cyrilzakka/clinical-trials huggingface dataset:
Laboratory Diagnosis of Spontaneous Bacterial Peritonitis

This study aims at evaluating the diagnostic accuracy of serum procalcitonin, PEC index, modified Wehmeyer, and Mansoura scoring systems for SBP in cirrhotic patients with ascites

Based on clinical diagnosis, SBP is commonly underdiagnosed because of its nonspecific or asymptomatic presentation. Therefore, a diagnostic paracentesis should be performed in all cirrhotic patients with ascites who require emergency room care or hospitalization, who demonstrate signs/symptoms suggesting SBP, or who present gastrointestinal bleeding, in order to exclude SBP. Several non-invasive methods were tried in many studies for SBP diagnosis, as alternatives to diagnostic paracentesis, e.g., fecal calprotectin. Moreover, numerous scores were proposed for SBP diagnosis with variable accuracies, such as procalcitonin, ESR, and CRP (PEC) index, the modified Wehmeyer SBP scoring system, and Mansoura scoring system. This study aims at evaluating the diagnostic accuracy of serum procalcitonin, PEC index, modified Wehmeyer, and Mansoura scoring systems for SBP in cirrhotic patients with ascites. participants will be subjected to: Clinical evaluation: medical history and physical examination, Routine Laboratory investigations, Serum procalcitonin, Ascitic fluid study, Ascitic fluid culture with antibiotic sensitivity, Abdominal ultrasonography. The following scores will be calculated: Modified Child Pugh score, MELD score, MELD Na score, PEC index, Modified Wehmeyer score, and Mansoura score.

Eligibility Criteria:
Inclusion Criteria:

* cirrhotic patients with ascites

Exclusion Criteria:

Infections other than SBP.

* malignancy.
* Antibiotic therapy before hospital admission.
* Chemotherapy or radiotherapy within 1 month before admission.
* Pancreatic diseases.
* contraindication to paracentesis
Visualized Monitoring of Fibrosis Formation in Heart Failure With 68GA-FAPI PET

This is a diagnostic study. Patients were included from patients with clinically suspected or confirmed heart failure, and 68Ga-FAPI and 13N-NH3 gated myocardial imaging were performed to evaluate the effectiveness of 68Ga-FAPI PET imaging in visualizing the degree of myocardial fibrosis in patients with heart failure. The subjects completed 68Ga-FAPI and 13N-NH3 gated myocardial imaging in a one-stop process, and collected general information, clinical data, echocardiography, blood routine, liver and kidney function indicators, 68Ga-FAPI and 13N-NH3 PET imaging results and other imaging data of the patients and volunteers.

Fibroblast activated protein (FAP) is a type II membrane-bound glycoprotein that is highly specifically expressed in activated fibroblast reactions. The 68Ga labeled fibroblast activated protein inhibitor (68 ga-fapi) has shown advantages of high uptake and high image contrast in imaging the activated fibroblast response, including its successful use in visualizing the degree of liver fibrosis. The molecular imaging probe targeting FAP combined with the mature myocardial perfusion imaging agent 13N-NH3 can help us to achieve the following objectives: On the one hand, to investigate the myocardial fibrosis in patients with heart failure and to visualize the formation of fiBER-activated protein in the process of heart failure; At the same time, the performance of 68GA-FAPI in differential diagnosis of heart failure and grading of heart failure degree was discussed, so as to make up for the insufficiency of clinical routine imaging technology in the diagnosis of myocardial fibrosis in heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 years or above), gender is not limited;
* Patients with clinically suspected or confirmed heart failure (supporting evidence includes visual examination, cardiac MRI, cardiac ultrasound, and serological indicators, etc.), and patients who agree to undergo 68Ga-FAPI and 13N-NH3 imaging;
* The patient or his legal representative can sign the informed consent.

Exclusion Criteria:

* Acute systemic diseases and electrolyte disorders；
* Pregnant or lactating women；
* Patients refuse to sign the informed consent.
Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

To minimize the effects of polymerization shrinkage in the restorative treatment, there are new composites called Bulk- Fill which the companies has developed this composites for example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization shrinkage and properties allow the material to be inserted in one layer being quickly than traditional composite. This clinical study is designed to compare the clinical performance of the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior) and V (cervical-surface posterior) fillings.

A patients with 3 caries lesions class one either two or five will be divided into 3 groups , cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (Bluephase Style Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will be restored by bulk fill composite (3M ESPE) and other bulk fill composite ( IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with the light curing unit.

