cyrilzakka/clinical-trials huggingface dataset:
The Use of QST to Characterize Somatosensory Functionality

Pain has a significant impact on quality of life and poses an enormous burden on the healthcare system. The subjective nature of pain complicates its mapping and treatment. Quantitative Sensory Testing (QST) aims to characterize the somatosensory phenotype using calibrated stimuli and subjective thresholds. This set of procedures enables quantification of the somatosensory function in small fibers (thinly myelinated Aδ and unmyelinated C), as well as large fibers (thickly myelinated Aβ). In this way, sensory loss (hypoesthesia, hypoalgesia) or sensory gain (hyperesthesia, hyperalgesia, allodynia) can be detected.

In this study, the inter-period reproducibility of thirteen QST parameters will be determined on the dominant hand, right forearm, right flank and lower back of 20 healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent has been obtained prior to any screening procedures.
* Subject is ≥ 18 years and ≤ 25 years of age.
* Subject is a non-smoker for at least 6 months before the start of the study.
* Subject has a body mass index (BMI) between 18-30 kg/m².
* Subject is in good general health, based on medical history and vital signs.

Exclusion Criteria:

* Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study, including conditions which affect the normal somatosensory functionality.
* Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand, right forearm, right flank or lower back which, in the investigator's opinion, might interfere with the study assessments.
* Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a user of drugs, or has a history of alcohol and/or drug abuse.
* Subject is unable to refrain from drinking caffeinated beverages 24 hours prior to each study visit.
* Subject has used concomitant drugs and/or treatments that may interfere, in the investigator's opinion, with the study results.
* Subject is in a situation or has a condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study.
* Female subject who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and is not using an adequate contraceptive method.
* Subject is participating in another trial which, in the investigator's opinion, might confound the results of the study.
A Research in Pharmacogenomics and Accurate Medication of Risperidone

Risperidone is a selective monoamine receptor antagonist. It plays an antipsychotic effect by antagonizing 5-HT2 / D2 receptor. As a second-generation antipsychotic drug, risperidone is metabolized to 9-hydroxy Risperidone in the body very quickly. There are individual differences in the pharmacokinetics and pharmacodynamics of risperidone. For example, CYP2D6 genotype can greatly affect the metabolism of risperidone, and provide evidence for adjusting the type and dose of medication to treat Schizophrenia. In this study, we will verify the correlation between the polymorphisms of genes related with risperidone drug metabolites, drug transporters, drug targets and drug metabolism, pharmacodynamics, adverse reactions in Chinese population, providing basis for clinical rational use of risperidone.

Subjects with schizophrenia will be recuited from several sub-centers. The relevant gene polymorphisms and risperidone drug metabolism, drug adverse reaction parameters are monitored through drawing blood samples at 0h, 6h, D27 and D56 of the risperidone drug administration. Information related to drug pharmacokinetics, pharmacodynamics and adverse reactions(serum prolactin levels) will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients that meet with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychiatric Interview (MINI);
* patients who have never received risperidone treatment or who need re-administration of risperidone after previous treatment with risperidone;
* Subjects and / or their guardians who agree to sign the informed consent.

Exclusion Criteria:

* patients who use CYP2D6 or CYP3A4 inducers or inhibitors as treatment drugs;
* patients with hepatic insufficiency;
* patients with renal insufficiency;
* patients who use other drugs that interact with risperidone;
* certain patients that the researchers consider to be unsuitable for the clinical trail.
Spinal Cord Stimulation for Intractable Mononeuropathy

Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large randomized controlled trial (RCT) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the "Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials" (IMMPACT) guidelines, and assess the stimulation paradigm preferences in these patients.

Objective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done.

Study design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus Medical Centre.

Study population: 12 patients suffering from intractable peripheral mononeuropathic pain.

Intervention: Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months.

Main study parameters/endpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG)
* Symptoms refractory to conventional medical management for at least 6 months according to treating physician
* 18 years or older
* Pain score on numeric rating scale (NRS) of at least 5 (average pain intensity in week prior to assessment)
* Stable or absent concomitant analgesics

Exclusion Criteria:

* Mononeuropathy located in the head or torso
* Mononeuropathy by avulsion at the plexus brachialis
* Life expectancy \<1 year
* Anticoagulant drug therapy or disturbed coagulation
* Immune-compromised patients
* Pregnancy
* Lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s)
* Patients with psychological factors or addiction that require treatment
Evaluating of New Screening Tool for Arthritis* in Psoriasis

This study evaluates a new screening tool for arthritis in psoriasis and compares its reliability with well-known screening tool (TOPAS 2).

Early diagnosis and treatment of PsA may prevent destruction in joints.Our aim is to create a simple and user friendly screening tool that can be used by dermatologists in out patient clinics.

A question pool will be created from a review of the literature and expert opinions from a physicians experienced in rheumatology and dermatologists .Psoriasis patients will answer these newly created questions. All patients will be examined by dermatology and also physical therapy and rehabilitation-rheumatology experts. The diagnosis of psoriatic arthritis (PsA) will be made by CASPAR (Classification criteria for psoriatic arthritis) criteria and ASAS (Assessment of Spondyloarthritis International Society) criteria for spondyloarthritis. Synchronously patients will be asked for to reply Turkish version of well known questionary named TOPAS 2. According to the results of collected data, statistically best matched questions will be selected for Turkish population. Also, the reliability of TUPAST (Turkish PsA Screening Tool) and TOPAS 2 (Toronto Psoriatic Arthritis Screen II) will be compared statistically.

Eligibility Criteria:
Inclusion Criteria:

* Psoriasis confirmed by dermatologist

Exclusion Criteria:

* Unable to consent and understand
* Known other rheumatological disease
The Effect of Spinal Flexion in the Lateral Decubitus Position on the Unilaterality During Spinal Anesthesia

For unilateral spinal block, spinal local anesthetics should take effect on the spinal nerves of one side. With full flexion of the spine, the cauda equina becomes tightened and hangs in the middle of the subarachnoid space. This study was performed to assess if flexion of the vertebral column facilitates unilateral spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status Ⅰ-Ⅱ, scheduled for elective knee arthroscopy under spinal anesthesia

Exclusion Criteria:

* Hemodynamically unstable patients
* Lumbar disease
* patients with back pain
Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction

This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients.

Part two: To investigate the effect of CHIP on cardiovascular outcomes in patients with AMI complicated with CKD stage II-IV nephropathy. Part three: To investigate the effects of CHIP on cardiovascular and renal outcomes in AMI patients with ESRD. Study endpoint: Primary end points: all-cause death, cardiac death, and nonfatal myocardial infarction. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure.

This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients.

Patients with confirmed AMI were divided into two groups based on eGFR values:

AMI+ normal renal function group (eGFR≥90 ml/min); AMI+ renal dysfunction group (eGFR \< 90 ml/min). Main outcome measures: CHIP carrying frequency, expression levels of IL-1β, IL-6, CRP, TNF-α, NLRP3 and other inflammatory factors.

Part two: To investigate the effect of CHIP on cardiovascular outcomes in patients with AMI complicated with CKD stage II-IV nephropathy. Patients with confirmed AMI complicated with CKD stage II-IV were divided into two groups according to CHIP sequencing results: CHIP group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identifi ed as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Study endpoint: Primary endpoints: all-cause death, cardiac death, nonfatal myocardial infarction,50% decrease in eGFR, or ESKD. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure. Part III: To investigate the effects of CHIP on cardiovascular and renal outcomes in AMI patients with ESRD. Patients with confirmed AMI combined with ESRD were divided into two groups according to CHIP sequencing results: CHIP group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Study endpoint: Primary end points: all-cause death, cardiac death, and nonfatal myocardial infarction. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with AMI received PCI.

Exclusion Criteria:

patients with severe heart disease, severe liver and kidney insufficiency, pregnancy, etc.
Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study

The primary objective of this study is to evaluate the feasibility of a novel app to facilitate heart failure patients to acquire lung ultrasound images and evaluate the quality of those images to expert scans, and to evaluate for relationships between the ultrasound data and pulmonary pressure data from the Abbott CardioMEMS system.

Feasibility study to compare an investigational Artificial Intelligence (AI) Auto B-line tool measurement on Lung Ultrasound (US) images acquired with an AI assisted guidance tool by novice ultrasound clinicians and heart failure (HF) patients, to standard of care heart failure monitoring of pulmonary artery pressure measured by the Abbott CardioMEMS system.

Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of heart failure at least three months prior to the date of consent
2. HF currently managed with the Abbott CardioMEMS device
3. Able to read and write in English.
4. At least 18 years of age or older on the date of consent.
5. Willing and able to provide written consent to participation
6. Expressed willingness to capture AI assisted US recordings immediately before or after taking their CardioMEMS measurements
7. Access to WiFi or cellular data connection at home
8. In the opinion of the investigator or delegate the subject, must be capable of complying with study procedures.

Exclusion Criteria:

1. Previous experience using an ultrasound device on themselves or others
2. Women who are pregnant or plan to become pregnant during the study
Development and Validation of a Theoretical Test for Chest Tube Insertion

The goal of the proposed study design is to develop and gather validity evidence of a theoretical test about cognitive skills which are important when performing Chest Tube Insertion (CTI). This study consists of two parts:

* The development of the theoretical test and its items. The test content will be based on a broad literature search, and on semi-structured interviews with content experts.
* The subsequent collection of validity evidence for this theoretical test and final selection of the test items, by testing groups that differ based on their expertise. The item analysis and observed difference in mean score between the groups will provide the validity evidence.


Eligibility Criteria:
Inclusion Criteria:

* Content experts will be recruited from the departments of surgery, pulmonology, and emergency medicine of various hospitals in Flanders and the Netherlands. They must have finished their residency training and be actively involved in training of junior physicians. A maximum of six experts will be recruited, and a minimum of one physician from each department will be included.
* The novice group will attract medical students at Ghent University, within their 5th or 6th year of undergraduate training, while having no experience with CTI.
* The intermediate group will include residents of the departments of surgery, pulmonology and emergency medicine of Ghent University Hospital, within their 1st - 3rd year of residency training and must have placed less than 20 chest tubes themselves.
* The experienced group will be recruited from the departments of surgery, pulmonology, and emergency medicine of Ghent University Hospital. They must have finished the residency training in their respective fields and must have performed more than 20 CTI independently. The content experts will not be eligible for participation.

Exclusion Criteria:

* For the novice and intermediate group: having to much experience in CTI.
Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

There has been an increase in ambulatory surgical procedures performed across Canada; ambulatory procedures account for almost 70% of all surgeries. Postoperative nausea and vomiting (PONV) and pain are the most frequently reported adverse events by patients prior to discharge after ambulatory surgery. The incidence can be as high as 70 to 80% in high-risk patients.

PONV is a cause of morbidity particularly in gynecological procedures and the incidence of patients experiencing PONV is as high as 58-75%. Apart from delayed recovery, the occurrence of PONV has been linked to gastric aspiration, psychological distress and wound dehiscence. The occurrence of PONV delays patient discharge and further more is a leading cause of unexpected admission after ambulatory anesthesia

Promethazine, is an antiemetic medication that has been widely used over the last 50 years, and although effective at reducing PONV, it tends to cause sedation. In this study, we are trying to determine if a smaller dose of promethazine, in addition to the standard treatment for post-surgical nausea and vomiting, will be more beneficial than the standard treatment on its own.

It is hypothesized that the use of low dose promethazine (3 mg) as part of a multimodal antiemetic regimen will be efficacious in preventing PONV without the sedative effects of promethazine.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is between 18 - 60 yrs of age

2 Patient's health is graded as class I-III according to the American Society of Anesthesiologists physical status classification.

3. The patient has 2 or more of the following risk factors:

* Female
* Non-smoker
* History of PONV/motion sickness
* Use of post-operative opioids (current surgery)

  4. Undergoing ambulatory gynecological laparoscopic procedures of at least 30 minutes duration

Exclusion Criteria:

* preexisting nausea, vomiting or retching, gastric outlet or intestinal obstruction
* clinical evidence of a difficult airway
* obesity (body mass index \> 40 kg m-2)
* scheduled to receive propofol for anesthesia maintenance
* current pregnancy
* psychiatric illness
* clinically significant major organic disease
* preoperative QTc interval \> 440 ms on electrocardiogram
* known hypersensitivity to promethazine, granisetron, ondansetron or other 5 HT3-receptor antagonists
Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis

The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (\< 3 cm) hepatocellular carcinoma for patients with cirrhosis.

With the improvement of cirrhosis complications coverage, hepatocellular carcinoma (HCC) tend to become the main cause of mortality for cirrhotic patients. Currently, the incidence of the HCC increase in occidental country and hid global prognostic remain very bad. The main indication factor for a curative treatment is the size lesion.

Cirrhosis is the main risk factor for HCC occurence. In France, HCC screening has been establish for cirrhotic patients with hepatic ultrasound and alfa-fetoprotein measurement with the aim of detected HCC when the size allows a curative treatment.

When a nodule is discovered during the follow-up, HCC diagnosis is done following the recommendations of European Association for the Study of the Liver (AESL) in 2000, updated by the American Association for the Study of Liver Diseases (AASLD)in 2005. Diagnostic is function of nodule feature on one or two enhanced imaging techniques among CTscanner, MRI and enhanced contrast ultrasound.

This diagnostic strategy raises several questions. First, neither the most efficient dynamic imaging association for nodules from 1 to 2 cm, nor the most efficient imaging examination for nodules from 2 to 3 cm are known. Second, only few studies have been carried out about imaging semiology of the small hepatocellular carcinoma. Thus, the imprecisions of the present recommendations regarding the choice of the best examination technique and the difficulties in the diagnosis of benign or malignant nature for small nodule can lead to a bad management of these patients.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 hears
* presence of one or several nodules \< 3 cm
* known or suspected cirrhosis

Exclusion Criteria:

* psychiatric disease
* contraindication to one of the 3 imaging examinations (CTscanner, MRI, enhanced contrast ultrasound
* patient already treated by chemoembolization
* recurrence on the coagulation zone of a nodule already treated by per-cutaneous tumour destruction
* presence of a tumour (\> 3 cm) associated to the nodule
* pregnant woman or breast-feeding woman
Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease

An adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. However, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome. Therefore, we want to study the effects of a 35-day inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites and immune cell states in chronic kidney disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Men and women in a ratio of 1:1
* Age 18-75 years
* Body mass index 25.0 - 39.9 kg/m\^2
* End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months

Exclusion Criteria:

* Malignant diseases
* Recent or current hospitalization
* Postoperative phase
* Acute infections
* Malnutrition
* Antibiotic treatment within the last 4 weeks
* Regular intake of probiotics and/or prebiotics
* Change of body weight of more than 2 kg in the month prior to study entry
* Known drug or alcohol abuse

Changes applied in July 2022 according to amendment no. 1:

* Two inclusion criteria were changed to improve recruitment

  * Age range was changed from 18-70 to 18-75 years
  * BMI range was changed from 18.5 - 34.9 to 25.0 - 39.9 kg/m\^2
* The intervention scheme was adapted to increase patient adherence

  * A 7-day adaption phase with half of the dose (15 grams per day) at the start of the intervention was introduced, changing treatment duration from 28 to 35 days

Changes applied in January 2024 according to amendment no. 2:

* One inclusion criteria was changed to improve recruitment

  * BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m²
* Last visit was brought foward by 4 weeks.
Nurse Practitioner Led Implementation of Team Huddles in Long-Term Care Homes

A pre-experimental design to conduct a process evaluation and to compare the outcomes after implementing team huddles for the intervention and control groups.

Staff working in long-term care (LTC) homes during COVID-19 frequently reported lack of communication, collaboration, and teamwork, all of which are associated with staff dissatisfaction, health concerns, perceived of lack of support and moral distress. The purpose of this study was to introduced regular huddles, led by a Nurse Practitioner, to support LTC staff during COVID-19. The objectives were to evaluate the process of huddle implementation and to examine differences between staff attending and not attending the huddles on outcomes of moral distress, job satisfaction, perceived support from the Nurse Practitioner, and health and mental health. Furthermore, we hypothesize that regular huddles can lead to improvements in resident-centred care and resident outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All staff working at the LTC home
* All residents living in the home between January and December 2021

Exclusion Criteria:

* N/A