bioihbjkbjnl/mcl2 huggingface dataset:
Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT
Condition: Neoplasm, Esophagus; Neoplasm, Squamous Cell
MeSH terms: Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms
Study type: Observational

Summary: 
      In this case-only study, the investigators try to define a novel staging parameter, the
      Primary Tumor Burden Score (PTBS).
    

Detailed description: 
      In this case-only study, the investigators try to define a novel staging parameter, the
      Primary Tumor Burden Score (PTBS), which will combine the proportion of residual primary
      tumor cells and pre-treatment pathological T stage (prepT stage). The investigators will also
      try to improve ypTNM stage by results of PTBS.
    

Intervention name(s): nCRT
Intervention type(s): Procedure
Intervention description(s): ESCC patients that recieved surgery and nCRT.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ESCC undergoing nCRT at the Department of Thoracic Surgery, Zhongshan
        Hospital of Fudan University (training cohort), and the Department of Thoracic Surgery,
        Zhongshan Hospital Xiamen Branch (validation cohort), between January 2010 and February
        2019 were reviewed. The inclusion criteria were (I) thoracic ESCC; (II) McKeown or
        Ivor-Lewis transthoracic approach; (III) locally advanced resectable tumor with cT3-4aNany
        staging treated with nCRT; (IV) no history of concomitant or prior malignancy.
      
Biospecimen description: 
      Patients' pathological sections
Lycopene In Preventing of Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development of cancer. The use of lycopene may be an effective way to prevent prostate
      cancer.

      PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine any dose limiting toxicities and the maximum tolerated dose of lycopene
           administered orally as a food based delivery system in healthy male subjects 18-45 years
           of age for the chemoprevention of prostate cancer.

        -  Determine the pharmacokinetics of this regimen in this population.

        -  Determine the dose range of this regimen to be used in the 3 month multiple dose study,
           based on the toxicity, pharmacokinetics and feasibility resulting from the present study
           in this population.

      OUTLINE: This is a dose-escalation study.

      Patients receive a single dose of oral lycopene in a mixture of tomato paste, water, and
      olive oil over 15 minutes on day 1. Patients are asked to maintain a diet that contains
      negligible carotinoid for 28 days.

      Cohorts of 5 patients receive escalating doses of lycopene until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients
      experience dose limiting toxicities.

      Patients are followed weekly for 4 weeks.

      PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
    

Intervention name(s): lycopene
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Lycopene
Primary purpose: Prevention
Keywords: prostate cancer
Beta2-mimetic and Central Nervous System
Condition: Adrenergic Beta-2 Agonist Effect; Albuterol Effect
Study type: Interventional

Summary: 
      Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and
      chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise
      and muscle performances. The underlying mechanisms are however unclear. Some data suggest
      that Salbutamol may have some effects on the central nervous system which may explain the
      improved exercise and neuromuscular performances. The present study aims to assess the
      effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using
      neurostimulation techniques and magnetic resonance imaging.
    

Detailed description: 
      The effects of Salbutamol intake will be assessed by using transcranial magnetic stimulation
      on one hand and magnetic resonance imaging on the other hand. Maximal voluntary activation
      and cerebral activation will be measured during motor tasks performed until exhaustion after
      acute inhaled slabutamol intake, acture oral salbutamol intake or oral placebo intake.
    

Intervention name(s): Salbutamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.; Acute oral intake of a placebo drug
Other intervention name(s): Albuterol; Albuterol
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania
Condition: Pediatric HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The goal of the research was to evaluate the performance of items within the Kizazi Kipya
      (K2) Orphan and Vulnerable Children (OVC) HIV risk screening tool in identifying HIV-positive
      children, to optimize an HIV screening tool for OVC and children and adolescents in facility
      settings and to assess the feasibility and acceptability of home-based HIV risk screening and
      testing.
    

Detailed description: 
      Under the ongoing community-based Kizazi Kipya (K2) OVC project, program staff currently
      administer a 13-item HIV risk screening tool to all K2 program beneficiaries, and refers
      those who screen positive to facility-based HIV testing. A subset of this 13-item tool is a
      module of four items that had previously been used as a standalone four-question screening
      tool in facilities in Zimbabwe.

      The primary objectives of this study are as follows.

        1. To evaluate the performance of a lay cadre-administered four-item subset of the K2 HIV
           risk screening tool that matches the Zimbabwe evidence-based tool in predicting the HIV
           status of vulnerable children/adolescents represented by two populations: (a) K2 OVC
           beneficiaries and (b) children/adolescents attending health facilities.

        2. To identify additional items in the K2 HIV risk screening tool that could be added to
           the four-question subset to improve the tool's performance.

        3. To assess fidelity to the administration of the OVC HIV screening tool items through
           structured observations of community case workers in the K2 program.

        4. To assess the acceptability of OVC HIV risk screening and testing implemented in the
           community among OVC beneficiaries in the K2 program.

        5. To assess the acceptability and feasibility of integrating the OVC HIV screening tool
           with HIV testing among OVC community case workers in the K2 program.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents (and their caregivers as applicable) participating in an orphans
        and vulnerable children (OVC) program or presenting for services at a study facility.
        Community care workers (CCWs) who have been conducting HIV risk screening in OVC households
        as part of their role in the OVC program.
      
Keywords: HIV Screen tool; orphans and vulnerable children; Tanzania
The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an
      insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose
      study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in
      healthy subjects.
    


Intervention name(s): SHR3824; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.; A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
Other intervention name(s): Henagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SHR3824 Type 2 diabetes mellitus SGLT2
Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week in Subjects With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary aim of this study is to observe any changes in MRI in MS patients who have
      switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.
    

Detailed description: 
      The primary aim of this study is to observe the effect of switching from daily injections of
      20mg glatiramer acetate (GA) (20mg/daily) to GA 40mg three times a week (40mg x 3/weekly) on
      thalamus pathology, as measured by changes in diffusion-tensor imaging (DTI) in patients with
      relapsing-remitting multiple sclerosis (RRMS). We hypothesize that GA 40mg x 3/weekly will
      exert similar, if not better effect on prevention of thalamic pathology, as compared to GA
      20mg/daily. The secondary objective of this study is to investigate the effect of switching
      from GA 20mg/daily to GA 40mg x 3/weekly on evolution of microstructural changes in normal
      appearing white matter (NAWM) and normal appearing gray matter (NAGM), as measured by DTI.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        One hundred fifty (150) consecutive RRMS patients who are on treatment with GA 20mg/daily
        for at least 12 months and who switched to GA 40mg x 3/weekly, because of convenience of
        application, will be recruited in the study.
Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER
      tablets of AZD3241 following multiple ascending doses administered to healthy male and female
      subjects including the effect of food.
    


Intervention name(s): AZD3241; Placebo Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet, Repeated Administration; Oral Tablet. Repeated Administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Safety; tolerability; healthy; Healthy volunteer study
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Day
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when
      administered BID for 28 days in adult subjects.
    

Detailed description: 
      This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to assess
      the safety, tolerability, and PK of oral TPOXX 600 mg when administered BID for 28 days in
      adult subjects.
    

Intervention name(s): TPOXX; TPOXX Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study is based on Animal Regulatory Rule; Does not apply
Other intervention name(s): tecovirimat; ST-246; Placebo
Intervention MeSH terms: Tecovirimat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
"Effects of Oral Citrulline on Protein Metabolism in Healthy Humans: a Prospective, Randomized, Double-blind , Cross-over Study" (Citrugrêle)
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The specific aim of this study is to determine whether oral citrulline administration
      enhances whole body protein synthesis in healthy humans in the postabsorptive state. Protein
      metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine.
      The investigators hypothesize that citrulline supplementation will decrease leucine oxidation
      without altering proteolysis, and consequently stimulate protein synthesis .
    


Intervention name(s): citrulline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.06 G/kg three times/day during 7 days; placebo (equimolar mixture of 6 non essential amino acids: alanine, aspartate, glycine, histidine, proline, serine) 0,006 g/kg 3 times/day during 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Infection Rates of Myeloablative Allo SCT Recipients Receiving Neutropenic Diets Versus Non-Neutropenic Diets
Condition: Hematologic Malignancies
MeSH terms: Hematologic Neoplasms
Study type: Interventional

Summary: 
      In the transplant community, there is debate regarding the most appropriate food services for
      stem cell transplant patients. Recommendations regarding the use of low bacterial diets have
      been based on theoretical concepts of reducing the risk of contracting infections from
      pathogens found in food sources rather than clinical trials. The evidence for the use of a
      neutropenic diet is weak. To date, there have been little to no randomized controlled studies
      addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is
      necessary as infection prevention in myeloablative stem cell transplant patients. For this
      reason, our research is aimed at providing data to substantiate the use of neutropenic diets
      in preventing infections in recipients of myeloablative stem cell transplants.
    

Detailed description: 
      In the proposed pilot study, a randomized design will be used to address the primary and
      secondary aims. Subjects will be randomized to either the experimental group receiving a
      non-neutropenic diet without restriction, or to the control group receiving the standard
      neutropenic diet. While randomization will occur prior to, or on the day of their inpatient
      admission and the subjects will begin study procedures upon admission to the Adult Stem Cell
      Transplant Inpatient Unit at Duke University Medical Center.

      The diet will continue until 1) the subject is no longer neutropenic, and/or 2) discharged
      from the inpatient unit to continue their care in the Adult Stem Cell Transplant Outpatient
      Clinic. By limiting the study to the time of care on the inpatient unit, we will minimize the
      opportunity for deviation from the assigned diet. Absence of neutropenia will be defined as
      an absolute neutrophil count of greater than 500/uL (manual differential) and a total white
      blood cell count of 1000/uL for three consecutive days.

