cyrilzakka/clinical-trials huggingface dataset:
Hypofractionated 3-Dimensional Radiation Therapy in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. ICORG 99-09

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor over a shorter period of time may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying the side effects of hypofractionated 3-dimensional radiation therapy and to see how well it works in treating patients with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.

OBJECTIVES:

Primary

* To evaluate the acute and long-term radio-induced toxicity (any organ) of hypofractionated 3-dimensional conformal radiotherapy in patients with newly diagnosed stage I-III non-small cell lung cancer.

Secondary

* To assess the radiological tumor response rate at 3 months after completion of radiotherapy.
* To assess the actuarial freedom from thoracic progression rate.

OUTLINE: Patients are stratified according to combined lung volume at 25 Gy (≤ 30% vs \> 30%). Patients are assigned to 1 of 3 treatment groups.

* Group 1: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy).
* Group 2: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy).
* Group 3: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy).

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer meeting 1 of the following stage criteria:

  * Stage I or II disease

    * Medically inoperable or patient refused surgery
  * Stage IIIA or IIIB disease (no pleural effusions)
* Radiation dose parameters must satisfy the required study dose-volume constraints

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Weight loss ≤ 10% within 3 months before diagnosis
* No other malignancy within the past 5 years, except nonmelanoma skin cancer
* No clinically significant cardiovascular disease (e.g., hypertension \[blood pressure \> 150/100 mm Hg\], myocardial infarction or stroke within the past 6 months, or unstable angina)

PRIOR CONCURRENT THERAPY:

* No concurrent chemotherapy
Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Diabetes

Arginase has recently been implicated in an array of vascular conditions including atherosclerosis , hypertension and vascular complication of diabetes. In this study we will determine of L-citrulline; a natural amino acid that is known to have inhibitory effects on arginase activity, on vascular function in type 2 diabetic patients.

Vascular dysfunction is a major cause of morbidity and mortality in diabetic patients. The pathological process is characterized by impaired endothelial cell production of the vasodilator and antiplatelet adhesion factor nitric oxide (NO) and/or decreased NO bioavailability. NO is a major regulator of vascular tone and integrity. In endothelial cells, NO is produced by activity of endothelial NO synthase (eNOS) on its substrate L-arginine. Reduced availability of L-arginine to eNOS has been implicated in vascular dysfunction in diabetes and a variety of other disease conditions. Arginase, which metabolizes L-arginine to urea and ornithine, competes directly with NOS for L-arginine. Hence increases in arginase activity can decrease tissue and cellular arginine levels, reducing its availability to eNOS and decreasing No production. During diabetes, elevated levels of arginase can compete with NOS for available arginine thus reducing vascular NO. We have recently shown that arginase activity is elevated in diabetes. In this proposal we implement a method of flow mediate dilation (FMD) to assess vascular function in diabetic patients. We will study the relation of our vascular function findings with arginase activity levels. We propose that arginase activity measurements could be novel marker of vascular dysfunction in diabetes. The effect of the natural amino acid supplements (L-citrulline) on levels of arginase activity in diabetic patients and vascular function will also be studied.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes Diabetic state: HbA1c\>6

Exclusion Criteria:

-
CT-Based Versus Conventional Simulation for Palliative Radiotherapy of Non-Small Cell Lung Cancer

Radiotherapy (RT) treatment to the chest is a standard way of trying to decrease symptoms like cough or shortness of breath. Before any RT can be delivered, it must be planned, either using conventional x-rays ("fluoroscopy") or using computer tomography ("CT") scanning. This study is being done because the investigators do not know which of these two common ways of RT planning is better for balancing both treating the cancer and decreasing side effects.

Standard RT planning will be performed under conventional simulation, followed by CT-simulation (for study purposes only). Retrospectively, 3D treatment fields will be designed using the CT-simulation data, and compared to the actual treatment fields planned using x-rays. Coverage of the tumour volume will be assessed, together with doses, field sizes and beam positions, to determine relative undercoverage of tumour and overcoverage of normal tissue between the two planning methods, if any.

Eligibility Criteria:
Inclusion Criteria:

* Patients with local symptoms secondary to histologically-confirmed non-small cell lung cancer
* Patients who will be receiving palliative-intent external beam radiotherapy
* Patients who are clinically appropriate for conventional radiotherapy planning
* Patients who can provide written informed consent

Exclusion Criteria:

* Patients who cannot provide written informed consent
A Disease Registry Encompassing the Care Of Patients With Multiple Myeloma on Panobinostat

This study aims to describe current treatment patterns in the real-world setting among patients with multiple myeloma who are initiating treatment with (or changing treatment to) panobinostat and explore the associations with baseline patient characteristics, healthcare resource utilization, and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* At least 18 years of age
* Clinical diagnosis of multiple myeloma that meets published diagnostic criteria
* Initiating panobinostat within 60 days of enrollment
* ECOG performance status 0-1
* Availability of documentation from the patient's medical records regarding previous myeloma treatment, response, and duration of response
* Willing and able to complete the PRO questionnaire

Exclusion Criteria:

* Diagnosed with any B-cell malignancy other than myeloma
* Estimated life expectancy \<6 months
* Currently enrolled in any interventional clinical trial at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the registry)
Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease

Chronic Kidney Disease (CKD) induces many metabolic troubles especially for the advanced CKD (stage 3b-5) patients and their prevalence and importance grow with the deterioration of the glomerular filtration rate (GFR). Among them, muscle wasting is common and multifactorial, partially explained by an imbalance between protein catabolism and synthesis. Muscular strength is also affected beyond the reduction of the lean body mass, resulting in profound fatigue.

The present study seeks to quantify the prevalence of low muscular strength production (dynapenia) in a cohort of elderly patients with advanced CKD, through a maximal voluntary contraction (MVC) handgrip test compared to control data available in the literature, matched in term of age and sex. It also aims to investigate the link between the reported fatigue (subjective) and the evolution of the MVC, called critical force (fcrit) during a fatiguing task (objective fatigability).


Eligibility Criteria:
Inclusion Criteria:

* Adults, aged 60 and over
* Social security coverage
* Signed informed consent
* For patient with Chronic Kidney Disease, estimated glomerular filtration rate (eGFR) less than 45ml/min/1.73m2 (Stage 3b) for at least 3 months
* For patient with Chronic Kidney Disease, stable clinical condition (i.e., Creatinine increased by a maximum of 25% in the previous 3 months)
* For control group, 1:1 recruitment with case matching with CDK patients on gender (i.e., male and female) and the presence of diabètes (i.e., presence and absence)
* For control group, blood test with control of renal function available and dated less than 6 months: with eGFR \> 60ml/min/1.73m2 (and control of glucose or glycated hemoglobin for diabetic controls)

Exclusion Criteria:

* Pregnant women
* Under guardianship or minor
* Neuromuscular disease
* Dementia
* Upper limbs history of surgery or pathologies preventing from fitting EMG electrodes or measuring handgrip force
* Life expectancy of less than 3 months estimated by medical judgment
* Programed hospitalization in the previous 3 months
* Participation to another interventional clinical trial
* Acute kidney disease
* On dialysis or expected start of dialysis within next 3 months
Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer

Study hypothesis:

The recurrence rate of HCC patients after radical resection is about 60-70%. This study is based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%.

Abstract:

This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.

Study treatment:

Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other supportive therapies are available in both groups.


Eligibility Criteria:
Inclusion Criteria

* Male or female patients \> 18 years of age.
* Without any prior anti-cancer therapy.
* Patients who have a life expectancy of at least 12 weeks.
* Patients already had radical resection of HCC.
* Definition of radical resection in this study:
* All tumors were moved out, with a clean resection margin.
* Number of tumors \<= 3.
* Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.
* No hepatic hilum lymphnode metastasis.
* No distance metastasis.
* Hepatocellular carcinoma with histological diagnose.
* No major post-operative complication.
* Patients who have an ECOG PS of 0, or 1.
* Cirrhotic status of Child-Pugh class A only.
* The following laboratory parameters:

  * Platelet count \>= 70 x 109/L
  * Hemoglobin \>= 8.5 g/dL
  * Albumin \>= 3.5 g/dL
  * Total bilirubin \<= 25umol/L
  * Alanine transaminase (ALT) and AST \<= 2.5 x upper limit of normal
  * Serum creatinine \<= 1.5 x the upper limit of normal
  * Prothrombin time (PT) \<= 3 seconds above control.
  * Patients who give written informed consent.

