cyrilzakka/clinical-trials huggingface dataset:
Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation

Prospective cohort study on patients with intertrochanteric fractures under direct oral anticoagulation (DOAC) therapy undergoing early surgical fixation (within 24 hours). The primary aim of this study is to evaluate the reduction of the peri operative blood loss. The secondary aim is to assess the influence of early surgical fixation of intertrochanteric fractures in patients with DOAC therapy on the 30-day and 1-year mortality. Moreover, the prospective cohort group of patients will be compared with a retrospectively analyzed age-, gender- and fracture-type-matched control group of patients who underwent delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours).


Eligibility Criteria:
Inclusion Criteria:

Prospective cohort study:

Patients with intertrochanteric fractures that need a surgical fixation and under treatment with a DOAC medication

Control group:

Patients with intertrochanteric fractures under DOAC medication with a delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours after the trauma)

Exclusion Criteria:

Prospective cohort group:

* patients with multiple fractures
* acute heart failure, kidney and lung failure and
* other concomitant diseases which prevent prompt fixation

Retrospective cohort group:

Patients with delayed surgical fixation due to other causes than DOAC medication (e.g. multimorbidity, acute myocardial infarction, acute heart, lung or kidney failure)
Bisoprolol in DMD Early Cardiomyopathy

This study aimed to use cardiac magnetic resonance imaging (CMR) to evaluate the efficacy and safety of bisoprolol therapy for boys with Duchenne muscular dystrophy(DMD) and preserved ejection fraction. On top of angiotensin-converting enzyme inhibitor (ACEI) , half of the participants will receive bisoprolol in combination, while the other half will not receive any beta-blocker.

By the age of 20 years, almost all the patients with Duchenne muscular dystrophy(DMD) have experienced dilated cardiomyopathy (DCM), a condition that contributes significantly to their morbidity and mortality. Studies have shown ACEI to be an effective therapy for DMD boys with early cardiomyopathy. Although bisoprolol has been demonstrated as an effective neurohumoral drug for adult patients with DCM, few data exist concerning its safety and efficacy for the patients with DMD. The investigators hypothesize that the treatment with bisoprolol in addition to background ACEI therapy for 12 months in participants with DMD and early myocardial damage evident with late gadolinium enhancement and preserved ejection fraction, would blunt decline in left ventricular systolic performance.

Eligibility Criteria:
Inclusion Criteria:

* Older than(including) 7 years old
* A definite diagnosis of DMD with muscle pathology confirming the expression of dystrophin lower than 5% and/or confirmed mutations in the DMD gene using a clinical accepted technique that completely defines the mutation.
* Using ACEI or ARB for more than 1 month
* Confirmed myocardial damage in one or more left ventricular segments evident by late gadolinium enhancement and preserved left ventricular systolic function(\>45%) by cine cardiac MR in 45 days
* Normal renal function
* Holter and blood pressure shows no contraindication of using bisoprolol

Exclusion Criteria:

* Having metal implanted in body
* Having claustrophobia
* Allergic to gadolinium
* Complicated with other cardiovascular diseases
* Medical history or Holter show bradyarrhythmia like II/III degree atrioventricular block, sick sinus syndrome etc.
* Systolic blood pressure lower than 90mmHg or rest heart rate lower than 75bpm
* Having COPD or asthma history
* Having other complications: tumor, endocrine diseases
* Having beta blockers therapy
* Planned operation in the future 12 months
* Allergic to bisoprolol
Modeling Multi-level Dyadic Behavior to Transform the Science and Practice of Psychotherapy Process and Outcome.

This is a short-term longitudinal study of psychotherapy process. Participants will be treated with 8 sessions of psychotherapy over the course of 8 to 12 weeks.

Enrolled participants were randomized to one of two psychotherapy conditions: 8 sessions of Brief Cognitive Behavior Therapy or Brief Interpersonal Psychotherapy (IPT) over a 12 week protocol.

In response to the COVID-19 pandemic, we completed the study in two phases. Phase 1 procedures were conducted entirely in-person and Phase 2 procedures were conducted via telehealth. Phase 1 recruitment began July 2018 and concluded in February 2020. Recruitment for Phase 2 began July 2020 and concluded March 2021.

This project aims to model the dynamics of individual and dyadic behavior on a moment-by-moment basis within each therapy session and over the course of treatment. These models will be used to test hypotheses about multimodal behavior dynamics, psychotherapy process, type of treatment, and treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65
2. Meet DSM-5 criteria for major depressive disorder (MDD), current episode, based on the Mini International Neuropsychiatric Interview (MINI)
3. Hamilton Rating Scale for Depression (HRSD-17) score ≥ 14 consistent with at least moderate depressive symptoms
4. If currently on antidepressant medication, must be on a stable dose for at least one month at the time of study entry and agree to remain on that dose for study duration
5. Fluent in English
6. Capacity to understand and give informed consent

Exclusion Criteria:

1. At high risk for suicide, that, in the clinical opinion of the investigator, would warrant a higher level of care such as hospitalization or intensive outpatient programs
2. Current depressive episode has psychotic features
3. Current depressive episode has been present for \> 104 weeks
4. Meets criteria for substance use disorders, as defined by DSM-5, in the past 3 months, except for caffeine or nicotine. (Limited substance use, not meeting criteria for substance use disorders, is not exclusionary).
5. Meets DSM-5 criteria for prior manic or hypomanic episode (bipolar I or II disorder) or a psychotic disorder including schizoaffective disorder or schizophrenia
6. Meets DSM-5 criteria for antisocial personality disorder (MINI)
7. Significant, unstable, psychiatric co-morbidity that, in the opinion of the investigators, requires an alternative treatment approach (i.e., unstable eating disorder, unstable borderline personality disorder)
8. Significant unstable medical illness that may explain depressive symptoms such as epilepsy, autoimmune disorder, chronic pain, or unstable endocrine disorder
9. Cognitive deficits that would preclude completion of study questionnaires or participation in psychotherapy
10. Unable to unwilling to comply with study requirements (i.e., complete forms, attend sessions)
Efficacy of Cardioviva™ Probiotic Yogurt Formulation

Background: Several studies have reported limited or no reduction in serum lipid concentrations in response to probiotic formulations. More recently, probiotics have shown promise in treating metabolic disease, due to improved strain selection and delivery technologies.

Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken twice per day over 6 weeks, in subjects with hypercholesterolemia.

Design: This is a double-blinded, multi-centric, placebo-controlled, randomized, parallel-arm study. The study will last a total of 10 weeks including 2-week wash-out, 2-week run-in, and 6- week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females.
* Aged 18-74 years old.
* Low Density Lipoprotein (LDL-C) above 3.4 mmol/L (\<15% variation between visits V1 and V2-1).
* Triglyceride (TG) levels below 4.0 mmol/l (check at V0 and V2-1).
* Body Mass Index (BMI) range was 22 to 32 kg/m2.
* Ability to understand dietary procedures.
* Judged by the investigators as compliant (\>80%) with product consumption (check at V2-1), and motivated.
* Signed informed consent form prior to inclusion in the study
* Note: Subjects were permitted to take stable doses of thyroid hormone, anti-hypertensive agents, and contraceptive hormones (e.g. contraceptive pills or patches), as long as these were continued equivalently throughout the duration of study.

Exclusion Criteria:

* Use of statin or other cholesterol lowering prescription drugs within the last 6 months.
* Use of plant sterols, omega-3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription supplements within last 3 months.
* History of chronic use of alcohol (\>2 drinks/day).
* Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
* Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
* Lactose intolerance or allergies to dairy products.
* History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
* Chronic user of probiotics or fiber laxative (greater than 2 doses/week), or stimulant laxatives.
* History of eating disorders.
* Exercise greater than 15 miles/week or 4,000 kcal/week.
* Pregnancy, breast feeding, or intent to get pregnant.
Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive

This is a prospective, controlled, randomized, open label study, aimed at comparing FVIII/VWF concentrates with FVIII concentrates at 200 IU/kg daily in their ability to induce immune tolerance in Haemophilia A patients with high responding inhibitors and poor prognosis for success.

The presence of Factor VIII (FVIII) inhibitor prevents FVIII infusions from working properly and makes treatment of bleeding episodes very difficult. Having an inhibitor is a serious and life-threatening complication in patients with Hemophilia. The usual treatment of patients with FVIII inhibitors involves "immune tolerance induction" (ITI). Immune Tolerance means that the body can accept infused FVIII and that FVIII is again effective in controlling bleeds. ITI involves giving high doses of FVIII regularly until the inhibitor disappears. This treatment is not always effective. The inhibitor persists in about 1 in 5 patients who undergo ITI.

There are 2 types of FVIII concentrates: FVIII concentrates derived from human plasma, which contain the von Willebrand factor, and concentrates of FVIII without VWF (recombinant or plasma derived). Both types of concentrates are commonly used to induce immune tolerance in patients with Hemophilia A. Retrospective studies in subjects with hemophilia and inhibitors at risk for failing ITI, have indicated a higher rate of success if patients were treated with von Willebrand containing factor VIII concentrates. It is not known whether the addition of Von Willebrand factor offers an advantage to achieving immune tolerance.

Eligibility Criteria:
Inclusion Criteria:

1. severe hemophilia A (FVIII\<1%);
2. male, any age;
3. high responders (peak inhibitor levels \> 5 BU);
4. any inhibitor level at study enrolment;
5. ability and willingness to participate in the study;
6. at least one of the following risk factors for ITI failure:

   * peak inhibitor titer \> 200 BU
   * titer at ITI start \> 10 BU
   * age \> 7 years
   * time between inhibitor occurrence and ITI \> 2 years
7. absence of high risk of cardiovascular, cerebrovascular or other thromboembolic events as deemed by the treating clinician.

Exclusion Criteria:

1. concomitant systemic treatment with immunosuppressive drugs;
2. concomitant experimental treatment;
3. previous ITI attempt;
4. previous history of myocardial infarction and/or cerebral stroke.
Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Some people have increases in heart rate and blood pressure. We will study the effect of a phenylephrine solution in place of an epinephrine solution to control blood loss. We think that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.

The injured area will be injected under the skin and a skin graft will be taken in the same way as we usually do. The only change will be the use of phenylephrine in the solution instead of epinephrine.

Our goal is to find whether or not phenylephrine or epinephrine solution results in a reduction of blood loss without affecting the rest of the body.


Eligibility Criteria:
Inclusion Criteria

a) Burn injury requiring debridement and grafting between 5-30% TBSA

Exclusion Criteria

1. Head and neck, hand, foot, or genital burns
2. On anticoagulants (except NSAIDs)
3. On monoamine oxidase inhibitor or tricyclic antidepressant
4. Coronary or peripheral vascular disease
5. History of arrhythmias
6. On a Beta-blocker
7. History of vascular abnormality
8. Hypertension
Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Presence of Aortic arch pathology
* Treatment planned with triple inner branch from Terumo Aortic
* Availability of the patients during the follow up period
* Informing patients about the study and providing written informed consent

Exclusion Criteria:

* Women of childbearing age
* Patients under 18 years
Micro-RNA Profile in Patients With Different Stages of Atherosclerosis According to CTA

The main purpose of this single-center study is to determine the spectrum and levels of cardiospecific circulating microRNAs in patients with different stages of atherosclerosis according to 640-slice multispiral computed tomography (MSCT).

The study will be conducted in two phases. Phase one. After signing the informed consent, patients with coronary heart disease, angina pectoris II-IV functional class, who underwent MSCT angiography of the coronary arteries for medical reasons, regulated in the relevant ESC and the Russian Society of Cardiology guidelines, will be included in the study. According to the results of MSCT, the participants will be divided into 4 groups: those with atherosclerotic plaques with signs of instability; those with stable atherosclerotic plaques without marked calcification; those with calcined atherosclerotic plaques; those with no signs of atherosclerosis of the coronary arteries. Plasma samples will be analyzed by microarray, using a cardiospecific set.

Phase two. Validation of the results obtained after the first phase will be performed on a larger sample of patients. Patients after signing an informed consent will also undergo MSCT angiography of coronary arteries and according to its results will be devided in 4 groups. To assess the level of microRNA expression in the blood of patients, real-time reverse transcription-polymerase chain reaction (RT-PCR) will be used.

The expected result of the study. For the first time ever, there will be determined the profile of circulating regulatory RNA in patients who underwent MSCT angiography of coronary arteries. Features of expression of circulating microRNAs will be compared with different severity degrees of the atherosclerotic process based on MSCT criteria. The results will be compared with each other (including the "control" group), which will allow to identify common patterns and specific differences.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the patient to participate in the study;
* Age 18-80;
* The presence of medical indications for MSCT angiography of coronary arteries in connection with suspected coronary heart disease.

Exclusion Criteria:

* Age less than 18 or more than 80;
* Pregnancy, breast-feeding;
* Patients who have not undergone (and do not plan) MSCT coronary angiography;
* Any surgical intervention on the heart in history;
* Severe heart failure (III-IV NYHA classes);
* History of myocardial infarction;
* The body mass index of 35 or more;
* More than twice the ALT and/or AST level;
* The presence of severe somatic pathology (except coronary atherosclerosis);
* Patient's refusal to participate in the study;
Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project

The proposed study aims to combine evidenced based tools and guidance (H.E.A.L.T.H.: Healthy Eating Activity Lifestyle Training Headquarters) previously tested that has been developed specifically for use by Army Soldiers and a remote clinical intervention model that includes mobile tracking technology/devices for physical activity, weight and nutrition. This program is called the H.E.A.L.T.H. Intensive.

The purpose of this investigation is to test the efficacy of a remote intervention to assist Soldiers in meeting standards for body fat and fitness. The intervention will include:

1. An Internet/Smartphone program for weight management and weight gain prevention developed during previous DoD research.
2. Integrated remote monitoring technology/devices, e.g. smart scales, activity tracking devices.
3. Individualized weight management and exercise recommendations based on data collected from web/mobile app/devices to be delivered via web/mobile app/Smartphone; participants will not travel to a clinical facility for the intervention.

The objectives are:

1. to further develop the H.E.A.L.T.H. intervention by merging components of the H.E.A.L.T.H. program, remote monitoring technology components, e.g. activity tracking devices, smart scales, and direct/individualized weight management and exercise feedback into a single and comprehensive intervention that targets weight and fat loss, improved fitness, improved sleep, and personal well-being for Soldiers and their family members.
2. Compare body weight, body fat, and activity changes associated with participation in the H.E.A.L.T.H Intensive intervention for six months and a six-month website only phase/follow-up phase, in comparison to participation in a wait-list control group; and
3. Evaluate blood biomarkers associated with changes in body weight. Evaluate changes in gut bacteria associated with body weight.

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female Soldiers who are members of the Louisiana National Guard

   * Direct family member of the LANG member who is enrolled in the study and will participate with the Soldier
2. ≥18 years old
3. For Soldiers: BMI ≥ 25, AND who exceeds Screening Table Weight AND maximum allowed body fat as outlined by AR600-9 Army regulations For Family Member: BMI ≥ 25
4. Has no known deployments (to the best of their knowledge) for one year upon beginning the study

Exclusion Criteria:

1. Soldiers and family members younger than 18 years of age
2. Soldiers and family members who are pregnant
3. Soldiers and family members who cannot read
4. Soldiers and family members who do not have daily access to wifi
5. Soldiers and family members who do not have access to a smartphone
Comprehensive Study on the Quality of Life in Cervical Cancer Patients

This is prospective cohort study. All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. Before and after the major therapy (including at least radical hysterectomy and/or radiotherapy), the patients accept (1) the questionnaires survey about quality of life; (2) urodynamic testing; (3) rectum dynamics testing and (4) ovarian reserve function. The survival outcomes (disease-free survival and overall survival) will be supplemented as secondary objectives.


Eligibility Criteria:
Inclusion Criteria:

* Primary uterine cervical carcinomas
* Aged 18 or older
* Accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study center
* Informed consents delivered

Exclusion Criteria:

* Not meeting any of the inclusion criteria
* Not accepting any of the four kinds of evaluations for quality of life
* Recurrent patients
* Not achieving response after above major therapy
Multiday Fully Closed Loop Insulin Delivery in Monitored Outpatient Conditions

Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can approximate the insulin release patterns of the normal pancreas. Timely and accurate knowledge of ambient glucose levels is important for insulin dose adjustments. Typically, glucose values are measured volitionally, several times a day, using capillary "fingerstick" samples. In addition, glucose in the interstitial fluid can be measured automatically and continuously using implantable glucose oxidase-based sensors. Recent study showed that this continuous measurement of glucose levels allows for a fully automated "closed-loop" insulin replacement therapy which requires an algorithm that receives glucose data, calculates an appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for development of a closed-loop insulin replacement system that integrates insulin delivery, glucose measurement, and control subsystems will present several challenges to biomedical engineers.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 to 70 years of age at time of screening
2. Subject's weight is between 50 and 120 kg
3. A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
4. Subject has ongoing use of an insulin pump ≥ 6 months prior to screening
5. Subject has an glycated hemoglobin value ≤ 9.0% demonstrated at the time of enrollment.
6. Subject uses a rapid-acting analogue insulin in his/her pump
7. Patient is willing to undergo all study procedures

Exclusion Criteria:

1. Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
2. Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
4. Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
5. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease within the past 6 months
6. Subject has a presence of a cardiac pacemaker or any other device that may be sensitive to radio frequency telemetry
7. Subject has any condition, including screening lab values that in the opinion of the Investigator may preclude him/her from participating in the study and completing study related procedures
8. Subject is actively participating in other investigational study (drug or device)
9. Subjects who consume alcohol daily