cyrilzakka/clinical-trials huggingface dataset:
Standardized Application of High Frequency Oscillatory Ventilation in the Acute Respiratory Distress Syndrome (ARDS)

The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea and refractory hypoxemia caused by various reasons. Although in recent years a variety of supportive care measures have significant progress, but the mortality rate of patients with ARDS is still as high as 35-40%. Mechanical ventilation is one of the main treatments with ARDS, which is widely used in clinical. The rational mechanical ventilation strategy can improve the oxygenation of patients with ARDS and reduce lung injury. Patients with ARDS usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion has heterogeneity. The protective mechanical ventilation strategies chosen by patients with ARDS in clinical practice are gradually being accepted and applied. The High-frequency oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal volume. Compared with conventional mechanical ventilation, HFOV may be able to more effectively improve oxygenation and reduce ventilator-associated lung injury. HFOV and protective ventilation strategy in ARDS is consistent with an important position in the treatment of ARDS, but not been widely adopted in clinical practice and is still only as a salvage treatment. Therefore, this study intends to use HFOV treatment with conventional mechanical ventilation by matching the cases in patients with ARDS. By comparing the influences of the patient's condition and mortality with HFOV, the clinical efficacy, safety, and health economics effectiveness of HFOV are further investigated and adaption time and parameter settings of HFOV are explored, which provide better treatment options for patients with ARDS and improve their prognosis.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years;
* lung protective ventilation (tidal volume 4-6ml/kg), airway plateau pressure is still higher than 30cmH2O, or the failure of conventional mechanical ventilation pneumothorax, bronchopleural fistula in patients with ARDS; of ARDS diagnosis in line with the 2012 Berlin ARDS diagnostic criteria.
* be able to sign informed consent.

Exclusion Criteria:

* severe pulmonary hemorrhage;
* severe intracranial high pressure;
* large airway stenosis and airway obstruction.
Effects of Resistance and Endurance Training on Synthesis of Individual Muscle Proteins in Young and Older Adults

Loss of skeletal muscle strength and skeletal muscle mass occurs with of aging. This are-related decline in skeletal muscle mass and skeletal muscle strength is a major underlying factor contributing to many of the metabolic disorders and frailty of the investigators rapidly expanding aging population. Endurance (aerobic) and resistance exercise training programs have been shown to effectively reverse the age-related decline in metabolic and contractile muscle functions. The investigators will measure synthesis rates of individual muscle proteins in 36 each of young (18-30 yrs) and 36 older (\> 65 yrs) people to determine their response to 8 weeks each of endurance, resistance, combined endurance and resistance training, or placebo exercise training.

Hypotheses.

1. to measure fractional synthesis rates of multiple muscle proteins and identify those that are enhanced by an endurance exercise program
2. to determine whether changes in protein synthesis in response to endurance exercise programs are dependent on age
3. to measure fractional muscle synthesis rates of multiple muscle proteins and to identify those that are enhanced by a resistance exercise program
4. to determine whether changes in protein synthesis in response to resistance exercise programs are dependent on age


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 18 to 30 or \>65 years
* Males and Females

Exclusion Criteria:

* Regular Exercise Program
* Smoking
* Cardiometabolic Disease (diabetes, cardiovascular disease, thyroid disorders)
* Drugs known to impair metabolic function (beta blockers, steroids)
* Allergies to lidocaine
* Physical disability that precludes exercise
GE Healthcare VolumeRAD Lung Nodule Detection Study

To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.

Digital tomosynthesis is a form of limited angle tomography that creates a series of section images using a conventional x-ray tube and generator, a digital detector, and appropriate reconstruction software. It creates section images from a series of projection images acquired as the x-ray tube moves along a prescribed path. Because tomosynthesis can minimize the visual presence of overlying anatomy - the ribs, for example - it has the potential to improve the detection of lesions such as pulmonary nodules when compared with conventional chest radiography.

The primary aim of this study is to determine whether the use of VolumeRAD tomosynthesis, in addition to CxR, increases physician accuracy in the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional posterior-anterior (PA) and lateral (LAT) chest radiography (CxR). This aim will be addressed by measuring free-response performance of experienced (with VolumeRAD), blinded expert readers' detection performance. Specifically, we will compare detection performance, as measured by the area under the alternative free response receiver operating characteristic (AFROC) curve, among readers viewing PA and LAT chest X-rays versus VolumeRAD tomosynthesis. The nodule will be the unit of analysis.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for chest CT as part of their needed medical care;
* If available, individuals who have had previous imaging to suggest they fulfill the needs of the study;
* 18 years of age, or older;
* In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures.

Exclusion Criteria:

* Children under 18 years of age;
* Women who are pregnant or who suspect they may be pregnant;
* Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules;
* Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules;
* Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung.
* Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample.
One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project

The goal of this cluster randomized study is to understand if using a One stop PrEP delivery model can improve the efficiency of PrEP service delivery, reduce the cost of providing PrEP and allow continuation on PrEP. The investigators will evaluate data from men and women ≥15 years of age unknown to be living with HIV seeking PrEP services at public health facilities in western Kenya.

This study will evaluate the effectiveness of one-stop PrEP services in 12 public health facilities in Kenya. The core implementation strategies to optimize one-stop PrEP care will include training of healthcare providers, technical assistance, joint clinic supervision with the county health officials, and abstraction of program data regarding PrEP initiations and continuations including characteristics of PrEP users for quality improvement. Within this large program, the study team will recruit a nested observational cohort to obtain detailed complementary individual clinical, behavioral, and mental health outcomes (including for clients who discontinue PrEP).

Eligibility Criteria:
Inclusion Criteria:

* ≥15 years of age
* Accessing PrEP services at implementing clinics.
* Eligible for PrEP per Kenya national guidelines

For in-depth and key delivery informant interviews

* Able and willing to provide consent
* Provides services at participating clinics (healthcare providers)
* Key policy maker
Assessment of Lumbar Spine Active Range of Motion in Women Who Were Experienced Cesarean or Vaginal Birth

Pregnancy may impact the musculoskeletal apparatus of females through pregnancy-associated biomechanical, vascular, and hormonal changes. Pregnant females may complain of lumbopelvic pain, especially during their last trimester. This lumbopelvic pain can be the result of an enlarged uterus and unstable lumbopelvic joints.

Cesarean birth can affect the lumbopelvic biomechanics through its impact on the sacroiliac joints and the abdominal muscles. while vaginal birth can trigger lumbopelvic pain through its impact on the pelvic joints like the symphysis pubis and sacroiliacs.

When puerperium is finished, most of these pregnancy-related changes assume its prepregnant conditions.

Physiotherapists are responsible for providing PT care for women to improve their quality of life during the puerperium and even during the delayed postpartum interval.

Eligibility Criteria:
Inclusion Criteria:

1. All women either primiparous or multiparous have not had anaesthesia (epidural, spinal, or general) for at least one year prior to the last obstetric anaesthesia.
2. Their ages ranged from 18 to 35 years.
3. Participants were assessed between the 6th week to the 12th week postnatal.
4. All participants were able to continue all assessment procedures.
5. They might have a mild or moderate myofascial LBP

Exclusion Criteria:

1. Women who were below 18 years old or above 35 years.
2. Women who did not continue all assessment procedures.
3. Women who had a severe myofascial LBP or any specific low back conditions.
Multicenter Study Into Individualized Scanning for Coronary Artery Disease

To evaluate intravascular attenuation of the coronary arteries and image quality in an individualized scan and CM injection protocol whereas both scan and injection parameters are tailored to the individual patient in a North American, European and Asian patient population.

To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in an American, European and Chinese patient population.

To evaluate the injection parameters required for an average American, European and Chinese patient population.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

  1. Referred for a clinically indicated CCTA scan.
  2. Patient aged older than 18.
  3. Subject must provide written informed consent prior to any study-related procedures being performed.
  4. Subject must be willing to comply with all clinical study procedures.
  5. Atypical or typical complaints of angina.
  6. No previous cardiovascular history.
  7. Possibility of 'flash' mode scan; patient heart rate below 70 beats per minute and regular rhythm.

Exclusion Criteria:

* The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

  1. Contraindications for CT coronary angiography, including:

     1. Inability to perform a breath hold for at least the expected scan time
     2. Unstable angina
     3. Hemodynamic instability
     4. Known history of CAD
     5. Pregnancy
     6. Renal insufficiency (defined as Creatinine \<1.5 mg/dL or GFR\<30 mL/min)
     7. Iodine allergy
  2. Insufficient cannula venous access (preferred 18G, minimal 20G cannula)
  3. Subject has an acute psychiatric disorder.
  4. Subject is unwilling to comply with the requirements of the protocol.
  5. Subject has previously entered this study.
Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases.

The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.


Eligibility Criteria:
Inclusion Criteria:

* Patient initiating treatment with RTX, delivered by the central pharmacy of Lille University Hospital
* Inpatient or outpatient at Lille University Hospital (in one of the following departments: internal medicine, rheumatology, neurology, dermatology, pneumology) and monitored every three months as part of routine care (as part of the surveillance of induction of RTX treatment)
* Patient with one of the following autoimmune diseases, defined by international criteria

Exclusion Criteria:

* Treatment with rituximab for a malignancy or a transplant reject
* Pregnant or lactating women
* People in emergency
* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent
* Persons deprived of their liberty
* People unable to consent
Annexin A2 as a Novel Diagnostic Marker in Hepatocellular Carcinoma

This study aimed to investigate the clinical utility of Annexin A2 serum level as a novel diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha fetoprotein the current marker ofhepatocellular carcinoma (HCC).

This study was carried out in HCC clinic , Ain Shams University Hospitals, Cairo; Egypt and included :Group 1: Fifty patients with early stage hepatocellular carcinoma(BCLC stage A); Group 2:Twenty five patients with chronic liver disease diagnosed based on clinical, laboratory, and ultrasonographic investigations; Control Group: Fifteen healthy, age and sex-matched subjects with seronegative hepatitis viral markers .All groups were subjected to thorough history taking, full clinical examination, and laboratory investigations including viral hepatitis markers: HBsAg and HCV antibodies using ELISA technique and HCV RNA using real time PCR for HCV antibody positive patients, AFP by electrochemiluminescence and Annexin A2 estimation using ELISA technique.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for HCC cases:

  1. Confirmed diagnosis of HCC according to the European association of study of liver diseases \[13\].
  2. Early stage HCC (Stage A), using the Barcelona Clinic Liver Cancer (BCLC) staging system, (single or 3 nodules \< 3cm PS 0) For all participants:.
* Informed consent from all participants before enrollment in the study.

Exclusion Criteria:

* For HCC patients:

  1-Imtermediate or advanced stage HCC as defined by BCLC 2. Major vascular tumor invasion or metastasis confirmed by radiological imaging studies.

  3. Patients with other suspected solid malignancies or metastatic liver tumors, 4. Other types of chronic liver diseases (CLD) such as autoimmune hepatitis and primary biliary cirrhosis.
* For all participants:

  * Refusal to participate in the study
Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reservetechniques

Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-4 oocytes.

Improve the follicular response in patients with low response, increasing the number of follicles in subsequent cycles to treatment with growth factors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must give written consent.
2. To be a healthy woman acting voluntarily, aged 18 to 42 years (both inclusive) at the time of study selection time of selection for the study.
3. Have a BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
4. Patients with low ovarian reserve (AMH \<1.1 ng/mL) according to the Bologna criteria.
5. Patients who are going to undergo IVF/ICSI cycle with low follicular response: who after a previous cycle of stimulation have obtained 0-3 or more follicular 0-3 oocytes have been obtained after a previous stimulation cycle; or if 0-3 oocytes are expected to be obtained at the present time (less than 4 follicles).

   oocytes (less than 4 follicles in the basal ultrasound).
6. To have recent analytical results (haemogram, biochemistry and coagulation); at least 11 months prior to inclusion in the study and a serology, according to clinical practice.

Translated with www.DeepL.com/Translator (free version)
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy

The rationale for the patient-centric, prospective, observational, non-interventional study design of JZP258-402 is to evaluate the transition experience of participants with narcolepsy treated with oxybate and to examine the impact of transitioning from Xyrem to Xywav in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18 years or older
2. Diagnosis of type 1 or type 2 narcolepsy by a physician
3. Active prescription for Xyrem with a stable treatment regimen for at least 2 consecutive months
4. Transitioning from Xyrem to Xywav within the next or past 7 days (- 7 days or + 7 days from the first dose of Xywav)
5. Able to read and understand English
6. Able to access to a computer/smart phone with internet connection
7. Not currently a Jazz Pharmaceuticals employees or an immediate family member of a Jazz employee
8. Willing and able to comply with the study schedule
9. Willing and able to provide electronically written informed consent
Study to Evaluate the Effect of the Treatment With Micardis® or MicardisPlus® on Blood Pressure

The primary objective was to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose, insulin Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential hypertension and diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Hypertension
* Diabetes mellitus

Exclusion Criteria:

* Age \< 18 years
Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer

The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven, newly diagnosed pancreatic adenocarcinoma or adenosquamous carcinoma
* no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or immunotherapy used for pancreatic cancer
* presence of at least one measurable lesion, which must meet the criteria of being ≥ 20 mm in at least one dimension by conventional CT/MRI or ≥ 10 mm by spiral CT scan
* age between 20 and 79 years at registration
* ECOG PS of 0 or 1
* adequate major organ functions
* ability to take the oral study medication (TS-1)
* no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration
* voluntarily signed the written informed consent form

Exclusion Criteria:

* pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
* presence of diarrhea ≥ CTCAE v.4.03 grade 2
* concomitant active infection or significant co-morbid medical conditions
* moderate or severe ascites or pleural effusion that requires drainage
* central nervous system metastasis
* prior or concurrent malignancies within the last 3 years
* concomitant treatment with flucytosine, phenytoin or warfarin
* pregnant women or nursing mothers, or positive pregnancy test
* severe mental disorder
* judged ineligible by physician for participation in the study due to safety concern
Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD and a clinical stable condition, i.e. at least three months from the last AECOPD and/or antibiotic treatment.

For patients with AATD this condition will be diagnosed by laboratory tests showing low levels of AAT and genotyping of AATD-related genes.

. Exclusion Criteria:

* The presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.
Arginine and Nitric Oxide (NO) Early Prognostic Markers for Non-union Development

Objective: Primary objective is to study the arginine-NO metabolism during fracture healing and dysfunctional fracture healing. Secondary objective: to investigate if differences or decreased arginine and NO concentrations in bone healing form a prognostic marker for non-union development Hypothesis: Early detection of disturbances in the Arginine and nitric oxide metabolism during fracture healing are a good prognostic marker for non-union development.

Study design: Prospective observational study. Study population: All acute fracture patients (age \>18 years), with a fracture of the tibia or femur attending the Department of General Surgery, to investigate the Arginine -NO metabolism during normal fracture healing and possible dysfunctional healing. In total 100 patients will be included during this study.

Main study parameters/endpoints:

Primary endpoints are arginine and Nitric Oxide levels in the plasma during normal and dysfunctional fracture healing the bone in patients with and without non-union Secondary endpoints are levels of Nitric Oxide citrulline, ornithine and other amino acids in bone and in plasma Other parameters: baseline demography details will be obtained, including possible confounders, such as bodyweight, smoking, alcohol abuse, which may interfere with the outcome of this study.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extent of the burden and risk associated with participation is expected to be low during this study. In total, 7 blood samples will be taken during this study (45ml, in total). During the primary (and possible secondary) surgical procedure, bone debris will be taken. Bone debris is usually discarded but will be used for analysis in this study. There is no extra surgical procedure necessary to obtain the bone debris.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Patient with a fracture of the femur or tibia for which a surgical procedure providing bone debris is performed as therapy

Exclusion Criteria:

* Patients with another bone fracture in their recent medical history
* Infectious complications, such as infected pseudo-arthrosis
* Use of chronic corticosteroids or nitrovasodilating medication
* Patients with severe metabolic disturbances (liver, and renal insufficiency, diabetes).
* Patients with metastases, haematological malignancies or chemotherapy