cyrilzakka/clinical-trials huggingface dataset:
Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study

Investigation of the effect of mechanical ventilation on biomarkers of microvascular damage

The objective of this study is to determine the effect of mechanical ventilation (MV) on endothelial biomarkers associated with ventilator-induced vascular injury (VIVI), and determine the correlation of these biomarkers with non-invasive microvascular perfusion monitoring data and semaphorin 3E levels.

Blood samples will be collected immediately pre-operatively and post-operatively.

Biomarkers will be expressed as an absolute value and as a relative percentage change from baseline to account for inter-individual variability. Hemodynamic and surgical variables will be extracted from the OR data: blood pressure, oxygen saturation, blood loss, fluid administration, length of surgery, and MV parameters such as tidal volume, inspired oxygen, respiratory rate, and positive end-expiratory pressure.

During surgery, patients will be monitored using a non-invasive near-infrared spectroscopy technique to quantify skeletal muscle microvascular perfusion. These devices will be applied immediately prior to induction of anesthetic and data collected until immediately prior to transfer to the post-anesthesia care unit.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or greater
* Patients undergoing elective orthopedic, endourologic, or plastic surgery procedure which is amenable to both general anesthetic or regional/neuraxial anesthesia

Exclusion Criteria:

* Emergency surgery
* Polytrauma
* Tourniquet use
* Controlled hypotension
* Mechanical ventilation less than 60 minutes in duration
* American Society of Anesthesiologists class 4 or greater
* Status postpneumonectomy
* Pulmonary hypertension
* Oxygen therapy during last month
* Severe obesity (body mass index ≥40 kg/m2)
* Immunosuppression within 3 months
* Diagnosed infection
* Shock
Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib

The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participated in and completed a previous dasatinib protocol (including but not limited to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving benefit from dasatinib as defined by the previous protocol
* Receiving dasatinib at the time of signature of informed consent
* Males and Females, ages 18 and older

Exclusion Criteria:

* All patients previously discontinued from a dasatinib study for any reason
* Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
* History of allergy to dasatinib
Effects of Low- Load Strengthening Using Different Exercises Modes During Blood Flow Restriction for Treating Shoulder Impingement Syndrome

Purpose of the study: This study compares effects of isometric, concentric and eccentric exercises for shoulder muscles by using low load blood flow restriction training on pain, strength and function in patients with SIS.

This study will be conducted at El hadra university hospital, Alexandria, Egypt. Study Design: Randomized Parallel Groups Clinical Trial. Participants: Sixty patients of both genders with unilateral shoulder impingement syndrome, with age range from 30-40 years will be randomly assigned to 1 of 3 groups. All patients will be referred by the orthopedic surgeon who will diagnose shoulder impingement syndrome based on clinical and radiological examination. Group 1: twenty patients will receive concentric training of rotator cuff muscles while applying blood flow restriction for 4 weeks. Group 2: twenty patients will receive eccentric training of rotator cuff muscles while applying blood flow restriction for 4 weeks. Group 3: twenty patients will receive isometric training of rotator cuff muscles while applying blood flow restriction for 4 weeks. The assessment for all groups will be done at baseline and after 4 weeks.

Eligibility Criteria:
Inclusion criteria:

Age range 30-40 years. - Pain localized to the proximal anterolateral shoulder region, - Positive for pain on at least one of the following three impingement tests: Hawkins-Kennedy, Neers, Jobes and Positive for pain on at least one of the following four tests: Painful arc, drop arm test, lift off test, and resisted external rotation (Fatima et al., 2021

Exclusion Criteria:

* Large, full-thickness rotator cuff tear, Moderate, severe glenohumeral or acromioclavicular joint osteoarthritis. - Glenohumeral joint instability including previous shoulder dislocation/subluxation. - Previous shoulder fracture. - Current neck pain/dysfunction with a somatic or radicular referral pattern indicative of cervical spine rather than shoulder as primary source of symptoms and/or pathology. - Neurological deficits of the upper limb. - Systemic inflammatory arthritic conditions (Fatima et al., 2021).
Effectiveness of Podiatry Care on Onychomycosis (EPOCAON)

Onychomycosis occurs in more than 50% of all pathologies unguinal, affecting the health and quality of life of the patient. Although the investigators have a wide therapeutic arsenal, there is still a disparity when carrying out an effective processing.

Hypothesis/Objectives:

To analyze if the use of the podiatric technique of aggressive unguinal abrasion with micrometer sports, in combination with topical treatment with amorolfin 5% in hairspray, significantly increases the effectiveness clinically as well as mycology.

The investigators will analyze the relationship between this intervention and the quality perception of life related to the health of the nails and the foot.

The investigators will Use results for next validation study in Spanish of the questionnaire NailQoL, as well as validation and reliability of the index SCIO and cost study-effectiveness of the processing.

Method:

The investigators will design a randomized control trial. The town will be recruited, informed prior consent will be obtained from patients of 5 Spanish centers of chiropody, with sample size of 313 patients. There will be a screening of 4 weeks to select patients with onychomycosis infections (clinic and mycology both positives); later the patients will be distributed randomly in 2 groups:

* GROUP AM+AU: Will be administered aggressive unguinal abrasion, weeks 0 (baseline), 12 and 24, followed by standard treatment of amorolfin 5%, two weekly applications during 36 weeks.
* GROUP AM: Will be administered exclusively standard treatment of amorolfin 5%, according to common format. The duration will be 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* People of both sexes with ages between 18 and 75 years.
* Having affected at least the nail out of the first toe of a foot.
* Having a confirmed diagnosis of onychomycosis with positive and evidence clinic mycology (KOH and Cultivation) both positive ones.
* The infection should be caused by a fungus dermatology. Will not afford another type of infection because of the possibility of false positives for pollution exogen.

Exclusion Criteria:

* Having received in 6 previous months some local treatment or systemic for the onychomycosis.
* Having dystrophies or alterations ungulates, apart from the ones specific to the onychomycosis, that could to interfere in the interpretation of results.
* Do not have skills for the application and tracking of the topical treatment with the hairspray ungual.
* Allergy to one of the ingredients of the nail lacquer
* Pregnancy or breastfeeding situation acquaintances at the time of recruitment.
* Use of some abrasive or cosmetic product (ej: nail paint) on the treated nail during the tracking of the study.
* Receiving some type of attendance podology or of Pedicure out of the own ones included in the study.
Effect of 4-week Oral Administration of a Fermented Dairy Product Containing Lactobacillus Rhamnosus CNCM I-3690, on Subjective State Anxiety Levels in Healthy Women Undergoing Academic Stress.

The purpose of this study is to assess the effect of Lactobacillus rhamnosus CNCM I-3690 consumption on subjective anxiety levels in healthy subjects undergoing academic stress.


Eligibility Criteria:
Inclusion Criteria:

* SI01: Free-living Participant who fully understands and agree to the objectives of the study, who gave signed and dated informed consent
* SI02: Women of 20 to 30 years of age inclusive
* SI03: Participants who are healthy as determined by medical evaluation including medical and surgical history and full physical examination.
* SI04: Body mass index (BMI) within the range 18 and 30 kg/m2 (bounds included).
* SI05: Woman participants.
* SI06: Student defending a bachelor's or master's thesis in front of a jury
* SI07: Subject who regularly consumes dairy fermented products containing live bacteria and willing to consume 2 units of investigational product per day during the study.
* SI08: Subject willing to strictly follow instructions on diet, medication and substance use for the entire duration of the study.

Exclusion Criteria:

* SE01: subject with chronic gastrointestinal disorders or symptoms, with celiac disease, diagnosed type 1 or type 2 diabetes mellitus, with psychiatric disease including but not limited to depression and general anxiety disorder
* SE03: subject with food allergy, history of atopic conditions (eczema, allergic asthma, allergic rhino conjunctivitis) requiring active treatment, with first degree relatives with coeliac disease, inflammatory bowel disease (IBD) or type 1 diabetes, with known or suspected lactose intolerance
* SE4: Subject with eating disorders, chronic or iatrogenic immunodeficiency (e.g. Chemotherapy, HIV), presenting a severe evolutive or chronic pathology (e.g. cancer, tuberculosis, Crohn's disease, cirrhosis, multiple sclerosis)
* SE5: Subject with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever and/or with a positive test for COVID-19 infection or presenting any symptoms of COVID infection in the past 2 weeks
* SE6: Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, and steroids prescribed in chronic inflammatory diseases, antiphlogistic, anti-inflammatory and PPIs)
* SE7: Subject who has planned to participate in another investigational study OR subject involved in any other clinical study within the preceding month
* SE8: Subjects planning to significantly change their diet during the period of the study or who have changed his/her dietary habits within the 4 weeks preceding the study (e.g. start of a diet high in fibres)
* SE9: Pregnant woman or woman planning to become pregnant during the study; breast-feeding woman.
The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes

The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.

The aim of this phase 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759

Eligibility Criteria:
Inclusion Criteria:

* between 19 years and 80 years old(male or female)
* Type 2 diabetes mellitus
* The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
* BMI between 21kg/m2 and 40kg/m2
* C-peptide ≥ 1.0 ng/ml
* Agreement with written informed consent
* HbA1c 7 to 10% after Run-in period

Exclusion Criteria:

* Type 1 diabetes mellitus or secondary diabetes mellitus
* Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
* Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide
* Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
* Treatment with anti-obesity drugs within 3 months
Probiotic Supplementation in Sport Performance and Gut Damage

This study will be performed with the aim to evaluate the effects of probiotic supplementation on sport performance and gut damage. Participants will be divided into two groups, placebo and experimental group. With the purpose to assess the effects of probiotics on the gut damage, a strenuous exercise session will be performed, and then blood samples will be taken to observe the variation of the selected intestinal damage marker. 24 hours after this strenuous session, performance tests will be performed. After the 4 weeks of supplementation, the same procedure will be followed to evaluate the effect of probiotics.

One week before the initiation of the study participants will be required to avoid consuming drugs, alcohol, cigarettes, probiotics, and any other food or liquid which could modify gut microbiota composition. For the baseline values, height, weight and sports performance test, of the participants will be collected. The same day, a strenuous exercise session will be performed in order to observe the variation of the intestinal damage marker (blood sample extraction just after finishing the strenous exercise session). 24 hours after that session sport performance tests will be conducted. Participants will then be randomly divided into two groups, one of which will take one probiotic capsule per day containing 10 billion colony-forming units (CFU) of Lactobacillus plantarum, and the other group will take one placebo capsule per day consisting of dextrose. The supplementation period will last 4 weeks.

After the supplementation period, the same process will be followed, with the same strenuous exercise session and immediate blood sampling to determine the effects of probiotics on the intestinal damage caused by exercise. 24 hours later, performance tests will be conducted to assess the effects of probiotics on sport performance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No injuries
* 1 year of CrossFit practicing experience

Exclusion Criteria:

* Drug, alcohol, cigarettes, probiotic intake
* Injuries
Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint by Using Fibre-reinforced Composite

The purpose of this study is to determine whether fibre-reinforced composite resin restorations are effective for single tooth replacement, elimination of tooth mobility following periodontal treatment and as an orthodontic retainer.

Adhesive dentistry is based on preventive dental approach. In presence of such advanced and minimally invasive techniques, destructive treatment methods should not be preferred for clinical situations, such as missing single tooth cases, tooth mobility following periodontal treatment and prevention of relapse after orthodontic treatments. Glass fibre is a reinforcement material, and increases the flexibility of the material together which it has been used. Fibre-reinforced applications by using direct or indirect techniques. This material and method is easily applicable, biocompatible, repairable and economical on a high extent.

Eligibility Criteria:
Inclusion Criteria:

* referring patients for missing tooth replacement or fixation of tooth mobility following periodontal treatment or maintenance of teeth in corrected positions following orthodontic treatment

Exclusion Criteria:

* insufficient interocclusal distance
* poor oral hygiene
Increasing Access to Colorectal Cancer Testing (IACCT) for Blacks

The purpose of this research study is to compare a new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.


Eligibility Criteria:
Inclusion Criteria:

* Community-based recruitment methods will be used including promotional flyers and word of mouth at locations such as churches, barber shops, civic/community social service centers, senior centers, cultural groups. The flyers will provide brief information and advertise a telephone number for potential participants to call the study office at Moffitt.
* Self identify as Black or African American
* Have no symptoms of colorectal cancer (CRC), or personal diagnosis of CRC or bowel inflammatory disease or related syndromes
* Have not had recent CRC screening per guidelines (never screened or overdue)
* Participants must provide at least two forms of contact information (mailing address, home telephone or cell phone or email address), and contact information of a secondary individual who has a number that is different from the participant (this person may be a relative or friend living with the respondent).
* Spouse or relatives of respondent are potentially eligible.

Exclusion Criteria:

* Individuals who have participated in a colorectal cancer screening (CRCS) research in the past 1 year will not be eligible for this study.
* Additional criteria may apply.
An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer

EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Colon Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Colon Cancer, stage III
* At least four weeks following prior standard treatment, with no evidence of disease
* Must use adequate birth control

Exclusion Criteria:

* Prior cancer vaccine therapy or concurrent participation in any other investigational study
* A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
* A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
* Women who are pregnant, intend to become pregnant, or who are breast feeding
First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

The purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of ARC19499 in patients with hemophilia.


Eligibility Criteria:
Inclusion Criteria:

Adult male patients ≥18 to ≤75 years of age.

* Hemophilia of any type or severity.
* Patients who are negative for hepatitis B surface antigen (HBsAg), and human immunodeficiency virus (HIV) I and II antibody tests at screening.
* Male patients who, with their partners, are willing to use 2 effective, methods of contraception (i.e., for both self and partner) throughout the study and for at least 3 months after discontinuation of study drug treatment.
* All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.

Exclusion Criteria:

* Female patients;
* If on a prophylactic coagulation factor concentrate regimen, inability or unwillingness to discontinue prophylaxis during participation in this study.
* Existence of other co-existing bleeding disorder (e.g., von Willebrand Disease).
* Medical history of venous or arterial thromboembolism.
* Scheduled for elective surgical procedure during the conduct of this study.
* Use of an investigational drug within 30 days of study entry.
* Transaminase values \> 3 x upper limit of normal (ULN) at time of screening.
* Haemoglobin \<12.0 g/dL.
* Participants who, in the opinion of the Investigator, have a significant infection or known inflammatory process on screening.
* Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
* Any medical condition the investigator believes would place the patient at increased risk as a result of participation in the study e.g. history of thromboembolic disease or stroke.
* Any medication the investigator considers may increase the risk of adverse effects during the study.
Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.

Prednisone, cyclophosphamide, etoposide, and methotrexate regimens are derived from a "metronidazole, etoposide, procarbazine and cyclophosphamide (PEPC) regimen" regimen that differs from the traditional "maximal Tolerance "chemotherapy, and the use of low-dose chemotherapy, frequent drug therapy, the purpose is to anti-angiogenesis and reduce drug resistance. At present, the program in our treatment of relapsed or refractory PTCL patients effective, safe and controllable, but also look forward to other joint treatment, so as to achieve better curative effect. To provide new treatment options for such patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically confirmed peripheral T-cell lymphoma (PTCL) patients;
2. Patients who have had at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) who have not remission or relapsed after remission;
3. For various reasons can not be hematopoietic stem cell transplantation in patients;
4. The age of 18-75 years old, male, female open;
5. ECOG (Eastern Cooperative Oncology Group) physical scoring 0-1 points;
6. Absolute value of neutrophil≥1.5 × 109 / L, platelet≥90 × 109 / L, hemoglobin≥90g / L;
7. The expected survival time ≥ 3 months;
8. No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation were performed within 4 weeks prior to enrollment.
9. Voluntary signature of written informed consent.

Exclusion Criteria:

1. Pregnancy, breastfeeding women and unwilling to take contraceptive measures of reproductive age patients;
2. B-mode ultrasonography showed that the width of end-diastolic pericardial dark area was ≥10mm;
3. Patients receiving organ transplants;
4. Patients receiving symptomatic treatment of pre-bone marrow toxicity within 7 days prior to enrollment;
5. Patients with active bleeding;
6. Liver function abnormalities (total bilirubin\> 1.5 times the upper limit of normal, ALT( alanine aminotransferase) / AST (Aspartate aminotransferase)\> 2.5 times the upper limit of normal or hepatic involvement of ALT / AST\> 5 times the upper limit of normal), renal dysfunction Creatinine\> 1.5 times the upper limit of normal), electrolyte abnormalities;
7. Persons with mental disabilities / those who can not obtain informed consent;
8. Patients with drug abuse and long-term alcohol abuse that may affect the evaluation of test results;
9. The investigators determined that they were not fit to participate in the trial.