bioihbjkbjnl/mcl2 huggingface dataset:
Renal Hemodynamics and Tubular Function in Patients With Obstructive Sleep Apnea and Healthy Controls
Condition: Obstructive Sleep Apnea; Healthy
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Nitrogen-oxide (NO) plays an important role for blood pressure regulation, renal
      hemodynamics, and the renal excretion of sodium. NO is synthesized from L-arginine in the
      vascular endothelium and have a very short half-life in plasma and is therefore very
      difficult to measure directly.

      L-mono-methyl-L-arginine (L-NMMA) is an analogue to L-arginine and a competitive inhibitor of
      NO, and therefore can be used to study the effect of NO on the circulation. In normal
      subjects, infusion of L-NMMA will cause an increase in blood pressure, decreased renal
      plasma-flow, decreased glomerular filtration rate, and a decreased excretion of sodium.

      Hypothesis: Patients with obstructive sleep apnea has a decreased activity in the NO-system.
      This is contributing to the hypertension often seen in these patients. Decreased activity in
      the NO-system can be revealed by diminished fall in renal hemodynamic and sodium excretion
      after infusion of L-NMMA.
    


Intervention name(s): L-NMMA (N-mono.methyl-L-arginine)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Basic Science
D-chiro-Inositol in Overweight Type 1 Diabetes Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral
      supplementation in addiction to folic acid compared to folic acid alone on glycaemic control
      as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin
      therapy.

      A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged 17-50
      years (13 males, 13 females), with disease duration > 1 year and BMI >25, attending as
      outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome
    


Intervention name(s): D-chiro-inositol; Folic Acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Treated group; Control group
Intervention MeSH terms: Folic Acid; Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: D-Chiro-Inositol, type 1 diabetes
Perioperative Fluid Therapy Optimization in Spinal Surgery
Condition: Hypovolemia; Hypervolemia
MeSH terms: Hypovolemia
Study type: Interventional

Summary: 
      The decision to give fluids perioperatively could be based on methods used to identify
      preload responsiveness, either invasive or noninvasive estimates of stroke volume variation
      during mechanical ventilation. This study compares fluid management using continuous
      noninvasive cardiac output measurement with standard perioperative fluid management.
    

Detailed description: 
      The aim of the study is to optimise fluid managemet and to reduce perioperative risks during
      spinal procedures in prone position. Adequate perioperative management guided by hemodynamic
      monitoring can help to reduce the risk of complications and thus potentially improve
      outcomes.
    

Intervention name(s): Standard care group; Noninvasive monitoring group
Intervention type(s): Procedure; Procedure
Intervention description(s): Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. Fluid boluses will be used according to anesthesiologists decision (timing and amount of fluids). In case of drop of mean arterial pressure (MAP) below 65 mmHg norepinephrine will be started (with initial bolus of 5 - 10 ug).; Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. In case of hypotension (defined as a mean arterial pressure below 65 mmHg), the intervention will be led according to a protocol based on cardiac index, systemic vascular resitance and stroke volume variation (SVV) values (ClearSight, Edwards).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fluid responsiveness, haemodynamical monitoring, ClearSight
Safety and Efficacy of Litramine in Overweight and Obese Subjects
Condition: Overweight; Obesity; Weight Loss
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      Preparations that bind to nutritional fat and inhibit its absorption could be decisively
      meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble
      fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after
      eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The
      medical device to be investigated contains a patented formula of fibre complex having a high
      ability to bind to dietary fat.

      Therefore, the rationale for this study is to confirm that Litramine's proven fat binding
      capacity to increase fat excretion and modulate the feeling of satiety will translate into
      measurable reduction in body weight. A double blind, randomized, placebocontrolled design has
      been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects
      on a energy-restricted diet.
    


Intervention name(s): Litramine; Placebo
Intervention type(s): Device; Device
Intervention description(s): 2 tablets 3 times daily (oral consumption, 30 minutes after meal); 2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: overweight; obesity; weight loss; body fat; waist circumference; satiety
Cervical Sensorimotor Control Training in Chronic Neck Pain
Condition: Nonspecific Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Impaired cervical joint position sense is associated with neck pain. This study will
      determine the effects of sensorimotor control training exercises on cervical joint position,
      pain, ROM and function in nonspecific chronic neck pain. There will be two groups ;
      experimental and control. Half of study group will receive cervical sensorimotor control
      training exercises and half of study group will receive conventional physiotherapy protocol.
    

Detailed description: 
      The study is Randomized Control Trail , which is being conducted in physical therapy Out
      patient department of Pakistan Railway hospital (April 2019-July 2019) . Sample size of 18
      individual was calculated using Epitool with 95% confidence interval (CI), and power 80%.
      Individual will be screened out according to inclusion criteria. Individuals will be
      allocated randomly into two groups , 9 in cervical Sensori-motor training group and 9 in
      conventional physiotherapy protocol group by sealed envelope method.

      Both groups will receive conventional physiotherapy protocol (hot pack, stretching exercises
      and strengthening exercises) for neck pain in common and the experimental group will receive
      cervical sensorimotor control training in addition to conventional protocol.

      Assessment will be done on baseline and 6th week.

      Data will be analysed on SPSS version 21.
    

Intervention name(s): Cervical sensorimotor control training exercises; Conventional Exercises
Intervention type(s): Other; Other
Intervention description(s): Cervical sensory motor training exercises consisting of cervical position sense and cervical movement sense exercises with 3 levels of difficulty and 5 repetitions * 3 sets for each exercise will be given. Some exercises are:
Head relocation with laser feedback:
head relocation to neutral and predetermined position with eyes opened (in horizontal / vertical direction) (5 reps x 3 sets) Head relocation to neutral, predetermined and to specific targets with eyes opened (in diagonal directions) (5 reps x 3 sets) Head relocation to neutral and predetermined position with eyes closed (in all directions)(5 reps x 3 sets) In addition to it conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility.; conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility exercises will be given to patients.
Other intervention name(s): Prioprioception Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cervical Pain; Kinesthesis
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
Condition: Acellular Pertussis; Hepatitis B; Haemophilus Influenzae Type b; Tetanus; Diphtheria; Poliomyelitis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the
      booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15
      months of age, and the immune persistence following the primary series. All children in this
      booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948
      (NCT01248884). No new subjects will be enrolled in this booster study.
    


Intervention name(s): Infanrix hexa; Prevenar 13; GSK217744
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose, licensed formulation, intramuscular into right thigh; Single co-administered dose, intramuscular into left thigh; Single dose, investigational formulation A or B, intramuscular into right thigh
Other intervention name(s): DTPa-HBV-IPV/Hib; Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The reason for this study is to assess the impact of lebrikizumab on vaccine immune response
      in adult participants with moderate to severe atopic dermatitis (AD).
    


Intervention name(s): Lebrikizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Given SC; Given SC
Other intervention name(s): LY3650150; DRM06
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Eczema; Skin Diseases
Prevalence of Primary Aldosteronism Among Hypertensive Patients With Atrial Arythmia
Condition: Primary Aldosteronism; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Hyperaldosteronism
Study type: Interventional

Summary: 
      Atrial arrhythmia is the most frequent cardiac arrhythmia. It is a source of significant
      morbidity.

      Hypertension is a major risk factor for atrial arrhythmias. Primary hyperaldosteronism (PA)
      is a common cause of secondary hypertension, associated with a high prevalence of arrhythmias
      with a specific, sometimes curative, treatment. The purpose of the study is to show that the
      prevalence of PA among hypertensive patients under 65 years old with atrial arrhythmia is
      high, justifying systematic screening.
    

Detailed description: 
      Atrial arrhythmia is the most frequent cardiac arrhythmia, affecting one million patients in
      France. It is a source of significant morbidity, a major deterioration in the quality of life
      and considerable health expenditure.

      Hypertension is a major and modifiable risk factor for atrial arrhythmias. Primary
      hyperaldosteronism is a common cause of secondary hypertension, associated with a high
      prevalence of arrhythmias, but also stroke, coronary artery disease, heart and kidney
      failure. This form has a specific treatment, sometimes curative.

      The objective of this study is to show that the prevalence of primary hyperaldosteronism
      among patients under 65 with atrial arrhythmias is high, justifying systematic screening in
      this population.

      The investigators will consecutively include 65-year-old hypertensive patients hospitalized
      in the department with atrialarrhythmia. They will benefit from an aldosterone to renin ratio
      assay under standardized conditions at 3 months.

      Patients whose aldosterone (pmol/l) to renin (mUI/l) ratio is greater than 64 will benefit
      from saline infusion test if necessary and adrenal scan. Patients with a definite diagnosis
      who would prefer surgical treatment will benefit from adrenal venous catheterization.
    

Intervention name(s): Primary Hyperaldosteronism diagnostic
Intervention type(s): Diagnostic Test
Intervention description(s): blood sample to obtain the aldosterone to renin ratio
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
CPI Training for Parents of Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this 24-week study is to determine whether the "Parent-based Crisis Prevention
      Institute (CPI) physical management training program" (i.e., P-CPI) is effective in
      increasing self-efficacy in parents of children with autism spectrum disorder (ASD).
    

Detailed description: 
      Parents of children with ASD deal with more stress, especially if their child demonstrates
      self-injurious and aggressive behavior. The purpose of this study is to evaluate whether
      "Parent-based Crisis Prevention Institute (CPI) physical management training program" (i.e.,
      P-CPI) for parents of children with ASD helps alleviate some of this stress and increase
      parental self-efficacy, physical management competency, and overall quality of life.

