cyrilzakka/clinical-trials huggingface dataset:
Far Infrared Therapy on Peritoneal Function of CAPD Patients

For patients with end-stage renal disease, peritoneal dialysis (PD) has been proven to be an alternative choice compared to hemodialysis as a type of maintenance renal replacement therapy. Despite this, long-term PD is associated with structural membrane changes that are believed to contribute to alterations in solute transport and loss of ultrafiltration. Previous studies have proven that far-infrared (FIR) therapy may improve not only the arteriovenous fistula patency in hemodialysis patients but also abdominal discomfort due to encapsulating peritoneal sclerosis in PD patients. Since there is little information concerning this issue, this study was conducted in order to evaluate the possible effects of FIR therapy on the peritoneal function of patients receiving continuous ambulatory peritoneal dialysis (CAPD). The objective of this study is to evaluate the effect of FIR therapy on the peritoneal function, protein loss, and ultrafiltration capacity of CAPD patients.

A total of 100 CAPD patients will be enrolled in this study, including 50 in treatment group who will receive FIR therapy for 6 months and 50 in control group. Many parameters of blood and urine samples as well as ultrafiltration amount, dialysate urea nitrogen, creatinine, Na+, K+, total protein, CA-125, and glucose degradation product (GDP) for the dialysate effluent of not only the first and last exchanges but also the total exchanges of daily PD regimen will be measured for both groups at day 1 and 6th month. However, only the FIR group will receive tests of blood, urine and dialysate on day 2. The significance of the study is that patients might benefit from the prophylactic therapeutic effects of FIR therapy, leading to the reduction of the hospitalization costs and the need for interventional procedures in CAPD patient care in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Chronic peritoneal dialysis patients who have not received any FIR therapy within the previous 12 months
* Patients on a standard continuous ambulatory peritoneal dialysis (CAPD) (1.5-2 L; 4-5 exchanges/day) or ambulatory peritoneal dialysis (APD) program

Exclusion Criteria:

* History of CAPD-related peritonitis within 3 months prior to the study period;
* History of cerebrovascular accident or myocardial infarction or interventional procedure (percutaneous transluminal coronary angioplasty or stent) for coronary artery disease within the 3 months prior to the study
Efficacy of Proximal Caries Infiltration

The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.

The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* children with one tooth surface with active caries lesions
* two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
* asigned informed consent.

Exclusion Criteria:

* children who do not cooperate during dental appointments
* primary molars supposed to exfoliate in less than two years
* lesions showing obvious cavitation or clear sings of inactivity
Pediatric Resuscitation With Feedback Devices

The aim of this study was to compare four different CPR feedback devices to standard BLS in terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators hypothesis was that there would be no difference between CPR methods in terms of chest compression quality parameters.

Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.

Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* medical profession (nurses)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Influence of the Shoulder Position on the Catheter Tip Location During Infraclavicular Subclavian Approach

Infraclavicular approach of the subclavian veins is commonly used for central venous access. Aberrant locations of catheter tip are frequently quoted for this approach, but few studies have been performed to document the relationship between the shoulder position and catheter tip location. This prospective study was performed to assess the influence of the shoulder position on the safe and proper placement of infraclavicular subclavian catheters.


Eligibility Criteria:
Inclusion Criteria:

* adult patients requiring central venous catheterization due to major procedures such as neurosurgery or thoracic surgery.

Exclusion Criteria:

* chest deformities,
* coagulopathy,
* diaphragmatic dysfunction,
* pulmonary malformation,
* history of prior clavicle fracture, or
* infection over the puncture site.
Epidemiologic and Clinical Characteristics of Optic Neuritis in China

This will be a hospital-based retrospective multi-center study on epidemiologic and clinical characteristics of optic neuritis among Chinese. The investigation will cover about 29 provinces or municipalities all around China.

This national investigation will be conducted to describe the epidemiology and clinical characteristics of optic neuritis in China. All the patients will be divided into 3 groups according to the serum demyelinating antibodies (Aquaporin-4 antibody seropositive group, Myelin oligodendrocyte glycoprotein antibody seropositive group and double seronegative group). The investigator will analyze the differences among the three groups.

Primary outcomes:

* To dig out the different visual acuity (VA, LogMAR) prognosis among the three groups;

  * To calculate the annual relapse rate (ARR) differences among the three groups (relapse times in all the follow-up time in each group/ follow-up time (years) in all in each group).

Secondary outcomes:

* Other epidemiological and clinical characteristics of optic neuritis patients will be analyzed among the three groups;

  * Orbital or Brain MRI is required in this study, which could avoid the misdiagnosis. We will collect and analyze these MRI data too (including the optic nerve lesions in T2 weight images and T1 enhanced MRI);

    * Results of optical coherence tomography (OCT) (including peripapillary retinal nerve fiber layer, macular thickness ,and ganglion cell and inner plexiform layer complex) at different time point are also needed in this study. However, OCT is not necessarily required;

      * Visual fields at different time points are also encouraged to provide if they are available.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of optic neuritis
2. The patients' medical records were complete

Exclusion Criteria:

1. Patients with unclear diagnosis of optic neuritis
2. Incomplete medical records
Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease

This study is a randomized clinical trial that compares the effectiveness of Plasma Rich in Growth Factors (PRGF) with conventional treatment for healing foot ulcers in diabetic patients who also have peripheral arterial disease. The goal is to assess how well PRGF promotes healing over a six-month period.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 18 years
* Diagnosis of type 1 or 2 diabetes
* Presence of one or more ulcers below the malleoli
* Ulcer size ranging from 1 to 25 cm2
* Peripheral Arterial Disease (PAD)
* Meet at least 2 of the following crieria:
* Absence of peripheral pulses at any level on physical examination of lower extremities
* Ankle pressure of 50-90 mmHg
* Finger pressure 30-70 mmHg
* Ankle-branchial index (ABI) 0.5-0.9
* Finger-arm index (FIBI) 0.3-0.7
* Transcutaneous oxygen pressure (TcPO2) 30-59 mmHg
* Degree of infection of the lesion on IDSA/IWGDF scale not greater than 1
* Availability of observation during the study period
* Properly completed patient informed consent

Exclusion Criteria:

* Ulcers grade 3 or higher
* Positive markers for HCV, AfHBs, HIV-I/II or TP
* Diabetes mellitus with poor metabolic control (evidence of glycosylated hemoglobin \>9%)
* Active systemic infection
* History of cancerous or precancerous lesions in the area of intervention
* On active treatment with other local treatment at the site of treatment
* On active treatment with immunosuppressants and/or other drugs contraindicating blood collection
* History of allergy to blood derivatives
* Previous diagnosis of coagulopathies
* Regular and continuous treatment (≥ 3 months) with NSAIDs (with the exception of the use of acetylsalicilic acid)
* Pregnancy or women of chilbearig age not taking effective contraceptive measures. These methods are, according to recommendations of the Clinical Trial Facilitation Group (CTFG) Contraception Working Group (CTFG) (V1.1), the following Hormonal contraception associated with ovulation inhibition, intrauterine decide (IUD), intrauterine hormone-releasing system, bilateral tubal ligation, vasectomy partner, sexual abstinence
* Breastfeeding women
* Treatment with monoclonal antibodies
* Any inabilities to participate in the study
Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital.

This study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "GIMEMA" or "BFM" or "NILG" approved by the Ethics Committee of Hospital. The purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.


Eligibility Criteria:
Patients with newly diagnosed of acute lymphoblastic leukemia enrolled from 1999 to 2011 at the Division of Hematology, Molinette University Hospital and candidates for therapeutic approach with curative intent.
Antipyretics for Preventing Recurrences of Febrile Seizures

We wanted to find out if the early use of antipyretics is capable in preventing recurrences of febrile seizures. When a child has had his/her first febrile seizure, the parents were instructed to give him/her antipyretic medication every time when the child had a new episode of fever during two years.


Eligibility Criteria:
Inclusion Criteria:

* First febrile convulsion

Exclusion Criteria:

* Any prior convulsion or antiepileptic medication
To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT

The purpose of this study aimed to compare the efficacy of Oxiris (Baxter) and M100 filters on IL-6 as primary outcomes and other blood cell counts, blood biochemistry (serum urea, creatinine, potassium, sodium), inflammation indicators (CRP, PCT), as secondary outcomes and safety (28 days mortality as a primary outcome and coagulopathy, lifespan of filter, usage of vasopressor, clinical conditions (ventilator-free days, ICU and hospital- length of stay) as a secondary outcome), clinical conditions (ventilator-free days, ICU and hospital- length of stay), and mortality of patients with pneumonia-related AKI.

The type of hemofilter will be decided using a simple randomization. For the intervention group, only the oxiris filter will be used during the treatment period, while for the control group, the M100 filter will be used throughout the treatment. If the filter becomes clogged within 24 hours, the investigator will replace it with the same filter as the previous one. However, if the filter becomes clogged after 24 hours and the patient still requires CRRT, the investigator will replace it with M100. This change in filter type will not affect the study results, as only the blood parameters during the first 24 hours of treatment will be evaluated for objective one. The oxiris filter will be used for the first 24 hours, or whichever is longer, and will be replaced with an M100 filter if indicated for both groups. Therefore, it will not affect the outcome of objective two compared to the standard arm group

Termination of CRRT will be done according to recent studies once the patient fulfills either one or more of these criteria: urine output and serum creatinine are indicative of kidney recovery, vasopressor cessation, increased urine output ≥500ml/24H without diuretics, correction of fluid overload, hemodynamic stability and the possible need to shift to intermittent dialysis.

The patient will be followed up until 28 days following ICU admission. To avoid any missing data, at least 3 contact numbers will be made available. If unable to get in contact with the patient, the application status of alive or dead will be applied to a national registry.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients aged\>18 years old
* Diagnosis of septic shock
* Diagnosis of KDIGO stage 3 acute renal failure

Exclusion Criteria:

* Moribund patient or patient that is expected to die within 72 hours
* Pregnancy
* patient with a bleeding tendency or known allergy to heparin
Genomics and Efficacy of Post-prostatectomy Salvage Radiotherapy With 'Extreme' Hypofractionation

The study aims to validate the Decipher® genomic test, in which patients with biochemical recurrence after radical prostatectomy are treated with salvage radiotherapy with extreme hypofractionation (5+ Gy/fraction).

Validating the Decipher® genomic classifier based on the expression of 22 RNA genes in the prospective study "esSBRT"

The esSBRT study ("Early salvage stereotactic radiotherapy (esSBRT) for biochemical recurrence after radical prostatectomy: a phase II study", RS1705/22 - opinion of the Central Ethics Committee IRCCS Lazio, Section IFO - Fondazione Bietti of 4 August 2022; NCT05667636) is a prospective phase II study developed and currently active at the Institute's Radiotherapy Unit, in which patients with biochemical recurrence of the disease after RP are treated on the prostatic lodge, and possibly on the pelvic lymph node stations, with hypofractionated radiotherapy in 5 sessions (5 Gy/fx). The aim is to be able to have a genomic classifier, such as Decipher®, for the patients enrolled in this protocol in order to complete the predictive evaluation. Furthermore, the project plans to profile PCa samples using a 'Comprehensive' panel of about 500 genes that allows to identify a specific molecular profile in the respective risk classes (low, intermediate and high) stratified with Decipher®. This evaluation would allow to identify the mutational structure of prostate cancer in an early stage of the disease, in particular by identifying the molecular alterations of the genes involved in homologous recombination repair (HRR) such as BRCA1, BRCA2, ATM, CDK12, CHEK2, PALB2.

The hypothesis is that the Decipher® risk classes (low, intermediate and high) correspond to a different risk of biochemical disease progression (defined as an increase in total PSA of 0.2 ng/ml above the nadir) independently or in addition to conventional clinicopathological criteria.

