cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of PRAX-222 in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy

The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.


Eligibility Criteria:
Inclusion Criteria:

* Has onset of seizures prior to 3 months of age.
* Has a minimum weight of at least 10 kg at screening.
* Has a documented SCN2A variant through genetic testing obtained via a laboratory accredited per Clinical Laboratory Improvement Amendments (CLIA) or College of American Pathologists (CAP) or equivalent.
* Additional inclusion criteria apply and will be assessed by the study team

Exclusion Criteria:

* Has any clinically significant or known pathogenic genetic variant other than in the SCN2A gene, or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder.
* Is taking more than 2 sodium channel blocking anti-seizure medications
* Additional exclusion criteria apply and will be assessed by the study team
Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population

In adolescents, mental health problems are frequently associated with substance misuse, even considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to complicate the patient's treatment and prognosis by increasing, among others, substance use problems, reckless behaviours, relationships and school problems and suicidal thoughts. It is therefore critical to invest time and effort into developing an efficient approach to prevent and reduce substance use problems and offer these children a more global and optimal treatment.

A brief personality-targeted intervention was developed with students of Canadian and English high schools based on four personality factors known to be implicated in the vulnerability to adolescent alcohol misuse (Impulsivity, Anxiety Sensitivity, Negative Thinking and Sensation Seeking) (Conrod et al., 2006,2008, O'Leary-Barrett 2010).

By helping the adolescents to develop better adaptive behaviours, this cognitive-behavioural intervention proved to reduce binge drinking, quantity and frequency of use and substance use problems (Conrod et al., 2006,2011).

The purpose of this study is to assess the impact of this intervention if combined to a regular treatment in a youth psychiatric population.

60 patients aged 14-17 years of a Child and Adolescent psychiatric department will be screened for personality risk with self-report assessments including the Substance Use Risk Profile Scale. Participants will be randomly assigned to a personality matched cognitive-behavioural intervention or a no-intervention control.

The main outcome measures of this study are alcohol and illicit drug outcomes. Secondary measures include mental health symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Motive for psychiatric consultation
* Able to provide consent from parent/guardian for participation in the study
Determine Functions of Pinhole Glasses on the Eyes

Pinhole glasses which is using pinhole effect may induce a functional change on the eyes, including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude, CS, Visual field(VF), Stereopsis.


Eligibility Criteria:
Inclusion Criteria:

* Age : between 20 and 50 years old
* Visual acuity : correctable distant and near visual acuity by glasses up to 20/20
* Others : Normal intraocular pressure, optic discs with a healthy appearance, and normal ocular alignment.

Exclusion Criteria:

* History of systemic or topical medication that might affect accommodation
* Others : Corneal pathologic features, previous ocular surgery, glaucomatous optic discs, glaucoma, cataracts of grade II or greater, vitreous opacity, or retinal abnormalities that might limit the accuracy of test.
Internet-based Acceptance Based Psychotherapy As an Adjunct to Chronic Pain Rehabilitation

The goal of this clinical trial is to evaluate how an acceptance based internet-delivered psychological treatment (IACT) tailored to patients with chronic pain is perceived, and if it meets the needs and expectations of those enrolled.

The main question it aims to answer is:

What are the expectations of patients with chronic pain prior to IACT treatment, and how do they experience IACT during and after treatment?

Participants will be offered a 7 week long treatment with therapist support. They will be interviewed before treatment starts, once during treatment, and again after treatment is completed.

This research project aims to interview adults with chronic pain to explore their expectations before, during, and after receiving internet-based Acceptance and Commitment Therapy (IACT). IACT aims to increase accessibility to psychological treatment by overcoming geographical, economic, social, or physical barriers. The study will investigate how IACT is received and how patient expectations align with their treatment experiences. This is important because previous studies have shown that chronic pain patients' experiences with IACT vary greatly, and there is limited knowledge about their specific needs and expectations regarding internet-based psychological treatment.

Chronic pain is a widespread and challenging condition affecting approximately 20% of the population. Internet-delivered psychological treatments, such as IACT, have emerged in the past 20 years, showing promising results in managing chronic pain. However, research on patient expectations and experiences with IACT remains limited. This qualitative study will use semi-structured interviews to gather data from 10-15 adults with chronic pain. Three interviews will be conducted per participant: before, during, and after IACT treatment. Thematic analysis will be used to analyze the interview transcripts.

The IACT treatment will consist of 7 modules delivered over 7 weeks. The study's findings will hopefully contribute to a better understanding of how expectations and needs influence the treatment process and outcomes for individuals with chronic pain receiving IACT. This knowledge can inform the development and delivery of more effective and patient-centered IACT programs.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be adults with sufficient understanding of Swedish to speak and read, have internet access, and currently be a patient at the Pain and Rehabilitation Clinic in Linköping.

Exclusion Criteria:

* Severe cognitive problems, or severe mental illness such as a psychotic episode
Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous endothelial progenitor cells in patients with chronic stroke.

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous endothelial progenitor cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80 chronic ischemia stroke or patients
* With stroke history of more than 6 months, less than 60 months
* NIHSS (NIH stroke scale) score of 7 or more points
* Internal carotid artery territory infarction measured by MRI
* Can be hospitalized and signed informed consent
* With fewer effect by traditional post-stroke treatments or rehabilitations

Exclusion Criteria:

* Lacunar infarction
* Recurrent thrombotic diseases less than 6 months
* Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
* Pregnant women
* Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
* Penicillin anaphylaxis or some other drugs allergy
* Autoimmune disease
* Inaccessibility for follow up
Investigating Inter-individual Variability in Glycemic and Insulin Responses

This study aims to test the following hypothesis in healthy lean young men:

* There are differences in glycemic response (GR) and insulin response (IR) between Chinese, Malay and Asian-Indian
* There are differences in GI values to the same food between ethnic groups
* There are ethnic differences postprandial GR and IR for high vs low GI foods
* Mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition influences inter-individual glycemic and insulinemic variability
* Ethnic differences in mastication, salivary amylase activity, gastric emptying rate and gut microbiota composition determines the inter-ethnic glycemic and insulinemic variability

There is extensive evidence that numerous biological digestive factors varies between individuals and influence postprandial glycemic response (GR) and insulin response (IR), which are well established risk factors that precipitate the development of Type 2 diabetes mellitus (T2DM). However, no study to date has measured and compared physiological parameters such as mastication, salivary amylase activity, gastric emptying rates and gut microbiota in a multi-ethnic Asian population, with varying prevalence of obesity and T2DM. The aim of this study is to investigate ethnic differences in GR and IR as well as the GI values of foods. Additionally, we aim to examine how physiological digestive factors contribute to inter-ethnic and inter-individual variability in GR and IR. The study outcomes can potentially explain, in part, the varying susceptibility to obesity, T2DM and DM control between Chinese, Malays and Asian-Indians in Singapore, as reflected by the differences in prevalence of obesity, T2DM and DM control among the three local ethnic groups.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to comply with study procedures and given written informed consent
* Chinese/Malay/Indian males, aged 21-40 years old
* Body mass index (BMI) between 18.5 - 24.9 kg/m2
* Fasting blood glucose between 4 - 6 mmol/L
* Sedentary adults, with \<1 episode of exercise per week
* Not have a history of food allergies or food intolerances
* Be a non-smoker
* Drinks less than 3 units of alcohol per day
* Not taking antibiotics for the past 3 weeks

Exclusion Criteria:

* Subjects with known chronic diseases, including diabetes, untreated hypertension, renal impairment, gastrointestinal problems, and other significant medical conditions
* BMI \<18.5 kg/m2 or \>25 kg/m2
* Fasting blood glucose ≥7.0mmol/l
* Alcohol consumption \>3 drinks / day
* Use of medications known to affect glucose metabolism
* Recent changes in weight of \>5% over the past 3 months
* Significant changes in diet over the past 3 months
* History of eating disorders or irregular eating habits
* Taking antibiotics medications over the past 3 weeks
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

A preliminary Study in Subjects Undergoing Low Anterior Resection


Eligibility Criteria:
Inclusion Criteria:

1. Subject, or authorized representative, signed a written Informed Consent
2. Subject is at least 18 years of age
3. Subject is scheduled for elective open resection
4. Stapled anastomosis created within 10cm of the anal verge
5. Subject is willing to comply with the follow-up requirements of the study

Exclusion Criteria:

1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen
2. Subject has unacceptable baseline hematological results
3. Subject on chronic preoperative treatment with steroids and anticoagulants
4. Subject with elevated liver function tests
5. Subject with abnormal kidney function
6. Subject with a BMI higher than 35
7. Subject participating in any other study for either drug or device which can influence collection of valid data under this study
8. Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
9. Anastomosis was performed differently from what was defined
10. Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
11. Subject has intraoperative bleeding in excess of 500cc
12. Subject has peritoneal carcinomatosis
Remifentanil Effect-site Prediction by Algometry

This study validates the pharmacodynamic analgesic predictions (effect) given by Minto's remifentanil pharmacokinetic and dynamic model in conscious sedation. This standard model is based on the electroencephalogram (EEG) changes induced by this opioid as a proxy for describing the remifentanil analgesic effect, which might be only valid for high concentrations. Validation of the standard remifentanil model for low concentrations under sedation is needed for safer remifentanil administration.

According to pharmacokinetic and-dynamic (PK/PD) models, the proper use of anesthetics depends on the effect-sites mechanisms and the time-courses of action. This aspect is crucial for the practitioners to target the desired effect-site concentrations of the drugs (drug concentration at brain) by optimizing the drug administration using target control infusion (TCI) systems operating under these model predictions.

