cyrilzakka/clinical-trials huggingface dataset:
A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML

patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be treated with halved dose for 12 months, and then stop for 12 months.

1.Patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years.

2。During the TKI reduction phase, the peripheral blood BCR/ABLIS was detected by Q-PCR every two months and continuously monitored for 12 months. In the TFR period, the peripheral blood BCR/ABLIS was detected once a month for the first 6 months; the peripheral blood BCR/ABLIS was detected once every two months for the next 6 months; after that, the peripheral blood BCR/ABLIS was detected once every three months.

3.If the patients detected molecular recurrence (loss of MMR, BCR/ABL IS\>0.1%),the original dose of 2G-TKI should be administered

Eligibility Criteria:
Inclusion Criteria:

1. Male or female over 18 years
2. Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP
3. Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years
4. Patients have maintained MMR (BCR/ABL IS\<0.1% or more) at least 2 years
5. in the past 24 months, at least three times recent molecular reactions have confirmed MMR
6. Patients have signed the informed consent

Exclusion Criteria:

1. patients with the presence or history of T315I mutation
2. patients with the presence of rare unquantifiable atypical transcripts
3. Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease
4. patients have history of accelerated or blast phase, or suspected blast disease
5. patients have received allogeneic hematopoietic stem cell transplantation
6. patients have severe abnormal liver and kidney function (ALT \> upper limit of normal, AST \> 3 times normal upper line, glomerular filtration rate \< 50%)
7. patients combined with other tumors or a history of other malignancies ECOG score\>3
8. Two-line abnormality in the patient's blood routine examination
9. women is pregnant or nursing
Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters

Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters?


Eligibility Criteria:
Inclusion Criteria:

* untreated Proliferative diabetic retinopathy

Exclusion Criteria:

* Previous photocoagulation
Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial

We will perform this single-center pilot trial to determine if the intraoperative urethral perfusion index is higher in patients assigned to maintaining postinduction baseline urethral perfusion index than in patients assigned to routine care (with blinded urethral perfusion index monitoring). As pre-planned substudies, we will also assess the agreement between a) urethral perfusion index-derived pulse rate and heart rate measured with an electrocardiogram and b) between the urethral perfusion index and the peripheral perfusion index.


Eligibility Criteria:
Inclusion Criteria:

* at least 45 years old
* scheduled for elective major abdominal surgery (involving visceral organs with an expected duration of at least 120 minutes)
* indication for an arterial catheter
* indication for an urinary catheter

Exclusion Criteria:

* Pregnancy
* Planned surgery: nephrectomy, liver or kidney transplantation surgery
* Patients who previously had surgery on the urethra or bladder
* Patients without clinical indication for continuous blood pressure monitoring with an intraarterial catheter
Split-Thickness Skin Graft Donor Site Wound Healing Study

The purpose of this research study is to discover whether instruments widely used in skin research can be used to measure wound healing in split thickness skin graft donor sites and whether these instruments can detect differences in healing when two different dressing products are used.

Currently there is no standard treatment to promote wound healing for split thickness skin graft donor sites and healing is determined based on clinical observation of the graft donor site and clinical judgement. Here we propose to use two instruments commonly used in skin research to measure wound healing. This study will validate the use of these two instruments, one that measures transepidermal water loss and the other that measures skin pigmentation to determine healing. To further validate the use of these instruments we will determine if these instruments can detect differences between two different wound dressing products that have been previously reported to heal skin graft donor sites at different rates.

Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years of age and over who have a split-thickness skin graft donor site.

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals who do not have a split thickness skin graft donor site.
Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.


Eligibility Criteria:
Inclusion criteria:

* Singleton pregnancy
* Cephalic presentation
* Reassuring fetal heart rate pattern
* Intact membranes
* Bishop score less than 6

Exclusion criteria

* Severe preeclampsia
* Prematurity ( \< 37 weeks gestation dated by first trimester ultrasound)
* Previous cesarean section or previous uterine surgery
* Intrauterine growth restriction
* Premature rupture of membranes
* Maternal colonization with Streptococcus Agalactiae at any time during pregnancy
* Multifetal pregnancy
* Breech presentation
* Stillbirth
* Any contraindication for vaginal delivery
Bioavailability of the Polyphenols Contained in a Red Grape Extract-based Drink and Their Metabolic Effects

