cyrilzakka/clinical-trials huggingface dataset:
DNase Treatment for Dry Eyes

The purpose of this study is to evaluate the tolerability and preliminary efficacy of DNase eye drops in patients with Sjogren's and Non-Sjogren Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Capable of giving informed consent and does provide informed consent.
* Documented Dry Eye Disease for at least 6 months.
* Schirmer I \<10
* Corneal/ conjunctival (Rose Bengal) staining ≥1
* Ocular symptoms must be considered as annoying or activity limiting (OSDI ≥13; mild).
* Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study.

Exclusion Criteria:

* Allergic to Deoxyribonuclease eye drops or any similar products, or excipients of Deoxyribonuclease eye drops 0.1%.
* Receiving or have received within 30 days any experimental systemic medication.
* Active ocular infection or ocular allergies.
* Any history of eyelid surgery or ocular surgery within the past 3 months.
* Corneal epithelial defect larger than 1 mm2 in either eye.
* The use of topical cyclosporine or corticosteroids within 2 weeks of enrollment
* Have active drug/alcohol dependence or abuse history
A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Definition: Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body.


Eligibility Criteria:
Inclusion Criteria:

* You must have been diagnosed with bladder cancer that has recurred or moved to a new part of the body.
* You must have at least one tumor that can be physically measured or scanned by x-ray.
* You may not have had previous chemotherapy (drug) treatment OR you have had surgery followed by one chemotherapy treatment at least 4 months ago.

Exclusion Criteria:

* You may not have used an experimental medicine or device within the past month.
* Cancer that has spread to your brain.
* If you are unwilling or unable to take folic acid or vitamin B12 supplements.
Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects

The goal of this study is to predict and prevent adverse drug events by investigating the impact of genetic variants, demographics, and environmental factors in subjects status post myocardial infarction and percutaneous coronary insertion who have experienced adverse drug events while on P2Y12 inhibitors.

The goal of this study it to validate Cipherome's drug safety score (DSS) in its predictive accuracy for severe adverse drug reactions (ADRs). The DSS is calculated on a scale of 0 to 1, with preliminary studies demonstrating that scores below 0.3 correlated with a higher chance of an ADR and scores above 0.7 correlated with a lower chance of an ADR.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years and older, who are on P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor).
2. Ability to provide informed consent.

Exclusion Criteria:

1. Lack of informed consent
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.

Normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. These imaging tests often give good information, but not in all patients and not every time. This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrent/metastatic prostate cancer. The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care. Better understanding how this new imaging test performs in identifying recurrent/metastatic prostate cancer may lead to better management of prostate cancer patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45).
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* Previously enrolled to MCC#18523
* Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
* Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (\>0.45)
* Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
* Age \> 18

Exclusion Criteria:

* No follow up information available post treatment
* Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
* Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
Seasonal Allergic Rhinitis In Pediatric Subjects

The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of seasonal allergic rhinitis.
* Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.

Exclusion criteria:

* Have significant concomitant medical conditions.
* Use of corticosteroids, other allergy meds during the study.
* Have abnormal ECG or laboratory abnormality.
Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients.

The pathophysiology of preeclampsia (PE) is thought to be endothelial dysfunction responsible for the maternal signs of de novo hypertension and proteinuria after 20 weeks. Current concepts suggest that the pathophysiology of preeclampsia and intrauterine growth retardation results from an imbalance of angiogenic factors.

A new angiogenic factor EG-VEGF (Endocrine Gland- Derived Vascular Endothelial Growth Factor) also known as Prokineticin 1 (PROK1) appears to be emerging in the pathophysiology of PE. EG-VEGF is a circulating factor which belongs to the family of prokinetics. Dr Alfaidy's MAB2 team at the Cancer and Infections Biology Laboratory (U1292 Biosanté INSERM / UGA / CEA, CEA Grenoble) demonstrated its key role in the control of key processes in placental development and provided evidence through the development of an animal model of preeclampsia. EG -VEGF is directly involved in the development of Pre-Eclampsia. Few studies have evaluated the expression of EG-VEGF in the human placenta.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have given birth by cesarean section at the maternity University Hospital Saint Etienne and all underwent a placenta pathological examination at the Saint Etienne University Hospital.
* For the pre-eclampsia group: patient with a diagnosis of pre-eclampsia
* For the control group: patient who had a normal pregnancy

Exclusion Criteria:

* Patient who gave birth naturally
* Underage patients or under guardianship
* Patients who do not speak or read French
* Childbirth under X
Pressure Difference Between Brain and Eye: a Possible Cause to Normal Tension Glaucoma.

