bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block
      with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of
      performance and safety when administered postoperatively in patients who undergo laparoscopic
      nephrectomy.

      To fulfill this purpose, three groups of patients each with 32 patients, will be formed.
      Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group
      will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after completion
      of surgery. The third (Control group) will not receive any blocks. After shifting patients to
      recovery all three groups will be put into intravenous patient controlled analgesia (PCA)
      Morphine as rescue analgesic regimen as per a set protocol. Morphine consumption over the
      first postoperative 24 hours, ease of performance of individual blocks and associated adverse
      events, adverse events associated with opioid use, patient recovery and satisfaction will be
      noted.
    


Intervention name(s): Transversus Abdominis Plane (TAP) Block; Quadratus Lumborum (QL) Block
Intervention type(s): Other; Other
Intervention description(s): 0.5 ml/kg of 0.25 % Bupivacaine deposited in the transversus abdominis plane under ultrasound guidance postoperatively; 0.5 ml/kg of 0.25 % Bupivacaine deposited in the anterolateral aspect of the quadratus lumborum muscle under ultrasound guidance postoperatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric
      nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.
    

Detailed description: 
      In a randomized, four-phase cross-over study the effect of simulated microgravity (13 days of
      bed rest), energetic restriction (-25%, fat reduced), and their combination on
      endothelium-dependent and -independent vasodilation will be compared with ambulatory control
      conditions. Using venous occlusion plethysmography cumulative intraarterial dose-response
      curves to endothelium-dependent (acetylcholine) and -independent (sodium nitroprusside)
      vasodilators will be constructed in 10 healthy male volunteers before and on day 13 of each
      of the four intervention periods.
    

Intervention name(s): bed rest, hypocaloric nutrition
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Educational/Counseling/Training
Single Dose Study of PF-04991532 in Healthy Subjects
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK)
      and preliminary food effect of PF-04991532 following single escalating oral doses in healthy
      adult subjects.
    

Detailed description: 
      Safety/Tolerability and PK
    

Intervention name(s): PF-04991532; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The tentative dosing schedule is 30, 100, 300, 600, 1200, and 2000 mg. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as extemporaneously-prepared powder in capsule (PIC) formulation.; Placebo to match PF-04991532 will be provided
Intervention MeSH terms: 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: phase 1; safety and tolerability; PK; T2DM; type 2 diabetes mellitus
GSK1349572 Drug Interaction Study With Etravirine
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers to determine whether there is a drug interaction between
      GSK1349572 and etravirine
    


Intervention name(s): GSK1349572
Intervention type(s): Drug
Intervention description(s): GSK1349572 50 mg in combination with Etravirine
Intervention MeSH terms: Dolutegravir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: healthy volunteer; pharmacokinetics; GSK1349572; integrase; etravirine
Virus DNX2401 and Temozolomide in Recurrent Glioblastoma
Condition: Glioblastoma Multiforme; Recurrent Tumor
MeSH terms: Glioblastoma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I trial, unicentric, uncontrolled. Intratumoral injection or intramural (into the
      resected tumor cavity) of DNX2401 into brain tissue will be followed by up to two 28 - day
      cycles of oral temozolomide (TMZ) in schedule of 7 days on/7 days off to evaluate safety of
      the combination. Completion of two full cycles of TMZ will be dependent upon tolerance and
      toxicity.

      The rationale in using the virus with chemotherapy begins with the lessons learned in many
      clinical trials in glioblastoma (GBM) about both the great difficulty of treating this
      disease with monotherapy and the limitations of the therapeutic virus. The best clinical
      results in recent years have been achieved with combinations of multiple therapeutics
      efforts, including, maximum resection and chemotherapy, immunotherapy and targeted therapies.

      There are very strong preclinical data about the synergy of DNX-2401 and TMZ proposed in our
      trial design. The dose-dense schemes of TMZ like the one we will use, have been developed
      with the aim to saturate o6-methylguanine-DNA-methyltransferase (MGMT). The published results
      to date have shown reasonable toxicity albeit with modest efficacy' these schemes are now in
      phase III trials. In addition, autophagy triggered by TMZ could help viral replication in the
      tumor cells 11.

      The last argument in favor of this virus + TMZ combination is the proved efficacy in killing
      GBM tumor stem cells. In vitro and animals models have shown this combination is much more
      effective that any of the treatments alone against GBM stem cells and the tumors derived from
      them.
    

Detailed description: 
      DNX2401 will be injected after stereotactic biopsy reveals intraoperative pathology
      confirming the presence of recurrent glioblastoma. The injection will be either intratumoral
      or intramural with injections throughout the post-resection cavity.
    

Intervention name(s): DNX2401 and Temozolomide
Intervention type(s): Procedure
Intervention description(s): Virus injection in the brain parenchyma after pathology confirmation of recurrent glioblastoma.
Temozolomide oral 14 days after virus injection.
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma; first recurrence; temozolomide
Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate the pharmacokinetics, safety and tolerability
      of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC)
      to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy
      volunteers.
    


