bioihbjkbjnl/mcl2 huggingface dataset:
Accuracy of 1.5 T Versus 3 T Magnetic Resonance Arterial Spin Labeling to Measure Renal Blood Flow
Condition: Hypertension; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      In this study we want to compare the accuracy of two methods to measure renal perfusion by
      MRI spin labelling technique: the first measurement done with the 1.5 T MRI versus the second
      one obtained with the 3.0 T MRI (Siemens MRI device).

      Additionally we want to compare the changes of renal perfusion caused by physiological
      stress. The used stress test is the cold pressor test done at the forehead.
    

Detailed description: 
      Magnetic resonance imaging based arterial spin labeling is a technique to measure renal blood
      flow. Renal perfusion measurement is an important tool to analyze renal function and to
      detect acute kidney injury. The perfusion measurement is based on two data acquisitions, one
      with a global inversion prepulse followed by one with a slice selective prepulse (FAIR). The
      prepulses lead to a labeling of blood water spins. In contrast to the global inversion
      prepulse, the slice selective inversion prepulse only labels the blood water spins inside the
      kidney but not the inflowing blood water spins. Subtraction of both images therefore reflects
      the local perfusion. A third image without the FAIR preparation pulse is measured to
      normalize the signal intensifiers on each patients.

      MRI based arterial spin labeling is a noninvasive assessment not using contrast agents to
      measure the functional parameters of the kidney. This is avoiding serious complications such
      as acute kidney failure and nephrogenic systemic fibrosis. There is no known negative impact
      to the patient. In addition we now want to analyze the validity of this MRI-technique by
      provoking acutely changes of renal plasma flow. As a further provocative maneuver we selected
      the cold pressor test as a physiological stress test. Forehead cooling activates the
      sympathetic nervous system and increases blood pressure and heart rate by causing pain. This
      mechanism has got an impact on renal haemodynamics. To minimize the possible cold injuries we
      use the 1°C ice water pack only for 60 seconds and avoid the contact to the eyes.

      In this study we want to compare the accuracy of two methods to measure renal perfusion by
      MRI spin labelling technique: the first measurement done with the 1.5 T MRI versus the second
      one obtained with the 3.0 T MRI (Siemens MRI device).
    

Intervention name(s): renal perfusion
Intervention type(s): Other
Intervention description(s): measurement of renal perfusion with MRI arterial spin labelling technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
A Randomized Study to Abate Truancy and Violence in Grades 3-9 in Chicago Public Schools
Condition: Attendance and Truancy; Student Engagement; Dropout
Study type: Interventional

Summary: 
      In partnership with the Chicago Public Schools (CPS), the goal of this project is to test the
      effectiveness of a manualized mentoring and case management program for students in grades
      1-8. Most of the current policy and research attention on dropout has focused on the dropout
      decision itself, even though dropout is more likely to be simply the end point of a
      longer-term developmental process. This project seeks to learn more about the relative
      effectiveness of preventing dropout through mentoring and case management programs, and to
      learn more about the relative effectiveness of intervening early vs. later.
    

Detailed description: 
      High school graduation is tremendously protective against involvement with crime and
      violence, as well as against the risk of adult poverty, unemployment, and poor health. Most
      of the policy and research attention on dropout has focused on the dropout decision itself.
      Yet dropout is almost always the end point of a longer-term developmental process. For this
      project the investigators have raised nearly $7 million in external support from the U.S.
      Department of Education, the National Institutes of Health, and the William T. Grant
      Foundation to learn more about the relative effectiveness of preventing dropout by trying to
      re-engage children in school much earlier during their academic careers.

      Specifically, this project is motivated by findings from the late University of Chicago
      sociologist James Coleman indicating that one of the strongest protective factors against
      school failure for children is having a strong relationship with a pro-social adult -
      something that far too many children do not currently have, particularly those growing up in
      distressed family and community environments. The investigators are partnering with other
      researchers at Northwestern, Duke, and the University of Minnesota to test at large scale the
      effects of a structured mentoring and monitoring programs called Check & Connect. To date,
      the project has completed its pilot year, and starting this academic year will work with
      nearly 500 elementary and middle school students distributed across 23 CPS schools on the
      West and South sides of the city. Students will receive Check & Connect assistance for two
      academic years total.
    

Intervention name(s): Check & Connect
Intervention type(s): Behavioral
Intervention description(s): Structured mentoring and case management
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Attendance; Truancy; Student engagement; Mentoring; Monitoring; Case management
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in
      patients with homozygous familial hypercholesterolemia (HoFH).
    

Detailed description: 
      Study Masking:

      Part A: Open Label Part B: Double Blind
    

Intervention name(s): Evolocumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypercholesterolemia; familial hypercholesterolemia; homozygous familial hypercholesterolemia
Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The purpose of this research is to compare short-term and long-term efficacy of laparoscopic
      hepatectomy and radiofrequency ablation in the Treatment of early hepatocellular carcinoma,
      and provide the evidence for the choice of surgical method from the pathology and cytology.
    

Detailed description: 
      Background:The aim of this study was to compare the efficacy of laparoscopic hepatectomy(LH)
      with radiofrequency ablation (RFA) in the treatment of early hepatocellular carcinoma (HCC).

      Methods:A total of 110 patients with early HCC with nodular diameters of less than 3 cm and
      up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were
      carefully monitored and evaluated during the 3-year follow-up period.

      Results:

      operation time, intraoperative blood loss, rate of blood transfusion, complications and
      mortality, postoperative liver function, resection margin, number of micrometastases
      ,long-term curative effect and survival time were collected and analysed.

      groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear
      regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves
      were used.
    

Intervention name(s): Laparoscopic Hepatectomy; Radiofrequency Ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period; A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Hepatocellular Carcinoma; Laparoscopic Hepatectomy; Radiofrequency Ablation; Micrometastases
Mass Balance Study of [14C]JAB-21822
Condition: Mass Balance Study in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects
    

Detailed description: 
      A phase I study to quantify the total mass balance in healthy subjects after a single dose of
      [14C]JAB-21822
    

Intervention name(s): [14C]JAB-21822
Intervention type(s): Drug
Intervention description(s): Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effectiveness of ATMX in Treating Adolescents With ADHD and SUD
Condition: Attention Deficit Disorder With Hyperactivity; Substance-Related Disorders
MeSH terms: Hyperkinesis; Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use
      disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in
      treating adolescents dually diagnosed with ADHD and SUD.
    

Detailed description: 
      High rates of ADHD have been reported in adolescents with SUD. In addition, untreated ADHD is
      a risk factor for developing SUD. Atomoxetine is a norepinephrine reuptake inhibitor, and is
      currently used to treat adolescents with ADHD. The purpose of this trial is to evaluate the
      efficacy of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

      This study will last up to 18 weeks. Participants will receive six treatments of
      manual-driven, cognitive behavioral therapy for substance abuse over at 6 or earlier weeks.
      Participants and their parents will partake in therapy sessions. Subjects who have completed
      at least 2 weeks of CBT will be eligible to enter the controlled trial, at which point
      participants will be randomly assigned to receive either atomoxetine or placebo, which they
      will take once daily for 12 weeks. At the Week 12 study visit, participants will be assessed
      for symptoms of ADHD and SUD.
    

Intervention name(s): Atomoxetine hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atomoxetine up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.; Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens
      handling, lens fitting characteristics and visual acuity of different hydrogel lens designs
      versus silicone hydrogel lenses
    

Detailed description: 
      This is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial
      comparing different lens materials (hydrogel vs silicone hydrogel). It is anticipated that
      this study will involve 2 visits, for each lens pair, as follows: Visits: V1 (lens
      dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear the test
      and control lenses in a series of three short fitting comparisons.
    

Intervention name(s): ocufilcon D; omafilcon A; methafilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.; Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.; Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.
Other intervention name(s): Hydrogel Contact Lens; Hydrogel Contact Lens; Hydrogel Contact Lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
Condition: Healthy; Obese
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream
      and how long it takes the body to eliminate when administered orally as tablet and capsule
      formulations along with effect of food on LY3502970 in healthy overweight and obese
      participants. The study will also evaluate the safety and tolerability of LY3502970 in these
      participants. The study is conducted in two parts (part A and B) and will last up to 135 days
      including the screening period.
    


Intervention name(s): LY3502970
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
miPlan: A Trial of miPlan Intervention vs. Standard of Care
Condition: Unintended Pregnancy
Study type: Interventional

Summary: 
      Using our experience in digital media, behavior theory, client-centered interventions, and
      family planning, we have prototyped a digital application ("app")-miPlan-to be used in the
      clinic waiting room prior to a contraceptive visit. The goal of this research is to refine
      the app and conduct a randomized controlled trial of the miPlan intervention vs. standard
      care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC
      uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge,
      self-efficacy and decisional balance for highly effective contraception post-app use,
      contraceptive satisfaction, and intention to continue method use. The research will consist
      of baseline activities as well as a three-month follow-up call.
    

Detailed description: 
      Using our experience in digital media, behavior theory, client-centered interventions, and
      family planning, we have prototyped a digital application ("app")-miPlan-to be used in the
      clinic waiting room prior to a contraceptive visit. The goal of this research is to refine
      the app and conduct a randomized controlled trial of the miPlan intervention vs. standard
      care contraceptive counseling. The aim of this study is to understand miPlan's impact in
      terms of contraceptive knowledge, intentions and behaviors. The primary outcome is LARC
      uptake, which will be measured via chart review at clinic discharge, i.e. immediately
      following a patient's family planning visit. The secondary outcomes are contraceptive use at
      discharge (measured via chart review immediately following patient's family planning visit),
      self-efficacy and decisional balance (both measured via adapted validated scales for each)
      for highly effective contraception post-app use (measured immediately following intervention
      and prior to contraceptive counseling session), contraceptive satisfaction (measured at 3
      months post baseline), and intention to continue method use (measured at 3 months post
      baseline). The research will consist of baseline activities as well as a three-month
      follow-up call.
    

Intervention name(s): miPlan intervention
Intervention type(s): Behavioral
Intervention description(s): miPlan mobile contraceptive counseling waiting room app intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to evaluate the effectiveness and tolerability of
      controlled-release paroxetine (Paxil-CR) compared to placebo (an inactive substance) for
      individuals who continue to have symptoms of post traumatic stress disorder (PTSD) despite
      receiving prolonged exposure therapy.
    

Detailed description: 
      Post Traumatic Stress Disorder (PTSD) is common in the general population with the National
      Comorbidity Survey reporting a lifetime prevalence of about 8% in the United States (Kessler,
      et al 1995). PTSD is associated with marked symptomatic distress as well as significant
      impairment, dysfunction and reduction in overall quality of life (Kessler, 2000). Both
      pharmacotherapeutic interventions, including serotonin selective reuptake inhibitors (SSRIs),
      and psychosocial interventions such as cognitive-behavior therapy (CBT) have demonstrated
      efficacy for PTSD (Davidson, 2001; Foa, 2000) However, although these interventions can be
      helpful, many patients remain symptomatic despite initial treatment. There is little data
      available to guide practice regarding the efficacy of "next step" strategies for patients
      remaining symptomatic despite treatment.

      In this study the researchers will examine the relative efficacy of the addition of the SSRI,
      paroxetine-CR, compared to placebo for patients remaining symptomatic despite a brief and
      intensive course of CBT.

      This is a two phase, 14-16 week research study in which participants who remain symptomatic
      at the end of one phase (4-6 weeks) enter into the next phase. In phase I, all participants
      receive prolonged exposure (PE) therapy. Participants who continue to have significant
      distress because of posttraumatic stress disorder after 8 sessions of therapy will enter
      Phase II. In Phase II subjects will receive 5 more sessions of PE therapy and be randomly
      assigned (by chance, like a flip of a coin) to receive paroxetine-cr (Paxil-CR) or placebo
      (contains no active medication). Participants receive this combined treatment over the next
      10 weeks.
    

Intervention name(s): Prolonged Exposure Therapy; Paroxetine-CR
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: post traumatic stress disorder; Prolonged Exposure Therapy; pharmacotherapy; double-blind; Anxiety Disorder
MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part B
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P.
      falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria
      (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P.
      falciparum (Part B).
    

Detailed description: 
      Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P.
      falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria
      (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P.
      falciparum (Part B). An approximation of this concentration in healthy subjects will help to
      identify the optimal dose of MMV390048 for subsequent Phase 2 studies in patients. The
      challenge model will enable characterization of the exposure-response relationship for
      MMV390048 and will also provide data regarding the safety and tolerability of MMV390048 in a
      controlled disease-like setting.
    

Intervention name(s): MMV390048 40mg; MMV390048 dose to be determined mg
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 2 will receive a single dose of MMV390048. Depending on the data obtained from the 40mg cohort, the dose in Cohort 2 will be determined.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria, induced blood stage model challenge
Paravertebral Block Versus Thoracic Epidural Analgesia
Condition: Lung Cancer; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Thoracic epidural analgesia (TEA) is the basic method of analgesia in patients undergoing
      pulmonary lobectomy. TEA is considered to be a safe and thoroughly investigated method of
      pain relief that rarely causes serious complications. However, blocking the nerves as they
      emerge from the spinal column (paravertebral block, PVB) may represent an alternative method
      with some potential benefits. In this study, TEA and PVB will be compared for patients
      undergoing pulmonary lobectomy by video assisted thoracoscopic surgery. The aim of the study
      is to test the hypothesis, that PVB is a time-saving procedure compared with TEA on the day
      of surgery and that PVB is as efficient in postoperative pain reduction as TEA.
    


Intervention name(s): Thoracic epidural; Paravertebral block
Intervention type(s): Drug; Drug
Intervention description(s): Standard thoracic epidural (needle inserted into the space between the covering of spinal cord and the cord itself) preoperatively. Standard thoracic epidural analgesia mixture (2 mg/ ml bupivacaine, 2 µg/ ml fentanyl and 2 µg/ ml adrenalin) with an infusion of 6-10 ml/hour until day 2 postoperatively. Thereafter reduction by 30 % every four hours.; Paravertebral block containing 5 ml bupivacaine 5 mg/ ml (optionally 10 ml bupivacaine 2,5 mg/ ml). In addition per-oral painkillers (oxycodone and paracetamol) from the day of surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epidural analgesia; Pneumonectomy