bioihbjkbjnl/mcl2 huggingface dataset:
Changes of Biomarkers in Response to Training and Antioxidant Treatment
Condition: Obesity; Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to compare the effects of an intensive 4 weeks exercise training
      program with or without additional treatment with antioxidants. 16 volunteers are included
      into the study and randomized into a treatment (n=8,Vitamine E 400 IU od + vitamine C 1g
      twice daily) and a non-treatment (n=8, training only) group. Before and after the training
      program, skeletal muscle biopsies will be taken to measure PGC-1alpha and PPARgamma mRNA
      expression. In addition before and after the training program individuals will have the
      following measurements: body weight, waist circumference, body fat content (DEXA scan),
      euglycemic-hyperinsulinemic clamps, ergospirometer (VO2 max), routine laboratory
      measurements, serum malondialdehyde concentrations.
    


Intervention name(s): Vitamin C, Vitamin E; Antioxidant treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily; no treatment
Intervention MeSH terms: Vitamins; Vitamin E; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: PGC-1alpha; PPARgamma; oxidative stress; training intervention
Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Although remifentanil provides profound analgesia during operation, postoperative occurrence
      of hyperalgesia and tolerance after remifentanil administration could be a challenge to the
      postoperative pain control. Evaluation of analgesia and anti-nociception during anesthesia is
      still a challenging issue. Surgical Pleth Index (SPI) is a non-invasive and simple access
      tool used to monitor autonomous nervous system during anesthesia. This technique is based on
      photoplethysmographic wave and heart beat analysis. SPI values range between 0 (no stress)
      and 100 (high stress level). The purpose of this study was to determine the appropriate use
      of Remifentanil for pain control in patients with SPI.
    

Detailed description: 
      Patients were randomized into either SPI-guided analgesia or standard practice (Control). In
      both groups, anesthesia was maintained with total intravenous anaesthesia(TIVA) to keep
      bispectral index values between 40 and 60.

      In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the
      operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group
      stopped remifentanil 10 minutes before the end of the operation.

      SPI was recorded before the intubation, after the intubation, directly before the end of
      surgery. The number of unwanted somatic events, hemodynamics, Patient-controlled
      analgesia(PCA) consumption, narcotic analgesics consumption, and recovery times were
      recorded.
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): Remifentanil is a potent, short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anesthetic.
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In this study, remifentanil gradually withdrawal goup (test group) and remifentanil immediately stop group (control group) were divided into two groups. In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group stopped remifentanil 10 minutes before the end of the operation.
Masking: Single (Participant)
Primary purpose: Supportive Care
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing
      loss associated with speech-in-noise impairment.
    

Detailed description: 
      This is a randomized-controlled, double-blind study of PIPE-505 or placebo given as an
      injection one time in subjects with sensorineural hearing loss associated with
      speech-in-noise difficulty. Visits to the clinic will occur at baseline, dosing, and days 1,
      7, 14, 30, 60 and 90 after treatment. Safety will be assessed by periodic measurement of
      vital signs, ear examination, electrocardiogram (ECG), blood laboratory analyses and
      occurrence of adverse events (AE). Efficacy will be assessed by periodic audiometry and other
      audiological tests.
    

Intervention name(s): PIPE-505; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intratympanic injection; Intratympanic injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hearing Loss; Cochlear synaptopathy; Deafness; Speech-in-noise hearing difficulty
Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure
Condition: Respiratory Distress Syndrome; Hyaline Membrane Disease; Preterm Infants; Premature Infants
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Premature Birth
Study type: Interventional

Summary: 
      There is little data published concerning the best approach to nasal continuous positive
      airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP
      therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial
      infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the
      use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP
      may be beneficial. On the other hand, removing CPAP too early may lead to complications that
      include: increasing apnea, increased oxygen requirement, increased work of breathing, the
      need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental
      study have demonstrated an improvement in lung growth after the prolonged use of CPAP.

      Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of
      preterm infants. The use of NC flow to generate positive airway pressure would minimize many
      of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas
      that is inadequately warmed and humidified, limiting the use of such flows due to increased
      risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.

      The purpose of this randomized controlled trial is to evaluate the clinical impact of two
      methods for weaning preterm infants from nCPAP.
    

Detailed description: 
      The objective of this study is to test the null hypothesis that in preterm infants with
      gestational age of 28 to 36 weeks who are stable on CPAP pressure of 5 cmH2O and with oxygen
      concentrations (FiO2) <0.30, keeping these infants on CPAP or changing them to NC flow of 1-2
      L/min will not make any difference in length of hospitalization, length of respiratory
      support and incidence of complications.
    

Intervention name(s): CPAP; Nasal Cannula
Intervention type(s): Device; Device
Intervention description(s): CPAP; Nasal Cannula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasal Continuous positive Airway pressure; Nasal Cannula; CPAP; Premature; RDS; HMD; NICU
Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      Design: Single-centre

      Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the
      efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural
      and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN).

      Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary
      temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health
      centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital
      outpatient department.

      Sample size: N=120

      Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three
      days (first and second day: 10mg/kg, third day: 5mg/kg).

      Statistical procedures: The primary analysis parameter is the proportion of clinical failures
      on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without
      PCR correction), the rate of early clinical failures, the rate of late parasitological
      failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the
      overall group of study children and for rural (n=50) and urban (n=50) study children
      separately.

      Study duration and dates: The study will be implemented in September-December 2005.
    


Intervention name(s): Amodiaquine
Intervention type(s): Drug
Intervention MeSH terms: Amodiaquine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amodiaquine; Efficacy; Malaria; Burkina Faso
The Effect on EPCs by Successful Cardiac Occlusion Device Implantation
Condition: Foramen Ovale, Patent; Heart Septal Defects, Atrial; Atrial Septal Defect
MeSH terms: Heart Septal Defects; Heart Septal Defects, Atrial; Foramen Ovale, Patent
Study type: Interventional

Summary: 
      All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen
      ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be
      identified and reviewed in cardiology clinics. These patients will be placed on waiting list
      to undergo the procedure. Patient-participants will be consented on the date of admission for
      device closure implantation.

      The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD closure and
      10 patients undergoing LAA closure. EPC will be measured on the day of the device
      implantation, day 0 and prior to discharge on day 1.

      Patient participants are admitted overnight after the device closure implantation. Then on
      subsequent out patient cardiology research clinic follow appointments on days (3-4) and
      (7-8).
    

Detailed description: 
      The objective of this study is to assess the effect, if any, on EPC count and cardiac device
      implantation.

      All patients awaiting LAA or PFO/ASD occlusion will firstly be reviewed in a cardiology
      clinic and assessed. Suitable patients will then be placed on a waiting list for occlusion
      device implantation and therefore identified as potential participants in the study.
      Patient-participants will be informed of the trial and given a chance to participate, this
      may be by face to face and or via invitation letter. All patient-participants will be given a
      copy of the patient information sheet.

      Formal consent to participate in the trial will occur on the morning of the procedure. This
      will avoid repeated visits by patients that may have to travel some considerable distance.

      The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD occlusion and
      10 patients undergoing LAA occlusion. EPC will be measured on the day of the device
      implantation, day 0 and prior to discharge on day 1, then on subsequent follow up
      appointments on days (3-4) and (7-8). Blood samples of 3-5ml will be taken to allow flow
      cytometric analysis for EPCs.

      Standard follow up for participants may include transesophageal echocardiography (TOE) at 3
      months after implantation. This will give a direct assessment of device related thrombus.
      Currently TOE is not standard of care in PFO follow up. If a TOE result is available for
      either group the investigators will use the results in our study.
    

Intervention name(s): Blood samples
Intervention type(s): Other
Intervention description(s): Blood samples at baseline and 3 timepoints for EPC analysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Restoring Sleep Homeostasis to Lower Blood Pressure
Condition: Hypertension; Pre-hypertension
MeSH terms: Hypertension; Prehypertension; Hypotension
Study type: Interventional

Summary: 
      Cutting back on sleep duration has developed into a common, highly prevalent habit in the
      adult population, and may lead to a major health problem. Large epidemiological studies have
      demonstrated that short sleep duration is associated with increased risk of cardiovascular
      disease (CVD). The investigators' preliminary data on the effects of experimental sleep
      reduction have shown elevation of blood pressure (BP) and inflammatory markers, such as
      interleukin-6 (IL-6) and C reactive protein (CRP), suggesting that both may play an important
      role in linking sleep loss and CVD risk. With this background, the investigators hypothesize
      that restoring sleep homeostasis, i. e. getting adequate amounts of sleep, is an effective
      behavioral intervention in the treatment of elevated BP.

      The investigators will test this hypothesis in subjects with BP above normal and with short
      habitual sleep duration, as verified by sleep logs and actigraphic recordings. Subjects will
      either undergo 6 weeks of mild sleep extension, in which 60 min of bedtime will be added to
      the habitual sleep duration, or subjects will maintain their habitual sleep duration for the
      following 6 weeks.

      Regarding their first specific aim, the investigators expect that sleep extension across 6
      weeks will lower BP, inflammatory (IL-6, CRP, cell adhesion molecules) and autonomic markers
      (catecholamines). In particular, the investigators expect that in subjects with mild BP
      elevation, i. e. with pre-hypertension, sleep extension leads to normalization of BP.

      This study presents a very first approach in using sleep behavior components for the
      treatment of elevated BP. Therefore, the investigators' second specific aim will characterize
      the strength of associations between changes in sleep duration, BP, and inflammation, and
      they will explore factors that are predictive for these changes. In particular, adiposity, as
      measured by percent body fat, has frequently been shown to be related to short sleep duration
      and inflammatory processes, but the role of adiposity in modulating the physiological
      consequences of changes in sleep duration has never been addressed.

      If the investigators' hypothesis is correct, sleep extension may be considered as an
      additional component in current lifestyle intervention programs in combating and preventing
      hypertension.
    


Intervention name(s): Sleep extension
Intervention type(s): Behavioral
Intervention description(s): Habitual sleep duration is extended by 60min/night over a 6-week time period.
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hypertension; Sleep; Blood Pressure; Inflammatory Markers
Impact of Remission Induction Chemotherapy Prior to Allogeneic SCT in Relapsed and Poor-response Patients With AML
Condition: Acute Myeloid Leukemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial compares outcome of two treatment strategies for patients with high-risk AML who
      failed to achieve or maintain a complete remission with standard therapy. Patients will be
      randomized between two strategies. The standard strategy is aimed at achieving a complete
      remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, .
      The alternative is a less toxic disease-control strategy of disease monitoring and, if
      necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which
      should be performed as soon as possible.
    

Detailed description: 
      Patients with high-risk acute myeloid leukemia (AML) who relapsed or showed a poor response
      to induction chemotherapy have a dismal prognosis. For these patients, allogeneic
      transplantation is the recommended treatment. While allogeneic transplantation may be
      considered as the ultimate treatment concept, the treatment path to transplantation is not
      well defined.

      The traditional approach to pursue a complete remission by means of aggressive reinduction
      chemotherapy prior to allogeneic transplantation. This approach is associated with
      potentially life-threatening toxicities and has limited efficacy. As a result, only some
      patients will reach allogeneic transplantation in complete remission.

      To reduce the number of patients who die or who are ineligible for transplantation due to the
      toxicity of aggressive induction chemotherapy, other bridging options have been explored. One
      promising alternative is to abstain from remission induction. Instead, disease control by
      means of less aggressive chemotherapy or simply monitoring leukemic proliferation can be
      considered.

      This randomized trial will identify if there is non-inferiority of the less toxic approach,
      compared to the standard approach of remission induction by aggressive chemotherapy prior to
      allogeneic transplantation.
    

Intervention name(s): HAM; LDAC and/or Mitoxantrone
Intervention type(s): Drug; Drug
Intervention description(s): High-dose cytarabine 1 - 3 g/m2 (days 1-3)/Mitoxantrone 20 mg/m2 (days3-5); Low-dose cytarabine 20 mg/m2 (days 1-10) and/ or mitoxantrone 10mg/m2 (max 3 doses)
Intervention MeSH terms: Mitoxantrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Accuracy of Tooth Guided Immediate Implant Placement at Molar Region
Condition: Immediate Implant Placement Guided by the Roots of Multiradicular Teeth
Study type: Interventional

Summary: 
      Introduction: The concept of immediate implant placement has become popular due to reduced
      trauma and reduced overall treatment time. Removal of molar teeth provides a challenging and
      intriguing dilemma due to multiple root morphology. In cases of extraction and immediate
      placement of implants in the molar region, removal of the inter-radicular septum should be
      avoided to attain initial implant stability at the time of placement, and prevent slipping of
      the implant into the extraction socket. Following this technique prevents the slippage of the
      implant and allows the implant to be guided into the inter-radicular septum.

      Objectives: To assess the accuracy of implant placement using the remaining roots of
      multi-radicular mandibular molars, evaluate bone density around implants and implant
      stability in fresh extracted site.

      Materials and Methods: A prospective study was done on 10 patients with badly destructed
      mandibular molars. The technique of implant insertion consisted of a progressive preparation
      of the implant site using the anatomy of the root of the multi-radicular mandibular molars to
      be extracted as a reference and as an aid to engage the inter-radicular septum.
    


Intervention name(s): Tooth guided immediate implant placement
Intervention type(s): Procedure
Intervention description(s): The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Percutaneous Fixation of Acute Scaphoid Fractures
Condition: Scaphoid Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw
    

Detailed description: 
      Aim of the work:

      To assessment outcomes of percutaneous Trans-trapezial fixation of acute scaphoid fracture.

      Operative Technique:

      Anesthesia: carried out under general anesthesia or brachial plexus block and under
      tourniquet control.

      Position: supine. Approach: Percutaneous Trans-trapezial fixation of acute Scaphoid fracture.
      Recording any intraoperative complication that may affect the result.

      Postoperative Follow Up:

      Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be
      removed and exercises will start.
    

Intervention name(s): Percutaneous fixation of acute Scaphoid fractures
Intervention type(s): Procedure
Intervention description(s): Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of the Örebro Prevention Program on Youth Drinking
Condition: Youth Drinking
MeSH terms: Underage Drinking
Study type: Interventional

Summary: 
      The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of
      13-16 year old youths in regular parental meetings. The program aims to encourage parents to
      maintain a restrictive attitude towards youth drinking throughout their children's teenage
      years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by
      the program developers showed a sustained alcohol-specific restrictivity among parents
      exposed to the program, and also a reduction on drinking measures among the youths of the
      exposed parents (Koutakis, Stattin & Kerr, 2008). This study aims to investigate whether
      these effects are sustained also when the program has gone into wide dissemination in Sweden.
    


Intervention name(s): Örebro prevention program; Business as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 presentations on alcohol-specific parenting practices to parents of 13-16 year olds youth; Regular alcohol prevention activities and curricula in Swedish schools
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Örebro prevention program; Youth drinking