cyrilzakka/clinical-trials huggingface dataset:
Effects of Contralateral Strength Training on Postoperative Strength Deficits in the Immobilized Lower Extremity

This is a prospective, randomized controlled trial that will enroll patients undergoing unilateral meniscal root repair or meniscus transplant. The objective of this study is to determine if immediate postoperative strength training of the contralateral (non-surgical) lower extremity reduces postoperative loss of strength in an immobilized lower extremity.

After the completion of surgery, patients will be randomized to either the experimental treatment (Group 1) or control group (Group II)for postoperative rehabilitation.

Group I will receive knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation. The experimental strength training will be performed with moderate resistance and will require moderate effort. Exercises will include unilateral leg presses, lunges, step ups, and step downs. These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.

Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for meniscal root repair
* Patient is indicated for meniscus transplant
* Patient is at least 18 years of age
* Patient is expected to survive at least 1 year beyond surgery
* Patient has intact lower extremities bilaterally
* Patient is willing to participate by complying with pre-and post-operative visit requirements
* Patient is willing and able to review and sign a study informed consent form

Exclusion Criteria:

* Lower extremity musculoskeletal defects
* Systemic neuromuscular disorders
* Failure to complete pre-operative BIDOEX strength assessment
* Failure to complete pre-operative self-assessment score intake forms
Outcomes Data of Adipose Stem Cells to Treat Parkinson's Disease

The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on the quality of life of people with Parkinson's disease (PD). SVF contains components with "regenerative" properties, including stem cells that may be capable of ameliorating specific disease conditions. This study is designed to evaluate quality of life changes in individuals with PD for up to 12 months following SVF treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for a stem cell/SVF treatment
* Subjects diagnosed with idiopathic Parkinson's disease
* Subjects ages 18 years and older
* Subjects willing and able to sign informed consent
* Subjects willing and able to perform follow up interviews and surveys

Exclusion Criteria:

* Subjects with additional major health diagnoses
* Subjects that are pregnant or breastfeeding
Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension

Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate in elevating blood pressure and are useful in selecting effective antihypertensive therapy.2,3

The researchers hypothesize that:

1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure control in patients with untreated hypertension as well as in patients with treatment refractory or resistant hypertension that are managed by Clinical Hypertension Specialists.
2. Renin-guided therapeutics will reduce the number of medications required to maintain blood pressure control to \<140/90 mmHg in hypertensive patients receiving 3 or more medications, while under the care of a Clinical Hypertension Specialist.
3. Renin-guided therapeutics selection will reduce the total cost of antihypertensive care provided by Clinical Hypertension Specialists.

Hypertension affects \~25% of adults. The prevalence of hypertension and related complications is greater among the elderly, obese, and ethnic minorities. Unfortunately, hypertension control rates remain in the 25% range and are often significantly lower for the high-risk groups noted.1 Since the high-risk groups are growing more rapidly than the general population, the prevalence of hypertension and associated morbidity and mortality will probably increase sharply in the years ahead unless successful strategies are implemented for dramatically improving blood pressure control.

Direct measurements of plasma renin reflect the relative balance between volume (V) and vasoconstrictor (renin \[R\]) factors underlying the elevated blood pressure in patients with essential hypertension.2 While many antihypertensive medications have effects on both the volume (V) and vasoconstrictor (renin \[R\]) components of elevated blood pressure, one or the other usually predominates

Eligibility Criteria:
Inclusion Criteria:

* Age, 21 years of age and older
* Male or female (post-menopausal or effective method of birth control)
* BP and treatment criteria noted above
* Willingness to provide written, informed consent
* Ability to adhere to study protocol

Exclusion Criteria:

* Uncontrolled diabetes or hyperlipidemia requiring medication changes
* Any active disease process requiring new diagnostic and therapeutic plans
* Any life-threatening illness
* History of alcohol or drug abuse in past 5 years
* Mental illness or personality disorder that interfere with adherence to study protocol
* Serum creatinine \>2.5 mg/dL unless documented stable for at least one year
* Dialysis for chronic renal failure, even if creatinine stable for at least one year
* Intolerance to two or more classes of antihypertensive medications
* Normal home BP (\<140/90 mmHg at baseline), i.e., office only hypertension.
Metabolic Syndrome Diagnosis and Education Trial

This study is being done to gain knowledge on how effective different approaches of providing a diagnosis and varying educational tools that include DVDs and multimedia or printed instruction sheets on your readiness to increase the subject's level of exercise, lose more weight, eat a healthier diet; and to assess the subject's awareness of their risk of heart disease and their readiness to participate in a comprehensive lifestyle modification program.


Eligibility Criteria:
Inclusion Criteria:

Any 3 of the following 5:

1. History of hypertension or either systolic blood pressure \>125 or diastolic blood pressure \>85 mmHg or documented history and receiving treatment for it
2. Abdominal circumference ≥40 inches in men or ≥35 inches in women
3. Fasting triglycerides ≥ 150mg/dL or receiving treatment for it
4. Fasting blood glucose ≥ 100mg/dL but \<126mg/dL
5. HDL cholesterol \<40mg/dL in men or \<50mg/dL in women or receiving treatment for it

Exclusion Criteria:

1. Documented diagnosis of metabolic syndrome in the clinical record, if previously seen at Mayo.
2. History of coronary artery disease
3. Diabetes mellitus, or using an oral hypoglycemic pill for glucose intolerance
4. Congestive heart failure
5. Familial hypercholesterolemia including familial hypertriglyceridemia,
6. Fasting LDL-cholesterol \>160 mg/dL
7. Fasting triglycerides \> 390 mg/dL
8. Have systolic blood pressure \>160 and diastolic blood pressure \>100mg/dL
9. History of hypertension with changes in their blood pressure medicines within the last 60 days before enrollment.
10. History of dyslipidemia and changes on their lipid lowering agents such as statins, ezetimibe, fibrates or niacin within the last 60 days before enrollment.
11. Secondary causes of obesity such as hypothyroidism, Cushing syndrome, or eating disorders
12. Pregnant women or women planning to get pregnant during the duration of the study
13. Advanced liver disease
14. Renal insufficiency
15. Having any other major chronic medical condition
16. Unable to do their basic chores at home due to musculoskeletal limitations or other factors affecting their functional status.
17. Physical activity of more than 60 minutes per week of moderate to intense exercise
Hyaluronate Injection for Lateral Epicondylitis

This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally been used to treat knee osteoarthritis. There are a small number of studies in the literature that suggest that HA injections can be very effective for tendinosis. Although LE has been studied with literally hundreds of articles published, very little treatment has proven to be efficacious. This study will investigate the effectiveness of hyaluronate in treatment of chronic LE. This will include a two arm study with one formulation of HA tested against saline injections as the control.

Patients will be randomized and blinded into one of the two arms. Patients will receive 3 injections total spaced over a 4 week period. After the injections are completed, patients will return for evaluation at 3, 6 and 12 months from the initial injection. A total of 72 patients will be divided into the 2 groups. The questionnaires will be administered by a research assistant blinded to the randomization. Three different outcomes measures will be collected, all patient-oriented including the Patient Rated Tennis Elbow Evaluation (PRTEE), Visual Analog Score (VAS) for pain while at rest and with maximum grip, and the short form Disabilities of the Arm, Shoulder and Hand (quickDASH).

The primary outcome measure will be the VAS for pain at 3 months from the initial injection. All measures will be evaluated at baseline then again at 12 months from the initial injection.

HA formulation will be Intragel (IBSA) which include 2cc with a concentration of 16mg per 2cc. The molecular weight with Intragel averaging 800-1200 kiloDaltons.

The syringes will be coded and the injections blinded. The injections will be given 1cm distal to the lateral epicondyle at the site of maximum tenderness. The needle will be introduced to the depth of the bone then withdrawn 1-2mm. The injection will be given in two locations in and around the point of maximum tenderness.

Eligibility Criteria:
Inclusion Criteria:

* Included will be patients older than 18 years with lateral epicondylitis. The criteria for diagnosis will include pain and tenderness at the lateral epicondyle worse with resisted wrist or finger extension (with the elbow in the extended position).

Exclusion Criteria:

* Excluded will be patients with history of prior elbow surgery, history of fracture or dislocation, known inflammatory or autoimmune disorders, or known hypersensitivity to HA.
* Exclusion will also include a known allergy to birds, feathers or egg products. If the patient has complaints of pain or tenderness on exam in the area of the radial neck, then a component of radial tunnel syndrome will be assumed and these patients will be excluded from study.
* Patients that are pregnant will be excluded.
* Patients with medial epicondylitis
* Prior elbow surgery
* Elbow steroid injection in the past 3 months
* Inflammatory condition, like rheumatoid arthritis or lupus
Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome

Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

AReMIS (Antiplatelet and Recurrent Myocardial Infarction Study) To compare the relative risk of new myocardial infarction (recurrent myocardial infarction or 'rMI') in patients with a history of acute coronary syndrome ('ACS': unstable angina or myocardial infarction), using ticagrelor, clopidogrel or prasugrel (if applicable) or none of these treatments, where aspirin is considered a covariate.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 years or more, both genders, with an acute coronary syndrome (ACS), agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.

No Exclusion Criteria.
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients

The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild Alzheimer's Disease
* Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)
* Clinical dementia rating (CDR) scores of 0.5 or 1
* Other inclusion criteria apply

Exclusion Criteria:

* Clinically significant neurological disease other than Alzheimer's disease
* Major psychiatric disorder
* Severe systemic disease
* Serious adverse reactions to any vaccine
* Other exclusion criteria apply
Retrospective, Non-interventional Study of Depo-Eligard®.

Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment

The study will provide data on the tolerance, safety and acceptance of Depo-Eligard® (leuproreline acetate) when used in routine clinical practice. Data on efficacy parameters such as testosterone, PSA levels, symptoms and treatment failure, if available will be collected.It will reflect the way Depo-Eligard® is used in routine clinical practice and how PSA, testosterone levels, symptoms and treatment failure, are used as parameters in the treatment for Prostate Cancer.

Patient data will be collected after a treatment period of six months.

Eligibility Criteria:
Inclusion Criteria:

* Patients having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization
* Patients on treatment with Depo-Eligard® for at least six months
* Written consent has been obtained
Hypothermia and the Effect of Ambient Temperature 2

Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The prior HEAT study conducted at our institution showed a difference in neonatal hypothermia with a change in ambient operating room temperature. The investigator's objective is to determine if an increase in ambient operative room temperature decreases the rate of neonatal morbidity. Operating room temperature will be randomized to the current institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for a period of 1.2 years.

This is an open, prospective, randomized, single center trial that will address the primary research question: Does an increase in ambient operating room temperature result in a lower rate of composite neonatal morbidities? During the 1.2 year study period, the operating room temperatures on labor and delivery will be adjusted to either the current standard of care with ambient operating room temperature of 20°C (67°F), or the maximum temperature allowable per hospital policy in the current operating rooms, which is 24°C (75°F), as determined by cluster randomization. Composite neonatal morbidities will be recorded including hypoglycemia necessitating treatment; need for respiratory support within the first 24 hours; culture-proven sepsis; and mortality. Association of outcomes with the types of passive and active warming performed will include these morbidities stratified by gestational age as well as maternal outcomes. In addition, an electronic survey will be administered to the operating resident physicians to assess their experience with the study conditions.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery unit during the study period.

Exclusion Criteria:

* Exclusion criteria include cases where a cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly and resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.
Dose Optimized BNCT for Head and Neck Cancer

The goal of this clinical trial is to evaluate the safety of applying BNCT with the dose optimization in patients with recurrent head and neck cancer. The main questions it aims to answer are:

- Dose optimized BNCT are conducted safety in these patients. Participants will receive dose optimized BNCT regulated as 12, 15, 18 Gy-Eq of the mucosal dose.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent to participate in the clinical trial on their own free will.
* Aged over 20 years at the time of consent obtaining.
* ECOG performance status (PS) of 0-2.
* Histologically confirmed a primary lesion of Head and Neck cancer.
* Following condition:

  1. Locally Recurrent Head and Neck Squamous Cell Carcinoma after chemo radiotherapy or radiation therapy.
  2. Primary Head or Neck Squamous Cell Carcinoma with no indicated of radical radiation therapy for the target lesions.
* More than one the target lesions based on RECIST (version 1.1)
* Local recurrent lesion localized to unilateral.
* Received a fractionated radiation therapy with total doses of ≥40 and ≤80 Gy at around 2 Gy per daily fraction at target lesion sites or an equivalent biologically effective dose.
* ≥50 days have passed since the last irradiation date of the prior radiation therapy at target lesion sites to the day of scheduled BNCT
* Have an estimated survival of ≥90 days after BNCT.
* Estimated able to receive the minimum tumor dose at least 20Gy-Eq.
* Screening test values that meet the following criteria.
* No abnormal findings of clinical concern in chest X-ray exam.

Exclusion Criteria:

* Active multiple primary cancers.
* Distant metastatic lesions.
* Active infections requiring systemic treatment.
* Serious complications.
* Poorly controlled diabetes mellitus.
* Poorly controlled hypertension.
* Chronic lung diseases.
* Kidney diseases.
* Cardiac diseases.
* Other serious complications.
* Phenylketonuria.
* Hereditary fructose intolerance.
* Current or past medical history of serious hypersensitivity to drugs or contrast media.
* Myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the scheduled BNCT.
* Grade ≥3 (CTCAE v4.0) symptom at the target site.
* Tumor invasion of the carotid artery or adjacent to over half of the carotid artery.
* Dental caries whose treatment has not been completed.
* Received antitumor drugs within 4 weeks prior to the scheduled BNCT.
* Participating in a clinical study of an unapproved drug except 18F-F BPA-PET/CT examinations within 4 weeks prior to the scheduled BNCT.
* Implanted with a cardiac pacemaker, ventricular assist device, or the like.
* Inability to immobilize at a right position during irradiation by the investigator (subinvestigator)
* Pregnant or who are breastfeeding during the period of the clinical trial.
* Mental illness or mental conditions.
* Poorly controlled epilepsy.
* Unable to comply with the protocol and to attend follow-up visits.
* With a history of BNCT.
* Considered unfit to participate in this clinical trial as assessed by the investigator.
Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice

This study will examine the impact of providing patient-reported outcomes measurement information system (PROMIS) scores to patients before appointments with their healthcare provider.


Eligibility Criteria:
Inclusion Criteria for patients:

* New and established patients seeking care at Michigan Medicine rheumatology clinics
* Patients should have access to the patient portal in MiChart patient portal
* Patients should have access to the internet at home to be able to complete the PROMIS PRO measures and study surveys online
* Patients should have completed PROMIS pain, physical function, and sleep disturbance measures at least one day before their baseline appointment
* At least one of the PROMIS PRO scores should be in the concerning zone (pain intensity ≥ 5, physical function ≤ 40, or sleep disturbance ≥ 60).

Exclusion Criteria:

* Non-English speakers
* under 18 years of age

Inclusion Criteria for providers:

* Rheumatology health care providers, including clinicians and advanced practice providers at Michigan Medicine who are currently treating rheumatology patients

Exclusion Criteria:

* Those not meeting the inclusion criteria
Strength Training Following Gastric Bypass for Obesity

We will assess whether undesirable loss of lean tissue following gastric bypass surgery for obesity can be minimized by protein supplementation and exercise training.


Eligibility Criteria:
* clinically severe obesity
* candidate for bypass surgery
* new york city local address
* willing to visit hospital weekly
Effectiveness of Animation-Based Education Given to Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery

It was conducted to measure the effectiveness of animation-based training given to elderly patients who will undergo coronary artery bypass graft surgery on the patients' pain, fear, anxiety and self-care management.

The study will be completed with 72 participants, 35 experimental and 37 control.

As a randomization method, simple randomization method will be used to ensure equal number of samples in the two groups, and patients will be verbally informed about the study and written informed consent will be obtained from the patients who agree.

In this study, the effectiveness of animation-based training given to elderly patients undergoing coronary artery bypass graft surgery on pain, fear, anxiety and self-care management will be evaluated.

Experimental: Patients in the experimental group will be given animation-based video training with a laptop one day before the surgery. The animation-based video training lasts 8 minutes and 35 seconds in total.

Patient Information Form, Self-Care Management in Chronic Diseases Scale, Visual Analog Scale, Hospital Anxiety Depression Scale, Surgical Fear Scale (Turkish Version) will be applied.

Control: In the preoperative period, no training will be given by the researcher to the patients constituting the control group. Patients in this group will receive the routine training of the clinic before surgery. Patient Information Form, Self-Care Management in Chronic Diseases Scale, Visual Analog Scale, Hospital Anxiety Depression Scale, Surgical Fear Scale (Turkish Version) will be applied.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older,
* No diagnosed functional disability,
* First scheduled coronary artery bypass graft surgery,
* Those who volunteered to participate in the study

Exclusion Criteria:

* Urgent cases,
* Cases with additional surgical procedures
AQCS for Detection of Early Cancer and Precancerous Lesions on Upper Gastrointestinal Tract

The purpose of our study was to assess the performance of esophagogastroduodenoscopy automatic quality-control system in real-time quality control of EGD.

Investigators developed a real-time quality control system of esophagogastroduodenoscopy(EGD) named EGD automatic quality-control system (AQCS). Investigators carried a prospective multicenter randomized controlled trial to assess the performance of this system in quality control of real-time EGD, including detecting the early upper gastrointestinal cancer and precancerous lesions, assessing inspection completeness, mucosal visibility, time of EGD procedure and other indicators.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-80 years old
* Patients scheduled for white light EGD examination with anaesthesia
* American Society of Anesthesiology risk class 1, 2 or 3

Exclusion Criteria:

* Patients with known advanced esophageal or gastric cancer
* Patients with a history of esophageal or gastric surgery
* Patients scheduled for therapeutic EGD
* Patients with stenosis or obstruction of upper gastrointestinal tract
* Patients with a history of serious anesthesia-related complications
* Patients in pregnancy or lactation phase
* Patients refused to sign the informed consent