Package
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.; The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).
Other intervention name(s): Nutriset
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Stunting; Hidden Hunger; Diarrhea; Vitamin A Deficiency
Physiological Upper Eyelid Laxity
Condition: Eyelid Laxity
Study type: Interventional

Summary: 
      This is a prospective, single-center study in normal subjects aged 20 to 89 years.

      The objective was to describe upper eyelid laxity by age group (20/29 years old, 30/39 years
      old, 40/49 years old, 50/59 years old, 60/69 years old, 70/79 years old and 80/89 years old)
      measured with the method of McNab and studying it according to her customary side of sleep.
      In addition, we evaluated a method for measuring tarsal laxity.
    


Intervention name(s): Measurement of the upper eyelid laxity
Intervention type(s): Other
Intervention description(s): Measurement using a soft slider of the distance between our 2 marks The difference obtained between the measurement and the initial 10 millimeters corresponds to the tarsal laxity.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Understanding Hypoglycaemia After Bariatric Surgery
Condition: Bariatric Surgery
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      Postprandial hyperinsulinaemic hypoglycaemia is an increasingly recognized adverse side
      effect of bariatric surgery. Affected individuals experience low glucose levels 1-3 hours
      after intake of meals, accompanied by symptoms such as drowsiness, sweating, hunger and
      palpitations. Hypoglycaemia can be serious and have potential dangerous health impact (e.g.
      road accident or fall due to loss of consciousness). The pathophysiology is incompletely
      understood and more research is needed in search of preventive and therapeutic strategies.
    

Detailed description: 
      Obesity is a major global health concern that is associated with significant disability and
      mortality. Worldwide, the prevalence of obesity has doubled since 1980, affecting 13% of the
      global population. Bariatric surgery has been shown to be the most effective and durable
      treatment of severe obesity and leads to significant improvement of obesity-related
      comorbidity. However, postprandial hyperinsulinaemic hypoglycaemia (PHH) after bariatric
      surgery is a metabolic complication that is increasingly being recognized. Prevalence rates
      of up to 72% have been reported. PHH may have serious implications for affected patients,
      including negative effects on morbidity, mortality as well as quality of life. The
      pathophysiology of PPH is incompletely understood and suggests decreased adaptation of beta
      cell function to increased insulin sensitivity. The latter has been postulated to be largely
      secondary due to external factors outside the beta cells as a result of anatomical and
      hormonal changes after Roux-en-Y gastric bypass (RYGB). However, the intrinsic mechanistic
      effects of altered beta-cell function after RYGB in vivo are unknown and more exploration
      could lead to a better understanding of PHH pathogenesis and help identify targets for
      possible interventions. Previous studies performed enhanced beta cell analysis by following
      insulin synthesis in real-time based on stable isotope labelling of C-peptide during an oral
      glucose tolerance test (OGTT) in cohorts with normal and diabetic glucose tolerance. Applying
      the same methodological approach, albeit in a different target population (PPH after
      bariatric surgery), the present study seeks to explore whether or not the insulin
      hypersecretion can be explained by an increase in insulin synthesis, and secondly, whether
      potentially increased insulin synthesis can be related to other glucoregulatory hormones and
      measures of insulin sensitivity.
    

Intervention name(s): Dietary Supplement: Glucose
Intervention type(s): Other
Intervention description(s): Intake of 75g of glucose with 1g of 13C leucine pre-feeding
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Roux-en-Y gastric bypass (RYGB); Hypoglycaemia; Insulin; Glucose; Incretins; Stable isotope
Glycaemic Index of Fibre-rich Flours in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The project aims to evaluate the glycaemic index of breads from different types of flour. In
      particular, we aim to understand the glycaemic and insulin responses as well as satiety and
      sensory profiles of the products.
    


Intervention name(s): Standard white bread; Experimental white bread; Standard High-fiber bread; Experimental High-fiber bread
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Bread to be consumed within 10 minutes after 10h fasting; Bread to be consumed within 10 minutes after 10h fasting; Bread to be consumed within 10 minutes after 10h fasting; Bread to be consumed within 10 minutes after 10h fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Latin square randomization for test products following reference treatment (as per standard protocol)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Condition: Extragonadal Germ Cell Tumor; Ovarian Cancer; Testicular Germ Cell Tumor
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Peripheral stem cell transplantation may allow doctors to give
      higher doses of chemotherapy and kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by
      peripheral stem cell transplantation or bone marrow transplantation in treating patients who
      have relapsed or recurrent germ cell cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate, overall survival, and disease-free survival of
      patients with refractory or relapsed germ cell carcinoma treated with high-dose induction
      chemotherapy comprising carboplatin and etoposide followed by autologous bone marrow or
      peripheral blood stem cell rescue.

