bioihbjkbjnl/mcl2 huggingface dataset:
Role of Indicator Test (Neuropad) in Detecting Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Observational

Summary: 
      Diabetes mellitus can result in damage to the nerves supplying the feet. Various tests can be
      used to assess nerve damage but no tests so far have been used to assess loss of sweating
      which can lead to dry skin, fissuring and ulceration. The indicator test (Neuropad) is a
      plaster which is applied to the sole of the feet just below the 1st and 2nd toes of both
      feet. If the color of the plaster changes to pink it indicates that there is no nerve damage
      to the nerves. However if the plaster retains the blue color or the color only partially
      changes to pink after 600 seconds then this is a positive test and the patient has nerve
      damage.
    

Detailed description: 
      With increasing nervous dysfunction, the function of the sweat glands in the feet also
      diminishes and can cease completely. As a result the skin becomes brittle and dry, making it
      more susceptible to fissuring and breakdown leading to foot ulceration. This is where the
      diagnosis using the Neuropad plaster might be useful. The Neuropad measures sweat production
      and have been proposed as a new test of neuropathy (8,9). The Neuropad examines the function
      of the sweat glands by means of a colour indicator. The indicator test enables the diagnosis
      of neuropathy in a substantial proportion of patients with normal clinical examination (10).

      This colour indicator, a cobalt-II-salt, is applied in the form of a plaster to the area of
      skin on the patient's foot to be examined. In healthy subjects, the moisture (sweat) on the
      foot changes the colour of the Neuropad plaster from blue to pink normally within minutes.
      However, if the colour does not change completely or very slowly, this indicates initial
      nerve damage. This test is, as yet, the only one that examines changes in moistness of the
      foot. The speed and scale of the colour change of the Neuropad plaster can then be assessed
      as indicators of sudomotor function and thus as indicators of diabetic neuropathy as well.
      Although the test has been done in patients with diabetic neuropathy it has not been used as
      a discriminator in painless and painful neuropathy, or in patients with Charcot
      neuroarthropathy.

      In this study we aim to assess the presence of sudomotor dysfunction in patients with painful
      and painless neuropathy and patients with Charcot foot.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Type 1 and type 2 diabetic patients with and without peripheral neuropathy (painless and
        painful) and Charcot neuroarthropathy; and non-diabetic subjects
      
Keywords: Diabetes; Diabetic neuropathy; neuropad; Painless peripheral diabetic neuropathy; Painful peripheral diabetic neuropathy; Autonomic peripheral neuropathy; Charcot neuroarthropathy
Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune
      system and stop tumor cells from growing.

      PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with
      recurrent, progressive, or relapsed anaplastic glioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the objective response rate in patients with recurrent or progressive
           anaplastic glioma treated with poly ICLC.

        -  Determine the efficacy of this drug, in terms of 6-month progression-free survival, in
           these patients.

        -  Determine the safety profile of this drug in these patients.

        -  Determine the survival of patients treated with this drug.

        -  Determine the tumor response rate in patients treated with this drug.

        -  Determine the biological effects of this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks. Courses repeat every 4
      weeks in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study.
    

Intervention name(s): poly ICLC
Intervention type(s): Drug
Intervention MeSH terms: Poly ICLC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult anaplastic astrocytoma; adult mixed glioma; adult anaplastic oligodendroglioma; recurrent adult brain tumor; adult anaplastic ependymoma
A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
Condition: Dravet Syndrome; Seizure Disorder
MeSH terms: Seizures; Epilepsies, Myoclonic; Epilepsy; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind,
      placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and
      pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult
      subjects with Dravet syndrome. Study 1501 and Study 1502 were conducted in parallel; Study
      1501 was conducted at approximately 30 study sites in North America; Study 1502 was conducted
      at approximately 30 study sites in Europe, Asia and Australia. Upon completion of the
      Baseline Period after initial Screening and Baseline charting of seizure frequency, subjects
      who qualified for the studies were randomized (1:1:1) in a double-blind manner to receive
      either 1 of 2 doses of ZX008 (0.2 mg/kg/day or 0.8 mg/kg/day; maximum dose: 30 mg/day) or
      placebo. Randomization was stratified by age group (< 6 years, ≥6 to 18 years) to achieve
      balance across treatment arms, with the target of 25% of subjects in each age group. All
      subjects were titrated to their randomized dose over a 14-day Titration Period. Following
      titration, subjects continued treatment at their randomly assigned dose over a 12-week
      Maintenance Period. Subjects exiting the study underwent a 2-week taper, unless they enrolled
      in a follow-on study. Subjects were followed for post-study safety monitoring.
    


Intervention name(s): ZX008 (Fenfluramine Hydrochloride); Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5. The product is sugar free and is intended to be compatible with a ketogenic diet.; Placebo solution for ZX008. The product is sugar free and is intended to be compatible with a ketogenic diet.
Intervention MeSH terms: Fenfluramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: seizure; tonic-atonic; clonic; epilepsy; myoclonic; encephalopathy
Hydrolyzed Fish Cartilage Effect on Knee Joint Functionality and Discomfort in Adult Population
Condition: Knee Discomfort
Study type: Interventional

Summary: 
      This study is an exploratory, non-comparative, multi-centric trial in 30 free-living healthy
      male and female subjects with moderate knee joint discomfort and loss of functionality.

      The objective of this trial is to determine whether oral administration of Cartidyss, a
      concentrated fish cartilage extract, can contribute to the improvement of knee joint
      functionality and discomfort in adult population
    

Detailed description: 
      30 patients will be enrolled during a 4-month period in 3 investigational sites and each
      patient will undergo 3 visits (V0: Inclusion visit at baseline, V1: Follow-Up Visit after 1
      month ± 3 day and V2: End Visit after 3 months ± 5 days).

      The primary objective of this trial is to determine whether oral administration of Cartidyss,
      a concentrated fish cartilage extract, can contribute to the improvement of knee joint
      functionality and discomfort in adult population, using a specific self-administered
      questionnaire. The secondary objectives of the study are to evaluate the effect of Cartidyss
      on knee function and pain at rest and while walking, with patient global assessment and
      quality of life at each time point. The tolerance, compliance, satisfaction, rate of
      responder to the supplementation and pain killer's consumption would be also evaluated as
      secondary endpoints.
    

Intervention name(s): Cartidyss
Intervention type(s): Dietary Supplement
Intervention description(s): Oral intake of two tablets of Cartidyss 500 mg, once daily in the morning, preferably during a meal, with water, during 3 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: knee discomfort; hydrolyzed fish cartilage; food supplement
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5
      mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum
      effective dose below the lowest dose of 30 mg tested earlier in Phase II.
    


Intervention name(s): Placebo; Ospemifene 5 mg; Ospemifene 15 mg; Ospemifene 30 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).; 1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).; 1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).; 1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopausal symptoms; Urogenital atrophy; Vulvar and vaginal atrophy in postmenopausal women; Vaginal atrophy
A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
Condition: Urothelial Carcinoma; Advanced Cancer
MeSH terms: Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with
      local advanced or metastatic HER2 positive endothelial cancer.
    


Intervention name(s): RC48-ADC
Intervention type(s): Drug
Intervention description(s): 2 mg/kg IV every 2 weeks
Other intervention name(s): Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
Intervention MeSH terms: Trastuzumab
Intervention model: Single Group Assignment
Intervention model description: Drug: RC48-ADC
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RC48-ADC; HER2
A Study of ABT-414 in Subjects With Solid Tumors
Condition: Squamous Cell Tumors
MeSH terms: Neoplasms, Squamous Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      A study of ABT-414 in subjects with solid tumors.
    


Intervention name(s): ABT-414
Intervention type(s): Drug
Intervention description(s): ABT-414 will be administered by intravenous infusion.
Intervention MeSH terms: ABT-414
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Relative Bioavailability Study of Acetaminophen 650 mg Extended Release Gelcaps Under Fasting Condition
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open labeled, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioavailability study comparing acetaminophen extended
      release gelcaps 650 mg of OHM Laboratories Inc. with Tylenol® Arthritis Pain caplets 650 mg
      of McNeil Consumer & Specialty Pharmaceuticals, in healthy, adult, human, male subjects under
      fasting condition.
    

Detailed description: 
      Following an overnight fast of at least 10 hours, all subjects were administered a single
      oral dose of acetaminophen 650 mg extended release tablet was administered with 240 mL of
      drinking water during each period of the study under supervision of trained study personnel.
      Both test (T) and reference (R) products were administered to the study subjects, one in each
      period (except subject no 40).

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical,
      serology parameters, urine analysis and urine drug screening) were measured at base line.
      Laboratory parameters of haematology and biochemistry (except glucose and cholesterol) were
      repeated at the end of the study.
    

Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Acetaminophen fasting study
To Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multiple-dose study to evaluate the plasma and CSF pharmacokinetics of
      K0706 in healthy adult male subjects.
    


Intervention name(s): K0706; K0706; K0706
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study; Study; Study
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346
      compared to placebo in patients with mild or mild to moderate stages of ALS.
    