Randomized placebo-controlled crossover study during which participants undergo two different experimental days. The participants consume a red grape based- drink (polyphenols: 300 mg/100 ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml). After 3 hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>25 and \<35 kg/m2
* Total cholesterol \<250 mg/dl
* Triglyceride \< 200 mg/dl.
* Fasting glucose \<100 mg/dl

Exclusion Criteria:

* Cardiovascular events (IMA or stroke) in the 6 months prior to the study
* Kidney or liver failure
* Anemia (Hb \<12 g/dl)
* Any chronic disease
* Intense physical activity
* Dietary supplements
Biology and Genetics of Smouldering Myeloma

Observational clinical trial recruiting Smouldering Myeloma patients (SMM) or potential SMM patients. Study involves collecting blood and bone marrow samples to determine the features of the tumour genome and BM microenvironment, including immune dysfunction that are key drivers of progression from precursor conditions (MGUS and SMM) to MM.

MM is a cancer of plasma cells characterised by bone marrow infiltration by malignant plasma cells, kidney impairment, bone pain and elevated calcium levels1. There are approximately 5,500 new cases diagnosed annually in the UK, with a median survival of 5 years2. Significantly, despite improvements in conventional treatment options, MM remains incurable; patients inevitably relapse and will eventually die from their disease.3 MM is always preceded by defined precursor conditions, termed MGUS, and SMM. However, only 7% of MGUS patients and 50% of SMM patients progress to MM over a 5-year period4. In the UK, current practice favours commencing treatment only when there is evidence of end organ damage as the overall benefit of initiating early therapy is uncertain.

There is an increasing understanding that progression is determined by evolving changes in the tumour genome5 and changes in the immune microenvironment which support tumour growth, leading to progressively dysfunctional anti-tumour immunity. This project correlates changes in the tumour genome and immune microenvironment in individual patients with tumour progression and also aims to compare characteristics in patients with good and poor clinical outcomes with the objective of defining the drivers for disease progression. Furthermore, we aim to explore the use of blood samples to monitor tumour dynamics and immune function. Finally, we will also study the spatial distribution of immune cells and tumour cells in the bone marrow.

Clinical impact: A deeper understanding of the pathogenesis of MM will allow us to risk stratify patients with MGUS and SMM, and manage them accordingly as well as identifying subgroups of patients with MM who require different types of therapies, eg. more intensive multi-drug approaches for patients with adverse risk genetics.

Eligibility Criteria:
Inclusion Criteria:

* Any individual with a confirmed or suspected diagnosis of MGUS, SMM, or MM.

Exclusion Criteria:

* Patients under the age of 18
* Patients with active symptomatic myeloma at diagnosis
* Patients with no evidence of MGUS, sMM or MM
* Patients with rapidly rising paraprotein or serum free light chains suggestive of progressive disease at time of diagnosis or inclusion into study
Ultrasound Guided Erector Spinae Plane Block in Breast Surgery

hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope

two groups will be enrolled the control group will receive local anaethetic only and the spread will be observed by floroscope. the seconed group, hyaloronidase will be added to local anaesthetics and the spread will be studied under image.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. ASA I, II, III
3. Elective surgery

Exclusion Criteria:

1. Patient refusal
2. Infection at injection site
3. Allergy to the given drugs
Evaluation of Three Types of Dressings After Hip Surgery

The purpose of this study is to determine if one of the new types of dressings (MEPORE PRO and/or MEPILEX BORDER ) will reduce the blister rate compared to the currently used HYPAFIX.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female 45 years old or older
* Hip surgery at Hopital de l'Enfant-Jesus between 02/2009 and 01/2010 (THR,rTHR, DHS, screw fixation, hemiarthroplasty, resurfacing)
* Signed consent form

Exclusion Criteria:

* Allergy to dressing
* Polytrauma / high energy trauma
* Wound at the surgical site prior to surgery
* Neurological deficit of operated side (hemiplegia, etc.)
* Bilateral fracture
LevineConservationModelandColorectalPatients

Colorectal cancer is one of the most common types of cancer in the world, ranking 3rd among cancers that cause death in men and women. In patients diagnosed with colorectal cancer, chemotherapy treatment is planned to prolong survival as in all other cancer patients. Among the side effects of chemotherapy treatment, it is known that fatigue develops between 50-90%, which is mild for one week in 45% of patients and persists for two weeks in 33%. In the literature, the incidence of chemotherapy-induced peripheral neuropathy is reported to be between 10-100% depending on the type and dose of the drug taken. Alejandro et al. (2013) reported that the incidence of oxaliplatin-related peripheral neuropathy was 84%, which was acute in 74% of patients and permanent in 48%. In addition, anxiety disorders are among the common mental symptoms in cancer patients and their prevalence has been reported to be 10-30%.

