cyrilzakka/clinical-trials huggingface dataset:
Severe Sepsis/Septic Shock on Admission to the General Surgical ICU

Severe sepsis/septic shock are serious complications of infection with high morbidity and mortality. Recent information showed that early and aggressive resuscitation may help improving survival and outcome especially the resuscitation within the first 3 hours. In surgical patients, either severe sepsis/septic shock bought them to the operating room or this sepsis might be found after surgery resulting in higher morbidity and mortality. Not only knowledge management, others possible risk factors should also be identified and corrected for outcome improving. This prospective observational study will be done in 800 adult surgical patients admitting to the general surgical intensive care unit. Incidence of severe sepsis/septic shock on admission along with risk factors associated with poor outcomes \[organ failure (AKI, ALI, PMI, liver failure, stroke), prolonged ICU length of, stay, ICU death\] will be recorded especially effect of amount and type of fluid replacement in the first 6 hours, 24, 48 and 72 hours after diagnosis. Outcome as major organ failure, ICU length of stay, ICU, 28 and 90 days mortality will also be study.

Consecutive severe sepsis/ septic shock patients who will be admitted to the general surgical ICU of Siriraj Hospital, Mahidol University, Bangkok, Thailand will be recruited to this study. Apart from demographic data (age, sex, BMI, comorbidity), detail of septic shock and resuscitation (preoperative and intraoperative resuscitation), vasopressor and steroid used, type and amount of fluid, blood and blood component used and shock reversal time. Complication associated with surgery, anesthesia and in ICU will also recorded. Clinical outcome as organ failure (Stroke, PMI, aki, ARDS); ventilator day, ICU and hospital length of stay, mortality (in ICU, 28 and 90 days mortality) and cause of mortality will be carefully recorded

Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years) surgical patient admitting to the general surgical ICU
* Consent to this study

Exclusion Criteria:

* Patient undergoing cardiothoracic surgery, neurosurgery and traumatic surgery
* Not consent to this study
Treating Depression With Transcranial Direct Current Stimulation (tDCS)

The purpose of this study is to see if transcranial direct current stimulation may improve the symptoms of depression.

The purpose of this study is to learn about a brain stimulating procedure called transcranial direct current stimulation (tDCS). In tDCS therapy, two moistened sponges are applied to the forehead while a small amount of electric current flows between them. These electrodes are placed on the head so that the electricity will pass through a region in the brain that is believed to contribute to depression. This study is intended to test the theory that the electromagnetic field created by the current may affect this region of the brain in a way that may improve the symptoms of depression. This may affect brain activity and function.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of a major depressive episode or bipolar disorder and is currently in a major depressive episode (without psychotic features)
* Total pretreatment HDRS (Hamilton Depression Rating Scale)-24 score \>= 18 (The Hamilton Depression Rating Scale is an interviewer scored tool for assessing the severity of depressive symtoms. The scale ranges from 0 (no symptoms, absence of depression) to 64

Category Ham-24 Score Normal, not depressed 9 or less Mildly depressed 10 to 19 Moderately depressed 20 to 29 Markedly/severely depressed 30 or more)

* Capable and willing to provide informed consent

Exclusion Criteria:

* History of depression previously untreated with medication, bipolar disorder, schizophrenia, schizoaffective disorder (non mood disorder), psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), psychotic features in this or previous episodes, amnestic disorder, dementia or mms\<24, DELIRIUM
* Significant current history of autoimmune, endocrine, viral or vascular disorder affecting the brain
* History of unstable cardiac disease, uncontrolled hypertension, or sleep apnea
* Changes in psychotropic medications within two weeks prior to study entry or patient is unable to maintain stable doses throughout the study trial
* Subject has an active suicidal plan and/or attempted suicide in the past twelve months
* Patients with a CGI of 6 or greater
* Subject is pregnant or has a positive pregnancy serum test
Reversibility of Cardiac Conduction Disturbances Following TAVI

The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.

In this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI.

In this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for electrophysiological (EP) study after TAVI implantation according to European Guidelines. Patients must have persistent electrocardiographic conduction disturbances (ECG-CDs) that are present from day 2 after TAVI implantation (≥ 48h post-procedure):
* De novo LBBB with QRS complex \>150ms and/or PR interval ≥240ms.
* QRS widening or post-procedural PR lengthening \> 20ms in patients with baseline ECG-CDs.

