bioihbjkbjnl/mcl2 huggingface dataset:
An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect
Condition: Obesity; Weight Loss; Diet
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Almost half of the Dutch population is currently characterized by overweight and obesity.
      Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight
      regain after weight loss: the yoyo-effect. The primary objective of this study is to
      investigate the association between the weight-loss-induced cellular stress response and the
      rate of weight regain. The secondary objective is to investigate the differences in cellular
      stress response and weight regain after rapid and slow weight loss. To investigate this,
      subjects will receive meal replacements replacing either all or part of the daily meals
      during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks
      while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week
      normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up
      period subjects will receive dietary advice according to the Dutch recommendations for
      healthy eating. The association between the amount of weight regain after the weight loss
      period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue
      metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein
      expression and gene polymorphisms in selected genes.
    


Intervention name(s): Meal replacement diet using Modifast; Normal diet combined with Modifast diet
Intervention type(s): Other; Other
Intervention description(s): modifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks; Combination of modifast and regular diet (1250 kcal/d) for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adipocytes
Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The project aims at developing the tailored intervention strategy of childhood obesity based
      on monitoring physical activities with accelerometer and dietary behaviors using diary. It
      probably raise the passion of obese children to control weight, form healthy life style, be
      effective in sustaining weight loss and early prevent adulthood diseases.
    

Detailed description: 
      The overweight and obese primary school students from 1-5 grades will be recruited according
      to "Body Mass Index Reference for Screening Overweight and Obesity in Chinese School-age
      Children". The participants with will be allocated with schools as the unit to four groups:
      tailored intervention based on monitoring physical activity and dietary behaviors, exercise
      intervention group based on the Happy 10 program, nutrition education intervention group. The
      three intervention groups received the designed interventions for the duration of 1 year.
      Before and after the intervention, we will carry out a questionnaire survey, a physical
      measurement, a fitness test, and a metabolic markers detection
    

Intervention name(s): Monitoring and Tailored prescription; Happy 10 program; Specified nutrition education; General Health Education
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Other intervention name(s): ZhiJi accelerometer UX-02 as physical activity monitor; happy 10 program developed by Center for Disease Control and Prevention, China
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Childhood obesity, intervention, effectiveness, comparison
Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients
Condition: Prediabetes; Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Objective of this study is to determine the safety and efficacy of administration of herbal
      supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks
      in the management of prediabetes and mild to moderate hyperlipidemia.
    


Intervention name(s): Salacia bark extract; Salacia leaf extract; Sesame seed extract; TLC; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Behavioral; Other
Intervention description(s): Lifestyle changes include diet, exercise, weight loss, etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Blood Sugar,; Lipoproteins,; Salacia,; Sesame,; Prediabetes,; Hyperlipidemia,; Herbal supplement
Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether oxytocin affects the modulation of startle
      reactivity by aversive social stimuli and to investigate the oxytocin effect on moral
      judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR)
      polymorphisms on behavioral responses to social stimuli.
    

Detailed description: 
      The neuropeptide oxytocin (OXT) can enhance the impact of positive social cues but may reduce
      that of negative ones, although it is unclear whether the latter causes blunted emotional
      responses. After OXT or placebo application participants are exposed to acoustic startle
      probes presented alone and during viewing of 60 color pictures mostly selected from the
      'International Affective Picture System'. The paradigm featured 20 negative (mostly
      threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. In the other part
      of the experiment, after intranasal OXT or placebo application participants respond to 60
      moral dilemmas.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT
Other intervention name(s): Oxytocin: Syntocinon-Spray, Novartis
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Oxytocin; Startle; moral dilemma; oxytocin receptor gene
Study of Excretion Balance and Pharmacokinetics of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

        -  To determine the excretion balance and systemic exposure of radioactivity after oral
           administration of [14C]-sodium valproate (VPA) .

        -  To determine the pharmacokinetics of sodium VPA and metabolite(s) and its contribution
           to the overall exposure of radioactivity.

        -  To collect samples in order to determine the metabolic pathways of sodium VPA and
           identify the chemical structures and main excretion route of the main metabolites.

      Secondary Objective:

      To assess the clinical and biological tolerability of oral solution of sodium VPA.
    

Detailed description: 
      Total study duration is 3 to 10 weeks, including a screening period of 8 to 28 days,
      treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks.
    

Intervention name(s): sodium valproate
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:Powder for oral solution reconstituted with water Route of administration: Oral
Other intervention name(s): LA40220
Intervention MeSH terms: Valproic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
the Effect of Retrolaminar Block on Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In recent years, as a part of multimodal analgesia, paravertebral blocks are replacing
      epidural analgesia due to the less side effects. Although the risk of pneumothorax is the
      most feared complication in paravertebral blocks, retrolaminar block (RLB) -which is a
      paravertebral block- significantly reduces this risk due to the anatomical technique of
      procedure. The investigators aim to investigate the effect of retrolaminar block with
      ultrasound- guided on perioperative analgesia for patients undergoing lumbar vertebra
      surgery.
    

Detailed description: 
      Retrolaminar block will applie before general anesthesia induction when patients will be
      awake and under midazolam (0.03 mg/kg) sedation and standardized monitoring at the
      preoperative block area in sitting position using in-plane approach. After sterilising the
      skin, the investigators will perform block by using 7-18 MHz convex ultrasound probe ( Esaote
      My Lab 6 US Machine, Florance, Italy) and a 22-gauge, 100-mm Stimuplex needle (B. Braun,
      Germany). The investigators will pass in a sagittal plane from medial to lateral at the
      mid-lomber level, and identified the hyperechoic laminae, transverse processes, ribs and
      pleura.

      The L3 laminae will be identified approximately lateral of the spinous process. The needle
      will insert in-plane, cephalad to caudad. After lamina contact and negative aspiration, 20 ml
      bupivacaine 0.25% will be injected at low pressure with intermittent negative aspiration on
      each side and spread of local anesthetic between laminae and paraspinous muscles will be seen
      without pain or paresthesia. Then 30 minutes later, the patient will be taken to the
      operating room.

      After general anesthesia prosedure, the patients will evaluate whether they have pain
      throughout 24 hours after the operation. The pain scores will be evaluated with visuel
      analogue scale.
    

Intervention name(s): retrolaminar block tecnique
Intervention type(s): Other
Intervention description(s): By using ultrasound probe, the needle with in-plane , after seeing vertebral lamina, the local anesthetic will injectate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Enhanced Recovery After Surgery for Emergency Caesarean Deliveries
Condition: Pregnancy Related
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Caesarean section (CS) constitutes a large proportion of the total surgical volume in
      low-income countries. This rate comes with challenges including surgical complications,
      shortage of beds, and consequently long waiting time for operations and high costs. These
      have led to the adoption of ERAS in developed countries in a bid to save costs by reducing
      hospital length of stay without compromising the health of the mother and her baby.
    

Detailed description: 
      CS is the most common major surgery at Mbarara Hospital (56.2%). This rate comes with
      challenges including surgical complications, shortage of beds, and consequently long waiting
      time for operations. Enhanced recovery programs are composed of preoperative, intraoperative
      and postoperative strategies combined to form a multi-modal pathway. ERAS requires a
      multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and
      realization of its advantages. ERAS has been seen to reduce duration of hospital stay,
      complications and costs. Although many of the elements of enhanced recovery after surgery are
      similar, it has not been tested in emergency CS and there is limited data about its
      applicability in low income settings like Uganda where 95% of CS are emergencies. The aim of
      this study was to assess the impact of ERAS protocols following emergency caesarean delivery
      in a low resource setting.
    

Intervention name(s): Enhanced recovery after surgery (ERAS)
Intervention type(s): Combination Product
Intervention description(s): The ERAS arm was exposed to standard preoperative, intraoperative and postoperative ERAS protocols of care. However, some were modified to our local resources and requirements as well as to the emergency nature of the surgeries.
Other intervention name(s): Accelerated recovery; Fast track surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The ERAS arm was exposed to modified ERAS elements including preoperative counseling and education, prophylaxis against nausea and vomiting (PONV), individualized goal directed fluid therapy, early mobilization at 6-8 hours postoperative, early feeding within 1 hour postoperative,urethral catheter removal at 6 hours, oral fixed combination non opioid analgesia, oral antibiotics and anti-emetics. PONV included intravenous metoclopromide and dexametasone, no ondansetron given. Patients in the control arm recovered with routine care.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions
Condition: Sexual Dysfunction; Rectal Surgery; Patient Satisfaction
Study type: Observational

Summary: 
      Sexual dysfunction after rectal surgery varies widely in the literature. Prevalence of sexual
      dysfunction before surgery and desire of patient to treat this condition is also not well
      established.

      Objectives of this prospective cohort study were to determine prevalence of sexual
      dysfunction with a questionnaire before and after surgery. Patient's satisfaction and quality
      of life were also collected regarding preoperative information given.
    


Intervention name(s): rectal surgery
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients between 18 and 65 years who will have a rectal surgery at the Centre
        Hospitalier Universitaire de Sherbrooke
Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face
Condition: Mid Face Volume Loss
Study type: Interventional

Summary: 
      To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume
      augmentation in the mid-face.
    

