cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer

RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.

PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.

OBJECTIVES:

Primary

* Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.

Secondary

* Determine the pharmacokinetics of oxaliplatin in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity.

Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of gastrointestinal cancer
* Receiving or planning to receive 8 months of oxaliplatin-based chemotherapy
* No pre-existing neuropathy
* No CNS disease or cerebral metastases

PATIENT CHARACTERISTICS:

* WHO 0-1
* Life expectancy ≥ 12 weeks
* No biliary or gastro-duodenal obstruction
* No familial, social, geographical, or psychological condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No other concurrent drug or agent that is potentially neurotoxic
Magnetic Resonance Imaging (MRI) of Brain Iron in Neurodegenerative Disease

Neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis are recognized as a major health concern at the present time. There is information in magnetic resonance imaging (MRI) studies regarding the role of brain iron in normal brain aging that may be enhanced with the use of better scanning equipment and procedures, and by correlating this information with clinical data. This research study aims to develop and evaluate a number of techniques that can potentially improve the effectiveness of three tesla (3T) magnetic resonance imaging of neurodegenerative brain disorders.

Eligibility: A healthy person without memory complaints or someone with neurodegenerative disease. However, the person should not have metal in the body (ie, pacemaker, implants, shrapnel, etc.), should not be pregnant, and should not have claustrophobic anxieties.

Study Procedures: During a regular office visit, a neurologist will perform a routine physical and neurological examination, including your medical and family history, to determine your eligibility for this study. You will then be scheduled for a series of neuropsychological tests, which take between 1 to 1.5 hours, and an MRI scan, which takes approximately 1 hour to complete. This is a longitudinal study and you may be asked to repeat these procedures approximately every six months for the duration of this 2 year project.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Healthy person without memory complaints OR person diagnosed with a neurodegenerative disease (ie, Alzheimer's disease, Parkinson's disease, multiple sclerosis)

Exclusion Criteria:

* MR contraindication such as metal in body (ie, pacemaker, implant, shrapnel, etc.)
* Pregnant
* Claustrophobic anxieties
Clinical Study of Stent Versus Direct Atherectomy to Treat Iliac Artery Occlusive Diseases

This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease.

This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease

Eligibility Criteria:
Inclusion Criteria:

1. The patients have non thrombotic arteriosclerosis obliterans of the common iliac or external iliac arteries
2. Clinical diagnosis of stenosis or occlusive disease
3. The patients have unobstructed distal outflow tract
4. Receiving surgical treatment at the same time

Exclusion Criteria:

1. The patients who have previously implanted stent(s) or stent graft(s) in target leg
2. Life expectancy less than 12 months
3. Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
4. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days
5. Receiving dialysis or immunosuppressant therapy
6. Recent stroke within past 90 days
7. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed
8. Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
9. Serum creatinine level \>/= 2.5 mg/dl at time of screening visit
10. Known or suspected active infection at the time of the procedure
11. Bleeding diathesis
12. Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
13. Patients are known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.
14. Patients are currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.
Case Management Dyad

The overall goal of this study is to test whether dyadic and focused case management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.

The purpose of this research is to test the impact of dyadic, focused case management on financial well-being, access to food, linkage to and retention in care outcomes for individuals living with or vulnerable to HIV. The study population is men who have sex with men (MSM) or same-sex attraction, gender-diverse persons, and cis-gender women living with or at increased vulnerability to HIV.

The study team will be testing the hypotheses that dyadic case management that is focused on financial wellness, will have better outcomes for folks living with or vulnerable to HIV. Analyses will be used to assess the efficacy of the intervention as an emerging practice.

