cyrilzakka/clinical-trials huggingface dataset:
Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.

Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.

In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.

Eligibility Criteria:
Inclusion Criteria:

* diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years

Exclusion Criteria:

* recent treatment with laser photocoagulation or intravitreal drugs
To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.

To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.

To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects aged 18-45 years (including boundary values), male or female;
* Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;

Exclusion Criteria:

* (Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation;
* (screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment;
* ALT and AST exceed the upper limit of the normal range;
Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs

This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly

This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly cause those have alot of problems concerning the accumulagio. Of plaque and so increased bacteria

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of disability like special needs autism and down syndrome

Exclusion Criteria:

* age below 13
Assessing Prevalence Of Beta Lactamase Production From Clinical Isolates Of Hospitalized Patients And Comparison Of Antibiotic Susceptibility Patterns

EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites).

Objectives:

* Comparison of antimicrobial susceptibility using disc-diffusion method
* Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients

n/a n/a

Eligibility Criteria:
Inclusion Criteria:

Isolates (as specified in the observational plan) from hospitalised patients

Exclusion Criteria:

Isolates obtained from outpatients will not be included for the study. Isolates from repeat cultures performed during in-patient follow-up that were previously recruited into the study will be excluded.

Isolates identified as commensals or contaminants will be excluded
The Effects of Nitrate, Caffeine, and Cold Exposure on Cardiovascular Function.

Dietary inorganic nitrate supplementation may have positive implications on cardiovascular function. The aim of this project is to determine if nitrate supplementation can attenuate the effects that caffeine and cold exposure have on the cardiovascular system.

Acute caffeine consumption and cold exposure elicit negative effects on the cardiovascular system. Humans are regularly exposed to such conditions of increased cardiovascular strain, which may lead to elevated chronic cardiovascular risk. On the other hand, dietary inorganic nitrate supplementation is well established to improve cardiovascular function in healthy individuals. Thus, acute nitrate supplementation may compensate for the negative effects that caffeine and the cold place on the cardiovascular system. These effects will be measured using peripheral blood pressure, pulse wave analysis, heart rate variability, forearm blood flow, flow mediated dilation, and blood and saliva markers.

Eligibility Criteria:
Inclusion Criteria:

* Blood pressure \< 130 mmHg systolic and \< 85 mmHg diastolic. BMI between 18.5 and 29.9 kg/m2. Females must be naturally menstruating (regular length cycle and menses) or using a form of combined hormonal contraception (for at least 6 months).

Exclusion Criteria:

* Existing cardiovascular or metabolic conditions. Experience any adverse reactions to experimental procedures or supplements. Allergies to supplements or breakfast items. Involved in any other studies. Blood pressure \> 130 mmHg systolic and \> 85 mmHg diastolic.
Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia

The primary purpose of this study is to effect of Ingaron®, a lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration of 100,000 IU (LLC NPP Farmaklon, Russia) on the effectiveness of antibiotic therapy in patients with community-acquired pneumonia who fell ill during the epidemiological rise of ARVI.

Pilot, open, single-centre, randomized controlled trial. Patients will be prescribed basic combination antibiotic therapy. In addition to antibiotic therapy, half of the patients will receive Ingaron®, a lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration of 100,000 IU (LLC NPP Farmaklon, Russia). The study drug solution Ingaron® will be administered intramuscularly at 100,000 IU once daily for 5 days.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of the inpatient department of both sexes aged 18 to 60 years.
2. Confirmed diagnosis - community-acquired pneumonia (causative agent not specified) of an uncomplicated typical course without respiratory failure and the duration of symptoms is not more than 14 days.
3. Risk class of lethal outcome I-II according to the Fine scale.
4. Availability of an Informed Consent voluntarily signed by the patient.

Exclusion Criteria:

1. Increased individual sensitivity to gamma interferon, Ingaron® and / or excipients that are part of Ingaron® or drugs used in antibacterial therapy.
2. The use of immunomodulating, immunostimulating or immunosuppressive therapy later than 1 month before enrollment in the study.
3. Bronchial asthma and/or COPD.
4. Congestive heart failure.
5. Acute diseases of the gastrointestinal tract or other pathologies that may affect the absorption, distribution, metabolism or excretion of drugs.
6. Chronic liver and / or kidney disease or other pathologies that may affect the absorption, distribution, metabolism or excretion of drugs.
7. Oncological diseases, autoimmune, immunosuppressive conditions at present or according to history.
8. Cerebrovascular pathologies.
9. Diabetes.
10. Pregnancy or lactation.
11. Smoking index over 10 pack/years.
12. Data on severe nervous or mental diseases, including history.
13. Violation of consciousness.
14. Participation of the patient in other studies with the use of drugs or other methods of therapy, including clinical, currently or later than 1 month before inclusion in the study.
Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis

Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus (RSV). Only supportive therapy, including suctioning nasal secretions, water-electrolyte balance maintenance, and oxygen supplementation when needed, is recommended. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty.

The aim of the study is to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

1. Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:

   * Tachypnoea (WHO definition).
   * Increased respiratory effort manifested as follows:

     1. Nasal flaring;
     2. Grunting;
     3. Use of accessory muscles;
     4. Intercostal and/or subcostal chest wall retractions;
     5. Apnoe.
   * Crackles and/or wheezing.
2. Aged 5 weeks - 24 months old.
3. A caregiver must provide written informed consent.

Exclusion Criteria:

1. Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation \< 85% on room air).
2. History of prematurity (gestational age \<34 weeks).
3. Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic).
4. Immunodeficiency.
5. Gastro-oesophageal reflux.
6. Diagnosis or suspicion of asthma.
7. Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment.
8. Inhaling bronchodilators within 24 hours before enrolment.
9. Inhaling steroids within 24 hours before enrolment.
10. Systemic steroid therapy in the preceding 2 weeks.
Modulation of Vascular Calcification in Chronic Dialysis Patients

50 patients will be randomized and treated with MCO or highflux dialysis for six months (24 weeks) after a run-in phase of 4 weeks Highflux treatment.

Serum samples will be drawn at baseline, after 4, 8 and 24 weeks.

Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples and calcification will be assessed with Alkaline phosphatase and Alizarin staining.

Primary endpoint:

In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months

Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase and WST8.

Secondary Endpoints:

Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical activity level after 6 months

Cell culture: Incubation of VSMC with serum samples obtained after 6 months

* Alizarin staining/WST-8
* Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants
* Apoptosis

The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years an older
* Chronic dialysis patients for at least 3 months

Exclusion Criteria:

* Serum albumin \<32g/L at the last routine albumin measurement
* Pregnancy
Inferior Vena Cava Collapsibility Index in Severe Sepsis

There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis.

To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients.

The research question is: In adult patients with sepsis, severe sepsis and septic shock what is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid resuscitation.

The study is an interventional cohort study using a convenience sample of adult patients in a university teaching hospital Emergency Department.

Eligible participants who consent to partake in the trial will have an ultrasound assessment of their inferior vena cava performed and the IVCCI will be calculated at enrolment.

Care will be provided in line with the published guidelines on sepsis management from the Surviving Sepsis Campaign and the College of Emergency Medicine.

A sample size calculation has been performed which indicates that 112 patient with severe sepsis or septic shock will need to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* signs and symptoms of infection with 2 or more SIRS criteria (pulse rate \>90/min, Temp \> 38 Celsius \< 36 Celsius, Respiratory rate \> 20 breaths per minute, or white cell count \>12 or \<4 x 10\^9/L)

Exclusion Criteria:

* in relation to this episode of care: Prior cardio pulmonary resuscitation, acute myocardial infarction, trauma, pregnancy or patient requiring immediate surgery.
* Patients who have received more than 20ml/Kg of IV fluid in the pre hospital environment
* Patients with known tricuspid regurgitation, congestive heart failure or pulmonary hypertension
* Patients receiving palliative terminal supportive care
Neural Correlates of Sensory Specific Satiety

Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination.The rewarding effect of sugar will be investigated in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. A gustatory stimulation paradigm designed to induce sensory specific satiety for glucose will be employed. The aim is to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior.

Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination. Since changes in taste, smell and appetite are commonly observed in obesity, previous studies investigated the relation of sensory specific satiety to weight gain, but observed conflicting results. To gain a more detailed understanding of the relationship between sensory specific satiety and weight homeostasis, we will examine the rewarding effect of sugar in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. We will employ a gustatory stimulation paradigm designed to induce sensory specific satiety for glucose. During fMRI scanning, glucose and water are applied orally using a gustometer. Furthermore, relevant hormonal satiety parameters are measured, as well as dietary behavior and food preferences in everyday life. This will allow us to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior. A better understanding of factors contributing to the development and maintenance of overweight are crucial for the development of new treatment options for obesity.

Eligibility Criteria:
Inclusion Criteria:

1. BMI between 17,5 and 35 kg/m².
2. Over age of 18 years.
3. Right-handedness.
4. Normal or corrected-to-normal vision.
5. Capacity to consent.

