bioihbjkbjnl/mcl2 huggingface dataset:
Correlation of Urinary Kallikrein With Cytokines, Proteinuria and Renal Function in Chronic Renal Disease Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria; Kidney Failure, Chronic
Study type: Observational

Summary: 
      Urinary kallikrein excretion is known to increase in patients with nephrotic syndrome and
      sick cell disease, but decrease in patients with chronic kidney disease or uremia. Some of
      authors consider urinary kallikrein is a marker of nephropathy. To evaluate the possible role
      of kallikrein kinin system in chronic kidney disease, we conduct a retrospective longitudinal
      observation study. Patients who participating in the "Efficacy of Pentoxifylline on Chronic
      Kidney Disease" study are included in the study. The morning spot urinary kallikrein and
      cytokines are measured at the time point of 0 and 12 month in addition to clinical
      parameters. The correlation of urinary kallikrein and cytokine concentration will be
      evaluated. Using multiple regression model, the relationship of urinary kallikrein excretion
      with degree of proteinuria, creatinine clearance and other clinical parameter will also be
      evaluated.
    


Observational model: Natural History
Time perspective: Retrospective
Keywords: Kallikrein; Cytokines; Proteinuria; Renal function; Chronic kidney disease
Clinical Validation of InferRead Lung CT.AI
Condition: Lung Cancer
Study type: Observational

Summary: 
      Lung cancer is the second most common cause of cancer-related death in men and women. Early
      pulmonary nodule screening is an effective means to prevent lung cancer, which is no less
      important than the diagnosis and treatment of lung cancer. Early lung cancer screening has
      been investigated and applied as a medical practice. InferRead Lung CT.AI by Infervision is a
      dedicated post processing application that generates CADe marks as an overlay on the original
      CT series intended to aid the radiologist in the detection of pulmonary nodules. This study
      was designed to evaluate radiologists' performance in detecting actionable nodules on chest
      CT when aided by InferRead.
    


Intervention name(s): Aided read with InferRead Lung CT.AI
Intervention type(s): Device
Intervention description(s): Radiologists read chest CT scans with the aid of InferRead Lung CT.AI
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Lung cancer screening eligible patients
Facilitating Participation in a Prostate Cancer Risk Assessment Program
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study was to examine whether a cognitive-affective preparation was more
      beneficial, in general, and more specifically for certain subgroups, such as African-American
      men and individuals with high monitoring style.
    

Detailed description: 
      High risk men enrolling in a state of the science Prostate Cancer Risk Assessment Program (N
      = 128) underwent a Pca counseling visit immediately followed by either a cognitive-affective
      preparation (CAP) session designed to help men process the information they received or a
      general health education session to control for time and attention (comparison group). All
      men chose to participate in Pca screening.
    

Intervention name(s): Cognitive Affective preparation; General Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate ("pre-live") and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback); A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cognitive-affective preparation; prostate cancer counseling
Study to Evaluate the Efficacy, Safety and Tolerability of N1539
Condition: Hysterectomy
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539
      in subjects undergoing open abdominal hysterectomy
    


Intervention name(s): N1539; N1539; N1539; N1539; placebo; Morphine; N1539
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg IV once per day; 7.5 mg IV once per day; 15 mg IV once per day; 30 mg IV once per day; IV placebo once per day; morphine 10-15 mg IV once per day; 60 mg IV once per day
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of CI-1012 in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if it is safe and effective to give CI-1012 to
      HIV-infected patients who do not have any symptoms of the disease. This study also examines
      how the body handles CI-1012.
    

Detailed description: 
      Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients
      entered at each dose level studied.
    

Intervention name(s): CI-1012
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Dose-Response Relationship, Drug; Administration, Oral; Drug Administration Schedule; CD4 Lymphocyte Count; Anti-HIV Agents
The Effect of High vs. Low Fluid Volume on Ocular Parameters in Prone Spine Surgery
Condition: Prone Position; Blood Volume; Intraocular Pressure
Study type: Interventional

Summary: 
      The purpose of this trial is to compare the effect of different fluid volume infusion on
      ocular parameters in patients undergoing spine surgery in prone position.
    

Detailed description: 
      In the prone position, the intraocular pressure and optic nerve sheath diameter increase
      progressively with time as compared with those in the supine position. Excessive fluid
      infusion may further increase intraocular pressure and optic nerve sheath diameter. Pulse
      pressure variation (PPV) is a dynamic index which can effectively assess fluid responsiveness
      during general anesthesia.Therefore,the investigators have designed a study to compare the
      effect of different fluid volume infusion guided by low and high PPV indices on intraocular
      pressure and optic nerve sheath of patients undergoing prone spine surgery with general
      anesthesia. One group of the patients will receive relatively loose fluid infusion (target
      value of PPV: 6%-9%),while the other group of the patients will receive limited fluid
      infusion (target value of PPV: 13%-16%).
    

Intervention name(s): Ringer's Lactate solution; Spine surgery under general Anesthesia in the prone position
Intervention type(s): Other; Procedure
Intervention description(s): Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.; The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to the limited fluid infusion group and the loose fluid infusion group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pulse pressure variation; intraocular pressure; optic sheath diameter; spine surgery; prone position
Social Connectedness Group Intervention in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study evaluates the feasibility of the Groups for Health (G4H) intervention for adults
      accessing support for depression in the UK. G4H targets improvements in adults' interpersonal
      functioning in order to reduce feelings of loneliness. The study will adapt the G4H
      intervention for delivery to adults seeking treatment for depression in the UK and estimate
      trial parameters (recruitment, retention, missing data and acceptability) of the adapted
      intervention, prior to a definitive trial. A mixed methods design of interviews and a single
      group, pre-post study will be employed.
    

Detailed description: 
      Background: Loneliness is frequently reported amongst adults with depression. Interventions
      to reduce loneliness in different populations have shown mixed results. The Groups for Health
      (G4H) programme has been developed according to the social identity approach within social
      psychology and has demonstrated preliminary efficacy for reducing loneliness in a
      proof-of-concept study conducted with Australian student sample. The present study will
      examine whether G4H can be adapted to suit the needs of a clinical population in the context
      of UK secondary care services.

      Objective: Phase 1 - To adapt the G4H intervention for delivery to adults seeking treatment
      for depression in the UK. Phase 2: To estimate trial parameters (recruitment, retention,
      missing data and acceptability) of the adapted intervention, prior to a definitive trial; to
      optimise the adapted intervention for delivery to adults accessing treatment for depression
      in the UK; to optimise evaluation procedures (candidate outcome measures)

      Trial configuration: sequential exploratory mixed methods design. Phase 1: one-to-one
      interviews. Phase 2: Activity 1 (intervention), single group, pre-post study. Activity 2
      (interviews): one-to-one interviews.

      Condition: Depression

      Interventions: group-based behavioural programme
    

Intervention name(s): Groups for Health
Intervention type(s): Behavioral
Intervention description(s): Group sessions, 5 modules x 1.5 hours (once per week). Modules focus on psychoeducation, mapping existing social networks, examining barriers to engagement in existing networks, goal setting and identifying new groups to join.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
An Open-label Clinical Study of the Pharmacokinetics and Safety of Elsulfavirine, 200 mg Tablets, With Single and Multiple Oral Administration in Healthy Volunteers
Condition: Covid19; HIV-1-infection
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label clinical study of the pharmacokinetics and safety of Elsulfavirine, 200 mg
      tablets, with single and multiple oral administration in healthy volunteers.
    

Detailed description: 
      The present study is an open-label, single-center, clinical study of the pharmacokinetics and
      safety of Elsulfavirin 200 mg tablets in four dosage regimens:

        -  Cohort I (N = 3). Single oral dose of 400 mg.

        -  Cohort II (N = 3). Single oral dose of 800 mg.

        -  Cohort III (N = 3). Single oral administration at a dose of 1200 mg.

        -  Cohort IV (N = 6). A single 1200 mg oral dose followed by 200 mg daily for 9 days.

      The study is descriptive and will not test any hypotheses. Based on previous studies and the
      intended descriptive objectives of the study, no control group is planned.

      To ensure safety, the following scheme for using the investigational drug is provided:

        -  The inclusion in the study of volunteers included in each subsequent cohort will be
           carried out strictly after the completion of the study by the last study subject
           included in the previous cohort and obtaining a safety opinion.

        -  Dosing in the multiple administration cohort will be 2 + 4. Initially, 2 volunteers will
           be included, after completion of participation, 4 more volunteers will be dosed.
    

Intervention name(s): Elsulfavirine
Intervention type(s): Drug
Intervention description(s): Elsulfavirin 200 mg tablets.
Other intervention name(s): VM-1500
Intervention MeSH terms: Elsulfavirine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Elsulfavirine; HIV-1; 2019-nCoV; SARS-CoV-2
Focal Cortical Atrophy After Myocardial Internal Capsule
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke; Atrophy
Study type: Interventional

Summary: 
      Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy,
      localized in the ipsilateral primary motor area, measured in mm, three months after
      infarction of internal capsule.

      The patient is compared to himself between day zero to ten and three months.

      The study hypotheses are:

        -  A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral
           infarction of the internal capsule. It is measurable accurately and reproducibly by MRI
           at three months. Other brain areas within the voluntary motor system will also be
           explored (supplementary motor area, pre motor area).

        -  This atrophy is correlated with achievement of pyramidal tract, assessed by the
           fractional anisotropy of its fibers.

        -  This atrophy is correlated with disability at three months, assessed by Rankin score.
    

Detailed description: 
      Twenty-two patients with ischemic stroke, subcortical, involving the internal capsule, will
      be included.

      Each patient will be compared to himself, on day zero to ten and three months.

