cyrilzakka/clinical-trials huggingface dataset:
Carotenoid Supplementation and Normal Ocular Health

Normal ageing affects vision as a result of preretinal and retinal changes. Photoreceptors, the light sensitive cells in the retina, degenerate and the rods (responsible for night vision) are most susceptible to damage with increasing age. Rod loss leads to poor vision in the dark which increases the risk of accidents amongst the elderly. Macular pigment (located in the photoreceptors)is thought to protect the retina and reduce the risk of age related changes. Dark adaptation, mediated by the rods, slows down with age, and is also reduced in AMD (age-related macular degeneration). Recent evidence suggests that lutein (the main component of macular pigment) supplementation improves the dark adaptation deficit in AMD subjects. Research into the effects of lutein in a normal human has not been previously conducted. Since the older population is increasing, our aim is to firstly establish the extent of night vision loss (using dark adaptometry) and secondly to examine the possibility of slowing down or reversing this loss through lutein supplementation.

It is believed that the macular pigment protects the retina against photooxidative damage which can lead to agerelated macular degeneration (AMD). It is also hypothesized to enhance visual performance in normal human eyes. Much of the research into lutein supplementation has been centered around AMD subjects. AMD can result from agerelated retinal photoreceptor dysfunction which could hypothetically be prevented or slowed down through early supplementation. To our knowledge, the effects of lutein in normal ageing, have not been studied previously.

Macular pigment is composed of lutein and zeaxanthin. These compounds absorb blue light and therefore protect the retinal photoreceptors. They also possess powerful antioxidant properties and therefore help maintain the integrity of the macular region. With increasing age, the visual performance worsens as a result of preretinal and retinal changes such as photoreceptor degeneration. Rods (responsible for night vision) are highly susceptible to degeneration in a normal aging eye and in AMD. Older subjects often complain of reduced vision in the dark which can contribute to increased risk of road traffic accidents and falls. Since the older population is rapidly growing, it is vital to study the mechanics of photoreceptor degeneration and the possible beneficial effects of supplementation with retinal carotenoids, particularly lutein.

The supplement that will be used in this study will be the commercially available Visionace Plus (details attached). The manufacturer of Visionace Plus is Vitabiotics. The placebo will be soya-based, also manufactured by Vitabiotics.

Eligibility Criteria:
Inclusion Criteria:

1. Not on food supplements containing lutein or zeaxanthin
2. Visual acuity at least 0.4 logMAR units (6/15 Snellen)

4. Body mass index of less than 35 5. No diagnosed ocular disease (e.g. established AMD, cataract, glaucoma) 6. Age between 50 and 90

Exclusion Criteria:

1. Diabetes
2. Any diagnosed ocular disease (e.g. AMD, cataract, glaucoma)
3. Under 50 and over 90 years old
Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic

The purpose of this study is to evaluate the Personalized Support for Progress (PSP) intervention in a Veterans Health Administration (VHA) Women's Wellness Clinic. PSP uses a peer support provider to help women identify their primary concern, develop a personalized plan to help address that concern, and provide practical and emotional support to implement the plan. The primary aim is to evaluate the feasibility, acceptability, and utility of PSP and the research protocol.


Eligibility Criteria:
Inclusion Criteria:

* Veteran status (non-Veterans will not be enrolled in this trial)
* Enrollment in the Syracuse VA Medical Center Women's Wellness Clinic
* Report high stress within the last month (Perceived Stress Scale \[PSS-10\] \> 18)
* Primary Care Provider approval for participation
* Ability to communicate in English including reading, writing, hearing, and speaking well enough to complete research and intervention tasks.

Exclusion Criteria:

* Any Veteran with "higher" suicide risk on the P4 or Veterans with "lower" suicide risk on the P4 and evaluated by the PI or another clinician to be clinically unstable or at risk
* Homicidality (screened via adaptation of the P4 screener and evaluated on the same criteria above)
* Homelessness (including literally homeless, imminent risk of homelessness, or fleeing/attempting to flee domestic violence per VA definitions)
* Veterans who are enrolled in or have had psychotherapy or changes to psychotropic medications in the last 12 weeks
* Veterans with impairment that would not allow them to engage in PSP including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in CPRS or reported by a PACT member)
* Veterans who are not available for outpatient PSP meetings (e.g., in a residential program)
* Veterans who have current VA or non-VA peer support engagement (an appointment within the last month and/or additional follow-up scheduled)
Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents

Severely brain injured patients are at high risk of intracranial hypertension. Among medical treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but not english speaking societies.

Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA versus placebo in the treatment of intracranial hypertension, and the underlying physiopathologic effects.

In case of intracranial hypertension, french neurocritical care society argue for the use of neuromuscular blocking agents before osmotherapy, barbituric coma, hypothermia and craniectomy.

English speaking societies don't sustain this approach. Since then, the use of NMBA remains controversial in case of intracranial hypertension and no study is available.

We propose to study severely brain injured patients presenting with intracranial hypertension and treat them with cisatracurium besilate or placebo.

Our hypothesis is that neuromuscular blockade might act on several parameters:

* Hemodynamics
* respiratory parameters, mechanical ventilation and blood gaz analysis
* cerebral velocities
* diminished O2 peripheral consumption
* cerebrospinal diffusion and concentration of cisatracurium and a metabolite laudanosine We wish to assess changes in ICP according to the above parameters in a controlled randomized non blinded fashion against placebo (NaCl 0,9%).

Eligibility Criteria:
Inclusion Criteria:

* - Age over 18
* Mechanical ventilation and deep sedation
* Severe traumatic brain injury
* Intracranial hypertension (ICP \> 20 mmHg during \> 15 minutes)
* Intracranial pressure monitoring
* Hemodynamically stable

Exclusion Criteria:

* - History of anaphylaxia with neuromuscular agents
* Hemodynamic instability
* Pregnant and/or breast feeding women
Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure

Staphylococcus aureus nasal carriage is a well-known risk factor for S. aureus surgical site infections (SSI). According to a recent study demonstrating 60% reduction risk of SSI due this bacterium after patients' screening and decolonization, recent French and WHO guidelines recommend in cardiac surgery the decolonization of nasal S. aureus carriers before surgery. In practice the decolonization procedures are not well-defined according notably to the duration and time of delivery before surgery and doses of topical antimicrobial drugs. The aim of the proposed study is to investigate the factors associated with failures of S. aureus decolonization: carriage state, compliance with treatment, S. aureus capacity of internalization in nasal epithelial cells, resistance to antimicrobial drugs used. This study will allow (i) to measure the frequency of patients with residual S. aureus carriage just before surgery, whatever they have been decolonized or not, (ii) to characterize the S. aureus nasal carriage state of patients before surgery, and (iii) to investigate the adding value of mupirocin dosage in the nose and urines of decolonized patients as a marker of compliance and efficacy of the decolonization process.


Eligibility Criteria:
Inclusion Criteria:

* Patient to benefit from cardiac surgery scheduled at Saint-Etienne University Hospital
* Surgery of first intention (no resumption)
* Patient affiliated or entitled to a social security scheme
* Patient agreeing to participate in the study and having signed the informed consent

Exclusion Criteria:

* Surgery in a context of infection
* Surgery in an emergency and semi-emergency context
* Protected major patient
* Pregnant
Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate

we conducted this study to compare between effect of nebulized and intravenous magnesium sulfate (MgSO₄) for better treatment of persistent pulmonary hypertension of neonates with less side effects.

Persistent pulmonary hypertension of the newborn (PPHN) is a serious syndrome characterized by sustained fetal elevation of pulmonary vascular resistance (PVR) at birth. The syndrome is seen in two of 1000 live-born infants and is associated with anormal or low systemic vascular resistance. Pulmonary hypertension is defined as a mean pulmonary artery pressure greater than 25 mmHg at rest and \> 30 mmHg during exercise. PPHN-targeted therapy is used for infants with PPHN who fail to respond to general cardiopulmonary supportive care. Oxygen and inhaled Nitric Oxide (iNO) are the only well-studied pulmonary vasodilators in neonates with PPHN. Magnesium is a potent vasodilator and hence has the potential to reduce the high pulmonary arterial pressures as it's able to dilate constricted muscles in the pulmonary arteries. However, its action is not specific and when given via an intravenous infusion, it will act on other muscles in the body including other arteries. Excessive magnesium causes hypotonia, hypotension, and cardiorespiratory failure. However, no studies have demonstrated long-term benefit. Delivering magnesium sulfate by nebulization may enhance effectiveness and minimizes systemic adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Newborns with documented persistent pulmonary hypertension as confirmed by echocardiography.
* Neonates born at ≥ 35 wk. gestation with a birth weight of 2.5-4 kg
* Neonates have to be connected to mechanical ventilation with an oxygenation index (OI) \>30 on two occasions at least 15 min apart.
* The echocardiogram had to show a predominant right-to-left or bidirectional shunt (through ductus arteriosus and/or foramen oval) and/or tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of the systemic systolic blood pressure.

