cyrilzakka/clinical-trials huggingface dataset:
Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients With Pseudomonas Aeruginosa

Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a Pseudomonas Aeruginosa chronic colonization.

Rates of DMBT1 (Deleted in Malignant Brain Tumor 1) will be compared between 2 groups of 30 CF patients : group 1 : with Pseudomonas Aeruginosa chronic colonization and group 2 30 CF patients without Pseudomonas Aeruginosa chronic colonization.

Eligibility Criteria:
Inclusion Criteria:

* CF patient 6 years
* Availability of sputum
* Signed Informed consent

Exclusion Criteria:

* Cardiac insufficiency
* Anti-inflammatory drugs on going
* Oral corticosteroid therapy
* Inhaled corticosteroids during the two weeks before inclusion,
* Patient awaiting lung transplantation
* Patient with a past history of heart/lung transplantation
* Patient with a sputum examination positive for : atypical mycobacteria, Burkholderia cepacia, Stenotrophomonas maltophilia,
* Patient chronically colonized with multiresistant Pseudomonas aeruginosa
* Orkambi© or Kalydeco© therapy
* Change of the CF treatment during the last 4 weeks +/- 2 days before inclusion : corticosteroid, pancreatic extracts, antisecretory drugs...
Genetic Contribution of Pain and Inflammation in IBS

The goal of the study is to identify possible polymorphisms on the loci of candidate genes that may be involved in modulation of pain and inflammation in irritable bowel syndrome.

Stored and de-linked blood or DNA from subjects with IBS will be utilized for analysis for possible polymorphisms at predetermined genetic loci located in chosen genes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with IBS and previously stored samples

Exclusion Criteria:

* Subjects without IBS and no previously stored samples
Impact of Preop Video on Patient Anxiety

To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery


Eligibility Criteria:
Inclusion Criteria:

* Prolapse surgery may include: apical repair with uterosacral ligament suspension, or sacrospinous/iliococcygeal ligament fixation, or sacrocolpopexy.
* They may also have a concomitant total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy, other compartment repairs for prolapse, or a suburethral sling for incontinence.
* Surgery by one of the fellowship trained Urogynecologists at TriHealth
* Age \>= 18
* English speaking
* Able to comprehend and answer the survey completely.

Exclusion Criteria:

* Concomitant procedure with another surgeon
* Resides in a nursing home
* Non-English speaking
* Patients with mental disability, Alzheimer's disease, dementia that would preclude complete answering of the survey or inability to answer the questions.
Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women

There is no widely used, statistically validated assessment for physical and mental health for the short- to medium-term in a postpartum population. PROMIS-29 has been validated for the assessment of these factors in a generic population, but has not been specifically evaluated for use with postpartum women.

This study is a longitudinal, single center observational cohort study designed to evaluate the reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 survey in a postpartum population. PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living. While this survey has shown utility in other populations, it has yet to be assessed in an obstetric population. The investigators plan to recruit patients who are recently postpartum from vaginal or cesarean delivery to complete virtual surveys at defined time points (0, 2, 6, and 12 weeks after delivery). The investigators will subject survey data to statistical measures of validity and reliability comparing with contemporaneously collected surveys of established metrics for quality of life (WHOQoLBREF) and general (global) state of health (numerical rating score 1-100).

The hypothesis is that the PROMIS-29 v2.1 questionnaire is a statistically valid and reliable means of assessing physical and mental health in a postpartum population.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and over
* singleton births
* 37 or more weeks gestational age
* multiparous or nulliparous patients
* spontaneous vaginal delivery or scheduled cesarean delivery with labor analgesia or neuraxial anesthesia
* give informed written consent

Exclusion Criteria:

* refusal to take part
* are unable to give or have withdrawn consent
* patients unable to communicate fluently in English
* patients who are less than 18 years old
* patients who had fetal demise or severely morbid fetal conditions such as intubation, cooling, expected surgical correction of congenital anomaly during hospitalization (although NICU admissions will be included)
* patients who were admitted in ICU
* patients who had failed neuraxial analgesia such as replaced epidurals or failed spinal requiring conversion to general anesthesia
* patients who had general anesthesia for cesarean delivery as defined by "GETA", including sedatives and deep sedation if not intubated
* patients who had intrapartum cesarean or had assisted/operative (i.e. vacuum, forceps) vaginal delivery.
Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)

We hypothesize that individuals with Alpha-1 Antitrypsin (AAT) deficiency have ongoing liver injury which is not detected by the usual blood tests used to look at liver function. This ongoing liver injury leads to cirrhosis in a significant number of adults with AAT deficiency.

Our overarching hypothesis is that liver disease in adults with AAT deficiency is the result of the accumulation of the abnormally folded protein within the endoplasmic reticulum of the hepatocyte. In some individuals, the intrinsic cellular mechanisms of the hepatocyte are sufficient to clear adequate amounts of the abnormally folded protein such that liver disease does not occur. In AAT deficient individuals who develop liver disease, environmental and other genetic factors stress the hepatocyte, and the normal cellular mechanisms that maintain homeostasis are disrupted, leading to liver disease.

For this proposal, our hypothesis is that the prevalence of liver disease in adults with AAT is higher than previously reported because liver injury and fibrosis is not accurately detected by available routine liver testing. Testing this hypothesis will require an initial evaluation for liver disease with liver function testing and imaging, and then histologic confirmation by liver biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Alpha-1 Antitrypsin deficiency confirmed to be PI\*ZZ by both genotype or another identified rare allele;
* Age range from 18-70;
* Willingness to consent to liver biopsy;
* Ability to travel to UF as necessary by protocol; and
* Platelet count greater than or equal to 50,000/mm3 and an INR less than or equal to 1.5.

Exclusion Criteria:

* Hemophilia, anticoagulant therapy that cannot be interrupted briefly, malignancy, or any other condition that would compromise the safety of a liver biopsy;
* Any known pre-existing medical condition that might interfere with the patient's participation in and completion of the study or any condition, which in the opinion of the investigator would make the patient unsuitable for enrollment;
* Active substance abuse including, but not limited to, alcohol, intravenous or, inhaled drugs;
* History of adverse reactions or allergy to the local anesthetic, sedative, or pre-medication used for the percutaneous liver biopsy;
* Poor venous access making the subject unable to complete the required laboratory testing schedule; and
* Females who are pregnant or lactating at time of enrollment. Should a female subject become pregnant during the follow up period after the initial liver biopsy, continued participation would be allowed if the following conditions are met: the subject desires to continue; a discussion of risk and benefits of participation between the principal investigator and the subject has occurred; and no liver biopsy would be performed in the follow up period.
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy

The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.

skin cutaneous atrophy due to corticosteroids limits the long-term use of highly potent topical glucocorticoids which are the treatment of choice for many inflammatory skin diseases. This atrophy results in fragile skin, delay of healing, purpura, irreversible striae, telangiectasia and secondary infections. Up to now, no treatments can prevent efficiently skin atrophy.

The mineralocorticoid receptor, belonging to the superfamily of nuclear receptors, is expressed in human epidermis but its actual function is unknown. Experimental results in animals obtained in INSERM unit U772 by Dr N FARMAN suggest that spironolactone which is a mineralocorticoid receptor antagonist 1- might limit epidermal atrophy and 2- might promote healing.

Study description We propose to test clinically these hypotheses for the first time on humans, at the CIC in BICHAT's hospital on healthy volunteers: 1- by applying on the skin a highly potent cutaneous corticosteroids in association or not with spironolactone, 2- by applying or not spironolactone on wounds after 3-mm punch biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sex, aged between 20 and 50 years
* Woman with effective contraception and pregnancy test negative before inclusion.
* Subject considered healthy after a detailed review (interview, clinical examination)
* Subject belonging to a social security scheme (beneficiary or have the right)
* Subject having signed a free and informed consent
* Integrity of the skin at forearms
* Subject available the next 7 weeks and able to go to CIC once a day from Monday to Friday
* Subject accepting four skin biopsies at D29
* no washing forearms during 2 hours after applications

Exclusion Criteria:

* Chronic Alcoholism
* Drug-addiction (comprehensive interview with a sampling in case of doubt)
* Woman pregnant or breast-feeding
* Subject involved in another trial or in exclusion period of another protocol
* Subject has already received more than 3700 Euros in compensation for damages suffered constraints in the past 12 months for his involvement in biomedical researches
* Subject has already participated in this protocol
* Phototypes 5 and 6
* Clinical skin atrophy
* History of severe chronic skin disease
* Problems of healing
* Treatment with oral corticosteroids, mineralocorticoids or spironolactone (Aldactone, Flumach, Practon, Spiroctan, Spironone, Aldactazine, ALDALIX, Practazin, Spiroctazine ...)
Adjuvant Radiation Therapy vs. Watchful Waiting Following Radical Prostatectomy in High Risk Prostate Cancer

The purpose of this study is to determine whether adjuvant radiotherapy following radical prostatectomy in prostate cancer patients with positive margins or capsular penetration improves biochemical, overall and/or cancer specific survival and whether adjuvant radiotherapy is reasonably well tolerated when compared to watchful waiting.

In this study the investigators will evaluate adjuvant radiation therapy vs. watchful waiting in prostate cancer patients with positive margins or capsular penetration after radical prostatectomy. This is a randomized, open label, multicentre, collaborative study of FinnProstate Group and Finnish Radiation Oncology group.

Eligibility Criteria:
Inclusion Criteria:

Patients with pT3aN0M0 or pT2N0M0 prostate cancer with a positive margin, gleason score 2-10, preoperative PSA \< 20 ug/l, postoperative PSA \<0.5 ug/l after surgery (within 8 weeks), the WHO performance status 0-2, life expectancy at least 3 months, informed consent obtained.

Exclusion Criteria:

Other simultaneous cancer therapy including systemic endocrine therapy; more than 12 weeks has elapsed since surgery for prostate cancer; metastatic disease (N+ or M1); cancer invasion to the seminal vesicles; any other previous malignancy within the last 5 years except basalioma or squamous cell carcinoma of the skin; any contraindication to irradiation (severe locoregional infection, prior radiation therapy to the prostate/bladder); any physical or mental condition, which in the opinion of the investigator, may interfere with patient's ability to comply with scheduled visits.
Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis

The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients.

Ulcerative Colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to the mucosal layer of the colon. Anemia is a consistent clinical feature of IBD, and is encountered in one third of patients \[1\] and Anemia in Ulcerative Colitis is most commonly the result of iron-deficiency due to chronic blood loss through ulcerations in the colon.

Oral Iron supplementation has been used for the treatment of Iron Deficiency anemia but may cause disease exacerbation in patients with UC \[2\]. Iron also can increase cancer risk \[3\], and is associated with many side effects such as constipation, diarrhea, nausea, vomiting, abdominal pain and hyperchromia of feces. Furthermore, studies have shown that oral iron supplementation fails to resolve anemia in 2 of 3 IBD patients. \[4\]

Sucrosomial iron is a new preparation of iron pyrophosphate delivered within a phospholipid membrane and coated with sucrester (sucrose esters of fatty acids). it has been shown to have better absorption and higher bioavailability while minimizing side effects in multiple patient populations.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* Confirmed diagnosis of Ulcerative Colitis
* Proven Iron Deficiency Anemia (Hb \< 12 for females and Hb \< 13 for males AND iron saturation \<20%)
* Hemoglobin level \> 8g/dl

Exclusion Criteria:

* Age below 18
* Hemoglobin level \< 8g/dl
* Recently hospitalized for disease flare (within 3 months)
* Hemoglobinopathies (including thalassemia)
* Isolated proctitis
* Indeterminate colitis
* Known liver or kidney disease
* Known Celiac Disease
* Extensive small bowel resection
* Use of anticoagulants or aspirin
* Known intolerance to oral iron therapy
* Uninvestigated anemia
* Pregnant or lactating women
* Known hypersensitivity to iron sulfate
* Transfusion in the past 4 weeks
* Erythropoetin within the last 8 weeks
* Rheumatoid Arthritis
* History of menometrorrhagia or frequent epistaxis
Comprehensive Yoga Program (SKY) as Adjunct Therapy for Prostate Cancer

This randomized pilot trial studies the effect of comprehensive yoga program (SKY) in reducing stress, pain, and fatigue, and improving psychological well-being in patients with prostate cancer. SKY is one of the most widely used breathing techniques derived from yoga. SKY Yoga may improve quality of life in patients with prostate cancer.

PRIMARY OBJECTIVES:

I. Determine any change in pain, fatigue and psychological well-being as a result of SKY in prostate cancer (PCa) patients.

II. Assess changes in some physiological parameters in response to SKY in the same subjects, compare these with those from Part 1, and assess whether these translate into clinical effects.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Control Group): Patients undergo collection of blood, saliva, and hair samples after signing consent (pre-test 1), within 6-8 weeks after pre-test 1 (post-test 1), and within 2-4 months after post-test 1 (post-test 2). Patients may receive yoga instruction for 1 week after post-test 2.

ARM II (Yoga Group): Patients receive yoga instruction over approximately 3 hours daily for 5 days of week 1 and over 2 hours once a week of weeks 2-13. Patients also undergo collection of blood, saliva, and hair samples within 2 months prior to starting yoga instruction, within weeks 2-3, and within weeks 14-15.

Eligibility Criteria:
Inclusion Criteria:

* Having finished radiotherapy at least two months ago
* Ability to speak and read English and give informed consent
* Have an interest in being part of a study to evaluate yoga-derived exercises and eager to practice some kind of relaxation exercise daily for 3 months

Exclusion Criteria:

* Have a diagnosis of psychiatric illness or other major illness in addition to PCa, such as other cancers, uncontrolled hypertension, lung disease, liver disease or heart disease
Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

A total of 60 patients scheduled for thoracotomy with the aim of excision of pleural or lung cancer, will be randomized by the use of a computer-generated table of random numbers to receive duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure or a placebo pill following the same time schedule.


Eligibility Criteria:
Inclusion criteria

* ASA I, II, and III patients scheduled for thoracotomy for pleural or lung cancer resection.
* Age above 18 years \& less than 65 years.
* Adequate coagulation function within 30 days of surgery, defined as platelet count 100,000/mL or more, INR≤ 1.5, and partial thromboplastin time ≤40 seconds.

Exclusion criteria:

* Allergy to duloxetine or to local anesthetics.
* Patients with educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barriers that would prevent understanding of the informed consent \& preclude accurate assessment of postoperative pain and/or ability to answer questions about pain.
* Patients with severe renal and/or liver disease.
* History of chronic pain, long term narcotic use and/or antidepressants.
* Reasons for exclusion after randomization will be protocol violations or patient request.
* Fever, evidence of infection, or other coexisting medical conditions that would preclude epidural placement.
Uptake of Genetic Counseling Among African American Women

A feasibility study incorporating an educational intervention with cancer genetic risk assessment (CGRA) in the UI Health mammography center

African American (AA) women with a family history of breast cancer who are eligible for genetic counseling and express an interest in participating in the study will be consented and complete a brief survey before and after viewing an educational video on genetic counseling. Survey questions will be read to each participant. The questions capture data on the following constructs regarding genetic counseling: knowledge, attitudes, normative beliefs, motivation, perceived social norms, intention, efficacy beliefs, skills, environmental constraints and opinions on the video. The research team will conduct a review of the UI Health Electronic Medical Record (EMR) 3-6 months after study enrollment to determine if the participant attended a genetic counseling session.

Eligibility Criteria:
Inclusion Criteria:

* African American female age 25-69 years
* Presenting for mammogram at UI Health mammography clinic
* No prior history of breast cancer
* Completed cancer genetic risk assessment (CGRA) in UI Health mammography center
* Recommended for genetic counseling based on CGRA performed at the time of the mammogram.

Exclusion Criteria:

* Unable to complete the informed consent and survey in English
* Previously had genetic counseling for hereditary breast cancer risk
* Prisoners
Comparison of Postoperative Analgesic Consumption of the Erector Spina Plane Block and Serratus Anterior Plane Block

To evaluate the ability of Erector spina Plane block and Serratus Anterior Plane block to decrease postoperative pain and analgesia requirements in patients undergoing thoracotomy.

Thoracic wall nerve blocks such as Erector spina Plane block and Serratus Anterior Plane block have become popular for preoperative pain control in patients undergoing thoracotomy.

Eligibility Criteria:
Inclusion Criteria:

ASA I- ASA II Patients

Exclusion Criteria:

* history of allergy to the study medication
* refusal to participate
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System

This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.

The overall goal of this clinical study is to demonstrate the safety and efficacy of the remote fitting option. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet is no worse with remote fitting than in an in-office setting.

Eligibility Criteria:
Inclusion Criteria All Subjects

* Ability to provide Informed Consent/Assent
* 13 years of age or older
* Unilateral or bilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D)
* Minimum of 6 months of CI experience with a minimum of 1 month experience with a Naída CI or Sky CI sound processor
* At least moderate open-set speech recognition abilities (defined as speech in quiet score ≥ 60% as assessed at Visit 1)
* Minimum average score ≥ 3 on the Mobile Device Proficiency Questionnaire (MDPQ-16)
* English language proficiency as determined by the Investigator
* Willingness to use a BTE sound processor for the duration of the study

Inclusion Criteria Specific to Aidable Residual Hearing Group

* Residual low frequency hearing sensitivity (pure tone average of \< 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear for unilaterally implanted subjects and in both ears for bilaterally implanted subjects
* Willingness to use an in-canal acoustic earhook for the duration of the study

Exclusion Criteria:

* Clinical presentation indicative of potential implanted device malfunction
* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
* Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator