cyrilzakka/clinical-trials huggingface dataset:
Incorporating Flow Limitation Into the Diagnosis and Quantification of Sleep Disordered Breathing

The diagnosis and treatment of sleep disordered breathing have come to the forefront of clinical medicine following recognition of the high prevalence and associated morbidity of sleep apnea. The effects on quality of life as well as societal costs have been well documented. The NYU Sleep Research Laboratory has spent the last several years working on the problem of improving the diagnosis of mild sleep disordered breathing which manifests as the upper airway resistance syndrome. Our approach has been to develop a non-invasive technique to detect increased upper airway resistance directly from analysis of the airflow signal. A characteristic intermittent change of the inspiratory flow contour, which is indicative of the occurrence of flow limitation, correlates well with increased airway resistance.

Currently all respiratory events are identified manually and totaled. This is time consuming and subject to variability. The objective of the present project is to improve upon the manual approach by implementing an artificially intelligent system for the identification and quantification of sleep disordered breathing based solely on non-invasive cardiopulmonary signals collected during a routine sleep study. The utility of other reported indices of sleep disordered breathing obtained during a sleep study will be evaluated.

Successful development of an automated system that can identify and classify upper airway resistance events will simplify, standardize and improve the diagnosis of sleep disordered breathing, and greatly facilitate research and clinical work in this area. Using a physiological based determination of disease should allow better assessment of treatment responses in mild disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sleep disordered breathing
Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis

The objective of the EQUODIA study is to evaluate the hemodynamic stability of hemodialysis with low dialysate flow in patients requiring emergency hemodialysis in the context of acute kidney injury or unscheduled end-stage renal disease, not in intensive care, compared to conventional triweekly high-flow hemodialysis.

Short daily hemodialysis has excellent hemodynamic tolerance, which has already been confirmed by clinical experience. This modality, commonly used in the patient's home through new machines allowing a low dialysate flow purification technique, can prove to be an innovative, effective and safe alternative for patients admitted for hemodialysis in an unscheduled situation (acute kidney injury, unscheduled end-stage renal disease not followed).

Up to now, no studies have evaluated the use of short daily hemodialysis with low dialysate flow in patients with acute kidney injury or unscheduled end-stage renal disease, requiring the initiation of emergency extra-renal purification.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female 18 years of age or older
* Patient requiring unscheduled hemodialysis for end-stage renal disease or acute kidney injury
* Patient able to understand the protocol
* Patient who has agreed to participate in the study and has given express oral consent
* Patient affiliated to a social security system

Exclusion Criteria:

* Patient with more than one dialysis session
* Intensive care patient (need for vasoactive amine infusion, non-invasive ventilation, assisted ventilation)
* Patient participating in interventional clinical research involving a drug/medical device
* Patient under guardianship, curator, deprived of liberty
* Pregnant or breastfeeding patient, or with the ability to procreate without effective contraception
* Patient refusing to participate
* Patient unable to understand the protocol and/or give express oral consent
Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.

Eligibility Criteria:
Inclusion Criteria:

* Patient has provided signed informed consent
* Patient is aged greater than or equal to 40 and less than or equal to 89 years of age
* Patient has a prostate size between 90g and 200g, as determined by MRI
* Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
* Patient has an IPSS score of at least 13 at baseline
* Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment
* Patient either: refuses surgical treatment OR is contraindicated for surgical treatment
* Patient meets ONE of the following criteria: baseline PSA \< 4.0ng/mL (no prostate biopsy required) OR baseline PSA \>/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months

Exclusion Criteria:

* History of prostate, bladder, or rectal cancer
* History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies
* History of open bladder, rectosigmoid colon, or other pelvic surgery
* Patient is unwilling to discontinue alpha blockers 1 month after study treatment
* Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment
* Neurogenic bladder or other neurologic disorder impacting bladder function such as Parkinson's disease, multiple sclerosis, cerebral vascular accident or diabetes
* Any other confounding bladder or urethral pathology, including urethral stricture, bladder neck contracture, or bladder atonia
* Active prostatitis or urinary tract infection
* Cystolithiasis within the past 3 months
* Serum creatinine \> 1.7mg/dL
* Inability to discontinue oral anticoagulant 2-5 days prior to study treatment
* Coagulation disturbances not normalized by medical treatment
* Iodinated contrast allergy that, in the opinion of the Investigator, cannot be adequately premedicated
* Gelatin allergy
* Known severe peripheral vascular disease or major iliac arterial occlusive disease
* Interest in future fertility
* Clinically significant cardiac arrhythmia or other cardiac disease (including congestive heart failure), uncontrolled diabetes mellitus, clinically significant respiratory disease, or known immunosuppression
* Other condition that the Investigator believes puts the patient at risk for a complication during the procedure
Analysis of Clinical Application of China's First Batch of TYRX Absorbable Antibacterial Envelope

This study is the first to use TYRX domesticly, reporting and summarizing its usage to validate its real-world effectiveness in CIED infection prevention.

This study is the first to use TYRX domesticly, reporting and summarizing its usage to validate its real-world effectiveness in CIED infection prevention.

Eligibility Criteria:
Inclusion Criteria:

* All patients who received the TYRX absorbable antimicrobial envelopes at our hospital from December 2023 to September 2024

Exclusion Criteria:

* Allergies to the envelope materials or antimicrobial drugs (minocycline and other tetracyclines, rifampin)
* Existing infections at the CIED implantation site
* Pregnant or breastfeeding women
* children and adolescents
Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).

The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.

Eligibility Criteria:
Inclusion Criteria:

* existing contact lens wearer
* read and signed statement of informed consent
* has clear central cornea
* requires spherical distance correction

Exclusion Criteria:

* has worn RGP contact lenses within the last 30 days
* is using any ocular medication
* has had refractive surgery
* has an infectious disease
* is pregnant or lactating
* is participating in another clinical research study
The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies

Development; It covers the areas of physical, mental, emotional and social development. Development in one area affects other areas as well. Infancy is the period in which children grow and develop the fastest. Babies need many environmental factors and stimulants in order to have a healthy developmental process. For the Covid 19 pandemic, many restrictions have been made in Turkey to reduce the spread of the epidemic and to maintain social distance between people. It has been suggested that individuals practice their own social isolation. It has also caused babies who spend their time at home during the pandemic process to be deprived of environmental stimuli. In current studies in the literature, it has been reported that the COVID-19 pandemic affects infant and child development significantly and negatively. It has been reported that the risk of delay in children who have experienced the COVID-19 pandemic is especially in the fine motor and communication areas. There is a limited number of studies in the literature on this subject. No study was found in Turkey. The aim of this study is to evaluate the neuromotor development of infants in early childhood (6-24 months) in the Covid-19 pandemic and to reveal the effects of the pandemic process. Denver II Developmental Screening Test was used to evaluate the neuromotor development of healthy infants aged 6-24 months, who applied to the healthy pediatric outpatient clinic of Acıbadem Altunizade Hospital, and Alberta Infant Motor Scale was used to evaluate gross motor functions.

It is an observational study. Purpose of the study: evaluating the neuromotor development of infants in early childhood (6-24 months) in the Covid-19 pandemic and revealing the effects of the pandemic process.

75 healthy infants aged 6-24 months were included.

* Will there be developmental delays in children born in the Covid 19 pandemic?
* In which parameter delay is observed the most.

Denver II Developmental Screenin Test and Alberta Infant Motor Scale were applied to the participants.

Eligibility Criteria:
Inclusion Criteria:

* 75 healthy infants aged 6-24 months were included.

Exclusion Criteria:

* Having a physical/mental/neuromotor/psychological problem
* Not between 6-24 months in the pandemic process
* Presence of a diagnosed disease
* Having a vision problem
* Having a hearing problem
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients

Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.

The investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between Envarsus and immediate release tacrolimus. Eligible patients will be enrolled within 8 weeks post-transplantation. They will be administered a baseline panel of neurocognitive tests. They will then be randomized to either continue on immediate release tacrolimus or Envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated.