Eligibility Criteria:
Inclusion Criteria:

* Cis-gender men who have had attraction or sexual activity with a male partner in the past 12 months
* Cis-gender women who are living with HIV or vulnerable to HIV (prescribed PrEP or previous sexually transmitted infection (STI) diagnosis)
* Gender-diverse persons
* Gap in HIV or PrEP care access in the past 24 months, defined as a gap greater than 6 months or detectable viral load at least one time in the past 24 months
* Self-reported financial or food insecurity

Exclusion Criteria:

* Cis-gender men without attraction or sexual activity with a male partner in the past 12 months
* Cis-gender women who are not living with or vulnerable to HIV (prescribed PrEP or previous STI diagnosis)
Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated RYGB performed minimum 3 months prior to the study.
* Fasting glucose \< 7,0 mM, HbA1c \< 48 mmol/mol 3 months after RYGB

Exclusion Criteria:

* Fasting plasma glucose \> 7,0 mM, HbA1c \> 48 mmol/mol 3 months after RYGB
* Dysregulated thyroid diseases, use of antithyroid treatment.
* Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
* Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake)
* Cholecystectomy.
Expiratory Muscle Strength Training (EMST) in Neuromuscular Disorders

The purpose of this study is to investigate the impact of expiratory muscle strength training (EMST) on the swallowing, breathing, oral intake, quality of life and cough function of people with oculopharyngeal muscular dystrophy (OPMD).

Outline:

Twenty participants with OPMD, with dysphagia, will be recruited from Neuromuscular clinics within Calgary. The investigators will enrol patients in a parallel group, sham-controlled, randomized clinical trial, with 10 participants in each group (active EMST and sham EMST).

Participants will have baseline measurements of: (i) global swallowing function via modified barium swallow study, (ii) maximum expiratory pressure, (iii) voluntary cough spirometry, (iv) forced vital capacity, (v) functional oral intake, (vi) patient report of self-perceived swallowing impairment (EAT-10 Questionnaire), and (vii) biomarker analyses.

Participants will undergo 5-weeks of EMST (active or sham). All baseline measurements will be repeated after 5-weeks of EMST and 10-weeks post-EMST to measure durability of effect.

Outcomes:

The end-goal of the current research is to obtain preliminary data for the benefit of EMST in a new study population, and direct future studies that may provide evidence for a new standard of care in treating neuromuscular diagnoses.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of oculopharyngeal muscular dystrophy (OPMD)
* 18 years of age or older
* Must be capable of providing informed consent
* Must be able to undergo respiratory function testing and swallowing studies
* Must have a forced vital capacity (FVC) greater than 60%
* A score of 3 or greater on the Eating Assessment Tool-10 (EAT-10; self-administered, symptom-specific outcome instrument for dysphagia. A score of 3 or greater indicates increased stress around eating)
* A score of 26 or greater on the Montreal Cognitive Assessment (MoCA; 30-point screening assessment used for detecting cognitive impairment. A score of 26 or greater is considered to be within functional limits.)

Exclusion Criteria:

* Severe coronary artery disease
* Acute myocardial infarction
* Moderate to severe hypovolemia
* Acute neurological events
* Unstable cardiac status
* Recent hernia
* Severe chronic obstructive pulmonary disease (COPD)
* Uncontrolled reflux issues
* Women who are pregnant, or who suspect they may be pregnant
* Cognitive impairment that would prevent comprehension of instructions and adherence to intervention guidelines (a score of less than 26 points on the MoCA)
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"

The purpose of this survey is to examine the effect on quality of life (QOL) improvement and convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a luteinizing hormone-releasing hormone analog (LH-RHa) 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice. Influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit was also evaluated.

This survey was designed to examine the effect on QOL improvement and convenience of switching to leuprorelin acetate 3 month depot 11.25 mg injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a LH-RHa 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice, as well as to evaluate the influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit .

For adults, leuprorelin acetate SR 11.25 mg injection kit (Leuplin SR 11.25 mg Injection Kit) is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal breast cancer participants who meet all the following criteria are to be enrolled in the surveillance:

  1. Participants who received 4 weeks of treatment with a repository LH-RHa preparation within 1 week prior to administration of Leuplin SR 11.25 mg Injection Kit.
  2. Participants receiving Leuplin SR 11.25 mg Injection Kit as adjuvant therapy.
  3. Participants with performance status grade of 0 or 1.
  4. Participants who answered all of the questions on the "QOL check sheet (I)" at the start (Week 0) of treatment with Leuplin SR 11.25 mg Injection Kit.

Exclusion Criteria:

* Participants who meet any of the following criteria are to be excluded from the surveillance:

  1. Participants with a history of hypersensitivity to ingredient(s) in Leuplin SR 11.25 mg Injection Kit or synthetic derivatives of luteinizing hormone-releasing hormone (LH-RH) or LH-RH.
  2. Pregnant women, possibly pregnant women, and nursing mothers.
  3. Participants with advanced (T4 or M1 according to the TNM classification \[General Rules for Clinical and Pathological Recording of Breast Cancer: 16th edition\]) or recurrent breast cancer.
Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)

The present study aims to evaluate the impact of a weaning strategy based on identification of early signs of respiratory distress by lung ultrasound and the consequent implementation of a "clinical optimization" protocol as compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated \>48h

Exclusion Criteria:

* Moderate/Severe COPD
* Spinal cord lesion
* Neuromuscular disease (previous)
* Lung fibrosis
* Tracheostomy
* Heart failure (EF\<50%)
* Lung/pleural cancer
* inadequate "window"for LUS
DDI Between BI Empagliflozin (10773) and Verapamil

Relative bioavailability of BI 10773 given alone and together with verapamil


Eligibility Criteria:
Inclusion criteria:

healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions
Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
* HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
* BMI (Body Mass Index) maximum 40 kg/m2

Exclusion Criteria:

* Metformin contraindications according to local practice
* Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial
Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth

This study was conducted to evaluate and compare the effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI). Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change.

This study was a parallel, two-group, double-blinded, randomized clinical trial. The proposal and consents were approved by the Research Ethics Committee. (REC) approval (P-PD-14-14). The Helsinki Declaration's guiding principles were followed when conducting the study. The Comprehensive Standards of Reporting Trials Statement (CONSORT) checklist's structure is followed in the study's presentation. The study was carried out at the Outpatient Clinic of the Removable Prosthodontic Department within the Faculty of Dental Medicine for Girls at Al-Azhar University.

In this study, fifty patients were initially evaluated. After conducting clinical and radiographic assessments, twenty patients who satisfied the inclusion criteria were selected in accordance with the sample size calculation. Each patient received an explanation of every procedure, and informed consent was obtained. These twenty individuals were subsequently divided randomly into two distinct groups (ten in each):

Group I: Ten patients received polyoxymethylene (acetal resin) partial dentures designed and fabricated using CAD/CAM technology. Group II: Ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.

All patients were evaluated clinically and radiographically. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI) at denture insertion, three months later and six months later. Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change at the time of denture placement, after three months, and after six months.

Eligibility Criteria:
Inclusion Criteria:

* Every subject should be free of any systemic diseases that might influence the results of the research.
* Patient's residual ridges should be covered with healthy mucosa.
* Their salivary flow and viscosity for all within normal limits.
* The patients are cooperative and ready to be called back as necessary.
* had a Class I Angle's ridge relation

Exclusion Criteria:

* Alcoholic or smokers' patients.
* Patients with xerostomia or excessive salivation.
* Patients with parafunctional habits.
* Patients with ulcerated or inflamed mucosa.
A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

A total balanced fluid replacement strategy is a promising concept for correcting hypovolemia. The effects of a balanced fluid management including a new balanced hydroxyethylstarch (HES) in elderly cardiac surgery patients will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>80 years

Exclusion Criteria:

* Chronic kidney dysfunction requiring dialysis
* Myocardial infarction within the previous 3 weeks
* Liver insufficiency
An Algorithm for Predicting Blood Loss and Transfusion Risk in Fast Track Total Hip Arthroplasty

Aim of these study is to create an algorithm, using data from patients that undergoing total hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.

