bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This an open label study to assess the pharmacokinetics of CT1812 in normal healthy
      volunteers.
    

Detailed description: 
      Open label study to assess PK in 36 older healthy volunteers. Subjects will be screened 35
      days prior dose to determine eligibility. On day -1 subjects will be admitted to the clinical
      research unit and on day 1 will be randomized to receive one of the following doses: 150 mg
      BID, 150 mg QD or 300 mg QD in the fed state. Subjects will be confined in the Clinical
      Research Unit where they will continue to receive study drug and complete safety assessments,
      PK and CSF draws, until day 16 when they will be discharged.
    

Intervention name(s): CT1812
Intervention type(s): Drug
Intervention description(s): Study Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open Label Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Glucose and Insulin Responses to Test Foods
Condition: Glucose Response; Insulin Response
Study type: Interventional

Summary: 
      In this study, postprandial glucose and insulin responses of different foods will be measured
      in individuals with varying body weight.
    


Intervention name(s): Reference Glucose; Test Food 1 (Cereal); Test Food 2 (Biscuit)
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Chemoradiotherapy for Patients With Locally Advanced Nasopharyngeal Carcinoma Using Raltitrexed-Cisplatin
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of raltitrexed and cisplatin
      neoadjuvant chemotherapy followed by concurrent radiotherapy with raltitrexed and cisplatin
      in patients with locally advanced nasopharyngeal carcinoma.
    

Detailed description: 
      Although concurrent chemoradiation is the standard treatment modality for locally advanced
      nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment
      related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui
      et al. showed that neoadjuvant chemotherapy followed by concurrent chemoradiotherapy was
      superior to the standard concomitant chemoradiation in terms of the 3-year OS without
      significantly exacerbating the acute toxicities.

      At present, PF regimen has been considered as the most classic chemotherapy regimen of
      nasopharyngeal carcinoma (NPC), but its efficiency is about 40%-60% , and always with severe
      gastrointestinal reactions, renal toxicity and oral mucosa reaction. Therefore, it is
      imperative to find a more safe and effective chemotherapy regimen.

      Raltitrexed is a specific thymidylate synthase inhibitor with a convenient administration
      schedule,acceptable and manageable toxicity, radiosensitising properties. It may offer
      advantages compared with standard 5-FU chemotherapy regimens used in locally advanced NPC.

      Therefore, the investigators initiated this study to evaluate the efficacy and safety of
      raltitrexed and cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with
      raltitrexed and cisplatin in patients with locally advanced NPC.
    

Intervention name(s): raltitrexed-cisplatin; Intensity-modulated radiotherapy (IMRT)
Intervention type(s): Drug; Radiation
Intervention description(s): Patients receive raltitrexed-cisplatin neoadjuvant chemotherapy every three weeks for two cycles, then receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles; Patients receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles
Other intervention name(s): Tomudex
Intervention MeSH terms: Raltitrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induction Chemotherapy; Concurrent Chemoradiotherapy
Stimulation of Diet-Induced Thermogenesis by Cold-Exposure
Condition: Thermogenesis; Brown Adipose Tissue
Study type: Interventional

Summary: 
      Human fat tissue is essentially white fat, the main function of which is to store excess
      energy intake, and to release it when necessary. Brown fat is far less abundant and is
      present in the body to burn fat (and thus energy) to generate heat to maintain body
      temperature around 96 degrees. This phenomenon is called thermogenesis. When humans are
      exposed to cold on a chronic basis, brown fat expands and becomes more active, and
      consequently burns more energy. The amount of brown fat is higher during winter, and daily
      short (20 minutes) exposures to cold might be sufficient to induce its activity.

      We hypothesized that daily short term (20 minutes) exposure to a cold environment (4 °C) for
      four weeks increases adaptive BAT-mediated thermogenesis. CIT and DIT will be increased
      proportionally (the increase in CIT and DIT will be correlated).
    

Detailed description: 
      This study will have 3 phases:

      Phase 1: baseline testing. This phase takes place at the beginning of the study to establish
      several physical, physiological and metabolic studies and includes measures of height,
      weight, body composition, sedentary and resting metabolic rate in a metabolic chamber as well
      as your metabolic and cardiac responses to cold.

      Phase 2: cold exposure (treatment) phase. This phase is initiated immediately after phase 1
      and will last 4 weeks. Each work day (Monday to Friday) subjects will have to spend 20
      minutes in a cold room wearing light clothes.

      Phase 3: post-treatment testing. The same physiological and metabolic studies measured at
      baseline will be repeated over 3 days.
    

Intervention name(s): Cold Exposure
Intervention type(s): Other
Intervention description(s): Participants will spend 20 minutes per day 5 times a week (workdays) in a cold room wearing light clothes (T-shirt, shorts and light shoes) for 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet-induced thermogenesis; Cold-induced thermogenesis; Brown adipose tissue; Brown fat
Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety,
      Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant
      (DLP-114).
    

Detailed description: 
      Phase 1 open-label study in stable schizophrenia patients designed to evaluate the safety,
      tolerability, and PK of switching from 2 mg/day or 3 mg/day oral risperidone to two DLP-114
      devices for a six or twelve-month dosing period.
    

Intervention name(s): Risperidone
Intervention type(s): Combination Product
Intervention description(s): Risperidone Implant
Other intervention name(s): DLP-114
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: risperidone; schizophrenia; implant
Segmental Epidural Anesthesia (SEA) V/S General Anesthesia for PCNL
Condition: Success Rate Under Segmental Epidural; Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy
      (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic
      technique and is used for the fragmentation and removal of stones of size more than 20 to 30
      mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL is a challenge
      because of the disease, surgical procedure, positioning, hypothermia,and the possibility of
      fluid absorption, dilutional anaemia and blood loss. General anaesthesia is the gold standard
      for this surgery.The advent of new drugs has refined the technique of general anaesthesia.
      However there are several issues related to prone position still to be addressed like
      accidental extubation and difficult reintubation, nerve injuries and post operative
      respiratory complications.

      Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established
      technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also been
      reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from the
      surgical site. This not only allows to limit the dose of the local anaesthetics, but also
      limit motor and sympathetic blockade. Selective sympathetic block is associated with
      respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our
      current study. In the present study the investigators aimed to evaluate the efficacy of
      segmental epidural for PCNL and compared it with standard technique i.e. GA.
    

Detailed description: 
      To evaluate efficacy the investigators compared intraoperative haemodynamics, surgical
      clearance of stones, post operative pain, surgeon's and Patient's satisfaction scores and
      postoperative complications and side effects in 60 ASA I and II patients undergoing PCNL
      surgery who received either General anesthesia or Segmental epidural Anesthesia.
    

Intervention name(s): PCNL under General Anesthesia; Segmental Epidural Anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients undergoing percutaneous Nephrolithotomy received General anesthesia.; Patients undergoing PCNL surgery received Segmental epidural anesthesia with 0.5% bupivacaine.
Other intervention name(s): Regional Anesthesia
Intervention MeSH terms: Anesthetics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Segmental Epidural; Regional Anesthesia for PCNL
Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?
Condition: Postoperative Complications; Hernia
MeSH terms: Hernia; Postoperative Complications; Hernia, Abdominal; Internal Hernia; Incisional Hernia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether drainage after prosthetic repair of
      incisional abdominal hernias increases or decreases complications such as infection, seromas
      and hematomas.
    

Detailed description: 
      Between 3 to 20% of patients who received a midline laparotomy will develop an incisional
      hernia.

      Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh
      repair is superior with regard to the recurrence (12-20%), but early postoperative
      complications include infections, hematomas and seromas.

      Some advocate the use of drains in order to diminish secretions and complications. Other
      claim that drains increase the complication's rate.

