cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Sacral Nerve Stimulation Before Definitive Implantation

Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe fecal incontinence. The test stimulation is minimally invasive, associated to low morbidity and relatively cheap. On the contrary, implantation of the definite stimulator is related to higher morbidity and considerable costs. A careful patent selection for definite implantation is therefore crucial. However, indication for implantation is actually based only on the subjective criteria reported in the patients´ diary only. Patients and care providers are likely to overestimate the real effect of SNS leading to an unjustified overuse of this expensive device. It is therefore necessary to evaluate real efficacy of SNS during the testing phase in a unbiased setting in order to avoid unnecessary morbidity and costs.

Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe faecal incontinence when conservative measures fail and surgical repair is not indicated. In a minimally-invasive approach and under local anaesthesia, an electrode is placed around sacral nerve root S2-4 and electrical stimulation is applied to the sacral spinal nerves. Effectiveness of SNS is definitively not only explained by placebo effect but the pathophysiologic mechanisms remain unclear. Suggested pathways include modulation of afferent nerve fibres and direct stimulation of the pelvic floor and anal sphincter muscle. After placement of the electrode, the patient is stimulated by an external stimulator for 1-3 weeks. During this period, the patient documents the number of faecal incontinence episodes or urgencies in a symptom diary. By convention, indication for permanent stimulation is based on a 50% reduction in the number of episodes. After a successful testing period, the permanent stimulator is implanted, generally in the upper gluteal region.

Previous studies report success rates up to 80%. The only randomized trial with a proper sample size evaluated the efficacy of SNS after definite implantation. In this study, 63% of the patients felt improved during the placebo period and might not really benefit from the device. The real success rate of SNS is therefore likely to be considerably lower. Efficacy of SNS during the testing phase has never been assessed in a blinded randomized study.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to SNS test for treatment of faecal incontinence after unsuccessful conservative (or surgical) treatment.

Exclusion criteria:

* Absence of informed consent.
* Patients not speaking french or german.
AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry

This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the usual clinical settings within the UK National Health Service. In addition, the study will collect data to understand patient characteristics receiving this type of pacemaker.

AVEIR™ stimulator (Abbott) obtained the approvals in July 2023 and started to be implanted in patients in Europe. As a leadless pacemaker, the AVEIR™ Leadless Pacemaker (LP) does not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter. AVEIR™ LP is intended to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target treatment group.

The purpose of this study is to understand long term safety and performance characteristic of this device. In addition, the study will collect anonymous clinical data and characteristics of the patients chosen to be implanted with AVEIR™ leadless pacemaker in routine clinical practice in approved centres across the UK.

Six hundred patients will be recruited in up to 15 centres during 2 years recruitment period. They will be followed up for 5 years after implantation of the leadless pacemaker. Investigators will record their age, sex, medical history, indications for receiving AVEIR™ and any complications related to the implantation procedure or the device itself. All the data will be collected in an anonymous format. Patients will be followed up according to the standard of care in the national health care system.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is intended to receive or was treated with a (AVEIR™) Leadless Transcatheter Pacing
2. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
3. Subject has been informed of the nature of the study, agrees to its provisions, and has provided a signed written informed consent, approved by the Regional Ethics Committee (REC).

Exclusion Criteria:

1. Subject is not suitable for implantation of the leadless device according to the expert opinion of their cardiologist.
2. Subject is not willing to comply with clinical investigation procedures and does not agree to return for all required follow-up visits, tests, and exams
3. Subject has been informed of the nature of the study, but does not agree to its provisions, and has not provided a signed written informed consent, approved by the REC
Health and Faith Working to Control Blood Pressure

Faith community nursing programs have grown out of churches as a response to the inequity of healthcare delivery to uninsured and underinsured communities. These programs provide outreach to community members and extend their services beyond just the parishioners of the churches, reaching more uninsured people than traditional medical services. Although faith community nursing programs have been established throughout the United States, no evaluation of these programs has been done. QueensCare is taking the lead in measuring the effect of parish nurses on health outcomes. In this project we have one specific aim: to measure the effect of parish nurse visits on blood pressure control on community-dwelling hypertensive patients. Our study will involve recruiting hypertensive patients from parish nurse led health fairs and interviewing subjects at the time of recruitment. Patients will either be randomized to parish nurse visits or primary care physician appointments. We will have a 4-month follow-up period with a re-check of blood pressures and an exit interview of the patient. From this study, we hope to better understand if parish nurse visits improve blood pressure and medication compliance among hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* We will be including adults who are 18 years and older who have attended a health fair or screening event at one of QueensCare Health and Faith Partnership parish nurse sponsored church events in Los Angeles.
* Patients must be either English or Spanish speaking.
* Patients will be enrolled by blood pressure readings at the screening event. We will be using the JNC 71 criteria for diagnosing hypertension.
* Patients with blood pressures above 140/90 will be defined as hypertensive.
* Diagnosed and previously undiagnosed hypertensive patients will be included in the study.
* The patient must also be able to come to the follow-up appointment in 4 months.

Exclusion Criteria:

* Pregnant women will not be included in the study.
* Patients who do not speak English or Spanish will be excluded from the study since we do not have the capacity to translate all our materials into multiple languages.
* Those deemed by the research assistant to be incapable to give informed consent (due to intoxication, dementia, or other causes) will also be excluded from the study.
* Patients younger than 18 years old will be excluded from the study.
* Patients who have seen a parish nurse in her office hours in the past 6 months will be excluded from the study. We do not want patients who have an already established relationship with a parish nurse to be enrolled in the study with the chance of being randomized to the physician-only arm, which would interrupt the continuity of care the patient is receiving from the parish nurse.
Investigation of the Passage of Antiviral Antibodies From Mother to Child

Infections remain a major cause of neonatal morbidity and mortality worldwide. At birth, multiple microorganisms, to which they are particularly vulnerable given the immaturity and naïve nature of their immune system, may infect newborns. Passive immunity by transplacental transfer of maternal antibodies is therefore of major importance in the first weeks and months of life before their own vaccination or until this period of immunological vulnerability has passed. Some factors are known to affect transplacental passage of antibodies but these have generally been studied in small series and many other parameters have not yet been investigated. The transmission rate of antibodies, particularly neutralizing antibodies, remains little explored, as well as the difference in transfer between antibodies induced by vaccination and those induced by natural infection, or the influence of maternal factors such as multiple pregnancy, other infections and treatment of these infections. A better identification and understanding of the factors that can affect transplacental transfer of maternal antibodies is crucial for optimization of vaccination strategies and close monitoring of particularly vulnerable newborns.

The investigators aim to include 4050 patients and collect a maternal at delivery cord blood sample.

The aim of the investigators is to measure and compare ratio of transplacental transfer of maternal anti-virus antibodies according to the mode of acquisition of immunity (post-vaccination, or post-natural or mixed infection), gestational age at birth (\< 32 Weeks of Gestation -WG-, 32-37 WG and \> 37 WG) for several virus (Hepatitis B virus, Varicella zoster virus, Rubella virus, Measles, Influenza Virus, Mumps Virus, SARS-CoV-2, Cytomegalovirus, Herpes Simplex Virus 1 and 2, Respiratory Syncitial Virus, Parvovirus B19, HTLV). The investigators also aim to identify factors likely to influence negatively or positively transplacental transfer of maternal antibodies as maternal age, maternal ethnic origin, parity and gestation, sex of the newborn, maternal chronic or acute infection/disease occurring during pregnancy; Birth weight, vaccine boost carried out during pregnancy (etc.) will also be studied.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old ;
* Pregnant patient (single or multiple pregnancy) ;
* Gestational age at the time of inclusion \> 22 Weeks of Gestation ;
* Patient affiliated or entitled to a french social security scheme ;
* Patient who expressed a non-objection to participate in the study.

Exclusion Criteria:

* Misunderstanding of the French language;
* Participation in another interventional trial of category 1. Participation in category 2 research, with minimal risks and constraints, will be left to the discretion of the investigator;
* Patient under curatorship or guardianship ;
* Patient's refusal to participate in the research.
Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)

This clinical trial evaluates whether an adaptive text-message intervention is useful in helping survivors of colorectal cancers (CRC) eat more whole grain foods and less refined grain foods. Most CRC survivors don't achieve the recommended intakes of whole grains or fiber, even though there is strong evidence that a high-fiber diet rich in whole grains lowers the risk of death from CRC. Dietary interventions are a promising approach for reducing death from CRC, and text message interventions specifically are a promising tool for reaching diverse populations. This trial evaluates a text-message based dietary intervention that continuously adapts message content to be specifically tailored for the participant for increasing whole grain consumption.

