cyrilzakka/clinical-trials huggingface dataset:
Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure

Assessment of intravascular volume status is difficult in critically ill patients. Evidence suggests that only 50% of hemodynamically unstable patients respond to a fluid challenge. Moreover, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading may compromise microvascular perfusion and oxygen delivery and cause or aggravate peripheral and pulmonary edema. Inappropriate fluid expansion can increase morbidity and mortality thus making it important to accurately assess fluid responsiveness in critically ill patients. The volume responsiveness can be defined as a 15% increase in stroke volume (SV) or cardiac output (CO) after a 500-ml infusion. This study tested whether echocardiographic parameters can predict fluid responsiveness in critically ill patients following a low volume 100-ml crystalloid solution infusion over 1 minute.

Fifty-four adult patients with circulatory failure were recruited for the study. As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, a 100 ml bolus of normal saline solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters were recorded1 minute after bolus administration. The remaining 400 ml of normal saline solution was infused at a constant rate over 10 minutes, and echocardiographic parameters were recorded again. The mean echocardiographic measurements over three consecutive respiratory cycles were recorded along with heart rate HR, systolic, diastolic and mean arterial pressures, central venous pressure, and Temperature also mechanical ventilation parameter (tidal volume, respiratory rate and PEEP) for each patient. Patients with an increase in CO after a 100 ml or total 500-ml infusion over 10 minutes (ΔCO500) of 15% or more were classified as responders (Rs) and those without an increase in CO was classified as non-responders

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute circulatory failure
* Mechanically ventilated \& sedated.(Tidal volume 6-8 ml/ kg, PEEP 5 mmHg, Richmond Agitation-Sedation Scale RASS (R) Score from zero to -3).
* Systemic inflammatory response syndrome
* Septic shock
* Controlled massive hemorrhage

Exclusion Criteria:

* Age of less than 18 years
* Cardiomyopathy
* Pulmonary edema
* Morbid obesity
* Pregnancy
* Increased intracranial tension
* Valvular heart disease
* Myocardial ischemia or infarction before the study
Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response

The purpose of this study is to explore the effects of propranolol on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled pilot trial.

The investigators' specific aim is to examine the effects of serial doses of propranolol on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled trial. The investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as skin conductance and heart rate variability, and whether anxiety predicts treatment response. The investigators' hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, as the investigators have demonstrated in previous single-dose studies. The investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.

Eligibility Criteria:
Inclusion Criteria:

* For participants with autism: High-functioning, native-English speaking subjects with ASD aged 15-30. High-functioning ASD is defined in this study by the DSM-V criteria plus Autism Diagnostic Interview-Revised (ADI-R) criteria for Autism, and Wechsler Abbreviated Scales of Intelligence (WASI) full scale IQ of at least 85.

Exclusion Criteria:

* For participants with autism: Non-autism learning disability (e.g. dyslexia),
* major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder),
* other neurological diagnosis,
* major head trauma,
* any of the following exclusionary criteria related to propranolol (diabetes, reactive airway/pulmonary disease, thyroid disease, bradyarrhythmias, unexplained syncope, narrow angle glaucoma, pregnancy, known hypersensitivity/adverse reaction to beta-blockers),
* any of the following exclusionary criteria related to placebo (severe allergy to lactose),
* any of the following exclusionary criteria related to the psychophysiological measurements (history of rash from adhesives).
A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China

The purpose of the study is to study the epidemic features and diagnosis of female breast cancer, especially the diagnosis and treatment of breast cancer.The disease-free survival (DFS) and the total survival time(OS) of the breast cancer patients will also be studied.

The study is a multicentric, retrospective clinical study based on the hospital. The target number of cases are X patients who are eligible for breast cancer after radical mastectomy. To collect the clinicopathological data and treatment data of the breast cancer patients and do the follow-up visit of all the patients who are included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Female patients;
* The hospitalized patients who are confirmed of the primary breast cancer histologically;
* The date of the inpatients are within the month we chosen;
* Patients who are within the month we chosen have been received or under receiving the relevant treatment including surgical treatment, chemotherapy and radiotherapy.

Exclusion Criteria:

* Male breast cancer patients;
* Patients with breast cancer who are not under the chosen time;
* Non hospitalized patients.
Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

According to protocol amendment of 16 October 2010 Austria is participating in this study.

Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis.

Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare.

Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. In this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease
* Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study

Exclusion Criteria:

* The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply
* An additional exclusion criterion is a parathyroid hormone- value of \> 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol
Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy

Main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.


Eligibility Criteria:
Inclusion Criteria:

* ASA Status 1-2 patients Exclusion criteria
* Patients with a body mass index (BMI) of \>40kg/m2
* ASA score of \>III
* Previous abdominal surgery
* Pregnant or breastfeeding patients
* Patients with coagulopathy
* Known local anesthetic allergy
* infection at the injection site
Study of Brain Control of Movement

This study will use transcranial magnetic stimulation to examine how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Normal healthy volunteers between the ages of 18 and 65 years may be eligible to participate.

