cyrilzakka/clinical-trials huggingface dataset:
Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients

The purpose of this study is to evaluate the efficacy and safety of azacitidine，venetoclax，and flumatinib in newly diagnosed Philadelphia chromosome-positive acute leukemia and accelerated phase or blast phase chronic myeloid leukemia patients.

This is a phase Ⅱ, open-label, single-arm, single-center study in newly diagnosed Ph-positive acute leukemia and CML-AP/BP patients. The patients will receive azacitidine, venetoclax, and flumatinib regimen in the induction treatment. The patients who respond to induction treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with induction therapy according to patient's wishes.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed Ph-positive ALL/AML/MPAL and CML-AP/BP without the history of chemotherapy or target therapy.
2. Age 18-65.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-3.
4. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
5. Creatinine clearance ≥ 30 mL/min.
6. Serum lipase ≤ 1.5 x ULN, amylase =\< 1.5 x ULN.
7. No consumption of grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax.
8. Provide informed consent.

Exclusion Criteria:

1. Patients with another malignant disease.
2. Patients has participated in or participating in other clinical trials.
3. Patients with uncontrolled active infection.
4. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
5. Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
6. Patients with uncontrolled active bleeding.
7. Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
8. Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
9. Patients with other commodities that the investigators considered not suitable for the enrollment.
Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting

This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy-chemotherapy combo for bronchial cancer in maintenance phase of first row metastatic treatment.

The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. A cost-benefit analysis will be done to compare hospital-at-home programme and classical day hospitalization.

Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress in terms of tumoral answer, survival without progression and global survival. Usually administered in the day hospitalization department, its preparation and administration to the patient are compatible with hospital-at-home management. This type of management has particularly developed in the context of the COVID pandemic and recommendations for good practices in hospital-at-home immunotherapy have recently been drafted by FITC (Société Française d'Immuno-Thérapie du Cancer). These recommendations open the way for administration of immunotherapy and chemotherapy combo in hospital-at-home. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy-chemotherapy combo. To follow up on the feasibility study of home immunotherapy (ImHADom) carried out at CH Pau from March 2019 to March 2021, the sponsor propose to evaluate with descriptive study the feasibility under the same conditions of chemotherapy-immunotherapy in patients treated in the maintenance phase of a first metastatic row.

This study will be proposed to all the patients in maintenance phase of first row treatment with at least one positive tumoral imaging assessment (stable disease or partial response) for whom home hospitalization has been decided and scheduled by the healthcare team in a medical staff meeting.

The patients included in the study will be followed according to the common practice: a consultation every 3 months during 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over,
* with bronchial metastatic cancer treated in first row maintenance phase by immunotherapy-chemotherapy combo,
* having at least one assessments of the response to immunotherapy received in day hospitalization with efficiency (stability or partial response),
* without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse effects related to immunotherapy
* eligible for a home-based hospitalization

Exclusion Criteria:

* Frail patients requiring a frequent medical assessment thus day hospitalization cares
Paxlovid for Treatment of Long Covid

The purpose of this study is to compare whether being treated with nirmatrelvir plus ritonavir for 15 days works better than being treated with placebo plus ritonavir to reduce severe symptoms of Long Covid.

Participants will have 5 planned visits to the study clinic over 15 weeks and will take the drug (or placebo) for the first 15 days.

This study uses the term post-acute sequelae of SARS-CoV-2 (PASC), which is another name for "Long Covid."

An exploratory sub-study will investigate the correlation of physical activity and biometric parameters from digital wearable devices with the subjective symptom severity and other patient-reported outcomes in the main study. All participants with iPhone 6S Plus or newer will be offered an opportunity to opt-in to this sub-study. An Apple Watch and Bluetooth-enabled blood pressure monitor will be provided to participants and data will be collected for the duration of the main study to track participants' physiological and behavioral trends in the Paxlovid versus placebo groups.

Eligibility Criteria:
Inclusion Criteria:

* Normal or near-normal kidney function
* History of confirmed COVID-19 infection that preceded the post-COVID symptoms
* Post-COVID-19 symptoms persisting greater than three months
* At least 2 post-COVID symptoms of moderate or severe intensity (fatigue, brain fog, shortness of breath, body aches, gastrointestinal symptoms, or cardiovascular symptoms)
* Willing to report all vaccinations
* Women of childbearing potential or men whose partners may become pregnant must use acceptable method of contraception during the treatment period and for 28 days after the last dose of the study drug
* Willing and able to adhere to study procedures and available for the duration of the study

Exclusion Criteria:

* Suspected or confirmed pregnancy or breastfeeding
* Severe liver disease
* Prior use of study drug or other COVID treatment within 30 days
* Hypersensitivity or other contraindication to any components of the study drug
* Current or expected use of any medication dependent on or inducer of CYP3A4
* Current or expected use of supplements or herbs (unless medically necessary) that cannot be temporarily held (period as determined necessary by investigators)
* HIV infection with viral load \>50 copies/ml
* Suspected or confirmed active COVID infection within 30 days
* History of COVID vaccine within 28 days prior to enrollment, or other vaccine (influenza, shingles, etc.) within 14 days of enrollment, or planned use of any vaccine until the primary endpoint has been met (10 weeks)
* Other medical condition(s) or concomitant therapy that would compromise participant's safety or compliance with the study protocol or significantly confound interpretation of study results, as determined by study investigators
* Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device
* Inability to provide informed consent
* Currently hospitalized
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)

The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Active subfoveal or juxtafoveal choroidal neovascularization secondary to AMD
* Best Corrected Visual Acuity (BCVA) between 70-25 letters (ETDRS) at Screening
* Intraretinal or subretinal fluid
* Central Subfield Thickness \> 300 µm

Exclusion Criteria:

* Pregnant or breastfeeding females or those with a positive pregnancy test.
* Females of childbearing potential who will not use a medically acceptable contraceptive method
* Current, previous chronic or recurrent condition according to the investigator's judgement.
* Concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications
* Concurrent disease in the study eye
* Previous treatment with systemic anti-Vascular Endothelial Growing Factor (Anti-VEGF) drugs or pro-VEGF treatments
* Concurrent disease in the study eye, other than AMD
Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.

The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile.


Eligibility Criteria:
Inclusion Criteria:

* Adults that is able to consent (≥ 18 years of age)
* Scheduled to undergo PCNL at Uhealth tower and Jackson Memorial Hospitals
* not currently immunosuppressed \[White blood count (WBC) \>= 2, not on immunosuppressive medications\]

Exclusion Criteria:

* unable to consent and \< 18 years of age
* currently immunosuppressed (WBC \< 2, not on immunosuppressive medications)
Bevacizumab in Advanced Hepatocellular Carcinoma

Primary liver cancer (hepatocellular carcinoma) is the fifth most common malignant disorder, with an increasing incidence in Europe and the USA as a result of the high prevalence of hepatitis C. Most patients are not suitable for potentially curative treatment. There is no standard palliative treatment for patients with advanced hepatocellular carcinoma (HCC), as no drug has been demonstrated to be efficient in this disease in terms of survival. The use of anti-vascular agents might be a promising approach in view of the highly vascular nature of this tumor. The aim of this phase II trial is to evaluate the potential benefit of bevacizumab in terms of disease control rate, progression-free and overall survival in adult patients with advanced primary liver cancer. Bevacizumab is an angiogenesis inhibitor already successfully used in patients with colorectal and renal cancers.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven HCC or alpha-fetoprotein level \> 400 ng/ml together with hypervascular tumor and cirrhosis documented by CT scan or MRI.
* HCC not amenable to curative treatment (resection, transplantation, percutaneous ablation)
* Presence of at least one dimensionally measurable target lesion with largest diameter \>= 2 cm.
* No previous chemoembolization, no previous radiotherapy
* Cancer of the Liver Italian Program (CLIP) score \< 4
* World Health Organization (WHO) performance status of 2 or less
* Life expectancy \>= 3 months.
* Age \>= 18 years.
* Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; platelet count, at least 75,000 per cubic millimetre; Hemoglobin, at least 8 g/dl)
* Adequate liver function (bilirubin, not more than 2 times the upper limit of normal); Adequate renal function (serum creatinine, less than 150 micromol per liter)
* Adequate coagulation function
* Written informed consent

