cyrilzakka/clinical-trials huggingface dataset:
A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT

Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.

Total Body Irradiation (TBI) continues to play an important role in myeloablative and non-myeloablative conditioning regimens for Allogeneic Stem Cell Transplant (ASCT). When TBI is used as part of a myeloablative regimen, it is combined with chemotherapy to eradicate malignant cells, as well as to immunosuppress the host to prevent rejection of donor hematopoietic progenitor cells (HPC).

This study is a single-institution study to assess the safety of linac based VMAT TBI for myeablative sreatment in hematologic malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Patients undergoing related, unrelated (including cord blood) hematopoietic progenitor cell (HPC) transplant, in which the protocol requires \>12 Gray of TBI, as part of the conditioning regimen.

   a. Conditioning regimens outlined per BMT SOP: CLNTX007: Selection of Conditioning Regimens for Blood and Marrow Transplantation - ADULTS.
3. Referral from the blood and marrow transplant (BMT) program for full-dose TBI, who meet inclusion and exclusion criterial per BMT SOPs.

   1. BMT program will initiate referral, utilizing Form: 170102, Radiation Oncology Consultation.
   2. Patients undergo pre-transplant testing, as defined in BMT SOPs:CLNAL002: Related (MRD, Haplo) Allogeneic Recipient Evaluation and Management or CLNAL011: Unrelated (MUD, MMUD, CBU) Allogeneic Recipient Evaluation and Management, per below.

   i. BMT SOP's include baseline pulmonary function tests (PFTs). Patient with decreased FVC, FEV1 and or DLCO (adjusted for hemoglobin) or pulmonary history will have pulmonary consult, at the discretion of the BMT physician prior to undergoing myeloablative radiation.

ii. Medical history and physical by BMT provider.

iii. The following laboratory tests (additional testing may be required for positive results):

* ABO group and Rh type
* Red Blood Cell Antibody Screen.
* HLA typing and confirmatory typing
* HLA antibody screen, class I and II, performed within 30 days of transplant.
* Complete blood count (CBC) with differential.
* Basic metabolic panel, including glucose and to include at a minimum electrolyte evaluation of potassium, calcium, magnesium, and phosphorus.
* Blood urea nitrogen (BUN)
* Creatinine
* Liver Function Tests including: Total bilirubin, Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Lactate dehydrogenase (LDH), Albumin, Total Protein, Urinalysis

Exclusion Criteria:

1. Patient receiving less than 1200 cGy of TBI
2. Previous history of thoracic radiation therapy including previous TBI
3. All premenopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
4. Prisoners
5. Patient not meeting transplant criteria per BMT physician.
Cognitive Intervention After a Brain Tumor

This study evaluates the feasibility and utility of two behavioural programs designed to reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of participants will complete training in either program, with the remaining third a wait-list control group.

Cognitive impairments (including problems with attention, memory or executive functions) are common in people with brain tumors, as a result of the disease and/or treatment effects. These deficits, even when relatively mild, can interfere with interpersonal relationships, occupational activities, functional independence, and quality of life. They may also contribute to caregiver burden.

Building on research in other cognitively-impaired populations, in this study we compare two behavioural interventions. The Brain Training (BT) and Brain Health (BH) interventions each offer a structured yet client-centered program through 8 weekly individual treatment sessions and between-session exercises. Contents include mindfulness practice, strategy training, and supportive psychoeducation including counseling around lifestyle factors to promote brain functioning.

Using a prospective randomized controlled design, 54 brain tumor patients are being enrolled in one of three study arms: BT, BH, or standard care (wait-list control). A battery of outcome measures is being administered (1) prior to intervention, (2) after the 8-week behavioural intervention (or wait-list) period, and (3) after an additional 4 months to evaluate longer-term outcomes. Analyses of variance will examine treatment effects, with regression analyses to explore moderating effects of participant demographics, severity of baseline cognitive impairment, and tumor and treatment factors (e.g., tumor location, radiation dose and distribution). Results of this trial will lay the groundwork for implementation of evidence-based supportive care to reduce and manage cognitive impairments following a brain tumor.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 or older
2. fluent in English
3. able to provide informed consent to all procedures
4. diagnosis of a brain tumor
5. indication of lasting post-treatment cognitive deficits (e.g., from clinical presentation, prior neuropsychological assessment, and/or self-report)
6. sufficient motor and sensory functioning to complete study activities
7. availability to complete all study activities
8. for patients treated with cranial radiation, at least 3 months post-radiation

Exclusion Criteria:

(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
Study of DNA in Blood Samples From Patients With Neuroblastoma

This research trial studies is deoxyribonucleic acid (DNA) in blood samples from patients with neuroblastoma. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

OBJECTIVES:

I. Perform in a blind study a multicentric study by analyzing serum from patients at diagnosis (with a known tumor v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) status determined in the Children's Oncology Group \[COG\] reference lab), in order to confirm our previous data and to define the most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases.

II. Define the limits of the procedure in non-metastatic patients and in those with reduced tumor burden (International Neuroblastoma Staging System \[INSS\] stage 1 and 2).

OUTLINE:

Circulating DNA is extracted from serum. Polymerase chain reaction (PCR) amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.

Eligibility Criteria:
Inclusion Criteria:

* Serum samples from neuroblastoma (NB) patients obtained through the COG (and legacy Children's Cancer Group \[CCG\]/Pediatric Oncology Group \[POG\] Biology Studies)

  * The MYCN status on corresponding tumors have been determined using standard techniques; the panel of samples must be obtained from NB patients with and without MYCN amplification tumors
* Cases will be drawn from clinical subsets at greatest likelihood to benefit from this testing ability, stage 1 and 2 NBs (both infants and toddlers), stage 4 patients under 18 months of age, and 4S patients
Islide-Establishing a Clinical Dermatopathology Online Discourse System

The trend is changed by a large number of low-cost computers, large-capacity computing power, and the rapid advent of network bandwidth. From the Internet to the WWW to Web2.0, the technology in addition brings impact on economic, social, and technological, but also on medical education about knowledge delivery globally and learning patterns.

Currently, many scholars start to take the affection of social network seriously. In the medical field, ECGpedia is the typical successful example. There are more than 250,000 members from 188 different countries in the website. On the other hand, the effect of data computing and transition improve the development of Gigapixel image presentation. For example, users can zoom in and zoom out on GoogleMap. The research team has being worked on this kind of search engine on pathology and anatomy slides in past three years. For education purpose, students can observe slides by using a virtual microscope directly.

This research will target on establishing a Clinical Dermatopathology Online Discourse System (iSlide). It will combine a virtual microscope platform and a biopsy diagnosis eLearning System. This survey will be focused on evaluating of this platform. The object is all interns in dermatopathology department at Wan Fang Hospital this semester. All the new physicians can learn from experienced experts. Users who have questions can search for help from others via this website. They can get assistance by thinking procedure learning model -scheme inductive and pattern recognition. In doing so, clinicians and pathologists can discuss with each other through this system. It also can improve the education and research development in this field.


Eligibility Criteria:
Inclusion Criteria:

* All interns in dermatology department of Wan Fang Hospital this semester.

Exclusion Criteria:

* N/A
Epidemiology of Sudden Death in Cameroon

Background The burden of sudden death (SD) in sub-Saharan Africa is unknown. The aim is to assess the incidence, etiology and patient characteristics of SD in a sub-Saharan country. Methods The Douala-SD study is a prospective, multicenter, community-based registry monitoring all cases of SD occurring in index areas of Douala city. Investigators will use the definition of SD as natural death occurring within 24h at the onset of symptoms. Demographic, clinical, electrocardiographic and biological variables (when available) of victims will be recorded. All deaths occurring in residents of health areas of interest will be checked for past medical history, circumstances of death, and autopsy (if possible). Conclusion This maiden Douala-SD study will provide comprehensive, contemporary data on the epidemiology of SD in a sub-Saharan African country and will help in the development of strategies to prevent and manage SD in Africa.

Two health areas were excluded for inaccurate data collection, and 2 other were randomly disqualified as investigators previously decided to conduct the survey in ≤ 4 areas. The mode of randomization aimed at includes no more than 1 health area per district. Finally, investigators retained 4 health areas representing 4 out of 6 districts of Douala. Thus, the sampling of 240,384 inhabitants will be monitored prospectively. All administrative staff and community-healthcare committee, the so-called " comité de santé" (COSA) of each health area will be a key component of the research team, helping identify every case of death in the area of concern. Every case of death will be reported by the staff of COSA in a specific questionnaire form. In addition to the deaths noted by members of each COSA, investigators will pay attention with all notices of deaths in local newspapers, radio, interrogation of health area residents, and death certificates from local medical centers.

