cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effects of Instrument Assisted Soft Tissue Mobilization Techniques Low Back Pain

The aim of this study is to determine whether the effectiveness of instrument-assisted soft tissue mobilization technique is different from passive prone lying when performed with a functional exercise in individuals with chronic nonspecific low back pain.

Individuals participating in the study will first be divided into two groups by randomization. While IASTM (Instrument Assisted Soft Tissue Mobilization Techniques) will be applied to one group in the prone position, IASTM will be applied to the other group with functional exercise. The pain, mobility, flexibility, disability and endurance parameters of the individuals assigned to the groups after randomization will be determined just before the application, immediately after the 1st application and immediately after the 6th application. The study will last for a total of 6 sessions, with two sessions per week for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with non-specific low back pain by a specialist physician
* 18-45 years old
* Having 3 or more pains on VAS for the last 3 months.
* Those who do not use analgesic drugs
* Not taking physiotherapy for the last 6 months.

Exclusion Criteria:

* Those with orthopedic, neurological, psychiatric and systemic diseases (such as fracture, osteoporosis, scoliosis, kyphosis, stenosis, cauda equina, myositis ossificans, severe nerve compressions, rheumatoid arthritis, cancer)
* Those with a history of spinal surgery
* Pregnant and lactating
* Open wound, infection, serious kidney disease
* Those who have limited hip joint movements
Identification of Genes Involved in Juvenile Idiopathic Arthritis by Wholel Exome Sequencing

Juvenile idiopathic arthritis (JIA) is considered to be a multifactorial disease caused by a combination of environmental factors and predisposing genetic factors. Twins studies found a strong heritability (strong genetic factors) but genetic studies such association studies of large cohorts of patient (GWAS or Genome Wide Association Study) have elucidated less than 20 % of the genetic basis of JIA. The vision of the genetics of multifactorial diseases has recently changed revealing a large clinical and genetic heterogeneity of these diseases. Indeed, the advent of next-generation sequencing identified non-multifactorial genetic hereditary disease related to mutations in genes having strong effect on the onset of the disease without real impact of environmental factors among the so called "multifactorial diseases" (Parkinson's, diabetes, osteoarthritis, Alzheimer's, hypertension ...)The investigators propose to study 30 families with several forms of JIA by next-generation sequencing. Identifying the genetic basis of JIA in these families will help to better understand the physiopathology of this disease and may help to the identification of novel therapeutic targets for other patients with JIA.


Eligibility Criteria:
Inclusion Criteria:

* AJI oligoarticular form \<4 joints
* AJI Polyarticular form\> 4 joints
* AJI Forms systemic arthritis
* duration For more than six weeks
* Onset of symptoms before the age of 16 years
* Or rheumatoid factor or ANA + or CCP +Acceptation of both parenth to participate to the research and to perfom blood samples for genetic studies

Exclusion Criteria:

* The (the) patient (e) is under tutorship or curatorship
* The (the) patient (e) is under judicial protection
* The (the) patient (e), or his parents, refuses to sign the consent
* It is impossible to give (the) patient (e) information lit
* JIA spondyloarthropathies such
* JIA type psoriatic arthritis or enthesopathy
* JIA not classifiable
A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma

The goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional TACE (Transarterial Chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres.

The main questions it aims to answer are:

* Is the treatment more effective than traditional TACE alone?
* What additional medical issues arise when using the microspheres?

Researchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes.

Participants will:

* Receive up to 3 treatments of TACE with or without microspheres
* Undergo checkups and tests every 30 days
* Keep records of tumor size and other safety issues


Eligibility Criteria:
Inclusion Criteria:

1. Age range: 18 to 80 years inclusive, regardless of gender;
2. Patients with primary hepatocellular carcinoma (HCC) at CNLC stage Ib to IIIa who require transarterial chemoembolization (TACE) treatment and are unsuitable for or refuse surgical resection, liver transplantation, and ablation therapy;
3. ECOG score ≤ 2, and Child-Pugh classification of A or B;
4. Presence of at least one untreated, measurable tumor lesion with a diameter ≥ 3.0 cm according to mRECIST criteria (the maximum diameter of the target lesion ≤ 10.0 cm);
5. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who are willing to receive antiviral treatment throughout the study period;
6. Voluntary participation in this clinical trial and signing of the informed consent form by the subject.

Exclusion Criteria:

1. Patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with TACE;
2. Received other antitumor systemic treatment within 28 days before enrollment;
3. Unsuitable for TACE due to lesion characteristics or vascular issues;
4. Vp3/Vp4 portal vein tumor thrombus;
5. Tumor occupying ≥70% of liver volume;
6. Decompensated cirrhosis or recent ascites drainage/TIPS;
7. Severe allergies to contrast agents or embolization materials;
8. Received blood products or certain corrective treatments within 7 days before enrollment;
9. Abnormal blood counts (WBC, platelets, neutrophils, hemoglobin);
10. Abnormal liver function tests (bilirubin, enzymes, albumin);
11. Renal impairment (creatinine, creatinine clearance);
12. Prolonged PT;
13. Unsuitable feeding artery for TACE or embolization risks;
14. Expected survival \<6 months;
15. Pregnant, lactating, or planning pregnancy;
16. Factors affecting study results or necessitating study termination (alcoholism, drug abuse, severe diseases);
17. Severe infections unsuitable for TACE;
18. Participation in other clinical trials within 28 days before enrollment;
19. Other reasons deemed unsuitable by the investigator.
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.

Exclusion Criteria:

* Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
* Personal history of gynecologic cancer
* Pregnancy
* Non-English speaking
* Unable to provide informed consent
A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of fisogatinib (formerly known as BLU- 554) administered orally in patients with FGF19 IHC+ hepatocellular carcinoma (HCC). The study consists of 3 parts, a dose-escalation part (Part 1), an expansion part (Part 2) exploring a once daily (qd) dosing schedule at the recommended Phase 2 dose (RP2D), and a Part 3 expansion of the qd dosing schedule at the RP2D in TKI naive patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of HCC by histological examination or by non-invasive criteria according to European Association for the Study of the Liver (EASL) or American Association for the Study of Liver Disease (AASLD) guidelines (Part 1, 2 and 3).
* For Part 1 and 2, the patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib.
* For Part 3, the patient has not received prior treatment with a TKI.
* Child-Pugh class A with no clinically apparent ascites
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* For Part 1, willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
* For Part 2 and 3, all patients must have an FGF19 IHC result available. Only FGF19 IHC+ HCC patients will be eligible for Part 3.

Key Exclusion Criteria:

* Central nervous system metastases
* Platelet count \<75,000/mL
* Absolute neutrophil count \<1000/mL
* Hemoglobin \<8 g/dL
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5x the upper limit of normal (ULN)
* Total bilirubin \>2.5 mg/dL
* International normalized ratio (INR) \>2.3 or prothrombin time (PT) \>6 seconds above control
* Estimated (Cockroft-Gault formula) or measured creatinine clearance \<40 mL/min
OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study

The purpose of this study is to evaluate the effect of BOTOX® (OnabotulinumtoxinA) on the number of headache days in patients with New Daily Persistent Headache (NDPH). NDPH is a benign form of chronic daily headache that comes in two forms: one that resolves on its own after months to years, or one that is difficult to treat and does not respond to preventive or abortive medications. Some patients experience migrainous features such as nausea, vomiting, photophobia, or phonophobia. BOTOX®, a treatment approved for chronic migraine, will be injected into specific muscles of the head and neck area by your study doctor, to evaluate its effectiveness in reducing or relieving NDPH days or severity. BOTOX has not been approved for NDPH and this is the first time it will be used for treatment of NDPH. All participants in this study will only receive BOTOX® and no other study drug.


Eligibility Criteria:
Inclusion Criteria:

Subjects aged 18 or older, male or female of any race with the diagnosis of NDPH meeting International Classification of Headache Disorders (ICHD-2) criteria will be included in the study. The criteria is as follows:

A. Persistent headache fulfilling criteria B and C B. Distinct and clearly remembered onset, with pain becoming continuous and unremitting within 24 hours C. Present for \>3 months D. Not better accounted for by another ICHD-3 diagnosis

Exclusion Criteria:

1. Those with relevant physical or psychological illness, particularly conditions that might put them at risk if exposed to OnabotulinumtoxinA (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other neuromuscular disease).
2. Diagnosis of other primary/secondary headache disorder.
3. Psychiatric disorders that could interfere with study participation.
4. Subjects who abuse drugs, including headache treatments and alcohol (DSM IV criteria).
5. Those allergic to compounds similar to the study medication.
6. Those who are pregnant or breastfeeding, or who do not use adequate contraceptive methods.
7. Those who have had any prior exposure to any botulinum toxin serotype.
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
2. Subjects must meet BSC labeled indication for CRT-D implantation.
3. Subjects must have a functional RA lead and RV lead implanted
4. Subjects who are willing and capable of providing informed consent
5. Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
6. Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

1. Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
2. Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
3. Subjects with documented history of permanent AF
4. Subjects with documented permanent complete AV block
5. Subjects who are expected to receive a heart transplant during the 12 months course of the study
6. Subjects with documented life expectancy of less than 12 months
7. Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC
Evaluation of the Occurrence of Early Thrombosis on Central Venous Catheter by Ultrasound in Pediatric Intensive Care Unit

The objective of this study is to prospectively describe the incidence of early venous thrombosis secondary to the placement of a percutaneous central venous catheter, in a pediatric intensive care unit, by systematic ultrasound screening.

In pediatric resuscitation, the use of a percutaneous central venous catheter is essential. It allows to administer strong osmolarity intravenous drugs or prolonged duration treatment and to carry out blood samples.

In the course of the placement of a central venous catheter, there is a risk of occurrence of early thrombosis between 20 and 45%, appearing mainly in the 4 first days. The occurrence is explained by the Virchow triad: endothelial lesion (linked to the central venous catheter), venous stasis, hypercoagulability. Ultrasonography is an imaging test that can be performed at the bedside, allowing the non-invasive collection of diagnostic elements of thrombosis (visible thrombus, non-compressibility of the vein, abolition of venous flow). Performing ultrasound for thrombosis screening is essential because of a very low clinical expression of thrombosis, while the consequences are potentially severe, including infection, embolism, venous insufficiency and loss of venous access for children who will need several central venous catheters during their lifetime.

Despite the knowledge of certain risk factors (i.e. assisted ventilation, history of cancer, transfusions,...), there is actually no consensus for the systematic screening of venous thromboses on central venous catheters. Systematic thromboprophylaxis is not recommended for central venous catheters (grade 1B). Concerning the curative treatment of central venous catheter thrombosis, unfractionated heparin or low molecular weight heparin (grade 1B) is recommended. If the central venous catheter is no longer needed for the care, it can be removed after 3 to 5 days of anticoagulants (grade 2C). It can also be kept under cover of anticoagulant treatment if its use is essential (grade 2C).

The objective of this study is to prospectively describe the incidence of early venous thrombosis secondary to the placement of a percutaneous central venous catheter, in a pediatric intensive care unit, by the systematic ultrasound screening.

Eligibility Criteria:
Inclusion Criteria:

- All children hospitalized in pediatric intensive care unit requiring the placement of a central venous catheter.

Exclusion Criteria:

* Impossibility of delivering an information in order to obtain a non-opposition.
* Absence of acoustic window (dressings).
* Removal of the catheter before performing the ultrasound.
Fatigue and Sleep in Patients With COVID-19

Recent studies show that patients who have contracted COVID-19 retain very significant fatigue after resolving the infectious episode. This fatigue may be explained by low-grade inflammation. There is more data for patients with COVID-19 who have been hospitalized than for non-hospitalized patients with milder forms.

However, COVID-19 related fatigue would not only affect elderly people with severe cardiopulmonary consequences but also young subjects without severities. This notion is not very widespread and to date, COVID contracted by young subjects is considered to have very few consequences on their health.

It is also known that the prevalence of sleep debt is significant in the general population and particularly in young people, and it is also known that sleep deprivation increases low-grade inflammation and facilitates the risk of viral contamination. The association between sleep deprivation, drowsiness and possibly low-grade inflammation raise questions about the mechanisms of fatigue in the general population.

Investigators are also entitled to wonder to what extent the chronic sleep debt suffered by the French population can explain an increased risk of contamination by COVID 19 but also significant residual fatigue after COVID infection.

Bordeaux University Hospital screens 2,000 subjects per day at risk of being infected by COVID, it would be very interesting to measure, in a population of young adults aged 18-45 years, frequently exposed to a sleep debt, sleep hygiene (bedtime and wake-up times, sleep and wake-up schedules, and overall sleep satisfaction), average sleep duration, level of fatigue and drowsiness and to compare these thresholds between subjects with or without COVID 19 according to nasopharyngeal PCR.


Eligibility Criteria:
Inclusion Criteria:

* Patient or healthcare professional going to screening center to perform a PCR test for COVID-19
* Between 18 and 45 years old
* Symptomatic or not
* Whether or not COVID-19 contact-case
* Accepting to participate to the research
* Informed and having expressly transmitted their non-opposition to participate in the study

Exclusion Criteria:

* Participants who do not speak French or who cannot read or write
* Patients who do not have contact information for recall
* Refusal to participate in the study.
* Majors under guardianship or curatorship.
Predicting Response to PD-1 Checkpoint Blockade Using Deep Learning Analysis of Imaging and Clinical Data

Immunotherapy has transformed cancer treatment with the PD-1 class of checkpoint inhibitors - pembrolizumab and nivolumab -- demonstrating durable responses in Stage IV metastatic tumors such as non-small cell lung cancer and melanoma. Despite these numerous successes, PD-1/PD-L1 checkpoint blockade therapies do have a number of shortcomings.

Many approaches to predict response to PD-1/PD-L1 checkpoint therapy have been investigated with limited success. Recent efforts exploring the utility of quantitative imaging biomarkers to predict response to PD-\[L\]1 immunotherapy have shown promise. The purpose of this retrospective multicenter study is to develop a multi-omic classifier to predict response to PD-1/PD-L1 checkpoint blockade for mutation negative (EGFR, ALK and ROS1) NSCLC

Recent Phase III studies have demonstrated the effectiveness of atezolizumab (PD-L1) in metastatic triple-negative breast cancer \[3\] and small cell lung cancer, while the standard of care for Stage III non-small cell lung cancer has changed with positive results of the PACIFIC Phase III study, where durvalumab (PD-L1) administered after chemoradiation showed a significant increase in overall survival.

Low response rates, generally in the 15% to 20% range in most diseases when used as a single agent, high therapy cost globally ($150,000 or more per year in the U.S) and serious immune-mediated adverse events, particularly when PD-1/PD-L1 inhibitors are combined with the CTLA-4 inhibitors (ipilimumab). Unpredictable and low patient response rates coupled with high drugs costs and serious toxicities can significantly burden healthcare systems, third-party payers and patients. Clearly, diagnostic tools to stratify patients according to response likelihood are necessary as PD-\[L\]1 checkpoint inhibitors continue to gain adoption.

The standard-of-care biomarker is an immunohistochemistry (IHC) test that measures levels of the PD-L1 protein expressed in tumor samples. Tumor mutational burden, presence of Tumor-Infiltrating Lymphocytes and inflammatory cytokines are being explored in multiple clinical trials involving PD-(L)1 often in combination with additional immuno-oncology (IO) therapies In such an approach, a non-invasive imaging scan can provide insight and information on the patient's entire tumor burden rather than a sample of a subset of lesions (as provided by biopsy or serum-based assays). When diagnostic images that depict all treatable lesions are further analyzed with computational techniques such as machine-learning and artificial intelligence, resulting in the identification of relevant imaging biomarkers, an accurate overall assessment of patient response to PD-\[L\]1 therapy may be attainable.

Eligibility Criteria:
Inclusion Criteria:Patients between 18 and 100 years of age -

Exclusion Criteria: Patient under 18 years of age

-
The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial

The use of electronic media in informed consent giving has become increasingly important in recent years. Due to the easy access to information via electronical media, patients are primed in a heterogeneous manner concerning expectations and wishes regarding surgical interventions. Inherent to its nature elective interventions are critically questioned as there is time for information gathering and reflection.

In this study, the investigators set out to investigate the effect of an educational video as a supporting element in the process of informed consent giving for one the most frequently performed interventions in general surgery, namely inguinal hernia repair.

In a multi-center setup, eligible patients for primary inguinal hernia repair will be randomly assigned to 1 of 3 groups. The intervention video provides basic principles of endoscopic extraperitoneal hernia repair. The second video is similar in length and design and displays general aspects of day surgery in the two study centres. The third group's link will lead to the digital version of the informed consent. Primary outcomes will consist of 1) score in a multiple choice test assessing gain of knowledge regarding hernia repair, 2) difference in the State-Trait Anxiety Inventory (STAI) and 3) patient satisfaction questionnaire (ICF, Picker Institute, Germany) as assessed 1-2 days after the first consultation.


Eligibility Criteria:
Inclusion Criteria:

* unilateral or bilateral hernia with indication for surgical therapy
* signed informed consent form for trial participation

Exclusion Criteria:

* Patients who have had surgery for ipsi- or contralateral inguinal or femoral hernia
* combination interventions (umbilical and inguinal hernia repair, e.g.)
* cognitive, audio-visual or linguistic handicap raising concern of complete understanding of the research project