cyrilzakka/clinical-trials huggingface dataset:
Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial

Heart failure, characterized by high mortality and morbidity rates, frequent hospital admissions, and prolonged stays in cardiology wards, significantly impacts patients' quality of life.

The REMOTI-HF is a single-center randomized controlled trial designed to assess the impact of remote monitoring, utilizing the HeartLogic and TriageHF algorithms, in patients with heart failure with implantable cardioverter defibrillator or cardiac resynchronization therapy. The primary endpoints include mortality, hospital admissions related to heart failure, and visits for worsening heart failure.

Moreover, we will explore the full capabilities of these algorithms, by analysing the association of physical activity, measured by the devices, with the same key outcomes. Additionally, the research will explore the relationship between the absolute values provided by the algorithms and NT-proBNP values.

Patients will be randomized into two arms: one with the activation of the algorithm and the other with no active algorithm. The algorithm is programmed to alert our team upon detecting a patient at risk of worsening heart failure. When an alarm is triggered, the patient will receive a telephone call from the investigation team. Subsequently, the patient may be scheduled for a hospital visit, or ambulatory medication adjustments can be made.

For patients in whom the algorithm is deactivated, no such alarm mechanism will be in place.

Patients in both arms will undergo comparison based on relevant heart failure events, defined as follows:

* All-Cause Mortality
* Hospital Admission for Heart Failure
* Hospital Visit for Worsening Heart Failure
* Ventricular Arrhythmias
* Atrial Arrhythmias

Additionally, the study will explore the association between physical activity measured by the devices and these specified events.

In addition to evaluating patient outcomes, a correlation analysis will be conducted to examine the relationship between the absolute value provided by the algorithm and absolute NT-proBNP values. This analysis aims to assess the concordance and potential predictive value of the algorithm's output with established biomarkers, specifically NT-proBNP, in the context of heart failure progression and severity (if possible).

Eligibility Criteria:
Inclusion Criteria:

* Possession of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device that is compatible with the HeartLogic or TriageHF algorithms.
* Left ventricular ejection fraction at the time of device implantation must be equal to or less than 35%.

Exclusion Criteria:

* Younger than 18 years old or older than 85 years old.
* Unable to be contacted when out of the hospital.
* Presence of severe cognitive impairment.
* Currently on the heart transplant waiting list
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows:

* To assess functional clinical score's evolution,
* To evaluate patient's satisfaction
* To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021.

Patients were implanted and followed as per standard of care led in the investigational site.

The following regulation and guidelines were followed for this investigation:

* Standard ISO 14155:2020 "Good Clinical Practice"undirectly applicable;
* Regulation (UE) 2016/679 (RGPD) ;
* Regulation (UE) 2017/745 (MDR) ;
* MEDDEV 2.12.1;
* Local regulation (loi " jardé ", loi " informatique et libertés "). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).


Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Major patient on the date of surgery
* Patient with foot pathology requiring Akin osteotomy
* Patient not opposed to the collection of data

Exclusion Criteria:

* Patient unable to understand and follow the postoperative instructions
* Patient with a contraindication to the use of the implant
* Non-implanted patient with a varisation staple
Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

The objective of the study will be to estimate the correction obtained with a metallic instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred EUROS ®) screw , without transplant at the adult as compared to that obtained with the surgery with complete exhibition of the rachis and bone graft.


Eligibility Criteria:
Inclusion Criteria:

* age \>18
* under guardianship
* vertebral deformation \>20°
* accept to participate

Exclusion Criteria:

* minor patient
* surgery not including the pelvis
Rehabilitation for Thoracoscopic Lobectomy

The main aim of this research is to compare the functional recovery after discharge with the preoperative physical activity as a hypothesis generating study.


Eligibility Criteria:
Inclusion Criteria:

* VATS-L
* Speaks and understands Danish or English.
* Informed consent obtained

Exclusion Criteria:

* Co-VATS-L.
* on the wheelchair.
* Living in nurse home.
* Using rollator to assist to walk.
* Unwilling to place the Actiwatch 2 or execute PPE.
Maintenance and Tissues Conditions of Fixed Screw-Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures

The aim of this study was to compare the prosthetic maintenance requirements between implant-retained ball overdentures versus fixed screw- retained implant prosthesis. Clinical and radiographic changes in peri-implant tissue with using PGE2 as a PICF biomarker were also evaluated. Selected patients had been divided into two groups:

1. Group (I): twenty seven patients had received implant-Supported ball over dentures.
2. Group (II): twenty-seven patients had received screw retained restorations Interventions and study procedures

Surgical and prosthetic procedures:

Surgical Procedures A radiopaque radiographic stent was formed and was positioned in the patient's mouth during cone beam scanning. Four implants were planned with two virtual replicas, in the place of the lateral incisor and the second premolar.

The stent was fabricated. After the healing period of four months finished, the patients were recalled and the super structure was fabricated according to the type of restoration Follow-up During the 12 months follow-up period, prosthodontic complications were recorded and calculated.

Postoperative care Along with a conventional oral hygiene assessment and functional checkup, follow up visits were scheduled every 6 months and up to 12 months total follow up period.

Clinical soft tissue measurements which include plaque index (PI), gingival index (GI), and PPD were measured at the mid-facial, mid-lingual, mid-mesial, and mid-distal aspects of each fixture using a graduated plastic probe to the nearest 0.5 mm. These clinical measurements were recorded after prosthesis delivery, 6 and 12 months postoperatively. The peri-implant marginal bone loss (MBL) was assessed radiographically after prosthesis delivery, 6 and 12 months postoperatively.

• Collection of peri-implant crevicular fluid (PICF) samples: PICF was collected.


Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients have Angle Class I maxilla-mandibular relationship.
* Age range between 40 and 70.
* Maxillary and mandibular ridges with no history of fresh extraction.
* Sufficient bone volume to house four implants in each arch.
* Sufficient zone of keratinized attached mucosa \>5mm over the crest of the upper and lower ridges.

Exclusion Criteria:

* the patients have a past history of head and neck radiation
* previous ridge augmentation or grafting
* Lack of any systemic diseases that could affect osseointegration of implants as uncontrolled diabetes , hypertension , and osteoporosis
* Heavy smokers who exceeding 20 cigarette/ day
* para-functional habits for example bruxism or clenching.
Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks

This trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of Quadratus lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy.

Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum block and paravertebral plane blocks are regional techniques performed for multimodal analgesia.

The aim of this study is to determine an effective analgesia method by comparing the postoperative analgesic effectiveness of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years, American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

* local anesthetic allergy
* Infection at the procedure site
* Body Mass Index \>35 kg/m2
* Anticoagulant use with bleeding disorder
* Chronic analgesia and opioid use
* with mental and psychiatric disorders
Using a Systematic Review in Clinical Decision Making: a Pilot Parallel, Randomized Controlled Trial

The purpose of this pilot study is to determine the feasibility of running a full-scale trial that compares two formats of a shortened systematic review to a full-length systematic review to be used in clinical decision-making.

Two shortened systematic review formats were developed to enhance their use in clinical decision making. An online randomized controlled trial is planned to make comparisons of the shortened formats to a full-length systematic review. To prepare for the full-scale trial, a pilot study will be conducted to test methods and procedures in order to refine the processes.

Eligibility Criteria:
Inclusion Criteria:

* Physicians who were in practice full- or part-time at study enrollment were recruited for participation
* Participants had to have access to the Internet as the study was conducted online.

Exclusion Criteria:

* The systematic reviews in all formats were only available in English, thus any participants who were not able to read and understand English were not eligible to participate.
* Anyone who had taken part in any phase of the development of the shortened versions of the systematic reviews (cased-based or evidence-expertise formats) were not eligible for recruitment.
Clinical and Histological Study of a Novel Dermal Substitute

The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects.

The main questions aim to answer are:

• Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the current standard procedure Participants skin elasticity will be measured by Cutometer® MPA-580 assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age: 1 to 70 years
* Full-thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a STSG:

  * Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans or similar condition
  * Reconstructive cases (elective surgery): e.g. scar formation after burn injury, giant congenital nevus, defect after removal of skin tumor, skin defect due to other surgical procedures
* Documented medical treatment decision of covering the full-thickness skin defects with either the two-step BTM/STSG procedure or with STSG alone or by using both techniques on different wound areas
* Informed consent by patients/parents or other legal representative

Exclusion Criteria:

* Infected wounds needing surgical procedure other than a dermal template
* Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin disease, any kind of congenital defect of metabolism including diabetes)
* Previous enrolment of the patient into the current study
* Adolescent/Adult patients or in case of children their parents/legal representatives unable to comply with the study protocol
* Adolescent/Adult patients or in case of children their parents/legal representatives having insufficient knowledge of local language
* Pregnant or breast feeding females
Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice

The primary objective of this study is to compare the medication adherence measured by PDC of patients with FDC or double-pill combination therapy in real-world Japanese therapeutic practice.The further objective of this study is how much influence the background of patients to the adherence.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension
* Patients must have their first prescription (defined as index date\*) for telmisartan and hydrochlorothiazide or Micombi® between 01/07/2010 and 28/09/2010
* Patients must have their first prescription (defined as index date\*) for telmisartan and amlodipine or Micamlo® between 10/12/2010 and 09/03/2011
* Patients must have at least 180 days follow up verified by the presence of prescription record

Exclusion Criteria:

* Patients who were under 40 years old at the time of enrolment
* Patients who prescribed the study drugs less than 90 days during a follow up period of 180 days
* Patients whose visits are less than 2 times during a follow up period of 180 days
Educational Intervention Targeting Nurses Attitudes and Knowledge About Cancer-related Pain Management

The purpose of this study is to investigate whether an intervention consisting of the implementation of guidelines about daily systematic pain assessment following a theory based education, targeting cancer-related pain and pain treatment, lead to a significantly positive improvement in RNs knowledge of, and attitudes towards their pain management. Furthermore will the interventions targeting the RNs influence the admitted patient's perception of their cancer-related pain?


Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis
* Aged 18 years and above
* Cognitively intact and able to verbally communicate
* At admission pain intensity \>1 on Visual Analogue Scale (VAS)

Exclusion Criteria:

* Trauma or planned and/or acute surgery.
RELATIONSHIP BETWEEN INITIAL PROBING DEPTH AND CHANGES IN CLINICAL PARAMETERS FOLLOWING NON-SURGICAL PERIODONTAL TREATMENT IN CHRONIC PERIODONTITIS PATIENTS

Aim: The aim of this study was to evaluate the relationship between initial probing depth (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT) in chronic periodontitis patients.

Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling and root planing was applied in two sessions. Probing depth (PD), clinical attachment level, gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites were grouped according to their IPD and root number of teeth as single- or multi-rooted.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy,
* Non-smoker,
* Chronic periodontitis diagnosed according to Armitage 1,
* Aged between 35 and 65,
* Not received any periodontal treatment within the last 3 months, • Have horizontal bone loss radiographically,
* Presence at least 20 natural teeth except third molars
* Consent to participate in the study.

Exclusion Criteria:

* Any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, HIV infection),
* Smoking,
* Antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study,
* Any physical limitations or restrictions that might preclude normal oral hygiene procedures.
Translation, Cross-Cultural Adaptation and Turkish Validation of the 25-Question Geriatric Locomotive Function Scale

25-question Geriatric Locomotive Function Scale (GLFS-25) is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals.

The purpose of this study was to translate and cross-culturally adapt the English version of the GLFS-25 into Turkish and to investigate the reliability and validity of the translated version of the scale.

Aging is an inevitable process that begins after birth and continues until the death of the individual, affecting the person mentally and physically. Approximately 21% of elderly individuals requiring care have locomotive organ disorders involving the bone, joint, muscle and nervous system. 25-question Geriatric Locomotive Function Scale (GLFS-25), developed by Japanese researchers in 2012, is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals. This scale provides an advantage in terms of locomotive ability and early detection of locomotive syndrome in the elderly. In addition, the scale provides the opportunity to decrease number of needing for hospital care of elderly individuals by early detection of locomotive functions and the risk of locomotive syndrome. Before a patient-reported outcome measure can be used in a society other than the one in which it was developed, it must be translated and culturally adapted. The GLFS-25 have been translated to different cultural settings and into many languages, including Brazilian, Iranian and Chinese. Data obtained from the culturally adapted versions contribute to a better understanding of the tools measurement properties. The studies reported that translated versions of GLFS-25 reliable and valid in older adults for functional assessment. Therefore, a Turkish version of the GLFS-25 would likely be that would be helpful in the functional state management and risk factor analyzes for locomotive syndrome of the Turkish older adult population. The purpose of this study was to translate and cross-culturally adapt the English version of the GLFS-25 into Turkish and to investigate the reliability and validity of the translated version of the scale.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 65
* who can answer the questionnaire on their own or with the help of their relatives

Exclusion Criteria:

* unable to walk without the assistance of another person
* having a brain disease or severe cardiovascular, pulmonary or renal disease
* having a history of lower extremity and/or spine fractures in the last 6 months
* were treated for acute trauma
Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast

The main purpose of this study is to validate the ultrasound scores PsASon22 and PsASon13 in patients with active psoriatic arthritis undergoing a treatment with Apremilast.

This is a prospective, multicentre, phase IV trial assessing the value of the ultrasound scores PsASon22 and PsASon13 in differentiating between clinically active and inactive patients with psoriatic arthritis, following a treatment with Apremilast for up to 24 months. Additionally, convergent construct validity, inter/intra-reader reliability, sensitivity to change and differences in change in certain patients will be tested for the ultrasound scores.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient ≥18 years and \<90 years of age
2. PsA according to CASPAR criteria
3. Peripheral manifestation (arthritis, tenosynovitis, dactylitis and/or enthesitis)
4. Active disease as defined by a DAPSA \>14 and clinical indication for treatment with Apremilast (as per approved indication for PsA, including failure to methotrexate)
5. Written informed consent

Exclusion Criteria:

1. Inability to perform US at any site included in the PsASon22 or PsASon13 score (f.e. due to complete destruction of a joint)
2. Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography.
3. Contraindication to Apremilast (as per patient information leaflet)
4. Current severe medical illness requiring hospitalization
5. Pregnancy or lactation
6. Inability of the patient to follow the treatment protocol
7. Fulfillment of the MDA Criteria or DAPSA≤14
8. Current treatment with any investigational drug
9. Current treatment with glucocorticoids at a prednisone equivalent \>10mg
10. Intra-articular glucocorticoid injection in one of the joints to be investigated clinically or by sonography, or intra-muscular glucocorticoid injection within 8 weeks before baseline
11. Change, including dosage changes or discontinuation, of csDMARD treatment (with the exception of leflunomide) in the last 4 weeks before baseline
12. Change, including dosage changes or discontinuation of leflunomide treatment in the last 8 weeks before baseline. (Exception: If patients stop leflunomide and complete an 11 day treatment with cholestyramine (8g, 3 x daily), prior to the baseline visit, they may enter the study.)
13. Current bDMARD, tsDMARD treatment
14. Prior bDMARD or tsDMARD treatment without a minimal washout period before baseline (the minimal washout period is twice the half-life of the respective drug)