Eligibility Criteria:
Inclusion Criteria:

1. Recipient of a kidney transplant
2. Age 60 or greater at the time of transplant
3. Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
4. Have IR tacrolimus as maintenance therapy
5. Have BMI \< 35 at time of transplant
6. Achieve therapeutic tacrolimus level within 4 weeks post-transplant

Exclusion Criteria:

1. Recipient of a simultaneous non-kidney transplant (pancreas)
2. Had an episode of rejection before study enrollment
3. Had a TIA/CVA after transplantation and before study enrollment
4. Had a neurologic injury after transplantation and before study enrollment
5. Blindness
6. Have an mTOR inhibitor as maintenance therapy
7. Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.
8. Adults unable to consent
9. Pregnant women
10. Prisoners
A Randomized Controlled Trial to Determine Outcome and Cost Effectiveness of Case Management of Chronic Obstructive Pulmonary Disease (COPD) Patients

This randomized controlled trial (RCT) will examine a nurse case management model for patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish municipality, and is performed in order to evaluate the use of case management as a tool in achieving integrated, quality and cost-effective care for this group of patients.

The main objectives are to evaluate how case management influences on hospital admissions, mortality, quality of life and self care, as well as to compare costs and cost-effectiveness of case management vs. usual care.

Case management is being implemented as a health service strategy that should contribute to maximize health outcomes within a cost-constrained environment. Evaluations of case management in Danish settings are sparse, and so far no Danish studies have evaluated the cost-effectiveness of case management.

This study is performed as a RCT, and the study focuses exclusively on patients with COPD. The patients will be enrolled and randomized after being referred to rehabilitation at the local rehabilitation center in Aalborg municipality, Denmark. 150 patients will be randomly assigned to two groups of 75 patients each. Participants in the control group will receive usual care, whereas patients assigned to the interventional group will receive case management besides their usual care. Each patient will be followed for 12 months. Patients in both groups will fill out questionnaires at baseline and 12 months. The data register system "Health - Planning and Quality" in the Northern Region of Jutland will be used to determine health care services and costs.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are clinically referred to rehabilitation at Aalborg Rehabilitation Center for their diagnosed COPD

Exclusion Criteria:

* Patients living outside Aalborg municipality, or who is considering to move to another municipality or country in near future.
* Patients without a telephone
* Patients with dementia
* Patients participating in other research studies
Ultrasonography of the Neuromuscular Degeneration Behavior in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease.

An exhaustive and frequent clinical evaluation can lead to establish an adequate and early treatment of the consequences of its evolution.

Objectives.

1. To evaluate the evolution of diaphragmatic and peripheral neuromuscular degeneration by ultrasound examination in patients with ALS and to establish possible evolution patterns.
2. To verify the relationship between the degenerative peripheral and diaphragmatic neuromuscular changes evaluated by ultrasonography and changes in clinical scales frequently used.
3. To compare the ultrasonographic features of subjects with ALS and a sample of healthy subjects Methods. A longitudinal observational study in a consecutive sample of patients diagnosed with ALS will be realized. All the patients will be examined 3 times, with an interval of at least 3 months between tests. Bilateral and cross sectional ultrasonography of several peripheral muscles and diaphragm will be performed at rest and during muscle contraction. All the images will be processed and analyzed for obtaining morphometric variables (muscle thickness) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded in peripheral muscles.Also clinical features will be noted, every time of the 3 exams, from Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-r), British Medical Council Research Scale(MRC), and routine pulmonary tests.


Eligibility Criteria:
Inclusion Criteria:

* Definite ALS

Exclusion Criteria:

* Primary Lateral Sclerosis (PLS)
* Other forms of motor neuron disorders
Clinic to Home Robotics-assisted Telerehabilitation for Upper Limb (CHISEL)

Hemiparetic weakness is common after stroke and only a small group of patients achieve useful upper limb function despite best rehabilitation efforts. This is due to the lack of intensive upper limb therapies to drive neuroplasticity either in clinic or at home.

In this study, we plan to pilot home-based, robot-aided-therapy using H-man to deliver intensive arm rehabilitation.

It has been assumed that stroke survivors reach a plateau in their recovery within 3-6 months of their stroke. They tend to receive minimal rehabilitation support once they are discharged to the community citing obstacles such as ambulation, transportation, and cost.

H-man is a novel telerehabilitation, upper limb training robot, that will deliver robot-aided therapy in patients' homes by clinic-based therapists through remote monitoring and under the supervision of their caregivers.

The study aims to refine and evaluate the feasibility, efficacy and safety of home-based training using the H-man robot.

Eligibility Criteria:
Inclusion Criteria:

1) Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging (2) Age 21 to 90 years, both males and females (3) At least \> 28 days (4) Upper limb motor impairment of Fugl-Myer Motor Assessment (FMA) scale 10 to 60 (5) Has a stable home abode and a carer/ NOK to supervise home based exercise. (6) Ability to sit supported continuously for 60 minutes (7) Montreal Cognitive Assessment (MOCA) score \> 21/30 (8) Able to understand purpose of research and give consent

Exclusion Criteria:

1. Non-stroke related causes of arm motor impairment
2. Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers.
3. Anticipated life expectancy of \< 6 months
4. Inability to tolerate sitting continuously for 60 minutes (5 Local factors potentially worsened by intensive robot-aided arm therapy and computer-based training: active seizures within 3 months, spasticity of Modified Ashworth Scale grades \>2 skin wounds, shoulder, arm pain VAS \>5/10, active upper limb fractures, arthritis, fixed upper limb flexion contractures.

(6) Hemi anaesthesia of affected limb (7) Severe visual impairment or visual neglect affecting ability to use H-Man robot (8) History of dementia, severe depression or behavioural problems (9) Pregnant or lactating females will not be allowed to participate (10) Absence of reliable carer to provide supervision during home training.
The Effects of Oxytocin in Obese Adults

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old;
* BMI greater than or equal to 30 kg/m2

Exclusion Criteria:

* Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months);
* history of medication changes within 4 weeks of enrollment;
* active substance use;
* history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease;
* hematocrit \>2% below normal;
* fasting glucose \> 125 mg/dL or hemoglobin A1c ≥ 7% ;
* ALT or AST \>2.5 times upper limit of normal;
* Cr \>1.5 mg/dL; hyponatremia;
* pregnancy or breastfeeding;
* unwilling to use medically acceptable form of contraception (females only)
* follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
* current smoking or tobacco use
Neutrophil Gelatinase-associated Lipocalin in Major Abdominal Surgery

Acute kidney injury (AKI) after major surgery is a well-known complication. The incidence of AKI after major surgery ranges from 13% to 50%. The morbidity and mortality rates increase in patients with AKI due to the treatments applied and the prolonged hospital stay. In addition, as a result of all these processes, hospital costs increase and burden the health systems.

Classifications such as Acute Kidney Injury Network (AKIN) or Kidney Disease Improving Global Outcomes (KDIGO) are used in the diagnosis of AKI. In these classifications, evaluation is made based on kidney damage, serum creatinine (Scr), and urine output. However, Scr; is affected by factors such as age, gender, diet, muscle mass, and medication. In addition, in healthy individuals in terms of kidney reserve, a loss of up to 50% in nephrons is tolerated by the body and there is no change in Scr values. Therefore, the onset of the increase in Scr values occurs 48-72 hours after kidney damage. This situation causes delays in the treatments applied and increases morbidity and mortality rates.

For these reasons, interest in biomarkers used in the early diagnosis of AKI has increased in recent years. Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 KDa, neutrophil-derived molecule from the lipocalin family. It is also secreted in small amounts from kidney, prostate, and respiratory tract epithelial cells. After ischemic and nephrotoxic acute tubular necrosis, NGAL levels peak at the 3rd hour and remain elevated for approximately 24 hours. In patients who do not progress to AKI, NGAL levels begin to decrease in the 1st hour after injury.

When the current literature is examined, scientific studies on NGAL have mostly been carried out on cardiovascular surgery cases to date. There are very few studies evaluating NGAL levels in patients who develop AKI after major abdominal surgery. These few studies evaluated either serum NGAL or urinary NGAL levels. In this study, both serum NGAL and urinary NGAL will be measured simultaneously to detect AKI that may develop in patients undergoing major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III,
* Patients undergoing elective major abdominal surgery

Exclusion Criteria:

* Chronic renal failure,
* Using nephrotoxic drugs,
* Patients with a history of kidney transplantation or nephrectomy