bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Milk and Meat on IGFs in Prepubertal Boys
Condition: Growth Disorders; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Growth Disorders
Study type: Interventional

Summary: 
      The objective of the study is to examine whether a 7-day high protein intake from either milk
      or meat in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3
      and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell
      function and amino acids.
    

Detailed description: 
      The objective of the study is to examine whether a high protein intake (PI) from either milk
      or meat, at a level often seen in late infancy, in healthy, prepubertal children can increase
      fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA
      insulin reststance, HOMA beta cell function and amino acids.

      IGF-I levels are positively associated with growth velocity in children and some studies
      suggest that a high animal PI can stimulate growth. During protein deprivation IGF-I
      decrease, but it is unknown whether a high PI can increase s-IGF-I in well-nourished
      children.

      Insulin is also a growth factor, and studies have found that postprandially, milk possess
      some insulinotrophic effect not related to its carbohydrate content. However, the effect on
      fasting insulin in children is unknown.

      Design: Twenty-four 8-y-old boys are asked to take either 1.5 l of skimmed milk (n=12) or the
      same amount of protein as 250 g low fat meat (n=12) daily for seven days. The remaining diet
      they can choose freely. At baseline and after seven days, anthropometrical variables are
      measured, diet is registered (3-d weighed records), and the blood analytes are determined
      after fast.
    

Intervention name(s): Skim milk; Lean meat
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Milk; Meat; Animal Protein; Growth Factors; IGF-I; IGFBP-3; Insulin
Modifications in Cardiovascular Risk Factors When Performing Physical Exercise in Hypertensive and Dyslipidemic Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Single-center, randomized, parallel-group, controlled, open-label study. The aim of the study
      was to evaluate the effects of an exercise training program intervention of different
      intensities (high intensity versus low-moderate intensity) on blood pressure reduction as a
      complementary strategy in hypertensive individuals being treated with at least one
      antihypertensive drug.
    

Detailed description: 
      All participants included in the study were referred by their primary care physicians, who
      prescribed physical exercise as a healthy lifestyle intervention added to the
      antihypertensive regimens in the framework of the "ACTIVA-Murcia Program".

      Participants in the HIT and LMIT groups followed the same physical training program, with the
      only difference being the intensity of the training. The program included two phases of
      physical exercise lasting 12 weeks and 16 weeks, respectively, separated by a 7-week rest
      period, which coincided with a holiday period. The times of both phases were not equal in
      terms of duration, since it is a community physical exercise program established by the
      Region of Murcia, and does not depend on the researchers.

      The program was developed by graduates in Physical Activity and Sport Sciences, who were in
      charge of teaching the exercises and supervised each training session.

      Participants assigned to the HIT and LMIT groups were given guidelines to continue physical
      exercise during the 7-week rest period, while participants in the control group were offered
      to participate in the program after the study.
    

Intervention name(s): Therapeutic physical exercise; No physical exercise
Intervention type(s): Other; Other
Intervention description(s): The physical training program was carried out 3 days a week in 1-hour sessions focused on basic endurance exercises (global body activities), strength (specific muscle region activities) and flexibility.
Intensity was be determined by Maximum Heart Rate (HRF).; No programmed physical exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-center, randomized, parallel-group, controlled, and open-label study was conducted.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood Pressure monitoring; Primary care; Physical exercises; Training intensity
The Function of Gastrointestinal Tract During Pregnancy
Condition: Constipation
MeSH terms: Constipation
Study type: Observational

Summary: 
      In this prospective study the function of gastrointestinal tract was assessed using
      constipation questionnaire (Rome criteria and bowel function index).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        400 pregnant ladies, 400 ladies who had delivered within three weeks and 200 control ladies
        who were not pregnant
      
Keywords: Constipation; pregnancy; delivery
Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and
      eliminated by the body under defined maximum dosing conditions and to evaluate the safety
      under these conditions.
    


Intervention name(s): Ibuprofen Cream (SST-0225)
Intervention type(s): Drug
Intervention MeSH terms: Ibuprofen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetic Study
Experimental Study of the Impact of a Group Therapy Psychological Intervention for Caregivers of Alzheimer's Disease Patients
Condition: Psychological Support to Caregivers of Azlheimer's Patients
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      A randomized controlled trial designed to test the effectiveness of a psychological
      intervention based on group therapy for the caregivers of Alzheimer's disease patients. The
      intervention consists of 14 sessions of a cognitive-behavioral psychological group therapy.
      This study aims to demonstrate that Alzheimer's patients' caregivers can benefit from group
      counseling, with an improvement in mood state, quality of life, perceived burden and a
      decrease in anxiety and depression. Two evaluations will be done: before the therapy sessions
      (basal) and when intervention is finished (final).
    

Detailed description: 
      The aim of this study is to conduct group therapy with Alzheimer's caregivers at three
      centers in the province of Barcelona: Hospital El Carme Badalona, Sanitary Center of Les
      Corts and Sarrià.

      The therapy sessions are conducted by an expert in group therapy (from the sponsor Pasqual
      Maragall Foundation) and the social worker of each of the centers. The study takes place for
      four months and consists of weekly therapy sessions of an hour and a half each (14 sessions
      in total), based on cognitive and behavioral theory. The participants and the control group
      are evaluated at the beginning and at the end of the study in terms of mood, quality of life,
      anxiety and depression.

      This study aims to demonstrate that Alzheimer's patient's caregivers can benefit from group
      counseling, resulting in an improvement in their emotional state, perceived burden, quality
      of life and a more positive attitude coping with the new situation.
    

Intervention name(s): Cognitive Behavioral Therapy Group
Intervention type(s): Behavioral
Intervention description(s): Therapy Groups
Other intervention name(s): 14 therapy sessions, once a week for one and a half hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Group Cognitive Behavior Therapy, Alzheimer's disease, Caregivers¡
Impact of CPAP Level on V/Q Mismatch in Premature Infants
Condition: Infant, Premature, Diseases; Respiratory Insufficiency Syndrome of Newborn
MeSH terms: Respiratory Insufficiency; Premature Birth; Infant, Premature, Diseases
Study type: Interventional

Summary: 
      Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs
      open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas
      of the lung that are open for gas exchange do not match up with the areas of the lung that
      are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch
      to changes in the amount (or level) of CPAP.
    


Intervention name(s): Continuous positive airway pressure (CPAP); level changes
Intervention type(s): Device
Intervention description(s): as per arm description
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP; Bronchopulmonary Dysplasia; Ventilator Induced Lung Injury; V/Q mismatch
A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether multi-convergent therapy is helpful to
      patients with inflammatory bowel disease who have functional abdominal symptoms or high
      perceived levels of psychological stress.
    


Intervention name(s): Multi-Convergent Therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management
Other intervention name(s): Mindfulness Meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multi-Convergent Therapy; Mindfulness Meditation; Functional Abdominal Symptoms; Irritable Bowel Syndrome; Inflammatory Bowel Disease; Psychological Stress
To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.
Condition: Vulvar and Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the
      Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem®
      (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to
      Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.
    


Intervention name(s): Estradiol Vaginal Tablets 10 mcg (Glenmark); Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk); Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): apply using the given applicator; apply using the given applicator; apply using the given applicator
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this trial are safety and efficacy (proof-of-concept) of induction of
      mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative
      colitis and persisting endoscopic activity despite pre-existing TNFi treatment.

      This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to
      achieve the similar exposures as the highest exposures tested and found safe and tolerable in
      preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing
      TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include
      assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific
      biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help
      understand BI 655130's mode of action.
    


Intervention name(s): Spesolimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12 weeks treatment; 12 weeks treatment
Other intervention name(s): BI 655130
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Water-Blueberry Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      We will study the effect of supplementation of 1 L blueberry juice to participants with at
      least one elevated cardiovasculat risk factor.
    

Detailed description: 
      Participants with at leat one elevated cardiovacsular risk factor, as defined as systolic
      blood pressure between 140 and 165 mmHg, diastolic blood pressure between 90 and 105 mmHg,
      low density lipoprotein (LDL) cholesterol ≥3.4 mmol/L, total/high density lipoprotein (HDL)
      cholesterol ratio >4 or smoking a minimum of 3 cigarettes daily.

      Subjects were randomized to two groups, where the blueberry group were supplemented with 1 L
      blueberry juice per day for four weeks. The control group consumed an equal amount of water.

      Clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and
      inflammation were measured in blood samples before amd after the intervention period.
    

