cyrilzakka/clinical-trials huggingface dataset:
COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)

COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related

This is a collaborative, 4 arms , non randomized clinical trial assessing the use of Convalescent Plasma from COVID-19 recovered donors to be used in oncological and non-oncological patients with current severe COVID-19 infection or in patients with risk factors of major complications secondary to COVID-19 infection

Eligibility Criteria:
Inclusion Criteria:

For all patients:

A. Patient must sign an informed consent to participate in this trial

B. Signed consent to participate in this trial must be given not after 14 days from the first day of symptoms COVID-19 related

1. Patients with severity criteria must have any of the following: dyspnea and or respiratory rate \>=30 per min and or saturation \<= 93% with fraction of inspired oxygen 21% and or ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaFi )\<300 and or lung images showing worsening in 24-48 hours

   or
2. Patients without severity criteria but with 2 or more factor risks:

A. 50 years or older

B. any of the following comorbidities: Diabetes Mellitus, Hypertension, Chronic Obstructive Pulmonary Disease, Chronic Kidney Failure, non-oncological related chronic immunosuppression

C. Total bilirubin\>1,2 mg/dl or Blood Urea Nitrogen\> 20 mg/dl or Lactate Dehydrogenase\>245 U/L

D. D-dimer \> 1mg/L

E. Neutrophils 7.3 x 10³ or greater and or Lymphocytes lesser than 0,8 x 10³ µl

F. C reactive protein \>9,5 mg/dl and ferritin \> 300 ug/ml

G. Interleukin-6 \>7 pg/mL

H. antineoplastic treatment such as radiotherapy- cytotoxic chemotherapy- immunotherapy- molecular therapy- oncological surgery during the last 8 weeks

Exclusion Criteria:

* known allergy to plasma
* Severe multiple organic failure
* Active intra brain hemorrhage
* Disseminated intravascular coagulation with blood products requirements
* Patient with an adult respiratory distress longer than 10 days
* patients with active cancer and life expectancy shorter than 12 months according with medical criteria
Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap

Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Eligibility Criteria:
Inclusion Criteria:

* Patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap.

Exclusion Criteria:

-
A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis

The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.


Eligibility Criteria:
Principal Inclusion Criteria:

* Outpatients between 18 and 80 years
* Have been diagnosed with advanced liver fibrosis or mild cirrhosis attributable to NASH, ALD, or following a sustained virological response to treatment for hepatitis C
* Have an ELF Score of at least 9.5 but no more than 13
* Have stable hepatic impairment, defined as no clinically significant change in disease status, and no previous liver cirrhosis decompensation episodes
* Body weight within the range of 50.0 kg to 140.0 kg
* Clinical frailty score \<6

Principal Exclusion Criteria:

* Child-Pugh score ≥7, as determined at screening
* MELD score ≥12, as determined at screening
* Estimated glomerular filtration rate \<60 mL/min per the CKD-EPI creatinine-cystatin C equation
* Current or history of HCC
* Be suffering from or have symptoms of an acute or chronic infection
* Have active hepatitis C infection
* Other causes of liver disease including, but not limited to, hepatitis B, autoimmune disorders drug-induced hepatotoxicity, Wilson's disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history review.
* Is a woman of childbearing potential
ECGi of SyncAV With MultiPoint Pacing

The objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging (ECGi) in patients receiving cardiac resynchronization therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Patients previously implanted with a SyncAV and MPP-enabled Abbott Quadripolar CRT pacing system
* Patient must be \> 18 years of age, able to provide informed consent and willing to comply with study requirements
* Sinus (or atrial paced) rhythm with intact AV conduction with PR interval ≤ 250 ms
* Patient has documented Left Bundle Branch Block (LBBB)

Exclusion Criteria:

* Resting heart rate \> 100 bpm
* AV Block (1st degree with PR\> 250 ms, 2nd or 3rd degree)
* Documented persistent atrial tachycardia or atrial fibrillation at the moment of enrollment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
* Recent (\< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for CRT programming changes in the opinion of the investigator
* Women who are pregnant or plan to become pregnant during the study course
Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure

Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.

Infertile women with history of previous IVF cycle failure will be subjected top a fresh IVF cycle. Following controlled ovarian hyperstimulation, ovum pick up and at the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.

Eligibility Criteria:
Inclusion Criteria:

- women with previous IVF failure undergoing fresh IVF cycle

Exclusion Criteria:

* women with hydrosalpinges women with intrauterine lesion like submucous fibroid or polyps
Denosumab for Prevention of Bone Complications After Bone Marrow Transplantation in Children

Children treated by bone marrow transplantation (BMT) experience bone toxicity. Those bone damages are caused by both a decrease of bone formation and an increase of bone destruction after BMT.For long term survivors, bone complications are major determinants of impaired quality of life. No standard treatment currently exists to prevent those bone injuries. Denosumab is a treatment which specifically blocks bone destruction for 4 to 6 months in adults. This trial will study whether it is safe to prescribe Denosumab to children after BMT in the aim of preventing bone complications.

Participant will receive one subcutaneous dose of Denosumab within 2 weeks after confirmation of bone marrow engraftment. The dose of treatment will be escalated between participants. Denosumab is supposed to be effective for several months (4 to 6 months). The biologic activity of Denosumab will be followed by the measure in the blood of a biomarker of bone destruction called CTX. This biomarker is supposed to decrease after Denosumab infusion, reflecting the blockade of bone destruction by the treatment. Bone density will be assessed by a radiologic test named DXA which a standard test. All blood and radiologic tests mandated by the study will be done at the same time as standard follow-up after bone marrow transplant. Thus, participants will not have extra visits at the outpatient clinic, or extra blood punctures, for the specific purpose of the study. Participants will be followed for 36 months after bone marrow transplantation.For experiencing graft versus host disease, a second dose of Denosumab will be allowed, followed by subsequent doses evry 4 to 6 months till a maximum of 4 doses within 24months after bone marrow transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age from 2 year to 21 years
* Allogenic hematopoietic stem cell transplantation (allo-HSCT) planned within 1 month.
* Informed consent signed by participant more than 18 year old, or parents or his/her legal guardian
* Teeth examination by a dentist in order to rule out or to treat latent teeth infections before allo-HSCT

Exclusion Criteria:

* Refusal of signing informed consent
* Prior inclusion in another therapeutic trial with a time elapsed from the last research drug dose to Denosumab, shorter than 7 half-lifes of the research drug
* Osteopetrosis
* Bisphosphonates treatment within 12 months before entering the trial
* Tooth infection not treated before allo-HSCT
* Child-bearing and breastfeeding women
Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have lymphoproliferative disorder that is associated with immunosuppression therapy.

OBJECTIVES: I. Evaluate the efficacy of rituximab in patients with B-cell lymphoproliferative disorders while under pharmacologic immune suppression for control of either allograft rejection or autoimmune disease. II. Evaluate the safety and direct toxicity of rituximab in this patient population, including the potential for opportunistic infections. III. Evaluate the secondary consequences of rituximab therapy in this population, including changes in the requirement for immunosuppressive drugs, effects on graft rejection, graft survival, and severity of autoimmune disease.

OUTLINE: Patients receive rituximab IV over several hours. Treatment repeats every week for 4 courses. Patients are followed every month for 6 months, and then every 3 months until relapse or 2 years.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Polyclonal or monoclonal B-cell lymphoproliferative disorder while under pharmacologic immune suppression for control of either allograft rejection or autoimmune disease Measurable disease as defined by one of the following: At least 1 tumor mass measuring 1.0 cm in largest dimension Greater than 25% marrow involvement Quantifiable extranodal disease Expression of CD20 antigen confirmed by biopsy or fine needle aspirate Progression of disease or stable disease following reduction of immunosuppressive medication and antiviral therapy Inability to further reduce immunosuppressive medication

PATIENT CHARACTERISTICS: Age: 3 to 70 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Not specified Cardiovascular: No congestive heart failure Pulmonary: No pneumonitis Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No serious nonmalignant disease No active uncontrolled bacterial, viral, or fungal infections

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy Endocrine therapy: At least 2 weeks since change in dosing and type of immunosuppressive drugs unless due to progression of disease Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery (except diagnostic surgery) Other: At least 30 days or 5 half-lives since other prior investigational drugs or whichever is longer
Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx

The aim of this prospective, randomized clinical study is to compare between propofol and isoflurane on perioperative immune cell populations and function in patients undergoing total laryngectomy surgery.

The perioperative period might be a critical time in primary cancer surgery because many factors can affect whether recurrence, or metastasis , or elimination by the immune system.

Cancer surgery can induce an acute inflammatory response, due to local tissue damage and the shedding of malignant cells into the blood and lymphocytic circulation although meticulous surgical manipulation. Many evidences suggest that several factors during the perioperative period can affect the immune system.

These could be attributed to the surgery per se, pain, anxiety, hypothermia, blood transfusion, anesthetic technique, and anesthetic drugs .Impairment in the immune system may allow malignant cells to escape immuno-surveillance and metastasize in the perioperative period.As well as increase the risk of postoperative complications, such as systemic inflammatory response syndrome, sepsis, and multi-organ failure.

Previous retrospective clinical studies of both breast and prostate cancer surgery have suggested an association between anaesthetic technique and cancer recurrence.

However ,other retrospective trials on various forms of cancer have shown no such benefit.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I- III
* Scheduled for total laryngectomy.

Exclusion Criteria:

* Patients refusal.
* Morbid obese patients (body mass index \>40 kg/m2).
* Allergy to local anesthetics agents used.
* Severely altered consciousness level.
* Psychiatric disorders.
* Severe or uncompensated cardiovascular disease.
* Severe renal disease.
* Severe hepatic disease.
* Severe endocrinal diseases.
Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma

This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D).

This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D). The phase Ia part consists of the dose escalation and PD marker exploration part. The phase Ib part consists of the dose expansion part.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, ≥ 18 years
2. Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas
3. Subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
4. Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Expected survival time ≥ 3 months.

Exclusion Criteria:

1. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
2. Subjects with active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
3. Active uncontrolled bleeding or a known bleeding diathesis.
4. Subjects with massive pleural effusion or massive ascites.
EUS-B-FNA vs EUS-FNA for Left Adrenal Gland Analysis in Lung Cancer Patients

The purpose of this study is to compare EUS-B-FNA (using the EBUS scope)with EUS-FNA for left adrenal gland analysis in lung cancer patients.

Rationale:

The adrenal glands are a predilection site for distant metastases (M1b) in patients with lung cancer.

However, even in a patient with a confirmed lung cancer an enlarged adrenal lesion is still more likely to be benign than to be malignant(4). Therefore tissue sampling of the left adrenal gland (LAG) is obligatory to either confirm or rule out metastases. Sampling is regularly performed by a transgastric endoscopic approach using a conventional GI-EUS scope. The aim of this study is investigate the success rate of endoscopic ultrasound guided fine-needle aspiration using the EBUS scope (EUS-BFNA) for left adrenal gland analysis in patients with lung cancer and an on imaging suspected left adrenal gland.

Hypothesis:

EUS-B guided transgastric FNA of suspected left adrenal glands (LAG) reduces the need for conventional EUS- FNA by half.

Study design:

A prospective cohort design Setting: international, multicenter

Study population:

Patients with (suspected) lung cancer, an indication for mediastinal nodal staging and a for malignancy suspected LAG on imaging.

Intervention:

All patients will undergo a mediastinal nodal staging procedure with the EBUS scope (EBUS + EUSB) (routine clinical care) followed by an evaluation of the LAG including LAG sampling (experimental). Subsequently, all patients undergo a conventional EUS procedure with sampling of the LAG (current standard of care)

Main study endpoint:

The proportion of patients with a successful EUS-B-FNA procedure for LAG analysis. Successful is defined as: LAG is visible, sampling is possible and adequate material for cytopathological evaluation is obtained. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Distant metastases of lung cancer like LAG metastases have significant impact on both the prognosis and treatment. In the majority of patients with an indication for LAG sampling by endosonography, there is also an indication for mediastinal nodal tissue sampling. In case both the mediastinal lymph nodes and the LAG can be evaluated with the same scope, patients can be evaluated for nodal and distant metastasis with just a single instead of two separate scopes. This will be beneficial for patients (reduced investigation time) and is additionally cost -effective. So far EUS-B of LAG has been shown to be safe and feasible.

Eligibility Criteria:
Inclusion Criteria:

* (Suspected) Lung Cancer
* For malignancy suspected LAG on imaging (enlarged based on CT and/or FDG avid based on FDG-PET);
* Indication for endosonographic mediastinal staging by EBUS;
* Indication for LAG sampling;

Exclusion Criteria:

* Contraindication for EUS;
* Pregnancy;
Complete Lifestyle Medicine Intervention Program

This project will use a mixed design and will be conducted at the West Parry Sound Health Centre. Based on similar studies there is an expected 10% drop-out rate so 20 participants per group will be invited to aim to have 15 finish. Total participants invited over the two-year study will be 40. The participants will be followed over a Complete 6-month Lifestyle medicine Intervention Program (CLIP) involving a collaboration between physicians, health coach, registered dietitians, and kinesiology. The CLIP will cover the 6 pillars of lifestyle medicine in 12-14 fundamentals of lifestyle medicine group classes.

Participants will have the option of a hybrid platform to ensure equal access. Participants will attend (virtually or in person) a weekly lecture on Lifestyle Medicine Pillars for 16 weeks followed by a weekly exercise program for 8 weeks. This program was inspired by the research team of Albert et al 2022.

The eligibility criteria for participation in the lifestyle medicine program include adults with chronic diseases such as

* prediabetes,
* type 2 diabetes,
* pre-hypertension,
* systemic hypertension,
* heart disease, dyslipidemia,
* and/or excess weight (BMI ≥ 25 (42)).

Patients will be invited through referral by their physicians, email by local heart disease and diabetes foundation, mail-out by nurse practitioner and community health teams. Metrics:

Participants will be evaluated using validated pre-and post intervention validated surveys provided by the American College of Lifestyle Medicine, The Lifestyle Assessment Short Form. Added to the validated survey included questions on demographic characteristics including gender, age, race and ethnicity, language use, education, health insurance marital status. Participants will complete The Well-being Assessment and Lifestyle Medicine Survey (American College of Lifestyle Medicine)

Eligibility Criteria:
Inclusion Criteria:

* prediabetes,
* type 2 diabetes,
* pre-hypertension,
* systemic hypertension,
* heart disease, dyslipidemia,
* and/or excess weight (BMI ≥ 25 (42)).

Exclusion Criteria:

* Healthy participants