cyrilzakka/clinical-trials huggingface dataset:
Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP

The investigators aim to investigate two major so far unresolved topics in CRSwNP research: (1) Thorough functional and molecular characterisation of barrier function in patients suffering from CRSsNP and CRSwNP and (2) effect of dupilumab treatment on barrier function in polyp patients. This will be achieved in patient-derived samples by employing measurement of barrier function in primary cell cultures in combination with a mass cytometry based imaging approach, transcriptomic analysis as well as cytokine and microbiome data of individual patients.

Primary objective 1: Characterization of differences in barrier function of the nasal epithelium in patients suffering from CRSsNP, CRSwNP with and without asthma or N-ERD (in absence of therapy with monoclonal antibodies). T Primary objective 2: Effect of dupilumab treatment on barrier function of the nasal epithelium in patients suffering from CRSwNP with and without asthma or N-ERD.

Eligibility Criteria:
Inclusion Criteria:

* 18-99 years of age
* Willingness to participate in the study
* Suffer from chronic rhinosinusitis defined as in EPOS 2020 criteria, see main text
* Group 1 (n=20, CRSsNP): Absence of nasal polyps
* Group 2 (N=60, CRSwNP): Presence of nasal polyps as confirmed by endoscopy or CT and planned therapy with dupilumab
* Presence or absence of non-steroidal anti-inflammatory drug (NSAID)-Exacerbated Respiratory Disease (N-ERD)
* Patients with a history of treatment with monoclonal antibodies will only be included if at least a washout period of 6 months has passed

Exclusion Criteria:

* Pregnancy (as determined by ß-HCG test) or breast feeding
* Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity
* Patients with cystic fibrosis or primary ciliary dyskinesia
* Patients with permanent immunosuppression
* A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Patients with clinically meaningful comorbidity as determined by the evaluating committee
* Patients with a history of exacerbation of chronic rhinosinusitis 4 weeks prior to the screening visit
* Intake of a burst of systemic corticosteroids for the treatment of CRS 4 weeks prior to the screening visit
Management of Robertsonian Translocation PGT-SR Attempts

to analyze if a probe strategy choice for PGT-SR studies of Robertsonian translocations (RT) influences the fate of embryos? Few studies discussed the importance of probe choices. However, those who did, demonstrated that analysis with locus specific probes improve a diagnosis of dubious results, and addition of a centromeric probe could affect the accuracy of diagnosis


Eligibility Criteria:
Inclusion criteria:

* Adult patient whom carrying robertsonian translocations in the context of PGT-SR management
* age \> 18 years

Exclusion criteria:

- age \< 18 years
Intravenous Lidocaine in Carcinologic ENT Surgery: A Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (ELICO)

Lidocaine, local anesthetic used for more than five decades, is being intravenously administered aiming at managing pain in different types of surgeries with promising results. Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to the difficulty of locoregional anesthesia and high level of opioid consumption.

This randomized study aims to compare quality of perioperative analgesia after infusion of intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to evaluate morphine consumption during the 48 postoperative hours.

Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months after carcinologic ENT surgery, and incidence of side effects that can be attributed to lidocaine infusion.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing major carcinological ENT surgery (total laryngectomy, oropharyngectomy with or without mandibulotomy, crico-hyoido-epiglotto-pexy, intraoral extended resection, partial laryngectomy, partial pharyngectomy, extended pelvectomy, pelviglossectomy, with or without pectoralis major flap or free flap, with or without lymphadenectomy)
* Patient receiving standardized Patient Controlled Analgesia (PCA)
* Written informed consent

Exclusion Criteria:

* Hypersensitivity to local anesthetics of the amide group,
* Acute porphyria
* Atrioventricular conduction disorders requiring permanent electro-systolic
* Epilepsy not controlled by treatment
* Hepatocellular insufficiency (PT\<50%) or cirrhosis
* Systolic heart failure (LVEF \<50%)
* Major inflation State
* Hypersensitivity to any component of Glucose 5%
* Treatment with beta-blockers or antiarrhythmic of Vaughan Williams classification
* BMI \> 30kg/m2
* Patient already treated for chronic pain with level 3 analgesic or for neuropathic pain
* Pregnant or lactating women
* Refusal to give consent
* Patient under legal protection measure
PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

A randomized controlled split-face pilot study was planned to investigate the preventive effect of tretinoin 0.05% cream on hyperpigmentation during phototherapy in patients with vitiligo.

Vitiligo is a chronic depigmentation disorder characterized by well-demarcated white macules and patches, reflecting selective melanocyte destruction. Hyperpigmentation at the treated areas is one of the limitations of phototherapy. Topical tretinoin (retinoic acid) has been well established to be effective for skin pigmentary disorders including melasma. This study aims to investigate the preventive effect of topical tretinoin on hyperpigmentation during phototherapy. A randomized controlled trial based on split-face was planned. The left/right face will be randomized to either tretinoin or placebo cream treatment groups. All lesions will be treated using phototherapy twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age: older than 19
* A patient with stable non-segmental vitiligo
* A patient with symmetrical vitiligo lesions on face
* A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
* A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria:

* Age: lower than 20
* A pregnant or lactating patient
* A patient with active or spreading vitiligo
* A patient who cannot understand the study or who does not sign the informed consent
* Women of childbearing potential not using an effective method of contraception properly
The Massachusetts General Hospital Optical Coherence Tomography Registry

Information will be collected prospectively in about 3,000 patients having Optical Coherence Tomography during cardiac catheterization. Subjects will be initially enrolled at sites outside of the United States, where Optical Coherence Tomography is approved by regulatory agencies. Subjects will be followed for up to 5 years.

This project will create a prospective registry of 3,000 patients with follow-ups of up to 5 years.

The aims of the project will be:

1. identify plaque characteristics on OCT that are associated with adverse cardiac events including myocardial infarction
2. to identify characteristics of stented arteries that are associated with adverse events including restenosis and stent thrombosis

Because detailed clinical, angiographic and intravascular imaging data will be gathered from a large number of patients with clinical follow-ups, we anticipate that the registry will be a tremendous resource for additional research questions going forward.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have had OCT imaging performed during cardiac catheterization and have provided written consent

Exclusion Criteria:

* None
Cardiaplication: A Novel Antireflux Operation

Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of medical therapy, many children are referred for surgical intervention. Techniques have evolved over the last 50 years; however, benefits in children remain the center of debate in many surgical forums. This is primarily owing to the high incidence of recurrence of reflux and need for revisions later in life. Some clinicians theorize that the pathophysiology of reflux in infants is different from that of the population at large, and that the traditional operation may not be the best suited for this patient population. We propose a study to test an alternative plication technique for modifying the gastro-esophageal junction at the Angle of Hiss. By plicating the cardia of the stomach, we hypothesize that we will create a valve which will limit reflux without disrupting the diaphragmatic crura, thus reducing the incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are too tight.


Eligibility Criteria:
Inclusion Criteria:

* Patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory GERD.

Exclusion Criteria:

* Inability to obtain consent
* Surgeon preference
Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers

This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have four Japanese grandparents who were born in Japan.
* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
* BMI of 17.5 to 27.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of personally signed and dated informed consent document.
* Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
* Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Screening blood pressure \>140/90 mm Hg.
* Screening laboratory abnormalities as defined by the protocol.
* Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability of the participant's legally authorized representative (e.g. their parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
* Weight \>=3.5 kg at the time of screening.
* Severe hemophilia A defined as less than (\<) 1 IU/dL (\<1%) endogenous FVIII documented in the medical record or as tested during the Screening Period.

Key Exclusion Criteria:

* Any exposure to blood components, factor VIII replacement products, including commercially available rFVIIIFc at any time prior to or during screening.
* History of positive inhibitor testing. A prior history of inhibitors was defined based on a patient's historical positive inhibitor test using the local laboratory Bethesda value for a positive inhibitor test (ie, equal to or above lower level of detection).
* History of hypersensitivity reactions associated with any rFVIIIFc administration.
* Other coagulation disorder(s) in addition to hemophilia A.
* Any concurrent clinically significant major disease that, in the opinion of the Investigator, would make the participant unsuitable for enrollment.
* Current systemic treatment with chemotherapy and/or other immunosuppressant drugs.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer

The purpose of this study is to determine the safety and efficacy of the concurrent use of erlotinib and radiation therapy in the treatment of locally advanced non-small lung cancer.

Non-small cell lung cancer (NSCLC) is still the leading cause of cancer death world-wide. Radiation therapy (RT) is one of the most important treatment choices in locally advanced NSCLC. Combination of RT and chemotherapy could improve treatment outcomes. However, the combined modality could not be used in many patients due to severe toxicities. EGFR-TKI shows great efficacy in the treatment of NSCLC, and many phase I/II studies established its safety in combination with RT. This phase II study is to further evaluate the efficacy and safety of the combination of RT and erlotinib in the treatment of locally advanced NSCLC. Eligible patients include patients with stage IIIA/IIIB NSCLC, who are not suitable for or refused to receive concurrent chemoradiotherapy. Eligible patients will receive oral erlotinib (150mg qd)throughout the course of thoracic RT (60-70 Gy). The primary endpoint is progression free survival and the second endpoints are overall survival and any grade III and above toxicities. We are going to recruit 50 patients for this study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years，
* Patients with stage IIIA-IIIB NSCLC
* adequate hematologic (WBC and platelet counts within normal limits), hepatic (total bilirubin level \<= two times the upper limit of normal), and renal (creatinine clearance \>= 50mL/min) functions
* No history of chemotherapy or less than 4 cycles neoadjuvant chemotherapy
* Can not tolerate or refuse concurrent chemoradiotherapy
* No history of thoracic RT
* Written informed consent obtained

Exclusion Criteria:

* With other malignancy
* With severe cardiopulmonary disease
* Compromised liver or renal function that could not tolerate the combined therapy
* Received thoracic RT before
* Pregnant or breast-feeding women
* Present with active infection
* Uncontrolled diabetes
* Concurrent use of other anti-cancer agents
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.

