bioihbjkbjnl/mcl2 huggingface dataset:
Physical Activity Intervention for Young Cancer Survivors
Condition: Breast Cancer; Quality of Life; Physical Activity
Study type: Interventional

Summary: 
      The proposed mixed methods pilot study will enroll 20 young breast cancer survivors into a
      12-week technology-based, remotely-delivered, peer-moderated physical activity program to
      examine the effects of the intervention on objectively measured physical activity and
      multiple aspects of quality of life; and conduct qualitative analyses to refine the
      intervention for a future randomized controlled trial.
    

Detailed description: 
      Young breast cancer survivors (i.e. those < 50 years old) have lower survival rates than
      their older counterparts and experience unique physical and mental challenges associated with
      their cancer treatments. Depression, anxiety, and poor body image are common in young breast
      cancer survivors. Research in older breast cancer survivors has shown that physical activity
      can decrease cancer recurrence and mortality, and improve many aspects of quality of life.
      Few physical activity intervention studies have been conducted in young breast cancer
      survivors, despite the fact that young survivors would be best served by age-specific
      interventions designed to target their needs. Remotely-delivered, technology-based
      interventions may be important to help young breast cancer survivors overcome unique barriers
      to increasing physical activity and improving quality of life.

      The study aims are: 1) Explore the feasibility and acceptability of a technology-based,
      remotely-delivered, peer-moderated physical activity intervention for young breast cancer
      survivors; 2a) Assess the invention's impact on change in physical activity; and 2b) Measure
      the intervention's effect on multiple aspects of quality of life
    

Intervention name(s): Exercise Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will use peer mentors, motivational interviewing, and technology (Fitbit, Fitbit Coach App, & Fitbit message board) to support behavior change. All participants will receive phone or video calls from their peer mentors every other week, and interact with their peer mentor and other participants through a private Fitbit message board at least weekly. Peer mentors will use Fitbit data to identify participants who need additional support to increase their activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Remote Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      In recent several clinical trials, remote preconditioning showed very powerful myocardial
      protection. However, the myocardial protective effect by remote preconditioning was not
      evaluated on the patients undergoing off pump coronary artery bypass graft surgery (OPCAB).

      The investigators hypothesized that the lower limb remote preconditioning could protect the
      myocardium during the OPCAB. In this study, the investigators will try to evaluate whether
      remote preconditioning could induce myocardial protection on the OPCAB patients.
    

Detailed description: 
      In recent two clinical trials on the patients undergoing cardiac surgery, remote
      preconditioning showed very powerful myocardial protection by simple and safe procedures such
      as the brief inflation of pneumatic tourniquet on the upper or lower limb. However, despite
      these impressive results, the clinical studies are lacking yet. Moreover, two previous
      studies were done on the cardiac surgery with cardiopulmonary bypass. Considering different
      mechanism, level of myocardial injury and the increasing popularity of OPCAB, we need the
      clinical study on remote preconditioning with the OPCAB patients.

      In this study, we will conduct randomized controlled clinical trials in which the remote
      preconditioning was induced by lower limb ischemia with double-blinded technique. Myocardial
      injury will be assessed by postoperative serum troponin I levels and they will be compared
      with those of control group.
    

Intervention name(s): remote ischemic preconditioning
Intervention type(s): Procedure
Intervention description(s): remote ischemic preconditioning (4 x 5 min lower limb ischemia with pneumatic cuff up to 200 mmHg with an intervening 5 min reperfusion; 2 cycles; before and after the coronary anastomosis )
Other intervention name(s): Blood pressure pneumatic cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: OPCAB; RIPC
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit
      vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior
      history of TB disease or known prior exposure to TB
    


Intervention name(s): 50 microgram antigen (Ag85B + ESAT-6); 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a; 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL suspension for injection x 2 with 2 months interval; 0.5 mL suspension for injection x 2 with 2 months interval; 0.5 mL suspension for injection x 2 with 2 months interval
Other intervention name(s): Antigen H1; Antigen H1 + IC31; Antigen H1 + IC31
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Vaccine; Ag85B; ESAT-6; IC31
Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis
Condition: Dehydration; Acute Gastroenteritis
MeSH terms: Gastroenteritis; Dehydration
Study type: Interventional

Summary: 
      The purpose of the study is assessment of volume status by bedside ultrasound in children
      with acute gastroenteritis
    

Detailed description: 
      The research will be conducted of emergency medicine department in the Derince Training and
      Research Hospital. Patients referred to acute gastroenteritis will be included to the study.
      After initial evaluation, the clinician will inform the principal investigator about the
      patient. The principal investigator will record the patient's demographic data, contact
      information, vital signs, history, physical examination findings, and weight. Than expirium
      and inspirium diameters of vena cava inferior will be measured with the bedside ultrasound
      and caval index will be calculated. An investigator who have had an ultrasound certification
      by Emergency Medicine Association of Turkey for six years will make the measurements. After 1
      week the patient will called up for re-evaluation. Applicants' weights will be measured again
      with the same weighing machine. The differences between initial and after one week weight
      measurement will be accepted as the gold standard method for volume loss. The weight loss of
      the patient, the dehydration findings detected on physical examination and the caval index
      will be compared.

      Data will be collected on predesigned data sheets, by an investigator and subsequently will
      be entered into a spreadsheet (Excel 2007; Microsoft, Redmond, WA). All recorded data will be
      checked by an another investigator to identify possible errors. Results will be submitted at
      least every two months.

      Linear regression will be performed with dehydration as the dependent variable and the caval
      index as the independent variable.
    

Intervention name(s): Measurement of inferior vena cava diameters with ultrasound
Intervention type(s): Device
Intervention description(s): The patient is placed in the supine position. Curvilinear probe is used. Subxiphoid view is obtained. The IVC is visualized in the longitudinal plane as it enters the right atrium. The diameter of the IVC for calculation of the caval index is measured 2 cm from where it enters the right atrium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ultrasound; pediatrics; gastroenteritis
Treatment of Advanced Solid Tumors With TSA-CTL(Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes)
Condition: Solid Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety of TSA-CTL in the treatment of
      advanced solid tumors.

      The secondary objective of this study is to evaluate preliminarily the effect of TSA-CTL in
      the treatment of advanced solid tumors.
    

Detailed description: 
      This is a single arm, open label and non-randomized clinical study with two parts.

      In Part 1, 9 subjects with advanced solid tumors will be enrolled into Groups A (no
      non-myeloablative lymphodepletion), B and C (non-myeloablative lymphodepletion with different
      chemotherapy intensities) to assess the safety and dose intensity of non-myeloablative
      lymphodepletion chemotherapy before cell infusion.

      Depending on results in Part 1, the study may proceed to Part 2, where 15 subjects with
      advanced solid tumors will be enrolled to receive TSA-CTL cell infusions with or without
      non-myeloablative lymphodepletion.
    

Intervention name(s): TSA-CTL; Cyclophosphamide; Fludarabine; Cyclophosphamide
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Patients will receive TSA-CTL iv over 20-30 minutes on day 0.; Cyclophosphamide 500 mg/m2/day iv on day -5 for one day.; Fludarabine 25 mg/m2/day iv over 30 minutes on day -5 and -4 for two days.; Cyclophosphamide 500 mg/m2/day iv on day -5 and -4 for two days.
Other intervention name(s): Tumor Specific Antigen Induced Cytotoxic Lymphocyte; Cytoxan; Fludarabine Phosphate; Cytoxan
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Fludarabine phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Melanoma; Colorectal Cancer; neoantigen
Peripheral Intravenous Puncture Guided by Vascular Ultrasound
Condition: Intravenous Puncture Assertivity; Intravenous Puncture Guided by Vascular Ultrasound; Intravenous Therapy Complications
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This research, aimed to verify whether the use of vascular ultrasonography (VUS) could lead
      to better results in the peripheral venous access implementation in children.

      Objectives: To compare, regardless of the number of venous puncture attempts, peripheral
      venous access obtained in children, according to VUS use or traditional method for peripheral
      intravenous catheter (PIC) insertion; assertiveness in the use of PIC in children, defined as
      success in the first attempt of puncture and PIC withdrawal according to release of
      treatment, related to VUS or traditional method and to describe the influence of VUS on PIC
      dwell time and development of local complications related to the use of intravenous therapy
      in children.
    

Detailed description: 
      Clinical, randomized and controlled trial, conducted in a pediatric surgery ward of a
      university hospital in São Paulo. Data collection occurred from February 26th, 2007 to July
      07th, 2008, after ethical merits of research approval. The sample comprised 382 venous
      puncture randomly allocated in the experimental group (EG), venous puncture guided by VUS, or
      in the control group (CG), traditional method of venous puncture. Variables related to
      children, intravenous therapy and professional characterization were collected. The dependent
      variables included the obtainment of peripheral venous access, the assertiveness, the
      catheter dwell time and the occurrence of local complications. For the statistical analysis
      were applied the Pearson Chi-square, Fisher's Exact, Generalization of Fisher's exact,
      Mann-Whitney, Likelihood Ratio and Prevalence Ratio (significance level of 5%).
    

Intervention name(s): IV puncture guided by ultrasound
Intervention type(s): Procedure
Intervention description(s): Comparisons between traditional and ultrasound group
Other intervention name(s): vascular ultrasound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: pediatric nursing; peripheral catheterization; ultrasonics; intravenous infusions
Xolair Treatment for Milk Allergic Children
Condition: Milk Allergy
MeSH terms: Milk Hypersensitivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a pilot feasibility study, using Xolair pretreatment for oral milk desensitization.
      The major assessment will be safety, and the investigators will evaluate for any type of
      reaction, including allergic reactions that occur during the course of the study.
    

Detailed description: 
      Our hypothesis is that pretreatment with anti-IgE mAb will greatly reduce the side effects
      and allergic reactions that occur during oral desensitization to foods and will enhance the
      development of oral tolerance in patients with severe milk allergy. Once desensitized to
      milk, children will be able to tolerate milk in a Double Blind Placebo Controlled Food
      Challenge.

      The study will also evaluate whether Xolair provides a robust durability of tolerance once
      administration of Xolair is terminated. We will examine the specific immunological mechanisms
      that mediate oral tolerance in children undergoing oral milk desensitization

      The trial will be conducted in three parts: (1) pre-treatment with Xolair for 8 weeks, (2)
      oral desensitization to cow's milk from weeks 9-16 and continued treatment with Xolair for 8
      weeks, and (3) double blind placebo controlled food challenge to milk.
    

Intervention name(s): omalizumab
Intervention type(s): Drug
Intervention description(s): Dosing table established for omalizumab
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Milk Allergy
PACT (Platelet Activity After Clopidogrel Termination)
Condition: Blood Platelets; Clopidogrel
Study type: Interventional

Summary: 
      Clopidogrel is a medication that is used to decrease the ability of platelets to form blood
      clots.

      The theory has been proposed that, in patients with coronary artery disease or stroke,
      increased platelet function after discontinuation of clopidogrel therapy is associated with
      an increased clotting risk. However, this theory has never been rigorously tested.

      The goal of this research is to determine whether discontinuation of clopidogrel results in
      increased platelet function.
    

Detailed description: 
      In this study, we will address the question: does discontinuation of clopidogrel result in
      platelet hyperreactivity? We will perform a double-blind, placebo-controlled, crossover study
      in normal subjects, in whom platelet reactivity will be measured before clopidogrel or
      placebo, during clopidogrel or placebo, and at various time points after discontinuation of
      clopidogrel or placebo. The dose of clopidogrel will be the standard, FDA-approved dose: 75
      mg daily. All subjects will be treated with aspirin 81 mg daily throughout the 57 days of
      study assessment in both the clopidogrel arm and the placebo arm, because the clinically
      relevant question is: in patients who remain on aspirin, does discontinuation of clopidogrel
      result in platelet hyperreactivity?
    

