cyrilzakka/clinical-trials huggingface dataset:
Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

Lymphoceles are a potentially serious complication of radical prostatectomy (RP) with pelvic lymph node dissection. They are associated with abdominal pain, urinary tract symptoms, fever, lower extremity swelling and deep vein thrombosis. They can be severe enough to necessitate intervention in 5% of patients after RRP with PLND, with sequela that could include infection and nerve damage. Studies evaluating strategies to preclude lymphocele formation after RP have included comparisons of the use of titanium clips vs bipolar coagulation to seal lymphatic vessels during pelvic lymph node dissection. In a recent prospective randomized trial comparing these approaches, no differences were observed in the rates of lymphocele formation as detected by ultrasound. There is a need to continue to test potential strategies to minimize the formation of lymphoceles after RRP.

Creation of a peritoneal iliac flap is one approach has potential towards this end. At the Lahey Hospital and Medical Center in Burlington, MA surgeons routinely fold the bladder into a peritoneal flap to overlay the area of extended lymphadenectomy. It is thought that this method prevents the formation of lymphoceles because the flap creates a window, which allows drainage of the lymph fluid into the peritoneal cavity to be reabsorbed. While the Lahey study supports the safety and effectiveness of the peritoneal flap approach, the procedure has never been evaluated through a randomized prospective trial and the practice is certainly not standard of care. We therefore propose a randomized, prospective clinical trial to be conducted in the Hartford Hospital Urology Department to examine the effectiveness of a peritoneal iliac flap on the formation of lymphoceles after RRP with pelvic lymph node dissection.

Hypotheses:

1. We hypothesize that, at 3 months after RP, rates of lymphocele formation (symptomatic and asymptomatic lymphoceles) will be significantly lower in patients who have pelvic lymph node dissection using the peritoneal iliac flap approach than in patients who have pelvic lymph node dissection using the standard approach.
2. Lymphoceles are often associated with lower urinary tract symptoms. We hypothesize that, after RP, severity of urinary bother symptoms and urinary incontinence will be significantly lower at each measurement period for patients who had pelvic lymph node dissection using the peritoneal iliac flap approach relative to patients who had pelvic lymph node dissection using the standard approach.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo robotic assisted radical prostatectomy with pelvic lymph node dissection for prostate cancer at Hartford Hospital.
* diagnosed with biopsy-proven prostate cancer, with intermediate or high risk features per D'Amico risk stratification
* ability to give informed consent to participate in the study

Exclusion Criteria:

* Patients with prior prostate irradiation and peri-aortic lymph node dissections will be excluded
Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Subjects waiting for Elective Cardiac Surgery (CABG, Cardiac Valve Operation, Congenital heart anomaly surgery, aortic surgery, etc.)
* Subjects over the age of 18
* Patients with type 2 diabetes
* Patients with prediabetes

  1. HbA1c 5.7% or more
  2. fasting blood glucose 100 mg/dL or more
  3. 2 hours 75g-OGTT 140 mg/dL or more

Exclusion Criteria:

* Emergency surgery patients
* Patients performing co-operation other than cardiac surgery
* Patients with type 1 diabetes
* Total Pancreatectomy patients
* Patients with high surgical severity (STS score of 8 or more or EURO score of 5 or more)
* Patients who do not consent to the study
* Severe patients who are deemed difficult to continue research during surgery (excluded at the researcher's discretion)

  1. Cases where severe weight gain and severe edema occur after surgery
  2. Cases where the surgery time is significantly longer than average
  3. Cases where cardiopulmonary bypass is used more than once during surgery
* Others who are deemed unsuitable for research progression at the researcher's discretion
Periostin Levels in Children With Adenoid Hypertrophy

Periostin is a matricellular protein that has been shown to be a marker of Type 2 inflammation associated with airway eosinophilia. Matricellular proteins are highly expressed at sites of injury or inflammation. Periostin involves tissue fibrosis and remodeling in the nasal mucosa in some of the otolaryngologic diseases. The up-regulation of periostin expression has been shown in allergic rhinitis, chronic rhinosinusitis with nasal polyps , and aspirin intolerant asthma. In the light of these findings the investigators aimed to evaluate the relation between adenoid hypertrophy and periostin levels.

A total of 40 patients-age ranged between 2 and 12 years- were planned to enroll in the study prospectively. Patients that were scheduled to undergo adenoidectomy were included in the study group (adenoid group). The control group comprised of 20 healthy children who had previously been treated for anemia in the out-patient clinic of the Pediatrics Department and were clinically healthy with normal complete blood cell counts at their follow-up visits.

Serum samples were obtained from the two groups. The samples were centrifuged at 1500 g for 5 minute and stored in -80 oC for later analysis of periostin levels. Adenoid tissue and normal mucosal tissue samples were obtained from the adenoidectomy patients and stored in -80 oC for later homogenization and measurement of periostin levels.

Eligibility Criteria:
Inclusion Criteria:

* The patients that were scheduled for adenoidectomy
* Healthy subjects that had not any kind of allergy, adenoid hypertrophy symptoms

Exclusion Criteria(for adenoid group):

* The subjects that had any kind of corticosteroid treatment 1 month prior to surgery, and antihistaminic treatment 2 weeks prior to surgery

Exclusion Criteria(for control group):

* To have allergic rhinitis symptoms
* To have high total IgE levels
* To have positive skin prick test
* To have acute respiratory tract infection
* To have asthma To have any kind of endocrin disease
The Effects of Mental Practice Combined With Proprioceptive Neuromuscular Facilitation on Muscle Strength of Upper Limb and Hand Grip

Influence of mental practice and proprioceptive neuromuscular facilitation on muscle strength of upper limb and hand grip will be measured in 30 to 50 healthy students with right dominant hand, Their age will be ranged from 18 to 26 years old. Subjects will randomly assigned to either proprioceptive neuromuscular facilitation (PNF) group or proprioceptive neuromuscular facilitation with mental practice (PNFMP) group.

PNF group: 15 - 25 individuals, these subjects will receive only PNF training. PNFMP: 15 individuals, these subjects will receive PNF training with MP. Training program will be conducted for every group for 5 weeks with 3 sessions x 30 min per week. Electromyography (EMG) device will be used to measure the electrical activity of muscles using surface electrodes. Hydraulic hand dynamometer will be used to measure hand grip strength.

Eligibility Criteria:
Inclusion Criteria:

1. The participant will be right-handed.
2. Previously untrained subjects.
3. Absence of a prior injury of the hand or arm

Exclusion Criteria:

1. History of a neurological disease.
2. History of musculoskeletal injury of upper limb.
3. Unstable medical condition
Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients

Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.

The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control of tracheal cuff pressure.

Eligibility Criteria:
Inclusion Criteria:

* Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.
* Predicted duration of mechanical ventilation \> or = 48h.
* Age \> or = 18 years.
* Signed informed consent.

Exclusion Criteria:

* Anticipated duration of mechanical ventilation\<48h after randomization.
* Tracheostomized patients.
* Patients with contraindication for semirecumbent position.
* Patients participating to another trial that might influence this study results.
Bakri Balloon in Placenta Previa

The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment.


Eligibility Criteria:
Inclusion Criteria:

1. All women delivered and presented with primary atonic PPH
2. Women who accepted to participate

Exclusion Criteria:

1. Traumatic PPH as excluded by examination under anesthesia.
2. With any suspected or clinical evidence of uterine infection
3. Women diagnosed to have preeclampsia or eclampsia after delivery.
4. Women who had DM during pregnancy
5. Women with history of DVT or other thromboembolic complication
6. Women with history of rheumatic heart disease.
7. Women with coagulation defects.
Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

The classical trigeminal neuralgia (CTN) is a common neuropathic pain in clinic by recurrent attacks of chronic sharp pain in the distribution of neuropathy branches of trigeminal neuralgia. With the lack of appropriate drug and surgery, acupuncture played a role in analgesia with its effective and few side effects. The study is designed to observe the therapeutic effect and safety of electroacupuncture (EA) in the treatment of CTN.

