cyrilzakka/clinical-trials huggingface dataset:
eGPA and Local Inflammation Within the Ear, Nose and Throat Area

Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed.

See Brief summary.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age

  * able to give informed consent
  * In CRSwNP group: availability of bilateral nasal polyps as diagnosed by endoscopy or CT scan
  * In Severe asthma group: clinical diagnosis of asthma with forced expiratory volume at one second(FEV1) \<80% AND either FEV1 reversibility \>12% initial or documented positive metacholine challenge (PC20 \< 8 mg/ml)
  * In eGPA group: Fulfilling the 2022 ACR/EULAR criteria for eGPA (Wechsler et al., 2017)
  * In GPA group: fulfilling the American College of Rheumatology (ACR)/EULAR GPA criteria (Robson et al., 2022)
  * In healthy controls: absence of asthma symptoms, no bronchial hyperresponsiveness

Exclusion Criteria:

* unable to give informed consent
* Active smoking \< (less than) 6 months from baseline visit
* Concomitant use of dupilumab within 6 months of baseline visit
* pregnant or breastfeeding woman
* in CRSwNP group: current use of asthma medication, eGPA
* in healthy controls: chronic use of local anti-inflammatory agents
* in healthy controls: use of immunosuppressive medication
* in healthy controls: use of antibiotics within the last month (before start study/screening/)
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis

The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.


Eligibility Criteria:
Inclusion Criteria:

* If a woman of childbearing potential, the study participant must not be pregnant at the time of consent and must take contraceptive measures to prevent a pregnancy while actively participating in the study
* The study participant may be of any gender or ethnic background.
* Must experience knee pain at least weekly for at least 3 months.
* Must have failed a minimum of 6 weeks of first line, conservative therapy
* Demonstrated clinical and radiographic evidence of OA diagnosis
* Grade 2, 3, or 4 Kellgren-Lawrence score in one knee.
* Normal or within protocol approved limits of laboratory blood and urinalysis tests
* Must be suitable for cellular therapy per the Investigator's opinion
* Must be suitable for liposuction per the Investigator's opinion
* Must possess the cognitive ability to understand the investigational nature of this clinical trial and voluntarily provide consent for study participation

Exclusion Criteria:

* Evidence of OA in the contralateral knee with a Kellgren-Lawrence score greater than 2
* If a woman of child-bearing potential, the study participant must not be pregnant or attempt to become pregnant while actively taking part in the study.
* Steroid injection in either knee within 60 days of providing informed consent
* The subject must not be diagnosed with any of the following diseases at the time of consent:

  * Osteonecrosis
  * Active autoimmune disease
  * Serious cardiac condition
  * Psychotic Diseases
  * Epilepsy
  * Uncontrolled diabetes
* Prescribed immunosuppressive therapy at the time of consent
* Evidence of cancer at the time of consent
* History of alcohol or substance abuse
* Regular smoker at the time of consent
* Received experimental medication or participated in another clinical study within 60 days of providing informed consent
* Concurrent diseases or circumstances that the Investigator judges to be a potential risk to patient health or a confounding variable in the assessment of study endpoints.
The Effects of Bevacizumab and Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration (AMD)

One concern about repeated intravitreal injections of bevacizumab (Avastin) and ranibizumab (Lucentis) in wet age related macular degeneration, is that in addition to blocking the proteins that triggers the development and proliferation of abnormal vessels in the center of the retina, they may also result in changes in the normal vessels that feeds the outer part of the retina.

Small vessels with fenestrations (such as those that feed the outer part of the retina, which are called choriocapillaris) appear to be especially sensitive to this protein (called vascular endothelial growth factor, VEGF) withdrawal.

It is estimated that global blood flow in the vascular layer under the retina (called choroid) may be indirectly assessed by measuring the amplitude of the ocular pulsation (the pressure inside the eye change according to the cardiac cycle, similar to the change in blood pressure) which is called Ocular Pulse Amplitude (OPA). The Pascal Dynamic Contour Tonometer (Pascal DCT) is a new tonometer (a device which measures the pressure within the eye) designed to measure intraocular pressure and ocular pulse amplitude.

No published study has yet assessed the effect of bevacizumab (Avastin) or ranibizumab (Lucentis) treatment for wet AMD (or on any other retinal disease) on OPA. This is our aim in this pilot study, in which we will measure the pressure within the eye just prior to bevacizumab/Ranibizumab treatment, followed by repeated measurements a week and a month after the treatment.

For this purpose, up to 60 patients with wet AMD will be recruited.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female in the ages of 50 year or older
2. Willing and able to sign an inform consent

Exclusion Criteria:

1. Any history, signs or symptoms of any retinal or optic nerve disease, except AMD and mild hypertensive retinopathy
2. In the presently bevacizumab/ranibizumab treated eye, prior PDT and/or intravitreal Kenalog, during the last 3 months.
3. History of ocular surgery with the following exception: extra capsular cataract extraction with implantation of a posterior chamber intra-ocular lens.
4. History of ocular laser treatment, with the following exceptions: Posterior capsulotomy following cataract surgery.
5. Cataract or other media opacity precluding adequate fundus visualization of both eyes
Aortic Distensibility

Can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms.

Hypothesis: ECG-gated multidetector CT and ECG-gated Dual Source CT can be used to create multiple volumetric datasets of the abdominal aorta over the time period of the cardiac cycle, allowing for direct and regional calculations of abdominal aortic distensibility over the entire volume of the abdominal aorta, providing insight into risk of abdominal aortic aneurysm rupture and early large vessel stiffness.

Eligibility Criteria:
Inclusion Criteria:

* AAA must be at least 3 cm to a maximum 4.9cm cross-sectional diameter.
* BMI 31 or less.
* Creatinine results \<2.0 and within six months prior to scan.
* US patients must have only normal creatinine (0.9 to 1.4) for one year before study visit.
* Patients who are originally scheduled for US, who are then subsequently rolled in this study, will have only a ultrasound scan as followup after the initial CTA.

Exclusion Criteria:

* Creatinine \> 2.0.
* Creatinine \<0.9 or \>1.4 for those who are scheduled for US.
* Atrial fibrillation or other arrythmia.
* Known AAA greater than 5 cm in size.
* Allergy to contrast dye.
CommunityRx for Hunger: A Hospital-Based Intervention

The goal of this research program is to reduce health disparities by deploying an information-based intervention to increase caregiver utilization of community-based food supports and satisfaction with care among food insecure caregivers of hospitalized children. We will conduct a randomized controlled trial to evaluate, versus usual care, the effects of the CommunityRx-H intervention on caregiver use of food resources (primary), caregiver patient satisfaction with care (primary), caregiver mental health-related quality of life (secondary), and caregiver household food security (secondary). The proposed research will yield an understanding of how to leverage a child's hospitalization to effectively intervene on the problem of food insecurity. Findings will inform the rapidly growing field of healthcare-based interventions to address health-related social needs.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* English-speaking
* Living in 1 of the 16 ZIP code target regions
* Self-identify as a primary caregiver of a child \<18 years old hospitalized in CCH's general, intensive care or transplant units

Exclusion Criteria:

* Recollection of previous receipt of a HealtheRx
Effect of Psychosexual Caring Program on Sexual Well-being of Infertile Women

The present study aims to examine the effect of the psychosexual caring program on the sexual well-being of infertile women.

The study will be conducted with 70 infertile women. The intervention group (n = 35) will consist of infertile women who receive a psychosexual caring program, and the control group will consist of infertile women who receive standard care. Standard care includes the information given by the nurse about the treatment methods to be applied once. A total of 4 interviews will be held in the intervention group. In the first interviews, pre-test data will be taken. The psychosexual caring program will be conducted online as a group intervention. The psychosexual caring program includes interventions to promote body awareness, the meaning of sexuality, and marital relationships by gaining communication skills, sexual communication, body knowledge, information about sexual health, and its dimensions. After online interviews with groups, data will be collected for primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with primary infertility as a result of gynecological evaluation made by experts,
* Planning an assisted reproductive treatment method for women,
* Being active in terms of sexual intercourse,
* Being able to read and write in Turkish,
* Volunteering to participate in the study

Exclusion Criteria:

* Having any known illness related to sexual dysfunction (diabetes, hypertension, heart disease, kidney failure and autoimmune and rheumatic diseases),
* Having a psychiatric diagnosis, •Not having computer or mobile phone and internet access
Development of a Cough Control Questionnaire (CCQ)

Chronic cough (\>8 weeks in duration) affects 5-12% of the global population, and is associated with considerable health status impairment and comorbidities. Currently, there are validated severity and impact outcome measures whilst objective measures with cough frequency monitoring is not available in routine clinical practice. Unlike other chronic respiratory diseases, namely asthma, there are no validated dedicated tools to assess the control of cough as a disease.

This study aims to develop a validated patient-focused tool to assess the control of cough, which may be useful to evaluate the benefit and value of treatments in both clinical and research settings.

This study will involve 3 phases:

* Phase 1: Literature review. Review of currently available validated tools to assess control in respiratory diseases.
* Phase 2: Development of Cough Control Questionnaire (CCQ). Patient focus groups will aid development of a conceptual framework of cough control and ensure content validity through qualitative research methods including thematic analysis. Expert panel review of cough control framework will also be undertaken. CCQ item development will be grounded in patient focus groups and expert review findings, and reviewed through cognitive debrief with patients.
* Phase 3: Validation of CCQ. Prospective consecutive patients with chronic cough will complete CCQ, cough severity assessments and health status assessments. Patients will be invited to undergo objective cough frequency monitoring and cough challenge testing.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 and over with acute and chronic cough (including refractory chronic cough and unexplained chronic cough) and able to read and write in English. A smaller number (n =20) of healthy volunteers will also be included with no evidence of significant respiratory disease.

Exclusion Criteria:

* Current smokers (or smoking within the last 12 months), respiratory tract infection within the last 4 weeks, use of angiotensin converting enzyme inhibitors (ACEi), and pregnancy
Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures

The primary objective of this prospective, randomized study is to compare cosmetic outcomes between absorbable and non-absorbable sutures in truncal and extremity lacerations in the pediatric and adult population. Secondary outcome measures include wound complications such as infection and wound dehiscence at the initial visit; and parental satisfaction and keloid formation after three months post repair.

Even though there some studies showing good outcomes using absorbable sutures in skin closure in clean surgical wounds, ED based studies still need to be conducted to convince ED physicians that the use of absorbable sutures to close the skin in traumatic lacerations are just as acceptable as traditional non-absorbable sutures. Use of absorbable sutures confers several advantages over non-absorbable sutures. For one, patients do not need an additional physician visit either in the office, or more often that not, in the emergency department. These visits add to ED overcrowding, prolonged length of ED stay and are often not reimbursed if seen in the emergency department. Moreover, adult patients need to miss work or school and children often have to miss school or daycare to have these sutures removed. The potential to avert another traumatic experience from suture removal in children who had been restrained for suture placement is another advantage of using absorbable sutures over non-absorbable sutures.

Eligibility Criteria:
Inclusion Criteria:

1. Isolated injury
2. Non-contaminated or minimally contaminated wounds
3. Linear laceration 1-5 cms
4. Topical adhesives not indicated

Exclusion Criteria:

1. Trunk and extremity lacerations less than 1 cm or greater than 5 cm.
2. Moderately contaminated wounds or dirty wounds
3. Wounds with visible foreign bodies
4. Wounds more than 8 hours old
5. Wounds that can be repaired using topical adhesives
6. Complex wounds needing surgical referral
7. Wounds caused by mammalian bites
8. Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction
9. Wounds in patients who are currently taking steroids
10. Wounds in areas of tension such as the joint or crease
11. Patients with allergic reaction to the topical anesthetic
12. Irregular wounds
Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft with appropriate rigid internal fixation hardware as an alternative to autograft bone graft with rigid fixation in subtalar arthrodesis procedures. The primary objective of this clinical trial is to compare the overall fusion rate of the investigational to the control treatment. Fusion will be determined by clinical findings, radiographs and computed tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis.
2. Patients must be able to attend follow-up examinations for the duration of the trial.
3. The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery.
4. Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria:

1. Younger than 18 years old or older than 80 years old.
2. Has a condition that prevents ambulation or completion of any of the trial measurements.
3. Requires fusion of additional hindfoot or ankle joints simultaneously (i.e. a pantalar, tibiotalocalcaneal or triple arthrodesis). Concomitant midfoot or forefoot procedures, such as osteotomies, tendon or metatarsal procedures are not exclusionary.
4. Has treatment planned for the arthrodesis which does not require the use of screws.
5. Has any active infection of the hindfoot, a systemic infection or bacteremia.
6. Has received any treatment within the past 12 months which may interfere with bone metabolism \[bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)\].
7. Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.
Intranasal Diagnostics in Food Allergy: a Feasibility Study

The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.


Eligibility Criteria:
Inclusion Criteria:

* Aged 6 - 17 years old
* Physician-diagnosis of food allergy on the basis of:

  * Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR
  * History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR
  * Evidence of \>95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months
* Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.

Exclusion Criteria:

* Contraindicated as acutely unwell or current unstable asthma:

  * Acute wheeze in last 72 hours requiring treatment
  * Febrile ≥38.0oC in last 72 hours
  * Recent admission to hospital in last 2 weeks for acute asthma
* Current medication

  * Use of asthma reliever medication in last 72 hours
  * Recent administration of a medication containing antihistamine within the last 4 days
  * Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop

Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos.

Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.

Faculty at the University of Michigan School of Public Health (UM-SPH), Johns Hopkins School of Nursing (JHUSON), and Michigan State University (MSU) are collaborating with LiquidGoldConcept (LGC), a company focusing on simulation-based training in maternal-child care, to evaluate the impact of high-fidelity simulation on health professional learner outcomes. For the Phase I SBIR, LGC is developing a high-fidelity newborn simulator for healthcare professional education in clinical lactation.

Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos.

Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in a health professional training program (e.g. medical student, nursing student, physician resident)

Exclusion Criteria:

-
Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania

This trial will assess any efficacious benefit and any safety issues associated with the concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I disorder, manic or mixed episodes


Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of bipolar disorder and currently meet DSM-IV-TR criteria for a manic or mixed episode
2. Female patients must test negative on a serum pregnancy test at the time of enrollment and agree to use medically accepted contraception throughout the study.
3. Have YMRS score \> or = 20 at both the screening (Visit 1) and randomization (Visit 2) visits.

Exclusion Criteria:

1. Have participated (been randomized) in a clinical trial of another investigational drug (including olanzapine or carbamazepine) within 30 days prior to Visit 1
2. Have a history of agranulocytosis (absolute neutrophil count\< 500/uL) during the patient's lifetime
3. Have acute, serious or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (HgbA1c\>8%); severe hypertriglyceridemia (fasting triglycerides \> or = 500 mg/dl;hepatic insufficiency (specifically any degree of jaundice); recent cerebrovascular accidents; uncontrolled seizure disorders; serious acute systemic infection or immunologic disease: unstable cardiovascular disorders (including ischemic heart disease); or renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases (specifically current absolute neutrophil count , \<1500/uL)
4. Have a substance dependence (except nicotine or caffeine), based on DSM-IV-TR criteria, within the 30 days prior to study entry.
5. Require concomitant treatment with any other medication with primarily central nervous system (CNS) activity, other than those allowed in the protocol.