cyrilzakka/clinical-trials huggingface dataset:
Neurodevelopmental Disorders in Children With Congenital Heart Disease

Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society.

The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up.

This study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.

Are selected children with "significant" congenital heart disease (aged from 6 to 66 months) in "Nord-Pas-De-Calais" fulfilling inclusion criteria. A reliable and valid questionnaire used to screen developmental delays of children aged from one month to 66 months is completed by volunteer parents at the time of the study. Data of the questionnaire is collected and a scoring by professional is provided ; children at risk for neurodevelopmental delays are depicted.

In parallel, medical and surgical history is also collected to detect risk factors for neurodevelopmental disorders.

The frequency of neurodevelopmental disorders in this screened population according to risk factors (among neonatal data, severity of congenital heart disease, surgery, length of stay at hospital,... ) will be evaluated. The ratio children with neurodevelopmental disorders for whom specific care was implemented/ children with neurodevelopmental disorders who did not have specific care despite neurodevelopmental disorders will be established.

Follow-up action will be taken for children at risk for developping neurological disorders highlighted by the screening.

This study will help implementing a specific program for evaluation and management of neurodevelopmental disorders for children with congenital heart disease in our region.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 66 months at the time of study
* living in region "Nord-Pas-De-Calais"
* with " significant" congenital heart disease (= complex congenital heart diseases operated or not, simple or moderate congenital heart disease who had cardiac surgery)
* Followed by the Pediatric Cardiology Department of Lille University Hospital, or patients having a cardiopediatric follow-up outside Lille University Hospital but having been taken in charge at the University Hospital of Lille for any reason (cardiac or not)

Exclusion Criteria:

Children :

* lost to sight
* Deceased
* with congenital heart disease, living in Nord-Pas-de-Calais but never having been taken in charge at Lille University Hospital
* with mild or moderate congenital heart disease not having undergone surgery or having only undergone cardiac catheterization
* with cardiac surgery not performed in the Centers of Jacques CARTIER and Marie LANNNELONGUE
Transcapillary Plasma Refill in Advanced Chronic Kidney Disease

Background: Haemodynamic instability during haemodialysis has long been linked to poor cardiovascular outcomes. It does not always reflect overall hydration but rather plasma volume depletion, with a delay in plasma refill from other body compartments, and vasodilatation, mediated by endothelial factors. Our understanding of these processes remains largely incomplete. Despite our ability to monitor relative blood volume during haemodialysis our knowledge concerning the factors affecting plasma refill remain incomplete. This may be due to variations observed between individuals. Understanding the pattern of fluid shifts variation between the different body compartment and the factors affecting these behaviours in different individuals or at different hydration states could be a vital component of our management of intradialytic haemodynamic instability but also overhydration.

Aims and Objectives: The aim of this study is to describe plasma refill rate, during haemodialysis using a non-invasive, continuous, real-time data capture during ultrafiltration. The study will attempt to describe different refilling phenotypes in the study population and seek association with biochemical and haematological parameters linked to variability in refilling rates.

Methodology: This study will attempt to describe variations in the plasma refill rate of prevalent dialysis patients during their normal haemodialysis treatment and during a session of 3 hours of haemodialysis preceded by 1 hour of isolated ultrafiltration using the in-built blood volume monitoring module of their haemodialysis machine and the TMON software that collects continuous, real-time data by interfacing with the computer network. To achieve this, a bolus of 100-300ml of intravenous dialysis replacement fluid will be administered at the beginning of each of the 2 studied sessions.


Eligibility Criteria:
Inclusion Criteria:

* Prevalent haemodialysis patient at CMFT and satellite units

Exclusion Criteria:

* Withdrawal of consent.
* Inability to provide informed consent.
ATTUNE TM Video-fluoroscopy Study

The proposed study is a retrospective, observational study. A group of 5 subjects with the AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral TKA motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. The obtained information helps the manufacturer (DePuy) to evaluate, bring to market and advance the implant. Furthermore the information will be integrated in a model, which will be developed at the Center for Orthopaedic Engineering, University of Denver. By means of this model, different conditions such as the use of an advanced prosthesis design can be simulated and tested.

The objective of this study is in a first step to demonstrate the capability of data collection and analysis of level gait, deep knee bend, sitting down onto a chair, standing up from a chair and stair descent on a limited sample size of five subjects. Secondly to quantify and describe the three-dimensional kinematics for the cruciate retaining (CR), fixed bearing AttuneTM TKA during daily activities such as those mentioned.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral TKA (ATTUNETM) due to osteoarthrosis (OA)
* Body mass index (BMI) ≤ 33
* Good clinical outcome, Knee injury and Osteoarthritis Outcome Score (KOOS) \> 70
* No or very low Visual Analog Scale for Pain (VAS) \< 2
* At least one year post-op
* Standardized general health survey score (SF-12) within the normal range for people in their age group

Exclusion Criteria:

* Actual significant problem on lower extremities
* Misaligned TKA
* Any other arthroplasty at the lower extremities
* Patient incapable to understand and sign informed consent
* Incapable of performing the motion tasks
* Pregnancy
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent.
* Intact parathyroid hormone (PTH) at least 350 pg/mL.
* Corrected calcium at least 9.0 mg/dL.
* Hemoglobin at least 9.0 g/dL.
* Adequate hemodialysis three times per week.
* Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests.

