cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears

The purpose of this research study is to evaluate tendon healing when using the Flexible Suturing System with Anchors (FSSA) to surgically repair full-thickness rotator cuff tendon tears.


Eligibility Criteria:
Inclusion Criteria:

Subjects MUST meet ALL the following criteria to be included in the study:

1. Underwent surgery to repair a torn rotator cuff tear with the Flexible Suturing System with Anchors (FSSA) and is able to obtain a follow-up MRI within 12 months +4 months / -1 month from the surgery date.
2. Tear size of the supraspinatus (SSP) with or without involvement of the infraspinatus (ISP), confirmed intra-operatively or with the pre-procedural MRI, is greater than or equal to 1 cm.
3. Between 18 and 70 years old at the time of surgery.
4. Able to understand the content of the subject information / Informed Consent Form (ICF) and is willing and able to participate in the prospective data collection protocol and comply with the required data collection.

Exclusion Criteria:

Subjects will be excluded from the study if they meet ANY of the following criteria:

1. Had a prior rotator cuff surgery on the index shoulder.
2. Has a subscapularis tear with a Lafosse score of 3 or greater, or a teres minor tear requiring repair.
3. Identified as being repaired in a hybrid approach, where a non-FSSA anchor is used in the case for SSP and/or ISP rotator cuff repair.
4. SSP and / or ISP tendon ruptures that are considered irreparable or only partially repairable at the time of the intervention.
5. At any time during the previous 18 months was involved in a workers compensation case or litigation related to bodily injury, whether related or unrelated to the index shoulder.
6. Has a history of chronic opioid use.
7. Subjects with condition(s) that contraindicate or complicate outcomes of ARCR such as:

   * Current or prior infection of the ipsilateral shoulder
   * Known inflammatory arthropathy or history of inflammatory arthropathy
   * Chronic joint disease
   * Concomitant labral fixation
   * Concomitant os acromial fixation
   * Glenohumeral joint instability (multiple dislocations/subluxations)
   * Subacromial or intra-articular injection within 3 months prior to surgery
   * Oral or injected steroid use in the following timeframe: 4 weeks prior to surgery through current date
   * Hamada 3 or greater rotator cuff arthropathy on X-ray
   * Goutallier atrophy \> Grade 3
   * Proximal humeral fracture or scapular fracture
   * Avascular necrosis of humeral head or glenoid
   * Immunodeficiency disorders
   * Chronic inflammatory disorders
   * Osteoarthritis \>2 (Samilson-Prieto)
8. Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
9. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients with Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures

This is a study to evaluate the safety and effectiveness of the Acolyte Catheter System used in CTO-PCI procedures. The system will be used for the placement and positioning of guidewires and catheters in the coronary vasculature for the treatment of patients with coronary chronic total occlusions with persistent symptoms following medical therapy.

This is a study to evaluate the safety and effectiveness of the Acolyte™ Catheter System used in CTO-PCI procedures as follows:

* Evaluate angiographic confirmation of guidewire placement beyond the CTO, in the true vessel lumen, in which the investigational device was utilized to facilitate crossing and/or re-entry.
* Evaluate in-hospital major adverse cardiac events (MACE).

Acolyte™ Optical Coherence Tomography (OCT) imaging will be utilized in all cases to inform guidewire advancement in the direction of true lumen. Additionally, Acolyte™ OCT imaging will be used to guide re-entry from the subintimal space to the true lumen.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years of age at the time of consent
* Subject is on medical therapy and continues to experience clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization
* Female subjects of reproductive potential must have a negative pregnancy test per standard of care for PCI
* Subject is willing and able to provided written informed consent
* Subject is willing to and able to comply with the study protocol requirements including all follow up visits post-procedure

Exclusion Criteria:

* Subject has history of allergy to iodinated contrast that cannot be managed medically
* Subject has evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment
* Subject has had previous coronary interventional procedure of any kind within 30 days prior to the investigational procedure
* Atherectomy procedure is planned for the target lesion
* History of stroke or transient ischemic attack within 6 months prior to procedure
* Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure
* History of bleeding diathesis or coagulopathy or refusal of blood transfusions
* Other pathology such as cancer, known mental illness, etc., or other condition which might, in the opinion of the Investigator, put the patient at risk or confound the results of the study
* Subject participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with this study's endpoints; or requires coronary angiography, intravascular ultrasound, or other coronary artery imaging procedures
Bile Acids and Incretins in Pancreas Kidney Transplant Patients

