cyrilzakka/clinical-trials huggingface dataset:
Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery.

These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory

This study is a randomized clinical trial conducted in the Department of Surgery of a tertiary public hospital. Patients undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. A total of 218 elderly patients undergoing urgent abdominal surgery( control group=109 and intervention group 109) randomly assigned to the intervention or control group.

Patient recruitment will begin in the 4-day after the surgical procedure, which will be identified through the list of patients admitted to the hospital and assigned to the Department. The doctor who decides the inclusion in the intervention or control group will not be the attending physician. Patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. Randomization will be performed by applying http://www.randomizer.org/. The information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 1, 3 and 6 after hospital discharge.

The intervention will consist of a multicomponent exercise training program, which will composed of supervised progressive resistance exercise training, aerobic and anaerobic exercises. This training period consist on 2 training sessions per week during 4 weeks after one week of discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years and older
* Able to tolerate exercise
* Able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair
* Able to communicate
* Undergoing urgent abdominal surgery
* Barthel Index\>60
* Informed consent: must be capable and willing to provide consent

Exclusion Criteria:

* Severe dementia (GDS 7)
* Duration of hospitalization \<4 days
* Unwillingness to either complete the study requirements or to be randomized into control or intervention group
* Unstable cardiovascular disease or other unstable medical condition
* Terminal illness
* Myocardial infarction in the past 3 months
* Upper or lower extremity fracture in the past 3 months
* Evisceration
Blood for Immune Response to Provenge® in HRPC

This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen.

This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen. The trial only involves the collection of additional blood samples for the purposes of monitoring immune response. These samples will be taken at 7 time points before, during and after patients receive Provenge® (Sipuleucel-T). There will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.

Eligibility Criteria:
Inclusion Criteria:

Patients who plan to receive standard of care Provenge® (Sipuleucel-T) at their primary physican's office.

Exclusion Criteria:

None
Effect of Constraining Joint Motions on Postural Control

A major advantage of understanding a neural control scheme is able to simultaneously perform multiple tasks based on the Uncontrolled Manifold (UCM) hypothesis by taking advantage of motor redundancy. The present study aims to investigate this hypothesis further by examining the effect of artificially eliminating knee and lumbar-thoracic joint motions on postural control when the arms performing targeting task simultaneously in standing. Subjects (Younger group: 20\~35 years old; Elder group: 60\~85 years old) will execute a targeting task with and without an additional ball-balancing task in standing with free joint motions and with restricted joint motions. The investigators expect to recruit 50 subjects for each group. Analyses of joint configuration variance on the stability of the center of mass (COM) position and the hand path will be performed using the UCM method of variance analysis. This method partitions joint configuration variance into one component consistent with the use of motor abundance and a component that leads to COM position or hand path variability. Furthermore, the differences between the younger group and the elder group will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

Participants are healthy with no self-reported neurological deficits, musculoskeletal conditions or motion sickness that affected their ability to maintain stable upright posture.

Exclusion Criteria:

Participants are healthy with self-reported neurological deficits, musculoskeletal conditions or motion sickness that affected their ability to maintain stable upright posture.
Relationship Between Bispectral Index (BIS) and Spectral Entropy (SpEn) During Desflurane Anaesthesia

The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.

During the last decade, an increasing number of monitor systems were developed designed to assess the depth of anesthesia.

Awareness is a rare occurrence of explicit recalls during anaesthesia with an incidence of 0,18% and the use of cerebral monitoring prevents about 50% of these events.

Different stages of awareness should be defined and implicit memorization is subconscious awareness without explicit recall and possible implicit recall with an incidence greater than awareness.

To assess implicit recalls, a large number of test can be used, for example the "word stem completation test" and the "free recall association test". These result easy to use and reliable in detect implicit memory.

Bispectral Index (BIS) and Spectral Entropy (SpEn) has been proposed, in recent years, as electroencephalographic monitors of anaesthesia depth.

The bispectral index is a monitor of anaesthetic depth approved by the Food and Drug Administration in the USA. The BIS monitor reports a dimensionless number between 0 (complete EEG inactivity) and 100 (awake state); BIS values from 40 to 60 are thought to be suitable for general anaesthesia. Spectral Entropy acquires the electroencephalograph (EEG) and frontal electromyography (FEMG) signals which are processed into three parameters: State Entropy (SE), Response Entropy (RE) and Burst Suppression Ratio (BSR).

SE is computed over the EEG dominant part of the spectrum (0.8-32 Hz), and therefore primarily should reflect the cortical state of the patient and results useful to assess hypnotic effects of drugs .

RE is computed over a frequency range from 0.8 to47 Hz. It includes both the EEG-dominant and EMG-dominant part of the spectrum . The SE and RE values below 60 correlate with a low probability of consciousness. Also Bispectral Index provides BRS, an evaluation of burst suppression in which cerebral activity results suppressed.

BIS and Spectral Entropy are intended to decrease the risk of intraoperative awareness and to enable the anesthetist to reduce risk of the under- and overdosing of anesthetic agents and to ensure faster and more predictable wake-up and extubation.

Previous studies result contrasting in the correlation between these devices with lack in evaluation of implicit memory.

The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologist physical status I-II
* Italian native speakers

Exclusion Criteria:

* Psychiatric or neurologic diseases
* Acoustic impairment
* Obesity (Body Mass Index \> 30)
* Substance dependence.
Transcranial Direct Stimulation in Chronic Pelvic Pain

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is that tDCS will decrease pain significantly when compared to sham stimulation.

The study encompasses two experiments: The first one involves patients with chronic pain, receiving 10 sessions of stimulation, active or sham (parallel design).

The second experiment involves involves healthy subjects, receiving active or sham tDCS over the primary motor cortex (crossover design).

Eligibility Criteria:
Inclusion Criteria:

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 VAS scale (for pelvic pain subjects only)
4. No history of or current genitourinary tuberculosis as self reported
5. No history of urethral cancer as self reported
6. No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
7. No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
8. No current vaginal infection as self reported
9. No active herpes in previous 3 months as self reported
10. No antimicrobials for urinary tract infections in previous 3 months as self reported
11. Never treated with cyclophosphamide as self reported
12. No radiation cystitis as self reported
13. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
14. Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
15. No urethritis for previous 3 months as self reported
16. No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported
17. Must not be pregnant
18. Eligible to MRI according to MRI screening checklist
19. No contraindications to tDCS:
20. No history of alcohol or drug abuse within the past 6 months as self reported
21. No use of carbamazepine as self reported
22. Does not have severe depression (with a score of \>30 in the Beck Depression Inventory)
23. No history of neurological disorders as self reported
24. No history of unexplained fainting spells as self reported,
25. No history of head injury resulting in more than a momentary loss of consciousness as self reported
26. Have had no neurosurgery as self reported
27. No history of psychological disorders as self reported
28. Must have the ability to feel pain as self reported
Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty

The purpose of this research is to determine the effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life determined by using the FACE-Q Scale.

Secondary objectives include:

To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs.

To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.

To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females of ages 21 and above.
2. Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
3. Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.

Exclusion Criteria:

1. Males and females below age of 21.
2. Subjects who have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
3. Subjects who are pregnant or nursing.
4. Subjects with a known allergy or sensitivity to any component of the study ingredients.
5. Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
6. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
7. Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose, implants, and previous surgical rhinoplasty.
8. Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.
A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection

A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).


Eligibility Criteria:
Inclusion Criteria:

* Participants with current ECG-based diagnosis of atrial fibrillation, sinus rhythm or sinus rhythm with frequent (at least once in 2 minutes) premature atrial or ventricular contractions.
* Age is between 18 - 99.

Exclusion Criteria:

* Participants who refuse to sign an informed consent.
* Participants with atrial fibrillation who are currently in a paced rhythm.
Bone Lead Levels and College Achievement Scores

This project studies the relationship between lead exposure and academic achievement in college students. Most studies of the neurobehavioral effects of lead have focused on performances at the low end of the distribution. There is evidence that lead affects outcome across the entire distribution. This is a retrospective cohort study of subjects whose cognitive function is adequate to gain admission to college. We will use x-ray fluorescence to measure bone lead concentrations in undergraduate college students and test the hypothesis that achievement scores are related to early lead exposure. Early lead exposure has been shown to have measurable effects on academic performance and neurobehavioral outcomes at 18 years of age. Should an effect be found in this study, the spectrum of lead toxicity would be expanded to include subjects with above average function.


Eligibility Criteria:
Current undergraduate student at the University of Pittsburgh who have taken the Scholastic Aptitude Test (SAT).
Nutrition Screening - Route to a More Practical Method

Observational study. Comparison of existing nutritional screening tools based on questionnaires with blood tests already performed on a routine basis.

No intervention undertaken.

Nutrition screening is of established benefit but is difficult to ensure in ordinary clinical practice. It is relatively labour intensive. The investigation aims to determine whether routinely collected laboratory data could provide comparable information without the need for personnel time. It is known that individual blood tests do not provide sufficient sensitivity or specificity but it is hypothesised that combinations of tests could do so.

Included subjects are those admitted to the University Hospital department of internal medicine. All are eligible other than those subject to protective isolation for infection control (COVID, etc). Data collection is in the form of questionnaires to permit the calculation of 3 tools widely used for screening for malnutrition and malnutrition risk, namely the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening 2002 (NRS-2002) and the Subjective Global Assessment (SGA). Nutritional status is documented by the patient's status according to the international definition provided by the Global Leadership Initiative on Malnutrition (GLIM).

The blood tests already performed on a routine basis are captured to go alongside the nutrition screening tools.

Analysis will aim to determine whether combinations of laboratory data can simulate or replicate the information provided by MUST and NRS2002.

Eligibility Criteria:
Inclusion Criteria:

In-patient in department of internal medicine

Exclusion Criteria:

Unable to complete questionnaire or in protective isolation
Phase 2 Study of MM-093 to Treat Patients With Uveitis

The purpose of this study is to evaluate the tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe uveitis.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and above
* Understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol - specific procedures being performed.
* Have been diagnosed with sarcoid or birdshot uveitis
* Be able and willing to comply with study visits and procedures per protocol.
* Women of child bearing potential must use medically acceptable means of birth control in an effective manner and agree to continue its use during the study and 6 weeks after the last dose of study drug.
* Sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 4 weeks after the last dose of study drug.
* Able to store patient kit/cooler containing study drug in a refrigerator at home.

Exclusion Criteria:

* Significant concurrent medical diseases including:

  * Cancer or history of cancer, or lymphoproliferative disorder (other than sarcoidosis or successfully resected cutaneous basal or squamous cell carcinoma) within 5 years before the screening visit.
  * Any condition for which participation in this study is judged by the physician to be detrimental to the patient, such as history of significant or unstable cardiac, pulmonary, gastrointestinal, neurological, or psychiatric disease.
  * Significant ongoing infection requiring systemic antibiotic, antifungal, antiviral, or ant anti-mycobacterial therapy.
* Autoimmune or connective tissue disorder other than sarcoid or birdshot uveitis, (e.g. Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Scleroderma.)
* Other known active eye diseases or eye infections (bacterial, fungal, or viral) that may interfere with the evaluation of uveitis.
* Grade 2 or above liver function abnormality
* Renal disease
* Any previous history of immunodeficiency syndromes or infection with human immunodeficiency virus (HIV), or a history of hepatitis C or chronic hepatitis B.
* Live viral or bacterial vaccinations within 3 months prior to screening, or planning to receive such vaccinations during the trial, or up to 3 months after the last injection of MM-093.
* Pregnant or breastfeeding women or women planning to become pregnant during the study or within 4 weeks after the last dose of the study drug.
* Scheduled elective surgery during study participation
* Participated in any previous clinical trials using MM-093 or have any prior exposure to MM-093.
* History of severe hypersensitivity to goat, sheep, or cow milk products derived from goat, sheep or cow milk (patients who are lactose intolerant are not excluded.)
* Any other acute or clinically important condition that the investigator feels would jeopardize the integrity of the study (e.g. a CTCAE grade 2 or above clinical finding or laboratory result.)
Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction

Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than clopidogrel and is associated with less interindividual variability. In the PLATO trial, it was found to be superior to clopidogrel with respect to cardiovascular outcomes and total mortality without increasing the risk of bleedings.

More potent and reversible receptor bindings are possible explanation for the superior outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake in tissue level and can induce adenosine triphosphate (ATP) release from human red cells, which both stimulate vasodilation of in red blood cells.


Eligibility Criteria:
* Inclusion Criteria:

  * Males and Females
  * between the ages of 18 and 75 years
  * STEMI patients treated with percutaneous coronary intervention
  * Able to provide informed consent
* Exclusion Criteria:

  * History of stroke or transient ischemic attack
  * Platelet count \< 100 000/μL
  * Known Bleeding Diathesis
  * Hematocrit \<30% or \>52%
  * Severe Liver Dysfunction
  * Renal Insufficiency (Creatinine Clearance \< 30ml/min)
  * Pregnant females
  * Cardiogenic shock or symptomatic hypotension or sitting SBP \< 95 mmHg
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System

The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.

The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.

Eligibility Criteria:
Inclusion Criteria:

Pre-Op Inclusion Criteria:

1 - Acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5, 6, or 7 Fr introducer sheath.

-

Exclusion Criteria:

Pre-Operative Exclusion Criteria:

1. - Significant bleeding diatheses or coagulopathy
2. - Planned endovascular or surgical procedures within next 30 days
3. - Planned ipsilateral femoral arteriotomy within next 90 days
4. - Arteriotomy in ipsilateral groin within the past 30 days with any residual hematoma, significant bruising or vascular complication
5. - Previous vessel closure device used in ipsilateral groin within the past 90 days
6. - Previous vascular surgery or repair in the vicinity of the target access site
7. - Severe peripheral vascular disease in the ipsilateral limb requiring surgical or endovascular treatment within the pervious 30 days or next 30 days
8. - Existing nerve damage in ipsilateral limb
9. - Extreme morbid obesity (BMI \> 4 kg/m2)

   Intra-operative Exclusion Criteria:
10. - Use of a procedural sheath that is \< 5 Fr or \> 7 Fr
11. - Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure
12. - Placement of an ipsilateral venous sheath for procedure
13. - Procedural sheath placement either through the superficial femoral artery and into the profunda femoris artery, or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery
14. - In subjects receiving unfractionated heparin, an ACT \> 350 seconds, or \> 250 seconds in the presence of a GP IIb/IIIa inhibitor
15. - Procedures or existing medical conditions that may extend index hospitalization beyond 24 hours post-procedure
16. - Systemic hypertension (SBP \> 180 mmHg) or hypotension (SBP \< 90 mmHg) just prior to enrollment