cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck

Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).

Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS). Among patients with VADS cancer, more than 60% reported daily alcohol consumption of more than 20 g / d. Such poisoning can be harmful, causing histological lesions of alcoholic liver disease, such as steatosis, alcoholic hepatitis, liver fibrosis and cirrhosis. In a population consuming more than 50 g of alcohol per day for 5 years, the prevalence of severe hepatic fibrosis is between 30% and 40%. In the therapeutic management of a cancer of VADS, the presence of cirrhosis is a prognostic element, increasing the postoperative risk of haemorrhage, surgical site infection and acute renal failure. The search for cirrhosis in the pre-therapeutic assessment is therefore important. The diagnosis of cirrhosis is not a problem when clinical, biological, radiological or endoscopic signs of hepatic insufficiency or portal hypertension are present. Asymptomatic cirrhosis is more difficult to diagnose without liver biopsy. Noninvasive hepatic exploration techniques have recently been developed and validated for the evaluation of liver fibrosis in the context of alcoholic liver disease. Fibroscan® (Echosens, Paris, France) is an imaging device for measuring the liver hardness (hepatic elasticity expressed in kPa), with a strong correlation with the presence of histological fibrosis of the liver. At the threshold of 19.5 kPa, Fibroscan can be used to diagnose cirrhosis with good diagnostic performance (Se 80%, Sp 90%, VPP 93%, VPN 70%) and good inter- and intra-observer reproducibility. Elastometry is a simple, reliable and non-invasive tool to systematically evaluate hepatic fibrosis in patients with VADS cancer. The examination can be performed during a routine care consultation. The post-therapeutic morbidity induced by cirrhosis in the cancers of VADS is not well known and there is no recommendation in France about the hepatic explorations to be carried out during the initial assessment of these neoplasias. It is essential to be able to specify this morbidity in order to adapt if necessary the therapeutic strategy of cancers of VADS.

The objective of this study is to systematically determine the presence of cirrhosis and / or liver fibrosis in patients with VADS cancer, in order to investigate their impact on the morbidity after treatment of squamous cell carcinomas of the head and neck.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Supported in the department of Orl \& CCF or Maxillo-Faciale surgery of the CHU d'Amiens
* Histological diagnosis of epidermoid carcinoma:

  * From the oral cavity
  * From the oropharynx
  * Hypopharynx
  * Larynx
* Any stage of cancer
* Affiliation to a social security scheme

Exclusion Criteria:

* Patient already treated previously for a cancer of the VADS
* Patient referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code
Pulmonary Function and Qi Deficiency Predicted by Acoustic Analysis

Acoustic analysis is a method of clinically non-invasive, low-cost, remote-operation, and can avoid direct face-to-face contact.

It has been proved by many researches in recent years that it has a high diagnostic rate in predicting diseases. Lung function is closely related to human vocalization and has the potential and need for sound analysis. From literature review, it can be inferred that the Qi deficiency constitution in TCM is related to the strength of heart and lung function.The purpose of this study is to investigate the correlation between cardiopulmonary function and Qi deficiency, and to predict the correlation between the data by computer algorithm and artificial intelligence. Furthermore, the artificial intelligence (AI) self-correction ability can be combined with sound analysis to simulate a sound analysis system that can predict cardiopulmonary function and degree of qi deficiency only through sound information.

Research motivation and questions:

1. Is the sound characteristic of an individual related to individual's qi deficiency and cardiopulmonary function?
2. Can lung function and qi deficiency be measured by sound analysis?
3. To understand the correlation between Qi deficiency and cardiopulmonary endurance index.
4. Is there any difference in sound characteristics before and after step test and does it help predicting cardiopulmonary function?


Eligibility Criteria:
Inclusion Criteria:

* Age: over 20 years old.
* Agreed and signed Informed Consent Form.

Exclusion Criteria:

* Known heart diseases, acute severe respiratory infection, severe arthritis or other orthopedic disabilities, severe hypertension, or pregnant.
68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings

Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by significant cancer-associated fibroblasts (CAFs) accumulation. Fibroblast activation protein (FAP) is a protein that is overexpressed on CAFs and can be non-invasively monitored by a novel radiotracer called 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT). In this study, we will explore the value of 68Ga-FAPI-04 PET/CT in patients with epithelial ovarian cancer who are scheduled for surgical intervention. The findings of 68Ga-FAPI-04 PET/CT will also be compared with that of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) PET/CT, which is one of the most commonly used modalities in evaluating EOC, and histological findings.

Patients with epithelial ovarian cancer who are scheduled for surgical intervention will be recruited in this study. They will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery. No tumor-specific treatment is allowed between the scan and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy. Three types of lesions will be marked based on 68Ga-FAPI-04 and 18F-FDG PET/CT findings, which is FAPI+/FDG-, FAPI-/FAPI+, and FAPI+/FDG+ lesions. The marked lesions will be explored by the surgeon, resected if possible, and compared with histological results. A fourth type of lesion will be added into the analysis if that lesion is both FAPI and FAP negative but is a histological-confirmed positive lesion.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed
* EOC patients who are scheduled for surgery. The diagnosis of EOC should be based on the previous histological results or cytological evaluation combined with a serum CA-125 to carcinoembryonic antigen ratio\>25 to confirm the primary diagnosis and exclude a nongynecologic cancer.

Exclusion Criteria:

* Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI-04.
* Tumor-specific treatment is necessary between the scans and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy.
* Pregnant or breast-feeding women.
* Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
A Study to Investigate Efficacy and Safety of NSI-8226 in Healthy Participants

A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.


Eligibility Criteria:
Key Inclusion Criteria:

1. At the time of initial screening, in general good health (age 18 to 65 years);

Key Exclusion Criteria:

1. Pregnancy or breastfeeding during the study.
2. Chronic infection - Treatment with prohibited medications.
3. Treatment with prohibited medications
Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.

The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.

Basal cell carcinoma (BCC) of the skin is the most common type of cancer that can be treated with various therapies including surgical removal. A number of factors can lead to the development of multiple BCC of the skin, including genetic disorders (e.g., nevoid basal cell carcinoma syndrome). Treatment of multiple BCC becomes much more challenging. In these trials, the experimental therapy: verteporfin PDT is compared to placebo PDT. PDT or photodynamic therapy in these studies is the combination of the photoactive drug verteporfin (given intravenously) and red light exposure of skin tumors.

The primary objective is to assess whether verteporfin PDT can completely eliminate multiple BCCs. Eligible subjects will have at least 3 BCCs. Study subjects won't know which treatment they have been been assigned to - this is done randomly (like flipping a coin). After study treatment, the BCCs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment. Safety will be assessed by testing blood samples before and after study treatment, and analyzing adverse events and skin reactions to the study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Currently has at least 3 eligible BCC skin tumors that have never been treated
* Is willing to have these tumor sites surgically removed

Exclusion Criteria:

* Has xeroderma pigmentosum
* Has BCC tumors that are the result of prior radiotherapy or immunosuppression due to an organ transplant
* Is immunosuppressed
* Has abnormal liver function
* Is receiving systemic chemotherapy or has received chemotherapy within the last two years
CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

The aim of this randomized controlled trial to investigate the effects of CPAP treatment on myocardial salvage index and clinical outcomes at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI).


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 80 years old
2. First-time STEMI
3. Successful PPCI (≥1 coronary artery) within 24h after symptom onset
4. Moderate to severe OSA (AHI≥15)
5. Written informed consent

Exclusion Criteria:

1. Prior myocardial infarction
2. Prior myocardial revascularization (PCI or CABG)
3. Cardiogenic shock (mean arterial pressure \<60mmHg), severe heart failure (Killip≥3)
4. LM or multivessel disease indicated for CABG
5. History of stroke
6. Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep \<4h/night)
7. Severe COPD: FEV1/FVC \<70% or FEV1 \<50% predicted value (within 4 weeks)
8. Predominantly central sleep apnea (≥25% central events or central AHI ≥10/h)
9. Previous or current use of CPAP
10. Severe comorbidities: eg. malignancy (life expectancy \<2 years)
11. Known or planned pregnancy
12. Known contraindication to CMR
13. Patients with contraindication to CPAP or who cannot tolerate it
14. Participation in other clinical trial in recent 3 months
15. Any condition that in the opinion of investigator that may jeopardize patient compliance, eg. significant memory, perceptual, or behavioral disorder, depression, severe alcohol consumption, or a history of noncompliance
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis

This study evaluates the effectiveness of photobiomodulation (PBM) in conjunction with mineral trioxide aggregate (MTA) pulpotomy for treating irreversible pulpitis in immature first permanent molars. PBM, also known as low-level laser therapy (LLLT), is used to enhance healing, reduce inflammation, and manage pain in young teeth. The randomized clinical trial involves 72 children aged 6-9 years, divided into two groups: one receiving MTA pulpotomy alone and the other receiving MTA pulpotomy with PBM. Clinical and radiographic outcomes will be assessed at intervals over 15 months. This research aims to determine the combined therapy's efficacy in improving pulp healing and reducing post-operative discomfort compared to MTA alone.

This randomized controlled trial evaluates the clinical and radiographic outcomes of MTA pulpotomy, with and without PBM, for immature permanent molars diagnosed with irreversible pulpitis. The study includes two parallel groups of 36 children each. Group I will undergo MTA pulpotomy alone, while Group II will receive PBM treatment alongside MTA pulpotomy.

PBM employs low-level laser therapy to stimulate pulp tissue regeneration, enhance mitochondrial activity, and reduce inflammation and pain, thereby potentially improving MTA pulpotomy outcomes. Key inclusion criteria involve children with deep carious lesions and clinical signs of irreversible pulpitis but without pulpal necrosis. Follow-up will occur at 3, 6, 12, and 15 months post-treatment to evaluate success based on the absence of clinical symptoms (e.g., pain, tenderness) and radiographic indicators of healing.

By comparing these two approaches, the study aims to provide insights into PBM's role as an adjunctive therapy for vital pulp preservation, particularly in pediatric dentistry.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 9 years.
* Non-contributory medical history (healthy otherwise).
* Presence of carious first permanent molars with the following characteristics:
* Deep caries extending to ≥2/3 of dentin.
* Positive response to cold testing.
* Clinical diagnosis of irreversible pulpitis (moderate or severe), with or without periapical periodontitis.
* Restorable tooth.
* Probing pocket depth and mobility within normal limits.
* No signs of pulpal necrosis, including sinus tract or swelling.

Exclusion Criteria:

* Insufficient bleeding after pulp exposure (indicating necrotic or partially necrotic pulp).
* Presence of systemic or medical conditions that may contraindicate participation.
* Teeth with unrestorable structure.
* Teeth showing signs of pulpal necrosis, such as the presence of a sinus tract or swelling.
Interventions to Prevent Falls. PRECAISAL Study

This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home.

Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.

The study tries to assess whether a group intervention following the principles of the LiFE program is no less effective than individual intervention in reducing the incidence of falls.

Eligibility Criteria:
Inclusion Criteria:

* Older than 70 years
* Live at your address
* Are at risk of falls
* Timed Up and Go Test time timed ≥ 12 seconds
* Able to walk 200 meters without personal assistance
* Speak and read in Spanish

Exclusion Criteria:

* Perform moderate to vigorous physical activity\> 150 min / week in the last 3 months
* Present any of the following medical conditions:

  * Heart failure (New York Heart Association class III and IV)
  * Recent stroke (\<6 months)
  * Parkinson's disease
  * In active cancer treatment (last 6 months)
  * Class III and IV chronic obstructive pulmonary disease
  * Unstable fracture of the lower limb
  * Lower limb amputated
  * Treatment for less than 6 months of depression
  * Uncontrolled resting blood pressure of a systolic pressure\> 160 or a diastolic pressure\> 100 or more
  * Not being available for home visits within 11 weeks of the initial assessment: having planned trips or transfers of more than 2 months within the first 6 months of the study
  * Moderate to severe cognitive impairment (Mini Mental cognitive assessment \<23)
  * Current participation in another scientific intervention trial.
Impact of IBD Activity on Frailty in Patients Over 60 Years

The goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of IBD activity on frailty in a prospective and longitudinal cohort of patients with IBD, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.

The main questions it aims to answer are:

1. Can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease?
2. Which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? At inclusion, clinical frailty indices will be calculated. Additionally, clinical variables related to IBD and comorbidities will be recorded. During follow ups visits frailty, comorbidities, IBD activity, changes in medical treatment for IBD, adverse effects, hospitalizations, and mortality will be reassessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥60 years with IBD (Crohn's disease or ulcerative colitis) diagnosed according to ECCO criteria and under follow-up in the IBD units of participating centers.
* Initiation of medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and/or biologics) due to clinical activity based on PRO2 scales (UC: PRO \>4; CD: PRO2 \>14) and/or biological activity (fecal calprotectin ≥500 mg/kg, C-reactive protein ≥10 mg/L).
* Signed informed consent for inclusion.

Exclusion Criteria:

* Lack or withdrawal of informed consent.
* Unclassified/indeterminate colitis.
* Change in medical treatment solely due to adverse events.
* Initiation of treatment only with salicylates and/or topical steroids for disease activity.
* Treatment intensification to manage disease activity.
* Patients with an ostomy.
* Comorbidities with a life expectancy of less than one year.
Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs. AZOPT dosed BID in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 YOA or older
* Either gender or any race
* OAG or OHT
* Currently on stable (at least 4 weeks) IOP lowering medication
* IOP at screening visit â‰¥ 18mmHg in at least one eye
* Mean IOP in same eye (at both eligibility 1\&2 visits
* 24 and 36 mmHg at 9AM
* 21 and 36 mmHg at 11AM and 4PM
* Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1

Exclusion Criteria:

Related to disease condition being investigated (OAG or OHT) in either eye

* Severe central visual field loss
* Angle shaffer grade \< 2
* C/D ratio \>0.8(horizontal or vertical measurement)

Related to ocular patient history or current ocular condition in either eye

* BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
* Ocular infection or inflammation or laser surgery within the last 3 months
* Intraocular surgery or trauma with the last 6 months
* Any abnormality preventing reliable applanation tonometry
* History or chronic, recurrently or current severe inflammatory disease
* History of or current clinically significant or progressive retinal disease
* History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study

Related to systemic or ocular medication in either eye

* Allergy/hypersensitivity to study medications
* Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period
* Use of oral CAIs during the study
* Recent use (\<4 weeks prior to the study) of Aspirin (\>1 gram)
* Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP
* Therapy with another investigational agent within 30 days prior to the Screening Visit
Elsamitrucin (SPP 28090) in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the safety of an experimental drug called Elsamitrucin in people with non-Hodgkin's lymphoma and to see if it can shrink their tumors. Elsamitrucin has not been approved by the Food and Drug Administration (FDA). However, the FDA is permitting the use of this drug for this study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NHL both B and T-cell that is refractory to or has relapsed after standard therapy or for which there is no known effective treatment.
* CT or MRI scans confirming measurable tumor size (lymph node must be \>1.0 cm in its longest transverse diameter). Measurement by PE is acceptable, in the case of palpable and reproducibly measurable tumors. Patients with CLL/smal lymphocytic lymphoma are eligible without bidimensional measurable disease.
* ECOG Performance Status 0-2
* Age greater or equal to 18 years of old
* AGC greater or equal to 1.0; platelets greater or equal to 75,000;Ggb greater or equal to 9.0. (Lower values may be accepted for cytopenias due to bone marrow involvement by lymphoma, after discussion with sponsor)
* Bilirubin less or equal to 2.0; SGOT and SGPT less of equal to 3 times upper limit of normal
* Creatinine \<1.5; BUN \<25
* Expected survival \>6 months

Exclusion Criteria:

* Prior therapy with Elsamitrucin
* Any therapy for lymphoma, including chemotherapy, antibody therapy, RT, or any investigational therapy within 28 days prior to study drug administration
* Steroid therapy within the last 4 weeks prior to study drug administration
* Evidence of clinically significant uncontrolled condition/s and/or is considered by investigator to be unable to tolerate the required therapy or procedures
* Known AIDS syndrome or HIV-associated complex (severely depressed immune system)
* Prior or other current malignancy within 5 years, except for adequately treated cone-biopsied in-situ cervical cancer or resected basal cell or squamous cell skin cancer
* Any current medical or psychiatric disease that would prevent informed consent and expected cooperation of the patient for therapy and follow-up
* Pregnant or lactating women.
Motivational Interviewing for Stroke

Motivational interviewing (MI) is a style of communication designed to elicit a person's own reasons for change to drive commitment toward a goal. The goal of this study is to assess the effect of trainee-led MI on patients diagnosed with acute stroke or TIA attributable to modifiable risk factors in comparison to conventional post-stroke counseling, based on patient outcomes, and meaning of work and sense of fulfillment for trainees.


Eligibility Criteria:
Inclusion Criteria:

* Patient presentation consistent with a stroke or TIA
* Patient is a current tobacco user and tobacco use contributed to the stroke
* Resident enrolled in study assigned to Vascular Neurology service during patient admission.

Exclusion Criteria:

* Patient unable or unwilling to follow up in the outpatient stroke clinic after discharge
* Patient has cognitive impairment or aphasia that would preclude meaningful participation in motivational interview (defined as a score of 0 on the National Institute of Health Stroke Scale \[NIHSS\] questions 1 and 9)
Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)

This study is a multicenter cohort study including patients diagnosed with tricuspid regurgitation during hospitalization. The primary outcome of the study is all-cause death, and the secondary outcome is cardiovascular events. The prognostic risk factors of patients with tricuspid regurgitation are evaluated, and the prognostic models are constructed through the follow-up observation.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 yrs.
* Patients diagnosed with tricuspid regurgitation during hospitalization.

Exclusion Criteria:

* Patients unable to provide informed consent.