      OUTLINE: Autologous peripheral blood stem cells (PBSC) or bone marrow is harvested. Patients
      receive carboplatin IV continuously and etoposide IV over 1 hour on days -5 through -3.
      Autologous PBSC or bone marrow is reinfused on day 0.

      PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
    

Intervention name(s): carboplatin; etoposide; autologous bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Carboplatin; Etoposide
Primary purpose: Treatment
Keywords: recurrent malignant testicular germ cell tumor; recurrent ovarian germ cell tumor; extragonadal germ cell tumor
Quetiapine Extended Release (XR) for the Treatment of Menopausal Depression
Condition: Major Depressive Disorder; Insomnia; Hot Flashes
MeSH terms: Sleep Initiation and Maintenance Disorders; Hot Flashes; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was designed to examine the efficacy and tolerability of quetiapine XR for the
      treatment of women who suffer from depression in the context of the menopausal transition and
      postmenopausal years. Besides the improvement of depressive symptoms, the investigators are
      interested in examining the impact of this medication on vasomotor symptoms (hot flashes,
      night sweats), sleep and overall quality of life.
    

Detailed description: 
      The menopause transition (or perimenopause) and the early postmenopausal years are marked by
      intense hormone fluctuations; hormone changes are frequently accompanied by the occurrence
      hot flashes, night sweats and sleep disturbance. Recent epidemiologic studies also
      demonstrate that perimenopause is a period of greater risk for the development of depressive
      symptoms.

      To date, serotonergic antidepressants such as paroxetine and escitalopram have shown to be
      efficacious for the treatment of women with depression and menopause-related symptoms. We
      hypothesize that the use of quetiapine for this sub-population will alleviate symptoms of
      depression; we also anticipate that its use may enhance quality of life and improve vasomotor
      symptoms - the latter possibly due to quetiapine's effect on 5HT receptors and/or due to its
      sleep-promoting properties (e.g., by increasing the duration of total sleep time [TST],
      enhancing sleep efficiency, and decreasing the number of awakenings due to hot flashes).
    

Intervention name(s): Quetiapine Extended Release
Intervention type(s): Drug
Intervention description(s): Quetiapine XR, 150-300 mg QHS, for 8 weeks
Other intervention name(s): Quetiapine extended-release (Seroquel XR)
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Insomnia; Hot Flashes; Menopause; Quetiapine
Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression
Condition: Major Depressive Disorder; Unipolar Depression; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder.
      Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently
      from existing antidepressant interventions including trials of medication and psychotherapy.
      A 15-25% of patients manifest a chronic, treatment-resistant course of illness, resulting in
      a need for additional treatment options. Brain stimulation techniques are considered as a
      promising therapeutic approach in affective disorders like MDD. Transcranial direct current
      stimulation (tDCS) is a non-invasive brain stimulation method that has been largely
      investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been
      proposed as novel treatment in MDD. In the largest 2x2 factorial randomized controlled trial
      in MDD to date, Brunoni et al. (2013) have shown that tDCS combined with an Selective
      Serotonin Reuptake Inhibitor (SSRI; sertraline) resulted in an antidepressant efficacy
      superior to placebo treatment, tDCS alone and sertraline alone.

      The purpose of this study is to explore the sustained efficacy and tolerability of repeated
      tDCS for the treatment of MDD. It is hypothesized that prefrontal tDCS in combination with an
      SSRI will provoke an antidepressant effect while antidepressant medication alone (sham tDCS)
      did not. This will be measured by the change from baseline in the Montgomery Åsberg
      Depression Rating Scale (MADRS) scores after 6 weeks of treatment.

      In this randomized, placebo-controlled multicenter trial (5 centers involved) patients with a
      diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS (anode over electrode
      position F3, cathode over F4, 5 sessions/week for 4 weeks followed by 2 sessions/week for 2
      weeks, 24 treatments in sum, 30min/day, 2mA intensity) or sham tDCS (frequency and duration
      correspondent active tDCS, ramp in and ramp out periods only without intermittent
      stimulation), as adjunctive treatment with a SSRI. Follow-up per patient is 3 and 6 months
      after the last tDCS treatment session. Before, during and after the treatment period
      different assessment scales will be conducted to record neuropsychological features and the
      course of the individual symptomatology.
    


Intervention name(s): Transcranial direct current stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): active/sham tDCS as adjunctive treatment with a SSRI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tDCS; SSRI; transcranial direct current stimulation; non-invasive brain stimulation; randomized controlled trial; prefrontal tDCS; neuromodulation
Effect of Interventions on the Progression of Knee Osteoarthritis
Condition: Osteo Arthritis of the Knees
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      There has been intensive search for a substance that can have disease-modifying activity for
      osteoarthritis. A number of medications have been reported to be of benefit on slowing
      progression of knee OA. This trial will be the first head to head comparison of these
      medications.

      Patients aged between age 40 to 65 will be enrolled. Patients will be assessed clinically
      using two scoring systems, the WOMAC index for knee arthritis and the SF 36 for overall
      physical and mental health. The knee X rays will be assessed on Kellgren and Lawrence grading
      and will also be measured for joint space narrowing at follow up. The response to arthritis
      medications on slowing down cartilage loss will be measured biochemically with COMP levels.
    


Intervention name(s): Diacerien; Glucosamine/Chondroitin; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Artrodar; Dirtacetylrhein; Zinc Sulphate
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Condition: Type 2 Diabetes Mellitus; Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that
      can be found in many plants. The purpose of this research is to study the effects of
      resveratrol on the action of insulin (a hormone produced in the body by the pancreas that
      regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.
    

Detailed description: 
      Participants will meet with the study team to discuss dietary recommendations. Each
      participant will be instructed to follow a standardized diet plan and to avoid vigorous
      exercise before beginning the study. Participants will be given a 28 day supply of
      resveratrol capsules (Two 500 mg capsules taken twice a day). A comprehensive study of
      whole-body insulin action called a pancreatic clamp will be done and small samples of fat and
      muscle will be taken before and after the administration of resveratrol.
    

Intervention name(s): Resveratrol
Intervention type(s): Drug
Intervention description(s): 1,000mg twice daily for 28 days
Other intervention name(s): 3,5,4'-trihydroxy-trans-stilbene
Intervention MeSH terms: Resveratrol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Resveratrol; Therapeutic Uses
Dietary Intervention Examining Tracking With Mobile Devices
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to test the effectiveness of two different weight loss
      interventions. Both of these interventions will provide weight loss information through twice
      weekly audio podcasts. In addition to the podcasts, participants will be asked to track their
      diet using either a wearable device on their wrist or through an app on their smartphone.
    

Detailed description: 
      This study will last approximately 6 months. Participants will attend one 1-hour orientation
      meeting at the beginning of the study and a 2-hour baseline assessment and training meeting.
      Additional assessments will be conducted at 3 months and 6 months. Weekly questionnaires will
      be administered. Everyone in the study will be asked to listen to 2 podcasts per week. Each
      of the podcasts will take about 15 - 20 minutes to listen to and so participants should
      expect to spend 30 - 40 minutes each week listening to podcasts. Participants will also be
      randomized to either track diet with an app on their smartphone or using a device they wear
      on their wrist. Each week, participants will be sent an email as a reminder on how to use
      their diet tracking device. They will also be encouraged to monitor their exercise and body
      weight.
    

Intervention name(s): Podcasts; Mobile Diet Application; Bite Counter
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive twice weekly podcasts that will cover topics related to weight loss.; Participants will use a mobile application on their smartphone to track their diet.; Participants will use a wrist-worn Bite Counter to track the number of bites in their diet per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Diet; Weight Loss; Tracking; Calories
rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The neurological basis of tinnitus is uncertain when there is no evidence of damage to the
      peripheral auditory system. However, neuroimaging studies of tinnitus patients show
      hyperactivity in several cortical regions, especially the auditory cortices and middle
      temporal regions. A potentially promising treatment modality for tinnitus is repetitive
      transcranial magnetic stimulation (rTMS). rTMS involves the application of frequent, repeated
      magnetic stimuli to the skull to induce electrical activity in the underlying cortical areas
      of the brain. When the magnetic device is placed on the skull, the resultant magnetic field
      passes through the skull and induces a small secondary current in the cortex. It has been
      hypothesized that the effect of the frequency used in rTMS differentially influences cortical
      activity with low-frequency (1Hz) stimulation decreasing and high-frequency stimulation
      (10-20 Hz) increasing cortical activity.

      Currently, reports on treating tinnitus with rTMS have focused on low-frequency stimulation
      of the left auditory cortex, an area that has been demonstrated to be hyperactive in
      tinnitus. The benefits of low-frequency auditory cortex stimulation are time limited however.
      Converging data implicate structures of the brain that are important for mood and attention
      as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment
      approach that targets these structures. A growing number of studies demonstrate involvement
      of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in
      the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal
      cortex has been shown to increase the durability of the TPC stimulation. The independent
      effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that
      increasing the intensity and duration of stimulation has beneficial treatment effects.
      However, the field is new and more work is needed to assess the effectiveness of this
      treatment, predictors and correlates of response, and safety.

      Herein, we propose an open-label pilot study investigating the effectiveness of rTMS
      stimulation of the dorsolateral prefrontal cortex, an area known to be important for mood and
      attention, in the treatment of tinnitus
    

Detailed description: 
      See description above.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study
Intervention type(s): Device
Intervention description(s): Repetitive transcranial magnetic stimulation, pilot study
Other intervention name(s): Tinnitus; rTMS; Dorsolateral Prefrontal Cortex; DLPF; fcMRI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tinnitus