cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients

This is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* Dyspnea at rest or minimal activity
* Tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest X-ray

Exclusion Criteria:

* Acute coronary Syndrome
* Hospitalization plan for PTCA or CABG
* Cardiogenic shock (Systolic Blood Pressure \< 80mmHg)
* Uncontrolled hypertension (Systolic Blood Pressure \> 180mmHg)
* Allergy, adverse drug reaction, hypersensitivity to statin
* Troponin \> 5 times upper limit of normal (ULN)
* Creatinine kinase-MB level \> 3 times ULN
* AST, ALT \> 3 times ULN or acute hepatitis
* Current or past history of muscle disease, rhabdomyolysis
* Life expectancy \< 6 months (e.g. metastatic malignancy, liver cirrhosis)
* Pregnancy or women at age of childbearing potential
Effects of Provider Commitments to Choose Wisely

Clinicians' decisions to order potentially unnecessary services -- such as those targeted in the Choosing Wisely® campaign -- are often affected by their high-pressure practice environments, which can make it hard to consistently avoid ordering low-value care. The field of behavioral economics offers a promising and highly scalable approach to decreasing use of low-value services: asking clinicians to commit to avoid ordering such services and providing them and their patients with resources to support adherence to this commitment. This project will evaluate the effects of such an intervention across 2 large health systems, Michigan Medicine and IHA, through a mixed-methods, stepped wedge cluster randomized trial. In each of the study clinics, clinicians will be invited to commit to following a set of targeted Choosing Wisely® recommendations. Clinicians who make such a commitment, and their patients, will receive access to key resources to support adherence to this commitment. To measure the effects of the intervention, automated clinical data and medical record data before and after the intervention will be examined. Surveys and semi-structured interviews of both clinicians and patients will also be conducted to determine the effects of the intervention on their decision-making and experiences.

A mixed-methods stepped wedge cluster randomized trial will be conducted in 8 primary care clinics of IHA, a private multispecialty group practice, and Michigan Medicine, a large academic health system. The study will test whether pre-encounter clinician commitments combined with patient and provider supports decrease overtreatment of type 2 diabetes among patients 65 and older, use of benzodiazepines and sedative-hypnotics among patients age 65 and older who have insomnia or anxiety, and use of PSA tests to screen for prostate cancer among men 75 and older. These 3 recommendations were chosen because they are commonly performed in primary care practice, have Choosing Wisely® recommendations against these low-value services, and represent situations in which clinician decisions about ordering of services can be unduly swayed by interactions with patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinician participants will be drawn from the pool of physicians, nurse practitioners, and physician assistants staffing the 8 primary care clinics.
* Patients of all 8 study clinics must meet criteria for one of the three Choosing Wisely® recommendations to be eligible to participate:

  * 65 and older with type 2 diabetes
  * 65 and older with insomnia and/or anxiety
  * male, 75 and older with no history of prostate cancer.

Exclusion Criteria:

* Patients who have cognitive impairment and/or a serious psychiatric diagnosis will not be eligible to participate in the surveys or interviews.
Exercise Intervention on Conflict Monitoring in Children With Attention-deficit Hyperactivity Disorder

The study mainly investigates the effect of high-intensity interval training on conflict monitoring in children with ADHD by using event-related potential and sLORETA techniques.

The present study will have two experiments, one is a cross-section study and the other is intervention study.

As for cross-section study, typical developmental children and children with ADHD will perform the stroop task while recording their brain waves.

The intervention is twice a week for 5 weeks and before and after the intervention, children with ADHD will randomly assign to either an exercise group or control group. They will perform the stroop task while recording their brain waves.

Eligibility Criteria:
Inclusion Criteria:

1. age between 7 and 12 years
2. diagnosed with ADHD by a pediatric psychiatrist, which is not required for TD
3. no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness.

Exclusion Criteria:

1. cannot follow the instruction
2. cannot complete all the procedure
Regaining Bladder Control in Postmenopausal Women With Osteoporosis

Conservative management for urinary incontinence has been shown to improve bladder control. We are conducting a study of the effectiveness of conservative management for urinary incontinence in women who also have osteoporosis. We hope to find that treatment for incontinence improves bladder control and thereby allows women to be more active and reduces their risk of falling and breaking bones.


Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women osteopenia or osteoporosis and stress urinary incontinence

Exclusion Criteria:

-
Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section

This is a pilot study of up to 10 women, which will test the hypothesis that the placement of copper IUDs through the uterine incision at the time of uncomplicated elective C-section is technically feasible and acceptable to women seeking long-term contraception.

Women will be enrolled in this study during late prenatal care. Consent for placement of the IUD will be verified prior to elective C-section. After removal of the placenta, the copper IUD will be placed through the incision at the fundus and the tail strings will be delivered through the cervix. Data will be collected about patient bleeding and possible infection during the immediate postoperative period. The visibility of the strings will be verified at discharge and at 2 and 6 weeks postpartum. Fundal placement of the IUD will be verified by ultrasound at the patient's last visit.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* Requires elective C-section
* Desires long-term contraception

Exclusion Criteria:

* Contraindications to copper IUD
Type 1 Diabetes Telemedicine

At the conclusion of this project, investigators will have assessed the effectiveness of home-based telemedicine for improving multiple important clinical and patient-centered outcomes in a high-risk pediatric cohort with T1D.

Aim 1. To test the hypothesis that home-based telemedicine is a feasible and acceptable method of care delivery for patients with poorly controlled type 1 diabetes (T1D) currently cared for at the University of California, Davis (UCD) Pediatric Endocrinology clinic. Specifically:

A) Patients and families choose to participate in telemedicine visits as a supplement to in-person care; B) Patients and families can utilize secure, internet-based platforms to upload and share glucose meter data and to establish an audio-video connection with a diabetes specialist in their home settings; C) Patients and families are satisfied with the experience of home-based telemedicine and would choose to receive future diabetes care via this modality.

Aim 2. To test the hypothesis that using home-based telemedicine, these patients can complete more frequent visits with a diabetes specialist than they previously completed via office visits alone.

Aim 3. To test the hypothesis that increased contact with a diabetes specialist via home-based telemedicine will lead to significant improvement in glycemic control for these patients.

Aim 4. To evaluate the effects of increased contact with a diabetes specialist via home-based telemedicine on high-cost health care utilization - specifically emergency department (ED) visits and diabetes-related hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

* age 1-17 years
* known diagnosis of T1D
* \>1 prior visit to the UC Davis Pediatric Endocrinology clinic (to avoid enrolling newly diagnosed patients)
* suboptimal glycemic control, defined as most recent hemoglobin A1C level of \>8%
* access to the internet via a device with video and audio capability (e.g. computer, tablet, mobile phone)
* ability to connect their home glucose meter to an internet-capable device via Bluetooth or physical cable for the purpose of data uploading.

Exclusion Criteria:

* Patients and parents whose primary language is not English
* Patients who have Western Health Advantage health insurance
Early Post-Operative Pain Control Following Wrist Operations

The purpose of this study is to demonstrate improved pain control and outcomes in wrist operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use of the standard local anesthetic, Marcaine.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* ASA physical status 1-3
* Undergoing either carpometacarpal arthroplasty or proximal row carpectomy operation
* Physically and mentally able to participate in the study and complete all study assessments
* Able to voluntarily give fully informed consent to participate in this study and complete all study assessments within the timeframes required.

Exclusion Criteria:

* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
* Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL
* Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study
* Any chronic condition requiring use of opioids for treatment of the medical condition for three (3) months or more
* Confirmed pregnancy at time of enrollment
* Patients unable to comply with the study requirements, i.e. inaccessible by phone, or deaf
Gametes Transfer vs. Embryo Transfer for Women Undergoing Assisted Reproductive Techniques: a Randomized Controlled Trial

Background: The cost for the treatment of infertility are limiting for the health care access, particularly if we consider that the success rate per cycle is approximately 35%. Alternative regimens for controlled ovarian stimulation (COS)have been described in the medical literature, that lead to a lower cost, fewer injections and less risk of adverse events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report excellent results with less manipulation as possible, which reduces the cost of laboratory of human and ethically be considered less complicated once fertilization occurs in the uterus and not in vitro.

Objectives: The main objective is to compare the reproductive outcomes between intrauterine transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the average number of eggs that are raised when using an EOC reduced cost.

Methods: This study will be conducted in the area of Human Reproduction, Department of Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study with random allocation of the participants in a 1:1 ratio, and we plan to include 100 participants. All participants will undergo an EOC reduced cost. We will compare the chance of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman allocated and to estimate the number of oocytes retrieved considering all participants.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing ART requiring COS, oocyte retrieval and embryo transfer at the fertility clinic of the university Hospital of the Medical School of Ribeirao Preto, University of Sao Paulo, Brazil.
* Age = 18-40 years
* BMI = 18-30 Kg/m²
* Antral follicle count (AFC) ≥ 5
* Semen concentration and progressive motility above the percentile 2.5 of the fertile men (Cooper et al. 2010): sperm concentration \> 9X 10⁶/mL, and progressive motility \> 28%.

Exclusion Criteria:

* None
PlayBionic: Interactive Mobile Training App

Often prosthesis users abandon their devices due to difficulties in prosthesis control and lack of motivation to train. To properly control a prosthesis, amputation patients must learn how to activate, isolate and sustain nerve signals to the muscles left at the stump. Results of clinical validations show that game-based training leads to an improvement in clinical parameters for prosthesis control and patient engagement.

Relevance:

Many users of a myoelectric arm prosthesis do not use their device because they find it too difficult to control the prosthesis. This may be due to the fact that patients cannot contract their muscles in the residual limb in a sufficiently controlled manner. Exactly this circumstance is trained during the physiotherapy with the patients. But at home many patients lack the motivation to continue the exercises from physiotherapy. Mobile games on the smartphone can provide patients with long-term motivation to continue the repetitive exercises that prepare the muscles for controlling a prosthesis at home.

Aim:

The aim of this study is to support patients in training at home with a game on their smartphone. This should increase motivation and improve the ability to control a prosthesis efficiently.

Design:

The Smartphone App is a rhythmic, music-based game consisting of different game modes. It has not only a display for real-time bio-feedback, but also many other audiovisually motivating incentives to continue playing the game. Similar to the classical control of a commercial prosthesis, the muscle signals are measured by two surface electrodes and, in this case, transferred to the app instead of the prosthesis. With these 2 electrodes the game is controlled. Test persons receive feedback on their performance through the constantly displayed bio-feedback, but also through high scores of the various levels and user statistics. By testing the muscle coordination twice a week, the neuromuscular improvements in the control of the game can be monitored.

Method/Procedure:

Eight transradially (below the elbow) amputated patients participate in this study. The intervention consists of playing with the smartphone training program using the muscle signals picked up by surface electrodes. The study will run over a period of 5 weeks, with participants playing with the training program at home for 4 weeks. The program should be used 5 times per week, therefore the intervention takes place 20 times in total. In the 5th week the final assessment, a final evaluation and the return of the devices take place. All usage data, such as starting and exiting the program and the duration of use, are recorded by the program itself and treated anonymously.

Eligibility Criteria:
Inclusion Criteria:

* Transradial amputees are included in the study.

Exclusion Criteria:

* Exclusion criterion is the inappropriate handling of the Android tablet or the computer ,as well as cyber sickness.
Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)

The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) in subjects with ESRD receiving hemodialysis, on bio-intact parathyroid hormone (biPTH), corrected serum calcium, serum phosphorus, and calcium phosphorus product.


Eligibility Criteria:
Inclusion Criteria: - Men and women must agree to use highly effective contraceptive measures throughout the study - Prescribed hemodialysis for at least 3 months before study day 1 - Cohort 1: The mean of 2 biPTH determinations obtained from the central laboratory must be greater than 160 pg/mL and less than or equal to 430 pg/mL - The mean of 2 corrected serum calcium determinations obtained from the central laboratory must be greater than or equal to 8.4 mg/dL Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Subjects receiving oral vitamin D - Pregnant or nursing females - Parathyroidectomy in the 12 weeks before day 1 - Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine and most tricyclic antidepressants). The antidepressant amitriptyline is permitted - Received, within 21 days before day 1, therapy with medications that are potent inhibitors (e.g. ketoconazole, itraconazole and erythromycin) or inducers (e.g., rifampin and St. John's Wort) of the enzyme CYP3A4. Phenytoin, phenobarbital and carbamazepine are also potent inducers of this enzyme. However, subjects on a stable dose of any of these anti-convulsants at baseline, with no evidence of seizure activity in the past 2 months may be eligible for the study - Experienced a myocardial infarction within 12 weeks prior to day 1 - Other investigational procedures are excluded - Currently enrolled in, or have not yet completed at least 30 days since ending other investigational device or drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - Participated in other studies with cinacalcet HCl - Disorder that would interfere with the understanding and giving of informed consent or compliance with protocol requirements
Everolimus on CKD Progression in ADPKD Patients

The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.

Considering the inhibitor activity of Everolimus on mTOR, our hypothesis is to evaluate its possible utility on the progression of CKD in ADPKD patients by reducing the rate of increase of renal cysts.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects over 18 years of both genders
2. Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
3. GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
4. Previous follow up of two years, with a creatinine evaluation at least once a year
5. GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)

Exclusion Criteria:

1. Pregnancy, lactating, males and females without adequate contraception
2. Leucopenia (\< 3,000 leucocytes/mm3) or thrombocytopenia (\< 100,000 platelets/mm3)
3. Dyslipidemia (cholesterol or triglycerides \> 260 mg/dl with treatment)
4. Urinary tract infection
5. Patients who cannot undergoing NMR
Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study introduced the principle of fast remission induction by means of a combination of standard Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose glucocorticoids in early Rheumatoid Arthritis.

The purpose of the present study is to compare different combinations of traditional DMARDs and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid Arthritis.

Besides the efficacy and effectiveness of these strategies, patient centered outcomes and potential implementation problems of such treatment strategies are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA as defined by the 1987 or 2010 revised American College of Rheumatology (ACR) criteria
* Early RA (less than 1 year)
* Use a reliable method of contraception for women of childbearing potential
* Able and willing to give written informed consent and participate in the study

Exclusion Criteria:

* Previous treatment with DMARDs
* Previous treatment with oral corticosteroids at a dosage of more than 10 milligrams (mg) prednisone within 4 weeks before baseline
* Previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg prednisone within 2 weeks before baseline
* Previous treatment with oral corticosteroids for more than 4 weeks
* Previous treatment with Intra Articular corticosteroids within 4 weeks before baseline
* Previous treatment with an investigational drug for the treatment or prevention of RA
* Contraindications for corticosteroids
* Contraindications for DMARDs
* Psoriatic Arthritis
* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
* Pregnancy, breastfeeding or no use of a reliable method of contraception
* Alcohol or drug abuse
Safety and Efficacy Study of Dual-axis Rotational Versus Standard Coronary Angiography

The purpose of this study is to assess the clinical safety and efficacy of dual-axis rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by directly comparing it to standard coronary angiography (SA).

Dual-axis rotational coronary angiography (DARCA) was developed as an innovative adaptation of rotational angiography (RA), but it requires a longer coronary injection compared to standard coronary angiography (SA). The risk of complications from the contrast agent (such as discomfort, warmth, pain, hypotension and bradycardia) is increased with the use of DARCA. It remains to be evaluated whether this approach is also suitable for coronary angiography, especially using in the patients with complex coronary lesions. Previous studies revealed promising results, but the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The purpose of this study is to evaluate the feasibility, safety, clinical tolerance, and hemodynamic effect of DARCA in comparison to the well-established SA.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* A clinical indication for diagnostic coronary angiography to evaluate possible CAD

Exclusion Criteria:

* Pregnancy
* Known allergy to iodinated contrast
* Renal insufficiency (\>1.5mg/dL)
* Cardiogenic shock
* Acute myocardial infarction within one week
* Prior coronary artery bypass graft treatment
* Prior percutaneous coronary intervention treatment