cyrilzakka/clinical-trials huggingface dataset:
Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis

Infectious vertebral osteomyelitis are infectious diseases of the vertebral bone, intervertebral disc and/ or adjacent tissue. Most of cases are due to hematogenous dissemination of pathogen but direct inoculation is an aetiology after surgery. Majority of cases concern adults after 50 years and the annual incidence ranging between 0.5 and 2.4 cases per 100 000 habitants in Europe but seems to increase during last 20 years.

The infectious spondylodiscitis is an important source of morbidity and mortality. The treatment is based on pathogen adapted antimicrobial therapy, which may be associated with bedrest. Surgical act is necessary when neurological complication occurs or when vertebral column instability is too important. The immobilization in bed is use to limit pain and neurological complications. However, the immobilization is based on few literature data and causes important complications especially in elderly.

The of immobilization in Nancy universitity hospital changed in 2019 after institutional recommendations based on expert opinion which recommend an early verticalization of uncomplicated spondylodiscitis. The investigators aimed to evaluate the consequences of this practice change on the hospitalization duration and complication rates due to spondylodiscitis and immobilization.


Eligibility Criteria:
Inclusion Criteria:

* Infectious spondylodiscitis proven by radiological exam
* Infectious spondylodiscitis with microbiological documentation

Exclusion Criteria:

* Patient included in COROSIVE study
* Vertebral prosthetic device infection
* Infectious spondylodiscitis relapse
Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury

The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with sensomotoric functioning and clinical outcome.

Injury of the spinal cord, for instance induced by trauma, is complex involving primary mechanisms caused by forces directly affecting the spinal cord and secondary mechanisms consisting of complex physiological processes after trauma.

Conventional magnetic resonance imaging (MRI) is the current standard to assess morphologic changes of the spinal cord after injury. However, conventional MRI provides little information regarding the health and integrity of the brain and spinal cord tissue itself, due to the fact that signal intensity changes are non-specific and do not correspond directly with physiological processes. This is reflected in the poor correlation of conventional MRI data with neurological and functional impairment in various spinal cord pathologies (such as multiple sclerosis compression myelopathy) and failure to provide reliable prognostic information.

By applying a combination of diffusion weighted imaging, functional MRI and magnetic resonance spectroscopy will give us a better understanding of the changes after injury of the cervical spinal cord, brainstem and brain. Correlating the imaging data with the neurological and clinical status of patients could improve the patient status prediction and therapy planning.

This study is divided into three sub-projects:

i) Reproducibility study of the MR measurements in healthy controls ii) Progression of MR biomarkers in subacute patients with SCI and comparison to chronic patients with SCI iii) Prediction of clinical outcome based on MR biomarkers

Eligibility Criteria:
Healthy controls:

Inclusion Criteria:

* age between 18 and 80 years
* no previous history of severe cervical trauma, traumatic brain injury, cervical surgery or signs of neurological impairment and no known neurological disease.

Exclusion Criteria:

* not meeting the MRI screening requirements
* unable to give consent
* unable to fulfill the above mentioned inclusion criteria

Subacute and chronic patients with spinal cord injury:

Inclusion Criteria:

* lesion level at or below C3
* etiology of the spinal cord injury is traumatic or non-traumatic
* age between 18 and 80 years
* time of trauma or onset of symptoms for subacute SCI patients is more than 3 weeks and for the chronic SCI patients more than 2 years

Exclusion Criteria:

* lesion level below L2
* other known pathology of the spinal cord/brain (e.g. MS) or progressive neurological disorders
* inability to meet the MRI screening requirements (e.g. pacemaker or other electronic devices),
* severe head trauma as defined by a Glasgow Coma Scale (GCS) of \< 14
* patients who are ventilator dependant
Whether Opioids Are Factor That Induced POD?

The purpose of this study was to investigate whether perioperative use of low doses of opioids could reduce postoperative delirium .

Postoperative delirium (POD) is a common postoperative complication of the elderly caused by a variety of factors. POD is an acute neuropsychiatric disorder characterized by disturbance of attention consciousness and cognitive function fluctuation, and more than 40% of elderly patients have symptoms of hypoactivity POD.The incidence of POD is as high as 17% to 61% in patients with neurocognitive impairment and patients undergoing complex or emergency surgery, which usually occurs between 1 and 3 days after surgery. POD will lead to prolonged hospital stay, functional impairment and even death. How to prevent and treat POD is an urgent clinical problem to be solved at present.

