cyrilzakka/clinical-trials huggingface dataset:
Pharmacogenetics of Ketamine in Children

The need to treat the children with painful diagnostic-therapeutic procedures has increased in the last years. There is evidence from a wide scientific literature that drugs available in the setting of procedural sedation and analgesia such as midazolam, fentanyl, nitrous oxide, ketamine and propofol are absolutely safe without a significant incidence of adverse effects, if administered by anaesthesiologists and also trained pediatricians outside the operating room. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that blocks glutamate excitatory effects. Ketamine's molecular mechanism is not restricted to the NMDA receptor. Several studies indicate interactions with a series of receptor systems, including opioid, cholinergic and dopaminergic receptors. Ketamine is a safe and effective drug during procedural analgesia and sedation applied to children outside the operating room. A recent multicenter study, showed that ketamine, without being associated with other analgesic or sedative drugs, is the drug regimen with the lowest risk of adverse effects during this procedures. Even though being safe, ketamine may cause some adverse effects. When ketamine is administered for procedural sedation outside the operating room, adverse effects more frequently recorded are emesis and recovery agitation, each with a prevalence of around 8%. Recovery agitation, defined as any abnormal behavioural response such as any combination of agitation, crying, hallucinations or nightmares after sedation, in some cases (around 1%) may be severe and leads to specific treatment, mainly benzodiazepines. Emesis and recovery agitation are minor adverse events, but both may be very unpleasant for the patient and may play a role in the perception of patients and their parents of the quality of sedation, especially in children who need repeated procedures. Identifying patients, particularly children with chronic illnesses and leukemia, at risk of emesis and recovery agitation may facilitate the choice of different drugs regimens, improving the quality of care. The aim of this study is the identification of genetic and epigenetic biomarkers useful to predict emesis and recovery agitation related to administration of ketamine for procedural sedation and analgesia applied to children and to correlate them with the pharmacokinetic profile.


Eligibility Criteria:
Inclusion Criteria:

1. Any child between 1 and 17 years of age needing sedation and analgesia for painful procedures, such as suture laceration, fracture reductions, burn medications, bone marrow aspiration, lumbar puncture, arthrocentesis, colonoscopy and others.
2. Use of intravenous ketamine as the sole sedative agent for the procedure.

Exclusion Criteria:

1. Children needing drugs other that ketamine for sedation, such as fentanyl, propofol, midazolam and dexmedetomidine .
2. Children with intellectual disability or with non typical neurodevelopment, such as children with autism.
3. Children with a history of allergy or hypersensibility to ketamine.
4. Parents limitations in language and understanding informed consent forms and procedures.
Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder

This study is going to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on Borderline Personality Disorder patients symptoms.

There is a great body of literature about the positive effects of rTMS therapy on various psychiatric disorders. In this study we are going to evaluate the effects of high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC)region in borderline personality disorder (BPD) patients. patients will be assessed by subjective measures for BPD.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed borderline personality disorder according to DSM IV.

Exclusion Criteria:

* Epilepsy
* Any metal device
* Psychotic disorders
* Bipolar mood disorder type 1
OsteoCool Tumor Ablation Post-Market Study

This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.

The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States, Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of this study is to collect real-world outcomes among a cohort of patients in the US, EUR and CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy), and benign bone tumors such as osteoid osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study will collect device, procedure and/or therapy related adverse events and device deficiencies. Lastly, subject outcomes (such as pain relief, quality of life, and function) will be evaluated using validated assessment measures.

Eligibility Criteria:
Inclusion Criteria:

1. Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region
2. A. Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors - no restrictions on location of lesion
3. Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
4. Localized pain resulting from no more than two sites total of metastatic disease
5. Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone tumors)
6. Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
7. At least 18 years old at the time of informed consent

Exclusion Criteria:

1. A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only)
2. Use of OsteoCool in vertebral body levels C1-C7
3. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone
4. Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection
5. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise
6. Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression
7. Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or mixed origin are eligible for the study
8. Pregnant, breastfeeding, or plan to become pregnant during the study duration
9. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results\*
10. Any condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation

    * Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
CureDuchenne Link®: A Resource for Research

CureDuchenne link is a data hub comprised of integrated biospecimens, clinical data, and self- and/or caregiver-reported information from participants. Anyone over 4 weeks old who has been diagnosed with DMD or BMD or who is a carrier of DMD or BMD can join. Parents or legal guardians can sign up their child(ren).

Individuals can participate through the CureDuchenne Link™ application (accessible via mobile device or web interface) and receive communications about research opportunities and community programs. Participation may be done using virtual methods, at a project site, and/or at community events nationwide.

All collected information will be stored in a secure, HIPAA-compliant data warehouse for approved researchers to use for studies relevant to DMD, BMD and other neuromuscular disorders. Combining health and outcomes data with biospecimens provides an impactful solution and novel resource for researchers, allowing for effective translational research.