      An MRI will be performed between day zero and ten, then three months of infarction sequences
      with traditional threeD enabling acquisition and tractography and The measurement of cortical
      thickness is in mm The measurement of fractional anisotropy of the pyramidal tract A clinical
      evaluation will be done between Day zero and Day ten then three months, using a neurological
      score (NIHSS), a score of functional disability (Rankin) and more analytical and sensitive
      tests such as dynamometer, the Finger Tapping test and test new plugs.
    

Intervention name(s): Additional MRI
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cortical focal atrophy; Stroke; Internal capsule; Corticospinal tract; Wallerian degeneration; Primary motor area.
Consequences of Human Inactivity
Condition: Inactivity; Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Epidemiological studies as well as both longitudinal animal and human inactivity studies
      indicate that low physical activity is associated with the pathophysiology of type 2 diabetes
      mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity
      (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a
      high energy dietary intake, and T2DM are also associated with dementia, depression, and
      impaired cognitive function. It is critical that we understand how inactivity alters body
      composition, glucose and lipid metabolism, and cognitive function, if normal physical
      activity can prevent these changes, and if there are any differences between sexes.

      The present protocol is divided in several in several sub-studies:

        1. To test whether and how a physically inactive lifestyle will influence body composition,
           glucose and lipid metabolism, and cognitive function.

        2. To test whether normal physical activity can prevent the deleterious effect of a
           physically inactive lifestyle despite a high-caloric intake.

        3. To test whether the influence of a physically inactive lifestyle combined with a
           high-caloric intake differs between sexes.
    


Intervention name(s): female inactivity and hypercaloric diet; inactivity; inactivity and hypercaloric diet; normal activity and hypercaloric diet; inactivity and iso-caloric diet
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): female inactivity and hypercaloric diet for 2 weeks; inactivity for 2 weeks; inactivity and hypercaloric diet for 2 weeks; normal activity and hypercaloric diet for 2 weeks; inactivity and iso-caloric diet for 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inactivity; Obesity; Type 2 diabetes; glucose metabolism; Lipid metabolism; Cognitive function
Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery.
Condition: Postoperative Pain
MeSH terms: Cleft Lip
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      this study will be undertaken to evaluate the safety and analgesic efficacy of adding
      ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain
      postoperatively following repair of cleft lip in children less than two years of age.
    

Detailed description: 
      Oro-facial clefts are the most prevalent craniofacial birth defects and the second most
      common birth anomaly, second only to clubfoot [Strong & Buckmiller 2001]. Cleft lip surgery
      is associated with appreciable postoperative pain in children Alleviation of postoperative
      pain is important in these patients. The fear of respiratory depression using opioids has
      renewed the interest in regional anesthesia to provide safe and effective postoperative
      analgesia. Infra-orbital nerve block has been advocated as a suitable local analgesic
      technique for cleft lip surgery and superficial surgery on the mid face [Morton 2004, Takmaz
      et al. 2009, Rajesh et al. 2011, Jindal et al. 2011].The infra-orbital nerve supplies the
      upper lip, lower eyelid, and adjacent skin of the cheek and nose. Unilateral or bilateral
      infra-orbital nerve block has been performed with a very high success rate.

      The investigators designed this study to evaluate the safety and analgesic efficacy of adding
      ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain
      postoperatively following repair of cleft lip in children less than two years of age.
    

Intervention name(s): Bupivacaine; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): Infraorbital nerve block using bupivacaine 0.25% on each side.; Infraorbital nerve block using 0.5mg/kg ketamine on each side.
Other intervention name(s): bucaine; Katalar
Intervention MeSH terms: Ketamine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled,
      parallel group, proof of concept, and dose range finding study to evaluate the efficacy,
      safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate
      OA of the knee.

      Objectives of the study:

        1. To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in
           subjects with osteoarthritis (OA) of the knee;

        2. To assess the safety and tolerability of multiple doses of X0002 when administered as a
           topical spray.
    

Detailed description: 
      This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled,
      parallel group, proof of concept, and dose range finding study to evaluate the efficacy,
      safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate
      OA of the knee.

      After a screening period of up to 3 weeks and radiographic evaluation of the target knee
      joint space, 225 subjects will be randomly assigned to 1 of 3 treatment groups in a 1:1:1
      ratio with a 2:1 ratio of active:placebo within each treatment group in a 1:1:1 ratio with a
      2:1 ratio of active:placebo within each treatment group (i.e., 2 subjects to active treatment
      and 1 subject to placebo):

      Group A: low dose of X0002, twice daily (BID, approximately every 12 hours; n=50) or placebo
      (low dose), BID (approximately every 12 hours; n=25); Group B: middle dose of X0002, BID
      (approximately every 12 hours; n=50) or placebo , BID (approximately every 12 hours; n=25) ;
      Group C: High dose of X0002, BID (approximately every 12 hours; n=50) or placebo, BID
      (approximately every 12 hours; n=25) .

      Safety and efficacy assessments will be performed at at 2, 4, 8, and 12 weeks of treatment.
    

Intervention name(s): X0002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Parallel Assignment; Parallel Assignment
Other intervention name(s): Active drug; Placebo powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2, Efficacy, Safety, Osteoarthritis