bioihbjkbjnl/mcl2 huggingface dataset:
Parents Helping Infants Study: Educational Intervention to Change the Knowledge, Attitudes and Behaviour of New Parents About Early Infant Crying
Condition: Shaken Baby Syndrome
MeSH terms: Shaken Baby Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research project seeks to implement an early intervention program that can be effective
      in the prevention of shaken baby syndrome (SBS) and infant abuse. The investigators'
      hypothesis is that the Period of PURPLE Crying intervention program can be effective in
      reducing the shaking and abuse of infants through changes in knowledge, attitudes and
      behaviours about early infant crying, especially inconsolable crying.
    

Detailed description: 
      The Period of PURPLE Crying phrase refers to the educational information and the action steps
      that caregivers need to know about the properties of early crying in normally developing
      infants that are uniformly frustrating to caregivers. The study will be implemented and
      evaluated in 1000 new mothers, by public health nurses during newborn home care visits in the
      Vancouver Coastal and Fraser Health Authorities. There are two treatment arms in the study.
      The first half of all subjects (n=500) will receive the PURPLE intervention materials (a
      video and a pamphlet) about infant crying. The second arm will receive comparable materials
      on infant safety and SIDS.

      Specific goals of the research program are:

        1. To change the understanding (i.e knowledge and attitudes) and reduce the frustration of
           parents of new infants about the normality of the frustrating properties of crying;

        2. To change the behaviour of parents to increase care giving contact in response to crying
           but to 'walk away' if frustrated or angry;

        3. To provide parents with the ability to educate other caregivers (relatives, baby
           sitters) to reduce frustration induced by inconsolable crying and obtain help if needed;

        4. To provide parents with the knowledge to protect their infants from occasional
           caregivers who could harm their infants because of the frustrating nature of early
           crying;

        5. To provide effective knowledge, skills and teaching materials to regional health care
           providers in direct contact with parents concerning crying, shaking and abuse.
    

Intervention name(s): The Period of PURPLE Crying Program
Intervention type(s): Behavioral
Intervention description(s): There are two treatment arms in the study. The first half of all subjects (n=500) will receive the PURPLE intervention materials (a video and a pamphlet) about infant crying. The second arm will receive comparable materials on infant safety and SIDS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Prevention; Randomized controlled trial; Community education; Shaken Baby Syndrome; Crying; Colic
Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults
Condition: Methemoglobinemia; Congenital Methemoglobinemia
MeSH terms: Methemoglobinemia
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 trial to assess the single-dose safety, tolerability, and pharmacokinetic (PK) of
      Methylene Blue Injection, USP 1 mg/kg in healthy adult voluneetrs.
    

Detailed description: 
      This is an open-label, single-center, one-arm, safety, tolerability, and PK study in healthy
      male and female volunteers of Methylene Blue Injection, USP. Following an overnight fast,
      twelve healthy adult male and female volunteers will receive a single dose of study drug at a
      dose of 1 mg/kg solution per kg given intravenously over a period of 5 minutes followed by
      serial venous blood sampling at 0.042, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10,
      16, 36, 48, and 72 hours postdose.
    

Intervention name(s): Methylene Blue
Intervention type(s): Drug
Intervention MeSH terms: Methylene Blue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
Condition: Hodgkin Lymphoma; Non-hodgkin Lymphoma; Lymphoma; Breast Cancer
MeSH terms: Lymphoma; Breast Neoplasms
Study type: Interventional

Summary: 
      To provide critical participant enrollment data necessary to complete a larger definitive
      clinical trial in the future.
    

Detailed description: 
      This study is a 2-arm, parallel design, single-blind randomized controlled pilot study
      designed to compare the effects of a tailored multi-level physical activity intervention
      (PAI) vs healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive
      function, health-related quality of life (QOL), strength and fatigue among lymphoma and
      breast cancer patients undergoing active treatment with anthracycline based chemotherapy
      (anthra-bC).
    

