cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.

The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part.

Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.

Eligibility Criteria:
Inclusion Criteria:

* Subject's written informed consent obtained prior to any study-related procedure
* Male healthy volunteers aged 18-55 years;
* Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
* Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
* Non- or ex-smokers who smoked \< 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking \> 1 year;
* Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
* A reliable method of contraception for the subjects and their partner.

Exclusion Criteria:

* Blood donation or blood loss less than 8 weeks before inhalation of the study medication;
* Positive HIV1 or HIV2 serology;
* Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
* History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
* Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
* Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).
* Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre.
* Heavy caffeine drinker (\> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day).
Nalysis of the Periodontal Microbiota in Elderly Subjects with and Without Alzheimer's Disease: a Case Control Study

The neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. The mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. In addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. The final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* ge greater than or equal to 70 years old
* Patient (or trusted person) having read and understood the study information note and signed the informed consent form
* Membership in a social security scheme
* for cases : Diagnosis of possible or probable Alzheimer's disease according to the DSM-V

Exclusion Criteria:

* Presence of a neurodegenerative pathology (excluding Alzheimer's disease for cases)
* Presence of a neurocognitive disorder (excluding Alzheimer's disease for the cases)
* Patient with or having had any kind of cancer, including oral or aerodigestive tract
* Patients with or having had autoimmune diseases (HIV, hepatitis)
* Patients with inflammatory diseases (such as rheumatoid arthritis (RA) or Gougerot-Sjogren's syndrome (GSJ))
* Patients with severe haemopathy
* Patients with severe acute or chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, pulmonary, neuropsychiatric pathologies, judged by the investigator to be incompatible with the study, as all these pathologies may interfere with the results of the oral flora sampling
* Patients who have undergone oral surgery in the two months prior to sampling
* Patients treated with oral retinoids, bisphosphonates, oral anticoagulants or anticonvulsants
* Patients who have had anti-cancer or immunosuppressive chemotherapy within the last 6 months
* Patient who has had antibiotic or anti-inflammatory treatment in the last 4 weeks
* A history of treatments (drugs and probiotics) taken in the month prior to sampling will be taken, as well as a record of toxic habits (tobacco, alcohol, other)
The Registry of Genetic Expression of Taiwan Urologic Cancer

This project is a nationwide precision medicine program for urothelial carcinoma and renal cell carcinoma.

This project providing free and immediate next-generation gene sequencing testing for patients with urothelial and renal cell carcinomas that have is diagnosed or that have previously received systemic therapy. The goal of this project is to assist participating institutions in integrating next-generation sequencing results and building a real-time data storage and sharing platform, as well as establishing a tumor molecular biological atlas of Taiwanese patients with urothelial carcinoma and renal cell carcinoma. The data will be linked with clinical prognosis to facilitate the rapid screening of patients for effective potential therapeutic drugs and clinical trials, which is anticipated to prolong the survival rate of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 20 and above. (Age \>= 18 years old from January 1, 2023).
2. Pathological reports showed renal cell carinoma or urothelial carcinoma.
3. muscle-invasive bladder cancer or positive of N/M grade, UTUC of T2 at least or positive of N/M grade, or stage III/IV RCC
4. Willingness to provide the residual biopsy/operative tumor samples for study.
5. Life expectancy more than 3 months.
6. Patients fully understand the protocol with the willingness to have regular follow-up.

Exclusion Criteria:

1. Inability to cooperate by providing a complete medical history.
2. Ineligible tumor tissue samples for next-generation sequencing of genetic testing.
3. Undesirable compliance.
4. Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping

The ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown.

The purpose of this study is to investigate

1. The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools.
2. The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment.

Our hypothesis :

1. The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation.
2. Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.


Eligibility Criteria:
Inclusion criteria:

1. age:20\~80 y/o
2. female patients with unilateral breast cancer after surgery
3. unilateral lymph edema ( circumference of affected side 2cm bigger than sound side）
4. do not receive any treatment of lymph edema Exclusion criteria

1. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant
Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant

Patients with B-cell lymphoma who relapse after autologous transplant tend to have a poor prognosis. Currently, there is no standard treatment for such patients. Bexxar is a radioactive antibody therapy that has shown a 60-80% response rate in non-transplanted patients with relapsed B-cell lymphoma. This study will test the safety and efficacy of Bexxar in the treatment of patients whose B-cell lymphoma has relapsed after an autologous transplant.

High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become the standard of care for relapsed/refractory chemotherapy-sensitive non-Hodgkin's lymphomas (NHL). However, one-half to two-thirds of such patients will relapse after ASCT, with subsequent poor prognosis, and new therapies are urgently needed for this patient population. Radioimmunotherapy (RIT) as a single agent therapy in patients with CD20 antigen-expressing relapsed or refractory low-grade, follicular, or transformed NHL has demonstrated overall response rates of 60-80% and has been approved by the FDA for use in this setting. While RIT is currently under investigation as a component of conditioning regimens for ASCT, the safety and efficacy of RIT after ASCT has not yet been well described. We will conduct a single-center Phase I dose-escalation trial of Bexxar (Tositumomab and 131I Tositumomab) for treatment of relapsed or residual CD20 antigen-expressing B-cell lymphomas following ASCT. Our primary aim will be to determine the safety, dose-limiting toxicity, and maximum tolerated dose of Bexxar in this post-ASCT patient population. Our secondary aim will be to describe the overall response rate, progression-free survival, time to treatment failure, and overall survival. Should Bexxar prove to be safe in this population, subsequent trials will be designed to investigate further the efficacy of RIT in the post-transplant setting.

Eligibility Criteria:
Inclusion Criteria:

* CD20 positive B-cell lymphoma
* Confirmed relapsed/refractory disease following autologous transplant
* Age ≤ 75 years
* Performance status 0 or 1
* Creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min
* Total bilirubin, AST, and ALT ≤ 1.5 x upper limit of normal (unless bilirubin due to Gilbert's)
* No active CNS disease
* No detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination
* Bone marrow cellularity ≥ 15% on histopathologic bone marrow examination
* Availability of adequate stored autologous stem cell product (≥ 2 x 106 CD34+ cells/kg)

Exclusion Criteria:

* Active infection
* Pregnant woman are excluded from the study
* Subjects not using contraceptives are excluded from the study
* ANC ≤ 1,500/μL and/or platelet count ≤ 100,000/μL
* Life expectancy of ≤ 2 months
* Prior anti-B-cell radioimmunotherapy (e.g., Zevalin or Bexxar) \[Patients who have received prior anti-B-cell monoclonal antibody therapy (e.g., rituximab or epratuzumab) will NOT be excluded.\]
* Prior total body radiation therapy
* Positive human anti-mouse antibody (HAMA) testing
The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.

Many previous studies have investigated the ability of various methods such as passive leg raising test , and inferior vena cava collapsibility index in predicting post-spinal hypotension, but none of them have succeeded in obtaining a good predictive value.

Our study aims to combine the passive leg raising test with the inferior vena cava distensibility index to aid in predicting post-spinal hypotension in elderly undergoing infra-umbilical surgeries.


Eligibility Criteria:
Inclusion Criteria:

* 1. 65 years of age or more. 2. ASA score I \& II. 3. Patients are scheduled for infra umbilical surgeries under spinal anesthesia.

Exclusion Criteria:

* Negative consent. Pre-existing hypertension Diabetes mellitus or autonomic neuropathy (patients diagnosed with autonomic neuropathy or having suggestive symptoms such as orthostatic hypotension, syncopal attacks, decreased sweating, and urinary incontinence) Emergency operations Absolute contraindications or failure to perform spinal anesthesia If PLR maneuver is contraindicated (intracranial hypertension) or possibly unreliable ( venous compression stocking, intraabdominal hypertension) Difficulties in IVC visualization due to increased subcutaneous fat tissue or gastric gas interferin
Treatment Modification to Reduce Symptom Burden in Hemodialysis

Many patients on hemodialysis experience high rates of symptom burden, such as pain, depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by modifying the usual guidelines used to manage patients on hemodialysis. For example, rather than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have treatment goals of less than 6.5, in order to reduce the number of pills they need to take and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone goals will also be modified, to see if these modifications help hemodialysis patients feel better.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patient
* transplant ineligible

Exclusion Criteria:

* dementia
* unable to answer questionnaires for any reason
Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease

Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.

This study is a randomized controlled trial that compares the operative outcomes and complications of fluoroscopic guided-percutaneous nephrolithotomy versus ultrasound-guided PCNL for renal stones. This study will be a prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either PCNL under fluoroscopic guidance or PCNL under ultrasound guidance. Patients will be asked to complete pre-operative, and postoperative quality of life questionnaires, and to allow the collection of one additional vial of blood for measurement of factors associated with inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for PCNL at participating institution
* Patients of all ethnic backgrounds
* Stone size over 10 mm in diameter and a density over 900 Hounsfield units
* Patients with a large calculus in the upper third of the ureter

Exclusion Criteria:

* Pregnancy
* infectious disease of the genitals;
* conditions that violate the configuration of the kidneys (curvature of the spinal column)
* anomalies in the development of the kidneys with impaired configuration and position of the kidneys (horseshoe kidney, bisque kidney, S-shaped kidney, L-shaped kidney, lumbar dystopia, iliac dystopia, pelvic dystopia)
* presence of nephrostomy drainage in the target kidney;
* urethral stricture or other reason leading to the inability to carry out ureteral catheterization;
* other conditions that are contraindications to surgical treatment, such as uncontrolled diabetes mellitus, acute cardiovascular conditions, liver failure, alcoholism, and drug addiction;
* patients who are unable to understand the purpose of the study or refuse further follow-up observation and instructions after treatment;
* patients with a history of mental illness;
* participation in another research that interferes with this research;
* acute renal failure;
* dissecting aortic aneurysm;
* acute hypertensive encephalopathy;
* heavy arterial bleeding;
* myocardial infarction less than six months before enrollment in the study;
* Stroke less than six months before enrollment in the study;
* Insufficiency of blood circulation III-IV New York Heart Association class;
* Severe rhythm and conduction disturbances;
* Increase in the level of liver transaminases by more than three times;
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials

This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.

The study is comprised of a Baseline Visit and 2 Follow-up Periods. For Follow-up Periods 1 and 2, which includes Baseline through Year 5 visits, assessments will be performed at the Investigational site. For the first 2 years (Follow-up Period 1), visits will occur every 6 months. For Years 3 to 5 (Follow-up Period 2) follow-up visits will be conducted annually. All patients will enter the study at the baseline visit and continue for 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Participated in an OAV101 clinical trial.
2. Written informed consent must be obtained before any assessment is performed.
3. Patient/Parent/legal guardian willing and able to comply with study procedures.

Exclusion Criteria:

There are no exclusion criteria for this study.
A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting

This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of tocilizumab therapy in a routine clinical practice in participants with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a maximum study duration of 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe RA according to revised American College of Rheumatology criteria
* Participants have started tocilizumab treatment according to routine clinical practice within 3 months prior to site opening and still in treatment, as well as participants who began treatment at enrollment

Exclusion Criteria:

* Participants who have started tocilizumab treatment more than 3 months prior to site opening
* Participants who have previously received tocilizumab in a clinical trial setting or for compassionate use
* Participants who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
* Participants with a history of autoimmune disease or joint inflammatory disease other than RA
Pawsitive Impacts of Therapy Dog Visits

The goal of this unique 18 month study is to better understand the experiences of pain patients in the Royal University Hospital (RUH) Emergency Department (ED), to create excellence in health care. The purpose is to measure the impact of visiting therapy dogs on reducing ED patient pain.

The goal of this unique 18 month study is to better understand the experiences of pain patients in the Royal University Hospital (RUH) Emergency Department (ED), to create excellence in health care. The purpose is to measure the impact of visiting therapy dogs on reducing ED patient pain.

The background rationale is that pain is the primary reason individuals attend an ED, patient pain is generally not well managed in EDs, Saskatchewan EDs have among the longest wait times in the country, and anxiety associated with ED waiting can negatively impact patients' pain.

Research suggests a therapy dog can change patients' perceptions of pain and its intensity and facilitate relaxation. The intervention will be examined for its impact on patients' sensory pain (i.e., physical pain severity), affective pain (i.e., emotional pain unpleasantness) and anxiety.

It is important to find creative, low-cost ways to respond to patients attending the ED for pain. The primary objective of this study is to generate new health-related knowledge on the ED pain patient experience. The secondary objectives are to implement effective end-of-grant knowledge translation and dissemination strategies and undertake a successful model of collaborative, multidisciplinary research among researchers, patient advisors and system representatives, rooted in a One Health framework.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Able to provide consent
* Attending the Emergency Department because of pain/discomfort
* Canadian Triage and Acuity Score (CTAS) of 2-5
* Willing to visit with a therapy dog team (intervention group only)

Exclusion Criteria:

* Pain medications (specifically immediate release acetaminophen and opioid analgesics) within an hour prior to the visit
Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

Patient positioning is an essential part of a preventive strategy for neurocritical care patients.

The aim of the study will be to determine whether the positioning of the bed is the same or better compared to the positioning of the patient's bed in the presence of pressure ulcer.

In the monocentric, intervention, prospective, randomized study, we will investigate incidence of pressure ulcer in 300 adult consecutive patients admitted to our Neurointensive Care Unit (NICU). All patients will suffer from acute primary brain disease and will be unconscious with artificial pulmonary ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Primary brain disease
* Hospitalization in JIP neurocenter
* Age\> 18 years
* Unconsciousness
* Artificial pulmonary ventilation

Exclusion Criteria:

* Intracranial hypertension
* Decubitus on the skin upon admission