PRIMARY OBJECTIVE:

I. Determine the intervention's feasibility and acceptability.

SECONDARY OBJECTIVES:

I. Estimate the effect of the intervention on the percent of grains consumed that are whole.

II. Estimate the effect of the intervention on total fiber intake (grams per day \[g/d\]).

EXPLORATORY OBJECTIVE:

I. Assess convergence of the reinforcement learning (RL) algorithm.

OUTLINE:

Patients receive nutrition education materials and then receive the adaptive text message intervention for 12 weeks on study. Patients who are food insecure also receive resources for food banks, information about meal delivery programs, and support for applying for Supplemental Nutrition Assistance Program (SNAP) benefits.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years.
2. Subject has provided informed consent.
3. Diagnosis of colon or rectal adenocarcinoma.
4. Not on active treatment at the time of screening and not expected to receive active anticancer therapy (e.g., surgery, radiation, chemotherapy) during the study period.
5. At least 6 weeks since a major surgery and fully recovered.
6. Owns a mobile phone and is willing and able to receive and send text messages.
7. Able to speak/read English or Spanish.
8. Based on a screening survey, eat grains and =\<50% of total grains are whole grains.

Exclusion Criteria:

1. Does not meet any of the above inclusion criteria.
A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases

Chronic kidney disease (CKD) refers to a variety of different diseases characterized by impairment of kidney structure and/or renal function. The prevalence of CKD in China is as high as 10.8%. With a population of more than 150 million, China has the largest number of CKD patients all over the world. People with CKD would not only progress to uremia and need renal replace treatment, it also significantly increases risk of cardiovascular disease than non-CKD population. It has created a heavy burden on people's health and national economy. There is an urgent need to establish an effective system for CKD prevention and control in China. Evidences from large sample cohort and real world based research are still rare. This study will provide good experience for reducing the occurrence and development of CKD.

This study is designed as an investigator-initiated, multi-center, prospective and observational real world study based on mainland Chinese population. The investigators aimed to investigate the occurrence, development, treatment, prognosis state and related risk factors of CKD in China.

This study based on the standardized data network, which provides efficient data collection, integration and analysis for researchers and clinicians in multi-centers.

The sample size of this study was estimated by statisticians, epidemiologists and clinicians. Real-world studies adopted an open standard for inclusion and exclusion, larger sample size could cover a wider group of patients and take the possibility of loss of follow-up into account. Subgroup analysis can be performed in a heterogeneous population and expand the significance of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition;
* Non-CKD patients with hypertension, diabetes, hyperlipidemia, hyperuricemia, eGFR (CKD-EPI formula) of 60-89 ml/min/1.73m\^2 and other risk factors for CKD;
* Healthy population.
* Signed the informed consent voluntarily.

Exclusion Criteria:

。Patients identified to be unsuitable for enrollment by the study physician.
Impact of 4 Months of Exercise Changes of Heart Health-related Epigenetic Markers in Healthy, Sedentary Individuals

We aim to analyze the impact of a single acute exercise intervention (ergometry) on the expression pattern of specific heart health related miRNAs in healthy, previously sedentary participants, and how this pattern will be changed after 4 months of increasing the weekly physical activity \>150 minutes.

Exercise induced changes in heat health related miRNA expression pattern are analyzed in plasma samples collected at rest and immediately after the completion of an all-out ergo spirometry test, conducted during the baseline examination. Additionally participants will perform a pulse wave analysis to evaluate their arterial stiffness, a bioimpedanzanalysis to evaluate their body composition, blood lipids will be measured as well as their exercise capacity.

After the baseline examination, all participants will perform once per week a supervised endurance and strength training at our facility. In addition, the participants will be provided with a digital application for planning and documentation of their home based physical activity. Together with an expert, they plan their weekly physical activities so that they reach 150 min of physical activity each week over a period of 4 months.

After this training/exercise intervention all participants will perform all measurements from the baseline examination again.

Eligibility Criteria:
Inclusion Criteria:

* \<150min physical activity per week
* \>18 years of age
* male and female
* signed inform consents

Exclusion Criteria:

* acute or chronic cardiovascular diseases, exempt arterial hypertension (systolic blood pressure \>140 mmHg and diastolic blood pressure \>90 mmHg in untreated and medical treated subjects)
* acute or chronic lung disease
* Alcohol (\>30g/day) or drug abuse
* Adipositas grad 2 (BMI \>35kg/m²)
* Orthopedic limitations to exercise capacity
* pregnant or breast feeding women
Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

The aim of this study is to compare the short-term clinical performance of two sphere contact lenses.

The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer.
2. Has read and signed an information consent letter.
3. Self-reports having a full eye examination in the previous two years.
4. Anticipates being able to wear the study lenses for the required time of the study.
5. Is willing and able to follow instructions and maintain the appointment schedule.
6. Has refractive astigmatism no higher than -0.75 DC.
7. Can be fit with the available lens parameters (sphere +6.00 to -10.00D).
8. Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study.
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear.
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study.
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
7. Has undergone refractive error surgery or intraocular surgery.
The Development and Validation of MRI-AI-based Predictive Models for CsPCa

This study retrospectively included patients who underwent prostate magnetic resonance imaging (MRI) and subsequent ultrasound-guided prostate biopsy at Peking University First Hospital from January 2019 to December 2023, and prospectively enrolls patients from January 2024 to December 2029. Clinical information such as age, PSA levels, PI-RADS scores, and digital rectal examination findings are collected. A well-performing artificial intelligence model is employed to measure prostate volume, transitional zone volume, and lesion volume using MRI images. Furthermore, prostate-specific antigen density (PSAD) and transitional zone-based prostate-specific antigen density (TZ-PSAD) are calculated using prostate volume and transitional zone volume. Utilizing the aforementioned data, machine learning predictive models for clinically-significant prostate cancer (csPCa) are developed and validated.

This study retrospectively included patients who underwent prostate magnetic resonance imaging (MRI) and subsequent ultrasound-guided prostate biopsy at Peking University First Hospital from January 2019 to December 2023, and prospectively enrolls patients from January 2024 to December 2029. Clinical information such as age, PSA levels, PI-RADS scores, and digital rectal examination findings are collected. A well-performing artificial intelligence model is employed to measure prostate volume, transitional zone volume, and lesion volume using MRI images. Furthermore, prostate-specific antigen density (PSAD) and transitional zone-based prostate-specific antigen density (TZ-PSAD) are calculated using prostate volume and transitional zone volume. Utilizing the aforementioned data, machine learning predictive models for clinically-significant prostate cancer (csPCa) are developed and validated

Eligibility Criteria:
Inclusion Criteria:

* The interval between prostate MRI and biopsy within 3 months
* Integrity of related data

Exclusion Criteria:

* PSA less than 50ng/ml
* Any treatment for PCa prior to either MRI or biopsy, including radical prostatectomy, radiotherapy, chemotherapy, and endocrine therapy
* Previous history of surgical treatment or 5α-reductase inhibitor therapy for benign prostatic hyperplasia
* Subjects undergoing MRI with an indwelling urinary catheter or suprapubic catheter
* Inadequate quality of MRI images
MethOxyflUraNe at moderaTe High AltItudes for PAIN Management

A randomised, double-blind, cross-over study to assess the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting.

Phase IV, randomised, double-blind, cross-over clinical trial to evaluate the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting, in 24 healthy volunteers

Primary outcome: To assess the analgesic efficacy of inhaled methoxyflurane at moderate high altitudes in a wilderness setting.

Secondary outcomes: To assess the comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 18 and 65 years of age (inclusive).
2. Able to provide informed consent and comply with study-related procedures

Exclusion Criteria:

1. History of diabetes
2. Renal or hepatic disease or impairment (defined as a value exceeding the maximum reference range)
3. Chronic or nociplastic pain
4. Chronic fatigue syndrome
5. Chronic/regular use of analgesic medications
6. Personal or familial history of malignant hyperthermia
7. Personal or familial history of anaesthesia-induced rhabdomyolysis
8. Personal history of anaesthesia volatile-induced hepatitis or drug induced liver injury
9. Recent volatile anaesthesia (within 6 months)
10. History of significant altitude-related illness
11. Significant underlying medical condition which precludes gentle exercise at moderate high altitude (\<2500 m ASL) as determined by the investigators
12. Hypersensitivity to Penthrox/Penthrop®, methoxyflurane or any fluorinated anaesthetic.
13. Concurrent treatment with CYP 2A6 or CYP 2E1 enzyme inducers (such as: phenobarbital, rifampicin, alcohol or isoniazid)
14. Pregnancy