Intervention name(s): Physical Activity Intervention (PAI); Healthy Living Control
Intervention type(s): Other; Other
Intervention description(s): Those who opt-in to attend in-person study visits and to undergo COVID testing will also complete an MRI exam and CPET testing. Participants unwilling to have COVID testing done will only complete an MRI exam and home-based testing. All testing will take place either within 6 weeks of initiating systemic treatments or within 8 weeks of completing radiation then at 3 & 6 months. Patients may participate in 1-2 training sessions per week offered under the direct supervision of a master's level clinical exercise physiologist, as well as 1-2 sessions at home. PAI sessions consist of slow aerobic warm-up, followed by 20 minutes of strength training,15 minutes of progressive intensity aerobic exercise (AE), and then 10 minutes of stretching for cool-down. Participants will have the ability to participate in training sessions facilitated via online channels at home.; Patients randomized to the control arm will either attend online sessions via secure video conferencing (e.g. Zoom) or telephone or to come to a centralized meeting location (if safety allows) to participate in organized health workshops. Session attendance will be required 2 times/month (over the 6 months). Make up sessions will be offered for those participants who have to miss a group session. Each session lasts 60 minutes and matches the number of visits made by the PAI group as much as possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Physical Activity Intervention; Healthy Living Intervention; Health-related Quality of Life
A Study of LJPC-501 in Pediatric Patients With Hypotension
Condition: Catecholamine-resistant Hypotension (CRH); Distributive Shock; High Output Shock; Sepsis
MeSH terms: Hypotension; Shock
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial
      pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the
      start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid
      therapy and vasopressor therapy. In addition, this study will evaluate the safety and
      tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the
      start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric
      Logistic Organ Dysfunction (PELOD) scores.
    


Intervention name(s): Angiotensin II
Intervention type(s): Drug
Intervention description(s): Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of hypotension in patients who do not respond to fluids and vasopressor therapy.
Other intervention name(s): Giapreza
Intervention MeSH terms: Angiotensin II; Giapreza; Angiotensinogen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients
Condition: Appetite Reduction; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Based on the creation of a somato-autonomic reflex, the stimulation of sensory nerve
      terminals located in dermatome T6 may cause a reflex, whose efferent pathways end in vagal
      nerve branches stimulating the gastric wall, similarly to the gastric pacemaker.

      The aim of this study was to evaluate the effect of percutaneous electroneurostimulation
      (PENS) of T6 dermatome on appetite, weight loss and dietary compliance.
    


Intervention name(s): Percutaneous electroneurostimulation of dermatome T6; Diet 1200 Kcal
Intervention type(s): Procedure; Behavioral
Intervention description(s): The patients underwent a percutaneous electroneurostimulation of dermatome T6 during 30 minutes, every week during 12 weeks. This intervention was associated to a diet 1200 Kcal; The patients assigned to this group must follow a 1200 Kcal diet during months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years
Condition: Osteotomy and Spinal Column Surgery
Study type: Interventional

Summary: 
      This study aims to find how hypnosis performed just before a painful surgery can change
      anxiety level, in children aged 10 to 18 years.
    

Detailed description: 
      Undergoing surgery can cause anxiety among children. Thus, peri operative anxiety can
      increase levels of pain, need for painkillers, and even length of stay in hospital.

      Caring for children must take in account their anxiety. This anxiety can be treated through
      drugs or others means such as hypnosis. Thus, the use hypnosis in surgery has been very
      poorly assessed.

      Parents will be given a consent form as well as an information note. This study aims to
      compare the level of post operative anxiety (D1)of children having hypnosis before receiving
      anaesthetics to the level of anxiety of children getting the usual care.

      All the children included in this study will have a pre operative consultation with the Pain
      Management Nurse.

      The study applies to inpatients, aged 10 to 18 years, who must go through orthopaedics
      surgery such as osteotomy (bone section) and spinal column surgery. 120 patients will be
      included in this study (60 in each arm) The primary outcome measure is the level of anxiety
      at day 1 (24 hours after surgery) Other outcome measure are

        -  the difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours
           after surgery)

        -  the use of morphine during the first 24 hours This study is a prospective randomized
           trial, comparing a usual analgesics procedure to an experimental analgesics procedure
           including hypnosis before anaesthesia.

