cyrilzakka/clinical-trials huggingface dataset:
Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy

The purpose of this study is to examine the effect of dietary cholesterol administered as whole egg or egg white (control)on muscle mass gain with resistance training in a young old population of men and women (age 50-69). It is hypothesized that dietary cholesterol will be significantly associated to muscle mass gain.

The primary objective of this proposal is to have 36 men and women (age 50-69) perform 12 weeks of resistance exercise training for the purpose of inducing skeletal muscle hypertrophy. These individuals will consume either 0, 1, or 3 whole eggs per day in a double-blind design to test the hypothesis that dietary cholesterol is essential for skeletal muscle hypertrophy. If so proven, this will confirm a very strong association between dietary cholesterol and hypertrophy observed in a previous study of 51 men and women (age 60-69). The current proposal is using a randomized double-blind, placebo controlled design to provide the most conclusive evidence that dietary cholesterol plays an essential role in skeletal muscle hypertrophy.

The secondary objective of this proposal is to test the hypothesis that increased dietary cholesterol consumption in the context of an exercise program does not alter blood cholesterol concentrations or other cardiovascular risk factors.

Eligibility Criteria:
Inclusion Criteria:

* men and women aged 50-69
* able to perform exercise testing and training

Exclusion Criteria:

* blood pressure \> 160/100
* cardiac arrhythmias
* cancer
* hernia
* aortic aneurysm
* kidney disease
* lung disease
* total cholesterol \> 240 mg/dl or \< 160 mg/dl
* current use of cholesterol lowering medications
* actively participating in \>1 hour per week of resistance training
Mesh Fixation in Lichtenstein Hernioplasty

This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.

Some 650 patients with inguinal hernia are operated using Lichtenstein operation in local anaesthesia. Mesh fixation is performed using 3 methods: Optilene™ mesh + cyanoacrylate glue (n=200), self-fixing Parietex Progrip™ mesh (n=200) and non-absorbable sutures with Ultrapro™ mesh (n=200). Operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* primary or recurrent inguinal hernia
* unilateral or bilateral

Exclusion Criteria:

* femoral hernia
* massive scrotal hernia
* allergy to polypropylene
* patient's refusal
Clinical Evaluation of a Dual Energy CT System

The main purpose of this study is to collect clinical raw scan data and Scanner user feedback using dual energy CT (computed tomography) scan modes on the investigational CT scanner. Additionally, image quality using prototype reconstruction algorithms that are in development will be evaluated and compared to standard-of-care images acquired with regulatory cleared diagnostic CT scanners for feasibility assessment and engineering development. Compared to standard clinical single energy (kilovolt,kV) scanning, dual energy (kV) scanning s provides more information about the material composition of the scanned patient and may allow for improved tissue, tumor characterization, and improved image quality.


Eligibility Criteria:
Inclusion Criteria:

1. Who are 18 year of age or older;
2. Able to sign and date the informed consent form; AND
3. Who have in the past year undergone a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities

Exclusion Criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
4. For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are in need of urgent or emergent care;
6. Diabetic patients on metformin (Glucophage)
7. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND
8. Who are unwilling to have GEHC personnel present for the CT exam
Use of Local Intraoperative Steroid in MIS TLIF

The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already currently used at Rush and are considered standard of practice. It is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. The medications provided in this study are approved by the Food and Drug Administration (FDA).

Postoperative pain is a well-known complication following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). It has been found that up to 40% of lumbar spinal patients will have either recurrent or persistent postoperative pain. Several studies have demonstrated reduced patient reported pain scores following steroid administration. However, few studies have investigated intraoperative local injection of corticosteroid at the surgical site in an effort to reduce the incidence and duration of postoperative pain for MIS TLIF patients.

The purpose of this study is to determine if the incidence and duration of postoperative pain is improved in participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing MIS TLIF.

The investigators hypothesize that participants undergoing MIS TLIF who receive local methylprednisolone along with the systemic dexamethasone will have:

1. Reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone.
2. Shorter hospital stay compared to participants receiving only systemic dexamethasone.
3. Better short- and long-term outcomes compared to participants receiving only systemic dexamethasone

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a primary 1- to 2-level MIS TLIF
* Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
* Patients able to provide informed consent

Exclusion Criteria:

* Allergies or other contraindications to medicines in the protocol including:

  (a) Existing history of gastrointestinal bleeding
* Current Smokers
* Lumbar spine trauma
* Bilateral cages
* Lack of consent
Influence of Trauma on Pain Area and Widespreadness in Chronic Pain Patients

It is well known that patients suffering from chronic pain report higher levels of pain, anxiety, and depression if they have experienced a traumatic event. However, little is know about pain area and widespreadness.

In this retrospective study, we want to investigate whether pain area and widespreadness differs in chronic pain patients with and without traumatic events. To test this hypothesis we will retrospectively analyse pain drawings collected at the pain outpatient department from Hannover Medical School. Participants will be divided into four groups depending on the severity of their traumatic events: no trauma; accidental trauma; interpersonal trauma; post-traumatic stress disorder (PTSD).


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain

Exclusion Criteria:

* None
Atacicept in Subjects With Optic Neuritis

This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days between onset of symptoms and study Day 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Pre treatment with immunosuppressants and immunomodulating drugs
* Relevant cardiac, hepatic and renal diseases
* Clinical significant abnormalities in blood cell counts and immunoglobulin levels
* Clinical significant acute or chronic infections
* Other protocol defined exclusion criteria could apply
Uganda PrEP and Harm Reduction Evaluation

This is an evaluation of programs to integrate PrEP into existing services for PWUD. PrEP will be delivered according to Uganda national guidelines and data from national monitoring and evaluation forms will be leveraged to address key outcomes. Additionally, research components will be implemented to support greater understanding of PrEP use and experiences of participants engaged with the PrEP programs.

The first facility-based medication-assisted treatment (MAT) program (with methadone) in Kampala launched in 2020, providing opportunity to integrate pre-exposure prophylaxis(PrEP) as part of a comprehensive HIV prevention package. Additionally, a community-based needle and syringe exchange program (NSP) provides opportunity to integrate PrEP and meet priorities of PWID while building rapport between providers and end-users. With two different service models - integrating PrEP into facility-based MAT and community-based NSP - there is a great opportunity to optimize the integration of PrEP and other HIV prevention services for PWUD. By integrating PrEP into two existing programs (MAT and NSP), this study will determine uptake and persistence of PrEP use and leverage these programs to conduct costing research and budget impact analysis.

Eligibility Criteria:
Inclusion Criteria:

* Accessing services from any of the programs implementing the integrated PrEP program described in this protocol
* Able and willing to provide informed consent
* Age ≥15 years

Exclusion Criteria:

* Any clinical or chronic medical condition that in the opinion of the investigator would make the participant unsuitable for the study or unable to independently provide informed consent.
Effect of Exercise on GDF-15 Levels in Prediabetic Patients

The aim of this study is to evaluate whether there is a change in GDF-15 levels in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program with guide-based exercise programs.

GDF-15, which has anorexigenic effects, increases with exercise. In prediabetic patients, GDF-15 is higher than healthy controls. The effect of exercise on GDF-15 levels in prediabetic patients is unknown.

The aim of this study is to evaluate whether there is a change in GDF-15 levels after the application of guideline-based exercise programs in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 30-34.9 kg / m2
* Sedentary life-style (Physical activity below 300 kcal / day will be assessed by Minnesota Leisure Physical Activity Questionnaire)
* Those who have sufficient motivation to participate in the exercise program (will be evaluated by face-to-face interview by the researchers)
* Having the same weight for 6 months before participating in the study (± 2.5 kg)
* Those diagnosed with prediabetes by oral glucose tolerance test and / or HbA1c measurement will be included.

Exclusion Criteria:

* Serious medical condition (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
* Having cardiovascular disease
* Having diabetes
* Using metformin
* Taking hormone replacement therapy
* less than 1 year life expectancy
* HIV positivity
* Substance use
* Functional dependence
* Cognitive weakness
* Those with other diseases that will affect the study result (respiratory diseases, muscle diseases, etc.)
* Those who use drugs or supplements that will affect the results of the study
Arterial dP/dt Dependency on Loading Conditions

In the present study the investigators aim to assess the changes of the arterial dP/dtmax induced by fluids and vasoactive drugs during abdominal surgery


Eligibility Criteria:
Inclusion Criteria:

patients scheduled for abdominal surgery informed consent acceptance

-

Exclusion Criteria:

* BMI\> 30 Kg /m2;
* Atrial Fibrillation;
* Congestive heart failure with FE \<35% and/or NYHA≥3;
* Severe known cardiac valve disease;
* Emergency surgery
* Shock or any acute conditions who required admission intensive care unit
REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry

The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. The primary hypothesis is that total intravenous anesthesia with remimazolam can increase days alive and out of hospital at postoperative day 30 compared with total intravenous anesthesia with propofol.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥45 years;
* Undergoing elective major surgery under general anesthesia (expected surgery time \>2 h, expected length of postoperative stay \>2 d);
* Fulfilling ≥1 of the following criteria:

  1. history of coronary artery disease;
  2. history of stroke;
  3. history of congestive heart failure;
  4. preoperative NT-proBNP \>200 pg/mL or BNP\>92 pg/mL;
  5. age ≥70 years;
  6. diabetes requiring medical treatment;
  7. ASA status 3 or 4;
  8. history of chronic kidney disease (preoperative sCr \>133 μmol/L or 1.5 mg/dL);
  9. history of peripheral arterial disease;
  10. preoperative serum albumin \<30 g/L;
  11. preoperative hemoglobin \<100 g/L.

Exclusion Criteria:

* Undergoing organ transplantation, cardiac, craniocerebral, burn or interventional operations;
* Low risk or minor surgery
* End-stage renal disease requiring renal-replacement therapy;
* Hepatic dysfunction (Child B or C);
* Previous liver or kidney transplantation;
* Previous allergy to general anesthetics;
* Unable to receive bispectral index monitoring;
* ASA score ≥5;
* Exposure to general anesthesia in prior 30 days or anticipated re-exposure to general anesthesia within 30 days after surgery;
* Need for prolonged airway protection or mechanical ventilatory support after surgery;
* Current participation in another interventional study;
* Previous participation in this study;
* Pregnant or breastfeeding women.
Endoscopic Stenting of Gastrointestinal Cancer

Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal stents(SEMS)is an alternative to palliative surgery and other palliative treatment options.The method has expanded to include patients with malignancies in the esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies have reported treatment with SEMS to be safe and effective. Prospective studies,and especially studies regarding Quality of Life improvement are needed.

PURPOSE:

The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stents(SEMS)in a defined population i Norway, especially Quality of Life changes.

The study is divided into four projects:

1. Establish a central register over all patients with malignant GI-obstruction who are treated with SEMS in the Eastern health region in Norway .Treatment incidence, methods used, treatment effect,complications related to the procedure,Need for reinterventions, hospitalisations and survival will be studied.
2. Quality of life(QoL) studies will be performed before and 14 days after treatment.The EORTC QLQ C30 and EORTCs organospecific modules will be used.
3. Gastric emptying before/after stent will be studied.
4. Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"

Eligibility Criteria:
Inclusion Criteria:

* Palliative SEMS treatment for malignant GI-obstruction in esophagus,gastroduodenal region, biliary tractus or colon
* SEMS treatment of acute malignant colon obstruction as a bridge to surgery

Exclusion Criteria:

* Not able to sign informed consent
* SEMS placement in other location last 4 days
Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data

The objective of this study is to investigate safety and effectiveness of apixaban compared to warfarin in very elderly patients with Non-valvular atrial fibrillation (NVAF). In addition to the absolute age, effects on higher age-related risk factors on relative risk of apixaban to warfarin is also investigated through subgroup analyses.

This is a retrospective non-intervention observational study to evaluate the difference in safety and effectiveness between apixaban and warfarin using a database provided by Medical Data Vision Co. Ltd. (MDV Co. Ltd.). Eligible patients will be extracted from the database and allocated to the pre-defined cohorts based on the actual age, age of NVAF diagnosis and types of anticoagulant therapy.

Patient characteristics will be balanced by an Inverse probability of treatment weighting (IPTW) method, and risk of stroke/SE (primary effectiveness endpoint) and major bleeding (primary safety endpoint) will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all the following inclusion criteria to be eligible for inclusion in the study.

  1. Diagnosed with Atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
  2. Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
  3. No use of the any Oral anticoagulants (OAC)s during the baseline period (the 180 days before the index date)
  4. Age of 18 years or older on the index date.
  5. Index date is at age 80 or older

Exclusion Criteria:

* Patients meeting any of the following criteria will not be included in the study:

  1. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period
  2. Having a cardiac surgery procedure record during the baseline period
  3. Having a joint replacement procedure record during the baseline period
  4. Having a procedure of prosthetic heart valve during the baseline period
  5. Having a diagnosis of venous thromboembolism during the baseline period
  6. Female patients with pregnancy during the follow-up period
  7. Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.
Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment

Objective of this trial is to establish the efficacy of an upfront targeted therapy consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed ocular adnexae marginal zone lymphoma The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE lymphoma treated with the experimental strategy.


Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of marginal zone lymphoma of the ocular adnexae (OAMZL)
2. Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid)
3. Absence of B symptoms
4. Previously untreated patients
5. No systemic antibiotic therapy in the last three months before enrolment
6. Age \>18 years
7. ECOG PS 0-2
8. Negative HIV, HBV and HCV serology
9. Adequate bone marrow, renal, and hepatic function
10. No previous or concurrent malignancies with the exception of surgically cured carcinoma in situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years
11. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
12. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
13. No concurrent treatment with other experimental drugs
14. Patient-signed informed consent obtained before registration

Exclusion Criteria:

1. Pregnant or lactating women
2. Known allergy to tetracycline
3. Patients unwilling to comply with the requirements of follow-up
4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)
5. Systemic lupus erythematous (tetracycline can exacerbate this condition)
6. Patients with large or rapidly enlarging tumors requiring immediate radiotherapy
The Effect of Cetirizine on Bronchoconstriction

The purpose of this study is to determine the effect of cetirizine, an oral antihistamine, on wheezing in patients with allergic rhinitis. Patients presenting to the pediatric emergency department who have a history of allergic rhinitis and who are wheezing will be asked to participate. Half of patients will receive a dose of cetirizine and the other half will receive placebo and their response will be monitored over the course of their emergency department visit with vital signs, physical examinations, and measurement of bronchoconstriction with spirometry.

This is a prospective randomized, placebo-controlled trial to look at the effect of cetirizine on bronchoconstriction in patients with allergic rhinitis who present to the Pediatric Emergency Department with wheezing. Oral second generation antihistamines such as cetirizine are already the standard of care for allergic rhinitis. Wheezing pediatric patients with allergic rhinitis who are not already on this therapy will be randomized to receive either age-appropriate-dosed cetirizine or placebo in addition to standard asthma therapy at the discretion of the treating clinician, and will be monitored every 30 minutes with asthma scores and FEV1 measurements. At the conclusion of 3 hours, each patient who received placebo will receive a dose of cetirizine, and each patient who received cetirizine will receive a placebo medication dose, such that initiating therapy for allergic rhinitis is delayed by no more than 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* History of allergic rhinitis
* Wheezing

Exclusion Criteria:

* Use of antihistamine within the past 72 hours
* Chronic Pulmonary Condition other than asthma
* Other contraindication to cetirizine
* Severe asthma exacerbation requiring resuscitation