cyrilzakka/clinical-trials huggingface dataset:
Impact of Complex Care Training of Hereditary Epidermolysis Bullosa on Caregiver Burden (FIREB)

Hereditary epidermolysis bullosa (EBH) is a rare, orphan disease characterized by skin and mucous membrane fragility.

The latest scientific data show that the proposed treatments are still in the experimental stage and that no curative treatment is available. The repercussions of this chronic disease, with neonatal onset, are major.

Epidermolysis bullosa requires multidisciplinary medical management, nursing care, psychological and social care.

Skin care involves preventing and treating chronic wounds and identifying their complications. The very great cutaneous-mucous fragility makes these treatments painful, long and complex, the caring hand itself being able to cause new wounds. Analgesics of different levels are not effective enough during treatment.

Along with counseling and education, nursing takes a central role in multi-professional accompaniment interventions to support and relieve families.

Parents became home caregivers out of necessity, and developed specific skills in epidermolysis bullosa, their child and dressings. They have great and demanding expectations of caregivers facing this rare disease, for which they are not trained in their degree course. Despite the severe nature of the disease, few studies have been carried out on the impact and psychosocial consequences on patients and their families, yet there is an expressed need for support.

The burden on parents is heavy, assessed by specific scales, but to date there are no studies examining the impact of epidermolysis bullosa care on caregiver stress.


Eligibility Criteria:
Inclusion Criteria:

* Nurse, nursing assistant, nursery nurse, childcare assistant, state graduates caring for patients with EBH and working at Necker Hospital.
* Having participated in the entire training program specific to the complex care of epidermolysis bullosa.
* Informed and not opposed to their participation in research.

Exclusion Criteria

* Person under tutorship or curatorship.
* Other health professionals (physiotherapist, doctor, etc.).
Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer.

During an In Vitro Fertilization (IVF) attempt, several embryos are obtained but not all of them can be transferred to the uterus in the same cycle due to the risk of multiple pregnancies. Thus, it is very common for these couples to benefit from cryopreservation. Patients scheduled for frozen embryo transfer (TEC) receive estrogen and progesterone replacement therapy to prepare the endometrium for implantation. Data from the literature recently showed that low progesterone on the day of embryo transfer was responsible for a significantly higher rate of implantation failure and miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient undergoing a frozen embryo transfer in an artificial cycle at the AMP center of the Toulouse University Hospital.
* Affiliation to a social security scheme or equivalent
* Patient fulfilling the conditions for access to the AMP according to French bioethics law
* Patient having given her consent (oral or written) after clear and fair information

Exclusion Criteria:

* Patient who received intramuscular administration of progesterone during the endometrial preparation phase.
* Patient with comprehension difficulties.
* Protected adult patient (safeguard of justice, guardianship or curatorship)
EEG@HOME (Phase 4 of the Project)

The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

In this stage of the project video-EEG recording with the prototype will be compared to the conventional way (cup-electrodes and collodion) of recording in the EMU.

Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional recording is completed, the patient will undergo a recording of maximum 5 hours with the prototype.

There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience and experience of the EEG-technologists will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Epilepsy with on EEG prominent IEDs

Exclusion Criteria:

* /
Nebulized Dexmedetomidine as a Premedication for Gastrointestinal Endoscopy in Pediatric Patients

This study aims to demonstrate that the application of nebulized dexmedetomidine to patients during pediatric upper gastrointestinal endoscopic procedures will significantly reduce the gag reflex and enhance both patient and practitioner comfort

Due to the intolerance of pediatric patients to the insertion of the endoscopic probe during upper gastrointestinal procedures, sedation and analgesia are required. In this patient group, the reflex to vomit is common during probe placement. Discomfort, pain, and hemodynamic changes can occur due to the vomiting reflex. In fact, this situation can lead to serious complications such as esophageal rupture. Inappropriate sedation conditions may result in increased post-procedural pain and agitation in patients.

Therefore, various sedative drugs are used for procedural sedation in pediatric patients. The use of these drugs during gastrointestinal endoscopy in the pediatric population can vary in terms of sedative, hemodynamic, respiratory, and side effects.

Dexmedetomidine, a highly selective alpha-2 agonist with central sedative and anxiolytic properties, has been tested in children for preoperative anxiolysis through nasal and inhalation routes. Due to its bioavailability of up to 82%, it is well absorbed systemically through oral and buccal routes.' It possesses sedative, analgesic, sympatholytic, and hemodynamic stability properties. Even at high doses, it has a unique feature of not causing respiratory depression, which gives it an advantage over other sedatives such as benzodiazepines, opioids, and propofol, all of which can cause dose-dependent respiratory depression. In this regard, it may be a good alternative for procedures like gastrointestinal endoscopy.

Based on these considerations, the investigators plan to conduct a randomized controlled study hypothesizing that nebulized dexmedetomidine as premedication in pediatric patients undergoing gastrointestinal endoscopy will significantly reduce the gag reflex.

108 patients will be included in the study. Patients will be divided into 2 groups.

* The control group (Group C)
* The group receiving nebulized dexmedetomidine (ND) (Group ND).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* 2 to 17 years of age,
* Patient undergoing in Upper Gastrointestinal Endoscopy

Exclusion Criteria:

* Patients with heart disease
* Patients with mental-motor retardation
* Patients with abnormal upper respiratory tract
* Patients with a history of asthma
* Patients with upper respiratory tract history in the last 4 weeks
* Patients with severe sleep apnea on polysomnography
* ASA \>III patients
* Patients with drug allergies
Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles

To analyse the impact on cycle outcome of LH supplementation in ovarian stimulation controlled with a GnRH antagonist in two ages groups: patients upto 35 years old, and patients aged between 36 and 39 years old.

All patients received an oral contraceptive pill with 0.030 mg of ethinyl-estradiol and 3.0 mg of drospirenone the cycle prior to ovarian stimulation. On the second day of menstruation, patients started ovarian stimulation as follows:

Patients \< 36: 225 IU/day of recombinant FSH (FSH alone group) or 150 IU of rFSH and 75 IU of rLH/day (FSH+LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration.

Patients 36-39: Initial dose of 300 IU of rFSH /day (FSH alone group)) or 225 IU of rFSH and 75 IU of rLH/day (FSH + LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration.

A maximum of 3 embryos were transferred on day 3 of embryo development.

Eligibility Criteria:
Inclusion Criteria:

* 1st-2nd IVF cycle.
* Age until 39 years old
* BMI: 18-29.9.
* Basal FSH \< 12 IU/L

Exclusion Criteria:

* LH:FSH \> 2 (PCO)
* Low response background (\< 5 oocytes)
* Endometrioma
* Recurrent pregnancy loss
* Any preimplantational genetic diagnosis indication
* Any systemic, metabolic or endocrinological disorder.
Histological Characterization of Vaginal Cuff Tissue Using Different Energy Sources During Robotic Hysterectomy

Vaginal cuff dehiscence, a rare complication of gynecologic surgeries, can be devastating, particularly when associated with bowel evisceration. A review of records from 1970 - 2001 at the Mayo Clinic in Rochester, MN revealed a low incidence (0.032%) of vaginal cuff dehiscence after pelvic operation via both abdominal and vaginal approaches3. At a single, large, tertiary care facility, total laparoscopic hysterectomy (TLH) was associated with an increased incidence of vaginal cuff dehiscence compared to other approaches (4.93% vs. 0.29% TVH, and 0.12% TAH)1. A review of our robotic experience revealed a vaginal cuff dehiscence incidence of 4.1%, which is comparable to the previously reported incidence for TLH2. An increasing number of laparoscopic hysterectomies are being performed in the United States with the rate of laparoscopic procedures increasing from 0.3% in 1990 to 11.8% in 20034. With 11.8% of 600,000 annual hysterectomies being performed via the laparoscopic route in the United States, there would be an estimated 3,400 cases of vaginal cuff dehiscence per year.

The cause of the higher rate of vaginal cuff dehiscence in both laparoscopic and robotic hysterectomies is currently unknown. One of the major differences between the laparoscopic and robotic approach as compared to the vaginal/abdominal route is the method by which the cervix is amputated from the vagina. With the vaginal and abdominal approaches, a colpotomy is made sharply with a knife or scissors. In contrast, the colpotomy is performed with electrocoagulation with the laparoscopic and robotic routes. One theory to explain the increased dehiscence incidence is the lateral thermal effects of electrocoagulation on the vaginal cuff which may adversely affect tissue healing.

This study aims primarily to shed light on the etiology of vaginal cuff healing after a robotic total hysterectomy. This will be done by comparing the extent of thermal injury at the cellular level using monopolar vs CO2 laser at the time of the colpotomy.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Patient over age of 18 years undergoing a robotic total hysterectomy
* Patients in Mayo Clinic (Arizona)

Exclusion Criteria:

* Patients with gynecologic malignancy involving the vagina
Square Step Exercises in Healthy Young Adults

This study aims to compare the effectiveness of Square Stepping Exercise and aerobic exercise on cognitive function and physical fitness in young adults. Participants aged 18-30 with low physical activity levels will be randomly assigned to either the Square Stepping Exercise Group or Aerobic Exercise Group. Both interventions will be supervised by a physiotherapist, performed twice a week for 40 minutes over 4 weeks. Cognitive function will be assessed using various tests, including attention, short-term memory, and executive function evaluations. Physical fitness will be evaluated through jump tests and balance assessments. Blinded assessors will conduct evaluations at baseline and post-intervention in both groups to determine the impact of square stepping exercise and aerobic exercise on cognitive and physical health in young adults.


Eligibility Criteria:
Inclusion Criteria:

* International Physical Activity Questionnaire score \<600 Metabolic Equivalents (METs),
* No neurological or orthopedic problems affecting gait, balance and lower extremities
* No vision or hearing problems, and no history of musculoskeletal surgery.

Exclusion Criteria:

* Participants who have pain due to a musculoskeletal problem
* Participants who are continuing another routine exercise program
RALPPS Venus ALPPS for Hepatocellular Carcinoma

Currently，the "ALPPS" (associating liver partition with portal vein ligation for staged hepatectomy) procedure which enables the rapid growth of the future liver remnant and extends surgical indication to patients with mid-advanced stage hepatocellular carcinoma becomes a research hot spot. However, the procedure has a high morbidity and mortality rate.Using radio-frequency ablation instead of in-situ split of liver to avoid forming a coagulation band in stage I will reduce the incidence of complications（bile leakage, abdominal infection,hemorrhage e.t.) The investigators named this technique as Radio-frequency Assisted Liver Partition with Portal vein ligation for staged hepatectomy （RALPPS）.Investigators hypothesized that the RALPPS might result in lower morbidity and mortality rate than ALPPS in the treatment of hepatocellular carcinoma . This Prospective Randomized Controlled Trial is on the Safety and Efficacy of radio-frequency assisted liver partition with portal vein ligation for staged hepatectomy for hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* An insufficient future liver remnant(FLR\<30% in normal hepatic function or FLR\<40% with hepatic cirrhosis or after chemotherapy）
* Liver function of Child-Pugh Class A or B.
* Liver Reserve Function：ICG-R15≤10％
* No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds.

Exclusion Criteria:

* Patients met the inclusion criteria but declined to participate.
* Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
* Main portal vein、inferior vena cava、common hepatic duct and hepatic vein have tumor thrombus.
* Extrahepatic or lymph node metastasis
Home-based Computer Gaming in Vestibular Rehabilitation

It is hypothesized that a home-based computer gaming rehabilitation program will improve gaze control and balance impairments in those with peripheral vestibular disorders (PVD). Ten people with peripheral vestibular disorders were started on a treatment program that consisted of playing computer games and while performing various balance exercises. On a weekly basis, each participant was contacted by email or telephone and asked to submit their computer gaming data to a trained vestibular physical therapist. Following review of this data, the physical therapist would contact the participant and progress their computer gaming program appropriately. At the completion of twelve weeks of home treatment, the participants returned for re-assessment and it was determined that the computer gaming program was an effective treatment for those with PVD. It was also determined that a monitored telerehabilitation program was an efficient and effective delivery method for this treatment.

A pre to post intervention case series study was carried out on ten participants diagnosed with peripheral vestibular disorders (PVD). Inclusion criteria consisted of: a) 20 to 70 year old, b) confirmed diagnosis of PVD on neuro-opthalmic, neuro-orthoptic, electronystagmography and caloric testing; and use of a home computer. Exclusion criteria consisted of those with migraine, central nervous system disorders (for example cerebral vascular accident or Multiple Sclerosis), recent fractures of the spine or lower extremities, inability to stand for 20 minutes continuously, or presence of dementia. It was hypothesized that a home-based computer gaming treatment delivered in a monitored telerehabilitation platform would be an effective treatment for those with PVD in that increased gaze stability and improved balance would be observed post-treatment. It was also hypothesized that decreased dizziness would be reported post-treatment. After initial assessment (pre-treatment), three in-clinic sessions were given to each participant to develop their specific home treatment computer program and ensure ability to use the program effectively. They were then started on their home program and monitored by a trained vestibular physical therapist for a 12-week telerehabilitation program. After the completion of the 12-weeks, the participants returned for a post-treatment assessment.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of peripheral vestibular disorder (confirmed on electronystagmography, bithermal caloric testing, neuro-ophthalmic, neuro-orthoptic examination)
* Access to a home computer

Exclusion Criteria:

* Central Nervous System disorders
* Vestibular migraine
* Benign Paroxysmal Positional Vertigo (BPPV)
* Recent fractures of the spine or lower extremities
* Inability to tolerate standing for 20 minutes
Using the Chinese Indigenization FS Scale in the Diagnosis of Fibromyalgia： Specificity and Sensitivity in Clinical Practice

This study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in China.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age; Patients with chronic widespread pain; Able to complete the questionnaire.

Exclusion Criteria:

* Terminal patients with severe psychiatric diseases, tumors, systemic lupus erythematosus, systemic sclerosis, or other serious diseases.
Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy

This is an open-label Phase 2a clinical study designed to evaluate the safety and efficacy of AVB-S6-500 in patients with IgA Nephropathy (IgAN). Approximately 24 patients will be enrolled. Several dose levels of AVB-S6-500 may be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of biopsy-proven IgAN
* Proteinuria ≥ 1g to 3g/24hr
* Stable estimated glomerular filtration rate (eGFR) for at least 3 months prior to screening and ≥ 45 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration formula
* Systolic BP lesser than or equal to 150 mmHg and diastolic BP lesser than or equal to 100 mmHg
* Patients who have been on a steady dose of ACE or ARB inhibitors for at least 3 months and throughout screening and who are not expected to have their dose adjusted during the study are allowed on study (patients who are not on ACEi/ARB due to inability to tolerate these therapies are also allowed)
* If a sexually-active patient, must agree to use a reliable method of birth control from at least 4 weeks prior to first dose of study drug, during the study and for 1 month following completion of therapy.

Exclusion Criteria:

* Patients with chronic urinary tract infections (UTIs) or taking prophylactic antibiotics to prevent recurrent UTIs
* Treatment with systemic immunosuppressants, including corticosteroids, within 8 weeks of the first dose of study drug
* Rapidly progressing nephropathy defined as falling GFR (≥ 15%) over past 3 mos
* Clinical or biological evidence of diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease
* Hemoglobin \< 9.0 g/dL
* History or clinical evidence of cirrhosis, or liver disease with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3x upper limit of normal
* Organ transplant recipient (including bone marrow) or a planned transplant during the study
* Have a diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at screening
* Recent active infection requiring hospitalization or i.v. treatment within 30 days prior to the first dose of study drug
* Received transfusion, plasmapheresis or plasma exchange, IV immunoglobulin (IVIg) within 90 days prior to screening
* Malignancy within the past 5 years. Exceptions are squamous cell carcinoma of skin, basal cell carcinoma of skin, and cervical carcinoma in situ which have been excised and are considered cured
* Females who are nursing, pregnant, or intending to become pregnant during the time of the study, or who have a positive pregnancy test at baseline
* Exposure to an investigational drug or device within 90 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
* Known sensitivity to any of the products to be administered during dosing
* Subject will not be available for follow-up assessment
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
* Prior exposure to AVB-S6-500
Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health

Posttraumatic stress disorder (PTSD) has devastating health consequences. Evidence-based PTSD interventions address the substantial burden of PTSD on the health of individuals and societies; however, several individuals receiving these interventions drop out and not all individuals experience improvement in PTSD symptoms. Moreover, these current PTSD interventions primarily target trauma memories. Notably, growing evidence suggests that PTSD symptoms are related to difficulties in the encoding and retrieving of positive memories as well.

Thus, the proposed study will examine effects of and targets underlying a novel PTSD technique focused on narrating and detailing positive memories - Processing of Positive Memories Technique (PPMT). Methodologically, 70 individuals will be randomly assigned to PPMT vs. Supportive Counseling (SC) for this study.

The aims of the proposed study include (1) examining PPMT's effects on PTSD symptom severity and stress systems' dysregulation (i.e., awakening salivary alpha amylase \[sAA\] and cortisol); (2) examining mechanisms underlying PPMT's effects; and (3) refining PPMT. It is hypothesized that the PPMT arm will report greater decreases in PTSD severity and sAA/cortisol ratios. Further, it is hypothesized that PPMT-related improved affect will mediate the association between study arm (PPMT vs. SC) and changes in PTSD severity. Lastly, feedback will be obtained from study participants on PPMT's feasibility, format, and content to refine PPMT.

The proposed study may contribute preliminary evidence on the potential significance of targeting positive memories in PTSD interventions.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Willing/able to provide informed consent
* Past month DSM-5 posttraumatic stress disorder (PTSD) diagnosis
* Working knowledge of English

Exclusion Criteria:

* Active suicidal intent or attempts
* Active psychosis
* Currently receiving mental health therapy (past 3 months)
* Dosage changes in psychiatric medications (past 3 months)
* Currently pregnant