cyrilzakka/clinical-trials huggingface dataset:
A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.

The Investigators of the Extracorporeal Life Support Registry in Lung Transplantation (ECLS Registry) has studied the impact of the type of intraoperative extracorporeal life support on primary graft dysfunction (PGD) after lung transplantation (LTx) in an international registry. The investigators have demonstrated that severe PGD at 48-72 hours is greater when LTx is performed using cardiopulmonary bypass (CPB) (43%) when compared to veno-arterial (VA) ECMO. However, PGD after VA ECMO remained high (29%) when compared to off-pump (12%). Conversely, there are retrospective series showing that when compared to off-pump technique, VA ECMO has reduced PGD rates and improved survival. Because selection bias and unknown confounders in retrospective studies could have been the cause of these conflicting results, part of the ECLS Registry Investigators are committed to a prospective multicenter randomized trial comparing off-pump versus VA ECMO LTx.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral Lung Transplantation (LTx) recipients.
* Mean pulmonary artery pressure \< or = 35 mmHg.
* Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.

Exclusion Criteria:

* Single lung transplant
* Multiorgan transplant.
* Donor after cardiac death (DCD).
* Re-transplant.
* Intention to use prophylactic post-operative ECMO.
* Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge resection are not an exclusion criterion.
* Previous pleurodesis.
* Preoperative ECMO and/or mechanical ventilation.
Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints

The goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.

Patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with TAC/TC/TCbH regimen were eligible for this multicenter, open-label, randomized trial. Patients were randomized (2:1) to receive QL0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of chemotherapy. The primary endpoint was the incidence rate of FN for cycle 1. The secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the pain (bone, muscle, or joint), ect.

Eligibility Criteria:
Inclusion Criteria:

* Aged≥18 years；
* The expected survival period is more than 3 months;
* ECOG≤ 2;
* Invasive breast cancer diagnosed by histopathology;
* Plan to receive TAC, TC or TCbH chemotherapy;
* Subjects with good hematology, liver, lung and kidney function ;
* Signed informed consent.

Exclusion Criteria:

* Known hypersensitivity to rhG-CSF or PEG-rhG-CSF;
* Female patients during pregnancy or lactation;
* The previous malignant tumors were not cured;
* Received chemotherapy or radiotherapy within 4 weeks before screening;
* Received PEG-rhG-CSF within 6 weeks before screening;
* Suffering from uncontrollable infectious diseases within 2 weeks before screening.
Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.

OBJECTIVES:

* Determine the extent and prognostic implications of variable s-SHIP expression and SHIP gene mutations in pediatric patients with acute myeloid leukemia.
* Determine the effects of aberrant s-SHIP expression on the PI3K/Akt pathway in these patients via electrochemiluminescence and phosphospecific flow cytometry assays.

OUTLINE: RNA samples are analyzed for variable s-SHIP expression and are screened for SHIP mutations. Cryopreserved cells (with known high- or low-s-SHIP expression) are analyzed for the levels of various components of the PI3K/Akt pathway via electrochemiluminescence and phosphospecific flow cytometry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Timing of Low Vision Rehabilitation in Anti- Vascular Endothelial Growth Factor (VEGF) Therapy

The purpose of this research is to collect preliminary data in preparation for conducting a randomized clinical trial to determine the relative effectiveness of vision rehabilitation in improving overall visual ability (primary aim) and reducing depression (secondary aim) in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration integrated over time.

This is a pilot study to understand the feasibility of conducting a randomized, controlled trial regarding the timing for vision rehabilitation in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration. Prior to initiating the clinical trial, the investigators must be assured that patients with loss in visual ability are willing to be randomized and amenable to deferring vision rehabilitation intervention. Although it is typical for patients receiving usual care to present for vision rehabilitation services years after the onset of anti-VEGF therapy, this manifestation may result from patients being unaware of the existence of vision rehabilitation services to enhance function and reduce depression. As part of the study recruitment, patients will be informed about vision rehabilitation care and, if suffering with difficulty performing everyday activities, they may be unwilling to defer vision rehabilitation. Additionally, the study design may not be feasible to answer the aim should patients in the delayed intervention arms suffer progressive loss in visual ability and seek vision rehabilitation services, resulting in a high drop-out rate.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years old
* Primary diagnosis of neovascular age-related macular degeneration in the index eye or in both eyes if habitual visual acuity (HVA) is equivalent in both eyes
* HVA \< 20/25 to ≥ 20/500 in the index eye
* Confirmed active anti-VEGF injections (a minimum of 2 injections in the past 3 months, a total of 8 injections maximum) in the index eye
* Full confrontational visual fields in the index eye
* Acknowledgement of having difficulty in visual ability function
* Visual ability estimates as measured by ≥ 2 goals identified on the Activity Inventory as important and with at least slight difficulty
* Telephone interview for cognitive status raw score is \> 29
* Ability to return to clinic to participate in rehabilitation
* No prior experience with vision rehabilitation service

Exclusion Criteria:

* Other progressive ocular conditions likely to compromise VA during the study period or upcoming eye surgeries
* Anti-VEGF injections in the index eye 8 months prior to enrollment
* Unable to give written consent to the study
* Impaired hearing or cognitive ability that precludes telephone interviews
* Insufficient spoken English or reading ability to complete interviews and understand study materials

  * The index eye is defined as the eye with better HVA, or the eye with more anti-VEGF injections if both eyes are with the equivalent HVA
ARIXTRA Local Study For Registration In China.

This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.


Eligibility Criteria:
Inclusion criteria:

* Patients undergoing either an elective major hip or knee replacement or revision.
* Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child.

Exclusion criteria:

* History of serious active bleeding in last 3 month
* Concurrent or history of thrombocytopenia ( Platelet\< 100x109/L)
* History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product
* Acute bacterial endocarditis
* Congenital or acquired bleeding disease in last 3 months
* Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia
* Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye
* Conditions need to leave a tubule in intradural or extradural
* Contraindication to anticoagulant or condition required to take long term oral anticoagulant
* Abnormality in hepatic (\>1.5x UNL), renal (Clcr \< 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb
* Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days.
* Concurrently to have hip and knee or double hip/knee replacement at the same time
Further Development and Initial Testing of RESTORE in Frontline Workers

There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health. The specific aims of this project are to refine and investigate the feasibility, initial safety, and efficacy of RESTORE for addressing mental health symptoms in first responders, health care workers (HCW), and Canadian Armed Forces members exposed to COVID-19-related traumatic or extreme stressors.

This uncontrolled pilot interventional study will examine the feasibility and preliminary efficacy of RESTORE. RESTORE is a guided self-directed online intervention to improve anxiety, depression, and posttraumatic stress disorder (PTSD) in individuals exposed to COVID-19 related traumatic or extreme stressors. RESTORE is based on evidence-based psychotherapies and has been designed to overcome many of the barriers associated with accessing evidence-based psychotherapies. The intervention will be iteratively refined over the course of the study. The guidance methods will also be refined and manualized over the course of the study

The primary hypotheses are that RESTORE will be safe, feasible, and desirable to participants, and will lead to improvements in mental health symptom severity from baseline to post-intervention. Secondary hypotheses are that RESTORE will lead to significant improvements in perceived health, quality of life, and functioning from baseline to post-intervention. Participants will be assessed at baseline, pre-intervention, during the intervention (after module 4), immediately after the intervention, and 1 month after completion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Canadian healthcare worker, first responder, or military member
* Experienced a traumatic or extremely stressful situation in the course of work related to COVID-19
* ≥ 18 years of age
* Scores at above clinical threshold, as defined by the investigators, on at least one of: Patient Health Questionnaire-9 (\[PHQ-9\] score ≥ 10), Generalized Anxiety Disorder Scale-7 (\[GAD-7\] score ≥ 10), and/or Posttraumatic Stress Disorder Scale-5 (\[PCL-5\] score ≥ 33)
* Access to a computer or a tablet with high speed internet access, be able to clearly see the screen of a computer or tablet, and be fluent in English
* Ability to provide consent

