bioihbjkbjnl/mcl2 huggingface dataset:
Normal Saline Use With Suctioning
Condition: Tracheostomy
Study type: Interventional

Summary: 
      A long-standing intervention during tracheostomy tube suctioning in acute care settings is
      use of saline to loosen and remove respiratory tract secretions, maintain airway patency, and
      prevent mucus plugs. Controversy exists regarding safely using saline prior to suctioning for
      head and neck cancer and mechanically ventilated patients. To date, all studies had
      methodological limitations. In 2013, the clinical consensus statement published by AAO-HNSF
      identified a research gap based on lack of strong scientific evidence. A single site,
      randomized controlled pilot study will be conducted to evaluate effects of saline
      instillation with tracheostomy tube suctioning; test feasibility of proposed methods and
      procedures; and ensure proposed outcome variables are measurable and not confounded by
      extraneous variables. Institutional review board approval will be obtained before eligible
      adult subjects (inpatient and intensive care units) are recruited and consented. Oxygen
      saturation and heart rate are primary outcome variables; secondary outcome variables are
      mucus plugs and ventilator-associated pneumonias; other demographic data and patient
      characteristic variables; and outcome variables on complications and length of stay. Mean,
      standard deviation, median, and interquartile range will be calculated for continuous
      variables using t-tests to compare pre- and post-assessment scores. Frequencies and
      percentages will be calculated for categorical variables using Chi square and Fisher Exact
      tests to compare pre- and post-assessment scores. Multiple regression analysis will be used
      to control for confounding variables. This study is innovative as the first to recruit both
      head and neck cancer patients and mechanically ventilated patients and to measure all major
      outcomes of interest in one study. Understanding the effects of normal saline instillation
      will enable development of evidence-based guidelines and standardized protocols for
      tracheostomy tube suctioning.
    


Intervention name(s): 3mL of normal saline from the pink sodium chloride bullet; Sham Comparator of 3mL normal saline
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mechanically ventilated patients; Normal Saline; Tracheostomy Tube Suctioning
Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigators postulate that the metabolic effects of LSG would be augmented with the use of
      liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased
      intrapancreatic and intrahepatic fat than either of them individually. However there are no
      studies till date which have evaluated the combined effects of two modalities of weight loss
      on the above mentioned parameters. This study plans to compare the effects of liraglutide in
      post- LSG obese patients in a placebo controlled design.
    

Detailed description: 
      Various studies have shown that bariatric surgery is associated with significant durable
      weight loss with associated improvement in obesity related comorbidities and quality of life.
      The degree of effect on obesity related comorbidities depends on the bariatric surgery
      approach, typically classified as restrictive and/or malabsorptive effect. Data from
      International Federation for the Surgery of Obesity and Metabolic Diseases states that most
      common surgical procedures being performed are Roux-en-Y gastric bypass (45%), sleeve
      gastrectomy(37%), adjustable gastric banding(10%) and biliopancreatic division with or
      without duodenal switch(2.5%)5. . LSG is technically a simpler procedure compared to RYGB
      with lesser operative and long term nutritional complications. The mechanism for weight loss
      in laparoscopic sleeve gastrectomy is gastric restriction and possible changes in gut
      hormones resulting from higher level of GLP-1, and lower levels of ghrelin, as a consequence
      of resection of gastric fundus.

      Therefore,investigators postulate that the metabolic effects of LSG would be augmented with
      the use of liraglutide leading to additional excess weight loss, improved glucose
      homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually.
      However there are no studies till date which have evaluated the combined effects of two
      modalities of weight loss on the above mentioned parameters. This study plans to compare the
      effects of liraglutide in post- LSG obese participants in a placebo controlled design.
    

Intervention name(s): Liraglutide 6 MG/ML; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily; Normal Saline SC daily
Other intervention name(s): Calorie restricted diet; Calorie restricted diet
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional , Placebo Control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Aripiprazole and Resistant Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Currently there are no controlled data on the management of postpartum depression that fails
      to respond to adequate antidepressant therapy. The investigators recently reported that a
      large number of patients responded to the addition of atypical neuroleptics after having
      failed antidepressant trials. Aripiprazole used adjunctively to antidepressants is effective
      in patients with resistant depression but it has not been studied in patients with resistant
      postpartum depression. The investigators propose to conduct a 6 week open-label study to
      assess the effectiveness and tolerability of aripiprazole used adjunctively to
      antidepressants in patients with resistant postpartum depression.
    