Exclusion Criteria:

* Decompensated cirrhosis (Child-Pugh score \> 7)
* CLIP score \> 4
* Variceal bleeding during the previous 3 months
* Thromboembolic event during the previous 6 months
* Medical condition requiring full dose anticoagulation or anti-platelet drugs
* Abnormal cardiac function with history of ischemic heart disease in the previous 6 months, uncontrolled hypertension, unstable angina, severe cardiac arrhythmia,
* No brain metastasis, No bone metastasis only
* Previous or current malignancies at other sites
* No concomitant antitumor treatment including tamoxifen or somatostatin analogs
* Unstable systemic diseases or active uncontrolled infections.
* Patients (male and female) not using effective contraception if of reproductive potential.
Hemophagocytosis in Critically Ill Adult Patients

The purpose of the study is to find out whether non-responsiveness to therapeutic recombinant human granulocyte colony-stimulation factor (rhG-CSF) is associated with hemophagocytosis in critically ill adult patients with cytopenias.

In children with bi- or pancytopenia, hemophagocytosis is known as life-threatening hemophagocytic lymphohistiocytosis (HLH). The purpose of the study is to find out whether adult patients with bicytopenia or pancytopenia fulfilling the clinical HLH criteria used in children reflect life-threatening hemophagocytosis and whether hemophagocytosis is associated with responsiveness to recombinant human granulocyte colony-stimulation factor (rhG-CSF) or not.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* critically ill adult patients
* leukopenia and thrombocytopenia
* rhG-CSF therapy

Exclusion Criteria:

* life expectancy \< 24 hours
* inclusion in other studies
* trauma patients with reanimation on scene or immediately dying on hospital admission
* pregnancy
* hematologic disorder, malignancy
* high dose corticosteroid treatment or chemotherapy
Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective:

* Group 1: Intermediate-acting (NPH) insulin at breakfast
* Group 2: Short-acting insulin (regular or aspart) before meals
* Group 3: Insulin glargine at breakfast

Question/Hypothesis:

Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?


Eligibility Criteria:
Inclusion Criteria:

1. Have undergone bone marrow, liver, lung, or renal transplant.
2. Be using once daily oral glucocorticoid therapy (total daily dose of Prednisone ≥10 mg, Hydrocortisone ≥40 mg, Dexamethasone ≥1.5 mg) administered in the morning and expected to continue for at least 2 weeks.
3. Have pre-existing or newly diagnosed diabetes mellitus established by any of the criteria listed below:

   1. Fasting plasma glucose ≥7.0 mmol/L (repeated x 1)
   2. Any plasma glucose ≥11.0 mmol/L
4. Have at least three pre-meal inpatient capillary blood glucose (CBG) readings ≥ 7.8 mmol/L
5. Be eating meals by mouth

Exclusion Criteria:

1. Heart, Pancreas, Islet cell transplant recipients
2. Previous use of Basal-Bolus or Pre-Mixed Insulin regimen
3. Diabetes mellitus type I
4. NPO (not eating meals by mouth)
5. Receiving enteral (tube feeds) or parenteral (TPN) nutrition
Comparison of Application Effects Between Long- and Standard Short- Peripheral Venous Catheters

Short PIVC (intravenous indentation needle) accounts for more than 50% of clinical infusion tools, but long PIVC is rarely used and studied in China. This study aims to explore the application characteristics and application effects of long PIVC in China. It provides reference for the correct selection of infusion tools, and promotes the clinical application and promotion of new intravenous therapy tools.

