bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of ExSpiron™ Measurements Derived Without Patient Specific Calibration
Condition: Non-Invasive Respiratory Volume Monitoring
Study type: Observational

Summary: 
      Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate
      measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after
      calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR
      values measured by the ExSpiron™ without prior spirometer calibration to values obtained with
      a spirometer calibration. In this study, the MV and TV values will be compared between the
      ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a
      spirometer
    

Detailed description: 
      In order to evaluate the performance of the device under the range of conditions encountered
      in the clinical environment, the respiratory volume monitor (RVM) was tested throughout a
      range of respiratory rates and also during erratic breathing patterns. At 4 and 36 breaths
      per minute (the extremes of the rates anticipated to be encountered in the clinical setting),
      and during erratic breathing, RVM and spirometry measurements were found to be
      highly-correlated (r=0.98 ±0.01 (mean ±95%CI) at 4 breaths/min, 0.97 ±0.01 at 36, and 0.93
      ±0.04 during erratic breathing). These studies also included calibration of the ExSpiron to
      the spirometer.

      The primary objective of the study is to compare the minute ventilation (MV), tidal volume
      (TV) and respiratory rate (RR) measurements collected and reported by the ExSpiron, without
      prior ExSpiron calibration, against acquired MV, TV, and RR measurements from an ExSpiron
      with prior individual specific calibration to a spirometer using either a Wright Spirometer
      or a Morgan Flow Volume Loop (FVL) Pneumotachograph Spirometer. A secondary objective will be
      to confirm the PadSet functionality after 24 hours of wear in accordance with current
      labeling.
    

Intervention name(s): ExSpiron
Intervention type(s): Device
Intervention description(s): Non-Invasive respiratory volume monitoring
Other intervention name(s): RVM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Respiratory measurements will be acquired from up to 100 subjects from a wide cross-section
        of the adult population. Potential subjects will be screened based on the following
        inclusion/exclusion criteria to determine eligibility.
TODAY! A Mobile App Study
Condition: Depression, Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      The aim of this study is to conduct a small randomized controlled trial (RCT) for a 10-week
      mobile phone intervention using principles of Cognitive Behavior Therapy to target general
      and minority stressors and treat anxiety and depression in young men romantically/sexually
      attracted to men.
    

Detailed description: 
      Investigators will conduct a double-arm RCT to develop the infrastructure and collection of
      data needed to power a larger RCT (e.g., rates of consent, retention rates). Clinical
      outcomes will be assessed for the purpose of detecting unexpected deterioration.
      Investigators will also collect usability feedback regarding the intervention which may be
      used to refine the treatment. Usage data will be used to identify under-used lessons and
      tools and improve their usefulness/appeal. Compliance with assessments will be monitored and
      used to improve retention protocols.
    

Intervention name(s): TODAY! App and Coaching
Intervention type(s): Behavioral
Intervention description(s): The TODAY! app uses the skill building structure of Cognitive Behavior Therapy (CBT). The intervention will be divided into "modules," each devoted to a particular skill. Skills addressed within the intervention include increasing social support, engaging in goal-driven behaviors and reducing mood-driven (i.e., avoidance) behaviors, seeking out positive activities, replacing cognitive distortions with more adaptive thinking styles, improving problem-solving skills, reducing avoidance patterns, and increasing alternate coping strategies. The intervention will be supplemented with brief human contact in the form of a motivational coach. The Coach will be trained on the Motivational Interviewing principles upon which the coaching protocol is based.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; anxiety; gay; youth; Cognitive Behavior Therapy
Sprint to Fitness: Effect of Outcome Expectations on Responses to Interval Exercise Training
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to research the effects of exercising at high intensities for
      short periods of time on exercise tolerance and motivation.
    

Detailed description: 
      The proposed research will investigate whether adding a treatment component that focuses on
      positive outcome expectations of a high-intensity interval training (HIIT) intervention
      produces greater improvements in psychological and physiological study outcomes. This project
      will yield empirical evidence that will inform how to help Americans meet physical activity
      guidelines; how to develop exercise programs that are more likely to promote exercise as a
      habit; and maintenance of health and a healthy body weight.
    

