cyrilzakka/clinical-trials huggingface dataset:
Identification of Genetic Basis of Atrioventricular Conduction Defects: From Congenital Forms to Degenerative Forms

Identification of genes involved in congenital atrioventricular block and progressive Cardiac Conduction Disease.

Atrioventricular blocks are a heterogenous group of diseases involving children with congenital atrioventricular block (CAB) and more frequently elderly patients affected by progressive Cardiac Conduction Disease (PCCD).

The aim of the study is to uncover the genetic model, likely more complex than previously appreciated, and characterize the gene expression remodelling leading to high degree of conduction defect.

The recent technological developments in genomics coupled to the availability of large and highly characterized biobanks of patients have now set the stage:

1. To identify rare genetic variants/new genes contributing to CAB and PCCD by exome sequencing on familial form suspected to impact strongly the phenotype
2. To identify common genetic variants modulating the risk of developing (severe) PCCD by GWAS
3. To estimate the prevalence and relevance of genes uncovered by TASK#1, #2 in large patient sets (PCCD and CAB) by NGS.

Eligibility Criteria:
Congenital atrioventricular block inclusion criteria:

* Patients with idiopathic congenital atrioventricular block diagnosed before the age of 15 years.
* Non-immune congenital atrioventricular block documented by a maternal serology (negative for anti-nuclear antibodies or anti Ro-SSA antibodies and anti La-SSB antibodies)
* Written consent to participate to the study and written consent of both parents.
* Parents of children with idiopathic congenital atrioventricular block.

Congenital atrioventricular block exclusion criteria

* Positive maternal serology
* Patients or parents who are unable to sign or who refuse to sign an informed consent

Progressive Cardiac Conduction Disease inclusion criteria

* Patients with isolated cardiac conduction disorder with a normal morphology of the heart confirmed by echocardiography.
* Relatives of patients with isolated cardiac conduction disorder
* Written consent to participate to the study

Progressive Cardiac Conduction Disease exclusion criteria

* Patients with cardiac conduction disorder associated with a structural cardiopathy or due to an identified cause
* Patients who are unable to sign or who refuse to sign an informed consent
Shiga Progression of Diabetes, Nephropathy and Retinopathy

The purpose of this study is to investigate whether the oral anti-diabetic drug, Thiazolidine (TZD) is effective in suppression of onset or progressin of diabetic nephropathy in Japanese type 2 diabetic patients.

2. Outcome measures:

1. Primary endpoint Onset or progression of diabetic nephropathy
2. Secondary endpoints (1)Progression of diabetes mellitus (2)Change in HbA1c (3)Change in albumin-creatinine ratio (4)Change in GFR (5)CHange in cystatin C

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Less than 8.0% in HbA1c
* Less than 300 mg/g Cr of urinary albumine level
* Concomitant therapy with SU and/or Biguanide
* Untreated hypertension and hypertension treated with ARB or ACEI

Exclusion Criteria:

* History of heart failure and concomitant heart failure
* History of administration of TZD agent
* Severe hepatic dysfunction with more than 3 times higher than upper limit of normal range of GOT, GPT or rGPT
* Severe renal dysfunction with more than 2.5 of Cr
* History of AE with TZD agent
* Insulin treatment
* Concomitant urinary track infection
Evaluation of the "Grasp Site" After Peeling of Epiretinal Membranes

The goal of this study is to compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site". The main questions it aims to answer are:

1. are there differences in grasp attempts between both forceps
2. are there differences in Instrument tissue interactions between both forceps
3. are there differences in postsurgical anatomical and functional outcomes at the grasp site between both forceps.

Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity acuity and cause metamorphopsia, occurring in approximately 20% of the population older than 60 years. Using vitrectomy with membrane peeling, postoperative improvement of visual acuity and metamorphopsia may be achieved in a majority of patients. The surgical method has been used for some time, the first report on the surgical method of vitrectomy with membrane peeling dates back to 1978, and since the introduction of intraoperative optical coherence tomography (iOCT), intraoperative iatrogenically induced changes in retinal tissue can be detected and correlated with postoperative changes. Our group has been able to record "stretching" of the retinal tissue using this technique and has also been able to record the rarely occurring subfoveal and extrafoveal elevations of the ellipsoidal zone due to membrane peeling. These changes did not significantly affect postoperative visual acuity in our study population but did affect the development of postoperative microscotomas. Besides "retinal stretching" during surgery, ILM peeling is shown to be another factor with association of new postoperative microscotomas. New postoperative microscotomas developed in some patients without "retinal stretching" and ILM peeling. Apart from these already known iatrogenic changes, the analysis of the "grasp site" at the "starting point" of epiretinal membrane peeling is of great interest, because at this location, grasping of the epiretinal membrane may be difficult especially in case of an adherent ERM and superficial retinal lesions may be induced.

Diaz et al. demonstrated that there are postoperative changes in the "nerve fiber layer" after ILM peeling, but in that study, no recording of instrument/tissue interactions was performed using iOCT.

The aim of this study is to compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site".

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic ERM
* Sheduled surgery (vitrectomy with membrane peeling), as defined by vision loss and/or metamorphopsia
* Age 18 and older
* Written informed consent for participation in the study

Exclusion Criteria:

* Macular edema due to other reasons than iERM
* Pregnancy (pregnancy test will be performed in women of reproductive age)
Early Use of Hyperimmune Plasma in COVID-19

The study assesses the efficacy of early administration of hyperimmune plasma in covid-19 patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in the WHO scale

Patients who satisfy eligibility criteria and in particular have started positive pressure respiratory support not more than no more than 48 hours are administered 200 to 300 ml in 2 or 3 times administered over a time window of 5 days. . Plasma titration will depend on the availability in the local Plasma Bank; any titre ≥ 1:80 will be acceptable. primary endpoint will be assessed at 28 days; vital status will be further investigated at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
2. Male or female adult patient ≥18 years of age at time of enrolment.
3. Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen..
4. Patient is hospitalized for COVID-19, is severely hypoxic with a P/F ≤ 200 while breathing room air or supplemental oxygen and requires positive pressure respiratory support, either non-invasive (helmet/mask CPAP or NIV) or invasive (endotracheal intubation and mechanical ventilation)
5. No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day
6. Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
7. The patient is not eligible in the Tsunami trial.

Exclusion Criteria:

1. Participation in any other clinical trial of an experimental treatment for COVID-19.
2. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30).
4. Pregnancy
5. Current documented and uncontrolled bacterial infection.
Mixed-method Research Protocol: Evaluation of a Relaxation Technique for Anxiety Management in Pre-surgical Pediatric Patients

Children exhibit anxiety before surgery: in particular, the literature reports that younger children have a higher level of preoperative anxiety than older children. Preoperative anxiety has been associated with side effects such as postoperative pain and emergence delirium (ED), which are generally treated with the administration of analgesics but can cause nausea, vomiting, and drowsiness.

In addition to pharmacological strategies, there are behavioral and psychological techniques commonly referred to as nonpharmacological techniques to reduce preoperative anxiety. These are a broad set of strategies and methods, more or less complex, that can be applied to children and adolescents to help them cope with preoperative agitation and for pain control.

Nonpharmacological techniques include distraction techniques that have shown promise in reducing pediatric anxiety and include listening to music , the use of humor, and the use of games . Several researchers have found active distraction to be an effective preoperative anxiolytic in children. Of relevant importance for reducing preoperative anxiety are relaxation techniques as shown in the literature and in particular by a randomized trial that demonstrated the effectiveness of this type of proposed nonpharmacological technique for reducing anxiety and pain in pediatric patients in a preoperative setting.

