cyrilzakka/clinical-trials huggingface dataset:
3 Tesla MRI in Patients With Bladder Cancer

RATIONALE: New diagnostic procedures, such as 3 Tesla magnetic resonance imaging (MRI), may help find bladder cancer and learn the extent of disease.

PURPOSE: This clinical trial is studying how well 3 Tesla MRI works in finding cancer in patients with bladder cancer.

OBJECTIVES:

Primary

* To evaluate whether 3 Tesla MRI can accurately determine the primary tumor (T) stage and pelvic lymph nodes (N) stage in patients with localized bladder cancer as compared to histopathology staging.

Secondary

* To determine whether 3 Tesla MRI can determine if the primary bladder tumor is responding to neoadjuvant chemotherapy at the mid-point of the planned treatment (after 2 courses).
* To assess whether an ex-vivo ultra-high-field MRI (4.7-11.7 Tesla) tissue scan can more accurately determine clinical stage of a primary bladder tumor and local extent of the disease (i.e., involvement of contiguous organs and regional lymph nodes) as compared to histopathology staging.

OUTLINE: Patients may receive neoadjuvant chemotherapy (typically four 21-day courses of cisplatin-based therapy) followed by standard radical cystectomy and lymph node dissection.

Patients undergo a 3 Tesla MRI scan at baseline to stage the primary tumor, regional lymph nodes, and to rule out distant sites of disease. The MRI includes diagnostic high-resolution anatomical images (e.g., T1-weighted and T2-weighted images along axial or optimal directions) and experimental images including functional MRI (e.g., dynamic contrast-enhanced MRI, diffusion-weighted MRI, MR spectroscopy, and chemical exchange-dependent saturation-transfer imaging). Patients also undergo a 3 Tesla MRI scan after 2 courses of neoadjuvant chemotherapy and after completion of neoadjuvant chemotherapy. Patients not receiving neoadjuvant chemotherapy undergo a 3 Tesla MRI scan 2-4 weeks before radical cystectomy and lymph node dissection.

Specimens from the radical cystectomy and pelvic lymph node dissection are examined ex-vivo by ultra-high-field MRI and the Micro-Imaging Specimen Study Form is completed. The specimens are then examined by the pathology department as per standard routine.

Eligibility Criteria:
Inclusion Criteria:

* Known bladder cancer
* Scheduled for radical cystectomy and lymph node dissection.
* Able and willing to give valid written informed consent.
* No contraindications to the MRI(magnetic resonance imaging).

Exclusion Criteria:

* Not pregnant, planning to become pregnant during the study, or nursing.
* No allergy to contrast agents.
* Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate(eGRF) less than 30 mL/min/1.73m2.
* Any condition conflict based on the investigation's clinical judgment that would prevent the patient from completion all trial assessments and visits.
* Inability or unwillingness to cooperate with requirements of this trial.
* Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR.
* Patients with sickle cell anemia and other hemolytic anemia.
Evaluation of Therapeutic Strategies in Pediatric Cataract Surgery

The purpose of this observational study is to assess the therapeutic strategies in the treatment of pediatric cataracts.

Technical progress and recently described potential issues have recently challenged the surgical treatment of pediatric cataracts. Many questions remain unsolved: primary vs secondary implantation, nature of the implant used. The aim of this study is to establish a systematic prospective register of all cataracts operated on in a tertiary pediatric centre in order to help answering these questions.

Eligibility Criteria:
Inclusion Criteria:

* Child cataract surgery from 1 September 2014 in the Department of Ophthalmology, University Hospital Necker-Enfants Malades
* Children aged between 0 and 17 years
* Child with unilateral or bilateral cataract

Exclusion Criteria:

* Child with bilateral cataract, one eye having previously been operated in another center.
* Children whose parents have notified the doctor their refusal of data collection
Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients

Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in the prevention of complications in seropositive for HIV patients. However, they develop some manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing cardiovascular risk.

Clinical trials in general population and in patients on hemodialysis have demonstrated a significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially triglycerides. Also in general populations it has been described a benefit effect of omega 3 acids on oxidative stress.

Objective: to know the effect of omega 3 acids on different markers of oxidative stress in seropositive HIV patients.

Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid peroxidation products) will be evaluated.

Sample size was calculated according to different variables. We selected the biggest one calculated for a difference in nitric oxide of 25% after treatment between groups and a standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of 31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost, a sample size of 35 per group was considered.


Eligibility Criteria:
Inclusion Criteria:

* Seropositive HIV patients from 20 to 55 years old
* On clinical score A1, A2, B1 or B2
* Patients who received highly active antiretroviral therapy for at least 3 months.

Exclusion Criteria:

* Patients diagnosed with diabetes mellitus
* Patients diagnosed with hypertension
* Patients using hypolipidemic agents or diagnosed with dyslipidemia before receiving HAART therapy.
* Patients using protease inhibitors
Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors

This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.

Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.

Eligibility Criteria:
Inclusion Criteria:

* Soft tissue tumor of extremities or trunk with expected resection of \>10cm tissue in any dimension.

Exclusion Criteria:

* No primary skin closure.
* Skin infection in area of operation (e.g. acne inversa).
Vinorelbine in Treating Older Women With Stage IV Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.

OBJECTIVES:

* Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
* Determine the toxicity profile of this drug in these patients.
* Determine the time to progression in patients treated with this drug.
* Determine the quality of life of patients treated with this drug.
* Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.

OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed stage IV breast cancer
* Eligible to receive first- or second-line chemotherapy
* At least 1 unidimensionally measurable lesion

  * At least 20 mm in longest diameter
  * Must be completely outside prior irradiation port unless there is proof of progressive disease after completion of prior radiotherapy
* No untreated brain metastases

  * Current metastatic CNS disease allowed only if previously treated and clinically stable at study entry
* No meningeal carcinomatosis
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 65 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
* Direct bilirubin normal if total bilirubin elevated or less than 2.5 times ULN because of Gilbert's syndrome

Renal:

* Creatinine no greater than 2 times ULN

Other:

* No grade 2 or greater peripheral neuropathy
* No other significant medical condition that would preclude study
* No active infection within the past 2 weeks
* No dysphagia or inability to swallow intact capsules

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* No more than 1 prior chemotherapy regimen for metastatic disease
* No prior vinca alkaloids
* At least 4 weeks since other prior chemotherapy and recovered

Endocrine therapy:

* Prior hormonal therapy allowed
* No concurrent hormonal therapy

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy to 25% or more of bone marrow
* At least 3 weeks since prior radiotherapy and recovered

Surgery:

* At least 3 weeks since prior major surgery
Inspiratory Muscle Training in Burned Adults

The study outlines burn injury impact, emphasizes need for long-term rehabilitation. Study assesses inspiratory muscle training efficacy in improving respiratory strength, lung function, and exercise capacity in adult burn patients.

The study aimed to evaluate the effectiveness of adding inspiratory muscle training to pulmonary rehabilitation in adult burn patients. Fifty-two participants were randomly assigned to either inspiratory muscle training plus pulmonary rehabilitation or pulmonary rehabilitation alone for 8 weeks. Inspiratory muscle training consisted of using a Powerbreathe device for inspiratory muscle strengthening.

Eligibility Criteria:
Inclusion Criteria:

* Burn-injured adults aged 20-49.
* Admitted to the clinic after acute treatment.
* Recovering from burns affecting at least 20% total body surface area.
* Partial or full-thickness burns.

Exclusion Criteria:

* Smokers.
* had open or unhealed wounds.
* had any known neurological deficit.
* neuromuscular diseases.
* musculoskeletal deformities.
* pulmonary diseases.
* severe cardiac problems.
* inability to participate in regular exercise.
The Young Adult Clinic (YAC) Study

The overarching aim of the Young Adult Clinic (YAC) study is to evaluate the DOZE app, a digital, transdiagnostic behavioral sleep medicine and self-management approach in young adult patients (ages 18-25) with chronic pain.

Sleep, activity, and pain interactions have the potential to impact almost all important protective and regulatory processes in the body. Long-term sleep disruption is associated with increased pain sensitivity, prolonged pain duration, and development of chronic pain. Degree of pain relief can directly impact the quality and disruption of sleep, mood, behavior, social participation, and has a devastating impact on Health Related Quality of Life (HRQL).

Transdiagnostic behavioral sleep medicine and self-management is a behavioral modification approach and is currently a frontline therapy like Cognitive behavioral therapy for insomnia (CBTi) in adults with sleep disorders. However, it is still in early stages of development for adolescent and young adult populations, and less so for youth with co-morbid mental and physical health conditions and chronic pain.

Primary aim: Assess the feasibility of implementing the DOZE app.

Secondary aim:

1. To examine the variance in effectiveness outcomes, including sleep health, pain, and overall Health Related Quality of Life (HRQL).
2. To determine the required sample size for a future definitive trial.

Eligibility Criteria:
Inclusion Criteria:

* Young adult patients aged 18 - 25 years old, who have
* Non-malignant chronic pain lasting more than 3 months, with
* Clinically assessed as having a sleep disorder
* English speaking with
* Access to a mobile phone or a computer with internet access.

Exclusion Criteria:

* Patients who require urgent CBT treatment as per their health care provider
* Patients who have received CBT in the past 3 months
* Patients participating in other psychological treatments and/or drug trials during the study
* Patients who have other significant medical conditions- Life threatening (e.g. cancer), neurological conditions (e.g. epilepsy)
* Patients who have other significant psychiatric conditions-Severe depression or active suicide intent
* Situations resulting in forced sleep disruption or derangement of sleep schedule such as night shift work \> 2 nights per week in the past 3months
* Pregnancy or breastfeeding.
* Inability to communicate with health care providers or the research personnel
* Inability to fill out self-report questionnaires, study materials, or follow instructions.
Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema

The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)

General Purpose

1. To comparatively evaluate the tolerability and efficacy of a fixed combination of furosemide (40 mg) and amiloride (10 mg) compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA)

Specific Purposes

1. To evaluate the effect on kalemia of the fixed combination of furosemide and amiloride compared with furosemide alone in the treatment of patients with HF functional class II (NYHA)
2. To evaluate the efficacy of the fixed combination of furosemide and amiloride in reducing edema of the LLLL, as compared with furosemide alone, in the treatment of patients with HF functional class II (NYHA).

Eligibility Criteria:
Inclusion Criteria:

1. Being over 18 years old
2. Must be able to follow instructions and attend study visits.
3. Diagnosis of CHF functional class II (NYHA) without prior use of diuretics
4. Women of childbearing potential who are using a reliable contraceptive method, as assessed by the principal investigator

Exclusion Criteria:

1. Any clinically significant, serious or severe medical condition (e.g., Thyroid, renal or liver disorder, Chronic Obstructive Pulmonary Disease, etc.)
2. History of acute myocardial infarction (within 6 months) or decompensated coronary artery disease
3. Pulmonary hypertension - PASP \> 45 mmHg
4. Fasting blood glucose above 150 mg/dl
5. Psychiatric or neurological disorders
6. A condition that, according to Principal Investigator's opinion, may interfere with the optimal study participation or which may put the patient at special risk.
7. Participation in any other investigational study within 12 months before signing the ICF.
8. Known medical history of allergy, hypersensitivity or intolerance to any of the components of the drugs to be used in this study.
9. Any medical treatment that is unrelated to the study and scheduled to the clinical trial period, except for non-serious well-controlled comorbidities which are already being followed up medically.
10. Another drug scheduled to be initiated after study entry.
11. Obesity - BMI \> 30 kg/m2
12. Pregnancy and lactation
Microbicides Acceptability Among Sexually Active Young Women

ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability, and attitudes among sexually active young women

ATN 062 will take place in parallel to another study, MTN 004, "Phase I Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women." ATN 062 will use quantitative and qualitative research methods. The quantitative method will consist of a computerized diary used by participants during the 14 days of the gel trial of MTN 004. The qualitative methods will include email messages sent by participants to a research assistant as a supplement to the diaries, as well as in-depth interviews through teleconferences to contextualize the recorded events. All study activities will be timed to coincide with those of MTN 004

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in MTN 004.
* Willing and able to provide written informed consent for ATN 062.
* Willing to participate as required by protocol, including completion of all assessments and follow-ups.

Exclusion Criteria:

* Refuses to have teleconferences audio recorded.
* Any social or medical condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models

The purpose of this study is to determine whether adding new methods of data visualization to routine clinical care will improve (i) surgical planning and (ii) surgical outcomes in patients with kidney and prostate tumors.

This early phase I trial studies how well indwelling pleural catheters with doxycycline work compared to indwelling pleural catheters alone in treating participants with malignant pleural effusions. These types of catheters are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. It is not yet known whether giving doxycycline with indwelling pleural catheters works better than indwelling pleural catheters alone in treating participants with cancerous pleural effusions.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with MPE undergoing IPC placement
* Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions

Exclusion Criteria:

* Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
* Inability or unwillingness to give informed consent
* Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)
* Pregnancy
* Previous intrapleural therapy for MPE on the same side
* Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy ≤ 2 weeks
* Doxycycline allergy
* Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
* Chylous effusions associated with malignant disease
Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma

This study will evaluate the efficacy of Once-daily Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient.

The study will measure the efficacy of once daily low dose ICS/ LABA in well controlled asthmatic patient comparing with low dose ICS in step down circumstance.

Eligibility Criteria:
Inclusion Criteria:

* Asthmatic patients who have well controlled asthma at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
* Age more than 18 year-old
* Patients who able to do spirometry without contraindication
* History smoking less than 10 pack-years

Exclusion Criteria:

* History of using systemic steroid previous 4 week and respiratory infection
* History of pulmonary tuberculosis with residual lung lesion by chest radiograph
* recent serious medical condition such as myocardial infarction, stroke, pneumonia etc.
Migraine Among Sohag University Students

Diagnosis of migraine among students and detect frequency among them and detect how far migraine affect their life


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 25 years old.
* students accept to give informed consent

Exclusion Criteria:

* Students refused to give informed consent
* Age less than 18 or more than 25 ears old.
Emails Promoting COVID-19 Vaccination Among Healthcare Workers

In this evaluation, two versions of emails will be sent to Geisinger employees who have not been vaccinated against COVID-19. A delayed-contact control group will be emailed after a delay of at least two days. The researchers hypothesize that either of the emails - which use content informed by behavioral nudge theory - will lead to more COVID-19 vaccinations than the delayed-contact control group.

The researchers aim to evaluate the effectiveness of email reminders in promoting COVID-19 vaccinations among Geisinger employees. The project will compare two emails, which will vary in the subject line and email content. Both emails will test different approaches that draw from principles in behavioral science: social proof, reframing, and scarcity. Employees receiving these emails will be compared with employees in a delayed-contact group, who will not receive emails. Employees in the control group will later receive one of the emails.The responses to the emails will help determine the communications later sent to the control group.

All emails will ask recipients if they want to receive a COVID-19 vaccination. If they click on a hyperlink indicating yes, they will be forwarded to an online registration and scheduling homepage. If they click on a hyperlink indicating no, they will be forwarded to an online questionnaire surveying people about their main reason for declining the vaccine at this time. The questionnaire will automatically present information intended to assuage the specific concern that people endorse, followed by a hyperlink to the scheduling site.

The data will be analyzed with logistic regression models with the control group as the reference group, to compare the two email conditions versus the control group. This set of analyses will only be conducted for scheduling a vaccination appointment as opposed to email engagement outcomes (e.g., number of emails opened), which will not be applicable for the control group. A second set of logistic regression models predicting scheduling a vaccination appointment and email engagement will also be run, comparing the two email conditions against each other. The data will be examined two days later (to help decide which email to send to the delayed-control group) and four days later (when the policy for employee vaccination will change, making the content of the email irrelevant).

Update: The researchers looked at 3 days of data - as the emails to the delayed contact group were only sent at that time - and 4 days of data when the policy for employee vaccinations changed.

Eligibility Criteria:
Inclusion Criteria:

* Employees at Geisinger Health System who have not gotten a COVID-19 vaccination

Exclusion Criteria:

* None