bioihbjkbjnl/mcl2 huggingface dataset:
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Breathing and Sleep
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a
      stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung
      disease.
    

Detailed description: 
      Patients with moderate to severe chronic obstructive pulmonary disease living below 800 m
      will be invited to participate in a randomized, cross-over field trial evaluating the
      hypothesis that nocturnal breathing and sleep during nights spent at moderate altitude are
      improved by oxygen therapy via a nasal cannula compared to room air (sham oxygen). Outcomes
      will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2
      nights each spent at moderate altitude (St. Moritz Salastrains, 2048 m) separated by a
      wash-out period of at least 2 weeks spent at low altitude (<800 m).
    

Intervention name(s): Oxygen; sham oxygen (room air)
Intervention type(s): Drug; Drug
Intervention description(s): Nocturnal nasal oxygen during stay at 2048 m
Other intervention name(s): Nocturnal nasal room air during stay at 2048 m
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: airway disease; bronchitis; emphysema; lung
Treatment Outcomes of ReACT for PNES
Condition: Convulsion, Non-Epileptic
MeSH terms: Seizures
Study type: Interventional

Summary: 
      This research study is examining the effects of Retraining and Control Therapy (ReACT; an
      intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic
      seizures (PNES, episodes resembling epileptic seizures but with no medical explanation).
      Participants engage in 8 individual therapy sessions consisting of either cognitive
      behavioral therapy or supportive therapy. Healthy control participants also complete
      pre-questionnaires and two computer tasks.
    

Detailed description: 
      Participants come to our laboratory for a total of 11 sessions. During the initial visit,
      participants complete several questionnaires assessing demographics, personality style,
      relationships with friends and family, as well as past and current PNES symptoms. They also
      completed two computer tasks: the magic and turbulence task and a modified Stroop task.
      Participants must provide EEG results indicating a diagnosis of psychogenic non-epileptic
      seizures.

      Participants receive a PNES diary to record all episodes during the course of the study. They
      are randomly assigned to either receive ReACT for PNES or supportive therapy, and they return
      8 times over the next 8 weeks for therapy sessions. If randomized to ReACT, participants and
      a family member learn how to change behaviors and thoughts to address PNES. If randomized to
      supportive therapy, they discuss stressors and how they relate to the PNES.

      Procedures are the same for each therapy group. The first therapy session lasts approximately
      90 minutes. All subsequent sessions last about one hour. After completing the 8 therapy
      sessions participants return one week later for a follow-up visit lasting approximately one
      hour. This visit consists of answering several questionnaires and an interview about current
      PNES symptoms. Participants return two months later for a final follow-up visit similar to
      the one week follow up visit. Lastly, participants and their parent are called 1 year after
      completing treatment and are asked to report PNES frequency over the last 30 days. They are
      also asked if they think ReACT was helpful, and if so, what the most helpful part of ReACT
      was.

      Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender,
      race and family income. They come for 1 laboratory visit to complete the initial visit
      questionnaires and computer tasks.
    

Intervention name(s): ReACT; Supportive Therapy
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Retraining and Control Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RNF and Betaseron® Tolerability Study
Condition: Relapsing Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with
      relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site
      pain scores from pre-injection to 30 minutes post therapy administration.
    


Intervention name(s): New Formulation of rebif - human interferon beta-1a; Interferon beta -1b
Intervention type(s): Drug; Drug
Intervention description(s): New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.; Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
Condition: Lymphedema; Lymphedema of Leg; Chronic Venous Insufficiency; Venous Insufficiency; Lymphedema, Lower Limb
MeSH terms: Venous Insufficiency; Lymphedema
Study type: Interventional

Summary: 
      To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression
      Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
    

Detailed description: 
      A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and
      Effectiveness of Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD)
      vs. an Advanced Pneumatic Compression Device (APCD) for Treating Lower Extremity Lymphedema.
      To evaluate the Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in
      contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to
      evaluate volume, quality of life, safety, adherence, and preference.
    

Intervention name(s): Cross over Device (PCD or Dayspring - alternate to first group)
Intervention type(s): Device
Intervention description(s): Cross over after three month of use and a month of washout period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems
Condition: Anxiety Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The present study (Echo) will promote much needed research and innovation that optimize
      service provision in first line health services for the alarmingly high number of school
      children who suffer from clinical and subthreshold levels of anxiety and depression. The
      effect of different versions of an evidence-based intervention for this group of children
      will be tested using a cluster randomized design involving 40 schools across Norway. The aim
      is to create a framework that allows more evidence-based psychosocial interventions to be
      provided at a lower cost to society. Echo will provide knowledge about three main evidence
      gaps for children: (1) The effect of school-based preventive interventions on anxiety and
      depression; (2) The effect of feedback informed systems, and; (3) the effect and
      cost-effectiveness of digital health interventions using online sessions and virtual reality
      technology.
    


Intervention name(s): Emotion child
Intervention type(s): Behavioral
Intervention description(s): The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other intervention name(s): Measurement Feedback System (MFS); Emotion parent
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The study will have a stratified, randomized cluster design. The schools are clusters randomized to different experimental conditions. The factors are (1) feedback from a MFS-system, yes/no, (2) Evidence Based Intervention, long/short (EBI), and (3) parental involvement, high/low. The three factors are related components that, together, should form the strongest intervention outcomes. Each of the 40 recruited schools will therefore be randomly assigned to one of eight experimental conditions
Masking: None (Open Label)
Primary purpose: Prevention
Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood
Condition: Obesity
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The investigators will compare 16sRDNA profile in cases and controls in order to identify
      bacteria associated with metabolic diseases that reside both in intestinal crypts and in
      blood.
    

Detailed description: 
      Experimental evidence suggests that bacterial translocation from gut to tissue could be an
      initial step leading to diabetes. To test this hypothesis, a bacterial component that is
      highly conserved between different species of bacteria, the 16S rDNA gene will be analysed
      both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and
      control.
    

Intervention name(s): obese patients; diabetic patients; patients free of obesity and diabetes; patients free type 2 diabetes
Intervention type(s): Other; Other; Other; Other
Intervention description(s): collection of blood sampling and biopsies; collection of blood sampling and biopsies; collection of blood sampling and biopsies; collection of blood sampling and biopsies
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: bacterial; gut; type 2 diabetes.; 16S rDNA gene; intestinal crypt
Auricular Acupuncture for Exam Anxiety in Medical Students
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Title of the study: Auricular acupuncture (AA) for pre-exam anxiety: A blinded randomized
      crossover study on healthy volunteers

      Study period: 04/2012 - 07/2012

      Institution: Department of Anesthesiology and Intensive Care Medicine University Medicine of
      Greifswald

      Aim of the study: To investigate the anxiolytic effect of auricular acupuncture (AA) in
      comparison to placebo acupuncture and no intervention during oral exams in anatomy at the
      University of Greifswald

      Design: Prospective blinded randomized crossover trial

      Intervention:

        1. AA using indwelling fixed needles, retained 24 h in situ

        2. AA using placebo needles

      Number of volunteers: N = 40

      Outcome measures: Anxiety level, Heart rate, blood pressure.
    


Intervention name(s): Auricular acupuncture; Placebo acupuncture
Intervention type(s): Device; Device
Intervention description(s): Auricular acupuncture with indwelling permanent needles; Placebo acupuncture with placebo needles
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.
    


Intervention name(s): PF-06650833
Intervention type(s): Drug
Intervention description(s): Two formulations of PF-006650833
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of rTMS Treatment on Alzheimer's and Sleep Quality
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This research is being conducted to study whether rTMS (repetitive Transcranial Magnetic
      Stimulation) could be potentially used as a treatment for Alzheimer's disease. rTMS is a
      technique that stimulates the brain by rapidly switching a magnetic field in a coil placed
      over your head. Prior to rTMS, single pulse TMS will be used to localize the specific brain
      region that we are interested in.
    

Detailed description: 
      Upon meeting the inclusion criteria and providing informed consent, each participant will
      complete a series of cognitive assessments and rTMS treatments at the TMS Lab at Riverview
      Health Center. Each treatment session will involve implementing rTMS, while the patient is
      involved in a cognitive exercise such as naming object or action. The study sessions will be
      scheduled as follows: Block 1: 5 days/week for two weeks followed by 2 days a week for 1
      week, followed by once a week for 1 week (total of 13 treatments); Pause: 4 weeks of no
      treatment; and Block 2: another 13 sessions of treatment with the same pattern as Block 1.
      One of these two sets of treatment (Block 1 or Block 2) will be sham and one will be real.
      Sham treatment sessions are identical to real treatment sessions, except that there is no
      magnetic stimulation. Patients will be randomly assigned to receive either sham or real
      treatment first. The purpose of sham treatment is to have a control group data that the
      plausible improvement as a result of rTMS can be compared to. By designing two sets of
      sham-real or real-sham treatment sessions, every participant will receive a real treatment,
      while we will also have control data.

      The cognitive assessments will be done at the baseline, and then on weekly basis. A subgroup
      of the study population will be recruited for investigating the second objective: effect of
      rTMS on sleep quality. Those patients will be required to sign a second consent; then, the
      patients will go through full-night sleep study at Misericordia Health Center at the same
      time intervals as their cognitive assessments.
    

Intervention name(s): rTMS real-sham; rTMS sham-real
Intervention type(s): Device; Device
Intervention description(s): In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.; In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Alzheimer's; rTMS; sleep quality; dementia; memory
Safety Evaluation of 3K3A-APC in Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary
      efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human
      activated protein C (APC), in in the treatment of acute ischemic stroke following treatment
      with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.
    

