cyrilzakka/clinical-trials huggingface dataset:
Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis

Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact or morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. the effect of this training has not yet been evaluated in cirrhosis. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤70 years
* Cirrhosis
* Child Pugh class A or B
* If required, primary or secondary variceal prophylaxis in place

Exclusion Criteria:

* Post-liver transplantation
* Hepatocellular carcinoma
* Active non-Hepatocellular carcinoma malignancy
* Significant cardiac disease - ejection fraction \<60% or known coronary artery disease
* Oxygen saturation at rest \<95%
* Known myopathy
* Hemoglobin (\<100 g/L)
* Chronic renal failure on dialysis
* Physical impairment making it impossible to ride an exercise bike or treadmill
* Orthopedic abnormality preventing exercise training
* HIV infection
* Patient unwilling to consent to study
Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage

The main purpose of this study is to analyse the on-going coagulation process after aSAH. For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a point-of-care test using a variety of activators to provide a targeted and a dynamic analysis of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH patients treated in Tampere University Hospital intensive care unit and 16 control patients (elective craniotomy due to non-ruptured intracranial aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, or cerebrospinal fluid erythrocyte count over 1000 x 106/l) AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA)
* Onset of symptoms ≤ 12 hours
* Expected to stay 72 hours in the ICU

Exclusion Criteria:

* Pregnancy
* Any long-term anticoagulant medication, except for low-dose aspirin (\<150 mg/day)
* Known active cancer
Assessment of the Efficacy on the 5th Day of Antibiotic Therapy for Febrile Urinary Tract Infections Among Children From 3 Months to 18 Years Old

The main objective is to describe the rate of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection in children between 3 months and 18 years of age.

This is a non-randomised prospective monocentric pilot study whose main objective is to describe the proportion of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection, in children between 3 months and 18 years of age. After being informed about the study, all patient meeting inclusion criteria will respond to a survey at D2, D5, D10 and D28 to evaluate the persistence of symptoms to determine the effectiveness of a 5-day course of antibiotic treatment. All patients will be treated in accordance to the French guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Child between 3 months and 18 years old
* Diagnosis of uncomplicated febrile urinary tract infection certain and defined by :

  * Naked fever (without an identifiable source of infection) for at least 24 hours for boys and 48 hours for girls.
  * A urine test strip with at least 2 crosses of leukocyturia ≥ or 1 cross of leukocyturia ≥ with positive nitrituria
  * A cytobacteriological urine test with leukocyturia greater than 10/mm3 in the case of catheterisation or Clean catch or greater than 100/mm3 if the collection is performed by bag (Urinocol®).
  * Positive bacteriological urine culture
  * Response to antibiotic therapy
  * Absence of other diagnoses that could explain the clinical picture

Exclusion Criteria:

* Children under 3 months old
* Immunodepression
* Underlying uropathy or known neurological bladder disease
Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair

This is a retrospective European multicenter study evaluating surgical treatment of patients with a complex ventral incisional hernia using robotic-assisted laparoscopic transversus abdominis release (rTAR) or open transversus abdominis release (oTAR).

Consecutive patients who undergo bilateral TAR in the treatment of their ventral incisional hernia in two European hernia centers are included in the study. A retrospective analysis of a prospectively maintained database and electronic patient files will be performed. Primary endpoint of the study was length of postoperative hospital stay. Secondary endpoints are intraoperative complications, in-hospital complications, overall and surgical site related complications during the first 30 postoperative days, overall and surgical site related complications during the reported follow-up period, and hernia recurrence during the reported follow-up period.

Data on the following variables wlll be collected.

* Patient characteristics: age, sex, body-mass index (BMI), comorbidities, smoking habits, previous hernia repair and hernia dimensions
* Intraoperatively: skin-to-skin operative time, wound contamination class (according to the center for disease control and prevention (CDC) classification)15, administration of antibiotics, mesh type used, mesh size, closure of the hernia defect, combined surgical procedures and intraoperative complications.
* Postoperatively at discharge: length of postoperative hospital stay and in-hospital complications.
* Postoperatively at 30 days after surgery: overall (according to the Clavien-Dindo classification)16 and surgical site related complications17, readmission rates during the first 30 days after surgery.
* During follow-up: duration of reported follow-up, reoperation rates and hernia recurrences during the reported follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.