Detailed description: 
      This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study
      conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236
      male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume
      augmentation to correct deficit in their mid-face volume.
    

Intervention name(s): experimental; comparator
Intervention type(s): Device; Drug
Intervention description(s): Neuramis® Deep Lidocaine; No-treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Brain Damage Due to Coronary Angioplasty in Percutaneous Intervention Patients
Condition: Silent Stroke; Coronary Disease
MeSH terms: Coronary Disease
Study type: Observational

Summary: 
      This study examines the formation mechanism and patient-related factors of silent cerebral
      infarcts, whose importance has become increasingly recognized in patients undergoing
      percutaneous coronary intervention.
    

Detailed description: 
      This study was produced from the assistant's thesis and was previously accepted as a poster
      at EuroPCR 2020. We recently completed the full-length article.

      This thesis study was supported by Ondokuzmayis University.
    

Intervention name(s): Blood serum Neuron-specific Enolase measurement
Intervention type(s): Diagnostic Test
Intervention description(s): The Silent Brain Injury ratio was compared by measuring the Neuron-specific enzyme level with venous blood sampling from both patient groups before and after percutaneous coronary intervention.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who were planned to have revascularization due to CTO in at least one coronary
        artery (CTO Group) and patients who were scheduled for single-vessel elective coronary
        intervention other than CTO were defined as Non-CTO (control group).
      
Biospecimen description: 
      venous blood serum
    
Keywords: silent brain injury; chronic total occlusion; percutaneous coronary intervention; Neuron specific enolase
Effects of Specific Lipid Fractions-enriched Infant Formulae
Condition: Infant Growth
Study type: Interventional

Summary: 
      This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month
      pilot safety study to evaluate the effects of specific lipid fractions-enriched infant
      formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth
      of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to
      growth of infants fed standard infant formula.
    


Intervention name(s): Standard infant formula; Standard infant formula with PL1; Standard infant formula with PL2
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      The investigators hypothesis is that the patients who receive a side to end anastomosis have
      bowel outcome and quality of life that is equivalent to those who receive a J pouch.
    

Detailed description: 
      The side to end anastomosis has become popular in recent years as it is technically simple to
      construct. The difference between the Baker type(side to end) of anastomosis and the J pouch,
      is that no formal pouch is constructed in the side to end. It has one staple line and the
      anastomosis.

      The investigators hypothesis is that the patients who receive a side to end anastomosis have
      bowel outcome and quality of life that is equivalent to those who receive a J pouch.
    

Intervention name(s): J Pouch
Intervention type(s): Procedure
Intervention description(s): Comparing J pouch, side to end coloanal surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: J pouch; colorectal; rectal cancer; coloplasty
Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG
Condition: Neuroendocrine Tumors; Heart Failure
MeSH terms: Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane
      I 123 in normal human volunteers.
    

Detailed description: 
      The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane
      I 123 in normal human volunteers. The low specific activity iobenguane I 123 has been shown
      to be useful for the detection and staging of neuroendocrine tumors in adults and children
      and imaging neuronal activity in the heart. The innovation in this proposal is through the
      use of patented solid phase technology to produce a proven diagnostic agent at extremely high
      specific activity to increase sensitivity and specificity and lower radiation exposure to
      normal organs without the pharmacologically active cold carrier compound. The FDA considers
      iobenguane labeled with two different isotopes of iodine [I-131 and I-123] as two distinct
      drugs requiring distinct regulatory applications.

      To meet the required quality standards for the chemistry, manufacturing and controls
      component of an IND application, GMP quality polymer drug precursor is used to generate the
      Ultratrace diagnostic iodine-123 agent. Analytical methods were validated with the proposed
      final drug formulation to demonstrate the final drug does not interfere with tests used to
      define the identity, purity, and strength of the agent. The drug product was verified for
      apyrogenicity and sterility before human testing. The IND application was written and
      submitted to the FDA and the Duke Medical Center IRB. MIP produces clinical trial material,
      and will conduct human testing of the radioactive drug substance for safety and superiority
      compared to conventional iobenguane I 123 in normal healthy volunteers.
    

Intervention name(s): no carrier added metaiodobenzylguanidine
Intervention type(s): Drug
Intervention description(s): Sequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG
Other intervention name(s): Ultratrace
Intervention MeSH terms: 3-Iodobenzylguanidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Phase 1; no carrier added metaiodobenzylguanidine; radiation dosimetry
Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate if dabigatran has a clinically relevant impact on the cardiac
      electrophysiology that is manifest as prolongation in QT-interval.
    


Intervention name(s): Dabigatran etexilate low; Dabigatran etexilate high; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment