cyrilzakka/clinical-trials huggingface dataset:
Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Preserved Ejection Fraction

A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically inactive participants with chronic heart failure with preserved or mid-range ejection fraction will be randomly assigned to intervention or control arms.

The six-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, monthly face-to-face sessions with the physician, and monthly telephone calls with the research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback).

The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of heart failure with preserved (HFpEF) or mid-range (HFmrEF) ejection fraction with New York Heart Association (NYHA) class II or III symptoms. The diagnosis requires the following conditions to be fulfilled:

   1. the presence of symptoms and/or signs of heart failure,
   2. left ventricular ejection fraction ≥50% (HFpEF) or 40-49% (HFmrEF),
   3. elevated levels of natriuretic peptides (BNP \>35 pg/ml and/or NT-proBNP \>125 pg/mL),
   4. objective evidence of other cardiac functional and structural alterations underlying heart failure.
2. Physically inactive, as determined by a question "As a rule, do you do at least half an hour of moderate or vigorous exercise (such as walking or a sport) on five or more days of the week?".

Exclusion Criteria:

1. Signs and symptoms of decompensated heart failure, uncontrolled arrhythmia or effort angina, severe or symptomatic aortic stenosis, persistent hypotension, recent shocks delivered by the automated implantable cardioverter defibrillator.
2. Co-morbid conditions that would affect adherence to trial procedures (e.g. inflammatory arthritis, active malignancy, renal disease requiring dialysis, uncontrolled diabetes, major depression or other significant psychiatric disorders, cognitive impairment, significant hearing or visual impairment).
3. Major surgery planned within the next 12 months.
4. Life expectancy shorter than 12 months.
5. Inability to walk from any reason.
6. Baseline six-minute walking distance \>450 meters. Patients covering more than 450 meters in the baseline six-minute walk test (6MWT) are excluded due to a possible ceiling effect.
7. Pregnancy.
8. Failure to perform the 6MWT.
Evaluation of Methods to Asses Visual Prosthesis Systems Using Sighted Volunteers and Visual Reality Simulator

A basic requirement for every therapeutic procedure is that there be an objective and validated method to assess the benefit of the treatment for the patient. Currently, there is no acceptable procedure to quantify the benefit obtained from visual prostheses.

The goal of the proposed research is to evaluate visual tasks and tests that will be given to a very large number of volunteers with normal vision who will be using a novel virtual prosthesis simulator. This device will simulate the realistic visual information that a visual implant can provide and will be used to measure implants in current clinical trials.


Eligibility Criteria:
Inclusion Criteria:

Normal or corrected to normal sight (up to +/- 3.5 D) - Healthy Age 18 to 45

Exclusion Criteria:

Had any incident of dizziness from video or computer game Minors or special population
Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules

Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.

In previous studies, the investigators had taken the approach of methylation profiling by high throughput bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. The investigators had learned methylation patterns that differentiate malignant vs. benign lesions from tissue samples by in-depth data mining, and then used pattern matching to classify plasma samples.

In this study, the investigators are going to validate the efficacy of ctDNA methylation test for diagnosing early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the post-surgery pathology.

This is a prospective, multi-center, observational cohort study and seeks to enroll 1230 participants with pulmonary nodules 5-30mm in diameter.

The assay analyzes the ctDNA methylation profiles of lung cancer-specific biomarkers non-invasively using whole blood specimens collected before invasive surgery.

The performance characteristics(sensitivity and specificity) of the pre-surgery ctDNA methylation test for detection of early lung cancer is evaluated in comparison to post-surgery pathology.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or above
* single pulmonary nodule found by CT scan.
* the diameter of the pulmonary nodule is between 5mm to 30mm.
* plan to accept pneumonectomy due to the pulmonary nodule.
* without any sign of lymphatic or distant metastasis.
* agree to sign informed consent.

Exclusion Criteria:

* pregnant or lactating women.
* the diameter of the pulmonary nodule is more than 30mm
* there are 2 or more pulmonary nodules in one single patient.
* any sign of lymphatic or distant metastasis
Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. The purposes of this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated the mortality ; and 3) risk factors for development of ARDS .

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 ) will be screened at ICU admission and daily for the occurrence of ARDS ( AECC criteria) for a maximum of 28 days after ICU admission.

Data collection:

1. For all patients, Demographic characteristics, admission category, the patient source intervention during ICU , APACHEII , SOFA score and discharge information will be collected
2. For patients with ARDS, data about ABG , parameters of MV, hemodynamic on day0 to day7 and last day of MV will be collected.
3. For patients without ARDS at ICU admission, data about risk factor for ARDS ,such as LIPS score, parameters of MV , and fluid balance on ICU day0 to day7 will be collected.

Eligibility Criteria:
Inclusion Criteria:

all patients age \>18 yrs admitted to 24 participating ICUs

Exclusion Criteria:

No patients should be excluded (regardless of age, underlying disease, life expectancy, etc).
A Prospective Observational Comparison of SMP and ESWL for the Treatment of Renal Stones ≥20 mm in Children (IAU-04)

ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. On the contrary, PNL has a higher success rate, does not require multiple sessions but is an invasive method. Compared to standard PNL, miniaturized PNL systems have been shown to decrease complications with comparable success rates. SMP is a unique miniaturized PNL system with integrated active irrigation and suction systems. The current literature lacks studies comparing SMP and ESWL prospectively in the pediatric population. In this study, the effectiveness, reliability, and reusability of ESWL and SMP will be compared.

To compare the success and complication rates of super-mini-percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the treatment of renal stones ≥20 mm in children.An international multicentre, prospective, observational study. Pediatric cases with renal Stones ≥20 mm who undergo ESWL or SMP will be evaluated and compared proespectively. The total number of departments planned to be included in the study is 10 and the number of cases is 180.

Eligibility Criteria:
Inclusion Criteria:

* Children ≤14 years old with renal Stones ≥20 mm
* Willing and able to sign informed consent
* Normal renal function
* No stone-related surgical history
* American Society of Anesthesiology (ASA) score 1-2

Exclusion Criteria:

* Congenital renal anomalies (horseshoe kidney, ureteropelvic junction obstruction)
* Uncorrected UTI
* Abnormal coagulation function
* Morbid obese children (BMI≥35）
Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions

The goal of this observational retrospective and prospective multicentric trial is to learn about the impact of bail-out stenting (BOS) after drug coated balloon (DCB) percutaneous coronary angioplasty (PCI) in de novo coronary stenosis.The main question to answer is:

- if BOS PCI leads to an higher rate of 1-year target vessel failure that DCB-only PCI.

Participants will receive DCB PCI in de novo coronary stenosis. Treatments they\&#39;ll be given should be:

* DCB-only PCI
* BOS PCI

Researchers will compare DCB-only and BOS group to see if addictive stent implantation for DCB-PCI complication is relate to an higher rate of target vessel failure.

Target vessel is the primary endpoint, defined as:

* cardiovascular death
* target vessel myocardial infarction
* clinical driven target vessel revascularization
* angiographic restenosis

Drug coated balloon (DCB) percutaneous coronary intervention (PCI) has been shown to be as effective as last generation drug eluting stent (DES) PCI in many randomized trials. However a not negligible rate of patients must receive a bail-out stenting (BOS) implantation after DCB-PCI. Only some studies report that the rate of MACE of these patients is higher than DCB-only or DES-PCI ones. Even if the BOS patients MACE rate is two times more than DCB-only or DES-only, due to the small amount of BOS patients in these studies there were not a statistically significant difference.

According to these evidence, BOSS study researchers will compare target vessel failure (TVF) rate in DCB-only and BOS group resulting from all vessel size de novo coronary artery stenosis DCB-PCI.

TVF as primary endpoint will include:

* cardiovascular death
* target vessel myocardial infarction (TV-MI). According to the third universal definition of myocardial infarction TV-MI will be considered a non fatal myocardial infarction with the evidence of myocardial necrosis in the vascular territory of previously treated target vessel
* clinical driven target vessel revascularization (CD-TVR). CD-TVR will be considered as any repeat intervention of any segment of the target vessel, defined as the entire major coronary vessel proximal and distal to the target lesion.
* Angiographic restenosis. It will considered in case of restenosis as either a \&gt; 50% loss of initial gain of the target lesion.

The trial will enroll all patients who received a de novo DCB-PCI from January 2020 to December 2023. The population will be divided into two groups:

* DCB-only PCI
* BOS PCI

Bail-out stenting will be done in case of high grade coronary dissection (\&gt; or equal to NHLBI grade C) or in case of \&gt; 30% recoil, according with International DCB Consensus.

Eligibility Criteria:
Inclusion Criteria:

* De novo DCB PCI of at least one coronary artery
* Hybrid PCI of bifurcation (main branch stent and side branch DCB)
* Hybrid PCI of coronary artery with more than one stenosis (at least 10 mm of distance between edge of stent and DCB PCI segment)

Exclusion Criteria:

* in-stent restenosis
* more than 1 year life expectancy
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.

This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant gestational age \>= 28 weeks
* Systolic blood pressure \>=160 mm Hg OR a diastolic blood pressure of \>=110 mm Hg measured twice more than 15 minutes apart
* Able to swallow pills
* \>= 18 years

Exclusion Criteria:

* Indication for emergent cesarean or known fetal anomaly
* Anti-hypertensive therapy received in the past 12 hours
* History of eclampsia or other adverse CNS complication (e.g., stroke or PRES) in this pregnancy
* Actively wheezing at time of enrollment or history of asthma complications
* Known coronary artery disease or type I DM with microvascular complications or signs of heart failure or clinical dissection of the aorta
Effects of Resistant Potato Starch on the Gut Microbiota

This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.0 and 34.9 kg/square meter (inclusive) that were generally healthy as determined by medical history and screening blood work.

Exclusion Criteria:

* Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.
Stanford Accelerated Recovery Trial (START)

The goal of this study is to determine whether administering Gabapentin prior to surgery affects duration of pain and opioid use post-surgery. The investigators aim to compare gabapentin to placebo in a prospective, randomized clinical trial in which patients will be followed post-surgery until pain resolves and opioid use ceases.

Gabapentin was originally developed as an anti-convulsant, but was quickly recognized as a medication with significant analgesic activity in patients with neuropathic pain. More recently it has begun to be appreciated that it may have some benefits in the peri-operative period. Pre-operative Gabapentin reduces preoperative anxiety, early post-operative pain severity, post-operative opioid use and post-operative delirium (presumably through reduced opioid consumption). These same attributes are shared by medications such as NSAIDS and tylenol and the use of peri-operative gabapentin has not permeated the standard of care. Early post-operative pain severity and preoperative anxiety have been implicated in our own research as risk factors for prolonged time to pain resolution and prolonged time to opioid cessation. Since these endpoints are generally synonymous with time to recovery, interventions reducing these times would be seen not just to increase comfort but to actually speed recovery.

Eligibility Criteria:
INCLUSION CRITERIA

* Age 18 to 75
* Undergoing a scheduled surgery
* English speaking
* Ability and willingness to complete questionnaires or use Palm Pilot

EXCLUSION CRITERIA

* Known kidney disease
* Currently receiving gabapentin or (pregabalin) lyrica already
* Cognitive impairment
* Previous history of excessive sedation or adverse reaction to gabapentin (not it was tried but ineffective for nerve pain)
* Coexisting chronic pain \> 4/10 disorder in area other than surgical target
* Plan to move out of state
* Condition that would in judgment of team member make patient likely to be lost to follow-up
* Elevated suicidality
* Known pregnancy
* Current symptoms of ataxia, dizziness, or sedation
* Narrow angle glaucoma
* Severe respiratory insufficiency (ie, severe emphysema or chronic obstructive pulmonary disease)
* History of gastric bypass surgery and obstructive sleep apnea requiring continuous positive airway pressure (CPAP)
Radiographic Evaluation of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft

Study about the comparison of post-operative results of secondary alveolar grafts according to two age groups: early secondary (4 to 7 years) versus late secondary (8 to 11 years) using a recently proposed score based on post-operative 3D CT analysis.

Comparison of the initial results of the graft in the two groups, with a reference 2D score and evaluation of the concordance between the results found with this score and those of the 3D score.

Finally, comparison of graft bone densities and nasal floor level (using 3D visualization) on post-operative TDMs in the 2 groups.

The aim of this study is to determine the optimal age for grafting using three-dimensional CT assessment.


Eligibility Criteria:
Inclusion criteria:

- Patients operated with an alveolar bone grafting for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021 and having had 3D imageries defined as:

* Group 1:

  o Patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3D imaging (CT, CBCT or scan) performed between the ages of 8 to 11 years.
* Group 2:

  * Patients operated with a late secondary alveolar graft between the ages of 8 to 11 years with a 3D imaging (CT, CBCT or scan) performed at least 1 year after the operation.

Exclusion criteria:

* Patients operated with an alveolar bone grafting before 4 years or after 11 years
* Patients without post-operative CT
Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice


Eligibility Criteria:
Inclusion Criteria:

* Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms
* Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included

Exclusion Criteria:

* Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer

This project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctDNA mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy individuals. A new comprehensive diagnostic model will be established and its diagnostic value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated.

Specifically, the study will involve the following subjects and quantities: 700 participants from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200 participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA methylation sequencing, proteomics, and genomics to establish a multi-omics-based early diagnostic model.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 100 years.
* ECOG performance status of 0 or 1.
* Pathologically confirmed Stage I-III gastric cancer patients.
* Patients who have not undergone any anti-tumor treatment (including chemotherapy, radiotherapy, targeted therapy, surgery, anesthesia, etc.) before blood collection.
* Subjects and their family members who can comprehend the research protocol and are willing to participate in the study, providing written informed consent.

Exclusion Criteria:

* Presence of other hereditary diseases or other tumors.
* Severe inflammatory reactions caused by acute illnesses within 14 days prior to blood draw or use of steroids.
* Previous organ transplantation, stem cell transplantation, bone marrow transplantation, or blood transfusion within the last month before enrollment.
* Pregnant women.
* Participation in other clinical trials requiring medication intake within the last 60 days (including anesthesia).
* Severe cardiovascular diseases, uncontrolled infections, or other uncontrollable comorbidities.
* Subjects or family members unable to comprehend the conditions and objectives of the study.
Complications Associated with Arterial Line Placement in Children

The purpose of this study is to find the risk factors for complications following arterial line catheterization. Ultrasonography is used to evaluate the size of artery which is cannulated, before and after catheterization. The complications include ischemia, bleeding, thrombosis and so on.

artery observation with ultrasound

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients under 5 years of age who require invasive arterial pressure monitoring

Exclusion Criteria:

* Patients who do not need invasive arterial pressure monitoring