bioihbjkbjnl/mcl2 huggingface dataset:
Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)
Condition: Blister of Foot
MeSH terms: Blister
Study type: Interventional

Summary: 
      Friction foot blisters are one of the most common and often debilitating complaints of all
      athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor
      hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine whether
      applying paper tape to the areas of the foot where blisters historically occur in endurance
      runners can prevent the incidence of friction blisters.
    

Detailed description: 
      Participants will be ultra-endurance athletes competing in Racing the Planet's 250 mile/7 day
      4 Desert events in 2014 (Jordan, Gobi, Madagascar, and Atacama. A convenience sample will be
      used, with full consent signed before inclusion into the study, with participants being
      informed that study inclusion is entirely optional and will not affect medical care.
      Randomization will be conducted for each participant, a coin will be flipped to determine
      which foot is to be taped, heads - right foot, and tails, left foot. The non-taped foot will
      be used as a control. The runner's normal sock/shoe system will be used to reflect natural
      wilderness conditions. Participants will have demographic data collected prior to the race,
      including age, gender, country of origin, number of marathons run prior, pack weight, and
      sock type. The study endpoint occurs when a hot spot or blister develops on either the
      treated or untreated foot. Runners will be instructed to treat suspected blisters or hot
      spots as they normally would, and to inform the study administrators the same day for visual
      inspection and final questionnaire to determine if they develop blisters or hot spots,
      whether they applied or re-applied tape themselves, removed tape, and the reasons for these
      actions.

      Participants will have tape applied to area(s) prone to blister on 1 foot, if no blister
      history, 1 area will be randomly assigned. The tape will be left on the selected foot until a
      blister or hot spot develops on either foot or the end of the race, whichever comes first. At
      that point, the study is over and the participant can continue or stop taping at their
      choice. If participants are prone to blisters or hot spots in particular areas, 1" paper tape
      applied to that site on trial foot. However, if the participant has no previous blister or
      hot spot experience, a site will be randomly assigned by picking a piece of paper out of a
      bag with the site written on a piece of paper (heel, toe, instep, head of 5th metatarsal).
      Therefore, a single participant can have more than 1 site on an individual foot.
    

Intervention name(s): Paper Tape
Intervention type(s): Device
Intervention description(s): Applied to blister prone areas of the foot
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the feasibility and efficacy of a virtual reality
      program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.
    

Detailed description: 
      Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled
      virtual environment; i.e., one in which the different components (constraints) of the
      environment can be displayed, graded, changed and monitored in a quantitative manner.

      Small preliminary studies suggest that VR may be used to augment chronic stroke
      rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility
      and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate
      chronic gait deficits after stroke. Study design-a single center randomized controlled trial
      of an experimental group and a usual care group.
    

Intervention name(s): Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).
Intervention type(s): Device
Intervention description(s): Training 2/w for 9 weeks (total 18 sessions).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke chronic gait deficits virtual reality training
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and
      subtropical regions of the world. The purpose of this study is to evaluate the safety and
      immune response to the dengue vaccine DEN4delta30-4995 in healthy adults.
    

Detailed description: 
      Dengue viruses account for more than 50 million cases of dengue fever and a half million
      cases of the more severe disease, dengue hemorrhagic fever/dengue shock syndrome. Infection
      with dengue viruses is the leading cause of hospitalization and death in children in at least
      eight Asian countries. The goal of producing a vaccine against dengue fever is to induce a
      long-lived antibody response against all four dengue serotypes. The rDEN4delta30-4995 vaccine
      candidate is a live attenuated recombinant virus derived from rDEN4delta30 for protection
      against dengue virus serotype 4. The purpose of this study is to evaluate the safety,
      reactogenicity, and immunogenicity of rDEN4delta30-4995 in healthy adults.

      This study will last 180 days (6 months). Participants in Cohort 1 will be randomly assigned
      to receive the highest dose of rDEN4delta30 or placebo at study entry. Participants in Cohort
      2 will be randomly assigned to receive a lower dose of rDEN4delta30 or placebo. Participants
      in Cohort 3 will be randomly assigned to receive the lowest dose of rDEN4delta30 or placebo.
      Cohorts 2 and 3 will begin after a safety review of all participants in the previous cohort.

      After initial vaccination, participants in Cohort 1 will be followed every other day for the
      first 16 days of the study, monitoring their temperature three times a day through Day 16 and
      recording these measurements in a diary. After Day 16, study visits will occur on Days 21,
      28, 42, and 180 and will include a physical exam and blood collection. Some participants will
      also be asked to undergo a skin biopsy or additional blood collection at selected visits.
    

Intervention name(s): rDEN4delta30-4995; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated rDEN4delta30-4995 vaccine (one of three doses); Placebo for rDEN4delta30-4995
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue Vaccine; Dengue Virus; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
Condition: Atypical Squamous Cells of Undetermined Significance; Cervical Cancer; High-grade Squamous Intraepithelial Lesion; Low-grade Squamous Intraepithelial Lesion
MeSH terms: Squamous Intraepithelial Lesions of the Cervix; Atypical Squamous Cells of the Cervix
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a
      placebo in treating human papillomavirus and preventing cervical cancer in patients with
      abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune
      response to kill human papillomavirus and abnormal cervical cells and may be effective in
      preventing cervical cancer
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Compare the effectiveness of SGN-00101 vaccine vs placebo in reducing the human
      papillomavirus (HPV)-16 viral load in patients with atypical squamous cells of undetermined
      significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) of the cervix with
      persistent HPV-16 infection who are at increased risk for developing a high-grade squamous
      intraepithelial lesion or invasive cervical cancer.

      II. Compare the natural history of HPV-16 viral load in patients treated with these regimens.

      III. Compare the effect of HPV-16 variants on viral load response in patients treated with
      these regimens.

      IV. Compare the relative effectiveness of these regimens on the regression of cervical
      cellular atypias (based on Pap test results), in terms of the regression of cytologic
      findings of LSIL and ASCUS to normal findings and resolution or regression of colposcopically
      defined cervicovaginal lesions, in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive SGN-00101 vaccine subcutaneously (SC) on day 1 of weeks 1, 4, and 8
      for a maximum of 3 injections in the absence of unacceptable toxicity or the development of
      an invasive malignancy or serious illness.

      ARM II: Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3
      injections in the absence of unacceptable toxicity or the development of an invasive
      malignancy or serious illness.

      Patients are followed at 12, 24, and 52 weeks after the last vaccination.
    

Intervention name(s): HspE7; placebo; laboratory biomarker analysis
Intervention type(s): Biological; Other; Other
Intervention description(s): Given SC; Given SC; Correlative studies
Other intervention name(s): HPV 16 E7/HSP65 Vaccine; HPV E7 Peptide Epitope Vaccine; SGN-00101; PLCB
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of aspirin may be an effective way to prevent
      the recurrence of polyps in colorectal cancer.

      PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating
      patients who have stage I, stage II, or stage III colorectal cancer that has been surgically
      removed.
    

Detailed description: 
      OBJECTIVES: I. Determine whether aspirin administered at a dose of 325 mg/day will decrease
      the number and size of new adenomas in patients with Dukes' A/B1/B2/C colorectal cancer who
      have undergone curative surgical resection. II. Assess whether this dose of aspirin will
      increase disease-free survival in these patients.

      OUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA,
      NSC-27223. Arm II: Control. Placebo, PLCB.
    

Intervention name(s): aspirin; placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: colon cancer; rectal cancer
Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      High blood glucose levels in hospitalized patients with diabetes are associated with
      increased risk of medical complications. Improved glucose control with insulin injections may
      improve clinical outcome and prevent some of the hospital complications. It is not known;
      however, what is the best insulin regimen in hospitalized patients. Recently, the use of
      basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart,
      glulisine) has been shown to facilitate outpatient glycemic control with lower rate of
      hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will
      determine the efficacy and safety of the combination of detemir and aspart insulin in the
      inpatient management of subjects with diabetes. We hypothesize that in patients with type 2
      diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus
      insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic
      events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a
      long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a
      rapid-acting insulin which is given subcutaneously several times a day and frequently before
      meals. Detemir and aspart insulins are approved for use in the treatment of patients with
      diabetes by the FDA.

      This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta
      and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will
      serve as principal investigator. A total of 65 patients will be recruited at Grady and 65
      patients at the Rush University Medical Center, Chicago, IL.
    


Intervention name(s): Detemir + aspart insulin before meals; NPH insulin + regular insulin
Intervention type(s): Drug; Drug
Intervention description(s): Detemir insulin SQ once daily + aspart insulin SQ before meals; NPH insulin SQ + regular insulin SQ before breakfast and dinner
Other intervention name(s): levemir; novolog; novolin N; novolin R
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; inpatient hyperglycemia; SQ insulin; Hospitalized patients with type 2 diabetes
Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension
Condition: Overweight and Obesity
MeSH terms: Hypertension; Overweight
Study type: Interventional

Summary: 
      To determine the efficacy of Palatinose versus sucrose on Flow Mediated Dilation (FMD) in
      healthy subjects with mild hypertension.
    


Intervention name(s): isomaltulose; sucrose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): replacement of sucrose with low-glycemic isomaltulose; conventional beverage with sucrose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glycemic Index; Overweight; Endothelial function; carbohydrate
Use of NPSP558 in the Treatment of Hypoparathyroidism
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 3

Summary: 
      Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with
      hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D
      supplements.
    

Detailed description: 
      Patients with a history of hypoparathyroidism will be randomized to receive placebo or study
      drug for 24 weeks, which will be injected daily in either thigh. During that time they will
      be monitored for safety (specifically, calcium levels in the blood and urine). In addition,
      the patients' intake of Vitamin D and calcium will be measured.
    

Intervention name(s): Placebo; NPSP558
Intervention type(s): Drug; Drug
Intervention description(s): Placebo for subcutaneous injection; Parathyroid hormone 50, 75, or 100 mcg injectable subcutaneously daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypoparathyroidism
Design and Development of a Mobile App to Improve Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men
Condition: HIV Infections; Pre-Exposure Prophylaxis
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study is testing feasibility and acceptability of a theoretically based mobile
      application (app), UPrEPU, to increase adherence to pre-exposure prophylaxis (PrEP) among men
      who have sex with men (MSM) to prevent human immunodeficiency virus (HIV).
    

Detailed description: 
      This study aims to develop an effective mobile application (app), UPrEPU to recognize the
      factors and decisions that affect PrEP adherence in high-risk populations to improve PrEP
      adherence. Key components of the app include a sex/PrEP diary using ecological momentary
      assessment to facilitate accurate data collection; PrEP taking reminder; HIV and sexually
      transmitted infections (STI) testing information and reminders; HIV and PrEP information and
      videos; geo-location.

      After eligible PrEP candidates agree to participate in the study, we will ask participants to
      install the app. Then, we will begin to collect their sexual diary and PrEP taking log via
      ecological momentary assessment. Participants will also complete monthly assessments. The
      monthly follow-up will test HIV/STI and drug concentration. The participants will be
      interviewed for difficulties when they use our app and giving feedback on it.
    

Intervention name(s): mobile app to improve adherence to PrEP self-management
Intervention type(s): Behavioral
Intervention description(s): Access to the mobile app which includes the sex and PrEP diary, information on HIV/STI testing, PrEP reminders and geo-location features.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non
      adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.

      Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at
      delivery and recording temperature and vaccine side effects in a memory aid for 7 days
      following each vaccination. Participants will be involved in study related procedures about 3
      at 5 months.
    


Intervention name(s): Non-adjuvanted A(H1N1)v influenza vaccine
Intervention type(s): Biological
Intervention description(s): 15 mcg HA/0.5 ml
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Vaccine; Pregnancy
Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors
Condition: Neuroblastoma; Rhabdomyosarcoma; Osteosarcoma; Ewing Sarcoma; Wilms Tumor; Desmoplastic Small Round Cell Tumor
MeSH terms: Neoplasms; Sarcoma; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Wilms Tumor; Desmoplastic Small Round Cell Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to
      characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor
      activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses
      (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or
      refractory malignant solid tumors.
    

Detailed description: 
      This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to
      characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor
      activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses
      (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or
      refractory malignant solid tumors.

      The study consists of a Dose Escalation Phase to determine the MTD (or MAD) of enoblituzumab
      followed by a Cohort Expansion Phase to further define the safety and initial antitumor
      activity of enoblituzumab. In the cohort expansion phase, 5 cohorts of 10 patients each will
      be enrolled to further evaluate the safety and potential efficacy of enoblituzumab
      administered at the MTD/MAD in patients with:1) neuroblastoma - measurable disease, 2)
      neuroblastoma - non-measurable disease, 3) rhabdomyosarcoma, 4) osteosarcoma, and 5) Ewing's
      sarcoma, Wilms' tumor, desmoplastic small round cell tumors, or malignant solid tumors of any
      other histology that test positive for B7-H3.

      All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid
      Tumors (RECIST) and immune-related response criteria (irRC). Disease assessment in patients
      with neuroblastoma will use neuroblastoma overall response criteria.
    

Intervention name(s): Enoblituzumab
Intervention type(s): Drug
Intervention description(s): enoblituzumab administered IV weekly for up to 96 weeks
Other intervention name(s): MGA271
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuroblastoma; Rhabdomyosarcoma; Osteosarcoma; Ewing Sarcoma; Wilms Tumor; Desmoplastic Small Round Cell Tumor; pediatric
Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment.
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim to compare Incidence of flare-ups and apical healing after single-visit or two-visits
      treatment of teeth with necrotic pulp and apical periodontitis after a two-year control
      period.

      110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working
      length was established with EAL and confirmed radiographically. M4 system with Flex-R files
      were used to complete canal preparation. Level of discomfort were recorded and cases with
      severe postoperative pain and/or swelling were classified as flare-ups.
    

Detailed description: 
      110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working
      length was established with EAL and confirmed radiographically. M4 system with Flex-R files
      were used to complete canal preparation. Level of discomfort were recorded and cases with
      severe postoperative pain and/or swelling were classified as flare-ups.
    

Intervention name(s): Ibuprofen for post operative pain; Acetaminophen 325 mg for Flare up
Intervention type(s): Procedure; Drug
Intervention description(s): All treatment sessions were approximately 50 minutes in length to allow for acceptable time for completion of treatment and retreatment in one or two visits. All the clinical procedures were performed by the author. Following local anesthesia with 2% lidocaine with 1:100,000 epinephrine (Septodont Saint-Maur des Fossés, France) and rubber dam isolation the tooth was disinfected with 5.25% NaOCl (Ultra bleach, Bentonville, AR, USA).; Each patient will be evaluated a week after completion the clinical procedures.
Other intervention name(s): Endodontic therapy; Endodontic procedures
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain