bioihbjkbjnl/mcl2 huggingface dataset:
SMS HPV Vaccine Reminders
Condition: Human Papillomavirus Vaccination
Study type: Interventional

Summary: 
      This study will take place at health centres and their affiliated schools and community
      immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the
      Makerere/Mulago/Columbia Adolescent Health Clinic, also in Kampala. While text messages can
      be used in populations with low literacy, families can opt to receive automated phone call
      reminders instead. The investigators will pilot assess the impact of vaccine reminders on
      human papillomavirus (HPV) vaccination. Caregivers of preteens/adolescents will be randomized
      and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). As
      this is a feasibility trial, the investigators expect to measure effect size but not
      necessarily achieve statistical significance.
    

Detailed description: 
      Cervical cancer is the leading female cancer in Uganda. Many women are diagnosed with
      late-stage disease, and 80% of women die within 5 years of diagnosis, making primary
      prevention critical. HPV is the principal cause of cervical cancer, making vaccination the
      single most important primary preventive measure. The national HPV vaccination program in
      Uganda began in November 2015 and focuses solely on preteen/adolescent girls. Two strategies
      have been adopted for the multi-dose series: 1) school-based and 2) community-based. However,
      in Kampala, only 29% of girls receive both needed doses. Reasons for undervaccination include
      school absenteeism on special vaccination days for those receiving vaccination as part of a
      school program, failing to remember to come to a health facility for a needed dose for those
      being vaccinated in the community, and lack of knowledge regarding HPV and the vaccines
      including vaccine misperceptions. While research regarding the use of text message vaccine
      reminders is strong in the U.S., their use has not yet been demonstrated in a
      preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries
      (LMICs). According to the World Bank, currently 89.9% of urban households in Uganda have a
      cell phone.
    

Intervention name(s): Text message reminder
Intervention type(s): Behavioral
Intervention description(s): Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Human papillomavirus; Vaccination; Text message; SMS; mHealth; Reminder; Uganda
Effectiveness Trial of the French Blues Indicated Depression Prevention Program
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot study is to test the effectiveness of French adaptation of the
      Blues program, a school-based indicated depression prevention intervention. The program will
      be delivered by the endogenous psycho-social staff of 3 Montreal secondary schools to
      adolescents with sub-clinical depressive symptoms and compared to a no-intervention
      (Informational Brochure only) control condition, designed to represent the "usual
      intervention" in these schools.
    


Intervention name(s): Blues program
Intervention type(s): Behavioral
Intervention description(s): Participants will attend 6 weekly 1-hour sessions of group cognitive-behavioral therapy administered by school staff, and will do home practice between sessions and after the program individually using a web site (called the Blues App)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Depression; Prevention; Adolescents; School; Effectiveness
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
Condition: Complication of Injection; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the incidence and intensity of possible pain on
      injection as well as patient satisfaction caused by propofol (a lipid based medication);
      Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a
      local anesthetic commonly used with propofol injection).
    

Detailed description: 
      Propofol (2,6-diisopropylphenol) is one of the most common induction and sedative agents used
      today. Properties that make this agent popular include rapid onset and quick recovery.
      However, as its use became more widespread, side effects such as pain on injection have
      attracted more attention. The incidence of pain on propofol injection is as high as 70 - 90%.
      Numerous studies report that more than 50% of patients recall the unpleasant burning
      sensation during injection.

      Many techniques to minimize pain on injection associated with propofol have been described;
      pre-administration of different medications including lidocaine, ketamine, thiopental,
      metoclopramide, dexamethasone, ondansetron, and remifentanil have been reported with mixed
      success. Some have even tried to use lidocaine with a tourniquet. Others have reported the
      use of distraction techniques including counting numbers aloud.

      Recently, a solvent mixture of medium chain triglyceride and long chain triglyceride has been
      tested for prevention of pain on propofol injection. Lusedra (fospropofol disodium), the
      water-soluble prodrug of propofol, does not cause pain on injection as it is water based
      medication. Demonstrating the benefit of fospropofol over propofol in patient satisfaction
      will improve acceptance by anesthesia providers.
    

Intervention name(s): Fospropofol; Propofol/Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.; We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).
Other intervention name(s): Propofol; Fospropofol; Pain on Injection
Intervention MeSH terms: Lidocaine; Propofol; Fospropofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fospropofol; Propofol; Colonoscopy; Lusedra
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
Condition: Bariatric Surgery Candidate
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs
      after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.
    

Detailed description: 
      The investigators are evaluating the ability of a single dose of zoledronic acid to improve
      bone outcomes after RYGB or SG surgery. The investigators have previously shown that RYGB and
      SG have negative effects on bone density, bone microarchitecture, and that bariatric
      procedures potentially increase the risk of fractures. The purpose of this study is to
      evaluate the safety and efficacy of zoledronic acid to prevent the high-turnover bone loss
      that occurs in adults who have chosen to undergo RYGB or SG.
    

Intervention name(s): Zoledronic Acid; Calcium citrate + vitamin D; Vitamin D3
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 5mg zoledronic acid; Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3; 1000IU Vitamin D3 gummy
Other intervention name(s): National Drug Code (NDC) 25021-830-82
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Zoledronic Acid; Vitamins
Intervention model: Single Group Assignment
Intervention model description: All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Roux-en-Y gastric bypass, sleeve gastrectomy
Metabolic Abnormalities - HIV Infected and Uninfected Males
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      To assess whether there exist significant differences in glucose metabolism, lipids, lactate,
      body composition, and bone density between HIV-infected and uninfected young men.
    

Detailed description: 
      The study involves a one-time collection of health and medical history data, blood and urine
      specimens, and physical assessments. This study will elucidate the need for a further
      in-depth study to understand the pathophysiological effects of protease inhibitor (PI)-based
      and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young
      men.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Approximately 250 subjects will be enrolled in the study. The number of subjects enrolled
        in each study group will be as follows: 50 HIV-negative subjects; 100 HIV-positive subjects
        who are antiretroviral therapy (ART) naïve; and two groups of up to 50 HIV-positive
        subjects each, one on an NNRTI-based regimen and the other on a PI-based regimen.
      
Keywords: HIV; AIDS; Adolescent Males; HIV positive; Treatment Naive; Treatment Experienced
Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a new medical technology can help reduce
      post-operative pain. The new technology is called Transcranial Direct Current Stimulation.
    

Detailed description: 
      This study aims to evaluate the effectiveness of transcranial direct current stimulation
      (tDCS) in the management of postoperative pain. Specifically, this study will determine
      whether patients undergoing any type of inpatient surgical procedure that routinely requires
      at least a 1-day inpatient stay post-operatively will report less pain and use less opioid
      analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered
      up to twice per day post-operatively. In addition to comparing the effects of real tDCS to
      sham tDCS, the present study will evaluate the interaction of dose (number and frequency of
      tDCS sessions) and surgery type.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): 20 minutes of either real or sham stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Resistance Training and Sleep in the Elderly
Condition: SLEEP DISTURBANCES Nec in ICD9CM
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Purpose: The objective of this study was to evaluate the influence of a session of resistance
      training on the sleep patterns of elderly people.

      Methods: Forty men aged 65 to 80 years, sedentary and clinically healthy were divided into
      two groups: the control group (n=18) and the resistance group (n=22). Both groups underwent
      two polysomnography tests, one at baseline and another after either a resistance training
      session (One Repetition Maximum - Strength Test, resistance group) or without physical
      exercise (control group).
    

Detailed description: 
      Upon completion of the baseline polysomnography (PSG), volunteers underwent body composition
      evaluations (total body mass, height and body mass index calculation) to characterize the
      sample. Three familiarization sessions were conducted with the exercise machines used in the
      study, and one repetition maximum test (1 RM) was completed in order to quantify the training
      session load. A PSG test was conducted on the same day of the exercise session for the
      resistance group, and the control group had a second PSG without exercise to compare the
      groups at both times.

      The body composition assessment, the adaptations to the exercises and the training sessions
      were held at the Center for Psychobiology and Exercise Studies.
    

Intervention name(s): Physical exercise
Intervention type(s): Behavioral
Intervention description(s): After the adaptation sessions, volunteers underwent a session of resistance training at 60% of 1 RM organized as follows: 3 sets of 10 to 12 repetitions on each exercise machine with a 1 minute and 30 second interval between each set and an interval of 2 minutes between each exercise machine, giving a total duration of training between 50 and 60 minutes. The sequence of exercise machines used was alternated by body segment. The sessions were performed at the same time of day (morning) under controlled temperature conditions (24 ± 21C).
Other intervention name(s): Resistance Training; Sleep Patterns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a multi-center, single-arm, open-label study in healthy participants to assess
      the pain, tolerability, injection leakage, safety, and usability of a single
      self-administered subcutaneous (SC) dose of etrolizumab. Some participants will receive
      "needle-experience" training using a needle and syringe on Days -7 and -5, and health care
      professionals (HCPs) will then assess the participant's suitability to self-inject with a
      prefilled auto-injector (AI). The remainder of participants will be "needle naïve" and will
      not have previously self-injected. Eligible" needle experienced" and" needle naive"
      participants will attend an AI training visit at the study site on Day -3 (three days prior
      to etrolizumab dosing on Day 1). Following training and simulated injections by the
      participant the HCP will determine if the participant is suitable to proceed to actual
      etrolizumab dosing. All eligible study participants will self administer a single dose of
      etrolizumab (by AI) on Day 1 and will be followed up to Day 85 following dosing. Pain,
      tolerability, safety and usuability will be assessed.
    


Intervention name(s): Etrolizumab; Prefilled Auto-injector (Rotaject)
Intervention type(s): Drug; Device
Intervention description(s): Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1.; Participants self-administered etrolizumabSC injection using a prefilled auto-injector.
Other intervention name(s): rhuMAB Beta7
Intervention MeSH terms: Etrolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Medical Decisions in the Hospital Setting- M-Safety
Condition: Diagnostic Errors
Study type: Interventional

Summary: 
      This project will introduce and evaluate an intervention designed to improve diagnostic
      decision making. The intervention will attempt to increase clinician mindfulness and reduce
      environmental distractions to promote focused thinking. A meta-cognitive intervention using a
      structured checklist will be evaluated to identify improvement in diagnostic and therapeutic
      decision-making and examine the role of mindfulness and architectural design in enhancing
      patient safety.
    

Detailed description: 
      This project will introduce and evaluate an intervention designed to improve diagnostic
      decision making. The intervention will attempt to increase clinician mindfulness and reduce
      environmental distractions to promote system 2 thinking. A meta-cognitive intervention using
      a structured checklist will be evaluated to identify improvement in diagnostic and
      therapeutic decision-making and examine the role of mindfulness and architectural design in
      enhancing patient safety.

      This a pretest-posttest design study that will be conducted with hospitalist physicians
      working at Michigan Medicine and/or the VA Ann Arbor Healthcare System. The proposed
      intervention will provide the participants with tools to help promote mindfulness and focus
      to assist with the diagnostic process. To reduce distraction, headphones to block out
      surrounding noise and table screens to limit distractions will be offered. To assist with
      diagnosis, a diagnostic checklist and use of a IPad to use an online diagnosis application
      will be provided.
    

Intervention name(s): Mindfulness breathing exercise; Diagnostic Checklist; Noise cancelling headphones; Privacy tablescreen; Diagnostic assistance application
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Spire monitor instructed mindfulness breathing; Checklist reminder for diagnosis; Noise cancelling headphones; Privacy Tablescreen; Diagnostic assistance application
Intervention model: Single Group Assignment
Intervention model description: Pre-posttest study design
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diagnostic Errors; Hospital Medicine
Bioinformation Therapy for Intestinal Cancer
Condition: Advanced Intestinal Cancer
MeSH terms: Intestinal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is the synergistic effect of cancer ablation and life information
      rehabilitation therapy on unresectable intestinal cancer.
    

Detailed description: 
      By enrolling patients with unresectable intestinal cancer adapted to enrolled criteria, this
      study will document for the first time the synergistic effect of cancer ablation and life
      information rehabilitation therapy. The efficacy will be evaluated according to local relief
      degree, progress free survival (PFS) and overall survival (OS).
    

Intervention name(s): Cancer ablation; Life information rehabilitation therapy
Intervention type(s): Device; Drug
Intervention description(s): Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.; Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other intervention name(s): Cryoablation or irreversible electroporation; "Qilisheng" Immunoregulatory Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer ablation; Life information rehabilitation therapy
To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]SB-681323 in Healthy Adult Males
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      SB-681323 is a p38 MAP kinase inhibitor and is currently under development by
      GlaxoSmithKline. This will be an open label study conducted at one site. Six healthy male
      subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will
      receive a single 10mg/ 50 µCurie oral dose of [14C]SB-681323. Urine and faecal samples will
      be collected until 216 h after dosing but subjects may be discharged after 168 h if 90% of
      the dose is recovered and/or <1% of the dose is excreted in a 24 h period. Blood and plasma
      will be collected at various sample times after dosing to measure parent drug and total
      drug-related material. Samples of urine, faeces and plasma will be transferred into separate
      study to characterise and quantify metabolites in these matrices. Safety will be assessed by
      adverse event monitoring, vital signs, ECG and clinical laboratory tests.
    

Detailed description: 
      This will be an open label study conducted at one site. Six healthy male subjects will be
      enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single
      10mg/ 50 µCurie oral dose of [14C]SB-681323. Urine and faecal samples will be collected until
      216 h after dosing but subjects may be discharged after 168 h if 90% of the dose is recovered
      and/or <1% of the dose is excreted in a 24 h period. Blood and plasma will be collected at
      various sample times after dosing to measure parent drug and total drug-related material.
      Samples of urine, faeces and plasma will be transferred into separate study to characterise
      and quantify metabolites in these matrices. Safety will be assessed by adverse event
      monitoring, vital signs, ECG and clinical laboratory tests.
    

Intervention name(s): A single 10 milligram (50 microcurie) oral dose of [14C]SB-681323
Intervention type(s): Drug
Intervention description(s): [14C] SB-681323 oral solution, is available as a powder which will be made into a solution of 0.1 milligram/milliliter (0.5 microcurie) [14C] SB-681323 in dextrose and water for injection on the day prior to dosing.
For a 10 milligram/50 microcurie oral dose of [14C]SB-681323, 100 milliliters of 0.1 milligram/milliliter (0.5 microcurie/milliliter [14C] SB-681323 oral solution will be dosed.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SB-681323,; ADME,; radiolabel
Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)
Condition: Contraception; Ovulation Inhibition
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigation of two transdermal hormone patch formulations for contraception regarding
      inhibition of ovulation over a period of 3 treatment cycles in healthy young female
      volunteers
    


Intervention name(s): Ethinylestradiol/Gestodene (BAY86-5016); Ethinylestradiol/Gestodene (BAY86-5016)
Intervention type(s): Drug; Drug
Intervention description(s): Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle); Transdermal patch: 0.55mg Ethinylestradiol (EE+1.05mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)
Intervention MeSH terms: Ethinyl Estradiol; Gestodene; Femovan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Female contraception; Ovulation inhibition