cyrilzakka/clinical-trials huggingface dataset:
Effects of Aerobic Training in Diabetic vs Non-Diabetic Post-Stroke Patients

The study aims to investigate the effects of aerobic training in post-stroke patients, both diabetic and non-diabetic, in terms of their metabolic response to exercise and psychosocial well-being. It is crucial to understand the metabolic changes that occur due to stroke and diabetes, including glucose and lipid profiles.

The study will explore how aerobic training can influence insulin sensitivity and lipid metabolism differently in diabetic and non-diabetic patients, which may affect overall recovery outcomes. It is also essential to assess psychosocial well-being, including depression and satisfaction with life. Aerobic exercise has been shown to improve mood and enhance overall quality of life in post-stroke patients. By assessing these variables comprehensively, tailored rehabilitation strategies can be developed to optimise metabolic and psychosocial outcomes in diabetic and non-diabetic post-stroke populations, ultimately improving overall well-being and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Male and female post-stroke patients will be inactive or insufficiently active.
* The Patient's age ranged from 18 to 74. They will have a balanced sitting position or can ambulate.
* The stroke will not last less than six months and not more than two years.
* Exercises will be performed at a vigorous intensity greater than 60% of the individual's maximum cardiorespiratory capacity.
* Patients with adequate cognitive abilities (Mini-Mental Scale \>24) to understand and obey instructions

Exclusion Criteria:

* Unconscious patients or communication problems that could prevent them from completing the tests used in the study.
* Those with bilateral or previous hemiplegia and sensory aphasia
* Comorbid neurological diseases (multiple sclerosis, Parkinson's disease, spinal cord injury, traumatic brain injury, brain tumour, etc.
* Those with any contraindications for the maximum exercise test
* Cardiovascular or pulmonary conditions (unsettled angina, current myocardial infarction during the last three months, congestive heart failure, severe heart valve dysfunction)
* Musculoskeletal problems such as extreme arthritis and fracture
Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. The main questions it aims to answer are:

* Is the virtual ileostomy a safe and effective alternative to the ileostomy?
* Is it scientifically reasonable to perform diverting ileostomy intraoperatively? Researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma.

Participants will:

* Performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer
* Continuous follow-up of their complications after the first surgery

This study is a national multicenter, large-sample, randomized controlled study

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rectal cancer confirmed by pathology
* Age ≥ 18 years
* Total mesorectal excision (TME) surgical procedures and colon-rectum or colon-anal anastomosis：1.anterior resection (AR/ PME), 2. low anterior resection (LAR) , 3.intersphincteric abdominoperineal resection (ISR), 4.transanal total mesorectal excision (TaTME)
* Signed informed consent
* Ability to understand the nature and risks of participating in the trial

Exclusion Criteria:

* Emergency surgery, open surgery
* ASA score \>3points
* Patients with combined complete intestinal obstruction
* Long-term history of using immunosuppressants or glucocorticoids
* Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade 2. Patients with a history of myocardial infarction or coronary artery surgery within 6 months before the procedure
* Chronic renal failure (requiring dialysis or glomerular filtration rate \<30 mL/min)
* Intraoperative combined multi-organ resection
* Combined cirrhosis of the liver
* Intraoperative findings of incomplete anastomosis and positive insufflation test
* Modified Bacon procedure(Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis)
* Due to an intraoperative accident the surgeon felt that a diverting ileostomy was necessary.
* Currently participating in other clinical trials
The eSVS® Mesh Randomized Post-Market Study

The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.

The study will enroll up to 200 patients at up to 6 sites. Patients will be enrolled upon meeting entrance criteria, including obtaining written informed consent. Eligible patients must be clinically indicated for coronary artery bypass grafting (CABG) using autologous saphenous vein grafts (SVG). The study is a prospective, randomized, repeated measure controlled trial based on each patient receiving one control SVG and one external Saphenous Vein Support (eSVS) Mesh treated SVG. Each patient will be their own control.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with multi-vessel coronary artery disease
* Requires Saphenous Vein Graft (SVG) Coronary Artery Bypass Graft (CABG) surgery of the Right Coronary Artery (RCA) and the Circumflex Artery (Cx) systems due to atherosclerotic coronary artery disease
* SVGs (eSVS Mesh AND Control) meet size requirements as outlined in eSVS Mesh Instructions for Use
* eSVS Mesh implant procedure can be performed as outlined in the eSVS Mesh Instructions for Use
* Are able to give their informed consent

Exclusion Criteria:

* Not able to give informed consent
* No appropriate target coronary vessels
* SVGs (eSVS Mesh or Control) do not meet size requirements as outlined in eSVS Mesh Instructions for Use
* eSVS Mesh implant procedure cannot be performed as outlined in the eSVS Mesh Instructions for Use
* Inability to tolerate or comply with normal post-surgical drug regimen
* Inability to comply with required follow-up coronary angiography/CT
Single Leg Cycling in COPD: Knowledge Translation to Pulmonary Rehabilitation

Pulmonary rehabilitation (PR) with supervised exercise training is a key part of care for patients with chronic lung disease (COPD). Patients can improve their shortness of breath, walking distance and quality of life. However, many patients do not improve their overall fitness. They are too breathless to train at a high enough intensity. In a laboratory training study, patients with COPD improved their overall fitness by using single leg cycling. Despite this knowledge, single leg cycling has not been used clinically. The objective of this project is to use and assess single leg cycling in a clinical setting. Single leg cycling can be incorporated into a clinical service (replacing traditional two legged cycling) as the predominant aerobic training strategy, resulting in improvements in cardio-respiratory fitness (peak oxygen uptake).


Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD referred for Pulmonary Rehabilitation

Exclusion Criteria:

* Unstable cardiac disease
* any neurological or orthopaedic condition that would make cycling difficult
PET/CT Imaging of Malignant Brain Tumors With 124I-NM404

The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in humans with brain metastases and GBMs. This goal will be accomplished by determining the optimal PET/CT protocol and comparing PET tumor uptake to MRI and calculating tumor dosimetry. A future aim of this study will be to compare non-invasive PET/CT and MRI findings with pathological specimens, which is the gold standard but is invasive and impractical in many cases, to determine the sensitivity and specificity of both techniques for accurately detecting tumor infiltration. The data obtained from this study will be used to develop larger diagnostic and therapeutic trials in brain tumors. The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will have a contrast enhanced brain MRI which documents evidence of GBM or metastatic brain tumor
2. Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained within 2 months of study inclusion
3. Female patients must not be pregnant or breast feeding and both women of childbearing potential, and men, must use appropriate means of contraception and must be maintained for at least 45 days after injection of I-124 NM404. Participants must not attempt to become pregnant during this time
4. Platelet count must be ≥ 160,000/µl, Hematocrit must be ≥ 22%, Leukocyte count must be ≥ 3,000/µL, Creatinine must be ≤ 2.5 mg/dL, ALT must be ≤ 130 U/L, AST must be ≤ 100 U/L, and urine or serum pregnancy test must be negative for pregnancy
5. Karnofsky score ≥ 60
6. For brain metastases patients: targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124I-NM404
7. For GBM tumors confirmed by surgical biopsy or suspected by MRI: no previous surgical resection (except for biopsy) or systemic or radiation therapy targeted to the GBM tumor -

Exclusion Criteria:

1. Life expectancy of \< 3 months
2. Allergy to potassium iodide (SSKI or Thyroshield)
3. Planned surgical resection or biopsy after injection of 124I-NM404 and prior to completion of the 3rd PET/CT scan
4. Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each over 3 days -
Study of Biomarkers of Heat Tolerance and Recovery During Ultra-endurance Exercise

Military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. Induced heat stress can impair performance and lead to pathologies. Faced with the challenges of global warming, this issue is becoming increasingly important in the practice of sport. While hyperthermia is known to impair endurance performance, the underlying thermophysiological responses and regulatory mechanisms during prolonged exercise remain poorly understood. The effects of hyperthermia on mental performance raise questions about the degradation of interoceptive capacities and the deleterious impact on behavioral regulation, an important component of thermal risk management in ultra-endurance exercise. What's more, despite the muscular and hydromineral consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are available on recovery kinetics. A better understanding of the factors conditioning recovery quality could help limit the deleterious consequences of ultra-endurance exercise.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* BMI between 18 and 25 kg/m2
* Weight ≥ 51 kg
* Minimum training volume 6 days/7, aerobic
* Participation in a running competition ≥ 6hours
* Having given informed consent

Exclusion Criteria:

* Presence or history of medical pathology
* Presence of significant deviation from normal electrocardiogram values
* History of heat stroke
* Known intolerance to heat
* Inability to swallow a capsule or refusal of rectal probe
* Alcohol consumption exceeding the equivalent of 3 glasses of wine per week
* Consumption of narcotics
* Smoking \> 0.5 pack of cigarettes per day
* On usual medication
* Pregnant or breast-feeding women
* Protected adult, under legal protection, guardianship or curatorship, or unable to give personal written consent
Total-Body Parametric 18F-FDG PET of COVID-19

The primary objective is to measure the change between COVID-19 patients and normal subjects; the secondary objective is to measure the change in COVID-19 patients between baseline and 4-month follow up.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive patients will have a previous positive COVID-19 test and radiographic findings, and/or a positive SARS-CoV-2 antibody test and be in early recovery.
* First PET/CT visit needs to be within 8 weeks of COVID-19 diagnosis.
* Ability to understand and willingness to sign an informed consent form.
* Ability to adhere to the study visit schedule and other protocol requirements.
* All persons ≥18 years of age.

Exclusion Criteria:

* Pregnant or lactating women.
* Any condition that would prohibit the understanding or rendering of informed consent.
* Unable to lie supine for 1-hour imaging with PET.
* Prisoners.
* Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.
Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

The purpose of the research is to collect and examine spinal disc and ligament tissues to see if there are any biological markers that can be correlated with MRI images to help us learn more about causes of back pain. Spinal discs are the pillow-like cushions between the bones of the spine. They act as shock-absorbers for the spine. Spinal ligaments support the disc structure during movement.

Degenerative disc disease is the most prevalent indication for spine surgery and the major source of back pain in afflicted patients. Age related degeneration of the intervertebral discs is not the exception, but the rule. Degenerative changes are associated with weakening of the disc and hypertrophy of the ligamentum flavum in the spine. The aim of this study is to determine if there are any local or systemic biomarkers that correlate with the severity of degeneration as indicated by radiological examination. To date, Imaging (XRay, MRI, CT scans) are the most widely used diagnostic tools for identifying degenerated discs. Physical changes in the disc are also associated with increased secretion and expression of inflammatory mediators in the tissue. The investigators are interested in measuring both gene and protein level changes of inflammatory mediators in degenerated discs in order to correlate these levels with imaging based indicators of degeneration. Protein level changes in the disc and ligamentum flavum have yet to be correlated with MRI-derived disc modic changes classification system. The investigators hypothesize that as the image characteristics of advancing degenerative disease increase, a corresponding change will be present in the secretion (or expression) of specific markers related to inflammatory processes in the disc. Cytokines found to be upregulated in disc tissue or ligamentum flavum will also be measured in patient's serum levels to begin developing a systemic diagnostic method for detecting disc degeneration.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Patients requiring surgery in lumbar spine region (L1-L2 to L5-S1)
3. Potential procedures: Spinal stenosis, discectomy, laminectomy, lumbar fusion, disc herniation.

Exclusion Criteria:

1. Patients requiring revision surgery in lumbar spine
2. Patients who have had a discography procedure performed at the same disc level as the one being operated on.
3. Known inflammatory conditions- Rheumatoid arthritis, Osteomyelitis, Discitis, Gout, Ankylosing spondylitis, and other infections.
4. Oncologic conditions- any history of cancer of any type.
The Effect of Dexmedetomidine for Emergence Cough

Dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation period after general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence.

Administration of dexmedetomidine before end of surgery could reduce airway reflexes and hemodynamic changes during tracheal extubation. Compared with remifentanil alone, administration of dexmedetomidine in combination with remifentanil is effective in relieving cough and hemodynamic changes without inhibition of respiration. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence using the modified up-and-down method.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under general anesthesia

Exclusion Criteria:

* predicted difficult airway
* body mass index \> 35 kg/m2,
* recent upper respiratory infection
* asthma
* current smoker
* patients using angiotensin converting enzyme-inhibitors
* uncontrolled hypertension
Vidéolaryngoscopy Study of the LPEC in Obese Patients

1. Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient
2. International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position

Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient

International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position

Eligibility Criteria:
Inclusion Criteria:

* Adults patients with BMI \> 35 undergoing general anaesthesia

Exclusion Criteria:

* pregnant women
* people with facial
* oropharyngeal abnormalities
Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments
* ECOG score 0 or 1;
* Part B: At least 1 measurable lesion according to RECIST 1.1

Exclusion Criteria:

* Known hypersensitivity to any ingredient of TWP-101;
* Receiving any anti-cancer drugs;
* History of serious systemic diseases;
* History of serious autoimmune diseases;
* Pregnancy or lactating women.
The Prefyx PPS™ System eRegistry

Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).

Registry to gather information about the long term use of the Prefyx PPS System which utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone) for the treatment of SUI. No additional procedures are required beyond the physician's standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for treatment of female Urinary Stress Incontinence (SUI)

Exclusion Criteria:

* Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
* Any patients with soft tissue pathology into which the implant is to be placed.
* Patients with any pathology which would compromise implant placement.
* Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis

This study is an exploratory study aiming to collect data about diagnosis efficacy (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology analysis. The standard of reference for diagnosis will be given by the site according to their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site and/or the more recent AFP results available). 10 additional subjects will be included to explore the diagnostic efficacy for HCC at half dose of P03277.


Eligibility Criteria:
Inclusion Criteria:

* Subject presenting with liver cirrhosis or chronic liver disease as shown by previous liver biopsy or by combination of clinical, endoscopic, biological, ultrasound parameters, and elastography
* Subject presenting with 1 to a maximum of 3 untreated hepatic nodule(s) of less than or equal to 3 cm (long axis) previously identified and/or characterized through enhanced CT and/or MRI within a maximum of 21 days before P03277 imaging, confirmed for HCC or not

Exclusion Criteria:

* Subject presenting with hepatic nodule more than 3 cm in addition to nodule(s) less than or equal to 3 cm
* Subject already treated for HCC by surgery or thermal ablation for which the resection or coagulation area is less than 2 cm from the new nodule(s)
* Subject previously treated by transarterial chemoembolization
* Subject with moderate or severe renal impairment (eGFR \< 60 mL/min/1.73 m2) based on measurement done or available within the 7 days before P03277 administration and assessed after any iodinated contrast agent administration, or with dialysis end stage renal disease (ESRD)
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a weight of ≥ 20 kg.
* Participant must have an age and sex specific BMI value no lower in range than the fifth percentile on the growth chart for children and adolescents.
* Participant is able to swallow the study medication tablet.
* Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
* Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by:
* Psoriasis Area Severity Index score 2-15,
* Body surface area 2-15%, and
* Static Physician Global Assessment score of 2-3 (mild to moderate)
* Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.

Exclusion Criteria:

* Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
* Psoriasis flare or rebound within 4 weeks prior to screening.
* Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
* History of recurrent significant infections.
* Active infection or infection treated with antibiotic treatment within 14 days of Study Day 1.
* Any history of or active malignancy or myeloproliferative or lymphoproliferative disease.
* Current use of the following therapies that may have a possible effect on psoriasis:
* Conventional systemic therapy for psoriasis within 28 days prior to Study Day 1 (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters).
* Phototherapy treatment (ie, ultraviolet B \[UVB\], PUVA) within 28 days prior to Study Day 1.
* Biologic therapy:

  * Etanercept (or biosimilar) treatment 28 days prior to Study Day 1
  * Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1
  * Other TNF or IL-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) within 12 weeks prior to Study Day 1
  * Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to Study Day 1.
* Use of tanning booths or other ultraviolet light sources.
* Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during screening or at Study Day 1.
* Female participant of childbearing potential with a positive pregnancy test assessed at screening and/or Study Day 1 by a serum and/or urine pregnancy test.