Opiates are commonly used perioperative sedatives and analgesics, which may be associated with the occurrence of postoperative POD in elderly patients and increase the risk of POD. It is not clear whether perioperative use of low doses of opioids could reduces the incidence of POD in elderly patients. In this study, reducing-opioids anesthesia was defined as the use of 1/3 of the conventional opioid dose to observe whether reducing-opioids anesthesia affected the incidence of POD in elderly patients undergoing gastric cancer surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients' age ≥65 years
* Underwent elective radical gastrectomy

Exclusion Criteria:

* Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy \<18, primary school \<21, junior school and above \<25
* Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants
* History of alcohol abuse or a history of drug dependence
* Have brain surgery or trauma
* Cannot with the completion of tests of Postoperative Cognitive Dysfunction
* Refused to participate in the study
Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion

This study is a randomized controlled non-inferiority trial designed to evaluate the impact of implementing the 'Early Recovery After Surgery Clinical Pathway (ERAS CP)' on patient-reported pain levels at the time of discharge following Oblique Lumbar Interbody Fusion (OLIF) surgery

Currently, the effectiveness of the ERAS has been widely confirmed in patients undergoing colorectal resection, and it has been verified to reduce length of hospital stay and complications. However, the ERAS protocol for lumbar fusion surgery is based on a few retrospective studies and remains a consensus statement. Recent retrospective studies targeting patients undergoing lumbar fusion surgery reported that implementing ERAS could accelerate post-operative functional recovery and reduce hospital stay. However, there is still a lack of high-quality evidence based on prospective studies.

Lumbar fusion surgery is known for potentially leading to severe postoperative pain, which poses challenges in consistently applying ERAS components, such as early ambulation or active oral feeding, after surgery. In light of this, the present study aims to validate the non-inferiority of pain levels at discharge within the ERAS group and to reconfirm the effects of ERAS as observed in retrospective studies.

Patients admitted for OLIF will be consecutively screened for eligibility. A computer-generated block randomization will be executed at a 1:1 ratio. In the ERAS group, patients will receive comprehensive education about the treatment process, and a clinical pathway that includes active ambulation and pain control will be protocolized and implemented. Should non-inferiority be demonstrated in both intent-to-treat and per-protocol analyses, non-inferiority will be declared.

Eligibility Criteria:
Inclusion Criteria:

1. Lumbar degenerative disease, requiring interbody fusion of 1-2 segments between L2 and S1
2. Capability of independent (or assisted) ambulation for at least 30 minutes with

   1. Taking intermittent breaks
   2. Enduring any discomfort
3. Voluntary informed consent to participate in the study.

Exclusion Criteria:

1. Previous history of lumbar interbody fusion
2. Manual Muscle Testing grade 3 or below
3. Neuropsychiatric disorders such as major depressive disorder
4. Musculoskeletal disorders other than lumbar degenerative diseases (inflammatory, myopathic, infections, etc.)
5. Diagnosis of malignant neoplasm
6. Refusal to participate in the study
Ifosfamide, Teniposide, and Paclitaxel in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of ifosfamide, teniposide, and paclitaxel in treating patients who have relapsed non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the toxicities associated with the combination of ifosfamide, teniposide, and weekly paclitaxel in patients with relapsed non-Hodgkin's lymphoma.
* Evaluate response rate and time to disease progression in these patients treated with this regimen.

OUTLINE: This is a dose escalation study of teniposide. Patients are stratified according to whether they proceed to stem cell transplant or not.

Patients receive ifosfamide IV over 1-2 hours on days 1-3 every 3 weeks, teniposide IV over 2 hours on day 1 every 3 weeks, and paclitaxel IV over 1 hour weekly. Patients who are not candidates for stem cell transplant continue treatment for 120 days in the absence of disease progression or unacceptable toxicity. Patients proceeding to stem cell transplant continue treatment for 36 days. Peripheral blood stem cells (PBSC) may be harvested at this time if autologous transplant is planned. Transplant patients may then continue with chemotherapy or proceed to autologous or allogeneic PBSC transplant.

Cohorts of 3-5 patients receive escalating doses of teniposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 5 patients experience dose limiting toxicities.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma

  * No lymphoblastic or small cleaved lymphoma
* Progressive disease following doxorubicin based chemotherapy

  * No more than 2 prior treatment regimens
* Measurable or evaluable disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No significant cardiac disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active or uncontrolled second malignancy
* No other medical problems that would preclude therapy
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior stem cell transplant allowed

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)

This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be \> 1.5 (0= no pain, 4 = very severe pain)

Exclusion Criteria:

* Subjects not meeting the Rome II criteria for the diagnosis of IBS
* Subjects with no stool for 7 days during the screen
Home Therapy With Replagal in Fabry Disease

The purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with Morbus Fabry disease receiving their Enzyme Replacement Therapy with Replagal (Agalsidase alfa) at home compared to receiving the infusions at the clinic or at doctor's practice.


Eligibility Criteria:
INCLUSION CRITERIA:

* Male or female patient with a confirmed diagnosis of Fabry disease
* Age\> 4 years
* Patient is under Replagal since at least 12 weeks ® therapy
* The patient is compliant, the previous Replagal ® infusions were performed approximately every 2 weeks in the center close to home or at the hospital / general practitioner at
* Patient has been well tolerated Replagal ® therapy, and there were in the last 12 weeks before inclusion in this study no significant infusion reactions to
* The patient has been selected before inclusion in this study for a home infusion therapy and has consented to (or their legal representative)
* The patient / be lawful. Representative has consented in writing to participate in this study.

Exclusion Criteria:

* Patient/legal representative does not give consent to participation in this study
* Patient/legal representative declines Replagal® home therapy
* The patient is participating in a clinical trial with a medicinal product
Epidemiological Study of Post-operative Chronic Pediatric Pain.

This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Chronic pain, defined as continuous or intermittent pain for 3 months or more, postoperative because in the territory of the surgical procedure and does not exist before the operation, is common in adults. Its prevalence varies according to the surgeries between 10 and 50% of the operated adults. The factors potentially responsible for their occurrence are gradually being highlighted in the recent literature, which has made it possible to develop an appropriate analgesic management strategy.

In pediatric surgery, acute pain has long been known and treated as early as possible using multimodal analgesic techniques. On the other hand, there are very few studies evaluating postoperative chronic pain 3 months after infant surgery, as was the case a few years ago in adults.

This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Eligibility Criteria:
Inclusion Criteria:

All children between the ages of 6 and 18, who are scheduled for surgery or video-surgery, scheduled or urgent, in the pediatric surgery department of the Bordeaux University Hospital.

All patients who consented to participate in the research.

Exclusion Criteria:

* All children operated on outpatient surgery.
* Children and parents with difficulties in understanding the questionnaires.
* Refusal of the child or one of the parents.
* Change of home planned during the post-operative follow-up period (3 months).
A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in mPCa Patients

The goal of this observational study is to compare the number of CTCs enriched by both sampling methods, leukapheresis and collection of peripheral blood in metastatic prostate cancer patients. The main questions it aims to answer are:

1. The advantages and disadvantages of two sampling methods for further diagnosis and treatment;
2. How to obtain further information on the tumour biology of CTC;
3. The mechanisms of prostate cancer invasion and metastasis Participants will have 7.5mL of peripheral blood taken as well as undergo leukapheresis.


Eligibility Criteria:
Inclusion Criteria:

1. male, aged 18-75 years; and
2. Evidence of metastasis (positive finding of metastasis on one of the following tests: CT and MRI; whole-body nuclear bone imaging, fluoride PET and PET-CT, cholinergic PET-CT and MRI; prostate-specific membrane antigen-targeted PET-CT); or clinical diagnosis of metastatic prostate cancer (tumour stage of T3 and above) by pathology of aspiration/surgical biopsy;
3. Good general condition, ECOG score 0-1, able to tolerate leukapheresis;
4. Normal haematological analysis, liver and renal function tests at screening;
5. Subjects (or their legal representatives) can understand the informed consent form.

Exclusion Criteria:

1. those who have received systemic combination therapy for tumours within 5 years;
2. those with poor general condition, severe haemodynamic instability, malignant arrhythmias, cachexia and infections
3. those with coagulation disorders, DIC or reduced platelets;
4. those receiving exogenous plasma at the time of the trial;
PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY

Cardiac amyloidosis is a condition where the heart muscle, amongst other tissues, is infiltrated by the abnormal build-up of proteins called amyloid. This stiffens and thickens the heart muscle over time which makes it less efficient and puts further stress and strain on the other chambers of the heart, leading to heart failure. The commonest form, that affects predominantly the elderly, is called 'wild-type' ATTR amyloid (TTR is the protein that accumulates). In this condition a patient has a 60% chance of admission to hospital each year after diagnosis. There is no current treatment for ATTR amyloid other than using water tablets to reduce excess fluid and prevent more serious fluid build up in lungs and other tissues. Increasing body weight is the most reliable clinical sign of this fluid build up.

