cyrilzakka/clinical-trials huggingface dataset:
Swallowing, Speech and Quality of Life of Patients With Carcinoma of the Oropharynx

The curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences.

The aim of this prospective pilot study is to describe swallowing, speech, but also patients' quality of life before and after therapeutic management (existing studies measuring these functions after treatment but not before).

This study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak then, as in normal practice, after 3, 6 and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient with stage T3 or T4 squamous cell carcinoma of the oropharynx previously untreated.
* Performance status 0 or 1
* Tumor histology proving squamous cell carcinoma

Exclusion Criteria:

* Visceral metastases at initial assessment
* Contraindication to surgery and / or chemotherapy such as:
* A history of other cancer (except basal cell carcinoma skin or cervical cancer in situ)
* 2nd associated cancer
The Effects of Intratesticular PRP Injection in Men With Azoospermia or Cryptozoospermia

The study will be conducted in men with a diagnosis of non-obstructive azoospermia or cryptozoospermia after obtaining written informed consent. The diagnosis of azoospermia and cryptozoospermia will be based on two semen analyses performed at least 15 days apart, followed by a documented micro testicular sperm extraction (TESE). A detailed history will be obtained, physical examination and laboratory evaluation will be performed prior to treatment. In physical examination, testicular volumes will be evaluated using an orchiometer. Serum FSH and testosterone values will be determined. PRP will be prepared by centrifugation of approximately 20 ml autologous blood obtained by phlebotomy. PRP (3 ml) will be administered into the seminiferous tubule or interstitial space of each testis. Sperm analysis, testicular volume (using orchiometer), serum FSH and testosterone levels will be reevaluated at 8 weeks post-procedure. Micro TESE will performed on the third month after PRP procedure.

Platelet-rich plasma (PRP) is a unique autologous agent derived from blood that is rich in growth factors, cytokines, and hormones; it has been reported to reduce oxidative stress and reactive oxygen species generation and upregulate the expression of various antioxidant enzymes. PRP is used in a variety of clinical applications in cell therapy. Based on World Health Organization guidelines, azoospermia is diagnosed when the absence of sperm is observed in two semen samples. Based on World Health Organization (WHO), cryptozoospermia is diagnosed when spermatozoa cannot be observed in a fresh semen sample; however, it is found after an extended centrifugation and microscopic search. All patients require a clinical work-up with physical examination, endocrine evaluation (follicle stimulating hormone (FSH), luteinizing hormone (LH) and testosterone) and genetic analysis. Scrotal and transrectal ultrasounds will be performed as indicated. Platelet-rich plasma (PRP), with its rich growth factor composition, has proven beneficial in regenerative therapy. The potential therapeutic role of PRP has not been studied in testis for non-obstructive azoospermia and cryptozoospermia. The investigators will investigate sperm parameters in non-obstructive azoospermic and crypotozoospermic patients treated with PRP.

Eligibility Criteria:
Inclusion Criteria:

* Azoospermia in at least 2 prior semen analysis.
* Diagnosis of Non-Obstructive Azoospermia or Diagnosis of Cryptozoospermia

Exclusion Criteria:

* Obstructive Azospermia
* Anatomical abnormalities in the genital tract,
* Cancer,
* Hepatitis
* Patients with systemic medical problems
* Patients with chromosomal disorders
Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery

The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.

Since current patient-reported outcome measures (PROMs) evidence related to static computer-aided implant surgery (s-CAIS) compared with conventional implant surgery (CIS), particularly in partial edentulous patients, were still limited. The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.

Eligibility Criteria:
Inclusion Criteria:

* Healthy or well-controlled systemic disease (ASA classification I,II)
* A partially edentulous ridge in the premolar-molar region with existing two-sided interproximal as well as antagonist contacts
* No sign of acute oral infection
* Periodontally healthy (or successfully treated)
* More than 2 mm of keratinized gingiva at the site of surgery
* Sufficient bony ridge for implant placement with or without simultaneous bone grafting

Exclusion Criteria:

* Diabetes mellitus
* Smoking more than ten cigarettes per day
* Pregnancy
* Psychiatric disorder
* History of radiation therapy at head and neck area and chemotherapy
* Bony pathologies, namely osseous dysplasia, odontogenic cyst, tumor
* History of soft tissue grafting at the prospective implant site
* Inadequate bony ridge with the need of bone augmentation prior to implant placement
Efficacy and Safety of 9MW0813 in Subjects With Diabetic Macular Edema

Phase III clinical study of the efficacy and safety of 9MW0813 and aflibercept (EYLEA®) in patients with diabetic macular edema (DME) in a multicenter, randomized, double-blind, parallel active-controlled study.

This is a multi-center, randomized, double-blind, parallel controlled phase 3 clinical trial.

The primary objective is to compare the similarity of clinical efficacy of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients.

The secondary objectives are to compare the similarity of safety, immunogenicity and pharmacokinetics of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients.

Eligibility Criteria:
Main Inclusion Criteria:

1. Age ≥ 18 years old, gender is not limited;
2. Diagnosed with type 1 or type 2 diabetes, and HbA1c≤10.0%;
3. The visual impairment of the study eye was mainly caused by diabetic macular edema;
4. OCT examination at screening and baseline, diabetic macular edema involving the fovea of the study eye, and central retinal thickness (CRT) ≥ 300 μm (using SD-OCT);
5. The best-corrected visual acuity (BCVA) of the study eye at screening and baseline measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart was between 73 and 24 letters (inclusive) (approximately equivalent to Snellen's visual acuity) score 20/40 to 20/320).

Main Exclusion Criteria:

1. Active proliferative diabetic retinopathy (PDR) exists in the study eye;
2. Structural damage to the fovea in the study eye, which may not improve BCVA after resolution of macular edema (eg, retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia, or organizing hard exudates) );
3. The study eye has any ocular disease or past medical history other than diabetic macular edema, and the investigator believes that it may affect the macular assessment or central vision (such as: cataract, retinal vascular occlusion, retinal detachment, macular traction, macular epiretinal membrane , macular hole, macular hemorrhage, preretinal fibrous proliferation involving the macula, various choroidal neovascularization);
4. The study eye has erythema of the iris, vitreous hemorrhage or traction retinal detachment;
5. The study eye has poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma drug treatment);
6. The study eye has received or may have received glaucoma filtration surgery (such as: trabeculectomy, sclerectomy and non-penetrating trabecular surgery) during the study period;
7. The study eye has received vitreoretinal surgery in the past;
8. Aphakic (except intraocular lens) in the research eye.
Validation of the Cervicothoracic Differentiation Test

The goal of this clinical trial is to compare the effects of two spinal manipulations in adults between the ages of 18-65 based on the results of a non-invasive clinical test. The main question it aims to answer is: • Does matched or unmatched region of manipulation based on the CTDT result in greater reduction of pain levels and improvement in range of motion in adults with neck pain compared to unmatched manipulations? Participants will be asked to:

* rate their pain with neck movement, complete brief questionnaires about their pain,
* have their neck range of motion measured,
* perform a test known as the cervico-thoracic differentiation test (CTDT),
* receive either a cervical or thoracic manipulation,
* repeat the range of motion measurements.
* A second session will occur 7-10 days later where questionnaires and range of motion measures will be repeated.

Researchers will compare the effects of manipulation matched to CTDT test result to individuals in the unmatched CTDT manipulation group to see if the CTDT may indicate which region will provide a greater treatment effect for individuals with neck pain.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18 and 65,
* must report neck pain with a Visual Analogue Scale (VAS) greater than or equal to 3/10.

Exclusion Criteria:

* History of motor vehicle accident (MVA) within the past 6 months,
* hypertension greater than or equal to 160/100,
* non-mechanical neck pain (pain that is not reproducible with movement),
* any past or present history of cancer,
* upper motor neuron (CNS) lesion symptoms ( a positive Clonus sign, Babinski sign, or hyperreflexia of DTR's),
* any infection that originates from the spine
* Current confirmed or suspected pregnancy, or recent postpartum (6 mos),
* known osteoporosis,
* rheumatoid arthritis,
* long-term use of corticosteroids (\>6mos),
* history of neck surgery,
* history of vertebral or rib fractures,
* blood clotting disorders,
* connective tissue disorders,
* radicular/neural pain/symptoms. Radicular pain and symptoms would include dermatomal changes (sensory loss or hypersensitization), myotomal changes (weaknesses of muscular along nerve distributions), decreased reflexes (hyporeflexia), pain that travels down the upper extremities, and pain that is referred into the upper extremities.
* clinical signs of instability of the vertebral segments in their neck
Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins

The investigators propose, as part of the study, to carry out for each patient:

* An analysis of monocytic populations by flow cytometry (CD14, CD16, CD45, CD68, CD115, CCR2, CX3CR1, CD163 and CD206).
* A population assessment of Myeloid-Derived Suppressor Cells (MDSC).
* Assays of cytokines and chemokines involved in inflammation by multiplex analyzes: Il-1 (α and β), Il-4, Il-6, Il-10, Il-13, TNF- α, TGF- β, CRP , leptin, IFN- β.
* Specialized dosages of proteins involved in bone metabolism. RANKL, osteoprotegerin, M-CSF, TRAPCP5.


Eligibility Criteria:
Inclusion Criteria:

* Major patients followed at the hemophilia treatment reference center,
* Presenting the diagnosis of severe, moderate or minor Hemophilia A / B,
* Having a social security system,
* Obtaining the oral non-objection collection from the patient after information.

Exclusion Criteria:

* Minor patients, under guardianship or curatorship.
* Causes of secondary osteoporosis:

  * Systemic corticosteroid therapy in progress (≥ 3 consecutive months, at a dosage ≥ 7.5 mg / d of prednisone equivalent).
  * other treatment or condition responsible for osteoporosis: prolonged or medicated hypogonadism, untreated active hyperthyroidism, hypercorticism, primary hyperparathyroidism.
* Treatment with biphosphonates, biotherapies or hormone therapy in the treatment of prostate cancer.
Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma

This study investigate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed CD20+ DLBCL
* 65 years old or over
* Scheduled to receive R-CHOP chemotherapy
* Informed consent

Exclusion Criteria:

* Other histology than CD20+ DLBCL
* Primary central nervous system DLBCL
* Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer \[papillary or follicular thyroid cancer\]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry
* Consent withdrawal
Blood Cultures's Profitability in Intensive Care Unit

The purpose of this study is to assess the blood cultures' profitability in intensive care unit and create a validated prediction rule for extractioning in critical patients.

Implementing a predictive rule blood cultures to determine the probability of positive or negative result, improving the profitability of the diagnostic test.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been extracted blood culture sample

Exclusion Criteria:

* Under-aged, pregnants, Major burns.
BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Dermatitis

The BioDay Registry aims to address the need for daily practice data regarding the effectiveness and safety of new systemic treatment options (like biologics and Janus kinase inhibitors) in patients with atopic dermatitis and effect on other atopic comorbidities in a multicenter setting. The registry already consists of several additional modules concerning atopic comorbidities, like food allergy and asthma, and a module for conjunctivitis during biologic treatment.


Eligibility Criteria:
Inclusion Criteria:

* All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry

Exclusion Criteria:

* Patients are not eligible for enrolment in case of presumed inability to answer questionnaires or not willing to answer questionnaires and will be excluded.
Virtual Intervention Stroke Initiative

The goal of this clinical trial is to determine if patients admitted to a primary stroke centre, such as the general internal medicine service of the Ottawa Hospitals General Campus, for acute ischemic stroke would benefit from a scheduled virtual assessment with a stroke neurologist to review investigations, results, and evaluations to identify stroke etiology, propose appropriate therapy, and guide decision-making and multidisciplinary assessment, similar to services provided to patients admitted to comprehensive stroke centres, such as the Civic Campus of the Ottawa Hospital.

Patients admitted to primary stroke centres do not have access to the same level of stroke expertise on site as do patients admitted to comprehensive stroke centres, resulting in increased length of stay with implications for access to stroke rehabilitation. Virtual access to stroke experts has been used in hyperacute stroke care through programs such as Ontario Telestroke, but this has not been routinely used for acute inpatient management. The investigators propose a system to provide virtual access to the stroke neurology team to patients admitted with stroke in a primary stroke centre. Patients at the General Campus of the Ottawa Hospital are currently admitted to Internal Medicine; this includes scheduled virtual assessment with a stroke neurologist and advanced practice nurse/interdisciplinary support to review investigations, results, and evaluations to identify stroke etiology, propose appropriate therapy, and guide decision-making and multidisciplinary assessment, similar to services provided to patients admitted to the Civic Campus. This will be developed with the assistance of Internal Medicine and will utilize technologies and assessment tools and strategies already being used for provision of virtual care in other settings. The goal of this project will be to prove that patients in primary stroke centres, with the assistance of virtual care, can benefit from the expertise available at comprehensive centers throughout their stay, and that this will result in an improved quality of care with benefits for patients, hospitals, and the community.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* admitted to the general internal medicine service of the Ottawa Hospital General Campus for acute ischemic stroke
* able to participate in video assessments with necessary accommodation/facilitation for participation (particularly if stroke results in physical or communication deficits)

Exclusion Criteria:

* patients who are unable, in the judgement of the study team or treating team, to participate in video assessments
PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients

This is a Phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen or rituximab-CHOP (R-CHOP) regimen.

Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) in which the Marqibo formulation and the 1-vial VSLI-RTU formulation of vincristine are administered in a 2-way crossover design over 2 treatment cycles (21 days each):

* Cohort A: Marqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1, and VSLI-RTU formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.
* Cohort B: VSLI-RTU formulation given at a dose of 2.25 mg/m2 with no dose cap during Cycle 1 and Marqibo formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.

Both formulations of vincristine sulfate LIPOSOME injection will be administered via a 60 (±10) minute IV infusion.

Blood samples for PK evaluation will be drawn at the following time points: immediately before infusion, 0.5 hour after the start of the infusion, 0.5 hour after the end of infusion (EOI), and 3, 8, 15, 24, 48, 72, and 96 hours post-EOI.

In addition to Marqibo or VSLI-RTU, all patients will receive standard doses (per institutional or regional guidelines) of cyclophosphamide, prednisone, and doxorubicin, (and rituximab if patient is on the R-CHOP regimen), on Day 1 and prednisone (or prednisolone if consistent with institutional or regional guidelines) on Days 2 to 5.

Eligibility Criteria:
Key Inclusion Criteria:

* Patient has a hematological malignancy and is eligible to receive CHOP or R-CHOP regimen.
* Patient must have adequate hematological, renal, and hepatic function as specified below within 30 days prior to the first dose of study treatment:
* Patient has a left ventricular ejection fraction ≥50% by multigated acquisition scan or echocardiogram within 30 days prior to the first dose of study treatment.

Key Exclusion Criteria:

* Patient has severe neurologic disorders (Grade 3 and above) including peripheral motor and sensory, central and autonomic neuropathy.
* Patient has a history of persistent active neurologic disorders including the demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.
* Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
* Patient has bowel obstruction, paralytic ileus, or uncontrolled chronic constipation.
* Patient has severe, active and uncontrolled hepatic disease or dysfunction.
Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).

Subjects who successfully completed the YKP509C001 study and could benefit from continued exposure to carisbamate.

This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed the YKP509C001 study
* Investigator believes subject could benefit from continued exposure to study drug
* Subjects must continue to meet all of the inclusion criteria from the YKP509C001 study

Exclusion Criteria:

* Subjects must continue to not meet any of the exclusion criteria from the YKP509C001 study
* There are no additional exclusion criteria in this study
Clinic Versus Home Spirometry

The study aims to assess the differences between spirometry performed with the NuvoAir Air Next spirometer in the clinic setting with both direct and virtual supervision via a video call, and in the home setting with virtual supervision. This is will be achieved by comparing lung function values, specifically the FEV1 and FVC measurements. We also wish to evaluate participant's perceptions of home spirometry, by using a survey.

This is a multi-centre, cross-over study. The study will enrol participants with a diagnosis of asthma and COPD, across participating study sites until 68 have completed the study.


Eligibility Criteria:
Inclusion Criteria:

* An ability to provide fully informed consent.
* A diagnosis of asthma or COPD.
* Male or female aged ≥18 and ≤ 80 years of age.

Exclusion Criteria:

* Symptoms suggestive of COVID-19.
* An exacerbation of asthma or COPD or symptoms of a respiratory infection within the 30 days prior to the first visit.
* Any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the Investigator(s), to impact on the ability to participate in the study.
* The presence of any contraindications to spirometry.