bioihbjkbjnl/mcl2 huggingface dataset:
Change Clubs for African American Women
Condition: Obesity; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      African American women have among the highest rates of overweight and obesity and few meet
      dietary or physical activity guidelines. The investigators seek to develop a new intervention
      strategy that will help alleviate health disparities, thereby improving quality of life,
      health care costs, and disease burden. The African American Collaborative Obesity Research
      Network (AACORN) recommends an eco-social, community-engaged approach to behavior change that
      is in line with cultural values of interconnectedness and care for others. The purpose of
      this study is to operationalize the AACORN paradigm to promote improvements in weight status
      and health through a civic engagement approach. To achieve this, participants will meet in
      church-based Change Clubs and be led through a 6 month curriculum, which includes both
      lessons in cardiovascular risk reduction and a civic engagement project. Civic engagement may
      lead to change in individual health behaviors by increasing self-regulation and
      self-efficacy. The investigators will measure club members' adherence to the Change Club
      intervention, defined as average number of sessions attended, retention in the clubs,
      satisfaction with the Change Club experience and achievement of at least 50% of
      self-identified benchmarks for community change within 6 months. In addition the
      investigators will compare anthropometric factors, diet and physical activity behaviors,
      blood pressure, cardiorespiratory fitness, and psychosocial factors before and after
      participation in the Change Club intervention.
    


Intervention name(s): Change Club Intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Primary purpose: Prevention
Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Teenagers and adults who are overweight or obese have an increase in fat in the abdomen,
      which increases their risk for diabetes and heart disease. Reducing abdominal fat is
      important to reduce risk for diabetes and for heart disease. Overweight teenagers also have
      low levels of growth hormone compared to normal weight teenagers, and teenagers with the
      lowest growth hormone levels also have the greatest abdominal fat. In children who are unable
      to make growth hormone for other reasons, giving back growth hormone leads to a decrease in
      abdominal fat. We are studying whether giving growth hormone in small doses to overweight
      teenagers can change body composition. We hypothesize that growth hormone will cause
      abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.
    


Intervention name(s): recombinant human growth hormone (rhGH); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.; Placebo will be administered by daily subcutaneous injections. Sham increases will be used.
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity; Adolescent; Insulin resistance; Growth hormone; Visceral fat; Adolescent obesity
Study Evaluating the Effect of Food on the Bioavailability of PN400 Components
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      We will evaluate the effect of food on the bioavailability of the components of PN400
    


Intervention name(s): PN400
Intervention type(s): Drug
Intervention description(s): naproxen/esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating
      multiple doses with and without a 64 g fat breakfast at the 50 mg dose level
    


Intervention name(s): BIBR 796 BS; Placebo; high fat breakfast
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparative Study of the Analgesic Effect of Spinal Anesthesia or Infiltration Anesthesia for Hemorrhoidectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Background and Objectives: Postoperative analgesia and early recovery are relevant for
      hospital discharge after hemorrhoidectomy. This study investigated the postoperative
      analgesic effect with local infiltration compared with spinal block.

      Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group (LG)
      received local infiltration under general anaesthesia; spinal group (SG) received a
      subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol
      infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of 0.5%
      hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and 1%
      lidocaine for SG. There were assessed: postoperative pain intensity, sphincter relaxation,
      motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and adverse
      effects.
    

Detailed description: 
      This is a prospective, randomized study, including 40 patients between 18 and 60 years, of
      both genders, ASA 1 or 2.

      Patients in group 1( n= 19 ) will be submitted to spinal block and group 2 (n=21) to local
      infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The
      infiltration will be performed with 10 ml of 0.75% ropivacaine on each side.

      Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 30 minutes,
      relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes
      until reached the criteria for discharge, motor blocked of the lower limbs every 30 minutes,
      BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea
      and vomiting), time to hospital discharge, and duration of analgesia.

      Adverse effects and complications will be noted.
    

Intervention name(s): Local Infiltration; Subarachnoidal block
Intervention type(s): Procedure; Procedure
Intervention description(s): Injection at perianal region with ropivacaine 0.75%(20ml); Injection at subarachnoidal space with bupivacaine 0.5% ( 2ml)
Other intervention name(s): local anesthesia; spinal anesthesia
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infiltration; hemorrhoidectomy; postoperative pain
Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance
      therapy, compared to standard HAART therapies.
    

Detailed description: 
      Different therapeutic strategies have been investigated to improve adherence to treatment and
      reduce toxicity. Both the reduction in the number of doses and the number of daily tablets
      have led to an improvement in therapeutic compliance. Similarly, the administration of new
      treatment regimens with a reduced number of tablets a day and without NTRI may be clinically
      useful in improving compliance with HAART and limiting NTRI-associated toxicity. These would
      comprise combinations of a PI, boosted with ritonavir, plus a non-Nucleoside and single
      therapy with PIs boosted with ritonavir.

      In this regard, the results obtained with lopinavir/ritonavir and with atazanavir/ritonavir
      are very promising and open up a possible channel of research with other PIs boosted with low
      doses of ritonavir.

      There are other PIs whose antiretroviral efficacy has also been demonstrated, such as
      saquinavir, but whose economic cost is much lower. Furthermore, saquinavir has a low toxicity
      profile, and the availability of saquinavir 500 mg facilitates comfortable administration,
      since it makes it possible to reduce the number of daily tablets to more than half.

      Moreover, it is important to take into account that the incidence of mutations that confer
      resistance to saquinavir on patients that fail on combinations including this PI is very low,
      which makes it possible to reuse the drug in future treatment regimens or salvage patients
      with other PI All these characteristics (high intrinsic potency, low number of tablets, low
      toxicity, low potential of selection of resistant viral strains in combination with
      ritonavir, and low economic cost) make single therapy with the new formulation of saquinavir,
      boosted with low doses of ritonavir, a possible therapeutic option as maintenance strategy in
      HIV-infected patients with maintained suppression of the viral load.
    

Intervention name(s): Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours
Intervention type(s): Drug
Intervention description(s): Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours
Other intervention name(s): Invirase
Intervention MeSH terms: Ritonavir; Saquinavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Saquinavir/ritonavir; Single therapy; Virological efficacy; Safety; HIV-1
Childhood Adenotonsillectomy Study for Children With OSAS
Condition: Obstructive Sleep Apnea; Snoring
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Snoring
Study type: Interventional

Summary: 
      The purpose of this research is to determine the effect of adenotonsillectomy surgery
      (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children.
      OSAS can cause health problems including poor growth, high blood pressure, diabetes and
      behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for
      children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve
      afterwards. This study will help determine if improvement occurs or if it does not. It will
      also look at whether certain groups, such as children who are overweight or of different
      ethnicities, are helped by the surgery.
    

Detailed description: 
      Because adenotonsillectomy is the usual treatment for OSAS, all children in the study will
      get surgery. However, in order to assess the extent to which adenotonsillectomy surgery
      improves breathing disturbances and sleep quality in children with OSAS, two groups will be
      studied. One group will get surgery early (one month after enrollment) and the other group
      will be re-evaluated for surgery within 7 months of enrollment.

      Children in both groups will be closely monitored through the 7-8 month study period and
      sleep and health educational materials will be provided to assist in establishing healthy
      habits.
    

Intervention name(s): Adenotonsillectomy (AT) - removal of adenoids and tonsils; Watchful Waiting
Intervention type(s): Procedure; Other
Intervention description(s): Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils; Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
Other intervention name(s): EAT; Watchful Waiting with Supportive Care (WWSC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sleep disordered breathing; Sleep apnea; Tonsillectomy; Adenoidectomy; Snoring; Neurobehavioral Manifestations; Obstructive Sleep Apnea Syndrome
North Carolina Newborn Exome Sequencing for Universal Screening
Condition: Metabolism, Inborn Errors; Hearing Loss; Hereditary Disease
MeSH terms: Hearing Loss; Metabolism, Inborn Errors; Genetic Diseases, Inborn
Study type: Interventional

Summary: 
      The NC NEXUS research study is exploring the utility of next generation sequencing in newborn
      screening and parental decision making. The National Institutes of Health (NICHD and NHGRI)
      are co-funding this study under a single U-19.
    

Detailed description: 
      The investigators will enroll and perform whole exome sequencing on two cohorts of patients.
      One cohort will consist of two hundred newborns with no known conditions whose parents will
      be recruited during the mother's pregnancy. The second cohort will include two hundred
      infants and children up to the age of five years with diagnosed conditions including
      conditions detected through standard newborn screening such as phenylketonuria and other
      inborn errors of metabolism, hearing loss and other rare conditions that may fit criteria for
      newborn screening in the future.

      Parents will be introduced to the study by their clinician or a study recruiter. Those who
      agree to enroll in Phase I will review an online decision guide and be offered a study visit
      conducted by a genetic counselor to obtain informed consent for genomic sequencing of their
      child. Parents consenting to have their child's genome sequenced will be seen after the
      child's birth or at a convenient pre-arranged time and duplicate saliva samples will be
      collected from the children and one sample will be sent to the BioSpecimen Processing (BSP)
      Facility and to Dr. Jonathan Berg's laboratory for sequencing and the other sent to the
      Molecular Genetics Laboratory (MGL) for DNA extraction and storage until needed for clinical
      confirmation. Results will be returned for diagnostic (in the Diagnosed cohort) and medically
      actionable disorders of childhood (both cohorts). Two-thirds of parents who consent to
      sequencing will be randomly assigned to be eligible to request additional findings and use a
      supplement of the online decision aid. All results will be reported to parents by trained
      genetic professionals (genetic counselors and clinical geneticists)
    

Intervention name(s): Well infant, whole exome sequencing; Diagnosed, whole exome sequencing
Intervention type(s): Genetic; Genetic
Intervention description(s): Whole exome sequencing will be performed in children with diagnosed conditions. Investigators will analyze results that are associated with their condition.; In addition to returning results of conditions associated with a child's phenotype, investigators will also analyze genes that are associated with conditions that have childhood onset and are medically actionable.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare two approaches to the measurement of fatty acid oxidation (ketone
      body flux and ketone body concentration) and determine which method demonstrates superior
      sensitivity and variability in the detection of moderate increases in ketogenesis rates.
    


Intervention name(s): Stable isotope tracer (13-C(4)-BHB)
Intervention type(s): Drug
Intervention description(s): A stable isotope tracer (13-C(4)-BHB), a commercially available lipid emulsion, and heparin will be administered intravenously. Ketone body concentrations will be measured before beginning the infusion, at approx. 135 minutes, and at approx. 255 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Resilience Measurement in Older Adults With Late-Stage Lung Cancer
Condition: Lung Cancer Stage III; Lung Cancer Stage IV
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study to test measures of physical and psychological resilience while
      using Self-System therapy (SST), to treat depression and lung-cancer-related distress in
      older adults (65 years and older).
    

Detailed description: 
      The investigator will examine the feasibility of delivering measures of psychological and
      physical resilience while delivering the SST intervention. The investigator will also examine
      whether participation in SST can help alleviate symptoms of depression and distress while
      helping improve overall physical functioning in older adults with advanced lung cancer.
    

Intervention name(s): Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience
Intervention type(s): Behavioral
Intervention description(s): The SST-LC is a brief structured intervention deliverable by video conference. The SST-LC Resilience protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors. The focus will be to test measures of resilience during the intervention period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Change in Brain Metabolism and Cognitive Function by Aripiprazole
Condition: Antipsychotics; Cognition; Brain Metabolism; Dopamine Receptor Occupancy
Study type: Interventional

Summary: 
      Dopamine receptor occupancy and brain metabolism were measured using positron emission
      tomography after the administration of aripiprazole. Working memory performance was also
      measured using N-back task.

      The investigators explored the relationship between changes in brain metabolism and working
      memory performance.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): single oral administration of aripiprazole
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the mean serum sodium at 48 hours following
      the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in
      children requiring maintenance IV fluid administration.
    

Detailed description: 
      Hyponatremia, has become increasingly recognized as a cause of morbidity and mortality in
      hospitalized children. The main etiology of hyponatremia in these children has been
      attributed to the use of hypotonic maintenance IV fluids. The practice of providing IV
      solutions containing 20-30 mmol/L of Na is based on "physiological needs" proposed by
      Holliday and Segarin 1957, derived from studies of 61 adults and children. The presence of
      non-physiologic ADH secretion in the great majority of hospitalized children due to nausea,
      stress, pain, and surgical interventions, has confirmed that Holliday and Segar's
      recommendations are frequently inappropriately applied. To avoid the development of
      hyponatremia, it has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the
      standard maintenance IV solution.

      The routine use of an isotonic maintenance fluid solution has not yet been studied, and
      concerns exist regarding the potential for hypernatremia and salt and water overload. If
      isotonic solutions are to be recommended routinely, their overall safety, and specifically
      the occurrence of dysnatremias and volume overload, should be evaluated in a controlled
      prospective trial.
    

Intervention name(s): Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids; Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids
Intervention type(s): Drug; Drug
Intervention description(s): Total daily fluid infusion equal to:
100 mls/kg/day for children weighing <10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those >20kg.; Total daily fluid infusion equal to:
100 mls/kg/day for children weighing <10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those >20kg.
Other intervention name(s): 0.45% Sodium Chloride/5% dextrose; 0.9% Sodium Chloride/5% Dextrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatrics; Hyponatremia; Sodium Chloride; maintenance fluids
Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy
Condition: Laparoscopy; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg
      intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain
      control in adult patients after laparoscopic surgery.
    

Detailed description: 
      Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were
      enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol
      was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given
      right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual
      analog scale (VAS) pain score were recorded.
    

Intervention name(s): Dexamethasone injection; Haloperidol Injection
Intervention type(s): Drug; Drug
Intervention description(s): Group A consisted of patients given 5 mg intravenous dexamethasone after induction.; Group B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended
Other intervention name(s): dexamethasone; haloperidol
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Haloperidol; Haloperidol decanoate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: dexamethasone; haloperidol; nausea; pain; vomiting