cyrilzakka/clinical-trials huggingface dataset:
The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility

Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.

Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.

Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.

Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian volume and antral follicle count.

Antral follicle count will be performed on the cyst post-surgery using light microscopy. The difference in hormone levels, especially AMH reflects the damage done during surgery to the ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.

Exclusion Criteria:

* Female patients with malignant ovarian cysts/masses.
Pregnancy in Women With HIV Infection

Women living with HIV face multiple challenges regarding pregnancy, encompassing not only their intention to procreate, but also difficulties during the course of pregnancy.

Compared to HIV-negative controls, HIV-infected women have a higher risk of pregnancy complications such as preeclampsia, gestational diabetes, or preterm labor. In addition, the treatment of HIV among pregnant women entails specific difficulties, such as changes in bioavailability of antiretroviral drugs, or the concern about the association of certain antiretrovirals with adverse pregnancy outcomes.

There is very little evidence about pregnancy among women living with HIV in Spain. Very few studies have been published, performed in single centers or in small cohorts with a limited number of patients. The Cohort of the Spanish AIDS Research Network (CoRIS) offers a unique setting to answer questions that are unlikely to be answered by a single study.

The aims of this study are (i) to describe the incidence of pregnancies and their temporal trends from 2004 to 2019, (ii) o describe the clinical and epidemiological characteristics of women who become pregnant, (iii) to assess the diagnostic delay among women diagnosed with HIV infection after becoming pregnant, (iv) to investigate the clinical course during pregnancy and its predictive factors, (v) to describe the antiretroviral treatment administered to pregnant women, (vi) to describe clinical outcomes after pregnancy, (vii) to describe the outcome of the conception in terms of interrupted pregnancies, spontaneous abortions, term pregnancies, type of delivery (vaginal or caesarean section) and HIV infection of the newborn, and (vii) to evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020.

Study population will be women from the cohort of the Spanish AIDS Research Network (CoRIS) who have become pregnant in the period 2004-2010.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive women recruited in CoRIS
* Became pregnant from January 2004 to November 2019
* or become pregnant during the year 2020 and agree to participate in a telephone survey
Acute Kidney Injury and Recovery Mode in Pediatric Liver Transplantation

Acute kidney injury (AKI) is a common complication after pediatric liver transplantation (PLT), and renal impairment after LT has proven to be related with increased graft failure and mortality. The recovery mode of kidney injury after PLT has not been systematically studied. Therefore, in this study the investigators aimed to systematically evaluate prognosis of AKI after PLT, combine the recovery mode of AKI with related risk factors, and establish a relationship between AKI and CKD.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received a liver transplant for the first time.
* Patients who were younger than 18 years of age at the time of transplant.

Exclusion Criteria:

* Patients with incomplete clinical data.
* Patients with less than 5 years of follow-up.
* Patients who have combined multiple solid organ transplants.
* Patients with preoperative renal impairment (eGFR\<60ml/min/1.73 m2 or prior renal replacement therapy).
Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy

Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). As balance is critical for underlying normal movement, improvements in static and dynamic balance are important goals in rehabilitation for ambulatory children with CP (Saether et al., 2013).

Balance deficits are among the symptoms that having a more profound impact on motor function and quality of life inn with CP children (Lai et al., 2017). Poor balance reduces the ability to perform gait-related activities and increases the risk of falling, which, in turn, limits participation in daily activities, including sports and physical activities (Usuba et al., 2015).


Eligibility Criteria:
Inclusion Criteria:

* Their ages will range from 6 to 10 years old.
* The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).
* They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).
* Their heights will be one meter or more.
* They will be able to follow the verbal commands or instructions.

Exclusion Criteria:

* Severe visual or auditory problems.
* Epilepsy.
* History of surgical interference in lower limbs.
* Botulinum toxin injections of the lower limbs during the previous six
Haloperidol vs Olanzapine for the Management of ICU Delirium

The purpose of this randomized clinical trial is to determine whether haloperidol is superior to olanzapine for the treatment of ICU acquired delirium. The hypothesis is that haloperidol is in fact superior to olanzapine in treating ICU acquired delirium and sustaining delirium free time.