Detailed description: 
      This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346
      compared to placebo in patients with mild or mild to moderate stages of ALS.
    

Intervention name(s): TCH346
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; ALS
Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy
Condition: Perioperative Pain
Study type: Interventional

Summary: 
      Postoperative abdominal and shoulder pain that are experienced in patients undergoing
      laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than
      post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours
      postoperatively
    

Detailed description: 
      The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed
      to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.

      The residual part of CO2 remains in the peritoneal cavity for several days after the
      operation and causes stretching of the phrenic nerve endings, local hypothermia, and
      diaphragmatic irritation by carbonic acid formation
    

Intervention name(s): Bupivacaine; isotonic saline; Bupivacaine + morphine; Bupivacaine + morphine + ketamine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): instillation of local anaesthetic in the abdominal cavity at the end of the procedure; instillation of local anaesthetic in the abdominal cavity at the end of the procedure; instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure; instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure
Intervention MeSH terms: Ketamine; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial
Condition: Brain Injuries, Traumatic; Cognitive Impairment
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      A considerable number of patients with mild and moderate traumatic brain injury (TBI)
      experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their
      capacity to return to work (RTW). Although several studies have described medical,
      psychological and work-related factors that predict RTW after TBI, well-controlled
      intervention studies regarding RTW in this group are scarce. Furthermore, there have
      traditionally been weak collaborations among rehabilitation services in the health sector,
      the Labor and Welfare Administration (NAV), and the work-places.

      The current project proposal describes an innovative randomized controlled trial (RCT) which
      will explore the effect of combined manualized cognitive rehabilitation efforts and supported
      employment in real-life competitive work settings for patients who have not returned to work
      8 weeks post-injury. The project combines the rehabilitation and vocational science
      perspectives; it involves multidisciplinary collaboration, and explores the efficacy of
      increased cross-sectorial collaboration between specialized health care services and the
      welfare system. If the intervention proves efficient, the project will further describe the
      cost-effectiveness and utility of the program, and thereby provide important information of
      use for policy makers. In addition, the study aims at generating knowledge on the RTW-process
      both for the persons with TBI, and their workplaces, and to disseminate this knowledge in
      order to create new multidisciplinary and collaborative practices. The project has potential
      to generate knowledge of relevance for other patients with neurological deficit.
    

Detailed description: 
      Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954
    

Intervention name(s): Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment); Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.; The Control Group receives usual assessment and treatment at Oslo University Hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with active treatment group compared to treatment as usual
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Rehabilitation; Supported employment; Mild and moderate TBI; Return to work; Randomized Controlled Trial
Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Condition: Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4; Peritoneal Carcinomatosis
MeSH terms: Neoplasms; Carcinoma; Peritoneal Neoplasms; Colorectal Neoplasms
Study type: Interventional

Summary: 
      Multicentric randomised trial. The goal of this clinical research study is to learn if
      hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of
      peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal
      cancer. The safety of this treatment will also be studied.
    

Detailed description: 
      Hyperthermic intraperitoneal chemotherapy(HIPEC) is a recently validated option for the
      treatment of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic
      program demonstrated a significant improvement of overall survival of the disease. It is not
      yet known whether surgery followed by HIPEC is effective on decreasing the rate of peritoneal
      carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer.Patients
      with a high risk of developing colorectal Peritoneal Carcinomatosis (PC), defined by
      Colorectal Cancer With a Resected Minimal Synchronous PC or Ovarian Metastases, or identified
      T4 by intraoperative pathological diagnosis, or Tumour Rupture in the Abdominal Cavity. If
      patients with a high risk of developing PC identified by preoperative examination, they will
      be informed and will sign the consent. After complete resection of their tumor, they will be
      randomised to surveillance alone (control group) or HIPEC (experimental group). All patients
      will receive the current standard postoperative adjuvant treatment : 6 months of systemic
      chemotherapy (currently including FOLFOX4, mFOLFOX6, CapeOx or Capecitabine regimen which
      could be modified if the standard is modified). Then a work-up is done to find recurrence. If
      the recurrence occurs, the patient will be treated with the best known treatment.
    

Intervention name(s): Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
Intervention type(s): Procedure
Intervention description(s): HIPEC with MMC: Mitomycin C (MMC) (30 mg/m2 of body surface area). Closed technique, as preferred. Duration: 60 minutes. Mean Intra-abdominal Temperature: 43°C.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peritoneal carcinomatosis; HIPEC; controlled clinical trial; colorectal cancer