cyrilzakka/clinical-trials huggingface dataset:
BIO|CONCEPT.ECG-Library (Collection of ECG Signals for Development of Algorithms)

Collection of Holter surface ECGs for the development of new sensing and detection algorithms

The aim of the study is to collect data from surface ECGs by using Holter ECG recordings from patients with different forms of diagnosed arrhythmias and/or specific ECG characteristics from heart diseases to support the development of new sensing and detection algorithms for implants.

Eligibility Criteria:
Inclusion Criteria:

* Patient is able to understand the nature of the study and willing to provide written informed consent.
* Patient is willing and able to attend Holter ECG procedure following a visit
* History of at least one of the following conditions (established via ECG prior to enrollment):

(A) Patient with pacemaker/ICD and

1. Ventricular stimulation \> 30 % or

   (B) Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and at least one of the following:
2. Frequent Ventricular Extrasystoles (VES) (incl. Bigeminus) or
3. Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) syndrome or
4. Atrioventricular Nodal Reentrant Tachycardia (AVNRT) or
5. Sinus Tachycardia at rest or
6. Atrial Flutter or
7. Any form of Ventricular Tachycardia (VT) or
8. Silent/Paroxysmal/persistent/permanent AF or
9. Brugada syndrome or
10. Long QT syndrome or
11. Right Bundle Branch Block (RBBB) or
12. Left Bundle Branch Block (LBBB) or
13. Myocardial Ischemia/Acute Myocardial Infarction or
14. Other abnormal QRS(T) complex, ST segment or T-wave morphology, i.e. any other QRS anomaly / ST segment elevation / ST segment Depression / T wave changes

Exclusion Criteria:

* Any condition which precludes the patient's ability to comply with the study requirements.
* Known allergy to patch electrodes.
* Pregnant or breast feeding.
* Less than 18 years old.
* Participation in another interventional clinical investigation
Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent form.
* Age \>= 18years.
* Moderate to severe chronic plaque psoriasis diagnosis.
* Participants who have participated in Tildrakizumab (Ilumetri®) clinical trials (Cohort 1) OR participants who, according to the physician's therapeutic decision, should start the treatment with Tildrakizumab (Ilumetri®) (Cohort 2).

Exclusion Criteria:

* Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
* Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®.
Evaluation Of The Effect Of Morphological Structure On Dilatational Tracheostomy Interference Location And Complications

In recent years, percutaneous dilatational tracheostomy has become a frequently performed procedure in intensive care units. However, tracheostomy procedure has risks of complications of varying severity, such as bleeding, subcutaneous emphysema, posterior tracheal wall damage, tracheal stenosis, infection, and fistula in the early and late periods. It is important to determine the anatomical position for tracheal puncture in reducing the risk of complications. It is not always possible to determine the optimal anatomical position for tracheal puncture in patients in the intensive care unit due to reasons such as obesity patient positioning difficulties and tracheal deviation. In this stuy, we have purpose to evaluate the effect of the morphological structure of patients on the dilatational tracheostomy interference location and complications in the percutaneous dilatational tracheostomy procedure (using anatomical landmarks) performed with the forceps dilatation technique, using fiberoptic bronchoscopy and ultrasonography.

A prospective observational study will be conducted in the Akdeniz University Hospital at the department of Anesthesiology and Intensive Care. Tracheostomy incision site will be determined by using anatomical landmark in all patients. Before the procedure, detailed anatomical measurements showing the morphological structure of the patient (neck thickness, thyromental distance, thyroid cartilage measurement, cricoid cartilage measurement, jugulomental distance, distance between clavicle and cricoid cartilage) will be recorded. In addition, measurements will be made and recorded by ultrasonography. In all patients, the percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy and the tracheal puncture level will be confirmed. Tracheostomy related complications will also be recorded.

Eligibility Criteria:
Example:

● Patients undergoing percutaneous dilatational tracheotomy

Inclusion Criteria:

● Clinical indication for tracheostomy

Exclusion Criteria:

* Age \<18
* Patients with severe coagulopathy
* Unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors)
Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Vaginal Delivery Episiotomy

To become "mother" is a beautiful gift given by God to woman. Giving birth is a powerful and life changing even with a lasting impact on women and their families. Pregnancy and labor are exceptional occasions in women's lives. Post-delivery is very decisive period for compassionate woman who had under gone episiotomy which is a throbbing and disquiet procedure during this time. Episiotomy wound healing takes weeks to years depending on health conditions and treatment of the perineum itself. Episiotomy care is very essential, if neglected it can lead to severe complications like infection, wound gapping.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous women
* Postnatal mothers delivered within 12-24hours.
* Have a normal vaginal delivery with episiotomy
* fand Second degree episiotomy.

Exclusion Criteria:

* Instrumental Delivery ( Forceps/ventous)
* Lower segment Cesarian section
* History of medical problem as hypertension and diabetes or anemia
* Perineal tear
* Infected wound
* Twin pregnancy
OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.


Eligibility Criteria:
Inclusion Criteria:

* Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
* An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.

Main Exclusion Criteria:

* Any previous treatment for neovascular AMD.
* Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
* Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

  * Additional inclusion/exclusion criteria apply.
A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines

This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.


Eligibility Criteria:
Inclusion Criteria:

* 15 or more headache days over a 30 day period
* A minimum of 7 treatment cycles with onabotulinumtoxinA

Exclusion Criteria:

* Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients

The scope of this multicenter, double blind, randomized, vehicle-controlled clinical investigation is to evaluate and confirm the performance and safety of the Relizema cream in the improvement of the dermatitis severity in paediatric patients. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 42 days of treatment.

This is a Pre Market Study to evaluate and confirm the performance of the RelizemaTM cream in the improvement of the dermatitis severity, assessed through a clinical parameter, the Investigator's Global Assessment (IGA) at baseline and at Visit 3, compared to vehicle.

To evaluate the performance of the RelizemaTM cream, compared to placebo in the eczema improvement through the EASI.

The safety objectives is to evaluate the local and general tolerability of Relizema cream compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Release of the written informed consent obtained prior to any study-related procedures, by both the parents/the guardian;
* Male and female infants, children, adolescent aged between 6 months and 16 years, inclusive;
* Presence of atopic dermatitis (AD) of mild-moderate severity:
* IGA score 2 (=mild) or
* IGA score 3 (=moderate)
* Patients with a baseline score for itch at least 4 on the NRS
* Patients/parents/guardian able to comprehend the full nature and the purpose of the investigation, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement

Exclusion Criteria:

* Severe dermatitis at inclusion;
* Pregnant and breastfeeding patients;
* Concomitant other skin disorders including skin infections;
* Use of antibiotics in the past 7 days;
* History of congenital or acquired immunodepression;
* Immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, any typology of lupus, rheumatoid arthritis) which could place the patient at risk or interfere with study results;
* Use of any topic or systemic drug for dermatitis in the past 10 days;
* Use of any topic emollient product for dermatitis in the 2 days before study treatment start;
* Any systemic treatment or procedure that could influence dermatitis activity within the past 30 days (or 5 half-lives);
* Use of any corticosteroids, immunosuppressant drugs or immunotherapy within the past 30 days (or 5 half-lives);
* Use of oral antihistamines and antidepressants in the past 30 days;
* Patients with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations;
* Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
* Concomitant or previous participation in other interventional clinical study in the past 3 months;
* Patients planning sun exposure or tanning booths or UV sources throughout the course of the study.
A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m\^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated CD20-positive DLBCL
* At least 1 bi-dimensionally measurable lesion (greater than \[\>\]1.5 centimeters \[cm\] in its largest dimension on the computed tomography \[CT\] scan)
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Adequate hematological function
* Low-intermediate, high-intermediate or high-risk International Prognostic Index (IPI) score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion greater than equal to (\>/=) 7.5 cm)
* Left ventricular ejection fraction (LVEF) \>/=50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or to any component of CHOP or obinutuzumab
* Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
* Participants with transformed lymphoma and participants with follicular lymphoma IIIB
* Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
* Prior treatment with cytotoxic drugs or rituximab for another condition (for example, rheumatoid arthritis) or prior use of an anti-CD20 antibody
* Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
* Corticosteroid use of \>30 milligrams per day (mg/day) of prednisone or equivalent, for purposes other than lymphoma symptom control
* Primary central nervous system (CNS) lymphoma and secondary CNS involvement by lymphoma, mantle-cell lymphoma (MCL), or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL
DC Vaccine in Colorectal Cancer

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m\^2 intravenously 3 to 4 days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with mutated peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. Information will be gathered from usual clinic visits for approximately 1 year following the End of Treatment Study Visit to evaluate for disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically-confirmed stage I and II hypermutated colorectal cancer (CRC)
* Surgically resected disease
* Male or female patients 18+ years of age
* ECOG performance status 0-1
* Certain laboratory values, performed within 14 days prior to consent
* Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
* Provide written informed consent

Exclusion Criteria:

* Prior malignancy within 3 years that may put subject at risk
* Pregnant or nursing women
* Concurrent treatment with systemic immunosuppressants including corticosteroids, calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local (inhaled or topical) steroids or replacement dose prednisone are permitted.
* Known allergy to eggs
* Any uncontrolled intercurrent illness or active ongoing infection thta may put subject at additional risk
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.

General Objectives -To identify the efficacy of the nutritional supplement Ocoxin-viusid to increase the quality of life of patients with epithelial advanced or metastatic ovarian cancer. Specific Objectives - Identify the influence of the research product on the nutritional status and quality of life of patients. - Describe the toxicity of the research product. - Identify the adverse reactions to the chemotherapy scheme and quantify the interruptions to it by acute toxicity.

Quality of life. It will be measured as: - EORTC Questionnaire QLQ-C30 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - EORTC Questionnaire QLQ-OV28 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at the beginning, in each cycle of QT and 3 weeks after the 3rd cycle of QT

Eligibility Criteria:
Inclusion Criteria:

1. Female patients 18 years of age or older.
2. Patients with diagnosis of ovarian epithelial cancer in stages III (not resectable) and IV.
3. Patients with general health status according to the Karnofsky Index ≥ 70 (Annex 12).
4. Life expectancy equal to or greater than 3 months.
5. Patients who give their informed consent in writing to participate in the study.
6. Normal functioning of organs and bone marrow defined by the following parameters: -Hemoglobin ≥ 90 g / L - Total Leukocyte count ≥ 3.0 x 109 / L Absolute Neutrophil Count = 1.5 x 109 / L -Platelet count ≥ 100 x 109 / L -Glycemia values ≤ 10 Umol / L -Values of Creatinine and total bilirubin within the normal limits of the institution. -Values of AST / ALT ≤2.5 times the upper limit of the normal interval established in the institution.
7. Patients with a history of cardiovascular disease, with ejection fraction ≥ 55%, measured by echocardiogram.

Exclusion Criteria:

1. Patients who are receiving another research product.
2. Patients with known hypersensitivity to QT with Carboplatin, Cisplatin and / or Paclitaxel.
3. Patients in stage III tributary of surgical treatment at diagnosis.
4. Patients with known hypersensitivity to any ingredient of the product research.
5. Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver diseases and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health or life at risk during your participation in the trial.
6. Pregnancy, breastfeeding or puerperium.
7. Patients with brain metastases and/or leptomeningeal carcinosis.
8. Patients' carrier of the human immunodeficiency virus (HIV).
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

The purpose of this study is to investigate the effect of thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation.

The primary goal is to register coagulation on basis of blood samples inclusive thromboelastography results.

The secondary goal is to register blood loss and use of blood products during operation.

The trial concerns 40 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years.
* Indication for elective surgery with removal of the urine bladder.
* Patient without anticoagulative, acethylsalisylsyre or NSAID medicine during the last 5 days,if using.

Exclusion Criteria:

* Cerebral haemorrhage
* Renal insufficiency demanding dialysis
* Manifest cardiac and hepatic insufficiency
* Disturbance in coagulation
* Hypernatriæmi
* Hyperchloræmi
* Pregnant or nursing
* Allergic to hydroxyethylstarch
* Participating in another trial-if interferring the present trial
* Incapable of managing his own affairs.
A Study to Evaluate JAK Inhibitor Cream in EGFR-inhibitor-induced Skin Rash

Epidermal growth factor receptor inhibitors (EGFRIs) are widely used targeted agents that have been approved for the treatment of various tumor types. In some clinical studies with EGFRIs, the incidence of dermatology AE, the skin rash, is reportedly as high as 95%, which profoundly impact the patients' quality of life. However no treament for onset skin rash has been approved to be effective by any clinical trial yet. Janus kinase (JAK) inhibitor, has been approved for or studied in a variety of skin conditions such as alopecia areata, atopic dermatitis, and psoriasis. Thus the investigators intend to evaluate the efficacy and safety of JAK inhibitor cream for the treatment of EGFRIs-induced skin rash in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Pathologically conﬁrmed cancer receiving EGFRI-based therapy (monotherapy or as part of a combination therapy regimen).
* Skin rash causally related to EGFRI therapy of grade 1 or higher (according to MESTT criteria).
* ECOG performance score \< 2.
* Able to use topical medications and complete questionnaires reliably with or without assistance.
* Life expectancy of greater than 6 months.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Use of any other topical medications in the treatment areas (face) within 7 days prior to randomization or duing the study.
* Use of Tetracycline (e.g. minocycline, doxycycline) within 14 days prior to randomization or duing the study.
* Use of other cancer medications known to result in skin rash in the face or upper chest/upper back area within 4 weeks prior to randomization or duing the study.
* Known hypersentitivity to JAK inhibitors.
* With other skin disorders that may affect efficacy evaluation, including but not limited to: eczema, psoriasis, etc.
* Uncontrolled intercurrent illness.
* Significantly abnormal lab test.
* Pregnant or nursing women.