bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Sage Extracts on Cognitive Function During Aerobic Exercise
Condition: Healthy
Study type: Interventional

Summary: 
      Extracts of sage have been reported to interact with central nervous system (CNS) mechanisms
      relevant to cognitive performance but, to date, no trial has clearly demonstrated the
      possible effects in healthy individuals in fatiguing conditions. The current study
      investigates the effects of this supplementation in healthy males and females versus placebo
      on cognition, heart rate and perceived exertion, during a fatiguing cycling exercise.
    

Detailed description: 
      Healthy males and females will be tested in fresh and fatiguing conditions to mimic
      individuals at the beginning or during a competition where cognitive function are important
      for decision making for example. Tests will be conducted during the warm-up (fresh), during
      fatiguing situations (during two consecutive 10-minutes pedaling exercises) and during
      recovery. Tests will include a reverse digit memory test (from 3 to 7 digits), a stroop test,
      a simple reaction time test. Moreover, heart rate and rating of perceived exertion will be
      quantified.
    

Intervention name(s): Sage extracts Cognivia; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cognivia is composed of 400 mg of aqueous extract from Salvia officinalis and the remaining 200 mg contained 50 µL of Salvia lavandulaefolia essential oil and encapsulated with gum acacia. It will be administrated the the morning before the endurance test (oral administration).; Made with maltodextrin. It will be administrated the the morning before the endurance test (oral administration).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cycling; cognition; sage; memory; fatigue
A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma
Condition: Colorectal Adenoma; Colorectal Neoplasm; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Observational

Summary: 
      Early detecting and removing of colorectal advanced adenomas can reduce incidence of
      colorectal cancer. Because of the less bleeding of advanced adenomas, the sensitivity of
      existing quantitative fecal immunochemical test (qFIT) is unsatisfying. A new technology
      qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin compared
      with existing commercially available qFIT, is developed and this study will prove the high
      diagnostic accuracy in detecting colorectal advanced adenoma.
    

Detailed description: 
      Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and
      cancer-related deaths worldwide. With progress of developing countries, it is predicted that
      the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035.
      The majority of colorectal cancer is thought to arise from precancerous lesions through the
      adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce
      incidence of colorectal cancer. Although colonoscopy is currently considered the most
      effective method for detecting advanced adenomas, individuals may be reluctant to undergo
      colonoscopy due to the uncomfortable feeling and the relatively high cost of colonoscopy.
      Conversely, stool tests are relatively cheap and more readily accepted. Annual fecal
      immunochemical test (FIT), one of the preferred methods of colorectal cancer screening, is
      economic and easy to use. However, the existing commercially available qFIT is insufficiently
      sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27%
      to 47%. To improve diagnostic accuracy in detecting colorectal advanced adenoma, an improved
      technology of qFIT, which have a higher sensitivity in extremely low concentration of
      hemoglobin in stool compared with existing commercially available qFIT, is developed. The
      investigators design this research to prove the diagnostic accuracy of the new qFIT in
      detecting colorectal advanced adenoma.
    

Intervention name(s): The new qFIT and colonoscopy with pathological examination
Intervention type(s): Diagnostic Test
Intervention description(s): Detect hemoglobin in stool by the new qFIT before colonoscopy, detect colon lesion using colonoscopy and pathological examination.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Continuous participants intending to undergo colonoscopy and meet the inclusion and
        exclusion criteria from Qilu Hospital were enrolled.
      
Biospecimen description: 
      stool samples
    
Keywords: Colorectal Adenoma; Colorectal Neoplasms; Occult Bleeding; quantitative fecal immunochemical test; Colorectal Cancer
Efficacy of Thymosin alpha1 for Severe Sepsis
Condition: Severe Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe
      sepsis.
    

Detailed description: 
      Severe sepsis is a disease of infectious origin with a high risk of death. Over the past
      decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight
      against infectious diseases, but it is unknown whether thymosin alpha1 is effective in
      treating severe sepsis.
    

Intervention name(s): Thymosin alpha 1
Intervention type(s): Drug
Intervention description(s): 1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days.
Other intervention name(s): Zadaxin
Intervention MeSH terms: Thymalfasin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sepsis; Immunotherapy; Thymosin
Effect of Hearing Aid Labeling on Speech Understanding Measures
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      New and experienced hearing aid users will be fit with two hearing devices. One will be
      labeled as an OTC (Over-The-Counter) device, the other will be labeled as a Prescriptive
      (i.e. professionally fit) device. Both devices will be generically programmed for a mild to
      moderate hearing loss. An objective speech in noise test will be completed with both devices.
    


Intervention name(s): Audeo P hearing aid labeled as "Prescriptive"; Audeo P hearing aid labeled as "OTC"
Intervention type(s): Device; Device
Intervention description(s): The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.; The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: A single group of participants will be involved in this study. All participants will be evaluated with both hearing devices.
Masking: Single (Investigator)
Primary purpose: Treatment
Intravenous Dexmedetomidine for Cesarean Section
Condition: Breast Feeding; Analgesia Obstetrical; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Nervous, anxiety, fear and other psychological reactions always appears in parturients during
      cesarean section. This study intends to investigate the effectiveness and safety of
      dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and
      breastfeeding after caesarean section.
    


Intervention name(s): Normal Saline; Dexmedetomidine 0.03ug/kg/h; Dexmedetomidine 0.05ug/kg/h; Dexmedetomidine 0.08ug/kg/h
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
Other intervention name(s): dexmedetomidine Injection; Dexmedetomidine Hydrochloride; dexmedetomidine Injection; Dexmedetomidine Hydrochloride; dexmedetomidine Injection; Dexmedetomidine Hydrochloride
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Butorphanol tartrate; Analgesia; Breastfeeding; Relative infant dose
Effect of Selective iNOS Inhibition During Human Endotoxemia
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Sepsis or endotoxemia is manifested by hypotension, resistance to vasopressors, myocardial
      depression,and altered organ blood flow distribution. The mechanisms underlying the
      cardiovascular dysfunction during sepsis are complex; however, they are partially mediated by
      an uncontrolled production of NO by inducible NO synthase (iNOS).Control subjects received 2
      ng/kg E. coli endotoxin, whereas the active intervention group received endotoxin in the
      presence of selective iNOS-inhibitor aminoguanidine. Hemodynamics, vascular responses to
      norepinephrine, acetylcholine and sodium nitroprusside, as well as circulating cytokines and
      other mediators of inflammation were measured. We tested the hypothesis that inhibition of
      NO-synthesis prevented the LPS-mediated insensitivity to noradrenalin and
      endothelial-dependent vasorelaxation. Furthermore, we tested whether NO participates in
      occurrence of the endotoxin tolerance in humans by using the iNOS inhibitor aminoguanidine on
      healthy volunteers with endotoxemia. At 0; 2 and 4 hours after the LPS challenge whole blood
      was stimulated with five TLR agonists in vitro and pro- and anti-inflammatory cytokines were
      measured.
    


Intervention name(s): Aminoguanidine; endotoxin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pimagedine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Endotoxemia; Aminoguanidine
Partially Replicate Bioequivalence Study of Quetiapine 25 mg in Healthy Volunteers Under Fasting Condition
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is conducted to evaluate and compare the relative bioavailability for
      Quetiapine in two different products containing 25 mg Quetiapine after a single oral dose
      administration under fasting conditions.
    

Detailed description: 
      A randomized, single-dose, partial replicate, three-phase, three-sequence, bioequivalence
      study of the two study products. Blood samples were collected at different time intervals and
      stored at -70⁰C freezer. Quetiapine plasma concentrations were analyzed using a validated
      LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the
      concentrations obtained using Phoenix WinNonlin® software.
    

Intervention name(s): Test product (T) 25 mg Film Coated Tablets; Reference product (R) 25 mg Film Coated Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Film Coated Tablets products containing 25 mg Quetiapine; Reference product (R) 25 mg Film Coated Tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, single-dose, partial replicate crossover, three-phase, three-sequence, two treatments bioequivalence study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Quetiapine; Replicate; Randomized
Psychometric Properties of the Turkish Version of S-ROM-Neck
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      Patient-reported joint motion assessment tools have been developed and applied successfully
      in several joints of the body. "The Self Administered Neck Mobility Assessment Tool
      (S-ROM-Neck)" questionnaire was developed by Langenfeld et al in 2018. With this
      questionnaire, the clinicians are able to evaluate the neck joint motion perception of the
      patients, subjectively. There is no Turkish version of the questionnaire. The aim of our
      study is to develop the Turkish version of the S-ROM-Neck questionnaire, to analyze its
      cultural adaptation, and to reveal its validity and reliability.
    

Detailed description: 
      Neck pain leads to a decreased range of motion in the cervical spine, bringing along
      functional losses. As a result, this situation is associated with many disabilities.
      Evaluation of neck joint motion is essential in patients with chronic neck pain. It is used
      to evaluate the neck pain level and functional deficit level of the patient. In this way, it
      is possible to evaluate the effectiveness of the treatment applied to the patient during the
      rehabilitation process. Generally, this evaluation can be made and interpreted by an
      experienced clinician. However, patient perception provides a better understanding of
      patients' needs and problems by converting clinical data into a patient-centered measure.
      Moreover, the patient's perspective can add valuable information to the examination by
      creating a holistic picture of the patient's problems, possible needs, and expectations. In
      2018, the "Self Administered Neck Mobility Assessment Tool (S-ROM-Neck)" survey was developed
      by Langenfeld et al. With this questionnaire, developers purposed to evaluate the neck joint
      motion perception of the patients, subjectively. There is no Turkish version of the
      questionnaire. The aim of our study is to develop the Turkish version of the S-ROM-Neck
      questionnaire, to analyze its cultural adaptation, and to reveal its validity and
      reliability.
    

Intervention name(s): No intervention will be applied
Intervention type(s): Other
Intervention description(s): No intervention will be applied
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Surveys and Questionnaires; Neck Pain; Range of Motion; Psychometrics
A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is comprised of two parts. The first portion of this study will be a double-blind,
      Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to
      paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part
      2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA
      approved products in patients with active but stable plaque psoriasis.
    


Intervention name(s): Ruxolitinib phosphate cream; Dovonex® calcipotriene 0.005%; Diprolene® AF betamethasone dipropionate 0.05% cream.; Placebo cream; Ruxolitinib phosphate cream; Ruxolitinib phosphate cream
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ruxolitinib phosphate cream 0.5%; Cream applied once or twice daily for up to 56 days.; Cream applied once or twice daily for up to 56 days; Cream applied once or twice daily for 56 days; Ruxolitinib phosphate cream 1.0%; Ruxolitinib phosphate cream 1.5%
Other intervention name(s): INCB018424; INCB018424; INCB018424
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A
      total of approximately 15 patients will be required. The purpose is to determine the levels
      of R, S methadone at various time intervals after drug administration. Patients will receive
      methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and
      propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients
      will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be
      utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to
      VAS scores, patient and parental satisfaction with analgesia, and a functional pain
      assessment.
    

Detailed description: 
      Study Procedures Following Surgery:

        -  VAS scores will be recorded at intervals of 1,2,3,4,5,6,8,12,16,20,24, 36, 48 , 72 hrs
           (after extubation).

        -  Blood samples for PK will require 5ml per sample and may be obtained from an existing IV
           or direct phlebotomy and will be obtained at 0min, 5min, 10 min, 15min, 20 min, 40 min,
           1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs
           after study drug administration.
    

Intervention name(s): methadone
Intervention type(s): Drug
Intervention description(s): 0.25mg/kg IV of racemic methadone at the induction of anesthesia.
Other intervention name(s): 0.25mg/kg IV of racemic methadone
Intervention MeSH terms: Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Methadone pharmacokinetics in adolescents
Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients
Condition: Kidney Transplant; Complications; Coronavirus Infection
MeSH terms: Coronavirus Infections; Disease Progression
Study type: Interventional

Summary: 
      SARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6
      (IL-6). The apparently strong association between blood levels of inflammaory cytokines and
      SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or
      anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of
      predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms
      have not yet been formally identified. Identifying such markers and evaluating their
      predictive value may be exploited to guide patient care management, and as such forms the
      core objective of this proposal.

      Because of strong inter-individual variations in the ability of innate immune cells to
      produce cytokines, the hypothesis formulate and intend to test is that innate IL-6
      responsiveness varies between recently infected Covid-19 patients and could predict disease
      outcome.

      To test this hypothesis, the investigator propose to follow recently infected kidney
      transplant patients with moderate Covid-19 symptoms. These patients stand a higher risk to
      progress to severe disease. The staff plan to collect a blood sample in these patients using
      a system whereby ex vivo cytokine production is initiated in the very same blood collection
      tube without prior separation and centrifugation, thus reducing labour and operator bias.
      After incubation with or without known innate immune stimuli, the cell-free phase from each
      collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content
      and disease outcome (encephalopathy, transfer to acute care or death) will be determined in
      115 Covid-19 kidney transplant patients with moderate symptoms followed in 9 centers.
    


Intervention name(s): blood sample
Intervention type(s): Other
Intervention description(s): a blood sample is taken on Covid-19 kidney transplant patients with moderate symptoms
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other