Exclusion Criteria:

* History or symptomatic ventricular dysrhythmias.
* History of angina pectoris or congestive heart failure
* History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months.
* History of or treatment for seizure disorder.
* Recent (3 months) parathyroidectomy.
* Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.
Health Impact Study of Aquatabs in Tamale, Ghana

The purpose of this study to determine whether Aquatabs, a water treatment tablet, reduces diarrheal diseases in a peri-urban population of Tamale, Ghana.


Eligibility Criteria:
Inclusion Criteria:

* Households with at least one child under 5 years old

Exclusion Criteria:

-
Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Infiltrations

The purpose of the study is to evaluate the efficacy and impact on morphine consumption of ropivacaine administered by local per and post hepatic surgery infiltration.

Patients will be randomized to either ropivacaine or physiological serum, with equivalent administration modalities in both arms.

Patients will be followed during 4 days after the surgery. They will also come back for a follow-up visit one month later.

It is necessary to enrol 100 patients. The estimated period of inclusion is 24 months.

This is a prospective, comparative, monocentric, double-blind randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥ 18 years
* Patients with histologically confirmed cancer
* Patients treated at the Centre Léon Bérard
* Patients requiring a surgery for hepatic metastases
* ASA \<= 3
* At least 3 weeks between surgery and chemotherapy
* Total bilirubin \< 1.5 x upper limit of normal range
* ASAT and ALAT \< 5 times x upper limit of normal range
* Creatinine clearance \> 60 ml per hour
* Serum creatinine \< 115 µmol/l
* Mandatory affiliation with a health insurance system
* Patients able to understand French
* Signed, written informed consent

Exclusion Criteria:

* Patients with a hepatocellular carcinoma or an initial liver cancer
* Patients treated chronically by morphine
* Patients that already have abdominal pain
* Patients who are allergic either to morphinics, local anesthesics, paracetamol, NSAID or cortisone
* Patients suffering from heart, kidney or liver insufficiency
* Documented history of cognitive or psychiatric disorders
* Pregnant or lactating women
* Difficult follow-up
Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease

The purposes of this study are to compare the effectiveness and side effects of US-guided and palpation-guided corticosteroid injections for de Quervain's disease.

De Quervain's disease is a common clinical disorder, characterized by pain at radial side of the wrist. It often interferes wrist and thumb movement, and may affect activity of daily life. It is caused by overuse and impaired gliding of the abductor pollicis longus (APL) and extensor policis brevis (EPB) tendons at the styloid process of the radius. It is associated with postpartum baby care, or jobs or hobbies that involve repetitive hand and wrist motions. The most effective treatment is corticosteroid injection into the tendon sheath of the conjoined tendons of APL and EPB. Over the past few years because of advancement of sonography in the musculoskeletal system, ultrasound (US)-guided intra-sheath injection has become popular, and it has been proved to improve the accuracy of placement of needle tip in the tendon sheath, however, studies comparing the effect and side effects of US-guided corticosteroid injection with palpation-guided injection for de Quervain's disease have never been reported before. The purposes of this study are to compare the effectiveness and side effects of US-guided and palpation-guided corticosteroid injections for de Quervain's disease.

The investigators plan to recruit 70 patients with de Quervain's disease, half of them will be randomly assigned into US-guided injection group, and the other half into the palpation-guided injection group. Each subject will receive one shot of injection and each subject will expect to fill in the evaluation form at baseline, and at 1 week, 3 months, and 6 months after the injection. Statistics will be performed after completing the patients' treatment and evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Pain and tenderness at the radial side of the wrist.
2. Positive Finkelstein sign, or pain on resistive maximal isometric contraction of extension and/or abduction of the affected thumb.
3. pain intensity on a 10-point visual analog scale (VAS) for pain to ≧ 3 on active thumb abduction or extension.
4. Patient agrees to receive either palpation-guided or US-guided local corticosteroid injection.
5. Age ≧ 20 years old.

Exclusion Criteria:

1. Presence of an absolute contraindication for corticosteroids or local anesthetics injection.
2. During pregnancy.
3. Severe systemic diseases with poor control.
4. Prior treatment with corticosteroid injection and/or surgery at the same anatomical location in the last 6 months.
5. Being unable to fill-in the follow-up forms.
Contact Force Sensing Use in Atrial Fibrillation Ablation

There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.

This study compares patients who have this procedure where this contact information is known (unblinded) versus those where the contact information is not known (blinded). The outcome is the rate of acute reconnection at 1 hour after achieving pulmonary vein isolation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic AF

Exclusion Criteria:

* Recent CVA
* Contraindication to warfarin therapy
Role of Caregiver in the Clinical Pathway of Patients With Breast and Prostate Cancer

The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options.

The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options. Moreover, a battery of self-report questionnaires will be administered, and sociodemographic and clinical data will be collected. The time window in which to deliver the support intervention is after the detection of a suspected cancer and before the visit with the oncologist, at the time when the patient undergoes diagnostic exams (to understand the type of tumor he/she is affected by), and the most suitable therapeutic protocol have to be discussed with the oncologist.

Eligibility Criteria:
Inclusion Criteria:

Patient:

* Patient aged ≥18 years at the time of recruitment.
* Patients who have just received a cancer diagnosis and have yet to discuss with their oncologist the treatment to undergo after diagnosis of breast or prostate cancer.
* Early-stage cancer (I or II).

Caregiver:

* Age ≥ 18 at the time of recruitment.
* Taking care of the patient.

Exclusion Criteria:

Patients:

* Presence of early mental disorders (before age 40) or severe neurological disorder.
* Patients with advanced stage cancer for which the path is already defined (palliative care patients).

Caregivers:

● Presence of early mental disorders (before age 40) or severe neurological disorder.
Pulp Revascularization Versus MTA Apexification

This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.

the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.

Eligibility Criteria:
Inclusion Criteria:

* Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.

Exclusion Criteria:

* History of allergy to any of the antibiotics in the tri-mix used in the study
* Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,...
* Psychological disturbance
* External / internal root resorption or cystic lesion.
Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD

This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.


Eligibility Criteria:
Inclusion Criteria:

* Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
* Smoking history of at least 10 pack-years

Exclusion Criteria:

* Any significant co-morbid disease
* Use of any maintenance therapy except short acting bronchodilators
Effect of Music Therapy on Postoperative Health Outcomes

Patients underwent surgical procedure experiences acute postoperative pain, but less than half report adequate postoperative pain relief. The poor management of pain after surgery is associated with inadequate sleep and poor mood. Music therapy is described as a non-pharmacological technique to accomplish individualized patient's goals for hospital treatment. Music has been used as a healing approach. In Saudi Arabia, there is a lack of evidence related to the effect of music therapy on pain and sleep among patients who underwent abdominal surgery. Studies are needed to address additional aspects of pain management and the promotion of sleep among Saudi adult postoperative people by using non-pharmacological modalities.

Aim: The study will investigate the effect of music therapy on acute postoperative pain and sleep quality among patients undergoing abdominal surgery. A randomized control trial design will be demonstrated to accomplish this study. A total sample of 60 cases who underwent general abdominal surgery will be recruited. The study will be carried on in general surgery wards in one of a University Hospitals in Riyadh city, KSA. Four tools will be used to collect the data: Socio-demographic and medical data sheet, Pain Numeric Rating Scale (PNRS) for pain, Insomnia Severity Index (ISI) and Opinions Questions Regarding music therapy. The intervention group will listen to the selected prerecorded music on individual CD players by using a headset for consecutive three days. Music therapy will be given for 30 minutes during day time; depends upon the analgesics peak action time to avoid the bias of the intervention. Once again, it will be played before bedtime.

Eligibility Criteria:
Inclusion Criteria:

Patients who will meet the following criteria will be eligible to participate in this study:

* Adult patients, including both sexes and aged between18-60 years.
* Had an abdominal surgery.
* Give informed consent and are hemodynamically stabilized.
* Willing to receive music therapy for three consecutive postoperative days by using Headset.

Exclusion Criteria:

* Patients will be ineligible to participate in this study if they have any of the following:

  * Hearing deficit.
  * History of chronic pain.
  * Metastasis cancer, on narcotic medication.
  * Dementia, or psychiatric diagnosis
AmplifEYE Colonoscopy vs Standard Colonoscopy

Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical data on this relatively new device is lacking and this study aims to compare the adenoma and polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.

This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All study team members will have a prior run-in phase of performing at least 5 AmplifEYE colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time, colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each group.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 50 to 79 years old
* Scheduled for screening, surveillance or diagnostic colonoscopy

Exclusion Criteria:

* Colonic strictures
* History of bowel surgery
* Per-rectal bleeding within six weeks
* Inflammatory bowel disease
* Pregnancy
A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment

The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.


Eligibility Criteria:
Inclusion Criteria:

* Adult (= or \> 18 years old) with NSCLC
* Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease
* Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
* Programmed death-ligand 1 (PD-L1) TPS Score \< 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* No active brain metastases
* Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Exclusion Criteria:

* Mixed small-cell lung cancer and NSCLC histology
* Myocardial Infarction within 6 months of study Day 1
* Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates
* Therapeutic or palliative radiation therapy within 2 weeks of study day 1
* Unable to take oral medication
* Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans