cyrilzakka/clinical-trials huggingface dataset:
Rivaroxaban for Antiphospholipid Antibody Syndrome

The antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood clotting (thrombosis). APS is among the most common cause of heart attack and stroke in patients under the age of 50 and is particularly prevalent in patients with autoimmune conditions. Patients with APS and prior thrombosis require lifelong anticoagulant therapy to prevent recurrent clots; such therapy is currently provided with warfarin. Warfarin requires frequent bloodwork monitoring, and many medications or foods can alter its effect, which can put people either at increased risk for clotting or bleeding. Rivaroxaban is a new mediation that prevents blood clots that does not require bloodwork monitoring and that has fewer interactions. This study is a pilot feasibility study which will: 1) examine our ability to identify 150 eligible APS patients; 2) measure our ability to obtain consent from 135 of these patients; and 3) test our hypothesis that we can obtain 95% compliance with daily rivaroxaban administration. The investigators propose to treat eligible patients with rivaroxaban 20 mg once daily. Patients will be followed for a minimum of one year and their rates of bleeding and thrombosis will be monitored as secondary outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Prior objectively-confirmed venous thrombosis, irrespective of history of arterial thrombosis
* Two or more prior positive APS serological evaluations at least 12 weeks apart
* Current treatment with warfarin administered to achieve an INR of 2.0 to 3.0, rivaroxaban or dabigatran at any dose currently used for secondary prophylaxis of thrombosis, or short term therapeutic dose LMWH (for example, for the treatment of recently diagnosed deep vein thrombosis). Patients not currently receiving anticoagulation but in whom anticoagulation is mandated, may also be enrolled if a 20 mg rivaroxaban dose would be appropriate

Exclusion Criteria:

* Prior recurrent thrombosis while taking warfarin with a demonstrated INR of 2.0 to 3.0, or prior recurrent thrombosis while receiving dabigatran or rivaroxaban
* History of isolated arterial thrombosis (no history of venous thrombosis) pending CTA approval by Health Canada
* Need for continued treatment with both aspirin (irrespective of dose) AND clopidogrel
* Pregnancy or planned pregnancy during the study period; women who may become pregnant will be required to utilize reliable contraceptive measures while on study drug
* Chronic kidney disease with calculated GFR \< 30mL/min
* Geographic inaccessibility
* Age \< 18 years
* Inability or failure to provide informed consent
The Permacol Dutch Cohort Study

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. It has been established that implementing a mesh reduces recurrence of the incisional hernia but still the results of repair are often disappointing. Incisional hernias can become increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair the incisional hernia by means of a synthetic mesh and other augmentation tools need to be implemented.

In the recent years the use of biological meshes has been gaining popularity. Recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. Biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. They include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. These shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh.

The aim of this study is investigate the short and long term effects of the Permacol© biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what is the true indication to use a biological mesh.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Complicated abdominal wall hernia repair
* Permacol© mesh implantation

Exclusion Criteria:

* No signed informed consent
* Operation other than Complicated abdominal wall hernia repair
* Implant other than Permacol© mesh implantation
Left Atrial Appendage Closure in Combination With Catheter Ablation

This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.

This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation.

This study will be conducted in accordance with the following procedures:

1. Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria.
2. Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation.
3. The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.

Eligibility Criteria:
Inclusion Criteria:

1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation
2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
3. With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
5. Provide informed consent to participate in the study;
6. Between 18-90 years

Exclusion Criteria:

1. myocardial infarction within 3 months
2. Stroke or systemic embolism within 3 months
3. Plan to receive heart transplantation;
4. Life expectancy less than 1 year;
5. Severe bleeding diseases that cannot be treated with short-term anticoagulants;
6. With left atrial or left atrial appendage thrombus;
7. With uncontrolled malignant tumor ;
8. Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr \<50%);
9. Women who are pregnant, or breastfeeding.
10. Other conditions not suitable to the combined procedure.
Engorgement Study With a Double Electric Breast Pump

The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement.


Eligibility Criteria:
Inclusion Criteria:

* first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner.

Exclusion Criteria:

* greater than one week postpartum
* less than 18 years of age
* non-English speakers
* not willing to use double electric breast pump
Family Mental Health Family Navigator Project (FMHN)

This study will focus on developing and testing a family-based mental health navigator intervention, the Family Mental Health Navigator (FMHN), to evaluate whether the intervention combined with mHealth is preliminary efficacious in improving mental health service initiation and engagement for publicly-insured youth.

The study will demonstrate how a family-based navigator intervention combined with mHealth may lead to improved mental health treatment initiation and engagement among publicly-insured youth. Publicly-insured youth have high rates of mental health symptoms relative to youth in the community, and are disproportionately racial and ethnic minorities, only perpetuating disparities in this population's mental health access and engagement. The proposed project will develop and test a family-based navigator intervention, the Family Mental Health Navigator (FMHN), a natural fit for improving publicly-insured youth's mental health service and clinical outcomes. The study will start with identifying the feasibility and acceptability of the FMHN intervention. Then, the study will determine whether the FMHN intervention improves publicly-insured youth mental health treatment initiation and engagement. Finally, the study will characterize patterns of pre- and post-service outcomes along the behavioral health services cascade of care, to further evaluate the feasibility, acceptability, and preliminary impact of the FMHN model.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking and/or Spanish-speaking youth
* Ages 6-17
* Are currently receiving services at the San Francisco General Hospital
* Are publicly insured
* Have an involved caregiver/legal guardian for consent
* Family has mobile phone access

Exclusion Criteria:

* Youth is not English-speaking nor Spanish-speaking
* Caregiver has impairment that would preclude providing informed consent
* Unavailable guardian for consent
Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients

The purpose of this study is to test whether the A-V sequential pacing strategy shown to effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure acutely in patients with hypertension (systolic blood pressure greater than 140 mmHg) despite medical treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has hypertension with systolic blood pressure \>140 mmHg despite at least one antihypertensive medication.
2. Patient has a clinical indication for a pacemaker or an electrophysiology study involving introduction of transvenous electrophysiology catheters to the right atrium and/or right ventricle.
3. Patient is willing and able to provide informed consent

Exclusion Criteria:

1. Patient is in atrial fibrillation at the time of the study
2. Patient has an ejection fraction less than 45%
3. Patient has a history of symptomatic heart failure, regardless of EF
4. Patient is undergoing an ablation procedure for a bypass track (WPW)
5. Patient has a history of resuscitation from ventricular fibrillation or sustained ventricular tachycardia
A Performance Study of (opportunistic) Salpingectomy

The goal of this clinical trial is to test the quality of the performance of opportunistic salpingectomies in women scheduled for adnexectomy. The main questions it aims to answer are:

* How many salpingectomies are incomplete?
* Are there any factors related to incomplete resection? Could the investigators develop a instruction video to optimize the surgical technique?

Participants planned for uni-or bilateral adnexectomy (removal of ovary and salpinx) will have their adnexectomy in two steps in the same surgical episode: first the salpingectomy (removal of the salpinx), then the oophorectomy (the removal of the ovary).

Rationale: Salpingectomy in post-reproductive women could reduce the risk of developing ovarian cancer. In women at high risk for ovarian cancer (because of genetic mutations) a risk reducing salpingectomy with delayed ovariectomy could be an advantage. It is considered that salpingectomy does not cause premature menopausal symptoms. Prospective randomized trials are being performed to estimate the true risk reducing effect of salpingectomy on ovarian cancer. Those studies are based on a complete bilateral salpingectomy.

Objective: The QOS study investigates the quality of performance of opportunistic salpingectomy and the risk factors associated with reminiscing fimbrial tissue after salpingectomy.

Study design: Multicenter interventional trial

Study population: Patients planned for unilateral or bilateral adnexectomy (removal of ovary and salpinx) will be counselled to participate.

Intervention: The gynecologist will perform the adnexectomy in two steps in the same surgical episode: first the salpingectomy (removal of the salpinx), then the oophorectomy (the removal of the ovary). The pathologist investigates for pathology and describes if fimbrial tissue (the last part of the salpinx adjacent to the ovary) has been left behind on the ovarian surface microscopically and macroscopically.

Main study parameters/endpoints: The primary outcome is the percentage of incomplete salpingectomies. Secondary outcome is the detection of factors related to incomplete resection of the salpinx. If necessary a guideline/instruction video could be developed to optimize the surgical technique. A total of 200 specimens are to be included to answer the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for uni- or bilateral adnexectomy. (may be in combination with hysterectomy) AND \* competent to act on itself

* dutch speaking
* signed informed consent

Exclusion Criteria:

\* Endometrial cancer or invasive cervical cancer

* radiotherapy in the pelvis in the medical history
* (partial) salpingectomy
* Pelvic Inflammatory Disease
* Adnexectomy for gender transformation surgery if wish to preserve the ovarian tissue.
* Surgery in two steps is not safe to perform
* Pregnancy
A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus

The main purpose of this study is to evaluate the effect of excipients sodium citrate and treprostinil without insulin on local infusion site pain in participants with type 1 diabetes mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII). The study may last up to 36 days including a screening period and 3 visits.


Eligibility Criteria:
Inclusion Criteria:

* T1D for at least 1 year and continuously using insulin for at least 1 year
* Using an insulin pump for at least the last 6 months
* Have hemoglobin A1c (HbA1c) value of ≤ 9.0%
* Have a body mass index (BMI) within the range of 18.5 to 35.0 kilograms per square meter (kg/m²)
* Have medical and laboratory test results that are acceptable for the study
* Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Have a pathologic tuning fork test as assessed with a Rydel-Seiffer tuning fork
* Are taking anesthetics or pain medication regularly or intermittently which could interfere with interpretation of pain scale
* Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the last 90 days prior to screening
* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within the last 6 months prior to screening
* Have any hypersensitivity or allergy to any of the diluents or excipients used in this trial
* Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product
* Have used or are currently using Lyumjev® as part of their standard insulin therapy
Energy Expenditure and Physical Activity in Preschoolers

The purpose of this study is to calibrate the Actigraph, Respironics and CamNtech monitors, in a wide range of children using energy expenditure measured by respiration calorimetry. Energy expenditure will be predicted from the combination of heart rate and activity measured by accelerometry. Prediction equations for energy expenditure will be tested and validated against a stable isotope method called doubly labeled water for the measurement of free-living total energy expenditure.

In this study, the investigators will apply advanced technology (fast-response room calorimetry, doubly labeled water (DLW), accelerometers and miniaturized HR monitors) and sophisticated mathematical modeling techniques (cross-sectional time series, CSTS and multivariate adaptive regression splines, MARS) to develop and validate prediction models that capture the dynamic nature of physical activity (PA) and energy expenditure (EE) in preschool-aged children. CSTS and MARS models for the assessment of PA based on activity energy expenditure (AEE) and for the prediction of minute-by-minute EE will be developed in 100 preschool-aged children using 12-h room respiration calorimetry as the criterion method and validated in an independent sample (n=50) against 12-h room respiration calorimetry and the 7-d DLW method. In addition, the investigators will develop algorithms for the classification of PA levels and sleep/awake periods using statistical and machine learning methods and incorporate the results into our prediction models.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls between the ages of 3-5 years will be recruited from the local community. A total of 150 children will be studied. In Phase I, 100 children will be studied and in Phase II 50 children will be studied.

Exclusion Criteria:

* any medical illness or medication affecting growth or limiting participation in physical activities or sports.
Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic insufficiency (PI) documented by fecal elastase \<100 mcg/gram measured at screening
* Diagnosis of CF based upon the following criteria:

  * two clinical features consistent with CF AND
  * either genotype with two identifiable mutations consistent with CF OR
  * sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis
* Forced Expiratory Volume Over One Second (FEV1) ≥30% predicted
* Clinically stable with no evidence of acute upper or lower respiratory tract infection

Exclusion Criteria:

* Pregnancy, breastfeeding or of childbearing potential and/or not willing to use accepted methods of birth control during enrollment in the study
* History of fibrosing colonopathy
* History of liver transplant or lung transplant
* Unable to discontinue enteral tube feedings during the study
* Subject weight \<40 kg
* Known hypersensitivity to food additives
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
* Unable to discontinue the use of pancreatic enzymes for a 72-hour period or any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy

Rotator cuff re-tear is a common delayed complication of arthroscopic rotator cuff repair. This process of re-tear is multifactorial and there has not been any readily identifiable perioperative measure that is predictive of subsequent rotator cuff failure. There have been no human studies looking at intraoperative assessment of rotator cuff vascularity, nor the predictive value that vascularity may have for rotator cuff re-tear. Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical patients. The aim of this study is to establish a standard dosing protocol for ICG in the arthroscopic visualization of rotator cuff vascularity.

The primary study objective is to determine optimal dosing of an intravenous fluorescence solution (IC-Green) for arthroscopic evaluation of rotator cuff vascularity. The primary endpoint is surgeon's ability to assess vascularity within the rotator cuff based on a 5-point likert scale. The likert values from each of the three doses will undergo an ANOVA test to compare means of the three doses.

Eligibility Criteria:
Inclusion Criteria:

* Patients has full or partial thickness rotator cuff tear and is scheduled to undergo arthroscopic rotator cuff repair
* Patient is at least 18 years of age and less than 80 years of age

Exclusion Criteria:

* Patient is less than 18 years of age or greater than 79 years of age
* Patient has a documented allergy to iodides
* Patients who have had iodide based radiology studies within the last seven (7) days prior to surgery
* Patient is pregnant
A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis

Determine if IV ketorolac is an effective agent in the prevention of post-ERCP pancreatitis. Determine if IV ketorolac provides improved post-procedure analgesia.

Determine if systemic mediators of inflammation are reduced in patients receiving IV ketorolac following ERCP.

Acute pancreatitis is the most common major complication of both diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity and an annual expenditure of approximately 150 million annually.(1,2) Non-steroidal anti-inflammatory agents (NSAIDs) have been shown to be effective in multiple prospective randomized controlled trial for the prevention of post-ERCP pancreatitis.(3-6) NSAIDs are postulated to inhibit phospholipase A2 and prostaglandin synthesis, which plays an important role in the inflammatory cascade in acute pancreatitis. Rectal suppository indomethacin (a potent COX-2 inhibitor) has been effective in preventing post-ERCP pancreatitis in clinical trials and is now recommended for routine use for ERCP by the European Society of Gastrointestinal Endoscopy.(7) Toradol® (ketorolac), an NSAID available in IV form, is a more potent COX-2 inhibitor and analgesic than indomethacin.(8,9) Ketorolac is routinely used postoperatively following major surgery to assist in pain control particularly following orthopedic procedures. IV ketorolac has never been evaluated for the prevention of post-ERCP pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to SFGH for ERCP
* Age 18-85
* Do not meet exclusion criteria

Exclusion Criteria:

* Acute pancreatitis at the time of ERCP
* Use of NSAIDs in the previous week
* Peptic ulcer disease
* Severe renal dysfunction
* Pregnancy
* Lithium therapy
* allergy to ketorolac