Exclusion Criteria

* Previous or concurrent cancer that is distinct in primary site or histology from HCC.
* History of cardiac disease.
* Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0)
* Known history of human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumors including metastatic brain disease.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* History of organ allograft.
* Known or suspected allergy to the investigational agent or any agent given in association with this trial.
* Pregnant or breast-feeding patients.
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.

Excluded therapies and medications, previous and concomitant:

* Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy.
* Antiviral treatment is allowed.
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatment in children and adolescents with moderately to severely active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject who completed the C87035 study (NCT00899678) through Week 62 or assessments when their participation in C87035 was terminated when the study was stopped by UBC
* Subject completed all assessments required for Week 62/Visit 23 at the time of termination
* Subjects maintain stable regimen of concomitant medications for Crohn's Disease (CD) throughout study

Exclusion Criteria:

* Subject who did not complete the C87035 study (Week 62 Visit), was terminated or did not complete all of the Week 62 assessments when their participation from C87035 was terminated when the study was stopped by UCB but did not complete all assessments required for Week 62/Visit 23 at the time of termination
Effect of the Vojta Therapy in Patients Multiple Sclerosis

Multiple sclerosis is the most common disabling neurological disease in young adults. Inflammation, demyelination, neurodegeneration, gliosis and repair processes are involved in its process, which are responsible for the heterogeneity and individual variability in the expression of the disease, the prognosis and the response to treatment. Clinically, MS manifests itself with the following symptoms: sensory focus, motor focus, spasticity, balance disorders, visual disturbances such as loss of vision or double vision or sphincter dysfunction.

The main subtypes of MS are relapsing-remitting, secondary progressive, primary progressive, and progressive relapsing. Clinically, RRMS presents the initial inflammatory phase, characterized by reversible flares with neurological dysfunction, followed by periods of remission. Approximately 40-50% of these patients progress to SPMS, where the disease gradually progresses from intermittent flare-ups to steadily progressive worsening, resulting in permanent disability due to massive axonal loss. PPMS is the most severe subtype, affecting approximately 10% of all cases, and manifesting as progressive degeneration without any remission.

From the field of Physiotherapy, one of the main tools for the treatment of MS is physical exercise. Numerous studies show that exercising is safe and beneficial in people with MS, as long as it is done correctly and supervised by health professionals. Physical exercise is considered an important part of symptomatic and supportive treatment for people with MS, since it induces improvement of physiological functions affected by lack of physical activity and helps to manage some symptoms, such as spasticity, fatigue and lack of balance There are therapies within Physiotherapy that help treat MS such as the Vojta Method and the Bobath Method.

Eligibility Criteria:
Inclusion criteria:

* Persons with MS who have signed the informed consent.
* Persons of both sexes.
* Ages between 20 and 65 years.
* Subjects of both sexes diagnosed with multiple sclerosis on the EDSS (Expanded Disability Status Scale).

Exclusion criteria:

* Persons with multiple sclerosis with EDSS scale score equal to or greater than 7.0.
* Occurrence of a flare during the period of the patient's participation in the study.
* Pregnant women.
* Oncology patients.
* Non-acceptance and non-signing of informed consent.
* Refusal to participate in the study.
* Patients with severe cognitive impairment that does not allow them to understand the development of the study.
* Patients with cardiovascular instability.
* Patients who do not complete at least 75% of the scheduled sessions. Patients who do not present any of the contraindications contemplated for Vojta therapy.
Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved CR following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of Overall Survival and disease free survival between two arms

Eligibility Criteria:
Inclusion Criteria:

1. Age 61 years or more
2. Newly diagnosed AML with \> 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.
3. Absence of central nervous system involvement
4. No contraindications for intensive chemotherapy, defined as:

   1. prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
   2. a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
   3. a Performance Status (PS) score of \> 2;
   4. uncontrolled severe infection.
5. Informed consent.

