bioihbjkbjnl/mcl2 huggingface dataset:
Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients
Condition: Knee Arthroplasty
Study type: Observational

Summary: 
      The aim of this observational study is to assess whether patient reported pain levels
      correlate with a Pain Index derived from deviations in multivariate physiology biomarkers
      captured in real-world setting. This study will be conducted using a clinical-grade wearable
      sensor to continuously monitor patient's physiology (pain related biomarkers) and allow
      subject participant to actively report their pain score, symptoms and quality of life using a
      mobile-based application.
    

Detailed description: 
      The designated clinical-grade wearable sensor used in this study is the Biovotion Everion MD
      (See Annex for product description), a Bluetooth-compatible device that will automatically
      sync with the mobile application used in this study.

      This study will recruit 55 patients aged 21 to 80 years who will be undergoing knee
      replacement, Anterior Cruciate Ligament(ACL), Knee Arthroscopy and Foot & Ankle related
      surgery. All study participants will be followed for an estimated total of 30 days(+6/-2
      days, if visit schedule is fall on weekend), beginning four days before surgery, the entire
      period as an in-patient (four to five days), and 20-days post-discharge.

      The changes in multivariate physiological biomarkers will be used to generate a Pain Index,
      and the Pain Index will be assessed against patient reported Numerical Rating Scale (NRS)
      pain.
    

Intervention name(s): Continuous physiology monitoring in ambulatory setting pre and post surgery
Intervention type(s): Device
Intervention description(s): This study will recruit 55 patients aged 21 to 80 years who will be undergoing total knee replacement surgery. All study participants undergoing total knee replacement surgery will be monitored using the wearable biosensor to continuously monitor physiology biomarkers. Participants will be followed for an estimated total of 39 days, beginning four days before surgery, the entire period during in-patient recovery (four to five days), and 30-days post-discharge at-home.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        55 study participants, aged between 21 to 80 years, regardless of gender, who is undergoing
        total knee replacement surgery will be enrolled for the study upon receiving informed
        consent.
      
Keywords: Knee Replacement; Wearable; Pain Score Quantification
Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery
Condition: Inadvertent Perioperative Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Cold gases given during laparoscopic cholecystectomy are the most important cause of
      hypothermia. However, even surgery alone is an 80% important cause of hypothermia.
      Inadvertent perioperative hypothermia is a common complication of the surgical process that
      can cause serious complications. In most of the patients, tremors, increase in pain,
      deterioration in comfort and changes in some physiological parameters can be seen. Despite
      this, there are not enough warming devices that nurses can use practically and are easy to
      use, affordable and comfortable for the patient. In the literature, it is stated in the
      evidence-based guidelines for determining the hypothermia risks of patients and taking early
      precautions.
    

Detailed description: 
      The parallel group randomized controlled three group study blinded by the evaluator aims to
      investigate the effectiveness of different warming methods in laparoscopic cholecystectomy
      patients. This study general surgery at Yozgat Bozok University Hospital in Turkey are
      performed in clinics. All patients are male and female patients who have undergone surgery
      and met the inclusion criteria.
    

Intervention name(s): Forced Air Warming; Peripheral Carbon Fiber Warming
Intervention type(s): Device; Device
Intervention description(s): It consists of the WarmAir® unit and FilteredFlo® blankets. FilteredFlo® blankets are a cover designed to cover the entire body and extremities with air channels that provide the appropriate distribution of patient warm. The WarmAir® warming device connected to the shroud via a pipe; it has three temperature settings, 32.2 C, 37.8 C, and 43.3 C.; It was developed by the researcher. Designed as gloves and socks, these warming materials have three layers. The first layer in contact with the patient and the third layer in contact with the external environment is a thermal material to maintain body temperature. The second floor consists of a USB-connected carbon fiber warmer and foil.
Intervention MeSH terms: Carbon Fiber
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Inadvertent Perioperative Hypothermia; laparoscopic cholecystectomy; nurse; pain; physiological parameters; shivering; thermal comfort
Ischemic Preconditioning in Endurance Athletes
Condition: Exercise
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of remote ischemic preconditioning on
      biochemical and functional indices of cardiac function induced by a 30 km run in healthy
      trained long distance runners.
    


Intervention name(s): Remote ischemic preconditioning
Intervention type(s): Other
Intervention description(s): Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset
Condition: Acute Ischaemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational

Summary: 
      This study will compare two ways of treatment for acute ischemic stroke: an endovascular
      treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a
      first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT
      in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours
      after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed
      separately.
    


Intervention name(s): EVT (endovascular treatment ); IVT (intravenous thrombolytic therapy)
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Fibrinolytic Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients younger than 80 with acute ischemic stroke produced by a main artery oclussion
        with a NIHSS > 6 (National Institute of Health Stroke Scale) receiving IVT or EVT within
        4.5 hours after onset.
      
Keywords: Ischaemic Stroke; Main artery occlusion; Endovascular treatment; Intravenous Thrombolytic Therapy
A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      • To evaluate overall safety and tolerability of SIR1-365 in patients with severe COVID-19

      Secondary Objectives:

        -  To assess the clinical efficacy of SIR1-365 in patients with severe COVID-19

        -  To assess the effects of SIR1-365 on multiple inflammatory biomarker levels including
           C-reactive protein (CRP), ferritin, lymphocyte and neutrophil counts, cytokines, and
           chemokines

        -  To assess the effects of SIR1-365 on biomarkers indicative of target engagement in
           patients with severe COVID-19

        -  To assess the effects of SIR1-365 on biomarkers indicative of kidney injury in patients
           with severe COVID-19

        -  To assess the effects of SIR1-365 on biomarkers indicative of cardiovascular endothelial
           cell damage in patients with severe COVID-19

        -  To characterize plasma pharmacokinetics (PK) of SIR1-365 in patients with severe
           COVID-19
    

Detailed description: 
      Study duration per participant is approximately 28 days including a 14-day treatment period
    

Intervention name(s): SIR1-365; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Route of administration: oral; Route of administration: oral
Other intervention name(s): Pharmaceutical form: tablets; Pharmaceutical form: tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
Condition: Hypogonadism; Precocious Puberty
MeSH terms: Hypogonadism; Puberty, Precocious
Study type: Observational

Summary: 
      OBJECTIVES: I. Evaluate the sleep-entrained patterns of gonadotropin-releasing hormone (GnRH)
      and sex steroid secretion in normal and hypogonadal children.

      II. Examine the acute effects of sex steroids on the sleep-entrained patterns of GnRH
      secretion in pubertal children and normal adults, either by stimulation of endogenous
      production with pulsatile injection or by intravenous infusion of GnRH.

      III. Examine the role of endogenous opioids by means of opioid receptor blockade in the sex
      steroid regulation of GnRH secretion in pubertal children and normal adults.
    

Detailed description: 
      PROTOCOL OUTLINE: This project involves several clinical protocols that study the regulation
      and role of pulsatile gonadotropin-releasing hormone (GnRH) secretion.

      Studies include dynamic and repeated stimulation tests of pulsatile GnRH; plasma luteinizing
      hormone, follicular-stimulating hormone, testosterone (T), estradiol (E2), and GnRH
      measurements at cyclic and episodic intervals; and evaluation of adrenal androgen patterns.

      Circadian rhythms of GnRH secretion are monitored during sleep and awake hours. Growth
      hormone secretory patterns and responses to provocative stimuli are studied as clinically
      indicated.

      Selected participants undergo an assessment of pituitary responsiveness following T, E2,
      and/or naloxone infusions. The suppressive effects of E2 are also studied during the early
      follicular phase of the menstrual cycle.

      Endocrinologically normal children and normal adult men and women are also studied.
    

Keywords: endocrine disorders; growth hormone deficiency; hypogonadism; precocious puberty; rare disease
Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm
Condition: Dementia
MeSH terms: Dementia
Study type: Observational

Summary: 
      WHIMS-Y provides valuable information on the long-term effects on risk of cognitive
      impairment of hormone therapy in a subset of WHI participants in the WHI Hormone Trials.
      Following cessation of study-prescribed HT cognitive function and impairment were assessed.
    

Detailed description: 
      The Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) is proposed to assess
      the long-term impact of random assignment to postmenopausal hormone therapy (equine estrogen
      alone or in combination with medroxyprogesterone versus placebo) among women who were aged
      50-54 at the time of randomization into the WHI hormone trials. Secondary objectives relate
      to the consistency of any treatment effects across unopposed or opposed therapy and whether
      there exists evidence of graded relationships between cognitive effects and age of
      administration, years from menopause, and baseline risk factors for cognitive impairment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women who enrolled into the HT arm of the Women's Health Initiative when age 50-54 at the
        time of randomization.
      
Keywords: cognition; memory; hormone therapy
Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Condition: Hypoactive Sexual Desire Disorder (HSDD)
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Observational

Summary: 
      Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone
      activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although
      DHEA is a precursor of testosterone it has other actions including involvement in the stress
      system. It is also linked to mood. This study focuses on measures of childhood stress,
      current mood and salivary stress hormones, in women with and without HSDD. We hypothesize
      that low levels of DHEA reflect dysfunction of the neuroendocrine stress response system
      involving the brain, pituitary and adrenal glands where DHEA is produced.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
      
Biospecimen description: 
      saliva samples
    
Keywords: Hypoactive Sexual Desire Disorder; HSDD; Cortisol; DHEA; Stress Hormones; Sexual Desire; Mood; Sexual Function; Childhood Maltreatment; Childhood Abuse
12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing
      strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up
      of smoking status to one year from randomization was performed in a non-treatment extension
      Protocol A3051019
    


Intervention name(s): CP-526,555 (varenicline)
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Condition: Opioid-use Disorder; Opioid Withdrawal
MeSH terms: Opioid-Related Disorders; Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to
      aid in the reduction of symptoms associated with opioid withdrawal in order to support
      clinical substantial equivalence to a predicate device.
    

Detailed description: 
      Prior evidence has demonstrated that non-invasive neurostimulation can modulate specific
      brains regions associated with opioid use disorder and reduce opioid withdrawal symptoms.
      This is a double blind, randomized, controlled, multi-center study in which subjects will be
      randomized in a 1:1 ratio to one of two groups: 1) active transcutaneous auricular
      neurostimulation (tAN) or 2) delayed-active tAN to determine reduction of symptoms related to
      opioid withdrawal. Subjects in the active tAN group will receive tAN immediately whereas
      those in the delayed-active tAN will have their therapy turned on after a 30 minute delay
      (inactive period). All subjects will be informed of their group assignment at the conclusion
      of the randomized, double blind period (following initial 30 minutes of active or inactive
      therapy) and all will continue to receive active tAN throughout the five-day study. Each
      clinical site will have pre-determined and qualified clinical opiate withdrawal scale (COWS)
      accessor(s) that will be blind to the subjects group designation during the randomized,
      double blind period and will not be informed that all subjects receive active therapy
      throughout the remainder of the study. This will ensure a non-biased assessment of the COWS
      score and maintain single blinding throughout the duration of the study.
    

Intervention name(s): transcutaneous auricular neurostimulation (tAN)
Intervention type(s): Device
Intervention description(s): Phoenix tAN system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: auricular neurostimulation; vagus nerve stimulation; transcutaneous; withdrawal symptoms
A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
Condition: Healthy Subjects (HS)
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label,
      single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and
      effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.
    


Intervention name(s): DaTSCAN™ Ioflupane (123I) Injection
Intervention type(s): Drug
Intervention description(s): Each participant will receive a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV injection with a nominal iodine (123I) activity of 111 MBq ±10%, in a maximum volume of 5 mL.
Other intervention name(s): Ioflupane (123I)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Single photon emission computed tomography (SPECT); Healthy Volunteer (HV)
A Phase 1 TH-302 Mass Balance Trial
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite
      profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent
      treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid
      tumors.
    


Intervention name(s): [14C] TH-302 (Label 1); [14C] TH-302 (Label 2); Unlabeled TH-302
Intervention type(s): Drug; Drug; Drug
Intervention description(s): [14C]-labeled TH-302 (Label 1) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.; [14C]-labeled TH-302 (Label 2) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.; Unlabeled TH-302 will be administered along with labeled TH-302 at the dose of 340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1 of Part A, followed by recommended Phase 2 dose (RP2D) of 480 mg/m^2 as monotherapy infusion over 30 minutes on Days 8 and 15 of Part A; and on Days 1, 8 and 15 of Part B, until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow up, or death.
Intervention MeSH terms: Phosphoramide Mustards
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 14C-TH-302; Advanced or Metastatic Solid Tumors; Evofosfamide
Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of BIA 9-1067 on the cardiac
      repolarization in adult healthy men and women volunteers.
    

Detailed description: 
      Single-centre, randomized, double-blind, placebo-controlled and open-label active-controlled,
      4-period crossover trial in healthy male and female subjects
    

Intervention name(s): BIA 9-1067; Placebo; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg and 800 mg of BIA 9-1067 (single-dose); single-dose; 400 mg moxifloxacin (single-dose)
Intervention MeSH terms: Moxifloxacin; Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067
Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol
Condition: Open Abdomen; Temporary Abdominal Closure Mechanisms
Study type: Interventional

Summary: 
      The open abdomen is a valid and accepted surgical tactic for the trauma and acute care
      patient. There have been many mechanisms described for its management, but the most accepted
      strategy is the vacuum pack. At our hospital the investigators have used for many years a
      double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial
      operation. At subsequent surgeries once the abdomen is clean the investigators leave the same
      subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the
      investigators try to tighten the mesh with sutures until the abdomen can be closed. This
      study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to
      determine which is related to a higher fascial closure rate.
    

Detailed description: 
      The Investigators plan to compare our double sylo-mesh protocol with the vacuum pack
      technique described by Barker et al. To accomplish this they have designed a randomized trial
      that will include patients that require an open abdomen strategy according to their attending
      physician either due to a traumatic or a medical cause. Once the surgeon decides to leave the
      abdomen open, one of the nurses will pick up an envelope from the randomization box and read
      out loud the patients allocation (Vacuum pack or Double sylo bag-mesh protocol) . During
      subsequent surgeries the patient must continue with the same strategy for a minimum of 21
      days or until fascial closure. The patients will be followed during their whole hospital stay
      to determine complication rates and fascial closures.
    

Intervention name(s): Vacuum Pack; Double Sylo Bag - Mesh Protocol
Intervention type(s): Device; Device
Intervention description(s): Vacuum Pack Technique described by Barker et al.; double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation.
At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. This mesh is resutured every day until the abdominal fascia is approximated enough to permit closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open Abdomen; Negative Pressure Wound Therapy; Temporary Abdominal Closure; Mesh; Abdominal reconstruction