bioihbjkbjnl/mcl2 huggingface dataset:
Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients
Condition: Obesity; Weight Loss; DNA Damage
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions
      disturb redox system by generating excessive reactive oxygen species (ROS) and causing
      oxidative stress (OS) leading to DNA damage. Very low calorie diet (VLCD) have rapid positive
      effect on weight loss, glucose homeostasis, inflammation and OS. The aim of study is to test
      the influence of 3-weeks VLCD on anthropometric, biochemical and genomic parameters in class
      II and III obesity patients.
    

Detailed description: 
      Obesity is a chronic disease associated with chronic inflammation, insulin resistance,
      dyslipidemia, oxidative stress and increased risk for type 2 diabetes, cardiovascular
      disease, stroke and multiple cancer types. Oxidative stress can lead to base lesions of DNA
      which could be detected with alkine comet assay and its version with use of
      formamidopyrimidine DNA glycosylase-endonuclease enzyme in fresh or frozen small volume
      samples. Dietary caloric restriction has beneficial effects on insulin sensitivity,
      inflammation, oxidative stress and DNA repair. Very low calorie diet (VLCD) data are scarce,
      especially on the changing levels of DNA damage.This study will assess the effect of a
      three-week VLCD used in Special Hospital for extended treatment of Duga Resa in individuals
      with BMI ≥ 35kg/m2 on the level of primary and oxidative DNA damage as well as body
      composition and biochemical parameters.
    

Intervention name(s): Very low calorie diet
Intervention type(s): Device
Intervention description(s): During 3 weeks in hospital patients will eat prepared very low calorie diet composed of 50-60% complex carbohydrates with low carbo-glycemic index, 20-25% proteins and 25-30% fat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Very low calorie diet; Alkine comet assay; FPG oxidative comet assay; DNA damage
The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The main purpose of this study is to investigate whether and in which doses vitamin D intake
      is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children
      during wintertime.
    

Detailed description: 
      The main objective of ODIN Junior is to investigate whether and in which doses vitamin D
      intake is needed in order to maintain serum 25(OH)D concentrations above deficiency and
      insufficiency cut-offs (30 nmol/L and 50 nmol/L, respectively) in 4-8 year-old Danish
      children during the winter time. The children will be randomized to receive tablets with
      either 10 micrograms/day or 20 microgram/day of vitamin D3 (cholecalciferol), corresponding
      to one and two times the recommended daily intake in children, or placebo for 20 weeks.
      Measurements and blood sampling will be performed before the beginning and by the end of the
      intervention.
    

Intervention name(s): Vitamin D3 (cholecalciferol)
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Children; Supplements; Cardiometabolic markers; Immune defense; Bone turnover; Muscle strength
Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      This study aimed to investigate the clinical utility of Annexin A2 serum level as a novel
      diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha
      fetoprotein the current marker ofhepatocellular carcinoma (HCC).
    

Detailed description: 
      This study was carried out in HCC clinic , Ain Shams University Hospitals, Cairo; Egypt and
      included :Group 1: Fifty patients with early stage hepatocellular carcinoma(BCLC stage A);
      Group 2:Twenty five patients with chronic liver disease diagnosed based on clinical,
      laboratory, and ultrasonographic investigations; Control Group: Fifteen healthy, age and
      sex-matched subjects with seronegative hepatitis viral markers .All groups were subjected to
      thorough history taking, full clinical examination, and laboratory investigations including
      viral hepatitis markers: HBsAg and HCV antibodies using ELISA technique and HCV RNA using
      real time PCR for HCV antibody positive patients, AFP by electrochemiluminescence and Annexin
      A2 estimation using ELISA technique.
    

Intervention name(s): blood sample
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Egyptian patients attending outpatient clinic for HCC , Ain Shams University
        Hospitals, Cairo Egypt (Group 1&2)
Mat Pilates and Vascular Function in Obese Females
Condition: Obese; Elevated Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Obesity is associated with progressive decreases in arterial health and function. It is
      crucial to prevent or reduce the negative effects of aging on the vasculature by implementing
      appropriate lifestyle interventions, such as exercise training. We examined the effects of a
      Mat Pilates training (MPT) regimen on arterial stiffness (pulse wave velocity, PWV), blood
      pressure (BP), wave reflection (AIx) and endothelial function in obese premenopausal women
      with elevated BP.
    

Detailed description: 
      Using a parallel experimental design, participants were randomly assigned to either MPT
      (n=14) or non-exercising control group (n=14) for 12 weeks. Participant in the MPT group
      trained 3 days/week . Participants' brachial to ankle PWV (baPWV), systolic and diastolic BP,
      AIx, plasma NO levels were measured at baseline and after 20 weeks of their assigned
      intervention.
    

Intervention name(s): Mat Pilates training
Intervention type(s): Behavioral
Intervention description(s): This group completed 12-weeks of training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Study type: Interventional

Summary: 
      This trial will investigate what surgical technique between pancreaticogastrostomy and
      pancreaticojejunostomy with transanastomotic externalized drains is associated with the
      lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk
      pancreatic remnants.
    

