cyrilzakka/clinical-trials huggingface dataset:
Detection of Keratoconus Progression Using Machine Learning

Keratoconus (KC) is a bilateral ocular disease characterized by progressive thinning and steepening of the cornea, usually in its inferotemporal region. The disease often occurs asymmetrically as one eye is more severely affected by the condition. The changes underlying KC lead to the generation of irregular astigmatism resulting in diminished visual acuity of the patients and can even lead to axial corneal scarring in advanced stages. The disease usually occurs in the second or third decade of life, but can develop at any age. KC is a complex condition involving environmental factors such as age, eye rubbing, contact lens use, atopy, sun exposure, hormones, toxins, as well as a genetic component. However, how these factors contribute to the disease is still unknown and intraindividual differences might exist.

KC can be categorized into different forms based on the stage of the disease. In clinical KC, there are both topographic and slit lamp findings of the disease.

The importance of corneal epithelial imaging in the diagnosis of keratoconus has been further demonstrated in several clinical studies. As new anterior segment optical coherence tomography (AS-OCT) devices provide more detailed measurements for instance of the corneal epithelium. This layer could therefore be an interesting marker for the prediction of KC progression and contribute to earlier diagnosis as well as better outcome of the disease.

The aim of this retrospective study is therefore to determine whether different topographical and volumetric data, for instance epithelial thickness maps (ETM), can be reliably used to predict the progression of KC using a machine learning algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Patients with KC progression as defined dependent on Kmax/year:

o

1. Kmax \< 48 Dioptres (D): \>0.5 D per year o
2. Kmax 48.01-53 D: \>0.6 D per year o
3. Kmax 53.01-58 D: \>0.8 D per year o
4. Kmax \> 58 D: \>1.5 D per year - Non progressive group: Patients with stable KC (KC progression dependent on Kmax \< than the values described above/year)

Exclusion Criteria:

* Relevant other ophthalmic diseases that are likely to influence the measurement outcome like corneal scars or epithelial dystrophies
* Too few measurements/too short follow-up to define progression of KC
Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

The purpose of this study is to compare the effectiveness and efficiency of doing a psychoeducational group program and the conventional treatment versus individual conventional care in patients with a mild/moderate depression disorder,in urban primary healthcare centers in Barcelona city.

Nowadays, the depression is one of the public health major issues, this is because of its prevalence and its economic and social repercussions. It is fundamental for the Primary Care to assume the management of these health problems.

Design:A randomised controlled trial of two groups (intervention and control), longitudinal and prospective.

Population of study: The subjects of the study are patients of 20 to 65 years old attended in 8 urban primary healthcare centers of Barcelona city, identified by the general practitioners and nurses with diagnosis of mild/moderate depression disorder according to the BDI scale.

The intervention group receive weekly a psychoeducational group program during 12 weeks run by 2 nurses. The program have a structured content where patient is educated about the illness, pharmacological treatment, the adherence to treatment, diet and physical exercise, problem solving, and cognitive-behavioral therapy.

In the control group the depression in treated as usual with the conventional care.

Measure's tool: The evolution of patients will be monitoring up to 1 year after the inclusion by a individual interview (the first visit and 3,6 and 9 months).The Beck Depression inventory (BDI) is a self-administered questionnaire that measure the symptomatology and severity of the depression.

The analysis variables are: patient's quality of life (EuroQoL-5D scale) ,clinical variables of the patient, pharmacological prescription, anxiolytics and antidepressants consumption , sociodemographic, number of visits to primary healthcare center, number of days of labour lost and cost.

Eligibility Criteria:
Inclusion Criteria:

* Beck Depression Inventory(BDI)\>10 and \<30.
* Diagnosis of mild/moderate depressive disorders.
* Signed the Informed Consent.

Exclusion Criteria:

* Patients diagnosed of severe mental psychiatric disorder,
* Patients diagnosed of a major depressive disorders,
* Patients with acute illness or near-terminal medical illness,
* using secondary mental health services,
* suicidal ideation or intentions,
* don't speak and understand spanish or/and catalan language,
* sensory or cognitive disabilities,
* illiteracy,
* does not know or not give consent to participate in the study,
* temporary residents.
Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study

Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a systematic approach to linking treatment and feedback components to enhance adherence.

Study Design: This will be a single group intervention involving a 28-day baseline (Phase 1), a 28-day treatment period with enhanced adherence feedback. Subjects will be treated with Cayston via a blue tooth enabled nebulizer.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be 18 non-adherent CF patients
* Stratified by age as adult supervised (8-12) adolescents (12-18) and young adults (19-30) and gender
* Balanced for ethnicity and disease severity -Non-adherence status will be determined at screening based on an MAQ score \< 6. -

Exclusion Criteria:

* Inability to give informed consent or assent
Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion

The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.

The levonogestrel Intrauterine system (LNG-IUS)(52 mg per 20mg per day release) is associated with medically benign changes to the menstrual pattern. Amenorrhea, the complete cessation of vaginal bleeding for at least 90 consecutive days, is perhaps the most extreme bleeding pattern experienced by some users during the first year. Amenorrhea prevalence is positively associated with duration of use, with approximately 8% of users.

Eligibility Criteria:
Inclusion Criteria:

* Included participants with normal regular menses prior to LNG-IUS

insertion

* Included participants of any age, race, ethnicity, or parity
* Contained bleeding and/or spotting data on the 52 mg (20 mg/d) LNG-IUS
* Collected daily menstrual bleeding data from written diaries for at least 90 consecutive days

Exclusion Criteria:

* Heavy or prolonged menstrual bleeding (menorrhagia)
* Actively breastfeeding
* Hormonal long-acting reversible contraceptive method (LNG-IUS, implant) within 3 months of enrollment
* Hormonal injectable contraceptive use within 6 months of enrollment
* First 3 months (90 days) of data from women with postpartum or postabortion LNG-IUS insertions
* Any anatomical or pathological condition (ie, uterine fibroids) that may have an impact on baseline menstrual bleeding pattern
Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis

The purpose of this study is to see if using a form of imaging during surgery helps the doctors to guide the placement of radiation catheters more accurately.

This method, called "image-guided surgical navigation" may allow the doctors to deliver radiation to the tumor that the patient needs and decrease the amount of radiation delivered to the nearby areas.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologic proof of a malignancy suitable for radiation therapy.
* Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration.
* If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible.
* If the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. \[Rades 2005, Nieder 2005, Sahgal 2012\]
* KPS ≥ 60
* Age ≥ 18 years old

Exclusion Criteria:

* Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria.
* Patients with kyphoplasty cement or hardware that would preclude effective catheter placement.
* Patients with paraspinal extension of disease with visceral involvement.
* Abnormal complete blood count. Any of the following:
* Platelet count \< 75,000/ml
* Hb level \< 9gm/dl
* WBC \< 3.5/ml
* Abnormal coagulation profile: INR \> 2.5 and/or PTT \> 80
* Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.
* Contraindications to general anesthesia
Thulium Fiber Laser En-bloc Resection vs Conventional Transurethral Resection of Non-muscle-invasive Bladder Cancer

Ongoing efforts aim at overcoming the challenges of conventional transurethral resection of bladder tumor (TURBT) such as the high recurrence rate, difficulty of pathologic interpretation and complications including wall injury. Possible advantages may have en bloc resection of bladder tumor which was previously shown to be effective and safe technique. Use of novel thulium-fiber laser may also provide additional safety and efficacy of the resection.

Objective. To prospective assess the safety and efficacy of Thulium-fiber en bloc resection of bladder tumor (Tm-fiber-ERBT) compared to TURBT.