      Participants who meet criteria will be randomly assigned to either the treatment group or the
      waitlist control group. Participants assigned to the treatment group will be invited to a
      6-hour P-CPI group training session. This parent-based training in CPI's Nonviolent Crisis
      Intervention® will include nonverbal, paraverbal, verbal, and physical intervention
      techniques. Participants assigned to the waitlist group will be encouraged to continue their
      existing medical support, or services, as they typically would. The waitlist group will be
      invited to participate in the P-CPI training at the conclusion of the post-assessment period.

      Baseline measures will be on the day of training for the treatment group and within five days
      of the P-CPI training for the waitlist group. Follow-up measures will be at 2-week, and 1, 2,
      and 3- month post-baseline. The treatment group will also participate in a follow-up group
      interview.
    

Intervention name(s): Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)
Intervention type(s): Behavioral
Intervention description(s): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.
Other intervention name(s): (P-CPI)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parent Training; Aggressive Behavior
Docosahexaenoic Acid (DHA) Effects on Cognitive Function, Craving and Psychosocial Factors in Heavy Cigarette Smokers
Condition: HEAVY TOBACCO SMOKERS
Study type: Interventional

Summary: 
      The purpose of this study is to assess effects of Docosahexaenoic Acid (DHA) as an add-on
      novel supplement on quality of life, cognitive function, craving and psychosocial factors in
      heavy cigarette smokers. In humans, no previous randomized, double blind controlled study has
      been conducted to evaluate these effects. The aim of the study is to 1. Test Docosahexaenoic
      Acid (DHA) beneficial effects on objective clinical indicators of cognitive function (choice
      reaction time, decision making, impulsivity, facial recognition) in smokers 2. Improvement of
      quality of life, cigarette craving, psychosocial factors and self-perceptions in smokers
      treated with DHA supplement
    


Intervention name(s): DHA; Oral ingestion of 5 placebo tablets
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): DHA ingested orally by heavy smokers; Oral ingestion of 5 tablets containing the following: gelatin,glycerine,water and soy oil made by the Solgar Pharmaceutical Co., Israel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
Condition: Sarcoma
MeSH terms: Sarcoma; Nerve Sheath Neoplasms; Neurofibrosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for
      tumor cell growth.

      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with
      unresectable or metastatic malignant peripheral nerve sheath tumor.
    

Detailed description: 
      OBJECTIVES:

        -  Determine response (confirmed, complete, and partial) in patients with unresectable or
           metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.

        -  Determine the qualitative and quantitative toxic effects of this drug in these patients.

        -  Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR) function
           (e.g., expression, phosphorylation, or markers of signal transduction downstream of
           EGFR) with response and progression-free and overall survival in patients treated with
           this drug.

        -  Determine the feasibility of accruing these patients in the cooperative group setting.

      OUTLINE: This is a multicenter study.

      Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the
      absence of disease progression or unacceptable toxicity.

      Patients who achieve at least a confirmed partial response and become resectable undergo
      surgical resection (with or without radiotherapy) and then receive 2 additional courses of
      erlotinib. Patients with responding disease who do not become resectable continue erlotinib
      as above. Patients achieving a complete response (CR) receive 2 additional courses of
      erlotinib beyond the CR.

      Patients are followed every 6 months for 2 years and then annually for 3 years.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
    

Intervention name(s): erlotinib hydrochloride
Intervention type(s): Drug
Intervention description(s): 150 mg per day, daily until disease progression
Other intervention name(s): OSI-774
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult neurofibrosarcoma; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage IV adult soft tissue sarcoma
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
Condition: Neoplasms, Glandular and Epithelial; Diphtheria; Tetanus; Whooping Cough; Poliomyelitis
MeSH terms: Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Neoplasms, Glandular and Epithelial
Study type: Interventional
Phase: Phase 3

Summary: 
      Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus
      [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined
      diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic
      and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.
    


Intervention name(s): Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF); Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF); Comparator: REPEVAX™ (Concomitant); Comparator: REPEVAX™ (Non-Concomitant)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.; GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.; REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.; REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Alcohol on Simulated Driving
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Previous studies have shown that alcohol significantly impairs driving performance. Acute
      alcohol administration also has a detrimental effect on secondary task performance during
      dual-tasks. The present study will investigate the effects of five different dosages of
      ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering
      performance and brain activity will be recorded in both single- and dual-task conditions.
    


Intervention name(s): alcohol
Intervention type(s): Drug
Intervention description(s): alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
Other intervention name(s): alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Alcohol; Driving; Multitasking; ERP; social drinkers