cyrilzakka/clinical-trials huggingface dataset:
Robotic-assisted vs. Open Partial Nephrectomy

ROBOCOP is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase III randomized controlled trial.

Surgical excision is the gold standard for the treatment for localized kidney cancer. An organ-preserving procedure should be carried out whenever possible in order to maintain kidney function. Partial nephrectomy can be performed through the conventional open technique as well as through a robotic-assisted approach. Although both methods belong to the standard care, there is still no published data from randomized controlled trials in the scientific literature comparing them. The ROBOCOP-trial is designed as a single-center comparison of the two surgical approaches in preparation for a phase III study. 50 patients are to be included in the trial within a period of 15 months. The primary endpoint is feasibility of patient recruitment. In addition, potential primary outcomes for a confirmative trial such as perioperative complications, quality of life, inflammatory response, survival and ergonomic aspects for the operating surgeons will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective partial nephrectomy for renal neoplasms
* Patient must be at least 18 years old and capable to consent
* abdominal MRI or CT scan
* curative-intent surgery
* robotic-assisted and open approach for surgery are both feasible
* ability of patient to understand the goal, consequences and alternatives of participation in the trial
* written informed consent

Exclusion Criteria:

* patients with solitary kidney
* multiple kidney tumors
* emergency intervention, for example because of bleeding or perforation
* 2nd malignancy that will make PN needless, this does not include secondary malignancies which are under curative treatment or cases in which death from RCC is more likely
* patient belongs to a vulnerable patient group
* simultaneous 2nd surgery
Therapeutic Exercise Programme to Improve the Functional Capacities, Depression and Anxiety of Patients with Chronic Kidney Disease During Haemodialysis Sessions.

Therapeutic Exercise During Outpatient Hemodialysis Treatment for Patients with Chronic Kidney Disease


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Treated for a minimum of 3 months with HD
* With clinical stability (good tolerance to sessions expressed as stable vital signs during the session)
* Voluntarily and with prior signed informed consent, have agreed to participate in the study

Exclusion Criteria:

* Physical or cognitive limitations that prevent following the intervention program
* Cardiovascular problems (unstable angina, uncontrolled arrhythmia, decompensated heart failure, pericarditis or myocarditis, severe untreated mitral or aortic stenosis)
* Uncontrolled arterial hypertension (SBP \> 200 mmHg and DBP \> 120 mmHg)
* Uncontrolled diabetes
* Severe neuropathies
* Acute systemic infection
* Severe renal osteodystrophy
* Stroke (cerebrovascular accident, transient ischemic attack)
Evaluating the Need for Transosseous Anchoring in Anterolateral Hip Prosthetic Surgery

The study aims to discuss the challenges associated with breakage or failure of the abductor mechanism after total hip arthroplasty, which can lead to gait issues, instability, and the need for revision surgery. Sutures play a crucial role in preventing these failures, with two main types: transosseous and tendon sutures. Transosseous suturing involves using non-absorbable threads anchored in the bone, while tendon suturing uses absorbable threads for layered closure.

Both techniques are commonly used, but there is a lack of evidence to determine which is more beneficial for patients. Current studies are limited and often focus on cases requiring revision surgery due to complications, with transosseous sutures generally being the preferred method.

A meta-analysis indicated that transosseous repair may result in lower dislocation rates and less postoperative pain, but further randomized clinical trials with long-term follow-up are necessary for definitive conclusions. The text proposes a prospective study to compare transosseous suturing with the common absorbable tendon suturing in primary hip surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Adult population
* Patients diagnosed with coxarthrosis (stages 2 and 3), confirmed by X-ray, according to D. Tonnis's classification of 1972
* Willingness to follow up for up to 12 months
* Patients capable of understanding the study and giving their informed consent

Exclusion Criteria:

* Difficulty understanding and following the study procedure
* Patients with previous surgery on the same hip
* Patients with a diagnosis other than the inclusion criteria (e.g. acute femoral fracture requiring total hip arthroplasty
Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

During liver transplantation (LT), hyperfibrinolysis is one of the most important modification of haemostasis. It is associated with t-PA and protein C increased activity. Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA, PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the clinical practice in the operating room.

The "Lysis Timer" is a device developed by Hyphen-Sysmex in collaboration with SD Innovation and Charleroi University Hospital (Belgium). It allows the implementation of the "Global Fibrinolytic Capacity", or GFC test, in a complete system associating i) the reagents for in vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal of the absorbance modifications related to clot formation into a numeric signal) and iii) a dedicated software treating the numeric signal to define clot lysis time.

The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.

The primary aim of this prospective, monocentric, observational study is to evaluate the Lysis Timer as a rapid diagnostic device for hyperfibrinolysis during liver transplantation. Lysis times provided by this device will be compared to the euglobulin lysis times and to the others parameters of fibrinolysis at the different stages of liver transplantation and more specifically at the anhepatic stage and after graft revascularization.

The secondary aims are to compare the results of the Lysis Timer, the thromboelastogram, the thrombin generation test and the standard laboratory tests in the context of hyperfibrinolysis during liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* adult patients benefiting from liver transplantation

Exclusion Criteria:

* age under eighteen
Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema

Tissue Elastography Assessement and Cuteous and Cubcutaneous Thickness Measurement Following Manual Lymph Drainage in Legs With Lymphedema

Hence the importance of evaluating the impact of an intensive five-day decongestive treatment on lymphedema in terms of cutaneous flexibility and edema regression.

Patients who are undergoing intensive decongestive treatment for four or five days in the department perform an ultrasound check/examiantion on the first day.

During this echography, in 5 usual measurement points are made an ultrasound image recording (for measurement of cutaneous and subcutaneous thicknesses) and an elastography sequence (an instantaneous measurement).

The study hypothesis is to note that intensive decongestive treatment has an impact on tissues flexibility and cutaneous and subcutaneous thickness.

No many authors discussed this suject, hence the interest of this study. All the data collected and the results obtained will serve for further studies.


Eligibility Criteria:
Inclusion criteria:

* Major patients with unilateral or bilateral lymphedema of the lower limb (s), stage II or III, of primary or secondary origin
* Major patients with admitted for the realization of an Intensive Decongestive Treatment (TDI) of three to five days in the lymphology unit of the Saint Eloi hospital, of Montpellier UHC.

Exclusion criteria:

* Patients with different lymphedema localisation than the lower limbs
* Patient with amputated
* patient not consenting or included in another clinical research study.
Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome

This study has been designed to determine the safety, tolerability and efficacy of QRX003 lotion 2%, 4% QAM or 4% BID in subjects with Netherton Syndrome (NS) in comparison to vehicle


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or non-pregnant female at least 14 years of age.
* Females must be post-menopausal , surgically sterile , or use an effective method of birth control , for the duration of the study and for 3 months following completion of treatment. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
* Subject has a clinical diagnosis of NS and agrees to genetic testing at Visit 1/Screening for confirmation of NS diagnosis if the subject does not have test results confirming a SPINK5 mutation.
* Subject has NS lesions in the Treatment Area (i.e., arms or lower legs).
* Subject is in good general health and free of any disease state or physical condition that might impair evaluation of NS or exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject has any skin pathology in the Treatment Area or condition that, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
* Subject has Fridericia-corrected QT ≥ 450 ms for males or ≥ 470 ms for females
* Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area.
* Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled.
* Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline.
* Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
* Subject has used ultraviolet phototherapy within the Treatment Area within 4 weeks prior to Visit 2/Baseline.
* Subject has used systemic prescription treatment for NS within 4 weeks prior to Visit 2/Baseline.
* Subject has used systemic biologic therapy for NS.
* Subject has used topical prescription treatment in the Treatment Area within 2 weeks prior to Visit 2/Baseline.
* Subject has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours prior to Visit 2/Baseline.
* Subject is currently enrolled in an investigational drug, biologic, or device study.
* Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.
Expanding Autism Diagnostic Biomarkers to Kenya

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. The investigators will recruit children from Moi Teaching and Referral Hospital (MTRH; Eldoret, Kenya) previously enrolled in the Health Equity Advancing through Learning Health Systems Research (HEAL-R) Autism at MTRH study (IREC/664/2023, approval number 0004633)

Eligibility Criteria:
Inclusion Criteria:

* Children enrolled in the HEAL-R Autism at MTRH study
* Children ages 14-72 months
* Caregivers of children must speak Kiswahili (local language) or English.

Exclusion Criteria:

* Children not enrolled in the HEAL-R Autism at MTRH study
* Children younger than 14 months or older than 72 months
* Caregivers of children do not speak Kiswahili (local language) or English.
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.


Eligibility Criteria:
Inclusion Criteria:

* Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.

Exclusion Criteria:

* Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol
Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.

The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles.

Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4.

The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Willing to give informed consent
* Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment
* Able to speak and understand Danish
* Diagnosed with breast cancer
* Paclitaxel naïve patients

Exclusion Criteria:

* Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation
* Type 1 or 2 diabetes
* Pregnant
* Breastfeeding
* Relapse of cancer diagnosis
* Diagnosed with human immunodeficiency virus (HIV)
* Participation in other clinical trials where the dose of paclitaxel is changed, or the aim is to prevent neuropathic pain or decrease NFL level (except if the intervention is to use cooling gloves).
* Previous treatment with neurotoxic chemotherapy
* Chronic pain from another cause
* Metastatic cancer
The Use of Wireless Sensors in Neonatal Intensive Care

The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b - monitoring between 2h to 8h per day for 2 to 4 consecutive days, and (c) Phase 2- monitoring for 96h continuously.

Study objectives include:

1. Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU.
2. Assess safety of using a special wireless sensor system in neonates.
3. Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.

Infants admitted in the NICU are all subject to continuous monitoring of vital signs such as heart rate, respirations and oxygen saturation (SpO2) by placing sensors, leads, or bands directly on infant's skin and connecting them to monitors via wires. However, despite the rapid technological advances in wireless monitoring and wearable devices across various industries, the health care sector has traditionally lagged. Therefore, the investigators aim to explore the safety and effectiveness of wireless monitoring (ANNE™ Monitoring System) and compare it with the traditional wired monitoring system on infants with variable degrees of maturity in the NICU.

More specifically, the investigators aim to examine (1) if it is feasible and to implement a wireless monitoring system in both term and preterm infants in the NICU; (2) if it is safe to use this particular wireless monitoring system among neonates; and (3) the accuracy of the wireless monitoring technology compared to the stand-of-care monitoring in the NICU.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants in room air at enrollment
* Term infants with perinatal asphyxia undergoing therapeutic hypothermia at enrollment
* Healthy preterm infants in room air at enrollment
* Preterm infants on continuous positive airway pressure at enrollment
* Preterm infants on conventional mechanical ventilation at enrollment
* Preterm infants on high frequency ventilation at enrollment
* Preterm infants on nasal intermittent positive end expiratory pressure at enrollment
* Preterm infants on continuous positive airway pressure at enrollment

Exclusion Criteria:

* Congenital anomalies and surgical conditions (ex: gastroschisis, omphalocele, congenital diaphragmatic hernia)
* Congenital heart disorders
* Congenital skin infections or known conditions with fragile skin (such as epidermolysis bullosa)
Efficacy of Treatment for Panic Disorder

The purpose of these questionnaires is to give us an overview of how panic has affected your life and perhaps also to give us some clues about things that may have set you up to experience panic.

For us to evaluate the efficacy of our treatment programs, we are interested in your responses before and after treatment. We use two methods to evaluate the efficacy of our treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As part of standard clinic procedure, each person in the program completes an in-person interview with a staff member who will determine your suitability for treatment. If you have received this questionnaire packet, it is likely that your concerns will be appropriately addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to assess the severity of your panic disorder; its impact on your functioning, and factors that may contribute to the onset or maintenance of your panic (e.g., depression, anxiety sensitivity). We will ask you to complete this questionnaire again when you have completed your treatment along with a brief telephone interview with a staff member of the Anxiety Disorders Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the Anxiety Disorders Clinic who receive a primary diagnosis of Panic Disorder, and are accepted for treatment at the clinic.

Exclusion Criteria:

* Individuals who either have not sought treatment for anxiety at the Anxiety Disorders Clinic or patients who did not receive a primary diagnosis of Panic Disorder.
Bivalirudin as a Procedural Anticoagulant in Pediatrics

Pharmacokinetics and safety of weight based bivalirudin in children


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant females, with an age range of birth to 16 years of age.
* Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease.
* Written informed consent from a legal guardian/parent.
* Life expectancy of at least 15 days at study entry.
* Assent of the patient if older than 8 years, whenever possible.

Exclusion Criteria:

* History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit.
* Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles.
* Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
* Known congenital or acquired bleeding or clotting disorder.
* Patients undergoing renal dialysis.\*
* Weight \< 2.5 kg.
* Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
* Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®).
* Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
* Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study.
* Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is \> 1.5.
* Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus.
* Patients who have received a dose of LMWH within 8 hours prior to study drug bolus.
* Patients previously enrolled in the study.
A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease
* No prior systemic treatment for metastatic disease
* Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
* Life expectancy ≥12 weeks
* Adequate hematologic, hepatic, and renal function
* Negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential

Exclusion Criteria:

* Unstable systemic disease
* Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors
* Other malignancy within 5 years prior to study entry
* Significant opthalmologic abnormality
* Inability to take oral medication
* Need for IV alimentation
* Prior surgery affecting absorption
* Active peptic ulcer disease
* Nursing mothers
A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

* psychiatric illness
* depression of generalised anxiety disorder
* suicidal risk
* substance abuse
* active cardiac disease
* pulmonary dysfunction
* liver disease
* renal impairment
* autoimmune disease
* chronic inflammatory rheumatoid disease
* current systemic infection
* epileptic
* active cancer
* sleep apnea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* for men : prostatic enlargement of genito-urinary disorders
* for women : pregnancy or breast feeding