For more than two decades, the pharmacodynamic properties of remifentanil relied on Minto's model, which is based on processed EEG as the reference to quantify the analgesic effect and effect-site concentration estimate. This remifentanil pharmacodynamic was modeled under conditions administered to volunteers rapidly and at very high doses to induce substantial changes in the spontaneous processed EEG. The experimental concentrations and infusion rates are far from sedative levels, where the EEG has shown a clear response to hypnosis but not to analgesia or nociception.

Under the hypothesis that pharmacological models should predict equally well the effects induced by drugs at different concentrations levels, the purpose of this study is to evaluate and validate the pharmacodynamic predictions given by Minto's model in patients under conscious sedation using the algometry as a reference of nociception.

The study recruits 100 female patients scheduled for benign gynecological surgery divided into three groups. A group of 35 patients receives a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. The second group of 35 follow the same protocol with a bolus of 1 mg of midazolam before the remifentanil infusion. The rest configures the control group under saline solution.

Experimental data consist of basal algometry (pressure pain threshold) aside from BIS index, blood pressure, and heart rate values and at time-points of 1.5, 5, 10, 15, 18, 20, and 25 minutes after induction.

Minto's remifentanil pharmacodynamic model validation relies on comparing the levels and temporal evolution of the algometry measurements during the whole experiment concerning the effect-site estimations provided by the TCI-pump Minto's model.

Eligibility Criteria:
Inclusion Criteria:

* Female patients scheduled for benign gynaecological surgery
* 18-80 years old
* ASA I-III

Exclusion Criteria:

* Morbid obesity
* Conduct disorder or anxiety-depressive syndrome
* Chronic treatment with psychotropic drugs or opiates
* Pregnancy
* Alcohol abuse
* Documented allergy to remifentanil or midazolam
* Refusal to participate in the study
Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations

This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers

This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.

Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~50 years in healthy male volunteers
2. BMI is more than 18 kg/m\^2 , no more than 27.0 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter

The purpose of this study is to demonstrate the stability of blood flow with the CentrosFLO catheter, during intermittent dialysis over a period of 6 months after placement.

The CentrosFLO™ Tunneled Dialysis Catheter is a 15F dual-lumen, double-D shaped catheter similar to other "split tip" catheters in the market: outflow ("arterial") and return ("venous") lumens that separate, a subcutaneous Dacron® cuff, extension sets with clamps and caps, and construction from Carbothane® material. The CentrosFLO™ catheter contains two small pressure-relief holes near the tips.

The main difference of the CentrosFLO catheter is in the design of the tip. Current "split tip" catheters have two free ends that diverge, but are each essentially straight segments. In the CentrosFLO catheter the arterial lumen bends in an arc back towards the venous lumen, and the venous lumen bends towards the arterial lumen. As a result, the catheter has two curved surfaces that will rest against the vena cava wall to automatically "center" the catheter within the vein. The contact points of the catheter against the vena cava wall should be smaller and more disperse than with current straight-tip or split catheters. The following drawing demonstrates the design of the catheter, showing the current recommendation that the arterial port always be to the left.

The goal of the study is to demonstrate the stability of blood flow with the CentrosFLO catheter, during intermittent dialysis over a period of 6 months after placement. The investigators plan to enroll 10 patients in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are initiating or continuing in-center intermittent hemodialysis who are scheduled to receive a tunneled dialysis catheter in the right or left internal jugular vein
* The patients may have had a prior tunneled catheter for dialysis in the right IJ site.
* Patients will be expected to need use of the catheter for more than 45 days

Exclusion Criteria:

* Patients in whom the catheter is planned to be placed into the same site as an existing catheter, by over-the-wire catheter exchange
* Patients unable to give informed consent
A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 61 weeks.

The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis.

The study will enroll approximately 600 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in a ratio of 3:1:1 to receive TAK-279, placebo, or apremilast which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

1. TAK-279
2. Placebo
3. Apremilast

This multi-center trial will be conducted worldwide. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 52 weeks (1 year). There will be a safety follow-up visit 4 weeks after their last day of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Plaque psoriasis for at least 6 months.
2. Moderate to severe disease.
3. Candidate for phototherapy or systemic therapy.

Exclusion Criteria:

1. Other forms of psoriasis.
2. History of recent infection.
3. Prior exposure to TAK-279 or active comparator.

Other protocol defined inclusion/exclusion criteria apply.
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on Frutal

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFR.


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin I,II, III e IV Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Cutaneous active disease (local and/or general) which can modify the study results
* Use of new drugs and/or cosmetics during the study
* Cutaneous reactive
* Previous participation in studies using the same product in test
* Volunteer which has immunodeficiency congenital or acquired
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.