bioihbjkbjnl/mcl2 huggingface dataset:
Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer
Condition: Anxiety; Cancer; Child; Nursing; Pain
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study aims to determine whether parental involvement during venipuncture reduces
      venipuncture pain and anxiety in children with cancer.
    

Detailed description: 
      This was a randomized controlled trial with parallel groups in which 60 children with cancer
      aged 6-12 were randomly allocated to a control group (n = 30) and a parent involvement group
      (n = 30). Each child's anxiety was evaluated by the child using the Children's Fear Scale
      before, during venipuncture, and each child's pain during the procedure was evaluated by the
      child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen
      saturation were measured with a pulse oximeter device before, during the procedure.

      Control group (n = 30): Routine venipuncture procedure was applied to the control group. The
      parent was present in the child's room but did not participate in the procedure.

      Parent involvement group (n = 30): A parent was involved in the procedure. The parent held
      the children in their arms and holding the extremity from which the blood was drawn, holding
      the hands of children and communicating with their children in the child's room, and in this
      way the parent was involved in the procedure.
    

Intervention name(s): parent involvement application
Intervention type(s): Behavioral
Intervention description(s): A parent was involved in the procedure. The parent held the children in their arms and holding the extremity from which the blood was drawn, holding the hands of children and communicating with their children in the child's room, and in this way the parent was involved in the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization was done using the closed envelope method. A total of 60 cards with 30 "parent involvement" and 30 "control" labels were placed in sealed envelopes by the nurse who conducted the study. Children were asked to choose one of these envelopes and placed in the selected group. Children were randomized into two groups: a parent involvement group (n = 30) and a control group (n = 30).
Masking: None (Open Label)
Primary purpose: Supportive Care
Functional Impact of Interval Training on Muscle Mass and Strength in Obese Adults
Condition: Obese; Muscle Strength; Interval Training
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The primary objective was to investigate the effectiveness of interval training and to
      evaluate the best available method for measuring body composition and functional capacity.

      Thirty obese subjects consecutively voluntarily participated in the current study. They
      ranked sedentary according to their level of activity (≥ 30-minute moderate physical activity
      3days/wk). The training sessions were divided into the warm-up phase, training phase and a
      cool-down phase. The training programs were completed 3days/week for 12 weeks. Body
      composition was calculated by skinfold thickness method and bio-impedance before and after
      training. Similarly, aerobic capacities were measured by lactate threshold testing and by
      Astrand submaximal testing.
    


Intervention name(s): Interval Training
Intervention type(s): Other
Intervention description(s): All individual of interventional group participated in an interval training program, which comprised of 3 days/week for twelve weeks. A booklet was given to each participant containing instructions and guideline about interval training. The interval training program was introduced as prescribed previously.17 After the workout, a cool down period of 5 minutes was given during which they perform paddling with low speed. All training program was supervised by a qualified physical therapist.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Obesity; Body composition; Exercise testing
Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
Condition: Type 2 Diabetes Mellitus; Renal Impairment
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK),
      safety and tolerability of LX4211 following once daily oral administration in subjects with
      type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.
    


Intervention name(s): LX4211; LX4211 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive LX4211 once daily for 7 days; Subjects will receive LX4211 placebo once daily for 7 days
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway
Condition: Infertility Unexplained
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Although many reports have investigated the relationship between subfertility and uric acid
      levels in semen, to the best of author knowledge, there is no study have been published to
      yet focus on the effects of asthenospermia treatments, such as given an oral zinc
      supplementation, on the activity of urate-related enzymes, which are important in fertility
      of human.
    

Detailed description: 
      The present study was designed to investigate the effect of zinc supplementation on the
      qualitative and quantitative characteristics of semen, along with uric acid levels and
      urate-related enzymes in the seminal plasma and spermatozoa of asthenospermic males.
    

Intervention name(s): Zinc Sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
Intervention MeSH terms: Zinc Sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Semen volume after treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uric acid; Adenosine deaminase; Zinc Sulfate; 5'-nucleotidase; Asthenospermia.; Xanthine oxidase
Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Condition: Eosinophilic Gastroenteritis
MeSH terms: Gastroenteritis; Eosinophilic Esophagitis; Enteritis; Gastritis; Eosinophilia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of an elemental diet on adult patients
      with Eosinophilic Gastroenteritis
    

Detailed description: 
      This prospective interventional study will investigate the effect of an exclusive, six week
      elemental diet in adult patients with Eosinophilic Gastroenteritis
    

Intervention name(s): Elemental Diet Therapy
Intervention type(s): Other
Intervention description(s): Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
Condition: Healthy; Obese
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of overnight fasting versus a diurnal
      fasting (during daily life activities) in females with and without obesity on inflammation,
      neurotrophins, energy metabolism, mood, food cravings, and appetite sensations.

      This study will be an acute fasting intervention.
    


Intervention name(s): Acute Fasting
Intervention type(s): Other
Intervention description(s): The volunteers will fast overnight (10 hours) and breakfast will be offered (bread, butter, ham and industrialized fruit juice). The participants will fast for another 10 hours during daily activities.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Acute fasting; Inflammatory response; Energy Expenditure
Relapse Prevention to Reduce HIV Among Women Prisoners
Condition: Opioid Dependence; HIV
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a feasibility and acceptability study assessing whether providing buprenorphine
      for women under criminal justice supervision leaving a controlled environment and returning
      to the community would prevent opioid relapse and reduce HIV risk behaviors.
    

Detailed description: 
      This study sought to enroll opioid dependent women under supervision in the criminal justice
      system and in a controlled environment (substance abuse treatment)but at at high risk for
      opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially,
      9 women were enrolled and received buprenorphine medication. After the first 9 participants,
      women were randomized to either buprenorphine or placebo. Women received the buprenorphine
      medication for 12 weeks in the community and at the end of the 12 weeks were transitioned
      either to another buprenorphine provider, methadone provider, or tapered off buprenorphine
      based on the participant's preferences. One additional follow-up at 3 months after treatment
      was conducted. The primary outcome was opioid positive urines at all time points.
    

Intervention name(s): Placebo; Buprenorphine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to match buprenorphine administered for 3 months; Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: opiates; HIV
Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans
Condition: Hyperlipidemia
MeSH terms: Cardiovascular Diseases; Hyperlipidemias
Study type: Interventional

Summary: 
      The hypothesis of this study is that the natural supplement Capros will decrease LDL levels,
      platelet aggregation, and serum concentrations of high sensitivity C-reactive protein in
      humans at risk for cardiovascular disease.
    

Detailed description: 
      A non-randomized, longitudinal study to determine the effect of Capros supplementation on a
      lipid profile, platelet aggregation and high-sensitivity C - reactive protein in 30
      volunteers at risk for cardiovascular disease.

      -Herbal Polyphenols/Antioxidants: Role in Cardiovascular Disease Prevention: Phenolic
      compounds are dietary antioxidants found in plants that are shown to inhibit LDL oxidation,
      inhibit platelet aggregation and adhesion, decrease total and LDL cholesterol, and induce
      endothelium-dependent vaso-relaxation. [Lapointe, Vita, and Mendes]. Epidemiologic studies
      suggest that higher polyphenol intake from fruits and vegetables is associated with decreased
      risk for cardiovascular disease. Among the numerous plausible mechanisms by which polyphenols
      may offer cardiovascular protection, improvement of the endothelial function and inhibition
      of angiogenesis and cell migration and proliferation in blood vessels have been the focuses
      of recent studies. Antioxidants in polyphenols, in addition to protecting LDL cholesterol
      against oxidation, may act at a vascular cell level by limiting cellular production of
      reactive oxygen species, and, thus, cell-mediated LDL oxidation. In traditional Indian
      medicine, the gooseberry (Phyllanthus emblica) has been used for thousands of years as an
      effective source of polyphenols and antioxidants. "P. emblica is considered beneficial
      against various diseases namely cancer, diabetes, liver treatment, and various other
      diseases."[Hiraganahalli]. Capros®, from Natreon, Inc., is a cascading antioxidant ingredient
      derived from Phyllanthus emblica. It has been used in cosmetics and food-and-beverage
      formulations in many countries, and, based on extensive scientific research, also shows
      particular promise as a dietary supplement.
    

Intervention name(s): Capros dietary supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: LDL cholesterol; anti-hyperlipidemic; hyperlipidemic; Capros; Natural Supplement
Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease
Condition: Alcoholic Liver Disease
MeSH terms: Liver Diseases; Liver Diseases, Alcoholic
Study type: Interventional

Summary: 
      Patient found to be malnourished after the nutritional evaluation would be randomized in the
      two groups of the study. The control group would receive standard nutritional counseling from
      a trained dietician where as those in the intervention group would be given 120 gm of a
      polymeric nutritional supplement providing around 500 Kcal per day over and above the
      standard nutritional counseling from a trained dietician. Both the groups would receive
      standard medical treatment. The polymeric nutrient supplement would be taken by the patients
      in this arm for a period of 6 months.
    

Detailed description: 
      Patients with ALD (Alcoholic Liver Disease) would undergo a detailed clinical evaluation.
      Information would be collected regarding the onset and duration of symptoms, etiology, and
      severity of disease, other baseline clinical features, demographic characteristics, routine
      biochemical and hematological investigations, upper GI endoscopic findings and radiological
      investigations, patients would also be screened for the assessment of nutritional status.
      Patient found to be malnourished after the nutritional evaluation would be randomized in the
      two groups of the study. The control group would receive standard nutritional counseling from
      a trained dietician where as those in the intervention group would be given 120 gm of a
      polymeric nutritional supplement providing around 500 Kcal per day over and above the
      standard nutritional counseling from a trained dietician. Both the groups would receive
      standard medical treatment. The polymeric nutrient supplement would be taken by the patients
      in this arm for a period of 6 months. A record would be kept for the medications taken by the
      patients.