The main aim of this study is to determine the trans-laminal cribrosa pressure difference (TLCPD) for normal tension glaucoma (NTG) patients from the brain and the eye in supine, upright and minor head down tilt positions. It is also to investigate the venous drainage system in the same body positions.

The trans-lamina cribrosa pressure difference (TLCPD), i.e. the difference between the intraocular pressure (IOP) and the intracranial pressure (ICP) has been suggested as a pathophysiological component in glaucoma. The theory is that high TLCPD, either due to elevated IOP or reduced ICP, can cause glaucomatous damage.

Normal tension glaucoma (NTG) patients has been found to have a slightly reduced ICP when measured in horizontal position. However, in a previous study in healthy adult volunteers the investigators have measured TLCPD at supine, sitting and 9 degree head down tilt positions and found that the TLCPD was posture dependent, with the largest difference in the upright position. Since humans are upright approximately two thirds of the day, one can expect that TLCPD in a diurnal perspective is primarily influenced by the ICP in the upright position.

In this study the TLCPD in different positions in patients with NTG will therefore be measured.

The study will be carried out in three parts.

1. TLCPD will be investigated by simultaneous measurements of IOP and ICP. For IOP the Applanation resonance tonometer (ART), developed by our research group, will be used. ART is independent of gravitation and possible to use in all body postures. In this study measurements will be performed in supine, sitting and head down tilt positions. ICP is measured continuously during the period of body position changes with a CELDA lumbar pressure measurement apparatus.
2. Brain and eye MRI investigation will be performed at a 3 Tesla GE scanner with a new generation 32-channels head coil. The images will be used to measure the cross-section area, the blood flow velocity and the flow direction in the jugular veins, as well as the structural properties of the optic nerve and optic nerve head.
3. Ultrasound imaging, using a high-resolution apparatus, will be performed to study the effects of postural changes on the blood flow velocity and the cross-section area of the right and left internal jugular veins and external jugular veins.

Eligibility Criteria:
Inclusion Criteria:

* Subject has normal tension glaucoma in one or both eyes (glaucomatous optic nerve head and corresponding visual field defects)
* Intraocular pressures before treatment did not exceed 21 mmHg. Occasional measurement up to 24 is accepted.

Exclusion Criteria:

* History of brain disease or brain surgery
* History of other neurologic or ocular disease causing visual field loss
* Use of anticoagulants other than acetylsalicylic acid
* Use of carbonic anhydrase inhibitors
* Previous lumbar puncture
* Claustrophobia
Validity and Reliability of Trunk Strength Device

The study aims to evaluate the accuracy and consistency of assessing trunk muscle strength using an isometric device (Pegasus, Leipzig, Germany). Thirty healthy volunteers will undergo maximal isometric strength testing with the device, repeated one week later to assess repeatability. Surface electrodes will measure muscle activation, while MRI scans will assess structural condition.

The aim of the study is to assess the validity and repeatability of trunk muscle strength evaluation using an isometric device (Pegasus, Leipzig, Germany) and to investigate it. Thirty healthy volunteer participants will undergo testing of maximal isometric (non-moving) strength using this device. The same strength measurement procedure will be repeated one week later for all participants to determine if the measurements are repeatable, i.e., if the device is capable of providing similar strength data in two closely timed measurements. To assess whether the device actually provides reliable strength data for the trunk muscles, surface electrodes will be additionally placed on the involved muscles to understand the extent of neural activation of these muscles during the test. Additionally, an MRI examination will be conducted for all study participants to assess the structural condition of the trunk muscles.

Eligibility Criteria:
Inclusion Criteria:

* both male and female subjects
* age between 18 and 59 years
* BMI \< 30 kg/m2
* cognitively intact (self-reported)
* autonomous walking

Exclusion Criteria:

* age under 18 years or over 60 years
* any prior spinal surgery or other musculoskeletal surgery having an impact on movement
* acute or chronic back pain in the last 6 months(self-reported)
* pregnancy (self-reported)
* inability to perform the planned set of activities included in the study (e.g. maximal voluntary contraction torque test)
* inability to give consent
Meat and Dietary Pattern Study

The objective of this study is to investigate how different types of meat consumed with two different dietary patterns affect risk for disease.

Association studies have suggested that dietary meat intake may have negative impacts on health. However, these association studies have done a poor job separating meat intake from overall dietary pattern, as well as isolating effects of processed meat from minimally processed meat. Meat is a good source of several essential nutrients, including high quality protein, iron, and vitamin B12. This dietary intervention is designed to investigate the effects of minimally processed meat and further proceeded meat, as part of two different dietary patterns (the typical American dietary pattern and Dietary Guidelines dietary pattern) on outcomes related to chronic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Male or female

Exclusion Criteria:

* Younger than 25 years old and older than 80 years old at the beginning of the intervention.
* Body mass index less than 18 or greater than 40 kg/m2.
* Blood pressure greater than 160/100 mm Hg or use of medication to treat hypertension for less than 6 months.
* Use of medications that will affect the study outcomes, including cholesterol lowering medications.
* Pregnant women, lactating women, women who plan to become pregnant during the study, or women who have given birth during the previous 12 months.
* Fasting blood glucose over 125 mg/dL or type 2 diabetes requiring medication.
* Body weight change of 10% in the past 3 months.
* History of bariatric or other gastrointestinal surgery that would affect digestion.
* History or presence of diabetes, kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
* Smokers, vapers, or other tobacco users (within 6 months prior to the start of the study).
* Use of an antibiotic within 1 month of the start of the study or during the study.
* Plans to have a colonoscopy during the study.
* Allergy to any food included in the study menus.
* Unable or unwilling to give informed consent or communicate with study staff.
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion).
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Organizational Skills Training for Children With ADHD

The purpose of this trial is to investigate the effect of organizational skills training, a parent and child training approach on organizational skills, inattentive symptoms and functional outcome in children age 6-13 years. Half of the participants will receive treatment as usual (TAU) and organizational skills training and the other half will receive TAU.

Organizational skills training (OST) is a behavioral intervention that has been increasingly used to address difficulties with time management and organization of materials in children with ADHD, that tend to persist despite medication and behavioral treatments. This randomized clinical superiority trial is going to investigate the effect of Organizational Skills Training, a group treatment approach for parents and children. The program is also involving a computerized program, vTime, that will help the children manage time more effectively. A total of 98 children with ADHD aged 6-13 years is expected to be randomized to either intervention or control group in a single blind design. Both groups will receive treatment-as-usual. The intervention group is going to participate in a group training for parents and children for 10 weekly sessions.

Eligibility Criteria:
Inclusion Criteria:

1. ADHD diagnosis after clinical interview K-SADS
2. age between 6-13 years, both inclusive; informed consent.
3. The child has to score at least one standard deviation (SD) above the mean on the Plan/Organize subscale on the Behavior Rating Inventory of Executive Functions (BRIEF) (parent edition) verifying problems with organizational skills.

Exclusion Criteria:

1. autism spectrum disorder
2. serious psychopathology requiring immediate clinical attention (e.g., severe depression or aggressive behavior)
3. head injury or verified neurological disease
4. intelligence quotient (IQ \<80)
5. medical condition, requiring primary treatment
6. no informed consent from custody.
The Impact of Non-monetary Incentives on Facility Delivery in Rural Zambia

This study measured the impact and cost-effectiveness of a low-cost, non-monetary incentive ("mama kit") on rural facility delivery rates in Zambia.

This clustered randomized controlled trial assessed the impact of providing a package of childcare items (a cloth, baby diaper, and blanket) to women conditional upon delivering at a facility on facility delivery rates in rural Serenje and Chadiza Districts in Zambia. Facilities were randomized to either provide the intervention or not. Facility-level antenatal care (ANC) and delivery registers were used to measure the percentage of women attending antenatal care who delivered at a study facility during the intervention period. Results from the trial were then used to model the cost-effectiveness of mama kits at-scale in terms of cost per death averted.

Eligibility Criteria:
Inclusion Criteria:

* Had an antenatal care record at one of the study facilities
* Had an estimated date of delivery (as measured by estimated date of last menstrual period, estimated date of delivery, or estimated gestational age in weeks as recorded in the antenatal care register) between June 1, 2013 - Aug 31, 2013.

Exclusion Criteria:

* Did not have an antenatal care record at one of the study facilities
* Had an estimated date of delivery outside of the intervention window (June 1, 2013 - Aug 31, 2013)
Right Ventricular Function in Obstructive Sleep Apnea

The purpose of this study is to determine the structural and functional cardiac alterations in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension and their correlation to the severity of OSA.

Many risk factors for OSA, such as male gender, obesity, and increasing age are the same as for cardiovascular diseases. This fact makes it more difficult to establish a causal relationship between OSA and cardiovascular diseases. The relationship between OSA and right ventricular (RV) function is controversial. RV dysfunction may be a result of chronic intermittent hypoxia and hypercapnia during apneic episodes. It may also occur secondary to left ventricular dysfunction as a result of increased afterload and sympathetic activity which causes secondary hypertension. As systemic hypertension is one of the most accompanying and contributing factors in OSA along with obesity, we tried to compare the effects of newly diagnosed OSA on RV function with an age and body mass index- matched control group.

Eligibility Criteria:
Inclusion Criteria:

For OSA patients (group1)

* Apnea Hypopnea Index equal or more than 15
* Epworth sleepiness scale equal or more than 10
* No previous treatment for OSA

Exclusion Criteria:

* Age \< 18 years
* Known hypertension, or 24-hour mean blood pressure of 135 and/or 85 mmHg or more
* Mean pulmonary artery pressure \> 25 mmHg
* Diabetes mellitus
* Left ventricular ejection fraction \< 60%
* Moderate to severe valvular disease
* Cardiomyopathy
* Renal failure
* Coronary artery disease
* Obstructive or restrictive lung disease demonstrated on pulmonary function test
* Connective-tissue or chronic thromboembolic disease
* Pericardial disease
* Cancer and/or other important comorbidities with an expected survival \< 2 years
* Suboptimal echocardiographic images for measurements
Comprehensive Management for Terminal Heart Failure Program:

Advanced heart failure presents with various symptoms, including pain, dyspnea, functional decline, reduced quality of life, and physiological deterioration, which can ultimately lead to spiritual distress. The functional losses experienced by patients-encompassing physical, social, and mental aspects-place a significant burden on caregivers, impacting their physical, mental, and spiritual well-being. This burden is further intensified by the stress of making major medical decisions, highlighting the need for palliative care that extends beyond the patient. Addressing how to holistically support both patients and caregivers is a key focus of palliative care.

Studies have shown that integrating palliative care with heart failure treatment significantly improves patients' quality of life, as well as their comfort and dignity at the end of life. Evidence from multiple studies demonstrates the benefits of palliative care for heart failure patients, including enhanced quality of life, reduced emergency department visits and hospitalizations, and increased participation in advance care planning discussions. Consequently, national guidelines in several countries, including the United States and Europe, recommend the early integration of specialist palliative care for heart failure patients. However, the optimal timing for intervention by palliative care specialists remains undetermined.

This study aims to develop and assess the feasibility and effectiveness of the Comprehensive Management for Terminal Heart Failure (COMFORT-HF) program. Participants will be randomly assigned to either the experimental group, which will receive the COMFORT-HF model, or the control group, which will receive usual care. The implementation of the COMFORT-HF model involves heart failure case managers conducting screenings to identify patients for referral to a specialist palliative care team. Once the shared decision-making process is initiated and both the patient and the primary heart failure care team agree, palliative care specialists and shared care nurses will collaborate with the heart failure team to provide comprehensive, coordinated care, including regular visits.

The study aim to validate that the COMFORT-HF model produces positive outcomes for patients with advanced heart failure, making it a promising approach for broader implementation and promotion.


Eligibility Criteria:
Inclusion Criteria:

1. Congestive heart failure at stage C or D
2. Age ≥ 18 years
3. Able to communicate in Chinese or Taiwanese

Exclusion Criteria:

1. Pregnant women
2. Patients who have previously received palliative care services