cyrilzakka/clinical-trials huggingface dataset:
A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®)

The general aim of this study was to assess the feasibility of treating acute myocardial infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition by paramedics


Eligibility Criteria:
Inclusion Criteria:

* Ischemic cardiac pain of \>= 20 minutes and \<= 6 hours
* Age 18 - 80 years
* Ability to give informed consent (witnessed verbal or written)
* Ability to follow protocol and comply with follow -up requirements

Exclusion Criteria:

* Current participation in another clinical trial
* Patient will be ineligible for pre hospital administration of actilyse if any of the following apply:

  * Acute myocardial infarction (AMI) treated with a thrombolytic agent within the preceding 4 days
  * BP (blood pressure) \> 180/100 mmHg (on one measurement)
  * Significant bleeding disorder within the past 6 months
  * Major surgery, biopsy of a parenchymal organ, or significant trauma (including any trauma associated with the current AMI) within 3 months
  * History of stroke, transient ischaemic attack, or central nervous system structural damage (e.g. neoplasm, aneurysm, intracranial surgery)
  * Oral anticoagulation
  * Recent (within 10 days) non - compressible vascular puncture
  * Pregnancy (positive urine pregnancy test) or lactation, parturition within the previous 30 days, or female of childbearing potential not using adequate birth control (oral contraception)
  * Severe liver disease, including hepatic failure, cirrhosis portal hypertension (oesophageal varices) and active hepatitis
  * Diabetes with definite history of retinopathy
  * Other serious illness (e.g. malignancy, active infection)
  * Bacterial endocarditis / pericarditis
  * Acute pancreatitis
  * Documented ulcerative gastrointestinal disease during last 3 month, arterial aneurysms, arterial / venous malformations
  * Any other condition that the investigator feels would pose a significant hazard to the subject if the investigational therapy was to be initiated
* Patients who are not excluded from thrombolytic therapy by the criteria above will, in addition, need to satisfy the following 'inclusion' criteria prior to the pre - hospital thrombolysis:

  * 12 lead ECG criteria: ST segment elevation \>= 0.1 mV in two contiguous electrocardiogram (ECG) standard leads indicative of AMI, or ST elevation \>= 0.2 mV in two contiguous chest leads and all left bundle branch block (LBBB) with clinical indication of AMI
Rituximab in Recurrent IgA Nephropathy

Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline for the care of kidney transplant recipients has concluded that there are no definite strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney is common and may contribute to graft loss, in particular, if cresentic formation, extra- or endocapillary proliferation were presented in kidney pathology. Herein, the investigators assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the investigators speculate that rituximab may have potential effect to reduce circulating polymeric forms of IgA and slow progression of recurrent IgAN.

Hypothesis: In kidney transplant recipients with active endocapillary proliferation pathology of recurrent IgAN, an intravenous infusion of 375mg/m2 of rituximab on 4 consecutive monthly dose is superior to conventional therapy in reducing 24-hour proteinuria, and slowing progression of recurrent IgAN.

Eligibility Criteria:
Inclusion Criteria:

* Any kidney transplant recipients between the age of 18 and 70 years of age and able to give informed consent
* GFR by 24h Creatinine Clearance (CrCl) \>30 ml/min/1.73m²
* Biopsy proven recurrent IgA nephropathy with endocapillary proliferation pattern

Exclusion Criteria:

* Clinical and histologic evidence of IgA combination with other forms of glomerulonephritis
* Clinical evidence of cirrhosis, chronic active liver disease or known infection with hepatitis B, C or HIV
* 24h CrCl \<30 ml/min/1.73m² at the time of screening
* Active systemic infection or history of serious infection within one month of entry
* Positive pregnancy test or breast feeding at time of study entry
* Patients receiving \>6 months therapy with oral prednisone \>5mg/day or glucocorticoid equivalent
* Live vaccine within 28 days of study enrollment.
Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season

This prospective annual release study is designed to evaluate the safety of 3 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza season

This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible participants will be randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 3 sites in the United States of America. Each participant will receive 1 dose of investigational product on Day 1. The duration of study participation for each participant is the time from study vaccination through 181 days after study vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 49 years
* Written informed consent
* Participant available by telephone
* Ability to understand and comply with the requirements of the protocol, as judged by the Investigator

Exclusion Criteria:

* Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
* History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations
* Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (example \[eg\], asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
* Acute febrile (greater than \[\>\] 100.0 degrees Fahrenheit \[F\] oral or equivalent) and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days prior to randomization
* Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
* History of Guillain-Barré syndrome
Lesinurad Tablet Relative Bioavailability

This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.

A change in manufacturing site of lesinurad tablets has been implemented. This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2.
* Subject has a Screening sUA value ≤ 7.0 mg/dL.
* Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

Exclusion Criteria:

* Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
* Subject has a history or suspicion of kidney stones.
* Subject has a history of asthma.
* Subject has undergone major surgery within 3 months prior to Day 1.
* Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities

Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.

The objective of this study is to investigate the effect of variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb results in more weight reduction.

The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.


Eligibility Criteria:
Inclusion Criteria:

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

* BMI 35 - 40 with a comorbidity
* or BMI \> 40

Redo- operation

* medical history: gastric sleeve/ mason / gastric band
* all BMI levels

Exclusion Criteria:

* Exclusion criteria for bariatric surgery (Fried Guidelines)
* Patients with language problems that interveins to follow medical advises
* Genetic diseases that intervens to follow medical advises
* Chronic bowel diseases
* Nephrologic (MDRD \<30) of liver diseases (AST/ALT more than twice the norm)
* Pregnancy
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator.

This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator. The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.

Eligibility Criteria:
Inclusion Criteria:

Adults ≥ 18 years of age.

Diagnosed with T2DM for at least 6 months.

HbA1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening.

Body mass index of ≥ 23 kg/m2.

Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change).

Exclusion Criteria:

Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma.

History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment.

Have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.

Received medication for weight loss within the last 3 months prior to screening.

Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract.

Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).

History of acute or chronic pancreatitis.
Comparison Between 2 Treatment Modalities of Trigger Finger: Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the Treatment of Trigger Finger

Trigger finger is a common cause of hand disability and pain in the general population. It is a pathologic condition of the digital pulleys and flexor tendons. Although the pathogenesis is incompletely clear and multifactorial, the most common cause of the trigger finger is the thickened flexor tendon and/or thickened first annular (A1) pulley located at the metacarpophalangeal joint. Currently, ultrasound is considered an effective and valuable tool for assessing the trigger finger, providing static and dynamic evaluations of this condition and a comparison with the adjacent normal digits. Recently, it has been reported that ultrasound-guided percutaneous A1 pulley precise release using a needle knife has received increasing attention in the clinical treatment of trigger fingers and achieved good results. To our knowledge, this is the first clinical study comparing the efficacy and safety of ultrasonic-guided percutaneous A1 pulley release with a needle knife and the ultrasonic-guided steroid injection in treating trigger fingers.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic trigger finger
* Trigger finger at the level of A1 pulley
* Trigger finger of Green's grades II or III

Exclusion Criteria:

* Patients with secondary causes of trigger fingers like diabetes mellitus, rheumatoid arthritis, gout, hypothyroidism, amyloidosis, and sarcoidosis.
* Patients with a previous history of first annular pulley release or injection.
* Patients with trigger fingers of Green's grade I and IV.
* Patients with trigger fingers at any level other than the A1 pulley.
International Study of Inflammation in COVID-19

This is a prospective multi-center observational study which purpose is to evaluate the ability of blood-based inflammatory markers to risk-stratify patients hospitalized for Covid-19. Blood-based biomarkers examined include: soluble urokinase plasminogen activator receptor (suPAR), C-reactive protein (CRP), procalcitonin, D-dimer, ferritin, lactate dehydrogenase and interleukin-6.

All consecutive patients hospitalized specifically for Covid-19 at the University of Michigan in Ann Arbor from February 1st, 2020 to date are included. Other participating centers will enroll patients depending on their variable capacity. Patients with a positive test for SARS-CoV-2 but hospitalized for non-Covid-19 reasons were excluded. Blood-based biomarkers including soluble urokinase plasminogen activator receptor (suPAR), C-reactive protein (CRP), procalcitonin, D-dimer, ferritin, lactate dehydrogenase and interleukin-6 are measured in samples collected within 48 hours of presentation. The primary outcome of the study is the composite endpoint of in-hospital mortality, need for mechanical ventilation and need for renal replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2 test result
* Covid-19 as the primary reason for hospitalization

Exclusion Criteria:

* Hospitalized primarily for non-Covid-19 reasons
Ventilation-Perfusion Matching in Early-stage Prone Position Ventilation

Prone positioning has been widely used in critical care medicine to improve oxygenation in patients with acute respiratory distress syndrome (ARDS). This study aimed to compare the effect of pronation on lung ventilation-perfusion matching between COVID19-associated acute respiratory distress syndrome (CARDS) and ARDS from other etiologies (non-CARDS) using electrical impedance tomography (EIT).

