bioihbjkbjnl/mcl2 huggingface dataset:
Coated Devices to Decrease Infection in the Intensive Care Unit
Condition: Critically Ill
MeSH terms: Infections; Critical Illness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which
      will demand placement of invasive devices for organ support (endotracheal tube, central
      venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated
      (Bactiguard®) or habitual (non-coated) devices.
    


Intervention name(s): Coated devices; Control
Intervention type(s): Device; Device
Intervention description(s): Gold-silver-palladium coated devices (endotracheal tube, central venous catheter and urinary catheter) will be used whenever necessary. All three devices are required to be inserted as soon as possible after randomization and need for all three devices are the main inclusion criteria; Devices without coating available at each participating intensive care unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sepsis; ventilator-associated pneumonia; catheter related bloodstream infection; urinary catheter-related infection
Relapse Prevention for Bipolar Type-II Disorder
Condition: Bipolar Disorder; Depression
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®),
      lithium, the combination of these two medications, and placebo in treating and preventing
      recurrent depressive episodes in people with bipolar type II disorder.
    

Detailed description: 
      Bipolar II (BP II) disorder is characterized by a high recurrence of major depressive
      episodes (MDE), and it is associated with substantial illness and deaths. Unfortunately,
      relatively little attention has been given to treatment of BP II. Concern that patients may
      switch from depressed to manic states during treatment of MDE has impeded the development of
      effective treatments for BP II MDE.

      BP II MDE patients are treated initially with fluoxetine for 10 weeks. Patients who recover
      from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine,
      lithium, a combination of fluoxetine and lithium, or placebo for 1 year. Patients undergo
      clinical and laboratory evaluations, including physical examinations, bloodwork, thyroid
      function tests, electrocardiogram (ECG), urinalysis, and HAM-D, YMR, CGI-S, CGI-I, and
      adverse events scales.

      For information on a related study, please follow this link:

      http://clinicaltrials.gov/show/NCT00602537
    

Intervention name(s): Fluoxetine; Lithium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Magnesium and Intraoperative Blood Loss in Meningioma Surgery
Condition: Meningioma
MeSH terms: Meningioma; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Meningioma is the most common central nervous system tumor and craniotomy with tumor removal
      was associated with moderate blood loss and blood transfusion. Magnesium has hypotensive
      effect and probably reduce intraoperative blood loss. Whether or not magnesium sulphate can
      reduce intraoperative blood loss and improve postoperative cognitive function is still
      inconclusive. So the investigators conduct the randomized control trial to compare the effect
      of magnesium with placebo control in blood loss and cognitive function in meningioma patient
      undergoing craniotomy.
    

Detailed description: 
      The investigators enroll 120 patient who admitted for craniotomy for meningioma removal.
      Then, the patients will be divided into two groups. The first group or group Mg will receive
      magnesium sulphate 40 mg/kg infuse for 30 min (started at skin incision), and then infuse
      magnesium sulphate 10 mg/kg/hr until the dura will be closed. The another group or normal
      saline group will receive the same amount of 0.9% sodium chloride. The anesthesia and surgery
      are standardized. The recorded data include patient demographic data, intraoperative blood
      loss, hemodynamics and pre and postoperative Montreal cognitive assessment score.
    

Intervention name(s): Magnesium group; Normal saline group
Intervention type(s): Drug; Drug
Intervention description(s): We will dilute magnesium 6 gram with 0.9% sodium chloride to 30 ml. The patient will receive magnesium sulfate 40 mg/kg infuse over 30 min started at skin incision and continuous drip 10 mg/kg/hr until the dura is closed. Anesthesia is standardized with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.; The patient will receive 0.9% sodium chloride the same amount of magnesium sulphate infuse over 30 min started at skin incision and continuous drip until the dura is closed. Anesthesia is standardized with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Other intervention name(s): Mg; NSS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We compare intraoperative blood loss in two group between the magnesium (study group) and 0.9% sodium chloride group (control group)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: Meningioma; Magnesium; Montreal cognitive assessment; blood loss; controlled hypotension; blood transfusion; neuroprotective; anesthesia
High-level Laser for Provoked Vestibulodynia
Condition: Vulvodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      This is a randomized feasibility and acceptability study investigating the effects of laser
      treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment.
      Participants will be randomized into the laser group or sham-laser group. The laser group
      will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6
      consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6
      consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be
      assessed at baseline and at post-treatment and will include: feasibility and acceptability
      variables, pain, sexual function, sexual distress, psychological variables and perceived
      improvement after the treatment.
    


Intervention name(s): High-level laser therapy
Intervention type(s): Radiation
Intervention description(s): Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
Other intervention name(s): Nd:Yag laser
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Baseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser; Provoked vestibulodynia; Pain; Sexual dysfunctions
Safety, PK and Efficacy of 15 Days of SCY-635 Treatment in Hepatitis C Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing
      hepatitis C virus (HCV) RNA levels.
    


Intervention name(s): Placebo; SCY-635
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet given once or three times daily for 15 consecutive days; oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
Condition: Chronic Myelogenous Leukemia; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or
      intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+)
      acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will
      continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)
    


Intervention name(s): dasatinib
Intervention type(s): Drug
Intervention description(s): Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID
Other intervention name(s): Sprycel; BMS-354825
Intervention MeSH terms: Dasatinib
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relationship Between the Gut Microbiota and Stress
Condition: Psychological Stress
MeSH terms: Stress, Psychological
Study type: Observational

Summary: 
      The relationship between the gut microbiota and stress is poorly studied in humans. In this
      study we aim to look for if stressed persons have different levels of key bacterial groups
      compared to the levels in non-stressed persons.
    

Detailed description: 
      The gut microbial flora will be analyzed with molecular genetic methods. Stress will be
      measured with cortisol levels in saliva and with questionnaire.
    

Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Observation of the gut bacterial flora in high- and low-stressed individuals
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Healthy Men, 19-35 years old.
      
Biospecimen description: 
      Fecal samples
Social Cognition Training in Schizophrenia
Condition: Schizophrenia; Social Cognition
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      People with schizophrenia show deficits in social cognition, the ability to process
      information about other people such as identifying their emotional expressions. Social
      cognition is associated with everyday life functioning and could therefore be an important
      treatment target. Several social cognitive training programs have been developed during the
      last years. Results indicate that social cognitive performance can be ameliorated through
      commonly used intervention techniques. However, it is less clear whether this improvement
      generalizes to everyday life. The purpose of this study is to investigate if a social
      cognitive training program (Training in Affect Recognition) improves performance on social
      cognitive and neuropsychological tests and leads to improved everyday life functioning in
      persons with schizophrenia. The study also aims at examining if an improvement is present
      three months after completion of the training intervention.
    


Intervention name(s): Training in Affect Recognition
Intervention type(s): Other
Intervention description(s): A 12-session social cognitive training programming covering emotion perception and social perception administered in a group setting to up to four participants with schizophrenia at the time
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: functional capacity; training; neurocognition
Clinical Observation of Warm Needling Combined With and Electroacupuncture Therapy on Ovulatory Dysfunction
Condition: Warm Needling; Electroacupuncture; Ovulation Dysfunction
Study type: Interventional

Summary: 
      To observe the effect of warm needling combined with electroacupuncture on the ovulation
      promotion rate and pregnancy rate in luteinized unruptured follicle syndrome (LUFS).
    


Intervention name(s): warm needling combined with electroacupuncture; The treatment with letrozole tablets was started on the fifth day of the menstrual cycle
Intervention type(s): Other; Drug
Intervention description(s): Treatment begins on the 5th day of the menstrual cycle, qd (once a day), usually for 6-8 consecutive days, and continuing to the day of ovulation.; Letrozole tablets were given at 2.5mg (Jiangsu Hengrui Pharmaceutical Co., Ltd., H19991001, 2.5mg per tablet), po (oral), qd, for 5-7 consecutive days. When the diameter of follicles reaches 18mm, Chorionic gonadotrophin is given at 5000u (Lizhu Group Lizhu Pharmaceutical Factory, Chinese medicine H44020668, 5000u per branch), with intramuscular injection, qd, to promote follicle discharge. Patients were also instructed to have sexual intercourse on the same day and on day 2.
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Acute Effects of LBBP Versus BVP for CRT
Condition: Heart Failure; Cardiac Pacing, Artificial; Cardiac Resynchronization Therapy
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with
      biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35%
      with left bundle branch block (LBBB).
    

Detailed description: 
      The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to
      evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart
      failure and LBBB.
    

Intervention name(s): left bundle branch pacing; biventricular pacing
Intervention type(s): Procedure; Procedure
Intervention description(s): left bundle branch pacing; biventricular pacing
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objectives of the trial are to determine whether a non-commercial soy protein product,
      consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol
      (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and
      affects other aspects related biomarkers.
    


Intervention name(s): Soy protein; 25 grams/day; Control protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Soy protein; Milk protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: hypercholesterolemia; cholesterol; soy
The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism
Condition: Contraception
Study type: Interventional

Summary: 
      The impact of different administration routes of hormonal contraceptives on androgen
      secretion, glucose metabolism and inflammation. A prospective randomized trial.

      The investigators assume, that transdermal or transvaginal hormonal contraception would have
      less effects on androgen levels, glucose metabolism and inflammatory markers than oral
      contraceptives.
    

Detailed description: 
      45 patients are recruited in the study. Each study group will consist of 15 women (aged 20-35
      years) receiving oral, transdermal or transvaginal hormonal contraception continuously for 9
      weeks. The subjects should have at least 2 months wash out period from all hormonal
      medication prior to the study.

      The measurements for serum sampling and OGTT will be performed before and after 9 weeks of
      medication.
    

Intervention name(s): Desogestrel-Ethinyl Estradiol contraceptive pill; Etonogestrel-Ethinyl Estradiol vaginal ring; Norelgestromin-Ethinyl Estradiol contraceptive patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.; Etonogestrel-Ethinyl Estradiol vaginal ring, which consists of 11,7 mg etonogestrel and 2,7 mg ethinyl estradiol. It delivers 0,120 mg etonogestrel and 0,015 mg ethinyl estradiol per day. Treatment continues continual for 9 weeks and the vaginal ring is changed every three weeks.; A combination transdermal contraceptive patch with 6 mg of norelgestromin and 600 microg of ethinyl estradiol. It delivers 203 microg of norelgestromin and 33,9 microg ethinyl estradiol per day. A continual use of patch for 9 weeks and the patch is changed every week.
Other intervention name(s): Mercilon; NuvaRing; Evra
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Etonogestrel; Desogestrel; NuvaRing; Norelgestromin; Contraceptive Agents; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral glucose tolerance test; hormonal contraception; androgens; crp
CBT for Premature Ventricular Contractions
Condition: Ventricular Premature Complexes
MeSH terms: Premature Birth; Ventricular Premature Complexes
Study type: Interventional

Summary: 
      The purpose of the present interdisciplinary research program is to develop and evaluate a
      disease-specific cognitive behavior therapy (CBT) protocol to increase quality of life (QoL)
      and reduce symptom burden in patients with Premature Ventricular Contractions (PVC).
    

Detailed description: 
      Patients will be recruited in collaboration with arrythmia specialist units in Stockholm and
      through advertisement in local newspapers and social media. All patients giving informed
      consent will be screened thoroughly by the research nurse and a psychologist before included
      by the study cardiologist. 20-30 patients that meet eligibility criteria will be included and
      receive 8-10 sessions of cognitive behavior therapy during 8-10 weeks. Due to the current
      Covid-19 pandemic, treatment will be delivered face-to face through a secure digital
      platform. The psychologist delivering the treatment will have direct access to the study
      cardiologist during treatment. Follow-up at 3 and 6 months.
    

Intervention name(s): CBT
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavior Therapy for PVC-specific anxiety education, in-vivo exposure, interoceptive exposure, behavioral activation, relapse prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electrophysiological Effects of Tipranavir Co-administered With Ritonavir on the QT Interval in Healthy Female and Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the
      QT interval more than placebo co-administered with ritonavir
    


Intervention name(s): TPV low; Placebo; Moxifloxacin; TPV high; RTV
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Avelox®
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
MRI Assessment of Leukemia Response to Therapy
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      The purpose of this study is to investigate if a type of magnetic resonance imaging (MRI)
      scan of the bone marrow before the start of standard chemotherapy can predict complete
      remission of leukemia patients after the therapy. This type of MRI scan, called dynamic
      contrast-enhanced MRI (DCE-MRI), measures bone marrow blood flow. For those patients who do
      not achieve complete remission status after initial therapy and will be treated with
      additional therapy, the investigators are also interested in determining if the second MRI
      exam before the additional therapy can predict complete remission. If successfully tested,
      the MRI exam may be used in the future to help with early identification of patients who are
      unlikely to respond to standard chemotherapy. This will allow for a personalized therapeutic
      plan to be developed for these patients at an early stage and prevent them from being exposed
      to toxic and ineffective therapies.
    


Intervention name(s): 3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system
Intervention type(s): Device
Intervention description(s): Each MR scanning session will include the pre-contrast multi-slice T2-weighted MRI with fat-saturation and T1-weighted MRI which are regularly acquired in clinical protocols. Following these acquisitions, high-spatial and temporal-resolution DCE-MRI will be performed. The total duration of a research MR session is expected to be less than 45 min.
Other intervention name(s): Magnetic Resonance Imaging (MRI)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic
      
Keywords: AML
Effects of Intranasal Oxytocin on Striatal Functional Connectivity
Condition: Healthy
Study type: Interventional

Summary: 
      To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state
      functional connectivity in healthy males.
    

Detailed description: 
      In a double-blind, between-subject, placebo controlled design, investigators plan to
      investigate the effects of oxytocin treatment on resting-state functional connectivity.

      Subject will receive either intranasal oxytocin or placebo administration and go through a
      seven-minute resting-state scan in MRI scanner to test whether oxytocin changes functional
      connectivity in the brain. Trait anxiety and mood questionnaires will be administered as
      control variables.
    

Intervention name(s): Oxytocin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Oxytocin, intranasally administrated; Saline, intranasally administrated
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Oxytocin; Resting-state; Functional connectivity; BOLD
Immobilization and Protein Supplementation (IM-PRO)
Condition: Disuse Atrophy; Aging
MeSH terms: Muscular Disorders, Atrophic
Study type: Interventional

Summary: 
      In the present study, the effects of 5 days of lower limb immobilization with or without
      twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be
      determined. A young group will be included to compare the changes in muscle mass and muscle
      fiber characteristics between young and old men.
    


Intervention name(s): Immobilization
Intervention type(s): Behavioral
Intervention description(s): Immobilization with protein (elderlY), immobilization without protein (elderly and young)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Immobilization; Protein supplementation