cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System

This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the ENVUE™ System guidance during the placement of the ENvizion Medical™ enteral feeding tubes.

Enteral nutrition is the preferred route for the provision of nutritional support in most critical ill patients with functional gastrointestinal tract. Achieving early enteral nutrition (EN) in critically ill patients is associated with fewer major complications, reduced mortality and length of hospital stay, and significant cost savings. It is estimated that approximately 1.2 million feeding tubes are placed blindly each year in the United States alone. Despite the obvious advantages of the enteral tube feeding, inadvertent placement of Enteral Feeding Tube (EFT) into the airway is relatively common and can result in significant pulmonary injury including pneumothorax and pneumonia. Airway misplacement occurs in 1.2- 4 % of blind EFT insertions, with 0.2 to 1.2% of all the feeding tube placements cause pulmonary complications to patients. The gold standard for detecting inadvertent placement of a feeding tube in the lungs is radiography. However, because of its cost, possible delay of feedings while waiting for radiography, and risk for radiation exposure, clinicians continue to seek for alternative methods to confirm correct placement.

All the above mentioned, emphasizes the fact that safe and effective delivery of nasoenteral tube feedings requires assurance that the feeding tube tip is in a proper position. The ENVUE™ System is an electromagnetic tracking system which tracks the path of the feeding tube during placement. The benefit of the system when EFT is misdirected into the pulmonary system is a real-time visual tracing, which may prompt users to withdraw the tube and reinsert it.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be \>21 years of age
* Patients must require placement of an enteral feeding tube
* Patients have an endotracheal tube, OR Do not have an endotracheal tube but are sedated (RASS score of -2 or less) and/or obtunded (Glasgow Coma scale of 9-12)
* Patients or legal authorized representative must be able to understand and adhere to all protocol procedures and be willing and able to provide written informed consent

Exclusion Criteria:

* Patients must not have a history of:

  * Esophageal varices or ulcers
  * Upper airway obstruction
  * Upper GI stenosis or obstruction
  * Trauma involving sinuses, nares face or neck that would prevent nasogastric (NG) or oral tube insertion
  * Deformities of the sinus cavities and/or skull base
  * Esophageal cancer or neoplasm
* Patients must not have a significant concomitant illness that would adversely affect their participation in the study
* Female patients who are pregnant or lactating
Phone Enabled Implementation of Cessation Support

The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.

The research team will conduct a group-randomized trial comparing three arms: 1) Ask about tobacco use, advise to quit, assist with brief counseling (AAA) as standard care; 2) Ask, advise, connect to phone-based counseling (AAC); and 3) AAC+ Nicotine Replacement Therapy (NRT). Our central hypothesis is that connecting patients to phone-based counseling with cessation medication is the most effective alternative. The hybrid design is informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework which emphasizes key steps and multilevel factors to optimize implementation success. The following specific aims will be pursued: 1) adapt and tailor an existing smoking cessation program to deliver phone-based counseling to smokers in Lebanon; 2) test the effectiveness and cost-effectiveness of a referral-based program that delivers smoking cessation services to primary care patients; and 3) identify the multilevel determinants of implementation and sustainability using mixed methods.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* A current daily cigarette smoker and/or a regular waterpipe smoker (smokes at least 1-2 times/week).
* Not pregnant
* Reachable by phone
* Interested in quitting
* Lives in Greater Beirut Area

Exclusion Criteria:

* Patients who use other tobacco products including vape exclusively.
* Any patient below 18 years old.
* Cigarette smokers who do not smoke on daily basis.
* Waterpipe smokers who smoke less than once/weekly
Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases

The purpose of this study is to understand if combining Low Vision Rehabilitation (LVR) with Emotional Regulation Therapy (ERT) can help people with inherited retinal diseases (IRDs) that experience emotional distress related to participants' vision loss.

The study team hypothesize that treatment with LVR will produce measurable functional gains and that these effects will be enhanced by ERT-linked improvement among the subgroup of IRD patients with elevated vision-related anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with vision impairment with IRD etiology
* Must have had a clinical exam with an IRD specialist within the three months of assignment to Arm
* Have had a Goldmann visual field that was tested with III-4e isopter within the last year
* Have a disability greater than zero theta in any of the domains of Michigan Retinal Dystrophy Questionnaire (MRDQ)
* Have an indication from the IRD specialist that the ocular condition will not deteriorate over the next 1- year
* Able to participate in 10 weeks of ERT sessions while being physically located in Michigan (these will take place in the first 10 months of the study)

Exclusion Criteria:

* Having other ocular comorbidities including those associated with an IRD such as control of cystoid macular edema (CME)
* Functional needs regarding low vision (i.e. activities of daily living) have been adequately addressed per a study low vision specialist
* Current mental health therapy
* The participant must not have an elevated suicidal intention (SI) or suicide risk based on Patient Health Questionnaire (PHQ-9) further information collected at screening (If suicidal intentions are identified, the study staff will complete the suicide protocol (per protocol)
* If the participant is using medication for mental health or psychiatry concerns, participants must be on a stable dose of the medication (1-month of taking), otherwise will be excluded
* Inability to complete study task requirements
Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome

Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.

In a randomized, controlled study of all out-of-hospital cardiac arrest patients in Oslo, Norway, half the patients are treated according to the international guidelines for advanced CPR, and the other half according to the same guidelines, except for no I.V. needle or drugs are given until 5 minutes after eventual return of spontaneous circulation.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest out-of-hospital

Exclusion Criteria:

* \<18 years old
* Trauma as cause of arrest
HPV Infections, Cancer of the Vulva and Therapeutical Success

HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.

HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.

After having retrospectively identified patients with vulvar cancer incl. their preinvasive lesions in the clinical registry the hpv status of the samples is prospectively analyzed using a new multiplex pcr Array. Two Groups are build: patients with hpv associated vulvar cancer and patients with non-hpv associated vulvar cancer.

Then, the rate of patients who respond to radiotherapy within the Groups is analyzed by building Kaplan meier plots according to the patients survival and recurrence rate.

Eligibility Criteria:
Inclusion Criteria:

* pts. who suffer from vulvar cancer and their preinvasive lesions
* positive informed consent
* complete set of data
* Treatment in luebeck university

Exclusion Criteria:

* opposite of above
To Evaluate the Safety and PK Characteristics in Healthy Volunteers-JW24107

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0106 and C2101 and administration of JW0107 in healthy volunteers under fasting conditions.

Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Subjects does not meet the inclusion Criteria
Motor REHAbilitation TEChnologies for CHIldren With Disability: A Cross-European Survey

The aim of the RehaTech4Child survey led by EACD is to identify the digital technologies (e.g., robotic devices and treadmill systems, virtual reality and gaming systems, telehealth) that are used in clinical practices throughout Europe, and to know more about how rehabilitation professionals use or not use digital technologies in motor rehabilitation practices within the paediatric population. This knowledge would eventually help in designing the future technological developments based on the feedback from rehabilitation professionals.


Eligibility Criteria:
Inclusion Criteria:

* Rehabilitation professionals who use or not technologies in pediatric motor rehabilitation
* Practice in Europe

Exclusion Criteria:

-
Tubeless VATS for Peripheral Lung Nodule

Chest tube placement after thoracoscopy surgery had been generally accepted as routine procedure for removal of the residual intrapleural fluid and air, however, it would cause post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay. According to the recent studies, omission of chest tube placement after minor thoracoscopic procedures (such as pulmonary wedge resection) had been safe and feasible, and it also reduced the post-operative pain and shortened the hospital stay. We will conduct a prospective randomized trial in National Taiwan University Hospital.

We will enroll 100 patients with peripheral lung nodule who will be randomly assigned to no chest tube placement (tubeless group) or chest tube placement (control group) after thoracoscopic wedge resection with out without lymph adenectomy. The primary endpoints are to compare the post-operative hospital stay and post-operative pain sale between the two groups. The secondary endpoints are to compare the intercostal neuralgia and wound satisfaction one month after surgery between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* CT revealed peripheral lung nodule, with both size and depth less than 2 cm
* Aged 20 to 80 years

Exclusion Criteria:

* Patients with ventilatory defect
* Previous ipsilateral thoracic surgery
* Bleeding tendency or anticoagulant use
* Comorbidity including congestive heart failure, liver cirrhosis, chronic renal disease
* Pregnancy or breast feeding
* Immunocompromised or long-term steroid use
* Severe infected patient
* Patient who can not sign permit
Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin


Eligibility Criteria:
INCLUSION CRITERIA:

* Diagnosis of type 2 diabetes mellitus for at least one year;
* Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
* Glycated hemoglobin between 7.5 and 11 % units, inclusive;
* Willingness to accept, and ability to inject insulin glargine therapy

EXCLUSION CRITERIA:

* Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
* Congestive heart failure requiring pharmacological treatment;
* Serum creatinine \> 1.5 mg/dl for males, or \> 1.4 mg/dl for females;
* Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
* Planned radiological examinations requiring administration of contrasting agents;
* Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
* History of hypoglycemia unawareness;
* Pregnancy or lactation;
* Failure to use adequate contraception (women of current reproductive potential only);
* Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
* BMI \>25 kg/m2;
* Malignancy except basal cell carcinoma within the last five years;
* History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse;
* Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study;
* Incapability to comply with study procedures
Influence of the 3D-sonographic Representation of the Fetal Face on the Health-conscious Behavior of Pregnant Women

Studies have shown that ultrasound examinations during pregnancy have a short-term anxiety and stress-reducing effect, without having any influence on the mother-child bond or health-conscious behavior.

It has not yet been investigated to what extent the representation of the child's face alone achieves a lasting positive effect if the representation in 3D form were permanently available.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women undergoing ultrasound

Exclusion Criteria:

* age \<18 years
Pubertal Induction in Individuals With Hypogonadism

The investigators wish to explore the variability of uterine, breast and bone outcome markers as surrogates to assess the adequacy of exogenous oestrogen replacement in individuals with hypogonadism.

The investigators will invite individuals with hypogonadism who require pubertal induction to participate in the study. The participants will receive conventional routine oestrogen replacement in the form of transdermal patch. The participants will be reviewed every 2 months for a total of 8 months to document uterine, breast and bone assessment. This will be completed using a variety of tools. After 4 months, the participants will receive an incremental increase in oestrogen dose.

Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of hypogonadism (Turner's syndrome, hypogonadotrophic hypogonadism, primary ovarian insufficiency, hypopituitarism, hypothalamic amenorrhoea, transgender)
2. ≥ 10 years of age
3. Oestrogen naïve i.e. no prior commencement of oestrogen treatment
4. Breast Tanner stage ≤ than 2

Exclusion Criteria:

1. Previous oncology treatment
2. Primary amenorrhoea secondary to chronic medical comorbidity
3. PCOS diagnosis
Burden of Illness in Hypoparathyroidism

Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. To further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a disease specific questionnaire, as well as the SF-36 are handed out.

Design:

In a cross-sectional trial the subjective health status and burden of illness in patients with chronic hypoparathyroidism will be evaluated by using a disease specific questionnaire as well as the SF-36.

Patients:

Patients will be recruited out of the patient population of the participating five medical centers.

Statistical Analysis:

Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. For further analysis data will be compared to sex- and age-matched controls.

Eligibility Criteria:
Inclusion Criteria:

* chronic hypoparathyroidism (\>12 months) under established therapy
* chronic pseudohypoparathyroidism (\>12 months) under established therapy
* written informed consent

Exclusion Criteria:

* age \<18 years
* no detailed documentation of hypo- or pseudohypoparathyroidism
Swiss Longitudinal Cohort

The planned research project is a prospective population-based cohort study, similar to the well-known Framingham study in the United States. So far, there is no similar research project in Switzerland.

It is planned to examine of three Swiss municipalities. Recruitment in a first Swiss municipality (Lostallo/Cama GR) started 2014 and ended in 2019. Overall, 496 participants were recruited in this municipality. The five-year follow-up in this municipality started in 2019. It is planned to start recruitment in a second Swiss municipality (Uznach SG) in 2020.

The examinations embrace a broad spectrum of measurements (for details the investigators refer to the published study protocol).


Eligibility Criteria:
Inclusion Criteria:

* Resident of Cama GR, Lostallo GR, or Uznach SG
* Age ≥6 years (no upper age limit), for voluntary blood sample ≥18 years
* Willing to participate in long-term study
* Written informed consent (in participants ≥6 years and \<18 years signed by parents)

Exclusion Criteria:

* No exclusion criteria
Artificial Intelligence in Image Recognition of Pouchoscopies in Patients With Restorative Proctocolectomy

The application of artificial intelligence in pouchoscopy of patients with restorative proctocolectomy might improve the diagnosis of pouchitis and neoplasms. The aim of this pilot study is to develop a convolutional neural network algorithm for pouchoscopy

Restorative proctocolectomy is the standard procedure for treatment of refractory severe colitis in inflammatory bowel disease as well as the standard procedure for carcinoma preventive treatment of patients with inflammatory bowel disease with colonic neoplasia and patients with familial adenomatous polyposis coli (FAP). Pouchoscopy can be used to monitor the success of therapy and to detect complications such as pouchitis or neoplasia. Artificial Intelligence assisted image recognition programs can support the examiner in finding a diagnosis and train physicians in training, objectify endoscopic findings in the context of studies and might make biopsies unnecessary, thus saving costs. The application of Artificial Intelligence in pouchoscopy has not been demonstrated to date. The aim of this study is to develop, an image recognition algorithm that reliably detects the different graduations of pouch inflammation. This requires training and fine-tuning of the image recognition program PiTorch using the largest possible amount of image data, which will be recruited from the image databases of the UMM and the Theresienkrankenhaus Mannheim. A test run for statistical evaluation will be performed on an independent cohort.

Eligibility Criteria:
Inclusion Criteria:

• All patients aged ≥ 18 years with inflammatory bowel disease and status after restorative proctocolectomy with ileoanal pouch who had received a pouchoscopy

Exclusion Criteria:

• Very poor endoscopic image quality
DAOIB for the Treatment of Brain Fog

This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.


Eligibility Criteria:
Inclusion Criteria:

* "post-COVID-19 condition" defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments
* physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits
* have sufficient education to communicate effectively and are capable of completing the assessments of the study

Exclusion Criteria:

* history of significant cerebrovascular disease
* Hachinski Ischemic Score \> 4
* major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments
* memantine use (memantine is an NMDAR partial antagonist)
* substance (including alcohol) abuse or dependence
* delusion, hallucination or delirium symptoms
* severe visual or hearing loss
* inability to follow the protocol