Delirium is defined as a disturbance of consciousness characterized by an acute onset of impaired cognitive function. Although delirium is thought to be common in the Intensive Care Unit (ICU) there are few studies that have evaluated its incidences, risks and outcomes. It has been associated with increased morbidity, and mortality and increased cost to the healthcare system. In addition to the uncertainty of the incidence of ICU delirium, there is a lack of information about the effects that certain pharmacological treatments have on delirious patients.

The standard pharmacological treatments for ICU acquired delirium are haloperidol and olanzapine as they have been shown to be equivalent in reducing its incidence. However, optimal dose and regimen have not been well defined.

The rationale for this study is to determine whether haloperidol is superior to olanzapine in the treatment of ICU acquired delirium. A secondary objective is to determine the most appropriate dosing regimen for the treatmet. The role of alternative agents quetiapine, risperidone, loxapine and methotrimeprazine will also be examined in a preliminary analysis.

Patients who develop agitation or delirium as defined by an Intensive Care Delirium Checklist (ICDSC) score of greater than or equal to 4 meeting all the inclusion criteria and no exclusion criteria will be eligible for randomization. Once randomized they will be screened for ongoing agitation and delirium as well prolongation of the QTc interval greater than 440 msec, development of extrapyramidal symptoms and development of a seizure disorder.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are 18 years or older who are admitted for more than 24 hours to the ICU.
* Patients screened for delirium using the ICDSC with a score greater than or equal to 4 or with clinical manifestations of delirium.

Exclusion Criteria:

* Patients unlikely to survive 24 hours.
* Patients with a primary neurologic reason (i.e. stroke, dementia-related psychosis) for ICU admission.
* Patients with QTc interval greater than 440 msec.
* Pregnant patients.
* Patients who are breast feeding.
* Patients in whom haloperidol, or olanzapine is contraindicated.
* Patients allergic to haloperidol, olanzapine, quetiapine, risperidone, loxapine or methotrimeprazine.
* Patients who do not have a urinary catheter.
* Patients who have received haloperidol, olanzapine, quetiapine, risperidone, loxapine or methotrimeprazine within 14 days.
* Patients unable to undergo assessment (i.e. patients with developmental disability or mental incapacity prior to ICU admission).
* Prolonged (greather than 24 hours) comatose patients who have a defined structural reason for their decreased level of consciousness.
Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis

The purpose of this study is the investigation of the functional and radiological results and subjective patient outcome after the implantation of a hip resurfacing endoprosthesis (Birmingham hip resurfacing).

High volumetric wear of polyethylene was the main factor in periprosthetic bone resorption and failure of historic hip resurfacing prosthesis. Metal-on-metal devices reduce the wear substantially and may solve this problem. The purpose of this study is the investigation of the functional and radiological result and subjective patient outcome after implantation of a hip resurfacing endoprosthesis (Birmingham Hip Resurfacing) during the first two years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological signs of coxarthritis
* Implantation of a total hip replacement indicated
* Informed consent

Exclusion Criteria:

* Osteoporosis
* Tumor
* Acute infection
* Higher grade congenital dysplasia of the hip
* Pregnancy
CARE Canadian ALS Riluzole Evaluation

Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or tracheostomy, to a group of recent historical controls for the treatment of amyotrophic lateral sclerosis (ALS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS confirmed by the following definition:

  (a)"Probable" or "Definite" Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria(b)"Peripheral" onset form (limb involvement) or a "Bulbar" form of ALS with a duration of five years, based on inquiry for the earliest symptoms of the disease
* A subject who simultaneously presents with bulbar and peripheral signs at onset of ALS disease should be stratified to the bulbar onset group. The neurologic progression of such subjects matches that of the bulbar onset ALS subjects.
* Pulmonary Function: forced vital capacity (FVC) must be 3 60% at study entry.
* Females of childbearing potential must be documented to be using acceptable birth control methods such as an IUD or oral contraceptives.

Exclusion Criteria:

* Previous treatment with riluzole
* Tracheostomy, or expected to undergo a tracheostomy within two months after study inclusion
* Signs of clinical dementia and/or major psychiatric disorders
* Serious concomitant disease or handicap likely to interfere with the subject's assessments or impact on the subject's survival
* A multiple conduction block has been shown on nerve conduction studies by electromyogram

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Results of Flexor Tendon Repair of the Hand in Children Below Six Years of Age

The incidence of flexor tendon injuries in pediatric patients has remained largely undocumented, with a frequency of 3.6 per 100 000 persons per year.The pediatric literature demonstrates a higher prevalence of flexor tendon injuries in men, caused by sharp objects (glass or knife)

The diagnosis of flexor tendon injuries is more challenging in younger children than in adults . and delayed diagnosis in children is common . An innocuous appearing skin wound and a subtle functional deficit may hinder both presentation and identification of the injury.Pediatric flexor tendon injuries heal rapidly and contractures are rare, as long as the joint has not been injured. but Inadequate management can result in loss of hand function .

Data involving children rehabilitation remain unclear, with some studies showing no difference between early rehabilitation protocols and four weeks of cast immobilization . Some studies claim that protocols are not necessary in children younger than six years of age, and that only immobilization is required and some studies show transition to a more aggressive early motion protocol .

Although the incidince of flexor tendon injury in children is not low but the reported cases below the age of six years remains low Which makes reported results less trustworthy. This created the need for a better designed and larger number study to report results in this age group.

Eligibility Criteria:
Inclusion Criteria:

* Acute flexor tendon injuries of the hand in both genders. All flexor zones are included. Cooperative patients aged between 0-6 years.

Exclusion Criteria:

* Uncooperative patients such as psychologically disturbed patients , who will not be able to follow the strict of protocol
* Age more than six years old .
* Associated fractures close to the tendon injury.
* Vascular injury requiring revascularization
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Delivery by Vacuum Extraction

In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal teaching using a Training Video for learning how to perform an assisted delivery by vacuum extraction on a pelvic Training model. Objective Structured Assessment of Technical Skills (OSATS) scores are the primary outcome. The investigators hypothesize that Hands-on Training is superior to a video-teaching with regard to the OSATS scores achieved by the Trainees.

The optimal mode of Training surgical novices how to perform an assisted delivery by means of vacuum extraction is unknown. We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized vacuum Extraction (VE) algorithm scheme on a pelvic training model. Probands are tested with a 24 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 48 hours, and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Medical Student
* no previous experience in assisted delivery
* no previous gynecologic surgery training

Exclusion Criteria:

* language barrier
* unwillingness to participate
Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many opioids can be added in caudal analgesia. This prospective randomized double blind study was done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II.
* Age 1-3 years.
* Patients scheduled for hypospadias repair surgeries.

Exclusion Criteria:

* ASA III, IV.
* Signs of infection at site of injection.
* Known coagulopathy disorder.
* Mental and / or developmental retardation.
Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)

The aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion.

The most frequent complication during ECMO is hemorrhage especially as a curative anticoagulant treatment is necessary. The primary hemostasis is also affected with a von Willebrand disease and thrombopathy, well known but not studied by recent tests.The identification of primary haemostasis deficits with these tools would allow to supply them and decrease the morbi-mortality related to the transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years old
* Patient with ECMO
* Patient hospitalized in an intensive care unit at the University Hospital of Rennes

Exclusion Criteria:

* Known history for constitutional pathology of the primary haemostasis
* Platelets \< 100000 / mm3 or hematocrit \< 28 % between H+12 and H+24
Predisposing Factors for Post-stroke Epilepsy

The goal of this observational study is to learn about epilepsy after a stroke (post-stroke epilepsy). The main questions it aims to answer are:

* What make some patients develop epilepsy after a stroke?
* Does sleep have an impact on the development of post-stroke epilepsy?

Participants will undergo:

* Electroencephalography (EEG)
* Magnetic resonance imaging (MRI)
* Polysomnography (only patients)

Blood tests will also be taken. The patient group will be compared to the healthy controls. Researchers will also look into medical records of stroke patients hospitalized at St. Olavs hospital and collect relevant information.

This study aims to study risk factors and clinical factors which might contribute to the development of post-stroke epilepsy. Researchers will look at the volume and size of the stroke-induced brain lesions and analyze inflammation markers. Patients and controls will undergo EEG and MRI. The correlations between sleep and epilepsy after a stroke will also be investigated through polysomnography. Relevant information about for instance age, comorbidities and NIHSS will be collected. Researchers will also collect relevant information from medical records of stroke patients hospitalized at St. Olavs hospital.

Eligibility Criteria:
Inclusion Criteria:

* First time stroke patients with capacity to consent, admitted to the stroke unit at St. Olavs hospital.
* Modified Rankin Scale (mRS) ≤ 2 before the stroke

Exclusion Criteria:

* Previous stroke or brain surgery
* Traumatic brain injuries
* Neurodegenerative diseases
* Brain tumors
* Epilepsy before the stroke
* Hydrocephalus
* Aphasia
* Serious psychiatric disorders
* MRI incompatibility and claustrophobia
Examining the Effect of Piano Playing Training on Fine Motor Skills in Parkinson's Patients

Piano playing may provide an engaging and accessible setting for finger and wrist movement training. Moreover, it has been found effective for improving manual dexterity and upper-limb function in other neurologic disorders, such as stroke and additionally beneficial for cognitive and psychosocial support in Parkinson's disease. However, no study has examined the effect of piano playing on dexterity in Parkinson's disease. The aim of this study is to test the efficacy of a novel piano-based training program on fine motor function in patients with PD. Participants with Parkinson's disease will take part in an individually tailored 6-week piano training program, combining weekly supervised training sessions (6x60 min altogether), with three independent at-home weekly 30 minutes practice sessions (18x30 altogether). Participants will receive a piano MIDI keyboard for home use during the study.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease patients
* Hoehn and Yahr stages I to III
* Self-reports of some dexterity difficulties

Exclusion Criteria:

* Participation in an ongoing clinical study or clinical study within 30 days prior to this study
* Atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease, or other degenerative disease), or other neurologic conditions influencing upper limb movement
* Significant psychiatric symptoms or history
* Significant or recent experience in piano playing (participants who are proficient piano players, or had studied piano for more than 3 years in the past, or for shorter periods in the last 5 years)
* Other significant fine motor skills (e.g., high proficiency in playing another musical instrument, video games, etc.)
* Mini Mental status examination (MMSE) score below 25
* Significant sensory deficits, e.g., hearing or sight impairment
* Unstable medical disorder
* Significant postural or action tremor, moderate dyskinesia
Lyon BJI Cohort Study

The prospective Cohort includes all patients with bone or joint infection (BJI), with or without implant. The aim of this Cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. Various data of patients included are collected and will be analysed.

Patients with a bone or joint infection are treated at the department of infectious diseases, at Infectious disease department of Hospices Civils de Lyon. They have regularly a consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It allows to the physician to follow the evolution of the patient under treatment and after discontinuation of the treatment.

Several data are collected during the follow-up concerning: demographics data, treatment including the use of off-label antibiotics for the treatment of BJI, adverse events, microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If there is an implant, the date of implantation and the number of the prosthesis infected are collected.

This cohort allows to improve knowledge concerning the treatment failure and the occurrence of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* patients with bone or joint infection, with or without implant
AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.

A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys XEN 45 Glaucoma Implant in refractory glaucoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Refractory Glaucoma
* Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
* Visual field mean deviation score of -3 dB or worse
* Shaffer Angle Grade ≥ 3
* Area of free, healthy and mobile conjunctiva in the targeted quadrant

Exclusion Criteria:

* Active Neovascular Glaucoma
* Previous glaucoma shunt/valve in the targeted quadrant
* History of corneal surgery, opacities or disease/pathology
* Anticipated need for ocular surgery
* Non-study eye with BCVA of 20/200 or worse