cyrilzakka/clinical-trials huggingface dataset:
Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation

The purpose of this Phase I study is to test the safety of combining afatinib with standard chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This study will then test the safety of afatinib at different dose levels when combined with the chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given during radiation treatment and the drug afatinib will be continued after chemotherapy and radiation.


Eligibility Criteria:
Inclusion Criteria:

* Unresectable or inoperable, stage III or locoregional recurrence without evidence of distant, metastatic disease
* Pathologic confirmation of NSCLC at MSKCC
* Documentation of a sensitizing EGFR mutation
* Age ≥ 18 years
* No contraindication to definitive thoracic radiation therapy with concurrent chemotherapy

Adequate organ function as defined by:

* Calculated creatinine clearance≥ 45 mL/min (by Cockcroft-Gault)
* Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease) and AST/ALT less than 3 x ULN
* Absolute neutrophil count greater than 1500/mm3
* Platelet count greater than 100,000/mm3
* Women of childbearing age must have a negative blood pregnancy test
* Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months there after

Exclusion Criteria:

* Prior chemotherapy or radiation therapy for this lung cancer (history of prior lung cancer that has been treated and deeded inactive by the clinician is acceptable)
* Ineligible for cisplatin or carboplatin per medical oncologist
* Ineligible for pemetrexed per medical oncologist
* Greater than minimal, exudative, or malignant pleural effusion
* Calculated creatinine clearance by Cockcroft \& Gault method ≤45 ml/min
* Unstable congestive heart failure
* Ejection fraction \<50% as assessed by MUGA or echocardiogram
* Interstitial lung disease
* Patient requiring on-going treatment with a potent inhibitor (cyclosporin, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital with quinidine, ritonavir, valspodar, verapamil) or inducer of P-gp (St. John's wort or rifampin)
* Women who are breastfeeding
Paricalcitol Improves Anemia of Inflammation

Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is a selective vitamin D receptor activator with potential benefits on anti-inflammatory cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.

Anemia of inflammation and secondary hyperparathyroidism (SHPT) are two common clinical complications in patients with chronic kidney disease. Eryptosis (accelerated red blood cell death) is a novel mechanism associated with renal anemia and several factors such us iron, erythropoietin and klotho (anti-aging hormone) deficiency have been associated with this process.

The use of the paricalcitol may inhibit pro-inflammatory cytokines expression, especially interleukine-6, which is one of the most important cytokine associated with the pathogenesis of the AI. If the use of the paricalcitol for the SHPT control may exert direct influence on the erythropoiesis process is not known.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years.
* Patients with CKD on hemodialysis of any etiology..
* Hemoglobin between 9 and 12g/dl at least 12 weeks before enrollment in the study.
* Hemoglobin plasma levels stabilized: Hb variation \<or = 1 g / dl for the two months prior to inclusion in the study.
* Patients with anemia of renal etiology.
* ESA treatment with stable doses for 2 months prior to baseline.Stable dose ESA Definition: Variation \<or = 3000UI/week.
* Iron status: Ferritin\> 200 ng / mL and/or transferrin saturation index (IST):\> = 20%).
* KT / V \>= 1.2 ( Daugirdas-2nd generation).
* Calcium concentrations between : 8.4 to 9.5 mg / dl and phosphorus: 3.5-5.5 mg / dl.
* Vitamin D 25OH normal \>= 15 ng / ml (patients with lower levels will be supplemented with calcifediol 16000 IU / bi-weekly for 6 weeks in selected patients).
* PTHi concentrations\> = 150 pg / mL and \<or = to 300 pg / ml.
* Patients who accept their inclusion in the study and sign informed consent.

Exclusion Criteria:

* Epoetin beta dose \> 18,000 IU / weekly.
* Pregnant woman of childbearing age or gestational wishes or not to use adequate contraception ( the Ogino-Knaus contraceptive method is considered unsuitable).
* Active bleeding episode or history of transfusion the 2 months prior to baseline.
* Patients with non-renal causes of anemia: malignancies, folic acid or vitamin B12 deficiency, hemoglobinopathies, hemolysis, pure red cell aplasia secondary to erythropoietin.
* Patients treated with the selective vitamin D receptor activator in the 3 months prior to inclusion in the study.
* Acute or chronic symptomatic: heart failure (IV-NYHA), infection or inflammatory disease, uncontrolled hypertension that requires the suspension of epoetin beta, thrombocytopathies, aplastic anemia.
* Immunosuppressive treatment with uncontrolled Hemoglobin level
* Allergy to paricalcitol or any of its components.
Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

The purpose of this research is to determine if both local anesthetics (mepivacaine and bupivacaine) are similar in their onset of sensory block to assess the efficiency of ultrasound-guided ankle blocks in our practice. Currently it is the standard of care to perform ankles blocks with both mepivacaine and bupivacaine. However, given similarity in their safety profile researchers would like to compare if one is non-inferior to the other in terms of onset time of ankle block.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old.
* Patients who provide informed consent to participate.
* Patients undergoing foot surgery who require a peripheral nerve block of the ankle as primary anesthesia.
* ASA (American Society of Anesthesiology) Physical Status Classification I - III.

Exclusion Criteria:

* Inability to consent.
* Allergy to local anesthetic.
* Infection at site of injection.
* Pregnancy.
* Coagulopathy.
* Hepatic or renal failure.
* Preexisting neuropathy in operative limb.
* Planned spinal anesthetic or general anesthesia.
The Outcome of Inserting Intercostal Tube or Pleurodesis for Malignant Pleural Effusion

Approximately half of all patients with metastatic cancer develop a malignant pleural effusion which is likely to lead to a significant reduction in quality of life secondary to symptoms such as dyspnoea and cough. The aim of pleurodesis in these patients is to prevent re-accumulation of the effusion and thereby of symptoms,and avoid the need for repeated hospitalization for thoracocentesis. Numerous clinical studies have been performed to try to determine the optimal pleurodesis strategy, and synthesis of the available evidence should facilitate this. The treatment of MPE is aimed at palliating symptoms since no intervention has been shown to improve survival in this population and since survival is generally limited in cancers that have spread to the pleural space. In this palliative setting, only patients symptomatic from their MPE should be submitted to further intervention. As well, further interventions in symptomatic patients should be limited to those patients who have experienced symptomatic improvement following initial therapeutic thoracentesis. The two main treatment approaches to MPE are to obliterate the pleural space via a pleurodesis procedure or to chronically drain the pleural cavity with Intercostal tube. The aims of this review were to ascertain the optimal procedure in cases of malignant pleural effusion in terms of patients' quality of life post procedure, recurrence of effusion.


Eligibility Criteria:
Inclusion Criteria:

* All patients presented with malignant pleural effusion to Assiut University Hospital regardless of sex and age

Exclusion Criteria:

* All patients presented with pleural effusion other than malignant pleural effusion, including patients with debilitating diseases and terminal patients.
Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma

This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles is the primary endpoint.

All the patients will be treated with Orelabrutinib combined with PD-1 inhibitor ：Orelabrutinib 150mg qd，Tislelizumab Injection 200mg d1 or Sintilimab injection 200mg d1， every 21-day for 1 cycle). Patients will be evaluated every 2 cycles by MRI scan during the first 6 cycles，and then the interval of investigation will be prolonged to 12 weeks. The patients who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) will receive further treatment. The patients progressed disease (PD) will withdraw from the trial and receive salvage regimens. The treatment will be continued for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.

During following-up, surveillance ophthalmologic examination and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old ≤75 Years old, male or female
* Primary Central nerves system lymphoma confirmed by cytology or histology according to WHO2016 criteria
* No evidence of systemic lymphoma
* Patients with a clear diagnosis of relapsed and/or refractory PCNSL: they received at least one regimen containing methotrexate.
* At least one measurable lesion according to Lugano 2014 criteria
* Adequate organ function and adequate bone marrow reserve

Exclusion Criteria:

* Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
* Active HIV, HBV, HCV or treponema pallidum infection
* Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
* Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
* Any systemic antitumor therapy performed within 2 weeks before enrollment
* Previous use of other BTK inhibitors or PD-1 inhibitors.
Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer

Surgery with or without neoadjuvant therapy is usually used as the treatment for resectable esophageal cancer or esophageal- gastric junction cancer. Patients who have a poor response to neoadjuvant therapy and have an incomplete (R1) resection or have metastatic lymph nodes in the resection specimen (N+) are especially at risk of recurrence, to continue with the chemotherapy± radiotherapy is often used in these cases. However, the overall survival is still poor. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival. The primary endpoint ofthe study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

Histologically proven esophageal or EG-junction carcinoma (Siewert I-II). The heart and lung function can tolerate surgery. The cancer is resectable and incurable therapy will be perfomed.

