cyrilzakka/clinical-trials huggingface dataset:
Skull Bon Variations in Patient with Congenital Unilatral Choanal Atresia

Identify skull bone Associated Anomalies in patients with cngenital unilatral choanal atresia

Choanal atresia is a rare congenital disorder caused by a failure to develop the posterior nasal cavity (choana), resulting in a missing opening between the nasopharynx and the nasal cavities.It is the most common congenital anatomical abnormality of the nasal cavities with incidence ratio approximately 1/5000-7000 live births

Generally, choanal atresia may affect one or both Choanae, although most studies show that the unilateral form is more common than the bilateral one,and the incidence is higher in females than in males Children with unilateral choanal atresia are subject to unilateral breathing usually have late unilateral nasal obstruction, persistent ipsilateral rhinorrhea, and recurrent rhinosiusitis Previous studies have shown that the ratio of bone to membranous atresia is 9:1; although a detailed review of CT findings with histopathological studies showed that mixed-wall atresia is the most common and is present in 71% of cases, while in 29% of cases we found a pure bone wall Computer tomography (CT) is presently the golden standard in diagnostics of nasal cavity diseases; thus, it can be applied successfully as a tool for assessing anatomical structures

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Congenital Unilateral Choanal Atresia

Exclusion Criteria:

Patients with severe craniofacial syndromes
Psychometric Properties and Cross-cultural Adaptation of the Turkish Version of Physcian Attitudes Toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)

Research has reported that the reasons for low implementation of CR are multifactorial at the health system, physician and patient levels. It has also been found that patients are more likely to initiate CR if physicians strongly and positively promote the importance of CR participation. Unfortunately, there are insufficient and ineffective data on CR, referral to CR and both clinical and cost-effectiveness outcomes of CR in Turkey. In this context, it is important to examine more objectively from the perspective of physicians who play a key role in referring patients to CR. However, in our country, there is no relatively objective measurement tool to evaluate physicians' attitudes towards CR. Therefore, this study aims to adapt the original "Physician Attitudes towards Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)" into Turkish and to examine its psychometric properties.


Eligibility Criteria:
Inclusion Criteria:

* To be a physician,
* Providing active service in patient diagnosis and treatment

Exclusion Criteria:

* Not providing active service in patient diagnosis and treatment despite being a physician (administrative position, etc.).
Effect of Sacubitril/Valsartan on Reduced Right Ventricular Ejection Fraction in Patients With CTD

Heart failure, one of the leading causes of connective tissue disease (CTD) mortality, has attracted increasing attention. Currently, no known study had focused on the effect of sacubitril/valsartan on right ventricular dysfunction and in the systemic disease induced heart disease. We aimed to observe the effect of sacubitril/valsartan on primary endpoints (6 minutes walking test and myocardial fibrosis) in CTD patients with right ventricular ejection fraction reduction (RV-HFrEF).

Patients with CTD frequently exhibit multi-organ pathophysiological and functional damage. Heart failure, one of the leading causes of CTD mortality, has attracted increasing attention. Mostly, patients with CTD present with nonspecific cardiac symptoms, normal ECG, and preserved left ventricular ejection fraction (LVEF) and therefore do not receive an early cardiac diagnosis and treatment. Pulmonary arterial hypertension (PAH), right ventricular (RV) dilatation and hypertrophy might become the first and the most frequent cardiac findings. Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitors, is a "superstar" which inhibits both neprilysin and renin-angiotensin aldosterone system that closely related to the heart failure mechanism. It has been strongly recommended as class I drug in treating the patient with chronic HFrEF from 2017 ACC/AHA/HFSA heart failure guideline for the ability of dramatically reduce the cardiovascular mortality rate.

Cardiovascular magnetic resonance (CMR) is able to depict myocardial characteristics from structure to tissue properties using cine and late gadolinium enhancement (LGE) sequences. Newly developed imaging studies to date include T1 mapping and T1-derived extracellular volume estimation. All the previous studies in CTD have been restricted to patients with advanced cardiac involvement.

Together with clinical assessment and multi-imaging tests, the aim of the present study is going to observe the effect of sacubitril/valsartan on primary endpoints (6 minutes walking test and myocardial fibrosis) in CTD patients with RV-HFrEF.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-75 years old.
* confirmed CTD（including systemic lupus erythematosus, myositis, polymyositis, systemic sclerosis, sarcoid, Sjögren's syndrome or mixed connective tissue disease）
* SLEDAI ≤ 6 in patients with SLE or ESR ≤ 30 in patients with SSc
* already have OPT for CTD at least 3 month
* RVEF ≤ 45%
* Providing written informed consent

Exclusion Criteria:

* Documented coronary artery disease or prior angiography for coronary artery disease (\>50% stenosis).
* Patients with known congenital heart disease or other systemic diseases that might induce RVrEF.
* Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate \< 30 ml/min/1.73 m2.
Cotrifazid Safety and Efficacy Against Malaria

The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)

Design: Open-label, block-randomised, comparative, multicentric trial. Setting: Four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea.

Participants: Patients of all ages with recurrent uncomplicated malaria Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP).

Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical and/or parasitological failure at day 14

Eligibility Criteria:
Inclusion Criteria:

All subjects \> 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study -

Exclusion Criteria:

A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin \< 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant.

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Project Breast47: Effect of an Educational Intervention

Breast cancer is the most frequently diagnosed malignant tumor in women. In 2018, in Spain, the estimated incidence was 101/100,000 women.

Screening strategies and greater knowledge of risk factors by the population have contributed to a better prognosis. Specifically, in the case of behavioral factors, making women aware of their influence enables them to establish preventive measures themselves.

Technologies are becoming a channel of communication, from a healthcare perspective, between the population and healthcare personnel. There are even specific terms like eHealth or mHealth. There is beginning to be evidence that collects the benefits and ways of using web-apps to achieve modification of risky behaviors and/or behaviors to prevent pathologies are acquired.

The use of digital media, such as a web-app, to publicize BC risk factors makes it possible to specifically establish measures aimed at reducing its prevalence, which in turn will contribute to reducing the number of cases of BC. CM.

On the other hand, making women aware of their BC risk factors, as well as quantifying the risk of developing the tumor, is useful for them to become aware of the magnitude of the problem and adopt measures to minimize their risk.

Since there is no digital strategy in Asturias that informs and reduces the risk of developing breast cancer, through the modification of the main risk factors, in young women, the present study has been proposed with the aim of evaluating the effectiveness and feasibility of an educational intervention for BC risk prevention through the use of a Web-App in women residing in health area VII of the Principality of Asturias.


Eligibility Criteria:
Inclusion Criteria:

* Women who agree to participate with no previous diagnosis of breast cancer

Exclusion Criteria:

* Women who do not have adequate physical or psychological characteristics to participate in the study
* Women who do not have the means to regularly access the web-app that will be used to develop the educational intervention
* Women who cannot be contacted by email
Assessment of Clinical Performance and Costs of the Endeavor Resolute Stent "in Real Life" in Spain.

The Redes registry is set up to document the overall clinical performance and costs of the Endeavor Resolute coronary stent in a "real life" subject population of 450 patients that require a stent in Spain. Primary objectives are the overall cost for patients during initial hospitalization and at 1-year follow-up, as well as the MACE rate at 30 days, 6 months and 12 months post procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \>18 years old
* Subject has agreed to participate in the study by signing the "Patient Informed Consent" and/or has authorized the collection and disclosure of their personal health information by signing the "Patient Data Collection Form".
* There is an indication for a drug-eluting stent and a clinical decision to use Endeavor Resolute in all the lesions found.
* Subject is able and willing to co-operate and to comply with the study protocol and undergo follow-up requirements.

