cyrilzakka/clinical-trials huggingface dataset:
Navigation System for Percutaneous Tracheotomy

We have studied a new technique for percutaneous tracheotomy. The instrument gives a three dimensional positioning of the puncture. The technique is used on patients on ENT surgery and intensiv care.

Percutaneous tracheotomy is a well-established method. Anatomical landmarks need to be identified. We introduce a new method that increases precision through three-dimensional navigation with a new instrument - SafeTrach.

SafeTrach is a pliers-like instrument. The inner shank acts as a ventilation tube while stabilizing the orotracheal tube in the trachea. The outer shank acts as a three-dimensional control instrument for the puncture needle.

We determined the puncture level in 20 patients using SafeTrach. We found that the distance from the vocal cords to the puncture site was about 45 mm for men and 42 mm for women. This was based on intraoperative measurements. In 13 patients, we studied the distance between the vocal cords and the optimal puncture site between the 2nd and 3rd tracheal ring with CT and found that the mean distance for men was 49.8 mm and for women 42.2 mm. We have used internal measurements in another 12 patients as follows: The orotracheal tube is positioned so that the proximal part of the cuff is just below the vocal cords. 2. The position of the tube is measured against the front teeth. 3. The orotracheal tube together with the inner shank is pulled up about 15 mm for both men and women. This means that part of the cuff lies between the vocal cords and you get an acceptable placement of the puncture needle.

By using SafeTrach you can use internal landmarks to indicate the puncture level. The positioning of the leg is done with high precision because SafeTrach acts as a stable guide. The navigation system minimizes the risk of extubation and damage to the posterior tracheal wall.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \>18 years old
* Patients requiring PDT for prolonged mechanical ventilation, airway protection or weaning failure

Exclusion Criteria:

* Pediatric patients
* Emergency tracheotomies
* Anatomical abnormalities due to hematoma/tumor/scarring from previous neck surgery/thyromegaly/unstable C-spine and difficult local anatomy. (Patients with obesity are not considered to be a hindrance for the SafeTrach technique as the location for puncture easily can be decided with help of the outer and inner shanks).
* Contra indication for re-intubation (suspected loss of airway during re-intubation)
* Coagulation abnormalities - INR\>1.5, PTT \>40, thrombocyte count \<50.000
Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis

Minimally invasive non-surgical therapy (MINST) is a new approach towards regeneration of deep periodontal defects. Important part of MINST procedure, besides usage of magnification loupes and piezo-electric devices seems to be the usage of special mini-curettes, originally mini-five and after mini-five of Hu-Friedy. So far only descriptive data about the clinical effects of such procedure are available and comparative studies that would include other treatment alternatives are lacking. Therefore, the aim of our study is, on split-mouth model, to compare the number of diseased sites (defined by probing depth ˃ 4 mm and bleeding on probing) after conventional non-surgical therapy and MINST with the usage of special mini-curettes. In addition, new 3D parameters obtained from 3D optical scanning will be developed for evaluation of volume changes of soft tissues.


Eligibility Criteria:
Inclusion Criteria:

* periodontitis Stage III, grade B/C
* at least 20 teeth
* at least 9 teeth (excluding molars) in the upper jaw
* without FPD, implants
* without occlusal trauma signs
* no pathology of endodontic origin
* without chronic systemic diseases
* no periodontal treatment in the last 6 months

Exclusion Criteria:

* poor oral hygiene (PI \> 20% at evaluation)
* antibiotic treatment in the last 6 months or during the observation period
* pregnant women, lactation, serious chronic systemic diseases, medication with known influence on periodontium or wound healing
Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients

This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.

Lung transplant recipients are at high risk for lung rejection and lung infection after transplant. This is diagnosed by performing lung bronchoscopies and lung biopsies. These procedures carry an increased risk for complications and are costly. This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 yrs) who had undergone single/double/heart-lung transplant
* Asymptomatic
* Normal spirometry defined as a FEV1 without significant drop from baseline (significant drop = \>10% decrease from baseline)
* Clear chest radiograph over allograft

Exclusion Criteria:

* Patients who are unable to consent for the procedure
* Patients with subcutaneous emphysema or other technical challenges that could interfere with satisfactory image acquisition- as deemed by the operator.
Community Reinforcement and Family Training (CRAFT) for Treatment-resistant Individuals With Alcohol Use Disorders

The present study examines the efficacy of the Community Reinforcement and Family Training (CRAFT) for Concerned Significant Others (CSOs) of individuals with alcohol use disorders (AUDs) using a randomized waiting list (WL) control group. It is hypothesized that after the Intervention group has received CRAFT and prior to the WL- group having received CRAFT, treatment utilization of individuals with AUDs are substantially elevated in the Intervention group.

CRAFT is an evidence-based intervention aiming to promote treatment entry by treatment refusing individuals suffering from addiction by coaching their Concerned Significant others (e.g., family members). The intervention is based on diverse elements such as communication training, contingency management, functional analysis of problem behaviors and strategies to improve the live of CSOs and aims to rearrange contingencies in the natural environment of the drinkers so that clean behavior is reinforced and drinking behavior is effectively discouraged. The intervention was developed for adult CSOs and usually consists of up to 12 weekly face-to-face sessions with a duration of one hour each.

Eligibility Criteria:
Inclusion Criteria:

* CSOs of individuals with an AUD according to the Diagnostic and Statistical Manual (DSM-IV) or the International Classification of Diseases (ICD-10)
* At least 18 years old
* At least 15 hours of contact per week to the addicted individual

Exclusion Criteria:

* History of severe domestic violence
* Current diagnosis of drug- or alcohol dependence of CSO
Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol

Exclusion Criteria:

* Patients can not complete the research; Abnormal hepatic and renal function; Patient is allergic to propafenone; There are conditions that researchers do not consider it appropriate to join the research.
Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes

The main purpose of this study is to evaluate the risk of postoperative mortality and complications in surgical populations with preoperative renal insufficiency.

This retrospective cohort study use the National Surgical Quality Improvement Program (NSQIP) database to evaluate the risk of postoperative morbidity and mortality in the surgical population. Patients with estimated. glomerular filtration rate(GFR) \< 60 ml/min per 1.73 square meter are defined as the renal insufficiency group. Patients with estimated GFR \> 90 ml/min per 1.73 square meter are defined as patients without renal insufficiency. Propensity score-matching methods and multivariate logistic regression are used to calculate the risk of postoperative morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with estimated GFR \< 60 ml/min per 1.73 square meter or currently on dialysis are included in renal insufficiency group.
* Patients with estimated GFR \> 90 ml/min per 1.73 square meter are included in non-renal insufficiency group

Exclusion Criteria:

* Patients population with estimated GFR between 60-90 is not included in the study
Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in non small cell lung cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.


Eligibility Criteria:
Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for non-small cell lung cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection
Sodium Nitrate to Improve Blood Flow

Investigators recently showed that tadalafil restores functional sympatholysis in patients with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also be restored by sodium nitrite- which is an indirect nitric oxide donor.


Eligibility Criteria:
Inclusion Criteria:

* Becker muscular dystrophy
* age 15-55 years of age
* ambulatory

Exclusion Criteria:

* hypertension, diabetes, or heart failure by standard clinical criteria
* elevated brain natriuretic peptide level (\>100 pg/ml)
* Left ventricular ejection fraction \< 50%
* cardiac rhythm disorder, specifically: rhythm other than sinus, supraventricular tachycardia, atrial fibrillation, ventricular tachycardia, heart block
* continuous ventilatory support
* liver disease
* renal impairment
* history of asthma or bronchospasm
* use of any medications other than common supplements
* unable to perform handgrip exercise
The Effect of Brachial Plexus Block on Diaphragm Movement

The purpose of this study is to quickly evaluate the degree of phrenic nerve block by observing the changes of diaphragm movement through ultrasound, and to find the best scheme for clinical application by controlling the concentration of narcotic drugs, so as to reduce respiratory related complications.

40 ASA grade I - II patients were selected from the patients who underwent shoulder ligament rupture repair surgery under selective general anesthesia combined with brachial plexus block analgesia in the sports medical center of our hospital. They were randomly divided into two groups: high concentration group (group I) and low concentration group (Group II), with 20 cases in each group. 40 patients underwent a single brachial plexus block under ultrasound guidance before general anesthesia. In group I, ropivacaine 100mg + normal saline to 20ml (0.5% ropivacaine 20ml), and in group II, ropivacaine 40mg + normal saline to 20ml (0.2% ropivacaine 20ml). The high-frequency ultrasonic probe was located in the intermuscular sulcus, clearly exposing the three trunks of the brachial plexus. Using out of plane technology, the drug solution was injected around the brachial plexus, Ultrasonic images showed that the drug solution evenly wrapped the nerve trunks. The diaphragmatic movement of patients was scanned and recorded before and 30 minutes after block. The dispensing nurse, the operator and the follow-up doctor are independent individuals, and the operator and the follow-up doctor do not know the patient grouping. After confirming the effect of nerve block, the operating doctor will carry out general anesthesia and start the operation. The patients were followed up 6 hours after operation, and NRS scores were made and recorded.

Eligibility Criteria:
Inclusion Criteria:

* operation type: patients undergoing shoulder ligament rupture repair under selective general anesthesia combined with nerve block analgesia
* age: 18 \~ 65
* ASA class I or II

Exclusion Criteria:

* patient rejection
* brachial plexus injury
* severe cardiovascular disease
* allergic to the drugs used in the test
* infection at the puncture site
* difficulty in understanding (unable to understand the pain assessment method)
* recent history of opioid use
The ACC Preclinical Research Platform for Precision Oncology

The ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.

This is a retrospective and prospective observational study, focused on the implementation and validation of the application of PDCM, generated from tissue or cells of patients, including paediatric patients, with solid and haematological malignancies, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.

An up-to-date database of all PDCMs available at the participating italian hospitals will be generated and enriched with new models generated during the course of the project. The sharing of models and procedures between the different hospitals will facilitate their molecular and phenotypic characterisation, also in parallel with the tumours of origin, as well as their validation as tools for testing the efficacy of drugs for precision medicine. By establishing common workflows and standards and performing cross-validation experiments it is planned to build a network of reference centres as a resource for drug screening on 2D and 3D models.

Eligibility Criteria:
Inclusion Criteria:

* Patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available.

Exclusion Criteria:

* none
Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study

The goal of this observational study is to explore the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery. The main questions it aims to answer are: 1. If intracorporeal anastomosis is safe in terms of short-term outcome? 2. If intracorporeal anastomosis can achieve the same oncological outcome as conventional extracorporeal anastomosis?

This study is a retrospective real-world research initiated by the Chinese Academy of Medical Sciences Cancer Hospital, including Cancer Hospital of the Chinese Academy of Medical Sciences, Shenzhen Hospital and Peking University First Hospital. The study aims to retrospectively analyze the clinical data of approximately 2,000 patients who underwent laparoscopic surgery with preoperative imaging staging of cT1-4aNanyM0 and pathological diagnosis of adenocarcinoma or high-grade intraepithelial neoplasia from April 2016 to April 2020. The patients will be divided into the intracorporeal anastomosis group (IA) and extracorporeal anastomosis group (EA) based on the surgical records. The primary endpoints of the study are 3-year disease-free survival (DFS) and 3-year overall survival (OS). The secondary endpoints include overall complication rate within 30 days, postoperative pain score, time to first flatus after surgery, time to first bowel movement after surgery, time to first oral intake after surgery, length of hospital stay, and postoperative quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily enrolled in this study and signed an informed consent form;
2. Age: 18-75 years;
3. Completion of colonoscopy and biopsy, with pathological confirmation of adenocarcinoma or high-grade intraepithelial neoplasia;
4. Preoperative enhanced CT or MRI examination showing no evidence of distant metastasis;
5. Preoperative staging as cT1-3NanyM0;
6. Underwent laparoscopic surgery.

Exclusion Criteria:

1. Contraindications to laparoscopic surgery;
2. Cases requiring emergency surgery due to acute bowel obstruction, perforation, or bleeding;
3. Patients with distant metastasis;
4. Patients with multiple primary colorectal cancers;
5. Patients with a history of malignancy;
6. Patients unwilling to sign the informed consent or unwilling to follow the study protocol for follow-up.
Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma

The aim of the study is to evaluate the use of irreversible electroporation in the treatment of locally advanced cancers of the head of pancreas with vascular spread. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven adenocarcinoma of the head of the pancreas (fine needle aspiration or biopsy)
* Pancreatic adenocarcinoma locally advanced on imaging at diagnosis
* Tumor of less than 7 cm in largest diameter
* No chemotherapy or abdominal radiotherapy within five years before the inclusion in the study

Exclusion Criteria:

* Pancreatic adenocarcinoma of more than 7 cm of diameter or immediately operable on imaging data
* Patient with contraindication of NanoKnife use
* Patient with neurostimulator
* Epileptic patient or with a myocardial infarction lasting less than 2 months
* Presence of visceral or lymph node metastases or peritoneal carcinosis at the initial workup
* Patient who cannot be treated with muscle blockers (curare)
* Patient with a metallic stent or a medical device implanted near the area treated by electroporation
Chasing Biomarkers in Post-concussion Syndrome

The goal of this study was to investigate the biomarkers, neurofilament light chain, inflammatory markers, calcitonin-gene-related peptide, and metabolites from the kynurenine pathway in patients with severe post-concussive symptoms. The main question it aimed to answer was:

* Are the biomarker concentrations significantly changed in patients with severe post-concussive symptoms compared to healthy individuals?
* Do the biomarker concentrations change at follow-up?

Participants were recruited from a recently published randomized controlled trial (Clinicaltrials.gov no. NCT02337101 / PMID: 31891145 ). The biomarker concentrations were compared to a healthy control group recruited from the Blood Bank at Aarhus University Hospital in 2022.

In the previously published RCT-study (PMID: 31891145), 86 participants with severe post-concussive symptoms provided blood samples at baseline (4 months after the concussion). Severe post-concussive symptoms were defined as having a Rivermead Post Concussion Questionnaire \>20.

Around 7 months later, a follow-up blood sample was obtained from 54 participants.

These blood samples were used to investigate blood biomarkers for the condition.

Eligibility Criteria:
Patients with severe post-concussive symptoms:

Inclusion Criteria:

1. Concussion caused by a head trauma based on the diagnostic criteria recommended by the World Health Organization (WHO) Task Force
2. Age between 18 and 30 years
3. Able to understand, speak and read Danish.
4. A score of 20 or more on the Rivermead Post Concussion Symptoms Questionnaire (RPQ).

Exclusion Criteria:

1. Objective neurological findings indicating neurological disease or brain damage.
2. Previous concussion leading to persistent post-concussional symptoms within the last two years.
3. Severe misuse of alcohol, prescription drugs and / or illegal drugs.
4. Severe psychiatric, neurological,or other medical disease that would impede participation in the intervention
5. Inability to speak and read Danish

Healthy control group (recruited from December 2021 - March 2022):

- Individuals from the Blood Bank at Aarhus University Hospital in Denmark.

Inclusion criteria were:

1. Age between 18-30 years
2. Equal distribution between the genders (60 men and 60 women). This number was based on a power analysis using published data from neurofilament light chain.
Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the reduction of moderate to severe nasolabial folds.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe, bilateral nasolabial folds
* Must understand and provide informed consent

Exclusion Criteria:

* Pregnant or lactating women
* History of skin hypersensitivity of atopic dermatitis
* Any illness of disease that, in the investigator's opinion, would make trial participation inadvisable
MRI and Computational Simulation Cardiology Study

The purpose of this study is to (1) quantify cardiovascular anatomy and physiology using magnetic resonance imaging under both resting and exercise conditions in patients who have congenital heart disease and in age-matched normal volunteers, (2) use computer models to reproduce and simulate blood flow in these patients, and then (3) to combine the imaging data and computer models to estimate values which cannot be directly measured and to predict physiological changes induced by exercise and medical or surgical therapies.

Investigators hope to gain a greater understanding of the hemodynamics of congenital heart disease and their associated operations as they pertain to real-life situations (i.e. upright and non-sedentary, rest and exercise). With this knowledge, investigators would look to optimize the geometry and physiology of the patients, potentially reducing several of the long-term complications found in congenital heart disease patients such as cardiomyopathy, pulmonary hypertension, arrhythmias, thrombosis and heart failure.

Eligibility Criteria:
Inclusion Criteria:

* patients will have congenital heart disease or acquired cardiopulmonary disease.
* normal volunteers will be willing to undergo MRI

Exclusion Criteria:

* patients unable to receive intravenous contrast material (this does not apply to normal volunteers)
* subjects with arrhythmias which will prevent MRI cardiac gating
* subjects with illnesses which make participation inappropriate. In addition, patients who would normally be excluded from an MRI study because of pacemaker implant, aneurysm clip, severe claustrophobia, or any other condition which, based on the Investigator's judgment, would preclude proximity to a strong magnetic field will be excluded from this study as well.
* NORMAL VOLUNTEERS may be excluded if they are not able to remain still during the exam or follow the instructions of the investigators.