cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.


Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
* Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
* Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene grafts: a) Femoral-femoral bypass grafting, b) Femoral-popliteal bypass grafting, c) Femoral-distal bypass grafting, d) Ilio-iliac bypass grafting, e) Ilio-femoral bypass grafting, f) Ilio-popliteal bypass grafting, g) Aorto-iliac bypass grafting, h) Aorto-femoral bypass grafting, i)Axillo-femoral bypass grafting, and j) Upper extremity vascular access for hemodialysis.
* A target bleeding site can be identified.
* Target bleeding site has moderate arterial bleeding.

Exclusion Criteria:

* Undergoing a re-operative procedure.
* Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
* Have an infection in the anatomic surgical area.
* Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
* Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
* Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
* Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
* Target bleeding site cannot be identified.
* Target bleeding site has mild or severe arterial bleeding.
* Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
* Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria.
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Eligibility Criteria:
Inclusion Criteria:

* Male or female in good general health
* Must have presbyopia

Exclusion Criteria:

* History of allergic reaction to the study drug or any of its components
* Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results
The Efficacy and Safety of TAF vs Other NAs in Patients With LVL

Patients with chronic hepatitis B should maximize the inhibition of HBV replication, which could reduce the incidence of liver cancer and liver disease-related complications. However, after 96 weeks of treatment with the first-line drugs, entecavir or tenofovir disoproxil fumarate, a certain proportion of patients still had low levels of HBV replication. Tenofovir alafenamide fumarate is a newly marketed anti-hepatitis B drug that is currently considered to be non-inferior to tenofovir disoproxil fumarate and safer bone and renal effects. Therefore, this research was put forward to investigate whether tenofovir alafenamide fumarate replacement for hepatitis B had a higher virological response rate and safety in patients with low levels of virus after 48 weeks of treatment with entecavir and tenofovir disoproxil fumarate.

Patients who meet the inclusion and exclusion criteria will be enrolled into the research. The participants will voluntarily choose to enter the experimental group or the control group with full informed consent. The control group will continue with the original regimen, while the study group will switch to tenofovir alafenamide fumarate antiviral therapy. Each group will enroll 100 participants.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg positive for over half a year;
* Age from 18 to 80 years old;
* Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate (300mg qd) for 48 weeks or more;
* HBV DNA level was between 20IU/ ml-2000 IU /mL (COBAS, Taqman).

Exclusion Criteria:

* Low-level viremia of HBV caused by non-standard medication;
* serum total bilirubin is more than 2 times the upper limit of normal (ULN), or ALT or AST is more than 5ULN, or serum albumin is less than 30g/L;
* Overlap with HAV, HCV, HDV, HEV or HIV infection;
* Other liver disease: drug liver disease, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease, etc.;
* Decompensated cirrhosis or liver cancer;
* Kidney damage, or autoimmune disease, or other organ failure;
* Combination of Entecavir or Tenofovir disoproxil fumarate ;
* Interferon therapy within half a year;
* Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate;
* Investigator considering inappropriate.
Effects of Different Physiotherapy Programs on Functional Constipation

This study compares the effectiveness of a more comprehensive behavioral treatment, physical activity and exercise program, as well as CTM and IF current stimulation approaches at different frequencies on functional constipation symptoms and quality of life, compared to their counterparts in the literature.

Functional constipation (FC), which is characterized by conditions such as excessive straining and difficulty in defecation, infrequent bowel movements, and incomplete defecation, is a common bowel disease that causes activity limitation and decrease in quality of life in children and adults, regardless of an organic etiology.

In the literature, there are studies showing the effectiveness of different physiotherapy approaches such as behavioral therapy, exercise, neuromodulation applications, kinesiotape, abdominal massage in FC, and investigate and compare the effectiveness of connective tissue manipulation (CTM) and interferential (IF) current stimulation applied in addition to behavioral therapy and exercise program. But there was any study which compare the effectiveness of these physiotherapy methods with each other and IF current stimulation at different frequencies (100 Hz and 0-100 Hz). In addition, there are no randomized controlled studies comparing the current effects of IF applied at 100 Hz and 0-100 Hz in individuals with FC.

The treatment methods to be applied in this study are behavioral therapy, physical activity and exercise program, CTM and IF current stimulation applied at a frequency of 100 Hz and 0-100 Hz.

The diagnostic method to be used is based on the Rome IV FC Criteria and the Bristol Stool Form Scale.

Eligibility Criteria:
Inclusion Criteria:

* being able to read and write in Turkish,
* being between 18 and 65 years of age
* having a diagnosis of functional constipation according to Rome IV criteria
* having body mass index \<35 kg/m2

Exclusion Criteria:

* being pregnant
* having comorbidities (chronic pelvic pain, neurological (Parkinson's, Multiple sclerosis, Spinal cord lesion, etc.), metabolic / endocrine (Diabetes Mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases
* health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.)
* malignancy, acute inflammation, intestinal tumor
* history of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy
* contraindications to Interferential Current (thrombosis, pacemaker, metal implant etc.)
* visual, auditory or cognitive problems which may prevent participation to the study
* tumor, presence of skin problems in the application area
* presence of laxative use for functional constipation in the last four weeks
* alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer)
Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®

The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women aged between 19 and 65
* Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume)
* Defect: isolated International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on articular cartilage
* The joint space is maintained over 50% relative to baseline
* Patients that are able to walk without aid
* Patients that agree to abide by strict rehabilitation protocols and follow-up programs
* Patients who provide written consent to the participation of the clinical trial

Exclusion Criteria:

* Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
* Kellgren and Lawrence grade ≥ 3
* Patients with arthritis associated with autoimmune diseases
* Patients hypersensitive to bovine protein
* Patients with Haemophilia or markedly reduced immune function
* Patients hypersensitive to antibiotics like gentamicin
* Patients with arterial bleeding and severe venous bleeding
* Patients with other diseases including tumors except for cartilaginous defects of joints
* Patients with a history of radiation treatment and chemotherapy within the past two years
* Patients who are pregnant, nursing a baby or likely to get pregnant
* Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
* Other cases where the investigator deems the patient ineligible for participation
iNOPulse for COVID-19

This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or above
2. Proven COVID-19 viral infection. Non-confirmed highly suspicious suspects may be enrolled.
3. Presence of radiographic findings compatible with pneumonia/pneumonitis.
4. Patients requiring at least 3 L/m oxygen via nasal canula to maintain O2 above 92%.
5. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine).
6. Willing and able to comply with treatment schedule and study procedures.

Exclusion Criteria:

1. Patient with severe hypoxemia who are unable to maintain an oxygen saturation (SpO2) \> 88% on a maximum supplemental oxygen of 6 L/m by nasal cannula and a non-rebreather facemask.
2. Participating in any other clinical trial for COVID-19
3. Pregnancy, or positive pregnancy test in a pre-dose examination.
4. Open tracheostomy.
5. Clinical contra-indication, as deemed by the PI or their designee.
6. Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as intravenous lidocaine, or topical benzocaine or dapsone at screening.
7. Known history or clinical evidence of heart failure or left ventricular dysfunction (LVEF \< 45%).
8. Significant hemoptysis
9. Unable to provide informed consent (proxy consent is acceptable if available)
10. Any of the following conditions at time of possible enrollment: Fulminant Liver Failure, Acute Coronary Syndrome , Renal Failure requiring dialysis, Bacteremia, Shock, Cardiac arrest, Cardiac arrhythmia requiring acute treatment, Delirium / Encephalopathy, Severe Disseminated Intravascular Coagulation, Gastrointestinal hemorrhage, Hypoglycemia, Pneumothorax, Rhabdomyolysis / Myositis, Seizures, or Acute Stroke
3D Camera - Telemedical Foot Ulcer Treatment

Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel.

The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "Diabetic Foot Study Group". Age 18-90 years

Exclusion Criteria:

* Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)
Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods

In this study, patients were retrospectively included, univariate and multivariate analysis of factors affecting their diagnosis inconsistencies was performed, and a new diagnostic model was constructed by logistic regression.

The evaluation of coronary function is becoming more and more important in the guidelines, in which coronary flow reserve (FFR) is the gold standard for diagnosis, but its measurement process requires the application of adenosine, vasodilator, etc. Some patients cannot be measured because of asthma and low blood pressure. A new instantaneous wave-free ratio (iFR), contrastive flow reserve fraction (cFFR) and quantitative flow fraction (QFR) have been developed for the evaluation of coronary function. However, in some patients, the new coronary function evaluation methods were inconsistent with FFR. In this study, patients were retrospectively included, univariate and multivariate analysis of factors affecting their diagnosis inconsistencies was performed, and a new diagnostic model was constructed by logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 and below 80 years old, regardless of gender;
* FFR was detected by coronary angiography;
* The coronary angiography images were clear, meeting the requirements of QFR analysis or detecting iFR, cFFR, and resting pd/pa during the operation.

Exclusion Criteria:

* 1) Coronary artery bypass graft (CABG);
* 2) Atrial fibrillation or flutter;
* 3) Left or right coronary opening lesions;
* 4) Pregnancy or breastfeeding.
Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)

Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years
* Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1).
* Current inhalative therapy with 5 µg iloprost using the I-Neb nebulizer
* WHO functional class III at the time of the patient's commencement of inhalative therapy with iloprost
* Hemodynamic diagnosis of Pulmonary arterial hypertension(PAH) showing mean pulmonary arterial pressure (mPAP) \> 25 mmHg, pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) \< 15 mmHg and pulmonary vascular resistance (PVR) \> 320 dyn•s•cm-5
* If non-specific types of chronic treatment for PAH are being administered: Stable dosage of these for at least the 4 weeks up to screening
* If PAH-specific drug treatments (such as endothelin receptor antagonist (ERA) or phosphodiesterase-5 (PDE5) inhibitors) are being administered: Stable dosage of these for at least the 3 months up to screening.

Exclusion Criteria:

* PAH related to any other etiology, especially to pulmonary veno-occlusive disease (PVOD)
* Clinically relevant obstructive lung disease
* Evidence of thromboembolic disease (probable pulmonary embolism) within 3 years before screening
* Cerebrovascular events within 3 months before screening
* Atrial septostomy within the 6 months before screening
* Severe arrhythmia, or severe coronary heart disease or unstable angina, or myocardial infarction within 6 months before screening, or congenital or acquired valvular defects with clinically relevant myocardial function disorders unrelated to PAH
* Systolic blood pressure \< 85 mm Hg, or uncontrolled systemic hypertension (systolic BP \> 160 mmHg or diastolic BP \> 100 mmHg)
* Hepatic impairment (Child Pugh B, C) or chronic renal insufficiency (creatinine \> 2.5 mg/dl) and /or requirement of dialysis
* Clinically relevant bleedings disorders or conditions with increased risk for hemorrhages (active ulcers, trauma etc.)
* Addition or dose change of PAH specific drug treatments such as ERA or PDE5 inhibitors within 3 months before screening, or addition or dose change of non-specific treatments for PAH such as calcium channel blockers, nitrates, digitalis, diuretics within 4 weeks before Screening, or any kind of prostanoid other than those mentioned in inclusion criteria within less than 5 half-lives before treatment
Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis

We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and placebo (NSS) controlled in a double-blind RCT.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic primary knee osteoarthritis with failed conservative treatment at least 3 months
* Kellgren-Lawrence grade I-III
* Gave informed consent
* Can do questionnaires

Exclusion Criteria:

* Severe deformity (varus or values from mechanical axis more than 5 degrees
* Allergy to hyaluronic acid
* Pain on hip or ankle
* Post-traumatic or post surgery of lower extremity
* Post infection of knee
* Previous hyaluronic acid injection within 6 months
* Pregnancy or lactation
* Underlying Rheumatoid arthritis, stroke, malignancy, venous occlusion
Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S. Aureus

The goal of this study is characterize the changes in bacterial diversity of the nares of hemodialysis patients. Another goal is to determine when hemodialysis patients become colonized with the bacteria Staphylococcus aureus, as nasal colonization with S. aureus is a major risk factor for invasive infection in hemodialysis patients. Fifteen subjects will be recruited into the study. Nasal swabs will be collected every month for six months or until one month after S. aureus colonization in order to determine any changes in the bacterial communities of the nose. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities in the patients' noses. This study will provide preliminary data on whether oral- and/or nasal-administered probiotics can eliminate nasal carriage of S. aureus.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 years or older
* On a stable hemodialysis schedule three times a week at Tufts Medical Center outpatient hemodialysis unit
* Able to speak English, Spanish, Cantonese, or Mandarin (One of these languages is spoken by \>95% of our hemodialysis population)
* Provides informed consent to participate in the study
* No plans to be absent from the dialysis unit in the next 6 months
* Willingness to report on adverse events during the study period

Exclusion Criteria:

* Patients in which hemodialysis was indicated for acute renal failure secondary to septic shock, acute tubular necrosis, or other condition which is felt to be temporary or secondary to a life threatening illness or likelihood of hemodialysis for less than 6 months.
* Treatment with systemic anti-staphylococcal antibiotic therapy within 30 days prior to enrollment or planned use of topical mupirocin applied to the nares
* Receiving peritoneal dialysis (concordance between the colonizing and infecting strain is not as high as in the hemodialysis population (105))
* Absolute neutrophil count less than 500/mm3 or anticipated fall in neutrophil count \< 500/mm3 (e.g. as a result of recent chemotherapy)
* Bleeding diathesis such as platelets count less than 20 or INR \>4 within the last 30 days
* On immunosuppressive therapy
* Anticipated renal transplant during the next 6 months
* Evidence of active bowel leak, acute abdomen or colitis
Observational Study of the Remodelling Process Following Myocardial Infarct

This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.

A multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. The trial was terminated in 2002 and the results of the main trial have been published. In this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. A total of 235 patients were included from 18 centres. Blood was taken at randomisation, 1 month, 1 year and 2 years.

The present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the Stavanger University Hospital. The study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction.

The data collected at the 3-year follow-up visit will be compared to data from the initial study.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the previous neurohormonal substudy of the OPTIMAAL trial
* Willingness to participate in the present study and ability to understand and sign the written informed consent

Exclusion Criteria:

* Myocardial infarction within 3 months of visit 1.
* Significant primary valve disease, confirmed by ECHO cardiography,
* Autoimmune disease likely to cause an increase in collagen turnover
* Active cancer disease
* Immunosuppressive treatment,
* Significantly reduced liver function
* Contraindications for performing a cardiac MRI scan (including claustrophobia, implanted ferromagnetic devices or known allergic reactions to Omniscan™).
* Inability to cooperate during the 1 month follow up period.