Exclusion Criteria:

1. Age ≤ 60 years
2. Newly diagnosed AML with \< 30% myeloid marrow blasts
3. Previously treated AML
4. Central nervous system involvement
5. Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
6. A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
7. A PS score of \> 2;
8. Uncontrolled severe infection.
Clinical Dementia Rating Medical Record

The assessment of severity of the cognitive and functional impairment is essential in the follow-up of patients with neurocognitive disorders and in the assessment of the effectiveness of therapeutics. However, the systematic assessment of the Clinical Dementia Rating (CDR) scale is limited due to the time required to complete it (approximately 45 min to 1 hour). Insofar as studies have shown correspondences between the CDR and scales measuring cognitive and neuropsychological performance, and as part of memory consultations, several functional and neuropsychological scales are systematically administered, we wish to conduct a study validating the feasibility of the CDR based on information already available in the patient's file compared to the evaluation of the CDR by the usual method (face-to-face interview in consultation).

This study should highlight the feasibility of scoring the CDR-SB from the files of patients in memory consultation, first in terms of reliability of the scores obtained compared to the standard evaluation, and on the other hand in terms of organization and duration of administration.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has CDR assessment in face-to-face interview during the memory consultation,
* Patient with an isolated cognitive complaint or a neurocognitive disorder
* Patient included in the MEMORA cohort

Exclusion Criteria:

* Patient or caregiver who does not wish their data to be used for research purposes within the framework of the MEMORA cohort.
Nasal Decolonization for Orthopedic Trauma Patients

Many surgical site infections are caused by bacteria that is transferred from a patient's nose to their open surgical wound. Some small studies have shown that putting povidone-iodine in a patient's nose reduces this risk. This study aims to evaluate the real-world effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University of Iowa.

Aim 1. Evaluate the real-world effectiveness of intranasal povidone-iodine (PROFEND®) in reducing Staphylococcus aureus colonization and surgical site infections (SSIs).

Aim 1a. Evaluate patients after surgery to determine S. aureus colonization and to survey patients on tolerability of intranasal povidone-iodine decolonization. The intranasal povidone-iodine swab will be administered to the patient's nares around one hour prior to the first surgical incision. It will then be re-applied around 12 hours later, for a total of two applications within a 24 hour period.

During the same visit at 24 hours after surgery, patients will also be administered a questionnaire to determine the tolerability of intranasal povidone-iodine decolonization. Questions will be asked about adverse events (e.g., itching, irritation) and how intranasal povidone-iodine felt (very pleasant, pleasant, neutral, unpleasant, very unpleasant).

Based on the data obtained from this aim, we will summarize the patient acceptance of intranasal povidone-iodine.

Aim 1b. Compare the rates of SSI among orthopaedic trauma surgery patients who received intranasal povidone-iodine to similar patients who received orthopedic trauma surgery before intranasal povidone-iodine implementation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing operative fixation of lower extremity fractures at the University of Iowa during the study period.

Exclusion Criteria:

* Patients unable to provide informed consent due to head trauma or dementia.
Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.


Eligibility Criteria:
Inclusion Criteria:

* Infant 0-28 days of life with indication of large or medium surgical procedure (definition according to the American College of Cardiology, American Heart Association - 2002)

Exclusion Criteria:

* Death or hospital discharge until 72 hours after surgical procedure
* New surgery until 72 hours after the studied surgical procedure
* Proved bacterial infection before surgery
* Ambiguous genitalia
* Chromosomal syndromes
Validation of AI Lumbar Spine Anatomy Measureing Function

Spinal degeneration and its associated clinical diseases are common ailments in aging societies. With the advent of a super-aging society, the importance of assistive technologies for spinal image interpretation is increasingly significant to enhance care efficiency and reduce medical personnel expenditure. Recently, due to the rapid development of artificial intelligence (AI) algorithm, AI-based computer-assisted detection (CADe) devices gradiually become a convenient method for spinal anatomy measurement. However, the accuracy of these devices has not been fully established. This study aims to validate the performance of RadiSpine (an application program) in spinal anatomy segmentation and measurement.


Eligibility Criteria:
Inclusion Criteria:

The subjects should be aged 20 or older and younger than 75, with an equal gender distribution of 50% male and 50% female. From this group, 150 subjects with reasonable datavalues will be selected, with a requirement that at least 30% of them are male and at least 30% are female.

Exclusion Criteria:

1. With history of spinal surgery
2. Spinal trauma
3. Spinal osteoporosis
4. Spinal metastasis or infection