      In the absence of a randomized controlled trial it's not clear whether drainage could
      influence positively or negatively the occurence of such complications when performing a
      prosthetic repair of abdominal incisional hernia.

      The aim of this study is to answer this question, comparing prospectively two groups of
      operated patients: the former with drainage and the latter without.
    

Intervention name(s): Prosthetic repair of abdominal incisional hernia
Intervention type(s): Procedure
Intervention description(s): Rives-Stoppa repair of incisional hernia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postoperative Complications; Drainage; Infection; Seroma; Hematoma; Recurrence; Abdominal Wall; Hernia; Surgical Mesh
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
Condition: Subarachnoid Hemorrhage; Optical Imaging
MeSH terms: Brain Injuries; Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe
      and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF);
      cerebral blood volume (CBV)) obtained.
    


Intervention name(s): NeMo Patch and NeMo Probe
Intervention type(s): Device
Intervention description(s): A plaster based patch (NeMo Patch) and a combined probe for ICP monitoring and near infrared spectroscopy (NIRS) are applied as sensors. Data are collected by a NIRS instrument (NeMo Control Unit)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
Condition: Bone Marrow Transplantation; Graft Versus Host Disease; Graft-Vs-Host Disease; Graft-Versus-Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation
      (MR4) in de novo bone marrow transplant recipients
    


Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Immunosuppression; Bone Marrow Transplantation; Graft versus Host Disease
Type 2 Diabetes Affect Exercise Induced Improvement in Insulin Sensitivity
Condition: Insulin Sensitivity/Resistance
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      This study investigates weather a family history of type 2 diabetes affects exercise induced
      improvements in insulin sensitivity in the hispanic population
    

Detailed description: 
      A family history of T2D (FH+) is a risk factor for developing insulin resistance (which
      precedes T2D) and T2D (Ryder et al., 2003). Exercise training on the other hand has been
      shown to improve insulin sensitivity and is highly effective to prevent/manage T2D. However
      it is not known if early signs of insulin resistance appear before being clinically diagnosed
      and if the benefits of exercise which prevent/cure T2D, are limited to the offspring of
      Hispanic T2D parents. Therefore, the proposed study will determine 1) if normoglycemic
      (normal blood glucose) offspring of T2D parents are insulin resistant, using the gold
      standard method to measure insulin sensitivity and metabolic flexibility (ability to switch
      between carbohydrate and fat oxidation) 2) if 8 weeks of exercise training improves insulin
      sensitivity and metabolic flexibility to the same extent in FH+ compared to normoglycemic
      offspring of parents without any history of T2D (FH-) and 3) if 8 weeks of exercise training
      will change the blood, lipid and molecular profiles relevant to insulin sensitivity to same
      extent in FH+ compared to offspring of parents without family history of T2D (FH-).
    

Intervention name(s): 8 weeks of combined exercise intervention
Intervention type(s): Other
Intervention description(s): The subjects will undergo an 8 week combined exercise intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo
Condition: Tinea Pedis
MeSH terms: Tinea Pedis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable
      efficacy to a Terbinafine solution applied once.
    


Intervention name(s): Bifonazole spray once daily; Bifonazole spray twice daily; Placebo; Placebo; Lamisil Once
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Application of one dose daily by means of an metered dose; Application of two dose daily by means of an metered dose; Application of one dose daily by means of an metered dose; Application of one dose daily by means of an metered dose; One application of Lamisil Once
Intervention MeSH terms: Terbinafine; Bifonazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bifonazole; Terbinafine; Reduced treatment duration; Efficacy; Safety; Athlete's foot; Moderate severity
Modified Measles Virus (MV-NIS) for Children and Young Adults With Recurrent Medulloblastoma or Recurrent ATRT
Condition: Medulloblastoma, Childhood, Recurrent; Atypical Teratoid/Rhabdoid Tumor; Medulloblastoma Recurrent
MeSH terms: Measles; Medulloblastoma; Rhabdoid Tumor; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a three arm Phase I study within the Pacific Pediatric Neuro-Oncology Consortium
      (PNOC).

