cyrilzakka/clinical-trials huggingface dataset:
Role of Diffusion -Weighted MRI in Evaluation of Urinary Bladder Masses

Urinary bladder cancer is a common malignant tumor of the urinary tract in both men and women. Proper management of the urinary bladder cancer depends on the stage of the lesions.

Differentiating the histopathological types, tumor grade and the depth of tumor invasion are very important for determining the therapeutic approach and are highly correlated with the recurrence, progression and patient's survival.

Radical cystectomy (RC) and lymphadenectomy after neoadjuvant chemotherapy is the standard treatment for muscle invasive tumors, whereas the treatment of choice for non-muscle invasive tumors is transurethral resection (TUR) ±chemo/immunotherapy.

Cystoscopy with biopsy is still the best tool for bladder cancer staging due to its high sensitivity in detecting lesions and the possibilities of tumor resections, but the main drawbacks are invasiveness, limitation in detection of flat lesions, and lack of the assessment of extra-vesical tumor invasion. Modern diagnostic modalities circumvent these limitations like blue-light cystoscopic examination and infrared cystoscopy.

For the radiological evaluation of the urinary bladder, magnetic resonance imaging (MRI) is a valuable imaging modality due to high tissue contrast and multiplanar imaging capabilities.

Diffusion-weighted images provides useful information for evaluation of local T stage of the urinary bladder cancer, specially in differentiating T1 stage or lower tumors from T2 stage and higher tumor stages.

Apparent diffusion coefficient (ADC) delineating the degree of water molecular diffusion and the degree of restriction to water diffusion in biological tissues is inversely correlated to the integrity of the cell membranes and the tissue cellularity.

The apparent diffusion coefficient (ADC) value has been revealed as quantitative measure of the degree of malignancy of the lesions. Decreased ADC values were reported with malignant lesions which have a larger cell diameter and more cellularity than normal tissue.


Eligibility Criteria:
Inclusion Criteria :• Age, any age will be included

* Sex, both genders are included.
* Patient presenting with heamaturia or intractable cystitis and urinary bladder mass lesions detected on ultrasound and/or CT examinations (with contrast).

Exclusion Criteria:

• General contraindications to MR imaging (pacemaker, metallic prostheses and clostrophobia).
Project Resurgence Communication Trial

Randomized, double-blind, of standard of care vs additional communication and factorial design of intervention letter vs. control letter and EHR vs mail delivery mechanism in patients who canceled visits and did not reschedule over a 90 day period starting March 9, 2020.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a cancellation or failure to show for a procedure or visit from March 9, 2020 through June 7, 2020 (90 days) and who have not rescheduled as of the date of randomization

Exclusion Criteria:

* Death
Determination of Gentamicin Dosing in Neonatal Patients

The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.

This study aims to verify dosages of gentamicin for use in Uniject, chosen based on a consideration of gentamicin pharmacokinetics, safety, efficacy, target population body weight, cost, feasibility and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* infants with culture proven sepsis
* infants 2000-2499 at birth
* infants \> 2500 gm at birth
* infants \< 2000 gm at birth
* in study site areas: Pakistan, Bangladesh and India

Exclusion Criteria:

* infants w/o culture proven sepsis
Impact of the Use of VERT on Body Image After Bariatric Surgery

The purpose ot the study is to assess the effectiveness of the use of VERT on improving body image at 12 months in patients who underwent bariatric surgery in the weight stabilization phase (between 18 and 30 months after bariatric) presenting dissatisfaction with their body image compared to standard follow-up in post-bariatric surgery (lack of specific management of body image).

Virtual reality therapy makes it possible to work on the integration of proprioceptive information via the reproduction of environments close to reality and therefore allow the patient to accept his new identity. This tool is used in an increasing number of indications and in particular in the management of dysmorphophobia in patients suffering from anorexia nervosa. In the context of bariatric surgery, only case reports have been published so far. Significant improvements in the body satisfaction scores of patients have been showed, in patients who had undergone bariatric surgery who presented bodily dissatisfaction after 6 weeks of virtual reality. However, larger numbers, longer follow-up periods and more rigorous methodologies are needed to confirm the impact of this practice. The hypothesis of the study is that virtual reality therapy could improve body image in patients who are dissatisfied with their body image after bariatric surgery.

Eligibility Criteria:
* inclusion criteria: patients who underwent bariatric surgery in the weight stabilization phase (between 18 and 30 months after surgery) presenting dissatisfaction with their body image according to the BSQ (score ≥ 111), to be affiliated to the French social security system. The prior, free and informed consent of the patient shall be obtained.
* exclusion criteria: patients with disabling nausea (Motion Sickness) from previous use of a virtual reality headset, patients who had from post-bariatric reconstructive surgery, epileptic patients, decompensation of a psychiatric pathology
Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams

To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very low energy aerated beverage with normal energy aerated beverages in healthy subjects.

The primary objective of this study is to assess if a very low energy foam has the same effect on satiety as the same volume of a reference normal energy foam, by testing for equivalence of these two foams. Treatment equivalence, is met if the 90% confidence interval (CI) of between-treatment differences in appetite AUC is within the range of -5 to +5 mm/min of the reference . Two other normal energy foams with slightly different compositions are also compared to the reference foam to test for possible effects of differences in composition (carbohydrate type, emulsifier) other than energy per se.

On each test day, volunteers will arrive at the clinic in a fasted state where they consume a standardized 250 kcal breakfast. Subjects receive one of the four test products 2.5 hours after start of breakfast and consume 400 ml of the test products with a spoon within 10 minutes. Each subject will be randomized to a treatment order according to a balanced (Williams type) design, and receive one of four test products each week for 4 weeks, separated by a one-week washout period (consumed on the same week day).

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 30 kg/m² (inclusive)
* Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).

Exclusion Criteria:

* Dislike, allergy or intolerance to test products
* Eating disorder (measured by SCOFF questionnaire, \> 2 "yes" responses)
* High or very high restrained eater measured by Three factor eating questionnaire TFEQ, restriction score \> 14
* Reported medical treatment that may affect eating habits/satiety
Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Habitually wearing Biofinity contact lenses.
* Monovision contact lens wearers.
* Other protocol-specified exclusion criteria may apply.
Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

The purpose of this study is to determine the influence of specific eye acupuncture to the ocular microcirculation in diabetic and healthy subjects.

Diabetes is combined with severe vascular damage at the different stages of the disease, causing reduction in retinal perfusion. Acupuncture is supposed to regulate the perfusion. We propose a study to evaluate the effect of acupuncture to the vascular auto regulation in patient with Diabetes, compared to healthy people without vascular or retinal diseases. The perfusion of the retinal vessel will be examined by Retinal vessel analyzer (RVA), Heidelberg retinal Flowmeter (HRF) and the Ocular blood Flowmeter (OBF) before, during and after standardized specific acupuncture at healthy volunteers and patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* persons over 18 years, men or women, diabetic diagnostics within the last year

Exclusion Criteria:

* medical use of anticoagulative substances, use of dorzolamide, use of immunosuppressive medication
* psychiatrics, epileptics
Hand OA AND Methotrexate Use

Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists. Synovitis has been demonstrated in hand OA imaging. Synovial inflammation due to the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.

The aim of the present study is to assess the efficacy of MTX in decreasing pain and inflammation in symptomatic hand OA.

Methods: One hundred and twenty patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with hand pain, \[\>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization\] for \> 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=60) or placebo (n=60) together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.


Eligibility Criteria:
Inclusion Criteria:

* primary knee osteoarthritis
* persistent pain
* synovitis

Exclusion Criteria:

* rheumatoid arthritis
* gout and pseudogout
* traumatic arthritis
* other secondary arthritis
* renal disease
* liver disease
Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization

Bladder catheterization is a procedure frequently performed in emergency departments and may cause symptoms such as pain and discomfort in patients. This study hypothesizes that lidocaine spray application will improve patient compliance and comfort from the outset and facilitate smoother medical procedures. In our prospective, case-controlled study, the patients were divided into two groups: Group L (lidocaine) and Group P (placebo). Pain conditions after bladder catheterization were evaluated at 0 minutes (during the procedure) and 15, 30 and 60 minutes after the procedure. Face Legs Arm Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used. All time periods in Group L, FLACC score and Wang Baker scores were found to be statistically significantly lower.The differences between the first measurement and the measurements at 15-30-60 minutes of the FLACC score were found to be significantly higher in group P than in group L. As a result, we recommend that lidocaine spray be applied before urinary catheter insertion. This study showed that lidocaine spray increased patients\&#39; sleep at the end and reduced the feeling of restlessness by reducing pain.


Eligibility Criteria:
Inclusion Criteria: The study included male patients over 18 years old, without trauma, with spontaneous urine output, and who were oriented and cooperative. -

Exclusion Criteria: Exclusion criteria were patients under 18 years old, female patients, patients with trauma, patients with globe vesicale (due to the need for rapid bladder catheterization), patients with anatomical variations, patients with urethral-bladder outlet problems preventing catheterization, and patients who refused to participate in the study.

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Educational Video for Improving Follow-up After an Emergency Department Visit for Asthma

The study will assess the efficacy of a three-part Emergency Department (ED)-based "Asthma Belief and Control" intervention on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an Emergency Department visit.

Inner-city children are particularly at risk for poor asthma treatment outcomes and frequently obtain their asthma care in the ED. Prior studies have had limited success in improving primary care follow-up, quality of care, and long-term outcomes after a pediatric ED visit for asthma. Prior ED-based interventions have been designed to address barriers to follow-up with a primary care provider (PCP) such as an inability to obtain a follow-up appointment or lack of transportation. Focus groups and surveys of inner-city families have found that beliefs about the benefits of follow-up care and the role of preventive asthma medications have a strong impact on adherence to therapy.

This study will develop a brief educational video about the benefits of follow-up asthma care using a multi-disciplinary panel of experts at the Children's Hospital of Philadelphia and focus groups of parents of children with asthma. This educational video will then be combined into an intervention along with symptom screening and a reminder phone call that has been demonstrated to improve follow-up rates in a previous study. The combined intervention will be tested using a randomized trial design to determine its efficacy on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an ED visit. The research is conducted as part of a research career development award.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-18 years
* History of Asthma:
* At least 2 prior episodes of bronchodilator treatment
* No underlying cardiac disease
* No other chronic lung disease
* Residence within Philadelphia city limits
* Discharged from ED after treatment for asthma

Exclusion Criteria:

* Prior study enrollment
* Parent unable to speak English
* No telephone to be reachable for follow-up calls
National Registry for Ichthyosis and Related Disorders

The ichthyoses are a family of genetic skin diseases characterized by dry, thickened, scaling skin. Dermatologists estimate that there are over twenty varieties of ichthyosis, with a wide range of severity and associated symptoms. This registry is designed to identify people in the United States with the ichthyoses and other related disorders and to collect information about their skin ailment and how it has affected them. The database is available for review by approved research applicants. The registry is confidential and provides investigators a way to share information about studies and trials with potential participants while maintaining participants' privacy.

Although the Registry is closed to new enrollment, it is still maintained in order to provide information related to understanding the diagnosis, pathophysiology, and treatment of ichthyoses. Support for studies continues and inquiries from investigators are welcomed.

The purpose of this registry is to support studies aimed at determining the cause of the ichthyoses and treating them more effectively. The Registry offers blinded information about well-characterized groups of individuals with specific diagnoses for study by skin biologists, pharmacologists, and others. The Registry also provides information about research projects to those that have enrolled in the Registry and expressed an interest in participating in studies.

Participants enrolled in the Registry by contacting the registry officials. All participants participated in a phone interview with the study research nurse. Participants were asked about diagnostic testing, treatments, birth history, medical history, degree and type of involvement, current physical condition, and other family members with skin disorders. A quality of life index was embedded in the interview. Participants also indicated whether they would like to be contacted about participating in clinical research. This information was complemented by an enrollment form from the enrollee's caregiver.

Diagnosis was confirmed by specific criteria based on clinical involvement, review of histology, and where appropriate, serum cholesterol sulfate determination or DNA analysis.

Eligibility Criteria:
Note: Accrual into this study has been discontinued as of 03/31/04.

Inclusion Criteria:

* Diagnosis of one of the ichthyoses, erythrokeratodermas, Darier disease, Hailey-Hailey disease, palmar-plantar keratodermas, pachyonychia congenita, extensive epidermal nevi, or related disorder

Exclusion Criteria:

* Ichthyosis Vulgaris
Health Literacy and Digital Health in Cancer Patients.

This is a multicentric, prospective, observational, transversal study, aiming to evaluate the health literacy of cancer patients using the approved French version of the Functional, Communicative and Critical Health Literacy (FCCHL) scale in 2 populations:

* Population A: patients age 65 and over treated in an oncology or oncogeriatric outpatient clinic, or seen in an oncology or oncogeriatric consultation.
* Population B: young patients age 18 to 64 treated in an oncology or outpatient clinic, or seen in an oncology consultation.

The following questionnaires:

* Approved French version of the FCCHL scale
* Questionnaire on the use of digital tools adapted from the questionnaire on digital tools,

will be completed once only. It will be completed by the participant during the oncology or oncogeriatric consultation or outpatient clinic appointment, in self-questionnaire mode or face to face, assisted if necessary by a family member or member of the medical team.


Eligibility Criteria:
Inclusion Criteria:

1. Man or woman.
2. Age ≥ 18 years.
3. Patient treated for cancer.
4. Patient who can read and understand French.
5. Patient seen in an oncology or oncogeriatric consultation or treated in an outpatient clinic.
6. Patient in treatment or about to start treatment that has been offered to them, from the announcement consultation to 2 years after the start of treatment

Exclusion Criteria:

1. Patient hospitalised for longer than 24 hours.
2. Patient with know cognitive impairment preventing them from answering the questionnaire.
Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion

Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)


Eligibility Criteria:
Inclusion Criteria:

* 1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
* 2) received a radical operation for their primary tumor and regional lymph nodes,
* 3) received chemo-radiation or radiation in pelvic before CIRT,
* 4) received re-irradiation by CIRT after their pelvic radiotherapy.

Exclusion Criteria:

* 1) received more than once prior radiotherapy in the same treatment field,
* 2) time to the last radiotherapy was \<1 year,
* 3) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (\<5 mm).
Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)

Little is known about affection of small airways in patients with pulmonary hypertension as well as the ideal diagnostic approach. The investigators therefore aimed to evaluate novel or not widely used lung function tests for the evaluation of airway function in patients with PH.


Eligibility Criteria:
Inclusion Criteria:

* known or first diagnosis of PH

Exclusion Criteria:

* inability to perform lung function testing
* unable or unwilling to participate
Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. The study aim to Evaluate the Safety and efficiency of Using the neoadjuvant therapy with Carilizumab and Apatinib in patients with Recurrent High-Grade Glioma.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Age 18-70 years old, both male and female.
3. After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma.
4. Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator.
5. KPS score ≥60；
6. Life expectancy \>12 weeks.
7. Adequate organ function defined by:

   1. HGB≥110g/L；
   2. WBC≥3.0×109/L；NEUT≥1.5×109/L；
   3. PLT ≥75×109/L；

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   1. BIL≤1.5ULN；
   2. ALT and AST≤2.0×ULN；
   3. creatinine \< 1.5 x ULN or estimated creatinine clearance≥50ml/min（using the Cockcroft-Gault formula）

Exclusion Criteria:

1. Presence of extracranial disease.
2. Previous treatment with a PD-1, PDL-1 or CTLA-4，VEGFR targeted therapy.
3. Pregnant or breastfeeding patients.
4. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.
5. Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
6. History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
7. Known drug or alcohol abuse.