Intervention name(s): HIIT + POE; HIIT only
Intervention type(s): Other; Other
Intervention description(s): Subjects will participate in high-intensity interval training (HIIT) with an additional treatment component to increase positive outcome expectations (POE) of exercise.; Subjects will participate in high-intensity interval training (HIIT) only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Exercise; behavior economics
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment
      period in men and women with moderate to severe hidradenitis suppurativa.
    


Intervention name(s): INCB054707; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): INCB054707 tablet administered orally once daily at the protocol-defined dose.; Placebo tablet administered orally once daily.
Other intervention name(s): Povorcitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hidradenitis suppurativa; Janus kinase (JAK) inhibitor; skin disease
Clinical Evaluation of a Cochlear Implant System
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      The primary objective of this study is to assess the usability of a Cochlear implant system.
    

Detailed description: 
      Measure participant ratings on satisfaction of a Cochlear implant system via use of validated
      and non-validated questionnaires.
    

Intervention name(s): Nucleus 7 Cochlear Implant System
Intervention type(s): Device
Intervention description(s): A new cochlear implant sound processor system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Global Effects of a Probiotic Strain on Lactating Women
Condition: Mastitis
MeSH terms: Mastitis
Study type: Interventional

Summary: 
      In this study, the investigators will try to confirm if application of probiotic strains
      isolated from breast milk actually have a beneficial effect on women suffering lactational
      mastitis. This project has been design to offer an integrated vision of the effects of
      probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators
      propose a multidisciplinary approach involving the application of microbiological,
      immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The
      hypothesis is that probiotherapy will cause different effects on the host, and the objective
      is the finding of markers that may support the beneficial effect of the strain in such
      condition.
    


Intervention name(s): Lactobacillus salivarius PS2; Lactobacillus salivarius PS2
Intervention type(s): Biological; Biological
Intervention description(s): 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days; 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
Intervention MeSH terms: TFF1 protein, human
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
Condition: Phantom Limb Pain
MeSH terms: Phantom Limb
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Severe pre-amputation pain is associated with phantom pain development, and phantom pain
      models assign major importance to central and peripheral nervous system changes related to
      pre-amputation pain. Several interventions have been evaluated for phantom pain prevention,
      including continuous brachial plexus blockade5, intravenous6 or epidural ketamine
      administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9,
      but their true effect remains unclear.
    

Detailed description: 
      In a prospective, randomized, double-blind trial, 65 patients undergoing elective lower limb
      amputation were assigned to one of five analgesic regimens. Patients in groups 1-4 had lumbar
      epidural catheter placed 48 hours before amputation, and received epidural
      bupivacaine/fentanyl or saline infusion before and/or after amputation. Patients receiving
      epidural saline also had IV Fentanyl Patient-Control Analgesia, whereas patients receiving
      epidural analgesia also had IV saline. Group 5 (control) received IM meperidine and oral
      codeine/acetaminophen. VAS and McGill Pain Questionnaire (MPQ) scores (for ischemic, phantom
      and stump pain) were recorded starting 48 hours before, continuing until 48 hours after
      amputation, and at 4 days, 10 days, 1 and 6 months after amputation. Phantom and stump pain
      intensity and frequency were the main study endpoints.
    

Intervention name(s): perioperative epidural catheter
Intervention type(s): Procedure
Intervention description(s): Perioperative epidural catheter in groups 1-4. Pre- and postoperative epidural analgesia in group 1. Preoperative IV PCA Fentanyl and postoperative epidural analgesia in group 2. Perioperative IV PCA Fentanyl in groups 2,3. IM meperidine p.o. codeine/acetaminophen, IV acetaminophen and IV parecoxib in group 5 (control)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: phantom; amputation; analgesia; pain; preemptive; perioperative; lower limb amputation; intensity of phantom limb pain; preemptive analgesia reduces phantom pain; perioperative analgesia reduces phantom pain; Severe Phantom Limb Pain (VAS>70 mm); resistant to medical treatment one week before amputation
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after
      administration of the first dose of the study vaccine. The Protocol Posting has been updated
      in order to comply with the FDA Amendment Act, Sep 2007.

      No additional subjects will be recruited during this long-term follow-up study and no vaccine
      will be administered.
    

Detailed description: 
      The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy
      of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with
      or without a dose of HBIg at birth. The current study describes the long term follow up of
      these subjects between Y16 and 20 after primary vaccination.
    

Intervention name(s): Engerix™ -B; Hepatitis B immunoglobulin (HBIg)
Intervention type(s): Biological; Biological
Intervention description(s): 3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study; 1 intramuscular injections at birth (primary study)
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B immunoglobulin; Hepatitis B antibody persistence
GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best)
      doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the
      tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and
      trastuzumab.
    


Intervention name(s): GW572016 oral tablets
Intervention type(s): Drug
Intervention description(s): Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.
Intervention MeSH terms: Lapatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ErbB2; Stage IV breast cancer; ErbB1; breast cancer; lapatinib; Herceptin; trastuzumab
Four Year Weight Change of Cornell Students
Condition: Weight Gain
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      Examining the effect of daily self-weighing on the ability of student to prevent from gaining
      weight during their four years at Cornell.
    

Detailed description: 
      A group of freshman volunteers were randomly assigned to one of two groups. Both groups were
      given an internet based scale (Withings). The experimental group was asked to weigh
      themselves daily. The controls were asked to weigh themselves three times within one week
      every six months in response to being contacted by our researchers.
    

Intervention name(s): Experimental
Intervention type(s): Behavioral
Intervention description(s): Asked to weigh themselves
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: among college students
Treatment of Atrophic Acne Scars With Platelet-Rich Plasma and Skin Needling
Condition: Atrophic Acne Scars
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Investigators will collect blood specimens from the participating patients and then blood
      samples will be centrifuged in order to collect platelet-rich plasma which is going to be
      injected in the atrophic acne scars. A split-face design is going to used in this randomized
      controlled trial. In the control side of the face, micro-needling to the skin will occur
      using a specific tool (Dermapen).
    

Detailed description: 
      Atrophic acne scar is a common problem with a challenging treatment. Platelet-rich plasma
      (PRP) is an autologous preparation of platelets in concentrated plasma that may be beneficial
      in the treatment of atrophic acne scars by promoting collagen deposition.

      Skin needling is a technique that uses a sterile micro needles to puncture the skin and
      release growth factors. The combination of skin needling and PRP could enhance the efficacy
      of both modalities.
    

Intervention name(s): Platelet-Rich Plasma; Micro-needling
Intervention type(s): Procedure; Procedure
Intervention description(s): This Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars; Micro-needling will be applied on the acne scars in one side of the face.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
"Awareness, Preconception, and Fear of Epidural Analgesia Among Childbearing Women in Saudi Arabia."
Condition: Assess Women Awareness and Fear About EDA for Labor
Study type: Observational [Patient Registry]

Summary: 
      The aim of our study is to measure the level of awareness, preconceptions, and level of fear
      regarding epidural analgesia among childbearing women in KKUH in Riyadh.
    

Detailed description: 
      This research was designed as a hospital-based observational cross-sectional study conducted
      at King Khalid University Hospital, using a self-administered questionnaire based on previous
      research.22-24-26 approved by the Institutional Review Board at King Saud University, College
      of Medicine, Riyadh, Saudi Arabia on 08.August.2022 Ref. No. 22/0592/IRB. The sample included
      pregnant women attending an obstetrical clinic for routine antenatal follow-up, and the data
      collection was conducted during the month of August 2022. The questionnaire included five
      parts (sociodemographic, preconception, awareness, fear, and desirability). a total of 26
      questions with multiple-choice answers. The sample size was determined using the Comrey and
      Lee criterion Comrey and Lee (1992) stated that a 200-sample size is acceptable. The
      questionnaire was completed by 202 participants who met the inclusion criteria that is being
      a pregnant woman and completing the survey, and the exclusion criteria were non-pregnant
      women and an incomplete survey. The data collectors made it clear to the participants that
      taking part in the study was completely optional, and the participants signed anonymous
      consent forms.
    