Intervention name(s): clopidogrel + aspirin; placebo; Aspirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clopidogrel 75mg plus aspirin 81mg, tablet by mouth daily for 14 days.; Placebo plus aspirin 81 mg, tablet by mouth daily for 14 days.; Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14.
Other intervention name(s): Plavix; aspirin; aspirin
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: blood platelets; platelet aggregation inhibitors; antiplatelet drugs; clopidogrel
Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester
Condition: Dyslipidemias; Hypercholesterolemia; Hyperlipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias
Study type: Interventional

Summary: 
      Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.
      LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols
      as esters per day) is less well known.
    


Intervention name(s): Plant stanol ester; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Prism Adaptation Treatment of Parkinson's Disease
Condition: Parkinson
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Subjects diagnosed with Idiopathic Parkinson's Disease, between ages of 40-85 inclusive, who
      have been referred for gait training. Since there can be subtle differences in the brain
      organization of left- and right-handed people that may influence some of the measurements,
      right handed participants are preferred. However, a left handed participant may be
      considered. Participants will be randomly assigned to one of two groups to undergo two weeks
      of twice-daily sessions. Group A receiving goggles fitted with lenses that distort vision and
      Group B patients receiving sham goggles
    

Detailed description: 
      The participants will be trained to undergo two daily sessions of visual adaptation at home
      for 14 consecutive days. For each adaptation session, subject will sit in a chair within
      reaching distance of a wall or cabinet upon which two dime-sized targets will be placed (one
      above the other, approximately ten inches apart). While wearing goggles, you will point
      rapidly to one target then the next, bringing the hand back to his/her torso between each
      pointing movement. They will be instructed to perform these movements "as quickly as
      possible" for a total of 50 pointing movements in each treatment session. After performing
      the 50 pointing movements, they will remove their goggles. Throughout the treatment period
      they will be asked to keep a diary in which they will log the time and duration of each prism
      adaptation session. At the first and second site visits, participants will be assessed for
      posture, gait and activities of daily living which will include some questionnaires.
      Questionnaires will be sent via mail after post-treatment at one week,1 month and 3 months.
    

Intervention name(s): Prism adaptation
Intervention type(s): Behavioral
Intervention description(s): Prism adaptation is one type of sensorimotor adaptation. Prism adaptation described any adaptation to a prismatic shift in vision (i.e. any magnitude or direction of shift). In this study we are using adaptation to upward-shifting prisms, which induces a downward sensorimotor after-effect.
Other intervention name(s): sensorimotor adaptation, visual adaptation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: problems of gait and balance
Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Observational

Summary: 
      The research purpose of this project is to create a registry, and blood and tissue bank for
      individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and
      molecular analysis of resected pancreatic tissue prospectively collected from a cohort of
      pancreatic cancer patients.
    

Detailed description: 
      Pancreatic cancer is the fifth leading cause of cancer-related death in the United States. In
      order to improve outcomes of this disease, significant research efforts have focused on
      understanding the changes that occur in the pancreas prior to tumor occurrence. The types of
      changes most often associated with tumor have been named pancreatic intraepithelial neoplasia
      (PanIN). It is not yet clear how to identify the PanIN lesions most likely to develop into
      cancer and the length of time required for this progression. In order to evaluate these
      questions, we are interested in examining the microscopic and genetic characteristics of
      PanIN lesions in two "high-risk" patients: 1) patients who underwent surgery for pancreatic
      cancer and developed tumor recurrence after surgery and 2) patients with a strong family
      history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas
      cancer. The surgical specimens from these patients will be evaluated by a pathologist for
      evidence of widespread PanIN lesions. In addition, PanIN lesions will be tested for
      abnormalities in several major genes that are known to be important in pancreatic cancer.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are identified by a clinician as having either 1) a strong family history of
        pancreatic cancer; or 2) evidence (radiological or pathological) of local tumor recurrence
        following surgical resection, will be included in the study.
      
Biospecimen description: 
      -  Blood samples

        -  Specimens of tumors, pre-cancerous lesions, and normal tissue from patients who need to
           have endoscopy or surgery for diagnosis or treatment of tumors that develop

        -  Samples of urine and stool, and duodenal aspirates if an individual will be having an
           endoscopy
    
Keywords: Pancreatic intraepithelial neoplasia (PanIN); Pancreatic Cancer; Recurrence of pancreatic cancer; Field Effect; Genetic mutations in pancreatic cancer