bioihbjkbjnl/mcl2 huggingface dataset:
Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.
Condition: Ischaemic Heart Disease; Aortic Stenosis
MeSH terms: Heart Diseases; Aortic Valve Stenosis; Myocardial Ischemia; Coronary Artery Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of
      standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing
      coronary artery bypass with or without aortic valve replacement.
    

Detailed description: 
      1. Haemodynamic effects, evaluated by invasive haemodynamic data (arterial line and PAC) of
           opioid given as single drug and in combination with Propofol (first 30 patients only).

        2. Cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4
           and 30

        3. Recovery quality and time parameters using objective ICU score criteria

        4. Cardioprotection effect evaluated by myocardial biochemical markers obtained
           preoperative and postoperative 4, 9 and 18 hours
    

Intervention name(s): Remifentanil; Sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia; Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia
Other intervention name(s): Ultiva; Sufenta
Intervention MeSH terms: Sufentanil; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cognitive dysfunction; Cardioprotection; Recovery; Renal function; ICU discharge
Effects of Sleep Deprivation on Food Intake and Motor Activity in Man
Condition: Healthy
MeSH terms: Sleep Deprivation
Study type: Observational

Summary: 
      Evidence that shortened period of sleep could be a risk factor for weight gain and obesity
      has grown over the past decade. Concurrent with the obesity epidemic, numerous studies have
      reported a parallel epidemic of chronic sleep deprivation. Sleep is important in maintaining
      energy balance (i.e. acute sleep deprivation impact the normal secretion of ghrelin and
      decreases leptin plasma levels). Surprisingly, in humans, there is no direct evidence that a
      shortened night has direct effect on energy metabolism during the following day.

      This study is set up to determine whether a partial sleep deprivation night has an impact on
      appetite and food energy intake and, concomitantly, on physical activity, during the
      following day.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy normal subjects
      
Keywords: Sleep deprivation; Food intake; Motor activity; Normal, healthy subjects
New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with severe acute
      respiratory distress syndrome (ARDS). But how to choose mechanical ventilation strategy is
      still not clear for severe ARDS patients supported by ECMO. Our previous work found that,
      compared to the traditional "lung rest" strategy, transpulmonary pressure guide new lung
      ventilation strategy can better maintain lung volume reduction lung collapse, atelectasis
      occurs. The severe ARDS patients receiving ECMO therapy were randomized divided into a new
      ventilation strategy group and the conventional ventilation strategy group. The new
      ventilation strategy is transpulmonary pressure guide ventilator setting method, and the
      conventional ventilation strategy is Extracorporeal Life Support Organization (ELSO) guide
      ventilation method. Compare the difference between the two groups of patients in lung injury,
      and explore the lung protection mechanism of new lung ventilation strategies guided by
      transpulmonary pressure. Our research group considered that transpulmonary pressure guide new
      lung ventilation strategy can provide more effective lung protection. And it will be further
      used in clinical work.
    


Intervention name(s): New lung ventilation strategy; Conventional ventilation strategy
Intervention type(s): Device; Device
Intervention description(s): New ventilation strateg: pressure assist control mode; inspiratory pressure was lowered to keep Ppeak less than 25cmH2O; set the PEEP at such a level that expiratory transpulmonary pressure stays between 0 and 5 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.; Conventional ventilation strategy: pressure assist control mode; keep the Ppeak between 20 and 25 cmH2O; set PEEP between 10 and 15 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Extracorporeal Membrane Oxygenation
Fistulotomy Versus Fistulotomy With Marsupialization
Condition: Fistula in Ano
MeSH terms: Fistula
Study type: Interventional

Summary: 
      It was a study comparing two standard procedures for fistula in ano
    

Detailed description: 
      It was a study which compared two standard surgical procedures for fistula in ano
    

Intervention name(s): standard fistulotomy; fistulotomy with marsupialization
Intervention type(s): Procedure; Procedure
Intervention description(s): in a standard manner fistula tract was identified and laid open without doing marsupialization; in this arm fistulotomy was done in a standard manner and marsupialization was done
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.
Condition: Postoperative Pain; Pain, Acute
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Pain is a global public health issue and represents the most common reason for both physician
      consultation and hospital admissions . When unrelieved or poorly controlled, it is associated
      with medical complications, poor patient satisfaction and increased risk of developing
      chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it
      combined with tramadol may have a better effect. The purpose of this study is to evaluate the
      analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the
      reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior
      approach (AMIS).
    


Intervention name(s): Dexketoprofen/tramadol (27mg/75mg); Tramadol hydrochloride; Paracetamol; Ropivacaine Hydrochloride 7.5 MG/ML; Levobupivacaine Hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h; Patients in group B received IV tramadol 75mg every 8h; Patients in group B received IV paracetamol 1g every 8h; 300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients; 10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol; Tramadol; Ropivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
POF Versus FOLFOX Versus FOLFOX Plus ip Paclitaxel in AGC
Condition: Malignant Neoplasm of Stomach Stage IV
MeSH terms: Neoplasms; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to compare the efficacy and safety of POF, FOLFOX, and FOLFOX plus
      paclitaxel(ip) as first-line treatment in AGC a phase II clinical trial.
    

Detailed description: 
      The biweekly 5-fluorouracil and leucovorin (LV5FU2) regimen associated with oxaliplatin
      (FOLFOX) is active in patients with AGC. Meanwhile, Paclitaxel monotherapy is also active in
      patients with AGC. In previous studies, we found that POF(A combination of oxaliplatin,
      fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in
      patients with advanced gastric cancer. This study is being done to find out if three drugs
      combination maintain manageable side effects but have better benefit than two drugs
      combination. Intraperitoneal paclitaxel showed high local concentration in abdominal cavity
      and low systemic toxicity. This study is being done to find out if the combination with
      Intraperitoneal paclitaxel and FOLFOX have higher local control rate and lower systemic
      toxicity.
    

Intervention name(s): POF; FOLFOX; FOLFOX plus PAC(ip)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU; Oxaliplatin plus Leucovorin plus 5-FU; FOLFOX plus intraperitoneally PAC
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Internet-based Study of Fertility and Early Pregnancy (PEEPS)
Condition: Fertility; Infertility; Pregnancy; Abortion, Spontaneous
MeSH terms: Infertility; Abortion, Spontaneous
Study type: Observational

Summary: 
      The purpose of this study is to assess the feasibility of conducting an Internet-based
      prospective pregnancy study with preconception enrollment with women completing daily
      journals for up to 12 months while trying to conceive and weekly through pregnancy if it
      occurs.
    

Detailed description: 
      There is a dearth of knowledge regarding the role that preconception health plays in
      fertility and early pregnancy loss. Classical methods of conducting prospective pregnancy
      studies with preconception enrollment to answer these questions are time-consuming in terms
      of recruitment efforts and expensive to carry out. The purpose of this project is to assess
      the feasibility of conducting an Internet-based prospective pregnancy study with
      preconception enrollment in the United States using the gold standard data collection
      approach of daily diaries during the trying to conceive period. We will accomplish this by
      enrolling 200 females of reproductive age who attempting to conceive and following them for
      up to 12 months and through pregnancy for those who become pregnant. Feasibility will be
      assessed by measuring: the number of women who screen eligible, the number of women who
      enroll, and compliance with journal use over time. We will also estimate the incidence of
      infertility, pregnancy and pregnancy loss as well as compare the demographics of women who
      enroll to the demographics of women who participate in community-based prospective pregnancy
      studies with preconception enrollment. The data from this project will be used to assess the
      feasibility of launching a larger prospective pregnancy study that is appropriately powered
      to examine the impact of preconceptional lifestyle factors on the incidence of infertility
      and early pregnancy loss.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We are looking for women ages 18-44 who are planning a pregnancy and have been trying to
        conceive for <3 months. Women must have reliable daily access to the Internet. The woman
        and her male partner may not have any known fertility problems.
      
Keywords: Fertility; Infertility; Pregnancy; Conception; Behavioral; Lifestyle; Preconception Care; Women's Health; Abortion, Spontaneous; Cohort Studies; Epidemiology; Internet
Physiotherapy in Hereditary Spastic Paraplegia
Condition: Hereditary Spastic Paraplegia
MeSH terms: Muscle Spasticity; Paraplegia; Spastic Paraplegia, Hereditary
Study type: Interventional
Phase: Phase 2

Summary: 
      Goal of this study is to develop and evaluate a physiotherapy concept that is focused on
      bilateral leg spasticity and aims to reduce spastic gait disturbance and to improve mobility
      in patients suffering from HSP.
    

Detailed description: 
      This is a randomized single-center parallel study with a control group design. A blinded
      block randomization in groups of four was performed in equal parts toward the treatment (TPC)
      or the control (regular standard-of-care) group using randomization.com. Group assignment was
      kept in a closed envelope which was opened by the participant at the end of the baseline
      visit. Therefore both, the movement disorder specialist as well as the physiotherapist, were
      blinded to the randomization result for the baseline assessment up to the beginning of the
      first physiotherapy training session.

      Therapeutic effects were evaluated at follow-up visits after 12 weeks (first visit,
      short-term effect) and after 26 weeks (second visit, long-term effect) comparing standard-of
      care with the TPC. Clinical evaluation is stated in detail below. Primary outcome assessment
      of this study was the change between baseline and follow-up assessment in treatment to
      control group in the spastic paraplegia rating scale (SPRS) score as a validated measure of
      disease severity (see Reference). Secondary outcome assessment was the change in walking
      distance in the Three-Minute-Walking test (3MW). Further exploratory outcome assessments were
      evaluated as effect sizes as specified below.
    

Intervention name(s): physiotherapy
Intervention type(s): Behavioral
Intervention description(s): Will receive two trainings. First training in week one after baseline assessment for three consecutive days 60 min twice daily by trained physiotherapists and in week three further two days with 60min once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Glucose-stimulated Pancreatic Islet and Intestinal Blood Flow in Healthy Subjects and in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Type 1 diabetes is the major type of diabetes in the young. The pathophysiology still needs
      clarification in order to reach feasible means of preventing the disease. This study aims in
      defining the differences in pancreatic and intestinal blood flow between subjects with and
      without type 1 diabetes and validating the methodology to achieve this. Earlier animal
      studies have demonstrated changes in pancreatic islet blood flow using microspheres. The aim
      of this study is to test and validate a method for the assessment of islet perfusion in
      humans using molecular imaging. The investigators hypothesize that glucose-stimulated
      pancreatic perfusion is enhanced specifically in islets in healthy subjects and that this
      increase is mostly suppressed in subjects with type 1 diabetes.

      Positron emission tomography (PET) is a non-invasive imaging technique, which can be used to
      study flow and metabolism of different organs. Using radiowater ([15O]H2O) and PET, cellular
      perfusion can be measured directly and noninvasively. Recently, diffusion weighted magnetic
      resonance imaging (DWI) has also been applied as a complimentary method for the assessment to
      quantitate changes in pancreatic blood flow.

      In the study 10 healthy subjects and 10 subjects with type 1 diabetes will be imaged on two
      separate days. Pancreatic and intestinal perfusion are first measured with [15O]H2O and
      combined PET/magnetic resonance imaging before and 5 and 15 minutes after intravenous glucose
      infusion. On the second day, PET imaging is replaced by dynamic DWI conducted in the same
      time schedule and with intravenous glucose stimulation.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects recruited via newspaper advertisements. Subjects with Type 1 diabetes
        recruited at the policlinics of endocrinology and internal medicine in the district of
        Turku University Hospital.
      
Biospecimen description: 
      Plasma, serum, faeces
Arginase Inhibition and Microvascular Endothelial Function in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The present project is designed to test the hypothesis that arginase contributes to
      microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular
      complications.
    

Detailed description: 
      Background

      The development of microvascular complications in diabetes is a complex process, in which
      endothelial dysfunction is of importance. Emerging evidence suggests that arginase is a key
      mediator of endothelial dysfunction in type 2 diabetes mellitus (T2DM) by reciprocally
      regulating nitric oxide bioavailability. The aim of this study was to test the hypothesis
      that arginase activity is increased and that arginase contributes to microvascular
      endothelial function in patients with T2DM and microvascular dysfunction.

      Method

      Microvascular endothelium-dependent and -independent vasodilatation are investigated in
      patients with T2DM (n =12) and healthy age-matched control subjects (n =12) with
      laser-Doppler flowmetry during iontophoretic application of acetylcholine and sodium
      nitroprusside, respectively, before and after intra-arterial administration of the arginase
      inhibitor N-hydroxy-nor-L-arginine (0.1 mg/min) for 120 min.
    

Intervention name(s): N-hydroxy-nor-L-arginine
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Highly Challenging Balance Program to Reduce Fall Rate in PD
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This study will test the hypothesis that two highly challenging exercise programs, one based
      at the VA medical center and the other conducted remotely, will both significantly reduce
      overall fall rates in patients with Parkinson's disease.
    

Detailed description: 
      Background/Rationale. Parkinson's disease (PD) is the second most common neurodegenerative
      disease, affecting over one million Americans. The cardinal clinical manifestations of PD
      include resting tremor, rigidity, bradykinesia, and postural instability/gait disturbance. In
      addition, people with PD fall frequently, with 60% falling annually and two-thirds of these
      falling recurrently. Identifying interventions that successfully improve postural control and
      reduce fall rate is critical to reduce disability, improve quality of life, and potentially
      increase survival in patients with PD. Recent randomized, controlled trials (RCT) have
      examined the effects of exercise and physical therapy interventions on reducing falls in
      patients with PD; however, with mixed results.

      Objectives. There is a limited availability of effective treatment options to reduce falls in
      PD. In this context, some studies suggest that highly challenging exercise approaches may
      lead to better outcomes. The investigators propose investigating the effects of two
      theoretically driven, progressive, highly challenging exercise programs: 1) a structured
      exercise program at the VA and 2) a structured exercise program at home. There will also be a
      control group in which health education is provided.

      Methods. The investigators propose to conduct an RCT evaluating effects on fall rate. A total
      of 162 VA patients with mild-to-moderate PD will be randomly assigned to one of the three
      3-month interventions: in-person exercise at the VA, remotely-delivered exercise, or health
      education. Outcomes will be compared between each intervention group and the control group.
      Fall rates will be compared between groups with the use of negative binomial regression
      models.
    

Intervention name(s): Facility-based structured exercise; Home-based structured exercise; Health education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Structured exercise program in a facility with instruction and encouragement; Structured exercise program in the home with instruction and encouragement; Provision of general information about a variety of topics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Parkinson's disease; Exercise therapy; Accidental falls