Exclusion Criteria:

EG-junction carcinoma (Siewert III). M1 stage according to the current (8th) version of TNMclassification system. The heart and lung function can't tolerate surgery. R2 Resection Status.
Dose-Effect Relation of Salivary Gland Irradiation

Optimization of radiotherapy to reduce xerostomia is difficult, because many gland locations cannot be seen with current imaging modalities and biological dose-effect are currently insufficiently understood. PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal. A reduction of PSMA accumulation in salivary glands is thought to correlate with loss of vital acinar cells. The PET images can be correlated with radiotherapy dose distributions in gland-based or voxel-based evaluations. This makes PSMA PET a suitable instrument to derive the radiobiological dose-effect relations that are required to develop better and gland-specific dose constraints for radiotherapy. The results of this study can contribute to lower toxicity and better quality of life in patients treated with high-dose radiotherapy in the head and neck.

Primary objective of this prospective observational study is to determine the gland-based dose-effect relation between conventionally fractionated radiotherapy (RT) and long-term loss of acinar cells, per salivary gland type. The study population consists of a maximum of 20 patients with HNSCC referred for high-dose (CC)RT. There is no therapeutic intervention. Diagnostic intervention is PSMA PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* HNSCC of the head-neck area, cTx-4 N0-3 M0
* Accepted for EBRT in a conventionally fractionated schedule of 6-7 weeks.

Exclusion Criteria:

* Age \<18y
* Pregnancy or lactation
* Participation in conflicting studies, e.g. with non-standard treatment and/or imaging
* Inability to provide informed consent
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
* Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
* Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

-Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Dexamethasone and COVID-19 Inpatient Mortality

The study aims to assess the effectiveness of dexamethasone initiation to reduce the risk of inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection, overall and stratified by COVID-19 severity subgroups.

This is a non-randomized, non-interventional study that is part of a research collaboration agreement between the US Food and Drug Administration (FDA) and Aetion to use real-world data to advance the understanding and the natural history of COVID-19 in specific patient populations, as well as treatment and diagnostic patterns during the coronavirus disease (COVID-19) pandemic.

This study compares inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection who initiate dexamethasone treatment with a matched cohort of patients with 'standard of care' who are non-users of corticosteroids of interest (dexamethasone, prednisone, methylprednisolone, hydrocortisone). Patients are compared overall and and stratified by COVID-19 severity subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized Patients with confirmed COVID-19 (diagnosis of U07.1 or positive or presumptive positive SARS-CoV-2 diagnostic laboratory test result) occurring between 21 days prior to the hospital admission date and the treatment index date.

Exclusion Criteria:

* No interaction with the healthcare system (medical encounter) in the 183 days prior to and including hospital admission (Day -183 to Day 0) to minimize the potential for misclassification of baseline covariates and/or new use
* No age or sex recorded in the 183 days prior to and including hospital admission (Day -183 to Day 0) as required for matching
* No geographic region recorded in 183 days prior to and including hospital admission (Day -183 to Day 0) as necessary to adjust for regional variation
* Any recorded use of any CSI (dispensing or remaining supply) in the 90-day washout prior to the treatment index date (Day T-90 to Day T-1) to satisfy new use definition
* Any record of a COVID-19 vaccine recorded on or any time prior to the treatment index date given that these patients are assumed to be selectively different (Day S to Day T)
Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

In this study, the investigators aimed to compare the efficacy of %5, %10 and %20 concentration dextrose prolotherapy (DPT) treatments in patients with primary knee osteoarthritis (OA). In this prospective, randomized, controlled, single-blind study, 128 patients who met the inclusion criteria were recruited and divided into four groups. Thirty patients from each group completed the study. %5 DPT was applied to Group 1, %10 to Group 2, and %20 to Group 3 in combination with home exercise program and hotpack therapy. Group 4 was given home exercise program and hotpack therapy. Groups were evaluated with VAS (Visual Analog Scale), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), knee ROM (Range of Motion), and Timed up and go test (TUG) parameters. DPT groups were evaluated in terms of side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-70 years,
* Knee pain for more than three months,
* Diagnosed with primary knee OA according to ACR clinical/radiological diagnostic criteria and Kellgren-Lawrence stage II-III.

Exclusion Criteria:

* Total knee replacement
* Rheumatological diseases, systemic infection, and malignancy
* Pregnancy or breastfeeding
* Taking a nonsteroidal anti-inflammatory drug (NSAID) in the last week, taking steroid drugs in the last month
* Undergoing anticoagulant or immunosuppressive therapy
* Knee injection in the last 6 months
Study to Determine the Feasibility of Sentinel Node Biopsy in Patients With Anal Cancer

The purpose of this study is assess the technical and operational feasibility of a specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal cancer.

SLNB is based on the premise that lymphatic dissemination from a tumour occurs in a stepwise fashion, with initial involvement of a primary node, called the sentinel node, before dissemination to the remainder of the lymphatic chain. If the sentinel node is histologically negative, then the remainder of the nodes in the same anatomic region will be at a lower (assumed to be minimal) risk of containing metastases. SLNB is part of standard care for patients with malignant melanoma and with breast cancer but has yet to be prospectively evaluated in patients with anal cancer.

Currently, the standard way to treat patients with anal cancer is to deliver a combination of chemotherapy and radiation to the tumour at the anus together with 'preventative' (prophylactic) radiotherapy to the lymph glands of the groin and pelvis. There is a growing perception for the need to reduce the morbidity of radiotherapy i.e. current regimens over-treat the patient and one approach is to reduce radiotherapy volume and/or dose where there is an absence or very low risk of nodal metastases.

This feasibility study is a vital first step in informing the design of a larger study examining the role of SLNB in clinical decision-making and outcomes for patients with anal cancer. In this trial eligible patients will attend for lymphoscintigraphy, to locate the lymph node, before sentinel lymph node removal by surgery. Detection rate of the sentinel node(s) will be the key outcome for the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell carcinoma (SCC) of the anus (any T size and/or those with recurrent disease)
* Equivocal lymph node involvement on standard CT staging or magnetic resonance (MR) staging or PET-CT scan, as determined by the anal cancer multidisciplinary team (MDT)
* Age \>= 18 years
* Written informed consent provided by the patient

Exclusion Criteria:

* Patients with unequivocal lymph node involvement on standard CT staging or MR staging, as determined by the anal cancer MDT.
* Unfit for surgical biopsy
* Patients undergoing palliative treatment
* Previous pelvic or inguinal area radiotherapy
* Other coincident cancers
* Previous inguinal surgery (e.g. hernia repair) with mesh insertion
Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis

This is a parallel group, single institution, prospective clinical study. The purpose of this study is to assess whether the Jawbone Up 24, a consumer based accelerometer, can be a feasible tool to study physical activity in cancer patients and patients with Amyotrophic Lateral Sclerosis (ALS).


Eligibility Criteria:
Inclusion Criteria:

* Patients \> = 18 years of age.
* Patient must be able to ambulate and complete the 6 minute walk test without use of a walker, cane, or any assist devices.
* Cancer patients or ALS patients who meet the following criteria:

Prostate cancer:

* Histologically confirmed prostate cancer.
* Patients who are initiating any chemotherarpy (examples are docetaxel, cabazitaxel, etc.) and/or hormone directed treatment for prostate cancer. Examples of hormone directed therapy include GnRH agonist or antagonists (such as leuprolide, goserelin, triptorelin, histrelin and degarelix), androgen receptor blockers (such as bicalutamide or enzalutamide), or androgen biosynthesis inhibitors (such as abiraterone).

Renal cancer:

* Histologically confirmed renal cell carcinoma (RCC).
* Metastatic disease, in the opinion of the treating provider.
* Starting any systemic therapy for metastatic disease

Brain cancer:

* Histologically confirmed high grade glioma.
* Status post concurrent radiation therapy and daily temozolomide.
* Starting adjuvant temozolomide therapy.

ALS patients who are:

* Already on a stable dose of Riluzole for at least one month.
* ALSFRS-R with \<or equal to 2 point decline in last month.
* Must have ALSFRS-R walking score of at least 3 or 4 and FVC at least 50% (to ensure patients are fit enough for ambulation and physical activity).

  - Technology requirement:
* Patients will need to own a smart phone that can interface with the Jawbone Up 24.
* Patients willing to provide their own internet access for this study. This will include either a data plan or Wi-Fi access on the patient's smart phone for use of the Jawbone App. They will also need internet access (through their smart phone or home computer) for setting up a SGHIx account. Patients are welcome to use the free guest Wi-Fi access within the Duke Outpatient clinic area for the purpose of this study.
* Patients will need a home computer or adaptor with USB port to charge the Jawbone Up 24.

Exclusion Criteria:

* Non-English Speaking or inability to read and understand English
* Presence of cardiovascular disease that would make physical activity risky at the discretion of the provider.
* Any patient who is unable to comprehend and operate the activity tracker at the discretion of the enrolling provider.