En bloc resection of bladder tumor (ERBT) was first employed by Kawada T. et al. in 1997. The technique showed promising results in terms of safety and tumor staging. Development of laser surgery and emergence of the holmium (Ho:YAG) and later thulium (Tm:YAG) lasers in the 1990s enabled laser ERBT with subsequent studies demonstrating high efficacy and safety of the new techniques. Ho:YAG and Tm:YAG ERBT have distinct advantages over conventional TURBT such as the complete absence of the obturator nerve reflex and hence, lower risks of perforation or bleeding as well as a higher quality specimens for pathologic examination, due to lack of the cautery effect. Recently, a new type of thulium laser was developed - that allows to decrease the penetration depth less than 0.15 mm, which is two times less than that of Tm:YAG. Another advantage is the decreased carbonization compared to Tm:YAG due to better water absorption of laser energy. All these aspects make Tm:YAG a precise tool that may improve the resection quality resulting in better management. Data on laser ERBT of NMIBC with Tm:YAG is limited and that on Tm-fiber laser ERBT is absent altogether. The investigators hypothesized that Tm-fiber laser ERBT would result in a lower probability of adverse events and better recurrence-free survival compared to conventional TURBT.

Eligibility Criteria:
Inclusion Criteria:

• Primary Ta or T1 bladder cancer (NMIBC)

Exclusion Criteria:

• Pure carcinoma in situ
Alice PDx User/Validation Extended Trial

The objective of this study is to test the usability of the Alice PDx device by both the end user (patient/participant) and the sleep technician. Data will be collected via questionnaires regarding the participant's ability to understand the participant user manual under home conditions and the technician's ability to set up the Alice PDx according to the health care provider manual. This study will also compare the physiological data recorded by the Alice PDx to the physiological data recorded by its predicate device the Alice 5 System and validate its equivalence. This will be evaluated by comparing the manual study scores for detected apnea and hypopnea events and on an event by event basis during a standard polysomnography (PSG)/ sleep study. The study will test the ability of the Alice PDx to record good quality data as determined by the Good Study Indicator (GSI) function of the Alice PDx firmware.

The primary hypothesis is that the participant will be able to successfully apply the Alice PDx basic leads following the participant user manual instructions and the sleep technician will be able to successfully apply the advanced leads in preparation for the sleep study. In addition, it will be demonstrated that the Alice PDx is equivalent to the Alice 5 System in its intent to record, display and print physiological data to the clinician/physician in order to aid in the screening/follow-up diagnosis of respiratory sleep disorders.

Alice PDx is a portable, diagnostic recording device. It may be used for obstructive sleep screening as well as follow-up and diagnostic assessment. The device may be used in a sleep lab or clinical setting by trained professionals and it may be used at home by patients as directed by their health care provider. The Alice PDx device is not currently approved by the Food and Drug Administration (FDA).

The Alice PDx device is capable of recording various physiological inputs and storing the data locally on a removable storage card. The device may also be connected directly to a PC (personal computer) running the Alice Sleepware software application. Sleepware can display live or pre-recorded data in a resolution consistent with the computer hardware specifications.

Eligibility Criteria:
Inclusion Criteria:

* Patients must call into a sleep lab or be referred to a sleep lab for a diagnostic polysomnogram
* Able to follow directions
* Able to provide informed consent

Exclusion Criteria:

* Participants requiring supplemental oxygen therapy
* History of having a previous sleep study/polysomnogram performed
* Current positive airway pressure (PAP) users
* Unable or unwilling to perform a polysomnogram
Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision

insertion of new intraocular lens enhanced for intermediate vision

Eligibility Criteria:
Inclusion Criteria:

* normal ocular examination apart from cataract.

Exclusion Criteria:

* previous ocular surgery.
* ocular pathology or corneal abnormalities.
* endothelial cell count below 2000 cells/mm2.
* corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).
Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study

Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as hemodialysis / hemofiltration. The exact reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant released substances play a crucial role in these procedures. These substances could be due to contact of blood cells with the Membrane in the dialyzer / hemofilter arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during hemodialysis and thus act as potential candidate products for the result of hypotonic phases in the Dialysis.

We will determine differences in RBC fatty acids profiling in hemodialysis patients before and after dialysis intervention. Furthermore a matched control group of healthy individuals will be profiled. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry.

It is believed that during hemodialysis / HLM / CVVH there is an increase in EETs / DHETs in the serum and in the erythrocytes. It is believed that shear forces play an important role in the release of erythrocyte EETs / DHETs.

Differences in Erythrocyte Fatty-Acid Status Profiling in:

* before and after hemodialysis intervention
* in hemodialysis patients and healthy individuals Venous blood will be collected from each subject in the sitting position

Eligibility Criteria:
Inclusion Criteria for hemodialysis patients:

* Patients who have a history of renal failure and undergo hemodialysis / hemofiltration
* Age over 18 years
* Ability to consent
* There is a written consent of the study participant

Exclusion Criteria for healthy control group:

* chronic illness requiring any medication
* pregnancy
* limitations regarding functioning in the hypoxic chamber
* inability to follow simple instructions relevant or severe abnormalities in medical history, physical examination
The Role of Narrow-Band Imaging Endoscopy in Diagnosing Gastric Intestinal Metaplasia

The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in case of suspected intestinal metaplasia

To detect intestinal metaplasia which consider pre malignant condition and use a targeting biopsy in case of suspected intestinal metaplasia which allowed us to better follow-up those patients.

Eligibility Criteria:
Inclusion Criteria:

* Dyspepsia

Exclusion Criteria:

* Pregnancy,
* Upper gastrointestinal bleeding,
* Previous gastric operation,
* Known gastric malignancy'
* Non cooperative patients
The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients

Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance.


Eligibility Criteria:
Inclusion Criteria:

* 1.Age between 20 and 70 years old; 2.Maintenance dialysis for longer than 3 months; 3.Diagnosis with chronic heart failure, Left ventricular ejection fraction (LVEF)≤40% or NT-proBNP\>12000pg/ml; 4.The patient signs an informed consent form.

Exclusion Criteria:

* 1.Patients with liver function impairment; 2.Patients with severe hypoglycemia/hypotension/ketoacidosis; 3.Patients with active pyelonephritis or symptomatic urinary tract infection; 4.Dapagliflozin allergies or severe adverse reactions; 5.Patients suffering from other severe diseases; 6.Patients participating in other clinical trials; 7.Pregnant or lactating women; 8.Failure to sign a written informed consent form; 9.Unable or unwilling to comply with the experimental protocol approved by the researcher
Social Dominance, Gender, and Cardiovascular Reactivity

To examine biopsychosocial processes that might contribute to the associations among social dominance, gender, and cardiovascular reactivity,.

BACKGROUND:

Social dominance, the tendency to exercise social influence and control, has been positively associated with coronary heart disease (CHD) risk among males, independent of biomedical risk factors and hostility. Exposure to dominant others behaviors also has been associated with elevated CHD risk. For females, submissiveness and a constellation of psychosocial behaviors opposite to urgency and competitiveness have been associated with increased risk for cardiovascular disease (CVD). The studies extend a growing literature concerning the central role of social relationships in health and illness and they test a theoretical model that addresses why social relationships and interpersonally-oriented person variables such as dominance may have differing consequences for the physical well-being of men and women.

DESIGN NARRATIVE:

The three studies were designed to test a social-contextual model of dominance and cardiovascular stress reactivity (CVR) that synthesized and elaborated earlier models in order to account for (1) cardiovascular consequences of exposure to dominant others and (2) differences in dominant men's and women's cardiovascular responses to social interactions. Because of the disproportionately high rates of CVD among Black Americans, both Black and white men and women were included in the studies.

Using a laboratory social interaction paradigm, study 1 refined and validated a coding system designed to assess dominant and hostile behaviors during dyadic social interaction. Study 2 examined two factors proposed to account for differences in dominant men's and women's cardiovascular responses to social interaction: (1) explicit role demands regarding dominance expression (i.e., the degree to which situations provided clear and salient cues regarding expected and acceptable behavior) and (2) gender composition of the dyad (i.e., same sex versus opposite sex). These two factors were manipulated independently while unacquainted, healthy young adult men and women participated in task-oriented dyadic discussions designed to activate motives to influence; cardiovascular responses were measured during the discussions and preceding rests. Study 3, a secondary analysis of data collected in study 2, examined associations between CVR and exposure to others' dominance. The aforementioned behavioral coding system was used to assess behavioral dominance observed in study 2 and path analytic techniques were used to model associations among CVR, one's own and one's partner's trait and behavioral dominance, gender, and situational factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria