cyrilzakka/clinical-trials huggingface dataset:
Computerized Guideline in Heart Failure: Implementation Process and Impact Evaluation

Objective: To assess the effectiveness of implementation process of an electronic Heart Failure guideline in primary care in the city of Barcelona.

Design: Two types of design will be applied, according to the specific aims. On the one hand it is a cross-sectional and a qualitative study, on the other hand it is quasi-experimental study. Pre-post intervention with a control group, as well as, of repeated measures in the intervention group

Eligibility Criteria:
Inclusion Criteria:

* general and nurse primary care practitioners working in Barcelona and Girona for the Health Catalan Institute.
* Managers involved in implementation process for the computerised clinical guideline in Barcelona from the Health Catalan Institute.
* patients with diagnoses of Heart Failure according to ICD-10 according to general practice clinical records.

Exclusion Criteria:

* Managers and general and nurse primary care practitioners working in Barcelona health Centres where there were any other quality improvement project related to Heart failure at the time of the intervention which we are evaluating. Managers from the control group (Girona).
* patients with a mental health disorder or terminal illness
A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines

The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

1. Participants (male or female) must be ≥18 years old, at the time of signing the informed consent.
2. At screening and baseline, participants must have moderate to severe glabellar lines at maximum frown (grade 2 or 3 on the relevant 4-point scale), as assessed by both the investigator and the participant.
3. Male or female (inclusive of all gender identities) participants are eligible to participate if they agree to practice adequate contraceptive methods during the study period and for at least 3 months after the study drug administration. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
4. Participant must provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
5. Participant must have the time and ability to complete the study and comply with instructions, at the discretion of the investigator.

Exclusion Criteria:

1. Known allergy or hypersensitivity to any components of the investigational product or any botulinum toxin serotype.
2. A history or presence of ptosis, significant facial asymmetry, excessive dermatochalasis at screening or baseline.
3. A history or presence of facial nerve palsy at screening or baseline.
4. A positive HIV, hepatitis B or hepatitis C test at screening.
5. History or presence of other concomitant diseases which are assessed by the investigator to be unsuitable for participation in this clinical research.
6. History of drug or alcohol abuse.
7. History or presence of epilepsy.
8. Have a serious mental disorder that, in the Investigator's opinion, may affect participant compliance with the study.
9. Female who is pregnant or breast feeding.
10. Abnormal laboratory tests that, in the Investigator's assessment, are not appropriate for participation in this study.
11. Participation in an investigational device or drug study within 30 days or 5 half-lives (whichever is longer) prior to screening.
12. Study center personnel, close relatives of the study center personnel, employees or close relatives of employees at the sponsor company.
Risk Assessment of Peritoneal Dialysis Failure Based on Catheter Tip Location.

The location of the catheter tip in radiographic planes 1 and 2, is a protection factor for the mechanical performance of peritoneal Dialysis. Instead radiographic planes 3 and 4 are risk factors.

Radiolucency of the peritoneal dialysis catheter, allow to classify the location of the tip into 4 radiographic planes. Plane 1: below the zone of a line on the head of the femur. Plane 2: is the area above the plane 1 and below a line connecting the two iliac spines. Plane 3: is the area that is above the plane 2 and below a line connecting the upper edge of the two iliac crests. Plane 4: is the area located above the plane 3.

Eligibility Criteria:
Inclusion Criteria:

* patients with functional class K-Digo 5d, initiating peritoneal dialysis program, with recent positioning of less than 2 weeks of dialysis catheter placement

Exclusion Criteria:

* patients with agenesis of pelvic bones that prevent divisions radiographic
Diet, Obesity and Genes (DiOGenes)

Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.

DiOGenes is a randomised controlled dietary intervention study in obese/overweight families (adults and children) in 8 different European countries, testing the efficacy and safety of diets differing in Glycaemic Index (GI) and protein content.

The 8 centres are divided into "shop centers" and "instruction centers", that provide different kind of dietary intervention and for a different length(see below):

The 2 Shop Centers (Denmark \& The Netherlands):

Dietary periods and clinical examinations:

1. Clinical examination 1 with anthropometry, blood etc.
2. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only)
3. Clinical examination 2 with anthropometry, blood etc.
4. 6 months dietary intervention period 1 (SUPERMARKET period)(Family)
5. Clinical examination 3 with anthropometry, blood etc.
6. 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family).
7. Clinical examination 4 with anthropometry, blood ect.
8. 12 months free-living period with no dietary intervention. (Family)
9. Follow up (only body weight registration)

The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic)

Dietary periods and clinical examinations:

1. Clinical examination 1 with anthropometry, blood etc.
2. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day). (Adults only)
3. Clinical examination 2 with anthropometry, blood etc.
4. 6 months dietary intervention period (DIETARY INSTRUCTION period). (Family)
5. Clinical examination 3 with anthropometry, blood etc.
6. 6 months free-living period with no dietary intervention. (Family)
7. Follow up (only body weight registration)

Note that, during the first 6 month intervention all families from the shop centers are provided all foods free of charge "SUPERMARKET PERIOD", whereas in the "Instruction Centers", the families receive dietary instruction only "Instruction Only".

Eligibility Criteria:
Inclusion Criteria:

* Families with healthy adults and children

Exclusion Criteria:

* Various
Esophagoscopy in Evaluating Treatment in Patients With Stage I-IV Head and Neck Cancer Who Are Undergoing Radiation Therapy and/or Chemotherapy

Brief Summary:

RATIONALE: Comparing results of diagnostic procedures, such as esophagoscopy, done before and after radiation therapy and/or chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying esophagoscopy in evaluating treatment in patients with stage I-IV head and neck cancer who are undergoing radiation therapy and/or chemotherapy.

OBJECTIVES:

I. To assess the prevalence of esophageal pathology (any esophageal abnormality, specifically: esophagitis, stricture/web, infections, neoplasms) as identified by esophagoscopy in patients with HNCA before and 3 months following primary radiation and/or chemotherapy.

II. To assess the changes in self-reported dysphagia symptoms as measured by the Eating Assessment Tool.

OUTLINE:

Patients undergo transnasal esophagoscopy at baseline and 3 months following completion of radiation therapy and/or chemotherapy.

Eligibility Criteria:
Inclusion

* Written informed consent must be obtained from all participants prior to beginning therapy; participants should have the ability to understand and be willing to sign a written informed consent document
* Primary diagnosis of head and neck carcinoma (oral, hypopharyngeal, laryngeal)
* Stage I-IV, undergoing treatment with radiation therapy +/- chemotherapy

Exclusion

* Medical history of esophageal dysfunction
* Pregnant women are not excluded from participation
One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty

This study investigates functional outcome and safety after one-stage versus two-stage revision of the infected knee arthroplasty.

Half of participants are treated with a one-stage surgical procedure, while the other half is treated with a two-stage procedure.

The investigators hypothesize that the functional outcome and quality of life of the participants is superior after one-stage surgery compared to two-stage surgery.

A two-stage approach is the standard surgical procedure in the treatment of the chronically infected knee arthroplasty, but promising results have been reported after a one-stage approach from single-centre studies.

The potential benefits for the patients treated with a one-stage approach are many as they only have to go through surgery and rehabilitation once with shorter total length of hospital stay. However, no randomized controlled trials comparing outcome after the procedures have been performed so far.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of periprosthetic knee infection
* \> 6 weeks from previous knee arthoplasty procedure (primary or total revision procedure)
* Speak and understand Danish and have given informed consent

Exclusion Criteria:

* Soft tissue problems requiring plastic surgery
* major bone loss requiring mega/tumor-prosthesis
* acute surgery due to sepsis
* malignant disease with less than 2 years life expectancy
* re-infection with previous two-stage procedure
* bilateral knee infection
Comparison of Robotic Versus Laparoscopic Surgery for Visceral Obesity in Mid-Low Rectal Cancer: A Propensity-Matched Analysis

Our team has previously published articles providing detailed descriptions of the steps involved in both RS and LS. All surgeries adhered to the total mesorectal excision (TME) principle. In RS, a surgeon employed the Da Vinci Xi surgical system featuring a five-port setup, while five physicians conducted LS with a similarly configured five-port approach. Both the RS and LS doctors are experienced. The surgeries were conducted according to standard procedures, and the RS group utilized totally robotic rectal resection.


Eligibility Criteria:
Inclusion Criteria:

(1) confirmed pathology of mid-to-low rectal cancer (within 10 centimeters from the anal margin); (2) availability of comprehensive pathological and computed tomography (CT) data; (3) presence of a diagnosis indicating visceral obesity.

Exclusion Criteria:

Multiple tumor
Investigation of the Value of ctDNA in Diagnosis, Treatment, and Surveillance of Surgically Resectable Colorectal Cancer

In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical specimens, and observation of patients undergoing radical resection of the tumor with or without adjuvant chemo- and/or radiotherapy.

A prospective, observational study to determine the value of circulating tumor DNA (ctDNA) for predicting the therapeutic effects of the combined modality treatment for colorectal cancer and the patients' long-term prognosis.

Research objects: patients with surgically resectable colorectal cancer. After giving fully informed consent, the prospective participants will undergo the classical combined modality treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, (post-NCRT for NCRT patients), postoperative week 1, post-ACT, postoperative year 1, 2, and 3. The next-generation sequencing of surgical specimens will be performed as well. Participants will be observed and examined during the entire course of treatment and the follow-up period. The 3 year disease free survival (3y-DFS) will be the primary end-point.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 75 years old.
2. Patients with surgically resectable colorectal cancer, while without distal metastasis of the disease.
3. Patients with ASA physical status scroe of I to III.
4. Patients who can fully understand the content of the informed consent form and sign it upon their own opinions.
5. Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups.

Exclusion Criteria:

1. Patient has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosis etc.).
2. Patient is pregnant or lactating.
3. Patient has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma.
4. Patient is participating in any other clinical trials within 30 days prior to screening.
5. Patient has severe mental illness.
6. Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.
Ureteral Stent Study

The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for urolithiasis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing ureteroscopy for urolithiasis in which temporary ureteral stenting is indicated

Exclusion Criteria:

* Patient is unwilling or unable to sign and date the informed consent
* Patient is unwilling to comply with the follow-up study schedule
* Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
* Patient is currently taking anti-cholinergic or other anti-spasm medications
* Patient is currently taking sildenafil, tadalafil, or vardenafil
* Patient has a known sensitivity to alpha-blocker medications
* Patient is currently undergoing chemotherapy or radiation therapy
* Patient has an active urinary tract infection
* Patient is in chronic renal failure, on hemodialysis, or on chronic peritoneal dialysis
* Patient requires bilateral shock wave lithotripsy, bilateral stents, or has bilateral symptomatic kidney stones
* Patient has had a ureteral stent within the past three months in either ureter
* Patient is unable to accurately detect or report bladder function or pain
* Patient has chronic pain
Clinician Communication About Sexual Health

The objective of this study is to adapt a previously tested brief intervention aimed at enhancing clinicians communication about sexual health (iSHARE) to a mobile web-based platform showcasing a two-part podcast and to assess the feasibility, acceptability, and preliminary effects of the intervention in breast cancer clinicians.

Specific aims are: 1) To assess the feasibility and acceptability of iSHARE in a mobile learning (mLearning) format and 2) To assess the preliminary effects of iSHARE in a mLearning format.

Eligibility Criteria:
Inclusion Criteria:

* Clinician is a medical oncologist or medical oncology advanced practice clinician (Nurse Practitioner, Physician Assistant) who treats breast cancer patients

Exclusion Criteria:

* Clinician has participated in previous pilot study of the intervention
Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event

Venous thromboembolic disease (VTE) is a common clinical entity whose two manifestations are deep vein thrombosis (DVT) and pulmonary embolism (PE). After an acute PE, almost half of the patients complain residual dyspnea, despite well-conducted curative anticoagulation. Some will present persistent defects on lung scan-scintigraphy, without pulmonary hypertension. This condition defines Chronic-Thrombo-Embolic Disease(CTED). The prevalence of CTED after PE is poorly known as are its risk factors.

The primary objective is to determine the prevalence of CTED at 3 or 6 months, depending on the provoked or unprovoked character, after a PE.

The secondary objectives are:

* To determine the potential risk factors for the occurrence of CTED.
* To look for an association between the persistence of DVT and the occurrence of CTED.
* To look for an association between the diagnosis of CTED and PE recurrence during the 12-month follow-up.
* To determine the diagnostic performance of the clinician alone compared to the lung scintigraphy (gold standard) for the diagnosis of CTED.
* To compare the impact on the quality of life (QoL) with or without CTED.
* To determine the correlation between impaired QoL and the degree of residual obstruction on lung scintigraphy.


Eligibility Criteria:
Inclusion Criteria:

* definite PE with expected life expectancy of more than 3 months - Age ≥ 18 years old.
* Patients with a first episode of symptomatic pulmonary embolism, diagnosed by CT angiography or pulmonary scintigraphy and treated in a conventional manner.
* Having received oral information about the study and having expressed a non-opposition to participate to the study
* Benefiting from a social security scheme

Exclusion Criteria:

* Patients with pulmonary hypertension.
* Patients who have already had a recurrence of pulmonary embolism or deep vein thrombosis of the lower limbs.
* Patients with a contraindication to performing a lung ventilation-perfusion scintigraphy.
* Patients at high risk of recurrence of venous thromboembolic disease (severe thrombophilia or active cancer).
* Classical contraindications to anticoagulants.
* Vulnerable patients: pregnant women, under guardianship or curatorship
* Premature termination of participation
* Recurrent pulmonary embolism diagnosed by CT angiography, or deep vein thrombosis diagnosed by venous Doppler ultrasound of the lower limbs within the first 3 or 6 months depending on the nature of the VTE.
* Occurence of pulmonary hypertension detected by trans-thoracic ultrasound (systolic pulmonary arterial pressure more than 35 mmgh).
A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome

Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations may develop. Several immunomodulating agents have been attempted in the treatment of pSS without achieving satisfactory results. Currently, there is no approved systemic treatment for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).

Each pSS patients (n=60) with Scores\>=6 on ESSDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety, clinical and immunologic response.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a primary Sjögren´s Syndrome
* ESSDAI score ≥ 6
* Liver values above 1,5 ULN
* Stable low dose systemic use of Glucocorticoids（\<=7.5mg） in the last 4 weeks before begin with Study medication

Exclusion Criteria:

* Secondary Sjögren's Syndrome
* Pre-treatment with Cyclosporine A
* Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimumab, other immunosuppressives
* Infection
* Neoplasia
* Relevant cardiac, pulmonary, neurologic or psychiatric disease
* Life-Vaccination within 4 weeks before begin with study medication
* Pregnant or breast-feeding
* Weight under 45kg or more than 80kg
Ultrasound-guided Neuromodulation Percutaneous

Chronic low back pain (LBP) is one of the most familiar musculoskeletal pains and alone has been the main origin of years lived with disability for the past three decades. LBP is identified as a nonspecific, painful or mechanical situation in the lower back, buttocks, or hips. Although an underlying origin in chronic LBP has been proposed to be due to a multitude of factors, a muscle hip disbalance has been recognized5. A limited hip internal rotation range of motion (IR-ROM) and hip abductor weakness were found in patients with LBP symptoms7

In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. However, authors hypothesize that neuromodulation (especially the US-guided PNM technique) may be used to obtain more therapeutic effects, including pain relief.

The main aim of this study was to investigate the effect of hip muscle strengthening by a simple single-shot procedure with the US-guided PNM technique in people with LBP. A second purpose was to discover if the stimulation point in the sciatic nerve territory may influence the change of strength in these patients Sixty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Lower Back Pain
* Having no other therapy

Exclusion Criteria:

* Other pathology (discal hernia, injured limbs, neurological pathology)
* Belenophobia