cyrilzakka/clinical-trials huggingface dataset:
Photodynamic Therapy (PDT) for Lower Urinary Tract Symptoms (PLUS)

The purpose of this study is to determine if transurethral photodynamic therapy with lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged prostate.

Photodynamic therapy (known as "PDT") is a treatment that uses light to make a drug work. This means the drug is "light-activated". Light-activated drugs do not work until a certain color of light shines on the drug. When the drug and the light combine, they react together to destroy tissue.

This study is investigating PDT with lemuteporfin as a possible treatment for an enlarged prostate. PDT with lemuteporfin may destroy overgrown prostate tissue and help urinary symptoms go back to normal.

This is a multi-center, randomized, sham-controlled, double-blind, dose-finding study in parallel groups of subjects with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). All subjects will receive a fixed dose of lemuteporfin injected transurethrally into the prostate followed by transurethral application of either one of three active light doses or a sham light dose. Subjects will be followed for safety and efficacy for a minimum of three months to a maximum of 12 months. The primary study endpoint will be the change from baseline in AUA SI score at three months.

Eligibility Criteria:
Inclusion Criteria:

* Men 21 years of age and older.
* Subjects with LUTS due to BPH with AUA SI scores of 13 and over and Qmax between 5 and 15 mL/sec.
* Subjects with urethral treatment length of at least 25 mm.

Exclusion Criteria:

* Subjects who have had previous minimally invasive or surgical treatment for BPH.
* Subjects who have unsuitable prostate dimensions.
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)

This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.


Eligibility Criteria:
Key Inclusion Criteria:

* Age 21 to 75
* Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation.

  * Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period

Key Exclusion Criteria:

* Have poorly controlled high blood pressure
* Have type 1 diabetes or poorly controlled type 2 diabetes.
* History of cirrhosis or evidence of cirrhosis by clinical, imaging or liver biopsy evaluation
* Are planning to try to lose weight during the conduct of the study.
* Have a BMI \<25 kg/m2

Other inclusion and exclusion criteria may apply.
Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19

Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.

Study objectives: Primary objective: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy or discharge from hospital in hospitalized patients with COVID-19 and respiratory dysfunction.

Secondary objectives: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 0.9%) on 28-day mortality, days alive and without ventilator treatment, days alive and without high flow nasal oxygen treatment (Optiflow), length of stay in the ICU, days alive and outside hospital, relapse of hypoxia, days alive and without need for supplemental oxygen, adverse reactions.

Exploratory objectives: To compare the treatment effect of aerosolized DNase I to that of placebo (NaCl, 9%) on quantification of NETs in respiratory secretions and on the incidence of clinical thromboembolic events.

Study design: Phase 2 open-label randomized controlled multicentre trial. The study period is 28 days from randomization. A long term follow-up on mortality and readmission will also be collected via patient medical records/registries at day 90, day 180, and day 360 after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Admitted to hospital ward or ICU
* A positive PCR test for SARS-CoV-2 from throat swab or nasopharynx
* An oxygen saturation ≤90% after maximum 15 minutes without supplemental oxygen
* Signed informed consent

Exclusion Criteria:

* Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
* Known or suspected allergy against Pulmozyme
* Chronic obstructive pulmonary disease stage III-IV or another comparable chronic respiratory disease
* Participation in a clinical study with an investigational product during the last 30 days
* Previous participation in this study
* Pregnancy. Women of childbearing potential must agree to use contraceptives for the duration of the study period
* Any condition that, in the opinion of the Investigator, would place the patient at increased risk or preclude the patient's compliance with the study
Kidney Involvement in COVID-19 Disease (COVKID)

Novel coronavirus disease (COVID-19) is a newly discovered contagious disease caused by SARS-CoV-2 virus, primarily manifesting as an acute respiratory illness with pneumonia, but can affect multiple organs such as kidney, heart, digestive tract, blood and nervous system. In previous reports of SARS and MERS-CoV infections, acute kidney injury was described in 5 to 15% of patients and was associated with a high mortality rate (60-90%). Recent reports showed renal abnormalities in COVID-9 infected patients. A recent Chinese study also reported that acute kidney injury was an independent risk factor for mortality. However, the exact mechanism of kidney involvement remains unclear: sepsis-related cytokine storm or direct cellular injury from the virus. Also, kidney involvement has not yet been well characterized: heavy albuminuria, hematuria or interstitial nephropathy alone.

A recent study identified viral RNA in kidney tissue and another study succeeded isolating SARS-CoV-2 from the urine sample of an infected patient. These data suggest that the kidney might be a target of this novel coronarivus.

The sponsor suggests characterizing kidney involvement in SARS-CoV-2 infection.

Study objectives are:

* To give an accurate characterization of kidney involvement in COVID-19
* To investigate the physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection
* To identify risk factors for kidney involvement in in SARS-CoV-2 infection
* To evaluate the impact of kidney involvement in in SARS-CoV-2 infection
* To assess the long-term health effect of kidney injury on survivors of in SARS-CoV-2 infection


Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 disease
* Age \> 18 years-old

Exclusion Criteria:

* Age \< 18 years-old
* Pregnancy
* Patient with tutor- or curatorship or in prison
* Patients who had undergone renal replacement therapy (RRT) before admission
Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.

To assess the diagnostic accuracy of Shear Wave elastography (SWE) for the diagnosis of pancreatic adenocarcinoma.

Pancreatic adenocarcinoma (PA) is the most common tumor of the pancreas, representing more than 90% of all solid pancreatic neoplasia and 55% -73% of solid pancreatic masses.

Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory. Endoscopic ultrasound (EUS) is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors. Based on only endosonographic features, it remains difficult to differentiate PA from other solid masses, the specificity (Spe) and accuracy of EUS for the diagnosis of pancreatic tumor malignancy range from 53-69% and 72-83%, respectively. Over the last 15 years, endoscopic ultrasound fine needle aspiration (EUS-FNA) or more recently fine needle biopsy (EUS-FNB) has demonstrated its efficiency for tissue sampling and pathologic diagnosis of PA. Complementary techniques have been developed to increase the diagnostic performance of EUS. EUS-Elastography (EUS-E) is another EUS image enhancement technique, which rational based on the difference in elasticity between the tissues. There are two types of elastographies: strain elastography (SE) and shear wave elastography (SWE).

Several studies have demonstrated the utility of ultrasound SWE (US-SWE) for the differential diagnosis of lesions of the breast, thyroid, prostate and for detection of pancreatic fibrosis and chronic pancreatitis. However, to date, there is no data about the performance of EUS-SWE for the differential diagnosis of pancreatic solid lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient with a solid pancreatic mass of indeterminate origin

Exclusion Criteria:

* Patient with ASA score 4 or 5
* Patient with contraindication to SonoVue injection
* Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
Yoga for Family Caregivers of Alzheimers Disease Patient

This study evaluates the effects of the practice of yoga in combination with compassion meditation on the quality of life, attention, vitality and self-compassion of family caregivers of patients with Alzheimer's disease.

Alzheimer's disease is a progressive brain disorder that involves the loss of reasoning, memory, language and the ability to live independently. Thus, patients who suffer from this disease often require care from another person and must adapt to ensure their health, functional capacity and safety. Caregivers have a poor quality of life due to the physical and psychological burden of caregiving. Such physical, psychological, social and financial burden can increase the risk of death. Within this scenario, techniques such as yoga and meditation have emerged as low-cost interventions that offer little or no risk to the practitioners. Yoga seeks to develop health and attention through physical postures, breathing exercises and formal meditative practices.

Eligibility Criteria:
Inclusion Criteria:

* be a family caregiver of Alzheimer disease patient
* age over 18 years
* completed at least the primary education level
* at least at the phase of stress resistance according to Lipp's Inventory of Stress Symptoms for adults

Exclusion Criteria:

* patient with asthma or chronic obstructive pulmonary disease (COPD)
* alcohol use (more than 5 drinks per week) or use of drugs-of-abuse;
* suffer from Cushing's syndrome
* under treatment with topical, nasal or any form of steroids within the last 30 days
* practice yoga, meditation or similar techniques
Exercise Impact in Elderly with Multimorbidity: HbA1c and Blood Pressure

The main objective of the study is to compare the effect of two different types of physical exercise modalities on glycated hemoglobin and blood pressure in elderly individuals with multimorbidity. The main characteristic of the proposal is that it is experimental, with two intervention groups with physical exercise that will be randomized in the order of participation of the groups and forwarded to the researchers regarding the evaluations and training periods. In addition, the study will be controlled, as it has a control group that will not perform any intervention with physical exercises during the study period. To allocate the participants in each exercise group and for the control group, the researchers will use the 1:1 method, the user will receive an automatic generator through the random.org website.

The main questions raised by the studies will be: Is land-based training more effective than aquatic training for this population in improving the primary outcomes? Is there a difference between training at these intensities and not doing any physical exercise in this population with these primary outcomes?

Participants in the 2 intervention groups will:

Train 3x per week for 10 weeks at intensities that will progress over the weeks.


Eligibility Criteria:
Inclusion Criteria:

* Being elderly adult 60 years old
* Having grade 1 medicated hypertension (systolic blood pressure ≥ 140 and diastolic blood pressure ≥ 90) and having type 2 diabetes mellitus
* Volunteers may have other morbidities such as: anxiety/depression, knee osteoarthritis or obesity
* Be fit for the practice of physical activity

Exclusion Criteria:

* Being a smoker
* Have severe musculoskeletal problems that prevent you from carrying out physical activities
* Unable to carry out the protocol completely
Periodontal Regeneration Using Dental Pulp Stem Cells (DPSCs)

The goal of this study is to evaluate if dental pulp stem cells (DPSCs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration.

In this randomized controlled trial, 29 chronic periodontitis patients presenting one deep intrabony defect and requiring extraction of one vital tooth were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of minimally invasive surgical technique. The dental pulp of the extracted tooth was mechanically dissociated to obtain micro-grafts rich in autologous DPSCs. Test sites (n=15) were filled with micro-grafts seeded onto collagen sponge, whereas control sites (n=14) with collagen sponge alone. Clinical and radiographic parameters were recorded at baseline, 6 and 12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of advanced chronic periodontitis
* FMPS\<20%
* FMBS\<20%
* infrabony defect \>2mm
* Probing depth \>5mm
* presence of 1 vital and intact tooth requiring an extraction as autologous source of DPSCs

Exclusion Criteria:

* smoking
* controindicazion for periodontal surgery
* systemic diseases affecting periodontal healing
* pregnancy an lactation
* fixed orthodontic appliance
* history of periodontal surgery at the experimental teeth
* prostethic restorations at the experimental teeth
* furcation defects
Using Duke Activity Status Index (DASI) to Select Optimal Cardiac Stress Tests

Cardiac stress testing with functional nuclear imaging is an invaluable technique in the diagnostic and prognostic evaluation of patients with known or suspected ischemic heart disease. Selection of the appropriate type of nuclear stress test: exercise stress Myocardial Perfusion Imaging (MPI) versus pharmacologic stress MPI is crucial for not only diagnostic accuracy and prognostic evaluation, but also for sound clinical decisions and resource utilization.

The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be a valid measurement of functional capacity. The investigators hypothesized that the DASI may be the screening tool that evaluates functional capacity and guides selection of the optimal stress MPI study.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18

Exclusion Criteria:

* None
Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children

This study aims to compare the effectiveness of coconut oil pulling with clove oil, coconut oil pulling alone, and fluoride mouthwash in reducing Streptococcus mutans levels in children aged 6-12 years. Participants will be randomly assigned to one of three groups:

1. Coconut Oil Pulling with Clove Oil Group - Daily swishing with coconut oil mixed with clove oil.
2. Coconut Oil Pulling Group - Daily swishing with coconut oil alone.
3. Fluoride Mouthwash Group (Control) - Using fluoride mouthwash as per standard guidelines.

The primary outcome is the reduction in Streptococcus mutans count, assessed through microbiological analysis of saliva samples at baseline, immediately after intervention, and after 4 weeks. Secondary outcomes include patient acceptability, adherence, and gingival health.

This randomized controlled trial will provide insight into natural alternatives for oral health maintenance in children.

Study Location: Cairo University, Faculty of Dentistry. Estimated Study Duration: May 2025 - January 2026.

This study is a three-arm, randomized controlled trial assessing the impact of coconut oil pulling with clove oil compared to coconut oil alone and fluoride mouthwash on Streptococcus mutans reduction in children. Participants will be recruited from the Pediatric Dentistry Department at Cairo University and randomly assigned using a 1:1:1 allocation ratio.

Saliva samples will be collected at three time points (baseline, immediately after intervention, and 4 weeks post-intervention) for microbiological analysis. The study will also evaluate secondary outcomes such as patient compliance (measured using the MMAS-4 scale), acceptability (using a 5-point Likert scale), and gingival health (assessed with the Löe \& Silness Gingival Index).

The findings aim to determine whether natural oil-based methods can serve as effective, non-invasive alternatives to fluoride-based mouth rinses in pediatric populations.

Eligibility Criteria:
Inclusion Criteria:

* 1.Children aged 6-12 years old. 2.Both male and female participants. 3.Patients in good general health condition with no systemic disease. 4.Patients' first guardians must provide written informed consent to participate in the study

Exclusion Criteria:

* 1.Patients who have recently received fluoride treatments (within the last 2 weeks).

  2.Patients with a history of recent antibiotic administration (within the last 2 weeks).

  3.Patients who have recently used antimicrobial mouth rinses in the last 12 hours or topical fluoride treatments.
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

This study will examine the effects of varying liquid viscosity on swallow physiology in infants with oropharyngeal dysphagia and brief resolved unexplained event (BRUE) and other children with dysphagia that would be at risk for symptoms of swallow dysfunction.

Infants with oropharyngeal dysphagia and in particular brief resolved unexplained events (BRUE) are a significant driver of pediatric health care expenditure since the mechanism for their swallow dysfunction is incompletely understood and therefore frequently goes unrecognized and untreated. We hypothesize that infants with oropharyngeal dysphagia and BRUE have measurable differences in swallowing physiology to explain their symptoms of cyanotic choking spells, that these differences can be quantified using pharyngeal high resolution impedance-manometry compared to videofluoroscopic swallow study results, and that this swallowing dysfunction can be safely corrected with a change of formula viscosity. Through this research project, we will systematically investigate the effects of thickened feedings on swallow function in infants with dysphagia and BRUE and perform detailed physiology studies on pharyngeal and esophageal motility as critical mediators of improved outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 0 to 21 years
* Admitted to Boston Children's Hospital after experiencing first lifetime BRUE, or with dysphagia symptoms such that they would be at risk for BRUE or other symptoms of swallowing difficulty
* Have had videofluoroscopic swallow study performed or might have future videofluoroscopic swallow study performed.

Exclusion Criteria:

* Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease
* Any nasal/pharyngeal/esophageal anomalies that might affect safe placement of the pharyngeal motility catheter
* Children fed exclusively by enteral tube
* Allergy to rice cereal or Gelmix thickener, which will be used to adjust liquid viscosity
Multicentric, Open Label With Retrospective Inclusion and Follow-up of Acetabular Prothetic Implant "Polymax"

Total replacement of hip joint is one of the most important medical innovations of the twentieth century. More than 100,000 hip replacements are being laid each year in France.

Improved fixation, reduced wear rates and reduced implant dislocation rates remain subjects of continuous improvement.

Hip implants cemented and cementless are part of therapeutic arsenal of orthopedic surgeons for joint replacement of the defective hip.

The anchor and friction torque are both essential to the survival of hip implants. Therefore acetabular implants without cement with ceramic insert or polyethylene in a metalback or full polyethylene coated with titanium grains without metalback are proposed, but they have their own complications (Squeaking, fractures, recovery difficulties, difficult radiographic analysis, high cost for ceramics, primary stability defects, instability of the instrument set, Titanium residues in absence of metalback. An alternative to these implants may be an acetabular component without cement with polyethylene insert with an end metalback to increase both polyethylene thickness and size of the head in order to expect a low complication rate with important longevity for a lower cost.

This study was conducted to ensure the safety and effectiveness of the acetabular implant "POLYMAX"


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from hip disease: primary or secondary hip osteoarthritis or osteonecrosis.
* Patient having been implanted with a POLYMAX implant;
* Patient having agreed to participate in a follow-up 5 years;
* Patient who have accepted the use of their data in the context of this study.
* Patient having pre-operative and post-operative data

Exclusion Criteria:

* Pre or post-operative Partial data
* Patients not available for follow up at 2 and 5 years ..
* Metabolic disease or autoimmune witch may interfere with bone growth not allowing the indication of a prosthesis without cement,
* Mental disorder or disease of proven behavior.
* Severe osteoporosis,
* Direct or indirect bone irradiation
Atrial Fibrillation Screening With a Smartphone Device and iECG Application

Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a primary healthcare environment using a smartphone device and iECG application as an opportunistic screening tool?

Objectives:

Detection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an opportunistic screening program using a smartphone device/application

1. Define the predictable value of the smartphone device with electrocardiogram (ECG) confirmation to detect AF in patients 65 years and older
2. Correlate screened patients cardiovascular risk profile and those that register cardiac rhythm irregularities for a better description of the general characteristics of Colombian population


Eligibility Criteria:
Inclusion Criteria:

* Females and males patients ≥65 years old attending primary care counselling
* Written informed consent

Exclusion Criteria:

* Patients with confirmed diagnosis of AF
* Patients who do not want to participate
* Patients consulting for acute conditions
* Patients presenting any diagnosed arrhythmia different than AF