Intervention name(s): Preservative free tafluprost 0.0015% eye drops; Preservative free timolol 0.5% eye drops; Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Preservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.; Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days; Preservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.
Intervention MeSH terms: Timolol; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: pharmacokinetics
Sexual Needs of Adolescents Living With HIV Since Childhood
Condition: Hiv; Perinatal HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      To improve the knowdelge about the sexual health needs of perinatally HIV-infected
      adolescents living in France.
    

Detailed description: 
      20 individual semi-structured interviews will be conducted with 20 young adults living with
      HIV sinc childhood and living in France. The aim of this study is to identify their sexual
      needs through exploring their personal experience of sexuality during their adolescence. The
      investigator intend to explore communication about the disease and sexuality within their
      families ; communication about sexual health with health care professionnals ; whether
      sexuality has arrose difficulties related to their chronic condition such as rejection or
      sadness ; whether there are differences in sexual needs regarding gender. A thematic analysis
      will be conducted by three researchers.
    

Intervention name(s): Interview
Intervention type(s): Other
Intervention description(s): Patients will be interviewed with a semi-structured qualitative interview in order to know how they lived their first sexual experiences and their sex lives during their adolescence
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young adults with a perinatally acquired HIV infection
      
Keywords: HIV; sexual Health; adolescent; sexual needs
Enhanced Smoking Cessation for University Students
Condition: Cigarette Smoker; Current Every Day Smoker
Study type: Interventional

Summary: 
      This trial studies how well a new smoking cessation and prevention intervention works in
      enhancing smoking cessation for university students. The new intervention may be easier to
      use for students to quit smoke.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To establish the feasibility of a new smoking cessation and prevention intervention
      including two new modules addressing alcohol use and depression.

      II. Demonstrate the feasibility of a smoking prevention website.

      OUTLINE: Participants are assigned to 1 of 2 arms.

      ARM I: Participants who currently smoke complete a survey over 30 minutes and discuss the
      survey results with the counselor over 30 minutes at week 2. Participants also complete 3
      internet surveys over 20 minutes.

      ARM II: Participants who currently do not smoke complete a survey over 30 minutes and discuss
      the survey results with the counselor over 30 minutes at week 2.

      After completion of study, participants are followed up at 3 months.
    

Intervention name(s): Survey Administration
Intervention type(s): Other
Intervention description(s): Complete surveys
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation (DBS) Leads
Condition: Parkinson's Disease; Essential Tremor
MeSH terms: Parkinson Disease; Essential Tremor
Study type: Interventional

Summary: 
      The purpose of this study is to provide proof-of-concept that directional stimulation, in an
      intraoperative setting, is perceivable in a subject and is different from omnidirectional
      stimulation. The tests will be performed using a dedicated DBS lead connected to external
      neurostimulator.
    


Intervention name(s): directSTN Acute lead connected to external neurostimulator
Intervention type(s): Device
Intervention description(s): Test phase will be performed intra-operatively, prior to chronic lead implant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the long-term safety and tolerability of
      certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely
      active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK),
      and immunogenicity of CZP treatment in children and adolescents with moderately to severely
      active Crohn's disease.
    


Intervention name(s): certolizumab pegol; certolizumab pegol
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg; 200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg
Other intervention name(s): Cimzia®; Crohn's Disease; Cimzia®; Crohn's Disease
Intervention MeSH terms: Certolizumab Pegol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Certolizumab Pegol; Cimzia®; Crohn's Disease; Children and Adolescents with Crohn's Disease
ACT-HF: Attention, Cognition and Self-Management in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This study is designed to determine if a relationship exists between problems with memory,
      attention, learning, insight and executive function and self management in heart failure.
    

Detailed description: 
      Eligible participants are those 75 years of age or less, with left ventricular ejection
      fractions of 40% or less, english speaking and no known cognitive deficits. Participants will
      be administered the Repeatable Battery for the Assessment of Neuropsychological Status and
      the Controlled Oral Word Association test at the study visit. They will also be asked to
      complete the Self-Care in Heart Failure Index and the Anosognosia Questionnaire for Dementia
      at their convenience and mail back to investigator. Participants will be contacted in 90 days
      to determine if they have been hospitalized, and if so, for how many days.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with history of heart failure 6 months or more meeting inclusion criteria
        recruited from outpatient clinic who receiving routine care for their heart failure
      
Keywords: Heart failure; Self management; cognitive dysfunction; Self management of heart failure
Day-Night Rhythm in Human Skeletal Muscle
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism
      in healthy lean subjects. Subjects will stay at the research facility for 44 hours with a
      standardized living protocol during which several measurements of skeletal muscle and whole
      body energy metabolism will be performed.
    

