cyrilzakka/clinical-trials huggingface dataset:
Remote Patient Monitoring for Patients With Heart Failure in France

The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France.

The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival

Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition.

Researchers will compare the following cohorts to see if RPM can improve their condition:

* Cohort 1: using RPM for follow-ups.
* Cohort 2: conventional care and not using any devices and solutions for the follow-ups.

TELESAT study is a national-scale observational prospective cohort study conducted in France from August 2018 to December 2022.

The study was conducted using the French national health data system known as the Système National des Données de Santé (SNDS) which covers approximately 99% of the French population.

Eligibility Criteria:
Inclusion Criteria:

* residing in France
* having heart failure
* adults over the age of 18 years
* New York Heart Association (NYHA) score≥2 and Brain Natriuretic Peptid (BNP)\>100 pg/ml or N-terminal pro BNP\>1000 pg/ml OR prior hospitalization for heart failure

Exclusion Criteria:

* physician's assessment deemed patient not be physically or mentally able to be remotely monitored
* had chronic dialysis
* severe liver failure
* the presence of any other medical condition resulting in a less than one-year life expectancy,
* an estimated low adherence to treatment
* lack of a stable place of residence
* refusing to participate in the program ineligible.
External Device for Erectile Dysfunction (3D-Erect)

The aim of this clinical trial is to test the safety and feasibility of a non-invasive 3D-printed external penile device to achieve successful and satisfactory sexual intercourse in men with erectile dysfunction (ED).

A clinical trial to test the safety and feasibility of our newly developed non-invasive 3D-printed external penile device for the treatment and recovery of erectile dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* males \>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.)
* having a female partner willing to participate in the study.

Exclusion Criteria:

* not willing to attempt sexual vaginal intercourse with their partner
* inability to wear/operate the external penile device for any reason
Oral Helicobacter Pylori Eradication

Helicobacter pylori (H. pylori) is a serious health threat that infects approximately half of the global population. In addition to colonizing the stomach, H. pylori has been shown to survive in the oral microenvironment and is associated with a variety of oral diseases, gastric eradication failure, and reinfection. Currently, traditional systemic antibiotic therapy has little effect on oral H. pylori, and mouthwashes available on the market for oral H. pylori eradication often contain multiple antibiotics or complex essential ingredients, which can cause unpredictable effects on the human body. Therefore, there is an urgent need for a mouthwash that does not contain antibiotics and is effective against oral H. pylori. This study focuses on the eradication effect of MAXPOWER Biological Antibacterial mouthwash on oral H. pylori in a population.

Inclusion criteria: oral H. pylori-positive patients, verified by H. pylori saliva test (HPS),aged 18-70 years visiting the outpatient clinic of Changhai Hospital from March 1, 2023, to August 1, 2023, were enrolled.

Exclusion criteria: (1) Zollinger-Ellison syndrome, gastric cancer, upper gastrointestinal bleeding, or active peptic ulcer; (2) the coexistence of significant concomitant illnesses, including heart diseases, renal failure, hepatic disease, previous abdominal surgery, lactation or pregnancy; and (3) not willing to participate in the study.

Written informed consent was obtained from all patients prior to participation in the study.

Eligibility Criteria:
Inclusion Criteria:Oral H. pylori-positive patients, verified by H. pylori saliva test (HPS),aged 18-70 years visiting the outpatient clinic of Changhai Hospital from March 1, 2023, to August 1, 2023, were enrolled.

Exclusion Criteria: (1) Zollinger-Ellison syndrome, gastric cancer, upper gastrointestinal bleeding, or active peptic ulcer; (2) the coexistence of significant concomitant illnesses, including heart diseases, renal failure, hepatic disease, previous abdominal surgery, lactation or pregnancy; and (3) not willing to participate in the study.

-
Diagnostic Protocol Of Painful Hip

Nondisplaced hip fractures may be radiographically occult and require MRI or single photon emission CT bone scintigraphy for accurate diagnosis. Both examinations are expensive and are not readily available in many hospitals. Ultrasound (US) examination is relatively inexpensive and preliminary data had demonstrated its efficacy in detecting occult fractures in other sites. Our objective is to evaluate US examination as a screening tool for occult hip fractures in posttraumatic painful hips in the elderly.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women above 40 years old
2. Trauma to the hip .
3. Extreme difficulty in walking or inability to step on the leg, following sensitivity in the hip joint area after local pressure or in a movement.
4. X ray of the pelvis aimed to the suspected hip joint (including AP lateral position and internal rotation) does not demonstrate fracture in the joint or the pelvis.

Exclusion Criteria:

1. None
Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Juvenile Idiopathic Arthritis (JIA)

Juvenile idiopathic arthritis (JIA) may progress asymptomatically leading to joint destruction despite treatment.

The aim of the observational study is to describe patients with silent arthritis comparing symptoms, clinical findings with results of ultrasound and magnetic resonance imaging (MRI).


Eligibility Criteria:
Inclusion Criteria:

* children without symptoms or with only mild joints swelling or with only minimal limited range of motion

Exclusion Criteria:

* patients with manifest arthritis
Allergy Immunotherapy in the Management of Eosinophilic Esophagitis

Eosinophilic esophagitis (EoE) is a disease that has increased in incidence over the past decade that affects males predominantly, and in adults, is characterized by heartburn, dysphagia, strictures and food impactions. These symptoms may require emergent endoscopic removal of foods and esophageal dilations due to remodeling causing significant impairment in quality of life. Treatment options are limited and often not well tolerated or effective. There is poor understanding of the natural history and long term prognosis. It has been associated with allergic sensitization; a high percentage of affected individuals having associated atopy and current literature demonstrates a seasonal distribution of incidence and severity of symptoms. Allergy immunotherapy (AIT) is a well established and effective treatment for allergic rhinitis and asthma which can induce tolerance to environmental allergens.

Given the efficacy of AIT and the association of aeroallergen sensitization and even seasonal variation of EoE symptoms, we hypothesized that AIT may be a treatment option for patients with EoE.

Purpose: To evaluate the role of allergy AIT in the management of EoE.

Research design: Patients with EoE and aeroallergen sensitization will be offered AIT as a treatment modality for EoE. They will be evaluated by questionnaire, laboratory tests, endoscopy and biopsy before and after treatment to determine if there is clinical, laboratory, endoscopic and histologic changes in their EoE.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for care at Naval Medical Center San Diego
* Diagnosis of EoE (with or without GERD)
* Positive skin test to aeroallergen(s)
* Able to provide written informed consent prior to the conduct of any study related procedure

Exclusion Criteria:

* All excluding conditions for Allergy immunotherapy (AIT) - pregnancy, severe asthma, uncontrolled asthma, taking a beta blocker, history of coronary artery disease. (Note: age is not typically an exclusion criteria for AIT, however this will be an adult only study).
* History of significant esophageal disease other than EoE (such as esophageal cancer, surgeries...)
* History of other systemic eosinophilic conditions (such as ...)
* Subjects with controlled asthma on inhaled steroids at the time of diagnosis of EoE may be included , however if a subject develops new asthma or worsening asthma during the study requiring new initiation of inhaled steroids, they may be discontinued to avoid possible swallowing of the medication and "treatment" of their EoE.
* If subject is judged by the investigator as unlikely to understand the scope of the study and/or is unlikely to comply with the study procedures and visits.
* Is currently or has recently been on AIT (within the past year)
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.

Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.

The research focuses on the measurement of pulse oximetry among lifeguard on the Atlantic coast of Gironde, France, before and after their daily training, using a standardized measurement protocol.

The follow-up will be done during the beach monitoring period during the summer of 2020. A total of 3 months of measurement collection is expected.

Eligibility Criteria:
Inclusion Criteria:

* Lifeguard working on the Girondine Atlantic coast
* up to 18 years old,
* no smoker,
* No chronic pathology.

Exclusion Criteria:

* Chronic cardiac pathology,
* Chronic respiratory pathology,
* Acrosyndrome,
* Smoker.
Vestibular Schwannoma Organoids

In standard of care regularly planned surgery, tissue will be obtained from patients who are suspicious for having vestibular Schwannoma (on MRI). The tissue that remains after the pathologist gathered sufficient for analysis, the remaining tissue is used for creating tumour stem cell organoids.

This project constitutes scientific research since the presence of tumor stem cells has not been shown in schwannoma before. Secondly the organoid model has not yet been described for VSs. The correlation between effect in schwannoma organoids and in patients has to be evaluated but can proof to be very valuable since it has been shown in a number of tumors. The tumor tissue will be acquired during regularly planned surgery. The tissue that is used is what is left after sufficient material has been sent to the pathologist to make the diagnosis. So the tissue that is used is removed routinely during surgery, but instead of banking it at the pathology department, it is used for the research project. Blood samples that can be used to compare normal DNA to tumor cells DNA will be acquired from central lines that are routinely placed during these procedures, so no additional interventions will be done in acquiring the tissue and blood for this study.

Eligibility Criteria:
Inclusion Criteria:

* MRI with suspicion for vestibular schwannoma
* Indication for surgery in the skull base committee
* 18 years or older

Exclusion Criteria:

* Refusal to participate
* Younger than 18 years
* Incapacitated
The Predictive Value of Prostate Spherical Volume Ratio in Lower Urinary Tract Symptoms and Clinical Progression of Benign Prostatic Hyperplasia:A Single-center Paired Validating Confirmatory Study

This study was a retrospective cohort study clinical trial designed to assess the predictive ability of the prostate morphometric parameter, Prostate Spherical Volume Ratio, in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia; and to compare the predictive ability of other anatomical parameters of the prostate (prostatic urethral length, intravesical prostatic protrusion, presumed circle area ratio, and prostate volume) in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia

This was a retrospective observational study approved by the Ethics Committee of Shanghai Oriental Hospital. We collected patients with BPH who underwent MRI, urine flow measurement and completed the IPSS questionnaire in our hospital between September 2022 and April 2023, measured each anatomical parameter of the patient's prostate by MRI, analysed the relationship of these prostate parameters with IPSS and urine flow, and conducted a follow-up of the clinical progression of the prostate in these patients to evaluate the predictive efficacy of prostate parameters for LUTS and clinical progression of benign prostatic hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* All patients had obvious lower urinary tract symptoms such as urinary frequency, increased nocturia, and a feeling of incomplete urination, etc. They all completed prostate MRI, IPSS questionnaire, and uroflowmetry for a clear diagnosis of BPH.

Exclusion Criteria:

* 1, previous history of bladder, prostate, urethra surgery; 2, the existence of other diseases that cause urinary dysfunction: such as neurogenic bladder, bladder stones, urethral stenosis, urinary tract infections, acute prostatitis, etc.; 3, the existence of mental, mental disorders, can not be accurately expressed and family members can not help to improve the IPSS scores; 4, to receive prostatic hyperplasia medication, such as: α-blocker therapy, 5α reductase inhibitors, etc. have not been discontinued for 6 months; 5, refused to participate in this study
The Influence of Demographic Parameters and ACL Injury on the Association Among Clinical, Functional and Biomechanical Parameters

This retrospective study aims at analysing demographics and clinical, functional and biomechanical outcomes in patients after ACL injury (conservative therapy and/or surgery) in patients of different ages and healthy controls. Demographics, as well as clinical, functional and biomechanical parameters were collected between 2019 and 2022 in two research projects approved by the Ethikkommission Nordwestschweiz (EKNZ 2019-00491, EKNZ 2019-01315, EKNZ 2020-00551). The primary research question analyzes if maximal SLH distance and LSISLH distance are related to the predictors age, sex, isokinetic muscle strength and the presence of injury.

Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the knee. ACL reconstruction using auto- and allografts is still the gold-standard technique and widely used in the surgical treatment of ACL ruptures. Potential deficits in the affected leg are frequently evaluated using the limb symmetry index (LSI) calculated as performance affected side/performance unaffected side x 100. Several factors other than injury may influence single leg hop (SLH) distance and LSI such as sex, age, and muscle strength. This retrospective study aims at analysing demographics and clinical, functional and biomechanical outcomes in patients after ACL injury (conservative therapy and/or surgery) in patients of different ages and healthy controls. Demographics, as well as clinical, functional and biomechanical parameters were collected between 2019 and 2022 in two research projects approved by the Ethikkommission Nordwestschweiz (EKNZ 2019-00491, EKNZ 2019-01315, EKNZ 2020-00551)

Eligibility Criteria:
Inclusion Criteria:

* Patients: 2-10 years since ACL injury
* Control subjects: no previous injury to the meniscus or the ligament apparatus of the knee

Exclusion Criteria:

* Bilateral injury or previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months
* Concomitant conditions that affect the mobility of the knee (e.g., neuromuscular diseases that affect lower limb movement, injury of the posterior cruciate ligament (PCL), more than one collateral ligament ruptured, fracture, luxation of the knee, tumorous disease, immunosuppressed patients)
* Inability to give informed consent
Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site

The main objective of this study is to observe whether basic fibroblast growth factor and Kangfuxin Liquid can promote the wound healing in the donor area and further evaluate the healing quality.


Eligibility Criteria:
Inclusion Criteria:

* Male / female patients aged 20-50;
* Burn area ≤ 30% TBSA;
* Patients who need auto skin grafting due to burns or skin defects due to trauma;
* The donor area is 100cm2, and the thickness of skin is 0.25mm (Split thickness skin donor site group)/0.40mm (Medium thickness skin donor site group). The donor site is the body part with similar skin color and sufficient skin area (except scalp);
* Not involved in clinical trials of other drugs;
* Subjects who have agreed to participate in the clinical study and signed the informed consent.

Exclusion Criteria:

* Subjects who were previously allergic to similar products or related components of test products;
* Subjects with other systemic or local skin diseases that may affect wound evaluation;
* Subjects with significant organ dysfunction / failure or other serious diseases, including clinical related cardiovascular disease or myocardial infarction within 12 months before enrollment; malignant tumor; serious neurological or psychiatric history; serious infection; active disseminated intravascular coagulation;
* Subjects with moderate malnutrition (BMI \< 17kg / m2) and severe anemia (HB \< 60g / L);
* Subjects proposed to use immunosuppressant, steroid hormone, epidermal growth factor and other drugs that may affect the wound healing of the donor skin within 3 months before admission or during the study period;
* Participated in clinical trials of any other drugs or medical devices within 3 months;
* History of major diseases that may affect general physical condition and other patients who are not considered by the researchers to be eligible for this study.
Bone Strength After Spinal Cord Injury

Background:

After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. This leads to a osteoporosis which is connected to a high fracture risk.

Aims:

To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and assessment of fracture risk in subjects with spinal cord injury.

Subjects:

250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord injury will be recruited for this study. For a reference group, 500 able-bodied persons will be measured analogously.

Methods:

Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur, distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone parameters of the tibia will be measured by using pQCT. All measurements will be done unilaterally. For the assessment of potential risk factors for reduced bone stiffness after spinal cord injury a questionnaire will be used.


Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury
* mobilized patients
* written informed consent

Exclusion Criteria:

* current fracture
* limited mobility
* contractures of the lower limbs
* decubitus ulcer
* pregnancy
Recurrence in Patients With Differentiated Thyroid Cancer

The aim of this study is to assess the recurrence-free survival (RFS) rate and recurrence-related factors, especially the relationship between RFS and RAI dose, in patients who received RAI after thyroidectomy.

Thyroid cancer is the most frequent cancer of the endocrine system, and its incidence is constantly rising worldwide. This is mainly because of advances in examination modalities that have made it possible to detect smaller cancers at an early stage.

Owing to advancements in screening techniques and treatment methods, the number of patients who die from thyroid cancer is small compared to the incidence.\[1\]

The most common type of thyroid cancer is differentiated thyroid cancer (DTC), which includes papillary and follicular carcinomas. Women are three times more likely to develop thyroid cancer than men. \[2\] Adjuvant RAI131 (AT) is recommended post thyroidectomy, because of its therapeutic impact on micro-invasions or micro-metastases, to reduce the likelihood of recurrence in patients who do not have metastases but have risk of recurrence according to the Japanese guidelines and American Thyroid Association guidelines \[3\],\[4\].

AT could prolong the survival of patients with intermediate-risk DTC \[5\]. Additionally, a meta-analysis has shown that AT is effective in reducing recurrence in some studies but not in others, and the effect of AT on recurrence prevention, especially in high-risk DTC, remains unclear.\[6\].

Although there are reliable reports discussing the relationship between the success or failure of remnant ablation \[7\],\[8\], recurrence after AT is rarely reported and the number of cases is small. In addition, no study has so far discussed the relationship between the success or failure of AT or remnant ablation and recurrence or death \[9\],\[10\].

Eligibility Criteria:
Inclusion Criteria:

* Patients with DTC (differentiated thyroid cancer) who underwent total or subtotal thyroidectomy without distant metastasis and gross residual tumors.
* Followed by ablation with RAI and underwent post RAI whole body scan.
* Having baseline TG (thyroglobulin), Anti-TG antibodies (anti thyroglobulin) and neck US.
* Patients with lymph node metastasis will be included if their lymph nodes had been dissected and no unresectable disease remained.

Exclusion Criteria:

* Patients who received RAI and missed follow-up.
* Patients with no surgical or pathological data.
Resistance Training in Adults With Obesity

The purpose of this project is two-fold: (1) to assess if two different resistance training protocols elicit different responses in the acute phase and (2) to assess if the same two different protocols will elicit different long-term responses on muscular strength, body composition and cardiometabolic health. The project will include 30 adults with obesity (defined as BMI ≥ 30 or abdominal obesity according to the International Diabetes Federation). In the acute phase blood lactate, heart rate, enjoyment and perceived exertion will be assessed after the two resistance training protocols. In addition, the mean 24-h blood glucose concentration after exercise will be compared between the two protocols.

For the long-term effects blood markers of cardiometabolic health, blood pressure, body composition, objectively measured physical activity and physical fitness will be assessed before and after the intervention. Also, perceived health-related quality of life will be assessed before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI ≥ 30) or
* Central obesity (defined according to the International Diabetes Federation).

Exclusion Criteria:

* Unstable angina
* recent cardiac infarction (last 4 weeks)
* uncompensated heart failure
* severe valvular illness
* pulmonary disease
* uncontrolled hypertension
* kidney failure
* orthopaedic/neurological limitations
* cardiomyopathy
* planned operations during the research period
* participation in a parallel study