Eligibility Criteria:
Inclusion Criteria: All witnessed and unwitnessed victims of unexpected natural death

-

Exclusion Criteria:

* Victims living in the area of interest for a short time frame (\< 12 months)
* Absence of information helping to determine circumstances of death
Task-sharing and Shifting Model for Acute Low Back Pain

Background: The aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. Models of care integrating task sharing and shifting (TS/S) can help face challenge of access to care by strengthening the role of healthcare professionals. In France, a new TS/S model is being implemented between family physicians (FPs) and physiotherapists (PTs) for acute low back pain (LBP) patients' care. The aim of this study is to evaluate the effect of this new model of care on patient clinical outcomes, healthcare resources use and patient satisfaction.

Design: Pragmatic cluster randomized controlled trial


Eligibility Criteria:
Inclusion Criteria:

* Patients from 20 to 55 years old
* Suffering from acute low back pain since less than 4 weeks
* Able to understand and speak French
* Whose family physician is included in the task-sharing and shifting model (only in the intervention group)

Exclusion Criteria:

* Protected patient according to the public health regulation,
* Patient unable to fill the survey,
* Non-availability of the physiotherapist to receive the patient (only in the intervention group)
Tiotropium In Exercise

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.


Eligibility Criteria:
Inclusion criteria

1. All patients must sign an informed consent
2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)
3. Age \>= 40 years
4. Medical Research Council Dyspnoea score \>= 2
5. Current or ex-smoker with a \>= 10 pack-year smoking history
6. Ability to exercise on treadmill

Exclusion criteria

1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
2. Clinical history of asthma
3. Use of supplemental oxygen therapy
4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
5. Recent history (\<= 12 months) of myocardial infarction
6. Unstable or life-threatening cardiac arrhythmia
7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years
8. Pregnant or nursing women
9. Known hypersensitivity to anticholinergic drugs or any component of the study medications
10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
11. Estimated life expectancy \< 2 years
12. Symptomatic prostatic hyperplasia or bladder neck obstruction
13. Known narrow-angle glaucoma
14. Any condition that is contraindicated for exercise
15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
16. Body mass index \< 18 kg/m2 or \>35 kg/m2 list truncated for space
Bare Platinum Coils Versus Second-generation Hydrocoils

Comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms.

The investigators aimed to analyze whether the use of second-generation hydrogel coils for the treatment of ruptured intracranial aneurysms improves clinical and angiographic outcomes compared with the use of bare platinum coils.

Eligibility Criteria:
Inclusion Criteria:

* 19 year old or older
* untreated ruptured intracranial aneurysms with an anatomy such that endovascular treatment with either bare platinum or second-generation hydrogel coils was considered feasible.
* person who agreed to study

Exclusion Criteria:

* contrast allgery (+)
* combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases)
* ineligible for coil embolization
Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial

The Ambu Auragain is a 2nd generation laryngeal mask airway that is widely used in adult and pedicatric patients. While its use is generally recommended in patients undergoing surgery in the supine position, depending on patient characteristics, type of surgery and experience of the anesthesiologist, it may also be used in the lateral or prone position. There have been reports of LMA use in patients undergoing short procedures in the prone position, but its safety in pediatric patients is not clear. This study was designed to compare oropharyngeal leak pressure between children undergoing surgery in the supine and prone position using the Ambu Auragain LMA.


Eligibility Criteria:
Inclusion Criteria:

Pediatric patients undergoing surgery within 2 hours under general anesthesia in either the supine or prone position using the Ambu Auragain LMA.

Patients aged 2-12 years, weight 10-30 kg, ASA class 1\~3

Exclusion Criteria:

Active URI, symptomatic lung disease (uncontrolled asthma, pneumonia etc), patients with history of difficult airway, anticipated difficult mask ventilation, risk of aspiration such as gastroesophageal reflux
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.


Eligibility Criteria:
Inclusion Criteria:

* The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
* The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
* The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
* The visual acuity score must be between 20/50 and 20/320 in the study eye

Exclusion Criteria:

* Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
* Anticipated need for ocular surgery during the 12-month study period
* Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
* Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
* Any infectious condition in the study eye
Vaginal Estriol Before and Vaginal Surgery for Prolapse

The purpose of this study is to determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life.

The aim of this randomized study was to evaluate the efficacy of low concentration of vaginal estriol gel (0.005%, 50 micrograms/1 g vaginal gel) in women with pelvic statics disorders before vaginal surgical treatment (group A), assessing the vaginal dryness, dysuria, vaginal maturation index (VMI), pH and the Vaginal Health Index (VHI). Secondary, to investigate the changes of sexual function and QoL. Women without pre surgical estriol treatment constituted the control group (group B).

Eligibility Criteria:
Inclusion Criteria:

* genital dryness,
* irritation/burning/itching of vulvas or vagina
* decreased lubrication with sexual activity
* discomfort or pain with sexual activity
* decreased arousal, orgasm, desire
* dysuria.

Exclusion Criteria:

* previous surgeries for pelvic organ prolapse
* urinary incontinence
* usage of medication
* chronic medical illness
* body mass index (BMI) ≥ 35 kg/m2
* endometrial thickness equal to or greater than 4 mm
* abnormal uterine bleeding
* hormone-dependent malignancies
* history of thromboembolic disease
* liver disease
* usage of HT for less than 3 months
* usage of phytoestrogens within 1 month before the start of the study
* partner affected by sexual disorder
* conflicting with the partner
A Single Dry EEG Electrode Allows to Estimate of the Level of Anesthesia During Colonoscopy Sedation.

We asked to a staff of digestive endoscopy and of the operating room to interpret the EEG traces obtained from a single dry electrode device to estimate the level of anesthesia during colonoscopy. They are required to produce a rank value (1 to 3) proportional to the anesthesia level. The rank values of anesthesia evaluated through the EEG traces will be correlated to the typically used "bispectral index" values simultaneously acquired. The expected efficacy of a low-cost single dry-electrode EEG would allow the monitoring of the level of anesthesia during non operating room procedures such as colonoscopy.

Monitoring of the level of anesthesia has two primary functions: to reduce the incidence of awareness during operation and to avoid too deep anesthesia that is associated with increased risks of mortality and postoperative cognitive impairment. This monitoring can be performed by processed EEG such as "Bispectral Index" that provides a simple interpretation numerical value proportional to the anesthesia level. Nevertheless, "Bispectral index" requires specific tools and disposable material that increases costs for non operating room procedure. Colonoscopy is a non operating room procedure typically performed without or with light sedation, less frequently requires deep sedation. The latter is performed by using Propofol a drug that has a low therapeutic index and might be associated with adverse effects such as respiratory depression, aspiration related to loss of airway reflexes and hypotension. The aim of the present study is to evaluate the reliable interpretation of the raw EEG traces by a staff of digestive endoscopy and operating room for monitoring the level of sedation during non operative room anesthesia to avoid adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* anesthesiologists and nursing staff of the operating room

Exclusion Criteria:

* specific knowledge of electroencephalography
Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.

Urinary incontinence and impotence are typical disturbances after radical prostatectomy. Although, several surgical methods are developed to decrease these disturbances, 8% and 50% of the patients suffer from permanent urinary incontinence and impotence, respectively.

Previously two studies have shown that endopelvic fascia preservation may decrease postoperative incontinence and impotence rates. Unfortunately these studies are retrospective decreasing their reliability.

The present study is prospective and randomized clinical trial. The investigators are going to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional and oncological results are followed up to 1 year after surgery.

180 patients going to radical prostatectomy as treatment of prostate cancer will be randomized 1:1 to two study arms: In the other arm endopelvic fascia are preserved during the operation, in the other arm the fascia are opened.

After the operation urinary continence and erection function are compared between the study arms. Additionally the investigators will study oncological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Localized prostate cancer
* Planned nerve-sparing robotic radical prostatectomy
* Gleason score 7 or less

Exclusion Criteria:

* Previous prostate surgery (TURP, TUIP, laser...)
* Planned lymphadenectomy
* T3 cancer