cyrilzakka/clinical-trials huggingface dataset:
The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus

The purpose of this study is to determine whether physiotherapy is effective in the treatment of a group of tinnitus patients with neck complaints.


Eligibility Criteria:
Inclusion Criteria:

* severe chronic non-fluctuating subjective cervicogenic somatic tinnitus, which has been stable for at least three months, combined with neck complaints

Exclusion Criteria:

* objective tinnitus
* subjective tinnitus with etiologies, such as hearing loss or Meniere's disease, severe depression (\> 19 on the Beck depression questionnaire)
* progressive middle ear pathology
* intracranial pathology
* traumatic cervical spine injury
* tumors
* cervical spine surgery
* any cervical spine condition in which physical therapy treatment is contra- indicated
* received physical therapy treatment directed to the cervical spine in the past 2 months
Thriving, Activity and Social Participation After Stroke

The aim of the study is to evaluate the effect of a group intervention programme for community dwelling elders with stroke or TIA.The intervention is inspired by a Lifestyle Redesign method developed in the USA. The study is conducted as a multi centre randomized controlled trial. Participants are recruited from five hospitals and the intervention is implemented at six to seven senior centres. The control group is offered physical activity at the senior centre once a week. The intervention group is offered the same with addition of the programme inspired by Lifestyle Redesign. The study will contribute to knowledge whether the intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or TIA.

Stroke is a common disease among older people. In Norway 60-70 000 people live with sequela after stroke. Depressive symptoms, anxiety and social isolation are occurring among 20 to 60 percent. Little is known about intervention for people with mild neurological symptoms who simultaneously perceive social isolation, depression and reduced satisfaction in their daily life after stroke. Lifestyle redesign (LR) is developed in the USA and is a health promoting group intervention programme with focus on the participants' exchange of experiences and involvement. The aim of the study is to evaluate the effect on thriving, activity and social participation of a group intervention program inspired by Lifestyle redesign for community dwelling persons with stroke. The study is conducted as a multicentre randomized controlled trial. Participants are recruited from five hospitals and the intervention is carried through at six to seven senior centres. The control group is offered a physical activity programme at the senior centre once a week. The intervention group is offered the same with the additional intervention programme also once a week. The study will contribute to knowledge whether this group intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or TIA.

Eligibility Criteria:
Inclusion Criteria:

* oral and written consent
* age 65+
* clinical stroke ref WHO definition
* home-dwelling previous to stroke
* home-service less than twice a week previous to stroke
* Barthel ADL-index \>14 of 20
* MMS \>23 of 30
* be able to communicate evaluated by Ulleval aphasia screening test

Exclusion Criteria:

* reduced consent
* severe disease
* clinical contradictions evaluated by the responsible physician
PuO2 in RenalGuard Pilot Study

The PuO2 in RenalGuard (PURE) study is planned as a single center, randomized controlled pilot study comparing renal oxygenation during cardiac surgery with cardiopulmonary bypass (CPB) with or without balanced forced diuresis using the RenalGuard (RG) system.

Renal oxygenation will be assessed by urine oxygen tension, continuously measured by optodes placed through the urine catheter. Measurements will start after induction of anesthesia and continue for 24 hours.

In total, 30 patients will be randomized 1:1 to RG or standard of care (SOC) during cardiac surgery with CPB. In the RG group, the forced diuresis with neutral fluid balance will be maintained from before the start of surgery until 3 hours after weaning from CPB.

The primary endpoint is the group difference (RG vs SOC) in delta PuO2, defined as the change in mean PuO2 from baseline to the last 5-minute period at 45 minutes after start of CPB.

The secondary endpoints include

1. Group difference in mean PuO2 before, during and after CPB
2. Group difference in time weighted area under the curve for PuO2
3. Group differences in renal near infrared spectroscopy (NIRS) before, during and after CPB
4. Group difference in urine and blood biochemistry including renal biomarkers
5. Group difference in urine output and fluid balance during surgery and first postoperative day
6. Group differences in postoperative AKI according to the KDIGO criteria
7. Time (minutes) with puO2 ≤ 15 and ≤ 10 mmHg during and after CPB
8. Dynamics of PuO2 during the early postoperative phase

Patients ≥18 years scheduled for cardiac surgery with CPB with estimated glomerular filtration rate ≥50 ml/min are eligible for inclusion. Exclusion criteria include patients on higher doses of furosemide, patients with AKI or under renal replacement therapy.

Patients will be analyzed according to study group. In patients where hemofiltration has been used during CPB, control group patients who has received furosemide and patients in the RG group who do not reach target urine flow will be excluded from the main analysis but will be included in a separate analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age
* scheduled for cardiac surgery with normothermic CPB
* Estimated glomerular filtration rate ≥50 ml/min as assessed by the CKD-EPI formula

Exclusion Criteria:

* Patient receiving furosemide at a dose\>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week
* Patient who cannot be urethrally catheterized for any reason
* Patient already dialysis dependent
* Known or suspected AKI (KDIGO criteria) at the time of screening
* Any condition which, in the judgement of the investigator, might increase the risk to the patient
Clinical Comparative Evaluation of the Use of Photodynamic Therapy in Conjunction With the Use of Vitamin D in Management Stage II Grade B Periodontitis Patients

Clinical Comparative Evaluation of the use of Photodynamic Therapy in conjunction with the use of Vitamin D in management Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.

This randomized clinical trial evaluates the effect of Photodynamic therapy alone with SRP versus Photodynamic therapy with SRP and Vitamin D regarding Clinical evaluation

1. Clinical attachment loss (CAL)
2. Probing pocket depth (PPD)
3. Bleeding on probing (BOP)

Eligibility Criteria:
Inclusion Criteria:

* Systemic healthy patients
* Patients aged \> 25 years
* Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease.
* Patients with interdental clinical attachment loss (CAL) of 3-4 mm with radiographic evidence of bone loss extending to coronal third of the root.
* Radiographic bone loss (RBL) will be diagnosed using periapical parallel technique using 6 radiographic images for full mouth (3- radiographic images for maxillary arch and 3- radiographic images for mandibular arch) including anterior, canine region and posterior teeth at baseline for diagnosis.
* No history of previous periodontal therapy.
* No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
* No previous periodontal surgery at involved sites.
* Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
* Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
* Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders

Exclusion Criteria:

Patients taking Vitamin D as a nutritional supplement were excluded from the study

* Smoking habits
* Pregnant and lactating mothers
* Patients who have been received periodontal surgery in the study area during the last 6 months.
COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. This is particularly true for obese patients, who have a higher incidence of hypoxia. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18≤ Age ≤70.
* BMI ≥ 28 kg/m².
* The ASA classification ranges from I to II.
* Patients have signed the informed consent form.
* Patients undergoing gastroendoscopy and colonoscopy procedure.
* The estimated duration of the procedure does not exceed 45 minutes.

Exclusion Criteria:

* Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
* Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
* Profound renal insufficiency necessitating preoperative dialysis.
* A confirmed severe liver dysfunction.
* Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
* Elevated intracranial pressure.
* Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
* Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
* Pregnancy or lactation.
* Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
* Urgent surgical intervention.
* Polytrauma.
* Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
* BMI\<28 kg/m².
* Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
* Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
* Presently engaged in concurrent participation in additional clinical trials.
* Patients considered ineligible by researchers for inclusion in this clinical trial.
AYLo - AutoimmunitY and Loss of y

The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies.

Through the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation.

A further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data.

Additionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders.

By integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male
* \> 50 years
* Diagnosis of arthritis (RA, PsA), collagen diseases (SLE, systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis (eGPA, GPA, MPA, IgG4-related disease, GCA, PMR), sarcoidosis, COPD, ILD or asthma bronchiale confirmed by the treating physician.

Exclusion Criteria:

* Female
* \< 50 years

Inclusion Criteria (Healthy controls):

* Male
* \> 50 years

Exclusion Criteria (Healthy controls):

* Female
* \< 50 years
* autoimmune, rheumatological diease
* pulmonary precondition
SN514-066b Enzyme in Deep Partial Thickness Burns

This study will examine the tolerability of a gel formulation of the enzyme SN514 in patients with burns suitable for enzymatic debridement. In a rising dose fashion by sequential cohort, concentrations of 0.1%, 0.2%, 0.4% and 0.8% will be tested. Groups of 3 will undergo daily debridement for up to 7 days. Extent of debridement and adverse signs and symptoms will be recorded daily. Dose escalation will stop if a dose level is found to be intolerable. Dose escalation may accelerate if a tested dose is entirely ineffective. There is no placebo control as all burn wounds require debridement.

The design of the study is a sequential rising dose to the maximum tolerated dose, in which each subject will be exposed to only one concentration of the test article. Dose limiting toxicities are defined as "Severe" or CTCAE v5 Grade 3 or higher adverse events. This study in burn patients is designed to apply SN514-066b over 25 cm2 (0.14% TBSA for a 1.73 m2 adult) up to 500 cm2 (2.9%), at sequentially rising concentrations of 0.1%, 0.2%, 0.4% and 0.8% (\&lt; 1.0 mg/cm2). The highest exposure would be 0.8% (8 g per 100 cc of gel) over 2.9% of 1.73 m2 = 800 mg or 11.4 mg/kg applied topically (70 kg patient).

Eligibility Criteria:
Main Inclusion Criteria:

1. Thermal burns caused by fire/flame, scalds or contact
2. Total burns area available for treatment is 25 to 500 cm2 (a larger area may be burned, but the treatment area must be limited to the stated size, and the treatment area must be exclusive of face, hands, genitalia and sites deemed to be at high risk for developing compartment syndrome)
3. Target burns for treatment is deep partial thickness (DPT) in depth

Main Exclusion Criteria:

1. Subject has another life threatening traumatic injury
2. Patient's proposed study wound site has any of the following conditions:

   * Electrical or chemical etiology
   * Pre-enrollment escharotomy
   * Area is devoid of circulation
   * Located on the face, perineum or genitalia
   * Clinical evidence of wound infection
3. Poorly controlled diabetes mellitus (HbA1c \&gt;12%)
4. BMI greater than 40 kg/m2
5. Cardio-pulmonary disease (MI within 6 months prior to injury, severe or unstable ischemic heart disease, severe or unstable heart failure, severe pulmonary hypertension, severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma, or uncontrolled asthma)
6. Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins)
7. Any conditions that would preclude safe treatment or adding further risk to the basic acute burn trauma (such as severe immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, severe cardiovascular disorder, significant pulmonary disorder, significant liver disorder including post alcoholic abuse impaired function or neoplastic disease, blast injury)
ALLoreactive T-Cell receptOr RePertoire in kidnEy tranSplantation

In this study, the investigators will establish a workflow to generate unique patterns of the donor-reactive T cell repertoire using mixed lymphocyte reactions to select alloreactive T cell clones prior to transplantation Tissue infiltrating as well as blood bound T cells will be characterized based on:

1. Identification of donor-specific T cell receptor sequences pre- and post-transplant by in vitro expansion to determine unique patterns
2. Quantification and comparison of donor-specific T cell clones in kidney biopsy and blood samples.
3. Analysis of the TCR repertoire diversities derived from kidney biopsy and blood samples and association of repertoire diversities with the histomorphological phenotype of T cell mediated rejection.
4. Identification of T cell subtypes within the donor-reactive population. The investigators specifically hypothesize that highly expanded donor-reactive T cell clones in both kidney tissue and blood samples at time of indication biopsy are associated with the histological phenotype of acute T cell mediated rejection. The investigators have previously shown that there is a strong correlation between highly expanded tissue-resident T cell clones and the repertoire found in periphery blood samples. To trace and quantify donor reactive T cells the investigators will apply a truly quantitative approach for immune repertoire profiling based on high- throughput sequencing. The investigators ultimate goal is to develop a diagnostic tool to assess alloreactive cellular immunoresponses based on peripheral blood samples.

Kidney transplant recipients receiving a non lymphodepletional induction therapy at the investigators center will be included in this study.

Alloreactive T cells are defined prior to transplantation via a mixed lymphocyte reaction of donor and recipient PBMC's.

Following transplantation PBMC's will be sampled at management (3 and 12 months) and for-cause biopsies and fifteen patients with histological proven acute T cell mediated rejection will be compared to 15 patients without histopathological signs of alloimmune response in time matched for-cause biopsies.

T cell receptor beta chains of T cells found in the circulation and the allograft biopsy will be sequenced via Next generation sequencing.

Abundance of alloreactive T cells of the overall repertoire pre-and post-transplant and their presence in the allograft will be assessed.

The diversity of the overall repertoire and alloreactive repertoire will be compared between these two groups.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplantation in our center

Exclusion Criteria:

* Donor not evaluated by our center
Remote Monitoring of Respiratory Health

Recently, interest in ways to monitor and care for patients remotely has significantly increased due to concerns for infection control as well as a way to increase access to regular clinic visits that may be limited for socioeconomic and geographic reasons. However, remote care can be limited by a lack of objective data to help guide clinical care. With respect to respiratory disease, caring for patients remotely may be enhanced by the ability of patients to monitor at home such things as vital signs, lung sounds, and lung function by spirometry. Enhanced methods to follow symptoms and track medication compliance may also be beneficial. These enhancements could improve care and quality of life both for persons with acute respiratory illnesses and those with chronic respiratory disease (such as asthma or COPD).

The purpose of this study is to develop and study methods for patients to monitor their respiratory health at home and make that data available to medical providers to improve their care.


Eligibility Criteria:
Inclusion Criteria:

* age 1 month or older with a diagnosis of chronic respiratory disease (ex. asthma, COPD), an acute respiratory illness or a healthy volunteer
* able to consent or assent with parental consent

Exclusion Criteria:

* people who do not consent
* significant cognitive impairment
* non-English speaking
The Effect of a Case-finding App on the Detection Rate of Atrial Fibrillation in Primary Care Patients

Atrial fibrillation is a cardiac arrhythmia commonly encountered in a primary care setting. Current screening is limited to pulse palpation and ECG confirmation when an irregular pulse is found. Paroxysmal atrial fibrillation will, however, still be difficult to pick up. With the advent of smartphones, screening could be more cost-efficient by making use of simple applications, lowering the need for intensive screening to discover (paroxysmal) atrial fibrillation.

This cluster randomized trial will examine the effect of using a smartphone-based application such as FibriCheck® on the detection rate of atrial fibrillation in a Flemish general practice population. This study will be conducted in 22 primary care practices across the Flanders region of Belgium and will last 12 months. Patients above 65 years of age will be divided in control and intervention groups on the practice level. The control group will be subjected to standard opportunistic screening only, while the intervention group will be prescribed the FibriCheck® app on top of this opportunistic screening. The difference in detection rate between control and intervention groups will be calculated at the end of the study.

The investigators will use the online platform INTEGO for pseudonymized data collection and analysis, and risk calculation.

Smartphone applications might offer a way to cost-effectively screen for (paroxysmal) atrial fibrillation in a primary care setting. This could open the door for the update of future screening guidelines.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is 65 years or older.
2. The patient has an electronic medical record (EMR) in the practice. This EMR contains all the patient information, for instance regarding medical history and medication and is managed by the general practitioner.
3. If the patient will be prescribed the FibriCheck® app, he/she signs the relevant patient consent form

Exclusion Criteria:

1. The patient has already been diagnosed with AF.
2. The patient is already under anticoagulant therapy.
3. The patient has a pacemaker. Active pacing during measurements influences the results obtained with the FibriCheck® app (26).
4. The patient is unable to use the FibriCheck® application independently due to cognitive disorders, functional limitations, visual impairments...