cyrilzakka/clinical-trials huggingface dataset:
A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports

The purpose of this study is to evaluate performance and safety of POLYSITE® and SEESITE® implantable ports allowing repeated and prolonged access to the venous system for the administration of chemotherapy, antibiotics, antiviral drugs, parenteral nutrition, and for blood transfusion or blood derivatives transfusion.


Eligibility Criteria:
Inclusion Criteria:

* Adult and paediatric population
* Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1-JAN-2018 and 31-DEC-2020

Exclusion Criteria:

* Patient who refused the data collection according to GDPR regulation applicable in France
* Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.
Risk Factors of Anxiety and Depression in Patients With Herpes Zoster Neuralgia

The goal of this observational study is to explore risk factors of anxiety and depression in patients with herpes zoster neuralgia, and the changes of certain serum biomarkers and functional brain magnetic resonance images of these patients.

Patients with herpes zoster neuralgia will be recruited and take Hospital anxiety depression rating scale (Hospital anxiety and 'scale, HADS) evaluation. According to the HADS Scores, patients will be divided into depression group and no depression, or anxiety group and no anxiety group. The clinical data the of two groups will be collected and statistically analyzed to explore the risk factors of anxiety and depression, including the changes of serum biomarkers and functional brain magnetic resonance imaging in patients with herpes zoster neuralgia accompanying anxiety or depression.

Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years old
2. Diagnosed as herpes zoster neuralgia
3. Signing informed consent

Exclusion Criteria:

1. Unable to complete the scale assessment
2. History of mental illness
Relationship Between Soft Tissue Volume and Gingival Phenotype: a Novel Classification System

Different classifications to describe alveolar ridge defects have been published over the past years but no single classification has been developed concerning soft tissue volume around teeth or dental implants. Moreover, while several studies investigated the effect of various augmentation techniques and materials on soft tissue volume change and volume stability there is a real gap of knowledge regarding how to evaluate the available soft tissue volume and when to consider it sufficient or deficient which would definitely improve clinical decision making and treatment planing. Therefore, our primary aim was to assess the application of a novel classification system based on the correlation between buccal soft tissue volume and gingival biotypes and, also to assess the sensitivity of such novel method.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients in a healthy systemic condition who required comprehensive dental treatment.
2. Both genders with age group \> 18 years old.
3. CBCT scans will be obtained as a part of the comprehensive dental treatment.
4. Patients should approve to deliver a signature to a written consent after study nature explanation.

Exclusion Criteria:

1. Patients with severe smoking habits \>10 cig \\ day.
2. Pregnant females, decisional impaired individuals, Prisoners and handicapped patients.
3. Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
4. Patients with fillings or crowns in the central incisors.
5. Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin),
Physiotherapy in Post COVID-19 Syndrome Patients

Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of a cognitive behavioral principles-based treatment program in fear avoidance beliefs, disability, pain catastrophizing and pain interference.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes.
* Agreed to participate.
* Post COVID-19 patients meeting the WHO definition for this disease.

Exclusion Criteria:

* Neurological or orthopaedic pathologies that limited voluntary movement.
* Cognitive impairment that prevented them from understanding and answering the questionnaires.
* Patients suffering from a reinfection with SARS-CoV-2.
* Patients who had been hospitalized due to COVID-19 infection.
* Patients who had pre-existing chronic pain according to the current IASP definition.
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study

Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.

* Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles.
* Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline.
* Evaluate skin effects and adverse event rate.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female between 21 and 75 years of age
* Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
* Understanding of the clinical investigation, agree to cooperate with the investigational procedures and willing to return for all the required follow-up visits
* Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment
* Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment
* Clinical diagnosis of stable, clinically typical Seborrheic Keratosis
* Minimum of two SK lesions
* SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point
* Undergo all study procedures including consent for global photographs of the SK study sites
* Agrees to refrain from using all other SK lesion removal products or treatments (topical medication including over-the-counter medications) during the study period

Exclusion Criteria:

* Implantable electronic devices (i.e., automatic defibrillator)
* Active infection or history of infection in designated test area within 90 days prior to first treatment
* Not willing or able to sign the Informed Consent
* Known to be immune-compromised
* Known to be keloid producer
* Taking blood thinning medications
* Insulin dependent, Type I diabetics
* Allergies to Lidocaine or Lidocaine-like products
* Employed by the sponsor, clinic site, or entity associated with the conduct of the study
* Family member of someone employed by the sponsor, clinic site, or entity associated with the conduct of the study
* Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
* Prior inability to complete required study visits during treatment period.
* Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study
Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones

This is a prospective randomized clinical trial which aims to compare the clinical outcomes of robotic flexible ureteroscopy and standard flexible ureteroscopy for the treatment of renal stones.

This is a prospective randomized controlled trial comparing robotic flexible ureteroscopy and standard flexible ureteroscopy for patients with treatment of renal stones. All consecutive patients who are scheduled for flexible ureteroscopy for treatment of renal stones would be screened for study eligibility. Patients are randomised to receive either robotic or standard flexible ureteroscopy with an allocation ratio of 1:1. by computer generated random block. The urologist performing the surgery could not be blinded due to the nature of the intervention. Patients receiving the treatment and investigators assessing for any disease recurrence are blinded from the allocated treatment arm.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old with informed consent
* Being willing and able to provide written informed consent

Exclusion Criteria:

* Patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture)
* American Society of Anesthesiologists (ASA) physical status classification system \>3
* Untreated urinary tract infection
* Renal stones \> 3cm in diameter
Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3

This study investigates the psychophysiological responses to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Participants were administered with either omega-3 or placebo for a period of 6 months and were exposed to three stimuli every three months: 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their omega-3/placebo condition clinical diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects between ages 7 and 16 years
2. Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
3. Subjects with willingness to participate in a randomized, double-blind controlled trial
4. Subjects with complete written, informed parental consent and child assent
5. Subjects with IQ of 70 or more

Exclusion Criteria:

1. Subjects who have IQ in the below 70
2. Subjects who are younger than 7 years old or older than 16 years old
3. Those without written parental consent
4. Those with brain pathology such as serious head injury, epilepsy, etc.
Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope

Recently, left paratracheal pressure was introduced as an alternative method to prevent pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen glottic visibility when using Pentax.However, the effects of left paratracheal pressure on glottic view when using Pentax are not studied yet. In this study, the subjects are divided into two groups (group I: left paratracheal pressure applied before intubation, group II: conventional cricoid pressure applied before intubation). Investigators will assess the glottic view during intubation using Pentax.

Primary outcome

- Duration of intubation

Secondary outcomes

* POGO (percentage of glottic opening) score before and after application of each intervention
* Glottic grade by Cormack Lehane
* The success rate in first attempt
* Intubation difficulty scale
* Hemodynamics during intubation
* Postoperative airway complications

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing surgery under general anesthesia
* American Society of Anesthesiologists Classification 1-2

Exclusion Criteria:

* Body mass index \> 35 kg/m2
* High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
* Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),
Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis

This study is designed to assess the effectiveness of nasal continuous positive airway pressure in reducing respiratory distress in children with bronchiolitis

In this study, after taking consent from caretakers, patients of brochiolitis will be randomly assigned to either a standard care group or a nasal continuous positive airway pressure group. Both groups will be followed for respiratory distress. Respiratory distress will be compared by using Seattle sore of respiratory distress.

Eligibility Criteria:
Inclusion Criteria:

* Children presenting with history of cough, and tachypnea and wheezing on clinical examination

Exclusion Criteria:

* Patients needing mechanical ventilation at the time of admission
* Patients whose caretakers refuse written informed consent
* Patients having consolidation on chest X-Ray
Beta Cell Function in Women With Turner Syndrome

Diabetes is more frequent in women with Turner syndrome. The purpose of this study is to see, in what ways the glucose metabolism is different in this study population. The hypothesis is that women with Turner Syndrome have an impaired insulin production (beta cell function).


Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome

Exclusion Criteria:

* Diagnosed diabetes
* BMI\>30
* Untreated cardiac or thyroid disease
* Cancer illness
Psychosocial Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus

The aim of the study is to research psychosocial and socioeconomic factors among families that might affect glycemic control in children and adolescent with type 1 diabetes mellitus. These factors might be: living conditions, structure of the family, socioeconomic status, divorces and parent's own glycemic control status (if parent's type 1 diabetes mellitus is present in the family).

This study is going to clarify if there are some socioeconomical or psychosocial factors that might influence child's type 1 diabetes mellitus glycemic control. Study population consists of 300-350 diabetic children aged 1-16 years who have diabetic controls at Tampere University Hospital and their families. Required information is going to be collected with 2 questionnaires, wich families are kindly asked to fill in.

Eligibility Criteria:
Inclusion Criteria: Type 1 diabetic children aged 1-16 years and their parents. Patient's and parents' willingness to participate

Exclusion Criteria: Type 1 diabetes duration under 1 year. Difficulties to understand written finnish.

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Autotaxin as Abiomarker in Systemic Lupus Erythematosus Patients

* Estimation of the serum ATX level in SLE patients in comparison to healthy subjects.
* Evaluation of the relation of serum ATX level with disease activity and different clinical manifestation in SLE patients

Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune inflammatory disease with unknown etiology . However, several genetic, immunological and environmental factors play a role in the etiopathogenesis of SLE . During the disease course, patients may be presented with diverse clinical manifestations (mucocutaneous, articular, neurological, or renal manifestations) . Anti-nuclear antibodies(ANA), anti- double stranded DNA (ds-DNA)and anti smith(SM) antibodies are common biomarkers of SLE. However the sensitivity and specificity of the current biomarkers are not ideal that the diagnosis of SLE can be missed .

Lysophospholipids are phospholipids with only one fatty acid chain, such as lysophosphatidic acid (LPA) and lysophosphatidylserine. Autotaxin (ATX), one of the enzymes that catalyze the formation of Lysophospholipid, is mainly responsible for the production of LPA in blood . Tumor necrosis factor (TNF), interleukin-6 (IL-6), and type I interferons, have been reported to induce the expression of ATX . ATX was reported recently as potential biomarkers of various diseases (serum ATX in malignancy and chronic hepatitis C, while in acute myocardial infarction ATX was overexpressed in cardiac tissue and in the synovium of rheumatoid arthritis patients) . Several studies have reported that serum ATX concentrations were higher in females than in males . The mRNA expression of ATX was found to be significantly induced by estrogen . There is growing evidence that ATX may play a role in the pathogenesis of SLE. Few recent studies have reported that serum ATX level can be a possible novel biomarker and key molecule in SLE .

Eligibility Criteria:
Inclusion Criteria:

* Patients who will be diagnosed as SLE according to the 2012 systemic lupus international collaborating clinics (SLICC) criteria .
* SLE Patients older than 18 years old.

Exclusion Criteria:

* SLE Patients younger than 18 years old.
* Patients with other rheumatic diseases or overlap syndromes.
* Patients with malignancy.
* Patients with chronic hepatitis C.
Collaborative Care Model on Type 2 Diabetic Patients

The purpose of this study is to determine the effectiveness of the collaborative care model in Singapore in which clinical pharmacists, nurses and dietitians are active participants who collaborate with physicians in caring for patients with Type 2 diabetes mellitus (DM).Since DM is a cardiovascular risk equivalent, co-morbidities such as hypertension (HTN) and dyslipidaemia (DLP) will also be evaluated to assess the holistic care provided for the investigator's patients afflicted with these top chronic diseases in Singapore.

Specifically, this study aims to evaluate the effectiveness of an integrated collaborative care model comprising of a healthcare team (physician, clinical pharmacist, nurse, and/or dietitian) compared to the usual or conventional healthcare model (physician-centered care) mainly in the clinical, humanistic and economic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 21 years with Type 2 DM (HbA1c \> 7%) and polypharmacy (≥ 5 medications) will be eligible for this study.

Exclusion Criteria:

* Patients with Type 1 DM or who are unable to communicate independently in English, Chinese or Malay will be excluded from this study.
Urine pH as a Predictor of Diabetes

Urine pH has been lately linked to insulin resistance. The early phase of Diabetes Mellitus involves insulin resistance. Thus, the investigators want to check if a simple cheap study like a urine analysis that can predict diabetes.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18

Exclusion Criteria:

* diabetes
* CKD
* urine infection
* UTO
* bladder dysfunction
CPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.

Video or No Video to decrease HCPOA/LAR anxiety and increase knowledge as it pertains to CPR.

Designated surrogate decision makers of 30 medical intensive care unit patients will be consented and enrolled to receive either a video describing CPR and it's outcomes after standard of care code discussions versus standard of care code discussions alone. All participants will complete a short questionnaire to determine their knowledge level regarding CPR and to assess their anxiety levels. Patients who view the video will also rate their comfort level while watching the video on a 5 point Likert scale.

Eligibility Criteria:
Surrogate decision maker or power of attorney identified within the first 48 hours of ICU admission.

Surrogates or power of attorney over the age of 18 y/o

Secondary Subjects:

* Admitted to the ICU
* Critically ill to the point of treating team discussing code status with LAR/POA/Family
The Spectralis-Cirrus Study

Retinal thickness measurement is one of the most important examinations in the follow up of exudative age-related macular degeneration. Prior studies have shown that there are a series of algorithm line failures in OCT examinations. This study is conducted to compare the quality of the examinations of to different spectral domain OCT machines concerning the positioning of algorithm lines. Furthermore the reproducibility of the examinations id tested, both machines provide different techniques to guarantee that in repeated examinations the same location is examined.


Eligibility Criteria:
Inclusion Criteria:

* Exudative age related macular degeneration

Exclusion Criteria:

* Macular pathologies other than age related macular degeneration (diabetic maculopathy, macular pucker, macular hole,
* Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
* Not consented patients
Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

The purpose of this study is to compare the live birth rates of high concentration of Hyaluronic Acid (0.5 mg/ml) transfer medium (EmbryoGlue®) to those containing low Hyaluronic Acid concentrations (0.125 mg/ml) (G2 medium) in women undergoing single fresh and frozen blastocyst transfer.

The single blastocyst-stage embryo transfer cycles will be randomised in a 1:1 allocation, with block sizes of 2 and 4 on the day of Embryo Transfer (ET). This randomisation process will be centrally managed via a web-based electronic data capture system and will be stratified according to the treatment center. The allocation sequence and the designated treatment will be completely concealed from the participating couples, clinicians - including those conducting the transfer procedures - and outcome assessors. Given the intrinsic viscous nature of EmbryoGlue, embryologists, who who are responsible for the procedures in the laboratory will not be subjected to blinding. Only at the end of the study, when data collection is completed, the allocation sequence will be revealed to the primary investigators.

Eligibility Criteria:
Inclusion Criteria:

1. All cycles with single blastocyst transfer will be considered eligible
2. Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes
3. No age restriction will be applied
4. Informed consent was signed

Exclusion Criteria:

1. Uterine anatomic anomalies
2. Women with untreated hydrosalpines
3. Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.
COVID-19 PCR Test Results in Asymptomatic Pregnants

In order to prevent contamination from the pregnant women hospitalized in this clinic, the RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before hospitalization. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant women who undergo intervention.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic pregnant women who will give birth in this clinic, dilatation and curettage due to missed abortion, cerclage due to cervical insufficiency, medical evacuation due to fetal anomaly, and routine PCR test taken for service for some treatments.

Exclusion Criteria:

* Having any COVID-19 infection symptoms (fever, cough, weakness, shortness of breath, sore throat, etc.)