Two different cohorts of patients undergoing total hip arthroplasty will be analyzed to obtain data about hemoglobin trends. The first group will be used to obtain the algorithm, the second one to validate results of the first group, determining sensitivity and specificity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hip arthritis

Exclusion Criteria:

* ASA 4 - 5
* Active treatment with warfarin
* Coagulation disorders
Clinical Significance of Assesment of Serum miRNA-30a in Childhood Nephrotic Syndrome

Childhood nephrotic syndrome is the most frequent glomerular disease that presents during childhood,primarily owing to a disturbed immune function.This disease is characterized by alterations in selectivity at the glomerular capillary wall that lead to an inability to restrict the urinary loss of protein.

Childhood nephrotic syndrome is the most frequent glomerular disease that presents during childhood,primarily owing to a disturbed immune function.This disease is characterized by alterations in selectivity at the glomerular capillary wall that lead to an inability to restrict the urinary loss of protein.The syndrome is characterized by the tetrad of nephrotic range proteinuria (\>40 mg/m2/hour), hypoalbuminemia (\<2.5 g/dl), generalized edema, and hyperlipidemia. It can be congenital or acquired.Currently,serum albumin, lipids, and proteinuria are the common diagnostic markers of childhood NS, but these markers may not accurately predict the outcome of individual patients because of the heterogeneity of the disease. Renal biopsy is more precise for establishing prognosis of renal outcome, but it has potential complications. Repeated monitoring is technically difficult, particularly for children. Therefore, there is still an urgent need to identify new non invasive diagnostic and prognostic biomarkers and new therapeutic targets for this disease.miRNA-30a expression in the serum of patients with nephrotic syndrome and analyzed the correlation between miRNA with largest over expression level and clinical features compared with healthy subjects.miRNA-30a expression level in drug resistant nephrotic syndrome patients was obviously higher than the drug sensitive patients and up-regulated most significantly in mesangial proliferative glomerulonephritis among different pathological types, while it decreased most obviously in glomerular lesions. miRNA-30a could be treated as the molecular marker in predict drug resistance, pathological type of nephrotic syndrome and follow up of resistant cases.

Eligibility Criteria:
Inclusion Criteria:

-Nephrotic children aged from 2 to 18 that admitted to Pediatric Hospital.

Exclusion Criteria:

* Congenital or infantile nephrotic syndrome
* Other kidney diseases
* Abnormal kidney function test
Gender-related Differences in Chinese Patients With AAD

Few data exist on gender-related differences in clinical features, management, and outcomes of acute aortic dissection (AAD) in China. Accordingly, we enrolled 2015 patients with AAD from 15 hospitals in China to access differences in clinical features, management and outcomes between men and women. in this study, our results provided new insights into gender-related differences in clinical features, management and outcomes in the Chinese patients with AAD. Important implications may be helpful to improve diagnostic and therapeutic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute aortic dissection

Exclusion Criteria:

* Simple dilated aneurysm and penetrating atherosclerotic ulcer
Design and Application of Vitamin D Films for Burn Healing After Cauterizing Surgery

One of this method's drawbacks is the healing of cauterized cartilage after processing. It was reported that the healing is so slow as no dosage form can reach this place in addition to the scares produced from healing is very irritable to the patient.

From this point, the investigators start searching for a solution to this problem and reach the repositioning of Vitamin D3 (calciferol) as an active ingredient for the rapidity and efficacy of burn healing.

The dosage form of choice that was reported before for intranasal application by the same team of investigators and gave good results. the intranasal films were proved for its convince, simplicity, efficacy, and compliance to patients.


Eligibility Criteria:
Inclusion Criteria:

* patients complain of nasal obstruction
* do not respond to medications
* treatment need surgery
* patients accept following up in a timely manner for 3 weeks

Exclusion Criteria:

* no nasal polyps,
* have problems with the surgical procedures
* have allergy with any of the treatment components (vitamin D3 or chitosan)
* don't follow instructions or miss the following up