cyrilzakka/clinical-trials huggingface dataset:
RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms

This is an appendix of master protocol (NCT05595369) designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This sub-study is a prospective, multi-center, double-blind, randomized, controlled trial evaluating nirmatrelvir/ritonavir (Paxlovid) in two dosing durations for the treatment of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The study is evaluating potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.

For this appendix of the master protocol (NCT05595369), participants will be randomized to Paxlovid (nirmatrelvir/ritonavir) vs. ritonavir control plus nirmatrelvir-matching placebo.

When there are multiple study interventions (sub-studies) available under the master protocol (NCT05595369), randomization will occur based on the specific inclusion/exclusion criteria of each appendix.

Eligibility Criteria:
See NCT NCT05595369 for RECOVER-VITAL: Platform Protocol level exclusion criteria which applies to this appendix

Additional Appendix Level Exclusion Criteria:

1. Known pregnancy\*
2. Active or expected breastfeeding during the study
3. Known eGFR \< 30 mL/min
4. Known severe hepatic impairment (Child-Pugh Class C)
5. Current use of drugs highly dependent on CYP3A for clearance\*\* and for which elevated concentrations are associated with serious and/or life-threatening reactions and which cannot be interrupted during the time of study administration and within seven days before and after study drug administration
6. Current use of potent CYP3A inducers\*\* where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance

   * A pregnancy test must be performed at the Baseline Visit for participants who are capable of becoming pregnant.

     * A guide of drugs that may be contraindicated are listed in Section 4 CONTRAINDICATIONS of the Full Prescribing Information of the EUA for PAXLOVID. https://labeling.pfizer.com/ShowLabeling.aspx?id=16474\&format=pdf
Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

The purpose of this study is to test comprehension of five numeric formats used to present data about treatment benefits and harms.


Eligibility Criteria:
Inclusion criteria

* Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).
Effect of Exercise Training in Alzheimer's Patients

The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.

Alzheimer's disease is a neurodegenerative disease characterized by progressive and irreversible degeneration of nerve cells. The loss of these cells leads to the continuous decline in muscle function with alterations in biochemical and haematological parameters. The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with official diagnosis of Alzheimer's disease;
* Subjects with MMSE higher than12.

Exclusion Criteria:

• Subjects with MMSE below 12 (indicating severe dementia and impairment).
Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery

Single center double blind randomised controlled trial. 60 subjects. Giving lidocaine IV or saline to patients due to robot assisted colorectal surgery. Primary outcome is cumulative morphine consumption at 24 hours.

Prospective double blind randomised controlled trial. The investigators are giving lidocaine IV or saline to 60 patients undergoing robot assisted colorectal surgery. Blinding and randomization is done by the hospital pharmacy. Both groups get otherwise the same treatment and a IV PCA (patient controlled administration) morphine pump for objectivisation of opioid consumption. Other outcome measures are NRS (numerical rating score) pain score, PONV (postoperative nausea and vomiting), use of antiemetics and opioid consumption up to 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* all patients due to robotic laparoscopic colorectal surgery, \> 18years of age, danish speaking

Exclusion Criteria:

* allergy to lidocain or amid local analgetics, atrioventricular blok, liver- and/or kidney failure, chronic use of opioids or NSAIDS, pregnancy, breastfeeding women, treatment with betablockers, porphyria
Role of Sleep Reactivity in Shift Work Disorder

The purpose of this project is to test sleep reactivity as an independent cause of Shift Work Disorder (SWD). The primary hypothesis is that those with high sleep reactivity will show persistent SWD symptoms after experimental reduction of circadian misalignment, which will then be mitigated with CBT.

The first aim of this study is to establish sleep reactivity as a predictor of insomnia in SWD independent from circadian misalignment. The second aim of this study is to establish sleep reactivity as a predictor of sleepiness in SWD independent from circadian misalignment. The third aim of this study is to probe sleep reactivity as a cause of insomnia in SWD. The fourth aim of this study is to probe sleep reactivity as a cause of sleepiness in SWD.

Participants with Shift Work Disorder (SWD, N=150) with high and low sleep reactivity will be enrolled. This study will use a two-step mechanistic randomized controlled trial design stratified by high and low sleep reactivity to examine the independent effect of sleep reactivity in SWD after experimental reduction of circadian misalignment. The first step will experimentally reduce circadian misalignment compared to a control. Those who achieve reduced circadian misalignment (melatonin onset at or later than 4am, i.e., compromised phase position) and remain symptomatic will continue to the second step where sleep reactivity will be probed with CBT compared to a sleep education control.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be working a fixed nightshift schedule, operationalized as: a) working at least three night shifts a week, b) shifts must begin between 18:00 and 02:00, and last between 8 to 12 hours, and c) must also plan to maintain the nightshift schedule for the duration of the study
* Participants must have Shift Work Disorder, which will be diagnosed based on ICSD-3 criteria
* Participants must show circadian misalignment, operationalized as a baseline melatonin onset between 18:00 and 01:00.
* Participants must be at least 18 years old

Exclusion Criteria:

* Insomnia disorder or excessive sleepiness predating the onset of shift work
* Termination of nightshift schedule
* Presence of other sleep disorders (e.g. obstructive sleep apnea, narcolepsy) determined by standard clinical polysomnography
* Diagnosis of bipolar disorder
* History of neurological disorders determined by self-report and medical history
* Pregnancy
* Alcohol use disorder
* Illicit drug use via self-report and urine drug screen if reasonable suspicion to test
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation

The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated by peri- and post-menopausal women at moderate risk for development of breast cancer.

Duavee® is tissue specific estrogen complex of bazedoxifene plus conjugated estrogen which is FDA approved for relief of menopausal symptoms and prevention of osteoporosis in women with a uterus who have not been diagnosed with estrogen dependent neoplasia. The overall purpose of this research is to demonstrate in a preliminary fashion that despite reduction in menopausal symptoms, (Duavee®) does not increase and may decrease proliferation in benign breast tissue in a cohort of peri- or post-menopausal women at moderately increased risk for breast cancer. If this pilot shows rapid accrual, good retention, and lack of significant increase in the risk biomarker Ki-67 in benign breast tissue, a larger prevention trial is envisioned

Eligibility Criteria:
Inclusion Criteria:

* Women with vasomotor symptoms with a uterus who are postmenopausal or in late menopause transition
* Body Mass Index (BMI) \<36 kg/m2
* Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration (RPFNA); If Class 0 or 4, must be resolved with additional procedures
* If previously on oral contraceptives or hormone replacement, off for 8 weeks or more prior to baseline RPFNA; the exception is low dose vaginal hormones
* Confirmed moderate risk of developing breast cancer
* RPFNA results within study defined range
* Kidney and liver function within study defined range
* Willing and able to comply with study related procedures

Exclusion Criteria:

* Previous biopsy showing evidence of breast cancer
* Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke
* History of renal or liver disease
* Prior ovarian or endometrial cancer
* Stopped or started hormone replacement within 8 weeks
* Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for RPFNA
* Currently taking or have taken specific medications in the past 6 months
* Participation on any chemoprevention trial within 6 months
* Current illness which would make potential participant unsuitable for enrollment
The Effect of Intraoperative Ephedrine Use on the Incidence of Hypothermia After Major Surgery

Intraoperative hypothermia is a common and potentially severe complication during major surgical procedures. The consequences of intraoperative hypothermia can be far-reaching, affecting patient outcomes, recovery times, and overall healthcare costs. Therefore, strategies aimed at preventing hypothermia are of paramount importance in modern surgical practice. However, despite all the measures taken, some patients may still become hypothermic at the end of surgery. Understanding these factors can enhance the quality of daily practice. Medications used intraoperatively can decrease the threshold for vasoconstriction, and some of them have been reported to influence thermoregulation. For example, ephedrine is a sympathomimetic amine used to maintain hemodynamic stability, but there is a report about its thermogenic effect. One study found that patients who received an intraoperative infusion of ephedrine had a significantly lower decrease in core temperature and these patients had a more stable hemodynamic profile. It was employed in obese patients for its thermogenic and appetite-suppressing effects until its adverse effects prevented its use. Ephedrine has an unintended yet significant effect on body temperature regulation, which has raised questions about its role in contributing to the incidence of hypothermia in the postoperative period. The purpose of this study is to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery.

