cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Single-blind Comparison Between Standard and Individualized Approach in Bowel Preparation Before Colonoscopy

This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.


Eligibility Criteria:
Inclusion Criteria:

* all patients \> 18 years of age undergoing elective colonoscopy on an outpatient basis

Exclusion Criteria:

* refusal to sign informed consent
* pregnancy
* advance kidney, liver or heart disease
* suspicion of malignant / benign stenosis of the digestive tract
Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure

The purpose of this study is to determine whether recombinant human hepatocyte growth factor is safe and effective in the treatment of fulminant and late-onset hepatic failure.

Fulminant and late-onset hepatic failure (LOHF) is intractable disease with high degree of fatality (70-80%). Only liver transplantation is established as a therapeutic modality to rescue patients with fulminant hepatic failure or LOHF. However, approximately 75% of the patients are not able to receive liver transplantation in Japan, and effective non-surgical treatment has not been established yet. Hepatocyte growth factor (HGF) is one of major agents stimulating liver regeneration and ameliorating hepatic injury.

In this study, recombinant human HGF is administered to patients with fulminant hepatic failure or LOHF, who can not receive liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of fulminant or late-onset hepatic failure
* Must be unable to receive liver transplantation

Exclusion Criteria:

* Under 16 years old
* Cancer patients
* Pregnancy-aged women
* Impaired renal function
* Impaired cardiac function
* Severe complications including pneumonia, sepsis, DIC and so on
Enhancing Diagnosis and Prevention of Cardiovascular Disease in Newham by Integrated Use of Electronic Health Records

The investigators will develop a "risk report" within the primary care electronic health record (EMIS) for patients attending for their National Health Service Health Check. The value of the report for reducing cardiovascular risk will be assessed qualitatively and also quantitatively in a non-randomised comparative trial.

The investigators will design a template within the primary care electronic health record (EMIS) that draws on Health Check data to provide a contemporary "risk report". Included in the report will be clear description of life-time cardiovascular risks, the factors driving those risks and how risk might be reduced through life-style and risk factor modification. The investigators will evaluate the benefits of providing patients with a risk report qualitatively by patient and clinician interviews. Quantitative analysis of the benefit of the risk report will be provided by a non-randomised comparative trial. First, a group of patients undergoing a conventional Health Check will be recalled after three months for a second Health Check, allowing measurement of the change in "Heart Age" - a convenient index of life-time cardiovascular risk. Following introduction of the risk report the investigators will recall a further group of patients for a second Health Check, allowing measurement of the change in "Heart Age". The effect of the risk report will be determined by comparing the change in Heart Age between the two groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 40-74 years

Exclusion Criteria:

* Prior diagnosis of heart disease, stroke, diabetes, kidney disease or dementia
Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

The aim of this study is to determine the maximum tolerated dose of hypo-fractionated radiation therapy and the toxicity of the treatment program.

Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT). Dose escalation will be as follows:

There will be 3 cohorts consisting of 3 patients each.

Dose escalation will be as follows:

There will be 3 cohorts consisting of 3 patients each. All patients will receive 18 fractions of HRT over the course of 6 weeks (3 fractions per week). Dose level I will be 54Gy (3 Gy per fraction), dose level II will be 55.8 Gy (3.1Gy per fraction), dose level III will be 57.6 Gy (3.2 Gy per fraction). After accrual of dose level I, all patients will be observed for a minimum of two weeks after completion of radiation treatments, for assessment of toxicity, before the dose can be escalated for the next cohort. After dose level II, patients will be observed for 6 months before enrolling patients on dose level III.

All patients will be seen weekly by their radiation oncologist during radiation therapy. Any observations regarding radiation reactions will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
* Clinical stage T1-2c (AJCC 6th edition)
* Gleason \<6 and PSA \<10 ng/mL
* Gleason =7 and/or PSA 10-20 ng/mL provided \<34% of core biopsies are positive for carcinoma
* PSA \< 20 ng/mL within 180 days prior to registration. PSA should not be obtained for at least 10 days after prostate biopsy.
* Zubrod performance status 0-1
* Age ≥ 18
* Patient must sign study specific informed consent prior to randomization.

Exclusion Criteria:

* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
* Evidence of distant metastases
* Regional lymph node involvement
* Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
* Prior androgen deprivation therapy (ADT)
* Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Previous or concurrent cytotoxic chemotherapy for prostate cancer
Micra AV Transcatheter Pacing System Post-Approval Registry

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release.

The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

The Micra AV Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra AV Registry will be prospectively followed for a minimum of 3 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent).

Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra AV system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's routine clinical care practice, those visits are reported. The total estimated registry duration is 4.5 years

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient is intended to receive or be treated with a Micra AV Transcatheter Pacing System and must be enrolled prior to the implant procedure

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Personalized Antisense Oligonucleotide Therapy for Rare Pediatric Genetic Disease: SCN2A

This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with SCN2A associated developmental epileptic encephalopathy

This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single pediatric participant with a de novo pathogenic gain of function SCN2A mutation associated with severe developmental epileptic encephalopathy.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided by the participant's parent(s)/guardian(s)
* Ability to travel to the study site, adhere to study-related follow-up examinations and/or procedures, and provide access to participant's medical records.
* Genetically confirmed mutation

Exclusion Criteria:

• Use of an investigational medication within less than 5 half-lives of the drug at enrollment
Neurolinguistic Programming, Progressive Muscle Relaxation Exercises, and Breastfeeding

The effect of neuro linguistic program and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy after caesarean section.

In this research, it is aimed to detemine the effect of neuro linguistic program and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy after caesarean section.

Sample size:

* There will be three groups in the study (two experimental groups and one control group).
* The sample size of the study is 99 people. The sample size will be divided into three and 33 people will be randomly assigned to each group.
* Experiment 1 group: neuro linguistic programme (NLP) group.
* Experiment 2 group: progressive muscle relaxation exercises (PMRE) group.
* Control group: non-intervention group

Data Collection Tools;

* Introductory Information Form,
* Breastfeeding Self-Efficacy Scale,
* Breastfeeding Charting System (LATCH)

Application time:

* NLP and PMRE interventions will be started at the sixth postoperative hour after caesarean section.
* Mothers who give birth by caesarean section are followed up in hospital for 48 hours and mothers are then discharged when their health condition improves. Therefore, data will be collected within 48 hours after caesarean section.
* NLP and PMRE groups will be started at the sixth postoperative hour, 3 times in 24 hours on the first day, 3 times in 24 hours on the second day, six times in total.
* Only NLP and PMRE will not be applied to the control group.
* Care and follow-up will be performed in parallel with the individuals in the experimental group.

Measurement time:

* Mothers will fill in the Introductory Information Form, Breastfeeding Self-Efficacy Scale, Breastfeeding Diagnosis and Assessment Measurement Tool (LATCH) before the application at the sixth postoperative hour.
* Then, in the first 24 hours, the necessary application will be performed once every eight hours according to the groups (for example, NLP application for experiment 1).
* At the end of 24th hour, Breastfeeding Self-Efficacy Scale and Breastfeeding Diagnosis and Assessment Measurement Tool (LATCH) will be completed.
* Then, in the second 24 hours, the interventions will be repeated once every eight hours.
* The total number of application sessions is six.
* NLP application will last 20 minutes each session and PMRE application will last 20 minutes each session.

Eligibility Criteria:
Inclusion Criteria:

* women who gave birth by caesarean section,
* primiparous,
* who are 19 years of age or older and 35 years of age or younger,
* who were born at 37 or more weeks of gestation,
* who had a singleton birth,
* whose caesarean section operation was performed with spinal anaesthesia,
* who do not have chronic diseases and any breast-related health problems .

Exclusion Criteria:

* mothers who did not meet the inclusion criteria,
* who wanted to leave the study voluntarily at any stage after being included in the study,
* who developed any health problems in themselves or their infants were excluded.
hCG-activated PBMC-therapy in RIF Patients

Despite the many research done in the field of infertility and in vitro fertilization (IVF), more than half of the embryos transmitted in the IVF and intracytoplasmic sperm injection (ICSI) do not implant successfully. Currently, pregnancy failure following at least three IVF/ET cycle, so that one or two high-quality embryos transmitted in each cycle is defined as recurrent implantation failure (RIF). Maternal and fetal factors can be a reason for implantation failure; maternal factors include endometrial receptivity, uterine anatomic abnormalities, and immunologic factors. Implantation failure with embryonic reasons includes genetic abnormalities and any factor that affects the implantation and growth of the embryo within the uterus. In recent years, the involvement of immune-related factors mainly natural killer cells (NK), dendritic cells (DCs), macrophages (MQ), regulatory T cells (Treg) and Th-1, in the endometrial differentiation and development and endometrial receptivity, as well as induction of immunological tolerance to the fetus, have been reported.

248 women with the history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients divided randomly into two groups, 50 patients received PBMC and 50 patients as the control group received PBS. PBMCs were obtained from patients themselves five days before embryo transfer (ET) and were cultured with hCG for 48 hours. Frothy-eight hours later, PBMCs were then administered into the uterine cavity of that patient from the study group two days before ET. PBS was inseminated into the uterine cavity of the control group instead of PBMC. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs 2, 24 and 48 hour after incubation by ELISA. The pregnancy occurrence was confirmed 12 days after ET through positive pregnancy test (β-hCG test). The success of implantation and the occurrence of clinical pregnancy were evaluated by ultrasound through the observation of the number and the location of gestational sacs at 5-6 weeks and confirming the embryo heart pulsation.

Eligibility Criteria:
All patients were evaluated in accordance with the following inclusion and exclusion criteria;

Inclusion Criteria:

1. Having at least three implantation failures following IVF
2. Having primary infertility
3. Age under 45 years old
4. Having regular menstrual cycles
5. BMI under 30

Exclusion Criteria:

1. Having polycystic ovary syndrome
2. The presence of uterine pathology;
3. Poor ovarian reserve
4. Having chromosomal abnormalities
5. Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, and anti-dsDNA
6. Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
7. Positive HIV, HCV or HBV tests
First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)

Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with wet Age-Related Macular Degeneration (wAMD), in the study eye.
* Subject must have received ≥3 prior injections with the same anti-VEGF product: bevacizumab, ranibizumab, or aflibercept) in the 6 months prior to the Screening Visit, in the study eye.
* Demonstrated response to the intravitreal anti-vascular endothelial growth factor (VEGF) treatment in the study eye.
* Best-corrected visual acuity (BCVA) using ETDRS charts of 25 letters (20/320 Snellen equivalent) to 85 letters (20/20 Snellen equivalent).

Exclusion Criteria:

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
* Subfoveal fibrosis or scarring \>50% of the total lesion, or atrophy in the study eye, confirmed by central reading center.
* Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia that would compromise vision in the study eye, confirmed by central reading center.
* Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of the study results.
* Active intraocular inflammation (grade trace or above) in the study eye.
* History of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the study eye.
* History of idiopathic or autoimmune-associated uveitis in either eye.
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye.
Developement of TipTraQ Home Sleep Test

The clinical study aims to develop and fine-tune the TipTraQ system, created by PranaQ, for home sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and Apnea-Hypopnea Index (AHI). This open-label, non-randomized study will recruit 240 subjects aged 20 and older from the Veteran General Hospital, Taipei.

Sleep Breathing Disorders (SBD) is a common disorder in the population. However, a lot of patients are not aware of this disease and do not receive proper treatment, which not only impacts their personal health but also causes public disasters. Thus, a screening tool to find those patients becomes a critical point-of-care issue. To achieve this goal, a wearable device that is suitable for the screening is needed. The goal of this study is developing and fine-tuning a new sleep screening platform, TipTraQ, developed by PranaQ. TipTraQ is composed of a wearable device designed as a convenient screening device based on the photoplethysmography (PPG) technique and an interpretable artificial intelligent (AI) system that takes the PPG signal recorded by the wearable device as input and outputs and outputs estimated total sleep time (TST) and apnea-hypopnea index (AHI).

The study is open-label and non-randomized, planning to recruit 240 subjects. Participants will use the TipTraQ device alongside a companion mobile app, with data analysis supported by AI technology hosted on a cloud server. The TipTraQ device will be worn over fingertip. The primary goal is to assess the robustness of the TipTraQ system and fine-tuned the algorithm by comparing its output against the gold standard PSG annotations made by sleep experts.

Eligibility Criteria:
Inclusion Criteria:

Subjects from the age of 20 and older that have an indication for an in-lab PSG study. The subject should be able to understand the study and sign the informed consent before being enrolled in the study. During the study period, the subject can withdraw from the study any time.

Exclusion Criteria:

Subjects with the following medical conditions will be excluded from this study:

1. Heart transplant
2. Heart failure, New Youk Heart Association (NYHA) classification III or IV
3. Chronic opioid medication user Devastating Severe strokes, with the modified Rankin score (mRS)≥4
4. Tracheostomy
5. Incapable of comprehending and signing the informed consent and questionnaires, including but not limited to subjects with severe Alzheimer's, unconscious by head trauma, or of someone with limited mental capacity
6. Cannot correctly follow the order to use the TipTraQ device
Preventing Diabetes in Latino Families

Purpose: This study will test the efficacy of a family-focused lifestyle intervention for reducing type 2 diabetes (T2D) risk factors and increasing Quality of Life (QoL) among high-risk Latino families.

Background: T2D disproportionately impacts Latino children, families and communities. The Diabetes Prevention Program (DPP) established that T2D can be prevented in high-risk adults through intensive lifestyle intervention. Although the DPP has been translated to a variety of adult populations and settings, engagement and effectiveness is diminished in minority communities and there are no family-focused diabetes prevention trials for Latinos. The culturally-grounded approach is guided by an Ecodevelopmental model that considers community, family, peer, and individual-level factors that influence health behaviors and health outcomes over time. The study will test the efficacy of a 16-week family-focused lifestyle intervention for reducing T2D risk and increasing QoL among high-risk Latino families as compared to control families. The study will use Integrative Mixed Methods to understand how family structures and processes influence intervention outcomes.

Eligibility Criteria:
Inclusion/Exclusion Criteria - Children

Inclusion

* Latino: self-report
* Age: 10-16 years
* Obesity: BMI ≥ 95th percentile for age and sex

Exclusion

* Type 2 diabetes: (standard American Diabetes Association criteria)
* Taking medication(s) or diagnosed with a condition that influences carbohydrate metabolism, physical activity, and/or cognition
* Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
* Self-identify as American Indian
* Unstable depression or other mental health condition that may impact QoL

II. Inclusion/Exclusion Criteria - Parents

Inclusion

• Parent of a child who meets the above child inclusion/exclusion criteria

Exclusion

* Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
* Self-identify as American Indian