cyrilzakka/clinical-trials huggingface dataset:
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients

To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)

To investigate the multimodality approaches for mHSPC

Eligibility Criteria:
Inclusion Criteria:

1. Male aged ≥18 and ≤75;
2. Histologically confirmed prostate adenocarcinoma;
3. Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
4. Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
5. Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
6. The surgeon believes the prostate can be removed;

Exclusion Criteria:

1. The surgeon believes the disease is unresectable;
2. Life expectancy less than 2 years;
3. Active spinal cord compression;
4. History of prior local treatment for prostate cancer;
5. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
6. Refusal to sign the informed consent;
7. Investigator believes the individual is not suitable for inclusion.
Safety Trial of Naproxen Sodium/ Diphenhydramine

The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory, male and female volunteers ages 12 and older
* History of experiencing occasional sleeplessness accompanied by aches and pains at least two times, but not continually for more than 14 days per month, in at least 2 of the past 3 months
* Female subjects of childbearing potential must be using a medically acceptable form of birth control, e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, for at least 1 month prior to screening (3 months on oral contraceptives), or double-barrier and have a negative pregnancy test at Screening. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or have had a hysterectomy and/or bilateral oophorectomy
* Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
* Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects \<18 years of age must sign a written assent and have parental or guardian consent).

Exclusion Criteria:

* History of hypersensitivity to naproxen sodium, acetaminophen, or any NSAIDs (Nonsteroidal Antiinflammatory Drugs), diphenhydramine or any other antihistamines, and similar pharmacological agents or components of the product
* Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies with the last 5 years
* A history of a chronic or severe sleep problem which does not respond to OTC (Over-the-counter) medication and/or requires a prescription hypnotic or sedative
* Currently experiencing chronic pain or on chronic NSAID therapy (defined as taking a daily \[5 to 7 days per week\] regimen of prescription or OTC NSAIDs)
* Current or past history of gastrointestinal ulcers or bleeding or other bleeding disorders
* Use of any OTC or prescription medications with which the administration of naproxen, acetaminophen, or any NSAIDs, diphenhydramine or any other antihistamines or sedatives, is contraindicated
* Chronic use of other products containing diphenhydramine, including topical products
* Use of steroids or blood thinning (anticoagulant) drugs (aspirin 81 mg is permitted if the dose has been taken for at least one month prior to screening)
STEP Together: An Effectiveness-Implementation Study of Social Incentives and Physical Activity

Higher levels of physical activity have been demonstrated to improve health across a wide range of contexts and reduce cognitive decline as adults become older, but more than half of all adults in the United States do not meet their physical activity goals. One type of physical activity that is broadly applicable to people of all ages is walking. This study will use a Hybrid Type 1 effectiveness-implementation design to adapt and test the effectiveness of two successful social incentive-based interventions, a gamification strategy and financial incentives donated to charity on the participants behalf, to increase physical activity among low-income, mostly minority families in community settings.


Eligibility Criteria:
Inclusion Criteria:

* Able to read and speak English;
* Has a smartphone or tablet;
* Lives in the Philadelphia area;
* Age 14 or older;
* Able to provide informed consent;
* Enrolled as a member of a 2 to 10 member family team with least one member 60 years or older.

Exclusion Criteria:

* Already participating in another physical activity study;
* An 18-month physical activity program is infeasible (e.g., metastatic cancer, unable to ambulate or provide informed consent) or unsafe (currently pregnant or told by a physician not to exercise);
* Do not have sufficient eyesight or dexterity to operate device;
* Average step count greater than 7,500 steps/day during the run-in period.
Impact of Escitalopram on Sperm DNA Fragmentation

Double-blind placebo-controlled randomized trial of daily escitalopram for 6 weeks in healthy men with normal semen analyses and no psychiatric history of depression, bipolar, mania or suicidal ideation. Hormone profiles, semen analysis, sperm DNA fragmentation, and sexual function will be measured at baseline, after 6 weeks of therapy, and 4 weeks after discontinuation of therapy (10 weeks into study).

SSRI medications, specifically escitalopram is a very commonly prescribed medication among men of reproductive age. Significant evidence exists that they may be harmful for paternal fertility potential in both animal and human studies. However, high quality data is lacking, particularly among commonly used SSRI's such as escitalopram. As such, it is important to properly evaluate the potential effect of escitalopram in a randomized placebo controlled fashion. Results will be important in guiding urologists, psychiatrists and family practitioners regarding discussion surrounding SSRI use in their patients interested in fertility.

Eligibility Criteria:
Inclusion Criteria:

* Normal semen analyses, or semen analyses with at least 5 million sperm
* Normal TUNEL value (\<7%)
* Willing to engage in at least weekly sexual activity, with a partner or alone for the duration of the 10-week study

Exclusion Criteria:

* Azoospermia or severe oligospermia (\<5million sperm per semen analysis)
* Presently attempting to conceive pregnancy
* Sexual dysfunction preventing ability to provide semen analysis throughout study or engage in weekly sexual activity
* Current psychiatric disorder including: bipolar, mania, depression, generalized anxiety, social phobia, panic attacks, obsessive compulsive disorder, and schizophrenia.
* Family history of bipolar disorder, or suicide (including 2nd degree relatives)
* Present use of psychotropic agents (prescription or herbal) or anticonvulsants
* Use of sleeping pills
* Alcohol consumption greater that 2oz/day
* Use of illicit drugs
* Inability to read, follow instructions or complete questionnaires in English.
* Use of hormonal medications in past 3 months (androgens, androgen blockade, anabolic steroids, estrogens, herbal)
* Use of medications to enhance sexual function
* History of chemotherapy or pelvic radiation
* Use of Monoamine Oxidase inhibitors (MAOi's) or tricyclic antidepressants (TCAs) within 14 days
* Liver disease
Effects of Resistin on Neutrophil Function

To assess the effect of resistin on neutrophil migration and intracellular bacterial killing


Eligibility Criteria:
Inclusion criteria:

* age ≥ 18
* gender: male or female

Exclusion Criteria

* Adults who are unable to provide informed consent themselves
* History of chronic kidney disease as defined by estimated glomerular filtration rate (GFR) \<60 ml/min prior to cardiogenic shock
* Patients with hematologic malignancies
* Pregnant women
* Patient/surrogate is not fluent in English
* Long-term immunosuppressive therapy
* Prisoner
* Patients on pre-existing continuous reno-renal therapy (CRRT) or intermittent hemodialysis (IHD
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
* Meet florbetapir F18 PET scan criteria.
* A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.
* Must consent to apolipoprotein E (ApoE) genotyping
* Must have a mini mental state examination (MMSE) score between 20 and 30
* Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times.
* Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening.
* Women not of childbearing potential may participate

Exclusion Criteria:

* Significant neurological disease affecting the central nervous system (other than AD), that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, history of transient ischemic attack or stroke, or epilepsy or recurrent seizures (except febrile childhood seizures).
* Current serious or unstable medical illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, psychiatric (including actively suicidal or deemed at risk of suicide, or current alcohol or substance abuse), immunologic, infectious, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of approximately

  ≤24 months.
* History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
* History of bleeding disorder or use of medications with platelet anti-aggregant or anti-coagulant properties (unless aspirin at ≤325 milligram (mg).
* Have had prior or current treatment with donanemab or aducanumab
* Have known allergies to donanemab or aducanumab, related compounds, or any components of the formulation
* Prior or current participation in any immunotherapy study targeting Amyloid beta
A Prospective Cohort Study of Heart Patients Included in Exercise Based Rehabilitation in Oslo

Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation.

Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac rehabilitation program.

A prospective cohort study including all cardiac patients referred for outpatient cardiac rehabilitation in a primary care clinic in Oslo. The main efficacy variable is the changes in exercise capacity (VO2peak) as a primary prognostic measure of successful rehabilitation. HRQoL are measured by self-report using the COOP/WONCA questionnaire and SF-36.

Eligibility Criteria:
Inclusion Criteria:

* stable coronary heart disease
* valvular surgery
* refered to high-intensity exercise training from a cardiologist

Exclusion Criteria:

* acute myocardial infarction within four week
* serious rhythm disturbances
* unstable angina pectoris
* known significant comorbidity
* symptomatic peripheral vascular disease
* obstructive pulmonary disease with forced expiratory vital capacity \< 60% of predicted
* left ventricular ejection fraction \< 40%
Freedom SOLO Stentless Heart Valve Study

The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.

The SOLO clinical investigation is a prospective, non-randomized, multicenter trial of the SOLO Freedom heart valve implanted in patients requiring aortic valve replacement.

Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female 18 years old or older.
* The subject or subject's legal representative is willing to sign the informed consent.
* The subject which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
* Any subject amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures.
* The subject is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
* Subject will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion Criteria:

* The subject has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
* The subject requires a double or multiple valve replacement (a valve repair is not considered an exclusion criterion).
* The subject has a previously implanted SOLO valve, within the clinical study, that requires replacement.
* The subject has active endocarditis or myocarditis.
* The subject is or will be participating in a concomitant research study of an investigational product.
* The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
* The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject.
* The subject is pregnant, planning to become pregnant or lactating.
* The subject has a congenital bicuspid aortic valve.
* The subject is known to be noncompliant or is unlikely to complete the study.
* The subject is undergoing renal dialysis for chronic renal failure or has been diagnosed with hyperparathyroidism.
* The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
* The subject has extensive calcification of the aortic root where removal of the calcified tissue cannot be achieved.
* The subject has a significantly dilated aortic root that is not surgically corrected.
* The subject requires replacement of the aortic root / full root procedure.
Randomized Controlled Trial of Virtual Reality

Measure pain and anxiety during a putative painful medical procedure (i.e., botulinum toxin injections) when Virtual Reality is employed compared to standard of care only using a Randomized Controlled Trial study design.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving botulinum toxin injections at Gillette Children's Specialty Healthcare

Exclusion Criteria:

* Patients who are fully anesthetized during their medical procedure
* Non-English speaking parents/patients
* Patients with history of motion sickness
* Patients with epilepsy
* Patients with a ventricular shunt
* Patients who have surgery during the study time period
Evaluating a Remotely Delivered Plant-Based Behavioral Weight Loss Treatment

Many individuals do not achieve clinically significant weight loss following traditional lifestyle modification interventions, potentially because weight loss is dependent upon calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for most. By contrast, non-energy-restricted whole food plant-based diets (WFPBD) have been demonstrated to promote clinically significant weight loss even without calorie prescriptions. The present pilot trial represents the first, to the knowledge of our study team, to empirically test a remotely delivered WFPBD behavioral weight loss intervention for adults with overweight or obesity. Over 12-weeks, participants (N = 21) will follow a non-energy-restricted WFPBD and received nutritional counseling and behavioral weight loss intervention. Participation will occur in two phases (Phase 1: n = 7; Phase 2: n = 14), between which iterative changes to the intervention will be made. Assessments will occur at baseline, mid-treatment, post-treatment, and 3-month follow-up. Data will be analyzed using an intent-to-treat approach. The primary aims of the study will be to assess retention feasibility and acceptability. The secondary aims will be to evaluate the preliminary effectiveness of the intervention on: (1) percent weight loss; (2) dietary intake (i.e., increased intake of low-fat plant-based whole foods and decreased in intake of processed foods and animal products); and (3) waist circumference. The exploratory aims will be to evaluate the preliminary effectiveness of the intervention on physical- and mental health-related quality of life, and to examine potential moderators of treatment success (plant-based diet history, internal disinhibition, social support vs. social sabotage, self-compassion, and psychological flexibility).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75
* Current BMI ≥ 25 kg/m2
* Reporting a desire to lose weight
* Have at-home internet access
* Proficiency in speaking, reading, and writing English
* Willing to consume a whole foods plant-based diet for the study duration

Exclusion Criteria:

* Use of medications for weight loss
* Recent weight loss (≥5% weight loss in prior 3-months)
* Current or planned pregnancy within the study period
* History of bariatric surgery
* Currently following a low-fat plant-based diet
* Diagnosis of a serious medical condition influencing weight, appetite, or eating behavior
* Diagnosis of a serious psychiatric condition that may influence weight, appetite, or eating behavior
* Current substance use disorder
* Participation in a concurrent weight loss program
* Planning on quitting smoking over the intervention period (if current smoker)
* Eating pathology (lifetime history of an eating disorder, ≥ 9 binge eating episodes in the past 3 months, or \> 5 compensatory episodes in the past 3 months)
Retrospective/Prospective Study of Pediatric Surgical Patients

UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients. At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report. Since it is a surgical and therapeutic first it needs to be aon regestiry of health research prior to publication.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patient with splenomegaly

Exclusion Criteria:

* NOn pediatric patients
Fiducial Localization and Individualized Radiotherapy -Prostate Cancer

This purpose of this study is designed to compare two types of images; magnetic resonance imaging (MRI) and Trans-Rectal Ultrasound (TRUS) to see which one performs more accurately for the image-guided insertion of Fiducial Markers(FMs) within the tumour. Though effective for guiding FM placement at the poles of the prostate gland due to excellent visualization of the prostatic boundaries, TRUS may not be ideally suited for marking the GTV. Conventional TRUS is neither sufficiently sensitive nor specific for accurate visualization of intra-prostatic tumor. A new interventional MRI technique enables needle guidance to the gross tumour Volume (GTV) for FM placement. It is of particular importance that both techniques be evaluated to enable which one is more effective so that it can be implemented in the designs of future trials involving dose-escalation to prostate.

The success of dose escalation strategies in prostate cancer over the last decade has relied on high accuracy in target delineation, localization and radiation delivery. Improved biochemical control with acceptable levels of toxicity (specifically rectal) has been achieved by stringently monitoring the location of the prostate during the course of radiation treatment. Studies in the early 1990's demonstrated that daily bony alignment was a poor surrogate for prostate gland location. Since then, various strategies have been devised to localize the prostate precisely during treatment. Of these, Transrectal Ultrasound (TRUS)-guided gold fiducial marker (FM) insertion and x-ray imaging of markers has been a broadly successful approach. TRUS guidance has been used for fiducial marker insertion within the prostate since 1985 in various centers throughout the world and has also been a standard practice in PMH since 1997 in men undergoing radical external beam radiotherapy. A retrospective comparative study of 106 patients evaluating the relative accuracy of endorectal MRI and TRUS in detecting the location of tumor reported an improved performance of endorectal MRI especially in the base and midgland regions. Over the last few years, mounting experience in the interpretation of prostate MRI, and addition of physiologic imaging sequences has further improved the performance of MRI in detecting and localizing the GTV.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. ECOG status ≤ 1
3. High risk localized cancer planned for RT under FM guidance
4. Gleason \> 7, PSA \> 20, Clinical stage ≥ T3
5. patients(pts) must give written informed consent

Exclusion Criteria:

1. pts \> 136 kg or \> 60 cm in girth
2. Pts with pacemakers, cerebral aneurysm clips, shrapnel injury or devices not compatible with MRI.
3. pts with severe claustrophobia
4. pts with bleeding diathesis and anticoagulative therapy that cannot be ceased prior to needle procedures.
5. Contraindications to endorectal probe, surgically absent rectum, severe hemorrhoids or previous colorectal surgery.
6. Latex Allergy
Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

Residual limping after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate a surgical treatment for residual limping and compare its results with non-surgical treatment. Our hypothesis is that surgical treatment followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.

Residual limping due to gluteus medius insufficiency after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate surgical reconstruction of gluteus medius using Achilles tendon allograft and compare its results and adverse events with non-surgical treatment. Our hypothesis is that surgical reconstruction followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Persisting limping with positive Trendelenburg's sign for at least 12 months after total hip arthroplasty
* Rupture/avulsion of the gluteus medius tendon verified with ultrasound or MRI
* Leg length discrepancy of less than 1 cm
* Femoral offset discrepancy of less than 25%

Exclusion Criteria:

* Neuromuscular disorders