Pancreas Kidney Transplantation (PKT) is the prominent treatment for type 1 diabetic patients with chronic kidney disease and improves patients' outcome. However, in spite of an optimized systemic insulin substitution, altered glucose metabolism and beta cell function are reported in these patients. The mechanisms behind these abnormalities are still unclear. Duodena-pancreatic anastomosis is performed in a heterotopic site (ileum) and thus could change physical and chemical properties of intestinal secretions, gut flora, as well as intestinal permeability. The effect of this procedure on gut derived metabolic factors, the enterohepatic cycle of bile acids, incretin secretion and intestinal flora have never been studied. This pilot prospective, study is aimed to evaluate the modification of bile acids concentrations and composition in PKT subjects, and the impact in glucose and incretin metabolism (measured by oral glucose tolerance test) one year after transplantation. The results will be compared to those of kidney transplant patients and control subjects.


Eligibility Criteria:
Inclusion Criteria:

Patients :

* BMI \<30 kg/m2
* Candidate for a first kidney transplant with a donor without the United Network for Organ Sharing (UNOS) criteria of extended donors and including living donors and pancreas-kidney donors (duodena-pancreas with ileal anastomosis and systemic drainage)
* Patients with conventional immunosuppression (maintenance with steroids, Tacrolimus and Mycophenolate Mofetil
* Willing and able to give informed consent

Control subjects :

* Potential living kidney donor

Exclusion Criteria:

* Subjects with a history of colectomy, gut resection or cholecystectomy
* For women : pregnancy
* Type 2 diabetes
* Type 1 diabetes
Association Between Persistent Organic Pollutants and Type 2 Diabetes /Thyroid Cancer

Persistent organic pollutants (POPs) are a class of organic pollutants in the environment characterized by persistent, bioaccumulation, long-range transport and biological toxicity. Due to its widespread distribution in the environment and Lipophilicity, POPs can bioaccumulate along the food chain and eventually accumulate in the human body. There are many types of POPs, including dioxins, polychlorinated biphenyls (PCBs) , polybrominated diphenyl ethers (PBDEs) and organochlorine pesticides (OCPs) . POPs is ubiquitous and Lipophilic in the environment, so the potential harm of POPs to human body has aroused wide concern. A growing number of studies have found that exposure to POPs may be associated with an increased risk of endocrine disease, particularly type 2 diabetes and thyroid cancer.

The aim of this study was to assess the effect of Persistent organic pollutant exposure on the development ofType 2 diabetes and thyroid cancer by analyzing serum Persistent organic pollutant concentrations in controls, and patients with Type 2 diabetes and thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

Group of Type 2 diabetes patients:

1. age 18 \~ 75 years old;
2. type 2 diabetes patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) , HBA1C ≥7.0% and \<10.5% ;
3. patients signed informed consent.

Group of Thyroid Cancer patients:

1. age 18 \~ 75 years old;
2. thyroid cancer patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;
3. patients who signed the informed consent form.

Control Group:

1. age 18 \~ 75 years old;
2. healthy population recruited from the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;
3. living in the monitoring area for more than 6 months within 12 months;
4. normal thyroid function and no history of thyroid cancer were needed in the control group;
5. Fasting Blood Glucose level of 0.7 mmol/l was needed in the Control Group of Type 2 diabetes Mellitus Without History of diabetes;
6. patients with informed consent.

Exclusion Criteria:

* Group of Type 2 diabetes:

  (1) pregnant, lactating women, patients with acute cardiac cerebrovascular disease; (2) patients with severe liver and Renal Impairment (related laboratory tests more than 2 times the normal) ; (3) patients with Type 1 diabetes; (4) participants in other clinical trials within 3 months; (5) patients with malignant tumors. (6) has the disease and so on serious anemia, is not suitable to carry on the patient which the blood draws the test.

Group of Thyroid Cancer:

1. patients with serious heart, liver and Kidney Diseases (related laboratory tests more than 2 times normal) ;
2. patients with other malignant tumors.

Control Group:

1. patients with serious heart, liver or kidney disease;
2. patients with iodine or Thyroid hormone;
3. patients with confirmed malignant tumor;
4. pregnant women or those who have recently taken contraception or estrogen.
Comparison of the Postoperative Analgesic Effects of SPSIPB and TPB in Mastectomy Operations

Breast cancer is the most common malignancy in women, and surgery is one of the cornerstone treatments for breast cancer. Postoperative pain can significantly reduce patients' quality of life and acute pain may even trigger chronic pain syndrome.

Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.

In this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and thoracic paravertebral block in the postoperative period in patients who underwent mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years
* American Society of Anesthesiologists (ASA) score I-II-III
* Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* ASA score IV and above
* Patients with a history of bleeding diathesis
* BMI below 18 or above 30 kg/m2
A Research for Combination of Prostate Health Index (Phi) and mpMRI PI-RADS in the Diagnosis of Prostate Cancer

Before prostate puncture, the patient's serum was collected for PHI detection, and multi-parameter MRI was performed to obtain the PI-RADS score. The sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically significant prostate cancer were explored.

This study is a multi-center prospective study. Patients who meet the indications for prostate puncture and whose PSA is in the gray area (4.0\~10.0 ng/mL) undergo standard prostate biopsy. The patient's serum was collected for PHI detection before puncture, and multi-parameter MRI was performed before puncture. To explore the sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically meaningful prostate cancer. Assess the benefit of combining PHI and mpMRI before biopsy compared with phi or mpMRI alone. Formulate clinical recommendations for PHI and mpMRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected prostate cancer
* Patients can perform standardized prostate biopsy

Exclusion Criteria:

* Have a history of prostate cancer
* Use of drugs that affect PSA before blood sampling
Safety and Tolerability Study With Single Ascending Doses of ORM-12741

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ORM-12741 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Good general health ascertained by detailed medical history and physical examinations
* Males between 18 and 45 years
* Body mass index (BMI) between 18-30 kg/m2
* Weight 55-90 kg

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
* Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
* Susceptibility to severe allergic reactions
* Regular consumption of more than 14 units of alcohol per week
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal finding in ECG, vital signs, laboratory tests or physical examination
* Participation in a drug study within 3 months prior to the start of this study
Mechanism of Cardiac and Cerebral Function Injury Caused by Intraoperative Limb Ischemia-reperfusion

As a simple auxiliary tool for lower extremity orthopedic surgery, tourniquet can effectively reduce intraoperative bleeding and ensure the clarity of the operative field, effectively shorten the operation time and improve the operation efficiency. The extensive use of tourniquets in lower extremity surgery will not only cause local paralysis, pain and other complications, but also bring about postoperative complications such as large drainage volume and deep vein thrombosis. Recent studies have found that tourniquet induced ischemia-reperfusion injury not only affects the local tissue structure and function of skeletal muscle, but also causes reperfusion injury in distant organs (such as heart, lung and brain). Therefore, improving tourniquet ischemia-reperfusion injury after knee replacement is of great significance to improve the quality of life of patients during the perioperative period. Therefore, the aim of this study was to investigate the effects of dexmedetomidine and tourniquet pretreatment on myocardial injury and brain injury caused by lower extremity ischemia-reperfusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing TKA under general anesthesia
* Voluntarily sign the informed consent
* ASA Grade I to III
* BMI 18-28 kg/m2

Exclusion Criteria:

* Congenital heart disease or history of cardiac surgery, heart conduction disease, frequent ventricular/atrial premature beats, atrial fibrillation and other serious arrhythmias
* Severe liver disease and kidney disease
* Temporary and permanent pacemaker implantation
* Patients with serious central nervous system diseases or serious mental disorders
* Recent history of sedation, antidepressant or opioid use
* Body mass index \>35kg/m2
* Participants in other clinical trials within 1 month prior to study enrollment.
Platelet Rich Plasma and Supraspinatus Tear

Rheumatology and Rehabilitation Department, Mansoura University Hospital. Forty patients with chronic partial supraspinatus tears will be included in the study. The diagnosis of the supraspinatus tear will be made by ultrasound examination

At inclusion in the study, demographic data (age, gender, duration of complaints, and body mass index) will be recorded.

Randomization

Patients will be randomized into two matched groups:

A) PRP-Injection Group - Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After the injection, patients will be instructed to limit the use of shoulder for at least 24 hours and to use cold therapy for pain. After the third injection, ROM, and stretching exercises will be allowed and one month after the end of injections, patients will be recommended to begin the strengthening program as tolerated. Exercise is performed with 10 repeats five sessions per week.

B) Physical Therapy Group - Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks). After the physical therapy, the exercise program will be continued as homework during the follow-up period.

Patients in t

Eligibility Criteria:
Inclusion Criteria:

chronic partial supraspinatus tears will be included in the study

Exclusion Criteria:

age \> 80 years, pregnancy, full thickness supraspinatus tears, other rotator cuff lesions with/without supraspinatus tears, systemic disorders such as diabetes rheumatoid arthritis, hematological diseases (co-agulopathy),
Vitamin D Levels And Myoma Uteri

Women with at least one uterine leiomyoma and polycystic ovary syndrome over 10 mm and women with normal ultrasonographic findings were included in the study. Blood samples were taken for biochemical analysis such as vitamin D, calcium, magnesium, phosphorus, thyroid stimulating hormone (TSH), hemoglobin (hb), hematocrit (htc), platelet (plt), and albumin. The study groups were compared in terms of these biochemical markers and family history of patients, daily sunshine hours, clothing preferences and education level.


Eligibility Criteria:
Inclusion Criteria: The reproductive age women (25-50 years) with at least one 10 mm or larger diameter leiomyoma detected by transvaginal ultrasound were the study group.

Exclusion Criteria:

* Patients with a history of myomectomy,
* chronic systemic disease
* malignancy
* history of adenomyosis
* women in menopause
* pregnant women
* vitamin D supplementation
* lactation
* abortion and pregnancy loss in the last 6 months
* oral contraceptive / hormonal agents in the last 3 months
Length of Cook Catheter Placement and Induction of Labor

The goal of this study is to compare cook catheter placement for 6 vs. 12 hours to see if there is faster time to delivery for people admitted to labor and delivery undergoing induction of labor.

Upon presentation to labor and delivery the participant will have a cook catheter inserted digitally or by direct visualization with a speculum. The uterine component of the balloon will be inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. In both groups participants will be started on hospital-based oxytocin protocol. This protocol beings with 2 milliunits/min of oxytocin, increasing by 2 milliunits every 15 minutes until regular uterine contractions occur. The maximum dose of oxytocin is considered to be 30 milliunits. The cook catheter will then be removed at 6 vs. 12 hours based on randomization. At that point health care providers will manage active labor. Health care providers many perform amniotomy at any point during the induction process with recommendation for amniotomy with cervix more than 4cm dilated. Labor interventions are at the discretion of the healthcare provider. The participants will have continuous fetal monitoring throughout their induction, labor and delivery. Need for operative delivery or cesarean section will be at the discretion of the health provider.

Eligibility Criteria:
Inclusion Criteria: Women undergoing cervical ripening for labor induction at term (37-41 6/7 weeks) with a singleton gestation in cephalic presentation. Women will need to have a bishop score \<6 or cervical dilation \<2cm with intact membranes to be included.

Exclusion Criteria:

* Non English speaking
* Contraindications to vaginal delivery
* Prior cesarean section
A "Stand Up and Move More" Intervention for Older Adults

The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities.

Based on successful pilot research in Rock County, WI, and the receipt of funding from the National Institutes of Health, the investigators expanded research to additional counties in Wisconsin for a total of four counties (i.e., Dane, Iowa, Rock, and Vilas counties). Sample size will increase and participants will be randomly assigned to the intervention group (Stand Up and Move More group) or a wait-list control group (who receive the intervention after 12 weeks). The Stand Up and Move More intervention/workshop involves sessions once/week for four weeks with a refresher session at 8 weeks. Assessments will be conducted before the intervention/workshop begins, and then again at 4 weeks and 12 weeks. We have added several questionnaires to examine potential mediators of behavior change (e.g., self-efficacy, self-regulation, outcome expectancies).

Eligibility Criteria:
Inclusion Criteria:

* adults older than 55 yrs of age
* inactive or low active (i.e., less than 60 minutes of physical activity/week)
* residents of Dane, Iowa, Rock or Vilas counties, and
* residing in a home or an apartment.

Exclusion Criteria:

* low levels of sedentary behavior (less than or equal to 6 hours/day),
* recent hospitalization (i.e., past month),
* uncontrolled medical conditions including: uncontrolled hypertension, heart disease, actively receiving chemotherapy or palliative care for cancer, stage 4 liver disease, end-stage renal or pulmonary disease, severe arthritis or any other orthopedic condition that could be made worse by standing up and moving more;
* inability to stand up without assistance of another person, and
* inability to speak or hear spoken English.