bioihbjkbjnl/mcl2 huggingface dataset:
Hyperspectral Imaging in Thoracic Surgery
Condition: Bronchus Anastomosis; Bronchus Stump; Tissue Oxygenation
Study type: Interventional

Summary: 
      The aim of this study is to find out whether hyperspectral imaging enables bronchus stump and
      bronchus anastomosis oxygenation.
    

Detailed description: 
      The bronchus before lung resection and the bronchus stump or bronchus anastomosis,
      respectively, are investigated. The hyperspectral imaging camera head is placed and aligned
      over the surgical (camera and object distance: 30 cm for all measurements). The Field of view
      is illuminated by 8 halogen spots (20 W each) and 100 wavelengths in the wavelength range
      from 500 to 1000 nm were applied. The software calculates the tissue oxygenation [%] ,
      organ-hemoglobin-index, near-infrared-Index and the tissue-water-index of the investigated
      tissue. The study was designed to investigate tissue oxygenation in the superficial (app.
      1mm) and deeper layers (app. 4-6mm) of the bronchus before and after lung resection.
    

Intervention name(s): HSI
Intervention type(s): Device
Intervention description(s): diagnostic hyperspectral imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an
      individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes
      mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro
      compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of
      multiple daily dose administrations for 14 days. Each subject will be randomised to a
      sequence of two treatments, either BioChaperone insulin lispro-Humalog® or
      Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an
      individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be
      determined at the screening visit. During the outpatient phase the subjects will keep their
      basal insulin constant (except changes for safety reason). They will self-measure blood
      glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per
      outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2
      hours post-prandial and at bedtime).
    


Intervention name(s): BioChaperone insulin lispro; Humalog®
Intervention type(s): Drug; Drug
Intervention description(s): Injection immediately before the start of the individualised standard meal; Injection immediately before the start of the individualised standard meal
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine whether an investigational drug combination consisting of
      Gemzar®, Taxotere®, and Xeloda®, (called GTX) is safe and effective in treating advanced
      pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of
      patients with pancreatic cancer.
    

Detailed description: 
      This Phase II multicenter study is designed to determine the response rate to a biochemically
      synergistic regimen with Gemzar, Taxotere, and Xeloda in patients with Stage IVB metastatic
      pancreatic cancer. It will further determine the overall and one year survival rates, the
      diseasefree interval, and the toxicities for this regimen in patients with metastatic
      pancreatic cancer.
    

Intervention name(s): Gemcitabine, Docetaxel, Capecitabine
Intervention type(s): Drug
Intervention description(s): 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.
Other intervention name(s): Gemzar; Xeloda; Taxotere
Intervention MeSH terms: Gemcitabine; Capecitabine; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stage IVB
Clinical Effects of Soluble Dietary Fiber Supplementation
Condition: Hypomotility; Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary
      fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with
      slow-transit constipation.
    

Detailed description: 
      Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks
      supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time,
      constipation symptoms and fecal bacterial population in two groups.
    

Intervention name(s): Pectin
Intervention type(s): Drug
Intervention description(s): pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks
Other intervention name(s): soluble dietary fiber
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: constipation; colon transit time; gut microbiota; soluble dietary fiber; disturbance of gut microbiota in constipation
A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, randomized, placebo-controlled, double-blind study to evaluate the safety,
      tolerability, pharmacokinetics, and preliminary activity of RO7105705 in two participant
      populations: healthy participants and participants with mild-to-moderate Alzheimer's disease.
      This study is a single dose, dose-escalation, and multiple dose study comprising
      approximately six single dose cohorts in healthy participants administered RO7105705, either
      intravenously (IV) or subcutaneously (SC), and comprising one or more multiple dose cohorts
      in healthy participants administered RO7105705 IV every week (QW), a total of 4 doses, and
      one or more multiple dose cohorts in participants with Alzheimer's disease administered
      RO7105705 IV QW, a total of 4 doses.
    


Intervention name(s): Placebo; RO7105705
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single or multiple doses of RO7105705 matching placebo IV.; Participants will receive single or multiple doses of RO7105705 IV or SC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Internal Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near
      a tumor to kill tumor cells.

      PURPOSE: This clinical trial is studying the side effects and how well internal radiation
      therapy works in treating patients with prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of
           external-beam radiotherapy) as definitive treatment for patients with intermediate-risk
           prostate cancer.

        -  To assess acceptable toxicity, defined as treatment related toxicity (urinary and
           rectal), no worse than that seen by patients treated with conventional therapy (grade 3
           urinary toxicity < 10% and grade 3 rectal toxicity < 10%).

      Secondary

        -  To achieve adequate dosimetric coverage of the prostate comparable to current standards.

        -  To assess the effect of treatment on sexual function.

      OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.

      Patients complete bladder, bowel, sexual function, and quality of life questionnaires,
      including the International Index of Erectile Function (IIEF) questionnaire, the
      International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life
      questionnaire at baseline and then at every follow-up visit.

      After completion of study treatment, patients are followed every 3 months for 1 year.
    

Intervention name(s): questionnaire administration; quality-of-life assessment; brachytherapy
Intervention type(s): Other; Procedure; Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer
The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Condition: Robot-Assisted Laparoscopic Radical Prostatectomy
Study type: Interventional

Summary: 
      Intraocular pressure is significantly increase during robot-assisted laparoscopic radical
      prostatectomy which is performed in a steep trendelenburg position at prolonged times of
      pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical
      visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing
      Robot-Assisted Laparoscopic Radical Prostatectomy.
    


Intervention name(s): deep neuromuscular blockade; moderate neuromuscular blockade; Rocuronium; Sugammadex; Atracurium; Neostigmine
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug; Drug
Intervention description(s): deep neuromuscular blockade using rocuronium and reverse with sugammadex; moderate neuromuscular blockade using atracurium and reverse with neostigmine
Intervention MeSH terms: Rocuronium; Atracurium; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: deep neuromuscular blockade; intraocular pressure
Glycemic and Insulinemic Impact of Oats With Additional Dried Fruits, Nuts and Seeds Soaked Overnight
Condition: Blood Glucose; Subjective Hunger, Insulin
Study type: Interventional

Summary: 
      The purpose of this study is to compare the glucose, insulin and subjective hunger responses
      elicited by oats with additional dried fruits, nuts and seeds soaked overnight in skim milk
      and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds
      cooked just prior to its consumption.
    


Intervention name(s): Overnight oats with additional dried fruits, nuts and seeds; Cooked cream of rice with additional dried fruits, nuts and seeds
Intervention type(s): Other; Other
Intervention description(s): Oatmeal; Cooked cream of rice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Oatmeal; Post-prandial glycemic response ; Post-prandial insulin response; Post-prandial hunger
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics
      of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir
      1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly
      with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a
      group of HIV patients without known liver disease and a group with moderate liver disease.
      The anticipated time on study treatment is <3 months, and the target sample size is <100
      individuals.
    


Intervention name(s): Ritonavir; saquinavir [Invirase]
Intervention type(s): Drug; Drug
Intervention description(s): 100mg po bid; 1000mg po bid
Intervention MeSH terms: Ritonavir; Saquinavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Naive
The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects
Condition: Multiple Sclerosis; Oxidative Stress
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the gene expression and activity of SIRT1, and
      forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple
      sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction
      between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy
      subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene
      expression and activity of above-mentioned genes in peripheral blood mononuclear cells of
      healthy subjects-treated with H2O2.
    


Intervention name(s): Melatonin; Hydrogen peroxide
Intervention type(s): Drug; Other
Intervention description(s): Melatonin is used for healthy subjects and multiple sclerosis patients; Hydrogen peroxide is only used for healthy subjects
Other intervention name(s): N-acetyl-5-methoxy tryptamine
Intervention MeSH terms: Hydrogen Peroxide; Melatonin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Multiple sclerosis; SIRT1; MnSOD; Catalase; Oxidative stress; Antioxidant enzyme
Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
Condition: Whiplash Injuries
MeSH terms: Whiplash Injuries
Study type: Interventional

Summary: 
      INTRODUCTION: Whiplash is an injury produced by an acceleration-deceleration mechanism that
      transmits energy to the cervical spine. According to the bibliography, the conservative
      treatment (motor control exercises and manual therapy) has shown benefits in approaching this
      lesion, but its efficacy is limited. Dry needling has already shown its usefulness in
      different musculoskeletal pathologies, however, its efficacy is unknown when it is included
      in conservative treatment.

      OBJECTIVES: The objective of this study is to assess the effects of the incorporation of dry
      needling in the conventional treatment with manual therapy and motor control exercises,
      compared to the conventional non-invasive treatment in patients with acute or subacute
      whiplash.

      HYPOTHESIS: The inclusion of dry needling in conventional non-invasive treatment is more
      effective than conventional non-invasive treatment in patients with acute or subacute
      whiplash.

      METHODS: A randomized clinical trial will be conducted in which the subjects of study will be
      assigned to two groups, a control group (conventional treatment) and an experimental group
      (conventional treatment and dry needling).
    


Intervention name(s): Motor Control; Manual Therapy; Dry Needling
Intervention type(s): Other; Other; Other
Intervention description(s): Neck Motor Control; Massage + Joint Mobilizations; Dry Needling in Neck Muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry Needling; Manual Therapy; Motor Control; Whiplash
Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients
Condition: Malocclusion, Angle Class III
MeSH terms: Prognathism; Malocclusion; Malocclusion, Angle Class III
Study type: Interventional

Summary: 
      Early orthodontic treatment of Class III malocclusions with skeletal and dentoalveolar
      imbalances, represents a continuous dilemma. This difficulty starts from their meticulous
      diagnosis and treatment planning till reaching satisfactory results and finally stability.
      Some appliances could be used to correct growing skeletal Class III patients, improving the
      skeletal and dentoalveolar relationships, creating proper conditions for final orthodontic
      treatment, more importantly avoiding surgery. These appliances remove patient compliance from
      the equation.
    

Detailed description: 
      Aim of the work: Evaluate the skeletal, dentoalveolar and soft tissue effects of two
      different force application systems which are the pulling force (CS 2000® appliance/ CS
      appliance) and the pushing force (Reversed Forsus fatigue-resistant device/ RF appliance).

      Materials and methods: A randomized controlled clinical trial will be conducted to address
      the aim of the study. Thirty three growing skeletal Class III patients (9-11 years) will be
      recruited upon a lateral cephalometric x-ray. Subjects complying with the inclusion criteria
      will be randomly assigned using a computer-generated list to one of the three groups Group I:
      Eleven patients treated with CS2000 appliance, Group II: Eleven patients treated with
      reversed Forsus Fatigue Resistant device and Group III: control group of Eleven untreated
      patients with a ratio of 1:1:1 allocation. A CBCT will be made before installing the
      appliances. After gaining a 2 mm positive overjet or a 6 months period, alginate impressions
      will be poured and dental casts will be made. Photographs and CBCTs will also be performed to
      record the dentofacial effect of the used appliances.

      Keywords: Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance,
      Reversed Forsus Fatigue resistant device.
    

Intervention name(s): CS 2000
Intervention type(s): Other
Intervention description(s): treating growing Skeletal growing Class III patients
Other intervention name(s): Reversed Forsus Fatigue resistant appliance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled clinical trial, parallel design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cone beam computed tomography; growing skeletal Class III; CS 2000® appliance; Reversed Forsus Fatigue resistant device
Vitamin D in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.

      PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D
      works in treating patients with prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol
           (vitamin D3) supplementation at four different oral doses in patients with prostate
           cancer.

      Secondary

        -  To examine the pattern of response of parathormone (PTH) following vitamin D3
           supplementation in these patients.

        -  To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

      Tertiary

        -  To track occurrence of infections, deep vein thrombosis, vascular events, and falls in
           these patients.

      OUTLINE: Patients are randomized to 1 of 4 treatment arms.

        -  Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.

        -  Arm II: Patients receive 6,000 IU of vitamin D3 once daily.

        -  Arm III: Patients receive 8,000 IU of vitamin D3 once daily.

        -  Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms
           continues for 6 months in the absence of disease progression or unacceptable toxicity.
    

Intervention name(s): cholecalciferol
Intervention type(s): Dietary Supplement
Intervention description(s): Given orally
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer
A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects
Condition: Asthma; Copd
MeSH terms: Asthma
Study type: Observational

Summary: 
      Smoking induces an inflammatory reaction in the airways which can ultimately result in
      persistent damage and the development of a Chronic Obstructive Pulmonary Disease (COPD).
      However, not all subjects who smoke end up with COPD. After long-term smoking, approximately
      20% of subjects develop COPD. At this time, it is unclear why some subjects develop COPD,
      whereas others maintain a normal lung function.

      In addition, smoking has important consequences in asthma. Patients with asthma who smoke
      have a more severe asthma and more often experience an asthma exacerbation. In addition, it
      has been shown that inhaled corticosteroids are less effective in smoking asthmatics.

      With this research project, the researchers will investigate the effects of smoking on the
      airways. To this end, the researchers will compare markers of airway inflammation, lung
      function and symptoms between healthy smokers and non-smokers of varying age. In addition,
      the researchers will compare those healthy subjects with patients with asthma and COPD which
      are characterized in earlier studies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy individuals
      
Biospecimen description: 
      Blood, induced sputum, bronchial biopsies, brush and lining fluid, urine
    
Keywords: bronchial; COPD; Asthma; sputum; biopsies
A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients
Condition: Intestinal Behcet's Disease (BD)
MeSH terms: Behcet Syndrome
Study type: Observational

Summary: 
      This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal
      Behcet's disease (BD) patients in routine clinical practice.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Intestinal Behcet's disease (BD) patients who are eligible to be prescribed adalimumab by
        the treating investigator as per Korean label will be enrolled.
      
Keywords: Intestinal Behcet's disease (BD); Adalimumab; Safety; Effectiveness; AMORE study