cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery

The primary objective is to compare mild cognitive impairment in the AL-208 group with the placebo group at 14 + - 3 days after CABG surgery


Eligibility Criteria:
Inclusion Criteria:

1. Males and females (of non-childbearing potential), 50 to 79 years of age.
2. Undergoing CABG surgery with the use of extracorporeal circulation.
3. Willing and able to complete cognitive testing.
4. Score \< 16 on the Center for Epidemiological Studies in Depression scale (CES-D).
5. Score \> or = 28 on the Mini-Mental State Examination (MMSE).
6. Willing and able to provide informed consent to participate in this study
7. Fluency in written and spoken English.

Exclusion Criteria:

1. Presence of any severe mental illness that could affect interpretation of efficacy data, such as schizophrenia or bipolar affective disorder; any untreated or unstable psychiatric condition including depressive disorder or anxiety disorder.
2. History of stroke or other significant neurological disorder
3. Transient ischemic attack (TIA) with ongoing cognitive sequelae
4. Chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery
5. Myocardial infarction (MI) within the last 8 weeks and/or previous history of more than 3 MIs
6. History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes \> 2.5 x upper limit or normal (ULN) at screening).
7. History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value \> 2.5 mg/dL at screening).
8. Known active alcohol or drug abuse.
9. Concurrent use of prescription medications known to enhance memory
10. General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization.
11. Cardiopulmonary bypass or thoracotomy within 2 years prior to randomization.
12. Undergoing valvular repair or replacement during scheduled CABG surgery.
13. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy.
14. Decompensating congestive heart disease
15. Subjects on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months
16. Receipt of any investigational agent or device within 30 days of screening.
Allometric-Pace Study

The goal of this observational study is to improve quality of life in sinus node dysfunction patients by utilizing allometric lower rate pacing (or called personalized lower rate, PLR) in standard commercially available dual-chamber pacemakers.

The primary objective is to achieve a significant improvement in patients' quality of life with use of PLR pacing in comparison with the control group with nominal lower rate in patients with implanted dual-chamber pacemaker.

The secondary objectives are to assess cardiac functional changes in echocardiography of ventricular mechanical performance with a PLR pacing in comparison with the control group with nominal lower rate, and to assess the viability of using elevated blood pressure as a marker for undetected bradycardia and providing allometric rate to correct bradycardia-related increase in arterial systolic blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients are at age of equal to or more than 60 years old
* Patients have plan to implant dual-chamber pacemaker
* Resting sinus heart rate is equal or less than 60 bpm, or average heart rate detected through 24-hour dynamic electrocardiogram is equal or less than 60 bpm
* Patients have diagnosis of SND. If patients have both sinus node dysfunction and AV block, conduction system pacing shall be available
* Patients have a history of hypertension, two times of blood pressure measurements at office visit are equal to or more than 130 mmHg in systolic blood pressure, diastolic pressure is equal or less than 80 bpm

Exclusion Criteria:

* Patients have or possible concomitant a diagnosis of heart failure, either reduced EF or preserved EF
* Patients have persistent or chronic atrial fibrillation or clinically significant paroxysmal atrial fibrillation
* Previously diagnosed with a history of organic heart disease: including congenital heart disease, coronary heart disease, old myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, cardiac amyloidosis, long QT syndrome, etc.
* Patients have a known secondary cause of hypertension
* Patients have hospitalization of a hypertensive emergency in the previous year
* Patients have a history of renal disease or renal-artery diseases
* Severe hepatic or renal dysfunction
* Active acute infection
* Patients cannot submit a signed informed consent form
* Patients are pregnant or plan to be pregnant during study period
* Patients participate in another study that will confound this study
Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

This study aims to evaluate the potential benefits of Monopolar Capacitive Resistive Radio-frequency (448 kHz) on the sports performance of Paralympic swimmers.

A randomized, double-blind, crossover, controlled and sham-controlled clinical trial

Evaluate the effectiveness of resistive capacitive diathermy as sports performance enhancement of Paralympic elite swimmers compared with a "sham" diathermy treatment and with a control group. The resistive capacitive diathermy is a medical device supplying low (448 kHz) radiofrequency with a maximum output power of 200 W, used to improve physiological aspects and theoretically allowing improvement in swimming performance. The sham diathermy treatment is administered with the device set on "on" but not active (not supplying energy) and control group will not receive anything, randomly assigned to either resistive capacitive diathermy treatment (group 1), sham-treatment (group 2) or control (group 3) athletes are submitted to a twenty minutes session prior swimming performance. The main outcome measures are the simulate swimming time trial (seconds) to assess time completing the presented course and Borg Scale for perceived exertion. Outcome measures are administered at completing each time trial.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed.
* Age between 18 y 70 years old.
* Already in the position of the International Paralympic Committee (IPC) classification.
* Know their personal mark (50-100mts).
* Having the capacity to fill and understand questionnaires, understand and follow verbal orders.

Exclusion Criteria:

* Pregnancy.
* Use of pacemakers or other types of electronic implants
* Non-intact skin (open wounds or recent burns)
* thrombophlebitis
* Known allergy to nickel and chromium
* Symptomatic anemia (hemoglobin below 12g / dl presenting any of these symptoms: tiredness, shortness of breath, dizziness, palpitations or headache).
* Present feverish process

Elimination criteria:

* Revocation of inform consent.
* Attend to less than three visits.
Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Non-valvular atrial fibrillation

Exclusion Criteria:

* Prior anticoagulant use \[Day -180, Day 0\]
* Stage 4 or 5 chronic kidney disease or end-stage renal disease \[Day -180, Day 0\]
* Dialysis or renal transplant \[Day -180, Day 0\]
* Recent major or clinically relevant non-major bleeding \[Day -180, Day 0\]
* Other indications for anticoagulation (DVT, PE, or prosthetic heart valve) \[Day -180, Day 0\]
* Use of an antiplatelet \[Day -180, Day 0\]
* Significant liver disease and coagulopathy \[Day -180, Day 0\]
* Use of CYP3A4 or P-gp inhibitors or inducers \[Day -180, Day 0\]
* Pregnancy or breastfeeding \[Day -180, Day 0\]
* Cancer \[Day -180, Day 0\]
* Bypass surgery, obesity, or the use of a weight loss or appetite suppressor \[Day -180, Day 0\]
* Mitral stenosis with or without insufficiency, mitral rheumatic insufficiency, and other/unspecified mitral valve disorders \[Day -180, Day 0\]
Prescribing Laughter for Sleep and Wellbeing in UAE University Students

This study is in line with the UAEs national drive to promote happiness and wellbeing. University students risk impaired psychological health, wellbeing, and sleep due to academic pressures. This research is the first to assess the feasibility of using a laughter prescription to improve psychological health and sleep in Zayed University students. Forty students will be recruited, and randomized to a control or laughter group.

The Laughie is a self created app or tool. It is a one minute recording of the user's joyful laughter on their smartphone. Once recorded, the user uses it by playing back the recording and laughing with it for the duration of the one minute. The Laughie acts as a prompt to guide the one minute of laughter.

In this research the experimental group each record their own Laughie, demonstrated and supported by the PI(s). They are then prescribed to laugh with their Laughie: 3x a day the first week (morning, lunch, and afternoon) and at least 2x a day during the second week. Immediately after using their Laughie they fill in a Laughie checklist to record whether they laughed for the full minute, whether they enjoyed their Laughie, and how they felt afterwards.

This study tracks sleep using wrist actigraphy in the control group (no Laughie prescription) and in the Laughie group. All participants complete one week baseline using sleep watches, and sleep diaries, prior to the Laughie intervention. They all then continue to track their sleep during the intervention. All participants complete WHO Five well-being, PSKI, and HADS pre and post intervention. During the intervention the Laughie participants complete Laughie checklists. All participants are invited for a final interview (the control group about the sleep equipment experience). A follow-up survey is sent to the Laughie group 2 months after their prescription.

Eligibility Criteria:
Inclusion Criteria: Registered Zayed University students, owner of a smartphone -

Exclusion Criteria: Chronic health conditions (cardiovascular disease, respiratory disease, cancer, diabetes), deafness, non-English speakers

-
ProQuad Dose Selection Study (V221-011)(COMPLETED)

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.


Eligibility Criteria:
Inclusion Criteria:

* In good health
* Negative clinical history of measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

* Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
* Immune globulin or any blood product administered in the past 3 months
Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma

Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.


Eligibility Criteria:
Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.
2. Age 18 years at the time of signing the informed consent form.
3. Life expectancy of at least 3 months
4. Able to adhere to the study visit schedule and other protocol requirements
5. Relapsed or refractory MM (only first or second relapse) in stage II or III after autologous SCT or conventional chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria) with detectable myeloma protein in blood or urine
6. All previous cancer therapies, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroids therapy.
7. ECOG performance status of £ 2 at study entry (see Appendix 01).
8. Laboratory test results within ranges
9. Females of childbearing potential must agree to contraception or abstinence
10. Disease free of prior malignancies for ³ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females.
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
4. Patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
5. Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3).
6. Use of any other experimental drug or therapy within 28 days of baseline.
7. Known hypersensitivity to thalidomide or purine analogues
8. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
9. Any prior use of lenalidomide or bendamustine in the last six months
10. Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
11. Known positive for HIV or infectious hepatitis, type A, B or C.
Study to Intervene With Nutrition for Gastroparesis

The study is a self-controlled study in which we will assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula in patients with gastroparesis, relative to their pre-enrollment nutritional diet regimen.

The study is a prospective self-controlled study in which we will assess the nutritional effects of Kate Farm Peptide 1.5 nutritional formula in patients with gastroparesis, relative to their pre-enrollment diet regimen.

The duration of the study will be 12 weeks. We plan to recruit a total of 30 patients. Patients will undergo a baseline measurement of their height, weight, symptom burden, resting energy expenditure, inflammation, and microbiome. After study initiation, patient will undergo repeat testing at 1- and 3-months post-enrollment. Including the screening and baseline visits, there will be a total of 4 visits required to complete the study.

Eligibility Criteria:
Identify inclusion criteria.

* Male or female gender
* Ages 18 to 65
* Established diagnosis of gastroparesis confirmed by gastric emptying study within the last 5 years.
* No changes to gastroparesis medications in the 3 months prior to recruitment.
* Patients with hysterectomy, appendectomy, cholecystectomy and fundoplication are ok to participate.
* Able to give informed consent.
* Patient willing to supplement diet with Kate Farms
* Ability to adhere to the study visit schedule and other protocol requirements.

Identify exclusion criteria.

* Are nursing or pregnant.
* Diagnosis of mechanical small bowel obstruction within 3 months prior to recruitment
* Patients with a history of gastric surgery, including gastrectomy, small bowel resection or bariatric surgery
* The use of narcotic medications in the month prior to study enrollment or during the study period
* Diagnosis of short gut syndrome
* Allergic to any ingredients in the Kate Farms formula
* Untreated small intestinal bacterial overgrowth
5-0 Prolene Versus 5-0 Fast Absorbing Gut

When using suture (stitches) to close wounds, surgeons can use suture that is absorbable or non-absorbable. Absorbable sutures naturally break down. Non-absorbable sutures need to be removed. We wish to determine how the cosmetic result of a specific absorbable suture (fast absorbing gut) compares to that of a specific non-absorbable suture (prolene).

The purpose of this study is to determine whether the use of 5-0 prolene during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut (both SOC). We will use a split wound model, where half of the wound is treated with 5-0 prolene and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument (research procedure). The scar width and adverse events will be recorded.

There are many options when it comes to closing a linear cutaneous wound, and an important consideration is choosing between non-absorbable and absorbable sutures. The overall aesthetic superiority between the two is not well understood. Studies to date have typically compared prolene (non-absorbable) and vicryl (absorbable) sutures and found no significant difference in cosmesis.1-4 One study found an increased pain score at 10 days with vicryl, but not at 6 weeks,1 while others have found no difference in pain.2-4 Another study found an increased number of complications with vicryl sutures, including infections and suture granulomas.4 This supports past observations that absorbable sutures can cause more of an immune response and therefore inflammation, despite the benefit of providing more prolonged support to wound edges compared to non-absorbable sutures.1

There is a lack of data, though, comparing prolene to other absorbable sutures, such as fast absorbing gut. In the setting of blepharoplasty, a study found that a running stitch of fast absorbing gut with a simple interrupted stitch of prolene at each end of the incision yielded better cosmetic results and fewer complications than a running stitch or subcuticular stitch using prolene.5 More studies are therefore needed to compare the outcomes of linear closures using only prolene compared to only fast absorbing gut. Using only absorbable sutures has the potential benefit of decreasing healthcare costs by reducing the number of appointments needed for suture removals, and, if superior in terms of cosmesis, corrective procedures.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure on the head and neck with predicted primary closure
* Willing to return for follow up visit.

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Pregnant Women
* Wounds with predicted closure length less than 3 cm
Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure

The purpose of the study is to monitor changes in brain structure and function between the pre-training and post-training, in a population of tactical team members wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.

This study will investigate the effectiveness of this device in tactical team members exposed to blast waves during tactical training. Subjects participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the tactical training or 2) Non-device wearing during the tactical training. The helmets of all participants will be outfitted with an accelerometer which will measure the magnitude of every concussive blast wave sustained by the subject. Effectiveness of the device will be determined via differences in brain MRI and EEG, vision and hearing testing prior to and following standardized breaching and diversionary device scenario training.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteer
* Able to provide written consent

Exclusion Criteria:

* Unable to provide written consent
* History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-tactical training screening:
* Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
* Glaucoma (Narrow Angle or Normal Tension)
* Hydrocephalus
* Recent penetrating brain trauma (within 6 months)
* Known carotid hypersensitivity
* Known increased intracranial pressure
* Central vein thrombosis
* Any known airway obstruction
* Any known seizure disorder