Detailed description: 
      Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several
      strategies to reduce the burden of this complication have been proposed in the last decade. A
      definite answer about what is the best technique to approach a high-risk pancreatic stump is
      still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic
      externalized drains have been proposed in this setting, but often studies do not provide a
      reliable risk stratification and result are extremely variable.

      The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy
      and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the
      lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk
      stratification will be provided through the Fistula Risk Score, a clinical risk score that
      has been extensively validated.
    

Intervention name(s): Pancreaticogastrostomy with external drain; Pancreaticojejunostomy with transanastomotic drain
Intervention type(s): Procedure; Procedure
Intervention description(s): Pancreatico-enteric anastomosis is provided according to the "Bassi technique", pancreatic remnant is pushed into the gastric cavity through a posterior gastrotomy. An externalized drain is placed into the main pancreatic duct.; Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Pancreaticoduodenectomy; Pancreaticogastrostomy; Pancreaticojejunostomy; Stent; Transanastomotic drain
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the immune response of healthy subjects who received neonatal
      vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The
      presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will
      be investigated by the administration of a challenge dose of hepatitis B vaccine and the
      comparison of their antibody concentration before and one month after vaccination.

      This protocol posting deals with objectives & outcome measures of the booster phase. No new
      subjects will be recruited during this booster phase of the study.
    


Intervention name(s): EngerixTM-B
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, one dose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Engerix-B; Hepatitis B
GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      This study will assess whether the presence of a particular form of a gene, GABRA2, affects
      the functional responses of the human brain to alcohol administration and will evaluate that
      relationship in the context of factors known to increase the risk for future alcoholism.
    

Detailed description: 
      Each subject completed a total of 2 2.8 hr-long clamping sessions.Within each session,
      procedures differed only by the content of the infusate. In one session, 6% ethanol was
      infused. In the other session, only vehicle was infused, quantifying the placebo response for
      every subject. The order of alcohol or placebo sessions was counterbalanced; subjects were
      blind to which session was which; sessions were scheduled to occur approximately 2 weeks
      apart. Measures were collected before, and at beginning and end of infusion, and included
      subjective perceptions, EMG, EEG, stop-signal performance, eye movements, and auditory
      responses. Design allowed analysis of effect of alcohol vs placebo, initial effect of alcohol
      and acute tolerance to alcohol.
    

Intervention name(s): Alcohol; Placebo
Intervention type(s): Other; Other
Intervention description(s): Alcohol (6% in saline vehicle) infused for 2.8 hour long clamping session (Breath alcohol level maintained at 60 mg/dL throughout).; Placebo (saline vehicle) infused for 2.8 hour long session.
Intervention model: Single Group Assignment
Intervention model description: Two session, within subjects, single blind
Masking: None (Open Label)
Primary purpose: Other
Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The Canadian population, as is the case in most developed countries, is ageing and becoming
      increasingly overweight and/or obese. Both ageing and obesity are associated with reduced
      cognitive performance which can impact adversely on the ability to undertake daily activities
      and increases the risk of loss of independent living and reduced quality of life. The
      investigators predict that consumption of ½ cup of pulses per day for 12 weeks will improve
      cognitive function in older overweight/obese adults and thus decrease the rate of cognitive
      decline that occurs in this at-risk population.
    

Detailed description: 
      This is a multi-site, randomized, controlled, parallel, dietary intervention food study
      designed to examine the impact of pulse-enriched foods on cognitive function and
      cardiometabolic health in obese adults. Recruitment will consist of approximately 160
      participants (n= 80 participants per site) at 2 sites located in Winnipeg and South
      Australia.

      Participants will be randomly allocated to one of 2 groups; a pulse group or a control group.
      The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day
      for 12 weeks. The control group will consume comparator foods for 12 weeks. The pulse and
      comparator food items will be provided to participants and they will be asked to incorporate
      these into their usual diet. Participants will be requested not to change their diet or
      physical activity habits during the study period, other than as required to comply with the
      study requirements. Five-day weighed food records will be completed during the week prior to
      baseline and during the final week of the study to monitor dietary intake, in particular
      intake of pulses. This will determine whether participants are incorporating the study foods
      as required, and will be used to evaluate associated changes in dietary intake and body
      weight, if they occur.
    

Intervention name(s): Pulse Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.; The control group will consume comparator foods for 12 weeks.
Other intervention name(s): Sanitarium; Heinz; Simplot
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Adult Obesity; Cardiometabolic health; Pulse Foods; Beans, Peas, Lentils; Cognitive Function
Acupuncture for Back and Neck Pain in an Emergency Room Setting
Condition: Back Pain; Neck Pain; Anxiety; Range of Motion
MeSH terms: Back Pain; Emergencies; Neck Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as
      an add-on therapy for the treatment back and neck pain in an emergency department setting

      Acupuncture is well established as an effective treatment for back pain. The investigators
      cumulative experience in Asaf Harofeh Medical Center has shown Acupuncture to be an Effective
      therapy for simple back and neck pain in an ER setting.

      This study will examine weather Acupuncture can decrease pain, increase range of motion and
      decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain
      without neurological findings. Acupuncture will be performed as an add on therapy on top of
      analgesic therapy.
    


Intervention name(s): Real Acupuncture; Placebo Acupuncture; No intervention
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Real acupuncture treatment in real acupuncture points; empty plastic acupuncture guide-tube located on the patients back in a non visable area and connected to a visible electric stimulator; Patients lay down for a period of 35 minutes without any treatment o intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: back pain; neck pain; anxiety; range of motion
Varenicline Adjunctive Treatment in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The principal aim of the project is to conduct an off-label adjunctive clinical trial
      evaluating varenicline as a treatment for core neurobiological and clinical deficits in
      schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.
    

Detailed description: 
      This is a double-blind, placebo controlled clinical trial in schizophrenia patients. Outcome
      measures include biomarkers and clinical symptoms and functions, and smoking cessation.
      Neurobiological and cognitive markers will be measured for short term (2 weeks) and
      longer-term (8 weeks). Current schizophrenia treatments are mostly ineffective against
      primary negative symptoms and the cognitive and information processing deficits associated
      with the disorder. Previous research has identified several neurophysiological deficits in
      schizophrenia that are enduring, frequently occurring before psychosis, and mark the disease
      liability. These schizophrenia endophenotypes provide important targets for novel treatment
      development as they represent the core deficits of the disorder. We hypothesize that
      sustained nicotinic and dopaminergic modulation by varenicline may ameliorate the core
      neurobiological deficits seen in schizophrenia patients, which would lead to subsequent
      clinical improvement. Neurobiological and neurocognitive markers and clinical and functional
      measures will be obtained to determine 1) short-term effect of varenicline on biomarkers; and
      2) longer-term improvement in clinical symptoms, smoking cessation, and functions; and how
      biomarker changes predict these improvements.
    

Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks; Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Varenicline; Neurobiology; clinical trial; cognitive deficits; Schizophreniform Disorder
BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden
Condition: Anxiety Disorder; Obsessive-Compulsive Disorder
MeSH terms: Anxiety Disorders; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test internet-delivered cognitive behavior therapy for
      children and adolescents with anxiety disorders and obsessive-compulsive disorder in a
      routine clinical setting in a rural part of Sweden.
    

Detailed description: 
      Aim The aim of this study is to conduct a pragmatic evaluation of ICBT for children and
      adolescents with anxiety disorders and OCD within routine health care in a rural area.

      Research questions

        -  Is ICBT an acceptable method for the patient group?

        -  Is ICBT effective in a clinical setting?

        -  Is further treatment needed after ICBT?

        -  What are the long-term effects of ICBT?

        -  What predicts treatment outcome?

        -  How does ICBT work in a clincal setting? (time spent, negative effects etc)?

      Design This is a uncontrolled intervention study where included families and children will be
      recruited consecutively during two years from a routine care CAMHS unit. All participants
      will be offered ICBT and assessed pre- and post-treatment, and at three-month follow-up
      through clinician ratings and self-report measures. The primary outcome measure is clinician
      rated severity of principal disorder at three-month follow-up. Long-term results will be
      assessed through study of medical records two years after completed ICBT.
    

Intervention name(s): ICBT
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Single Doses of MK -5475 on Pulmonary Vascular Resistance (MK-5475-002)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study of MK-5475 in participants with Group 1 pulmonary arterial hypertension (PAH) will
      assess the safety, tolerability and pharmacokinetics (PK) of inhaled MK-5475. There is no
      formal hypothesis to be tested.
    

Detailed description: 
      In Part 1, one panel (Panel A) of up to 8 participants will dose in up to 3 dosing periods,
      with a minimum washout of 7 days between dosing periods. In each dosing period, 6
      participants will receive MK-5475 and 2 will receive placebo, with 2 different participants
      receiving placebo in each of the dosing periods. Review of available safety data will occur
      prior to escalating to the next dose level.

      Participants from Part 1 may continue into Part 2, which will assess safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) of single-dose inhaled MK-5475. Three
      additional panels of participants (Panels B, C and D) will be enrolled into Part 2.
      Participants in Panel A will participate in 2 open-label dosing periods to assess PD measures
      associated with right heart catherization (RHC) [Period 2] and functional respiratory imaging
      (FRI) [Period 3]. Participants in Panels B, C, and D will participate in 3 dosing periods:
      Period 1 (open-label assessment of safety/tolerability and PK), Period 2 (FRI period) and
      Period 3 (RHC period).
    

Intervention name(s): MK-5475; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single inhaled dose of MK-5475 120, 165, 240, 300, 360, or 480 ug depending upon randomization; Single inhaled dose of placebo to match MK-5475
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 of the study will evaluate safety, tolerability, and pharmacokinetics in this population using a sequential study design. Review of available safety data up to 24 hours post dose of at least the first 4 participants must occur prior to escalating to the next dose level. A break to review PK data from Periods 1 and 2 will occur after completion of Period 2. Review of safety will occur after completion of Period 3 in all participants from Panel A, prior to initiation of Part 2. An optional break to review rolling PK data from Panel A Period 3 will be dependent upon exposures observed in Periods 1 and 2.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment