cyrilzakka/clinical-trials huggingface dataset:
Topical 0.05% Clobetasol Propionate in Vaseline Versus UVA-1 Phototherapy in Vulvar Lichen Sclerosus

Lichen sclerosus is a rare, chronic cutaneous disorder with a predilection for the genital area. Any age group may be affected, although it is seen more often in postmenopausal women. The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol.

Here we compare UVA1 phototherapy with 0,05% clobetasol propionate in vaseline for the treatment of vulvar lichen sclerosus.

Genital lichen sclerosus is a rare chronic inflammatory connective tissue disease. The association with other autoimmune diseases and the detection of autoantibodies against ECM-1 point to an autoimmune genesis. Genital lichen sclerosus typically affects women around and after the menopause. Common sites of affection are the vulva (clitoris and labia majora) and the anus in women, the prepuce and the glans penis in men. Skin lesions include ivory-white, atrophic, porcelain-like plaques with a tendency to atrophy and fissures in the advanced stages.

First-line therapy for genital lichen sclerosus in the active, inflammatory phase is the use of topical glucocorticoids. Alternatively, topically applied hormone-containing emollients and topical calcineurin inhibitors are widely used. However, the use of topical corticosteroids is because of the associated long-term side effects (atrophy, striae) limited.

In the treatment of localized scleroderma (morphea), a similar sclerosing disease, the use of ultraviolet radiation (UVA1) has proved highly effective. After a pilot study, the high-dose UVA1 phototherapy (120 J / cm ²) was significantly more effective was a low-dose UVA1 (20 J / cm ²), however no difference could be found in subsequent studies. Meanwhile, the medium-dose UVA1 phototherapy in circumscribed scleroderma has been determined as the most effective therapy regime and is included in the german dermatological guidelines (see also AWMF guideline for diagnosis and therapy of circumscribed scleroderma at: http://www.uni-duesseldorf.de/awmf/ll/013- 066.htm).

Eligibility Criteria:
Inclusion Criteria:

* patients with genital lichen sclerosus
* Age \> 18 years
* Willingness to participate in this study
* No topical steroids within the last 4 weeks

Exclusion Criteria:

* Age \< 18 years
* Known photodermatosis (eg, solar urticaria, polymorphous light eruption)
* Known genodermatosis with UV-sensitivity
* Treatment with photosensitizing drugs
* History of skin cancer
* significant UV exposure 3 months before study entry
* application of UV radiation therapies outside of the study conducted by UV irradiation: as: PUVA, UVA (including UVA1), UVB (including SEA) in the last 4 weeks before study entry or during the study period
iTotal Pilot Study of ConforMIS Custom Total Knee Implant

To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant.

Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom instruments will show faster functional recovery, including gait and patient functional outcome scores, when compared to standard, off-the-shelf total knee components inserted with non-navigated instruments (the present standard of care in total knee surgery).

The experimental design was changed based on enrollment hurdles to be a single cohort observational study where ConforMIS patients were enrolled and followed for 6 months with 6 minute walk used as the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

- undergoing total knee arthroplasty

Exclusion Criteria:

- BMI \>40
Telemedicine for Adolescents With Insulin-dependent Diabetes

Investigators hope that providing patients and families with additional ways of communication with the diabetes care team will improve diabetes control.

Study Group Study group will be asked to test blood glucose at least 4 times a day Each time the study subject takes a meter reading the meter time-stamps the reading. All meter readings will upload to the cloud via" Myglucohealth" website, where they can be accessed by caregivers, including providers and parents. Device will be programmed to coax patients when readings are due. Parents will be notified by device about the blood glucose testing results. Provider will set device to alert patient or patient's family if patient has not yet tested or uploaded a test or send alerts to parent if uploaded numbers are outside an identified range (\<70 mg/dL \> 300 mg/dL). As per the standard of care, parents are trained to administer sugar containing liquids, or inject extra insulin for hyperglycemia correction. Parents will be encouraged to contact study personnel if they are concerned about the diabetes control. Study personnel will access home blood glucose monitor data, and provide insulin dosing advice. Parents will be asked to upload blood glucose readings prior to each visit.

Control group Subjects will continue routine care which requires blood glucose testing at least 4 times a day. Parents will use customary ways to communicate (pager, email, fax or phone) with the Diabetes team, if they are concerned about glycemic control..

Study group will have two virtual visits (months 3 and 6) Control group will have all quarterly visits in person. A laptop will be used for virtual visits and will be set up with the help of the TTUHSC Information Technology Security Officer.

Eligibility Criteria:
Inclusion Criteria:

-- Age 10-18 years

* Multiple daily injections regimen
* Duration of diabetes \> 12 months
* HbA1c \> 7%
* Lives outside of Lubbock
* Committed to visit schedule

Exclusion Criteria:

* Foster care or residential facility
* Psychiatric illness
* Developmental delay
* Reading at \< 4th grade level
* Pregnancy
* Known seizure disorder
Evaluating the Effects of Popular Music on Cardiopulmonary Resuscitation Training

This study aims to analyze short- and long-term effects of musical memory created by using a national popular song on achieving the recommended compression rate and depth and compression-breath rate for nursing students, who received CPR training.

In this study, used a popular Turkish song, entitled, 'More Beautiful Than You' and performed by Duman, to create a musical memory to be used as a mental metronome and analyzed short- and long-term effects of using popular national songs on achieving recommended compression rate and depth and compression-breath rate for nursing students, who received CPR training and performed CPR on high-fidelity simulation mannequins for the first time.

Students in the intervention group practiced CPR with music. Students in the control group practiced CPR with a standard mannequin.

CPR performance of the participants was evaluated just after the CPR training (short-term) and six weeks after the training (long-term).

Nursing students that agreed to participate received two hours of theoretical lecture on basic life support for healthcare professionals.The training was based on the 2015 American Heart Association (AHA) guidelines for CPR and Emergency Cardiovascular Care (ECC) and was provided by an emergency medical expert that had an AHA First Aid Trainer certificate.

Following the theoretical lecture, participants were allocated to the intervention and the control groups and performed at least 5 cycles of CPR (1 cycle=2 minute) on a high-fidelity simulation mannequin at the practice laboratory. During the performance, one of the students delivered rescue breath with a bag valve mask (BVM) whereas the other student performed compression. Participants switched positions after each cycle with 120 compressions.Following the training, students in the control group received the standard CPR training whereas the participants in the intervention group listened to the song to be used in CPR and then performed CPR while listening to the song. CPR performance of the participants was evaluated just after the CPR training (short-term) and six weeks after the training (long-term).

Eligibility Criteria:
Inclusion Criteria:

* third-year nursing students
* who were enrolled in the nursing department
* who did not receive prior CPR training

Exclusion Criteria:

* students that did not agree to participate
Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo

Apelins are substances which occur naturally in the body, and have an important role in heart disease. They have been shown to make blood vessels dilate, and improve the way the heart works.

The investigators have devised 2 sets of experiments to investigate how the apelins affect blood vessels.

In the first group of experiments,the investigators will give healthy volunteers up to 3 different apelin substances, and use special research techniques to see how they affect the way that blood vessels work in the forearm.

In the second group of experiments, the apelins will be given along with another form of apelin which blocks the effects of apelin in laboratory experiments. The investigators want to see if it blocks the effects of apelin in healthy humans.

The investigators intend to test the hypothesis that:

Apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by an apelin receptor antagonist.

This study will help us to understand more about how apelins work, and to suggest how they might be used to treat heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 70 years
* Non-regular smoking (\<5 cigarettes per week)
* If female, postmenopausal or on days 2-9 of menstrual cycle

Exclusion Criteria:

* Hypertension (sustained BP \>160/100mmHg)
* Ischaemic Heart Disease
* Renal, respiratory or neurological disease
* Diabetes mellitus
* BMI \>30, BMI \<18
* Pregnant
* Smoker
* Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study.
* Current involvement in other research studies
Optimal EGFR TKIs Treatment Strategies for Lung Adenocarcinoma Harboring EGFR Exon 19 Deletion Variants

To determine the optimal EGFR TKIs treatment strategies for lung adenocarcinoma harboring EGFR exon 19 deletion variants

RNA extraction: The investigators will extract total RNA from cell lysates by using Tri-reagent (Molecular Research Center, Inc., Cincinnati, Ohio) and an RNA Mini Kit (Qiagen, Hilden, Germany) according to the manufacturer's instruction. RNA obtained from the Mini Kit column will be eluted. The quantity and quality of the purified RNA will be evaluated using a NanoDrop ND-1000 spectrophotometer will be stored at -80 °C for further mutational analyses.

Data acquisition: The investigators will record and follow participants' clinical information, including ethnicity, age, gender, smoking status, histological types, lung cancer stage (the TNM status), metastatic sites, ECOG score, CT/CXR imaging, chemotherapy or radiation treatment at the time of diagnosis of lung cancer and through the entire clinical courses. Specific marker such as TTF1, is used to ensure the diagnosis of primary lung tumor. Clinicopathologic stage assigns according to the seventh tumor-node-metastasis classification. The investigators assess the treatment responses according to the Response Evaluation Criteria in Solid Tumors (RECIST) using the unidimension method, and record the best response achieved per treatment. Treatment response, progression-free survival, and overall survival are recorded prospectively for further analysis.

Statistical analysis: All categorical variables will be analyzed with Pearson's χ² test, except where a small size required the use of Fisher's exact test. The progression-free survival curve and overall survival will be plotted by the Kaplan-Meier method and compared by the log-rank test. Multivariate analysis for overall survival will be performed using the Cox's proportional hazards model. Two-sided p-values of less than 0.05 is considered significant. All analyses will be performed using SPSS software (version 16.0 for Windows; SPSS Inc.).

Eligibility Criteria:
Inclusion Criteria:

* Patients have signed the informed consent (201103013RC and 201111039RIC) before 2019/12/31 and authorized the Institutional Review Board of Nation Taiwan University Hospital to review the new study for approving the usage of residual specimens.
* The residual samples from various sources, including surgical tissues, computed tomography (CT)-guided needle aspiration and/or biopsy, echo-guided needle aspiration and /or biopsy, bronchoscopic biopsy or brushing, bronchoalveolar lavage (BAL), endobronchial ultrasound guided needle aspiration, and lymph node aspiration, and pleural effusion specimens. The samples will be collected at the time of diagnostic procedure performed. All patients should sign an informed consent for purpose of using samples for molecular genetic testing.
* 1000 residual specimens will be used for the study.

Exclusion Criteria:

* Patients didn't sign the informed consent (201103013RC, 201111039RIC)
* The residual specimens are not qualified.
SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care

This research study is testing the use of a smartphone app to identify clinically meaningful changes in the behaviors of patients' with gynecological cancers by using passively collected smartphone data.

This is a pilot study of patients with advanced gynecologic cancers and oncology providers from the Dana-Farber Cancer Institute's Gynecologic Oncology Program to explore the feasibility and acceptability of a smartphone-based real-time behavioral anomaly detection system (SIGNAL).

The research study procedures include screening for eligibility and study interventions including smartphone data collection, surveys, and a brief interview once you have completed the study to learn more about your experiences on the study.

Participants will download the adapted Beiwe app for a 6-month period and the investigators will collect passive smartphone sensor data and active PRO data bi-weekly.

Eligibility Criteria:
Inclusion Criteria:

* Women \>18 years of age with newly diagnosed ovarian cancer (i.e. prior to completion of cytoreductive surgery-whether primary or interval cytoreductive surgery).
* Own a smartphone (Android or iOS).
* Capable of downloading and running the study apps.
* Can read and provide informed consent in English.
* Do not have cognitive or visual impairments that would preclude use of the app.

Exclusion Criteria

* Patients will be ineligible if they are participating in an investigational drug treatment trial that requires structured symptom or toxicity reporting at the time of enrollment.
* Patients with severe cognitive impairments or who appear too weak, emotionally distraught, agitated or ill to participate, as judged by either the research study staff or an oncology provider, will be excluded.
* Patients who are unable to provide informed consent in English will be excluded because the smartphone app is only available in English at this time.
* Children and young adults up to age 17 will be excluded because the diagnosis of metastatic gynecologic cancers in this age group is rare and the proposed instruments are not designed for people of those ages.
Cisplatin in Castration Resistant Prostate Cancer

It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of prostate cancer
* Age 18 yrs or older
* Able to provide written, informed consent
* Subjects who have received docetaxel for metastatic disease are eligible if absolute neutrophil count is greater than 100 and platelet count is greater than 100,000 and their bone marrow reserve is deemed to be adequate
* Subjects with castration resistant prostate cancer, as defined by having testosterone level of less than 50 Nano gram/dl, being treated with enzalutamide with a rise in PSA, confirmed with a repeat measurement within 1 to four weeks, or asymptomatic radiographic progression

Exclusion Criteria:

* Subjects with estimated glomerular filtration rate of less than 50 ml/min
* Subjects with hearing impairment. The treating physician may decide which subjects should not receive cisplatin based on audiometry or based on clinical judgment.
* Subjects with grade 2 or greater neuropathy
* Subjects who in the opinion of the treating physician could not tolerate the standard hydration before receiving cisplatin
* Chemotherapy naïve subjects who in the opinion of the treating physician should receive docetaxel instead of enrolling on the trial and receive cisplatin
THRIVE+ Pharmacy Liaison-Patient Navigation Intervention

This is a pragmatic comparative effectiveness trial (n=364) to compare two screening and referral program models to address health-related social needs (HRSN) among the intermediate risk population of Boston Accountable Care Organization (BACO), a Medicaid ACO. The first study arm is THRIVE-Basic, the low-touch usual care model already implemented in all primary care clinics at Boston Medical Center (BMC) where patients are screened for HRSN and receive a printed paper resource referral guide. The second study arm is THRIVE+, which enhances the THRIVE-Basic model by engaging a pharmacy liaison-patient navigator to provide targeted navigation services and motivational interviewing to ensure connection to hospital- and community-based resources. The patient navigators will also interface directly with a partner community organization, Action for Boston Community Development (ABCD), to further help connect patients receiving THRIVE+ to community resources for HRSN. All patients in our study will receive pharmacy services via an existing Pharmacy Care Program. Patients in study arm 1 will be connected to a pharmacy liaison, which is standard clinical practice for intermediate risk ACO members in the BMC General Internal Medicine clinics. Patients in study arm 2 will receive systematic screening for and addressing of HRSN (THRIVE+) via a pharmacy liaison-patient navigator (a pharmacy technician trained as a patient navigator to deploy both pharmacy services and the THRIVE+ intervention), thereby avoiding duplication of services and multiple touches. Assignment to the study arms will be linked to existing Pharmacy Care Program enrollment activities and will be based on medical record number. The investigators' rationale for the study is that if patients' HRSN are addressed, patients will be better positioned to manage chronic conditions, adhere to preventive care plans, and less likely to use the emergency department (a conduit to inpatient care) for ambulatory care-sensitive conditions. The effectiveness of these two models will be compared with respect to alleviating HRSN and reducing acute health care utilization over a 12-month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Identified as within the 3rd to 10th percentile for healthcare utilization and cost among Boston Accountable Care Organization (BACO) Medicaid ACO membership at the time of enrollment in the clinical program; and
* Attend a primary care visit with a primary care provider (PCP-nurse practitioner or physician) in General Internal Medicine at Boston University Medical Center.

Exclusion Criteria:

-Patients who are receiving services from the BACO complex care management program.
Contraceptive Counseling Following an Abortion

The purpose of this study is to determine whether contraceptive counseling is effective on acceptance and use of methods in women following an abortion.

Contraceptive counseling is considered an essential component of post abortion care (PAC) programmes and it is recommended to prevent unintended pregnancies and unsafe, repeated abortions. Indeed, most maternal deaths related to unsafe abortions could be prevented by expanding and improving family planning provision.

Eligibility Criteria:
Inclusion Criteria:

* Within the first 10 days (plus or minus 5 days) after an abortion
* Live in Recife or whereabouts in Recife(Brazil)

Exclusion Criteria:

* Clinical diagnosis of Gestational Trophoblastic Disease
* Women HIV positive
* Psychiatric pathology
Application of Powdered Vancomycin in the Surgical Wound in Haiti

Vancomycin, a tricyclic glycopeptide antibiotic, was originally indicated for the treatment of penicillin-resistant S. Aureus. It has a bactericidal action, inhibiting the biosynthesis of the cell wall of Gram-positive bacteria. Various studies have reported the application of intraoperative vancomycin powder to the wound prior to wound closure as a method of antibiotic prophylaxis. Intrasite administration of the drug should theoretically minimize rapid absorption into the systemic circulation, thereby reducing drug-associated side effects. The precipitated concentration gradient between the local wound and the scaffold should also reduce the occurrence of drug resistance. In Haiti, monitoring patients post-operatively is often difficult. The Mortality, Morbidity and Use of Services Survey (EMMUS-VI 2016-2017) reports that the non-use of a health facility is motivated in 58% of cases by the excessively high economic cost of care. Also, SSIs represent a challenge for clinicians. The best solution to the consequences of SSI in this context is prevention. In the present study, the investigator tested the hypothesis that the use of vancomycin powder in the surgical wound would decrease the occurrence of SSI.

Type of study

This is a single-center prospective study with balanced blind randomization 1: 1 in parallel group.

Method and materials

After approval of the research protocol by the hospital ethics committee, the randomization sequence will be created using Stata 9.0 ware statistical software and will be stratified by center with a 1:1 allocation using random block sizes of 2, 4 and 6." "Participants will be randomly assigned following simple randomization procedures to 1 of 2 treatment groups. A group of patients will receive 2g of powdered vancomycin in the operative wound before its closure, and another group will not receive it. Both groups will benefit from the same preoperative asepsis protocol. One hour before the incision, 1g of intravenous ceftriaxone will be administered to the patients, this dose is maintained during the 48 hours postoperative every 12 hours. At discharged the two groups of patients will receive oral cloxacilin 500mg three times a day for one week. Patients are dressed every 2 days until the surgical wound has healed. Patients will be seen in the outpatient clinic at 2, 4, and 6 weeks, then at one year.

The significance level for the statistical tests is 0.05%. investigator used chi-square tests to assess the degree of relationship. The frequency of the patient's demographic, clinical and therapeutic characteristics are calculated. We used pubmed, google scholar, medline to perform the literature review. The consort guide will be used for the methodology.

Eligibility Criteria:
Inclusion Criteria:

* patients with 18 years and older
* lower extremity fractures

Exclusion Criteria:

* patients with impaired consciousness,
* those with an open Gustillo and Anderson type III fracture
* those with a C reactive protein \> 6.
* those with date of trauma more than 48 hours
* those with passage of purulent secretion in the wound