Exclusion Criteria:

* unilateral transversus abdominis release
* patients with a stoma or parastomal hernia
TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

The purpose of this study is to determine the effectiveness,safety and Input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing.

A Muti-center randomized controlled study with large samples to observe improvement of motor function,severity of spasm,ADL(activity of daily lives),by standardized protocols of TCM techniques(massage and herbal bathing) combined with conventional rehabilitation on spasm after stroke in 1 month.Modified Ashworth scale,Fugl-Meyer Index and Modified barthel Index were used for spasm,motor function and ADL.And also the follow up research within 3 months and 6 months focus on the efficacy duration of TCM on spasm.Try to find suitable timing for intervention on spasm by CTM(Massage and herbal medicine bathing)and the connection between spasm severity and treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* According to the diagnostic criteria of stroke and diagnosed by CT or MRI
* Patient must be between the ages of 18 and 85 years.
* All patients were examined at least 1 month after stroke and less than 12 months.
* At least a set of spasmous muscles' level ≥1+ of dysfunctional extremities (modified Ashworth scale)
* Body movement function decreased significantly.
* The doses and kinds of anticonvulsant drugs should be used stable for more than 1 month if they are used
* Patient must understand and be willing, able and likely to comply with all study procedures.
* Patient must be able to give voluntary written informed consent.

Exclusion Criteria:

* Significant cognitive defects(MMSE\<16)，unable to finish the Fugl-Meyer scale,etc..
* Other significant limb diseases such as fracture, severe arthritis,amputation
* Joint contracture formation
* Patients with significant pain and swelling suffering from complex regional syndrome after acute stroke
* Accept botulinum toxin or alcohol nerve block 3 months prior to the start of the experiment
* Patients need nerve block at any point of time during the whole experiment procedure.
* Serious cardiac,hepatic or renal insufficiency and patients with shock.
* Limb skin of patients who need medicated is visible wound.
* Patients with cancer or pregnancy
* Patients who participate in other clinical studies within 6 months
Evaluating the Effects of Cannabis Use and Circulating Cannabinoids on Tumor Infiltrating Lymphocytes in Malignant Melanoma

The goal of this proposal is to determine how cannabinoid use affects the tumor immune microenvironment (TME) of melanoma by correlating TILs with reported cannabinoid use and circulating plasma cannabinoids. The central hypothesis is that cannabinoid use decreases TILs in melanoma in a dose-dependent fashion. This is important because cannabinoid-driven TME changes in melanoma may alter patient outcomes mediated by TILs and response to standard of care ICI treatments.

Specific Aim 1.Assess how systemic cannabinoids remodel tumor infiltrating lymphocytes (TILs) within the melanoma tumor microenvironment. We hypothesize that decreased grade of TILs and exhaustive differentiation of T cells in melanoma are associated with lower cannabinoid receptor (CB1/CB2) expression and higher levels of systemic exogenous cannabinoids. Aim 1a.) Correlate plasma levels of cannabinoids with TIL grade. Aim 1b.) Correlate plasma levels of cannabinoids with TIL T cell immunohistochemical markers of exhaustion. Aim 1c.) Correlate plasma levels of cannabinoids to TIL CB1/CB2 expression.

Specific Aim 2. Determine the relationship between peripheral T cell activation and circulating cannabinoid levels in patients with melanoma. We hypothesize that the phenotypic activation of peripheral T cells is inversely associated with increased plasma levels of systemic exogenous cannabinoids. Aim 2a.) Immunophenotype peripheral T cells from patients with melanoma. Aim 2b.) Correlate plasma levels of cannabinoids with peripheral T cell phenotypic activation.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven melanoma, any stage

  * Biopsy obtained within 4 weeks of anticipated enrollment
  * Patients \>21 years old
  * Report no cannabis use in the last year or chronic cannabis use (at least weekly use for 3 months or more)

Exclusion Criteria:

* Patients unwilling or unable to provide informed consent
Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE)

Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. This treatment failure has been partly overcome by the addition of ifosfamide and etoposide (IE). We have ever retrospectively compared the activity of apatinib + IE in relapsed or refractory osteosarcoma in two sarcoma centers in China and concluded that for osteosarcoma with multiple sites of metastasis, apatinib + IE demonstrated clinically meaningful antitumor activity and delayed disease progression in patients with recurrent or refractory osteosarcoma after failure of chemotherapy. However to overcome the influence of other interventions on the outcome, we are currently performing a prospective trial to investigate this combination, from which more accurate data on this treatment strategy are expected.


Eligibility Criteria:
Inclusion Criteria:

1. advanced recurrent and refractory osteosarcoma confirmed by histopathology;
2. initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital;
3. progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy);
4. measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ;
5. Eastern Cooperative Oncology Group performance status ≤ 1 ;
6. acceptable haematologic, hepatic, and renal function.

Exclusion Criteria:

1. those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
2. those who had severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction\<50%, and hypertension that could not be well controlled with antihypertensive drugs.;
3. all patients were assessed by the sarcoma board including a thoracic surgeon with at least 10 years surgical experience. Patients with lung metastases only were carefully assessed for eligibility for metastasectomy, of whom those who were suitable for surgery were excluded from this study;
4. weight loss of 20% or more before illness;
5. brain or leptomeningeal metastasis;
6. surgical procedure or radiotherapy within 4 weeks of enrollment;
7. activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
8. proteinuria or hematuria, denutrition with albuminemia \<25 g/L;
9. women who were pregnant or breast feeding, other malignancy;
10. positive HBV/HCV/HIV serology, and known allergy to the experimental agents.
Adenosine and A2A Receptors in Human Brown Adipose Tissue

This study investigates the significance of adenosine and A2A receptors in human brown adipose tissue (BAT) in vivo. Using positron emission tomography (PET), perfusion and the density of A2A receptors will be measured in supraclavicular BAT and other tissues in healthy men. The investigators hypothesize, that adenosine can activate BAT, and that adenosine A2A receptor density changes when BAT is activated by cold exposure.

Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is important and beneficial in fighting against the epidemic of obesity and diabetes.

Adenosine is a purine nucleoside released locally in BAT when noradrenaline and ATP are released from sympathetic nerves. Recently it was found that adenosine activates murine and human brown adipocytes, and recruits beiging of white fat via adenosine A2A receptors (A2AR). Furthermore, studies with mice have shown improvements in glucose homeostasis after administration of A2AR agonists.

In this study the investigators use the PET radiotracer \[15O\]-H2O to quantify perfusion of BAT, white adipose tissue (WAT) and muscle in three conditions: room temperature, cold exposure and intravenous infusion of adenosine. Another PET radiotracer \[11C\]TMSX is used to quantify adenosine A2A receptor density of BAT, WAT and muscle in room temperature and during cold exposure.

Eligibility Criteria:
Inclusion Criteria:

1. Male sex
2. BMI 20 - 28 kg/m2
3. Age: 18- 40 years
4. Normal OGTT
5. Healthy, no regular medication

Exclusion Criteria:

1. BMI \< 20 kg/m2 or BMI \> 28 kg/m2
2. Low or high blood pressure
3. Asthma or other obstructive lung disease
4. Sick sinus syndrome, prolonged QT-interval, or any heart disease
5. Any chronic disease that could affect the study outcome, including diabetes
6. Mental disorder or poor compliance
7. Eating disorder or excessive use of alcohol, tobacco smoking or drug use
8. Past dose of radiation
9. Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
Finger Imaging to Detect Blood Flow in the Fingertips

The purpose of this study is to develop a small, easily used device to detect a person's blood flow in their fingertips.

To develop a hand held touch-pad device for identification of individuals, to help with banking and, possibly for detection of anxiety. This is done by their fingerprint and, other digital anatomy and vascular biometrics.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female who can give informed consent

Exclusion Criteria:

* Under the age of 18
Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors

Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow, pressure, resistance index, venous effluent pH) are correlated with better recovery of renal function (without dialysis during the first week after transplant).

Observation or Investigation Method Used :

The study is multicenter, prospective, open, controlled and randomized:grafts are divided into two parallel groups:

* group 1 corresponds to a conservation of grafts in static incubation
* group 2 corresponds to conservation using a pulsatile perfusion machine

Duration and Organizational Arrangements for Research :

The total duration of the study is planned for 36 months. This duration includes:

* an inclusion period that will last 24 months,
* the follow-up of recipient patients from the day of transplantation until twelve months after the operation


Eligibility Criteria:
Inclusion Criteria for marginal graft:

* donors over 60 years of age
* donors between 50 and 60 years of age with at least one of the following characteristics :

  * history of diabetes mellitus
  * history of high blood pressure
  * serum creatinine \>1,5 mg/dL
  * death by stroke (haemorrhagic or thrombotic)

Inclusion criteria for recipient :

* patients registered on the kidney transplant waiting list likely to receive a marginal kidney
* immunized patients whose anti-HLA antibody specificities have been determined

Exclusion Criteria for recipient:

* pregnant or breastfeeding women
* people who have been incarcerated
* minors
* adults under guardianship
* people who are not affiliated with the French healthcare system
* people with HLA immunization whose HLA antibody specificities have not been determined
Novel Approaches to Reducing Tobacco Related Harm

The purpose of this study is to assess initial reactions to alternative nicotine/tobacco products among smokers living with HIV.

Participants will sample 4 alternative nicotine/tobacco products and provide initial reactions to the products.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected adults age 18 and older currently receiving HIV care
2. Self-report smoking ≥10 cigarettes/day of a brand delivering \>0.5mg nicotine for \>2yrs
3. Have afternoon expired CO concentrations of ≥10ppm or morning urinary cotinine \>100ng/ml (as measured with NicAlert)

Exclusion Criteria:

1. Impaired mental status as assessed by observation
2. Acute intoxication as measured by breath alcohol level (BAL) \> 0
3. Current use of nicotine replacement or other pharmacotherapy for smoking cessation
4. Previous use of e-cigarettes
5. Use of other tobacco products (e.g., chew tobacco, cigars) on \> 10 of the past 30 days
6. Unstable HIV or associated comorbidities, as determined by a licensed medical professional.
7. Pregnancy (Females testing positive for pregnancy and any participants wishing to quit immediately will be referred to community smoking cessation treatment and will be excluded from the study)
8. Blood pressure at or above 160/100 or below 90/50
9. Heart rate at or above 105 bpm or below 45 bpm
CNAP Accuracy Dependent on Hemodynamic Variables

Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP.

Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP. Body mass index and age may have impact on the accuracy of PPV measured non-invasively on the basis of volume-clamp technique.

Eligibility Criteria:
Inclusion Criteria:

* need for invasive blood pressure measurement

Exclusion Criteria:

* age under 18
* emergencies
* cardiac dysrhythmia
Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients

This clinical trial studies how well 3-dimensional multi-parametric ultrasound (3D MPUS) imaging works as a decision-support tool for patients with liver tumors undergoing therapy. Continuous and dynamic imaging of patients undergoing therapy is required to monitor early-phase treatment response. 3D-MPUS is an inexpensive and safe method, which may provide complementary quantitative functional (perfusion) and tissue characterization information to anatomical radiological assessment or blood biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is planned to undergo a new course of cancer therapy\*.
2. Participant is age \>/=18 years.
3. Participant has at least one target lesion (≥1cm and \<14cm) amenable to imaging with ultrasound
4. Participant is willing to comply with protocol requirements.
5. Participant has given written informed consent to participate in this study.

   * Any line of cancer therapy is allowed, including systemic and localized treatments, after any prior treatment. For systemic combination treatments, prior treatment with either drug is allowed at the discretion of the investigators, including rechallenges with the same drug combination, for example upon progression on imaging after a treatment break. For combination treatments where patients start treatment with different drugs at different times, the start date of treatment is determined at the discretion of the investigators and can be the start date of the first drug or of the combination treatment. Repeat participation in the study is allowed, if patients are eligible again per their treatment plan

Exclusion Criteria:

1. Participant has documented anaphylactic or other severe reaction to any ultrasound contrast media or polyethylene glycol (PEG).
2. Participant has any comorbid condition\*\* that, in the opinion of the treating provider or the Protocol Director, compromises the participant's ability to participate in the study.

   * Examples: any mental condition that compromises the ability to follow a consent discussion, or to make informed decisions (except if represented by a Legally Authorized Representative \[LAR\]); any condition that makes the participant not a good candidate to have ultrasound exams with contrast agent.
Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay.

This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.

The study will be carried out in 4 phases:

1. First phase: Enrollment and selection phase.
2. Second phase: Intervention phase ( enteral bovine colostrum administration) .
3. Third phase: Evaluation phase.
4. Fourth phase: collected data analysis and results.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life

Exclusion Criteria:

* Exclusion criteria

Patients with any of the following will be excluded:

1. Obvious major congenital abnormalities.
2. Infants expected to be \>72 hours of age at the time of randomization.
3. Parental consent lacking/refusal