The study nurse will work with the responsible physician to assess the eligibility for enrollment and sign the informed consent. Were randomly assigned to the control group (to receive a new 24G/22G (0.7mm\*19mm/0.9mm\*25mm) short PIVC (closed needle protected venous catheter system) puncture) or the intervention group (to insert a new 3F (8cm) or 4F(10cm) long PIVC) for daily routine maintenance until catheter removal, General demographic data, laboratory-related data, catheter-related data, catheter-related complications (unplanned extubation, phlebitis, catheter blockage, catheter-related thrombosis, catheter-related bloodstream infection, exudation, etc.) and patient satisfaction were collected.

The control group will receive a new 24G or 22G short peripheral venous catheter for puncture using direct view aseptic technique, while the intervention group will be implanted with a new long peripheral venous catheter selected by the puncture operator using aseptic technique depending on the puncture location and venous conditions. After successful puncture, blood was returned in both groups and easily washed with 0.9% sodium chloride solution. The catheter was considered to be placed in the correct position and could be used normally. Intravenous infusion therapy should be started immediately after successful catheterization. The catheter should be checked at least 3 times a day and washed with 10 ml.9% sodium chloride solution before each intravenous therapy. After disconnection of any infusion, pulse flushing with 0.9% sodium chloride solution 10ml and positive pressure sealing tube flushing to seal the catheter. Patient information was collected during the study, including sociodemographic information, duration of intravenous therapy, and details about catheter failure.

Eligibility Criteria:
Inclusion Criteria:

1. A male or female aged 18 years or older who is able and willing to give written informed consent;
2. Identification of the patient's medical diagnosis based on the competent physician and the study nurse at any time during the hospital stay, and judgment that the duration of peripheral intravenous infusion therapy needs to exceed 4 days;
3. Subjects with good compliance and can cooperate with catheter maintenance and observation.

Exclusion Criteria:

1. Patients who are delirious and unable to cooperate;
2. Patients requiring central venous access;
3. Patients suffering from connective tissue diseases or blood diseases;
4. Patients allergic to catheters or dressings;
5. any subject in a condition deemed by the investigator to interfere with the evaluation of results or pose a health risk to the subject.
Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection

In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin sodium and sulbactam sodium for injection (2:1) for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.

Piperacillin sodium and sulbactam sodium for injection (2:1) plays a therapeutic role by the former inhibiting bacterial cell wall synthesis by irreversible competitive inhibition of β-lactamase. The antimicrobial effect of cefotaxime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.

Eligibility Criteria:
Inclusion Criteria:

1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Age\>18 years old, Gender: both
3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
4. patients were volunteers and signed informed consent form;
5. patients did not participate in other clinical trials.

Exclusion Criteria:

1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pregnant and Lactating women
3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.
Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

This protocol is for a series of descriptive analyses conducted within a cohort of patients using linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, and other oral and non-insulin injected hypoglycemic medications between May 2011 and July 2012.

Understanding 1) the existing utilization patterns for linagliptin, sitagliptin, saxagliptin, and other oral and non-insulin injected hypoglycemic agents and (2) the differences in utilization patterns between these agents will help with the design, analysis and interpretation of comparative effectiveness and safety studies of linagliptin, other DPP-4 inhibitors, and other agents.

The study will provide an overview of existing utilization patterns for linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, other oral and non-insulin injected hypoglycemic agents, in order to detect potential selective prescribing patterns that might lead to channeling bias.


Eligibility Criteria:
Inclusion criteria:

* diagnosis of type 2 diabetes mellitus
* a dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012
* at least 6 months enrolment in the database preceding the date of the first dispensing

Exclusion criteria:

* age \< 18
* missing or ambiguous age or sex information
* at least one diagnosis of type 1 diabetes mellitus or secondary diabetes