Exclusion Criteria:

* Infants of parents who refuse to give informed consent.
* Infants of mothers who receive magnesium sulfate within 48 h before labor.
* Congenital heart diseases other than patent ductus arteriosus (PDA) and foramen ovale.
* Major congenital anomalies, including congenital diaphragmatic hernia and lung hypoplasia.
* Prior need for cardiopulmonary resuscitation
* Mean arterial blood pressure (MABP) \< 35 mmHg despite therapy with volume infusions and vasoactive inotropes.
* Impaired kidney function; and prior administration of pulmonary vasodilators or prior administration of surfactant.
J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor

RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.

PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.

OBJECTIVES:

Primary

* To assess whether the incidence of major anastomotic leak after low anterior resection, in patients with rectal cancer, is reduced by using the J-pouch reconstruction vs straight colorectal anastomosis.

Secondary

* To compare the global anastomotic leak (major and minor) rate, the incidence of other complications in addition to anastomotic leak, and the functional outcome and the quality of life in these patients.
* To describe, in the J-pouch reconstruction group, the feasibility of the colonic J-pouch.

OUTLINE: Ths is a multicenter study. Patients are stratified according to clinical center, gender (male vs female), and neoadjuvant treatment types. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical straight stapled colorectal anastomosis.
* Arm II: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical J-pouch stapled anastomosis reconstruction.

Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), and the MSKCC Bowel Function Questionnaire.

After completion of study treatment, patients are followed at 1, 6, 12, and 24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed rectal adenocarcinoma meeting the following criteria:

  * Mid and/or low rectal cancer
  * Tumor site ≤ 11 cm from anal verge
  * Must have a temporary stoma (ileostomy or colostomy)
* Must be scheduled for a total mesorectal excision with a low anterior rectal resection and mechanic colorectal anastomosis that is potentially curative or with a microscopic residual resection (R0-R1)
* No locally recurrent disease
* No distant metastasis

PATIENT CHARACTERISTICS:

* Must be able to understand the study

PRIOR CONCURRENT THERAPY:

* No prior handsewn coloanal anastomosis
* No prior colonic resection
* No prior surgery for local recurrence
Tislelizumab with Azacitidine in the Treatment of R/R AML

Acute myeloid leukemia(AML) is a clonal hematological malignancy. 50%-90% adult AML patients can achieve complete remission(CR) after standard induction chemotherapy,but 10%-25% patients cannot achieve CR, which is called 'primary refractory disease'.Most of patients who achieved CR will relapse during the next 3 years, and the prognosis is poor.So refractory and relapse diseases are still the hotspot of clinical research.Immunologic escape is one of the mechanisms for tumor cells to survive from chemotherapy. Studies have shown that PD1 and PDL1 levels are upregulated in AML patients, the same phenomenon was observed after the treatment of demethylating agents such as azacytidine. Combination of PD1 blockades with azacytidine may improve the efficacy of the treatment.

In this phase 1/2 study, 20 patients will be enrolled and treated with azacytidine and tislelizumab regimen. The primary endpoint is composite complete remission rate.Toxicities of treatment need to be observed. And relationship between PDL1 expression on AML cells and efficacy will be studied. Treatments include azacytidine 75mg/m2/d, subcutaneous injection,day1-7, every 28 days for three cycles tislelizumab 200mg,day 8,every three weeks, for 4 doses.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of AML according to FAB or WHO criteria
* refractory or morphological relapsed AML
* age over 18 years old
* ECOG PS 0-2
* written informed consent

Exclusion Criteria:

* acute promyelocyte leukemia
* solitary extramedullary relapsed disease
* other hematological diseases
* antecedent stem cell transplantation
* AML with BCR_ABL positive
* acute panmyelosis with myelofibrosis or sarcoma
* with other active organ malignancy(needing treatment)
* active heart diseases
* unfit for enrollment after investigator's evaluation
Children's Sleep in the ICU

Prospective evaluation of sleep in children admitted to the Intensive Care Unit at Nationwide Children's Hospital to determine how children sleep while admitted to the Intensive Care Unit


Eligibility Criteria:
Inclusion Criteria:

* Any patient admitted to the Intensive Care Unit, or soon to be admitted to the ICU
* Age from 0 days to 17 years 364 days at the time of enrollment
* Any patient with anticipated ICU stay of at least overnight with a minimum of 12 hours duration

Exclusion Criteria:

* Any patient with Admitted with Traumatic Brain Injury, Admitted with an Active Seizure Disorder, Severe Developmental Delay that might impair normal sleep architecture, Known abnormal EEG, any patient actively receiving Mechanical Ventilation
Non-invasive Detection of Anastomotic Leakage

Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with malignant tumors of the esophagus or pancreatic head. These procedures are associated with high morbidity rates, which are strongly correlated with the occurrence of anastomotic leakage. Current diagnostic methods, including clinical, biochemical and radiological techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which ratifies the need for development of novel and accurate non-invasive diagnostic tests for detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic status of an individual, which is associated with a systemic immunological response. The aim of this study was to determine the diagnostic accuracy of urinary volatile organic compounds to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients were aged 18-90 years
* American Society of Anesthesiologists (ASA) physical status of 3 or lower
* All participants were capable to understand the study information and signed written informed consent

Exclusion Criteria:

* None
A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer

The purpose of this study is to evaluate the switch from Nivolumab Intravenous (IV) infusions to Nivolumab Subcutaneous (SC) administration in participants with resected Stage IIIA/B/C/D or Stage IV melanoma or resected invasive Urothelial Carcinoma (UC) originating in the bladder who have high risk of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder.
* All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment.

Exclusion Criteria:

* History of ocular or uveal or mucosal melanoma.
* Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC.
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
* Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases.

Other protocol-defined inclusion/exclusion criteria apply
Rheumatoid Arthritis Satisfaction Outcome Research

RA satisfaction OR: This study aim to compare treatment satisfaction and quality of life between patients who have been using tofacitinib citrate and patients who have been using adalimumab for 6 months or more and less than 2 year in RA treatment of rheumatoid arthritis.

RA satisfaction OR: This study aim to compare treatment satisfaction and quality of life between patients who have been using tofacitinib citrate and patients who have been using adalimumab for 6 months or more and less than 2 year in RA treatment of rheumatoid arthritis.

Study design: Non-interventional, multi-centers, cross-sectional study

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 years or older
2. Patients diagnosed with RA
3. Treatment groups:

1) Tofacitinib citrate users: Patients currently on treatment with tofacitinib citrate in RA therapy for 6 months or more 2) Adalimumab users: Patients currently on treatment with adalimumab in the RA therapy for 6 months or more 4. Reading and writing with enough proficiency to complete assessment instruments in Korean

Exclusion Criteria:

1. Patients currently on tofacitinib citrate or adalimumab for 2 year or more
2. Patients taking Azathioprine and cyclosporine
3. Patients participating in other drug interventional study
4. Patients who have been treated with bDMARDs except Rheumatoid arthritis.
Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes

The proposed study will inform efforts to prevent diabetes and promote weight loss in a high-risk population and generate a reproducible, scalable, and sustainable model for use with other insurer groups and clinical settings that work in immigrant populations with a high burden of chronic disease.

The study "Integrated Community-Clinical Linkage Model to Promote Weight Loss among South Asians with Pre-Diabetes" aims to test the effectiveness and assess the implementation process of an integrated intervention to support weight loss for South Asian patients at-risk for type-2 diabetes mellitus (T2DM) in primary care settings. The integrated intervention involves:

1. An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to increase screening and identification of South Asian patients at-risk for T2DM with BMI \>23 kg/m2 and registries to track outcomes: and
2. Registry-driven community health worker (CHW)-led health coaching for patients. Using a stepped-wedge design, we will implement the study in 25 New York City PCP sites enrolling 2,840 South Asian patients at- risk for T2DM.
3. Provider Surveys (n=40) to capture data on satisfaction with workflow before and after intervention, information sources for EHR-CHW initiatives before and after intervention, acceptability of and satisfaction with the integrated EHR-CHW intervention, and barriers and facilitators of point-of-care use of the tools.
4. Key Informant Interviews (n=35) with physician champions at each site and/or administrator of each site, Health first representatives, and CHWs. At baseline, the interviews will be incorporated into the workflow analysis to assess current satisfaction and usage of EHR and health coaching. At follow-up, the interviews will assess barriers and facilitators to the implementation and adoption process of the integrated EHR-CHW intervention, fidelity to the interventions, and to solicit recommendations for the replication and scalability of the intervention to other sites and insurer organizations.

Eligibility Criteria:
Inclusion Criteria:

* self identify as South Asian;
* are at least 21 years of age and younger than age 75,
* had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months;
* have a BMI of \>23; and
* have incident pre-diabetes as determined by HbA1c test (last A1c test date in the last 12 months).

Exclusion Criteria:

* Patients under the age of 21 and older than 75 will be excluded.
* Individuals with a diagnosis of diabetes or pre-diabetes during the 12 months prior to intervention implementation will be excluded.
* Pregnant women and all visits with an obstetrician gynecologist are excluded.
* No children or vulnerable subjects will be enrolled in this study.