The study will investigate the clinical performance and efficacy of a bulk-filled composite resin restorative material for a period of 5 years

Eligibility Criteria:
Inclusion Criteria:

* must have given written informed consent to participate in the trial
* need at least three posterior restorations
* must be available for the required post-operative follow-up visits
* have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
* At least one occlusal and proximal contact on a natural tooth
* Cavities depth \> 2 mm in cervico-occlusal

Exclusion Criteria:

* have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations
* have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
* chronic periodontitis
* present with any systemic or local disorders that contra-indicate the dental procedures included in this study
* an unstable occlusion
* severe bruxing
* teeth with periapical pathology or expected pulp exposures
* are pregnant.
* Endodontically treated teeth
Inter-day Reliability of the Oral Glucose Tolerance Test Using Indirect Calorimetry

The main aim of this study is to determine the inter-day reliability, by using indirect calorimetry, of the post-prandial macronutrient oxidation and energy expenditure after consuming oral glucose load solution.

The maintenance of blood glucose concentrations and the oxidation of carbohydrate after consuming carbohydrate is related with a low risk of mortality and morbidity from cardiometabolic diseases. The oral glucose tolerance test is a diagnostic test widely used in the clinical field. However, its inter-day reliability has not been deeply studied. Therefore, it is of clinical interest to study the inter-day reliability of the diagnostic test oral glucose tolerance test using indirect calorimetry and monitoring the response of the glucose levels.

20 young adults will undergo two trials visit with 7 days of separation between conditions. Each evaluation day will conform to the following tests:

1. Basal metabolic rate assessment through indirect calorimetry.
2. Basal heart rate variability through heart rate monitor.
3. Intake of the corresponding glucose load solution.
4. Postprandial nutrient oxidation and energy expenditure assessment through indirect calorimetry
5. Glucose monitoring through Glucose meter.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Ages 18-30 years
* BMI: 18-27.5 kg/m2
* Stable weight over the last 3 months (body weight changes\<35kg)
* Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.

Exclusion Criteria:

* History of cardiovascular disease
* Diabetes or hypertension
* Pregnant, planning to become pregnant, or breastfeeding
* Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
* Any non-controlled medical condition which could influence results or could be worsened by the participation in the study.
* Claustrophobia
* Needle phobia
* Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
Glycomacropeptide and Women's Health

This is a study about how a dietary supplement containing a whey protein affects hormones controlling hunger and satiety (leptin and ghrelin) in postmenopausal women with a body mass index between 28 and 35 kg/m2. Participants can expect to be in study for 4 weeks.

The purpose of this research study is to understand how a dietary supplement containing glycomacropeptide (GMP) affects blood sugar levels and hormones that regulate hunger and satiety. This study is being conducted to find new ways to help women lose weight and reduce their chance of getting diabetes.

Eligibility Criteria:
Inclusion Criteria:

* no more than 10 years past menopause as defined by the date of last menses, less than 90 years old, BMI of 28 to 35 kg/m2.

Exclusion Criteria:

* BMI\>35 kg/m2, diabetes, and/or an active medical problem or condition that would interfere with study outcomes (malignancy, inflammatory condition, gastric bypass surgery or participation in another study)
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Eligible subjects must have a diagnosis of narcolepsy per the International Classification of Sleep Disorders (ICSD-3), and exhibit symptoms of both cataplexy and EDS. Subjects meeting the entry criteria will be randomized in a 1:1 ratio to receive either AXS-12 or placebo for five weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 15 and 75 years of age, inclusive
* Primary diagnosis of narcolepsy with cataplexy
* Willing and able to comply with the study requirements

Exclusion Criteria:

* Other clinically significant conditions potentially causing EDS
* Clinically significant psychiatric disorders
DataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL

The BNP-PL is a multicenter, observational study in which patients are prospectively followed in order to investigate clinical course and management of pulmonary hypertension in Poland.

All patients diagnosed with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension confirmed in right heart catheterization, will be eligible to participate in the study.

The BNP-PL Registry is an initiative of the Polish Cardiac Society Task Force for Pulmonary Vascular Diseases This study is conducted by the Polish Cardiac Society. All centers of pulmonary hypertension in Poland which are accredited by the National Health Fund have been invited to join the study. The data is administrated by the Jagiellonian University Medical College on the basis of an agreement between the Polish Cardiac Society, Jagiellonian University Medical College and pulmonary hypertension centres.

The goal is to describe current practice and outcomes in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

The data collection will have no impact on the way the patient is diagnosed and treated.

Collection of data on patients with pulmonary hypertension is carried out via the electronic platform.

No personal data is entered into the project database.

Eligibility Criteria:
Inclusion Criteria:

Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed after 1st March 2018 (incident cases) who:

* are aged \> 3 months at the time of enrollment
* fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mPAP) of 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance (PVR) of 3 Woods.

Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed before 1st March 2018 (prevalent cases) who:

* are aged \> 3 months at the time of enrollment
* fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mPAP) of 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance (PVR) of 3 Woods
Open Label Extension in Adults With Binge Eating Disorder (BED)

To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults


Eligibility Criteria:
Inclusion criteria:

1. Completion of an antecedent SPD489 BED Double-blind Study
2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED
3. Subject has a body mass index (BMI) of \> or =18 and \< or =45

Exclusion criteria:

1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
2. Subject is considered a suicide risk or risk to harm others
Cocoa Flavanols and Painfree Walking Distance

To characterize potential vascular long-term effects of flavanols in patients with peripheral artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study will be performed in 62 patients randomized in two groups. Patients will twice daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days months.

62 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 250m will be enrolled.

Patients will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 60 days.

The general condition, the pain free walking distance and the vascular function measured by Doppler Ultrasound will be determined before and two month after cocoa ingestion

Eligibility Criteria:
Inclusion Criteria:

* peripheral artery disease (Fontaine IIb)
* diabetes mellitus
* \> 18 years

Exclusion Criteria:

* acute and terminal renal failure
* acute infection
* heart failure (NYHA III-IV)
* arrhythmias
Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer

The primary endpoint of this study is to determine whether cycles of short term FMD exposure to a fasting-mimicking diet is effective in reducing total cholesterol levels.

the short term FMD exposure to a fasting-mimicking diet reduce total cholesterol levels

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* WHO performance status score 0-2
* Early stage breast cancer, ER positive, receiving an adjuvant endocrine treatment with aromatase inhibitor
* Hypercholesterolemic (total cholesterol \&amp;gt;200mg/dL)
* Ongoing treatment with aromatase inhibitors (at least six months of drug exposure)
* Adequate renal, hepatic, and hematopoietic function
* Written and informed consent for biomaterial submission and participation in the clinical trial
* Compliance with treatment and follow up protocol
* No other investigational agent may be administered concurrently to patients enrolled in this trial
* Patients with skeletal pain are eligible if bone scan and/or RX examination fails to disclose metastatic disease
* The interval between the onset of systemic adjuvant therapy with AIs and the randomization should be at least 6 months
* Patient is accessible geographically for follow-up and must be able to provide dietary data via telephone recalls
* Must be medically able to accept either dietary supplementation group prior to randomization.

Exclusion Criteria:

* Underweight (BMI \&amp;lt; 18.5 kg/m2)
* Current or past eating disorders identified with the SCOFF Questionnaire (Useful Eating Disorder screening questions) \[19\]
* Malnutrition Universal Screening Tool (MUST). It considers body mass index, weight change and acute disease effect equally and determines a malnutrition risk score. A score ≥1 identify a patient at moderate risk of malnutrition;
* Treatment with any investigational or non-registered drug other than the study product(s) within 30 days preceding the first dose of study product, or planned use during the study period
* Use of statins or supplements similar to statins (e.g red rice) or other drugs that interfere with lipid absorption (e.g ezetimibe)
* Known to have difficult-to-control hypertension, coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on ECG, previous myocardial infarction, or congestive heart failure Patients with diabetes are not eligible for the study
* History of allergic reactions likely to be exacerbated by any component of the investigational product used in the study
* Other concurrent, severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk
* Previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the Investigator to have been cured
* Psychiatric or addictive disorders that may compromise the ability to give informed consent or to comply with study procedures.
Effect of Pilates Exercise Versus Circuit Exercise Training on Gestational Hypertension

The purpose of the study is to investigate the effect of Pilates exercises versus circuit exercise training on blood pressure and lipids in gestational hypertensive women.

Gestational hypertension is one of the most common disorders seen in human pregnancies. The disorder progresses into pre-eclampsia, a dangerous condition that can prove fatal to expectant mothers. If it is untreated several complications result such as eclampsia, stroke, the need for labor induction and placental abruption, preterm delivery, and low birth weight.

Most pregnant women use medication during pregnancy despite increasing availability of information about teratogenic risks. Medication use during pregnancy still causes uncertainty and concern among pregnant women and their health care providers. Medication use has a harmful effect on the fetus such as congenital anomalies, preterm birth, low birth weight, growth retardation of the fetus, and developmental delays in totality. It remains unknown what the major concerns are among pregnant women regarding medication use.

Health organizations recommend lifestyle changes that include increased levels of physical activity. Also, some researchers have recommended aerobic training for 30 minutes per day that is supplemented with resistance exercise.

Pilates exercises have been showed to be safe modality for pregnant women. It showed many benefits on childbirth. It also yields a significant decrease in clinical systolic and diastolic and mean blood pressure at rest and over 24 hours, in hypertensive non-pregnant women. Pilates may be recommended as a non-drug intervention for the prevention, treatment, and control hypertension. Circuit exercise training is also a non-drug intervention may reduce systemic arterial hypertension to lower cardiovascular risk.

Due to the progressive increase in maternal estrogen with pregnancy, maternal fat deposits switch from anabolic to catabolic states to maintain appropriate development of the fetus and placenta. This switch to catabolism increases the breakdown of fat stores, which increases total cholesterol and triglyceride available for maternal and fetal utilization. Further, it is essential for a normalized maternal lipid profile to ensure healthy fetal development and pregnancy outcomes.

Therefore, this study will be conducted to provide evidence based for the effectiveness of Pilates exercise and circuit training on blood pressure and lipid profile in gestational hypertensive women for healthcare providers interested in women's health.

Eligibility Criteria:
Inclusion Criteria:

* They will be diagnosed by obstetrician after 20 weeks' gestation as having blood pressure higher than 140/90 without any organ damage.
* Age will range from 25-35 years old .
* Body mass index (BMI) will range from 30-34.9 Kg/m².

Exclusion Criteria:

* Cardiac problems
* Cognitive problems
* Poorly controlled hypertension
* Diabetes mellitus
* Inflammatory stage of arthritis
* Osteoporosis
Ideal Frequency of Postoperative High Volume Saline Irrigations Following Endoscopic Sinus Surgery

The aim of this study is to determine what the ideal frequency of high-volume sinonasal saline irrigation in the early postoperative period following ESS for medically refractory CRS. We will evaluate once, twice, and three times daily frequency sinonasal saline irrigation protocols. Our hypothesis is that three times a day sinonasal saline irrigations for the first week is ideal with no difference between frequencies after 1 week.

Chronic Rhinosinusitis (CRS) is a common inflammatory condition of the upper respiratory tract lasting more than 8 to 12 weeks. Major symptoms include facial congestion/fullness, facial pain/pressure, nasal obstruction/blockage, purulent nasal drainage, and reduction or loss of smell. The diagnosis must include two major symptoms and either endoscopic evidence of polyps, edema or mucopurulent discharge from the middle meatus and/or CT changes in the mucosa of sinuses or ostiomeatal complexes.

CRS has an estimated prevalence of 5% in the Canadian population, and up to 16% in some adult populations in the United States. Sinusitis is associated with a major societal health care burden, costing billions of dollars a year in North America. The medical treatment of CRS includes topical saline and corticosteroid sprays, systemic steroids and antimicrobials. Specifically, sinonasal saline irrigation is a safe, nonpharmacologic treatment, and an important and efficacious component in the management of CRS. Sinonasal saline irrigation can vary by concentration (e.g. hypertonic, isotonic, hypotonic), pressure (e.g. passive or active), and volume (e.g. high and low).

A recent evidence-based review by Rudmik et al. recommended sinonasal saline irrigation in the early postoperative period following endoscopic sinus surgery. Although 'daily' sinonasal saline irrigations are recommended, the ideal frequency is unknown since there have been no studies evaluating this topic.

This is a prospective, randomized, single blind study evaluating the subjective and objective outcomes of different sinonasal saline irrigation frequencies in patients who receive ESS for medically refractory CRS. Both disease-specific quality of life (QoL) and endoscopy scores will be measured at 1 week, 3 weeks, and 2 months postoperatively. The expected total number of patients to be enrolled in this study is approximately 75 (25 per arm), with a planned completion time of two years.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of CRS as per guidelines (\> 18 years old)
* Documented failed medical treatment of CRS
* Planned ESS for the treatment of CRS
* Able to read and understand English

Exclusion Criteria:

* Pregnant
* Cystic Fibrosis
* Diagnosed immotile cilia syndrome
* Diagnosed immunodeficiency syndrome
* Diagnosed fungal sinusitis
* Sinonasal tumours or obstructive lesions