cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Principal Investigators:

The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.

Study Design:

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Primary Objective:

The primary objective of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

Secondary Objectives:

In patients receiving a non-licensed CBU:

* Assess incidence of transmission of infection
* Assess incidence of serious infusion reaction
* Determine 1 year overall survival after cord blood transplantation
* Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
* Assess cumulative incidence of chronic GVHD
* Determine platelet engraftment of \>20,000 mcL and \>50,000 mcL

Eligibility Criteria:
Inclusion Criteria:

* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age

Exclusion Criteria:

* Patients who are receiving only licensed CBUs
* Cord blood transplant recipients at international transplant centers
* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
Effect of Cequa™ in Subjects With Dry Eye Disease

This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.

This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.
2. Aged of at least 18 years.
3. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.
4. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.
5. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit

Exclusion Criteria:

1. Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.
2. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.
3. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.
4. Subjects who had already Use initiated any systemic or topical ocular medication.
Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4
* Between the ages of 18 and 55, inclusive
* Baseline EDSS score between 0.0 and 5.0, inclusive
* Have been treated with Avonex for at least the 12 months prior to randomization
* Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
* Cranial MRI scan demonstrating lesions consistent with MS.
* Have given written informed consent to participate in the study.

Exclusion Criteria:

* Primary progressive, secondary progressive, or progressive relapsing MS.
* MS relapse has occurred within 50 days of randomization
* A clinically significant infectious illness within 30 days prior to randomization
* History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks.
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
* Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3
* Abnormal blood tests at Screening Visit
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects

The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects.

Glepaglutide is a proposed International Nonproprietary Name for ZP1848


Eligibility Criteria:
Inclusion Criteria:

* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
* Body Mass index between 18 and 30.0 kg/m2
* Able to comply with all the trial procedures
* females will not be pregnant or lactating
* If female of childbearing potential or male agree to use contraception as defined in the protocol
* Male subjects must also be willing to refrain from donating sperm from trial Check-in until 90 days after the last dose

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of bowel obstruction, stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and/or cholecystectomy or hernia repair will be allowed).
* Clinically significant abnormality on 12-lead ECG
* Clinically significant abnormality in hematology, clinical chemistry, or urinalysis
* History of alcoholism or drug/chemical abuse within 2 years
* Alcohol consumption of \> 21 units per week for males and \> 14 units for females
* Positive urine drug screen
* Positive hepatitis panel and/or positive human immunodeficiency test
* Receipt of any investigational product within 30 days or 5 half-lives
* Previous exposure to GLP-1, GLP-2, human growth hormone, or analogs thereof 30 days prior to Check-in
* Use or intend to use any medications/products known to be strong inhibitors or strong inducers of cytochrome P450 3A enzyme, including St. John's wort
* Use of tobacco, smoking cessation products, or products containing nicotine (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum ) within 3 months prior to Screening
* Receipt of blood products within 2 months prior to Check-in and throughout the trial.
* Donation of blood or significant blood loss from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening and throughout the trial.
* Poor peripheral venous access.
Effects of Proxelan Somministration in Patients With Chronic Prostatitis

The purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa motility/concentration variations and the semen cytokines level decrease.


Eligibility Criteria:
Inclusion Criteria:

- prostatitis like symptoms for at least three months

Exclusion Criteria:

* significant post-voidal residual volume
* Meares and Stamey test suggestive for bacterial infection
* neoplasms,
* urinary stones,
* antibiotic therapy in the previous three months,
* irritable bowel syndrome,
* previous radiotherapic or chemiotherapic treatment,
* urethral stenosis,
* neurogenic bladder
* previous prostatic surgery
LED Therapy for Third Molar Surgery

LED Therapy for third molar surgery

LED Therapy using 830 nm in the mandibular third molar surgery

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Asians;
2. 20-55 years old;
3. Having mandibular third molars that are inappropriately erupted and need to be extracted due to caries, orthodontic reasons and/or periodontal disease;

Exclusion Criteria:

1. Underlying diseases: diabetes, cardiovascular disease, coagulation disorder, osteoporosis, hypertension, neurological disease, psychological disorder, tumor, systemic infection or cyst at the extraction site;
2. Women who are preparing for pregnancy, pregnant or breastfeeding;
3. Medication history: use of analgesics, anti-inflammatory drugs and/or antibacterial drugs 2 weeks before tooth extraction, need for systemic medication other than acetaminophen after surgery, allergy to acetaminophen, use of anticoagulants, bisphosphonates;
4. Bad habits, such as addicted to smoking, drinking, etc.;
5. Volunteers who have recently participated in other clinical trials;
Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed informed consent;
* Current diagnosis of schizophrenia;
* Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
* Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
* Females are not pregnant, not breast-feeding;
* Females are post-menopausal or surgically sterile or practicing birth control;
* Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control

Exclusion Criteria:

* Diagnosis of schizoaffective disorder;
* Diagnosis with mental retardation;
* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
* Acute psychosis hospitalization within past 6 months;
* Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
* Current clozapine treatment;
* Suicidal ideation or behavior;
* BMI of 39 or greater;
* Relevant drug sensitivity or allergy;
* Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;
* Recent clinically significant illness/infection or surgery;
* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
Genetic Determinants and Clinical Consequences of Early-onset Severe Obesity

The aim of the present study is to identify new obesity-related genetic defects and determine their association with clinical manifestations in families with childhood-onset severe obesity. The investigators hypothesize that by exploring children with severe early-onset obesity they can find new obesity-related genetic defects and by exploring obesity-associated clinical manifestations the investigators can elucidate the outcomes of severe childhood obesity.

Obesity is a complex disorder with many contributing genetic and environmental factors. The genetic causes and mechanisms for severe childhood obesity are still incompletely understood. It is acknowledged that obesity in some individuals could be a consequence of rare genetic variants with strong effect - these rare variants might be population specific.

The aims of this study are to determine

* inheritance patterns of early-onset obesity
* new obesity-related genetic variants and disease-causing gene mutations
* the association between obesity-related genetic defects and clinical manifestations
* the association between obesity-related genetic defects and psychiatric symptoms

in patients with early-onset obesity and their first-degree relatives

Significant advancements in genetic methodology provide new tools to explore genetic defects underlying obesity. Family-based approach provides several advantages compared to cohort studies to investigate genetic determinants of complex diseases.The unique genetic composition of the Finnish population enables identification of novel genetic entities.

Discovery of genetic defects associated with severe childhood-onset obesity will increase the investigators understanding of the pathogenesis of obesity and allows early detection, by genetic testing, of those at increased risk and optimal targeting of preventive measures.

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents age 10-18 years
* height-adjusted weight \>60 % before the age of 7 years.
* Finnish descent

Exclusion Criteria:

* patients with a known endocrine or genetic disorder underlying obesity (e.g. Prader-Willi syndrome, hypercortisolism, hypothyroidism)
Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study

The purpose of this study is to determine the optimal duration of anticoagulation therapy (3 months versus 12 months) with direct oral anticoagulant (edoxaban) for isolated distal deep vein thrombosis.

Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. There have been many clinical studies evaluating PE and/or proximal DVT, although data on isolated distal DVT (IDDVT) has been quite limited. However, IDDVT was reported to account for about half of all the diagnoses of DVT detected on ultrasound in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines suggest the same approach for IDDVT patients with cancer as proximal DVT patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that IDDVT patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, we will randomly assign IDDVT patients with active cancer to receive either edoxaban for 3 months (short DOAC group) or edoxaban for 12 months (long DOAC group).

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly found isolated distal deep vein thrombosis
* Patients complicated with active cancer
* Patients who are scheduled to be treated by anticoagulation therapy.

Exclusion Criteria:

* Patients with anticoagulation therapy for the index event before 10 days of allocation.
* Patient under anticoagulation therapy for the purpose of other than the index event.
* Patients with thrombolysis therapy or IVC filter at the Index event.
* Patients with creatinine clearance less than 30 ml/min.
* Patients who are expected to have a life prognosis of 3 months or less.
* Patients with pulmonary embolism.
* Patients who are not appropriate for the participation of the study.
Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa

Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.

It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.

Eligibility Criteria:
Inclusion Criteria:

* prior vasa or cesa operation as part of the URGE I study
* stress urinary incontinence
* mixed urinary incontinence

Exclusion Criteria:

* previous urogynecological surgery
* avulsion of cesa or vasa tape
* pregnancy
* neurologic/psychological reasons for incontinence
* body weight \>100kg
* syndrome of dry overactive bladder
Cross-sectional Study of Use of Speckle Method in Early Diagnosis of Cardiovascular Dysfunction

Speckle tracking (STE) is a novel echocardiographic technique which permits calculation of myocardial velocities and deformation parameters such as strain and strain rate (SR). It is demonstrated that these parameters provide important insights into systolic and diastolic function, ischaemia, myocardial mechanics and many other pathophysiological processes of the heart. In this preliminary study, we investigated the role of STE in detection of early ventricular dysfunction in patients with Sjogren Syndrome, focusing on cardiorespiratory fitness.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sjogren Syndrome

Exclusion Criteria:

* previous cardiovascular events
* unstable angina
* stroke
* diagnosis of heart failure
* incapacity to provide an informed consent
A Pilot Study of The CKM JumpStart Tool

This is a randomized pilot study to test the feasibility and acceptability of a tool to promote discussion about conservative kidney management (CKM) among older patients with advanced CKD and their providers.

This study is a randomized pilot study to test the acceptability and feasibility of a novel communication tool, called the CKM Jumpstart Tool, to promote discussion of CKM between patients with advanced CKM and their healthcare providers, the investigators hypothesize that the Guide will be feasible and acceptable to patients and their healthcare providers as reflected in greater discussion of CKM between them following use of the Tool as compared with usual care. The investigators will enroll 76 patients aged 75 years and older with advanced CKD and their healthcare providers from University of Washington Medicine and Veterans Affairs Puget Sound Health Care System. Patients will be randomized together in a 1:1 fashion to receive the intervention or usual care. Data from participants will be collected at the time of enrollment (T1), within 2-weeks of their following clinic visit with their healthcare provider (T2), and approximately 3-month after this clinic visit (T3). The primary outcome measure and measure of feasibility is difference in patient-reported rates of discussion of CKM with a healthcare provider at T2 and T3. The investigators will also evaluate whether provider document in the medical chart of patients whether they had a discussion about CKM with the patient at T2 and T3. The investigators will also collect attrition rates at T2 and T3 as a measure of acceptability. The investigators will further assess user experience of the CKM JumpStart by performing a qualitative analysis of post-intervention interviews with patients and nephrologists, coding for themes elucidating pros, cons and other considerations with using the CKM JumpStart Tool and discussion about CKM.

Eligibility Criteria:
Patients

Inclusion:

* Adults aged ≥75 years
* Advanced CKD as defined as having at least 2 outpatient measures of eGFR \<25 ml/min/1.73m2 separated by \>90 days in the prior year and with at least 1 eGFR measure \<20.
* English-speaking
* Receive care from a provider at UW Medicine or VA Puget Sound
* Open to discussing their values and treatment options for kidney disease with their provider.

Exclusion:

* Unable to complete the informed consent process
* Currently receiving maintenance dialysis

Providers Inclusion

* Their patient is a participant in the study.
* Are a UW Medicine or VA Puget Sound provider or trainee.

Exclusion

• None
Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation

This project aims to evaluate the scalability of an established, evidence-based, multi-component intervention, Senior PharmAssist\^TM (SPA), designed to improve function and quality of life of older adults with limited incomes. The investigators propose to refine existing SPA replication materials such as community readiness assessments, educational tools to facilitate implementation of care processes, and data collection tools for quality improvement with input from community stakeholders interested in implementation of the SPA intervention. After gathering feedback from key stakeholders in 3 diverse communities in North Carolina, and refining tools accordingly, SPA staff will then provide technical assistance to support implementation in these communities, using the Institute for Healthcare Improvement learning collaborative approach, to facilitate community agency staff implementation of the SPA core components with racially diverse older adults with limited incomes using small scale tests of change with feedback.

The investigators will collect data from key stakeholders including older adults, community volunteers, and agency staff regarding facilitators and barriers to implementation of SPA, and obtain aggregate data regarding older adult participants served, including demographics, participant satisfaction, and self-rated health. Data will be analyzed using a multiple case study design that incorporates both qualitative data on barriers and facilitators, as well as aggregated data on older adults enrolled in community programs.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 or older
* Currently or soon to be enrolled in Medicare
* Income is at or below 200% of Poverty Line
* Lives in one of 3 targeted communities learning to implement the Senior PharmAssist\^TM core services
* Seeks assistance with medications, Medicare counseling, or tailored referrals from agencies participating in Senior PharmAssist\^TM learning collaborative

Exclusion Criteria:

None