cyrilzakka/clinical-trials huggingface dataset:
To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy

The main objective of this trial is to assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood loss and hospital stay will be record, respectively. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours after surgery.

Single port laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions. Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate that the techniques are feasible provided that both optimal surgical technical expertise with advanced skills and optimal instrumentation are available. Recently, Lee et al. performed the multiple channel single port-access laparoscopic-assisted vaginal hysterectomy (SPA-LAVH) in 24 patient. All cases but 3 were performed exclusively through a single port. The median operative time, weight of the uterus, and estimated blood loss were 119 minutes (range 90 to 255 minutes), 347 g (range 225 to 732 g), and 400 mL (range 100 to 1000 mL), respectively. The median hospital stay (postoperative day) was 3 days (range 3 to 7). Although there are a limited number of studies demonstrating the feasibility of single-port access laparoscopic-assisted vaginal hysterectomy (LAVH), single-port surgery is "new-old" (i.e., a revisited and unstandardized technique) because the major disadvantage of limited movement caused by collisions of the laparoscopic instruments has been mitigated by the development of multi-channel approaches. Therefore, the investigators used a 2-channel single-port system, which was different from the previously published 3-channel single-port technique11,12 to reduce collisions and aid the assistant in controlling the scope without interfering with the surgeon's instruments. To our knowledge, there are no randomize control trial to evaluate of 2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess the feasibility of 2-channel and multiple-channel single port laparoscopy in the treatment of benign uterine disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
* American Society of Anesthesiologists (ASA) physical status of patient: classification I-II

Exclusion Criteria:

* The procedure will be required to conversion to laparotomy.
* Any cardio-vascular diseases.
* Malignant disease
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)

This study performs assessments of pituitary functions by basal hormone levels in the acute phase after TBI and/or SAH followed by detailed endocrine tests (insulin-induced hypoglycemia or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing hormone releasing hormone \[GHRH-arginine-CRH-LHRH\] test) after 4 and 12 months.

Recent data have demonstrated that hypopituitarism seems to be a frequent finding after traumatic brain injury (TBI) and/or subarachnoid hemorrhage (SAH). However, most of these studies referred to retrospective evaluations. There are only few prospective data, and no longitudinal study routinely taking into account the assessment of anterior pituitary function in the acute phase after TBI or SAH so far.

We prospectively evaluate pituitary functions in patients in the acute phase after TBI or SAH and a control group of patients with trauma not involving the brain. Endocrine data included basal anterior pituitary lobe hormone, IGF-1 and testosterone serum levels (Immulite 2000) within the first 8 hours after TBI or SAH. Further endocrine evaluation was performed by means of either a combined GHRH-arginine-CRH-LHRH test or an insulin-induced hypoglycemia test after 4 months and 12 months. To rule out an assay related bias with regard to GH and IGF-1, all hormone levels were cross-checked by a supersensitive assay in another laboratory.

Eligibility Criteria:
Inclusion Criteria:

* TBI or SAH
* Control group: injury without involvement of the brain/skull

Exclusion Criteria:

* Pregnancy
Beneficial Effects of Music on Cognition and Consciousness Level

Exposure to music improves cognitive function in 'healthy' participants and in brain-damaged patients. However, it is still difficult to understand what precisely in music causes a positive effect : are they emotional components, familiarity or preference which improve cognition or is there any specific effect of music? Moreover, it is not yet possible to characterize the neural and functional links between the brain systems solicited by music and those associated with other cognitive functions enhanced by music.

Finally, researches on brain-damaged patients have not exploited the potential effect of music on the level of alert and perceptual awareness, while this type of stimulation could be a valuable tool to improve cognition in patients with a disturbance of consciousness and alertness.

The main objective is to describe the impact of music on the brain's response to self-referential or neutral stimuli in brain-damaged patients with persistent consciousness disorder after a coma and in healthy participants.


Eligibility Criteria:
Brain-damaged patients :

Inclusion Criteria:

* Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
* Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
* Lack of autonomic crisis since one week minimum
* Medical condition considered stable
* Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

Exclusion Criteria:

* Hearing Problem
* Uncontrolled Epilepsy
* Autonomic crises
* Medical unstable state
* Pregnant or likely to be (interrogation data) or breastfeeding woman

Healthy participants :

Inclusion Criteria:

* Subjects with normal hearing
* Absence of neurological disorder
* Subjects able to understand the experimental instructions

Exclusion Criteria:

* Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz
* Neurological disorders
* Pregnant or likely to be (interrogation data) or breastfeeding woman
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program

PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.

Patients in the intervention group will be proposed:

* A regular geriatric follow up including an attentive screening of joint symptoms and functionality,
* An adapted treatment of join pain,
* Weekly sessions of adapted physical activity (Taï Chi),
* And a systematic correction of vitamin D deficits.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years old
* Non metastatic breast cancer, with or without node metastases
* Hormone Receptor (HR) positive breast cancer patients
* Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy
* Introduce an hormonal therapy during 5 years
* Life expectancy \> 6 months (at the discretion of the investigator)
* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
* Patient must be available for follow-up
* Having given written informed consent prior to any procedure related to the study

Exclusion Criteria:

* No other primary malignant tumor \< 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer
* Patient with an experimental treatment in the 30 days prior to the enrollment
* Evidence of metastatic disease
* Not under any administrative or legal supervision
Effect of Sildenafil in Individuals With Migraine Pretreated With Erenumab

An outstanding scientific question, that merits further investigation, is whether dilation of intracranial arteries is implicated in the pathogenesis of cephalic pain in migraine. Here, we hypothesize that experimentally-induced dilation of intracranial arteries using intake of sildenafil (a potent vasodilator) can induce cephalic pain with migraine-like features in people with migraine, who prior to the infusion are administered erenumab (anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody.


Eligibility Criteria:
Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
* Age ≥18 years upon entry into screening.
* History of migraine without aura for ≥12 months with a frequency of 1-5 migraine attacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.

Exclusion Criteria:

* History of any primary headache disorder other than migraine without aura, or tension-type headache with a frequency of ≥5 headache days per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
* History of any secondary headache disorder before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report.
* Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.
* Prior intake of therapies targeting the CGRP signaling pathway, including anti-CGRP ligand monoclonal antibodies, anti-CGRP receptor monoclonal antibodies, and small molecule CGRP receptor antagonists.
* The participant is at risk of self-harm or harm to others as evidenced by past suicidal behavior.
* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator will pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
* Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study.
* Evidence of current pregnancy or breastfeeding per participant self-report or medical records.
* Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants' and investigator's knowledge.
Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State

Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).


Eligibility Criteria:
Inclusion Criteria:

* Adult
* COPD Patients stage 3 et 4
* Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
* Weaned from tobacco for at least 6 months
* vaccinated against pneumococcal
* Have not been included in a pulmonary rehabilitation program during the 6 months preceding the screening visit inclusion
* Patient pre-included not showing exacerbation since the pre-inclusion visit

Exclusion Criteria:

* Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
* Patient with an indication of oxygen is expected in the coming year
* Progressive malignant disease known
* Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year
* Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
* Patients with severe cardiovascular disease
* Pregnancy
Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Injections

Low back pain is one of the leading causes of disability and its social burden and economic cost are quite high. The lifetime prevalence in the population is frequently reported between 40% and 70%. Although there are many reasons that can lead to low back pain, radicular pain, which develops mostly secondary to lumbar disc hernia, is one of the most common pathologies.

Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods. epidural injections; includes transforaminal, interlaminar and caudal approaches. The advantage of the transforaminal approach is that it allows access to the anterior epidural area, which is the region of pathology, and that it can spread to the target specifically around the inflamed nerve roots. The standard imaging technology used for steroid injections with this approach is fluoroscopy.

However, the aforementioned approaches carry the risk of dural puncture, epidural hematoma, epidural abscess, nerve damage, paralysis and many complications. In addition, radiation exposure is another problem. It may be possible to avoid a significant part of these risks by applying interfacial blocks used in regional anesthesia and postoperative pain control in the lumbar region. Recently, Erector Spina Plan Block (ESPB), an interfascial block technique, has been frequently applied under ultrasound (US) guidance as an alternative method to conventional paravertebral block. Investigators also frequently refer to this procedure in the clinic for patients with lumbar radicular pain.

In the literature, there are case reports of lumbar ESPB applied to patients with radicular pain due to disc herniation. Beyond case-level reports, there is no clinical study investigating the efficacy of this procedure technique for applications in the lumbar region. Starting from here, the aim of this study is; Investigators determined to compare the efficacy of erector spina plane block and transforaminal anterior epidural steroid injections in patients with radicular pain due to lumbar disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Radicular low back pain
* Failure to respond to conservative treatments
* Single level lumbar nerve root compression due to disc herniation
* Agree to participate in the research

Exclusion Criteria:

* Patients younger than 18 years and older than 65 years
* Those with non-radicular low back pain
* Those with nerve root compression due to reasons other than disc herniation
* Those with Modic type-1 changes in lumbar MRI
* Those with spinal stenosis or spondylolisthesis
* Those diagnosed with spondylodiscitis
* Pregnant
* Those with inflammatory rheumatic disease
* Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)
Melatonin in Acute Stroke

This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep.

Stroke is a major cause of debilitation in the first world, with few therapeutic options when it comes to improvement in quality of life and morbidity, besides physical and occupational therapy. It affects people of all nationalities, creeds, and socioeconomic classes through a narrow array of mechanisms. With all those mechanisms, a common outcome is shared: derangement of the brain parenchymal architecture. This derangement is non-selective in its destruction with obscuration of the blood brain barrier and the glymphatic system, and with bleeding as a common sequela; the oxidative stress of the hemoglobin-heme-iron compound causing further injury. This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep. Any increased time spent in a restful state because of melatonin increases the clearance of waste products after a catastrophic event, like in stroke.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the Neuroscience Critical Care Unit with a confirmed ischemic stroke
* Patients with a clinical history and examination consistent with an ischemic stroke (stroke must be confirmed by a brain CT and/or MRI scan)
* Eligible patients will have been treated with TPA and/or thrombectomy.

Exclusion Criteria:

* Prisoners
* Patients with severe cognitive impairment and/or aphasia (if no family member is available to sign consent)
* Recent (\<1 month) infection
* Pregnant females
Plasma Marine n-3 Polyunsaturated Fatty Acids and Patient and Graft Survival

This study will evaluate the association between n-3 polyunsaturated fatty acids and patient and graft survival. The association between other fatty acids and mortality and graft loss endpoints will also be evaluated.

This observational study focuses on the effects of marine n-3 polyunsaturated fatty acids (PUFAs) intake, measured as fatty acid levels in plasma phospholipids, and mortality and graft loss endpoints in renal transplant recipients. Data on morbidity, mortality and graft loss in The Norwegian Renal Registry is matched against data on fatty acid composition in a large renal transplantation cohort of approximately 2000 patients with a median follow up time of about 5 years. It is a follow up study, although retrospectively evaluated. It will evaluate the role of marine n-3 PUFAs as a prognostic marker in renal transplantation by investigating the association between the levels (weight percentage of total fatty acids) of marine n-3 PUFAs in plasma phospholipids and events, including mortality and graft loss.

Eligibility Criteria:
Inclusion Criteria:

* Received a renal transplant. Signed informed consent.

Exclusion Criteria:

* Under the age of 16 years.
Comparison of the Effect of MCFA and LCFA on Postprandial Appetite and Lipemia

The main objective is to investigate if foods high in coconut oil (MCFA) or palm oil (LCFA) have different impacts on postprandial blood lipid levels and appetite via a visual analog scale (VAS).

Postprandial lipemia has been recognized as a cardiovascular disease risk factor. The rate of postprandial triglyceride production and clearance in the blood, as well as the appetite, are influenced by the quality of the food consumed, such as the length of saturated fatty acids. The study will include 24 healthy adults ranging in age from 18 to 40 years old, of both sexes and it will be conducted at the University of Jordan. The study will involve two experimental test days, each separated by at least a week of washout interval, and each test day will last for 6 hours. All subjects will be randomly assigned to one of the experimental meals using computer-generated tables. Blood serum samples (2 mL) will be taken after an overnight fast and 2, 4, and 6 hours after eating the meals, and blood lipid profiles \[total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG)\] will be examined in a private lab. After that, participants will be allowed an ad libitum intake of standard meals. Each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50 years
* Males and females
* Apparently healthy
* Fasting triglyceride (TG) \< 2.5 mmol/L or 222 mg/dl at the time of screening.
* Body mass index (BMI) in normal range (18.5-24.9).
* Stable weight for at least 3 months

Exclusion Criteria:

* Consumption of lipid-lowering drugs or any medication that might affect appetite.
* Consumption of any supplement that may affect lipid metabolism or appetite on a regular basis for the past month.
* Regular consumption of two or more fish meals a week over the previous month.
* A history of diabetes, gastrointestinal , liver disease, congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft or established atherosclerotic disease.
* Current smokers
* Pregnant , breastfeeding, postmenopausal or suffer from polycystic ovary syndrome (PCOS)
* Athlete
* Being on a diet or lifestyle changes for the past month.
The Use of Low Molecular Weight Heparin in Hemodiafiltration

Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease stade V treated with hemodiafiltration
* age \>18 year
* Hematocrit \> 30%

Exclusion Criteria:

* treatment with vitamin K antagonists
* treatment with other anti-coagulants or heparin besides the heparin used during dialysis
* active bleeding, infection or malignancy
* heparin associated allergy
* hepatic failure
* trombocytopenia \< 120.000/µl