In this study, it is aimed to reveal the effect of nursing interventions based on Levine's Conservation Model on fatigue, peripheral neuropathy and anxiety levels in colorectal cancer patients receiving chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-75
* Diagnosed with primary and new colorectal cancer (Stage II and III),
* The decision to start the FOLFOX treatment protocol has been taken,
* Having a smartphone,
* Being literate,
* Ability to speak and understand Turkish,
* Open to communication and cooperation.

Exclusion Criteria:

* History of neuropathy or diabetes,
* History of hypothyroidism, renal failure,
* Hearing, speech and vision problems,
* Receiving radiotherapy or immunotherapy,
* Psychiatric diagnosis or ongoing treatment.
Aerobic Training and Diet on the Immune System in Postmastectomy Patients Receiving Chemotherapy

The purpose of the study was to investigate the impact of aerobic exercise combined with diet protocol on the immune system in post-mastectomy patients receiving chemotherapy.

Chemotherapy reduces circulating lymphocytes levels, which affect lymphocytes in breast cancer patients during the therapy itself or up to 3 months after the last chemotherapy cycle, so the study is developed to investigate the impact of aerobic exercise combined with diet protocol on the immune system in post-mastectomy patients receiving chemotherapy. Sixty post-mastectomy women were receiving chemotherapy and aged from 40-60 years selected from the outpatient clinic of the oncology department in the New Cairo hospital in the Police Academy. They will be assigned randomly into three equal groups, the aerobic exercises and diet protocol group, the diet protocol group, and the aerobic exercises group. The immunological markers; total lymphocyte count (TLC), neutrophil-to-lymphocyte ratio(NLR), and platelet-to-lymphocyte ratio(PLR) will be measured at baseline and after twelve weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female post-mastectomy patients.
* Age range is between 40-60 years old.
* All patients will enter the study after having their informed consent.
* All patients are undergoing chemotherapy treatment with AC protocol (Adriamycin with endoxan) for four cycles (every 21 days ).
* All patients have finished the first stage of chemotherapy treatment

Exclusion Criteria:

* Cardiac disease patients.
* Uncontrolled hypertension patients.
* Patients with thyroid disease.
* Patients with lymphatic complications.
Real-time Early Detection of Nephrotoxicity by Urinary Biomarker Analysis With SeroFlow Technology

The study aims to perform real-time validation of the RenaFAST kit (a point-of-care test kit that quantifies three urinary proteins) in predicting acute kidney injury(AKI) among patients prescribed drug therapies of nephrotoxic potential. Based on the type and duration of drug therapy, a maximum of 5 time-point urine samples will be collected from consenting patients and a real-time biomarker analysis will be conducted using the RenaFAST kits.

All eligible patients who fulfill the inclusion and exclusion criteria will be approached for consent. The patients with the highest AKI risk (with all 3 urine biomarkers, Clusterin, monocyte chemoattractant protein-1 (MCP1), and Beta-2 microglobulin (ß2MG), above prediction threshold set by the study) will be identified. The nephrology consultants within the research team will perform a medical chart and physical review(where required) of these patients, noting potential actions to be taken in data collection forms. This will help in evaluating if indeed there are perceived interventions that could potentially be delivered in response to early prediction of AKI.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive a projected ≥7 days of therapy of antimicrobials including aminoglycosides (i.e., gentamicin or amikacin), vancomycin, polymyxin, amphotericin and foscarnet.
* Patients who receive a projected ≥7 days of Calcineurin inhibitors (cyclosporin, tacrolimus)
* Patients who receive a projected ≥7 days of anti-virals (Cidofovir and Ganciclovir)
* Patients who receive Anti-cancer drugs (Chemotherapy such as cisplatin, Ifosfamide, Methotrexate, Pemetrexed) or
* Patients who receive Anti-cancer drugs (Immunotherapy such as immune checkpoint inhibitors as well as types of VGEF inhibitors that are associated with acute kidney injury)

Exclusion Criteria:

* Patients with AKI prior to therapy initiation.
* Patients with baseline eGFR \< 15 mL/min/1.73m2 (stage 5 chronic kidney disease)
* Patients admitted to intensive care unit at study baseline, as critical illness is a natural confounder to AKI
* Females who are pregnant
* Immediate post-kidney transplant recipients (initial 3 months following transplant).
Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)

To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (H\&N) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old)
* H\&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation.