Tele-monitoring is the practice of monitoring patients from a distance and has been shown to reduce heart failure admissions and death in patients with heart failure from any cause. Due to reduced access to primary and secondary care during COVID-19 the investigators instigated tele-monitoring of heart failure in ATTR amyloid patients. This appeared to be an effective intervention in the pilot study. The investigators propose to monitor the weight of patients with cardiac amyloidosis at home and intervene where a build up of fluid is observed by telephone discussion with a doctor. The investigators propose to evidence this in a prospective clinical trial. The investigators will evaluate the effect fairly by comparing tele-monitoring with usual care.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged ≥18 at the date of signing informed consent which is defined as the beginning of the Screening Period.
2. An established diagnosis of ATTR cardiomyopathy as defined by protocol.
3. Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (R2) (2016) and applicable regulations, before completing any study-related procedures.
4. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
5. Currently a patient at a study site (NAC).

Exclusion Criteria:

1. An inability to have or use BodyTrace device scales at usual residence (for example no mobile network cellular signal)
2. On dialysis or end-stage renal failure (eGFR \<25mL/min)
3. Serum albumin \<20g/dL or other non-hypervolaemia cause of tissue oedema (e.g. protein-losing enteropathy, nephrotic syndrome)
4. Use of greater than 2 oral diuretics (e.g. on maximum oral diuretic therapy)
Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning

Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker, commonly used cardiovascular medication in patients with cardiac diseases such as hypertension or angina pectoris, on cardioprotective role of remote ischemic conditioning has not been well documented. The purpose of the study is to investigate the effect of beta-blocker on remote ischemic conditioning in healthy volunteers.

This study is prospective cross-over study investigating effect of beta-blocker on cardioprotective role of remote ischemic conditioning. Eleven male healthy volunteers are going to take oral beta-blocker (carvedilol, 12.5 mg once) or not before undergoing remote ischemic conditioning (consisting of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion of upper arm), separated by 6-day wash-out period. To evaluate cardioprotective effect of remote ischemic conditioning, blood samples will be obtained before and after remote ischemic conditioning. Form the samples, human dialysate will be obtained and be perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Changes of infarct size of the rat heart will be compared between the beta-blocker and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer
* Not taking any medication

Exclusion Criteria:

* BMI \< 18 kg/m2 or \> 30 kg/m2
* Allergic history of any medication
* Baseline SBP \> 150 mmHg or \< 100 mmHg
* Baseline DBP \> 100 mmHg or \< 50 mmHg
* Strenuous exercise, excessive caffeine or alcohol, smoking 24 h prior to experiment
* Cannot undergoing remote ischemic conditioning for any reason
* Refuse to enroll
Telephone Counseling to Enhance the Quality and Safety of Romantic and Sexual Relationships in People Living and Aging With HIV

The purpose of this study is to determine if a brief behavioral intervention delivered over the telephone is effective at reducing occasions of condomless sex in persons living and aging with HIV.

Estimated rates of condomless anal and vaginal intercourse among HIV-positive older adults remain high. Brief motivational interventions delivered face-to-face have demonstrated efficacy at reducing condomless sex in HIV-positive persons. However, these interventions are not contextualized to the unique sexual health needs of HIV-positive older adults. Further, many HIV-positive older adults have difficulty accessing face-to-face services due to transportation, stigma, and other barriers. Telehealth interventions represent one delivery approach that overcomes such barriers.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Have access to a landline or cellular telephone
* Be 50 years of age or older at some point during study participation
* Report engaging in one or more occasions of condomless anal and/or vaginal intercourse with an HIV-negative or unknown HIV serostatus sex partner in the 3 months prior to study enrollment. An exception to this criterion is participants whose HIV viral load is undetectable and whose only condomless sex is in the context of a monogamous sexual relationship with an HIV-negative partner.

Exclusion Criteria:

* Active suicidal ideation as determined by the Patient Health Questionnaire 9-item Depression Module