cyrilzakka/clinical-trials huggingface dataset:
The Effects of Device-guided Breathing Exercises on Blood Pressure in Patients With Hypertension

The purpose of this study is to determine whether breathing-exercises with the Resperate or listening to a discman with freely chosen music are effective in the treatment of hypertension

Hypertension is an important risk factor for the development of macrovascular events. Lowering blood pressure leads to a reduced risk of developing these complications. To treat hypertension effectively you can use blood pressure lowering drugs, but it is also important to use proven and safe non-pharmacological interventions. It is suggested that Breathing Rate and Systolic Blood Pressure can be linked directly together by the baroreflex. With the use of the Resperate, people will lower their breathing rate by breathing similar to music patterns which could theoretically lead, through the described link, to blood pressure reduction. Patients will be randomize into two groups: one will get a discman with freely chosen music and the other the Resperate. Patients are instructed to use the breathing device or discman for 15 minutes at about the same time every day during the 9 week study period, except for the first week.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Known hypertension with a SBP between 130-170 mmHg at previous visit to the internal outpatient department and at the last visit to the internist
* Treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months
* At Baseline the SBP should be between 140-160 mmHg

Exclusion Criteria:

* Patients with known diabetes
* Patients with heart failure (NYHA III-IV)
* Patients with pulmonary disease
* Patients with insufficient knowledge of the Dutch language to understand the requirements of the study
Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery

This is a prospective pilot study in which the effects of ascorbic acid administration are investigated in adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass (CPB). Ascorbic acid (Vitamin C) is an essential cofactor in the biosynthesis of catecholamines, and critically ill patients are known to be ascorbate-deficient. In addition, cardiopulmonary bypass (CPB) decreases ascorbic acid concentrations. Cardiac vasoplegia is the loss of vascular tone despite adequate volume status and cardiac output, occurring commonly in patients after CPB. This necessitates the administration of vasopressors and alternative agents which can have deleterious effects. The administration of ascorbic acid to cardiac surgical patients may improve microcirculatory function, enhance endogenous catecholamine levels and decrease the need for exogenous vasopressor support.

1. Specific Aims

The investigators aim to determine the feasibility of performing a study that can assess the impact of ascorbic acid administration on the development and severity of cardiac vasoplegia in cardiac surgical patients undergoing procedures at high risk for vasoplegia.

Specific Aim 1: Determine the feasibility of administration of high dose intravenous ascorbic acid in the operative and post-operative environments as well as sample size for a prospective, randomized, placebo controlled study.

Specific Aim 2: Determine baseline ascorbic acid plasma levels in a small cohort of cardiac surgical patients.

Specific Aim 3: Determine the impact of ascorbic acid administration on microvasculature as measured by dark field microscopy.

Eligibility Criteria:
Inclusion criteria:

* 18 years of age or older
* Undergoing cardiac surgery with the use of cardiopulmonary bypass
* Undergoing myectomy or valve replacement/repair

Exclusion criteria:

* Coronary artery bypass grafting (CABG)
* Circulatory arrest
* Active infection or sepsis
* Severe hepatic disease or ascites
* Pre-operative renal dysfunction requiring dialysis
* Pre-operative midodrine
* Pre-operative oral or intravenous steroid use
Venous Thromboprophylaxis in Bariatric Surgery

The main aim of this study is to compare the influence of total body-weight (TBW), lean body-weight (LBW), ideal body-weight (IBW) or Body Mass Index (BMI) on peak anti-Xa levels at steady-state in bariatric surgery (BS) morbidly obese patients receiving a fixed double dose of dalteparin (5000 IU subcutaneously, twice daily a day) for venous thromboembolism (VTE) prevention. Secondary aims of this study are to identify which body size descriptors (BSD) has the greatest impact and could further be explored for an adjusted low molecular weight heparin (LMWH) dosing algorithm for achieving optimal VTE prevention in BS severely obese patients.

Severely obese patients undergoing bariatric surgery (BS) are at increased risk for venous thromboembolism (VTE). How standard LMWH regimen should be adapted to provide both sufficient efficacy and safety in this setting is unclear. The aim of this study is to compare the influence of four BSD on peak anti-Xa levels in BS obese patients receiving high LMWH fixed doses to identify which one had the greatest impact and could further be proposed in LMWH-based thromboprophylaxis dosing algorithms.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 70 years old
* BMI ≥ 40 Kg/m² or BMI ≥ 35 Kg/m² with at least one or more obesity-related co-morbidities ( including type II diabetes (T2DM), hypertension, obstructive sleep apnea (OSA), non-alcoholic fatty liver disease, severe osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease)
* scheduled for sleeve gastrectomy (SG) or gastric bypass procedure (GBP)
* informed consent

Exclusion Criteria:

* anticoagulant administration within 48 hours preceding surgery
* on-going antiplatelet therapy
* pregnancy
REFRAME RPD Post-Market Clinical Study

To evaluate the change in patient Oral Health-related Quality of Life (OHRQoL) from wearing a cobalt chrome (CoCr) removable partial denture (RPD) to wearing the Solvay Dental 360TM polymer Removable Partial Denture (RPD) for 8 weeks.

Cohort study conducted in the United States \& United Kingdom to assess Oral Health Related Quality of Life (OHRQoL) in patients receiving the study polymer Removable Partial Denture (RPD) as compared to their baseline Cobalt Chrome (CoCr) Removable Partial Denture (RPD) Oral Health Quality of Life (OHRQoL).

Eligibility Criteria:
Inclusion Criteria:

* with the absence of 3 or less teeth per saddle, excluding third molars
* partial denture in one arch only
* with previous denture wearing experience, and Cobalt Chrome (CoCr) Removable Partial Denture (RPD) fitted in the previous 24 months and the patient is currently and routinely wearing the denture
* With a stable oral health in terms of absence of disease activity affecting the periodontium, dental hard tissues (caries), pulp and the structural/aesthetic integrity of restored teeth
* With at least 1 posterior natural tooth occlusal stop (molar or premolar)
* Class I, Class II and Class III (Kennedy's Classification)
* Occlusal spacing (static and dynamic) around clasp assembly including the occlusal rest

Exclusion Criteria:

* Patients requiring extensive treatment prior to the provision of a removable partial denture (RPD)
* Patients with active primary disease; caries, periodontal disease or symptoms of pulpal or apical pathology to the remaining teeth
* Patients with irreversibly compromised structural/aesthetic integrity of restored teeth that cannot be restored as part of the provision of treatment.
* Patients with an opposing Removable Partial Denture (RPD). Removable Partial Denture (RPD) to only be in one arch and must oppose a full denture or a dentate arch which provides a stable occlusal relationship
* Canines are NOT to be replaced with the Removable Partial Denture's (RPDs). Patients must have their natural canines present
Study of DC-CIK Combined With Chemotherapy for Advanced Solid Tumor

Combinations of Dendritic cell-activated cytokine-induced killer cell (DC-CIK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

Patients in group A will receive 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of DC-CIK with chemotherapy in patients with treatment-refractory solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with treatment-refractory advanced solid cancer can not accept operation;
2. Age 10 to 90 years;
3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
4. Estimate survival \> 3 months;
5. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
6. Without any other malignant disease;
7. With more than one scalable lesions;
8. Patients Voluntary attempt, and informed consent;
9. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

Exclusion Criteria:

1. Patients who do not conform to the inclusion criteria;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;4.
5. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)
The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy

In severe cases after craniotomy, tracheal intubation is often required, and the removal of tracheal intubation presents certain risks and challenges. Premature removal of the tracheal intubation can lead to failure of extubation and increased proportion of re-intubation, resulting in increased risk of airway injury and hospital-acquired pneumonia, resulting in prolonged hospital stay and even adverse effects on neurological outcomes and mortality. However, delayed extubation can also lead to an increased risk of hospital acquired pneumonia, affecting early recovery and neurological recovery. It can be seen that the accurate evaluation of the possibility of tracheal intubation and the appropriate timing can have a greater impact on the prognosis of patients after craniotomy. However, there are currently no relevant standards or guidelines to guide clinical work. Previous studies have shown that for general critically ill patients, Peak cough flow (PCF) can play a certain role in predicting tracheal intubation, but the results of each study are not consistent. The predictive value of PCF for tracheal intubation and extubation in patients after craniotomy is less relevant. This study intends to use Pneumotachograph to measure the active and passive PCF of patients with extubation, to explore the predictive value of PCF for tracheal intubation after craniotomy, and to provide guidance for the development of clinical extubation decisions.

The objection of this study is to evaluate the preditive value of PCF for endotracheal extubation in patients undergoing craniotomy. For patients who met the inclusion criteria, the PCF value will be measured before the removal of entracheal tubes, and the predictive value of PCF will be evaluated by ROC curves, as will as the cut-off value of PCF.

According to state of consciousness, patients will be grouped as consciousness and unconsciousness group, and the predictive value of PCF for endotracheal extubation will be evaluated seprately in both groups. For patients with disturbance of consciousness, only passive PCF value will be measured. For lucid patients, inaddition to passive PCF value, the voluntary PCF value will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Post- craniotomy
* ICU LOS ≥ 24h

Exclusion Criteria:

* no extubation attempt during the ICU stay;
* underwent tracheostomy without extubation attempt;
* pregnant or lactating women;
* enrolled in other clinical trials;
* declined to participate in the study.
Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise

Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men. However, after a short training break, COVID-19 induced lock down prevented a re-start of the HIT resistance exercise training in the FrOST cohort.

The aim of the present observational study is thus to determine the effects of 6 months of deconditioning on health related parameters under special regard of osteosarcopenia in this cohort of older men with osteosarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* participants of the FrOST study (NCT03453463)

Exclusion Criteria:

* medication and diseases with potential impact on study outcomes during the last 26 weeks.
Improved ICU Outcomes With Protocolized Management of Analgesia, Sedation and Delirium

To assess pain, agitation, and delirium experienced by critically ill patients daily and evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of stay, mortality and costs of care between pre- and post-protocol groups.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to ICU

Exclusion Criteria:

* Repeat admission within the same hospitalisation; moribund patients
MRI to Characterize and Predict CF Liver Disease in PUSH Cohort

Specific Aim 1. Determine if valid results of non-sedated MRI based assessments of liver stiffness and lipid content can be obtained in more than 90% of children and young adults with cystic fibrosis.

Specific Aim 2. Determine hepatic lipid content using the HepaFat sequence and liver stiffness using MRE. Investigators will compare the results obtained by MRI with PUSH study grayscale ultrasounds in CF patients with normal, heterogeneous, homogeneous or nodular (cirrhotic) pattern on ultrasound.

Specific Aim 3. Creation of an imaging core lab to centralize evaluation of MR imaging data, allow for remote image upload, electronic data storage, and remote image viewing/interpretation. This infrastructure will be utilized to standardize image post processing.

Specific Aim 4. Using the longitudinal PUSH study, determine if MRI based imaging improves discrimination of subjects at risk for progression to advanced CF liver disease (development of cirrhosis) compared to using US imaging alone

This proposal will be a cross sectional study of the current well-characterized PUSH cohort. Patients will receive an MRI at the time of their scheduled PUSH ultrasound. Ideally, the MRI will be performed the same day or a similar time point near liver ultrasound (+/-90 days, but Investigators will allow a larger window due to the slow progression of fibrosis).

Blinded radiology review of imaging sequences will be performed by a local study radiologist with central review performed by the Imaging Core. Analysis by the Imaging Core will include calculation of the liver stiffness, liver and spleen volume, and hepatic and lipid content for all MRI studies.

Eligibility Criteria:
Inclusion Criteria:

1. Currently enrolled in longitudinal follow up in PUSH study at a site with MR elastography.

Exclusion Criteria:

1. Age under 6 years (all current patients at time of opening of this study will be greater than 6 years of age).
2. Internal appliance or hardware that is not compatible with MR.
3. Inability to obtain MRI within 6 months of US.
4. Inability to cooperate with MRI.
Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children

The coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement.

In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children.

In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.


Eligibility Criteria:
Inclusion Criteria:

* school-age children in the Academy of Lyon
* parental consent

Exclusion Criteria:

-
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment

This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216)


Eligibility Criteria:
Inclusion Criteria:

1. Participant must be ≥ 18 to ≤ 70 years, at the time of signing the informed consent.

   BMI ≥ 18 kg/m2 up to ≤ 32 kg/m2.
2. Participants (including partners) must use reliable methods of contraception during the study and until 7 days following the last dose of investigational product.
3. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.

   Participants with hepatic impairment only:
4. Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available.
5. Unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening, or treatment-naïve participants

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
2. QTcF (male) \> 470ms，QTcF (female) \> 480ms
3. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
4. Participates who donated blood or bleeding profusely (\> 400 mL) in the 3 months.
5. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
6. Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening

   Participants with Normal Hepatic Function Only:
7. Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.

   Participants with Hepatic Impairment Only:
8. Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.
9. Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices
Comparison Between Automated and Manual Component Impaction in Total Hip Arthroplasty

This study will investigate and evaluate the ergonomic impaction and the operational efficiency of the KINCISE™ impaction system in comparison with the manual impaction of a handheld traditional mallet in total hip arthroplasty (THA) procedures.

The automated impaction technology of Depuy Sythes (J\&J, Warschau), i.e. KINCISE™, can help surgeons impacting the femur in THA surgeries with constant and consistent energy. Furthermore, the bone preparation, implant positioning and implant assembly automate. Next to that, the KINCISE™ is developed to eliminate mallet impaction methods and thus can reduce the physical fatigue of the surgeon during THA procedures, leading to more reproducible and accurate femur manipulation even during the last procedure of the OR day. Two main research questions will be investigated: "Does the KINCISE™ automated impaction lead to a significant reduction in mental and physical fatigue in comparison with mallet impaction?" and "Does the KINCISE™ automated impaction lead to a reduction in OR time?".

Measurements will be executed during 4 OR days. During each OR day exclusively Kincise impaction (N=2) or handheld traditional mallet impaction (N=2) will be performed. The impaction technique will be randomised and the OR setup will be equal in both situations. The one participant in the study is an orthopaedic hip surgeon. He will execute all the THA procedures and undergo all the physical and cognitive tests. The entire study will be assessed by 2 parties of experienced assessors who are not involved in the surgical procedures: BeScored Institute and DEO.

Each OR day, 2 evaluation sessions and 1 mid break session will be held, led by BeScored Institute: in the morning from 06:50am till 08am, during the afternoon from 03:30pm till 04:40pm and during lunch breaks from 11:30am till 12:05pm. Before each morning evaluation session a cognitive task test of 5 minutes will be executed to get familiar with the cognitive tasks of the evaluation sessions. During each evaluation session the following tests will be executed in the same order: psychometric assessments (7 minutes, consisting of 'mindfulness inventory for sport' questionnaire, perfection for stress scale and observed physical fatigue), energy evaluation and stress levels (5 minutes, consisting of heart beat variability measurements, saliva cortisol levels and saliva alfa-amylase levels), cognitive tasks (30 minutes, consisting of Simon test, pattern-comparison test and psychomotor test) and physical tests (20 minutes, consisting of handgrip test, shoulder endurance, planking and isometric mid-thigh pull performance). During the mid break session only the psychometric assessments and cognitive tasks will be executed.

During the THA procedures itself, DEO will evaluate other ergonomics and operational efficiency using the validated DEO Data Collection Platform including datapoints specific to the use of automated and manual impaction, and RULA and REBA methods.

Eligibility Criteria:
Inclusion Criteria:

* Hip surgeon

Exclusion Criteria:

* /