      All the patients would be followed up at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3
      months, 6 months, and 1 year after inclusion. Clinical, nutritional and biological data were
      collected at each visit. All these patients would receive standard treatment of cirrhosis
      consisting of withdrawal from alcohol along with symptomatic treatment including B vitamins,
      diuretics, salt restriction, lactulose, beta blockers, and antibiotics after bacteriological
      samples if needed. All patients would receive endoscopic surveillance for portal
      hypertension. An adequate prophylaxis by ligation or beta blockers would be performed as
      needed. The patients with a past history of spontaneous bacterial peritonitis will receive
      antibiotic prophylaxis.
    

Intervention name(s): Polymeric nutritional supplements; Standard Nutrional Treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections; Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the
      hospitalization of infants and young children in developed and developing countries and can
      be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000
      annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against
      human rotavirus gastroenteritis. This study will provide data for Korean regulatory
      authorities about the immunogenicity and safety of this vaccine in Korean children aged 2
      months at the time of the first dose.
    

Detailed description: 
      The study consists of two groups of children recruited in different centers in Korea. One
      group will receive the HRV vaccine and one group will receive the placebo. The vaccine or
      placebo will be administered starting at 2 months of age according to a two dose schedule (0,
      2 months). The study will consist of three visits. At the first visit, one blood sample will
      be taken before vaccination and the first dose will be administered. At the second visit (2
      months after first dose), the second vaccine will be administered. At the third visit (2
      months after second dose), a blood sample will be taken. A 15-day (Day 0 - 14) follow-up
      period will be observed for general symptoms solicited in the study (fever,
      fussiness/irritability, diarrhea, vomiting, loss of appetite and cough/runny nose). A 43-day
      (Day 0 - 42) follow-up will be observed for other unsolicited symptoms. Serious adverse
      events will be followed-up throughout the study. A stool sample should be collected from the
      child at any point during the study if he/she develops any GE.
    

Intervention name(s): Live attenuated human rotavirus vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Prophylaxis of Rotavirus Gastroenteritis
A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the effects of orally inhaled tiotropium +
      olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after
      12 weeks of treatment in patients with COPD.
    


Intervention name(s): Respimat inhaler; tiotropium+olodaterol (low dose); tiotropium + olodaterol (high dose); Respimat inhaler; Respimat inhaler; placebo to tiotropium+olodaterol
Intervention type(s): Device; Drug; Drug; Device; Device; Drug
Intervention description(s): Respimat inhaler; 2.5 µg tiotropium + 5 µg olodaterol; 5 µg tiotropium + 5 µg olodaterol; Respimat inhaler; Respimat inhaler; comparator
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Condition: Mumps; Varicella; Rubella; Measles
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK)
      Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy
      children in their second year of life.
    

Detailed description: 
      Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine)
      serve as control.
    

Intervention name(s): Measles, Mumps, Rubella and Chickenpox (live vaccine)
Intervention type(s): Biological
Other intervention name(s): Measles; Mumps; Rubella and Chickenpox (live vaccine)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Prophylaxis measles, mumps, rubella and chickenpox
Accuracy of Pulse Oximeters With Profound Hypoxia
Condition: Oximetry
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound
      hypoxia.
    


Intervention name(s): Oximeter
Intervention type(s): Device
Intervention description(s): Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding arterial blood draw samples to assess oximeter accuracy.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adult volunteers.
Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation
Condition: Hypertension; Chronic Kidney Disease; Renal Transplantation; Sympathetic Activity
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The study is aiming to document the safety and effectiveness of renal denervation in patients
      after renal transplantation with hypertension. Catheter-based renal denervation will be
      performed using CE marked, percutaneous Symplicity catheter.
    


Intervention name(s): Catheter-based renal denervation
Intervention type(s): Device
Other intervention name(s): Renal denervation with Symplicity Catheter Medtronic/Ardian
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Stimulus Validity on Speech Recognition
Condition: Hearing Impaired
MeSH terms: Deafness; Hearing Loss
Study type: Observational

Summary: 
      The effects of talker variability will be investigated with four groups of listeners (young
      normal-hearing; old normal-hearing; young hearing-impaired; old hearing-impaired).
      Experimental conditions will include between-talker differences, speaking rate, lexical
      difficult and semantic/linguistic context. A preliminary experiment will evaluate the
      relative merit of adaptive vs fixed-level methods of stimulus presentation.
    


Intervention name(s): Talker variability
Intervention type(s): Behavioral
Time perspective: Prospective
Keywords: Hearing loss, speech recognition