In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. The primary end point was the proportion of patients who had a reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).

Eligibility Criteria:
Inclusion Criteria:

* men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS)
* increased intestinal permeability on Lactulose/Mannitol permeability test
* able and willing to cooperate with the study
* \*absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and throughout the study duration

Exclusion Criteria:

* current participation in another research protocol or unable to give informed consent
* women with a positive urine pregnancy test or breastfeeding
* history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue
* + hydrogen breath test for bacterial overgrowth
* + antiendomysial antibody titer
* use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study
* known allergy to glutamine
* abdominal surgery except for removal of gallbladder, uterus, or appendix
* Abnormal blood urea nitrogen(BUN) and/or creatinine
A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China

The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose bladder cancer by comparing with clinical standard method (includes medical imaging (MRI, CT, etc.), cystoscopy, pathological examination).

In this clinical trial, the testing kit to be evaluated is a Human Multigene Methylation Detection Kit (Fluorescent PCR Method), which is intended to qualitatively detect methylation levels of multiple genes in human urine specimen in vitro by Fluorescent PCR Method, and the standard method used in clinical diagnostic includes medical imaging, cystoscopy, pathological examination.

Subjects will provided urine specimen as required for the evaluation of the testing kit followed by a examination of standard method. Technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis.

The results of the testing kit will be compared with the standard method, and the effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for bladder cancer detection under normal clinical use will be assessed through statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Subject must meet all three of the following criteria to be eligible for the study:

  1. Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;
  2. Who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination;
  3. Any subject who is required to meet any of the following conditions:

     1. Who is diagnosed with or suspected of bladder cancer.
     2. Who has high risk factors for bladder cancer (such as engaged in contact with aromatic amines, dyes, rubber, aluminum, leather and other occupations, schistosomiasis infection, family genetic history, smoking, drinking, etc.).
     3. Who has hematuria symptoms (such as cystitis, stones, etc.).
     4. Who has other diseases that can be easily confused with bladder cancer.

Exclusion Criteria:

* Subject with any of the following conditions shall be excluded:

  1. Who has undergone surgery or chemoradiotherapy.
  2. Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.
Abnormalities of Preoperative Ascending Urethrocystography and Outcomes of Living Donor Kidney Transplantation

To evaluate effects of abnormalities in preoperative ascending urethrocystography on the short-term outcomes of LDKT

The incidence of surgical complications after kidney transplantation (KT) has decreased in recent decades due to improvements in surgical techniques and immunosuppression protocols. However, the preoperative abnormalities of the urinary tract may influence the outcomes of KT. Hence, the preoperative evaluation of the urinary tract is a critical step in the KT process to identify the potential risk factors for poor outcomes .

Ascending urethrocystography (AUC) is a key diagnostic tool to assess the integrity and functionality of the lower urinary tract . It provides detailed insights into the bladder, urethra, vesicoureteral valves, and surrounding structures, identifying any abnormalities that could pose risks during or after KT . Understanding this issue is crucial, as certain urological anomalies may predispose patients to complications such as urinary leaks, infections, or delayed graft function, potentially leading to poorer short-term outcomes .

Although AUC is used indiscriminately as a screening test for urological abnormalities, only 6% of all KT recipients may have abnormal lower urinary tract . Few studies have looked at the yield from AUC and attempted to assess objectively whether certain patients could be selected for KT based on a positive result in AUC . Accordingly, the impact of abnormalities detected in AUC on the short-term outcomes of living donor KT (LDKT) remains inefficiently studied .

This is the rationale to conduct this cohort study on patients undergoing LDKT. We hypothesize that the presence of abnormalities in AUC will influence the surgical outcomes and short-term survival rates after LDKT

Eligibility Criteria:
Inclusion Criteria:

* Pediatric and adult patients undergoing LDKT in Assiut Kidney Transplantation Unit.
* Patients with preoperative evaluation by AUC.

Exclusion Criteria:

* Patients with a primary non-functioning graft after LDKT.
* Patients with missing relevant preoperative or postoperative data.
* Patients refusal to participate in the study.