This study plan to investigate the effectiveness of a breathing/relaxation intervention (Ladybug/Sunshine method) on pediatric patients' anxiety levels before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 5 years and 15 years;
* Admission for minor surgical conditions of low intensity, such as inguinal hernia, phimosis, sebaceous cysts, vascular malformations, skin lesions, ankyloglossus, afferent to the unified pediatric surgery day-surgery service of AOU Meyer;
* Knowledge of the Italian language and ability to express oneself;

Exclusion Criteria:

* Presence of cognitive impairment reported in history
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)

To examine the effects of Physical Therapist (PT) wound care modalities (pulsed wound irrigation (PWI) + electrical stimulation (ES), PWI only, and ES only) on wound healing in patients with spinal cord injuries (SCI).

It is hypothesized that PWI + ES will demonstrate the greatest rate of wound healing due to the combined effect of these treatments, which positively impact several aspects of the wound healing cascade. It is hypothesized that all patients will demonstrate improved quality of life from receiving wound care treatments by Physical Therapists due to individualized education and treatments which engage patients in their wound healing process and promote self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled at inpatient rehabilitation at Carolinas Rehabilitation Charlotte
* Diagnosis of spinal cord injury and concomitant pressure injury to sacrum or ischium
* Agreeable to wound care treatment by Physical Therapist (PT)
* Able to perform informed consent
* Over 18 years of age
* Physician order for PT wound care evaluation and treatment
* Bates-Jensen Wound Assessment Tool (BWAT) \>31 on initial evaluation

Exclusion Criteria:

* Pain which limits ability to tolerate wound care treatments
* Unable to perform informed consent
* Pregnancy
* Bates-Jensen Wound Assessment Tool (BWAT) \<30 on initial evaluation
Preliminary Evaluation of a Point-Of-Care Liver Function Test

The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase test with the standard of care test used in an HIV clinic at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.

The DFA transaminase test provides rapid categorical measurement of ALT in a whole blood specimen taken via finger-stick. The test is based on the platform technology of "paper microfluidics" (also known as "patterned paper"), in which hydrophobic barriers are patterned into a sheet of paper in order to create microfluidic, hydrophilic paths within the paper, through which flow can be directed towards specific detection zones. The test is designed for visual color-coded readout in three ALT ranges ("bins") that correspond to the ranges of AST and ALT (\<3x the upper limit of normal (ULN), 3-5x ULN, and \>5x ULN) currently used for clinical management decisions per US TB and HIV treatment guidelines. The bin cutoffs are common to treatment guidelines used around the globe, including those used by the Vietnam Ministry of Health.

The colorimetric readout is designed to be read by eye using a visual "read guide" allowing the reader to make a semi-quantitative estimate or assign a categorical value into one of three bins. Alternatively, if the device is scanned (e.g. desk-top scanner) or photographed (e.g. cell phone or standard digital camera, see (9)) and read with image-analysis software, it should be possible to generate a quantitative result. Additionally, multiple control zones notify the user of insufficient sample volume, hemolysis, or damaged reagents.

The overall goal of this study is to conduct a preliminary field evaluation of an investigational transaminase test in a population at risk for DILI. The primary objectives are:

1. Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.
2. Determine inter-operator variability.
3. Determine device failure rate as defined by invalid test results.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years old) patients receiving HIV treatment through the HTD clinic
* Must be receiving routine scheduled ALT monitoring on day of enrollment
* Willing to undergo finger-stick in addition to routine care
* Must be able to provide informed consent.

Exclusion Criteria:

* HIV-negative, or HIV-positive but not on treatment
* Not receiving transaminase monitoring for routine care
* Unable or unwilling to provide informed consent
* Less than 18 years old
Prognostic Study of HPV Virus Integration in Women With HSIL

Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.

A total of 1000 women with HSIL were recruited from multiple centers. In this prospective cohort study, 4 samples of cervical exfoliated cells and fornix secretions were collected at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal flora diversity sequencing, and 2 samples of peripheral blood (whole blood and serum) were collected at enrollment. The effects of HPV integration status and microbiota changes on the outcome and progression of HSIL were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive cancer;
* No surgical treatment or conization only;
* Obtain informed consent.

