cyrilzakka/clinical-trials huggingface dataset:
First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants

This is a Phase 1, first-in-human study involving single and multiple oral doses of TS-161 in healthy male and female participants. The safety, tolerability, pharmacokinetics and pharmacodynamics of TS-161 will be evaluated.

The study includes 3 parts; Part A (single ascending dose: Cohorts 1 to 5) , Part B (single dose, cerebrospinal fluid \[CSF\] collection: Cohort 6), and Part C (multiple ascending dose: Cohorts 7 to 9). Participants will be assigned to one of the 9 Cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female participants between 18 and 55 years of age, inclusive
* Body weight ≥ 45 kg
* Body Mass Index (BMI) 18 - 30 kg/m\^2, inclusive

Exclusion Criteria:

* Significant history or presence of medical disorders or condition capable of significantly affecting the absorption, metabolism, or elimination of drugs
* History or presence of psychiatric or neurologic disease or condition
* History of seizures
* Abnormal EEG observed at screening
* Abnormal blood pressure
* Breast cancer within the past 10 years, or any other malignancies within the past 5 years
* Clinically significant abnormal results in electrocardiogram, blood and urine test
* History or presence of liver disease
* Participants using medication or supplements within 14 days prior to dosing
* Use of N-methyl-D-aspartate (NMDA) receptor modulators (example: dextromethorphan, ketamine, amantadine, memantine) within 90 days of screening
* Loss of blood or blood products in excess of 450 mL within 60 days prior to screening
* Used any investigational drug within 60 days prior to screening
* Recent history of alcohol or drug abuse
* Any participant who currently uses or has used tobacco products or nicotine-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) for one month or more prior to screening

Exclusion Criteria for Part B only:

* Significant abnormalities in lumbar spine
* History of clinically significant back pain, back pathology, and/or back injury
* History of migraines, and/or frequent, severe headaches
* History or presence of significant active bleeding or coagulation disorder or use of non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion
* Allergy to lidocaine (Xylocaine®) or related drugs
* History of adverse reaction to lumbar puncture or epidural procedure
Use of the Flipped Classroom Model With Nursing Students

This study aimed to evaluate the effect of the flipped learning model on the concept of asepsis and learning skills of nursing students. It is aimed to continue teaching the knowledge and skills regarding the subject of flipped teaching outside the classroom. Other goals include raising awareness by focusing on the student, transferring relevant learning to behavior, and students' repeated lessons with videos according to their own learning speed. In the research, students in the experimental group will be shown the principles of asepsis through videos 15 days before the normal course period, and the training will last for four weeks in total. A knowledge test will be administered before and after the training.

The flipped learning model offers students and faculty members the opportunity to teach a course other than the traditional one. It is a blended teaching method in which the activities carried out in the classroom are integrated outside the classroom and the teaching activities carried out outside the classroom are integrated into the classroom. In this model, students can access videos, presentations or recordings prepared as course materials before coming to class, through technological devices such as computers, tablets and smartphones. Students have the opportunity to watch and listen to the prepared course content wherever and whenever they want, as many times as they want. Watching as many resources as they want according to their own learning speed brings about effective and easy learning. Afterwards, when the student comes to the classroom, the information learned is reinforced by the instructor, and the areas that are not understood are solved with questions and answers. Lesson hours for students who take an active role in the classroom are also important in terms of using time effectively. The student is at the center of this learning method and the student assumes individual learning responsibility. Considering nursing education within the scope of all these beneficial results, it is obvious that effective learning will be achieved. This study aimed to help students easily adapt to the principles of asepsis.

Videos containing the principles of asepsis will be presented to the experimental group students 2 weeks before the infection control course (11/11/2023). Normal lecture and practice periods will begin between (11/11/2023-12/12/2023) and the education will last 4 weeks in total. When the study period ends, students will be given a knowledge test and then again 2 weeks later. The implementation period of the study will last until 20/12/2023.

Control group students will be educated only during the normal course. The research will be conducted with first-year students of Bilecik Şeyh Edebali University Nursing Department.

Eligibility Criteria:
Inclusion Criteria: Being a first-year nursing student and receiving training on the concept of asepsis for the first time.

Volunteering to participate in research.

Exclusion Criteria: Students who did not volunteer to participate in the research
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea

Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea symptoms after the use of antibiotics, often combined with abdominal pain, bloating and bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of AAD.


Eligibility Criteria:
Inclusion Criteria:

* occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive FMT and sign informed consent; willingness to provide stool samples.

Exclusion Criteria:

* non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed consent; unwillingness to provide stool samples.
Reliability and Versatility of Pedicled Anterolateral Thigh Flap in Reconstruction of Soft Tissue Defects

a prospective case series study for evaluation of the reliability and versatility of pedicled anterolateral thigh flap in the reconstruction of soft tissue defects as regards flap survival and complications, donor site morbidity and aesthetic outcome.


Eligibility Criteria:
Inclusion Criteria:

* All patients with clean hip, thighs or lower abdomen defects either traumatic or non_traumatic that cannot be closed primarily.

Exclusion Criteria:

* Patients with possible compromise of vascular pedicle due to previous trauma or surgery.
* Patient refusal
Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants

The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.

Approximately 48 healthy adult participants (36 participants will be on ALXN2030 and 12 participants will be on placebo) are expected to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* QTcF ≤ 450 msec at Screening and on admission (ie, on Day -1).
* Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
* Participants of Japanese descent must be between 20 and 60 years of age.
* BMI within the range 18-32kg/m2 (inclusive) at Screening.

Exclusion Criteria:

* Current or recurrent disease
* Current or relevant history of physical or psychiatric illness.
* Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
* Female participants who are pregnant or breastfeeding.
* Major surgery or hospitalization within 90 days prior to dosing on Day1.
* History of allergy or hypersensitivity to an oligonucleotide or GalNAc moiety or any excipients of ALXN2030.
Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial Protocol

Acute ischemic stroke (AIS) patients with basilar artery occlusion (BAO) present a devastating, life-threatening prognosis.

Urgent recanalization with endovascular mechanical thrombectomy is routinely performed in patients with BAO although the level of evidence is lower than that in anterior circulation occlusions (randomization in this population versus medical treatment alone having been impossible in recent studies). Recently, a large retrospective study supports the interest of thrombectomy in this population .

Speed and grade of the recanalisation have a major impact on clinical outcome. Favorable outcome at 90 days is strongly associated with the successful recanalization status at the end of the endovascular procedure (OR=4.57, 95%CI=1.24-16.87, P=0.023).

First pass effect has been shown to be a strong marker of efficacy of endovascular procedure with significant correlation with clinical outcome.

Thrombectomy with Stent retrievers dramatically changed the prognosis of anterior circulation large vessel occlusion strokes and currently used in BAO patients (posterior circulation). Contact aspiration (CA) is currently used in anterior large vessel occlusions (COMPASS trial, Lancet 2019), with similar rates of recanalization and favorable outcomes (Boulanger M, 2019), as well as in BAO patients .

However, the benefit of CA compared to SR for the treatment of BAO remains under debate with the superiority of first line CA compared to SR or no difference. Available data are based on retrospective studies with no data from RCT.

In this context, a randomized controlled trial is needed to assess the benefit of CA versus SR.


Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years

* AIS with BAO on non-invasive imaging (CT or MRI)
* Eligible for thrombectomy : groin puncture undergone within 24 hours of first symptoms or of last time the patient was seen normal
* Being covered by a national health insurance
* Informed consent obtained from the patients/his proxy or following an emergency procedure

Exclusion Criteria:

* Known or suspected pre-existing (chronic) large vessel stenosis / occlusion in the symptomatic territory (basilar artery)
* Severe contrast medium allergy or absolute contraindication to use of iodinated products
* Clinical history, past imaging or clinical judgment suggesting intracranial stenosis of the basilar artery
* Pregnancy (urine or serum beta HCG test for women of child-bearing potential)
* Person deprived of liberty
* Patient benefiting from a legal protection (guardianship or curatorship)
Effect of Sevelamer on P-cresol Levels in CKD

The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years,
* CKD stage 3-5

Exclusion Criteria:

* Existing or previous treatment within the last 1 year with a phosphate binder;
* hyperphosphatemia (\>5.6 mg/dL);
* hypophosphatemia (\<2.5 mg/dL);
* malnutrition,
* malignant neoplasms,
* current history of gastrointestinal and/or endocrine diseases.
A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases

The purpose of this study is to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild allergic diseases. Eligible subjects will be randomized to the YH35324 group, the placebo group, or the omalizumab group.

YH35324 is a drug under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 has a high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophil, thereby inhibiting histamine release caused by degranulation when exposed to allergens Based on its non-clinical study results, this study aims to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or subjects with mild allergic diseases.

Eligibility Criteria:
Inclusion Criteria:

* 19\~55 years old, Atopic Healthy Subjects or Subjects With Mild Allergic Diseases
* Serum total IgE level of 30 to 700 IU/mL or \> 700 IU/mL
* Signed the informed consent form

Exclusion Criteria:

* Hyperimmunoglobulin E syndrome or malignancy
* Positive drug screen result
* AST or ALT \> 1.5 \* Upper normal range
* eGFR \< 60mL/min/1.73m2
* Allergy immunotherapy initiated or Administration of a live vaccine within 3 months prior to randomization
* History of participation in another clinical trial within 6 months prior to randomization
Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial

The purpose of this study is to determine whether using an additional 48 hours of oral naproxen, after other post-operative pain medications have been stopped, will be effective in reducing opiate pain medication requirements and contribute to improved pain management.

At St. Joseph's Healthcare Hamilton, the Acute Pain Service (APS) is responsible for the immediate post-operative pain management of many surgical inpatients. While cared for by APS, the patient receives multimodal analgesia, including adjunctive medications (acetaminophen and naproxen/ketorolac) scheduled around the clock. When APS discontinues the epidural/pain pump, all adjunctive medications are discontinued and the patient is usually started on 'as needed' opiate or combination opiate (i.e. Tylenol#3) medications. On occasion, APS will write an order for an additional 48 hours of naproxen, but this practice has not been formally evaluated at this site. This randomized, placebo-controlled study proposes to evaluate this bridging strategy to see if regularly scheduled naproxen after discontinuation of other post-operative medications will affect the daily doses of opiate pain medications used, side effects of those opiate medications and pain scores of patients.

Eligibility Criteria:
Inclusion Criteria:

* undergone Head \& Neck and Thoracic surgery
* admitted to Chest, Head and Neck or Step-Down at St. Joseph's Healthcare
* pain management by APS (epidural/pain pump) including naproxen/ketorolac
* able to take oral medications (by mouth, feeding tube or NG tube)
* reasonably able to communicate in English and provide consent

Exclusion Criteria:

* pre-existing chronic pain (morphine equivalent doses over 200mg/day in 5 days previous to surgery)
* recovering from cardiac, urological, orthopedic, laparoscopic or ambulatory surgery
* chronic NSAID therapy (daily for more than 3 weeks or high dose (over 81mg) ASA at least 4 days/week for more than 3 weeks)
* pregnancy, diagnosis of sepsis, history of stroke or transient ischemic attack, CHF (NYHA 3 or 4), allergy or contraindication to NSAIDS as defined by APS protocol
GADD34 and Type I IFN Response Genes in SLE

GADD34 (Growth Arrest and DNA Damage inducible-protein) is a regulatory subunit of PP1 (phosphatase 1) phosphatase which dephosphorylates eIF2alpha (eucaryotic initiation factor 2 alpha subunit), representing a negative feedback loop of the unfolded protein response (UPR). Moreover, GADD34 is necessary for type I interferon (IFN) production in response to viral infection in murine models. We investigate here the expression of GADD34 in systemic lupus erythematosus (SLE), in which type I IFN has an important pathogenic role.

We report a case-control study on GADD34 gene expression in PBMC (peripheral blood mononuclear cells) of SLE patients (n=60) and age- and sex-matched healthy controls (n=30). The level of GADD34 gene expression, as well as of type-I IFN response genes in PBMC is measured by quantitative PCR.


Eligibility Criteria:
Inclusion Criteria:

* Man and woman over 18 years old.
* Patients suffering from SLE (SLICC criteria)
* Patients having given their "Non-opposition"
* Patients with social security affiliation (required in France)

Exclusion Criteria:

* Patients suffering from other auto-immune disease (except SAPL, thyroiditis, and Gougerot Sjogren syndrome)
* Patients with viral infection within 15 days
* People with special protection (defined in articles L1121-§5-8 and articles L3212-§1-3 of French health care law)
High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty

The study is designed to test the hypothesis that high dose candesartan treatment compared to quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent angioplasty in peripheral occlusive artery disease.

Patients are randomly assigned to treatment with either candesartan 32 mg/d or Quinapril 20 mg/d before the angioplasty. Walking distance, intima media thickness and crurobrachial pressure ratios are compared after 6 weeks, 3 months and 6 months. After 6 months an angiographic control is performed.

Eligibility Criteria:
Inclusion Criteria:

* male and female
* peripheral occlusive arterial disease Stad IIb Fontaine classification

Exclusion Criteria:

* patients with lesions not available for PTA
* renal insufficiency
* patients on calcium-antagonists
Effects of Sensory and Motor Deprivation on Brain Plasticity

Investigation of changes in gray and white matter during immoblisation after injury of the right upper extremity via two MR Investigations of the brain at two different times.

Investigation of changes in gray and white matter during immoblisation after injury of the right upper extremity via two MR Investigations of the brain at two different times. Immobilisation at least 12 days. Time between the 2 investigations: 12-14 d.

Eligibility Criteria:
Inclusion criteria:

* Right handed
* Injury of right upper extremity where immobilisation is needed

Exclusion criteria:

* TBI, neurological or psychatric deseases
* Other cerebral deseases
* Standard MRI Exclusion criterias such as pacemaker, epilepsia etc
ACT for the Home Management in Malagasy Children

The purpose of this study is to assess the feasibility, the acceptability and the effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home management of presumed malaria in Malagasy children by the community-based service providers.

Primary objective

To assess the feasibility, the acceptability and the effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home management of presumed malaria in Malagasy children by the community-based service providers

Secondary objectives

To assess the reliability of the use of the malaria rapid diagnostic tests (RDT) by the community-based service providers in the Malagasy home management strategy

To assess the frequency of short-term and long-term side effects of the Artesunate + Amodiaquine Fixed Dose Combination used for the home management of presumed malaria in Malagasy children by the community-based service providers

To assess the real burden of the malaria in children under the age of five years in 2 different epidemiological strata of Madagascar (central highlands and equatorial strata)

Type of study

Follow-up of a cohort of 1200 children under the age of five years during 1 year

Studied population

All children under the age of five years (2 months to 5 years) having fever and consulting the community-based service provider, residing in the zone covered by the community-based service provider throughout the entire follow-up period Investigators Four community-based service providers, four field physicians and two supervisors number of district: 2 (Moramanga and Manakara)

condition: fever intervention: artesunate + amodiaquine phase: phase IV

Eligibility Criteria:
Inclusion Criteria:

* All children under the age of five years (2 months to 5 years) having fever and consulting the community-based service provider, residing in the zone covered by the community-based service provider throughout the entire follow-up period, having signed an informed consent

Exclusion Criteria:

* Children with no informed consent
The Value of the Trendelenburg Position During Routine Colonoscopy: A Pilot Study.

Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at the tip, through the colon. The insertion process can be difficult in some patients, resulting in an uncomfortable and lengthy procedure.We postulate that raising the foot of the bed so that the stretcher forms a 15 degrees angle with the floor ("Trendelenburg position") may make the colonoscopy easier and more comfortable to the patient.

Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at the tip, through the colon. The insertion process can be difficult in some patients, resulting in an uncomfortable and lengthy procedure. Colonoscopy procedures are typically started with the patient positioned on their left side. If there is later difficulty advancing the colonoscope, the patient is shifted to other positions (e.g. back, right side, prone). We postulate that raising the foot of the bed so that the stretcher forms a 15 degrees angle with the floor ("Trendelenburg position") may make the colonoscopy easier and more comfortable to the patient. This is a position commonly used in gynecologic surgery. This is a pilot project for us to gain experience with doing colonoscopy this way. The enrolled patient will be assigned randomly to 2 groups: one in the standard left lateral position and one in the 15 degree Trendelenberg position. We will be collecting data regarding the procedure from each group in the form of questionnaire and data sheet which will be filled during or at the conclusion of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient age between 18-75 years old.
* Colonoscopy performed for polyp surveillance or colon cancer screening purposes.
* Patient able to provide informed consent.

Exclusion Criteria:

* History of colon resection
* History of inflammatory bowel disease
* Pregnancy
* History of ischemic optic neuropathy or glaucoma
* Patient unable to provide informed consent
* Patients who did not fast for ≥2 hours prior to presenting for the procedure
Celiac Disease Database

The focus of this study is to create a database containing information about patients with celiac disease. This database will allow us to examine clinical and epidemiologic features of the University of Chicago Medical Center patient population. We have the largest population of patients with celiac disease in the mid-West and as such this study using information gathered from our database can greatly contribute to our current understanding of this disease.

This database will allow us to examine clinical and epidemiologic features of the University of Chicago Medical Center patient population.

Eligibility Criteria:
Inclusion Criteria:

* Must be a patient at The University of Chicago Medical Center
* Clinical diagnosis of celiac disease or gluten sensitivity

Exclusion Criteria:

* Currently being treated at a healthcare facility other than The University of Chicago Medical Center
* Not diagnosed with celiac disease or gluten sensitivity