Intervention name(s): survey- no intervention
Intervention type(s): Other
Intervention description(s): survey- no intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        included pregnant women attending an obstetrical clinic for routine antenatal follow-up
      
Keywords: Awareness, preconception, fear, epidural analgesia, labor pain
A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, multi-center, phase 1 study of DSP-2033 (Alvocidib) in combination
      with cytarabine/mitoxantrone (ACM regimen) or cytarabine/daunorubicin (A+7+3 regimen) in
      patients with acute myeloid leukemia (AML).
    

Detailed description: 
      This study consists of 2 cohorts of the ACM regimen part for Japanese relapsed/refractory AML
      patients and 1 cohort of the A+7+3 regimen part for Japanese newly diagnosed AML patients.
      The purpose of this study are as below.

        1. To evaluate the safety of DSP-2033 (Alvocidib) in combination with
           cytarabine/mitoxantrone (ACM regimen) in Japanese patients with relapsed or refractory
           AML and to confirm its tolerability.

        2. To evaluate the safety of DSP-2033 （Alvocidib) in combination with
           cytarabine/daunorubicin (A+7+3 regimen) in Japanese newly diagnosed AML patients and to
           confirm its tolerability.
    

Intervention name(s): Alvocidib; Cytarabine; Mitoxantrone; Cytarabine; Daunorubicine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): ACM regimen:30 mg/60 mg, 30-minute intravenous (IV) infusion, followed 4-hour IV infusion from Day 1 to Day 3 A+7+3 regimen: recommended dose (RD), 30-minute IV infusion, followed 4-hour IV infusion from Day 1 to Day 3; 300 or 667 mg/m2/day, 72-hour continuous IV infusion starting on Day 6 (ACM regimen); 14 or 40 mg/m2/day, IV infusion over 1 hour to 2 hours at 12 hours after the end of DSP-AraC administration (acceptable range + 3 hours); 100 mg/m2/day, continuous IV infusion for 7 days from Day 5 to Day 11 (A+7+3 regimen); 60 mg/m2/day, 30-minute IV infusion for 3 days from Day 5 to Day 7
Other intervention name(s): DSP-2033; DSP-AraC; DSP-MIT; DSP-DNR
Intervention MeSH terms: Cytarabine; Mitoxantrone; Alvocidib; Daunorubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This study consists of 2 cohorts of the ACM regimen part and 1 cohort of the A+7+3 regimen part.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Newly diagnosed AML; Relapsed/refractory AML; Alvocidib
Effects Of DP-b99 On Neurological Function In Subjects With Acute Ischemic Hemispheric Stroke
Condition: Brain Ischemia; Stroke; Cerebrovascular Disorders
MeSH terms: Stroke; Cerebrovascular Disorders; Brain Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine if DP-b99 can improve neurological function (for example strength and
      coordination) in the 3 months after an acute stroke
    

Detailed description: 
      The study will include a Screening/Baseline Period, a Treatment Period, and a Post-treatment
      Follow-up Period. During the Screening Period, subjects will be selected for the study on the
      basis of inclusion and exclusion criteria (see below). A screening computed tomography scan
      to exclude brain bleeding will be performed. The patient's informed consent will be obtained.
      The patient will be randomly allocated to DP-b99 or placebo. Immediately after this
      randomization and baseline assessments (lab tests and ECG), subjects will be given a 2-hour
      intra-venous infusion of DP-b99 or placebo. Additional 3 such infusions will then be given
      daily to a total of 4 consecutive treatment days, which make up the "Treatment Period".
      Throughout the 4-day Treatment Period the treatment's safety and the National Institutes of
      Health Stroke Scale (NIHSS) score will be evaluated daily. (The NIHSS assesses certain
      abilities of the patient, e.g. strength, speech, vision and coordination). If their condition
      requires, patients may have to stay in hospital more than these 4 days, regardless of their
      participation in the study.Subjects will be further assessed for NIHSS score changes and
      safety (lab tests and ECG) during the Post-treatment Follow-up Period, with data collected 30
      and 90 days after the stroke. Other outcome scales (Barthel Index and Modified Rankin Scale)
      will be also used in the Day 30 and Day 90 visits
    

Intervention name(s): DP-b99
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cerebral Ischemia; Ischemic Brain Injury; Brain Infarction; Brain Ischemia