bioihbjkbjnl/mcl2 huggingface dataset:
Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?
Condition: Neonatal Temperature; Kangaroo Mother Care
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to assess the effectiveness and the safety of a woolen cap in
      maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care
      (KMC).
    

Detailed description: 
      Background: Neonatal hypothermia is an important challenge associated with morbidity and
      mortality. Preventing neonatal hypothermia is important in high resource countries, but is of
      fundamental importance in low resource settings where supportive care is limited.

      Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly
      recommended for temperature maintenance. During KMC, the World Health Organization (WHO)
      guidelines recommend the use of a cap/hat, but its effect temperature control during KMC
      remains to be established.

      In the hospitals participating to the projects of the non-governmental organization CUAMM,
      KMC represents a standard of care, but the head of the babies often remains uncovered due to
      local habits or to the unavailability of a cap.

      Objective: The aim of the present study will be to assess the effectiveness and the safety of
      a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during KMC.

      Methods: This is a multicenter (three hospitals), multi country (three countries),
      prospective, unblinded, randomized clinical trial of KMC treatment with and without a woolen
      cap in LBWI. After obtaining parental consent, all infants with a birth weight <2500 g and
      candidate to KMC will be assigned to KMC with woolen cap or to KMC without cap group in a 1:1
      ratio according to a computer-generated randomized sequence. The primary outcome measure will
      be the temperature in the normal range (36.5-37.5°C) in course of KMC during the first week
      of life. In all participants, axillary temperature will be measured with a digital
      thermometer 4 times per day. In addition, maternal and room temperature will be recorded.
      Secondary outcome measures will be: episodes of apnea; sepsis; mortality before hospital
      discharge; in-hospital growth; age at discharge.
    

Intervention name(s): Woolen cap
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
Condition: Nasal Congestion
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the food-effect bioavailability of an extended release formulation of
      phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl
      product.
    


Intervention name(s): Phenylephrine HCl Extended Release; Phenylephrine HCl Immediate Release
Intervention type(s): Drug; Drug
Intervention description(s): One phenylephrine HCl 30 mg extended release tablet orally; One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Insulin Sensitizer Metformin on AD Biomarkers
Condition: Alzheimer's Disease; Vascular Dementia; Dementia; Memory Impairment
MeSH terms: Alzheimer Disease; Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 2

Summary: 
      Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive loss of
      memory and other cognitive functions. It is the most common cause of dementia in older
      adults, affecting approximately 18 million people worldwide, including almost 500,000 in the
      Philadelphia tri-state area. After age 65, the incidence of AD rises exponentially, doubling
      every five years. By age 85, almost half of us will have AD. In 2030, as many as 7.7 million
      Americans could have AD, and by 2050 this number could rise to 11-16 million people. The
      annual cost of AD in the United States is about $200 billion. AD-related medical
      complications are among the most common causes of death in the elderly population. Despite
      these alarming statistics, a "cure" for AD may not be essential since delaying the onset of
      AD by just 5 years could have a profound impact on this disorder by reducing the incidence
      and cost of AD by 50% between now and 2050.

      AD is difficult to recognize in its earliest stages, in which the principal complaint is
      typically an increase in episodes of forgetfulness. This stage is now commonly referred to as
      mild cognitive impairment (MCI). Neuroimaging and CSF biomarkers have demonstrated good
      accuracy in predicting which MCI patients later "convert" to AD and which tend to remain
      stable or revert to more normal cognition. The diagnosis of AD itself is made when increased
      loss of memory and other cognitive abilities (eg, language, praxis, and executive function)
      affect daily functioning. As the symptoms of dementia inevitably worsen, patients may become
      incapable of even basic activities such as feeding and dressing themselves. The disease
      course often spans more than a decade, creating a vast social and financial burden on society
      and extracting an immeasurable emotional toll on family members.

      Clinical and preclinical evidence is accumulating that brain insulin resistance may play a
      role in the pathogenesis and/or progression of Alzheimer's disease and that ameliorating
      insulin action in the brain may benefit cognition symptomatically and modify disease
      pathology.
    


Intervention name(s): Metformin; Placebos
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This pilot study used a randomized, double-blinded, placebo-controlled 16 week crossover design to examine the effects of metformin on biochemical, neurophysiological, and cognitive biomarkers of AD.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Vascular Dementia; Dementia; Memory Impairment
Comparison of Erector Spina Plane Block and Thoracic Epidural Block
Condition: Breast Neoplasms; Pain, Postoperative
MeSH terms: Breast Neoplasms; Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this randomised controlled and double-blind study, is to compare the effects of
      erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics
      and analgesia in patients undergoing unilateral mastectomies due to malignancy.
    

Detailed description: 
      Patients will be randomised into two groups as Group E (those who received general anesthesia
      after the erector spina plan block) and Group T (those who received general anesthesia after
      thoracic epidural block).

      After the block skin conductivity (galvanic skin response - GSR), body temperature changes,
      sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain
      scores and analgesic consumption will be recorded.
    

Intervention name(s): Erector spina plane block before general anaesthesia; Thoracic epidural block before general anaesthesia
Intervention type(s): Other; Other
Intervention description(s): After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be directed between the erector spina muscle and the transverse process of the T4 vertebra using the in-plane technique. The location of the needle will be confirmed by hydrodissection with saline after touching the transverse process. After the plan open, 5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine and 10 ml of saline, including hydrodissection, will be given in a total amount of 25 ml. Then a 20-G epidural catheter will be inserted 3-4 cm and fixed.; After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be entered through the T4-5 interspinous space (median or paramedian approach). After reaching the thoracic epidural area by loss of resistance method, the epidural catheter will be advanced and fixed to remain 3-4 cm in the epidural area. Following the test dose (2 ml of 2% lidocaine), 3 ml of 2% lidocaine, 5 ml of 0.5% bupivacaine and 5 ml of saline will be administered intermittently in a total volume of 15 ml.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Smoking Habits and Smoking Cessation in Young Adults
Condition: Smoking Cessation; Smoking; Habits
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and effectiveness of varenicline and
      nicotine patch combined with motivational interview technique in smoking cessation of young
      adults over 12 months follow-up.
    

Detailed description: 
      Most teenage smokers are still smoking when they become adults confirming that stopping of
      smoking at young age is difficult although majority of young smokers want to quit. Young
      smokers experience many relapses partly due to the lack of appropriate and available
      cessation services. The discomfort experienced during cessation attempts is likely to be
      negatively associated with cessation success. Quitting of smoking is by the far most
      important procedure in preventing COPD progression. In Finland, 18-35% of young adults smoke,
      the variability being associated at least with socioeconomic background, education and
      geographical area. Our recent studies on male military draftees have shown that smoking is
      much more frequent in Northern than Southern Finland. However young men want to quit and
      accept new smoking restrictions. Very few studies are available on quitting attempts or
      counselling, pharmacotherapy and/or their combinations in young adults who want to quit.
    

Intervention name(s): varenicline; Nicotine cutaneous patch 15mg/16h; Nicotine cutaneous patch 10mg/16h; Placebo cutaneous patch
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day; One patch for 16hours/day and duration of 8 weeks.; One patch 16hours/day and duration of 8 weeks; No active medication.O ne patch 16hours and duration for 8 weeks
Other intervention name(s): Champix; Nicorette; Nicorette; Leukomed T
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: smoking cessation; young adults; motivational counselling; smoking; nicotine replacement therapy; therapy
The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
Condition: Extracorporeal Membrane Oxygenation
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP)
      administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill
      pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions
      during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and
      anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump
      changes. In addition, this may lead to less overall transfusion with all products (red blood
      cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be
      neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and
      pediatric cardiac critical care units. Subjects will be randomized to receive every other day
      FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours)
      and FFP use will be compared between the two groups There is a small risk that study subjects
      may receive more FFP transfusions and therefore have the increased associated risks however
      it is also possible that these subjects may benefit from less ECMO circuit changes and/or
      fewer transfusions of all blood products.
    


Intervention name(s): Fresh frozen plasma
Intervention type(s): Biological
Intervention description(s): Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
Other intervention name(s): FFP, plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: FFP; fresh frozen plasma; ECMO; extracorporeal membrane oxygenation; anticoagulation; transfusion
A Study of ACE-2494 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess safety, tolerance, pharmacokinetic, and
      pharmacodynamics of single doses of ACE-2494 in healthy postmenopausal women.
    

Detailed description: 
      Subjects will be evaluated for study inclusion/exclusion criteria during the screening period
      (within 4 weeks prior to Day -1) and eligible subjects who have signed the informed consent
      form (ICF) will be enrolled and treated with study drug (ACE-2494 or placebo) on Day 1.
      Subjects will be randomized (3:1, ACE-2494: placebo) to receive one dose of either ACE-2494
      or placebo, respectively, on Day 1.

      The primary objective of the study is to evaluate the safety and tolerability of single
      ascending doses of ACE-2494 in healthy postmenopausal women. The secondary objectives are to
      characterize the pharmacokinetic (PK) profile and pharmacodynamic (PD) effects, including
      serum biomarkers, fat, lean, and bone mass (DXA), muscle volume and intramuscular fat
      fraction (MRI).
    

Intervention name(s): ACE-2494 or placebo
Intervention type(s): Drug
Intervention description(s): Recombination fusion protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ACE-2494
Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation in Type 1 Diabetes.
Condition: Hypo-unawareness; Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Insulin treatment often causes the blood glucose levels to fall too low (hypoglycemia).
      Hypoglycemia can be associated with confusion and disorientation as well as other symptoms
      such as palpitations, sweating and tremors. Medium chain triglycerides (MCT) can be used as a
      fuel in the brain during low blood sugar levels and therefore may prevent or reduce some of
      the confusion and disorientation seen during hypoglycemia. We would like to determine if a
      diet supplemented with medium chain triglycerides can improve cognitive function during
      hypoglycemia, diabetes control and also look at brain activity.
    

Detailed description: 
      30 subjects with well controlled type 1 diabetes will be recruited for the study. If you
      agree to participate you will be scheduled for, dietitian visits, and a study visit which
      will include insulin and glucose infusions, an MRI scan and brain function tests. All visits
      will be on the Hospital Research Unit (HRU) on the 10th floor of Yale New Haven Hospital. You
      will be randomized to either the MCT-supplemented diet or the standardized western diabetic
      diet. If you are on the MCT diet, the MCT oil will be given to you and you will be shown how
      to incorporate it into your diet. The MCT supplemented diet is for two weeks (with a two
      gradual transition onto the diet) and the standardized western diet is for two weeks (with a
      1 week transition onto the diet). At the end of the study you will be admitted to the
      Hospital Research Unit for the insulin 'clamp' and MRI scan. A 'clamp' is a procedure which
      involves insulin and glucose infusions. During a 'clamp' study, the insulin infusion is held
      constant, while the glucose infusion is adjusted every 5 minutes as needed to maintain the
      desired blood glucose levels. Compensation for the study is $750.
    

Intervention name(s): Medium chain triglycerides
Intervention type(s): Dietary Supplement
Intervention description(s): 4 tablespoons/day for 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medium chain triglycerides; hypoglycemia; cognitive function; functional MRI
Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis
Condition: Bronchitis; Cough
MeSH terms: Bronchitis; Acute Disease
Study type: Interventional

Summary: 
      Studies show, guidelines state, and performance measures assert that antibiotic prescribing
      for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe
      antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States
      each year. Previous successful interventions have only reduced the antimicrobial prescribing
      rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis
      can be brought to near zero percent in actual practice while maintaining patient safety and
      satisfaction. The goal of this study is to develop an Electronic Health Record
      (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis
      with a goal of reducing the antibiotic prescribing rate to near zero percent.
    

Detailed description: 
      We will use a multi-modal implementation - including computerized decision support, reporting
      tools, and clinician feedback - and quality improvement techniques to ensure adherence to the
      algorithm and reduce the antimicrobial prescribing rate to near zero percent. The duration of
      the intervention will be 4 years.
    

Intervention name(s): Demonstration of near zero antibiotic prescribing for patients with acute bronchitis
Intervention type(s): Behavioral
Intervention description(s): A controlled, continuously-monitored, implementation of an EHR-integrated diagnosis and treatment algorithm for acute bronchitis in a large, diverse primary care practice.
Intervention MeSH terms: Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Antibiotic; Antimicrobial; Prescribing; Cough; Acute Bronchitis
Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain
Condition: Chronic Lower Back Pain; Healthy Control Subjects
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Placebo and nocebo responses have mainly been studied in healthy humans for pharmacological
      rather than psychological interventions. Moreover, only few studies examined patients or
      tested how previous experience and attitudes affect placebo and nocebo responses. On the
      psychological level expectancy and classical conditioning have been identified as two primary
      mechanisms. Both seem to be important with classical conditioning potentially having more
      long-term effects and expectancy being more important in nocebo effects. There is some
      initial evidence from the investigators own research that patients may be more prone to these
      effects and the investigators have also shown that placebo effects may last up to several
      years after treatment. The investigators therefore examine previous attitudes to
      pharmacological interventions for chronic pain in patients with chronic back pain and
      subdivide them into groups with high of low belief in the respective treatment modality. The
      investigators then apply a pharmacological placebo and study the interaction between the
      prevailing attitude (implicit and explicit) and the placebo effect with respect to pain
      perception but also to neurobiological mechanisms using functional magnetic resonance
      imaging. In addition to expectancy, conditioning of placebo will be examined and the
      long-term effects of the intervention will be determined.
    


Intervention name(s): Administration of a pharmacological placebo
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Condition: Dementia With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients
      with dementia with Lewy bodies.
    

Detailed description: 
      The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a
      24-week double-blind treatment period in patients with dementia with Lewy bodies.

      The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).

      Subjects completing this study will be eligible to enroll in an extension study of RVT-101
      (Study RVT-101-2002).
    

Intervention name(s): RVT-101 35 mg; RVT-101 70 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once daily, oral, 35-mg tablets; once daily, oral, 35-mg tablets; once daily, oral, matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dementia with Lewy bodies; Lewy bodies; intepirdine; RVT-101; dementia