cyrilzakka/clinical-trials huggingface dataset:
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

PROTOCOL SUMMARY

Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

Short Title: FeCitrate

Protocol Number: KP FeCitrate

Study Phase: 4

Study Site(s): Los Angeles Kaiser Sunset Medical Center

Number of Subjects: 55

Study Arms: 1

Indication: Hyperphosphatemia in end stage renal disease

Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a "real world" environment

Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).

Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (\<5.5mg/dl) 6 months before and after treatment with ferric citrate

Statistical Methods: Not powered to detect statistical significance

Eligibility Criteria:
Inclusion Criteria:

* Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate
* Mean serum phosphorus 4.0-\<8.0 mg/dl for 6 months prior to enrollment
* No allergy to iron
* Mean corrected serum calcium \> 8.0 mg/dl for 6 months prior to enrollment
* Mean PTH \< 1000 pg/ml for 6 months prior to enrollment
* Mean ferritin \< 1500 ng/ml and mean iron sat \< 50% for 6 months prior to enrollment

Exclusion Criteria:

* History of gastrointestinal bleeding within past 6 months
* History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months
* Acute kidney injury equal to or less than 3 months before the initial screening date
* Active malignancy
* Functioning renal transplant
* Patients with iron overload syndrome (e.g., Hemochromatosis)
* History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease
* Active or past history of calciphylaxis
Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers.

The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence.

This Spectrofluorometer must be initially validated in healthy volunteers. In the long term, it will be used clinically to measure residual photosensitivity of patients who received a photosensitizer in photodynamic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Man and woman over 18 yers old
* Women of childbearing age under contraceptive
* Healthy volunteers able and willing to follow all procedures of the agreement with the study protocol.
* Healthy volunteers affiliated to the social security
* Ability to provide written informed consent
* Patient's legal capacity to consent to study participation

Exclusion Criteria:

* Healthy volunteers with scars or open wounds on the palms
* Healthy volunteers with warts on their hands
* Healthy volunteers with blister on their hands
* Healthy volunteers involved in another clinical trial
* Pregnant or breastfeeding women
* People in emergencies
* Deprived of liberty or under supervision
Study to Learn More About the Safety and Effectiveness of Rivaroxaban (Xarelto) When Given Together With Acetylsalicylic Acid to Indian People With Narrowing of the Arteries of the Heart (CAD) and/or With Reduced Blood Flow in the Arteries of the Legs and Arms With Symptoms (Symptomatic PAD)

This is an observational study in which data from Indian people with coronary artery disease and / or symptomatic peripheral artery disease who will be receiving the drug rivaroxaban (Xarelto) are studied.

Coronary artery disease (CAD) is a condition where the arteries that bring blood and oxygen to the heart become hardened and narrow. Peripheral artery disease (PAD) is a condition with reduced blood flow in the arteries of the legs and arms. People with CAD and / or PAD with symptoms may receive rivaroxaban from their doctors to prevent problems (for example, stoke) caused by blood clots and hardening of the arteries.

In this study researcher want to gather more information on the safety and the effectiveness of rivaroxaban when given together with the drug acetylsalicylic acid (also known as "aspirin") to people with CAD and / or PAD with symptoms in the routine practice in India. Researchers are especially interested whether patients under treatment experience any events such as minor or major bleedings, stroke, sickness of the heart or blood vessels. In addition, information on why and when treating doctors decide to start or stop the treatment with rivaroxaban and acetylsalicylic acid is of interest to the researchers.

The study plans to enroll about 300 male or female patients who are at least 18 years old and are already treated with the two drugs or at least with rivaroxaban.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) patient.
* Diagnosis of CAD or PAD.
* Treatment with Rivaroxaban 2.5mg tablet, co administered with acetylsalicylic acid (ASA), for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events within 4 weeks prior to enrolment. also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made.
* Patients who are willing to participate in this study (signed informed consent).

Exclusion Criteria:

* Contra-indications according to the local marketing authorization.
* Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5mg given for CAD/PAD.
* Participation in an interventional trial.
Survey of Health Preferences in Cancer Patients (QALY-Cancer)

This study will evaluate health utilities in patients with breast or colorectal cancer.

The cost-utility analysis (CUA) is an increasingly used method to help health decision-maker. The CUA uses the Quality Adjusted Life Years (QALY) that combines the length of life with the health related quality of life (HRQoL) into a single score.

In Quebec, no QALY calculation tool has been adapted to its linguistic and socio-cultural context, neither for its general population nor for a particular subpopulation, like patients with cancer.

The objectives will be to analyze the extent of the divergence in terms of health states utilities between the general population and patients with breast or colorectal cancer; to develop a QALY preference weights dataset for patients with cancer; to perform "mapping" with different health-related quality of life questionnaires by correlating SF6Dv2 with EQ-5D-5L, EORTC QLQ-C30 and FACT- G. The data will be collected with a self-administered online survey. Patients outcomes will be measured at the beginning of the chemotherapy treatment cycle and about 8 days after the start of chemotherapy. Health utilities will be measured with a hybrid method using the time-trade-off (TTO) and the discrete experimental choice (DCE) method using SF6Dv2 questionnaire for health states.

Eligibility Criteria:
Inclusion Criteria:

* to be 18 years of age or older;
* to reside in Quebec;
* have already had a chemotherapy treatment cycle;
* be on the eve of a new round of chemotherapy treatment;
* have breast or colorectal cancer

Exclusion Criteria:

* being over 80 years of age;
* not be able to complete a computer questionnaire;
* can not read or write in French;
* not be able to sign a consent form;
* the only treatment offered is surgery;
* presence of metastases to the brain;
* patient with delirium, psychosis or severe depression (i.e. chronic condition with treatment)
Gastric Cancer Screening and Alarm Symptoms in Early Gastric Cancer

Most of the early gastric cancer are asymptomatic. Symptoms of advanced gastric cancer are weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal bleeding. Gastric cancer found according to warning symptoms such as gastrointestinal bleeding, weight loss usually can not be cured. Therefore, early gastric cancer can not be detected and impossible to treatment if endoscopy is performed according to the warning signs. National gastric cancer screening is conducted in men and women of more than 40 years old. The purpose of screening for gastric cancer is discovering a case of possible cure, so increasing the survival rate. The purpose of this study is review of the feasibility of screening for gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* gastric cancer patients in St.mary's hospital

Exclusion Criteria:

* gastric lymphoma, gastric GIST patients in St.mary's hospital
Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.

Twenty-four (24) week, randomized, two-arm, single-masked, clinical trial to evaluate safety, tolerability, and to explore the efficacy of two dose levels of suprachoroidal triamcinolone acetonide suspension (Triesence®, 2.4 mg, and 4.0mg) administered using the Oxulumis® microcatheterization device in subjects with previously treated Diabetic Macular Edema.

After a screening period, approximately 20 eligible Diabetic Macular Edema subjects will be treated using a 1:1 ratio to receive a single administration of one of two dose levels of triamcinolone acetonide (low dose, 2.4mg. or mid-dose, 4.0mg, respectively). If for any reasons treatment in randomized subjects cannot be completed, additional consecutive subjects will be randomized until the target number of approximately 20 treated subjects is reached.

From Week 4, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to twenty-four (24) weeks.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus.
* Diabetic macular edema involving the center of the fovea in the study eye
* Best-corrected visual acuity in the study eye of ≤73 (early treatment of diabetic retinopathy study) ETDRS letters (approximate Snellen equivalent of 20/40 or worse)
* Short-lived, limited, or no response to prior ocular injection therapy

Exclusion Criteria:

* Macular edema is considered due to a cause other than diabetes mellitus in the study eye.
* Condition, in the study eye, in which visual acuity is not expected to improve from the resolution of macular edema
* Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within sixteen (16) weeks prior to screening.
* Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye.
* Active malignancy or history of malignancy within the past five years.
* Prior intravitreal (IVT) treatment with anti-Vascular endothelial growth factor (VEGF) in the study eye: last injection within four weeks, before screening
* Prior ocular treatment with steroids in the study eye: last injection (intra- or periocular) with triamcinolone acetonide within three (3) months, with dexamethasone implant (Ozurdex®) within six (6) months before screening.
* Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is exclusionary.
* Prior treatment with suprachoroidal steroids is exclusionary.
* Uncontrolled diabetes with a hemoglobin A1c (HbA1c) \> 12% or any other uncontrolled systemic disease at screening.
A Clinical Comparison of Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add

The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses.

The aim of the study is to evaluate the overall lens satisfaction between two soft multifocal contact lenses when compared to each other after 15 minutes of daily wear each.

Eligibility Criteria:
Inclusion Criteria:

1. They are at least 18 years of age.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction,) and have done so for at least the past three months.
4. They have a minimum reading add of +0.75DS (based on their spectacle refraction)
5. They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and refractive astigmatism of no greater than -0.75DC in each eye.
6. They are able to achieve distance HCVA of +0.10 logMAR or better in each eye.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are aphakic.
4. They have had corneal refractive surgery.
5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND)

Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Routinized pill-taking can lead to successful long-term ART adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. This study proposes to test this combined approach for promoting long-term ART adherence using a Stage III Sequential, Multiple Assignment, Randomized Trial (SMART) design in one of the largest HIV clinics in Uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.

Building on a previous R34 study, we will adapt and deliver the INMIND approach to 550 ART initiators at Mildmay. Participants will initially be randomized to receive either usual care (Control, n=275) or daily text messages (Messages, n=275) to support adherence routines. At months 1 and 2, participants may revise their adherence plans. Those showing \<80% adherence in month 3 will be re-randomized to receive either monthly or monthly escalated prize incentives for the next three months. Adherence will be monitored for an additional 12 months (total follow-up: 18 months) to assess long-term routine maintenance and recovery after interruptions. The SMART design will help identify the most cost-effective intervention sequencing. A cost-effectiveness analysis and stakeholder dissemination will support future scale-up. We hypothesize that Messages will be more effective than Control as a first-stage treatment; that monthly escalated prizes will be more effective than monthly prizes as a second-stage treatment; and that the mechanisms of lack of Salience and Present Bias will mediate the effect of INMIND on our primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male and female clients age 18 and older.
* Started ART at Mildmay or another clinic within the preceding 1 month
* Able to speak and understand either English or Luganda.
* Have their own cell phone or have consistent access to someone else's phone.
* Willing to receive daily text messages for the 6 months of intervention duration.
* Willing and able to use the WisePill device distributed for adherence verification for the duration of the study.

Exclusion Criteria:

* Not mentally fit to consent.
* Language other than Luganda or English.
* Not willing to consistently use the Wisepill device for adherence measurement.
Evaluation of the School Kids Influenza Prevention Project

Children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders.


Eligibility Criteria:
Inclusion Criteria:

- Enrolled in the urban school district

Exclusion Criteria:

- Attends a school in the urban district containing a school-based health center
FLAVIOLA Health Study

Atherosclerosis progressively occurs with increasing age in the general population. So far most dietary intervention studies with flavanols were performed over short time frames and in small groups of young healthy and older patients with manifest cardiovascular disease, respectively. Vascular health is defined as absence of vascular disease and the presence of optimal parameters that determine the development and progression of arteriosclerosis (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether flavanols can improve parameters of vascular health, most importantly endothelial function, when given repetitively to healthy middle aged and which factors affect the efficacy of flavanol interventions.


Eligibility Criteria:
Inclusion Criteria:

* male, age 35-60 years, healthy
* female, age 35-60 years, healthy

Exclusion Criteria:

* diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)
A Comprehensive Assessment and Follow up Descriptive Study on Bipolar Disorder

The purpose of this study was to investigate the reliability and validity of the bipolar index (BPX) to diagnosis bipolar disorder, and to verify the stability of it in identifying bipolar disorder; the secondary purpose was to understand the dynamic changes of bipolar disorder in natural status.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old；
2. Be able to understand the content of assessment and cooperate；
3. Currently patients are depressive episode, and / or manic / hypomanic episode, also can be mood stable；
4. Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of bipolar disorder (Type I, II, rapid cycling, mixed episodes)；
5. Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of depressive disorder；
6. No other mental illness or a history of physical disease，or patients with physical disease;
7. Not received modified ECT at least four weeks or more before entering the group.

Exclusion Criteria:

1. Can not understand the content of assessment and cooperate；
2. Meet the diagnosis criteria of schizophrenia and other psychotic disorders;
3. Meet the diagnosis criteria of Diagnosis of mental retardation or pervasive developmental disorder;
4. Clinically significant neurological disease or loss of consciousness more than one hour of traumatic brain injury；
Safety and Dose Finding Study of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia B

A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in adult males with moderate/severe to severe hemophilia B.

Hemophilia B is an X-linked recessive genetic bleeding disorder caused by mutations in the factor IX (FIX) gene. FIX is produced in the liver and is critical for fibrin clot formation. Hemophilia B is characterized by frequent, spontaneous internal bleeding that can lead to chronic arthropathy (joint damage), intracranial hemorrhage, and even death. In patients with moderate/severe to severe hemophilia B, the majority of bleeding episodes occur in the joints and, if not treated, lead to debilitating damage and a decreased quality of life.

This study will evaluate the safety and efficacy of the adeno-associated virus (AAV) to deliver human factor IX (hFIX) gene, the healthy gene necessary to make FIX, to the liver where FIX is normally produced. This study will determine if AAVrh10 can produce clinically meaningful FIX levels in patients with moderately/severe or severe hemophilia B.

This study was previously posted by Dimension Therapeutics, which has been acquired by Ultragenyx in November 2017.

Eligibility Criteria:
Inclusion Criteria:

1. Male ≥ 18 years of age.
2. Moderate/severe or severe hemophilia B (baseline FIX activity ≤ 2% of normal or documented history of FIX activity ≤2%).
3. At least 3 bleeding episodes per year that require on-demand treatment with FIX OR are treated with a prophylactic regimen of FIX.
4. At least 100 days exposure history to FIX.
5. No documented history of inhibitors (neutralizing antibodies) to exogenous FIX.
6. No known allergic reaction to exogenous FIX or any component of DTX101.
7. Willing to stop prophylactic treatment with recombinant FIX at specified time points during the study.

Exclusion Criteria:

1. History of significant liver disease (ie, portal hypertension).
2. Significant hepatic inflammation or cirrhosis.
3. Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
4. History of human immunodeficiency virus (HIV) infection AND any of the following: CD4+ cell count \< 350 cells/mm\^3, change in antiretroviral therapy regimen within 6 months prior to Day 0, or plasma viral load \> 200 copies/mL, on 2 separate occasions, as measured by polymerase chain reaction.
5. Anti-AAVrh10 neutralizing antibody titer \> 1:5.
6. Participation (current or previous) in another gene therapy study.
7. Participation in another investigational medicine study within 3 months before screening.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
External Beam Radiation Therapy - Target Volume

Delivery of conformal radiation therapy following radical prostatectomy is limited by the inability to define the clinical target volume (CTV). This stems from a poor understanding of patterns of local recurrence and limitations of standard imaging techniques.Magnetic Resonance Imaging (MRI) is a promising modality for imaging the prostatic bed following radical prostatectomy. MRI provides more detailed postoperative anatomy to guide CTV delineation, the ability to document local recurrence patterns, and a method to assess intrafraction prostatic bed motion and deformity to define appropriate planning target volume margins. The aim of this pilot study is to develop a technique for external beam radiation therapy (EBRT) following radical prostatectomy based on MRI-delineation of the CTV. Twenty patients will be enrolled in this pilot, development phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients following radical prostatectomy for prostate adenocarcinoma with one or more of the following adverse features:

pT2 + positive surgical margins ) pT3 ) PSA ≤ 2ng/ml Persistently elevated PSA at 3 months )

* Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse
* Patients being planned for radiation therapy
* No evidence of distant metastases
* Age ≥ 18 years
* ECOG performance status 0 or 1
* Informed consent

Exclusion Criteria:

* Contraindications to MRI Patients weighing \>136 kgs (weight limit for the scanner tables) Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.
* Severe claustrophobia
* Inflammatory bowel disease or collagen vascular disease
* Previous colorectal surgery
* Previous pelvic radiotherapy