cyrilzakka/clinical-trials huggingface dataset:
The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib

This is an observational, non-interventional, single-country, multi center, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC) who had been treated with Afatinib at any line.

This is an observational, non-interventional, single-country, multicenter, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic EGFR mutation-positive NSCLC who had been treated with Afatinib s at any line.

The study is carried out by hospital-based oncologists/pneumonologists specializing in lung cancer under real-world conditions of daily clinical practice. Investigators were selected through a documented and structured feasibility process which accounted for physicians' qualifications, previous participation and experience in similar clinical studies, recruitment potential, and retention capability. In addition, in order to represent variations in current real-world patterns of care, research sites were recruited from various geographic regions in Greece, also taking into consideration the regional setting and type of healthcare site/institution (publicly/privately owned, specialized oncology/pulmonology clinic, university clinic).

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Patients diagnosed with Non-small cell lung cancer
* metastatic disease
* Afatinib treated in any line
* EGFR mutated

Exclusion Criteria:

-
Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection

The objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer.

The hypothesis is that the use of this medical device would reduce the postoperative pain and increase the efficacy of cough and expectoration. The evolution of the operated patient would be better.

The present study is the first evaluation of the efficacy of a selective chest wall restriction belt.

The efficacy will be estimate on forced expiratory volume in one second (FEV1) at D3 by comparing 2 groups: a control group of patients with conventional follow-up and an experimental group of patients with conventional follow-up and a daily wear of the selective chest wall restriction belt after surgery.

Eligibility Criteria:
Inclusion Criteria :

* Patients with segmentectomy or lobectomy for lung cancer or lung cancer suspicious,
* Surgical approach : video-assisted thoracic surgery (VATS) or thoracotomy,
* Patients affiliated to social security or similarly regime,
* Patients who gave their consent to participate in the study.

Exclusion Criteria :

* Patients with outcomes of the pulmonary function test at the preoperative assessment : forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) \> 45% predicted post-operative values and VO2max (maximal oxygen consumption) between 10 and 12 ml/kg/min,
* Patients with a waist size \> 120 cm
* Patients with medical treatment for chronic pain (neuropathic pain,...)
* Patients with tuberculosis or other pulmonary infectious pathology proven (aspergillosis, lung abscess, actinomycosis,...),
* Patients carrying a resistant germs or extended-spectrum beta-lactamase (ESBL),
* Paraplegic patients
* Patients with a diagnosed, progressive and/or uncontrolled neurological disease
* Patients with a progressive psychosis or a serious psychotic history (hospitalization)
* Patients who are in exclusion period of another interventional study
* Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
IL-26 and Systemic Lupus Erythematosus

Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy, underscoring the need to better dissection of the pathogenic mechanisms. Concordant with preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could be a marker of the disease activity and then a potential therapeutic target. In the present study, serum IL 26 level in lupus patients and control will be measured.


Eligibility Criteria:
Inclusion Criteria:

* diagnostic of Lupus according to ACR criteria ( four criteria are necessary)
* age \> 18 years old

Exclusion Criteria:

* treatment by cyclophosphamide, rituximab, belimumab in the year before inclusion study
Study of Etafill in Patients With Cataract Surgery Via the Anterior Chamber

This prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etafill in patients undergoing cataract surgery.

The performance is measured by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.


Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for cataract surgery via the anterior chamber
* A negative urine pregnancy test at Visit 1 or 2
* Capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent

Exclusion Criteria:

* Patients with a known hypersensitivity to HA or other components of the device.
* Patients with corneal scars or corneal dystrophies interfering with study measurements
* Abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator)
* Any other condition that in the opinion of the investigator would interfere with the participation in this investigation
* Any person dependent on the investigator or employees of the investigation site institution or the Sponsor.
* Current or previous (within 30 days of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study
* Patients whose participation in clinical trials is prohibited by the Austrian Medical Devices Act
The Influence of HDL Function on Cognitive Function

Older people with diabetes mellitus are at risk of cognitive decline and dementia. We therefore propose to examine the potential influence of HDL function on global cognitive function and brain structures in older people with DM.


Eligibility Criteria:
Inclusion Criteria:

Participants with DM

Exclusion Criteria:

Participants refuse blood taking
Stress and Tooth Structure Loss in Dental Students.

The study is designed as a pilot study. The primary objective of the current study is to collect data on the expression and progression of tooth structure loss in dental students under stressful conditions and different dietary habits using intraoral scanners (IOS). Stress levels will be evaluated using Percived Stress Scale (PSS-10). Eating habits will be queried using reflux and dietary questionnaires. The data obtained will later be used in the case-control design of a multicenter study on the same topic. Conducting the pilot study will allow for a critical evaluation of the study's design, participant retention rate, and recruitment process.

The first scan (baseline: T0) is performed during the Dental Prosthetics I course, at the beginning of the 8th semester. Follow-up scans T1 and T2 are performed at the beginning of the 10th semester and after completion of the state examination. The scans are performed by a study doctor or doctoral student using a digital intraoral scanner (Trios, 3 Shape, Denmark). Accompanying the scanning process, study participants will be asked to complete a questionnaire regarding stress levels (PSS) and dietary habits. A medical history and dental findings are also collected. Each scan will take no longer than 10 minutes. The entire examination will take no longer than 45 minutes. The T0 and T1, T2 scans will be overlaid with evaluation software and compared in terms of tooth wear.

Eligibility Criteria:
Inclusion Criteria:

* At the time of the baseline examination of the study the participants must be dental students and participate in the Dental Prosthetics Course I in the summer semester 2023, at the Dental School of Medical Faculty Carl Gustav Carus at the Technical University of Dresden
* Presence of study teeth (at least one antagonist pair of first molars (16/46 or 26/36).
* Complete dentition, if necessary, dentition with complete gap closure up to the first molar in the maxilla and mandible
* Presence of a canine guidence
* Written informed consent of the participating persons

Exclusion Criteria:

* Age \<18 and \>40
* Study teeth restored with dentures
* Extensive restorations over 1/3 of the occlusal surface on the study teeth
* Removable dentures
* Ongoing orthodontic treatment
* Existing pregnancy/lactation
* Addiction or other medical conditions that do not allow the subject to understand the nature and scope and possible consequences of the clinical study
* Indications that the participant is unlikely to comply with the protocol.
Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository

Hidradenitis suppurativa (HS) is a common and debilitating skin disease that is poorly understood and understudied. As a result, little is known about disease prognosis and few effective treatments exist for this condition. This prospective observational cohort study aims to comprehensively characterize the clinical and biological features of HS. The results of this research will provide a basis for the development of an HS clinical classification system and identification of potential treatments for HS.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 10 years of age
2. Diagnosis of HS by a dermatologist or practitioner experienced in making a diagnosis of HS
3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Inability to give informed consent or unavailability of a parent/guardian who is able and willing to give informed consent.
An Online, Compassion Intervention for Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM).

The goal of this research study is to evaluate a programme that is based on Compassionate Mind Training (CMT) over four-weeks. The programme intends to share information and strategies to reduce diabetes distress, self-criticism, and shame, and improve physical health in people who have Type 1 and Type 2 Diabetes Mellitus.

This Randomised Controlled Trial (RCT) will compare a CMT intervention for people with Type 1 and Type 2 Diabetes Mellitus with a waitlist control group who will be given access after the study.

The outcome measures will be completed at baseline (week 0), post-intervention (week 4), and at follow-up (week 8).

Eligibility Criteria:
Inclusion Criteria:

* Resident in the United Kingdom;
* Clinician diagnosed Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus;
* Self-managing condition;
* Diabetes diagnosed over a year ago.

Exclusion Criteria:

* Diagnosis of Gestational Diabetes or Pre-Diabetes.
* Current severe mental health condition;
* Currently self-harming or suicidal;
* Currently engaging in psychological therapy.
Multiple Noninvasive Examination Modality to Evaluate the Severity of Ocular Surface Disorders

Here the investigators proposed this study to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. The investigators especially focus on the possibility of using OCT to predict the condition of limbal epithelial stem cells, aiming to use this patient-friendly tool to detect the patient's limbal conditions.

In vivo confocal microscopy, anterior segment optical coherence tomography, keratograph and impression cytology are noninvasive, rapid and easily repeatable technique to investigate ocular surface disorders. In vivo confocal microscopy (IVCM) enables morphological and quantitative analysis of ocular surface microstructure. Optical coherence tomography (OCT) allows for imaging of the morphology of biological tissue with micrometer scale resolution at imaging depths of 1 to 2mm below the tissue surface. \[1,2\] Anterior segment OCT (ASOCT) has been developed to evaluate corneal diseases\[3-8\] in different layers. Keratography includes noninvasive meibography and tear interferometry. The former demonstrates the morphology of meibomian glands whereas the later observes quality and quantity of the lipid layer of the tear film. Impression cytology shows the morphology of the corneal and conjunctival epithelial cells, their staining behavior, and nuclear/cytoplasmic ratio could be observed in detail.

Here the investigators proposed this clinical trial to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. The investigators especially focus on the possibility of using ASOCT to predict the condition of limbal epithelial stem cells, aiming to use this patient-friendly tool to detect the patient's limbal conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patient who is able to understand and cooperate with the examination: aged over 5 years.
* Patient or the legal representative is able to read and sign an informed consent form.
* Patient with one of the diagnosis listed below:

  1. limbal insufficiency
  2. phlyctenulosis
  3. ocular rosacea
  4. ocular graft-versus-host disease (GVHD)
  5. dry eye syndrome (both aqueous deficiency or increased evaporative forms of dry eyes)
  6. other ocular surface diseases (advancing wave-like epitheliopathy, long term use of anti-glaucoma eye drops)

Exclusion Criteria

* Patients who decline to receive any of the non-invasive examinations mentions in this clinical trial.
* Patients younger than 5 years old.
Contribution of Lower Limb Venous Colour Doppler Ultrasound in the Diagnosis of Pulmonary Embolism Recurrence

Venous thromboembolic disease is a clinical entity including pulmonary embolism (PE) and deep vein thrombosis (DVT). It is a chronic disease with 30% recurrence rate at 10 years. In patients with recurrent PE clinical suspicion, an objective and accurate diagnostic method/strategy is warranted to exclude or confirm a PE new episode diagnosis and to decide on treatment initiation.

Recurrent PE diagnosis raises several issues related to the limitations of clinical scores, D-dimer testing, and diagnostic imaging used for a first episode diagnosis. Most importantly, residual obstruction on chest imaging reported in more than 50% of cases at 6 months can make it difficult to distinguish between an old and a new thrombosis in the absence of possible comparison with a previous imaging carried out under the same modalities.

There are currently few recommendations about the diagnostic strategy for patients with a recurrent PE clinical suspicion and these recommendations are not very consistent due to the lack of a validated strategy. None of current guidelines have included imaging-detectable lower-limb DVT within the strategies despite a reported high prevalence of PE-associated DVT. In one study using venography, 82% (95% CI 76.5 - 86.9) of angiographically-proven PE patients had an associated proximal or distal deep vein thrombosis, of which 42% were asymptomatic. In another study using lower-limb venous ultrasound, a proximal or distal DVT was detected in 93% (95% CI 85-97) of patients with PE.

In this study, patients with PE clinical suspicion and a previous PE episode have a standard diagnostic work-up based on clinical probability assessment, D-dimer testing and diagnostic imaging (pulmonary CT angiography, ventilation perfusion scan).

A bilateral lower-limb venous colour doppler ultrasound (CDUS) is performed in parallel in these patients as usually carried out in our hospital for the diagnosis management of patients with clinically suspected PE. This test is performed and interpreted by an independent sonographer unaware of the results of the standard diagnostic work-up.

Lower-limb venous CDUS is then compared to the results of the standard work-up as interpreted during expert panel meetings by members involved in the diagnosis and management of patients with PE and DVT.

Data will be collected both retrospectively and prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Adult consecutive patients (\>= 18 years old)
* Hospitalized for clinical suspicion of pulmonary embolism recurrence with at least one of the following symptoms: acute dyspnea or worsening of chronic dyspnea, chest pain, hemoptysis or syncope

Exclusion Criteria:

* Time between onset of symptoms and diagnosis \> 15 days
* Pregnant women
* Contra-indication to CT pulmonary angiography
* Lower-limb CDUS not possible to perform for technical reasons
* Lung scans not possible to perform for technical reasons
Brief CBT for Patients Undergoing TAVR

Adult patients scheduled to undergo TAVR were randomized to receive brief bedside cognitive behavioral therapy for depression/anxiety or treatment as usual.

Depression and anxiety are common symptoms in patients undergoing cardiac surgery and associated with increased cardiac morbidity and decreased functional status. Cognitive behavioral therapy (CBT) has been shown to be an effective intervention to treat these symptoms after cardiac surgery, but has not yet been studied in patients undergoing less invasive cardiac procedures such as Transcatheter Aortic Valve Replacement (TAVR). This study will examine the effect of CBT on symptoms of anxiety and depression in patients undergoing TAVR.

The CBT protocol was loosely structured on the Managing Depression and Anxiety using Education and Skills (MADES) protocol described in Dao and colleagues (2011). The current intervention was designed to address the needs of individuals who may develop anxiety or depression symptoms post-TAVR. The CBT intervention consisted of four 30 to 60-minute bedside treatment sessions with a trained clinician while the participant was hospitalized for TAVR.

Main outcome measures were self-reported symptoms of depression and anxiety as measured by the Beck Depression Inventory-II and State Trait Anxiety Inventory Form Y1. Secondary outcomes included health related quality of life and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 years of age and older
2. Voluntary participation
3. Informed consent obtained
4. Patients with severe aortic stenosis and high surgical risk who are undergoing TAVR

Exclusion Criteria:

1. Current psychiatric instability (eg., suicidality, schizophrenia, bipolar disorder, active alcoholism or substance abuse)
2. Severe cognitive impairment, i.e. dementia
3. Life threatening co-morbidities
4. Inability to provide consent
Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient

Infection after epidural catheter placement is fortunately rare. When it does happen, the affected person can become seriously ill.

This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the number of bacteria that can be grown from the skin washed with each disinfectant prior to placing an epidural catheter for pain control in labour.

The use of chlorhexidine for skin asepsis for the placement of intravascular catheters is known to decrease the incidence of central line colonization and blood stream infection when compared to the use of povidone-iodine. While the development of an infectious complication following spinal or epidural analgesia, such as epidural abscess or meningitis, is fortunately rare, when it does happen, there can be devastating consequences for the affected individual. The low frequency of infection makes a trial with an endpoint of clinical infection not feasible, however a reduction in skin and needle contamination following attempts at asepsis should reduce the risk of infectious complication. Ongoing work by the authors is examining the skin culture rates following randomized standardized skin disinfection. The purpose of this randomized trial is to compare needle culture rates to further assess effectiveness of skin disinfection following a standardized skin preparation with either povidone-iodine or chlorhexidine in pregnant women requesting lumbar epidural pain relief in labour.

Eligibility Criteria:
Inclusion Criteria:

* Parturients requesting lumbar labour epidural analgesia while investigator is assigned to the Obstetrical Anesthesia Service

Exclusion Criteria:

* Known allergy to either skin disinfectant
* Requirement to receive antibiotics prior to placement of lumbar epidural catheter
* Immunosuppression of the participant
Effects of Weekly Hippotherapy Frequency on Children With Cerebral Palsy

The hippotherapy is considered a therapeutic modality that provides numerous benefits in the rehabilitation process and has often been recommended by doctors for children with cerebral palsy. Despite being in frank ascent, this therapy still lacks scientific evidence. Objectives: To analyze and compare the effects of hippotherapy program, often 1 or 2 days a week in gross motor function, trunk balance and functional performance of children with cerebral palsy.

Study characterized by a controlled experiment with a sample of 24 children, aged between 2 and 4 years, were randomly divided into control group (CG), with 9 participants, with the use of 1 to week and experimental group, also with 11 participants, 2 times a week intervention. The call followed protocol and took place once or twice a week lasting 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Children from 2 to 6 years of age with diagnosis of Cerebral Palsy, besides medical, physiotherapeutic and psychological referral with indication of the practice of Hippotherapy
* Children classified with GMFCS levels 2, 3, 4 or 5
* Understanding, agreement and signing of the Free and Informed Consent Form
* Understanding, agreement and signing of the Free and Informed Assent Term, when applicable
* Possibility to participate in a riding program 1 or 2 times a week for a period of 16 weeks
* Conduct traditional physiotherapy concomitantly 1 or 2 times a week

Exclusion Criteria:

* Presence of associated syndromes or structural deformities that make Hippotherapy impossible
* Present seizures without medication control
* Does not have enough hip joint amplitude for riding (about 20 degrees of abduction)
* To have an invasive or surgical procedure during the study
* Have previously participated in an Equine Therapy program