cyrilzakka/clinical-trials huggingface dataset:
Liposomal Lidocaine Gel for Oral Topical Anesthesia

This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.

This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated 2,5 and 5% lidocaine gel formulations on the palatal mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
Suramin in Treating Patients With Recurrent Bladder Cancer

RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.

OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer.
* Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients.

OUTLINE: This is a dose escalation study.

At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity.

Patients are followed at 2-4 weeks.

PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study over 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven recurrent superficial bladder cancer

  * Intermediate prognosis as defined by the following:

    * Recurrent, multiple Ta, T1 carcinoma
    * Multiple (1-7) tumors
    * Tumors resected previously must be histological grade G1 or G2 OR
* Previously treated superficial bladder cancer requiring followup cystoscopy

  * Recurrent disease diagnosed at surgery
* No tumor invasion into muscle or carcinoma in situ

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,500/mm3
* Platelet count at least 150,000/mm3

Hepatic:

* No clinically significant hepatic disease

Renal:

* Creatinine clearance greater than 60 mL/min

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* No history of adrenal insufficiency
* No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or nonmelanoma skin cancer
* No history of difficult catheterization
* No confusion or disorientation
* No other condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent biologic therapy

Chemotherapy:

* No concurrent chemotherapy

Endocrine therapy:

* No concurrent corticosteroids

Radiotherapy:

* No prior radiotherapy to the bladder
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
* At least 4 weeks since prior major thoracic or abdominal surgery

Other:

* Recovered from prior therapy and stable for 4 weeks
* At least 6 weeks since prior intravesicular therapy
* No prior or concurrent investigational drugs
* No concurrent anticoagulants
Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF

Clinical trial about the effect of endometrial scratch on pregnancy rates in patients undergoing a treatment with in-vitro fertilization with donor eggs, when doing the endometrial biopsy during the cycle prior to the embryo transfer.

The aim of this clinical trial is to investigate whether an endometrial scratch during the cycle prior to embryo transfer cycle is effective or not in increasing pregnancy rates. Previous studies about this issue have not shown clear conclusions about the effectiveness of this method.

The endometrial scratch is a simple technique that consists in performing a mild injury to all the internal walls of the uterus with a Pipelle Cournier.

To achieve the trial objective, all participating patients are randomly divided into two groups. Once patients decide to participate in the trial, they are assigned to each group according to the randomization list:

Group A: Patients with transfer of fresh embryos after taking an endometrium biopsy during the previous cycle and then following the conventional preparation protocol.

Group B: Patients with transfer of fresh embryos with the conventional preparation protocol.

Eligibility Criteria:
Inclusion Criteria:

* Female undergoing IVF treatment with donor eggs

Exclusion Criteria:

* Severe male factor ( less tan 2 million spermatozoa per ml )
* Uterine abnormalities
Study of Comprehensive ANd Multimodal Marker-based Cohort of Progressive Supranuclear Palsy(PSP)

The purpose of this cohort study is to develop a reliable biomarker in progressive nuclear palsy (PSP).

Progressive supranuclear palsy is a rapidly progressive neurodegenerative disease without a cure. Thus, the development of a biomarker that reflects and monitors disease severity in PSP is critical for early diagnosis and performing a successful clinical trial. Thus, we will prospectively recruit patients with PSP and collect comprehensive clinical, imaging and blood biomarkers at baseline with longitudinal follow-up for 1 year.

Eligibility Criteria:
Inclusion Criteria for the patient group:

* Age 50 to 80 years, male or female
* Progressive supranuclear palsy (PSP) patients who are diagnosed as Probable, Possible or suggestive PSP with Movement Disorder society diagnostic criteria for PSP (Hoglinger et al., 2017)

Exclusion Criteria for the patient group:

* Subjects with clinically significant psychiatric illness
* Subjects with cancer or severe medical illness
* Lactating, pregnant, or possibly pregnant
* Subjects with small vessel disease (\> grade II) in brain MRI or other structural lesions by causes other than PSP
* Subjects with severe dementia patients (MMSE \< 19 or MoCA \<13 or General deterioration scale \>= 5)

Inclusion Criteria for the healthy control group:

* Age 50 to 80 years, male or female
* Those who agreed to participate in this study

Exclusion Criteria for the healthy control group:

* Those with a history of any neurological diseases
* Lactating, pregnant, or possibly pregnant
* Subjects with clinically significant psychiatric illness
* Subjects with cancer or severe medical illness
Extracellular Volume Associated With New-Onset Atrial Fibrillation

Left ventricular fibrosis is strongly associated with atrial fibrillation (AF). However, the relationship between LV fibrosis and new-onset AF (NOAF) after ST-segment elevation myocardial infarction (STEMI) is currently unknown. This study was to investigate the relationship between different regions of ECV and NOAF during the acute phase of STEMI. ECV in integral (integral ECV), non-myocardial infarction region (NMI-ECV) and myocardial infarction region (MI-ECV) was obtained by CMR.

This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University. All patients underwent CMR during hospitalization, which included T1 mapping sequences. The blood sampling was collected within 24 hours of the CMR examination. Inclusion criteria: 1. Successful pPCI (TIMI flow ≥ 2) within 12 hours after symptom onset; 2. Admission to the cardiac care unit for continuous electrocardiogram (ECG) monitoring after pPCI. Exclusion criteria: 1. Poor image quality; 2. History of myocardial infarction; 3. History of atrial fibrillation; 4. Malignancy, or inflammatory disease; 5. Severe valvular heart disease; 6. Thyroid dysfunction. NOAF was defined as post-admission atrial fibrillation without a history of atrial fibrillation. ECG monitoring revealed a suspicious rhythm during admission, and an immediate 12-lead ECG confirmed NOAF. Infarct-related arteries (IRA) were recorded based on CAG findings. ECV in integral (integral ECV), non-myocardial infarction region (NMI-ECV) and myocardial infarction region (MI-ECV) was obtained by CMR.

Eligibility Criteria:
Inclusion Criteria:

* Successful pPCI (TIMI flow ≥ 2) within 12 hours after symptom onset
* Admission to the cardiac care unit for continuous electrocardiogram (ECG) monitoring after pPCI

Exclusion Criteria:

* Poor image quality
* History of myocardial infarction
* History of atrial fibrillation
* Malignancy, or inflammatory disease
* Severe valvular heart disease
* Thyroid dysfunction
Treatment of Central Sleep Apnoea in Patients With Heart Failure With Nasal High Flow Therapy (nHFT)

To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure (CHF) and central sleep apnea (CSA).

This study is a prospective one armed uncontrolled intervention pilot study investigating 4 weeks of nHFT at home in 10 patients with CHF and CSA.

Study population: 10 CHF patients with a Left Ventricular Injection Fraction(LVEF)\< 45% and CSA/Cheyne Stokes Respiration (CSR) (apnoea/hypopnea index (AHI) \> 15/hour); with at least 50% of the total number of events having a central character will be included. Patients with other diseases that will influence the respiratory system negatively during sleep i.e. chronic obstructive pulmonary disease (COPD Global Initiative of Obstructive Lung Diseases (GOLD) class 3 and 4), neuromuscular diseases and thorax cage deformities, as well as patients with CHF and CSA that use another form of treatment for their CSA at the time of inclusion, will be excluded.

Intervention: nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively.

Main study parameters/endpoints:

1. To investigate the effect of nHFT with and without oxygen in reducing the apnoea/hypopnoea index during sleep after 4 weeks use nHFT.
2. To investigate improvements in oxygen desaturation index, sleep quality and sleepiness, physical condition, left ventricular ejection fraction (LVEF), heart beat variability (HRV), N-terminal natriuretic peptide (NTproBNP) after 4 weeks use nHFT .
3. Physiological condition; work of breathing and respiratory drive and measuring mouth-throat pressure.

Eligibility Criteria:
Inclusion Criteria:

1. Moderate to severe CSA/CSR (AHI\>15), in which CSA is defined when at least 50% of the apnoeas are central apnoeas
2. Heart failure with reduced ejection fraction, defined as a LVEF \< 45% of predicted

Exclusion Criteria:

1. Other diseases affecting respiration during sleep (COPD GOLD 3 or 4, neuromuscular disorders, thorax cage deformities)
2. At the moment of the inclusion, the patient does not have a therapy to treat the CSA, such as continuous positive airway pressure (CPAP), oxygen, bilevel intermittent positive airway pressure (BiPAP) or acetazolamide.
Hemodialysis Access Surveillance Evaluation Study

The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting).

Investigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients undergoing dialysis therapy via an upper extremity arteriovenous access (arteriovenous fistula or an arteriovenous graft) will be enrolled to have monthly surveillance flow measurement using Transonic system or physical examination of the arteriovenous access by qualified person at least once a month for a period of 2 years.

Exclusion Criteria:

* Patients requiring surgical intervention on the arteriovenous access.
* History of access thrombosis (one or more access thrombosis of the current arteriovenous access).
* Patients with signs of access infection.
* Patients with a malignancy.
* Patients with life expectancy of less than six months.
* Unable to understand the study.
* Unable to sign the consent form.
* Patients with psychiatric disorder.
* Age less than 18 or greater than 80 years.
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Pentoxifylline Therapy in Biliary Atresia

The purpose of this study is to determine whether pentoxifylline reduces liver damage in infants with biliary atresia.

Biliary atresia (BA) is a devastating liver disease of infancy of unknown etiology, characterized by bile duct obstruction, live fibrosis, and cirrhosis. BA has no known medical treatments. The only proven treatment is a surgical portoenterostomy (the Kasai procedure, or KP) which can achieve bile drainage and improve outcomes in some cases. The KPs success is variable depending on several factors including age of the infant, experience of the surgeon, and extent of liver fibrosis at the time of KP.

In this study, the investigators conduct a phase II trial of a potential new medical therapy for BA: pentoxifylline (PTX). PTX is a methylxanthine derivative closely related to caffeine that has been used safely in infants with other diseases such as sepsis. In adults, PTX has been shown to have a number of properties beneficial to the liver, including preventing liver fibrosis, improving liver regeneration, and reducing cirrhosis-related complications.

The trial's objective is to determine whether PTX has sufficient biological activity against BA to warrant further study. PTX will be administered orally for 90 days as an adjunct to standard therapy (i.e. KP if appropriate). The primary outcome will measure the change in serum conjugated bilirubin levels after 90 days. Secondary outcomes include changes in body weight, serum markers, liver imaging, and time to liver transplant in infants with BA.

Eligibility Criteria:
Inclusion Criteria:

* 0-180 days old
* Diagnosed with biliary atresia through liver biopsy and/or intra-operative cholangiogram
* No previous Kasai portoenterostomy performed at another institution
* Able to take medications orally
* Legal guardian signs consent after understanding risks and investigational nature of study

Exclusion Criteria:

* Infants greater than 180 days old
* Infants receiving a Kasai portoenterostomy at another institution
* Infants unable to take medications orally
Application of Shock Wave Technique in Conservative Treatment of Rotator Cuff Tear

This study is a prospective cohort study and is a single-center clinical trial. Sample: This study will enroll about 22 patients from the Department of Sports Medicine and rehabilitation outpatient department of Beijing Third Hospital who are diagnosed with rotator cuff tear and choose conservative treatment.

A single-center randomized controlled clinical trial was conducted to compare the effect of ESWT combined with conventional rehabilitation training on patients with rotator cuff tear. To explore the effect of ESWT on the clinical efficacy of patients with rotator cuff tear, and to explore the application of shockwave technology in the conservative treatment of rotator cuff tear. It provides a new treatment idea for patients with rotator cuff tear who choose conservative treatment, promotes tendon healing for patients with partial rotator cuff tear, improves shoulder joint function, and provides a new treatment plan for patients to accelerate their return to life and exercise, and provides a theoretical basis for the clinical application of ESWT.

Eligibility Criteria:
Inclusion Criteria:

* Identify patients with rotator cuff tears and choose conservative treatment
* Able to complete cardiopulmonary exercise tests
* Able to cooperate with rehabilitation training and complete questionnaire survey

Exclusion Criteria:

* Previous shoulder surgery history
* Irreparable rotator cuff damage
* Retear after ARCR
Functional Tests to Resolve Unsolved Rare Diseases. Rares.

Rares diseases are a heterogeneous group of conditions which need important tools for diagnosis.

The use of high-throughput sequencing is able to diagnose half of the patients. For the other part it is impossible to conclude due to the presence of variants of unknown significance (VOUS). Functional analysis are needed to bring strong argument to reclassify variants as pathogenic or benign. The main objective is to evaluate the diagnosis yield of this strategy.

The main objective is the improvement of the diagnosis of rare genetic diseases. The investigator lab is expert for diagnosis of some rare diseases such as neurodevelopmental disorder, albinism, cystic fibrosis and congenital heart defect. Actually with implementation of high-throughput sequencing for diagnosis, a high number of genetic variants are found and need to be interpretated. The ACMG classification is used to classify variants with argument of variant frequency, predicted effect on protein and in-silico prediction. Functional evidence is a strong argument to help classify VOUS. The investigators propose the use of RNA-Seq, minigene and luciferase assay for study of VOUS to bring argument to classify them as benign or pathogenic.

Eligibility Criteria:
Inclusion Criteria:

* Minor and adult patient.
* Registered for the social security system.
* Informed consent signed by patient or parent of a minor patient.
* Patient affected by one of the rare diseases studied (albinism, congenital heart defect, cystic fibrosis, neurodevelopmental disease)
* Patient bearing variants of unknown significance (VOUS)

Exclusion Criteria:

* Refusal to participate in research protocol.
* Patient under administrative supervision
* Pregnant or nursing women
Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus

The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.

The safety and efficacy of ipamorelin in the management of post-operative ileus

Eligibility Criteria:
Inclusion Criteria:

* willing to comply with protocol
* undergoing bowel resection surgery
* ASA Class I-III
* Females must not be pregnant
* Body weight 40-150 kg

Exclusion Criteria:

* mentally incompetent or unable to provide informed consent
* clinically unstable
* significant liver disease
* clinically significant lab or EKG abnormalities
* alcohol or illicit drug abuse
* history of or current surgery that would prevent proper evaluation of safety or efficacy of drug
Immunological Tolerance After Frequent Rabies Booster Vaccinations

To study immunological tolerance effect after frequent rabies booster vaccination

Previous studies had shown lower antibody titers among those who received frequent rabies booster vaccination, compared to ones who had got primary immunization. We study immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cell, and cytokines in those who received frequent rabies booster vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Previously received rabies vaccination

Exclusion Criteria:

* Had immunocompromised conditions
* Received blood or blood product within 3 months
* Received anti-malarial drugs
Speech Therapy and Functional Dysphonia After Thyroidectomy

Following a thyroidectomy, voice and swallowing alterations, which more frequently would appear to be caused by lesions of the laryngeal nerve, may occur. But, voice and swallowing changes can also occur in the absence of lesions of the inferior laryngeal nerve or the external branch of the superior laryngeal nerve, defining a condition called central compartment syndrome or functional post-thyroidectomy syndrome. It has been demonstrated that, in the presence of the aforementioned syndrome, the quality of the voice undergoes a deterioration immediately after thyroidectomy surgery with a lowering of pitch.

The purpose of this study will be to verify the effects of early speech therapy, including pre-operative speech therapy counseling (during which the patient will be provided with indications to be implemented in the immediate post-operative period).


Eligibility Criteria:
Inclusion Criteria:

* awaiting Total Thyroidectomy surgery
* able to sign a written consent

Exclusion Criteria:

* Under the age of 21 or over the age of 65
* Previous vocal cord paralysis
* History of vocal or laryngeal pathologies that have required therapy
* Presence of speech disorders or lung pathologies
* Previous neck surgery
* Presence of malignant diseases
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient

investigator will see the efficacy of tranexamic acid in limb salvage surgery patients which will prevent blood loss and help in conservation of blood products.


Eligibility Criteria:
Inclusion Criteria:

* Limb sarcoma of upper and lower limb
* Limb salvage

Exclusion Criteria:

* liver insufficiency
* renal insufficiency
* allergic to drug
* history of thromboembolic condition
* pregnancy
* metastatic disease
Relationship Between Gestational Diabetes and Type 2 Diabetes

The overall objective of this research project is to study the impact of preventive practices on the T2D-related risk profile among women with and without prior GDM and their children exposed and unexposed to GDM.

Type 2 diabetes (T2D) is a growing public health problem owing to its prevalence as well as its high morbidity and mortality rates. The identification of high-risk populations is of great importance particularly because the onset of T2D can be prevented or delayed by lifestyle modifications. Among high-risk populations, women with previously diagnosed gestational diabetes mellitus (GDM) are at particularly high risk of developing T2D. The success in reducing the occurrence of T2D among women with previous GDM could be achieved only if appropriate preventive measures are undertaken. According to the American Diabetes Association (ADA) and the Canadian Diabetes Association (CDA), lifestyle modifications aimed at reducing body weight and increasing physical activity are recommended and women are encouraged to be breastfeeding their infants. Certain factors have been suggested as determinants of behavioral practices in women with prior GDM including cognitive and environmental factors. A better understanding of these issues is essential for developing effective preventive strategies and possibly reducing the prevalence of T2D in the population. Moreover, in utero exposure to maternal impaired glucose tolerance or diabetes may increase the risk of developing overweight or diabetes in offspring. Since March 2012 we thus test the presence of childhood metabolic alterations predictive of future T2D in GDM-exposed and unexposed offspring and investigate environmental factors during the postnatal period that are associated with prevention of metabolic alterations.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥18 years with or without a diagnosis of GDM in the past 3-12 years and their children.

Exclusion Criteria:

* Pregnant women, women with type 1 diabetes.