cyrilzakka/clinical-trials huggingface dataset:
The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect

The purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with Integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. The study team will be looking at the subject's satisfaction with how the skin graft site looks and how well the skin graft site is functioning.

The radial forearm fasciocutaneous free flap (hereafter referred to as RFFF) was described more than 30 years ago as a fasciocutaneous flap for microsurgical transfer. It was soon after established as a safe and reliable flap for transfer of fascia and cutaneous tissue. Currently, it is used to repair any defect in which a relatively thin island of skin is needed with a fascial strength layer . While the flap itself is very reliable, it leaves a donor site that can be very unsightly and has multiple known complications including loss of pronation, pain, paresthesias, cold intolerance, and skin graft necrosis. The donor site is typically covered with a split thickness skin graft (hereafter referred to as STSG). In an effort to minimize these complications, several groups have described a technique of placing Integra© dermal substitute (hereafter referred to as Integra) underneath the STSG to provide a thicker support and decrease overall morbidity associated with the defect. These studies have shown success in decreasing overall morbidity including increasing range of motion and improving aesthetic quality of the donor site. However, the largest study to date has included only 29 subjects. Furthermore, these studies do not provide a comparative cohort of subjects repaired with a classic STSG to show effectiveness of this technique when compared to a classic repair. Our goal is to perform a prospective study comparing subjects repaired with a classic STSG and those repaired with one step Integra and STSG applied at the same time. These subjects will be evaluated for overall donor site aesthetic quality and functional outcome as described below.

Eligibility Criteria:
Inclusion Criteria:

* All subjects who receive a radial forearm free flaps in the included time period, including subjects with head and neck cancer, traumatic defects, chronic wounds, or any other problems that require a radical forearm free flap for reconstruction.
* Have had a distal, anterograde fasciocutaneous flap
* Age ≥ 18 years
* Ability to understand and the willingness to sign an IRB-approved informed consent document.
* Smokers and tobacco users will be included in this study

Exclusion Criteria:

* Subjects who have had an osteocutaneous or musculocutaneous flap.
* Subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a "reverse" radial forearm flap
* Pregnant women will be excluded due to the lack of clinical studies evaluating INTEGRA template in pregnant women.
A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer

To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer

patients were randomized to receive either: 70Gy in 35fx in 7wks at 2Gy/fx concurrently with weekly cisplatin 40mg/m2 (Arm A) or 74Gy in 33 fractions (fx) in 6.5 weeks at 2.24Gy/fx (Arm B). Volumetric Modulated Arc Therapy (VMAT) plans were created for both treatment arms

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and ≤70 years old.
2. Histopathologically confirmed squamous cell carcinoma of head and neck.
3. Locally advanced tumors (T3-T4 \&/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition).
4. Patients not exposed to radical surgery for current disease.
5. Performance status (ECOG) 2 or less.
6. No associated co-morbidity with contraindication to chemotherapy.
7. Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L)
8. Accepted renal functions. (BUN \& serum creatinine \<1.5x upper limit of normal value with normal GFR).
9. Accepted liver functions. (total bilirubin and direct bilirubin \< 1.5 x ULN \& alanine aminotransferase and aspartate aminotransferase \< 3 x ULN)
10. Informed consent.

Exclusion Criteria:

1. Patients with distant metastatic lesions, as detected by imaging techniques.
2. Patients with history of other head and neck malignancies.
3. Patients with history of previous head and neck irradiation.
4. Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection.
5. Women who are pregnant or breast feeding.
Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

The purpose of this study is to see how effective treatment of high doses of chemotherapy is for your tumor. We will also be looking at the side effects and risks of this treatment.

You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy tumor cells, but it can also destroy normal bone marrow cells. These cells produce white blood cells (which fight infection), red blood cells (which carry oxygen) and platelets (which allow your blood to clot). With too few of these cells there is a serious risk of infection and bleeding.

Therefore, before treatment begins, we will collect some of your own blood cells, called peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs are thawed and given back to you. These healthy PBPCs will replace the blood cells that the high dose chemotherapy destroys and allow your bone marrow to recover and produce blood cells. In a prior study we treated 69 patients in a similar way. More than half were able to avoid or delay brain radiation. This new study will use a different high dose chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic evidence of an anaplastic oligodendroglioma. For this study, World Health Organization classification criteria will be used. Central pathology review must take place prior to high-dose therapy but need not occur prior to study entry and induction therapy.
* Pathologic evidence of an anaplastic mixed glioma (i.e. oligoastrocytoma). Again, histopathologic diagnosis will be made using World Health Organization classification criteria. To qualify as a mixed tumor there must be a minimum of 25% oligodendroglial element. Central pathology review must take place prior to high-dose therapy but need not occur in advance of enrollment or induction therapy.
* The diagnostic surgical procedure may have been a complete resection, partial resection, or biopsy.
* Karnofsky performance status \> or equal to 60.
* Granulocyte count \> or equal to 1.5 X 109/L.
* Platelet count \> or equal to 100 X 109/L
* SGOT \< than or equal to 2X upper limit of normal.
* Serum creatinine \< than or equal to 1.5X upper limit of normal
* Bilirubin \< than or equal to 1.5X upper limit of normal
* All patients must sign written informed consent.

Exclusion Criteria:

* Systemic or leptomeningeal metastases (excluding contiguous leptomeninges)
* Prior cranial radiotherapy or systemic chemotherapy
* Other concurrent malignancy (with the exception of cervical carcinoma in situ or basal cell carcinoma of the skin) or serious illness if this would interfere with the prescribed treatment.
* Pregnant or lactating women
* Refusal to use effective contraception
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer

Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic Breast Cancer.

Nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival. There is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥18 years
* Patients with histologically or cytologically confirmed, HER2-negative, metastatic Breast Cancer
* No prior first line treatment for metastatic Breast Cancer
* Previous hormonotherapy for metastatic Breast Cancer is allowed
* One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
* ECOG performance status ≤2
* Adequate haematological, renal and hepatic function
* Urine protein \<2+ (dipstick)
* Life expectancy of ≥12 weeks

Exclusion Criteria:

* Previous first line treatment for metastatic colorectal cancer(progression \>12 months after the end of adjuvant treatment)
* Previous radiotherapy to target lesions
* Patients with brain metastases and/or cancerous meningitis
* Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
* Patients participating in interventional clinical trial
Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia

Patients presenting with large myocardial infarction and signs of persistent ischemia after successful percutaneous coronary intervention, have a poor prognosis with respect to outcome and development of heart failure in the future.

The hypothesis of this study is that in patients in whom persistent ischemia is present, use of intra-aortic balloon pump will be beneficial and improve outcome.

In some patients presenting with large myocardial infarction and poor hemodynamic condition, intra-aortic balloon counterpulsation is effective in alleviating cardiogenic shock. In others, the use of intra-aortic balloon pump has no effect at all. The investigators believe this is dependent on the presence of persisting ischemia after successful epicardial reperfusion, known as no-reflow.

In the presence of persisting ischemia, the investigators believe us of the intra-aortic balloon pump will relieve ischemia and improve outcome.

Eligibility Criteria:
Inclusion Criteria:

* Acute ST-segment elevation myocardial infarction with summed ST-segment deviation ≥15 mm.
* Insufficient ST-segment resolution (\<50%) on the ECG made 10-30 minutes after the primary PCI in the catheterization laboratory.

Exclusion Criteria:

* Initial summed ST-segment deviation less than 15 mm
* ST-segment resolution \> 50% on the ECG performed in the catheterization laboratory
* Chest pain onset less than 2 or more than 8 hours before arrival
* Severe aortic valve stenosis/regurgitation
* Aortic abnormalities prohibitive for use of intra aortic balloon pump
* Full blown cardiogenic shock with immediate requirement of left ventricular assist device as judged necessary by the operator
* Inability to provide informed consent
* Pregnancy
* Inability to perform coronary angiography by the femoral approach
Unexpected Positive Cultures in Rotator Cuff Revision Surgery

In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus.

A prospective interventional study will be implemented to compare the results of non-randomized patient samples, whether positive or negative, taken during rotator cuff re-intervention. The objective is to assess whether these samples do not affect clinical outcomes and tendon healing rates.

Rotator cuff injuries are a common pathology with a 30% prevalence in the general population. If rotator cuff repair fails, patients often experience persistent pain, and bacteria can be detected during the revision period in approximately 30% of cases, even in the absence of septic symptoms. This type of infection, referred to as low-level infection, occurs in around 5% of cases and is frequently implicated as a contributing factor to poor outcomes of the intervention.

Bacteriological samples are routinely collected during revisions, especially for prostheses. The appropriate course of action in cases where these samples test positive, yet there are no signs of infection, remains to be clarified. Notably, administering antibiotics in response to unexpected positive cultures (UPC) during the revision period for total shoulder prostheses does not appear to significantly impact results or infection rates.

In the context of rotator cuff re-interventions, the impact of UPC has not been well-documented. The management of UPC, particularly regarding antibiotic therapy, has not been thoroughly studied and is not currently recommended. Further research is needed to establish guidelines for managing positive cultures in the absence of infection symptoms during rotator cuff re-interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged 18 or over
* Patient requiring re- intervention for Rotator Ruff Revision Surgery for non-healing of the same tendons after a first intervention (delay \<2 years)
* Patient requiring arthroscopy
* Patient having had realized a MRI of the shoulder in the 6 previous months
* Affiliate participant or beneficiary of a social security scheme
* Participant having been informed and not having objected to the use of their data

Exclusion Criteria:

* Patient with at least one clinical sign of infection (fever, redness)
* Patient with a new distant rupture on a healed cuff (\> 3 years)
* Patient with a history of shoulder surgery other than initial Rotator Ruff Surgery
* Patient having received antibiotic treatment in the 2 weeks preceding inclusion
* Participant in another research
* Participant in a period of exclusion from another research still in progress at the time of inclusion
* Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Participant hospitalized without consent
Study to Monitor the Effects of Androgen Suppression Treatment on the Heart

Suppression of effects of androgens with male sex hormones, androgen suppression treatment (AST), has been known to reduce deaths and prolong life in advanced prostate cancer. There have, however, been concerns raised in previous studies that androgen suppression may be associated with increased rate of heart attacks, particularly in older men. This study looks at prostate cancer patients in The Ottawa Hospital Cancer Clinic to see if treating these patients with androgen suppression is associated with a decrease in blood flow to the heart muscles by using Positron Emission Tomography (PET) and brachial artery ultrasound.

Treatment group: Prior to the initiation of AST, subjects will have a baseline N-13-ammonia PET scan and a brachial artery ultrasound at the University of Ottawa Heart Institute. Blood glucose and a lipid profile will be obtained. These tests will be repeated 6 - 9 months after starting AST.

Cancer control group: The same testing and intervals will be performed. Normals control group: Baseline testing will be done to establish a normal.

Eligibility Criteria:
Inclusion Criteria:

Cancer Population:

1. Diagnosis of prostate cancer
2. Treatment group: Scheduled to start AST, at Ottawa Hospital under the care of Radiation Oncology, Urology or Medical Oncology.

Control group: no AST scheduled as a treatment option for prostate cancer.

Non-Cancer Control Group

1. Male with low pre-test likelihood of coronary artery disease
2. No previous history of cancer.

Exclusion Criteria:

1. Known coronary disease including any of previous revascularization, history of myocardial infarction, coronary disease with \>= 50% stenosis in a major coronary vessel on previous angiography, evidence of previous myocardial infarction on 12-lead electrocardiogram, positive myocardial perfusion scan, previous cardiac PET scan, stress echocardiogram or exercise stress test.
2. Subjects with a Summed Stress Score of \>4 attributed to coronary disease on baseline PET images
3. Patients previously treated with AST
4. Patients with a life expectancy of less than 1 year.
Favipiravir in High-risk COVID-19 Patients

The study aims to investigate the efficacy of favipiravir in high-risk COVID-19 patients. The study population includes symptomatic mild-to-moderate COVID-19 inpatients, within first 7 days of illness, who are 50 years old and above, and have 1 or more comorbidities. The study is designed as a randomised, open-label, multicenter clinical trial where the patients are randomised 1:1 to groups receiving favipiravir (5 days) versus no favipiravir.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible to be included in the study only if they fulfil ALL the following criteria:
* RT-PCR confirmed COVID-19 cases
* Aged 50 years and above, AND have one or more co-morbidities
* Within the first 7 days of illness (from symptom onset)
* Mild to moderate clinical severity

Exclusion Criteria:

* Asymptomatic stage 1 patients
* Patients with SpO2 less than 95% without oxygen therapy
* Patients who needs oxygen supplements
* Patients with concomitant bacterial or fungal infection (confirmed by culture) prior to initiation of study
* Patients with congestive heart failure
* Patients with severe hepatic impairment (\>Grade 3: ALT \>10 times of upper normal limit)
* Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 30 ml/min) at the time of screening.
* Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
* Pregnant or nursing women or women planning pregnancy.
* Female patients who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 7 days after the end of favipiravir administration
* Male patients whose partner cannot agree to use the contraception method described in (9)
* Patients with a history of gout or on treatment for gout or hyperuricemia
* Patients receiving immunosuppressants
* Patients who received interferon or drugs with reported antiviral activity against COVID-19 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination) within 7 days of illness.
* Patients in whom this episode of infection is a recurrence or reinfection of COVID-19 infection
* Patients who have previously received favipiravir
* Patients who are not able to provide written consent by themselves
* Other patients judged ineligible by the principal investigator or sub-investigator
Precision Medicine for Stem Cell Transplantation

A study of patients undergoing haematopoietic stem cell transplantation, a procedure in which patients are infused with stem cells from a donor, resulting in a new immune system that eliminates cancer or replaces diseased bone marrow. This study aims to develop new blood tests that predict the onset of acute graft-versus-host disease (aGvHD) and leukaemia relapse, two life-threatening complications that frequently limit the success of treatment. Predictive tests would allow doctors to individualise prophylaxis and intervene early to abort complications before they develop. The study will also create a large collection of clinically annotated blood samples from 300 transplant recipients to support future research and provide a resource to the transplant research community.

Precision Medicine for Stem Cell Transplantation (PM-SCT) is a prospective cohort study of patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT). The study aims to develop novel biomarkers that predict the onset of acute graft-versus-host disease (aGvHD) and post-transplant relapse of acute myeloid leukaemia (AML). The study will also build a collection of clinically annotated longitudinal blood samples from 300 HSCT recipients to support additional mechanistic research and provide a resource to the transplant research community.

Patients will be recruited and consented prior to admission for HSCT. Enrolled patients will undergo sequential blood collection beginning prior to conditioning, then on the day of transplant (day 0), followed by days 7, 14, 21, 28, 56 (2 months) and 90 (3 months) post-transplant. Samples will be collected, processed, and stored by the MCRC Biobank. The period of observation for each patient is 6-months. Clinical data will be collected prospectively: on admission, with each blood sample, and at 6-months post-transplant. Bone marrow aspirates taken within this period as part of routine care will also be collected, these are typically performed around day 100 and whenever there is suspicion of disease recurrence. The study aims to identify all patients who develop aGvHD, collecting an additional blood sample at the onset of treatment for those who receive systemic corticosteroids (PO or IV steroid equivalent to ≥0.5mg/kg prednisolone). Additional clinical data will be collected at treatment onset and 7, 14, 21 and 28 days after starting systemic corticosteroids. These assessments will provide the clinical data necessary to establish diagnostic confidence, severity at onset/peak, response to treatment and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Any recipient of allogeneic haematopoietic stem cell transplantation (HSCT)
* Children/infants may participate, there is no age restriction
* Patients participating in other clinical trials remain eligible

Exclusion Criteria:

* Weight \<5kg
* Recipients of autologous stem cell transplants
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone

This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 3months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)