In this prospective study, both COVID19-associated ARDS (CARDS) patients and patients with ARDS from other etiologies (non-CARDS) were enrolled. Electrical impedance tomography (EIT) was used to evaluate the changes in ventilation and perfusion between supine and prone positions. Baseline values of the area of DeadSpace, shunt, ventilation-perfusion matching (VQmatch) were identified at the time of enrollment. Within the defined VQmatch region, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region. Prone position was applied immediately after the baseline data were collected. After 2 hours of proning, another EIT examination was conducted. Parameters such as DeadSpace, shunt, VQmatch, and other common measurements before and after pronation were taken and compared to evaluate the effect of prone positioning on CARDS and non-CARDS patients.

Eligibility Criteria:
Inclusion Criteria:

* Above the age of 18
* Diagnosed with ARDS based on the Berlin Definition of ARDS
* Under mechanical ventilation

Exclusion Criteria:

* Contraindications to EIT examination and prone position
* Refusal of signing the informed consent
Additive Beneficial Effects of Atorvastatin Combined With Amlodipine In Treatment of Hypertension

The investigators hypothesized combination therapy would be superior to monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension

Exclusion Criteria:

* Chronic renal disease
* Severe hypertension
A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients with Solid Tumors

To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors.

This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of IT injections of VRT106 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of VRT106 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of VRT106, and preliminarily exploring the anti-tumor effects of VRT106.

Eligibility Criteria:
Inclusion Criteria:

* Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
* Males and females at 18-75 years of age, inclusive, at the Screening Visit.
* Subjects must have histological or cytological diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
* Have at least one injectable lesion.
* An Eastern Cooperative Oncology Group (ECOG) score of 0-1.
* An estimated survival time of ≥ 12 weeks.

Exclusion Criteria:

* Subject has received any anti-tumor treatment 4 weeks before using the IMP.
* Subject has received any prior oncolytic viruses or other gene therapies.
* Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
* Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
Health Benefits of Tart Cherry in Ulcerative Colitis

Ulcerative Colitis (UC) is a long-term inflammatory condition of the digestive tract. People with UC often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. In addition, they require long-term treatment with frequent negative effects, the need of surgery and hospitalisations. Therefore, people with UC report a lower health-related quality of life (HRQOL) compared with healthy individuals. The most common medication for inflammatory bowel disease is a strong immunosuppressant which has previously (in 2017) been found to be the most expensive medication prescribed at hospitals in the NHS. Unfortunately, biologics has a lot of negative side effects and thus reducing the need of them in patients can benefit both the NHS as a whole by reducing the cost and improving the quality of life of patients by reducing the unwanted side effects of the biologics. Supplementation of Montmorency tart cherry juice might be a simple, safe, and low-cost intervention for improving symptoms in patients with UC. This is because it has the potential to naturally reduce inflammation in the digestive system and thus improve symptoms. Research in animal models has shown a potential for improvement in physiological responses with similar supplements including blueberries, black raspberries and even Montmorency tart cherries, with only one study in human participants exploring bilberry supplementation.

However, despite anthocyanins concentrations from Montmorency tart cherries being superior to other berries, dietary interventions using tart cherry supplementation for UC have not received any attention in human participants. The primary purpose of the proposed investigation is to undertake a placebo randomized control trial examining the ability of a Montmorency tart cherry juice supplement to provide symptom relief and health related wellbeing outcomes in those with mild to moderately active UC and to understand the biological mechanisms behind any changes in symptoms.


Eligibility Criteria:
Inclusion Criteria:

* An established diagnosis of UC for at least 6 months
* Current mild to moderate disease activity
* Age between 18 and 65 years
* Stable use of medication for at least 3 months respectively.

Exclusion Criteria:

* Diabetes
* HIV
* Hepatitis B and C infection
* Abscesses
* Unstable medical conditions that would likely prevent the subject from completing the study
* Food allergies to cherries.
The Impact of Water Activities on Motor Development in Infants

The study will be conducted at various city swimming pools in Warsaw. The study participants will include 20 infants participating in aquatic baby classes once a week and 20 infants not participating in any classes and their parents. The study will be conducted in a quiet and calm room, which will be prepared in advance and equipped with a smooth mat, a lounger and infant toys. The estimated time to conduct the study is about 30 minutes.

The examination will be carried out twice: before the start of the two-month course and after its completion. Each time in the presence of a parent or legal guardian, after signing a consent form for the study.

The selected methods of assessing motor development are fully non-invasive and consist of the following tests:

1. Alberta Infant Motor Scale (AIMS)-a test involving observation of motor development, in which each activity is assessed as existing or not. The sum of the scores from all trials is then placed on a centile grid, the results of which will indicate how many children of a certain age are achieving a given level of motor skills.
2. Early Motor Development Questionnaire (EMQ)-will be conducted on the basis of a ready-made form and in an anonymous manner based on parents' current knowledge of their children's development.


Eligibility Criteria:
Inclusion Criteria:

* infants age 3-12 months

Exclusion Criteria:

* any disability that would affect motor development