cyrilzakka/clinical-trials huggingface dataset:
Glioma Brain Tumours - E12513 - SensiScreen Glioma

Validation of a new platform for the molecular characterization of patients affected by glioma. The new platform includes a series of faster, less expensive real-time PCR methodologies that, in comparison to standard analyses (DS, MS-PCR), are also characterized by higher sensitivity and consequently can be able to identify mutations in ctDNA extracted from liquid biopsies as well. The development of these assays will allow the analysis of molecular markers alteration even in liquid biopsies, providing a less invasive sampling than tissue biopsies, a procedure that sometimes is characterized by side effects or that allow the collection of few tissues for the histological and molecular diagnosis.

This study will not interfere with the patients routine treatment pathway and there will be no deviation from the standard of care: the molecular characterization of the tissues will be performed according to the standard diagnostic routine using the currently approved methodologies. For the retrospective study, it will be used the left-over DNA. For the cohort, that includes the collection and the subsequent analysis of liquid biopsies (prospective study), blood and CSF will be sampled during surgery.

The mutations in the molecular markers will be analyzed in tissue as well as in plasma and CFS samples by the new real-time based assays. Then, the qualitative and quantitative values obtained on liquid biopsies with the new methodology will be compared to the results of the standard methodologies already obtained, for diagnostic routine, on surgical tissue samples of the same patients.


Eligibility Criteria:
Retrospective Cohort

Inclusion Criteria:

* Patient with available tissue material or with available molecular data concerning the tissue biopsy obtained during surgery and analyzed for diagnosis

Exclusion Criteria:

* Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
* Inability to consent and follow the procedures of the study (for alive patients)

Prospective Cohort

Inclusion Criteria:

* Age ≥ 18 years old
* Affected by suspected glioma and requiring surgery
* Patient with available tissue material or with available molecular data concerning the tissue biopsy obtained during surgery and analyzed for diagnosis
* Written informed consent

Exclusion Criteria:

* Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
* Inability to consent and follow the procedures of the study
* Women who are pregnant or breast feeding
Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study

Rationale: The trapeziometacarpal (TMC) joint is one of the most common areas in the hand and wrist to develop osteoarthritis (OA). Currently, the two most widely used procedures are the trapeziectomy and the TMC-joint arthroplasty, both with their own pros and cons. No studies have demonstrated superiority of TMC-joint arthroplasty over gold-standard trapeziectomy. And no clinical studies show short-term recovery and patient experience after trapeziectomy or TMC-joint arthroplasty.

Objective: To gather insight in short-term recovery and patient experience after a trapeziectomy or TMC prosthesis regarding pain, pain medication, function and quality of life.

Study design: A prospective observational cohort diary study.

Study population: In total 200 subjects with TMC-joint osteoarthritis will participate: 100 subjects will have trapeziectomy and 100 subjects will have TMC-joint arthroplasty

Main study parameters/endpoints: The main study parameters are the pain, function and quality of life during the first 8 weeks after surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will have no direct benefit from participation in this study. Subjects will only complete a diary and questionnaires for this study. Therefore, we expect no risks from participation. The burden for subjects consists of approximately five minutes daily for the diary in the first eight weeks after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Failed conservative treatment for osteoarthritis
* Planned for trapeziectomy or TMC-joint arthroplasty
* Age 18-75 years
* Willing and able to comply with the postoperative functional assessment and to participate in a rehabilitation schedule

Exclusion Criteria:

* Mentally disabled patients
* Active infection
* Current malignancy
* Infiltration (corticoids \< 3 months)

The following criteria is specific for the TMC-joint arthroplasty group and is an addition to the criteria mentioned above:

* Trapezium height \< 8 mm
Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity

The purpose of this study is to evaluate four different nasal continuous pressure systems, which are usually applied on our neonatal intensive care unit, with regard of their effect on bradycardia and desaturations in preterm infants.

BACKGROUND:

Apnea of prematurity (AOP) is a common problem in preterm infants. Nasal respiratory support using either Continuous Positive Airway Pressure (CPAP) or Intermittent Mandatory Ventilation (IMV) are, among others, widely used treatments. Which of the different systems is the most efficient, however, is unclear.

OBJECTIVE:

Efficiency of different CPAP systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants.

METHODS:

In a prospective, randomized, cross-over trial 32 preterm infants Infants will randomly allocated to receive nasal CPAP delivered by one of the following sys-tems: (1) a conventional IMV-System (Stephanie, Stephan GmbH, Germany with PIP 15 cmH2O, RR 10/min) delivering CPAP via short binasal prongs (Hudson RCI, USA); (2) the Infant-Flow-System (EME Ltd, Great Britain) with CPAP delivery via short binasal prongs; (3) the Infant-Flow-AdvanceTM-System used in the pressure assist mode with PIP 10 cmH2O, RR 10/min; and (4) a nasal underwater bubble CPAP with application via binasal prongs (Hudson RCI, USA).

All systems will be adjusted to achieve an approximate PEEP of 6 cm H2O. Each study lasts 24 hours, during which chest wall and abdominal movements, SaO2, tcPCO2, ECG, esopha-gus pressure and CPAP-/IMV-pressure will be recorded continuously. Infants will be studied in room air in a 15° head tilt prone position while being treated with caffeine (3mg/kg/d).

PRIMARY OUTCOME MEASURE Cumulative percentage of bradycardia (heart rate \<80/min) and desaturation (SaO2 \<80%) per hour.

Eligibility Criteria:
Inclusion Criteria:

* gestational age at birth \< 34 weeks
* postconceptional age and body weight at study ≤38 week and \>1000 g
* requirement for N-CPAP to treat AOP as judged by the attending neonatologist

Exclusion Criteria:

* congenital or chromosomal abnormalities
* acute infections
* intraventricular hemorrhage
* additional inspired oxygen to maintain pulse oximeter saturation SpO2 \>92%
* patent ductus arteriosus
Aerobic Exercise Intervention for Knee Osteoarthritis

This trial will test if walking or bicycling exercise is effective as a non-surgical treatment option for patients with knee osteoarthritis.

Traditional, conservative medical treatment of osteoarthritis has been directed at improving functional status through reducing joint pain and inflammation and maintaining or restoring joint function. Exercise is an adjunct therapy in the clinical management of patients with osteoarthritis of the knee. However, it is not uniformly accepted. The central hypothesis of this work is that the Surgeon General's exercise guidelines can be successfully implemented as an effective nonsurgical option for treatment of patients with early stages of knee osteoarthritis.

Patients with knee osteoarthritis will be randomized into a control group, a walking exercise group, and a stationary cycling exercise group. The individuals in the exercise groups will be required to exercise three times per week for one year using emerging public health recommendations for aerobic exercise in the adult and aging population. Patient outcome will be assessed using objective gait analysis measurements, knee radiographs to quantify joint space narrowing, magnetic resonance imaging, a general health questionnaire (SF-36), a disease/site specific questionnaire (WOMAC), and a visual-analog pain scale. All subjects will be studied at 0 and 52 weeks.

Eligibility Criteria:
Inclusion Criteria

* Current symptoms of chronic (6 months), stable pain and/or stiffness in one or both knees during weight-bearing activities
* Involved joint is primary factor limiting physical or functional activity
* Radiographic signs of mild or moderate arthritis
* Mild joint space narrowing (at least 2mm remaining)

Exclusion Criteria

* Current participation in a regular exercise program
* Existing medical condition that would preclude increased physical activity
* Subjective complaint of instability (giving way)
* Ligamentous instability greater than Grade I
* Knee flexion contracture greater than 15 degrees
* Asymptomatic osteoarthritis of both knees, incapacitating arthritis, or inflammatory arthritis
* Major reconstructive surgery on a lower extremity joint
* Multiple major joint involvement
* Any condition which severely limits local ambulation, such as amputation or stroke
* Gait aids used majority of time for ambulation
* Cannot use step-over-step techniques in either ascending or descending stair conditions
* Not able to undergo MRI scan (e.g., cardiac pacemaker)
* Dementia or inability to give informed consent as determined by a Folstein Mini Mental score greater than 24
A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis

Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro-diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests detect several gene mutations related to the above-mentioned pathologies. The development of IVD tools requires the evaluation of analytical parameters including biomarker stability.

The present specific study therefore aims to collect whole blood samples in PAXgene DNA tubes to complete the analytical validation of IVD tools and the evaluation of the stability of the DNA in PAXgene DNA tubes and the reagents in the IVD tools.


Eligibility Criteria:
Inclusion Criteria:

* Donors who sign the informed consent forms for sample collection and for genotyping.
* Adults, both genders, aged 18-85 years.
* Not under any administrative or legal supervision

Exclusion Criteria:

* Anyone who did not sign the Informed Consent form.
* Subjects aged below 18 years and older than 85 years are excluded.
* Pregnant, parturient and nursing women are excluded
Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants

The burden of disease experienced by underweight children is significant, particularly in low- and middle-income countries. Gut dysbiosis, an imbalance in microbial composition, is thought to play a role in nutrient malabsorption leading to underweight infants and failure to thrive. Bifidobacterium longum subspecies infantis (B. infantis) is a commensal bacterial strain important in the breakdown of human milk oligosaccharides (HMOs). A decrease in abundance or absence of B. infantis could lead to inadequate HMO processing, elevating intestinal pH and increasing the risk of pathogen overgrowth. Bi-26 is a B. infantis probiotic strain that is being evaluated in this study for its impact on weight gain and other health outcomes in underweight infants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be between 30 days and 120 days of age (inclusive), at the time of enrollment (study Day 1)
* Hospitalized for acute non-surgical illness
* Completed acute stabilization phase of treatment, including fluid rehydration and antibiotic course, prior to enrollment (study Day 1)
* WAZ at enrollment (study Day 1) is less than negative 2 (\<-2)
* Any sex
* Participant's parent(s)/legal guardian is capable of giving informed consent which includes agreement to comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
* Participant's parent(s)/legal guardian agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to relocate from the study area for the duration of the study
* Participant's parent(s)/legal guardian has easy access to reliable refrigeration (for storage of investigational product)
* Participant receives some feedings from breastmilk and mother intends to continue breastfeeding.

Exclusion Criteria:

* Congenital condition (suspected or confirmed) that the investigator considers likely to interfere with feeding or with normal growth and development
* Infant has not been discharged from hospital since birth or has not been at home for at least one week since birth
* Infant hospitalized with septic shock during current hospitalization
* Infant required mechanical ventilation during current hospitalization
* Infant with acute kidney injury on hospital admission
* Infant with severe jaundice and suspected kernicterus
* Infant receiving treatment for suspected or confirmed tuberculosis, or suspected or confirmed human immunodeficiency virus (HIV) infection
* Ongoing infant antibiotic (e.g. as prophylaxis in sickle cell disease) and/or probiotic usage
* Ongoing maternal antibiotic and/or probiotic usage for breast-feeding infants
* Inability of participant's parent(s)/legal guardian to comply with protocol requirements, as per investigator assessment.
Production of iPSC Derived RPE Cells for Transplantation in AMD

No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC will offer valuable source of tissue for transplantation in these forms of AMD and may form basis for a future treatment option in terms of cell transplantation.

It has been shown that adult human skin cells or human blood cells can be reprogrammed to become stem cells. This type of stem cell is called an induced Pluripotent Stem Cell (iPSC).It has been shown specifically that this type of stem cell can be produced from adult human skin cells or blood cells can in turn be converted into Retinal Pigment Epithelial (RPE) cells. These RPE cells are a very important cell type in the human retina that are abnormal and ultimately lost in Age-related Macular Degeneration (AMD). Although it has been shown to be possible to make RPE cells from adult human skin, it has not been done to a level to fulfil regulatory requirements for human transplantation in AMD.

This is a feasibility study involving 10 patients. The efficiency of creating an iPSC-Derived RPE cells from a patient's own skin or blood will be examined. A sample size of 10 patients will allow us to potentially consolidate the safety and efficacy of this method in order to create these cells within the context of a future transplantation trial.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over the age of 18 years
* Subjects with the ability to give informed consent
* Subjects with known AMD (both wet and dry)

Exclusion Criteria:

* Unable to give informed consent
* Subjects unable to give blood sample for medical reasons
* Subjects with coagulopathies
* Subjects who are known to be at risk of keloid scarring
Comparative Study of the Bioavailability of Magnesium Administrated by Two ChronoMag Smart Tablet® 50 mg Versus Three Mag2® Tablets 100mg.

This clinical study is composed of two steps. The first step aims at validating the pharmacokinetic approach based on the magnesium concentration in erythrocyte and plasma.

According to these results and if this pharmacokinetic approach is validated, the second step will set up. The second phase aims at comparing the relative bioavailability of magnesium administrated by two different drug formulations: ChronoMag Smart Tablet® (two tablets50mg) versus Mag2® (three tablets100mg).

" Go/no go " comparative biodisponibility study. Randomised, cross-over, controlled and double-blind, monocentric study in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Patient aged between 18 and 50
* Patient with a normal blood magnesium rate between 0.65 and 1.05 mmol/l
* Patient with vital signs values considered as normal by the investigator before drug administration
* Sufficient cooperation and understanding to comply with the requirements of study.
* Patient without medication during the 7 days preceding the inclusion
* Acceptance to give a written consent.
* Affiliation at system of French social security.
* Inscription or acceptation of inscription at national register of voluntaries participant at research.

Exclusion Criteria:

* Against magnesium-indication: hypersensitivity known at carbonate or magnesium chloride or at one of the excipients.
* Patient with medication or supplementation of magnesium
* Severe renal insufficiency with a creatine clearance ≤ 30ml/min
* Medical and chirurgical history considered as incompatible with the study
* A progressive pathology during the inclusion
* A consumption of more than 50g of dark chocolate per day
* An excessive alcohol consumption, an excessive tobacco consumption ( more than 10 cigarettes a day), an excessive tea, coffee or drink with caffeine consumption or drug addictions
* Patient who participated in another clinical trial located in exclusion period or received benefits \> 4500 euros during 12 months before the beginning of trial.
* Patient with cooperation and understanding insufficiency to comply with the requirements of protocol
* Minor or patient with social protection (curatorship, tutorship...)
* No affiliation at system of French social security
Pantoprazole in Cisplatin Nephrotoxicity

Pantoprazole in Cisplatin Nephrotoxicity

Pantoprazole in Cisplatin NephrotoxicityPantoprazole in Cisplatin Nephrotoxicity. Is it protective?

Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck cancer

Exclusion Criteria:

* GFR less than 59.
* DM
* Elevated liver enzymes more than 3 fold.
Perfusion CT as a Predictor of Treatment Response in Patients With Rectal Cancer

A research study of rectal cancer perfusion (how blood flows to the rectum over time). We hope to learn whether perfusion characteristics of rectal masses may be predictive of response to treatment and whether rectal perfusion characteristics can be used to follow response to treatment.

Recent advances in computed tomography (CT) technology have made CT perfusion imaging feasible for the assessment of tumor perfusion in solid tumors of the abdomen. CT perfusion has shown promising results in serving as a noninvasive method of predicting response to therapy in cancer patients. CT perfusion parameters have also been found to correlate with immunohistologic markers of angiogenesis in a number of solid tumors, suggesting a possible role for CT perfusion as a noninvasive biomarker of tumor angiogenesis. The goals of the investigators study are twofold: first, to determine the relationship between baseline CT perfusion characteristics of rectal cancers and their response to treatment, and second, to determine if perfusion CT can be used to subsequently monitor tumor response to treatment. The investigators hope to enroll those patients with locally advanced rectal cancer undergoing standard CT for pre-treatment planning, integrating CT perfusion imaging into the current abdomen/pelvis imaging protocol with close clinical and radiologic follow-up after treatment to determine response to therapy and time to disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected or biopsy-proven, locally advanced rectal cancer will be eligible for enrollment.
* Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.
* No life expectancy restrictions.
* ECOG and Karnofsky Performance Status will not be employed.
* Patients with renal failure are ineligible for this study (GFR must be \> 60)
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have undergone prior treatment for rectal cancer are ineligible for enrollment.
* No restrictions regarding use of other investigational agents.
* Patients with severe contrast allergy are ineligible.
* Patients who are pregnant or are trying to become pregnant are excluded from this study.
* Patients who are cancer survivors or HIV-positive will not be excluded.
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, aged 18 and older
* Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
* Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements per day)
* Ability to provide written informed consent

Exclusion Criteria:

* ≥12 high volume, watery bowel movements per day associated with a clinical syndrome of volume contraction, dehydration, or hypotension compatible with a "pancreatic cholera"-type clinical syndrome
* Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
* Karnofsky status ≤70% - unable to care for self
* Surgery within 60 days prior to screening
* A history of short bowel syndrome
* Life expectancy \<12 months
* History of substance or alcohol abuse within 2 years prior to screening
* Previous exposure to a tryptophan hydroxylase (TPH) inhibitor
* Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening
AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma

This study involved a comprehensive analysis of 256 PTC patients from Sun Yat-sen Memorial Hospital of Sun Yat-sen University (SYSMH) and 499 patients from The Cancer Genome Atlas. DNA-based next-generation sequencing (NGS) and single-cell RNA sequencing (scRNA-seq) were employed to capture genetic alterations and TME heterogeneity. A deep learning multimodal model was developed by incorporating matched histopathology slide images, genomic, transcriptomic, immune cells data to predict LNM and disease-free survival (DFS).


Eligibility Criteria:
Inclusion Criteria:

≥ 18 years of age Diagnosis of Papillary thyroid carcinoma at least one months before trial Willing to return for required follow-up (posttest) visits

Exclusion Criteria:

The patient requires valve or other likely surgery The patient is unable to carry out any physical activity without discomfort The patient had thyroid ache within three months prior to enrollment The patient refuses to give informed consent The patient is a candidate for coronary bypass surgery or something similar