Exclusion Criteria:

* Subject is a childbearing or breastfeeding female.
* Subject has a known hypersensitivity or allergy to acetylsalicylic acid, heparin, clopidogrel, ticlopidine, drugs such as zotarolimus, rapamycin, tacrolimus, sirolimus or other similar drugs, or any other analog or derivative drug, cobalt, chrome, nickel, molybdenum or contrast media.
* Subject has a contraindication to anticoagulants and/or antiplatelets.
* Subject's lesion might prevent proper balloon inflation during angioplasty.
* Primary or rescue angioplasty.
* Subject has one or more drug-eluting stents other than Endeavor Resolute in other lesions.
* Intention for elective treatment with other drug-eluting stent other than Endeavor Resolute.
* Current medical condition is associated with a life expectancy ≤ 12 months.
* Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the consent form in this study. Subject can only be enrolled once in this study.
* Subject has a medical condition preventing follow-up as established in the protocol or limiting participation in this study.
* Subject cannot guarantee follow-up.
Technology to Improve the Health of Resource-poor Hispanics With Diabetes

This study evaluates the efficacy and implementation of a telehealth-supported, integrated diabetes group visit program led by Community Health Workers (CHWs). Primary study relates to efficacy and a secondary study addresses mentored implementation.

The number of Hispanics diagnosed with diabetes is escalating in the US with disproportionately higher prevalence and complication rates than other ethnicities. CHWs are a well-established and culturally sensitive means to bridge gaps in care to individuals with diabetes. However CHWs are often left unsupported, placing patients at risk of substandard care or harm. Telehealth is a term used to describe a range of technologies to support healthcare delivery via communication with the patient or a member of the healthcare delivery team. Though telehealth has been implemented into diabetes programs for many years, there is a paucity of data showing the use of telemedicine for CHW training and support.

The primary study (n=89; Cohorts 1,2) compares clinical outcomes and treatment satisfaction of individuals who receive diabetes care in a 12-month telehealth supported, integrated CHW-led group visit program compared to those in usual care (wait list control). Group visits are 6-months and CHWs contact patients weekly to bimonthly (mobile health (mHealth)) for 12-months. This phase with have two cohort waves, separated by 6-months. The wait list control group for Cohort 2 will explore telehealth, clinician-patient encounters. A secondary study (n=59; Cohorts 3,4) at a new clinic evaluates the ability to implement the program. In the first phase of the secondary study the research team will conduct a RCT of individuals randomized to the diabetes program (intervention) vs usual care (control) to assess clinic feasibility. The clinic team will observe this process and learn the project protocols during Phase 1. In the second phase, the clinic team will lead the group visits while the research team mentors them to conduct the project in-person at the group visits and via telehealth each week (ZOOM video conferencing). Another secondary study (n=138; Cohort 5) aims to expand the reach of the education and CHW intervention for individuals who may not be able to or cannot come to the clinic for group visits. Specifically, individuals will received the education from the program monthly via a secure text message video, CHWs will contact weekly to bimonthly to advocate for their needs, and participants will receive their routine care as usual in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic adults with diabetes, low-income (earn less than/equal to 250% federal poverty level)

Exclusion Criteria:

* not able to understand Spanish, group visit is not appropriate for care i.e., need individualized care, pregnancy, etc
Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (CTC)

The purpose of the study is to determine whether the type of anesthesia during breast cancer surgery has any impact on the way a patient's immune system functions for a brief period after surgery. If the investigators find that one type of anesthesia versus the other is more beneficial to a patient's immune system, then the investigators may use this information to design a larger study to exam the effect of anesthesia better.

There are two different types of anesthesia that the investigators can use for subjects undergoing breast surgery. The first type is called "general anesthesia" (GA) which is when a person "goes to sleep" with a breathing tube and then receives intravenous (IV) pain medicine during and after surgery to minimize surgical pain. The other type of anesthesia is called "regional anesthesia" (RA), or "nerve blocks" which numb up the nerves that supply the breast area. By doing this type of anesthesia, subjects often don't go "to sleep" with a breathing tube, instead, they get heavy IV sedation and take a "deep nap" during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy
* Written informed consent must be obtained from each subject prior to entering the study
* Subjects with primary non-metastatic AJCC stages I, II or III, scheduled to undergo either unilateral mastectomy with or without Sentinel lymph node biopsy or axillary dissection, or unilateral lumpectomy with Sentinel lymph node biopsy or axillary lymph node dissection
* Able to stay overnight in the hospital post surgery

Exclusion Criteria:

* Any subject younger than 18 years or older than 85 years of age
* History of previous breast surgery (aside from biopsy), planned breast conserving operation (isolated lumpectomy) or reconstruction (rectus or latissimus flap)
* American Society of Anesthesia (ASA) classification of 4 or greater, or any contraindication to having regional anesthesia
* Any subjects who receives an intraoperative or postoperative blood transfusion during the period of venous blood sampling
* Subjects who are pregnant. Exclusion of the possibility of pregnancy by testing (urine HCG) or by history (tubal ligation, hysterectomy, or menopause) is required prior to inclusion in the study
* Subjects with active infectious process at the site of proposed paravertebral injection
* Subjects with significant allergy to local anesthetics
* Subjects who convert from RA to GA during surgery
FDG-PET in Advanced Melanoma

This clinical trial studies how well FDG-PET/CT measures early response in patients with stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, \[18F\]fluorodeoxyglucose (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before, during, and after treatment may improve methods for predicting which patients may benefit from therapy.

PRIMARY OBJECTIVES:

I. To correlate treatment-induced changes in FDG uptake with changes in tumor size and progression-free survival (PFS) in patients receiving therapy for advanced melanoma.

II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or expression of available molecular biomarkers from patients receiving therapy for advanced melanoma.

OUTLINE:

Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have signed Institutional Review Board (IRB)-approved informed consent documentation
* Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present
* Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents
* Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with PET Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at least one lesion measuring at least 2 cm in the longest diameter

Exclusion Criteria:

* Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential
* Subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers and other contrast media used in PET/CT
* Subjects incapable of giving informed written consent, for the following reasons:

  * Inability to adhere to the experimental protocols for any reason
  * Inability to communicate with the research team
  * Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
  * Prisoners or other individuals deemed to be susceptible to coercion
Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci

The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. Images obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are compared to whole-mount histology.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old, with prostate cancer and scheduled for radical prostatectomy

Exclusion Criteria:

* Medical history of prostate surgery or radiotherapy of prostate
* Medical history of abdominal perinéanal amputation or whole of state which prevent to use endorectal probe
Colorectal Cancer Screnning Colonoscopy Under Hypnosis

Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated

Colorectal cancer is the 3rd most common cancer. Colonoscopy, a screening examination, has led to an increase in patient survival. In more than 90% of cases, this examination is performed under general anesthesia (GA) because it is considered painful, even though several studies have shown its feasibility without GA with a good tolerance in 75% of cases. However, only 28% of patients accept the examination without GA because of great apprehension. GA entails an increased risk of complications but also additional costs. Thus, performing colonoscopies without GA would reduce risks and costs by 15 to 30%. In order to make the examination more acceptable and less anxiety-provoking, methods such as hypnosis have been tested with the result that pain and anxiety are reduced and the hemodynamic state of the patients is stabilized, thus reducing the examination time. To date, the majority of studies on hypnosis, of varying indications, are small, mono-centric and non-randomized.

The use of hypnosis for colorectal cancer screening colonoscopies would reduce patient anxiety, avoid complications related to GA and reduce the organizational constraints and costs related to GA.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Undergoing a screening colonoscopy (mass screening Fecal Immunochemical Test positive or as an individual (family history of colon cancer or adenoma, personal history of adenoma, cancer, chronic inflammatory bowel disease) or in the context of a transit disorder, hemorrhage or anemia
* Affiliated with a French social security system
* Having signed a written consent

Exclusion Criteria:

* Patient requiring emergency colonoscopy
* History of colonic resection
* Carriers of behavioral disorders and/or psychiatric illness
* Limited cognitive abilities making it impossible to read or fill out a discrete choice questionnaire (language problems, comprehension problems)
* Contraindication to hypnosis, preventing quality interaction (comprehension and/or language problems, hearing impairment)
* Contraindication to general anesthesia
* Under a legal protection regime
* Pregnant or breastfeeding woman