cyrilzakka/clinical-trials huggingface dataset:
Calcium and Bone Mass in Young Females

We originally suggested that calcium in the diet is important in determining the amount of bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of the girls was 11 years, and they had not yet reached puberty. The study will also provide information about the effect of calcium on body composition (body fat) and blood pressure in young women.

We have been giving calcium to one group of participants in this study and giving a placebo (an inactive pill, or "sugar pill") to the other group. The results of this research will be important in preventing osteoporosis, because building more bone as a young person should reduce a woman's chances of developing osteoporosis later in life.

This study evaluates the effect of calcium on bone mass accretion over 7 years in a cohort of 354 young females who were in pubertal Stage II at the start of the study. The average age of study participants at entry was 11 years; at the end of the study participants were 18 years old.

The study looks at skeletal development under the influence of heredity, nutrition (calcium), and physical exercise. We gave calcium to participants in one arm of this clinical trial calcium. Participants in the other arm of the trial were given a placebo. The main outcome variable is the bone mass measured at different skeletal regions.

The study will also provide data about the efficacy of calcium supplementation with regard to hypertension prevention and obesity. The results of this research will be important in preventing osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* Pubertal stage II
* Calcium intake below a threshold level
* Caucasian
* Normal health

Exclusion Criteria:

* Medications affecting calcium and bone metabolism
* Chronic diseases
* Metabolic bone disease
* Abnormality in calcium metabolism
SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes

The study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus

The study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus The study compares sodium glucose cotransporter 2 inhibitors to Dipeptidyl peptidase 4 inhibitors in elderly patients with type 2 diabetes mellitus

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes and benign prostatic hyperplasia should be on monotherapy with either SGLT inhibitor or DDP4 inhibitors

Exclusion Criteria:

* unable to consent to the blood sampling or ultrasound Any other diabetes control measure other than SGLT inhibitors or DDP 4 inhibitors
AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA

The goal of this observational and diagnostic study is to develop and validate an artificial intelligence assisted approach for coronary computer tomography angiography-(CCTA)-based screening and diagnosis of cardiomyopathies in patients with suspected coronary artery diseases. This study aims to develop a computerized CCTA interpretation using artificial intelligence for multi-label classification task to assist cardiomyopathy diagnosis in the clinical workflow.

Cardiovascular diseases (CVD) are the leading causes of death and disability worldwide. With coronary artery disease accounting for a large proportion of CVD disease burden, coronary computer tomography angiography (CCTA) has become widely used for a comprehensive assessment of the total coronary atherosclerotic burden. In contrast, cardiac magnetic resonance (CMR) remains the gold standard for evaluating and diagnosing cardiomyopathies. However, clinical application of CMR has been hindered by the time and cost of examination and shortage of qualified doctors and staff. Consequently, the value of CCTA in screening and diagnosis in cardiomyopathies warrants further investigation.

The ability of artificial intelligence to learn distinctive features and to recognize characteristic patterns on big data without extensive manual labor makes it highly effective for interpreting CCTA data. Although very few studies investigated the diagnostic value of CCTA for myocardiopathies, which is by far not established or applied in clinical practice by radiologists, automated image analysis has a clear advantage compared to humans by offering objective and uniform solutions. Further, whether a comprehensive, end-to-end, artificial intelligent approach can be used to analyse CCTA for diagnosis multi-classifications of cardiomyopathies remains unknown.

Therefore, this study aims to develop and validate an artificial intelligence assisted approach on CCTA for screening and diagnosis of cardiomyopathies in patients with suspected coronary artery diseases.

Eligibility Criteria:
Cardiomyopathy cohort:

* Inclusion Criteria:

  1. A clinical diagnosis of cardiomyopathies, including hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, cardiac amyloidosis, myocarditis, arrhythmogenic right ventricular cardiomyopathy, and coronary artery disease/ischemic heart disease.
  2. At least one CCTA before surgery or implantable device treatment.
* Exclusion Criteria:

  1. No recorded diagnosis of cardiomyopathy or undetermined type of cardiomyopathy.
  2. A clinical diagnosis of secondary cardiac abnormalities due to other organic or systemic diseases.
  3. Surgery or implantable device treatment before CCTA examination.

Control cohort:

* Inclusion Criteria: participants with at least one CCTA examination.
* Exclusion Criteria: clinical diagnosis of cardiovascular diseases (including cardiomyopathy, history of myocardial infarction, history of cardiac surgery, stent implantation, ICD implantation and so on) or secondary cardiac abnormalities due to systemic diseases.
Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy

Assessment of cognitive function in patients undergoing elective carotid endarterectomy

Classical treatment for ICA stenosis is carotid endarterectomy (CEA), which has been proven effective in preventing future stroke as well as improving cerebral perfusion. However, the influence of CEA on cognition is less defined, it remains unclear whether CEA can improve cognitive function. A change in cognition is one of the most threatening diseases of recent years, cognitive impairment significantly impacts patients, families, and healthcare system.

The difference in the cognitive outcome may be accounted for microembolic events and adverse changes in haemodynamic circumstances.

The aim of our study is to identify those factors what may have role in the postoperative cognitive decline.

The study was approved by the Ethical Committee of the university ( SE RKEB: 17/2019) and written informed consent will be obtained from all patients.

The investigators intend to enroll patient aged more than 18 years undergoing elective carotid endarterectomy at our hospital ( Semmelweis University Heart and Vascular Center). Exclusion criterion included young age (less than 18 years), incapacity and urgent surgery. The investigators would like to register at least 100-150 patients in our study.

Most relevant anamnestic dates, the results of the laboratory and radiological reports will be recorded. Cognitive functions will be assessed one day before, one day and six month after the surgery using MMSE and a questionnaire called Frailty to characterize beside cognitive function the physiological reserve of the patients too.

The investigators manage patients undergoing carotid endarterectomy with general anaesthesia, using inhaled or total intravenous agents.

During the operation the investigators record beside the routine monitoring (intraarterial blood pressure, ECG, oxygen saturation, EtCO2, MAC) the cerebral tissue oxygen saturation using a near-infrared cerebral oximeter (Invos Cerebral/Somatic Oximeter) and the activity of the brain using GE Entropy Module.

The investigators would like to register the changes in the haemodynamic and cerebral condition and compare these results against the clinical outcome and the changes of the questionnaires.

Statistical analyses will be performed using Statistical Package for the Social Sciences.


Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 years, undergoing elective carotid endarterectomy

Exclusion Criteria:

* younger than 18 years, incapacity, urgent surgery, lack of consent
Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients

Early orthodontic treatment of Class III malocclusions with skeletal and dentoalveolar imbalances, represents a continuous dilemma. This difficulty starts from their meticulous diagnosis and treatment planning till reaching satisfactory results and finally stability. Some appliances could be used to correct growing skeletal Class III patients, improving the skeletal and dentoalveolar relationships, creating proper conditions for final orthodontic treatment, more importantly avoiding surgery. These appliances remove patient compliance from the equation.

Aim of the work: Evaluate the skeletal, dentoalveolar and soft tissue effects of two different force application systems which are the pulling force (CS 2000® appliance/ CS appliance) and the pushing force (Reversed Forsus fatigue-resistant device/ RF appliance).

Materials and methods: A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty three growing skeletal Class III patients (9-11 years) will be recruited upon a lateral cephalometric x-ray. Subjects complying with the inclusion criteria will be randomly assigned using a computer-generated list to one of the three groups Group I: Eleven patients treated with CS2000 appliance, Group II: Eleven patients treated with reversed Forsus Fatigue Resistant device and Group III: control group of Eleven untreated patients with a ratio of 1:1:1 allocation. A CBCT will be made before installing the appliances. After gaining a 2 mm positive overjet or a 6 months period, alginate impressions will be poured and dental casts will be made. Photographs and CBCTs will also be performed to record the dentofacial effect of the used appliances.

Keywords: Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 8 years to 11 years.
* Cervical vertebrae maturation index (CVMI 2 and 3) identified on the lateral cephalometric radiograph.
* Angle Class III molar relation.
* Skeletal class III ANB ranges between (-4) - (0).
* Wits appraisal ranges between (0) - (-5).
* Patients with good oral hygiene, and a healthy periodontal condition.
* Reversed over jet (-1) - (-6).
* Normal vertical growth pattern (SN/MP angle 28˚-38˚).

Exclusion Criteria:

* A discrepancy between centric relation and maximum intercuspation.
* Patients who underwent previous orthodontic treatment.
* Patients currently receiving drug therapy that may affect orthodontic tooth movement.
* Congenitally missing teeth or extracted teeth.
* History of systemic disease or craniofacial syndromes or presence of cleft.
Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer

This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the Flexitouch® system is more effective than standard home maintenance therapy in treating lymphedema.

PRIMARY OBJECTIVE:

I. Compare the effectiveness of the Flexitouch® System to standard home lymphedema therapy (Manual Lymphatic Drainage) in the management of lower-extremity lymphedema in women with a history of cervical, vulvar, or endometrial cancer.

SECONDARY OBJECTIVE:

I. Compare the quality of life (QOL) and functional status between patients using the Flexitouch® System and those following standard home lymphedema treatment (Manual Lymphatic Drainage) programs in the management of lower-extremity lymphedema

OUTLINE: This is a multicenter study. Patients are stratified according to site of cancer (cervical vs vulvar vs endometrial) and stage of lymphedema at diagnosis. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.

ARM II: Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks.

Clinical staff measure patients' lower limb (both) volumes and patients complete quality of life questionnaires at baseline, every 8 weeks during treatment, and at completion of study treatment.

Eligibility Criteria:
Criteria:

* Has lower-extremity lymphedema on one side of the body caused by surgery, chemotherapy, and/or radiation therapy.
* At least 6 months since clinic therapy for lower-extremity lymphedema
* Is within 3 years from finishing cancer treatment
* No active or recurrent cancer
* More than 3 months since cancer treatment
Multimodal Endoscopic Image Fusion for Assessing Infiltration in Superficial Esophageal Squamous Cell Carcinoma

The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the extent of esophageal cancer invasion than what is currently possible with ultrasound technology. This research endeavors to harness the synergy of endoscopic ultrasound (EUS) and Magnifying endoscopy, augmented by the pattern recognition and correlation capabilities of artificial intelligence (AI), to detect early esophageal squamous cell carcinoma and its invasiveness, along with high-grade intraepithelial neoplasia. The overarching goal is to ascertain the potential and significance of this approach in the early detection of esophageal cancer.

The project's primary goals are to develop three distinct AI-assisted diagnostic systems:

An AI-driven electronic endoscopic diagnosis system designed to autonomously identify lesions.

An AI-based EUS diagnostic system capable of automatically delineating the affected areas.

A multimodal diagnostic framework that integrates electronic endoscopy with EUS to enhance diagnostic accuracy and efficiency.

The study was executed in two distinct phases. The initial phase, designated as the modeling phase (Phase 1), involved a retrospective analysis of eligible subjects from a consortium of medical institutions, including the First Affiliated Hospital of Naval Medical University, West China Hospital of Sichuan University, Provincial Hospital Affiliated to Shandong First Medical University, the First Affiliated Hospital of Soochow University, the First Affiliated Hospital of Henan University of Science and Technology, and the First Affiliated Hospital of Shihezi University, all selected prior to January 1, 2024. The second phase, known as the real-world evaluation phase (Phase 2), prospectively enrolled consecutive patients who were scheduled to undergo magnometric endoscopy and EUS at the aforementioned hospitals between April 2024 and June 2024.

Eligibility Criteria:
Inclusion Criteria:

Patients requiring magnifying endoscopy and endoscopic ultrasonography. Individuals of either sex, aged 18 years or older.

Exclusion Criteria:

Inability to complete esophageal electronic endoscopy. Absence of biopsy or surgery, resulting in unobtainable pathological results. Patients who have undergone endoscopic lesion destruction or piecemeal resection, preventing the acquisition of an en bloc resection sample.

Patients with significant endoscopic, imaging, or pathological evidence of advanced esophageal cancer.

Patients presenting with marked esophageal stenosis or dilatation. Individuals with a history of other malignancies. Patients who have received neoadjuvant radiotherapy. Patients who declined to participate in the study and did not provide informed consent.
Online Acceptance and Commitment Therapy for Reducing Anxiety

The main objective of this study is to test the effectiveness of an Internet-delivered Acceptance and Commitment Therapy (ACT) program in reducing anxiety symptoms.

The purpose of this study is to test the effectiveness and level of acceptability of an Internet-delivered Acceptance and Commitment Therapy (ACT) program in reducing symptoms of anxiety. The effectiveness of the intervention will be compared with a wait-list control group using a randomized control trial (RCT) design. The participants with high / clinical levels of anxiety from the active treatment group will have the opportunity to read seven ACT modules and receive personalized feedback for their completed homework assignments.

The intervention will be delivered online and participants will have seven weeks to complete the seven modules (we might add one extra week of treatment for all participants in the event they need to compensate the treatment delays accumulated during the previous seven weeks).

Eligibility Criteria:
Inclusion Criteria:

* be fluent in Romanian
* be over 18 years of age
* have high levels of anxiety
* have access to an Internet-connected computer

Exclusion Criteria:

* suicidal ideation
* substance abuse
* severe psychiatric disorders
* a recent change in psychotropic medication (i.e., the dose has been changed within the last month)
Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.

Compare the efficacy between 3 ventilation modes (CPAP, PSV and PSV with Target Volume) on patients with obesity hypoventilation syndrome already treated with CPAP but with persistent desaturations.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 20 to 75 years old.
* Body mass index \> 32 kg/m2
* Nocturnal oxygen desaturation 5 mn ≤ 88% under CPAP,
* PaCO2 \> 5,9 kPa in diurnal, spontaneous ventilation

Exclusion Criteria:

* Patients with COPD and VEMS/FVC \< 65%
* Patients with CHF and periodic breathing (Ejection Fraction \<40%)
* Patients with a recent respiratory decompensation in the month preceding inclusion
the Related Factors of Bariatric Surgery on Bone Mineral Density

Obesity and related metabolic diseases have become a chronic disease that is a threat to human health. Bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. Laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. Laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. However, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. Long-term gastroesophageal reflux may lead to Barrett's esophagus or esophageal cancer. Nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise.

In this study, prospective randomized controlled trials were conducted to explore the possible causes of bone mineral after bariatric surgery and to explore ways to prevent bone mineral after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

-For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI \<45, you can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In our country, the BMI less than 45 is majorities.

Exclusion Criteria:

-BMI\<27.
The ALIGHIERI Survey: an Italian Overview of Global Impact of tHe COVID-19 pandemIc on General surgERy practIce

Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. R

Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. .

Eligibility Criteria:
Inclusion Criteria:

* alla surgeon in activity

Exclusion Criteria:

* none