      All subjects enrolled will follow the standard prophylactic antibiotic regimen. Other
      supportive care will also be consistent in the two groups.
    

Intervention name(s): Non-neutropenic Diet
Intervention type(s): Other
Intervention description(s): Non-neutropenic diet is without restriction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neutropenic Diet, Non-Neutropenic Diet, Allogeneic SCT
Drug-drug Interaction Study of CTP-543 and Rifampin in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 open-label study of the effect of rifampin on the pharmacokinetics of
      CTP-543 in healthy subjects.
    


Intervention name(s): CTP-543
Intervention type(s): Drug
Intervention description(s): Rifampin as oral capsule
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Rifampin; Drug-drug interaction; CTP-543
Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation
Condition: Neurologic Neglect Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral
      neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to
      pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses
      induce a shift to the right visual field for improving symptoms in short term.

      Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency
      resulting from stroke with encouraging results. The hypothesis of the study is to evaluate
      the usefulness of brain stimulation as an adjunctive intervention to optimize and increase
      the rehabilitation of unilateral neglect to long-term.

      Thus, the main objective is to evaluate the effectiveness of standard treatment with
      prismatic adaptation with anodal tDCS or sham tDCS.
    


Intervention name(s): transcranial direct current stimulation (tDCS); Control: placebo stimulation
Intervention type(s): Device; Device
Intervention description(s): Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).; electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurologic neglect syndrome; post stroke; transcranial direct current stimulation (tDCS); prismatic adaptation
Orexin-A Levels in Insomnia Patients
Condition: Insomnia; Anesthesia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational [Patient Registry]

Summary: 
      In the pathophysiology of insomnia, the increase of the orexin-A (OXA) peptide released from
      orexin neurons in the lateral hypothalamus plays an important role. Orexins takes part at the
      emergence of anesthesia. In the literature, investigators could not attain any studies about
      the arousal of insomnia patients from anesthesia. In this study, the effect of this peptide
      on the emergence process from anesthesia was investigated by comparing plasma OXA levels
      before and after anesthesia in insomnia patients.
    

Detailed description: 
      ASA (American Society of Anesthesiologists) I-II patients aged 18-65 years who underwent
      elective laparoscopic cholecystectomy were included in the study. Patients were evaluated
      with the Jenkins Sleep Disorders scale and Epworth Sleepiness scale during preoperative
      examination and were divided into insomnia and control groups. Blood samples were obtained
      for OXA and glucose levels at anesthesia induction, 5 minutes after extubation and 30 minutes
      after extubation. The times from stopping anesthesia to eyes opening and extubation and
      end-tidal sevoflurane concentrations at these time points were recorded.
    

Intervention name(s): Jenkins Sleep Disorders scale and Epworth Sleepiness scale
Intervention type(s): Diagnostic Test
Intervention description(s): Jenkins Sleep Disorders scale and Epworth Sleepiness scale
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male patients undergo elective laparoscopic cholecystectomy under general anesthesia
Matrix Metalloproteinases and Diabetic Nephropathy
Condition: Diabetes Mellitus, Type 1; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Matrix metalloproteinases (MMPs) are a family of protein-degrading enzymes that are involved
      in the breakdown and remodeling of many tissues and organs. Abnormal activity of these
      enzymes has been implicated in many disease processes including rheumatoid arthritis, dental
      disease and metastatic cancer. Recent studies also suggest that elevations in blood sugar may
      abnormally effect MMP enzyme activity. Decreased activity of some of these MMP enzymes may be
      a partial cause of the abnormal enlargement of the kidney (renal hypertrophy) seen at the
      start of diabetic kidney disease (nephropathy). Preliminary clinical data from our laboratory
      confirm that children with newly diagnosed type 1 diabetes mellitus (DM) have lower blood
      levels of some of these enzymes at the time of very high blood sugar readings. However, these
      enzyme levels become normal again as blood sugar levels improve with insulin treatment. In
      the present study, we propose to investigate the hypothesis that MMPs are involved in the
      cause of diabetic kidney disease by measuring concentrations of specific MMPs and some
      related proteins in the blood and urine of patients with type 1 DM who are between the ages
      of 14-40 years. We will enroll some patients who are recently diagnosed with diabetes, some
      who have had diabetes for several years, but without signs of kidney disease, and some with
      long-term diabetes and various degrees of kidney disease. Continuous Subcutaneous Glucose
      Monitoring, conducted for 3-4 days, will also be provided as a part of this study, to
      determine how different levels of blood sugar control might relate to different levels of MMP
      enzyme activity in the blood. We anticipate that this study will help to establish a link
      between abnormal MMP activity and the cause of nephropathy in type 1 DM, allowing scientists
      to design better therapies for the prevention and treatment of diabetes-related kidney
      problems.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Type 1 Diabetes mellitus, ages 14-40 years.