bioihbjkbjnl/mcl2 huggingface dataset:
Collaborative Care Intervention for Chronic Kidney Disease
Condition: Kidney Transplant; Depression; Pain
MeSH terms: Depression
Study type: Interventional

Summary: 
      The aims of the present study will be to pilot test the efficacy of a collaborative care
      intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain,
      fatigue and improve quality of life.
    

Detailed description: 
      Symptom management is critical to maintain quality of life in those with life limiting
      conditions. Stepped collaborative care interventions have been widely employed in the primary
      care setting for the treatment of depression and more recently have been utilized to treat
      other symptoms (e.g., pain) in a variety of settings. A recent meta-analyses concluded that
      collaborative care interventions were superior to usual care and are more cost-effective than
      face to face and pharmacological treatment for depression. Collaborative care interventions
      have begun to be extended to other settings but have not been tested in patients who are
      being treated with dialysis. The aims of the present study were to pilot test the efficacy of
      a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms
      of depression, pain, fatigue and improve quality of life.
    

Intervention name(s): Collaborative care
Intervention type(s): Behavioral
Intervention description(s): Therapist will use iPad (Vidyo) once a week during dialysis for approximately one hour. The therapist will teach the patient cognitive-behavioral strategies to manage their mood and pain. The PI is a clinical psychologist and will provide supervision to the therapist providing the intervention. The sessions for depression will include (1) intake, (2) review of the rational for using CBT to treat depression and/or pain, (3) identifying thought patterns, (4) changing thought patterns, (5) relaxation techniques, (6) rest-activity pacing, and (7) coping strategies. Homework to practice these techniques will be provided after each session.
Intervention model: Single Group Assignment
Intervention model description: Patient and caregiver will receive an IPAD with Vidyo software to complete the treatment sessions
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Collaborative care intervention; kidney transplant
Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes
Condition: Bronchopulmonary Dysplasia; Chronic Lung Disease
MeSH terms: Lung Diseases; Bronchopulmonary Dysplasia
Study type: Observational

Summary: 
      Important developmental processes continue until the completion of 40 weeks gestation. Even
      during fetal life, intrinsic and environmental factors determine the balance between health
      and the onset and development of diseases. Thus, it is crucial to understand the mechanisms
      that regulate normal development and the pathways that contribute to disease pathogenesis.

      Neurotrophins are a family of four proteins that support the growth and survival of neurons.
      Their secretion increases during brain development, when new neurons are being formed and
      existing ones are branching to assemble complex neuronal circuits. In addition to their role
      in promoting neuron growth and development, neurotrophins are also a product of neuronal
      activity. Neurotrophins are also responsible for the maintenance of peripheral sensory
      neurons, including those in the lungs. Airway innervation is responsible for many aspects of
      lung function including the regulation of airway smooth muscle tone, mucus secretion, and
      reactivity; therefore, a physiological expression of neurotrophins in the lungs is required
      for normal lung function.
    

Detailed description: 
      Currently, there is no reliable method to identify infants who will have poor
      neurodevelopmental and respiratory outcomes. The ability to make such predictions would be
      beneficial for both making care decisions in the neonatal intensive care unit and for
      identifying infants who require earlier and more intense intervention. We intend to determine
      if neurotrophins can be utilized to predict an infant's long-term outcomes. Neurotrophins are
      a family of four proteins that support the growth and survival of neurons. Their levels have
      been shown to increase with brain development and decrease with brain injury. Neurotrophins
      have also been associated with development of airway injury in the neonate and later
      respiratory disease such as asthma. We plan to correlate serum neurotrophin levels with
      respiratory outcomes and neurological outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        neonates in Neonatal Intensive Care Unit (NICU)
      
Biospecimen description: 
      Blood
    
Keywords: Biomarkers; Neurotrophins
Comparisons of Complications Related to Two Approaches of Ultrasonography-guided Subclavian Venous Catheterization
Condition: Complication of Treatment; Catheterization
Study type: Interventional

Summary: 
      For performing subclavian venous catheterization, two approaches (supraclavicular and
      infraclavicular) have been used successfully in various clinical practice. However, there
      remains controversy concerning which approach is safer and causes less complications during
      ultrasonography-guided subclavian venous catheterization. In this context, the investigators
      sought to compare supraclavicular approach with infraclavicular approach in terms of
      post-procedural complications during ultrasonography-guided subclavian venous
      catheterization.
    


Intervention name(s): Supra- vs Infraclavicular approach using ultrasonography
Intervention type(s): Procedure
Intervention description(s): In the supraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle. Meanwhile, in the infraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: subclavian venous catheterization
The Effect of Wireless Fetal Monitoring System on Comfort, Pain and Satisfaction
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      Wireless EFM shortens labor duration, increases birth satisfaction, and reduces perceived
      pain during labor. With wireless EFM, comfort in labor increases and higher labor comfort
      increases birth satisfaction. As perceived pain in labor decreases, birth satisfaction
      increases. Therefore, wireless EFM practice is recommended during the antepartum and
      intrapartum periods.
    

Detailed description: 
      Problem Wired Electronic Fetal Monitoring (EFM) limits the woman's freedom of movement during
      labor, causes inability to cope with labor pain, lack of comfort, and a decrease in labor
      satisfaction.

      Background While EFM is performed as wired and wireless in the antepartum and intrapartum
      periods, wired application is common in the world and in our country.

      Aim This randomized controlled study was conducted to evaluate the effect of the wireless
      fetal monitoring, which is used during birth, on the woman's comfort, labor pain and birth
      satisfaction.

      Methods The study population consisted of 88 women, divided into two groups the experimental
      group (n=44) and the control group (n=44). The data were collected with the Personal
      Information Form, Childbirth Comfort Questionnaire (CCQ), Visual Pain Scale (VAS), and Birth
      Satisfaction Scale-Revised (BSS-R). During the intrapartum period, the wireless fetal
      monitoring system was used in the experimental group and the wired fetal monitoring system
      was used in the control group.
    

Intervention name(s): wireless fetal monitoring system
Intervention type(s): Device
Intervention description(s): The wireless fetal monitoring system shortens the period of labor by enabling the woman to be more mobile during the intrapartum period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Pain; Birth; Chilbirth Satisfaction; Wireless Fetal Monitoring; Comfort
Predicting the Response to Montelukast by Genetic Variation in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine a specific variation in the genetic code for an
      enzyme (LTC4 synthase) which plays an important role in the airway inflammation associated
      with asthma. We hypothesize that asthmatic patients with this variant gene will have a better
      response to montelukast than patients with the wild type gene, as measured by the ability of
      montelukast to protect against a hypertonic saline challenge.
    

Detailed description: 
      Multiple genetic polymorphisms in the leukotriene pathway have been described but their
      clinical relevance is unclear. A single nucleotide polymorphism in the LTC4 synthase promoter
      region has been associated with increased LTC4 synthase mRNA and a trend toward improved
      bronchodilatory response to leukotriene modifiers in severe asthmatics. This study will
      examine mild to moderate asthmatics with the variant gene and evaluate the bronchoprotective
      response of montelukast in a double-blind, placebo-controlled cross-over fashion.
    

Intervention name(s): Montelukast
Intervention type(s): Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Leukotriene receptor antagonist; Hypertonic saline challenge
Sleep Disorders and Gastroesophageal Reflux Disease (GERD)
Condition: Insomnia; GERD
MeSH terms: Gastroesophageal Reflux; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate Gastroesophageal Reflux Disease (GERD)as a cause of sleep
      disturbance. Patients with GERD may experience all or some of the following symptoms: stomach
      acid or partially digested food re-entering the esophagus (which is sometimes referred to as
      heartburn or regurgitation) and belching. Even very small, unnoticeable amounts of rising
      stomach acid may cause patients to wake up during the night.

      This study will also investigate the effect of Rabeprazole, (brand name Aciphex) on patients
      with known insomnia. Rabeprazole is an FDA approved medication already marketed for the
      treatment of GERD.
    

Detailed description: 
      Participants with known insomnia will undergo an overnight pH and sleep study. Those found to
      be eligible after the first sleep study (those with significantly poor sleep quality and no
      significant sleep apnea) will be started on 2 weeks 20 mgs, twice-a-day, rabeprazole. Upon
      completion of the 2 week course of rabeprazole, subjects will repeat the overnight pH and
      sleep studies. Upon completion of these studies, participation is complete.
    

Intervention name(s): Rabeprazole
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Gastroesophageal Reflux Disease (GERD); Sleep Disturbance
Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS)
Condition: Lateral Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      The aim of our study is to determine the most efficient radiologic examination to assess the
      ankle sprain seriousness and so improve the therapeutic care.
    

Detailed description: 
      The lateral ankle sprain is the most frequent purpose of consultation in emergency
      traumatology of the locomotive system.

      If the ankle sprain is neglected or badly cared, it can induce a recurrence or several
      complications particularly functional ones. So a gravity diagnosis is necessary in order to
      choose the most accurate treatment.

      Considering the difficulty of the clinical estimation, additional examinations aim to support
      the positive diagnosis, to clarify the gravity and to dismiss differential diagnosis.

      Thus we suggest to evaluate three strategies in order to get a gravity diagnosis, make a
      better choice of treatment and so decrease the long-term functional complications :
      instability and recurrence.

      The patients are randomly separated into three groups of 130 people. All the patients have a
      radiography and then, according to their group, they have either an ultrasonography or an
      ultrasonography and a stress radiography or only a stress radiography. The patients are
      followed up during two years by sending two questionnaires (CAIT and LEFS) at one and two
      years. The functional scores of these questionnaires assess and compare the functional
      complications for each group. Thus the radiologic examinations can be assessed in term of
      prognosis.
    