Eligibility Criteria:
Inclusion Criteria:

* patients enrolled at IRE under the "esSBRT" protocol (meeting the criteria of the same);
* patients who express written informed consent personally or through their legal representative/witness/curator/guardian/support administrator (participation in the ancillary study and data processing)

Exclusion Criteria:

* all exclusion criteria adopted for the "esSBRT" study.
Earbud EEG Feasibility Study

The goal of this study is to characterize the ability of the NextSense ear-EEG device to detect pathologic electrographic signatures of epilepsy and physiologic signatures of sleep in subjects undergoing simultaneous inpatient continuous EEG monitoring, polysomnography, or ambulatory EEG monitoring at home.

For nearly half a century, conventional electroencephalography (EEG) has been the standard of care for monitoring cerebral activity, particularly in the clinical domains of epilepsy and sleep disorders. Standard EEG involves highly time, labor, and cost intensive processes and typically requires subjects to be monitored by specially trained staff in the inpatient setting. Existing ambulatory EEG options are limited to about 3 days in duration because of decline in electrode fidelity beyond that timeframe. There is a need for unobtrusive, easy to use, longitudinal monitoring solutions that can extend to the ambulatory setting.

This study will assess whether novel NextSense EEG Earbuds are able to 1) detect seizures of varying types/localizations as well as interictal epileptiform activity (IEA) waveforms compared to simultaneously recorded conventional scalp EEG, or in some cases, intracranial EEG; and 2) detect characteristic electrographic signatures of AASM defined sleep stages compared to simultaneously recorded polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age and older admitted to the Epilepsy Monitoring Unit at Emory University Hospital for long-term inpatient scalp or intracranial cEEG monitoring for diagnostic or pre-surgical evaluation, or patients 18 years and older admitted to the Emory Sleep Center at the Brain Health Center for polysomnography.
* To enhance the likelihood of having a sufficient number of enrolled subjects with an adequate number of seizures, investigators may identify patients more likely to have epileptic rather than non-epileptic seizures based on the medical history.
* All patients who are undergoing ambulatory EEG monitoring at home.

Exclusion Criteria:

* Inability to safely tolerate earbuds (e.g. antecedent skin breakdown, recent injury to ear).
* Subjects who cannot have all 16 non-midline scalp EEG electrodes placed, since these EEG channels are required to accurately assess the performance of the seizure detection function.
Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers


Eligibility Criteria:
Inclusion Criteria:

* BMI: 18 BMI 30 kg/m²
* Healthy female volunteers
* Age 18-35 years (smoker not older than 30 years, inclusive)
* Ovulatory pre-treatment cycle, at least 3 month since delivery
* Abortion or lactation before the first screening examination
* Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
* Regular intake of medication other than OCs
* Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle
iGrow Readers Nutrition and Physical Activity Curriculum Efficacy

The objective of this study was to determine the efficacy of the iGrow Readers curriculum in changing diet and physical activity knowledge among preschool-aged children. The secondary objective of this study was to better understand the relationship between diet and physical activity related outcome variables in preschool aged children and their primary caregivers.

The objective of this study was to determine the efficacy of the iGrow Readers curriculum in changing diet and physical activity knowledge among preschool-aged children. The secondary objective of this study was to better understand the relationship between diet and physical activity related outcome variables in preschool aged children and their primary caregivers.

iGrow Readers was created to support literacy development among preschoolers, while promoting nutrition and physical activity messages. This program utilizes the social cognitive theory because it focuses on different environments influencing individual's behaviors and knowledge acquisitions, primarily through observing others within the context of social interactions and experiences. Developmentally appropriate preschool-aged children books, including relevant Native American books, facilitate the themes of healthy physical activity and nutrition practices. The program, a 6-8-week educational curriculum, helps young children understand the benefits of making healthy decisions involving nutrition and physical activity.

Eligibility Criteria:
Inclusion Criteria:

3-5 year old children attending a participating early childhood care facility. All early childhood care facilities had at least two classrooms available. All children provided assent and their participating guardian provided consent.

Exclusion Criteria: