cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Sandblasting on the Rebonding Strength

Patients at the Orthodontic Department of University of Aleppo Dental School will be selected if they meet the inclusion criteria then fixed orthodontic treatment with 0.018-inch slot MBT appliances will be applied for those patients.

The aim of this study is to compare Two rebonding procedures by applying a split-mouth design. The clinical failure rates of the two rebonding procedures will be evaluated.

The sample of this study will be chosen after examination of patients referred to the Department of Orthodontics at the University of Aleppo Dental School then subjects who meet the inclusion criteria will be included in this trial.

An information sheet will be given to each possible candidate. Then consent forms will be obtained.

All patients will receive both rebonding procedures by applying split-mouth design. Each patient will be asked to select an opaque sealed envelope from a box with 20 ones. Ten envelopes will Include instructions for applying sandblasting prior to acid-etching on the right upper premolars and acid-etching alone on the left upper premolars. In contrast, the other ten envelopes will include opposite instructions.

A total sample of 80 premolars will be obtained to study the clinical failure rates of the two rebonding procedures.

The 80 premolars will be randomly divided into two groups:

* The first group in which the enamel will be prepared using sandblasting prior to acid-etching.
* The second group in which the enamel will be prepared using acid-etching alone.

Eligibility Criteria:
Inclusion Criteria:

1. good general health and oral hygiene
2. willing and able to comply with the trial procedures
3. No crossbite, scissor bite, or occlusal interferences with the bonded/rebonded brackets in the premolars region (to prevent any potential early bond failure)
4. no craniofacial anomalies.

Exclusion Criteria:

1. any type of pervious orthodontic therapy
2. any need for ortho-surgical treatment or teeth extraction.
Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography

The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.

The secondary objectives of this study are:

* to compare the diagnostic performance of emergency compression ultrasonography performed with and ultra-portable device (V-Scan®) with that of emergency compression ultrasonography performed with a classic device
* to compare the diagnostic performance of emergency compression ultrasonography between patients suspected of having DVT arriving through the emergency department versus similar patients sent in by their generalist
* to compare the diagnostic performance of emergency compression ultrasonography among patients with suspected DVT according to pre clinical probability testing based on the Wells score (low, medium or high probability).

Currently, the use of ultra-portable ultrasound in this indication is not part of routine care, and this study is therefore considered interventional in nature.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given informed consent and signed consent
* The patient must be a member or beneficiary of a health insurance plan
* Patient consulting in the vascular exploration and medicine department for suspected first episode of deep vein thrombosis
* Ambulatory patient: defined as any outpatient coming in for a consult directly from their place of residence or via the emergency department
* Patient does not have a history of venous thromboembolism

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is an adult under any kind of guardianship
* The patient refuses to sign the consent
* It is not possible to correctly inform the patient
* Patient has a history of venous thromboembolism
AYActive Study! A Physical Health Activity Intervention

The purpose of this pilot study is to explore the feasibility, acceptability, and efficacy of a 6-week mobile health (mHealth) physical activity intervention among adolescent and young adult (AYA) cancer survivors being treated at the University of Iowa Hospitals and Clinics.

The purpose of this pilot study is to explore the feasibility, acceptability, and efficacy of a 6-week mobile health (mHealth) physical activity intervention among adolescent and young adult (AYA) cancer survivors being treated at the University of Iowa Hospitals and Clinics. Eligible participants will receive a Fitbit activity monitor and access to the mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races. AYA cancer survivors between 13-39 years are invited to participate and the impact of this intervention will be tested over 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female cancer survivors
* Diagnosed between 13 and 39 years old
* Currently 3-24 months post-treatment (or in maintenance therapy)
* Receiving survivorship care at HCCC/UIHC
* In remission
* Physically able to walk without limitations
* Own a smartphone with a data plan that is also capable of receiving and sending texts
* Able to understand English and provide informed assent/consent

Exclusion Criteria:

* Physically unable to walk without limitations
* Actively receiving cancer treatment
* Does not own a smartphone with a data plan
* Visual or cognitive impairments causing inability to read, complete or sign the consent form and survey
* Participants with diagnosis of thyroid cancer (due to differences in physical, psychological, emotional, and social effects)
* Presence of a psychiatric disorder that is not managed/unstable or suicidal ideation/actuation in preceding 12 months
* Currently meeting physical activity requirements per American Cancer Society guidelines (150 or more minutes per week of moderate to vigorous physical activity)
Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes

A new diabetes education program for the initiation of intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 ICT) was developed.

In the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. It is expected that the new developed program (MEDIAS 2 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this programs will be tested.

The results regarding the intervention arms "MEDIAS ICT" vs. " ACC" (control condition) will be separately analyzed and published.

The MEDIAS 2 ICT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 10 lessons of 90 minutes each. MEDIAS 2 ICT is designed to help patients perform multiple-injection insulin therapy and adjust their insulin doses depending on carbohydrate consumption, physical exercise, and pre-prandial glucose levels. In addition, MEDIAS 2 ICT focuses on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment.

The active comparator condition (ACC) consist of a combination of two previously established and evaluated education programs - a diabetes education program to initiate mealtime insulin and a hypertension education program for the treatment of hypertension. These education programs were developed in the 1980s and 1990s and were more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes and hypertension.

Both treatment arms (MEDIAS 2 ICT and ACC) consisted of 10 lessons, which were conducted as group sessions.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* age \< 75 and age \> 17 years
* two years diabetes duration with oral treatment
* BMI \> 20 nad BMI \< 40 kg/m²
* informed consent

Exclusion Criteria:

* current psychiatric disease
* dementia or other severe cognitive impairment
* severe complications
* severe conditions (e.g., cancer)
* gestational diabetes
A Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery

This is a prospective, single-centre case control comparison of expression of target genes responsible for energy utilisation, mitochondrial function and oxidative stress and levels of histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery patients. The study aims to test several inter-related hypotheses in a consecutive sequence of patients undergoing coronary artery bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pre-existing paroxysmal, persistent or chronic atrial fibrillation,

Exclusion Criteria:

* Patients with pre-existing inflammatory state: sepsis undergoing treatment, acute kidney injury within 5 days, chronic inflammatory disease, congestive heart failure.
* Emergency or salvage procedure.
* Ejection fraction \<30 %.
* Patient in a critical preoperative state (Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 AKI \[20\] or requiring inotropes, ventilation or intra-aortic balloon pump).
* Pregnancy.
Prognostic Significance of CMR-Confirmed Infarct in MINOCA Patients from Sweden and Australia

Myocardial Infarction (MI) with Non-Obstructive Coronary Arteries (MINOCA), occurring in 6-8% of MIs, refers to patients who experience a heart attack without obstructive coronary artery disease (CAD) or significant atherosclerosis. One of the challenges inherent to MINOCA lies in its propensity to mimic non-coronary-related pathologies, such as myocarditis or takotsubo. Thus, Cardiac Magnetic Resonance (MRI) imaging has been recommended as the central diagnostic tool for confirming MINOCA diagnosis while excluding the others. However, the resource-intensive nature of MRI, combined with its limited availability in hospitals, poses barriers to patient access and limits research activities that could produce significant impact. Therefore, this project's aim is to curate the largest dataset of suspected MINOCA patients with MRI, via a collaboration between Sweden's nationwide registry and South Australia's state-wide registry, to answer the following key questions: (i) What is prognosis of MINOCA, as confirmed by MRI? (ii) What are the characteristics and prognosis of patients who had MRI compared to those who did not? (iii) What clinical parameters are associated with MINOCA on MRI?

This project will utilize DataSHIELD, an innovative platform that enables pooled statistical analysis of sensitive data without compromising individual-level privacy. This multicentre, comprehensive study will have a major impact on contemporary practice. It will be able to provide the significance of MINOCA diagnosis (myocardial scar on MRI), alongside identifying clinical factors associated with its occurrence and its correlation with long-term outcomes.

This is crucial for informing clinical guidelines, policy decisions around reimbursement for MRI, and developing effective clinical trials to enhance the management of MRI-confirmed MINOCA patients


Eligibility Criteria:
Inclusion Criteria:

1. Discharge diagnosis of MINOCA - acute presentation with (a) universal criteria for acute MI (b) non-obstructive coronaries on angiography.
2. Cardiac MRI - at least within 3 months of acute presentation

Exclusion Criteria:

1. Patients without satisfactory images on cardiac MRI
2. Follow-up data not available (ie international visitors).
3. Suspicion of an alternative cause for presentation (such as sepsis, pulmonary embolus, primary cardiac arrhythmia or trauma) which would not be consistent with the label of MINOCA.
4. Clinically evident non-ischemic diagnoses - myocarditis, Takotsubo, other cardiomyopathies prior to CMR
HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions

A clinical study for patients with HIV that investigates the best way to reduce HIV transmission risk, and to improve the overall health of people living with HIV/AIDS. Participants will complete four assessments over the course of one year and will be randomly assigned to a five-week treatment program.

The main purpose of this research study is to investigate the best way to reduce HIV transmission risk and to improve the overall health of people living with HIV/AIDS. This study tests an intervention program that aims to improve knowledge, motivation, and skills. The intervention program is designed to motivate participants to take their medications routinely, improve the quality of life for those living with HIV, and decrease risky behaviors that may lead to HIV transmission.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Recent alcohol use

Exclusion Criteria:

-
The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI

The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.

1. Aim

   -We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
2. Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with infertility to the unit of Assisted Reproduction Techniques- of the Department of Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function, who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation) with rFSH were included in the study. 52 patients were considered responsive to stimulation and composed the normal control group (Group 1). On the 7th day of stimulation transvaginal ultrasonography was carried out. Patients who had at least 6 follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of \<250 pg / ml were considered to have suboptimal response to stimulation and were divided into two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3 (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 23-39
* Body mass index between 18 and 30 kg/m2
* Baseline FSH ≤12 IU/l, E2 ≤ 80 pg/ml
* The presence of both ovaries and uterine cavity capable of sustaining a pregnancy
* Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation
* Who were having their first or second IVF trial.

Exclusion Criteria:

* Grade III-IV endometriosis
* Clinically significant condition preventing them from undergoing gonadotrophin treatment
* More than two previous assisted cycles
* Who had a single ovary
* Unexplained gynaecological bleeding
* Polycystic ovary or an ovarian cyst of unknown aetiology
* Previously diagnosed with a space occupying lesion like submucous myoma , polyps, septum, synechia in the uterine cavity
* Have a chromosomal anomaly.
Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults

The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

* are 18 to 59 years of age, inclusive, on the day of screening
* have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry
* are generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination
* are physically and mentally capable of participating in the study and follow its procedures
* agree to keep a daily record of symptoms for the duration of the study
* if female of childbearing potential: have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

* have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
* are at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
* currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
* have any inherited or acquired immunodeficiency
* have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\> 800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
* have a history of severe allergic reactions or anaphylaxis
* have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating
* have received any blood products or immunoglobulins within 90 days prior to study entry
* have donated blood or plasma within 30 days prior to study entry
* have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
* have a functional or surgical asplenia
* have a known or suspected problem with alcohol or drug abuse
* were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
* are a member of the team conducting this study or are in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
* if female: are pregnant or lactating
PHARMACODYNAMICS ASSESSMENT PRODUCT HEPARIN SODIUM (INTRAVENOUSLY) OF THE SWINE 5.000UI/ML OF BLAU FARMACÊUTICA S/A IN HEALTHY SUBJECTS IN COMPARISON OF SODIUM HEPARIN APP PHARMACEUTICALS

The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP Pharmaceuticals, through the determination of activity of the following markers:

* Anti-FXa;
* Anti-FIIA.

The pharmacodynamic profile of the drug will be assessed through:

* Reason for Anti-FXa activity / Anti-FIIA;
* TFPI activity.

The aPTT activity marker will be evaluated as an exploratory objective.

Eligibility Criteria:
Inclusion Criteria:

* a) Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways; b) Being male, aged between 18 and 55 years old and clinically healthy; c) BMI ≥ 18.5 and ≤ 30.

Exclusion Criteria:

* a) Participation in clinical trials in the 12 months preceding the survey; b) Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems; c) acute illness in the period up to 07 days before the beginning of the study; d) determining Chronic administration of medications, such as hypertension, diabetes or any other that requires continued use of any drug; e) Hemoglobin \<13 g / dL; f) Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory; g) Use of medications that interact with heparin (see Section 7.8.1); h) history of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism; i) History of coagulopathy and bleeding diathesis; j) Presence of bruises on physical examination. k) Changes in skin or subcutaneous tissue of the place where the injection is made (eg liposuction in the abdomen).

  l) absolute platelet count below 100 x 109 / L; m) A history of acute haemorrhage in the last 30 days; n) history of sensitivity to biological products derived from mammalian albumin or any component of the formulation;

  a) history of allergy or major disease Steven Johnson; p) History of present use or there are at least 12 months of tobacco; q) current or previous history (less than 12 months) of illicit drug use;
"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices

The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients: the diagnosis of liver cirrhosis will be based on previous needle liver biopsy or on the combination of clinical, biochemical, and radiological findings. If biopsy findings are unavailable and in case of non-complicated cirrhosis, non-invasive markers will be used.
* Variceal bleeding at endoscopy from gastroesophageal gastric varices type 2 or isolated gastric varices type 1 or 2 (Sarin classification) according to the following criteria: endoscopic signs of an active spurting or oozing from gastric varices (GV); adherent blood clots, white nipple signs, or erosions on the GV and absence of other bleeding sources.
* Hemodynamically stable patient (Mean arterial pressure above 65 mmHg) without clinical significant rebleeding (Baveno criteria) within 12 hours after the initial endoscopy with glue obliteration.
* Written informed consent obtained.

Exclusion Criteria:

* Pregnant woman or breastfeeding.
* Minor and patients older than 75 years.
* Non cirrhotic portal hypertension.
* Hepatocellular carcinoma outside the Milan criteria or other cancer at a palliative stage.
* Child Pugh score \> 13.
* History of severe or refractory hepatic encephalopathy unrelated to gastrointestinal bleeding.
* Congestive heart failure.
* History or presence of pulmonary hypertension.
* Patients with other indication for TIPS.
* Uncontrolled gastric variceal bleeding.
* Portal vein cavernoma.
* Patient who have previously received a TIPS procedure.
* Failure to receive clear information in patients without an identified trusted person.
* Refusal of the participation agreement by signing the information form and consent as defined.
* Exclusion period from another biomedical study.