bioihbjkbjnl/mcl2 huggingface dataset:
Habituation to Food as a Risk Factor for Pediatric Obesity
Condition: Obesity in Children
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The study is designed to assess habituation of behavioral responding for food as risk factors
      for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight
      children.
    

Detailed description: 
      Cross sectional data have shown slower habituation is related to greater energy intake, and
      habituation is slower for overweight/obese compared to leaner youth, but it is not known
      whether this is a result of being overweight, or whether slower habituation is a risk factor
      for weight gain. The goal of this application is to study individual differences in
      behavioral (responding for food) habituation as risk factors for alterations in zBMI and body
      fat over a two year period in 200, 8 to 12 year-old non-overweight children. This project
      will provide the first test of the hypothesis that slow habituation to food is a risk factor
      for increases in zBMI in non-overweight youth.
    

Intervention name(s): Standardized Assessments
Intervention type(s): Other
Intervention description(s): Children were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up.
Intervention model: Single Group Assignment
Intervention model description: Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.
Masking: None (Open Label)
Primary purpose: Basic Science
Interleukin-6 Secretion in Adipose Tissue Following Sprint Exercise
Condition: Metabolism in Adipose Tissue
Study type: Interventional

Summary: 
      Low volume sprint exercise training has been shown to reduce body fat despite small total
      energy expenditure (for ref see Gillen and Gibala 2014). IL-6 has been shown to increase
      adipose tissue lipolysis in vitro. Therefore, in an initial study on effects of sprint
      exercise on adipose tissue metabolism the investigators will examine acute short-term
      exercise effects on adipose tissue IL-6 exchange.
    

Detailed description: 
      PURPOSE: Low volume sprint exercise training has been shown to reduce body fat despite small
      total energy expenditure (for ref see Gillen and Gibala 2014). IL-6 has been shown to
      increase adipose tissue lipolysis in vitro. Therefore, in an initial study on effects of
      sprint exercise on adipose tissue metabolism the investigators examined acute short-term
      effects on adipose tissue IL-6 exchange.

      METHODS: Four female and four male subjects perform repeated sprint exercise (3 x 30s with 20
      min rest between; Wingate-test). Blood samples are repeatedly obtained, up to 120 min after
      the last sprint (9 min post ex), from catheters inserted percutaneously into brachial artery
      and a superficial subcutaneous vein on the anterior abdominal wall providing access to the
      venous drainage from the subcutaneous adipose tissue and analyzed for IL-6 by ELISA and
      lactate by spectrophotometry. Fat biopsies from the stomach will be obtained before, 15 min
      and 120 min after the last sprint. Blood flow will be determined by administration of
      Xenon-133 in the adipose tissue of the stomach. The release rate of Xenon-133 will be
      registrated continuously during the total investigation.

      SUPPORT: This study is supported by grants from the Swedish National Center for Research in
      Sports
    

Intervention name(s): Repeated 30-s sprint exercise
Intervention type(s): Other
Intervention description(s): Analyze of Interleukin-6 concentration before and after repeated 30-s sprint exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison Between Two Tissue Acquisition Techniques by Endoscopic Ultrasound. (EUS)
Condition: Digestive Cancer
Study type: Observational

Summary: 
      There are various techniques to obtain tissue samples by using fine needle guided by
      endoscopic ultrasound (EUS). These techniques attempt to obtain the most adequate material
      with the best quantity and quality for analysis. Currently studies that compare the results
      concerning capillary technique versus wet technique are not available. In this sense, the
      authors consider necessary to explore both techniques documenting the results that can define
      which could be the best method so that it can routinely be used in cases of digestive
      neoplasia.
    

Detailed description: 
      The aim of the study will be compare both techniques guided by endoscopic ultrasound
      (Capillarity versus Wet) and identify which obtains the best sample quality for
      histopathology analysis as tissue acquisition method in patients diagnosed with tumors of
      pancreas, biliary tract, liver or lymph nodes.

      The researchers are planning a prospective, pilot study in 30 subjects. All patients will be
      submitted to both techniques of tissue acquisition (capillarity versus wet) in the same
      procedure of endoscopic ultrasound. Obtained samples for histopathology analysis will be
      submitted to a blind examination by two different pathologists.
    

Intervention name(s): Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Intervention type(s): Procedure
Intervention description(s): Patients will be submitted to both techniques of tissue acquisition in the same procedure of endoscopic ultrasound. Capillarity technique, requires not remove the stiletto from the needle until the punctures are done for the biopsy sampling. Wet suction technique, requires saline solution to replace the air column. Samplings will be placed in two different jars, where Jar 1 corresponds to Capillarity Technique sampling and Jar 2 to Wet Technique. Once the sampling preparation is concluded will be send to the Pathology Department to be subsequently blindly analyzed by two independent pathologists, that means they would not be aware of the tissue acquisition method used in each of the microscopic slides to analyze.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Referred to the Endoscopy Department from their corresponding basic health care units
        within the Mexican Social Security System
      
Biospecimen description: 
      Biopsies of suspicious digestive tumors obtained by endoscopic -ultrasound. Cellularity and
      sample quality will be documented.
    
Keywords: Capillary technique; Wet technique; Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Condition: Infertility
MeSH terms: Infertility; Aneuploidy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS)
      on patients with low ovarian reserve in an effort to improve success during in vitro
      fertilization and decrease the time to successful pregnancy.
    

Detailed description: 
      Patients will undergo a stimulated IVF cycle culminating with an ultrasound guided egg
      retrieval procedure and either a fresh or frozen embryo transfer as clinically appropriate
      and without regard to study. All embryology laboratory procedures will be conducted per
      routine. Once the embryo(s) have reached the blastocyst stage of development patients will be
      randomized into either the study group or the control group. The SOLAIRE Trial is "blinded"
      which means neither patients nor the RMANJ study doctor/staff will know to which group the
      embryos were randomized. The study group will have their embryo(s) biopsied for CCS on day 5,
      if appropriate, for a fresh day 6 embryo transfer. The control group will not have CCS
      testing performed on their embryo(s) and may proceed with a fresh or frozen embryo transfer
      as clinically appropriate. The maximum amount of embryos that can be transferred is two per
      RMANJ protocol. All post-transfer care and pregnancy monitoring will be identical and per
      routine protocol regardless of study participation.
    

Intervention name(s): Comprehensive Chromosomal Screening
Intervention type(s): Other
Other intervention name(s): PGD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Single Embryo Transfer; Double Embryo Transfer; CCS (Comprehensive Chromosome Screening); Aneuploidy; Low Responders
Postprandial Lipemia and Glycemia Following a High-Fat Meal
Condition: Hypercholesterolemia; Postprandial Hyperglycemia; Lipid Disorder
MeSH terms: Hypercholesterolemia; Hyperglycemia; Hyperlipidemias; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The goal of this clinical trial is to determine the acute effects on postprandial lipemia and
      glycemia by supplementing a high-fat meal with either white button (WB) or shiitake (SH)
      mushroom powder in relatively healthy adults, aged 18 to 35.
    


Intervention name(s): Mushroom Powder
Intervention type(s): Dietary Supplement
Intervention description(s): Ground shiitake mushrooms or ground white button mushrooms
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mushroom; lipid metabolism; postprandial lipemia; postprandial glycemia
Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in
      subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via
      subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of
      3 injections. Study drug will be administered under close observation in a facility equipped
      to handle medical emergencies. Subjects will not be discharged from the facility until at
      least 1 hour following the injection or 1 hour after their vital signs have stabilized.
      Safety will be assessed by pre- and post-treatment serial measurements of vital signs,
      clinical laboratory assessments, and the recording of adverse clinical events.
    


Intervention name(s): RA-18C3
Intervention type(s): Drug
Intervention description(s): For subjects weighing 27-53 kg: 100 mg (1 ml) administered every three weeks by subcutaneous injection.
For subjects weighing > 53 kg: 200 mg (2 ml) administered every three weeks by subcutaneous injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne Vulgaris
Attitudes About Smoking: A Telephone Survey
Condition: Asthma
Study type: Observational

Summary: 
      This study involves telephone surveys of parents of young urban children with and without
      asthma to assess attitudes about smoking including personal smoking bans in their homes and
      cars, and beliefs about public policies regarding smoking.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parents of children in the Rochester City School District
Exposure-based Treatment for Avoidant Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic low back pain often results in psychosocial and physical disability. A subgroup of
      these patients shows fear of (re)injury and avoidance behaviour leading to higher disability.
      The purpose of this study is to determine whether exposure in vivo is more effective in the
      treatment of fear avoidant chronic back pain patients than psychological treatment as usual
      (cognitive behavioural psychotherapy).
    


Intervention name(s): Exposure in vivo; Cognitive Behavioural Psychotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5-10 sessions based on an individualized fear hierarchy; graded activity, relaxation techniques and cognitive interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Low Back Pain; Cognitive Behavioural Therapy; Exposure; Fear avoidance; Cognitive Behavioural Therapy in chronic low back pain; Exposure in vivo in chronic low back pain
Effectiveness of Vitamin D in Primary Dysmenorrhoea
Condition: Primary Dysmenorrhoea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial.
      Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients
      were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400
      mg ibuprofen twice a day,2 days before the date of menstruation and continued through the
      first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin D
      group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group
      Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of
      vitamin D are more prominent
    

Detailed description: 
      An excessive uterine production of prostaglandins is the pathogenic trigger of dysmenorrhoea.
      Nonsteroidal anti-inflammatory drugs (NSAIDs) are the currently accepted drugs for the
      management of this disorder. The capacity for synthesizing vitamin D and the presence of
      vitamin D receptor in human cycling endometrium have also been demonstrated. Because vitamin
      D reduces the synthesis of prostaglandins, a beneficial effect of vitamin D for the uterus is
      possible.Vitamin E inhibits the release of arachidonic acid and the conversion of arachidonic
      acid to prostaglandin via an action on the enzymes phospholipase A2 and cyclooxygenase.
    

Intervention name(s): Vitamin D; Vitamin E; Ibuprofen
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Other intervention name(s): Devit-3 damla barcod number 8699525590435 ,DEVA Holding AŞ; Evicap d-alfa-Tokoferol, KOÇAK Farma; profen Dinçtaş İlaç
Intervention MeSH terms: Vitamin D; Vitamins; Vitamin E; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitamin D
A Pumpkin Seed, Isoflavonoid and Cranberry Mix in LUTS/BPH
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The aim is to assess the efficacy of a mix of Pumpkin Seed Extract, Soy Germ Isoflavonoids
      and Cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. The
      patients will be evaluated based on the severity of LUTS, urological quality of life, and
      erectile function.
    

Detailed description: 
      This is a single-arm prospective open-label trial investigating a combination of pumpkin
      seed, isoflavonoid and cranberry mix in improving LUTS, urological quality of life, and
      erectile function in BPH patients. The compound will be administered orally two tablets daily
      for 3 months. Recruited patients will be seen at 3 visits: initial visit (visit 1), 1-month
      visit (visit 2) and 3-month visit (visit 3) and their data will be collected in a dedicated
      case report form.
    

Intervention name(s): Novex
Intervention type(s): Drug
Intervention description(s): Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
Condition: Inflammatory Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin
      alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and
      Caucasian participants.
    


Intervention name(s): Efavaleukin alfa
Intervention type(s): Drug
Intervention description(s): Administered as a single dose SC injection.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic lupus erythematosus (SLE); Steroid-refractory chronic graft-versus-host disease (GvHD); Ulcerative colitis; Single-dose study; Efavaleukin alfa; Regulatory T Cells (Tregs); Inflammatory
A Screening Study To Assess The Cognition Status in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Observational

Summary: 
      This multi-center screening study will conduct a cognition assessment to collect reference
      data for comparison to patients with depression in healthy volunteers. Data will be collected
      for 6 weeks.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Blood Samples
Progression Delaying Effect of Escitalopram in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This study aimed to test whether escitalopram would slow the brain atrophy in patients with
      mild to moderate AD over the 52-week period.
    

Detailed description: 
      -  Study institutions: Four university hospitals in Korea

        -  Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial

        -  Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at
           stable dose within 2 months (Escitalopram 37 : Placebo 37)
    

Intervention name(s): escitalopram; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period); 5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; escitalopram; MRI
Phase IIa Multicentre Study Investigating of VR040 in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      'Off periods' where people with Parkinson's disease are slow, stiff and unable to function
      are disabling, and a treatment which can converts people to a "on", good, able to function
      state would be extremely useful. We assessed safety, tolerability and efficacy of inhaled dry
      powder apomorphine (VR040) in a clinic-based study in this setting.
    

Detailed description: 
      Background: 'Off' periods increase as Parkinson's disease progresses and the benefits of
      standard therapy wane. Subcutaneous apomorphine rescues 'off' periods, but patient
      self-injection and adverse cutaneous effects are sometimes problematic.

      Methods: We assessed safety, tolerability and efficacy of inhaled dry powder apomorphine
      (VR040) in a clinic-based Phase II study. Of 48 patients recruited at 9 sites, 47 were
      randomized 2:1 inhaled apomorphine:placebo. Respirable doses (drug predicted to reach the
      lung) ascending through 1.5mg, 2.3mg, 3.0mg, and 4.0mg until efficacy was achieved, were
      administered to patients in a practically defined 'off' state. The primary endpoint was the
      response in unified Parkinson's disease rating scale Part 3 (UPDRS 3), at the highest dose
      received by the patient. Secondary endpoints included time to 'on', the proportion of
      patients converting from 'off' to 'on', and pharmacokinetics.
    

Intervention name(s): VR040/Aspirair® inhaler; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dry Powder inhaled apomorphine
Other intervention name(s): Inhaled apomorphine
Intervention MeSH terms: Apomorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; inhaled apomorphine; convert "off" to "on"