bioihbjkbjnl/mcl2 huggingface dataset:
Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      The purpose of this observational protocol is to evaluate the use of everolimus in routine
      clinical practice for heart transplants.

      Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety
    


Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: Transplantation, heart; Organ transplant
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by
      the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of
      AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive
      the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen,
      will be allowed if a need for additional painkillers would arise. A number of patients will
      receive naproxen as control.
    


Intervention name(s): AZD1386; Naproxen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 95mg, oral solution, single dose; 500mg, capsule, single dose; AZD1386 Placebo oral solution
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Analgesic effect
Study to Improve Partner Services for STD Prevention
Condition: Trichomonas Vaginalis; Urethritis
MeSH terms: Trichomonas Infections; Urethritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study was to examine the efficacy of patient-delivered partner treatment
      (PDPT) compared to standard partner referral (PR) and booklet enhanced partner referral
      (BEPR).
    

Detailed description: 
      For partner treatment, index women who were diagnosed with trichomonas vaginalis and index
      men who were diagnosed with urethritis were randomized to one of three study arms:

      Standard partner referral (PR) - index patients were instructed to tell their partners that
      they need to go to a clinic for STI evaluation and treatment.

      Booklet-enhanced partner referral (BEPR) - index patients were given a wallet-sized booklet
      containing 4 tear-out cards with information for the partner and treatment guidelines for the
      providers that would see the partners. The partners could then present this card at a clinic
      to help the clinician better treat them. If index patients had more than 4 partners, they
      were given additional booklets.

      Patient delivered partner treatment (PDPT) - index patients were given packages containing 2
      gram metronidazole (for TV patients) or azithromycin 1 gram and cefixime 400 mg (for
      urethritis patients) for up to 4 identified sex partners. When cefixime was no longer
      available, ciprofloxacin 500 mg was used. These packages contained written instructions about
      how to take the medication, warnings about side effects and a nurse's pager number to call if
      there were any questions or if the partner encountered any problems. All medications were
      distributed in containers with childproof caps and the partner's initial and birthdates were
      written on the bottle. This was a requirement of the Louisiana State Pharmacy Board. Names
      were not documented on the index patient's study or medical records.
    

Intervention name(s): Patient-delivered partner treatment; Booklet-enhanced partner referral
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: patient-delivered partner treatment; partner referral; sexually transmitted diseases
Sexual Function During COVID 19 Pandemic
Condition: Sexual Dysfunction
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The outbreak of a new Coronavirus disease (COVID-19), caused by the 2019-nCoV infection in
      December 2019 is one of the most severe global epidemic health problems.The rapid contagion
      of this Novel virus has provoked the World Health Organization (WHO) to classifying the
      outbreak as a "Public Health Emergency of International Concern" on January 30 2020 to a
      "Pandemic" on March 11th 2020
    


Intervention name(s): Electronic questionnaire
Intervention type(s): Other
Intervention description(s): Assess the current sexuality according to the gender using sexual questionnaires for men and women were adapted from the Arabic validated version of the five-item International Index of Erectile Function which is a validated, multidimensional, self-administered questionnaire used for the clinical assessment of erectile dysfunction.and for female Arabic validated version of the Female Sexual Function Index
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        health care staff, regardless of gender, who is actively working during the outbreak, will
        be invited to participate in this study by filling anonyms electronic survey. And an age
        matched group of non-health worker individuals.
A Comparison of the Sedation During Endoscopy in Children
Condition: Failed Moderate Sedation During Procedure
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of this study was to investigate the efficiency and safety of midazolam plus
      ketamine versus fentanyl plus propofol administered to children undergoing UGE and to
      determine the most appropriate sedation protocol.
    

Detailed description: 
      The patients were given a spray of lidocaine 10% as a topical pharyngeal anaesthesia before
      sedation. Intravenous midazolam bolus dose 0.1 mg/kg (maximum 4 mg) was administered to Group
      A. Two minutes later, ketamine bolus dose 1 mg/kg was given intravenously. Patient responses
      to verbal and tactile stimuli were evaluated two minutes after ketamine application. Ketamine
      0.5 mg/kg (maximum of 2 mg/kg) was added in two minute intervals if adequate sedation was not
      achieved initially. The endoscopy process was initiated by the endoscopist if there was no
      response. If the patients were agitated after the procedure started, a ketamine 0.5 mg/kg
      single dose was applied. Intravenous fentanyl bolus dose 1µg/kg was administered to Group B.
      Two minutes later, propofol bolus dose 1 mg/kg was given intravenously. Patient responses to
      verbal and tactile stimuli were evaluated two minutes after propofol application. Propofol
      0.5 mg/kg was added in two minute intervals if adequate sedation was not achieved. The
      endoscopy process was initiated by the endoscopist if there was no response. If the patients
      were agitated after the procedure started, a propofol 0.5 mg/kg single dose was applied. None
      of the patients were given an antidote after the process during recovery.

      All patients were monitored for peripheral oxygen saturation, heart rate (HR), respiratory
      rate, and RSS during the procedure. Oxygen (2L/min) by nasal cannula was given to all
      patients during the procedure. Hypoxia (peripheral oxygen saturation <90% during 60 seconds),
      apnea, laryngospasm, tachycardia (defined as 30% more than the average heart rate by age),
      bradycardia (30% less than the average heart rate by age), increase in oral secretions (more
      than enough to warrant aspiration), flushing, coughing and vomiting were assessed as
      complications and recorded.
    

Intervention name(s): Ketamine and Midazolam; Propofol and Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): This group was injected intravenous midazolam 0.1 mg/kg (maximum 4 mg), two minutes later, ketamine 1 mg/kg was given intravenously before the start of endoscopy.; This group was injected intravenous fentanyl 1 mcg/kg, and two minutes later, propofol 1 mg/kg was given intravenously before the start of endoscopy.
Other intervention name(s): Ketalar (Ketamin, Pfizer) and Dormicum (Midazolam, Roche); Propofol Lipuro (Propofol, B-Braun) Fentanyl (Fentanyl, J&J)
Intervention MeSH terms: Midazolam; Fentanyl; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
The Interaction Between Calcium and Vitamin D Intake
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      We will study the relative importance of high calcium intake and vitamin D supplementation
      for calcium homeostasis, as determined by serum parathyroid hormone (PTH) and biochemical
      bone markers. We also intend to examine the interaction of vitamin D and calcium intake on
      calcium homeostasis. We hypothesize that optimal calcium supplementation and optimal vitamin
      D supplementation will lead to lower serum levels of PTH and markers of bone resorption
      compared with the placebo. We also theorize that when taken together, optimal calcium
      supplementation and optimal vitamin D intake will result in lower serum levels of PTH and
      bone markers compared with calcium or vitamin D taken alone.
    


Intervention name(s): Calcium and vitamin D supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Arm 1: 1,200 mg daily of calcium supplementation and placebo; Arm 2: 100 microgram daily of Vitamin D and placebo; Arm 3: 1,200 mg of calcium and 100 microgram of Vitamin D daily; Arm 4: placebos only.
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Bone resorption; Calcium homeostasis; Bone markers; Calcium and Vitamin D supplementation; Parathyroid hormone levels; Interaction between calcium and vitamin D supplementation
Non-invasive Brain Stimulation as a Treatment for Dysarthria Post-stroke
Condition: Dysarthria; Stroke
MeSH terms: Stroke; Dysarthria
Study type: Interventional

Summary: 
      The proposed study aimed to determine if tDCS can help post-stroke patients with dysarthria.
    

Detailed description: 
      A total of 9 Cantonese-speaking chronic post-stroke patients who are suffering from
      dysarthria was recruited and randomly divided into treatment group and sham group. For the
      treatment group, an anodal high-definition tDCS of 2 milliampere (mA) lasting for 15 minutes
      was delivered to the primary motor cortex (SM1) in 10 daily sessions during a 2-week period.
      For the sham tDCS group, the same setting of tDCS electrodes was applied on the scalp, but
      the stimulation only lasted for 30 sec in order to cause similar sensation on the scalp as
      the other group. Simultaneous to the tDCS stimulation, both groups will receive speech and
      voice therapy for 30 minutes.

      An array of outcome measures reflecting speech production ability including acoustic,
      kinematic, perceptual and self-perceptual qualities was obtained before and after
      stimulation. It was anticipated that post-stroke dysarthric patients will see improvement in
      speech production after stimulation. The results provided important insights into the effects
      of tDCS on articulatory movement in individuals with dysarthria post-stroke.
    

Intervention name(s): Real tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): 2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 15 minutes. Speech therapy was delivered simultaneously.; 2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 30 sec. Speech therapy was delivered simultaneously.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to
      determine the effectiveness of the rotavirus vaccine.
    

Detailed description: 
      The hypothesis is that a three dose series of BRV-PV administered orally to healthy Indian
      infants, with the initial dose given at 6-8 weeks of age and followed by vaccinations at
      monthly intervals, will significantly reduce the incidence of severe rotavirus
      gastroenteritis (SRVGE). Duration of follow-up is until aged 2 years of each enrolled child.
      The study is powered to detect vaccine efficacy significantly greater than 10% (95%
      confidence interval lower bound > 10%) if the true vaccine efficacy is 50% or higher.
    

Intervention name(s): Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent; Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: rotavirus; rotavirus vaccine; BRV-PV
Pay-it-forward RCT for Gonorrhea and Chlamydia Testing
Condition: Gonorrhea Male; Chlamydia;M
MeSH terms: Chlamydia Infections; Gonorrhea
Study type: Interventional

Summary: 
      This is a randomized controlled trial which will evaluate dual gonorrhea/chlamydia test
      uptake and other outcomes in men who have sex with men (MSM) in three trial arms - 1) a
      pay-it-forward testing arm, 2) a pay-what-you-want testing arm, and 3) standard of care arm.
    

Detailed description: 
      At both of the program sites, MSM partaking in HIV and syphilis testing will be offered dual
      gonorrhea/chlamydia testing. First, all men will be provided a brief (5 minute) introduction
      to gonorrhea and chlamydia testing using a pamphlet. Program organizers will then explain the
      pay-it-forward program to each man separately. Briefly, men will be told that the hospital
      list price of gonorrhea and chlamydia testing was 150 RMB ($24 USD), but previous men
      attending the clinic had donated money to cover the cost of his test. Thus, each man could
      receive a free gonorrhea and chlamydia test, then decide whether to donate money
      (pay-it-forward) for future men to receive the same option. Men will be assured that donating
      is completely optional and advised to pay any amount that is feasible for them. Each man's
      gonorrhea and chlamydia test fees will be covered by a combination of the initial funding
      pool from the program organizers and the donations from previous participants. Men will also
      be shown a postcard with a message written by a previous pay-it-forward contributor. Messages
      will contain information encouraging men to be tested/slogans to promote sexual health and
      testing (i.e. taking ownership of their health). They will be told that they could also write
      a postcard message for a future participant.

      Men will then decide whether or not to receive combined urine gonorrhea/chlamydia testing.
      Program organizers will inform participants of their test results via WeChat. Patients with
      positive test results will be counseled and directed to the WeChat page of designated
      hospitals where they could make an appointment to receive treatment and follow-up.
    

Intervention name(s): Pay-it-forward; Pay-what-you-want
Intervention type(s): Other; Other
Intervention description(s): Participants will be offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option.; Participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3-arm superiority randomized controlled
Masking: None (Open Label)
Primary purpose: Screening
An Intervention to Improve Adolescent Headache Self-management
Condition: Pain; Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of a new app to help adolescents with
      chronic or reoccurring headaches self manage pain.
    

Detailed description: 
      Headaches dramatically affect adolescents' overall functioning and quality of life. We have
      developed a highly engaging mobile-based program that will help adolescents to make
      connections between behaviors and symptoms, and to ultimately improve functioning and quality
      of life. The mobile-based program will provide a state of the art pain tracker, a variety of
      coping strategies, and information about self-management of symptoms. This app will offer a
      maximally engaging way to help adolescents track their pain, make connections between
      lifestyle and pain, and learn key self-management skills.

      The study involves the participant being randomized into either the experimental group, where
      he/she will be using this mobile application to track their headache symptoms, or the control
      group, where he/she will receive headache treatment as usual; the control group will not be
      using an app for this study. The intervention will last for two months.

      Participants will be assessed at baseline, at 2-months post baseline, at 3-months post
      baseline, and at 6-months post baseline. All participants will be asked to complete online
      questionnaires about their headaches. We plan to enroll 144 adolescent participants with
      headaches, as well as one caregiver (meaning a parent/guardian) for each adolescent.
    

Intervention name(s): pain self management app on smartphone
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: self management app; headache; adolescent
Comparison of Different Video Laryngoscopes in a Manikin With Immobilized Cervical Spine
Condition: Tracheal Intubation
Study type: Observational

Summary: 
      To determine whether different video laryngoscopes facilitate intubation in an manikin with
      immobilized cervical spine compared with standard laryngoscopy.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        anaesthesiologists
Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty
Condition: Fecal Incontinence in Children
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence
      and faecal soiling which negatively impacts the social life of these children prohibiting
      their participation with their bears.
    

Detailed description: 
      most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence
      and faecal soiling which negatively impacts the social life of these children prohibiting
      their participation with their bears so this study aims prevent faecal incontinence so
      continue life time without any interference with social life and activities
    

Intervention name(s): Biofeedback electrical stimulation
Intervention type(s): Other
Intervention description(s): biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty
Other intervention name(s): Biofeedback
Intervention model: Sequential Assignment
Intervention model description: pretest post test
Masking: None (Open Label)
Primary purpose: Treatment
Effects of TENS Therapy Following Arthroscopic Knee Surgery
Condition: Meniscus Tear
Study type: Interventional

Summary: 
      Following standard of care procedures for arthroscopy knee surgery it is anticipated that
      Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and
      improve functional outcomes.
    


Intervention name(s): TENS Treatment with functional or disabled unit
Intervention type(s): Device
Intervention description(s): TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
Other intervention name(s): EMPI Select Pain Control System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
My Lifestyle Intervention of Food and Exercise
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest
      among women with a history of breast cancer (stages 1-3) who are also overweight or obese.
      The purpose of this study is to compare a tailored nutrition, physical activity, and
      behavioral weight management program for breast cancer survivors against a widely available
      commercial weight management program. We hypothesize that an intervention tailored to the
      unique psychological, nutritional and physical needs of breast cancer survivors will provide
      superior physiological and psychological benefits compared to an existing commercial program.
    


Intervention name(s): Tailored Lifestyle Intervention (TLI); Commercial Weight Loss Program (CWLP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.; This intervention is a generic, widely-available weight management program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cancer; Breast cancer; Breast cancer prevention; Breast cancer recurrence; Weight loss; Weight management; Overweight; Obesity