cyrilzakka/clinical-trials huggingface dataset:
Comprehensive Evaluation of Visual Function

The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.

The purpose of the research is to study the level of visual functioning in individuals with various eye conditions when using different types of eyeglass lenses. Therefore, the goal of this study is to determine factors that may account for variability in the visual functioning of individuals with a range of refractive errors and their ability to perform everyday activities when equipped with different types of lenses. We hypothesize that the subjects will perform visual tasks of function better when using iZon™ Wavefront-Guided Glasses than with conventional glasses. This hypothesis is based upon the glasses yielding better visual acuity and because the design of the glasses reduces the effects of glare. This research is important so that alternate treatments and vision correction may be implemented which will have a more beneficial impact on those with refractive errors and visual impairment.

Eligibility Criteria:
Inclusion Criteria:

* Have normal vision
* Are far-sighted or near-sighted
* Have no eye diseases Subjects aged 18 and over, who have refractive errors ranging from +5.0 to -5.0 and/or who have eye disease will be included in the study.
Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer

This phase III trial studies how well a telehealth self-management program works in improving survivorship care and outcomes in stage I-III non-small cell lung cancer or colorectal cancer survivors. Survivor self-management program focuses on coaching patients on follow-up care after cancer treatments. Participating in the program may improve knowledge and confidence about follow-up care, communication with cancer care and primary care doctors, and quality of life after cancer treatment in non-small cell lung cancer or colorectal cancer survivors.

PRIMARY OBJECTIVES:

I. Determine the efficacy of the intervention on care coordination, communication, and primary care provider (PCP) knowledge, comparing the intervention and attention control arms at 4 and 8 months post-accrual.

II. Determine the efficacy of the intervention on survivor outcomes, comparing the intervention and attention control arms at 4 and 8 months post-accrual.

EXPLORATORY OBJECTIVE:

I. Assess the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (SURVIVOR SELF-MANAGEMENT): Patients receive a personalized care plan/resource manual. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) about self-management skills building, then 3 maintenance telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) for additional self-management skills building support. A copy of patient's care plan is also sent to their PCP.

ARM II (ATTENTION CONTROL): Patients receive an American Society of Clinical Oncology (ASCO) care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to review a handbook about life after cancer treatment, then 3 monthly telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) to answer questions about the handbook. A copy of the ASCO care plan is also sent to their PCP. After study initiation, patients are followed up at 4 and 8 months.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer (NSCLC) and colorectal cancer survivors who are 4 months post-treatment completion
* History of stage I-III disease
* Ability to read or understand English
* All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.

This study will be carried out on 100 patients with liver cirrhosis and ascites who will be enrolled from Tanta University, Tropical Medicine Department in the period between January 2014 to 6 months. The selected patients will be randomly assigned to receive 400 mg of norfloxacin daily or 1200 mg of rifaximin daily and will be classified into two groups :

Group 1 : 50 patients will be treated with 1200 mg of rifaximin daily. Group 2 : 50 patients will be treated with 400 mg of norfloxacin daily.

Eligibility Criteria:
Inclusion Criteria:

* Previous episode of SBP
* Total protein in the ascitic fluid below or equal to 1.5 g/dL

Exclusion Criteria:

* Allergy to quinolones
* Antibiotic therapy in the 2 weeks preceding inclusion
* Recent ( within the previous 2 weeks) episode of digestive hemorrhage
* Hepatocellular carcinoma or other neoplasias able to shorten life expectancy
* Pregnant and lactating women
CO2-laser Treatment for Caesarean Section Scars

Fractional Co2-laser for treatment of mature caesarean section scars.

Randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.

Eligibility Criteria:
Inclusion Criteria:

* mature caesarean section scar

Exclusion Criteria:

* systemic uncontrolled disease
* recent or current cancer
* smoking
* keloid formation
* wounds or local disease int treatment area
* pregnancy or lactation
Pain Reduce Following Refractive Surgery

applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain

Assessed for pain at 1, 2 and 4 hours and 1, 3 and 5 days. Comparison to non study eye will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent bilateral PRK for myopic correction.
2. Age 18-60.
3. Patient complains of significant pain.
4. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits

Exclusion Criteria:

1. Any other anterior segment abnormality other than that associated with PRK.
2. Any abnormalities associated with the eye lids.
3. Prior laser treatment of the retina.
4. Any ophthalmic surgery performed within three (3) months prior to study excluding PRK.
5. Diagnosis of glaucoma.
6. Active diabetic retinopathy.
7. Clinically significant inflammation or infection within six (6) months prior to study.
8. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
9. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device.
10. Specifically known intolerance or hypersensitivity to contact lenses.
11. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
12. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.


Eligibility Criteria:
Inclusion Criteria:

1. Adults and children (age 2 or older) being managed or treated for nonalcoholic fatty liver disease. Diagnosis is based on the clinical judgement of the care provider.

Exclusion Criteria:

1. Inability to provide informed assent/consent.
Effects of Acute and Chronic Empagliflozin Heart Failure

This is a 60-patient randomized, double-blind, placebo-controlled mechanistic study to understand the utility of empagliflozin in worsening heart failure (HF) patients with or without diabetes. Participants will be randomized to empagliflozin or placebo for 6 weeks, followed by a crossover of placebo patients to active therapy at 6 weeks-12 weeks.

This is a 60-patient randomized, double-blind, placebo-controlled mechanistic study to understand the utility of empagliflozin in worsening heart failure (HF) patients with or without diabetes.

The broad study design aims to evaluate change in gold standard determined body fluid spaces, sodium avidity, and cardio-renal biomarkers longitudinally in patients treated with placebo vs. empagliflozin over a 6 week period. Primary analysis of the randomized intervention will occur during the 6 week double blind period. Crossover of placebo patients to active therapy from 6-12 weeks will provide additional exploratory mechanistic data at low incremental cost and provide added benefit to enrollment of the study.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of worsening heart failure (worsening of congestive symptoms with current therapies) in the opinion of the investigator.
* A planned outpatient diuretic intervention (either up-titration of loop or addition of thiazide diuretic) for worsening heart failure per treating clinician. Diuretic intervention can occur via an unplanned in person visit (e.g., outpatient ambulatory clinic, emergency department, same day access visit) or via a telephone encounter (e.g., patient calling the clinic with reported weight gain and SOB that is prescribed uptitration of diuretic therapy).
* Estimated or reported weight gain of at least 5 lbs.
* Chronic daily oral loop diuretic dose ≥ 20mg furosemide equivalents for at least one month prior to enrollment
* Estimated GFR (eGFR) ≥ 20 mL/min/1.73 m2
* Age ≥ 18 years old
* Signed informed consent
* English speaking participants only

Exclusion Criteria:

* Need for heart failure hospitalization at the time of randomization
* Current use or plan to initiate renal replacement therapy
* Significant bladder dysfunction or urinary incontinence
* Inability to comply with the serial urine collection procedures
* Chronic use of natriuretic doses of thiazide diuretics (≥50mg hydrochlorothiazide or equivalent)
* Critical stenotic valvular disease, complex congenital heart disease or prior heart transplant
* History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
* History of or current urosepsis or frequent urinary tract infections
* Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study) or active bleeding
* Pregnancy or breastfeeding
* Appears unlikely or unable to participate in the required study procedures, as assessed by the study PI, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease)
Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated with Robotics in Patients with Erosive Osteoarthritis

This is a randomized, evaluator-blinded, non-profit, single-center, exploratory, medical device clinical trial aimed at evaluating the efficacy in terms of reduction of functional limitation of the combination of occupational therapy, paraffin therapy, and robotic arm mobilization compared to the center's SoC, i.e. paraffin therapy and occupational therapy.


Eligibility Criteria:
Inclusion criteria:

* Male and female patients aged between 35 and 70 years.
* Diagnosis of erosive osteoarthritis of the fingers confirmed clinically and radiologically.
* Presence of persistent functional limitation (at least 6 months) in finger flexion
* VAS value pain referred only to the hands \> 5 in the week prior to enrollment in the study.
* Patients not responding to anti-inflammatory and steroid therapy used in the last 2 years.
* Patients eligible for occupational therapy and paraffin therapy.
* Signature of the Informed Consent Form for participation in the study and processing of personal data.

Exclusion criteria:

* Patients aged \< 35 years and \> 70 years.
* Patients with diagnosis of overlapping arthritic pathologies.
* Patients undergoing hand surgery in the 6 months prior to the evaluation.
* Patients with functional alterations to the hands due to trauma.
* Patients with cognitive or mental disorders.
* Corticosteroid use within 6 months prior to baseline.
* Patients unable to use robots with mechanical arms
Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence

INTRODUCTION: Stress urinary incontinence is a common condition in women and can be defined as the involuntary loss of urine on exertion, exercise, sneezing or coughing. This pathology causes physical discomfort and impacts the quality of life in a negative manner. Physiotherapeutic exercises is a treatment with low cost and high patient attendance. It can be applied with focus on strengthening the pelvic floor muscles or on muscular synergism. OBJECTIVE: To compare the effectiveness of Kegel exercises performed alone or performed in association with the strengthening of the muscles of the hip in the treatment of stress urinary incontinence. METHODOLOGY: The study is a randomized, blinded clinical trial. It aims at assessing objectively the strength of the pelvic floor, the improvement in the number of episodes of loss and impact on quality of life. The study will accept up to 40 women, who will be divided into two groups of physical therapy: group 1 (that will strengthen the pelvic floor muscles with Kegel exercises) and group 2 (that will perform strengthening the pelvic floor muscles with Kegel exercises associated with the strengthening of muscles of the hip). The two groups will be evaluated at the beginning and at the end of treatment.

the strength of the pelvic floor muscles will be evaluated with the aid of a perineometer

Eligibility Criteria:
Inclusion Criteria:

* Women with 30 to 70 years of age;
* Clinical diagnosis of stress urinary incontinence;
* Urodynamic study.

Exclusion Criteria:

* Stress urinary incontinence with sphincter deficiency;
* Urinary urgence;
* Mixed urinary incontinence;
* Pregnant women;
* Neurological or muscular disease that interfere with continence;
* Urinary infection;
* Genital prolapse;
* Gynecological surgery for urinary incontinence in the last year;
* Hormone replacement therapy;
* Strength 0 in functional evaluation of the pelvic floor muscles.
Detection of Immune Changes as a Result of Surgical Trauma in Human Subject

Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study to characterize the cellular and molecular mechanisms immune response to surgical trauma. Additionally, detailed information about patients' recovery profile will be recorded over a period of 6 weeks, with the eventual goal of linking immune responses to recovery profiles.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 90
* Planning to undergo hip surgery
* Fluent in English
* Willing and able to sign informed consent and HIPAA authorization

Exclusion Criteria:

* Any systemic disease that might compromise the immune system
* Diagnosis of cancer within the last 5 years
* Psychiatric, immunological, and neurological conditions that would interfere with the collection and interpretation of study data
* Pregnancy
* Any other conditions that, in the opinion of the investigators, may compromise a participant's safety or the integrity of the study
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PLX5622 in Healthy Adult Volunteers

The purpose of this study is to study the safety and tolerability of a single dose of PLX5622 in healthy, adult human volunteers. This will be the first time PLX5622 has been taken by humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female subjects, 18-65 years of age inclusive
* BMI 18 to 32 kg/m2 inclusive
* Female subjects must be surgically sterile or postmenopausal for the past year and have a negative urine pregnancy test. Male subjects and their partners of childbearing potential must be willing to use two methods of contraception, one of which must be a barrier method (e.g. condom) for up to 90 days after the last study drug administration.
* Willing and able to remain in the clinical research unit as required by the protocol
* Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* History or presence of any disease, medical condition, or surgery, which may have an effect on drug absorption, metabolism, distribution, or excretion of the investigational product
* Laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis) that the investigator believes show clinically relevant significant abnormalities for the normal reference range
* Any abnormality in the ECG (including QTc ≥450 msec) that in the opinion of the investigator increases the risk of participating in the study
* History or presence of alcoholism or drug abuse within the year prior to dosing
* Tobacco use, either current or within 3 months prior to dosing
* Use of any prescription medications or herbal remedies within 14 days prior to dosing, or use of over-the-counter medications or vitamins within 7 days prior to dosing, unless approved by the Sponsor
* Donation of whole blood within 56 days prior to the study
* Plasma donation within 7 days prior to the study
* Participation in an investigational device study or receipt of an investigational drug within 4 weeks prior to dosing
* Positive urine test for drugs of abuse
* Confirmed HIV, hepatitis B, or hepatitis C infection
Mechanisms of Disease R/R in CAR-T for Hematologic Malignancies

The primary purpose of this IRB protocol is to perform immune profiling focusing on the measurement of Myeloid derived suppressor cells (MDSCs) over time in patients receiving Chimeric antigen receptor (CAR) T therapy and determine the correlation between immune profile and disease relapse/resistance in CAR T therapy.

The primary purpose of this IRB protocol is to perform immune profiling focusing on the measurement of MDSCs over time in patients receiving CAR T therapy and determine the correlation between immune profile and disease relapse/resistance in CAR T therapy. Blood samples and accompanying health information (including PHI) may be collected from standard of care, non-significant risk, research-only procedures or obtained from our Division Research Repository and Database (Duke IRB Pro00006268) or DUHS Biospecimen Research and Biobanking protocol (Duke IRB Pro00035974). All hematologic malignancy patients treated with commercial CAR T products will be screened and enrolled for the study.

The investigators will perform multivariable regression to see if the number and function of MDSCs can be used as independent factors to predict disease relapse at 1 year after CAR T treatment, overall survival or progression-free survival. The studies will not require additional invasive procedure solely for the study.

The investigators will use blood samples that are performed as part of standard care. Therefore, no additional procedure is needed. The major potential risk associated with the study is the breach of confidentiality.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
2. Has a confirmed diagnosis of hematologic malignancy and will be undergoing CAR T therapy with commercial CAR T product.
3. Patient who has a confirmed diagnosis of hematologic malignancy and will be receiving CAR T therapy under clinical trial protocol will also be eligible if the clinical trial sponsor and the investigator approve patient participation in the study.

Exclusion Criteria:

* NA
Patient Satisfaction With Mechanical Cervical Ripening

In this study, we aimed to compare three mechanical methods such as foley catheter, cook balloon catheter and modified double-balloon Foley catheter for cervical ripening in terms of patient satisfaction

This is a prospective observational study. The planned sample size is 34 pregnant women per group with 90% power and 0.05 alpha error.

VAS score systems and Salmon's item list were used to evaluate the satisfaction level.

The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score \<6, using a foley catheter cook balloon catheter or modified double-balloon Foley catheter for cervical ripening and high-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders).

The exclusion criteria are being younger than 18 or over 40, communication problems, bishop score \>6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred uterus (cesarean or myomectomy), known fetal structural or chromosomal anomaly, presence of non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage, operative delivery, presence of maternal, fetal or neonatal complication.

The primary outcomes are the differences in satisfaction level between methods with using either the VAS score system or Salmon's item list and pain scores.

The secondary outcomes are the effects of giving birth within 24 hours, parity status, the length of the first stage of labor education level and cesarean section due to failed induction on the satisfaction level.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40
* Singleton pregnancy
* Vertex presentation
* Bishop score \<6
* Using a Foley catheter cook balloon catheter or modified double-balloon Foley catheter for cervical ripening
* High-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders).

Exclusion Criteria:

* Being younger than 18 or over 40
* Communication problems
* Bishop score \>6
* Being at active labor
* Multifetal pregnancy
* Non-vertex presentation
* Scarred uterus (cesarean or myomectomy)
* Known fetal structural or chromosomal anomaly
* Presence of non-reassuring fetal cardiotocography before cervical ripening
* Regional anesthesia during the first stage
* Operative delivery
* Presence of maternal, fetal or neonatal complication.