cyrilzakka/clinical-trials huggingface dataset:
Comparing Rates of Glaucoma in Professional Wind Versus Non-Wind Instrument Players

The purpose of the present study is to compare rates of glaucomatous optic neuropathy in professional wind versus non-wind instrument players in the Philadelphia Orchestra. A secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind instrument players under variable playing conditions.

Participants of this study will be any current or retired member of the Philadelphia Orchestra. Approximately 100 participants will be divided into 2 groups: 1) wind instrument players and 2) non-wind instrument players.

A wind instrument is defined as any instrument that contains a resonator, in which a column of air is set into resonation by the player blowing into a mouthpiece at one end of the resonator. A non-wind instrument is defined as any instrument that does not meet the wind instrument criteria.

On the day of the eye examinations, the investigator will provide a brief overview to explain the purpose and goals of the study to all potential participants. The examination team will be set up in an adjoining room. Members of the orchestra will be able to visit the examination team at any time during their practice session. A trained technician will perform the following for both eyes for all participants:visual acuity,undilated fundus color photography and intra-ocular pressure measurement. The investigators will record the examination findings using a standard form. Demographic information, including ocular, medical, social, and family history, will be documented for all participants.

Eligibility Criteria:
Inclusion Criteria:

* Play wind or non-wind instrument for average of 1 hour per day for minimum of 5 years.
* Normal general health.

Exclusion Criteria:

* Incisional eye surgery \<1 month prior to visit 1.
Creating Welcoming Faith Communities for People With Serious Mental Illnesses

The goal of this intervention study is to test a behavioral intervention to increase inclusionary practices toward individuals with serious mental illness in faith communities. The main questions it aims to answer are:

1. To determine if the behavior-based intervention leads to an increase in inclusionary practices (e.g., conducting outreach with mental health agencies).
2. To determine if the behavior-based intervention is effective in increasing inclusive practices by members and leaders of faith communities.
3. To determine if the intervention leads to a greater understand of mental illness and a decrease in stigmatizing beliefs by congregation members.
4. To determine if the intervention results in individuals with serious mental illness and their family members reporting less discrimination and increased inclusion.

Congregations will be asked to create an inclusion committee that will then work on developing systems and changing congregational practices to become more inclusive. All congregation members will be invited to a half-day training that will provide information on mental illness and inclusion, and will provide tips and strategies when they encounter situations or behaviors that are less familiar to them. All congregation members will be given the opportunity to participate in a survey about congregational practices.


Eligibility Criteria:
Inclusion Criteria:

* member or attendee of the faith community participating in the training

Exclusion Criteria:

* under the age of 18
Rapid Detection of Group B Strep- 35-37 Week Study

The purpose of this study is to determine whether a rapid bedside diagnosis of Group B Strep growing in the vagina and rectum can be performed with similar success to the routine culture.

Early Onset Group B Strep (GBS) neonatal infections is one of the leading infections in newborns, nearly all of which are acquired by vertical transmission at the time of childbirth. Most cases can be prevented by identifying women who are colonized with GBS in the vaginal-rectal area and giving these colonized women prophylactic antibiotics in labor. About 15 -20% of women are colonized and nearly all of these women are asymptomatic. Because it takes up to 48 hours to obtain culture results, it is currently recommended to perform cultures in the clinic about 3 - 5 weeks prior to their due date and then prophylaxing those women colonized with GBS with antibiotics when they come in to labor. There are several downsides to this strategy. All women who present with preterm labor are treated until culture results become available (overtreatment), women who go into labor while waiting for culture results are all treated (overtreatment), prior studies have shown 33% of women are positive at 35 weeks, but negative at birth (overtreatment) and 10% are negative at 35 weeks and positive at birth (undertreatment), lost or missing culture results (over- or undertreatment). Using microfluidics and fluorescent PCR, a new test can identify GBS reliably in 30 to 45 minutes in vitro. This study proposes to evaluate the clinical performance (sensitivity, specificity, positive and negative predictive value) of the microfluidic rapid GBS technique in selected women presenting at 35 - 37 weeks to antenatal clinics at the University of Michigan compared to standard culture.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older
* Mentally capable of giving informed consent
* Presentation for regularly scheduled 35-37 week cultures

Exclusion Criteria:

* Inability to give informed consent
* Evidence of ruptured membranes by clinical or laboratory criteria
* Use of any antibiotic within the previous 7 days
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria (All Subjects):

* Male or female (sterile or postmenopausal) subjects between 18-75 (both inclusive) years of age and healthy as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations (except for renal impaired subjects).
* Subjects must have a BMI between 18 kg/m2 and 38 kg/m2 and weight at least 50 kg and no more than 120 kg.
* Additional inclusion criteria for subjects with normal renal function:

  * An absolute GFR as determined by MDRD equation and conversion within normal range as determined by GFR \> 90 mL/min

Inclusion Criteria (for subjects with impaired renal function):

- Subjects must have documented stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as a stable absolute GFR, for 4 weeks prior to study entry.

Exclusion Criteria (All Subjects):

* Subject has received a renal transplant at any time in the past and is on immunosuppressant therapy
* History or presence of impaired cardiac function
* Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of drugs
* Administration of CYP3A4/5 inhibitors or inducers or CYP3A4 substrates with narrow therapeutic windows
* Administration of medications that prolong the QT interval
* Subject has a history of immunodeficiency diseases, including HIV, as confirmed by (HIV-1, HIV-2) test
* Receipt of investigational product in another clinical trial within 4 weeks of dosing

Exclusion Criteria (for subjects with impaired renal function):

* Severe albuminuria \> 300 mg/day
* Subjects undergoing any method of dialysis
* Subjects with renal impairment due to hepatic disease (hepatorenal syndrome)

Other protocol-defined Inclusion/Exclusion may apply.
Diuretic Testing in Chronic Kidney Disease

The goal of this clinical trial is to predict the progression of chronic kidney disease by diuretic testing in patients with chronic kidney disease. The main questions it aims to answer are:

Does a worse result of a diuretic test predict the progression of chronic kidney disease?

If there is a comparison group: Researchers will compare the diuretic test in patients with chronic kidney disease to healthy participants to see if the results are different in a healthy kidney.

Participants will undergo diuretic testing. This involves the administration of bumetanide and hydrochlorothiazide with subsequent blood and urine collections.


Eligibility Criteria:
Inclusion Criteria for CKD subjects:

* CKD stage G3 (creatinine-based eGFR 30-59 mL/min/1.73m2) during the last outpatient visit

Inclusion Criteria for Healthy subjects:

• eGFR within the expected range for age (a decline of 1 ml/min/1.73 m2 per year starting from age 40 is considered the normal age-related decline in kidney function

Exclusion Criteria:

* Known intolerance or allergy to the diuretics
* Current systemic chemotherapy for malignancy
* Kidney transplant recipient
* Use of calcineurin-inhibitors
* Life expectancy \< 12 months
* Current immunosuppressive treatment for glomerulonephritis
* Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
* Hypokalemia or hyperkalemia (K+ \< 3.0mmol/L or K+ \> 5.5 mmol/L) at inclusion visit
* Hypo- or hypernatremia (Na+ \< 130 mmol/L or Na+ \> 150mmol/L) at inclusion visit
* Inherited tubulopathy as the cause of CKD
* Autosomal dominant polycystic or tubulointerstitial kidney disease causing CKD
* Clinically relevant heart failure (New York Heart Association class III or IV)
* Therapy-resistant hypertension, defined as systolic blood pressure \> 180mmHg at the inclusion visit
* Current treatment with inhibitors of Organic anion transporters: probenecid, pravastatin, cimetidine, cephalosporins, acetazolamide \[22\]
* Active hepatitis during last outpatient visit
* Liver cirrhosis in advanced stage (Child-Pugh B or C)
* Active drug- or alcohol abuse
* Not being able to tolerate a 28-day washout of one of the drugs interfering with diuretic testing.
* Women who are pregnant, breastfeeding, or planning on becoming pregnant before the test day
Home Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research

The purpose of this study is to test Mobile Technologies in Assisting Patients \& Family Caregivers in Healthy Living and complex home care by connecting to information and professionals from a distance.

HPN (Home Parenteral Nutrition) families with TPN (Total Parenteral Nutrition) users are typically geographically distant from one another (peers) as well as professional providers. Real-time mobile access to health related information, peer and professional support will be tested in this study.

Eligibility Criteria:
Inclusion Criteria:

* 13 years or older total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care)
* TPN users (also called HPN users) must be receiving intravenous nutrition for a non-malignant short bowel disorder
* Read, write, speak English and provide informed consent
* Be able to participate in group clinic visits

Exclusion Criteria:

* enteral nutrition dependency only
* less than 13 years of age
* 13 through 17 years of age without parental consent
* currently enrolled in an intervention study or HPN management program
* severe cognitive impairment
* disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics
Inotuzumab Ozogamicin - PF-05208773

Inotuzumab Ozogamicin Expanded Access Program


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Chronic Pain in Spinal Cord Injury

This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.

This double masked placebo-controlled trial will randomize patients (n=100) with a greater than 6 month history spinal cord injury and a greater than 3 month history of associated pain to a daily dose of amitriptyline or placebo for 6 weeks. Patients will be examined before randomization by a study physician or nurse masked to their treatment assignment. They will be assessed by telephone interview before, during treatment, at the end of treatment and 4 months later to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain.

Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury six months ago or longer
* Pain for 3 months or longer

Exclusion Criteria:

* History of cardiovascular disease, seizures, or glaucoma
* Currently taking antidepressant medications
* Currently hyperthyroid or taking thyroid medicine
* Currently pregnant
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient

The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

Up to 61% of critically ill patients have sleep deprivation in ICU. Sleep deprivation can cause delirium and lead to prolonged ICU length of stay and mechanical ventilator days. However, pharmacologic interventions to improve sleep quality and prevent sleep deprivation are poorly tested for efficacy and safety in ICU patients. There were reports of gabapentin increasing slow-wave sleep in healthy populations and insomnia patients with insignificant adverse events. Therefore, gabapentin might increase slow-wave sleep resulting in improving clinical outcomes in adult critically ill patients. The objectives of the study were to evaluate the efficacy, especially on slow-wave sleep, and safety of gabapentin in adult critically ill patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older)
* Patients admitted to ICU not more than 24 hours at the time of randomization

Exclusion Criteria:

* Patients admitted to ICU less than 72 hours
* Patients receiving gabapentin within 14 days prior to randomization
* Patients receiving restorative drug (trazodone, mirtazapine, olanzapine, agomelatine, and pregabalin) within 7 days prior to randomization
* Patients having contraindications to gabapentin
* Patients receiving high dose vasopressors more than 1 hour during ICU admissions
* Patients presenting with severe respiratory failure (PF ratio \< 100)
* Patients presenting with RASS \< -2 at the time of randomization
* Patients having target RASS of \<-2 during ICU admissions
* Terminal ill patients
* Pregnancy
Avis-PHAGEinLYON Clinic

Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. The primary objective is to quantify the phage therapy requests received at the Hospices Civils de Lyon. 1500 patients will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* - Patient referred to the Hospices Civils de Lyon for a phage therapy request from 01/01/2015 to 01/01/2028.
* Avis-PHAGEinLYON clinic study information notice provided to the patient

Exclusion Criteria:

* - Opposition of trial participant
Comparing Magnetic Resonance Imaging/Spectroscopy Techniques

Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are diagnostic tests that allow researchers to look at different chemical properties of tissue. Magnetic resonance imaging and spectroscopy studies can be used to gather or evaluate information about various aspects of patient s bodies or to monitor changes in the biochemistry and physiology of patient s bodies.

Unlike other diagnostic techniques (CT scan and PET scan) MRI and MRS do not use ionizing radiation. Some studies have shown that MRI is more effective at distinguishing normal parts of the anatomy from abnormal anatomy, especially in the brain. MRI has become the diagnostic test of choice for evaluating patient with multiple sclerosis.

The purpose of this study is to evaluate normal volunteers and patients with a variety of diseases with magnetic resonance imaging. Researchers will attempt different magnetic resonance imaging methods and techniques as well as different levels of magnetic strength.

Background:

MRI is a constantly evolving imaging modality. Pulse sequences are often modified to improve their performance. However, many of these changes have not yet been approved by the FDA and therefore, are not considered standard of care. Some of these sequences require the use of new types of imaging coils, which are also investigational.

Objectives:

The major purpose of this protocol is to inform patients undergoing MR scans in the Clinical Center that they be scanned with MRI sequences and/or coils which may or may not be FDA approved and to get the patient s consent for this. This is not a formal research study since specific disease entities and specific pulse sequences are not studied in a systematic way. Rather, the purpose is to give NIH patients access to gradual improvements in MR technology that would otherwise not be available to them.

Eligibility:

All patients who, by virtue of the NIH protocol in which they are enrolled, qualify for MRI will be eligible for participation in this protocol.

Design:

Up to 99,999 participants will be enrolled in this study.

Eligibility Criteria:
* INCLUSION CRITERIA:
* All patients undergoing MRI in the Clinical Center.
* Patients must be able to provide informed consents.

EXCLUSION CRITERIA:

* Contraindications to MRI.
* Inability to understand consent form or consent process and the absence of a suitable guardian.
* Adults who are or may not be able to consent
* Patients in whom the scan must be performed quickly, i.e. those patients under anesthesia, anxious patients, those requiring emergency medical care, or others in which it is deemed inappropriate to prolong a study.
* Refusal to Participate.
* Pregnant women and fetuses
* Neonates
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101.

Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.


Eligibility Criteria:
1. Ability to provide written informed consent;
2. Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit; OR recurrent CDI
3. An outpatient prior to Treatment
4. Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period.

Exclusion Criteria:

1. Pregnant, breast-feeding, or considering becoming pregnant during the study
2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
5. Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
6. Major intra-abdominal surgery within the past 60 days prior to Screening
7. Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
8. History of total colectomy/ileostomy or bariatric surgery
9. Planned hospitalization or invasive surgery during the study
10. Severe acute illness unrelated to CDI
Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )

This is a single centre retrospective study in repeated implantation failure patients: \< 39 years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred without implantation, absence of known causes of implantation failures (uterine malformation, thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).

Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally. Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to standard IVF cycles.


Eligibility Criteria:
Inclusion criteria:

* women \< 39 years
* repeated implantation failure: at least 4 day 3 good quality embryos or 2 good quality blastocysts transferred without implantation

Exclusion criteria:

* partner with severe male factor, or abnormal sperm Fluorescence in situ hybridization (FISH) analysis
* presence of uni or bilateral hydrosalpinx, uterine malformation, thrombophilia, uncontrolled thyroid disfunction or autoimmune disease
The Relationship Between Cadaveric Allograft Skin and HLA-Sensitivity in Burn Patients

The purpose of this research study is to look at how the body's immune system reacts to temporary skin grafts from deceased donors.

Some burns will heal best with the use of temporary skin grafts from cadavers before covering the burns with grafts of the patient's own skin. This is the usual care for these types of burn injuries recommended by burn surgeons. This skin is applied in the operating room and removed after several days. During that time, the body's immune system will make antibodies to the skin. Normally, these antibodies are harmless. However, extra antibodies can make it difficult to find donors for transplants. The results of this study will be used to better understand how to treat a subset of burn patients with very severe burns in a way that allows them to receive tissue transplants (e.g. face transplants, hand transplants).

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older
* Burns of deep partial thickness or full thickness depth totaling less than or equal to 10% total body surface area.
* Injury requiring staged reconstruction with allograft skin (experimental group)
* Injury requiring reconstruction with autograft skin (i.e. no cadaver skin; control group)

Exclusion Criteria:

* Burns exceeding 10% total body surface area.
* Pre-existing allosensitization at time of injury
* Blood or blood product transfusion requirement
* Pregnancy at the time of injury or during study period
* History of solid organ transplant during study period
* History of autoimmune disorder (systemic lupus erythematosus, etc.)
* History of mechanical circulatory support (extracorporeal membrane oxygenation, ventricular assist device, total artificial heart) during study period