A total of 120 subjects with CTN who met the inclusion criteria will be included in the study. The subjects will be randomly divided into EA+ Carbamazepine group, EA+placebo group, sham EA+Carbamazepine group and sham EA+placebo group. The indexes of main outcome evaluation are 1)Intensity of pain (Evaluation of the pain by VAS with 0-10 points) and 2)Brief introduction of 2-week pain. The indexes of secondary outcome evaluation are 1) Brief Pain Inventory-Facial scale(BPI-Facial); 2) Patient Global Impression of Change(PGIC); 3) Short-Form McGill Pain Questionnaire; 4) Short- Form 36 Questionnaire. This study will evaluate whether EA has the advantage over carbamazepine in the immediate effect, long-term effect and post effect of the analgesia in CTN. At the same time, the study also will demonstrate whether EA has a synergistic effect with carbamazepine on the treatment of CTN, or even whether EA has an alternative effect on carbamazepine. Furthermore, we will establish a standardized, effective and convenient therapy program of EA to promote according to the results.

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffer from the pain with electric shock, shooting, stabbing occurs in one or more branches of the trigeminal nerve.
2. The visual analogue score(VAS) baseline score ≥5, have a attack more than 3 times a day, at least 4 days a week.
3. 18 years ≤ age ≤ 80 years.
4. Clear consciousness, have the ability of pain perception and resolution, can complete the basic communication.
5. Signed informed consent and volunteered to participate in this study.

Exclusion Criteria:

1. Those patients with epilepsy, head injury or other related neurological diseases.
2. Patients with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or unable to cooperate with the treatment.
3. Combined with hypertension but poor control.
4. Severe depressive with definitive diagnosis recently.
5. Pregnant and lactating patients.
6. Installing pacemakers.
7. For any other reason that is not suitable for the treatment of EA.
Immunosenescence and Hepatitis B Virus (HBV) Vaccine Efficacy in Chronic Renal Disease Patient

The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.

The risk of infection with hepatitis B during exposure to blood is high (30% against 1.8% for Hepatitis C Virus and HIV 1%) and dialysis patients are a population at risk. Vaccination against this virus, which is very effective in the general population (vaccine response: 90 to 95%), is highly recommended in dialysis patients. However, numerous studies have shown that HBV vaccination was less effective in patients with chronic renal disease than in the general population. The reasons for low vaccine response are poorly understood. However, recent data suggest that renal failure could induce accelerated immunosenescence.

The aging of the immune system, or immunosenescence, is a complex and profound phenomenon of the immune system during life. The gradual reduction of the generation of naive T cells in the thymus is the major cause of immunosenescence. But this process is also associated with an accumulation of lymphocytes at the end of differentiation.

In this context, the decrease in vaccine response and increased infections in renal insufficiency might be correlated, as in the elderly population, with the aging of the immune system. The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency.

Vaccination against HBV is not performed for the purposes of the study, but due to the existing vaccine indication for the subject. Included patients receive vaccination as routine care according to the recommendations and the vaccination schedule recommended by the Health Authority.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an indication of HBV vaccination
* Patient with renal disease, with a creatinine clearance between 15 and 60ml/min
* Patient who have never been vaccinated against HBV
* Patient with negative serology for HBV
* Patient able to understand the reason of the study
* Patient not opposed to the conservation of biological samples for scientific research

Exclusion Criteria:

* Patient infected with Hepatitis B or with history of vaccination against HBV
* Patient suffering from psychotic illness
* Patient with any history of immunosuppressive therapy
* Patient with infectious and/or cancer diseases in evolution
A Pilot Study of the Feasibility of Setting up a Logbook for Allogeneic Haematopoietic Stem Cell Patients at the University Hospital of Amiens

Hospitalization for allogeneic haematopoietic stem cell transplantation constitutes a particular time in the management of patients with malignant hemopathies both for the patient, for his entourage or for the nursing staff. For the patient, the strict protective isolation set up during this period is a source of isolation in the broad sense and is associated with an escape from external events and society. It also constitutes a physical barrier (mask, charlotte, surblouse and overshoes worn by caregivers or visitors) and even psychological in relations with relatives. Moreover, this period is also difficult because of the possible complications of conditioning (mucositis, transit disorders, fever ...) and allograft itself (graft versus host disease, no transplant, relapse disease...). The patient may be weakened and diminished, which can give a feeling of helplessness and uselessness to the family. Finally, this therapy can have serious physical and psychological consequences for the patient and his entourage (especially in the case of family allograft) who do not always have the possibility to express themselves verbally. Published studies in hematology report depressive, anxious and post-traumatic stress disorders in patients and relatives during allogeneic haematopoietic stem cell transplantation. It is therefore important to reduce these symptoms, particularly those related to the cut-off during hospitalization for allogeneic haematopoietic stem cells.

Over the last decade or so, the logbook has been used in some resuscitation services in intubated patients, with the main objective of filling the "memory gap" mentioned by the intubated patients when they woke up and limiting the trauma associated with this Cut in the world corresponding to the sedation period. For this purpose, the use of a logbook in Hematology, by analogy with what is used in the resuscitation services, could be a means of limiting the psychological complications related to the allograft.


Eligibility Criteria:
Inclusion Criteria:

* Major hospitalized patient for allogeneic haematopoietic stem cells
* Patient agreeing to participate

Exclusion Criteria:

* Patient refusing to participate
* Patient hospitalized for reasons other than allogeneic haematopoietic stem cells
The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes

The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months.

The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.


Eligibility Criteria:
Key inclusion criteria:

1. Age below 7 years of age (at inclusion)
2. Type 1 diabetes for at least 6 months
3. Insulin pump user for at least 3 months
4. Treated with rapid or ultra-rapid acting insulin analogue

Key exclusion criteria:

1. Physical or psychological disease likely to interfere with normal conduct of the study
2. Untreated coeliac disease or thyroid disease
3. Current treatment with drugs known to interfere with glucose metabolism
4. Subject/carer's severe visual impairment
5. Subject/carer's severe hearing impairment
Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.

Mortality of patients with COVID-19 associated acute respiratory distress syndrome (CARDS) treated with veno-venous extra-corporal membrane oxygenation (vv-ECMO) is increasing over time since the beginning of the COVID-19 pandemic. The objectives were to retrospectively describe over the first ten days after vv-ECMO implantation, the ventilatory management of CARDS and to assess the impact of static respiratory system compliance (CRS) on the first day of vv-ECMO on 180-day mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ARDS secondary to COVID-19 pneumonia requiring ECMO-VV support, hospitalized in the intensive care units of the CHRU of Nancy, Marseille or Bordeaux between 01/03/2020 and 31/12/2021.
* Age \> 18 years old

Exclusion Criteria:

* Respiratory parameters not available on ten first day of VV ECMO implantation.
* Patient refusal to participate in the study
Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding

The purposes of this study are:

* To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena.
* To collect italian data for Mirena in clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with Idiopathic Menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator and according to the international and national guidelines. These women should also accept to be on contraception during the time period that they have Mirena in situ
* Body Mass Index = 18-30

Exclusion Criteria:

* One or more of the following disorders: Current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product
* Nulliparity
* Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study.
* History of diabetes mellitus, cardiovascular disease and thyroid abnormalities
* Anticoagulation therapy
* Cancer history including breast cancer
Interventions for Parent Caregivers of Injured Military/Veteran Personnel

This randomized clinical trial will test a behavioral caregiving intervention that has been used successfully for dementia and spinal cord injury caregivers to provide services to stressed and burdened parent caregivers of post 9/11 service members/veterans. This intervention is six intensive individual sessions that will teach problem solving, cognitive restructuring and stress reduction targeted to an individual assessment of the care dyad's needs. It will be compared to another method of delivering content, education webinar sessions, which are analogous to the usual standard of care and will function as an attention control arm. The objective of the study is to determine which of these delivery mechanisms is more effective at helping parent caregivers of injured post 9/11 returning troops to improve their depression, anxiety, and burden, and to determine the feasibility of using individual sessions with this population of caregivers.


Eligibility Criteria:
Inclusion Criteria:

1. Identify as a parent who serves as the primary/main caregiver for a post 9/11 service member or veteran with a diagnosis of traumatic brain injury or post traumatic stress disorder or physical injury and at least 1 activity of daily living limitation or 2 or more instrumental of daily living limitations;
2. provide 3 hours or more of care per day for at least 6 months;
3. endorse at least 2 caregiving stress behaviors (overwhelmed, often needing to cry, angry/frustrated, cut off from family/friends, moderate/high levels of stress, and declining health); and
4. have a telephone.
5. Internet access is desirable but not mandatory.

Exclusion Criteria:

1. current diagnosis of schizophrenia or other major mental illness; or
2. auditory impairment that would make telephone use difficult