cyrilzakka/clinical-trials huggingface dataset:
Prevention of Capsular Contracture Using Trental and Vitamin E

The main purpose of this research study is to determine if the use of Trental and Vitamin E will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with breast implant reconstruction following radiation treatment. Another goal is to find out the impact that Trental and Vitamin E have on implant loss or need for surgical intervention in the setting of chest wall radiation after reconstruction. In addition, the investigators want to evaluate the patient's sense of well being and quality of life.

This is a single center, 18-month study in which 30 women will receive Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months. Subjects will begin the treatment regimen within four weeks after completion of radiation treatment and will remain on the study drugs for six months. Following completion of active treatment, all subjects will enter the twelve-month observational phase of the trial in which they will be evaluated for changes in breast tissue using the following objective tools: Bakers Grade Assessment, Visual Analog Scale (VAS), implant revision or loss, breast photographs, adverse event assessment and the Quality of Life tool (SF-12).

Eligibility Criteria:
Inclusion Criteria:

* Female subjects
* \> 18 years of age
* Expected survival at least \> 6 months
* Undergone mastectomy with expander or implant reconstruction \> 3 weeks before radiation therapy
* Completed chest wall irradiation in the past two weeks
* Willing to stop herbal medications as directed by physician
* Willing to stop daily use of supplemental vitamin E (Multivitamin with vitamin E component is acceptable)
* Willing to travel to a Legacy Health System facility
* Agree to attend study visits outside of standard of care visits
* Normal PT-INR for subjects taking Coumadin

Exclusion Criteria:

* \< 18 years of age
* Pregnant or lactating
* Have final implant placed \< 3 weeks before start of radiation therapy
* Have evidence of ongoing infection or implant exposure before start of radiation therapy
* Radiation completed more than 16 days prior to study start
* Retinitis Pigmentosa
* Unable to comply with protocol
* Unable to provide written informed consent
* Unwilling or unable to stop supplemental vitamin E
* PT-INR outside of acceptable range for subjects taking Coumadin
* Investigator does not believe study participation, for any reason is in the best interest of the patient
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation

This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.


Eligibility Criteria:
Scan Reader Criteria (5 total):

* Board-certified in radiology or nuclear medicine
* Professional experience interpreting PET scans
* Naive to study protocol
* No previous training or exposure to Avid Flortaucipir F 18 read methodology

Scan Criteria:

- Previous enrollment in Study A05 confirmatory cohort (NCT02016560), or A16 (NCT02516046)

Scan Study Population Criteria for FR01 (A05 confirmatory cohort):

* Cognitively-impaired
* mild cognitive impairment (MCI) or dementia with suspected neurodegenerative cause
* mini-mental status exam (MMSE) score of 20-27, inclusive

Scan Study Population Criteria for FR01 (Study A16):

* Subjects at end of life (less than or equal to 6 months)
* Imaged with flortaucipir F18 and came to autopsy
Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group) or with AS210 (control group) to determine the safety and relative efficacy of both products.

Multicenter, randomised clinical trial in out patient in which patients with chronic (arterio-) venous leg/foot ulcers are treated with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group). During a pre-inclusion evaluation period of 4 weeks (non healing) chronicity of ulcer is ensured (ulcer size change of \< 30%). To determine ulcer type ABI, Doppler and CEAP is performed.

The test group will receive 2 applications of Tiscover®. Week 0: wound activating pre-treatment, application of at least one quarter of the wound surface. Week 1: removal of patches, application of patches on total wound surface.

The control group (16 patients) will follow the same application protocol.

Eligibility Criteria:
Inclusion criteria:

* Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3)
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth \< 1 cm
* Target ulcer duration ≥ 12 weeks but ≤ 15 years
* Acceptable state of health and nutrition
* Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations

Exclusion Criteria:

* History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
* Refusal of or inability to tolerate compression therapy.
* Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
* \>30% change of wound size in 4 weeks or confirmed by historical data
* Presence of deep vein thrombosis or contra indication for compression therapy
* Severe co-morbidity reducing life expectance to \< 1 year
* Use of oral corticosteroids and/or cytostatics \>20 mg/per day;
* Severe infection of ulcer, active cellulitis, osteomyelitis
* Severe malnutrition
* Uncontrolled diabetes mellitus, HbA1c \> 12% (108 mmol/mol)
* Anaemia Hb \<6 mmol/l
Effective Antibiotic Treatment of MRSA

To evaluate the effective duration (in days) to clinical improvement of outpatient antibiotic regimens in the treatment of superficial abscesses caused by MRSA in patients that present to the emergency department.

Skin and soft tissue infections-cellulitis, furuncles, carbuncles, and abscesses-make up approximately 1-2% of emergency room visits annually. While abscesses are generally incised and drained, there is no definite standard treatment regimen or duration of treatment that practitioners have adhered to regarding antibiotic use. Historical evidence suggests that antibiotics may not be necessary for simple superficial abscesses, though a number of antibiotics-including penicillins and cephalosporins-may be used for treatment of large and/or complicated abscesses. These antibiotics however are ineffective against what is becoming an increasingly common pathogen- community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA).

At our institution, it is estimated that 60-70% (unpublished observation) of cultured abscesses are caused by CA-MRSA. These patients have generally been treated with incision and drainage, with the addition of an antibiotic left to the practitioner's discretion. Also, there has been no universally accepted duration of treatment established to observe clinical improvement of such abscesses. Common antibiotic regimens range from 7-14 days of treatment for cellulitic infections. While there has been one prospective trial regarding the use of antibiotics in simple abscesses, there has been no published prospective study on the use of antibiotics in treating CA-MRSA abscesses in adults. Furthermore, while 7-14 days of treatment seems the recommended duration of treating cellulitic infections, no study has evaluated the duration of treatment needed to observe clinical improvement of abscesses caused by CA-MRSA. We wish to prospectively evaluate the duration of treatment necessary to observe clinical improvement of abscesses caused by CA-MRSA among multiple different antibiotics (ie. cephalexin, clindamycin, and trimethoprim/sulfamethoxazole) after standard incision and drainage in patients presenting to the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* All patients age 18 and older, presenting to the emergency department with an abscess with a diameter greater than three centimeters
* Informed consent

Exclusion Criteria:

* Patients who are presumed to have community-acquired pathogens
* Under 18
* Abscess less than three centimeters in diameter
COMPARISON of EFFICACY and SAFETY of NARROWBAND UVB with 0.1% TACROLIMUS VS NARROWBAND UVB with 0.005% CALCIPOTRIOL in TREATMENT of VITILIGO

Patient of stable and limited vitiligo less than 20% BSA will be recruited And evaluation of efficacy and safety of narrowband UVB with topical tacrolimus vs narrowband UVB and calcipotriol will be assessed

Evaulation of efficacy and safety of narrowband uvb and tacrolimus and NBUVB and calcipotriol in patient if stable vitiligo with body surface area less than 20% It will be assessed by VASI score and VIisual analogie scale

Eligibility Criteria:
Inclusion Criteria:

- Localized vitiligo Age 15 to 70years Body surface upto 20% Stable more than 3 months

Exclusion Criteria:

* • Pregnant or lactating female patients.

  * Skin malignancy or any other malignant skin condition.
  * Photo induced or photo aggravated dermatosis like (SLE, photodermatitis, rosacea, psoriasis, pemphigus vulgaris) along with vitiligo.
  * Prior history of allergy to tacrolimus or calcipotriol.
  * Other form of treatment for vitiligo within at least 1 month.
Effect of Implementing Sleep Care Bundle on Nurses' Practice and Patients' Outcomes

Sleep is a fundamental physiological requirement for the human body to heal and overcome an illness or injury . Good sleep is essential for patient recovery and restoration of normal daily functions . Critically ill patients often experience poor sleep quality due to shortened sleep times, increased daytime sleep, and disrupted circadian rhythm . Poor sleep quality is one of the most common complaints of patients who survive their critical illness. Patients' complaints include trouble initiating and maintaining sleep and frequent awakenings with difficulty returning to sleep

Sleep plays an important role in restoring the health of individuals who are ill or injured and essential for critical illness recovery. Poor sleep quality during hospitalization may lead to post-hospital symptoms and increase readmission rates and mortality . Sleep disruption is associated with immune system dysfunction, decreased resistance to infection, changes in nitrogen balance, and impaired wound healing. Therefore, using a standardized non-pharmacological sleep promotion strategy as a sleep care bundle is proposed to reduce the incidence of delirium and improve sleep quality. Internationally, investigations performed to evaluate the effect of implementing sleep care bundle on patients' outcomes had reported its effectiveness. However, studies that addressed the effectiveness of implementing sleep care bundle on critical care nurses' practice and patients' outcomes in Egypt are scarce. Moreover, from our empirical observations, investigators found that there are no available standards of sleep care in the study setting. Furthermore, most nurses do not realize the importance of good sleep for critically ill patients. Therefore, the present study will be carried out to address this issue. Hopefully, the current investigation might generate attention and motivation for using this bundle and for conducting further research studies in this area.

Eligibility Criteria:
Inclusion Criteria: Inclusion criteria

* Adult patients of ≥ 18 years old.
* Fully consciousness (Glasgow coma scale score 15; orientation to person, place, and time).
* Spent at least 3 full nights in the above-mentioned ICUs.

Exclusion Criteria:

History of sleep disorder as insomnia and sleep apnea.

* History of mental disorders.
* Patients who are on sedative or narcotic drugs.
* Patients who have visual or hearing impairment.
* History of skin diseases (e.g., contagious skin, eczema).
The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications

The combination of vitamin and mineral supplementation may improve:

* glycemic control
* lipid profile
* oxidative stress
* blood pressure
* nephropathy indices
* neuropathy indices

A total of 75 diabetic patients (39 men and 36 women), aged 36 to 69 years, having diabetes for at least 3 years, was recruited for this study. Type 2 diabetes was defined as fasting plasma glucose 126 mg/dl (two times repeated) or taking oral glucose-lowering agents.Diabetic patients were stratified by sex and randomly assigned to one of the three treatment groups using block randomization procedure. Depending upon the treatment groups, each subject received two capsules per day, 1 with breakfast and 1 with dinner, for a period of 4 months. Each capsule contained one of the following preparations and hence determined the corresponding groups: Group MV: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg); Group MVB: both of the above mineral and vitamin supplements plus vitamin B1 (5 mg), vitamin B2 (5 mg), vitamin B6 (5 mg), biotin (50 µg), vitamin B12 (5 µg) and folic acid (0.5 mg); Group P: starch (placebo). All of the study medications, including the placebo, were supplied by Pharmaceutical Sciences Research Center (Tehran University of Medical Sciences, Iran) and were indistinguishable from each other. They were stored at 20-25 0C.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for 3 years

Exclusion Criteria:

* Resting blood pressure \>160/100 mmHg
* Taking vitamin and/or mineral supplement, thyroid hormones, estrogens, progesterone, diuretics or antihypertensive agents
* Having history of myocardial infarction and hepatic disease
* Pregnant
Financial Incentives and Recruitment to the APT Webstudy

This single-blind, three-arm, randomized, controlled trial will assess the impact of messages and financial incentives on the enrollment of demographically diverse individuals to the Alzheimer Prevention Trials (APT) Webstudy. The APT Webstudy is a novel, online registry that employs quarterly cognitive testing using validated platforms. The APT Webstudy implements fully remote assessments, coordinated by the Alzheimer's Therapeutic Research Institute (ATRI) under USC IRB #HS-17-00746. The purpose of the current study is to test whether we can increase enrollment of diverse individuals into the registry. To do this, we will work with Contra Costa Regional Medical Center (CCRMC), the county public hospital and its affiliated health centers in Contra Costa County, California, to test whether sending messages with and without financial incentives to patients who receive primary care with the health system can increase enrollment to the APT Webstudy. The investigators hypothesize that 1) a certain small financial incentive and an award opportunity based incentive (or a drawing with a prize) will increase enrollment rates of CCHS members into the APT Webstudy relative to the control group. The investigators further hypothesize that the award opportunity incentive will increase the enrollment rate of CCRMC patients into the APT Webstudy more than a certain financial incentive with the same expected value.


Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

* Patients empaneled at Contra Costa Regional Medical Center (CCRMC), the county public hospital and its affiliated health centers.
* Age 50 or older
* Literate in either English or Spanish

Exclusion Criteria:

* Below age 50
* Documentation of prior dementia diagnosis
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
* Otherwise healthy

Exclusion Criteria:

* No active STIs
The Effect of Peanut Ball Application on Delivery Process

This study was carried out to evaluate the effect of peanut ball application on labor process, birth pain, and birth comfort. The data of the study were collected between July 2021 and July 2022 in a Training and Research Hospital in Istanbul. 115 pregnant women who met the inclusion criteria of the study were included in the sampling, and the study was completed with 102 (experimental n: 51; control n: 51) pregnant women. Data were collected with an introductory information form, visual and verbal pain scales, Birth Comfort Scale, and birth follow-up form.

A group was determined to be involved in the study after obtaining consent from the pregnant women participating in the research. The purpose of the study was explained to all pregnant women, informing them that the data would be anonymized and privacy principles would be adhered to.

Experimental Group: Pregnant women who received the peanut ball application were provided with necessary information about the ball and how to use it through visual aids showing the positions provided by the midwife. A total of 5 positions were shown to the pregnant women. The peanut ball was used when the cervical dilation reached 6 cm. Pregnant women in active labor, the transition phase, and the second stage with the peanut ball were directed to change positions every 30-45 minutes. Emphasis was placed on selecting positions in which the pregnant women felt comfortable.

Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was observed that pregnant women generally spent the time before delivery lying down and connected to electronic fetal monitoring.

In the Birth Monitoring Form, the gestational week found in the patient's file, interventions and medications applied in the first stage of labor, the situation of episiotomy application in the second stage, the newborn's birth time, and 1st and 5th APGAR scores, newborn's length, weight, head circumference, and gender were recorded. In both groups, labor pains during the dilation stage were evaluated three times using the Visual Anolog Scale (VAS) when the dilation was at 6 cm, 9 cm, and 10 cm. During this period, the pregnant women were asked to rate the pain they felt on the VAS scale from 1 to 10, and the values expressed were recorded by the researcher. The childbirth comfort scale and the form indicating mothers' views

Eligibility Criteria:
Inclusion Criteria:

* Primiparous pregnant women
* 37w-40w gestational week (term)
* Pregnant women over the age of 18 years

Exclusion Criteria:

* Pregnant women who gave birth by cesarean section
* who had received epidural anesthesia/analgesia
Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures

The proposed project will be a multi-centre, prospective observational study to determine the prognosis and determinants of functional outcomes of patients with proximal humerus fractures. Approximately 10 centres will participate in this observational cohort, each enrolling at least 50 patients over the course of 2 years.


Eligibility Criteria:
Inclusion Criteria:

males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture

Exclusion Criteria:

pathologic fractures patients likely to be lost before completing follow-up patients who do not provide consent patients who do not speak English and who do not have a translator that will be available during consent discussion and at each follow-up.
Monitoring of Circulating Tumor DNA and Its Aberrant Methylation in the Surveillance of Surgical Lung Cancer Patients (MEDAL, MEthylation Based Dynamic Analysis for Lung Cancer).

Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients.

Studies have already demonstrated the feasibility of circulating tumor DNA as a surrogate to reveal tumor mutation status in lung cancer patients and a few researches have shown the potential ability of using circulating tumor DNA in surveillance. However, no study focused on the value of methylation status of circulating tumor DNA in the surveillance and no strict prospective study has been performed in surgical lung cancer patients.

The investigators plan to analyze the dynamic change of circulating tumor DNA and its methylation status longitudinally from preoperation to long term follow-up in surgical lung cancer patients, and compare assessment value between circulating tumor DNA detection with methylation , traditional imaging examinations and traditional blood tumor markers in the monitoring process.

Eligibility Criteria:
Inclusion Criteria:

Aged 18 to 80 years

* Lung cancer was suspected preoperatively.
* Received curative surgical therapy
* No malignant tumor history within the past 5 years
* No being received any treatment prior to resection
* Patients must have given written informed consent

Exclusion Criteria:

* The pulmonary nodule is pure ground glass opacity
* Unable to comply with the study procedure
* The postoperative pathology is not NSCLC.
* Unqualified blood samples
Improving Outcomes for Older Adults Undergoing Radiation Therapy

The purpose of this study is to improve healthcare received by people ≥ 65 years who are receiving radiation therapy (RT). The study will primarily examine patients ability to complete RT, changes in a patients' daily function and self-reported toxicities. To collect this information, study participants will be asked to complete surveys and physical and cognitive function assessments at five different timepoints in their treatment: before RT, End of RT, and at 1, 3, and 6 months follow up visits. Findings of this study will help radiation oncologists make more informed decisions for future patients receiving RT.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be ≥ 65 years
* Patient must have pathologically confirmed cancer
* Patient must have the ability to provide informed consent, or have a legally authorized representative (LAR) present to provide informed consent on the participant's behalf
* Must be radiation oncology patient at Mount Sinai Hospital, Mount Sinai Downtown, or Mount Sinai West.

Exclusion Criteria:

* There is no exclusion criteria