cyrilzakka/clinical-trials huggingface dataset:
Developing a Patient Oriented Discharge Summary for Stroke Inpatients

There is a need to improve the discharge process for patients with stroke, which has been reported to be a particularly stressful time for patients. A Patient Oriented Discharge Summary (PODS) meeting has been shown to be an effective approach for minimizing discharge-related stress and fostering self-management skills in other patients being discharged from rehabilitation into the community. The purpose of this study is to develop and evaluate whether a PODS meeting can minimize stress around the discharge process and improve patient satisfaction with this process. There are two main hypotheses regarding the PODS program: 1) it will help in-patients with stroke understand key issues related to knowledge required once discharged and 2) it will increase levels of self-efficacy in in-patients with stroke. Potential subjects are encouraged to participate if they are a Sunnybrook - St. John's Rehab admitted in-patient with a stroke diagnosis who are 18 years or older and meet the following criteria: (a) fluent in English; (b) cognitively intact; and (c) have minimal or no aphasia.The participant will be asked to answer some surveys 8-10 days prior to discharge about their knowledge and confidence in managing their stroke.

The participant will then be asked to meet with a clinical staff member who will hold a one-hour PODS meeting. In the meeting, a discharge plan will be created and given to the patient that covers a number of topics that will be useful following their return to the community. One day following the PODS meeting, the participant will be asked to answer the same survey they completed prior to the PODS and again 3-5 days following discharge. If the participant is interested they will be asked to undergo a brief interview to get their feedback on the PODS Program. It is anticipated that about 20 people will participate in the program with all 20 patients completing the surveys with 6 being asked to complete the brief interview.

To the best of the investigators knowledge, there is little risk associated with this study. Participants may become uncomfortable during the interview while discussing their experiences. By participating in this study, patients will be provided with a chance to gather information and learn problem solving and self-management skills prior to discharge. It is the hope of this project that it can lead to a more effective approach in supporting the transition from the hospital to the community for patients with stroke


Eligibility Criteria:
Inclusion Criteria:

* Have a stroke diagnosis.
* Must be minimally aphasic.
* Physically and cognitively be able to participate in a one-hour PODS session and are capable of undergoing the PODS meeting, as well as the study assessments in person and by phone (surveys, telephone interview).

Exclusion Criteria:

* Participants who are unable to communicate fluently in English
Evaluation of the Care Path of Patients Who Have Been Sexually Assaulted

The main objective of this study is to describe the care pathway of patients presenting in the medico-judicial unit of the Raymond Poincaré Hospital in Garches, France, following a complaint for sexual assault and suggest ways to improvement of the care adapted to the characteristics of the participants.

AS secondary objectives, the study aims to:

* Analyze the population of victims of sexual assault seen in consultation at the medico-judicial unit of Raymond Poincaré Hospital.
* Analyze the decision elements of the initiation of the post-exposure treatment and evaluate them against the recommendations.
* Analyze the data collected on the patients and their follow-up in consultation of infectious disease of the hospital of Garches following a sexual assault.
* Identify obstacles encountered by participants to follow the complete follow-up path.

For this purpose the data collection will be done initially within the forensic unit of Raymond Poincaré Hospital. Then, in a second step, the patients requiring the setting up of a post-exposure treatment, are addressed in the service of infectious diseases. The compilations of the data necessary for the study will then be continued until 3 months after the sexual assault.

For the collection of data, they will be based on the medical records of the victims.

Eligibility Criteria:
Inclusion Criteria:

* People declared being victim of sexual assault;
* Consult at medical-legal unit;
* Judicial requirement.

Exclusion Criteria:

- Absence of judicial requirement.
A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis

An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants above 18 years of age
* Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period
* Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated)

Exclusion Criteria:

* Participants involved in interventional trials
* Participants with life expectancy less than 1 year
* Active malignancy
* Planned living kidney transplant within 6 months.
Management of Pancreatitis: the Role of Supportive and Drainage Treatment

This study aims to investigate the natural clinical course, diagnostic possibilities and treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The management of severe acute pancreatitis varies with the severity and depends on the type of complication that requires treatment. Although no universally accepted treatment algorithm exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage, followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated to produce superior outcomes to traditional open necrosectomy and may be considered as the reference standard intervention for this disorder.

Despite overall reduced mortality in the last decade, MSAP and SAP are devastating diseases associated with mortality ranging from less than 10% to as high as 85%, according to various studies. The management of SAP is complicated because of the limited understanding of the pathogenesis and multi-causality of the disease, uncertainties in outcome prediction and few effective treatment modalities. Generally, sterile necrosis can be managed conservatively in the majority of cases with a low mortality rate (12%). However, infection of pancreatic necrosis can be observed in 25%-70% of patients with necrotizing disease; it is generally accepted that the infected non-vital tissue should be removed to control the sepsis. Laparotomy and immediate debridement of the infected necrotic tissue have been the gold standard treatment for decades. However, several reports have shown that early surgical intervention for pancreatic necrosis could result in a worse prognosis compared to cases where surgery is delayed or avoided. Therefore, several groups worldwide have developed new, minimally invasive approaches for managing infected necrotizing pancreatitis. The applicability of these techniques depends on the availability of specialized expertise and a multidisciplinary team dedicated to the management of SAP and its complications.

Eligibility Criteria:
Inclusion Criteria:

1. fluid collections within two weeks of disease onset;
2. single- or multi-organ failure;
3. CTSI \> = 7 (initial CT performed within 7 days after the onset of disease.); and (4) acute physiology and chronic health evaluation (APACHE) II score \> = 8.

Exclusion Criteria:

1. patients without APD interventions;
2. patients who underwent necrosectomy directly after APD without PCD as a bridge therapy;
3. previous percutaneous drainage or surgical necrosectomy during the episode of pancreatitis;
4. previous exploratory laparotomy for acute abdomen and intraoperative diagnosis of AP.
Oral Cancer Screening Among Nursing Home Dentists in Ohio

RATIONALE: Learning about oral cancer screening practices, knowledge, and opinions of Ohio nursing home dentists may help the study of oral cancer in the future.

PURPOSE: This clinical trial is studying oral cancer screening among nursing home dentists in Ohio.

OBJECTIVES:

* To develop a comprehensive sample of nursing home dentists in Ohio.
* To document knowledge of oral cancer detection among these dentists.
* To describe opinions of these dentists about oral cancer screening competency.
* To describe the current oral cancer screening practices of these dentists.

OUTLINE: Participants are stratified according to geographical location (urban vs rural).

A comprehensive sample of nursing home dentists practicing in Ohio are contacted through a recruitment letter and are asked to respond to questions regarding oral cancer screening practices, knowledge of oral cancer detection, and opinions about oral cancer screening using a newly developed survey, which is based on parts of an existing, pre-tested instrument (Oral Cancer Prevention and Early Detection Survey).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Dentist practicing either full-time or part-time in a nursing home setting in the state of Ohio

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Effect of PEEK and Co-Cr Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinial Trial

A fixed all-on-four prosthesis will be fabricated for the mandibular arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months


Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patient with old satisfactory maxillary and mandibular dentures requiring an implant supported restoration
* Implant sites must allow for implant placement
* Patients with no systemic conditions that may interfere with implant placement

Exclusion Criteria:

* General contraindications for implant surgery( Poor oral hygiene- diabetes- pregnancy or nursing- drug abusers)
Sinus Lift With Hydroxyapatite Nano Particles Versus Tenting Technique

twenty recruited patients indicated for sinus augmentation and immediate implant placement will be divided into two groups (10 in each of the two groups), to compare bone formation and implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles \[Nanostreams\] or augmentation with graft less tenting technique with simultaneous implant placement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm of residual ridge as per MISCH criteria
* Both sexes

Exclusion Criteria:

* Sinus pathology
* Heavy smokers more than 20 cigarettes per day
* Patients with systemic disease that may affect normal healing
Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of asthma and baseline lung function tests as determined by the protocol
* Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

* Severe asthma
* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

This randomized phase 3 trial studies how well modified Dakin's solution works in reducing radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.

Radiation therapy in this study is regulatory medical care based on the patient's needs and the radiation oncologist's judgment. It is not possible nor necessary to explicitly define the dose or duration of treatment.

PRIMARY OBJECTIVES:

I. To determine the proportion of patients who develop grade 3 radiation dermatitis (as defined by the Stanford Radiation Dermatitis Scoring System) as an adverse effect of radiation therapy or chemoradiation therapy for a head and neck cancer when initiating the use of prophylactic hypochlorite (HOCl) (modified Dakin's solution) at the start of therapy (experimental arm) compared to placebo (control arm).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (EXPERIMENTAL): Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.

ARM II (CONTROL): Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.

At the time that Stanford Radiation Dermatitis Scoring System (SRDSS) Grade E radiation dermatitis develops, the participant will transition to standard management for radiation dermatitis. SRDSS, by grade, is as follows.

* A. No skin change
* B. Faint, barely detectable erythema
* C. Follicular rash, hyperpigmentation, evolving erythema
* D. Dry desquamation, brisk erythema
* E. Moist desquamation
* F. Bleeding, ulceration, and/or infection

SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion."

After completion of study, patients are followed up at 6 to 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer who plan to undergo radiation therapy to the head and neck region
* At least 18 years of age
* Able to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy NOT excluded)
* The physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 Gy
* Scleroderma or discoid lupus
EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
3. Must have measurable or non-measurable disease
4. Must be able to comply with study and follow-up procedures

Exclusion Criteria:

1. Small cell, carcinoid, or mixed small cell lung cancer
2. Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
3. Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC
4. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication
5. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
6. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
7. Pregnancy or lactation
Treatment Of Shallow Periodontal Pockets Using PRF As an Adjunct To Scaling And Root Planing In Periodontitis Patients

Platelet rich fibrin (PRF) has been widely used in regenerative dentistry since it provides plenty amount of growth factors that enhance wound healing and tissue regeneration. Platelet derived growth factor-BB (PDGF-BB) is a growth factor with essential functions such as regulation of cell migration, proliferation, and differentiation. This study aims to evaluate the efficacy of PRF in improving the clinical periodontal parameters and GCF level of PDGF-BB.

Split mouth randomized clinical trial is the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. Randomization in this study will be achieved using toss of coin method in which periodontal pockets will be designated either control site or test site. PRF will be used as an adjunct to scaling and root planing to treat the test sites. While control sites were treated by scaling and root planing only. Clinal periodontal parameters were recorded and GCF level of PDGF-BB will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment.

Eligibility Criteria:
Inclusion Criteria:

•periodontitis

Exclusion Criteria:

* Periodontal therapy for the last 3 months
* Medical history of systemic diseases such as diabetes.
* Patients wearing dental prosthesis
* Alcoholic patients
* Teeth with grade II mobility, endodontic lesions, and teeth with untreated caries
Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection

The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. The primary outcome measure will be urinary tract infection (UTI) rates within 30 days from the BOTOX-A procedure. Secondary outcomes will assess patient satisfaction with the two post-procedural prophylaxis medications.

The purpose of this randomized controlled non-inferiority study is to determine if methenamine hippurate is non-inferior in regards to UTI rate when compared to routinely prescribed antibiotic prophylaxis following intradetrusor BOTOX-A injections for women with OAB. As a secondary aim, this study will also compare patient medication satisfaction, as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G) for the two prophylactic medication arms.

Comparators: Methenamine hippurate versus routinely prescribed antibiotic prophylaxis Methenamine hippurate is an oral non-antibiotic antiseptic medication widely used in the prevention of recurrent UTIs.

164 women will be randomly assigned to each treatment option: 82 to methenamine hippurate and 82 to routinely prescribed antibiotic prophylaxis. The primary outcome of UTI rates within 30 days of the BOTOX-A procedure will be calculated for each study arm. The FACIT-TS-G will be administered to participants at the conclusion of the 30-day period.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder

Exclusion Criteria:

* cisgender male individuals
* neurogenic reasons for bladder symptoms (i.e. spinal cord injury, multiple sclerosis, etc.)
* known allergy and/or contraindication to methenamine hippurate
* currently already taking methenamine hippurate at the time of the procedure
* taking antibiotics for any reason on the day of their BOTOX-A procedure
* positive UTI at time of procedure (positive dip at time of procedure)
* history of bladder cancer
* history of pelvic radiation
* surgically altered detrusor muscle
* pre-procedural need for catheterization
* diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
* pregnant or lactating individuals
A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

* History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

The primary objective of this study is to evaluate the radiological efficacy of SC natalizumab over time through Week 24 in natalizumab-naïve participants, as measured by brain magnetic resonance imaging (MRI). The secondary objectives of this study are to evaluate additional lesion-related radiological efficacy measures over time, relapse-based clinical efficacy measures, disability improvement and worsening (EDSS), pharmacokinetic and pharmacodynamic parameters, the immunogenicity of repeated doses, and safety in treatment-naïve participants of SC natalizumab.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of RRMS according to the McDonald criteria
* Treatment-naïve in respect to natalizumab as disease modifying monotherapy for RRMS
* No or not more than one prior MS disease-modifying therapy
* Highly active RRMS, as defined by at least one relapse in the previous year and at least one T1 gadolinium-enhancing lesion or ≥3 new or enlarging T2 lesions
* EDSS score ≤ 5.5 at Screening
* Estimated glomerular filtration rate (eGFR) \>30 millilitre per min (mL/min), as estimated using the Cockcroft-Gault formula.

Key Exclusion Criteria:

* Primary- and secondary-progressive MS
* Participants for whom MRI is contraindicated
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study
* History of severe allergic or anaphylactic reactions or known hypersensitivity to any antibody drug therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.