cyrilzakka/clinical-trials huggingface dataset:
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

* risks of hemorrhage
* thromboembolic risks
* weight less than 40 kg
* pregnant, suspect pregnancy, or subjects who want to become pregnant
Early Flu Shots in SOT

Although time from transplant has been a factor in vaccine response, there is limited data on immunizations that occur in the first post-transplant year, and there are no data that suggest influenza vaccination early post-transplant may have any adverse effects on the graft. It is suggested that early vaccinations may lead to reduced immunogenicity due to induction immunosuppression. However, not vaccinating patients may leave them vulnerable to influenza infection for a period of time. This study is designed to look at the immunogenicity and side effects of the standard of care influenza vaccine in patients between 31 and 365 days post-transplant.

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Influenza vaccine is effective in the prevention of influenza infection and is recommended by the Canadian National Advisory Committee on Immunization (NACI). The annual influenza vaccine is suggested for transplant patients as the standard of care starting from 3 months post-transplant. Most recent guidelines now suggest that it is reasonable to get a flu shot starting earlier at 1 month post-transplant. Anti-rejection drugs are now tapered more quickly and it is possible that antibodies will be produced against the flu shot as early as 1 month post-transplant. The study hypothesizes that kidney and liver transplant recipients in the early post-transplant period (31-180 days) will have similar immunogenicity as those in the late post-transplant period (\>180 days).

Eligibility Criteria:
Inclusion Criteria:

* Kidney, liver or pancreas transplant recipients on at least one immunosuppressive medication
* Age ≥ 18
* Outpatient status
* Greater than 30 days post-transplant

Exclusion Criteria:

* Has already received influenza vaccination for 2017-2018 season
* Egg allergy or allergy to previous influenza vaccine
* Febrile illness in the past one week
* Active Cytomegalovirus viremia
* Use of Rituximab in the past one year
* Ongoing or recent (in past 30 days) therapy for acute rejection
* Chronic kidney insufficiency (creatinine clearance ≤30mL/min or dialysis-dependent
* Previous life-threatening reaction to influenza vaccine (i.e., Guillain Barre Syndrome)
* Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next four weeks
Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults

Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and carnitine-containing foods within the human gut microbiome. Elevated serum TMAO was previously reported to be associated with an elevated risk for cardiovascular events.

Aim of this study was to investigate the association between plasma levels of TMAO with the Mediterranean diet in a cohort of healthy adults.


Eligibility Criteria:
Inclusion Criteria:

healthy subjects of both gender

Exclusion Criteria:

* age\>65 years
* \> BMI 30 kg/m2
* vegetarians
* smokers
* gastrointestinal diseases or complaints
* chronic illnesses or other metabolic diseases (including trimethylaminuria)
* abnormal blood chemistry values indicative of organ dysfunctions
* nutritional supplements, antibiotics or probiotics within 2 months of recruitment
A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis

The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.

SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety, tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Completion of MF-TG101348-001 study
* Diagnosis of myelofibrosis
* At least 18 years of age

Exclusion Criteria:

* Any acute or chronic medical abnormality that may increase the risk associated with study participation
Diesel Exhaust Inhalation, Systemic Nitric Oxide Inhibition and Cardiac Output

Exposure to combustion-derived fine particulate air pollution is associated with cardiovascular mortality and morbidity. In previous studies, exposure to diesel exhaust (a major constituent of urban particulate air pollution) has been shown to impair two important functions of the vascular endothelium: vascular vasomotor function and endogenous fibrinolysis. Our subsequent studies suggest this impairment of vascular function is mediated by a reduction in nitric oxide bioavailability. In this study we aim to investigate the cardiovascular responses to systemic nitric oxide synthase inhibition following exposure to dilute diesel exhaust.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Non smokers
* No regular medication (except oral contraceptive)
* No recent respiratory tract infection (within 6 weeks)

Exclusion Criteria:

* History of asthma or respiratory disease
* Smoking history
* Pregnancy (positive urinary pregnancy test)
Evaluation of Diagnostic Accuracy of Artificial Intelligence in Treatment Planning for Non-growing Class II Cases

The goal of this observational study is to evaluate the diagnostic accuracy of artificial intelligence in non-growing class II cases. The main question it aims to answer is:

Is Artificial Intelligence (AI) accurate in choosing a treatment modality for non-growing class II cases -whether to camouflage or surgical treatment?

participants already undergone orthodontic treatment, their pre-treatment and post-treatment records will be collected from the archive of orthodontic department at Cairo university


Eligibility Criteria:
Inclusion Criteria:

cases of non-growing patients with class II malocclusion

Exclusion Criteria:

Growing patient with class II malocclusion
Comparison of Upper Extremity Exercise Capacity and ADL Between Subjects With Bronchiectasis and Healthy Controls

Bronchiectasis is a chronic lung disease characterized by permanent dilatation and destruction, resulting from the destruction of elastic tissue and muscular components in the bronchial walls, due to infection or inflammation. The exercise tolerance, physical activity level, respiratory and peripheral muscle strength of patients with bronchiectasis are lower than those of healthy individuals. The decrease in exercise tolerance occurs while performing upper extremity activities as well as lower extremity tasks. Many studies have reported that upper extremity exercise capacity is reduced in chronic obstructive pulmonary disease (COPD), a disease similar to bronchiectasis, and that patients often experience significant dyspnea and fatigue during upper extremity tasks that are important for daily life. The mechanisms causing this situation may be neuromechanical dysfunction of the respiratory muscles (diaphragm and accessory respiratory muscles) (thoracoabdominal asynchrony) and changes in lung volume in activities involving the upper extremities. The disturbances in ventilatory mechanics in patients with COPD cause upper extremity exercise to be terminated at low workloads compared to healthy individuals. Upper extremity exercise has been defined as part of pulmonary rehabilitation. The determination of upper extremity exercise capacity may play a predictive role in maintaining and improving upper extremity and daily life activity level in patients with chronic lung disease.

Six-minute Pegboard and Ring test (6PBRT) is used to evaluate extremity exercise capacity and upper extremity function and endurance. The 6PBRT score and upper extremity daily living activities show a clear relationship in patients with COPD, and it can be used to determine and improve the performance of daily living activities in pulmonary rehabilitation programs. Glittre Activities of Daily Living (Glittre ADL test) covers activities that are necessary for daily living and commonly used activities. The Glittre ADL test produces similar cardiorespiratory responses when compared with the six-minute walk test. In this study, unsupported upper extremity exercise capacity and upper extremity function/endurance and the performance of daily living activities will be compared in participants with bronchiectasis and compared with healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bronchiectasis and being clinically stable,
* Being 18 years old or older,
* Being able and willing to complete the informed consent process.

Exclusion criteria:

* Individuals with bronchiectasis whose clinical condition is unstable,
* Individuals with bronchiectasis who have severe neuromuscular, musculoskeletal, and rheumatological problems,
* Being unable to cooperate,
* Not being willing to participate in the study

The healthy controls will be composed of individuals who volunteered for the study without any known disease. Healthy individuals who did not volunteer to participate in the study will not be included.
Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow

Studying Carbon monoxide effects on brain vessels in healthy volunteers with magnetic resonance imaging.

In this study we will systematically investigate the headache-releasing properties of carbon monoxide as well as measure the effect of carbon monoxide on mean blood flow rate in the brain's large vessel with magnetic resonance imaging. These studies are important for understanding and further investigating the carbon monoxide's headache-releasing effect in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18-50
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than 5 dage /month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* Smoking
* Primary relatives with current or previous migraine
Assessment of the Predictive Value of the Acetic Acid Test in Surgery Condition for the Detection of Dysplastic Lesions in Patients With Anal Condylomatosis

Anal condylomatosis is an anal canal mucosa pathology caused by HPV infection (Human Papilloma Virus). This condition is common, especially in immunodepressed patients.

These lesions are not accessible to topical medical treatment because of their location. They should be treated surgically because they may degenerate into squamous cell carcinoma.

In the operating room, lesions are identified by a complete proctologic examination, more or less supplemented by an acetic acid test. Acetic acid allows to detect mucous degeneration (dysplasia) in the form of intense bleaching. The interpretation of this test may nevertheless be difficult in case of local inflammation or scarring. These false positives may lead to unnecessary surgical gestures. The surgical procedure consists of a mucosectomy or destruction of the condylomatosis by electrocoagulation.

The acetic acid test is used at the discretion of the surgeon. However, there is little data on its performance or consensus on its use.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* programmed surgery for anal condylomatosis in the visceral surgery department of the Hôpital de la Croix Rousse in Lyon
* patient in receipt of the social security scheme
* patient who did not oppose his participation in the study.

Exclusion Criteria:

* Pregnant women
* Patients protected by law
Use of Non-invasive 4D Ultrasound Clarity System in Prostate IMRT/RapidArc Therapy

A single arm phase II study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT.

Primarily, this is a single arm phase I study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) or Volumetric Modulated Arc therapy (VMAT) with the aid of volumetric image guidance to ensure accuracy and real-time 3D ultrasound images as observational record of the prostate motion. All the recruited patients are prescribed and treated with either VMAT or IMRT treatment. In order to simulate the behaviour of prostate motion in an IMRT scenario, the group of VMAT patients will be required to remain in treatment position for an additional 7 minutes depending on techniques used (once a week).

In order to assess the level of acceptance of the treatment position, responses to the same comfort survey for the current treatment position (i.e. using leg immobiliser) by a cohort of 60 patients treated in another IGRT treatment room will be used as the baseline. In addition, RTT satisfaction questionnaire will also be administered to assess the handling of the new immobilizer.

Acute toxicity will be measured at preset intervals using CTCAE version 3.0 and as will International prostate symptom score (IPSS) questionnaire which focuses on urinary symptoms. Symptoms or toxicities reported from this study is relevant for patients treated with IMRT or VMAT with full bladder protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

* Patient who cannot abide to the departmental hydration protocol
* Prostatectomy cases
* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol requires contact of ultrasound probe to the perineum area.
* Patient enrolled in other clinical trials
The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.

The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* duration of type 1 diabetes longer than 12 months
* insulin pump therapy longer than 3 months
* treated by the same type of insulin longer than 3 months
* written informed consent by patients and parents

Exclusion Criteria:

* celiac disease
* diabetes related complications (e.g. nephropathy)
* any disease judged by the investigator to affect the trial
* withdrawal of consent to participate in the study
Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

Alteration in the sense of taste is a frequent symptom that is closely linked to chemotherapy exposure, lowering quality of life and nutritional status. Malnutrition is of particular concern in muscle-invasive bladder cancer (MIBC), as malnutrition is associated with many negative outcomes from radical cystectomy (the surgical procedure in MIBC), which include higher morbidity, poor wound healing, and higher rate of infections after surgery.

It is essential to understand taste changes among participants receiving chemotherapy for MIBC to create future treatment trials.


Eligibility Criteria:
Inclusion Criteria:

* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
* Age ≥ 18 years.
* Histologically proven MIBC (Muscle Invasive Bladder Cancer) without metastatic disease Diagnosis.
* Planning to undergo neoadjuvant chemotherapy and radical cystectomy for MIBC

Exclusion Criteria:

* No prior systemic chemotherapy for MIBC.
* Cannot be simultaneously enrolled in any therapeutic clinical trial, unless receiving standard neoadjuvant chemotherapy on said clinical trial.
* Any oral or cognitive pathology impairing the ability to perform taste testing procedures.
* No other known malignancy within previous 2 years with the following EXCEPTIONS: Low-grade prostate cancer on active surveillance, CLL on surveillance / observation, non-melanoma skin cancers.
* No psychiatric illness/social situations that would limit compliance with study requirements.
Radial-Probe Endobronchial Ultrasound in Detecting Atelectasis in Patients Undergoing Peripheral Bronchoscopy

This trial studies how well radial-probe endobronchial ultrasound works in detecting the complete or partial collapse of the lung in patients undergoing peripheral bronchoscopy. Diagnostic procedures, such as radial-probe endobronchial ultrasound and bronchoscopy, use a thin, tube-like instrument inserted through the nose or mouth to view and take pictures of the inside of the trachea, air passages, and lungs.

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients identified as developing intraprocedural atelectasis detected by radial-probe endobronchial ultrasound (RP-EBUS) during peripheral bronchoscopy under general anesthesia.

SECONDARY OBJECTIVES:

I. To describe the most common locations for developing intraprocedural atelectasis detected by RP-EBUS.

II. To describe the proportion of evaluated bronchial segments per patient that are identified as developing intraprocedural atelectasis by RP-EBUS.

III. To identify patient and procedural characteristics that may predispose to the development of atelectasis.

OUTLINE:

Patients undergo bronchoscopy per standard of care, RP-EBUS of the left and right lungs during bronchoscopy procedure, and RP-imaging over 3-5 minutes at the end of the bronchoscopy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions
* Recent computed tomography (CT) performed no more than 4 weeks prior to the bronchoscopy
* Voluntary informed consent to participate in the study

Exclusion Criteria:

* Patients with baseline lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) in dependent areas of the lung as seen on most recent CT
* Pregnancy
* Ascites
* Known diaphragmatic paralysis
Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged between 18 and 75 years old (including the cut-off value);
2. undergoing unilateral Total Knee Arthroplasty (TKA);
3. Voluntarily participate in the study and sign a written informed consent;

Exclusion Criteria:

1. There is a high risk of bleeding or abnormal bleeding related indicators:
2. Evidence of venous thrombosis, such as the presence of related symptoms or auxiliary tests indicating thrombosis; Or have a history of venous embolic disease.
3. Acute myocardial infarction or ischemic stroke occurred within 6 months before screening.
4. Presence of malignant tumors or history of malignant tumors.
A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with good general health as judged by the physician
* Body weight of 65-95 kg (both inclusive)
* Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician
Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block

The study is aimed at patients with low back and leg pain. The experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers, and the control group underwent puncture under the guidance of ultrasound alone by sonographers.

A total of 60 patients with low back and leg pain were randomly divided into two groups, 30 people in each group. Patients in the experimental group underwent selective lumbar nerve root block puncture under the real-time ultrasound-CT fusion imaging of the sonographer, and the control group underwent puncture under the sole ultrasound guidance of the sonographer. This study was used to compare the difference between the effects of pure ultrasound guidance and ultrasound-CT fusion imaging guidance on selective lumbar nerve root block.

Eligibility Criteria:
Inclusion Criteria:

Patients who need lumbar nerve root block treatment

Exclusion Criteria:

1. Tumor patients
2. Patients who have had lumbar spine surgery before
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects

The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* A history of drug induced agranulocytosis and history of liver and hematological problems while taking amodiaquine.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.