cyrilzakka/clinical-trials huggingface dataset:
Perfusion Augmentation Through Exercise

Large cerebral vessel occlusion is a common phenomenon in the general population and accounts for 13-35% of ischemic strokes. Chronic stenosis in the large cerebral arteries is associated with cerebral hypoperfusion, cognitive decline and an increased risk of stroke or recurrent stroke, respectively.

Even with upgrowth of surgical or endovascular interventions, mechanical reopening of the occluded vessels is often not possible. Alternative treatment opportunities include minimal-to-moderate blood pressure elevation (typically by ceasing antihypertensives) waiting for collateral circulation to develop spontaneously. Another conservative approach to increase cerebral perfusion is aerobic exercising. Physical activity has shown to lead to cerebral blood flow increase, especially in activated brain areas of healthy human and rat models. However, it is remains unknown, how physiological adaptation to physical activity expresses in persons after stroke due to large vessel occlusion. Herein, it is hypothesized that aerobic exercise facilitates the development of an extensive and functional vascular collateral network in persons with ischemic stroke and perfusion compromise.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients of 18 years of age or above
* Subjects after ischemic cerebral stroke (≥ 3 months) due to large vessel occlusion
* Subjects do not qualify for flow augmentation through ECIC bypass or endovascular treatment
* Persistent deficit in BOLD-CVR
* Functional Ambulatory Categories \>2
* Discharged from hospitalization / inpatient rehabilitation
* Living independent before stroke (mRS ≤3)
* Written Informed Consent

Exclusion Criteria:

* Severe cardiac disease, such as instable angina pectoris, pericarditis, heart failure (New York Health Association \> II°), or hemodynamically significant valvular dysfunction
* Complete arterial stenosis
* Peripheral artery disease with mild to moderate claudication at \< 200m or 200-1000m of walking
* Contra-indication, such as a history of a seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker, neuroleptic medication
* Inability to follow the procedures of the study, e.g., due to language problems (unable to follow to stage commands), psychological disorders (major depression), and / or a neurodegenerative disease (dementia)
* Known or suspected non-compliance, documented drug, or alcohol abuse
* Pregnancy
Tele-Yoga Therapy for Chronic Pain

Chronic pain is highly prevalent and associated with a large symptom burden, that is had been more concerning during Covid-19 outbreak and lockdown. Benefits of yoga in chronic pain management are very well known. With this background we developed Tele-Yoga therapy program and evaluated the success of this single arm study.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain for at least 3 months
* Having access to internet and video calls

Exclusion Criteria:

* Pregnant or breast-feeding women,
* Patients not willing to give written consent
* Patients with severe psychiatric or personality disorder
* Malignancy
Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia

This is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.The main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase (test drug code: SSS11) in patients with gout and hyperuricemia.The experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。


Eligibility Criteria:
Inclusion Criteria:

* A patient with clinical diagnosis of gout (according to the 2015 ACR/EULAR gout classification criteria), non acute attack phase, and hyperuricemia {under normal purine diet, blood uric acid\>420 µ mol/L (7 mg/dl) not tested twice on an empty stomach on the same day}。
* Screening period blood uric acid\>420 µ mol/L (7mg/dl)。

Exclusion Criteria:

* Within 14 days prior to enrollment (or within 5 half lives of the drug, whichever is longer), medication that lowers uric acid levels or affects uric acid levels and related drugs (allopurinol, febuxostat, benzbromarone, probenecid, benzenesulfonazolone, Tongyifengning tablets, etc.) must be taken, or during the study period, other drugs that lower uric acid levels or affect uric acid levels and related drugs other than experimental drugs must not be discontinued。
* Patients with acute gout attacks within 14 days prior to enrollment。
* Previously received uric acid oxidase or treated with similar drugs such as pegolase or rabulidase。
* Individuals with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD enzyme activity levels below the lower limit of normal。
* Individuals with a history of catalase deficiency or evidence that meets the diagnostic criteria for catalase deficiency。
* Malignant tumor patients (whether treated or not)。
Post Operative Walking Enhancements for Recovery (POWER) Trial

This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they will be given a goal number of steps to take on each post-operative day) following in-patient gynecologic surgery.

This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. treadmill-augmented post-operative care (placement of non-motorized treadmill in their room) following in-patient gynecologic surgery.

We will approach all women undergoing gynecologic procedures that are expected to ambulate within 12 hours of their operation and are anticipated to remain hospitalized at least 18 hours. Following confirmation of eligibility, we will enroll subjects either in the clinic when they are being consented for their gynecologic procedure or upon presentation to the hospital the day of their procedure. Randomization will occur at the completion of the gynecologic procedure when it has been confirmed by the primary surgeon that the patient is able to ambulate independently within 12 hours after completion of the procedure. At that time, participants will be randomized using opaque envelopes prepared by the study statistician in a 1:1 ratio to receive usual post-operative care or treadmill-augmented care.

All patients will have a pedometer placed on their person in the post-anesthesia recovery unit (PACU) which will be removed the day of their discharge. The primary outcome assessed will be number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.

Pedometer will be placed on patients using a lanyard and pedometer clip in the recovery room. No participant will start ambulation without physician's clinical order. When the patient is ready for the first ambulation she will be accompanied by a nurse to sit up in a chair. Once the patient is able to ambulate herself she may ambulate in her room or in the hallway or if randomized to treadmill group she will be able to ambulate on the treadmill. She will be wearing her pedometer at all times until discharge from Loyola.

Eligibility Criteria:
Inclusion Criteria:

* Independent ambulation pre-operatively
* Undergoing gynecologic procedure
* Expected to ambulate within 12 hours of their procedure

Exclusion Criteria:

* Children under the age of 18
* Inability to ambulate independently prior to their surgery
* Primary surgeon does not want patient to ambulate within 12 hours of procedure
* English is not the primary language spoken by the patient
Stress Management Training for School Staff

The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.

The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.

This study builds on previous work in other working populations with high stress levels inherent in the specific work process.

Eligibility Criteria:
Inclusion Criteria:

* Public school teacher
* Able tor read English

Exclusion Criteria:

* Unable to read English
Urodynamic Studies Prior to Surgery for Stress Urinary Incontinence

This retrospective descriptive study is to determine what proportion of Cincinnati Urogynecology Associates patients who underwent surgical management for stress urinary incontinence (SUI) would qualify for a basic office exam (BOE) alone, using the inclusion and exclusion criteria of the Value of Urodynamic Evaluation (VALUE) trial, and thus could have potentially had Urodynamic studies (UDS) omitted from their preoperative workup.

Urodynamic studies (UDS) are an assessment tool used to evaluate physiologic variables during bladder filling, bladder storage, and bladder emptying. They are commonly performed as part of the routine preoperative evaluation of women with symptoms of SUI. However, UDS are costly, with payments allowed by Medicare quoted at greater than $500, time consuming, uncomfortable, and have been shown to increase the risk of urinary tract infection. But most concerning is the fact that UDS have not been shown to improve surgical outcomes.

In 2012, the Value of Urodynamic Evaluation (VALUE) trial evaluated 630 women who underwent a basic office exam (BOE) or BOE plus UDS, and concluded that for women with uncomplicated, demonstrable SUI a BOE alone was not inferior to evaluation with UDS for outcomes at 1 year. This recent publication has resulted in urogynecology practices across the country evaluating their own standard of care when it comes to preoperative evaluation of SUI.

Cincinnati Urogynecology Associates, TriHealth Inc. standard practice is to perform UDS on all patients undergoing surgery for SUI. The providers of Cincinnati Urogynecology Associates, TriHealth Inc. would be remiss if the providers did not follow this trend and evaluate their own personal practice of preoperative UDS in patients presenting with SUI.

Eligibility Criteria:
Inclusion Criteria:

* All women 18 years of age or older
* Underwent surgery for SUI performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc. between January 2015 and December 2015

Exclusion Criteria:

* Age \< 18 years old
* Concomitant surgery for anterior or apical pelvic organ prolapse
Visual Restoration for Hemianopia

The purpose of this research is to assess the efficacy of a visual training task on reducing the size of a visual field deficit caused by brain damage in adults, and its ability to improve visual functions in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Ages 21-75 years old
* Ability and willingness to sign informed consent
* Willingness to participate in both the training and evaluation sessions
* MRI or CT scan demonstrating lesion in the occipital lobe of the brain and/or affecting white matter tracts that provide visual input to the occipital lobe of the brain
* Brain injury due to ischemic or hemorrhagic causes that occurs after age 18 and at least 90 days prior to screening visit
* At least two reliable HVF's demonstrating good fixation and a stable homonymous incomplete (e.g., quadrantanopia or relative defect) or complete hemianopia
* Reliable HVFs with repeat HVFs if randomization takes place more than 4 weeks after screening visit
* A homonymous, contiguous visual deficit measured by the 24-2 HVF to be a minimum of two testing locations high and two testing locations wide, where impaired locations are any that measure a threshold of less than 15 dB.
* Demonstration of good fixation on visual training task - able to fixate the small targets presented as fixation letters reliably for 1000ms with jitter over less than 1 degree of visual angle in any direction away from target edge

Exclusion Criteria:

* Physical, neurological or mental disability that would interfere with study intervention
* Concurrent participation in "vision therapy" other than standard occupational or physical therapy
* Unreliable visual fields on prior testing, indicated by greater than 20% fixation losses, false positives, or false negatives.
* Inability to discontinue medications judged to affect training and/or assessment (e.g., Ritalin, amphetamines, dopamines, or chemotherapeutic agents)
* Physical condition likely to preclude completion of the clinical trial (e.g. end-stage or uncontrolled cancer, uncontrolled epilepsy, or end-stage heart disease)
* Ocular or neurological condition that would interfere with training or assessment (e.g. damage to the optic nerves or lateral geniculate nucleus, any degenerative ocular condition)
* Best corrected vision worse than 20/40
* Impaired foveal Humphrey sensitivity as indicated by the HVF tests.
* Presence of vision loss resulting from ocular disease or disorder
* Presence of bilateral visual acuity loss from any source
* Inability to demonstrate fixation stability on eye movement monitored testing
* Inability to follow training instructions
Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones

Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Although both techniques have been used for many years, there are no studies comparing the efficacy of the two. The purpose of this study is to find out which technique is more effective.

Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.

Eligibility Criteria:
Inclusion Criteria:

* 1 or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented)
* Adults able to provide informed consent

Exclusion Criteria:

* Pregnancy or lactation
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility

We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.


Eligibility Criteria:
Inclusion Criteria:

-Primary infertility and no prior fertility treatment

Exclusion Criteria:

* No internet access
* Non-English speaking
* History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD
* Psychotropic medication change in the previous month
* Previously seen at another fertility clinic
* Previous MBSR course
* Previous mindfulness meditation retreat
The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, in People with Multiple Sclerosis

The aim of this study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people with Multiple Sclerosis with moderate severity.

A total of 30 MS subjects to be enrolled in the study. Subjects to be assigned into one of two groups named: Group 1 - Elliptical Training and Group 2 - Treadmill Training. Effort capacity will measured by heart rate and RPE.

Outcome measures will be measured by using, 6 min. walking test (6MWT), Timed Up \& Go (TUG), Berg Balance Scale (BBS) and 10 Meter Walk Test (10MWT) to be used to assess the quality of life at Baseline (T0), During study - 6 weeks from baseline (T1), End of training program - 12 weeks from baseline (T2) and 6 weeks post T2 (T3).

The exercise program to be applied for 12 weeks with 2 trainings per week.

Eligibility Criteria:
Inclusion Criteria:

1. Patients signed Informed Consent Form
2. At least 6 months post MS diagnosis
3. 25-55 years old adults
4. EDSS 3.0-6.5
5. Standing stability - for at least 30 seconds
6. 6MWT - minimal distance to be measured as 210 meters
7. No physical routinely training e.g. walking, elliptical or cycling within 3 months prior screening visit.

Exclusion Criteria:

1. Active Heart Disease
2. Lungs and/or respiratory system diseases
3. Metabolic Disease
4. Any other medical condition(s) which might impact the patient's participant in the study, as per PI medical judgement
5. Major medical treatment change (as per PI medical judgement) up to 12 weeks prior ICF signature by the patient.
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
* Subject is 18 years of age or older.
* Subject agrees to not participate in another study of an investigational agent during the study.
* Subject must be receiving hemodialysis 3 times weekly for at least 3 months
* Other Inclusion Criteria may apply

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
* Other investigational procedures while participating in this study are excluded.
* Anticipated or scheduled parathyroidectomy during the study period.
* Subject has received a parathyroidectomy within 3 months prior to dosing.
* Anticipated or scheduled kidney transplant during the study period.
* Subject has known sensitivity to any of the products or components to be administered during dosing.
* Subject has participated in a prior clinical trial of AMG 416
* Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
* Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
* Other Exclusion Criteria may apply
Healthy Aging and Memory Study

This project will focus on the development and testing of efficient, cost effective measures that are specifically designed for use in Alzheimer's Disease (AD) primary prevention trials.

This project will focus on the development and testing of efficient, cost effective measures that are specifically designed for use in AD primary prevention trials. The new or improved measures that have been developed will then be evaluated in 650 nondemented subjects enrolled in a simulated Alzheimer's disease prevention trial. Once enrolled, subjects will be followed for four years with annual clinical evaluations and interim six-month phone calls.

Eligibility Criteria:
Inclusion Criteria:

* 75 years or older.
* Fluent in English or Spanish.
* Stable medical condition for four weeks prior to screening visit.
* Stable medications for four weeks prior to screening visit.
* Either cognitively normal, or mild cognitive impairment. If MCI, the subject's CDR at screening have a global score of 0.5.
* mMMSE score greater than 88 for subjects with at least 8 years education, or greater than 80 for subjects with less than 8 years education, and FCSRT total free plus cued recall score greater than 44 with 3 learning trials.
* Willing to participate in four to five year follow-up study.
* Willing to identify person who can serve as informant.
* At least six years education or work history sufficient to exclude mental retardation

Exclusion Criteria:

* Meets DSM IV criteria for dementia
* History of clinically significant medical illness that would interfere with participation in trial, including active malignancy, myocardial infarction, or cerebrovascular accident within the past year
* Alcohol or substance abuse and/or active major psychiatric disorders
* Concurrent participation in a clinical drug trial
* History of mental retardation
MoCa Test for the Early Detection of Mild Cognitive Impairment During Annual Assessment of Young Adults With Diabetes and in a Control Group Without Diabetes

T2D and cognitive impairment are two of the most common chronic condition found in persons 60 years and older. Diabetes type 2 increases with age and studies suggest that the diabetes is one of the risk factor for cognitive impairment and dementia.

Although there is much recent research showing that diabetics at every age have more cognitive impairment and dementia than non-diabetics, relatively little attention has been paid to the implications of this complication in the management of T2D in terms of screening, prevention, education and treatment adherence.

There are now guidelines for periodic evaluation of patients with diabetes as early detection of complications of the disease, but so far there are no similar assessment and monitoring of cognitive function.

In this study the investigators examine cognitive function in young diabetic patients (from 20 to 55) using the MoCa test, that allows detection of mild cognitive impairment, and may be carried out during a visit, an annual advisory diabetes clinic.

1. Patients on a routine visit to the diabetes clinic, who meet the inclusion criteria, will be recruited for the test. They will be given an explanation of the study and the questionnaire by the principal investigator.
2. Sign a consent form.
3. Performance and execution of MOCA test:

   * Fingerstick blood glucose for pre-cognitive testing performed (to avoid testing any participant with a serum glucose \< 70 mg/dl);
   * In the presence of hypoglycemia, the participant should be given a snack and begin the test only after the glucose level rises. Alternatively delay executing the Test
4. Details from the patient's file are registered, such as: duration of the disease, family history, presence of macro and micro vascular complications, lifestyle, years of education, and the results of relevant laboratory accuracy.
5. For each patient a medical file is opened containing the initials and serial number of his research. All results are then encoded and analyzed anonymously

Eligibility Criteria:
Inclusion Criteria:

* type 1 and 2 diabetes meIlitus
* 20 to 55 years old
* up to 15 years of diabetes disease duration
* fluent speech and read hebrew's language only

Exclusion Criteria:

* not meeting the inclusion criteria
* psychiatric disease
* dementia
* chronic use of alcohol or illegal drugs
* use of medication that can alter the attention or cognition of the participant
* active cardiovascular disease in the previous six months before the investigation
* oncology disease in the previous six months before the investigation