Intervention name(s): Blueberry juice
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Cardiovascular disease; Blueberruy; Antioxidants; Oxidative stress; Inflammation
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Condition: Depression; Depressive Disorder; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine
      reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied
      in the development program for the treatment of major depressive disorder (MDD), for
      vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral
      diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will
      investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri-
      and postmenopausal.
    


Intervention name(s): Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks; Placebo, daily (QD), tablet form, treatment period up to 8 weeks
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; vasomotor symptoms; menopause; diabetic neuropathy; fibromyalgia
Home Visit Intervention in Pediatric Palliative Care
Condition: Pediatric Cancer; Palliative
Study type: Interventional

Summary: 
      A randomized controlled trial to compare the quality of life between participants who were
      given palliative care (a 3-month home visit) and those who were not (intervention vs control
      group) was conducted. Participants consisted of children with cancer aged 2-18 years old. A
      two-way communication between a trained health worker and participants with or without their
      parents were conducted as the intervention (report by proxy or self-report). Interventions
      were given in 6 sessions (1 session every 2 weeks) focusing on problems solving education,
      symptoms management, self-care, communication, decision making, and long-term care plan
      assistance. In the first and twelfth week of the intervention, all participants were assessed
      with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0.
      Symptomps intensityof anorexia, sleep diturbance, and pain will be asessed in each visit.
      Participants were followed, Emergency Room (ER) admissions were recorded during follow up
      period. During the follow up period, ER admissions were recorded further.
    


Intervention name(s): Palliative home visit
Intervention type(s): Other
Intervention description(s): a 3-month home visit, providing two-way communication between a trained health worker and patients with or without their parents were conducted as the intervention (report by proxy or self-report). Interventions were given in 6 sessions (1 session every 2 weeks) focusing on problems solving education, symptoms management, self-care, communication, decision making, and long-term care plan assistance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arm of control group and intervention group
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: palliative; cancer; pediatric
Placental Passage of Free and Esterified Phytosterols in Humans
Condition: Mother Fetus Relations
Study type: Observational

Summary: 
      Total plasma cholesterol rises by 60 % with progressing pregnancy in humans. Because
      lipid-lowering drugs are contraindicated during pregnancy, natural compounds, such as
      phytosterols, may be a safe and effective alternative to prevent undesirable effects.
      Information on phytosterols in pregnancy is so far very limited. To date, to the best of our
      knowledge, no studies have characterized the maternal-fetal gradient of free and esterified
      phytosterols in full-term human pregnancy. For this purpose, maternal and cord blood
      cholesterol and non-cholesterol sterol (campesterol, stigmasterol, sitosterol) concentrations
      were measured in term pregnant women at delivery by using gas chromatography-mass
      spectrometry.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women
Blood Glucose and Body Fat Regulatory Effect of Peanut Skin Extract
Condition: Obesity
Study type: Interventional

Summary: 
      The regulatory effects of the peanut skin extract (Sugarlock®) on body fat and blood glucose
      was demonstrated in a double-blind, placebo-controlled study. .
    

Detailed description: 
      Peanut skins, a by-product of peanut processing industry, is usually discarded as a waste in
      despite of the high content of phenolic compounds. Polyphenol extract from peanut skins has
      been demonstrated to inhibit α-amylase activity in vitro. Hence, the aim of this study was to
      evaluate the regulatory effects of the peanut skin extract on blood glucose and body fat by a
      double-blind, placebo-controlled, clinical study. Subjects with simple obesity (body mass
      index [BMI] ≥ 27 or body fat ≥ 30%) ingested 4 Sugarlock® (n = 16) capsules or placebo (n =
      14) a day for a total of 6 weeks. Anthropometric measurements (body weight, body fat, blood
      pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total
      cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen
      (BUN), AST, ALT were examined every three weeks. Also, 5 subjects were randomly selected for
      MRI scans to examine the distribution and thickness of abdominal fat layers before and after
      the trial.
    

Intervention name(s): Sugarlock®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects ingested 2 capsules (Experimental group) in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every three weeks. Five subjects were randomly selected to take MRI abdominal scans before and after the trial. After 6-week consumption, anthropometric measurements were examined on week 8 for a follow-up observation.; Subjects ingested 2 capsules placebo in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every three weeks. Five subjects were randomly selected to take MRI abdominal scans before and after the trial. After 6-week consumption, anthropometric measurements were examined on week 8 for a follow-up observation.
Other intervention name(s): peanut skin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: peanut skin; body fat; blood glucose; waistline; body weight