Exclusion Criteria:

* Patient has been evaluated by an audiologist within the past 12 months
* Use of a hearing aid
* Received a cochlear implant
* Cannot complete simple forms in English
Effectiveness of Mat Pilates and Aerobic Training on Fatigue and Depression

The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females

The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females. In this study, the researcher will also compare the effects of Mat Pilates and Aerobic training on fatigue and depression levels among postpartum females.

Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery
* Singleton pregnancy

Exclusion Criteria:

* Caesarean delivery
* Vacuum-assisted delivery
* Sexually Transmitted Diseases
* Menopause females
* Any condition regarding Obstetrics \& Gynecology
* Any physical or mental illness
CRP and PCT as Predictors of Sepsis Cause

The aim of this retrospective study is to determine the predictive role of serum level of procalcitonin (PCT) and c-reactive protein (CRP) in determining the causative agent of sepsis in surgical intensive care unit (ICU) patients. The main question it aims to answer is: what serum level of PCT and CRP is predictive of gram+ and gram- sepsis in patients with positive blood cultures in the surgical ICU. The study will be retrospective and will include all patients with positive blood cultures who were hospitalized in the surgical ICU of University Hospital Osijek in the period from January 2019 to May 2022.

PCT is a good biochemical marker of severe bacterial infection. Numerous studies have confirmed its role in the diagnosis of sepsis, especially sepsis with positive blood cultures. This retrospective study will include septic patients who were hospitalised in the surgical ICU between January 2019 and May 2022, and who had at least one positive blood culture. The values of PCT, CRP, white blood cells count and platelets count, as well as the overall outcome of the treatment, will be recorded for the patients included in the research. The aim of the research is to examine the differences in the level of PCT, CRP, white blood cells count and platelets count between patients with gram+ and gram- blood cultures. Also, the predictive value of PCT and CRP in differentiating gram+ from gram- hem will be examined.

Eligibility Criteria:
Inclusion Criteria:

* hospitalisation in surgical ICU
* diagnosis of sepsis
* gram+ blood culture isolate
* gram- blood culture isolate

Exclusion Criteria:

* younger of 18 years old
Training Intensity After Coronary Bypass Grafting

The purpose of this study is to investigate the effect of high and moderate intensity exercise training after coronary bypass surgery. The subjects are randomised to training at either 60-70% or 85-95% of their maximal capacity daily for four weeks. Primary outcome measure is change in maximal aerobic capacity, measured as change in maximal oxygen consumption, after the training period. Secondary outcome measures are change in quality of life, heart rate variability, ultrasound measures of the heart and blood variables, including endothelian markers.

The exercise part of cardiac rehabilitation today is often composed of low to moderate intensity training. Several studies have found interval training with high intensity to be more effective in improving physical capacity in healthy subjects and also in different patient populations. We therefore wish to compare high intensity interval training with moderate intensity training in patients operated with coronary bypass surgery. Maximal oxygen consumption is shown to be the best indicator of how many years you life, both in healthy persons and in cardiac patients.

The subjects in this study is attending a four week rehabilitation program at an residential institution in Norway. They are randomised to do either a moderate or a high intensity aerobic training session each day.

The hypothesis in advance, was that high intensity interval training lead to a greater improvement in maximal oxygen consumption than training with moderate intensity. We also hypothesised that there would be no difference between the two groups after 6 months, since then the patients had to administer their own exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Coronary Artery Grafting (4-12 weeks ago)

Exclusion Criteria:

* Not able to exercise on a treadmill
* Left ventricle ejection fraction \< 30%
* hemodynamic significant valve deficit (\> NYHA classification II)
A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma

This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-70 years of age;
* glioblastoma, confirmed histologically;
* no previous chemotherapy or radiotherapy for glioblastoma;
* non-methylated MGMT promoter in the tumor.

Exclusion Criteria:

* prior systemic treatment for glioblastoma multiforme;
* prior treatment with Avastin;
* significant cardiovascular disease;
* other active malignant disease.