Exclusion Criteria:

* During pregnancy or lactation;
* Patients with a history of genital tract cancer;
* Previous history of hysterectomy, cervical surgery or pelvic radiotherapy;
* Received treatment related to genital tract infection, HPV or other STDs pathogen infection in the past one month;
* Use of antibiotics or vaginal microecological improvement products in the past 1 month.
An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy

The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).

This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), observational (a clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes) and multi-center (when more than one hospital or medical school team work on a medical research study) study of topiramte in participants with epilesy. The study population will be all the epilepsy participants visiting outpatient study center over a period of two months. Topiramate will be administered as per Investigator's discretion for 52 weeks. Participants will visit the trial site for evaluation of endpoint at Baseline, Week 12, Week 26, and Week 52. Efficacy will primarily be evaluated by percentage of participants which will be retained to topiramate treatment uptil Week 52. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants with all type of epilepsy
* Participants with more than 2 episodes of seizure during last 1 year
* Participants who can comply with the visit schedule and are willing and able to complete evaluation procedures specified in the protocol during the treatment period
* Female participants with child bearing potential and who use proper contraceptive methods during the study period

Exclusion Criteria:

* Participants who have known hypersensitivity reaction or allergy to the study drug
* Participants who have taken topiramate within the three months of study start
* Participants who are determined not to be suitable for the clinical study participation by an Investigator's discretion
* Pregnant and nursing female participants
The Coping With and Caring for Infants With Special Needs Intervention in Down Syndrome Infants

The objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. This is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in Spain between January 2024 and March 2024. An evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions.

The Infant Motor profile will be the primary outcome instrument.


Eligibility Criteria:
Inclusion Criteria:

* Babies with Down syndrome
* Families involved in Pediatric Physical Therapy

Exclusion Criteria:

* Other associated developmental disorders
* To not speak Spanish
* Do not sign informed consent
POC HIV Testing and Early DTG Use for Infants

This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.


Eligibility Criteria:
Inclusion criteria for point-of-care infant HIV testing:

1. Mother 18 years of age or older
2. Mother willing and able to provide verbal consent for infant testing
3. Infant birth weight ≥1.5kg
4. Presence of any of the following risk factors:

\<12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of detection) for last test performed or at any time \>24 weeks gestation in pregnancy; CD4 cell count known to be \<350 cells/mm3 within the past year; Self-described poor adherence in pregnancy (1 or more complete days of missed ART)

Exclusion criteria for point-of-care infant HIV testing:

1) Medical condition making it unlikely that the infant will survive to 24 months

Inclusion criteria for infant longitudinal treatment cohort:

1. Mother 18 years of age or older
2. Mother willing and able to provide written informed consent for study participation for herself and her infant
3. Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
4. Infant eligible for ART treatment in accordance with the Botswana government program
5. Infant birth weight ≥1.5 kg

Exclusion criteria for infant longitudinal treatment cohort:

1. Medical condition making it unlikely that the infant will survive to 24 months
2. Infant unable to start treatment-dose ART \< 168 hours of age
3. Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown
Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation

This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.

This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality. The study will include up to 30 subjects. We will enroll patients with atrial flutter and patients with atrial fibrillation who are scheduled to undergo RF ablation of the cavotricuspid isthmus (CTI). Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study. We will be assessing the feasibility of the KODEX-EPD tissue pressure (TP), tissue thickness and lesion transmurality applications.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be aged \>18 years.
2. Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
5. Subject is deemed amenable to therapeutic ablation for atrial flutter or atrial fibrillation.

Exclusion Criteria:

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
3. Patient had experienced previous stroke (TIA or CVA).
4. Thrombi detected in the heart.
5. Known marked valvular insufficiency (moderate-severe and severe)
6. Life expectancy less than 12 months.
7. Known severe renal insufficiency (stages G4 and G5, characterized by severe reduction in GFR \[15-29 ml/min/1.73 m2\] and GFR \[\<15 ml/min/1.73 m2\], respectively).
8. Subjects that according to the clinical judgment of the caring physician do not fit for the study.
9. Previous right atrial ablation procedure or cardiac ablation procedure performed within 90 days prior to enrollment.