This study aims to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery. The primary goal is to determine the effect of intraoperative ephedrine use on the incidence of hypothermia after major surgery. The secondary goal is to identify patient characteristics associated with an increased risk of hypothermia despite all measures taken. The results of this study could have important implications for the quality of care for patients undergoing major surgery.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients (age 18 years) who received ephedrine during general anesthesia undergoing major surgical procedures

Exclusion Criteria:

* Patients undergoing minor surgical procedures
* Patients scheduled for day surgeries
* Patients patients (those under the age of 18)
* Patients with a history of thyroid disease
* Patients undergoing brain surgery
* Patients undergoing radiological interventions,
* Trauma patients
* Patients directly transferred from the intensive care unit to the operating room
* Patients with preoperative fever (either low or high)
* Patients who have received vasoactive agents within 24 hours before surgery
* Patients with sepsis and/or septic shock, or fever within a week before surgery
* Patients who have received vasoactive agents
Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures

The study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (TXA) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. Patients who present to the hospital with a hip fracture will be recruited and randomized into two treatment arms. The treatment group will receive 1950mg of oral TXA (three tablets, 650 mg each) and the control group will be given three tablets of oral placebo while in the Emergency Department. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.

There remains a high incidence of blood transfusion in patients following hip fractures. Tranexamic acid (TXA) has well-studied efficacy in decreasing blood loss and transfusion requirements in the context of general trauma, as well as several elective orthopaedic procedures. Although blood is lost in hip fracture surgery itself, it is also known that there is significant blood loss pre-operatively following the hip fracture event, particularly in extracapsular hip fractures. A prospective, randomized, double blinded, placebo controlled trial will elucidate the roll of early administration of TXA in a population of patients who sustain hip fractures. The study aims to investigate the hypothesis that early administration of TXA following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. There will be two treatment arms in the study. The treatment group will be given 1950mg of oral TXA (3 tablets, 650mg each) in the emergency department following diagnosis of hip fracture. Those randomized to the control group will be given 3 tablets of oral placebo in the emergency department following diagnosis of hip fracture. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age over 50
* Clinical diagnosis of acute femoral neck, intertrochanteric or subtrochanteric femur fracture

Exclusion Criteria:

* anticoagulant use at time of admission to emergency department
* documented allergy to tranexamic acid
* history of deep vein thrombosis or pulmonary embolism
* hepatic dysfunction (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 60)
* renal dysfunction (Creatinine \> 1.5 or Glomerular Filtration Rate \< 30)
* active coronary artery disease (event within 12 months)
* history of cerebral vascular accident within 12 months
* presence of drug eluting stent
* color blindness
* active cancer
* coagulopathy (International Normalized Ratio \> 1.4, Partial Thromboplastin Time \> 1.4 times normal, platelets \< 50,000)
Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation

Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation

To investigate the effect of Chuna manual therapy on gate, 20 patients with lumbar disc herniation were studied. The gait analysis was performed before the first treatment, after the seventh treatment, after the 14th treatment, and compared with the data of 20 normal subjects.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI
* Patients with radiculopathy
* Patients aged 19 to 60
* Patients with an Oswestry Disability Index (ODI) of ≥10
* Patients who have agreed to participate in the clinical study and given written informed consent

Exclusion Criteria:

* Patients who were unable to walk for more than 5 minutes due to pain
* Patients with a serious disease that may limit gait(such as spinal metastasis of the tumor, acute fracture and spinal dislocation)
* Patients with chronic conditions that may interfere with the interpretation of the therapeutic effect or outcome(such as chronic kidney failure)
* Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
* Patients with severe mental illness
* Patients who are currently on on steroids, immunosuppressants, psychiatric medications, or other medications that can affect outcome
* Patients who are pregnant or planning a pregnancy
* Patients who are participating in other clinical studies or if it is difficult for you to participate in clinical research as determined by the researcher
Fatty Acid Oxidation Disorders & Body Weight Regulation Grant

Several hormones involved in body weight regulation increase the subject's ability to burn fat for energy. The purpose of this study is to investigate how burning fat for energy may affect those hormones and body weight in children. The study will also determine if eating a diet higher in protein alters the amount of fat you burn and how these hormones control body weight.

A role for mitochondrial fatty acid oxidation in the peripheral signaling cascade of leptin, adiponectin and insulin has recently been proposed from animal studies but has not been investigated in humans. Children with trifunctional protein (TFP, including deficiency of long-chain hydroxyacyl-CoA dehydrogenase) and very long-chain acyl-CoA dehydrogenase (VLCAD) deficiency, inherited disorders of long-chain fatty acid ß-oxidation, lack an ability to oxidize fatty acids for energy. They have increased levels of body fat and circulating leptin and a high incidence of obesity. Current therapy for children with these disorders is based on frequent meals and consuming a low fat, very high carbohydrate diet. Despite treatment, exercise induced rhabdomyolysis is a common complication of TFP and VLCAD deficiency that frequently leads to exercise avoidance. The effects of these genetic defects on body composition and weight regulation have not been investigated. The contribution of fatty-acid oxidation during moderate intensity exercise in children has also not been reported.

Two groups of subjects were recruited: one group of subjects had a long-chain fatty acid oxidation disorder (n=13). The other group is a group of controls (n=16). We studied peripheral signals of body weight regulation, glucose tolerance, body composition, and exercise metabolism in subjects with a long-chain fatty acid oxidation disorder compared to normal controls.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of TFP, LCHAD, CPT2 or VLCAD deficiency
* at least 7 years of age
* willingness to complete overnight admission
* generally healthy

Exclusion Criteria:

* inclusion in another research project that alters macronutrient intake
* diabetes, thyroid disease or other endocrine dysfunction that alters body composition.
* pregnancy
* anemia
Substudy of MEET-OS (NCT04948632): Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices

The objective of this ancillary study of the MEET-OS study is to assess the technical feasibility of using Biobeat® monitoring devices after ambulatory surgery at high risk of complications.

The secondary objectives are to assess: i) the patient's experience and tolerance ii) the occurrence of clinical disturbances in the patients's home after ambulatory surgery with high risk of postoperative complications iii) to determine the impact of the data obtained with the monitoring devices on the clinical care decisions during postoperative follow-up.

With increasingly complex surgeries and increasingly comorbid patients, ambulatory surgery are not always at low risk of postoperative complications. Among the new support tools available for monitoring patients remotely, devices for monitoring vital signs could be of interest to healthcare staff in charge of monitoring, more precisely when comorbid patients are involved or when interventions at high risk of complications are performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old undergoing elective outpatient surgery under general or regional anesthesia
* Internet access for the patient or their caregiver from home
* Written, oral and spoken comprehension of French
* Considered to be at high risk of postoperative complications, defined by one of the following two criteria: an ASA 3 score or an ASA score of 2 + surgery at intermediate or high risk according to the classification of Glance and al.

Exclusion Criteria:

* Patient's or caregiver's inability to learn and to use digital technologies
* Conversion of ambulatory to inpatient hospitalization on the day of surgery
* Patient's refusal
* Operation performed under regional or neuraxial anesthesia alone
* Trophic skin disorders contraindicating the installation of the Biobeat® monitoring device on the torso (deformation, irritation, infection, ulceration, etc.)
* Patient with pacemaker
* MRI or CT scheduled post-operatively
* Tattoo on the torso or refusal to shave the area where the Biobeat® monitoring device should be installed
* Pregnant or breastfeeding women
* Allergy to one of the technological components