Eligibility Criteria:
Inclusion Criteria:

1. Any of the following are true:

   1. Currently has a confirmed diagnosis of DMD/BMD based on genetic testing, muscle biopsy, or clinical diagnosis.
   2. Currently has a confirmed diagnosis of carrier status for DMD/BMD based on genetic testing.
2. Parent/guardian (for minor participants) or participant gives informed consent and/or assent as required by local regulations.
3. Is age 4 weeks or older at the time of consent.

Exclusion Criteria:

1. Is a foster child or ward of the state.
2. Is a prisoner.
Effects of Methylprednisolone After Total Knee Arthroplasty

The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty.

The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.

In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total knee arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Elective total knee arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria:

* Alcohol or medical abuse
* Allergies to local anesthetics or methylprednisolone
* Age \< 18 years
* Daily use of opioids or glucocorticoids
* Pregnancy or breastfeeding (fertile women)
Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)

The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. Patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.

Following the safety verification of the Phase I study (TICAP trial) that has been implemented and completed, the efficacy will be verified in this Phase II clinical study. The rationale of this study is based on the animal studies that transplanted cardiac progenitor cells may regenerate damaged myocardium by giving rise to cardiac muscle and vascular cell types. Preclinical and phase I studies indicate the possibilities of cardiac function improvements and reduced myocardial fibrosis by progenitor cell infusion.

The efficacy of cell transplantation is assessed as the primary endpoint of the Phase II clinical study. The improvements of cardiac ejection fraction assessed by echocardiography, ventriculography, and cardiac MRI, which are conducted before and after treatment, are assessed as the evaluation items. The absolute values of the improvement of cardiac ejection fraction obtained by the above three imaging modalities before and after treatment are compared between two groups of the transplantation group and non-transplantation group.

Eligibility Criteria:
Inclusion Criteria:

1. Age: Age is 0 year or more and 20 years or less at the time of enrollment.
2. The patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries.
3. The ventricular ejection fraction \<60%.

Exclusion Criteria:

1. Cardiogenic shock
2. A patient with unstoppable extracorporeal circulation
3. A patient with lethal, uncontrollable arrhythmia
4. A patient with a complication of coronary artery disease
5. A patient with a complication of brain dysfunction due to circulatory failure
6. A patient with malignant neoplasm
7. A patient with a complication of serious neurologic disorder
8. A patient with high-grade pulmonary embolism or pulmonary hypertension
9. A patient with high-grade renal failure
10. A patient with multiple organ failure
11. Active infection (including endocarditis)
12. Sepsis
13. Active hemorrhagic disease (e. g. gastrointestinal bleeding, injury)
Study of Colorectal Cancer Screening Options

The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.

The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.

Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who are non-adherent after receiving stool test outreach, who have an upcoming clinical appointment, and who are offered a commercially available colorectal cancer blood test versus usual care (i.e. reminder to complete stool testing during their clinical appointment).

Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the test (based on available test performance characteristics) and willingness to obtain/offer the test on an on-going basis, based on qualitative interviews; assess preliminary rates of follow-up colonoscopy completion (after an initial abnormal test result) among participants allocated to the blood test vs. usual care condition.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-75
* Received a FIT test in the last 3-9 months yet did not return their FIT
* Upcoming appointment or willing to reschedule an appointment at KPNW within 2 - 6 weeks
* Able and willing to provide informed consent if in the intervention arm

Exclusion Criteria:

* On KPNW's do not contact list
* Having a legal authorized representative
* Non-English speakers
Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors

Gastrointestinal tumors (esophageal cancer, gastric cancer, colorectal cancer) seriously threaten human health, with a high incidence rate and cancer related hope mortality. Digestive endoscopy is the main method for screening gastrointestinal tumors. Early screening of gastrointestinal tumors can improve the detection of early cancer and improve prognosis. The five-year survival rate of early stage tumors after comprehensive treatment can reach 90%, while the five-year survival rate of late stage tumors is less than 30%. Therefore, the screening of gastrointestinal tumors is very important.

Studies have shown that there are similarities in risk factors for gastrointestinal tumors, such as age, gender, family history, smoking, alcohol consumption, etc. Currently, established digestive malignancies are targeted at a single malignant tumor. At present, there is a lack of understanding of the overall risk factors associated with gastrointestinal tumors and the establishment of relevant risk prediction models.

Therefore, we conducted a prospective, multicenter cross-sectional study to explore the independent risk factors of combined gastrointestinal tumors and establish a risk prediction model for combined screening of gastrointestinal tumors.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-80 who undergo both gastroscopy and colonoscopy simultaneously

Exclusion Criteria:

* （1）Previously diagnosed with esophageal, gastric, or colorectal cancer; (2) Suspected presence of gastrointestinal obstruction or perforation; (3) Previous history of esophageal, gastric, or colorectal surgery; (4) Those who are not suitable for endoscopic examination due to serious diseases or unstable hemodynamics; (5) Individuals who are unable to obtain relevant information due to communication barriers such as mental or neurological disorders; (6) Pregnancy or lactation period; (7) Not willing or unable to sign the informed consent form.
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Opioid Use Disorder (MK-4305-098)

People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a diagnosis of OUD and is currently in treatment for OUD.
* Is on a verified, stable dose of medications for opioid use disorder (MOUD) treatment.
* Has sleep complaints that meet Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for the diagnosis of insomnia.
* Has a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the study.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has current uncontrolled major co-morbid psychiatric illness including bipolar disorder, schizophrenia, or any psychiatric condition with psychotic features.
* Has current diagnosis or history within 5 years of any of the following: narcolepsy, sleep paralysis, severe periodic limb movement disorder, restless leg syndrome, cataplexy, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behavior disorder, significant degree of sleep-related breathing disorder, excessive daytime sleepiness (EDS), or primary hypersomnia.
* Is at imminent risk of self-harm.
* Has a known history of stroke that may confound the diagnosis of insomnia.
* Has a clinically significant movement disorder such as akinesia.
* Has a history of hepatitis or live disease.
* Has habitual use of central nervous system (CNS)-depressants or stimulants that may be responsible for the participant's disturbed sleep.
* Has a history of malignancy, ≤3 years prior to start of study, with the exception of non-melanoma skin cancer, prostate cancer or localized carcinoma in situ of the cervix.
* Has a history of hypersensitivity to more than 3 chemical classes of drugs, including prescription and over-the-counter medications.
* Has donated blood products or had phlebotomy within 8 weeks prior to start of study.
* Has a history of trans-meridian travel within 2 weeks prior to start of study.
PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent after being informed of the clinical trial
2. Males or females 19 years of age
3. Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.

Exclusion Criteria:

1. Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
2. Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol
Cardiac Output Monitoring With Estimated Continuous Cardiac Output (esCCO) vs. Transpulmonary Thermodilution (TPTD)

The main goal of our study is to assess the accuracy and reproducibility of continuous beat-to-beat cardiac output (CO) measurement using pulse wave transit time in patients undergoing off-pump coronary artery bypass grafting.

Using appropriate statistical methods the cardiac index values obtained via pulse wave transit time with esCCO system will be compared with traditional transpulmonary thermodilution technique.

Eligibility Criteria:
Inclusion Criteria:

* Elective isolated off-pump coronary arteries bypass grafting.
* Age \> 18 years and \< 80 yrs.
* Preoperative echocardiographic ejection fraction \> 0.35

Exclusion Criteria:

* Simultaneous operation (carotid endarterectomy, ventricular aneurysm resection, etc.).
* Constant form of atrial fibrillation.
* Severe valve dysfunction.
* Peripheral vascular disease (including significant peripheral arteriopathy" which precludes the use of peripheral plethysmography).
* The surgical requirement to harvest both radial arteries.
* Intraaortic balloon pump.

Discontinuation Criteria:

* Transfer to cardiopulmonary bypass (on-pump CABG).
* The PEEP test will be discontinued before standard duration in patients with PEEP-induced profound MAP decrease below 50 mm Hg, bradycardia (\< 50/min) or CIPCA \< 1.9 l/min/m2 exceeding 1 minute.
Lung Ultrasound for Physiotherapy in Hospitalized Patients With Respiratory Complications

This study aims to evaluate the relevance of using point-of-care lung ultrasound (LUS) in modifying the physiotherapist's treatment plan for patients hospitalized in a general ward.

Hospitalized patients often confront respiratory issues stemming from diverse causes, such as pneumonia. Physiotherapists rely on a range of clinical and imaging data to inform their treatment decisions. Yet, they face challenges due to the absence of readily accessible, sensitive, specific, and reliable measurements to tailor the most effective physical therapeutic interventions based on individual clinical scenarios. Point-of-care Lung Ultrasound (LUS) holds promise in addressing these existing gaps.

This study aims to evaluate the impact of integrating LUS into clinical practice by comparing physiotherapists' initial clinical assessments and treatment plans with those made after incorporating LUS findings in patients admitted to a general ward.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in a general ward
* Acute respiratory symptoms (\< 48h)
* Chest X-ray available within 24h before or after the use of LUS

Exclusion Criteria:

* Any conditions precluding the use of LUS (thoracic skin lesions, thoracic bandage, subcutaneous emphysema)
* Inability to understand instructions due to cognitive impairment or due to language barrier