Intervention name(s): Ankle echography; Ankle echography + stress radiography; stress radiography
Intervention type(s): Other; Other; Other
Intervention description(s): Ankle echography; Ankle echography + stress radiography; ankle stress radiography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ankle; diagnosis; sprain; care; injury; stress radiography; ultrasonography
Perioperative Changes of Cognitive Function According to Jugular Vein Insufficiency in Robot-assisted Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve
      system to prevent retrograde blood flow to the brain. Anatomical studies revealed that
      bicuspid or tricuspid valves were located in both jugular veins 2 cm above the
      subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. IJVV incompetence
      (IJVVI) may result in retrograde flow which leads to brain congestion and increase of
      intracranial pressure, which can cause brain dysfunctions in some patients. IJVVI has been
      reported to be associated with transient global amnesia (TGA), cough syncope, exertional
      headache, transient ischemic attack, and air embolism. Demographic data are associated with
      the development of IJVVI. Akkawi et al. demonstrated that old age over 50 years and male
      gender are the risk factors for IJVVI. A few physiologic conditions are related with IJVVI
      including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension.
      Robot assisted laparoscopic prostatectomy (RLP) is one of the most common robotic surgery
      because of its significant benefits such as smaller incision, less severe postoperative pain,
      less intraoperative bleeding, and shorter hospital stay compared to traditional radical
      prostatectomy. The patients undergoing RLP are mostly over 60 years old, have neurologic,
      cardiac and pulmonary comorbidities. For RLP, patients are in Trendelenburg position most of
      the time during surgery, which could cause increases in intra-abdominal and intrathoracic
      pressure.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were over 50 years old with ASA class I or II, scheduled for robot-assisted
        laparoscopic prostatectomy
Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
Condition: Feeding Patterns; Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      This study examined changes in bone metabolism (markers of bone turnover, calcium metabolism)
      with a bout of acute treadmill running preceded by either a single, mixed meal or an
      overnight fast.
    

Detailed description: 
      Ten physically active males aged 28 ± 4 y (mean ± 1SD) completed two, counterbalanced, 8 d
      trials. After 3 d on a standardised diet, participants performed 60 min of treadmill running
      at 65% VO2max on Day 4 following an overnight fast (FAST) or a standardised breakfast (FED).
      Blood samples were collected at baseline, before exercise, during exercise, for 3h after
      exercise and on four consecutive follow-up days (FU1-FU4). Plasma/serum were analysed for β
      CTX, P1NP, OC, bone ALP, PTH, ACa, PO4, OPG, cortisol, leptin and ghrelin.
    

Intervention name(s): Overnight fast
Intervention type(s): Other
Intervention description(s): Overnight fast from 21:00 h
Other intervention name(s): Fasting
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: feeding patterns; aerobic exercise; osteoclasts
Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in
      Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose,
      Multiple-administration Study in Patients With Chronic Hepatitis B (CHB)
    

Detailed description: 
      This study includes 3 cohorts of 25 mg BID, 50 mg BID and 100 mg BID. 30 patients with
      chronic hepatitis B will be enrolled in this study and each cohort will enroll 10 patients
      (GST-HG141 tablets : PBO=8:2). All enrolled patients will be given research drugs twice a day
      for 28 days (D28 was administered only once in the morning). And each cohort requires at
      least 4 subjects with elevated ALT. Tolerability, pharmacodynamics and pharmacokinetics will
      be evaluated according to the protocol.
    

Intervention name(s): GST-HG141 tablets; Matching Placebos for GST-HG141 tablets
Intervention type(s): Drug; Drug
Intervention description(s): Administrate GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses; Administrate the placebos for GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role of Interleukin-6 in Exercise
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to understand the role of interleukin-6 during physical activity
      in patients with type 2 diabetes.
    


Intervention name(s): Sport; Tocilizumab; Sitagliptin
Intervention type(s): Behavioral; Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, drug levels and drug
      effect of BMS-986278 in healthy adult participants and Japanese participants.
    


Intervention name(s): BMS-986278; Sildenafil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BMS-986278; Idiopathic Pulmonary Fibrosis (IPF); Sildenafil
An Evaluation of Appearance-based Interventions for the Promotion of Sleep
Condition: Sleep Habits; Healthy
Study type: Interventional

Summary: 
      This study evaluates the efficacy of appearance-based interventions in promoting healthy
      sleep. One group of participants will receive standard information about sleep (control
      group), while the other group will receive information about how sleep affects their physical
      appearance (intervention group).
    


Intervention name(s): Appearance-based intervention; Pamphlets
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: participants
Guanfacine to Improve Substance Use Outcomes in Women
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive
      flexibility and result in associated lower drug use in women with substance use disorder
      (SUD) in an outpatient clinical setting.
    

Detailed description: 
      This study proposes to extend previous Phase I experimental work to address the following
      specific aims: (1) assess GUA's target engagement of drug craving and cognitive flexibility
      in a laboratory challenge session and in a 10-week outpatient clinical study, (2) demonstrate
      target validation by showing that reduced drug craving and improved cognitive flexibility
      will predict lower drug use outcomes during the 10-week clinical trial in SUD women, and
      finally, (3) evaluate data replication and scalability of GUA target effects across two
      clinical sites (Yale and SUNY-Stony Brook).
    

Intervention name(s): Guanfacine; Behavioral Counseling
Intervention type(s): Drug; Other
Intervention description(s): Guanfacine 3mg/day Versus Placebo; placebo
Other intervention name(s): Tenex,; Manualized Drug Counseling
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention