cyrilzakka/clinical-trials huggingface dataset:
Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement

Retrospective data analysis of mortalities and the evaluation of the quality of care offered, using the Fishbone method.

Evaluation of mortalities seen between 01 January 2017 and 31 December 2018. Analysis of the mortality decision into preventable, non-preventable and potentially preventable categories. Identifying the associated risk factors and co-morbidities in a single centre study in Johannesburg. Further analysing was performed on the subset of preventable mortalities and further do the fishbone model of quality of care. RedCap data was utilized for all data points. A further comparison was done to the MNM classification based on the team and an independent senior surgeon.

Eligibility Criteria:
Inclusion Criteria: All mortality of patients seen in the Department who were 18yrs or older

-

Exclusion Criteria:

* incomplete data death in the Emergency department
Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

In neonates and infants \</= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.


Eligibility Criteria:
Inclusion Criteria:

* children \</= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

* presence of a known bleeding disorder or coagulopathy.
* age \> 6 months,
* lack of informed consent.
Health Education Provided to Primary School Students

This study was conducted in a primary school in turkey.It was aimed to examine the effects of health education given to children in primary school period.As a result, it has been seen that education can be effective.

Investigation of the Effects of Health Education Provided to Saraçoğlu Toki Mustafa Çetin Primary School Students on Health Screening Results The aim of this study is to find the effect of health education given to primary school students on health screening results.

The research is a pre-test and post-test quasi-experimental model with a single subject group. Saracoglu Toki Mustafa Cetin Primary School is that located in Turkey; It was held between September 2019 and March 2020. It was aimed to reach the entire universe, not choosing the sample. The pre-test screening was completed with 460 students and the post-test screening with 400 students. An Introductory Information Form and Screening Test Application Form were used to collect data. After the health education was given by the researchers using visual, auditory materials and drama technique, the results were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* All students who regularly attend school at Saraçoğlu TOKI Primary School and who had no communication problems and whose parents gave their research approval were included in the study.

Exclusion Criteria:

* Students who could not attend school were excluded from the study.
A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions

To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.

This is a large-scale single center case-control study. Patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results.Record the location and quantity of gastric xanthoma and situation of Helicobacter pylori infection in each patient.

Eligibility Criteria:
Inclusion Criteria:

1. Age range from 18 to 75 years old, regardless of gender;
2. Endoscopic/pathological diagnosis: chronic non atrophic gastritis/chronic atrophic gastritis/intestinal metaplasia/dysplasia Hyperplasia/gastric cancer
3. Voluntarily sign an informed consent form.

Exclusion Criteria:

1. Previously underwent upper gastrointestinal surgery
2. Previous diagnosis of malignant tumors
3. Individuals who are unable to cooperate with the questionnaire survey due to mental disorders or other reasons
4. Those who cannot be observed by endoscopy due to acute upper gastrointestinal bleeding or other reasons
Computational Fluid Dynamics Predicting Intraprosthetic Thrombus Formation and Progression Following EVAR

Intraprosthetic thrombus (IPT) formation and its progression to limb graft occlusion (LGO) are significant complications following endovascular aneurysm repair (EVAR). Morphological metrics based on preoperative CTA have limited predictive value for these complications. This study aims to assess the potential of computational fluid dynamics (CFD) in predicting IPT formation and its progression to LGO after EVAR.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 and above;
2. Patients undergone endovascular aneurysm repair;
3. Signed informed consent forms, willing to receive treatments.

Exclusion Criteria:

1. inflammatory aortic aneurysm;
2. patients diagnosed with connective tissue diseases;
3. patients diagnosed with atrial fibrillation;
4. patients lacking post-operative CTA;
5. Patients who are participating in other clinical projects;
6. Patients are not suitable to participate in this study.
Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer

It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and post-operative sensitivity. In comparison with the vertical preparation technique, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost

A healthy relationship between dental restorations and the periodontium is of prime importance for the clinical longevity and esthetic harmony of full coverage restorations . One of the Most Common complications, derived from fixed prostheses is gingival recession, which constitutes an important clinical concern. This problem is largely associated with iatrogenic effects produced during dental preparation or as a result of poor prosthetic fit which can cause chronic inflammation leading to gingival margin recession around the restoration .

Eligibility Criteria:
Inclusion Criteria:

1. The patients in this study will be in the range of 18-50 years
2. Have no active periodontal or pulpal diseases, have teeth with good restorations
3. Psychologically and physically able to withstand conventional dental procedures
4. Able to return for follow-up examinations and evaluation
5. No tooth mobility or grade 1 can be accepted
6. Patients with teeth problems indicated for single posterior crowns:

   1. Badly decayed teeth
   2. Teeth restored with large filling restorations
   3. Endodontically treated teeth
   4. Malformed teeth
   5. Malposed teeth (Tilted, over-erupted, rotated, etc.)
   6. Spacing between posterior teeth

Exclusion Criteria:

1. Patients under the age of 18 or being incapable of taking out a contract
2. Patient with active resistant periodontal diseases
3. Patients with any medical condition that impaired correct oral hygiene
4. a conspicuous medical or psychological history
5. bruxism, or known allergic reaction to the materials used.
6. pregnant female patients
Endosponge Vacuum Therapy (E-VAC) Registry of Intestinal Anastomotic Leaks and Perforations

The purpose of this registry is to collect data on the clinical use of endoluminal vacuum (E-Vac) therapy to treat both upper and lower intestinal leaks and perforations.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing E-Vac Therapy
* Age \> 17 years

Exclusion Criteria:

* 17 years of age or younger
* Undergone an E-Vac placement \> 14 days before consenting
A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System

A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)

This study is a multiple center, randomized, double-blind, vehicle-controlled, and multiple-dose study to assess skin irritation and skin sensitization in healthy subjects.

Subjects will be randomized prior to the first TDS application. The total duration of the study from Screening to Follow-up is approximately 95 days for subjects participating in the Induction Phase and the Challenge Phase of the study and potentially up to 156 days for subjects requiring to complete Re-Challenge Phase.

Skin irritation will be monitored by visual scoring scales. TDS adhesion will be assessed during TDS wear period. Safety will be monitored throughout the study by clinical and laboratory evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female
* Body mass index ≥ 18.0 and ≤ 35.0 kg/m2
* Medically healthy, as deemed by the Investigator
* Have a skin type with Fitzpatrick scale score of I, II, or III

Exclusion Criteria:

* History or presence of alcoholism or drug abuse
* History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds
* Positive urine drug or alcohol results
* Female subjects with a positive pregnancy test or who are lactating
* Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study:

  1. Inducers of cytochrome enzymes and/or P-glycoprotein
  2. Anti-inflammatory drugs or cyclooxygenase 2 analgesics
  3. Beta-blockers
  4. Cholinergics and anticholinergics
  5. Muscle relaxants, anti-Parkinsonian, or neuroleptic medications
* History or presence of significant skin damage deemed by the investigator to potentially interfere
* Any medical or surgical procedure or trauma
* Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment
Advanced Neuroimaging in Idiopathic Intracranial Hypertension

Idiopathic intracranial hypertension (IIH) is characterized by elevated intracranial pressure leading to symptoms like papilledema, headache, and cognitive dysfunction. While the etiology is complex, abnormal cerebrospinal fluid dynamics due to venous outflow restriction from transverse sinus stenosis (TSS) is common. TSS may disrupt the glymphatic system, a brain-wide network facilitating cerebrospinal fluid and interstitial fluid exchange, by impairing CSF absorption, altering perivascular space dynamics, and disrupting pressure gradients crucial for waste clearance. Venous sinus stenting (VSS) can improve symptoms in many patients by alleviating venous congestion, but its effects on glymphatic function are unclear. This prospective study aims to evaluate novel quantitative brain imaging metrics as surrogate markers to better understand IIH pathophysiology before and after VSS in patients with refractory IIH and TSS. The investigators will use advanced MRI techniques, including MR elastography (MRE) to assess brain stiffness, diffusion tensor imaging (DTI) to evaluate water diffusion, arterial spin labeling (ASL) imaging to measure blood-brain barrier (BBB) permeability, and functional MRI to analyze pain networks. The investigators hypothesize that 1) these noninvasive imaging metrics will correlate with the degree of venous congestion and changes after venous sinus stenting (VSS) and 2) the imaging findings will correlate with clinical treatment outcomes. By correlating imaging markers with venous pressures and symptom changes, the investigators aim to gain insights into IIH mechanisms, expand diagnostic tools, and potentially guide clinical decision-making and treatment response monitoring. The overarching goal is to better understand IIH's underlying pathophysiology, which could lead to improved diagnostic criteria, more targeted treatments, and better prediction of treatment outcomes for patients with this challenging condition.


Eligibility Criteria:
Inclusion Criteria:

• Refractory IIH patients who require and plan to have a venous sinus stenting

Exclusion Criteria:

* History of head trauma and shunting or leak repair
* Major concurrent, active non-cephalic pain syndrome
* Contradictions for MRIs
A Study of ARRY-334543 in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).


Eligibility Criteria:
Key Inclusion Criteria:

* Histological or cytological evidence of malignancy.
* Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
* Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
* Additional criteria exist.

Key Exclusion Criteria:

* Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
* Use of an investigational medication or device within 30 days prior to first dose of study drug.
* Major surgery within 30 days prior to first dose of study drug.
* Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
* Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
* Pregnancy or lactation.
* Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C.
* Additional criteria exist.
Clinical Characteristics of Importance to Outcome in Patients With Spondyloarthritis

The objective of the study is to investigate extra-articular manifestations, pain mechanisms, patient-reported outcomes, comorbidities and association between these conditions in patients with spondyloarthropathy (SpA) treated with Biologics. Further, to assess the predictive value of baseline pain profile on treatment outcome after ≥ 3 months.

Patients with spondyloarthropaty, who initiate or switch biologics in routine care due to an active disease state, will be enrolled in this observational study.

The overall aim is to investigate extra-articular manifestations, pain mechanisms and patient-reported outcomes and elucidate if these factors - independently or by interaction - influence treatment response after ≥ 3 months. Patients will have a baseline visit, an eye examination and a follow up visit after ≥ 3 months. Clinical examinations will be performed at both time points and include:

1. Clinical examination (the spinal movement)
2. Assessment of pain mechanisms by clinical evaluation (BASDAI, tender points,) and pain questionnaires (PainDETECT).
3. The SPARCC Enthesitis Index will be used to enthesitis count.
4. Interview and questionnaires regarding lifestyle, comorbidity, function and quality of life
5. Blood samples
6. Urine samples
7. Stool samples

Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of extra-articular manifestations, comorbidity and pain mechanisms will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with SpA
* ≥18 years of age at time of consent
* Ability and willingness to give written informed consent and to meet the requirements of this protocol
* Patients must have a history of active disease and a BASDAI \>40 (10-100) or elevated C-reactive protein, despite current or previous NSAIDs therapy

Exclusion Criteria:

* Age \< 18 years
* No consent
* Pregnancy
* Active or latent TB
* Diagnosed Human immunodeficiency virus
* Diagnosed hepatitis
* Current or past malignant disease
* Recurrent or chronic infection (viral, fungal or bacterial)
* Multiple sclerosis
* Heart failure (NYHA class III/IV)
Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care During Vertebroplasty and Kyphoplasty

This randomised, double-blind study compared remifentanil and dexmedetomidine for monitored anaesthesia care (MAC) during minimally invasive corrections of vertebral compression fracture (vertebroplasty (VP) and kyphoplasty (KP)).

In total, 80 ASA physical status I-III patients scheduled for VP and KP randomly received remifentanil or dexmedetomidine to maintain OAA/S scale ≤ 4 during the procedures. Multiple hemodynamic variables of patients were recorded and the frequency of oxygen desaturation, respiratory depression, intraoperative need for other opioids, recovery time, operator satisfaction score, and patients' overall pain experiences were also compared.

The investigators are expecting that both remifentanil and dexmedetomidine appear to be quite safe for MAC during VP and KP. Thus, dexmedetomidine may be an alternative for MAC during VP and KP in elderly patients.

All patients fasted for 8 h before the procedure and were premedicated with midazolam 0.02 mg/kg. In the prone position, patients were monitored by ECG, non-invasive blood pressure, and pulse oximetry, and received supplemental oxygen (3 L/min) via a nasal cannula during the procedure.

Study drugs were prepared in 20 mL and 50 mL syringes to maintain a double-blind design. One anaesthesiologist administered normal saline or dexmedetomidine contained in the 20-mL syringe during the initial 10 min for loading dose of dexmedetomidine. Then, another investigator who did not know which syringes contained remifentanil or dexmedetomidine adjusted the infusion rate with a 50-mL syringe according to patients' response. After all patients in both groups received a bolus dose of propofol 0.3 mg/kg, patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h, and patients receiving dexmedetomidine were given that drug at 0.3-0.4 µg/kg over 10 min, followed by continuous infusion of dexmedetomidine 0.2-1 µg/kg/h throughout the procedure. Levels of patient sedation were checked during the procedure and infusion rates of the study drugs were adjusted to maintain alertness/sedation below 4 on the OAA/S scale.

Mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO2), respiratory rate (RR), and adverse effects of the study drugs were recorded during the procedure. Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg. Duration of PACU stay was also recorded.

Operator satisfaction score and patient's overall pain experience were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled for vertebroplasty or kyphoplasty under monitored anesthesia care
* ASA status I-III
* aged more than 65 years old.

Exclusion Criteria:

* obesity (BMI \> 30 kg/m2)
* hypotension (systolic blood pressure \< 100 mmHg)
* bradycardia (heart rate \< 60 bpm)
* heart block
* baseline oxygen desaturation (SpO2 \< 90%)
* sleep apnea
* asthma, or chronic obstructive pulmonary disease
* those who refused to give informed consent
Preventing Perinatal Depression

The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD).

The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD). Pregnant participants will be surveyed at three time points: pre-intervention, post-intervention, and 6-weeks postpartum. Surveys will include self-report measures evaluating depressive symptoms, mindfulness skills, emotion regulation, and participant satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* gestational age at intervention onset between 12 and 30 weeks
* English fluency
* no previous experience in a mindfulness-based intervention group
* ability and willingness to participate in a telehealth intervention

Exclusion Criteria:

-
Influence of Oxidative Dysbalance on Secondary Osteoarthritis

The important role of mechanical joint stress for the insert and progress of osteoarthritis (OA) is supported by recent studies. The degeneration of joint cartilage is caused either by unphysiological load of a healthy joint or physiological load of a damaged joint. The exact mechanisms leading from increased weight bearing and overuse to cartilage degeneration are mostly unknown.

The hypothesis of the study is that parameters of oxidative stress in the joint synovial space reflect damages possibly leading to OA. These parameters correlate with parameters of oxidative stress in the peripheral blood. Aim of the study is the identification of such non- invasive obtainable biomarkers which represent the degenerative and regenerative changes in joint.

Patients with clinically manifest OA typically consult the physician at time of irreversible cartilage destruction. This is due to the long time clinically silent progress of the disease. A biomarker screening profile for joint damage is a valuable tool for the detection of over use and joint damaging conditions especially in competitive sports. This would provide a method for OA risk assessment for the patient before clinical symptoms occur. For this the first step is the identification of biological substances reflecting pathologic changes in the joint.

Since preterm chondrocyte senescence, apoptosis and ageing related changes are key factors in OA pathophysiology and each of these factors is closely related to oxidative dysbalance the measurement of these factors and correlation with the amount of joint damage is promising.

Eligibility Criteria:
Inclusion Criteria:

* Planned knee joint arthroscopy
* No history of trauma

Exclusion Criteria:

* Neoplasia
* Rheumatoid arthritis
* Intake of Steroids, cytostatic drugs,immunosuppression
* Pregnancy or lactation
* Addiction
* Participation in other clinical trials