Exclusion Criteria:

* Elevated risk of suicide
* Currently enrolled in another intervention or treatment (e.g., cognitive behavioural therapy) for stress responses related to the COVID-19 pandemic
Paclitaxel in Treating Older Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients who have solid tumors.

OBJECTIVES:

* Determine whether there is a relationship between pharmacokinetic measurements of paclitaxel and aging.
* Determine whether there is a relationship between the toxic effects of paclitaxel and aging.

OUTLINE: Patients are stratified according to age (cohort 1: patients 55 to 64 vs cohort 2: patients 65 to 75 vs cohort 3: patients 75 and over).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven nonhematologic malignancy

PATIENT CHARACTERISTICS:

Age:

* 55 and over

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin less than 1.5 mg/dL
* SGOT less than 2.0 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.5 times ULN

Cardiovascular:

* No uncontrolled or severe cardiovascular disease

Other:

* No serious intercurrent medical illnesses that in the judgement of the investigator compromise patient care
* No psychiatric conditions that would preclude study
* No requirement for antibiotics for active acute infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No more than one prior chemotherapy regimen allowed
* No prior paclitaxel allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiation therapy

Surgery:

* Not specified
Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera

The purpose of this study is the identification of the maximum tolerated dose (MTD) of the investigational medicinal product. Moreover the safety and tolerability will be assessed and an exploratory analysis of efficacy and biomarker modulation will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained prior to any study specific screening activities and able to comply with this protocol.
2. Patients age ≥18 years
3. Confirmed diagnosis of PV according to either the WHO criteria (2008, appendix 6) or the PSVG (appendix 7) criteria plus JAK-2 positivity, including newly diagnosed, pre-treated and on cytoreductive therapy.
4. Eastern Cooperative Oncology Group performance status ≤ 2
5. If female of childbearing potential - have a negative urine pregnancy test result within 7 days prior to the scheduled first application of investigational product and agree to employ adequate birth control measures for the duration of the study.

Exclusion criteria:

1. Diagnosis of any other myeloproliferative disorder
2. Any clinically significant illness or surgery within 4 weeks prior to dosing
3. Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
4. Uncontrolled hypertension (systolic \> 150 mmHg and diastolic \> 100 mmHg, or clinically significant (i.e. active) cardiovascular disease: CVA/stroke (≤ 3 months prior to enrolment), myocardial infarction (≤ 3 months prior to enrolment), significant coronary artery stenosis, unstable angina, New York Heart Association (NYHA) Class 2 or greater Congestive heart failure, or serious cardiac arrhythmia requiring medication.
5. Previous treatment with Interferon for PV
6. Concurrent treatment with cytoreductive agents other than Hydroxyurea and investigational agents of any type
7. History of malignant disease, including solid tumours and haematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years
8. History of severe allergic (like anaphylaxis) or hypersensitivity reactions (like angioedema), any known or suspected intolerance to the investigational product.
9. Use of any investigational drug or participation in any investigational drug study within the last 4 weeks
10. Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety and sleep disorders
11. Organ transplant, past or planned
12. Inadequate liver function defined by serum (total) bilirubin \> 2,5 x ULN and/ or AST and ALT \> 2,5 x ULN
13. Clinically significant ECG findings
14. History of renal disease requiring haemodialysis or seizure disorder requiring anticonvulsant therapy
15. Pregnant or lactating females (pregnancy test to be assessed within 7 days prior to study treatment start)
16. Acute or chronic infections or autoimmune diseases (collagen diseases, polyarthritis, immune thrombocythemia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder).
Lower Urinary Tract Symptoms in Women and Adjustment Disorder

Our hypothesis that the prevalence of AD in uro-gynecologic patients with LUTS who are seeking medical help for their condition is higher than that of the general population (indicated by high scores at the ADNM-20; score above 48). Taking into consideration that affective disorders, anxiety and depression among patients with LUTS present with a prevalence of 17-23% \[20\] as well as through long personal experience, we hypothesize that the prevalence of AD in this group is 20%.


Eligibility Criteria:
Inclusion Criteria:

* Female patients seeking medical help for lower urinary tract symptoms
* German speaking

Exclusion Criteria:

* Pelvic floor Prolapse symptoms or Stage III or more by medical examination
* Inability to understand the purpose of the study
Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"

The evaluation of the clinical data has demonstrated the conformity of the Resorbable Collagen Membrane (RCM), EZ CureTM, with the relevant essential requirements for its use in periodontal applications. The RCM is intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) procedures. It acts as a barrier against the migration of epithelial cells within the bone defect (performance) and thus complies with several surgical indications in the treatment of maxillofacial bone defects. It has been concluded that the risks associated with the use of this device are acceptable when weighted against the benefits to the patients.

In order to improve the clinical data on the RCM, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:

1. Tissue regeneration (mucosa health on the site of implantation)
2. Safety (report of any adverse event)
3. Radiographic analysis of periodontal tissues


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged from 18 to 70
* Periodontal defects (e.g. cyst, bone tumour, crest augmentation...)
* Aleveolar bone defect after tooth (teeth) extraction
* Non opposition form (consent of the patient)
* Patients affiliated to the French social security
* Patients not under guardianship or judicial protection

Exclusion Criteria:

* Pregnancy of breastfeeding women
* Severe smoker (\>10 cigarettes per day)
* Acute infections
* Allergies to the material (if an allergy of any kind is suspected, adequate exams must be carried out in advance)
* Refusal of the patient to adhere to surgical follow-up and to the limit in activity level
* Fever and/or local inflammation
* HIV positive known
* History of uncontrolled diabetes (untreated or not stabilized by treatment)
* History of treatments for previous corticosteroids, long-term (more than 6 months) and interrupted for less than 3 months
* History of chemotherapy in progress or during the last three months
* History of cervico-facial radiotherapy
* History of bone disease with disorders of blood circulation which is defined as Akbers-Schönberg disease or Paget's disease
* Known severe hyperparathyroïdism
* History of severe immune deficiency
Diagnosis of HCM With AI-ECG

The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HCM

Exclusion Criteria:

* Patients with ventricular pacing
Efficacy of Iodine Complex Against COVID-19 Patients

The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.

Eligibility Criteria:
Inclusion Criteria:

* Positive PCR with mild to moderate disease

Exclusion Criteria:

* Allergic to iodine
* Any co-morbidity other than hypertension and dietetics
A Pilot Study to Evaluate a Molecular Method for Plaque

This study is to evaluate the sensitivity of the molecular method and its ability to split a stannous fluoride toothpaste versus a negative control.


Eligibility Criteria:
Inclusion Criteria:

In order to be included in the study, each subject must:

* Provide written informed consent to participate in the study;
* Be 18 years of age or older;
* Agree not to participate in any other oral/dental product studies during the course of this study;
* Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
* Agree to maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time;
* Agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss or whitening products;
* Agree to return for all scheduled visits and follow study procedures;
* Must have at least 16 natural teeth;
* Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study;
* Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;
* Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
* Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
* Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm;
* Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm.

Exclusion Criteria:

Subjects are excluded from study participation where there is evidence of:

* Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
* Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
* Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
* Need an antibiotic prophylaxis prior to dental visits;
* A history of hypersensitivity to oral care products containing stannous fluoride;
* A history of hypersensitivity to dyes (from products containing food dyes);
* Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
* Are pregnant (Self-reported) or lactating.