In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp or skin. Brief electrical currents are passed through the coil, creating magnetic pulses that stimulate the brain. During the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscle will be recorded on a computer through electrodes applied to the skin over the muscle. In most cases, the study will last less than 3 hours.

The purpose of this study is to investigate the influence of voluntary inhibition of movement, using either negative motor imagery or Go/NoGo reaction task, on cortical inhibitory mechanisms. Intracortical inhibition (ICI) and silent period (SP) are two major cortical inhibitory mechanisms demonstrated by transcranial magnetic stimulation (TMS). Alterations in these inhibitory mechanisms have been extensively studied in various situations, but the influence of voluntary inhibition has not been elucidated yet. In normal volunteers, therefore, we plan to determine if voluntary inhibition of movement influences these cortical inhibitory mechanisms. The primary outcome measures would be any changes in motor evoked potential (MEP) size and intracortical inhibition (ICI) parameters.

Eligibility Criteria:
Volunteers who are greater than or equal to 18 years old.

Subjects must not have any medico-surgical illness.

Subjects must not have neurological illness.

Subjects must not have psychiatric illness.

Subjects must not be taking any medication with potential

influence on nervous system function.

Subjects must not have a pacemaker.

Subjects must not have an implanted medical pump.

Subjects must not have a metal plate or a metal object in the skull or eye.

Subjects must not have a history of seizure disorder.
Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

Primary dentition is the most suitable space maintainer for permanent teeth. However, as infants often lose their primary teeth too soon, using a space maintainer is the most efficient, long-lasting, and economical way to prevent malocclusions and function impairment in the future. Regarding personalized appliances, space maintainers in digital pediatric dentistry have made significant progress. Digital technology decreases the manual manufacturing stages that take a long time and increases the reliability and durability of digital fabrication procedures.


Eligibility Criteria:
Inclusion Criteria:

* apparently, healthy cooperative children having recent premature loss of lower primary molars
* the permanent successors of the lost primary molars were not expected to erupt within 6 months
* Angle's class 1 occlusion with normal primary molar relation
* Presence of teeth on the mesial and distal side of the edentulous area
* Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
* Radiographically, presence of permanent successors.
* parents and children were accepting the new treatment modality.

Exclusion Criteria:

* children exhibited poor oral hygiene, para-functional oral habits, severe crowding, space loss, and abnormal occlusion
* Extraction of primary molars exceeding three months.
* Radiographically, absence of permanent successor.
* uncooperative children
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration

The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.

Ertapenem is an antibiotic belonging to carbapenems family and used in infections with Gram-negative bacilli with extended spectrum beta lactamase (ESBL). Its efficacy has been demonstrated in abdominal, soft tissue, pulmonary, skin and gynaecological infections. Recently it has been compared to ceftriaxone in urinary infections demonstrating his efficacy and tolerance.

The purpose of this study is to assess its benefit in probabilistic strategy by demonstrating its prostatic diffusion in significant concentration when administrated in a pre-operative single injection.

Patients were divided in two groups receiving a single injection of 1g of ertapenem 1h or 12h before endoscopic surgery of prostate hyperplasia.

Concentration of ertapenem was measuring on blood sample and on chips resection of prostate during endoscopic surgery.

To demonstrate the prostatic diffusion in significant amount of ertapenem, the prostatic concentration of ertapenem had to be higher than the minimal inhibitory concentration (MIC) for 40% of the time of injection interval.

Eligibility Criteria:
Inclusion Criteria:

* Acceptance and understanding of the consent form (signed)
* 18-80 years old patients
* BPH needing endoscopic resection according to French Urology Association recommendations
* Procedure and follow up made in investigator center
* normal digital rectal examination
* PSA :
* patient \> 69 years old, not necessary
* patient \< 69 years old, PSA\<20 and if 4\<PSA\<20, the ratio free PSA/total PSA must be \>10%
* patient with renal clearance \>60 estimated with MDRD
* patient affiliated to the social security

Exclusion Criteria:

* personal or familial history of prostatic or genito-urinary cancer
* personal history of pelvic irradiation
* personal history of hormone-therapy
* personal history of prostatic adenomectomy by abdominal approach
* personal history of allergy to beta-lactamines
* urinary tract infection or bacterial colonisation at the time of procedure
* carbapenems treatment in the two weeks before surgery
* hyperresponsivness to ertapenem or other carbapenems antibiotic
* patient with renal clearance estimated with MDRD \<60
* patient with catheter or probe permanently
Screening for Cancer in Patients With Unprovoked VTE

Open and multicenter randomized clinical trial (1:1) comparing limited screening with extended screening with the performance of Positron emission tomography-computed tomography (PET-CT) scan in the search for neoplasms in patients with unprovoked venous thromboembolic disease at high risk of developing cancer at follow-up.

Introduction: Cancer screening in patients with unprovoked venous thromboembolic disease (VTE) is controversial. In the last years, a score has been developed that selects patients at high risk of developing cancer during follow-up.

Objective: To estimate the impact of an active cancer search strategy using 18-fluordesoxiglucose (FDG) PET-CT in unprovoked VTE with high-risk to develop cancer.

Specific Objectives: 1) Number of neoplasms diagnosed in the screening process: 2) number of neoplasms diagnosed at an early stage, 3) impact on survival of the strategy; and 4) impact on the quality of life.

Cancer will be considered from 30 days up to 12 months after the diagnosis of VTE.

Scope: 20 Spanish hospitals. Design: Open-label, multicentre Randomized clinical trial (1: 1) comparing the performance of PET-CT versus limited screening for cancer.

Population: Patients older than 18 years with unprovoked VTE at high risk of presenting cancer at follow-up (≥3 points in the score of Jara-Palomares et al., Chest 2017).

Follow-up: 12 months after VTE. Sample: The sample size calculated is 650 patients, to obtain a power of 80%, with a level of significance of 5%, and taking into account a 10% loss of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years.
* Diagnosis of venous thromboembolic disease (proximal deep vein thrombosis of lower limbs, pulmonary embolism or both) unprovoked.
* High risk classification according to previously published and validated scale
* Signature of informed consent form

Exclusion Criteria:

* Impossibility to continue an adequate follow-up.
* Contrast hypersensitivity used for PET / CT (fludeoxyglucose (18FDG)) or any of the excipients according to the characteristics of the product.
A Systemic Screening for TB Disease in High-risk Groups in Barcelona

The purpose of this screening study is to identify and screen vulnerable population in Barcelona for active pulmonary tuberculosis

If eligible and verbal consent is obtained, individuals:

1. Will attend a small talk/lecture about Tuberculosis (TB) disease
2. Will be interviewed and screened for the presence of TB symptoms: cough, blood in sputum, fever, weight loss, night sweats and chills lasting for \>2 weeks
3. Individuals screened positive for TB will be referred to the hospital for further testing (Chest X-ray, visit, lab tests)

Eligibility Criteria:
Inclusion Criteria:

-Belonging to a population at high risk for tuberculosis (TB)

Exclusion Criteria:

-Not belonging to a population at high risk for tuberculosis (TB)
A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg

The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.


Eligibility Criteria:
Inclusion Criteria:

* Taking daily stable statin doses for at least 4 weeks prior to screening visit.
* LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or,
* LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit.
* Must be willing to discontinue other lipid-regulating therapies during the study

Exclusion Criteria:

* History of acute significant cardiovascular disease.
* Current clinically significant cardiovascular disease.
* History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.
Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn

Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To date, little information is known about the effect of hawthorn when taken with other drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects will be recruited by advertisement. The design of the study will include a 10-day and a three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover. There will be a three-week washout period in between treatment phases. On day 10 (phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration. Additionally, the subjects will be assessed for any clinical toxicities or adverse events. The significance of this study is to provide the clinician with information regarding the safe use of digoxin in combination with the herbal supplement, hawthorn.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Not regularly taking any prescription or non-prescription medications (including natural products or supplements) and is willing to avoid all medications other than the study drugs during the study period.
* Willing to avoid drinking any alcohol throughout the study period.
* Does not currently smoke and is willing to avoid smoking during the study period.
* Willing to adhere to dietary restrictions as required during the study.
An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients

1. Demographics data;
2. Nutritional evaluation data;
3. All biochemical monitoring data during the study period;
4. All nutritional treatment data will be recorded daily during the study period, including actual calorie intake, protein intake, and the proportion of calorie/protein administered by EN and/or PN route. The nutritional treatment protocol will be decided by the attending physician, the investigator will not intervene.
5. A blood sample (5 ml) will be drawn from every patient immediately after they enroll into the study, and the metabolomics of the samples will be analyzed analysis using a combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish metabolic profile baseline.
6. We will establish a sub-group that contains 20 patients (chosen from enrolled patients according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take one blood sample daily during the whole study period. The plasma sample will be used for metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be used for metabolic dynamic modeling.
7. Clinical outcomes data, which include: 1) Complications after the operation (intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization


Eligibility Criteria:
Inclusion Criteria:

* age: 18-70
* patients are underwent Whipple operation or subtotal gastrectomy and ever admitted to intensive care unit (ICU) after the operation
* receive parenteral or enteral nutrition \> 3 days

Exclusion Criteria:

* has metabolic disorders: diabetes, thyroid disease
* Pregnant or breastfeeding
* The presence of drug or alcohol dependence
* The presence of tuberculosis, HIV infection and other acute infectious disease
* Serious liver, kidney, heart and other vital organ failure