      This study will look to determine the safety and recommended phase 2 dose of the modified
      measles virus (MV-NIS) in children and young adults with recurrent medulloblastoma or
      atypical teratoid rhabdoid tumor (ATRT).
    

Detailed description: 
      This is an open label, multi-center, Phase I study to assess the safety of administering
      MV-NIS directly into the tumor bed (for locally recurrent medulloblastoma or ATRT patients)
      or into the subarachnoid space (for disseminated recurrent medulloblastoma or ATRT patients).

      For locally recurrent patients (patients in the first arm) MV-NIS will be directly
      administered into the tumor bed following a standard of care surgical resection. For patients
      with disseminated recurrence (patients in the second or third arm), MV-NIS will be injected
      via lumbar puncture (LP).

      Patients in the second arm will receive a one-time administration of MV-NIS. Patients will be
      closely monitored for 30 days after injection, and then followed for evaluation of 6 month
      progressive free survival and overall response rate.

      Patients in the third arm will receive two administrations of MV-NIS. Patients will be
      closely monitored for 56 days after injection, and then followed for evaluation of 4 month
      progressive free survival.
    

Intervention name(s): Modified Measles Virus; Modified Measles Virus Lumbar Puncture
Intervention type(s): Biological; Biological
Intervention description(s): Administration of MV-NIS either into the tumor bed, if surgery to remove local tumor; Administration of MV-NIS into the cerebrospinal fluid via lumbar puncture
Other intervention name(s): MV-NIS; MV-NIS LP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: measles virus; recurrent medulloblastoma; recurrent ATRT
BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod
      administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy
      with persistent proteinuria of between 1-6 g/day.
    


Intervention name(s): Blisibimod; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IgAN; IgA Nephropathy; A-623; Blisibimod; Kidney Disease; Persistent proteinuria
The AID Study 2: Artificial Intelligence for Colorectal Adenoma Detection 2
Condition: Colon Cancer
MeSH terms: Adenoma
Study type: Observational

Summary: 
      Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and
      removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related
      deaths, there exists a disappointing level of adenomas missed at colonoscopy. "Back-to-back"
      colonoscopies have indicated significant miss rates of 27% for small adenomas (< 5 mm) and 6%
      for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and
      colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as
      high as 12%. The clinical importance of missed lesions should be emphasized because these
      lesions may ultimately progress to CRC.

      Limitations in human visual perception and other human biases such as fatigue, distraction,
      level of alertness during examination increases such recognition errors and way of mitigating
      them may be the key to improve polyp detection and further reduction in mortality from CRC.
      In the past years, a number of CAD systems for detection of polyps from endoscopy images have
      been described. However, the benefits of traditional CAD technologies in colonoscopy appear
      to be contradictory, therefore they should be improved to be ultimately considered useful.
      Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have
      shown potential to assist polyp detection during colonoscopy.

      Average experienced endoscopists (each having performed <2000 screening colonoscopies) will
      perform the endoscopic procedure.
    


Intervention name(s): AI
Intervention type(s): Device
Intervention description(s): Artificial intelligence colonoscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Based on the observed prevalence of adenomas (35%) among patients undergoing colonoscopies
        at our center within the last 12 months, a sample size of 322 subjects per arm could allow
        for a 90% power to show the non-inferiority (primary end-point) of the AI-aided arm by
        excluding that the one-side 95% CI will exclude a difference of 10% in favour of the
        standard group. Such sample size will also have a 80% power to detect as statistical
        significant (α=0.05; two-sided test) a 10% absolute increase in the detection rate of
        adenomas in the AI-aided arm (secondary end-point).

        Performing a sub-stratification according to operator experience, we will planning to
        enroll the 322 subjects per arm performed by experts and 322 subjects per arm performed by
        average operator.
      
Keywords: Artificial Intelligence