cyrilzakka/clinical-trials huggingface dataset:
ReVital-CORE Program

Pilot feasibility study of the ReVital Chemotherapy Online Resiliency Evaluation (CORE) program. As part of standard of care, patients starting a new chemotherapy regimen are referred to complete a pre-chemotherapy cancer rehabilitation evaluation (i.e., prehab) and invited to enroll in the ReVital-CORE program study.

Once enrolled in ReVital-CORE, participants will complete a monthly online evaluation for 1 year. If frailty (or pre-frailty) is detected on any survey, physical or occupational therapy will be initiated for standard of care rehabilitation evaluation and treatment.

All patients starting a new chemotherapy regimen will be referred to completed a prehab evaluation with a specialized physical or occupational therapist be and invited to enroll in the ReVital-CORE program for the pilot, feasibility study.

Participants in the ReVital-CORE program study will be emailed an online evaluation each month via for one year. Once completed, the evaluation is automatically scored into: frail, pre-frail or robust categories using a validated frailty index. Any patient categorized as frail or pre-frail will be re-referred to rehabilitation by their cancer care team. For frail and pre-frail individuals, standard of care rehabilitation therapy will include either/and occupational and physical therapy evaluation and treatment and will be billed via their insurance.

The purpose of this pilot study is to evaluate feasibility of the of the ReVital-CORE Program for individuals starting a new chemotherapy regimen. Secondary aims are to evaluate the prevalence, trajectory and predictors of frailty during the first year of chemotherapy treatment; and evaluate the impacts of prehab/rehabilitation for participants identified as frail and pre-frail.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* English speaking
* Starting new chemotherapy treatment with oncology partner
* Provide informed consent

Exclusion Criteria:

* Eligible for hospice care
A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing

The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM® VOLBELLA™ XC in adult participants seeking correction of hollowing of the tear troughs.


Eligibility Criteria:
INCLUSION CRITERIA:

* Age 22 or over and in good general health
* Has "Moderate" or "Severe" infraorbital hollowing (grade 2 or 3 on the Allergan Infraorbital Hollows Scale (AIHS)) for each eye as assessed by the Evaluating Investigator (i.e., both eyes must qualify but do not need to have the same score)
* Is able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable if they will be used for all subject self-assessments)
* Ability to follow study instructions and likely to complete all required visits
* Written informed consent has been obtained

EXCLUSION CRITERIA:

* Has hyperpigmentation in the infraorbital area (does not include dark circles under the eyes not due to hyperpigmentation)
* Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
* Has ever undergone fat injections above the subnasale or is planning to undergo this procedure during the study
* Has tattoos, piercings, facial hair (i.e., beard, mustache), or scars that would interfere with visual assessment of the infraorbital hollows
* Has undergone volume augmentation with semipermanent dermal fillers (e.g., calcium hydroxyapatite, poly-L-lactic acid) or temporary dermal fillers in the malar area, temples, or around the eyes within 12 months before enrollment or is planning to undergo such treatment during the study
* Has begun using any new over-the-counter or prescription oral or topical, anti-wrinkle products within 30 days before enrollment or is planning to begin using such products during the study. Subjects who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study)
* Has active or recurrent inflammation or infection in either eye
* Has active autoimmune disease
* Females who are pregnant, nursing, or planning a pregnancy
* Is an employee (or a relative of an employee) of the treating investigator (TI), evaluating investigator (EI), or Allergan, or a representative of Allergan
* Has a condition or is in a situation which in the TI's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
Health Related Quality of Life in Lung Transplantation in Strasbourg

The aim of this study is to study the quality of life in lung transplant patients. The cohort includes all of the surviving and transplanted patients at the New Civil Hospital in Strasbourg between 2008 and 2018. The main objective is to assess the quality of life of this cohort by two questionnaires which are the SF36 (generic score) and the saint Georges's questionnaire (specific score).

The secondary objectives are the measurement of survival after lung transplantation, the comparison of the quality of life of these patients with that of the general population by the SF36 questionnaire, the search for perioperative factors influencing the quality of life and finally the search for an association between quality of life and socio-professional life.


Eligibility Criteria:
Inclusion Criteria:

* Transplants survivors in Strasbourg hospital between 2008 et 2018
* Patient able to answer a questionnaire in french

Exclusion Criteria:

* Pregnancy
* Vulnerability
* Safeguard of justice, curatorship or tutorship
* Emergency situation
* Difficilty in understanding
Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial

The purpose of this study is to determine the cost-effectiveness of biennial screening with mammography and MRI compared to mammography alone in women aged 50-75 years and who show \> 75% mammographic density.

Women with very high mammographic density have a four to six fold higher breast cancer risk than women with low mammographic density. At the same time, the sensitivity of mammography is seriously impaired in women with high mammographic density, leading to many missed cases. Nevertheless, in the Netherlands this high risk group is currently screened between the age of 50 and 75 years with mammography only. MRI is likely to lead to better detection of breast tumors in women with high mammographic density, because it has a much higher sensitivity than mammography. The DENSE trial investigates the additional value of MRI for breast cancer screening in this risk group. Participants with extremely dense breasts (ACR4) and a negative mammogram are randomized to 'additional MRI' (n=7,237) versus 'current practice' (n=28,948).

Eligibility Criteria:
Inclusion Criteria:

* Dutch breast cancer screening participants, aged 50-75 years
* \> 75% mammographic density
* Negative mammographic examination (BIRADS 1 or 2)

Exclusion Criteria:

Contraindications for MRI

* The presence of intracorporeal metals
* Adverse reaction to a (gadolinium-based) contrast agent in the past
* Severely impaired renal function (GFR \< 40 mL/min)
* Pregnant or lactating women
* Claustrophobia
* Adiposity (\> 150 kg)
Evaluation of Hemostasis Time on Partial Pulpotomy in Teeth With Clinical Signs Indicative of Irreversible Pulpitis

The aim of this prospective study is to investigate the influence of time taken to achieve hemostasis on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

OBJECTIVE:-

1. To evaluate clinical and radiographic success of time taken to achieve hemostasis on outcome of partial pulpotomy in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
2. To evaluate OHRQoL and pain incidence \& severity after partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

Participants will of age group 18 to 45 years will be included and divided into two groups based on hemostasis time:

I(Intervention) - 6minutes C (Comparison) - 7-12 minutes

TITLE:- Evaluation of hemostasis time on partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

P (Population) - Mature permanent molars with clinical signs of irreversible pulpitis.

I (Intervention) - 6minutes C (Comparison) - 7-12 minutes O (Outcome) - Assessment of clinical and radiographic success at 12 months of follow up .

Assessment of OHRQoL at baseline, post-operatively every 24 hours for 1 week \& incidence and severity of pain at baseline and post-operatively every 24 hours till 1 week.

Time taken to achieve hemostasis has been suggested as a reliable surrogate measure to determine the depth of inflammation in the pulp. In absence of any other intraoperative indicator, it serves as a useful guide to the extent of pulp tissue removal required during pulpotomy. This trial will help formulate evidence based guideline regarding time for hemostasis advisable to achieve optimum success during pulpotomy in teeth with signs indicative of irreversible pulpitis.

Eligibility Criteria:
Inclusion Criteria:

* Mature permanent mandibular molars with carious pulp exposures and signs suggestive of irreversible pulpitis.
* vital pulp with demonstrable bleeding upon entry.
* The tooth is restorable.
* Tooth with mobility and probing depth within normal limits.
* Soft tissues around the tooth are normal with no swelling or sinus tract.
* No evidence of chronic apical periodontitis (PAI 1,2)

Exclusion Criteria:

* patients who report history of antibiotic intake in past 1 month or analgesic intake in past 3 days.
* pregnant women.
* absence of opposing teeth
* 3rd molars
* medically compromised patients .
* Tenderness on percussion positive
* pathologic mobility
Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis

The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.

Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application.

Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3 units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin infusion. Besides timing of the glargine dose, no other changes in standard patient care will occur in those patients enrolled in this study, the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm.

Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 8/1/2014 to 7/31/2016.

Eligibility Criteria:
Inclusion Criteria:

* Bicarbonate \<18 mg/dL
* Anion gap \>16
* Blood glucose \>250 mg/dL
* Ketonemia or ketonuria

Exclusion Criteria:

* Pregnant women
* Refused consent
* Patient left ED against medical advice
Effect of Mulligan'Mobilization With Movement on Pain, Disability and Range of Motion in Patients With Knee Osteoarthritis

we tested the effect of adding the mobilization with movement to the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA.

study hypothesis: there will be no significant difference between traditional physical therapy program and the mobilization with movement plus the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA


Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral osteoarthritis knee age ranges from 30-60 years old grade 1 or 2 on Kallegren and Lawerance scale. body mass index not more than 36

Exclusion Criteria:

* history of major knee injury or surgery, tumors, osteoporosis, patients undertaking analgesics, patients with uncontrolled hypertension, bleeding, dermatological problems, psychiatric disorders, hearing problems, cognitive problems and pacemaker.
Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy.

OBJECTIVES:

* Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse.
* Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease.

OUTLINE: This is a randomized study.

* Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks.
* Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy.

Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter.

PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically documented invasive adenocarcinoma of the prostate staged pT3 pN0 after radical prostatectomy

  * Preoperative staging must have been T0-3 N0 M0 based on physical exam, chest x-ray, bone scan, CT or MRI of entire pelvis and abdomen, and serum PSA
  * At least 1 of the following features must be present:

    * Complete capsule invasion (i.e., perforation)
    * Positive surgical margins (microscopic or gross)
    * Seminal vesicle invasion
* Radiotherapy must begin within 16 weeks following surgery, after recovery of urinary function

PATIENT CHARACTERISTICS:

Age:

* 75 and under

Performance status:

* WHO 0-2

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other malignancies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No more than 4 months of preoperative hormonal therapy

Radiotherapy:

* Not specified

Surgery:

* Radical prostatectomy required within 12 weeks with recovery of urinary function
Response of Liver to 12 Weeks of Resistance Band Training Program in Burned Patients.

Serum concentrations of alanine transaminase (ALT) and aspartate transaminase (AST) significantly increased immediately upon burn trauma and remained significantly elevated for about three years.

Resistance training has been shown to reduce the risk of insulin resistance, aminotransfer¬ase levels, dyslipidemia and impaired fasting glucose and can be beneficial for glucose-lipid metabolism.

1. Measurement procedures:

   Serum blood draws will be taken by certified technicians with the participant in a seated position.

   Spectrophotometry is the measurable analysis technique using electromagnetic spectra. It deals with the ranges of wavelengths such as near ultraviolet, near-infrared and visible light. A device called a spectrophotometer is used to measure the absorbance or transmittance through a liquid sample. The spectrophotometer measures a specific wavelength and it is possible to choose any wavelength in the spectrophotometer register as the double beam sends a beam through a blank reference sample and one through the sample to be measured.

   Normal values that will be used for patients are 0-45 IU/l for Alanine transaminase (ALT) and 0-35 IU/l for Aspartate transaminase(AST) Measurements will be taken before the treatment (pre-treatment) and after 12 weeks (post-treatment).
2. Therapeutic procedures:

Resistance band for resistance training:

Resistance training will be performed for 12 weeks for 3 sessions/week on non-consecutive days. The program will consist of six exercises: triceps press, biceps curl, lat pull-down, leg press, leg extension and sit-ups using a resistance band. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching followed by resistance training that will be done as a cir¬cuit, ending with a 5-minute cooldown. The 1 repetition maximum (1RM) is measured at baseline and following the intervention. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first 3 weeks, progressing to two circuits, using 60% of their 1RM and repeating 10 times for the second 3 weeks. During the third 3 weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last 3 weeks, patients will do three circuits using 70% of their 1RM and repeat 10 times. A 90-second rest will be allowed between sets of exercises.

Eligibility Criteria:
Inclusion Criteria:

The subject selection will be according to the following criteria:

* Age range between 20-45 years.
* Male and female patients will participate in the study.
* All patients have burn with BBSA about 30% to 50%.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* The potential participants will be excluded if they meet one of the following criteria:
* Cardiac diseases.
* Burn of sole of foot.
* Exposed hand or foot tendons.
* Upper or Lower limb amputation.
* History of liver diseases.
* Body mass index (BMI=kg/cm2)\<30%.
Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder

The 82.1% treatment failure of post-traumatic stress disorder(PTSD), associated with gunshot wounds, is related to high incidence of chronic pain syndrome as well as resistance to the PTSD treatment. Defining treatment failure predictors among the PTSD patients with gunshot extremity wounds and the following therapy would improve treatment outcomes.

It has been noted that the PTSD in military combatants results from their direct participation in military actions. The study revealed that if a military combatant was wounded during the action operation, his emotional and subjective feelings will 100% lead to the PTSD. Other scientists state about the PTSD remote treatment failure in 80% of the military combatants. The study evidences about 82.1% of the PTSD m-related wounds treatment failure, which was essential for the subsequent studies. Some authors state about treatment effectiveness of psychopharmacological drugs and psychotherapy, which is rather questionable. Traumas and somatic diseases in the PTSD patients are known to accumulate their negative effects. So, definition of the PTSD treatment failure predictors may improve treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* gunshot wounds
* post-traumatic stress disorder
* patients who need anesthesia

Exclusion Criteria:

* the patient has no post-traumatic stress disorder
* the patient has no gunshot wounds
Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy

This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Juvenile idiopathic arthritis evolving for more than a year

Exclusion Criteria:

* intra-articular infiltration performed less than a month ago
Taste Properties of HIV Inhibitor

The purpose of the study is to assess the taste properties of HIV inhibitor


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women of non-childbearing potential professional sensory panelists
* Aged between 25 and 80 years

Exclusion Criteria:

* History of relevant drug or food allergies, cardiovascular or Central nervous system (CNS) disease, clinically significant pathology, history of mental illness
* Positive HIV test
Effect of Music on Nursing Students' Skills, Anxiety

Objectives: This study aimed to determine the effect of music on nursing students' skills, anxiety, self-confidence perception, and vital signs.

Design: Single-blinded study with parallel groups. Setting: Faculty of Nursing. Participants: Sixty first-year students who took the Nursing Fundamentals course were randomly assigned to the intervention (n = 30) and control (n = 30) groups.

Methods: Data were collected using the Student Information Form, Subjective Self-Confidence Assessment Tool, and State Anxiety Scale from April 6 to 11, 2022. The students in the intervention group listened to music for 15 min before and during the peripheral intravenous catheter placement skill practice, while no intervention was applied in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Taking the Nursing Fundamentals Course for the first time
* Not placing an IV catheter before
* Volunteering to work

Exclusion Criteria:

* Being a healthy vocational high school graduate
* Being a foreign student
Black Pooling Project

To conduct a person-level meta-analysis by pooling 9 United States studies with both black and white cohorts.

BACKGROUND:

Over the last three decades a sustained and marked decline in death rates from coronary heart disease (CHD) has occurred for all major demographic groups of the US population. Recently, however, the decline has proceeded less rapidly in blacks than in whites, and in women than men. These trends have focused further attention on possible heterogeneity in the risk factor patterns among the demographic sub-groups. As is well recognized, the knowledge on CHD risk factors and statistical models used to predict personal risk of CHD have been based on studies among white populations. In some epidemiological studies with samples from black populations, large variation in the effect of specific factors has been noted. Given the small sample of blacks under investigation, however, low statistical power exists for many of the black-white comparisons. The fundamental obstacle to progress in this area remains the absence of the cohorts of sufficient size that is representative of all four major groups. Hence, a strong rationale exists to undertake a "pooling project" to clarify a set of important unanswered questions in cardiovascular disease epidemiology.

DESIGN NARRATIVE:

Person-level meta-analysis will be conducted by pooling 9 large United States epidemiologic studies with both black and white samples: the First National Health and Nutrition Examination Survey (NHANES I) Epidemiological Follow-up Study, the NHANES II Mortality Follow-up Study, the Charleston Heart Study, the Evans County Heart Study, the Chicago Heart Association Detection Project in Industry, the Atherosclerosis Risk in Communities Study (ARIC), the Follow-up Study of the screenees for the Multiple Risk Factors Intervention Trial (MRFIT), the Follow-up Study of the participants from the MRFIT, and the Follow-up Study of the participants from the Hypertension Detection and Follow-up Program (HDFP). Black-white comparison will be performed on the CHD incidence and mortality, exposure-outcome relationship, patterns of co-morbidity (or coexistence of risk factors) and population attributable risk. Multivariate risk functions will also be examined in blacks and whites in the three contexts: ordering risk, magnitude of relative risks, and estimation of absolute risk.

Eligibility Criteria:
No eligibility criteria