cyrilzakka/clinical-trials huggingface dataset:
User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.

An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.


Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study, subjects must fulfil all of the following criteria:

1. Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form
2. Aged 18 years and over, both gender
3. Bladder dysfunction, all diagnosis practicing IC at least 2 times daily
4. Using catheters in the sizes available in the investigation (15 cm, CH 12 or 40 cm CH 12/14, Nelaton tip)
5. Experienced users of IC defined as a minimum of 4 weeks on therapy prior investigation start
6. Adults able to read, write and understand information given to them regarding the investigation

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

1. Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
2. Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
3. Involvement in the planning and conduct of the investigation (applies to both Wellspect/site staff).
4. Previous enrolment in the present investigation.
5. Simultaneous participation in another clinical investigation that may impact the primary endpoint.
6. Expected or severe non-compliance to the CIP as judged by the investigator and/or Wellspect.
Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years

Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in elderly patients.

The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients undergoing knee arthroplasty.

Investigators use the FloTrac sensor/Vigileo haemodynamic monitoring system to assess modification blood pressure, stroke volume and cardiac output during anesthesia and specialy after every bolus of spinal anesthesia, after inflating the tourniquet and after putting it off.

they recorded number of hypotension episodes, ephedrine bolus and consumption until 2 hours after the end of surgery.

The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia (CSA) in elderly patients undergoing knee arthroplasty.

Inclusion criteria:

Adult patients, aged more than 65 years scheduled for elective total knee arthroplasty under regional anesthesia.

Study Design :

Patients had a transthoracic echocardiography one to three months before the surgical procedure, performed by a cardiologist.

An oral intake of 250 ml of water was taken 2 hours before surgery. In the operating room, patients received monitoring with electrocardiogram, pulse oximetry and had their blood pressure measured and recorded via an indwelling radial arterial catheter putting under local anesthesia.

This catheter was connected to the FloTrac sensor/Vigileo haemodynamic monitoring systeme to track continuously stroke volume and cardiac output.

All patients were given nasal oxygen during all the procedure to keep oxygen saturation \> 95 %. Fluid therapy was limited to 4 ml/kg/h until tourniquet release.

Subarachnoid puncture was performed with a 19-Gauge Tuohy needle at the L3-S1 interspace using a midline approach. Three cm of a 22-Gauge catheter was introduced through the needle. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected through the catheter. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10.

Ephedrine 6 to 9 mg was given if systolic arterial pressure \< 90 mmHg or \< 100 mmHg with clinical signs of poor tolerance (dizziness, anxiety, dyspnea, vomiting).

Sample size We included 20 patients in this observational study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, aged more than 65 years
* scheduled for elective total knee arthroplasty
* under regional anesthesia

Exclusion Criteria:

* contraindication to regional anesthesia
* or the patients who refused to give consent,
* patients with anemia (hemoglobin \< 13 g/dl for male and hemoglobin \< 12 g/dl for female),
* cardiac arrhythmias,
* NYHA score \> 2,
* ASA \> 2
* Cardiac ejection fraction \< 50 %,
* valvulopathy,
* pulmonary artery hypertension
* and relaxation abnormality
Comparison Between Handheld Rebound Tonometer and Applanation Tonometer in IOP Measurement in Paediatric Glaucomas

To compare the accuracy between handheld rebound tonometer \& applanation tonometer in IOP measurement in pediatric glaucoma cases


Eligibility Criteria:
Inclusion Criteria:

* Patients attending to our pediatric glaucoma clinic diagnosed with glaucoma aged \>18 years old are subjected to IOP Measurements.

Exclusion Criteria:

* \*\*Patients aged more than 18 years old

  * patients with scarred cornea
Optical Genome Mapping in Hematological Malignancies

Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer


Eligibility Criteria:
Inclusion Criteria:

* Minor/Major Patients
* Patients with suspected hemopathies for whom we receive a sample for diagnosis in the chromosomal genetics laboratory or for whom a diagnosis of hemopathy has already been made.
* No objection made or consent given

Exclusion Criteria:

* Patients under judicial protection (guardianship, curatorship, ...),
* Refusal to participate
Dose-Finding of Lower Limb Mirror Therapy After Stroke.

This study will investigate the maximum dose per day of using mirror therapy for ankle exercise after stroke. The design is a 3+3 rule based, dose- finding study. Each cohort will consist of three participants. The first cohort will be assigned to do a dose of 15 minutes each day for two weeks. The second and subsequent cohorts will exercise at target dose set accordance to the nine preset rules and the modified Fibonacci sequence (mFBS).The study will continue until the stopping rule is triggered. The last dose tested will be identified as the maximum tolerable dose per day.

Procedure:a 3+3 rule-based, dose-escalation design (Colucci et al,2017). recruitment process: the study will begin with a cohort of three participants (n=3). Each of the subsequent cohorts will also be of three participants. The start dose will be set at 15 minutes (cohort one). Participants will do ankle dorsiflexion exercise at the set dose with the mirror for two weeks. The second and subsequent cohorts will exercise at dose set in accordance to the nine preset rules and the modified Fibonacci sequence (mFBS) .

Sample size: The target sample size is not usually predefined for a dose-finding study. The final sample size will be determined by the response of consecutive cohorts to the set dose. Usually, in pharmaceutical dose-finding studies, the sample size lies between 12 and 40.

Data analysis : The data for each cohort will be analysed using descriptive statistics. No significance testing is involved.

Eligibility Criteria:
Inclusion Criteria:

* Participants have had a stroke for six weeks or more before recruitment to this study, and are discharged from NHS statutory stroke rehabilitation.
* Participants will be at least 18 years of age
* Able to produce some voluntary contraction of paretic ankle ( motricity index between 9 and 19).
* Ability to understand and follow simple verbal instructions (one-stage commands), i.e. sufficient communication, orientation, and memory to participate in mirror therapy ankle exercise.
* Participants will have had no lower limb injury in the last six months and were able to walk independently indoors before the index stroke.

Exclusion Criteria:

* Foot or ankle contracture that prevents 50% of the passive range of motion.
* Any condition that can be exaggerated by performing the therapy.
Abdominoplasty with Ventral Hernia Repair Versus Hernioplasty .

Comparison between hernioplasty alone versus concomitant abdominoplasty with ventral hernia repair regarding efficacy and post-operative recurrence of hernia.

Ventral hernias are very common and do present a challenge because of the risk of recurrence.

Ventral hernias of the abdomen are defined as a non-inguinal, nonhiatal defect in the fascia of the abdominal wall. Annually, there are about 350,000 ventral hernia operations. The repair of these abdominal wall defects is a common surgery performed by general surgeons. Surgery is typically recommended for individuals with acceptable operative risk, symptomatic hernias, or those at elevated risk of developing complications from a hernia. They can affect an individual's quality of life and can lead to hospitalizations and even death in some cases.\[1\]\[2\]\[3\] Common causes of acquired ventral hernias include previous surgery causing an incisional hernia, trauma, and repetitive stress on naturally weak points of the abdominal wall. These naturally occurring weak points in the abdominal wall include the umbilicus, semilunar line, ostomy sites, bilateral inguinal regions, and esophageal hiatus. Obesity is a large component of hernias as well because it stretches the fascia of the abdomen causing it to weaken. Specifically, the action of repetitive weight gain and loss leads to weakening.\[4\] Reported recurrence rates after VHR in the literature vary widely and range from 2.7% to 20% for primary ventral hernia (umbilical and epigastric) to 32-37% for incisional hernia repairs, depending on the series in question. (5) Abdominoplasty can be performed in combination with hernia repair in patients with ventral hernias, especially when associated with large midline ventral hernias, diastasis of recti and the associated laxity and abdominal shape deformity, represent aesthetic and functional problems for the patients. So, the surgical treatment of both pathologies at the same time is highly recommended if the patient's general condition permits. This can be achieved by a comprehensive technique incorporating abdominoplasty performed by a transverse lower abdominal incision into any of the hernia repair techniques.(6) The procedure continues to become increasingly popular, and this is attributed to the increasing rates of obesity and subsequent use of weight loss surgery

Aim(s) of the Research (50 words max):

Is to compare the outcome and efficacy of the combined procedure of (abdominoplasty and hernioplasty) to hernioplasty alone according to rate of post operative recurrence of hernia .

Eligibility Criteria:
Inclusion Criteria:

* Patients with age more than 20 years and less than 60 years old.

Female patients.

Patients having ventral hernias with BM more than 25 kg/m2. Patients with floppy abdomen Patients with divercation of recti Patients with an (ASA) classification of 3 or less with no history of DM or other major comorbidities as cardiopulmonary, hepatic, or renal impairment.Exclusion Criteria:

-
Calcium Carbonate to Augment Labor Contractions

The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.

This study plans to study the acceptance and safety of using calcium carbonate as an medicine to help the labor induction process. The study aims to find if the use of calcium carbonate will lead to better labor contractions and increase the percentage of vaginal deliveries and improve delivery outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Nulliparas (no prior pregnancy lasting 20 weeks or greater of gestation)
* Gestational age above 36 weeks, at enrollment
* Present for induction or augmentation of labor inclusive of medical indication, elective induction at greater than 39 weeks' gestation, trial of labor after cesarean
* Singleton gestation (a multiple gestation reduced to a singleton, either spontaneously or therapeutically, before 14 0/7 weeks of gestation is acceptable)
* Ability to give informed consent
* Planned to undergo initiation of oxytocin infusion by their maternity care provider

Exclusion Criteria:

* Unable to understand or read English
* Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment
* Non-vertex presenting fetus at enrollment
* Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy)
* Multi-fetal gestation (twins, triplets, and higher order multiples)
* Known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity.
* Deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature \&lt; 36 weeks of gestation.
* Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)
* Suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission)
* Known severe fetal growth restriction (estimated fetal weight \&lt;3rd percentile) or abnormal umbilical artery Doppler studies (given the increased likelihood for anticipated neonatal intensive care unit admission)
* Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
* Known allergic reactions to synthetic oxytocin intravenous solution or to Calcium Carbonate
* Significantly impaired consciousness or executive function (e.g., intubated or sedated)
* Patients treated with calcium channel blockers such as nifedipine or magnesium.
* Chronic renal failure and hyperphosphatemia.
* Inability to tolerate oral intake (i.e., nausea/vomiting)
Urinary Marker for Oxidative Stress in Human Cisplatin- Induced Renal Injury

We previously reported early measurement of urinary MDA might be a useful marker for the prediction of CDDP-induced renal damage in rat. The purpose of this clinical study is to test whether the changes of human urinary excretion of MDA, and can be used as early biomarker for the prediction of development of CDDP-induced ARF.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients have neck cancer
FLuid Responsiveness Prediction Using EXtra Systoles

In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.

Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring elective CABG or OPCAB surgery
* Patient's age ≥ 18 years

Exclusion Criteria:

* Patient refusal
* Pregnancy
* EF \< 35%
* End stage kidney failure (defined by the need for haemodialysis)
* Patients with atrial fibrillation or frequent and coupled extra systoles (e.g. trigemini)
Clinical Study to Assess the Effectiveness of the Device Patello

The device "Patello" was designed to passively mobilize the Patella in cranial-caudal direction. Its application field lays in the rehabilitation of any knee pathology where knee range of motion may be restricted due to the Patella mobility.

The effectiveness of the device Patello has not been tested so far. This clinical study aims to assess and proof the effectiveness of this device. The aim is to objectify the movement of the Patella induced by the device Patello in cranial / caudal direction. As outcome parameter serve ultrasound measurements of a bony reference point of the femur and the Patella and its displacement / distance after mobilization.

Eligibility Criteria:
Inclusion Criteria:

* no operation and / or actual problems (pain at rest or during strain) of the muscular or bony parts of the lower extremities
* closed and intact skin conditions in the area of the knees and thighs
* no fear of the intervention
* willingness to participate on all 2 measurement days

Exclusion Criteria:

* operation and / or actual problems (pain at rest or during strain) of the muscular or bony parts of the lower extremities
* open skin conditions in the area of the knees and thighs
* fear of the intervention
* no willingness to participate on all 2 measurement days
Long Term Evaluation of Function and Quality of Life After Pollicisation

The study aims at describing long term functional outcome of patients that underwent pollicisation surgery.

The hypothesis of the study is that there are prognostic factors of good function results of pollicisation (based on T-GAP classification for function) that will be searched on univariate and multivariate analysis.


Eligibility Criteria:
Inclusion Criteria:

* More than 7 years and less than 50 years
* Underwent unilateral or bilateral pollicisation surgery
* For children : non opposition of the parents
* For adults : non opposition

Exclusion Criteria:

- Patients able to understand the research and to answer to forms
User Evaluation Study of SyncVision System With Software v4.X

This is a prospective, single-arm, unblinded, case observation study evaluating a commercially released 'Conformité Européenne' (CE)-mark co-registration software system along-side of a commercially- released CE-mark coronary physiology and X-ray system during routine clinical workflow. The purpose of this study is to collect Professional user feedback regarding clinical utility of the SyncVision 4.X system.

The PREPARE II study will enroll a maximum of 200 patients in up to 5 sites. No follow-up will be performed. The PREPARE II study will only collect data during diagnostic angiogram or percutaneous coronary intervention (PCI) procedure, when performed as per standard hospital care.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible and indicated for cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice
* Males over the age of 18 years and post-menopausal females
* Patient is able to give written informed consent prior to using his/her study data for evaluation and documentation

Exclusion Criteria:

- Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation
Fetal Endoscopic Surgery for Spina Bifida

This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.

Introduction:

Spina bifida is a congenital malformation characterized by a failure in neural tube closure. Unprotected fetal neural tissue at the spine level undergoes not only progressive neurodegeneration in spinal cord, but also the impairment in brain development, hindbrain herniation or Chiari II malformation probably due to pressure disturbances resulting from a continuous leakage of cerebrospinal fluid through the defect. The neurological consequences at birth are irreversible and sometimes devastating, including paraplegia, sphincter urinary and fecal incontinence, hydrocephalus, cranial nerve disturbances, respiratory problems and death due to spinal cord injury and brain maldevelopment.

Intrauterine fetal open repair of the defect has proved to improve hindbrain herniation and decrease the need of cerebrospinal shunting.

Hypothesis:

The investigators hypothesize that minimally invasive surgery of spina bifida is feasible and may minimize surgical aggression and obstetrical complications, with similar neonatal and neurological results.

Intervention:

In this study the investigators propose a fetoscopic skin closure technique. After a maternal laparotomy the uterus is exteriorized, the amniotic cavity is accessed by fetoscopic approach. The placode is dissected from the surrounding tissue and dropped into the opened spinal canal, untethered. Part of the cystic tissue is resected. The edges are then closed to the midline.

Follow up:

After surgery patients are followed up at the Fetal Medicine Unit every one or two weeks.

The mode of delivery is decided according to obstetric criteria. Neonates will be examined at birth, and followed up regularly at least until 30 months. Patients are lifetime followed up by our Multidisciplinary myelomeningocele (MMC) Committee that comprises professionals from the Spina Bifida Unit, Neonatologists, Pediatric Surgeons, Pediatric Urologist, Pediatric Orthopedic Surgeons, Radiologists, Rehabilitation, Pathologists, Pediatric Neurosurgeons, Obstetricians and Fetal Therapists.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age \> 18 years old
* Singleton pregnancy
* Gestational age between 18 0/7 weeks and 26 6/7 weeks
* Isolated neural tube defect between T1 and S1
* Cerebellar herniation (Chiari type II)

Exclusion Criteria:

* Fetal anomalies non related to neural tube defect (NTD) including chromosomal abnormalities
* Body mass index \> 35 kg/m2
* Maternal disorders contraindicating surgery
* Genetic anomalies with poor prognosis
* Sever kyphosis (\>30º)
Adolescent Cancer Telemedicine for Pain Management

Pain in adolescents undergoing treatment for cancer is a common problem, often related to treatment or to the cancer itself. Due to increasing outpatient-based cancer treatment, the burden of care and pain management has shifted to the home environment. Yet, there are limited interventions that target the management of pain at home. Adolescence is marked by increased need for independence and social integration, both of which can be impaired by pain or fear of pain. To address unique needs during this developmental period, this study will test a telemedicine program to enhance pain knowledge and pain control strategies in adolescents ages 12-21 years who are undergoing treatment for cancer.

Fifty-six teens will be randomized to an intervention or wait-list control condition. Patients randomized to the waitlist control condition will receive the intervention following completion of the waitlist condition. The intervention will consist of four weekly 30-45 minute telemedicine (online via videoconferencing platform) sessions with a trained social work or psychology provider. Sessions will focus on pain psychoeducation, coping tools, communication, and stress management. Participants will complete online questionnaires assessing pain coping, pain management, and pain-related impairment at pre-intervention, post-intervention, and 1- and 2-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Age 12-21 years
2. At least two months post cancer diagnosis
3. Experienced pain in the past month as defined by at least one pain experience rated \>3 on a 0-10 Numeric Rating Scale
4. Access to the internet for intervention sessions
5. Fluent in English (Given that the intervention will be delivered in English, all adolescents will need to be fluent in English to participate.)

Exclusion Criteria:

1. Significant cognitive impairment that may affect their ability to participate