Exclusion Criteria:

1. History of head injury or surgery.
2. History of neurological disorder.
3. Severe psychiatric comorbidity.
4. Lifetime or current medical illness that could potentially affect appetite or weight (including eating disorders diagnosis)
5. Smoking.
6. Current psychotropic medication.
7. Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers).
8. Pregnancy.
Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

This is a single site, double-blind, randomized, placebo-controlled, crossover study to assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy, opioid-experienced, non-treatment-seeking subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be capable of understanding and complying with the protocol and has signed the informed consent
* Must be 18-55 years of age
* Must have a body mass index of 18.0-30.0 kg/m2 at screening
* Female subjects must agree to use an acceptable method of contraception from date of consent and until two weeks after the last dose
* Subjects must be willing not to use alcohol-, tobacco, caffeine-, or xanthine-containing products while resident at inpatient facility
* Subjects must be an experienced opioid user who meets the following criteria: 1) has used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions in the past five years; 2) has used opioids at least 2 times in the two years prior to screening; and 3) is not physically dependent on opioids, as assessed by medical history and naloxone challenge performed at screening

Exclusion Criteria:

* Must not have any current or piror significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders.
* Must not have current or past opioid, alcohol, or other durg dependence (excluding nicotine and caffeine) or showing signs of withdrawal following the naloxone (Narcan) challenge.
* Please contact site for additional information about other exclusion criteria.
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)

This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.

Study participants were screened up to 14 days prior to their elective cardiac surgery. For the purpose of this study, hypertension was defined as systolic blood pressure (SBP) ≥140 mm Hg immediately prior to initiation of study drug.

On the day of surgery, an IV bolus dose of clevidipine (Bolus 1 - pre-anesthesia) was administered to each eligible study participant during Treatment Period 1 to decrease BP before induction of general anesthesia. The dose (either 125 μg, 250 μg or 500 μg) given was based on the assigned cohort for each participant, listed in the 'Arms' section below.

At the discretion of the investigator, a second IV bolus dose of clevidipine (Bolus 2 - with anesthesia) could have been administered during Treatment Period 2 at either 125 μg, 250 μg or 500 μg, based upon the earlier observed response to Bolus 1. This dose was administered after the induction of anesthesia, to decrease BP prior to cannulation of the ascending aorta for initiation of cardiopulmonary bypass.

Assessment of safety was performed throughout Treatment Periods 1 and 2 with Adverse Events (AEs) followed 6 hours post final bolus dose and Serious Adverse Events (SAEs) followed 24 hours post final bolus dose.

Eligibility Criteria:
Inclusion Criteria:

* Require elective cardiac operation involving the use of cardiopulmonary bypass
* Age 18 years or older
* A history or hypertension and/or expected to require perioperative antihypertensive therapy in the opinion of the investigator
* Written informed consent
* Pre-anesthesia baseline SBP ≥140 mm Hg just prior to bolus, measured using an arterial line

Exclusion Criteria:

* Receiving either intravenous vasopressor or intravenous vasodilatory therapy in the 72 hours prior to dosing
* Critical left main coronary artery stenosis
* Critical aortic valve (\<0.5 cm3) or mitral valve (\<1.0 cm3) stenosis
* Acute myocardial infarction within the prior 14 days
* Fully paced cardiac rhythm
* Known or suspected aortic dissection
* Requiring preoperative intra-aortic balloon pump counterpulsation therapy
* Contraindication to transesophageal echocardiography
* Positive pregnancy test or breast feeding
* Intolerance or allergy to calcium channel blockers
* Allergy to soybean oil or egg lecithin
* Any condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the patient from completing the study
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Measuring the Effect of Radiation Therapy on Patient Activity Levels

The goal of this study is to measure the effect of radiation therapy on the activity levels of patients. This will be achieved by tracking their activity levels during a treatment course of radiation therapy.

At the University of Pittsburgh (UPMC) St. Margaret and UPMC Shadyside, in the department of radiation oncology, breast, prostate, head and neck, and lung cancer patients will receive the standard treatment for their cancer and in no way will this study interfere with this treatment. Prior to initiation of radiation, consenting patients will be given Misfit activity tracking devices (accelerometers) to be worn on their wrist to track their activity levels throughout the course radiation therapy. Bracelets will be given to patients by the PI or co-investigators (MDs involved in patient's care) at date of consent and returned at completion of the study. The bracelets will track daily steps taken, calories burned, miles walked, and restful and restless sleep. Again, the purpose of the study is merely to measure the affect radiation therapy has on activity levels of patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Breast, Prostate, Lung or Head and Neck Cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Ability to walk 100 feet without rest
* Signed informed consent

Exclusion Criteria:

* Any other noncutaneous cancer diagnosis under active treatment
* Known metastatic disease
Treating PCOS With Digital Intervention vs. Metformin

With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.

This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

Eligibility Criteria:
Inclusion Criteria:

Female aged 18- 45; Meet Rotterdam criteria; Insulin Resistance

Exclusion Criteria:

Women who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (≥ 3 times the upper limit of the normal range); Abnormal renal function (GFR\<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, pioglitazone, and antidepressant medication in the last 3 months.