      Expected impact of this study :change in procedures, decrease of anxiety levels in patients
      by the use of hypnosis before anaesthesia.
    

Intervention name(s): Pre operative nurse consultation and Hypnosis; Pre operative nurse consultation
Intervention type(s): Behavioral; Other
Intervention description(s): Pre operative nurse consultation with pain management nurse, the day before surgery and 5 to 10 minutes of hypnosis, just before anesthesia, with trained nurse.; Pre operative nurse consultation with pain management nurse. Usual care and anesthesia
Other intervention name(s): Hypnosis, HYPNOANALGESIA; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: hypnosis; HYPNOANALGESIA; surgery; children; anxiety; morphine; pain; A-VAS; orthopaedics; osteotomy; tenotomy; arthrodesis; spinal column surgery
SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the concentration of oxygen the study volunteer breathes. The accuracy of a
      noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation
      measurements from a laboratory blood gas analyzer.
    


Intervention name(s): Red Diamond Disposable Pulse Oximeter Sensor
Intervention type(s): Device
Intervention description(s): Noninvasive Pulse Oximeter Sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Bariatric Surgeries in Elderly
Condition: Bariatric Surgery
Study type: Observational

Summary: 
      an examination of the different aspects of bariatric surgery in elderly in comparison with
      non-elderly patients.
    

Detailed description: 
      the study examines the success rate, complications, revisions, days of hospitalization and
      co-morbidities in elderly and in non-elderly patients that underwent bariatric surgery in our
      medical center
    

Intervention name(s): clinical measurements
Intervention type(s): Other
Intervention description(s): follow up on the number of complications, revisions, hospitalization and co-morbidities
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients underwent baritaric surgery
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate the effectiveness of Aripiprazole long-acting
      injection in recent onset and chronic schizophrenia patients
    

Detailed description: 
      The aim of this study is to investigate the effectiveness of Aripiprazole long-acting
      injection in recent onset and chronic schizophrenia patients
    

Intervention name(s): abilify maintena
Intervention type(s): Drug
Intervention description(s): aripiprazole 400mg or 300mg, IM, Once a month
Other intervention name(s): aripiprazole
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aripiprazole; long-acting injection
Project Q Pilot: Smoking Cessation for Light Smokers
Condition: Tobacco Use Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this pilot study is to evaluate the feasibility, acceptability, and
      preliminary efficacy of an intervention to promote smoking cessation among light smokers.
    

Detailed description: 
      The three-arm randomized controlled trial compares Arm 1) standard smoking cessation plus
      support text messages, 2) enhanced cue exposure treatment (lab-based + interactive SMS
      texting) + D-cycloserine placebo, Arm 3)will include a combination of cognitive behavioral
      cessation counseling, enhanced cue exposure treatment (lab-based + interactive SMS texting)
      and a cognitive-enhancing drug - D-cycloserine. In addition to an in-person screening visit,
      we will conduct three in-person treatment visits and an inperson follow-up visit.
    

Intervention name(s): Cognitive behavioral cessation counseling; Counseling and placebo drug intervention; Counseling and active drug intervention
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): Standard smoking cessation plus support text messages; Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo; Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Light Smoker
Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial
Condition: Frailty
MeSH terms: Frailty
Study type: Interventional

Summary: 
      The study aims to explore feasibility of implementing a tailored CGA to older adults with
      frailty and evaluate staff and patients perception of the intervention. In line with this,
      the objectives of the study are:

        1. To assess applicability of finding older adults with frailty using eFI and delivering
           subsequent CGA and care planning at patients' home

        2. To investigate staff and older adults' perception of CGA programme

        3. To assess the health care resource usage and cost of the CGA programme

        4. To measure key health related outcome domains including function, quality of life,
           loneliness, pain, falls and mobility.
    


Intervention name(s): CGA group
Intervention type(s): Other
Intervention description(s): CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Comprehensive Geriatric Assessment; Frailty; electronic Frailty Index; eFI; Care and Support plan; Primary Care
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection
Condition: Surgical Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      This prospective study evaluates the role of negative pressure wound therapy or wound VAC as
      a dressing over the incision to prevent poststernotomy wound infection in high risk patients.
    

Detailed description: 
      Surgical site infection after cardiac surgery is a major cause for increased morbidity and
      mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected
      wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site
      infection after routine cardiac surgery is unknown.
    

Intervention name(s): Prevena Incision Management System; Conventional sterile dry wound dressing
Intervention type(s): Device; Other
Intervention description(s): negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days; regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy
Other intervention name(s): negative pressure therapy; wound VAC; Prevena; poststernotomy wound dressing; standard dressing after sternotomy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses AZD8848 in Healthy Subjects
Condition: Safety,; Tolerability,; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics
      of multiple ascending doses of AZD8848 in healthy subjects.
    

Detailed description: 
      A Phase 1, Single Centre, Double-blind, Randomised, Placebo-controlled, Study to Investigate
      the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics after Administration of
      Multiple Ascending (MAD) Once Weekly Inhaled Doses of AZD8848 in Healthy Subjects
    

Intervention name(s): AZD8848; Placebo to match AZD8848
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses inhaled IMP via a nebulizer; Multiple doses inhaled matching placebo via a nebulizer
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety,; tolerability,; Phase I,; pharmacokinetic,; pharmacodynamic,; inhaled
Effect of Brisk Walking on Primary Dysmenorrhea
Condition: Dysmenorrhea Primary
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Dysmenorrhea is a common problem in women. Exercise is commonly cited as a possible remedy.
      We will measure the effect of brisk walking on primary dysmenorrhea among medical students.
    


Intervention name(s): Brisk walking
Intervention type(s): Behavioral
Intervention description(s): Walking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fascia Release Techniques Applied to Plantar Flexor Muscles and Acute Efficacy of Kinesio Taping
Condition: Balance; Distorted; Fascia; Anomaly
Study type: Interventional

Summary: 
      The aim of this study; The aim of this study is to examine the effects of kinesio taping
      technique and percussive massage technique applied to plantar flexor muscles on
      proprioception, balance and flexibility in healthy individuals.
    

Detailed description: 
      The sample of the study will consist of healthy individuals who have not had any discomfort
      or surgical operation related to the lower extremity in the last 6 months. The demographic
      information of the individuals who agreed to participate in the study will be recorded and
      their written consent will be obtained. Participants will be divided into 2 groups as kinesio
      taping and Percussive Massage groups by randomization method. The dominant lower extremities
      of both groups will be applied. The Percussive Massage group will be applied to the posterior
      part of the sural fascia for 5 minutes, 3 times a week, including the plantar flexor muscles.
      In the kinesio taping group, taping will be done in accordance with the fascia correction
      technique, including the plantar flexor muscles, and it will be requested to stay for 3 days.
      Both groups will be evaluated before and after the application. Joint position sense test
      will be used to evaluate proprioception. In the evaluation of balance, the one-leg standing
      test will be considered. In the evaluation of flexibility; The flexibility of the hamstring,
      gastrocnemius, and plantar fascia will be examined. The Straight Leg Lift Test will be
      performed to look at the flexibility of the hamstring muscle. Pre- and post-intervention data
      were statistically analyzed and compared.
    

Intervention name(s): taping; massage
Intervention type(s): Other; Other
Intervention description(s): Kinesio taping will be applied in accordance with the fascia correction technique, including the plantar flexor muscles, and it will be requested to stay on the skin for 3 days.; Percussive Massage will be applied to the posterior part of the sural fascia, including the plantar flexor muscles, 3 times a week for 5 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: kinesio taping and percussive massage techniques
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: proprioception; flexibility; balance