Detailed description: 
      Recent evidence from both observational and experimental studies indicates that disobeying
      our normal day-night rhythm negatively influences our metabolic and cardiovascular health,
      possibly leading to obesity and type 2 diabetes mellitus (T2DM). An important hallmark of
      obesity and T2DM is a decreased skeletal muscle mitochondrial function. Interestingly, recent
      research indicates that also skeletal muscle mitochondrial function under the influence of a
      day-night rhythm. The main objective of this study is to investigate the presence of a
      day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function)
      of healthy young participants. Therefore, subjects will stay at the research unit for 44
      hours, with standardized meals and sleeping time. During this period we will take five muscle
      biopsies, perform indirect calorimetry measurements and blood draws.
    

Intervention name(s): Standardized living protocol
Intervention type(s): Other
Intervention description(s): Subjects stay at the research facility for 44 hours and adhere to a standard sleeping, eating and activity protocol. During this protocol, multiple measurements will be performed including skeletal muscle biopsies (m. vastus lateralis), blood draws, indirect calorimetry and MRS measurements.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Circadian Rhythm
Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections
Condition: Soft Tissue Infection
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections; Emergencies
Study type: Observational

Summary: 
      To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric
      skin and soft tissue infections treatment failure rate, as well as emergency department
      process outcome.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children presenting to participating pediatric emergency departments
      
Keywords: pediatric; soft tissue infections; ultrasonography; effectiveness
The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids,
      weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24
      months follow-up.
    


Intervention name(s): Enhanced Diabetes Education; Standard Diabetes Education
Intervention type(s): Other; Other
Intervention description(s): Provide enhanced diabetes education; Provide Standard Diabetes Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Diabetes
Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      A 24 week study to compare the use of Metformin, birth control pills and a carefully planned
      intensive lifestyle program that includes weight loss and exercise. These approaches will be
      compared to placebo (a pill that contains no active substances. Metformin, birth control
      pills and the lifestyle management program will be used on this research study to compare
      their ability to:

        1. reduce fasting glucose levels

        2. reduce androgen hormone levels

        3. improve sex steroid binding, and

        4. improve lipids (fatty substances in the blood)
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles,
      (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels,
      such as unwanted hair growth or acne. This condition often becomes recognized at the time of
      puberty. The standard treatment for this condition is oral contraceptive pills, which are
      used not for contraception, but to cause a regular, monthly bleeding pattern.

      Many adolescents with PCOS have increased levels of insulin, a hormone that controls the
      body's sugar balance. These increased insulin levels may play a role in the development of
      polycystic ovary syndrome. There are several medications now available, which can decrease
      the insulin levels by improving the action of insulin in the body. Metformin is one of these
      drugs. Metformin is a drug currently used in the management of diabetes to control blood
      sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic
      ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed
      or diminished.
    

Intervention name(s): Metformin; Oral Contraceptive Pills (Yasmin); Lifestyle Modification; placebo
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): Metformin 425mg. capsules, 2 capsules BID x 24 weeks; Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks; weekly classes x 24 weeks for training in diet, exercise and behavior modification skills; placebo to the active metformin arm. 2 capsules BID x 24 weeks.
Other intervention name(s): Yasmin oral COntraceptive tabs; pharmacy matched placebo capsules
Intervention MeSH terms: Metformin; Contraceptive Agents; Contraceptives, Oral; Drospirenone and ethinyl estradiol combination; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Overweight Adolescent Girls; Irregular Menstrual Cycles
Investigation of Peak Expiratory Flow and Physically Fitness in Obese and Overweight Adolescents
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Observational

Summary: 
      Due to the increasing prevalence of childhood obesity and overweight, health problems may
      begin to appear at an early age. The aim of this study is to examine physical activity level,
      core performance, anthropometric measurements and peak expiratory flow in overweight and
      obese adolescents compared to normal weight adolescents.
    

Detailed description: 
      Due to the increasing prevalence of childhood obesity and overweight, health problems may
      begin to appear at an early age. Overweight and obese people are at risk for medical
      conditions that can lead to greater morbidity and mortality. Lack of physical activity is a
      well-known risk factor for obesity and the relationship between them has been supported by
      many studies. It has also been reported by studies that obesity affects respiratory
      parameters. In overweight and obese adolescents, a relationship is likely between the
      affected respiratory parameters and the weakened core region. There are not enough studies on
      this subject in the literature. Therefore, the aim of the study is to examine the physical
      activity level, core performance, anthropometric measurements and peak expiratory flow in
      overweight and obese adolescents in comparison with normal weight adolescents.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study will consist of 60 volunteer adolescents who are obese, overweight and normal
        weight studying in the 5th, 6th and 7th grades of secondary school.
      
Keywords: peak expiratory flow; core muscle strength; physical activity