cyrilzakka/clinical-trials huggingface dataset:
PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL

The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.

Leukemia is the leading cause of cancer in children in Europe and the U.S. with an annual incidence of appoximately 3,5 cases per 100.000 children 0-14,9 years.

Although the rate of cure has increased significantly, treatment is still unsuccesfull in appoximately 20 % of the patients. There is great variation in the how the individual patient processes the different chemotherapeutic agents. Furthermore there is a signifikant difference regarding the severity of sideeffects and toxicities. So far it has not been possible to predict which patients are at speciel risk of developing toxicities.

Acute pancreatitis is a severe sideffect/toxicity when treating ALL. Patients are at risk of developing pancreatitis, because of the drug Asparaginase. The condition can not be prevented and in severe cases, e.g. hemorhaggic pancreatitis the only solution is to discontinue the drug, in spite of the fact that Asparaginase is on of the most important drugs when treating leukemia.

In the current study we will map the occurence of pancreatitis, hepatotoxicity and hyperlipidemia among approximately 1000 children and adolescents with leukemia. This study is unique because it is the largest study of its kind regarding Asparaginase associated pancreatitis. Among other things it will involve extensive genetic analysis.

We believe that this study will improve the possibilities, not only, for individualized treatmentVi mener at dette studie vil forbedre mulighederne for individ orienteret behandling, but also for other studies like this regarding other toxicities in patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* IR- or SR- type ALL, and treatment with Peg-Asparaginase

Exclusion Criteria:

* HR ALL, and changing subgroup from IR or SR to HR
Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer

This is a prospective, single-arm, open-label，single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.

Eligible patients receive AK104 (10mg/kg, iv, Q3W) combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis :90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycles. Patients assessed by Multi-Disciplinary Treatment (MDT) to meet the criteria for surgical resection undergo gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
2. Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT.
3. Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma
4. At least one measurable tumor lesion per RECIST v1.1;
5. Major organ functions are adequate;
6. Expected survival is ≥ 3 months;
7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1;

Exclusion Criteria:

1. Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma;
2. Previously received immune checkpoint inhibitors, including but not limited to programmed death 1 (PD-1) inhibitors and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors;
3. Central nervous system, lung, or bone metastases;
4. Known history of active or autoimmune disease;
5. Known history of other malignancies;
6. Known history of severe cardiovascular and cerebrovascular diseases;
7. Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding;
8. Active infection or fever of unknown origin;
9. Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;
10. Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis;
11. Known history of mental disorder or psychoactive substance abuse;
12. Hypersensitivity to the drugs of this regimen;
Telemedicine Makes the Patient Stay in Hospital at Home

The goal of the project is to study whether multidisciplinary follow- up performed via telemedicine to the patient in his or her own home, will improve the healthcare services offered to a particular group of patients. The hypotheses are that this could increase the treatment options, increase knowledge translation, give significant socioeconomic benefits, and allow greater accessibility to specialized healthcare services, as well as increase the involvement of patients and those working in primary healthcare.

The goals of rehabilitation are to improve functional level, decrease secondary morbidity and enhance health-related quality of life. The costs associated with pressure injury are considerable. In addition to direct treatment- related costs, pressure injury also impact the hospital performance metrics. On top of the financial implications, pressure injury have a significant impact on patient morbidity and -mortality, as well as on health related quality of life. The researchers believe there is a large potential for improvement in treatment of pressure injuries. An multidisciplinary approach, including home-based rehabilitation programs, might help prevent pressure injuries and their complications, and thus reduce associated costs. The investigators conducted a pilot in 2012, in which patients with spinal cord injury and pressure injury were monitored through multidisciplinary outpatient home care, using telemedicine. The project was beneficial for the consumers/ patients, especially in terms of consumer- participation and -contribution, improved quality of life, and a better cooperation between primary and specialized healthcare services. Retrospective economic analysis indicated that telemedicine provides great savings for public healthcare services, and that using telemedicine with other patient groups with similar problems, could be beneficial. A positive outcome of the current study can be made available to most people with pressure injury. Knowledge about pressure injury will contribute in both planning and establishment of good treatment lines for the patients, as well as contribute to environmental savings, and more proper use of the health resources. This may reduce the consumption of hospital services, because a larger proportion of services are provided by the municipality. An important scientific significance of this research will thus be to improve, simplify and streamline health care and health- related services.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic or non- traumatic SCI and ongoing pressure injury.
* Consent to participate.

Exclusion Criteria:

* Patients who are unable to give their consent due to cognitive problems.
* Patients who do not have a permanent/ known address.
Lipid Profile in Diabetic and Non Diabetic CKD Patients

The goal of this observational study is to compare blood lipid (fat) levels in participants with chronic kidney disease (CKD) with diabetes and without diabetes and who over 20 years old.

The main question this study aims to answer is:

Does having diabetes make fat problems worse in people with chronic kidney disease (CKD), or is there no connection between them?

Researchers will compare the blood lipid (fat) levels in people with chronic kidney disease (CKD) who have diabetes and those without diabetes to see if having diabetes makes lipid problems worse in CKD patients, or if there is no connection between diabetes and changes in lipid levels.

Participants will need to fast for 10 hours before undergoing this test. This means not eating any food or drinking anything except water.

Samples will be taken and sent to laboratory immediately.


Eligibility Criteria:
Inclusion Criteria:

* Patients of chronic kidney disease (CKD) presenting to the Sohag University Hospital
* Patients aged above 20 years of age.
* All patients who have given consent for enrolling into the study.

Exclusion Criteria:

* Patients aged 20 years of age or below.
* Patients on lipid-lowering drugs.
* Kidney transplanted patients.
Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors

To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.

To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.

Eligibility Criteria:
Inclusion Criteria:

* Can fully understand and sign informed consent form(ICF) voluntarily Male and female patients 18-80 (inclusive) years of age
* Stage: IIIb/IIIc/IV (AJCC version 8)
* ECOG Performance Status (PS): 0-1
* At least one measurable lesion as per RECIST 1.1

Exclusion Criteria:

* Subjects with characterizedALK or ROS1 activating mutations that predict sensitivity to anti-ALK-therapy or anti-ROS1-therapy; T790 mutations is uknown or positive
* Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. Patients' neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for ≥3 months at least two weeks prior to entering the study.)
* Prior exposure to MET-directed or third generation EGFR inhibitors therapy Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy
* Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product
Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis

Oral curcumin-containing supplement will be given to colorectal cancer patients with unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to completion of (or withdrawal from) chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age : 20 Years and older
* Histologically confirmed adenocarcinoma of the colon or rectum
* Patients with primary colon or rectal cancer and unresectable metastatic lesions.
* Patients with no primary cancer related symptoms.
* ECOG performance status of 0 - 2
* Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
* ASA score of \< 3
* An informed consent form has been signed by the patient.

Exclusion Criteria:

* Colorectal cancer other than adenocarcinoma
* The patient received adjuvant chemotherapy within the past 6 months.
* The patient received chemotherapy for metastatic colon cancer.
* The patient was planning to have curative surgery for the metastatic lesions.
* Patients with peritoneal carcinomatosis.
* Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
* ASA score of \> 4
* The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate.
* Patients with an active infection, which need antibiotic therapy, during the randomization period.
* Pregnant or breastfeeding women
* Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
Implantable Loop Recorder in Traumatic Syncope

Prospective, observational registry enrolling consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation with the aim to evaluate the incidence of recurrence of traumatic syncope during follow-up.

This observational, prospective registry enrolled consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation according to current clinical practice. The patients were evaluated every 6 months based on current clinical practice and the risk of recurrence of traumatic syncope was assessed during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* patients with recurrent, unexplained, traumatic syncope
* patients underwent implantable loop recorder implantation

Exclusion Criteria:

* patients unable to attend scheduled outpatient visits
Inflammatory Regulation Effect of NAC on COVID-19 Treatment

Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Adult above 18 years of age
* Admitted to the hospital With confirmed COVID-19 by RT-PCR test
* On oxygen supplement

Exclusion Criteria:

* Active use of NAC
* Known NAC allergy
* In the opinion of the treating team, progression of death is imminent and inevitable within the next 24 hour, irrespective of provision treatment
* All patients enrolled in any other investigational drug studies in COVID-19.
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss

The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a current diagnosis of age related sensorineural hearing loss in the range of 30-60 dB, averaged over 2 and 4 kHz in at least one ear.
* Subjects must have symmetric hearing loss
* Subjects who can read, speak and comprehend English.

Exclusion Criteria:

* Subjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss
* Subjects who have hearing disorders other than age related sensorineural hearing loss
* Subjects with moderate or greater tinnitus
* Pregnant females; breastfeeding females; females of childbearing potential
Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer

The purpose of this study is to determine whether p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis.
* Measurable disease at the time of initial therapy
* Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy.
* Responsive disease to standard chemoradiation therapy as defined by RECIST
* Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation
* CBC with an absolute neutrophil count (ANC) \>/= 1,000/uL, hemoglobin \>/= 8.0 g/DL and platelet count \>/= 75,000/uL.
* Normal prothrombin time (PT) and partial thromboplastin time (aPTT), unless on monitored anticoagulation therapy for medical conditions not excluded in the trial.
* Liver enzymes: total bilirubin less than or equal to 2mg/dL; AST and ALT less than 1.5X the upper limit of normal.
* Creatinine clearance of \>/= 60 mL/min
* Pulmonary: DLCO greater than 50%
* Cardiac: left ventricular ejection fraction greater than 45%

Exclusion Criteria:

* Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation
* Pregnant or lactating woman
* HIV infection confirmed by NAT
* Common variable immunodeficiency
* Active CNS malignancy
* Active bacterial, fungal or viral infection
* Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care
* Prior history of autologous or allogeneic hematopoietic cell transplantation
* Presence of protocol specific comorbid conditions
The Validity and Reliability Study of Turkish Version of the Sense of Competence in Dementia Care Staff (SCIDS) Scale

The purpose of the study is to adapt the SCIDS into the Turkish version and validate it in the social and cultural context of Turkey to assess staff competency in dementia care in the long-term care setting.

Most existing tools measuring care adequacy are targeted at family caregivers. Tools targeting formal dementia carers have focused primarily on dementia care knowledge, care attitudes and care workloads separately. There is less research investigating the assessment of competence in dementia care among formal healthcare staffs. There is no validated tool to accurately assess staff competency in dementia care in the long-term care setting in Turkey. Schepers et al. developed a scale dedicated to assessing Sense of Competence in Dementia Care Staff, including relationship building, maintaining personality, professionalism, and care challenges. Today, the scale has been used to evaluate the effectiveness of training programs and has demonstrated its applicability.

Eligibility Criteria:
Inclusion Criteria:

* Working as a dementia care staff for at least 1 year

Exclusion Criteria:

* Not volunteering
Effect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension

Tadalafil may lower the pulmonary artery pressure in patients with Chronic Obstructive Lung Disease and secondary pulmonary hypertension and thereby improve patients quality of life.

Twenty outpatients with Chronic Obstructive Lung Disease (COPD) and secondary pulmonary hypertension are treated in a cross-over design with Tadalafil or placebo for 4 weeks. Primary effect parameter is 6 min. walking test.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic obstructive lung disease

Exclusion Criteria

* Patients with asthma
Effects of Exercise on Cognitive Function in Glioma Patients

The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility and to determine the effect size of an exercise program in improving objective cognitive functioning.

Clinical stable patients with 1) low grade glioma (LGG) or 2) anaplastic glioma under age 70 will undergo a home-based exercise program (intervention) or will be assigned to the active controle group. Patients in the intervention group will undergo a 6-month home-based exercise intervention. An individual exercise prescription will be based on the patients' level of aerobic fitness (VO2peak) as measured with cardiopulmonary testing (CPET; on a cycle ergometer with ECG and gas exchange measurement) at baseline. Patients will exercise (e.g., running, biking, swimming) three times per week for 6 months. Session duration will vary between 20 minutes and 45 minutes. Patients in the active control group will be advised to walk regularly based on brochures from 30minutenbewegen.nl.

All primary and secondary outcomes will be assessed at baseline (T0; prior to randomization), and at completion of the 6-month exercise intervention (T1), and at a similar time-point for patients in the active control group. These will include indicators of feasibility (accrual, adherence, compliance and attrition), subjective and objective physical fitness measures, neuropsychological performance scores, and self-reported cognitive symptoms and mental wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Grade II and III gliomas
* age \< 50 years
* Karnofsky score \> or equal 80
* clinically stable for a minimum of 6 months prior to study entry
* no recent anti-tumor treatment
* interested in undergoing a physical exercise program
* mild to moderate neuropsychological impairment based on normative comparison of objective test performance
* relative VO2peak that leaves room for further improvement of cardiorespiratory fitness.

Exclusion Criteria:

* patients with serious orthopedic conditions or motor deficits
* patients with serious cardiovascular, cardiopulmonary and neurological conditions (or risks)
* patients judged to have psychiatric (including alcohol and drug abuse)
* patients with severe cognitive problems
* patients who report to engage in vigorous exercise (≥7 METs) for more than 20 minutes on at least 3 days per week on a regular basis will be excluded

For assessment purposes, study participants will need to have basic fluency in the Dutch language.
Comparison Between Latanoprost , Travoprost and Tafluprost in Reducing IOP Fluctuation in POAG Patients

Elevated IOP is a key risk factor for the progression of glaucoma. IOP is subjected to diurnal fluctuation in healthy individuals and higher fluctuation in POAG . So, once-daily antiglaucoma drugs must have consistent efficacy throughout the day. Prostaglandin analogues (PGAs) have become the first-line drops for medical treatment of glaucoma worldwide. In our study, we compare between the efficacy and tolerability of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on diurnal IOP fluctuation in patients having POAG, IOP fluctuation was assessed before treatment , then 2 weeks and 6 weeks after. A comparable and significant reduction in IOP fluctuation occurred in the 3 groups. Side effects were mild and tolerable.


Eligibility Criteria:
Inclusion Criteria:

* Both genders aged 18 years or more.
* Newly diagnosed POAG cases having :

IOP more than 21 mmHg Open angle on gonioscopy Showing both structural and functional damage (confirmed with OCT and visual field)

Exclusion Criteria:

* Angle closure glaucoma.
* Secondary glaucomas.
* Advanced glaucoma likely to be uncontrolled on monotherapy or needing a low target IOP.
* History of ocular trauma, laser or intraocular surgery.
* Any other ocular disorder including uveitis and cystoid macular edema.
* Known history of allergy or sensitivity to any components of the study medications.