Detailed description: 
      This was a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study
      intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following treatment
      with tPA, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic
      stroke.

      Approximately 115 subjects were to be randomized, which included the planned 88 subjects in
      groups of 4 subjects to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional
      placebo subjects who were enrolled during safety review pauses. This study used a modified
      version of the continual reassessment method (CRM) in order to establish a maximum tolerated
      dose (MTD).

      Eligible subjects received 3K3A-APC or placebo every 12 hours for up to 5 doses
      (approximately 3 days), or until discharge from the hospital, whichever occurred first.
      Subjects were monitored for safety evaluations through Day 7 (or discharge, if earlier) and
      were expected to be seen on Day 7, 14, 30, and 90 for safety and outcome evaluations.
    

Intervention name(s): 3K3A-APC; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion; Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Other intervention name(s): 3K3A-Activated Protein C; Matching Placebo
Intervention MeSH terms: Protein C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ischemic stroke; stroke; APC; 3K3A; 3K3A-APC; activated protein C; RHAPSODY
Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM
Condition: Diabetes Mellitus (DM)
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus
      modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens
      for glycemic control in hospitalized diabetic patients with diabetes.

      Methods: In a prospective trial, patients with diabetes will be randomized to receive either
      traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin
      for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥
      150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day
      for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.
    


Intervention name(s): regular insulin; 70/30 insulin; Glargine; glulisine
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): lantus; apidra
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 D M; sliding scale insulin; 70/30 insulin; basals insulin; supplemental insulin
Chronopharmacology of Valsartan in Normotensive Subjects
Condition: Healthy Normotensive Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The choice of drug administration time may affect the pharmacokinetics and/or drug response,
      and knowledge of any such circadian rhythm-dependent effects may help to reduce side effects
      or to enhance efficacy. This study designed to investigate the potential influence of the
      time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in
      healthy subjects.
    

Detailed description: 
      International guidelines recommend the use of long acting, once-daily medications that
      provide 24h efficacy; they improve adherence to therapy and minimize BP variability with
      smoother and more consistent BP control.

      Valsartan has been approved to be used once-daily, without any specification of
      treatment-time in package insert. Several trials have investigated the differential effects
      of morning versus evening administration of valsartan in hypertensive patients, however, the
      results of these studies were contradicting. Furthermore, the specific administration time
      dependent dose response curve have not been previously investigated. So, this study designed
      to investigate the potential influence of the time of drug administration on the
      pharmacokinetics and pharmacodynamics of the valsartan in healthy subjects.
    

Intervention name(s): Valsartan
Intervention type(s): Drug
Intervention description(s): single oral dose of 160 mg valsartan under fasting conditions
Other intervention name(s): Diovan
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronokinetics; chronodynamics; chronopharmacology; valsartan
Parker Flex-it Stylet Versus Malleable Stylet in Orotracheal Intubation Using a Fiber-optic Laryngoscope
Condition: Orotracheal Intubation
Study type: Interventional

Summary: 
      Objectives: To compare the safety and efficacy of Parker flex-it directional stylet (PFDS)
      versus conventional malleable stylet (CMS) in orotracheal intubation (OTI) using fiber-optic
      Macintosh laryngoscope.

      Background: OTI is used in general anesthesia for anesthetic delivery and ventilation of
      patients. OTI delay or failure may adversely affect patient outcomes, therefore, anesthetists
      with sufficient clinical experience and skill should perform OTI. However, in emergency
      situations, experienced anesthetists may not be available, and the patient may have a high
      Cormack-Lehane grade. A stylet is commonly used in the emergency department to aid insertion
      of the endotracheal tube during direct laryngoscopy.

      Patients and Methods: This was a prospective, randomized, double-blind clinical trial;
      carried out on 80 patients requiring OTI under general anesthesia at our hospital. Patients
      were randomly allocated into two equal groups; group DS, intubated using PFDS, and group MS,
      intubated using CMS.
    


Intervention name(s): Parker Flex-it Directional Stylet; Conventional Malleable Stylet
Intervention type(s): Device; Device
Intervention description(s): Parker Flex-it Directional Stylet; Conventional Malleable Stylet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Conventional Malleable Stylet; Orotracheal Intubation; Parker Flex-it Directional Stylet
Effect of THAI Traditional Massage on Bone Markers
Condition: Osteoporosis
MeSH terms: Osteoporosis; Bone Resorption
Study type: Interventional

Summary: 
      The purpose of this study is to explore the skeletal effect of Thai traditional massage by
      examining the changes in biochemical markers of bone turnover immediately after the massage.
    

Detailed description: 
      Each subject received Thai traditional massage for 2 hours by a single masseuse.
    

Intervention name(s): Thai Traditional massage
Intervention type(s): Procedure
Intervention description(s): Thai traditional massage for 2 hours by a single masseuse.
Other intervention name(s): Thai massagae
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Thai Traditional massage; Bone Formation; Bone Resorption