cyrilzakka/clinical-trials huggingface dataset:
Ketorolac on Posterior Thoracolumbar Spinal Fusions

To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Elective thoracolumbar posterior lumbar instrumented interbody fusion
* Minimally invasive spine surgery (MIS)
* 3 or fewer levels
* Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)
* Consent to study participation

Exclusion Criteria:

* Active tobacco smoker or history of tobacco smoking in the past 6 weeks
* Previous history of surgery at operative level(s)
* History of chronic inflammatory/rheumatological condition
* History of systemic steroid use in the past 3 months
* Auto/Workers' compensation patients
* Traumatic pathology at the operative levels
* Infection at the operative levels
* Tumor at the operative levels
* Major psychiatric illness as diagnosed by psychiatrists and on major anti- psychotic/depressants
* Patients on chemotherapeutic agents in the last 6 months
* Patients who has a history of allergy to Ketorolac
* Patients with a history of chemical addiction requiring professional rehabilitation and/or assistance
* Patients with current creatinine \> 1.5mg/dl
* Patients with history of coagulopathy
* Patients with history of hepatic impairment
* Patients with uncontrolled cardiovascular disease
Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker

Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site

Right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. Pacing at various sites had different effects on synchrony and tricuspid regurgitation. This study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. Ultrasound and ECG parameter indices are applied.

Eligibility Criteria:
Inclusion Criteria:

patients consent to LP implantation surgery

Exclusion Criteria:

1. Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava;
2. Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system;
3. Patients with myocardial infarction;
4. Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves;
5. cannot understand or are unwilling to give informed consent.
Assessment of Bioavailability of Phenolics From an Orange Peel Extract

In this study, the bioavailability of a specific orange peel extract is tested. The composition and morphology of the test product is altered compared to the generic product, which is used as a control. Due to intellectual property issues, more information cannot be given at this moment. Also the difference in bioavailability between a capsule and a lozenge is tested. The hypothesis is that the bioavailability of the altered extract will be improved compared to the control.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* BMI 18.5 to 25

Exclusion Criteria:

* pregnancy
* smoking
* alcohol or drug abuse
* use of medication
* use of nutritional supplements
* abnormal liver or kidney function
Post COVID-19 Syndrome Treatment with Variable Pulse Transcranial Magnetic Stimulation

The purpose of this study is to test if Variable Pulse TMS (Transcranial Magnetic Stimulation) can result in objective improvements in patients with Post COVID Syndrome (PCS).


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had a recent episode of COVID-19 and who present to the Post COVID-19 Clinic at Mayo Clinic Rochester with at least one of the PCC symptoms of interest - anosmia, tinnitus, fatigue. Symptoms consistent with PCC lasting at least 1 month after the positive test date. Subjects must have ongoing symptoms for \> 4 weeks following the start of an acute covid infection. This is consistent with the CDC definition for post covid conditions. Start date is determined by date of first positive COVID test. There is no limitation of maximum time from acute infection start.
* At least one of the PCC symptoms of interest:

  * Anosmia: Olfactory Threshold Test scores corresponding to Anosmia or Hyposmia
  * Tinnitus: \>0 score on Tinnitus Handicap Inventory (not present prior to SARS-COVID 2 infection)
  * Fatigue: Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above

Exclusion Criteria:

* Implanted electronic devices, including pacemakers, defibrillators, implant medication pumps, or vagus nerve stimulators (VNS)
* Active alcohol abuse: \>14 drinks a week or formal diagnosis, illicit drug use or drug abuse
* Any seizure history within the past 10 years
* Intracranial implant within 30 cm of magnet (e.g., aneurysm clips, endovascular coil, cerebral shunts, brain stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
* Enrolled or plans to enroll in an interventional trial during this study
* Previous stroke with residual deficits
* Subjects unable to comprehend or follow verbal commands
* Subjects unable to comprehend and sign the informed consent
* Based on PI's or local physician's assessment that subject unable to tolerate the trial procedure due to medical condition
* Clinical abnormality or clinically unstable medical condition, as indicated by medical history, physical examination, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results
* Pregnant or trying to become pregnant; negative urine pregnancy test at screening will be required for females of childbearing potential
* Any condition which in the judgment of the investigator would prevent the subject from completion of the study
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.

The main question\[s\] it aims to answer are:

* the recommended dose for Phase 2
* to evaluate the safety and tolerability of the combination therapy
* to determine the pharmacokinetics of TNG260
* to evaluate the initial antineoplastic activity

Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of TNG260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Is ≥18 years of age at the time of signature of the main study ICF.
* Has ECOG performance status of 0 or 1.
* Has measurable disease based on RECIST v1.1.
* All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytical method
* Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor.
* Adequate organ function/reserve per local labs
* Adequate liver function per local labs
* Adequate renal function per local labs
* Negative serum pregnancy test result at screening
* Written informed consent must be obtained according to local guidelines

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its excipients
* Uncontrolled intercurrent illness that will limit compliance with the study requirements
* Active infection requiring systemic therapy
* Currently participating in or has planned participation in a study of another investigational agent or device
* Impairment of GI function or disease that may significantly alter the absorption of oral TNG260
* Active prior or concurrent malignancy.
* Central nervous system metastases associated with progressive neurological symptoms
* Current active liver disease from any cause
* Clinically relevant cardiovascular disease
* A female patient who is pregnant or lactating
Clinical Outcome of Triheptanoin Treatment in Patients With Long-chain Fatty Acid Oxidation Disorders (LC-FAOD) Treated Under Expanded Access Program

The primary objective of the study is to evaluate the clinical outcomes for the trigger event of patients who receive triheptanoin in the emergency Investigational New Drug (eIND) program.

The study is a retrospective chart review of patients in the USA with LC-FAOD who received triheptanoin via eIND request from their metabolic or treating physician before 01 September 2018. Participating study sites will provide the medical records of subjects who meet eligibility criteria, and relevant data regarding the trigger event (the reason the patient was placed on triheptanoin) and key details about hospitalizations during the study period will be extracted.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of any age with confirmed diagnosis of one of the LC-FAOD disorders including: mitochondrial trifunctional protein (TFP) deficiency, carnitine palmitoyltransferase deficiencies (CPT I and CPT II), very long chain acyl-CoA dehydrogenase (VLCAD) deficiency, long-chain 3-hydroxy-acyl-CoA dehydrogenase (LCHAD) deficiency, and carnitine acylcarnitine translocase (CATR) deficiency
* Treatment initiation with triheptanoin was via eIND before 01 September 2018
* Treated with triheptanoin in the USA
* Willing and able to provide written, signed informed consent, or where appropriate for subjects under the age of 18, or provide written assent and written informed consent by a legally authorized representative after the nature of the study has been explained and prior to any research-related procedures. To obtain and review medical records of deceased individuals, informed consent from next of kin or appropriate legal entity will be obtained, as applicable.

Exclusion Criteria:

* Unwilling to sign informed consent or assent to release of medical records
Biomarkers of Theta Burst Stimulation in Major Depressive Disorder

This study investigates the brain-based biomarkers of treatment response to accelerated theta burst stimulation (aTBS) in patients with Major Depressive Disorder resistant to pharmacological treatment(MDD) in an open label design.

Theta burst stimulation (TBS) is a newer form of rTMS which requires less stimulation time and produces longer lasting post-stimulation effects in the cerebral cortex (4). It has been shown to be effective in inducing synaptic plasticity and has similar or better efficacy in treating depression compared to rTMS (4).Newer accelerated TBS (aTBS) protocols that condense stimulation sessions down to several days rather than weeks have shown similar response rates when compared to prolonged TBS protocols, also with similar tolerability and safety. In order to develop aTBS as an effective treatment for MDD, future research should focus on identification of reliable predictors for better outcome to TBS. The main objectives were: 1) To directly compare multiple different brain-based measures (neuroimaging and electrophysiology) to identify which has the most power in accurately predicting response to TBS compared to sham. 2) To track both short and long-term longitudinal electrophysiological (EEG) changes related to the therapeutic effects of TBS.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must meet the DSM-5 diagnostic criteria for single-episode Major Depressive Disorder (MDD).
2. Participant must have failed to respond to \>1 but \<4 classes of oral antidepressant treatments in the current episode of depression.
3. Participant must have a HAMD total score of at least 18

Exclusion Criteria:

1. The participant's depressive symptoms have previously demonstrated nonresponse to:

   * An adequate course of rTMS/TBS over DLPFC in the current major depressive episode, defined as at least 3 weeks of treatment, 5 times weekly
   * An adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT.
2. Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression.
3. Participant has a current or prior DSM-5 diagnosis of Axis I comorbidities, including psychosis, bipolar disorder, obsessive compulsive disorder, based upon clinical assessment and confirmed by the MINI.
4. Participant has a current or prior DSM-5 diagnosis of Axis II comorbidities, including severe borderline personality disorders, antisocial, schizotypal, schizoid personality disorders based upon clinical assessment and confirmed by the MINI.
5. Participant has severe suicidal ideation/plan/ intent.
6. Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria.
7. Participant has a current or past history of seizures and neurological problems, e.g. head injury, stroke, progressive neurological disorder and complicated and unstable medical disorders, e.g. cardiovascular-related conditions, diabetes.
Adaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression

Harley and colleagues demonstrated that adding Dialectical Behavior Therapy (DBT) skills-groups and therapist consultation to treatment as usual successfully reduced symptoms of depression. The present study will expand upon these findings. Second, DBT is not known for reducing suicidal ideation (SI), a major risk factor for suicide . The present study will tailor the aforementioned skills-groups to specifically target suicidal thoughts and behaviors through Cognitive Behavior Therapy (CBT) strategies aimed at increasing problem-solving deficits, hopelessness, and negativistic thinking. Third, the present study will extend this DBT-based approach to a novel population. Fourth, the present study is the first DBT intervention to employ state-of-the-art multi-method measurement (including objective assessment) of suicidal thoughts and behaviors.

The investigators hypothesize that participants in the DBT skills (DBT-S) group will show improvements in level of suicidality as measured by decreased scores on the Beck Scale for Suicide Ideation as compared with participants in the Wait List-Treatment as Usual (WL-TAU) group.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will be at least 18 years of age.
2. Participants will meet criteria for Major Depressive Disorder (MDD) on the Structured Clinical Interviews for Axis I DSM-IV Disorders
3. Participants must report current suicidal ideation on the Self-Injurious Thoughts and Behaviors Interview
4. Participants must have an outpatient psychiatric provider who they see "regularly" (i.e., at least every other week for therapy, case management, or medication management).
5. English language proficiency.

Exclusion Criteria:

1. DSM-IV diagnosis of bipolar disorder, schizophrenia, psychotic disorder NOS, or personality disorders.
2. Active current substance dependence.
3. Severe or unstable medical conditions that would prohibit regular group attendance or participation.
4. Other group therapy.
5. Significant dementia or cognitive impairment that would interfere with the learning of DBT skills.
A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee

The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment.

The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.

Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy.

Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo.

Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At each Treatment Visit, subjects will undergo efficacy assessments and safety procedures. During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours.

Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).

Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
* Men and their female partners must use two forms of birth control
* Clinical and radiographic evidence of chronic knee osteoarthritis
* An average NPRS score of \>=5 and \<=9 over a 4-7 day washout period of their previous osteoarthritis medications
* Ambulatory
* Have provided written informed consent
Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury

The purpose of this study is to see whether esophageal pressure (PES) measurements will allow the investigators to choose the best method of mechanical ventilation in patients with acute lung injury (ALI).

The current standard of practice for ventilating patients with acute respiratory distress syndrome (ARDS) is the ARDSnet protocol (N Engl J Med 2000; 342:1301-1308) which has been shown to improve survival by limiting tidal volumes and thus preventing over distention of the lungs. However, the lungs can also be damaged by under-inflation during mechanical ventilation, and current practice ignores the effects of chest wall compression of the lungs, which can cause under-inflation. The investigators have observed that a fraction of critically ill patients with apparent ARDS have lung function abnormalities caused by extrinsic compression which can be estimated by PES measurements. Changing ventilator settings to apply normal physiological pressure to the lung has been beneficial in many such patients. This protocol will formally test the clinical utility of PES measurements in patients with ARDS.

This is a randomized controlled trial of therapy directed by esophageal balloon measurements (PES) versus therapy directed by ARDSnet protocol, the current standard of care.

Eligibility Criteria:
Inclusion Criteria:

Patients with ALI/ARDS according to the International Consensus Conference criteria:

* PaO2/FiO2 ratio \< 300
* Acute onset
* Bilateral infiltrates on chest radiography
* PAOP \< 18 or, in patients without a pulmonary artery catheter, no other evidence of abnormal cardiac function

Exclusion Criteria:

* Patients with esophageal varices
* Patients with esophageal trauma
* Patients with recent esophageal surgery
* Patients with coagulopathy (platelets \< 80k or International Normalized Ratio \[INR\]\> 2 )
* Post transplant patients
* Patients with significant broncho-pleural fistula
Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours

The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia.

Enhanced Recovery after Surgery (ERAS). A series of components that combine to minimize stress and to facilitate the return of function have been described: these include preoperative preparation and medication, fluid balance, anesthesia and postoperative analgesia, pre- and postoperative nutrition, and mobilization.

Nutrition therapy is the provision of nutrition or nutrients either orally (regular diet, therapeutic diet, e.g. fortified food, oral nutritional supplements) or via enteral nutrition (EN) or parenteral nutrition (PN) to prevent or treat malnutrition.

Head and neck cancer surgery usually means surgery to treat cancer of the mouth, throat or larynx . The surgery is complicated and people often experience problems such as wound infections and wound breakdown, as well as infections such as pneumonia.

The use of a nutritional supplement enriched with Omega 3 fatty acids is associated with a greater preoperative weight loss, reduced postoperative pain and decreased postoperative levels of C reactive protein in patients undergoing Roux-en-Y gastric bypass.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I or II .
* Patient undergoing mandibular or oral cavity tumour resection.
* Body mass index (BMI) between 18.5-24.9.
* Patient with serum albumen above 3 gm.
* Patient with written valid consent

Exclusion Criteria:

* Patient refusal and uncooperative patients.
* Patient ASA III or IV.
* Age more than 60 or less than 18.
* Serum albumen less than 3.
* Pre-existing severe malnourishment.
* Allergy to test drugs.
* Patients on tranquilizers, hypnotics, sedatives and other psychotropic patient on steroids and NSAID.
Determination of the Glycemic Index Values of 10 Cereal-based Products

To determine the Glycemic index values for 10 cereal-based products

To determine the Glycemic index values for 10 cereal-based products per international standard (ISO26642:2010) for glycemic index determination.

Eligibility Criteria:
Inclusion Criteria:

* 10 healthy participants, male and female (non-pregnant, non-lactating) of mixed ethnicity, aged between 18 - 65 y
* BMI: 18 - 25.0 kg/m2 (bounds included)
* Non smokers
* Normal glucose tolerance (assessed by 50 gram oral glucose tolerance test performed within the last 30 days: fasting \<6 mM, 2 hr glucose \<7.8 mM)
* Stable weight and dietary habits. Normal eating patterns and no history of eating disorders or recent dieting
* Normal sleep patterns (ie. at least 6 hours of sleep per night)
* The participants are required to avoid alcohol and unusual levels of food intake and physical activity for the 24 hours before each test session.
* Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion Criteria:

* Food allergy or intolerance to the study ingredients (eg. gluten, etc.)
* Regularly taking prescription medication other than standard contraceptive medication
* Taking any medications known to affect glucose tolerance (eg. acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis)
* Suffering from any illness or disease
* Following a restricted diet
* Smokers
* Eating disorders
* Abnormal glucose tolerance or known history of diabetes mellitus.
* Individuals currently participating in other acute metabolic studies
* Failure to meet any one of the inclusion criteria