bioihbjkbjnl/mcl2 huggingface dataset:
VAC071: A Study to Assess Efficacy of the ChAd63/MVA PvDBP Vaccines
Condition: Malaria, Vivax
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, Phase IIa, controlled human malaria infection (CHMI) study aimed to
      assess whether the new vivax malaria vaccines ChAd63 PvDBP and MVA PvDBP can protect against
      malaria infection.

      The participants will receive one or two doses of ChAd63 PvDBP followed by one dose of MVA
      PvDBP 8 weeks later.

      Approximately 4 weeks after the second vacccination, the volunteers will be challenged
      (deliberately infected) with malaria by intravenous injection blood-stage
    

Detailed description: 
      Volunteers will be recruited and vaccinated at the CCVTM, Oxford.

      There will be two groups vaccinated in the trial, with an optional third group included if
      fewer than 6 volunteers complete group 2. Up to 19 volunteers will be included in total.
      These will be compared to a matched number of infectivity controls, receiving no vaccination,
      who will be recruited as part of a separate study (VAC069 - NCT03797989).
    

Intervention name(s): ChAd63 PvDBP and MVA PvDBP
Intervention type(s): Biological
Intervention description(s): one dose of 5 x 10^10 vp ChAd63 PvDBP and one dose of 2 x 10^8 pfu MVA PvDBP 8 weeks later, in a heterologous prime-boost regimen.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PvDBP; efficacy
Helping Men Have Healthy Babies
Condition: HIV/AIDS; HIV Prevention
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Many men living with HIV (MLWH) want to have children. HIV-RNA suppression can minimize
      sexual HIV transmission risks while allowing for conception. The study will evaluate a safer
      conception intervention that leverages men's motivations to have healthy babies in order to
      promote serostatus disclosure and early ART initiation. The intervention is based on the
      investigators' Safer Conception Conceptual Framework, which considers individual, dyadic, and
      structural factors that affect periconception risk behavior.
    

Detailed description: 
      The study will evaluate and test a safer conception intervention that leverages men's
      motivations to have healthy babies in order to promote serostatus disclosure and early ART
      initiation. The intervention is based on a Safer Conception Conceptual Framework, which
      considers individual, dyadic, and structural factors that affect periconception risk
      behavior.

      The researchers will conduct an open pilot to refine the intervention. The study will enroll
      men who want to have children with uninfected or unknown status female partners. Men will
      participate in three study sessions offering motivational interviewing and problem solving to
      help men develop a plan to have a healthy baby. The counseling will explore safer conception
      options including safe disclosure, delaying conception attempts until on ART with viral
      suppression, STI testing and treatment, timing condomless sex to peak fertility. The primary
      outcome is HIV RNA suppression at 12 weeks. Secondary outcomes include acceptability,
      feasibility, early ART uptake, adherence, serostatus disclosure, couples HIV counseling and
      testing uptake, and limiting unprotected sex to peak fertility.
    

Intervention name(s): Safer Conception for Men with At Risk Partners
Intervention type(s): Behavioral
Intervention description(s): CBT based safer conception counseling with longitudinal follow-up and booster sessions. The primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.
Intervention model: Single Group Assignment
Intervention model description: Men will be offered 3 safer conception counseling sessions plus 2 booster sessions
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Vitamin E Fortified Whey Drink on Nutritional, Inflammatory and Oxidative Markers in Hemodialysis Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on
      nutritional status, inflammatory markers and oxidative stress in hemodialysis patients
    

Detailed description: 
      The aim of this interventional study was to evaluate the effect of vitamin E fortified whey
      drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis
      patients. 92 hemodialysis patients were selected for the study. Inclusion criteria included:
      mean age of 17-65 years old; having mild, moderate or severe malnutrition based on the SGA
      (subjective global assessment) assessment; being dialyzed at least 2 times a week for 3
      months. Exclusion criteria included: hospitalization in the last month; active infection;
      using immunosuppressant drugs or multi-vitamins; pregnancy. The Ethics Committee of Shiraz
      University of Medical Sciences reviewed and approved the protocol of this study.Informed
      consent were signed by all of them for participating in the study. Weight and height of the
      patients were recorded for BMI (body mass index) calculation. Then, all of the patients were
      assigned into 4 groups:

        1. consumption of 220 milliliters of whey drink three times a week,

        2. consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E
           three times a week,

        3. consumption of 400 milligrams of vitamin E three times a week,

        4. control group: no intervention. Patients were followed for 2 months. At the beginning
           and the end of the 2-month intervention period, 10 milliliters of blood were taken from
           all of the patients and nutritional status of the patients were assessed as the primary
           outcome. Serum levels of malondialdehyde, c-reactive protein, albumin, transferrin and
           lipoproteins were also measured. SGA, MIS and SF-12 questionnaires were filled for all
           of the patients at the beginning and the end of the study.
    

Intervention name(s): whey drink,; whey drink fortified with vitaminE; vitamin E
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): consumption of 220 milliliters of whey drink three times a week,; consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,; consumption of 400 milligrams of vitamin E three times a week,
Intervention MeSH terms: Vitamins; Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: whey protein; malnutrition; oxidative stress; hemodialysis
Johns Hopkins Interactive eGuide to Colonoscopy and Ipad Office Education to Improve Colonoscopy
Condition: Colon Cancer Screening; Colon Cancer Surveillance
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The investigators will attempt to improve the patient experience before colonoscopy. The
      investigators will provide an in-office ipad video series and an electronic web guide to help
      patients learn all the best ways to prepare for colonoscopy. The investigators will then
      follow the patients who receive this eGuide to colonoscopy and observe whether or not they
      enjoyed the additional access to information from their providers, and will monitor whether
      or not they were better prepared for their colonoscopy.
    

Detailed description: 
      This study would assess the ability of an e-intervention in patient education and
      instructions during peri-procedure and procedural day visits to improve the experience of
      gastroenterology procedures. This study would seek to show that through this alternative
      educational measure, there would be an increased show rate to colonoscopy appointments, an
      increased preparation quality, and an increase in patient understanding and satisfaction with
      the colonoscopy procedure. The investigators will attempt to track procedure completion rate
      and polyp detection rate for individual providers.

      The e-intervention would be multimodal. In the pre-procedure setting, ipad would be able to
      provide a viewpoint for the video education, a template for the patients (or caregivers) to
      send themselves links to appropriate instructions to remind them of their obligations by
      secure email. This e-intervention would supplement traditional printed and website accessible
      instructions.
    

Intervention name(s): eGuide to Colonoscopy and in office ipad education
Intervention type(s): Other
Intervention description(s): The investigators will follow patients who receive in office Ipad video education and at home web portal access to the Johns Hopkins eGuide to Colonoscopy.
Other intervention name(s): Educational intervention with eGuide to colonoscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Colonoscopy; Screening colonoscopy; Electronic education; Ipad; Patient education
Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds)
Condition: Anxiety; Pain
MeSH terms: Emergencies; Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the effectiveness of the video-based intervention over and
      above current standard practice for pain control in the pediatric emergency department (ED).
      This is a single-center trial based at the IWK Health Centre. The primary outcome will be
      based on the Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the
      video-taped pain response of the research participants (3-5 years old).
    

Detailed description: 
      The purpose of this study is to determine if the pain and anxiety that children experience
      when they have venipuncture procedures performed can be reduced by a video-based distraction
      and coping strategy intervention. An instructional video has been designed to educate parents
      and children about what is going to happen during the venipuncture procedure, to teach coping
      skills that can be used before and during the painful procedure, and to provide distraction
      during the procedure by using an entertaining video segment.

      Approximately 168 children (3-5 years of age) who are seen in the IWK ED requiring
      venipunctures for blood collection or IV starts will be randomized. Parent and child training
      in distraction and coping strategies will be provided by means of a self-administered
      video-delivery via a portable DVD player. Fifty percent of the eligible participants will
      receive the distraction and coping strategies intervention and 50% will receive the standard
      medical care provided by the IWK ED. Those receiving standard care will be evaluated for
      outcome results and then be compared to the intervention group. It is expected that children
      who receive the intervention will report less pain and anxiety associated with venipunctures
      than those who receive standard care.
    

Intervention name(s): PAT
Intervention type(s): Behavioral
Intervention description(s): Cognitive-Behavioral/Relaxation Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Anxiety; Pediatric Pain; Emergency room procedures
Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3%
      ophthalmic gel as compared to matching placebo in healthy subjects.
    

Detailed description: 
      One hundred and five (105) healthy male and female subjects will be randomised in a 4:1 ratio
      to receive a single ocular instillation of Chloroprocaine 3% ophthalmic gel or matching
      placebo (vehicle) (84 subjects will receive chloroprocaine and 21 subjects will receive
      placebo). The assigned investigational product (3 drops) will be instilled in the right eye
      of each subject. Administrations will be performed at the clinical centre by the Investigator
      or his deputy on study day 1. For each administration, the 3 drops will be instilled at a 1
      min ± 15 sec interval.
    

Intervention name(s): Ocular gel
Intervention type(s): Drug
Intervention description(s): 3 drops instilled in the right eye
Other intervention name(s): No other intervention names
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination
      with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with
      metastatic pancreatic cancer.
    

Detailed description: 
      The study is being done in 2 parts. The first part is the dose escalation (Phase I) part of
      the study where the dose of irinotecan is increased until the highest safe dose of irinotecan
      is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin.

      After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and
      cisplatin is defined, the second part of the study (Phase 2) will use these defined doses to
      look at how effective these drugs are against advanced pancreatic cancer.
    

Intervention name(s): Gemcitabine; Taxotere; Xeloda; Cisplatin; Irinotecan
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV on days 4 and 11 of a 21 day cycle; IV on days 4 and 11 of a 21 day cycle; Twice a day orally on days 1 through 14 of a 21 day cycle; IV on days 4 and 11 of a 21 day cycle; IV on days 4 and 11 of a 21 day cycle
Other intervention name(s): Gemzar; Docetaxel; Capecitabine; Platinol; Camptosar
Intervention MeSH terms: Gemcitabine; Docetaxel; Capecitabine; Irinotecan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 BA Study, Single Center With Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single dose in healthy volunteers to assess bioavailability (amount of study drug in the
      system) between different formulations of ABT-874.
    


Intervention name(s): ABT-874
Intervention type(s): Drug
Intervention description(s): See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Open Label; Healthy Volunteers
Heart Rate Variability Biofeedback for Smoking Cessation Treatment
Condition: Tobacco Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to conduct an open trial examining the feasibility and
      acceptability of a refined heart rate variability biofeedback and smoking cessation treatment
      using a hybrid model wherein individuals receive the majority of the intervention virtually.
    

Detailed description: 
      The present investigation is an open trial investigating the feasibility and acceptability of
      heart rate variability biofeedback smoking cessation treatment (HRVB-SCT) for individuals who
      smoke cigarettes. Significant findings will also support the expansion of HRVB as a
      transdiagnostic treatment adjunct that alters cardiac vagal functioning to promote emotional
      and behavioral regulation, changing the status quo of cognitive-behavioral intervention
      approaches and decreasing the health and economic burden of smokers who suffer from emotional
      distress.

      The goals are to: (a) assess the feasibility and acceptability of the HRVB-SCT intervention
      (b) assess the efficacy of the intervention in modifying smoking behavior and emotional
      distress; and (c) collect additional information to assist in further refining the
      intervention for a larger R01 RCT.
    

Intervention name(s): Cognitive-Behavioral Smoking Cessation; Heart Rate Variability Biofeedback; Nicotine patch
Intervention type(s): Behavioral; Biological; Drug
Intervention description(s): Participants will be provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.; Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.; All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Other intervention name(s): Cognitive-behavioral therapy; Smoking cessation counseling; Biofeedback; Respiratory biofeedback; Transdermal nicotine patch; Nicotine replacement therapy
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Intervention model description: All participants will receive individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Heart Rate Variability Biofeedback
Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
Condition: Colorectal Cancer
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was developed to test the hypothesis that the risk of colorectal cancer recurrence
      was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during
      colorectal surgery.
    

Detailed description: 
      We conducted a 4- to 8-year follow-up of 204 patients with colorectal cancer who were
      randomly assigned to 65% nitrous oxide (n=97) or nitrogen (n=107), balanced with isoflurane
      and remifentanil. The primary outcome was the time to cancer recurrence. Our primary analysis
      was a multivariable Cox-proportional-hazards regression model that included relevant baseline
      variables. In addition to treatment group, the model considered patient age, tumor grade,
      dissemination, adjacent organ invasion, vessel invasion, and the number of nodes involved.
      The study had 80% power to detect a 56% or greater reduction in recurrence rates (i.e.,
      hazard ratio of 0.44 or less) at the 0.05 significance level.
    

Intervention name(s): nitrous oxide; nitrogen
Intervention type(s): Drug; Drug
Intervention description(s): 65% nitrous oxide administered during surgery; Nitrogen administration during surgery
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: nitrous oxide; cancer recurrence; colorectal surgery
Open-label Extension Study Of RN624
Condition: Osteoarthritis; OA Knee Pain; Arthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have
      previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624
      on an open-label basis.
    


Intervention name(s): RN624 (PF-04383119)
Intervention type(s): Drug
Intervention description(s): 50 mcg/kg
Intervention MeSH terms: Tanezumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Monoclonal antibody
To Assess the Safety of a Sunscreen Product
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The objective of this study was to assess the safety and appropriateness of a sunscreen
      product for use on sport users, under supervised outdoor use conditions.
    


Intervention name(s): SPF 50 Y65 110 (BAY 987516)
Intervention type(s): Drug
Intervention description(s): Subjects applied the assigned products to all sun-exposed areas of their face and body liberally and evenly, in accordance with instructions. Sun exposure was divided into two periods. Each period consisted of direct sun exposure (out of water; Cycle A) and water exposure (Cycle B). Cycles A and B were repeated two times before study closeout.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Sunscreen active
Supreme LMA and Endotracheal Intubation Use in Caesarean Section
Condition: Complications; Cesarean Section
Study type: Interventional

Summary: 
      The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for
      positive pressure ventilation and good first attempt insertion rate of 98% in low-risk
      patients undergoing Caesarean section. It has a double aperture design that facilitates the
      introduction of an orogastric tube to aspirate gastric contents. The current practice is to
      use endotracheal intubation with rapid sequence induction in general anaesthesia for
      Caesarean section.

      The primary study hypothesis is the first attempt insertion success rate of SLMA and
      endotracheal intubation are equivalent with a difference of less than 3%.
    

Detailed description: 
      We propose a randomised controlled trial to study the first attempt insertion success rate of
      supreme LMA versus endotracheal intubation in general anaesthesia for elective Caesarean
      section.
    

Intervention name(s): Endotracheal intubation; Supreme Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): Portex endotracheal tube 6.5mm or 7.0mm internal diameter; Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Airway, Cesarean