cyrilzakka/clinical-trials huggingface dataset:
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab.

Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months.
* Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥12.
* Have ≥10% body surface area (BSA) involvement.
* Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) or overweight (BMI ≥27 to \<30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2DM).

Exclusion Criteria:

Medical Conditions

* Have Type 1 Diabetes Mellitus (T1DM).
* Have insulin-treated Type 2 Diabetes Mellitus (T2DM).
* Have a prior or planned surgical treatment for obesity.
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
* Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis).
* Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions:

  * basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years.
  * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization.
* Have serious disorder or illness other than PsO.
* Have a history of chronic or acute pancreatitis.
* Have any prior use of ixekizumab or tirzepatide.
* Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.
Role of Osteocytes in Myeloma Bone Disease

Progress in the treatment of myeloma and myeloma bone disease has substantially increased overall survival, but relapse is inevitable and better treatment is needed. The bone microenvironment is tremendously complex, so that targeting single interactions between tumor and bone is unlikely to be effective. Treatments need to block centrally important, multifunctional pathways. The investigators data point to a central role of the osteocyte to induce heparanase, a multifunctional mediator of myeloma bone disease. Increased heparanase due to FGF23 may make systemic inhibitors of heparanase less effective in bone than elsewhere. FGF23 neutralizing antibodies have been developed for non-cancer conditions of FGF23 excess, such as chronic kidney disease (Shimada \& Fukamoto, 2012), and could be used in MM alone or in combination with heparanase inhibitors. Complete neutralization of FGF23 has adverse effects, but neutralization of FGF23 excess may be practical, or in the future, suppression of excess FGF23 biosynthesis by osteocytes.

The investigators hope to determine serum FGF23 and heparanase, Dkk1 and plasma klotho levels in patients with newly diagnosed and relapsed myeloma compared to healthy controls with this exploratory study.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years but ≤ 95 years at the time of consent
2. Subjects must be English-speaking
3. Must voluntarily sign the most current informed consent and HIPAA documents prior to study participation.
4. Have no prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers can also be enrolled as healthy volunteers.
5. Have no known liver or kidney disorders

Exclusion Criteria:

1. Pregnant females will be excluded from the study.
2. Subjects allergic to xylocaine will be excluded.
3. Subjects with an acute illness (Ex. upper respiratory infection, viral illness) in the past seven days will be excluded.
4. History of bleeding disorders.
5. Subjects deemed incompetent by treating physician
6. Institutionalized, mentally disabled subjects
7. Subjects who are prisoners
Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.

This is a single site, single-blind, randomized trial with three experimental conditions tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07 nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study will examine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted (e.g., little cigars, large cigars, pipes) and/or non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers, dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing products. Toxicant exposure across the three conditions will also be examined.

Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who are at least 18 years of age with a history of regular smoking for at least 1 year and no serious quit attempts in the last 3 months
* No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications.
* Subject has provided written informed consent to participate in the study

Exclusion Criteria:

* Regular use of tobacco products (including e-cigarettes) other than cigarettes
* Regular use of nicotine replacement or other tobacco cessation products for purpose of quitting.
* Pregnant or breastfeeding (due to toxic effects from tobacco products).
* Planned quit date within the next two months.
* Does not have a way that the research team can communicate with them by phone or e-mail.
* Not able to read and write English well enough to complete study activities without translation.
Simulator Based Powered Mobility Training of Children With Special Needs

This study compared conventional powered mobility practice to simulator based practice of children with special needs aged 6-18 years.

This study compared conventional powered mobility practice to simulator based practice of children with special needs aged 6-18 years.

The study has 3 stages: 1) Simulator validity study 2) Powered mobility outcome measures reliability and validity for children 6-18 years 3) Intervention study to compare simulator based practice and powered mobility practice.

1. Simulator validity study included 30 children aged 6-18 years, proficient powered mobility drivers. All participants had physical disabilities- CP or Neuromuscular conditions.
2. This stage included the first 30 children from the intervention study. Data for the study was based on the first evaluation out of the two evaluations in the study.
3. This stage included 36 children aged 6-18 years in need of powered mobility practice to become a proficient driver. The particpants were divided into two groups- experimental (simulator based practice) and control group (standard powered wheelchair practice).

Eligibility Criteria:
Inclusion Criteria:

* Children with a physical disability that are not proficient powered mobility driver
* Children that can use a joystick

Exclusion Criteria:

* Children with visual accuracy limitations that cannot be corrected with glasses or contact lens;
* Children who have a severe intellectual and developmental disability as defined by the Israel Ministry of Welfare's index for intellectual and developmental disabilities and reported by parents; Children that have a unstable medical conditions that prevent them from participating in powered mobility training (e.g., epilepsy)
* Children that can operate a powered wheelchair via switches or a scanning device.
A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for this study.


Eligibility Criteria:
Inclusion Criteria:

1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
2. Age: 18 - 75 years old
3. No prior systemic anti-cancer therapy for advanced HR+ disease.
4. Eastern Cooperative Oncology Group \[ECOG\] 0-1

Exclusion Criteria:

1. Patients who received prior treatment with any CDK4/6 inhibitor.
2. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke

This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.

There is emerging evidence regarding the increased risk of perioperative stroke in patients with PFO, leading to an important clinical practice question: whether PFO should be considered in the perioperative risk assessment in non-cardiac surgery patients. The evidence base, however, comes from retrospective studies with numerous limitations.

Patients referred for general, orthopedic, urological, gynecologic, spinal, or thoracic surgery will be screened and consented during the surgery pre-admission clinic visit, and then undergo PFO screening using transcranial Doppler (TCD) and transthoracic echocardiography (TTE). Patients screened PFO+ (n=102) and matched PFO- controls (n=102) will have DW-MRI between postoperative days 2 and 7. Study personnel will conduct phone surveys at 30-day and 1-year post-surgery to collect data on other clinical outcomes. Patients will also be administered cognitive and patient-reported outcome measures assessments before enrollment, and 30-day and 1-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. patients 18 years and above;
2. referred for an elective, non-cardiac, non-vascular and non-brain surgery;
3. with an estimated hospital length of stay ≥2 days. We will include patients referred for general, orthopedic, urological, gynecologic, spinal or thoracic surgery.

Exclusion Criteria:

1. patients in need for long-term, perioperative anticoagulants;
2. those with comorbidities that potentially increase the risk of perioperative stroke;
3. contraindications to MRI;
4. unable to complete or adhere to the study.
The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate

Gastroesophageal(GERD) reflux disease is a very common problem among pediatric population and has be proved to contribute in numerous otolaryngological manifestations. Trails of empirical treatment of antireflux medications is often used as a diagnostic test. However, the investigators believe GERD can cause rhinitis and nasal obstruction. Nasonex is considered as first line treatment for nasal obstruction. Hence, the proposed study aims to define the relationship between GERD and rhinitis using randomize control trial where one group of patients will receive nasonex and placebo, while the other group will receive nasonex and antireflux medications.

The proposed study is a randomized controlled trial in which children with nasal obstruction will be randomized to receive either antireflux medication lansoprazole (prevacid) and mometasone furonate (nasonex) or only nasonex and placebo. The diagnosis of nasal obstruction will be made by history and physical examination.

The study will take place at Montreal children's hospital. After the patients or parents of the patients agree for their children to take part in the study and sign a consent/assent form, baseline information will be collected and the patients will asked to fill out three questionnaires for GERD symptoms and nasal symptom. After that eligible patients will undergo sinus x-ray, nasal endoscopy and allergy skin test (these test are routine performed for all patients with symptoms of nasal obstruction). Then the patients will further be sub-divided into two groups based on the allergic skin prick test (SPT); allergy positive and allergy negative group. In each group patients will randomly allocated to one of the two study arms; group A will receive lansoprazole (prevacid) and mometasone furonate (nasonex) and the other group will receive nasonex and placebo. The lansoprazole/placebo will be discontinued after 3 months and the patients will undergo nasal endoscopy and will be asked to fill out the three questionnaires again to assess the improvement. The patients will be follow for another 3 months, the patients will again undergo nasal endoscopy and will asked to fill out the three questionnaires to assess the improvement and sustainability.

Eligibility Criteria:
Inclusion Criteria:

* 7 (seven) to 17 (seventeen) years of age.
* Nasal obstruction as main complaint.

Exclusion Criteria:

* Structural cause of nasal obstruction (deviated nasal septum, adenoid hypertrophy, nasal polyps, nasal tumors)
* Received antireflux medication during the last three months.
* Acute sinusitis
A Comparison of the Effects of Krill Oil and Fish Oil Supplementation on Muscle Function in Older Adults

The aim of the study is to compare the effects of Krill Oil and Fish Oil supplementation on muscle function in older adults. The secondary aim is to investigate the mechanisms underlying the beneficial effects previously observed.


Eligibility Criteria:
Inclusion Criteria:

* Older adults (aged 60 years or older). BMI less than 30kg/m2

Exclusion Criteria:

* Participants (diagnosed and being treated for a pre-existing medical condition (cancer, kidney disease, liver disease, diabetes mellitus and cardiovascular disease, uncontrolled hypertension, gait disturbances limiting the ability to perform assessments of muscle function, dementia, affecting muscles known to use drugs (e.g., steroids). History of allergy to fish or fish oil and regular consumption of more than1portion of oily fish per week or use of fish oil or krill oil supplements will also be excluded.
The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting

Long treatment durations may not always be feasible for patients due to pressure to get better quickly, long travel distance to treatment clinics, inflexible working hours, or childcare. To overcome these challenges intensive treatments are currently emerging and several research studies have shown significant and lasting results of diagnosis-specific intensive treatments. A transdiagnostic treatment in a group setting can contribute to a more efficient course of treatment for patients.

Research suggests that Metacognitive Therapy (MCT) is an effective treatment for anxiety disorders. However, MCT has not previously been used on inpatients over a two-week period. To make the treatment tangible for patients and easy to administer for therapists over a short time, attention training technique (ATT) will mainly be used as a changing technique.

The main aim of the study is to explore the feasibility and efficacy of intensive and short-term MCT for anxiety disorders in a group setting.

Design: The study will use randomized control trial with a waitlist control. Cohorts of 12 included patients will be randomly assigned to active treatment or waitlist for two weeks. The waitlist patients will receive the same treatment immediately after the two-week waiting period.

Inclusion criteria: Adults ranging from 18 to 30 years of age meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia will be included in the study. Further the participants must be able to communicate in Norwegian and provide written consent.

Exclusion criteria: Exclusion criteria will be ongoing drug abuse, history of psychotic episodes, current suicidality, or participants not able to adapt to an intensive group format.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 30 years
* Meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia
* Provide written consent to partake in the study

Exclusion Criteria:

* Ongoing drug abuse
* History of psychotic episodes
* Current suicidality
* Participants not able to adapt to an intensive group format
CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors

The objective of the study is to construct a noninvasive approach 68Ga-ACN376 PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Aged \>18 years old; ECOG 0 or 1;
* 2. Patients with solid tumors;
* 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
* 4. life expectancy \>=12 weeks.

Exclusion Criteria:

* 1. Significant hepatic or renal dysfunction;
* 2. Is pregnant or ready to pregnant;
* 3. Cannot keep their states for half an hour;
* 4. Refusal to join the clinical study;
* 5. Suffering from claustrophobia or other mental diseases;
* 6. Any other situation that researchers think it is not suitable to participate in the experiment.
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers

This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 12-18 months old toddlers if they
* are in good health at time of entry into the study
* are available for all the visits scheduled in the study
* have been granted a written informed consent, signed by their parents

Exclusion Criteria:

* a history of rabies immunization
* a history of Japanese encephalitis immunization or disease
* a significant acute or chronic infectious disease at the time of enrollment
* fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment
* being under treatment with corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment
* administration of any vaccine within the past 14 days before enrollment
* known immunodeficiency or an autoimmune disease
* history of allergy to eggs, egg products
* known hypersensitivity to neomycin, tetracycline, amphotericin-B
* planned surgery during the study period
* being enrolled in any other investigational trial contemporaneously
* the family plans to leave the area of the study site before the end of study period
* history of febrile convulsions
* history of wheezing
Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study

Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively.

As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule.

Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril.

Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application.

It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Subject affiliated or entitled to a social security plan
* Subject having signed the consent to participate in the study

Exclusion Criteria:

* Pregnancy in progress
* Acute or chronic rhinorrhea
* Allergy to mupirocin calcium or excipients
* Any medication taken during the week preceding the beginning of the study
* Notable medical history (cardiovascular, pulmonary, neurological pathology, etc.)