cyrilzakka/clinical-trials huggingface dataset:
Blood Flow Restricted High-Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors

Individuals surviving Chronic Ischemic Stroke have lingering walking deficits long after their infarct. The main goal of this study is to compare two high intensity treadmill walking programs to see which improves walking more. The main question we aim to answer is: How does blood flow restricted high-intensity treadmill training impact walking function? Participants will be randomly separated into two groups. One group will perform the high intensity treadmill training with blood flow restriction on their Stroke affected leg, while the second group performs high intensity treadmill training only. Every week participants will be asked to walk on the treadmill for a total of 75 minutes during 2x 1-hour sessions. On visit 1, participants will undergo strength, balance, and walking testing. They will then be treated 2x weekly for 4 weeks (visit 2-9) and be re-tested to track progress on visit 10. Participants will again be treated 2x weekly for 4 more weeks (visit 11-18) and be tested to see the end results on visit 19. Researchers will then compare both groups to see if blood flow restriction training changes walking function, strength, and balance.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older with history of single ischemic stroke \>6months.
* Ambulate without physical assistance over 10M with or without mobility aides and bracing in 180 seconds or less.

Exclusion Criteria:

* Concurrent physical or occupational therapy.
* Vulnerable populations such as adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners will be excluded.
* Resting BP \>160/100mmHg even with medication.
* People who have taken analgesics, dopamine, antipyretics, and any other drugs that can affect the function of the autonomic nervous system in the last 2 weeks and likely to be treated with such drugs during the course of the study.
* Individuals who score 9 (greater than normal or minimal impairment) or more on the Short Blessed Cognitive Assessment (6 item) will be unable to give informed consent.
* Any medical condition (including heart failure, unstable angina, aortic stenosis, arrhythmias, hypertrophic cardiomyopathy, depression of ST-segment, previous or active deep vein thrombosis (DVT) in the hemiparetic lower extremity, pulmonary embolism (PE), bypass surgery within last 3 months.) that, in the opinion of the investigator, might jeopardize the participants' safety.
Patient Satisfaction in Cutaneous Surgery

The primary objective of this study is to measure the overall level of satisfaction in patients after cutaneous surgery in 4 different categories, including the surgeon, facility, procedure and recovery and outcome.

Secondary objectives are to identify factors associated with patient satisfaction level and determine the correlation between patient satisfaction and surgeon clinical perception.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Is in a self-reported stable health condition
* English speaking
* Is willing and has the ability to understand the study, provide informed consent and communicate with the investigator
* Recommended to have and scheduled for cutaneous surgery
* Agrees to follow-up at scheduled times

Exclusion Criteria:

* Unable to speak or read English
* Did not complete an 8th grade education
* A history of mental illness
* Any other disability or condition that would prevent completion of questionnaire
Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer

The purpose of this study is to find out whether adding ZD1839 to standard treatment (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than cisplatin and radiation alone.

This is a Phase I-II, open-label, dose-escalation study in subjects with advanced head or neck cancer. Subjects will receive daily ZD1839 during a course of standard radiation therapy accompanied by cisplatin.

Subjects are adults with Stage III-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, who are in medically stable condition, with an Eastern Cooperative Oncology Group (ECOG) Performance Status of £ 1, stable hepatic and bone marrow function, and a life expectancy of at least 6 months. Subjects should have no previous cancer history (with the exception of squamous cell carcinoma of the skin or cervical cancer in situ) and no prior treatment with radiation, chemotherapy, or definitive surgical therapy. Subjects in the Phase II portion of the trial must have measurable disease as defined by RECIST criteria.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. For the Phase II portion of the study: measurable disease as based on RECIST criteria.
* Stage III or IV disease, M0.
* Life expectancy \> 6 months.

Exclusion Criteria:

* Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
* Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of squamous cell carcinoma of the skin or cervical cancer in situ.
* Previous treatment with radiation, chemotherapy, or definitive surgical therapy.
* Distant metastatic disease.
* Documented evidence of HIV infection (because the interaction of ZD1839 with Highly Active Anti-Retroviral Therapy \[HAART\] is unknown).
* Substance abuse or psychiatric problems that would interfere with compliance.
* Pregnancy or breast-feeding (women of child-bearing potential).
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
* Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
A Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic Carcinoma

This is a phase II, open-label, single-arm, multicenter study of the efficacy and safety of atezolizumab treatment in participants with advanced thymic carcinoma who failed prior systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of thymic carcinoma by the central pathology laboratory
* Advanced disease not amenable to curative treatment
* At least 1 prior line of chemotherapy
* Progression of disease must be documented prior to study entry
* Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
* Availability of a representative tumor specimen that is suitable for biomarkers research via central testing
* ECOG performance status 0 or1
* Life expectancy \> 3 months
* Adequate hematologic and end-organ function within 14 days prior to the first study treatment
* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
* For women of childbearing potential: agreement to remain abstinent or use contraception

Exclusion Criteria:

* Disease which is amenable to radical treatment with surgery or radiation or a combination of treatments.
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Active tuberculosis
* Significant cardiovascular disease within 3 months prior to initiation of study treatment unstable arrhythmia, or unstable angina.
* Prior treatment with chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent.
* Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)

ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)

This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination of ublituximab + umbralisib (U2) in participants with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL).

Eligibility Criteria:
Inclusion Criteria:

* Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that warrants treatment
* Adequate organ system function as specified in the protocol
* Ability to follow protocol procedures.

Exclusion Criteria:

* Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1
* Prior exposure to any PI3K inhibitor or venetoclax
* Autologous hematologic stem cell transplant within 6 months of study entry. Prior allogeneic hematologic stem cell transplant is excluded
* Active Hepatitis B or Hepatitis C.
Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers

The investigators hypothesize that the use of leptospermum scoparium honey as a type of dressing and/or debridement agent on stage III or IV pressure ulcers has an increased efficacy and safety compared to the current treatment protocol that includes the use of hydrogel/Vaseline, collagenase, and silver alginate dressings as the standard of care. Utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as a treatment for Stage III and Stage IV pressure ulcers will not be inferior to the comparison treatment of standard of care wound dressings. Moreover, this research design will enable the research team to determine if the honey based dressings are equivalent to or superior to the comparison treatment.

Therefore, the investigators specific study objectives are as follows:

1. Primary Objectives: Determine if the use of honey as an alternative treatment will reduce site inflammation/irritation and pain associated with pressure ulcers compared to the standard treatment options. Specifically, the investigators will monitor patient PUSH scores, Braden Risk Scale scores, granulation and/or epithelial tissue progression, length of time to heal, patient pain assessments via the Wong Baker Face or Numeric Scale, wound odors, and incidence of adverse events (measured by allergies, stinging sensations, bacterial infections that warrant antibiotic intervention, etc.).
2. Secondary Objective: Patients in the honey treatment group will have lower costs per healed ulcer than patients in the standard collagenase treatment group.

Design: Non-inferiority Trial. This design is intended to demonstrate that Leptospermum scoparium Honey treatment is no worse than the standard treatment for pressure ulcers.

Data Collection Procedures:

Members of the research team will administer all wound care treatments on all of the patients in this research project. After initial evaluation and documentation of the presence of pressure ulcers, patients with Stage III and Stage IV ulcers are randomized into the two groups; treatment and control. Patients that develop nosocomial Stage III and Stage IV pressure ulcers will also be included in this study and randomly placed into one of the groups. The following protocol will be followed.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years old and older)
* Newly admitted patients with a diagnosis Pressure Ulcers (Stages III and IV) or patients who develop nosocomial pressure ulcers Stage III and Stage IV
* Ability to provide written informed consent (either patient or legal personal representative)

Exclusion Criteria:

* Patient/representative refuses to give written informed consent
* Patient diagnosed with terminal illness
Real-life Data from Diabetic Patients on Closed-loop Pumps

To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.

In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes. Their use has been validated in clinical trials, but international investigative centers participating in clinical trials are not always representative of secondary care centers, and the patients they manage are also different. The eligibility criteria for participants in clinical trials are more stringent and restrictive than those of the usual patient population of diabetes/endocrinology centers. The socio-demographic characteristics of patients in clinical trials, in particular the ratio of males to females, age or ethnicity, do not necessarily reflect those observed in patients actually using the device.

Eligibility Criteria:
Inclusion Criteria:

* type I diabetic
* with a closed-loop insulin pump

Exclusion Criteria:

* under legal protection order
* patient or legal guardian objecting to the use of the data in the research
Nasal Fentanyl And Renal Colic

The purpose of this study is to determine whether nasal fentanyl is effective in the treatment of renal colic in adults in emergency department.


Eligibility Criteria:
Inclusion Criteria:

* The patients were adults aged 18 to 65 years, presenting in ED with classical clinical symptoms of renal colic (sudden monolateral flank pain with inguinal irradiation) with a 10-cm visual analog scale (VAS) greater than or equal to 7

Exclusion Criteria:

* Were analgesia within 6 hours of arrival
* Allergy to opiates and NSAIDs
* Opiates abuse, known or suspected abdominal aortic dissection or aneurism,
* Presence of peritonitis
* Hemodynamic instability
* Pregnancy, breastfeeding, anticoagulant therapy.
* Patients with known renal, pulmonary, cardiac or hepatic failure, as well as those with renal transplantation, were also excluded.
Diagnosis and Phenotype Characterisation Using Genomics in Patients With Inherited Bone Marrow Failure (IBMDx Study)

This project seeks to perform whole genome sequence (WGS) and whole transcriptome sequence (WTS) analysis on 350 patients with suspected inherited bone marrow failure syndromes and related disorder (IBMFS-RD) in order to increase the genomic diagnostic rate in IBMFS.

IBMFS-RD are a heterogeneous group of rare diseases resulting in significant morbidity and early mortality. These syndromes are individually and collectively rare (affecting \<1 per 10,000 people) and a significant proportion are unexplained by mutations in known genes. Whilst rare, these familial conditions are also likely underdiagnosed due to their relatively recent description and also due to lack of accessible genomic testing.

For patients with clinically suspected IBMFS-RD, receiving a genomic diagnosis is critical to:

* Establish a precise and reliable diagnosis (including distinguishing a monogenic aetiology from more common acquired or autoimmune causes of bone marrow failure which have dramatically different treatments (e.g. immunosuppression)
* Inform prognosis, clinical course, optimal treatment choice and screening for non-haematological organ dysfunction
* Optimise allogeneic haematopoietic stem cell transplant (HSCT) chemotherapy conditioning and minimise regimen-related toxicity
* Inform risk-benefit analysis of performing allogeneic HSCT to potentially prioritise other therapies (including novel gene therapy strategies)
* Avoiding the catastrophe of HSCT donation from occult genetically affected relatives
* Provide counselling (including stem cell donor counselling) and offer genetic testing for potentially affected family members
* Provide accurate reproductive counselling and reproductive options to affected individuals

This study aims to provide WGS and WTS to a national cohort of patients with IBMFS-RD to determine diagnostic rate, health economic impact, health implementation challenges and other exploratory endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 3 months
2. able to give informed consent (or parent/guardian able to give informed consent)
3. a clinicopathological diagnosis (or differential diagnosis) of inherited bone marrow failure syndrome or related disorder (IBMFS-RD) as per the study team

Exclusion Criteria:

1. A clinicopathological diagnosis of an acquired bone marrow failure syndrome (including acquired aplastic anaemia and hypoplastic myelodysplastic syndrome) as per the study team
2. Existing definitive genomic diagnosis for patient's haematological phenotype
A Study to Evaluate Bioequivalence and Adhesion of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA in Healthy Adult Women

The purpose of this study is to determine the bioequivalence of the hormones (ie, norelgestromin \[NGMN\] and ethinyl estradiol \[EE\]) from the transdermal contraceptive patch and to evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component, as compared to the currently marketed EVRA patch.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2), inclusive, and body weight not to exceed 100 kilogram
* Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This will be documented and signed by the investigator in the source document
* Participant must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening and negative urine pregnancy tests on Day -1 of each treatment period
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Participant must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing an effective method of non-hormonal birth control (example \[eg\], intrauterine device \[IUD\], double barrier method, male partner sterilization) before admission and throughout the study

Exclusion Criteria:

* Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, cholelithiasis (gall stone disease), chronic idiopathic jaundice, family history of cholestatic jaundice, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Participant has clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
* Participant has abnormal thyroid stimulating hormone level at screening
* Participant has clinically significant abnormal 12-lead ECG, vital signs, or physical examination at screening as deemed appropriate by the investigator
* Participant has a history or presence of disorders commonly accepted as contraindications to sex hormonal therapy including, but not limited to, the following: a) Deep vein thrombophlebitis or thromboembolic disorders; b) Cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines; c) Benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products; d) Known or suspected estrogen-dependent neoplasia
The Only Blood Culture for Diagnosis of Bacteremia - Comparative Study of Practice

Current recommendations for the diagnosis of bacteremia based on the embodiment February-March blood cultures separated by a minimum interval of 30 minutes. Each blood culture comprises seeding a pair of aerobic and anaerobic vials inoculated each with 5 to 10 ml of blood. The sensitivity and specificity of this technique depends essentially on the amount of blood removed since there is a direct relationship between the volume of blood inoculated into each flask and the efficiency of the technique. A preliminary study conducted at the University Hospital of Caen found that 14-30% of patients depending on the services had received only one blood culture. In addition, at least four blood cultures in 24 hours were taken for 10 to 20% of patients. The practice of a single blood culture reduces the sensitivity of the analysis due to insufficient total amount of blood collected. The practice of too many blood cultures increases the risk of false positive (presence of contaminating bacteria), generates extra work for healthcare personnel (and laboratory) and represents a significant cost for an unproven benefit.

The investigators propose to evaluate a single blood culture sampling technique with seeding 4 vials (2 aerobic and anaerobic 2).

Blood cultures will be collected from patients admitted with on of the following signs: fever (≥38.5°C), hypothermia (≤36°C), chills or shock. For the first blood culture, 40 mL of blood will be obtained aseptically by a single phlebotomy and equally distributed into two BacT/Alert FA aerobic bottles and two BacT/Alert FN anaerobic bottles (bioMérieux, La-Balme-les-Grottes, France). The four bottles will be labelled from one to four in the following order: aerobic-anaerobic-aerobic-anaerobic. Within the next 24 h, one to three other 20-mL blood cultures consisting of a single pair of aerobic and anaerobic bottles will have to be performed, spaced by a minimum of 30 minutes. Bottles will be incubated for 5 days or until positivity reported by the BacT/Alert 3D instrument.

Eligibility Criteria:
Inclusion Criteria:

* Patient who is at least 18 years
* Patients admitted to an emergency department of a three CHU Caen, Lille, Rouen
* Patient with clinical justifying the realization of blood cultures (as good practice recommendations)
* Patients who received information about the study or if his legal representatives or his close entourage
* Patient not objecting to the venipuncture

Exclusion Criteria:

* Patient who direct venipuncture is impossible
* Patient refusing venipuncture
* Patient aged under 18
* Patient with impaired vigilance and not accompanied by a family member or a trusted person may receive clear information protocol
* Vulnerable Patient and not accompanied by a family member or a trusted person may receive clear information protocol