Intervention name(s): aripiprazole
Intervention type(s): Drug
Intervention description(s): The starting dose of aripiprazole will be 2 mg and the dose adjusted to a maximum of 15 daily
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aripiprazole; adjunctive therapy; mood stabilizers; major depressive disorder; postpartum; Augmentation therapy; resistant
Bioavailability of EPA + DHA in a SMEDS Formulation
Condition: Bioavailability
Study type: Interventional

Summary: 
      This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) +
      docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation
      compared with a standard omega-3-acid ethyl ester product in healthy men and women.
    


Intervention name(s): EPA + DHA in SMEDS Formulation; Lovaza (active comparator; already FDA approved)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation; A single dose of 840 mg EPA + DHA administered as Lovaza. This intervention was used as an active comparator in this study. Lovaza was already FDA-approved when the study was conducted.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in
      promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment
      injection heroine users.
    

Detailed description: 
      A randomized study is planned for 5 years to evaluate the effectiveness of the Therapeutic
      Workplace in promoting methadone treatment and abstinence in unemployed injection drug users.
      Participants will be recruited through street outreach, at agencies that serve the target
      populations, and informal word-of-mouth referrals. Participants will be invited to attend the
      workplace and to enroll in the methadone treatment. To engage participants in the workplace,
      they will be allowed to work independent of whether they enroll in methadone treatment and
      independent of their drug use. The workplace participants (N=162) will be randomly assigned
      to three groups. The "Usual Care Control" participants will be allowed to work independent of
      their methadone use or urinalysis results. The "Methadone Contingency" participants will be
      required to take methadone to attend work, and will receive a brief pay decrease for failing
      to take their medication. The "Methadone & Abstinence Contingency" participants will be
      required to take their medication in order to attend work, as well as receive a brief pay
      decrease for any positive urine samples for both cocaine and methadone.
    

Intervention name(s): methadone contingency; Methadone & Abstinence Contingency
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.; Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace and they had to provide opiate and cocaine negative urine samples to maintain the maximum pay.
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL
      cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other
      lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive
      compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol,
      as well as blood pressure and arterial health.
    

Detailed description: 
      The proposed study design is a 3-period randomized crossover dose-response study to evaluate
      the effect of freeze dried strawberry powder supplementation on LDL-C and vascular health.
      Research participants will be overweight or obese (BMI 25-39 kg/m^2) but otherwise healthy
      adults with moderately elevated LDL-C (>116 mg/dL or >3.0mmol/L), blood pressure <160/100
      mmHg, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, and
      triglycerides below 350 mg/dL. Subjects will be randomly assigned to three supplementation
      periods: 1) low dose freeze dried strawberry powder (13 g/d); 2) high dose freeze dried
      strawberry powder (40 g/d); and 3) a placebo powder. Each powder will be provided for 4-6
      weeks, separated by a 2-week washout period between treatment periods. Baseline and endpoint
      testing will include blood collection and vascular testing.
    

Intervention name(s): Low Dose Strawberry Powder; High Dose Strawberry Powder; Placebo Powder
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder; 40 g freeze dried strawberry powder; 40 g color and taste matched placebo powder
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Strawberry Powder; Cardiovascular Disease Risk Factors
A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
Condition: Dental Plaque; Dental Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed
      toothpaste and manual toothbrush.
    


Intervention name(s): China Crest® Pro-health 7 Complete Toothpaste; China Crest® Cavity Protection Toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse; Crest® meliliangje manual toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg
      (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar
      extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg
      tablets) in a sub-group of subjects.
    


Intervention name(s): Acetaminophen ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose (2 tablets) Acetaminophen ER 750 mg; Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acetaminophen; Paracetamol Analgesics; Analgesics; Non-Narcotic Pain; Postoperative Pain; Antipyretics Dental Surgery; Third molar extraction
A Primary Care Educational Intervention for Families of Overweight Children
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the research is to find out if an educational booklet is helpful to families
      with overweight children. The educational booklet contains information for parents about
      nutritious eating, physical activity, and strategies for healthy living.
    

Detailed description: 
      The prevalence of overweight among children has at least doubled in the past 25 years. In the
      year 2004, 18.8% of children ages 6-11 were overweight. Being overweight as a child is
      clearly associated with adulthood obesity. In addition, complications once prevalent only in
      adults are now being seen in overweight children and adolescents. These include hypertension,
      hypercholesterolemia, and type II diabetes which are well known risk factors for
      cardiovascular disease. Obesity is also associated with low self-esteem among some groups of
      overweight adolescents.

      Primary care providers are in a unique position to combat this epidemic. However, a recent
      survey found that only 12% of pediatricians felt highly effective in their ability to treat
      obesity. Furthermore, physicians reported that low self-efficacy in treating obesity was
      associated with a lack of patient educational materials. Few written resources for families
      of overweight children have been tested in the primary care setting. Much of the research on
      childhood overweight has been conducted in specialty obesity clinics where the resources and
      patient population may differ from those of primary care offices.

      Kid STRIDE is an educational booklet designed for parents of overweight children. It includes
      information about nutrition, physical activity, and strategies for healthy living. It is
      hypothesized that the booklet will be distributed to and used by parents of children who are
      overweight or at risk for overweight. This study will analyze parents' perceptions of this
      booklet in order to improve its potential value. Information obtained from this pilot study
      will be used to prepare for a future study to determine the effectiveness of this
      intervention.

      The purpose of this study is:

      Aim 1 is to determine the distribution rate and uptake rate of an educational booklet for
      parents of children between the ages of 8 and 12 who are overweight.

      Aim 2 is to describe parents' perceptions of the educational booklet.

      Aim 3 is to assess the impact of the intervention on BMI as measured by change in BMI
      z-score.
    

Intervention name(s): Educational booklet
Intervention type(s): Behavioral
Intervention description(s): Parental perception of educational booklet and evaluating any change in child's weight.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Overweight
Taste Disorders and Their Relation to BMI, FFQ, and EORTC QLQ-BR23 in Breast Cancer Patients During Chemotherapy.
Condition: Breast Cancer; Taste Disorders; Dysgeusia; Ageusia; Quality of Life
MeSH terms: Breast Neoplasms; Taste Disorders; Dysgeusia; Ageusia
Study type: Observational

Summary: 
      Taste disorders in cancer patients during chemotherapy could be consider as multifactorial
      disease, it is related with changes of food consumption. Approximately 36-69% of the patients
      under chemotherapy suffer oral toxicity or dysgeusia

      A prospective case- only observational study was conducted in patients of the Hospital
      General de México for two years. A self-reported taste survey was used, and patients scored
      their results in a Likert scale.
    


Intervention name(s): Taste disorder´s test
Intervention type(s): Other
Intervention description(s): Each patient performed their own test placing three drops with a disposable dropper from each bottle into the center of the tongue for whole-mouth testing.
Other intervention name(s): Taste disorders
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of Oncology ward in Hospital General de Mexico between 20 and 60 years old with
        newly diagnosed breast cancer.

        and chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC)
        or Docetaxel.
An Open, Randomized, Multicentre, Phase II Pilot Study
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate efficacy, safety and quality of life adjuvant
      docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely
      resected NSCLC Stage I-II.
    

Detailed description: 
      Open multicentre, centrally randomized, two-arm parallel-group, phase II pilot-study.
      Duration of the Treatment : Arm A - will be 4-6 cycles Docetaxel 75mg/m2 and Cisplatin
      75mg/m2 on day 1 every 21 days.

      Arm B untreated control group - best supportive care. A follow-up check-up examination will
      be performed every 3 months for a total of three years.
    

Intervention name(s): Docetaxel; Docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel (Taxotere) 75 mg/m² as a 1 hour i.v. infusion, followed immediately by cisplatin 75 mg/m² as a 1 hour i.v. infusion, on day 1 every 21 days for 6 cycles.
Dose reductions and/or treatment delays or discontinuation of treatment are planned for arm A in case of severe haematological and/or non haematological toxicities.
Premedication:
Dexamethasone 8 mg p.o. (or any other steroid commonly used) will be given -12 h, -3 h, -1 h before start of docetaxel infusion, then + 12 h, +24 h and + 36 h post infusion.
All patients should receive a prophylactic antiemetic premedication to prevent nausea and vomitus, which includes a 5-HT3 antagonist prior to start of each docetaxel infusion.
Hyperhydration Patients will require intravenous hydration according to institutional guidelines.
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSCLC; Docetaxel
Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy Young Individuals
Condition: Dietary Supplementation
Study type: Interventional

Summary: 
      The aim of this study was to determine whether grape seed extract (GSE) supplementation could
      reduce the blood pressure (BP) in response to static exercise and post exercise muscular
      ischemia (PEMI) in normotensive young adults. In 12 healthy subjects (7 male and 5 female,
      24.6±3.4 yr), we compared acute effect of both GSE (600 mg) and placebo (PL: 600 mg) on
      changes from rest in systolic BP (SBP), diastolic BP (DBP), mean arterial pressure (MAP),
      heart rate (HR), stroke volume (SV), cardiac output (CO), and total peripheral resistance
      (TPR) during static exercise (SE) and PEMI. Subjects completed 2 min of SE at 30% of maximal
      voluntary contraction (MVC) followed by 2 min of PEMI.
    


Intervention name(s): Grape seed extract
Intervention type(s): Dietary Supplement
Intervention description(s): Acute effect of dietary supplementation with GSE on hemodynamic responses during static exercise and muscle metaboreflex and during cycling exercise.
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention