cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Spine Surgery Analgesic Pathway

Investigators plan to study the role of spine surgery analgesic pathways - for procedures with high risk of postoperative pain - in improving the quality of recovery

This is a randomized controlled trial comparing "spine surgery analgesic pathway" with "usual care" in improving postoperative quality of recovery and pain management in spine surgery patients. At the time of surgery office visit or at the time of preoperative assessment by anesthesia care team, risk factor for suboptimal pain management will be identified and documented. Patients will be assessed at the time for surgical office visit for their risk for severe post-operative pain. Patients with 2 or more risk factors will be classified as high-risk for severe postoperative pain and the patients with less than 2 factors as low risk. After obtaining informed consent spine surgery patients will be randomized 1:1 in one of the 2 study groups on the day of the surgery:

1. "Usual care" group A
2. "Care pathway" group B

If the participant is randomized to the "spine surgery analgesic pathway" group the participant will be evaluated by the Acute Pain Management Service (APMS) before the surgery for their specific pain management needs. The participant will also get some additional medication for pain in preoperative and intraoperative period. Before surgery the participant will receive Acetaminophen and Gabapentin pills. During the surgery, once the participant is asleep the participant will receive an infusion of ketamine and lidocaine through the participant venous line. After the surgery the participant will receive pain medications as per current standard protocol including acetaminophen and gabapentin. Pain management team specialist will follow for pain control after a surgery as needed.

If the participant is randomized to the "usual care" group the participant will be given placebo preoperatively; the rest of the time pain medication will be provided in a routine manner as per the anesthesia care team and the surgical team. Pain management team specialist will follow for pain control after a surgery as needed.

The primary outcome will be assessed on post-operative day 3: The participants will complete a short survey about quality of recovery.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old at time of surgery - Adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patients.
* Posterior spine surgery
* Surgery performed at Cleveland Clinic main campus

Exclusion Criteria:

* Allergy or hypersensitivity to lidocaine, ketamine, acetaminophen, gabapentin
* Current or recent drug abuse (within past 6 months)
* Pregnancy
* Immune system disease such as HIV, AIDS
* Undergoing immunosuppressive treatment
* Recent history of sepsis
* Contraindications to lidocaine such as heart block and hepatic insufficiency
* Heart failure with ejection fraction less than 30%
* Liver dysfunction manifested with increased liver enzymes to double the normal and INR of 2 or higher
Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life in Early HER2-Positive and Triple-Negative Breast Cancer Patients

The goal of this trial is to learn if a home-based exercise program (intervention) reduces fatigue and improves quality of life in adult patients with early breast cancer who are proposed for preoperative chemotherapy.

Conducted at Centro Hospitalar Universitário de Santo António, Porto, Portugal. It compares a structured exercise program prescribed by the physical and rehabilitation medicine team to routine counseling for physical activity by the medical oncologist.

All participants will:

1. Visit the hospital 3 times for physical assessments, at beginning of chemotherapy (T0), at 3-months (T1) and 1 month after surgery (T2)
2. Reply to questionnaires of fatigue and quality of life, at T0, T1 and T2
3. Adhere to routine medical oncology visits, treatments and exams

Participants of the intervention-arm will additionally:

1. Receive a exercise book, with exercise instructions and calendar
2. Have two in-person lessons about the exercise program
3. Visit the hospital 1 additional time, to have the second lesson
4. Wear a sport bracelet while exercising, to monitor heart rate Recruitment began in April 2024, with results to be shared in medical publications and conferences.


Eligibility Criteria:
Inclusion Criteria (must meet all):

* Adult patients,
* Any gender,
* Diagnosed with breast cancer, of HER2-positive or triple-negative subtypes,
* Proposed to neoadjuvant systemic cancer therapy. May be included: Patients non-eligible for anthracyclines or anti-HER2 therapies; patients with oligometastatic disease proposed for primary/neoadjuvant systemic cancer therapy with intent of radical treatment.

Exclusion Criteria:

* Patients that do not perform any neoadjuvant antineoplastic therapy, for example because of refusal, impeditive comorbidities, re-staging or other reasons.
* Contraindications for exercise or impediments to perform the intervention program, because of previous comorbidities or according to medical assessment (e.g. blindness).
* Patients who are unable to take questionnaires because of language or cognitive barriers (even with small help from a relative or investigator, still cannot answer properly).
* Luminal-like subtype, with hormonal receptor expression and HER2-negative.

Individual participants will be discontinued from the trial, in agreement with their physician where appropriate, if any health problem arises that will significantly affect their safety to participate in exercise for more than one month or if the participant decides to withdraw their consent.
Safety And Efficacy Of Bosutinib

The objective of this surveillance is to collect information about

1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
2. the incidence of adverse drug reactions in this surveillance
3. factors considered to affect the safety and/or efficacy of this drug.

The patients should be registered by central registration system.

Eligibility Criteria:
Inclusion Criteria:

* Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug
* Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug

Exclusion Criteria:

* Patients with a history of hypersensitivity
* Women who may possibly be pregnant or become pregnant
Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia

The purpose of this study is to investigate whether education about the neurophysiology of pain is able to improve central pain inhibition in patients with Fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnose fibromyalgia
* Widespread pain
* Dutch speaking
SCAD : a Registry of Spontaneous Coronary Artery Dissection

Spontaneous coronary artery dissection (SCAD) is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes (ACS), predominantly afflicting young women without conventional atherosclerotic risk factors. Knowledge of SCAD has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6. Like all rarer diseases however, a better understanding of SCAD will require international collaboration. At present, there is no European or International SCAD registry despite increasing recognition that there are key differences in the diagnosis, interventional and medical management of SCAD compared with conventional atherosclerotic ACS. The ESC-ACCA Study Group on Spontaneous Coronary Artery Dissection supported by the European Observational Research Programme will now build the first pan-European SCAD registry to advance our understanding of current management of this condition, inform guidelines, educate clinical colleagues and advance research.

Observational, multicentre, international retrospective and prospective cohort study.

Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled.

Patient data will be collected at the following time-points:

* First SCAD event visit (retrospectively on chart review)
* First follow-up: at time of enrolment
* Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion

Approximately 30 countries and 120 sites will participate in this registry.

Eligibility Criteria:
Inclusion Criteria:

* Patient having signed an Informed Consent
* Patient aged 18 years and over
* SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery

Exclusion Criteria:

* Patient unwilling or unable to consent
* Patients with iatrogenic or atherosclerotic coronary dissection
Stress and Marijuana Cue-elicited Craving and Reactivity

The purpose of this study is to explore the interaction between stress and marijuana cues, in hopes that it may lead to the development of new treatments for marijuana dependence.

Although use of marijuana is widespread, little research has focused on the treatment of marijuana use disorders or on predictors of relapse. Although several factors contributing to relapse have been explored in other dependencies (i.e., alcohol, cocaine), little research has focused on drug cue-related or stress-induced relapse in marijuana-dependent individuals. Cue reactivity is a construct measured in a laboratory procedure where an individual's subjective, behavioral, and physiological responses are assessed following exposure to drug-related environmental cues or stressors. Investigating the effects of drug-related environmental cues and stress in marijuana-dependent individuals will be useful in guiding treatment development.

Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Methods (DSM)-IV Criteria for Marijuana Dependence
* Between the ages of 18 and 65
* Must abstain from marijuana use the day of testing and other drug use three days prior to testing

Exclusion Criteria:

* Must not be taking any psychoactive medication, or medication that alters the hypothalamic pituitary adrenal (HPA) Axis functioning
* Must not be taking any medications that alter heart rate or skin conductance monitoring
* Cannot meet criteria for current major Axis I disorder (may alter response to stress)
* Cannot be morbidly obese (Body Mass Index \>39)
* Cannot meet current abuse or dependence criteria of other substances in past 90 days
* Must not have a medical condition that impacts HPA functioning (Hypertension, chronic pain, Addison's disease)
Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)

Primary objective:

* Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c\<7% and/or a final decrease of HbA1c\>15% compare to the basal value (HbA1c final - HbA1c basal).

Secondary objectives:

* Determination of the predictive criterion of HbA1c final,
* Determination of the predictive criterion of weight variation,
* Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),
* Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).

Safety:

* Adverse Event (AE)/Serious Adverse Event (SAE) assessments


Eligibility Criteria:
Inclusion Criteria:

* Known type 2 diabetes for at least 2 years
* No history of Ketoacidosis
* BMI\> 25 \& \<35 kg/m2
* Type 2 diabetes treated with oral bi or tritherapy for at least 6 months

  * With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),
  * and metformin at minimal posology 1700mg/day (1320 mg of metformin),
* HbA1c \>= 7.5 and \<11% for 2 different dosages during the last year

Exclusion Criteria:

* Type 1 diabetes
* Glucophage intolerability
* Pregnancy
* Breast feeding
* Partial pancreatectomy
* Hypersensitivity to insulin glargine excipient
* Renal failure with creatinin\>135 µmol/L for male and \>110 µmol/L for female patient
* Hepatitis with transaminases \>3ULN
* Pre-proliferative or proliferative retinopathy
* Acute cardiovascular accident within the last 6 months
* Previous treatment with insulin within the last 6 months before randomization
The Treatment of Acne Vulgaris With Radiofrequency Device

Radiofrequency emmitting device, normaly used for thermage treatments will be used on 22 mild to moderate acne patients faces.

The aim of the study is to check whether RF heating of subcutaneous and dermis will improve acne in needed patients.


Eligibility Criteria:
Inclusion Criteria:

* mild-moderate Acne
* age over 18
* otherwise healthy

Exclusion Criteria:

* age under 18
* pregnancy
* systemic acne treatment in the last month
* local acne treatment in the last month
Telemedicine Clinic for Prostate Cancer Patients

This randomized, open label study will evaluate a nurse and pharmacist led clinic conducted remotely from Grand River Regional Cancer Centre at Grand River Hospital (GRRCC/GRH) using OTN teleconferencing as a platform for patients with prostate cancer receiving oral chemotherapy agents.


Eligibility Criteria:
Inclusion Criteria:

1. Male over 18 years of age with prostate cancer receiving oral treatment with abiraterone or enzalutamide.
2. Ability to provide consent to study.
3. Willingness to complete study questionnaires and a semi-structured exit interview.
4. Adequate command of the English language to complete study questionnaire and survey.
5. Access to technology to allow a link to the virtual telemedicine clinic. (excluding control group)
6. Willingness to participate in videoconference with pharmacist or nurse from their home environment. (excluding control group)

Exclusion Criteria:

1. Patients receiving oral anti-cancer therapy other than abiraterone and enzalutamide.
2. Patients lacking the technology at home to participate in the virtual telemedicine clinic. (excluding control group)

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Deucravacitinib Adherence Study

Psoriasis patients are very poorly adherent to topical treatment. If adherence issues are ignored, poor adherence may limit the real-world efficacy of deucravacitinib, too. Forty psoriasis patients recruited from Wake Forest Baptist Health Dermatology Clinic will be enrolled. Twenty will be randomized to a reporting intervention designed to promote better adherence and the remaining 20 patients will serve as controls who will not receive a reporting intervention. Through qualitative interviews of the 40 patients recruited, we plan to study the behaviors of the most adherent patients to better understand specific beliefs and behaviors of adherent patients and to identify practical, modifiable factors that can improve adherence. We will also compare treatment outcomes and efficacy of deucravacitinib between the most and least adherence patients.

STUDY OBJECTIVES

* PRIMARY OBJECTIVE: The primary objective of the proposed study is to identify adherence outliers (high and low adherence), specific beliefs, and behaviors that correspond to better and worse adherence to oral treatment of psoriasis.
* SECONDARY OBJECTIVE: The investigators will study the efficacy and safety of deucravacitinib in patients who are highly adherent to treatment compared to patients who do not take the medication as directed (including both those who undertreat and overtreat).

  * Safety endpoints will include reported adverse events.
  * For the characterization of adherence to deucravacitinib, adherence endpoints will include the proportion of subjects with 80% or greater adherence, days with missed treatment, days with overuse, and premature discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate-to-severe plaque psoriasis. Standard criteria for moderate-to-severe plaque psoriasis will be used (BSA greater than or equal to 3% or face/palm/sole/genital involvement or severe effect on Quality of Life).
* Subject must be 18 years of age or older.
* Subject must have a working knowledge of English.
* Approved birth control methods required for females of childbearing potential.
* Baseline TB test.

Exclusion Criteria:

* Patients without a diagnosis of moderate-to-severe plaque psoriasis.
* Patients under 18 years of age.
* Patients with severe or unstable comorbid conditions.
* Patients with active malignancy or malignancy in past 5 years (not including appropriately treated cutaneous basal and cutaneous-limited squamous cell carcinomas).
* Patients who are pregnant or breastfeeding.
* Patients with any other skin condition that prohibit or confound the ability of the investigator to interpret skin findings.
* Patients with active substance or alcohol abuse disorder; or history of substance/alcohol abuse disorder within 6 months prior to study enrollment.
* History of, or active, severe depression and/or suicidality.
* Patients with active or latent tuberculosis as determined by quant-TB baseline testing
* Patients that are taking concomitant biologics, systemics for the treatment of psoriasis and/or phototherapy.
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients

Observational study Primary Objective: To study whether ECMO alters the PK of anti-infectives including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO

Secondary Objectives:

Develop Population PK models of anti-infectives, including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO

Develop Physiological-Based PK (PBPK) model of anti-infectives, including: voriconazole, posaconazole and caspofungin in critically ill patients on ECMO

Study population: Critically ill patients on ECMO

Methodology: Observational study to determine whether ECMO alters the PK of anti-infectives, by developing PK models

This is a non-interventional descriptive study in that the anti-infective drug selection and dosing will be at the discretion of the clinician, based on the clinical context and unit guidelines. Doses will be reconstituted and administered as per local hospital protocols in line with patient's routine care. Patients will be asked to provide additional blood samples over the course of the anti-infective dosing schedule, these samples will be taken from existing arterial lines to help guide treatment in future patients on ECMO receiving these anti-infectives.

Anti-infective drug selection and dosing will be at the discretion of the clinician, based on the clinical context and unit guidelines. Doses will be reconstituted and administered as per local hospital protocols and based on routine standard care.

Blood samples will be drawn from an existing arterial line and collected in 3 ml tubes with Lithium Heparin anticoagulant.

All patients will be sampled over a single dosing period on the second day of Extra-Corporeal Membrane Oxygenation (ECMO) treatment, or of an antibiotic course where antibiotics are commenced whilst the patient is on ECMO. Where possible, sampling during one extra dosing interval will occur on days 4-8 of ECMO treatment and/or prior to the next tubing change. Where two or more anti-infectives of interest are prescribed for one patient, collect data on timing of administration for both drugs and sample according to the antibiotic with the longer dosing interval.

Blood samples (2ml) will be collected from an existing arterial line at the following time points 0 (pre-starting infusion, pre-Nasogastric (NG)/Oral (PO) dose), 1 (end of infusion or 1hour post NG/PO dose), 2, 3, 4, 8 and either 12 (for twice daily regimen) or 24 (for once daily regimen) hours on the second day of ECMO.

Where a patient is receiving medications where a validated drug assay exists in addition to the study drug (such as other anti-infectives), analysis of the additional therapy will also be attempted where practical.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years and \<90 years
2. Currently undergoing ECMO for respiratory +/- cardiac dysfunction
3. Clinical indication for the anti-infectives, including voriconazole, posaconazole and caspofungin

Exclusion Criteria:

1. History of allergy to any of the study drug
2. Pregnant women
Carbohydrate Intolerance Questionnaire Study

The purpose of this study is to evaluate the validity of using a carbohydrate intolerance questionnaire (CIQ) and/or other health markers as a means of predicting response to insulin sensitivity as determined by an oral glucose tolerance test (OGTT).

This study will utilize a carbohydrate intolerance questionnaire (CIQ). Responses to a CIQ will be correlated with diet inventories, baseline body composition and health assessments, a standard metabolic panel, fasting glucose and insulin levels, a homeostatic insulin resistance model (HOMA), a two hour oral glucose tolerance test (OGTT), and a carbohydrate sensitivity symptom questionnaire administered during the OGTT.

Eligibility Criteria:
Inclusion Criteria:

* Participant is female
* Participant is between the ages of 18 and 60

Exclusion Criteria:

* Participant is pregnant or nursing
* Participant is diabetic or pre-diabetic
* Participant has a Body Mass Index (BMI) \< 22
Optimizing Mental Health Management With AI-Guided (GenAIS TM) Dietary Supplementation

The study "Optimizing Mental Health Management with AI-Guided (GenAIS TM) Dietary Supplementation" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing mental health disorders, specifically depression and anxiety. This 6-month randomized controlled trial included 160 participants diagnosed with major depressive disorder or generalized anxiety disorder. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in mental health scores, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Diagnosed with major depressive disorder (MDD) or generalized anxiety disorder (GAD) according to DSM-5 criteria.
* Moderate to severe symptoms as indicated by scores on HAM-D (≥17) for depression or GAD-7 (≥10) for anxiety.
* Stable on psychiatric medication for at least 3 months prior to the study.
* Willingness to provide genetic and metabolic data.
* Written informed consent.

Exclusion Criteria:

* Current or past history of severe psychiatric conditions such as schizophrenia, bipolar disorder, or other psychotic disorders.
* Current substance abuse or dependence within the last 6 months.
* Significant medical conditions like severe renal, hepatic, or cardiovascular diseases.
* Pregnancy or breastfeeding.
* Recent changes in psychiatric medication within the last 3 months.
* Participation in another clinical trial within the last 30 days.