Exclusion Criteria:

* Patients with previous pacemaker or implantable defibrillator.
* Patients with baseline complete right bundle branch block.
* Patients in need of cardiac resynchronization or physiological stimulation following TAVI.
* Valve-in-valve procedures.
* TAVI procedures in patients with severe aortic insufficiency.
* Inability to sign the informed consent form.
A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.

The purpose of this study is to determine the effectiveness of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).


Eligibility Criteria:
Inclusion Criteria:

* Genotypes Hb SS, Hb SC, sickle β°-thalassemia, sickle β+ -thalassemia
* Pain consistent with vaso-occlusive crisis (clinical judgment) and not attributable to other causes
* Serum CRP ≥5.0 mg/L at time of screening
* Fever defined as oral temperature ≥38.0°C at time of screening
* Age ≥5 years

Exclusion Criteria:

* New or suspected new pulmonary infiltrate diagnosed by chest radiography
* Females who are nursing, pregnant or intend to become pregnant
* Renal dysfunction defined as a creatinine level \>1.2 mg/dL for subjects aged 18 or less or a creatinine level \>1.5 mg/dL for subjects over the age of 18
* Hepatic dysfunction (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>3 × upper limit of normal)
* Acute neurologic dysfunction
* Any medical condition for which transfusion may be needed imminently, and/or hemoglobin \<5 g/dL
* Red blood cell transfusion within 30 days prior to screening
* Parenteral or oral corticosteroid therapy (inhaled steroids acceptable) within 7 days prior to screening
Remote Monitoring of Uroflowmetry

The aim of the study is to assess the possibility of using remote monitoring of urination.


Eligibility Criteria:
Inclusion Criteria:

1. Men over 18 years old.
2. The patient has performed uroflowmetry according to indications in the hospital no later than 7 days before the planned inclusion in the trial.
3. Qmax = or \<15 ml / sec.
4. The patient has a smartphone (with Android 4.0 and higher, iOS 10.0 and higher) with Internet access

Exclusion Criteria:

1. A patient with emergency conditions requiring surgical treatment
2. Intellectual and cognitive abilities of the patient that do not allow him to follow the doctor's instructions and make it difficult to use the smartphone.
Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

The main purpose of the present study is to perform a 10 weeks dietary intervention study with a follow-up for 52 weeks in children from 7-14 years of age with overweight or obesity. In a caloric restricted and increased physical activity setting the control group will consume a low-moderate protein (15E%/day) diet whereas the intervention group will consume a higher protein (25E%/day) diet. Furthermore, the investigators want to investigate the effect of frequent follow-up after intervention.

Compared to the low-moderate protein diet, the investigators hypothesis that a diet with higher consumption of protein-containing foods will more effectively induce weight loss (a reduction in BMI-SDS) or weight maintenance in children with overweight or obesity, and improve risk factors for type 2 diabetes and Quality of Life.

The study will be performed in collaboration with the staff of the well-established multi-component-overnight camps (Julemærkehjem) in Denmark. The multi-component-overnight camps are intensive weight loss camps to which Danish schoolchildren, from 7-14 years of age, are referred to for 10-weeks intervention focusing on healthy lifestyle, healthy eating, new habits and increased physical activity.

The primary outcome is anthropometry (BMI-SDS, fat mass, fat-free mass). Secondary outcomes are blood-tests measuring metabolic, inflammatory and liver markers and questionnaires investigating Quality of Life, Eating Behavior, Eating Habits and Disturbed Eating.

The children will be measured at baseline, 10-weeks and 52-weeks follow-up. Furthermore, participants will be invited to follow-up investigation 3 years, 5 years, 7 years and 10 years, respectively, after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* The child attends a multi-component-overnight camp in Hobro or Fjordmark between September 2020 and December 2021.
* The child is between 7 and 14 years of age (inclusive) while attending camp.
* At least one parent/guardian submit written and oral consent to participate with his/her child.
* Parent/legal guardian has submitted oral and written consent to participation of their child. In case of shared custody both parents must submit written and oral consent before their child can participate in the trial.

Exclusion Criteria:

* The child has a disease, diagnose or eating disorder that require treatment.
* The child or parent/guardian participate in another clinical trial or plan to do so in the near future.
* The parent/guardian do not understand the written informed consent.
* The child or parent/guardian are unwilling to or unable to comply with the study protocol and instruction given by the study staff.
A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers

The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* A minimum body weight of 50 kg and a body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2)
* A seated blood pressure between 90 and 140 millimeters of mercury (mmHg) systolic/50 and 90 mmHg diastolic (inclusive)
* Female subjects had a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening

Exclusion Criteria:

* A known allergy or history of significant adverse reaction to naloxone, other opioids or related compounds, or to any of the excipients.
* Any documented clinically significant infection, injury, or illness within 1 month prior to screening.
* An active malignancy of any type, or had been diagnosed with cancer within 5 years prior to screening.
* A documented history of alcohol or drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within 2 years prior to screening. Alcohol abuse was defined as greater than 14 drinks per week.
* Positive serology test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
* A positive urine test result for alcohol, drugs, or cotinine at screening or check-in.
* A condition that the Investigator believed would have interfered with the ability to provide informed consent or comply with study instructions, or that could confound the interpretation of the study results or put the subject at undue risk.
* Used any opioids for 30 days prior to Day 1.
* Required treatment with monoamine oxidase inhibitors (MAOIs) within 30 days prior to Day 1 and during the study.
* Presence of an ongoing upper respiratory infection, rhinitis, rhinorrhea, or nasal congestion.
Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial

This study will focus on grade I to III knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.

The current methods for treating knee osteoarthritis include delaying the disease progression and joint replacement surgery. The usual treatment methods are mostly temporary, such as taking drug and hyaluronic acid injection. Therefore, finding the safe and effective methods will greatly reduce medical resource, medical expenses and surgery cost, etc., and restore the patient's quality of life. Platelet lysate is the product of complete activation from autologous platelet. It contains rich growth factors and cytokines such as PDGF, TGF-β, VEGF, EGF and IGF, etc. It can support cell growth and doesn't have any white blood cells in it. It is superior to the platelet rich plasma because of reducing the overall inflammatory response and pain of the patient during treatment.

Eligibility Criteria:
Inclusion Criteria:

* 50 to 80 years old
* Study Subjects must be willing to sign Informed Consent to participate in the study
* In the past month, at least seven consecutive days in the squat, standing, walking or going up and down the stairs, the most serious degree of visual analogy of the knee pain (Visual Analogue Scale) is greater than or equal to 40 (the most pain is 100, not painful is 0)
* Morning joint stiffness is less than 30 minutes
* X-ray：Grade 1-3 radiographic OA as defined by the K-L classification

Exclusion Criteria:

* Knee instability
* The knee joint is obviously deformed (\> 5 degree valgus or varus deviation on X-ray)
* Clinical diagnosed as Pes tendinitis, Chondromalacia
* Taking NSAIDs or steroids (including oral and injection) within one week
* Using anticoagulant drugs for a long time
* Platelet count is less than 150,000 / UL, or coagulation disorders, prothrombin time (PT value) is less than 11 seconds or greater than 16 seconds
* Leukemia, sepsis, platelet dysfunction or other blood related diseases
* tumors, infections or the trauma before the same site
* Pregnancy
Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers

The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine. The investigators believe that etravirine's drug concentrations will be increased when administered in combination with boceprevir. Additionally, the investigators believe that boceprevir and etravirine are safe when administered alone or in combination.

To investigate the potential for drug interactions between boceprevir and etravirine, participants will receive each drug alone and the drugs in combination for 11-14 days. The pharmacokinetics of boceprevir and etravirine when given in combination vs. alone will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-60 years
* Absence of HIV-1 and HCV antibodies at screening
* Ability and willingness to give written informed consent before the first trial-related activity

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements.
* Participation in any investigation drug study within 30 days prior to study.
* Currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results.
* Use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions:aspirin, acetaminophen, once daily multivitamins, mineral supplements and hormonal oral contraceptives (other than those that contain drospirenone). Concomitant medications other than those listed above must have been discontinued at least 14 days before study entry.
* Currently active dermatitis or urticaria or diagnosis of eczema or psoriasis.
* History of significant drug allergy (i.e., anaphylaxis and/or angioedema)
* Subjects with the following laboratory abnormalities at screening as defined by the 2004 Division of AIDS Table for grading the Severity of Adult and Pediatric Adverse Events and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (\>1.1 x upper limit of laboratory normal range (ULN); hemoglobin grade 1 or greater (≤ 10.9 g/dL); platelet count grade 1 or greater (≤ 124.999 x 109/L); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN); total bilirubin grade 1 or greater (≥ 1.1 x ULN), any other laboratory abnormality of grade 2 or above
Smoking Cessation Smartphone App for Cancer Patients (Quit2Heal Study)

The goal of this study is to determine whether the novel smartphone application designed specifically for cancer patients to quit smoking (Quit2Heal) provides higher quit rates than the current standard smoking cessation app.

Cigarette smoking has harmful effects on cancer patients' treatment and prognosis, but there are systemic barriers to delivering smoking cessation interventions to cancer patients. One solution for addressing these barriers is to give patients immediate access to smoking cessation treatment via a smartphone application. The Quit2Heal smartphone app is engaging and tailored to the specific needs of cancer patients, and can be integrated into routine cancer care. The goal of this study is to determine whether Quit2Heal provides higher quit rates than the current standard smoking cessation app.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* diagnosed with cancer in the past 12 months
* has smoked a cigarette (even a puff) in the past 30 days
* interested in learning skills to quit smoking
* willing to be randomly assigned to either smartphone application
* resides in US
* has at least daily access to their own smartphone
* knows how to login and download a smartphone application from the Apple app store or Android Play app store
* willing and able to read in English
* not currently using cessation medications or enrolled in other smoking cessation programs, and
* has never used the NCI's Quit Guide smartphone application.
* willing and able to complete one follow-up survey
* willing to provide email, phone, and mailing address.

Exclusion Criteria:

* The exclusion criteria are opposite of the inclusion criteria listed above.
Contrast Echocardiography in Patients With Pulmonary Arteriovenous Malformations (PAVMs)

Pulmonary arteriovenous malformations (PAVMs) are thin-walled abnormal vessels which provide direct capillary-free communications between the pulmonary and systemic circulations. Patients with PAVMs have usually have low blood oxygen levels and are at risk of other complications including strokes, brain abscesses, pregnancy-related complications and haemorrhage. We hypothesise that the complications of PAVM patients arise from their PAVMs and not the more recognised intracardiac forms of shunting. We propose to perform echocardiograms to enable assessment of the presence of other causes of capillary-free communications between the pulmonary and systemic circulations.


Eligibility Criteria:
Inclusion Criteria:

* patients with pulmonary arteriovenous malformations (PAVMs)

Exclusion Criteria:

* unable to provide informed consent
Feasibility Study of Metformin Therapy in ADPKD

This study is being done to determine if treatment with metformin, a drug widely used for the treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly decreased kidney function. The study will also evaluate the effects of metformin on kidney growth and kidney function.

Patients with ADPKD are still in need for a well-tolerated treatment that can be used long-term to prevent cyst growth and kidney function decline. Metformin has a long track record of a low risk-to-benefit profile in patients with diabetes or at risk for diabetes. Metformin inhibits two key processes responsible for the growth of polycystic kidneys, i.e. fluid secretion and cell proliferation, as shown in cell cultures and animal models of ADPKD. Experiments in animal models of chronic kidney disease demonstrate that metformin administration prevents kidney fibrosis and preserves kidney function. Diabetic patients who are treated with metformin appear to develop less kidney failure and live longer than patients who are treated with other anti-diabetic medications. Therefore this drug is promising for people with ADPKD, with the potential to slow cyst enlargement and preserve kidney function.

Eligibility Criteria:
Inclusion Criteria:

* Autosomal Dominant Polycystic Kidney Disease and
* An estimated glomerular filtration (GFR) rate of 50-80 ml/min/1.73 m2;
* Subject is able to sign an Informed Consent

Exclusion Criteria:

* Diabetes mellitus,
* Active infection,
* Congestive heart failure,
* Liver disease,
* Alcohol or substance dependence,
* Cigarette smoking within the last 12 months;
* Females who are pregnant or breast feeding, or
* Are unwilling to use contraception;
* Are unable to undergo magnetic resonance imaging, or
* Have a contraindication to the use of metformin