cyrilzakka/clinical-trials huggingface dataset:
Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects

The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures, be able and willing to provide a written informed consent.
2. Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
3. Body weight ≥50.0 kg, body mass index (BMI) of 24.0-35.0 kg/m\^2 (both inclusive) at screening.
4. Weight change does not exceed 5 kg within 3 months before screening.
5. Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).

Exclusion Criteria:

1. Known or suspected hypersensitivity to trial product(s) or related products.
2. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
3. Abnormal and clinically significant blood pressure at screening.
4. History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization.
5. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
6. Presence of any clinically significant results in examination at screening visit.
7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
8. Presence of - clinically significant ECG results.
9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
10. Addiction to tobacco and alcohol.
11. Individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period.
12. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
Prevalence of Sarcopenia in Geriatric Patients

To assess the prevalence of sarcopenia among inpatients on acute geriatrics and geriatric rehabilitation wards of a Swiss university department of geriatric medicine using the most recent diagnosis definitions from european guidelines.


Eligibility Criteria:
Inclusion Criteria:

- All patients \>65 years old admitted to acute geriatrics and geriatric rehabilitation at the study site

Exclusion Criteria:

* Lack of informed written consent
* Implanted defibrillation device
* Acute Sepsis, severe volume overload or dehydration
* Life expectancy of \< 3 months according to treating physician
* Unremovable bandages
* Patients in isolation rooms on the ward
* Measurement is not possible due to organizational reasons
* Inability to follow the procedures, e.g. due to language problems, psychological disorders
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients

The purpose of this study is to investigate the intra-saliva penetration of voriconazole in different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in children, ambulatory patients and in patients in whom blood drawing is difficult.


Eligibility Criteria:
Inclusion Criteria:

* patients from the adult hematology ward treated with voriconazole
* pediatric patients treated with voriconazole, age 5-18 years
* patients from the pneumology ward treated with voriconazole

Exclusion Criteria:

* Age under 5 years
* Women who are pregnant or lactating
* Mucositis stage 3 or 4 (WHO)
* Patients which received the following drugs within 14 days before study entry: rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz and barbiturates.
* Patients which received the following drugs within 24hours before study entry: quinidine, ergotamine, sirolimus, saquinavir, amprenavir, nelfinavir, ritonavir and sulphonylureas.
Mindfulness Training for Smoking Cessation

Participants will complete this study remotely, either at home or at their preferred location using an online platform. The investigators propose to test the effects of a mindfulness training \[MT: Headspace\] intervention compared to a time and attention psycho-education control \[control: TedTalks\] among N=200 adult smokers of a nicotine product. Previous studies suggest that mindfulness training may be beneficial in reducing craving during tobacco abstinence. During the study, participants will complete baseline questionnaires, followed by two weeks of daily MT or control training and self-report on questionnaires assessing affect, cognition, and smoking behavior using Ecological Momentary Assessment (EMA) for remote data capture. Following this two weeks of training, participants will complete a smoking quit attempt and complete daily EMA questionnaires for two weeks. The first day of the smoking quit attempt will include a remote Zoom video session following overnight smoking abstinence. During this session the participants will complete a remote stressor task (Trier Social Stress Test, TSST), and the investigators will collect EMA data on affect and smoking behavior before and after the TSST. One month after the start of the quit attempt, participants will complete a phone call as a follow-up to assess smoking behavior over the previous 30 days, and to complete a debriefing. Study objectives are to test the effect of MT on: (1) smoking lapses during the follow-up periods; and (2) stress (affect, smoking urge, withdrawal symptoms) during the TSST.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Smoke at least 5 cig/day for the past year
* English fluency
* Motivation to quit smoking in next 30 days, or willing to make a practice quit attempt
* Reside in California
* Have remote video capability (i.e., computer, laptop, tablet with working camera and audio) in order to complete all data collection procedures (Note that the study does not have resources to provide these materials)
* Have working smartphone capable of downloading the app for EMA assessments

Exclusion Criteria:

* Current use of any nicotine replacement products (i.e., nicotine patch, gum, lozenge) or smoking cessation medications (i.e., Chantix, Bupropion, Wellbutrin, Zyban)
* Current mindfulness or meditation practice of greater than 5 minutes each day.
Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects

The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy , male or female subjects
* Age of 18 to 45 years
* Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight \> 50 kg for male, \> 45 kg for female
* Written informed consent signed and dated by the subject
* Subjects who are willing and able to comply with study procedures

Exclusion Criteria:

* Any clinically significant disease or surgery within 4 weeks prior to the beginning of the study
* Known hypersensitivity to the study drug or similar drugs
* History of any serious disease, including but not limited to circulatory system, endocrine system, central nervous system, hematology, immunology, metabolic diseases and psychiatric disorders
* History of gastrointestinal, hepatic, and renal diseases, affecting drug absorption and metabolism
* Any clinically significant abnormal clinical laboratory tests
* Abnormal ECG or vital signs
* A positive test for HIV antibody
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
* History of alcohol consumption within six months of the study defined as: an average weekly intake of \> 14 units
* History of regular tobacco use or nicotine containing products within three months prior to screening
* Consumption of too much tea or coffee (\> 8 cups/day)
* Use of any drug, which inhibits or induces hepatic drug metabolism, within 30 days prior to the beginning of the study
* Use of any drug within 14 days prior to the beginning of the study
* Participate in other clinical trials within 30 days prior to the beginning of the study
* Blood donation within 30 days of dosing
* All female subjects must not be of child-bearing potential
* Pregnant or lactating women
Ventricular Tachycardia Ablation in LVAD Patients

The CHANNELED-Registry is a multicenter retrospective study to (1) systematically assess the mechanism and origin of ventricular tachycardia in patients with end-stage heart failure carrying an left ventricular assist device (LVAD) and (2) to evaluate procedural parameters and outcome of ventricular tachycardia ablation in this special subset of patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients with end-stage heart failure with an LVAD implanted undergoing VT ablation

Exclusion Criteria:

* Patients \<18 years, pregnant women, patients undergoing VT ablation without an LVAD
Regenerative Endodontics Using Different Intracanal Medicaments on Radiographic Outcomes and Periapical MMP-8 Levels

Two-session regenerative endodontic treatment was applied to 20 immature mandibular first molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis. At the end of the first session, calcium hydroxide \[Ca(OH)2\] was applied to 10 randomly selected teeth and double antibiotic paste (DAP) intracanal medicaments were applied to the other 10 teeth. The effects of intracanal medicaments on periapical MMP-8 levels were determined by immunofluorometric assay (IFMA) in periapical tissue fluid samples taken from the distal root canal in the first and second sessions.

The aim of the study was to investigate the effects of two different intracanal medicaments used during regenerative endodontic treatment (RET) on periapical MMP-8 in relation to the radiological outcomes of RET. After local anesthesia and rubber dam isolation were provided, disinfection procedures were applied gently in accordance with the current RET protocol of American Association of Endodontics (AAE) on the molar teeth. Periapical tissue fluid samples were taken with paper points placed to protrude 2 mm from the distal root canal tip. Calcium hydroxide \[Ca(OH)2\] was placed in 10 randomly selected teeth and double antibiotic paste (DAP) intracanal medicaments were placed in the other 10 teeth. Fourteen days later in the second session, the final sampling procedure was performed as in the first session. Then, the treatment was completed according to the current RET protocol of AAE and permanent restorations were made. The success of the treatment and its effect on root development were evaluated by comparing the standard radiographs taken at the end of the treatment and 12 months follow up. MMP-8 levels were measured by immunofluorometric assay (IFMA) in the periapical tissue fluid samples. First and second session MMP-8 levels were compared according to the groups of medicaments \[Ca(OH)2 and DAP groups\] placed in the root canals.

Eligibility Criteria:
Inclusion Criteria:

- Healthy children with irreversible pulpitis with symptomatic apical periodontitis (SIP-SAP), indication for RET and informed consent from the patients.

Exclusion Criteria:

* Children with extra oral swelling or luxation with a deep periodontal pocket and whom application of RET was contraindicated.
* The teeth were indicated for vital pulp therapy (assesed during treatment)
* Children who have used antibiotics in the past 3 months and are uncooperative during treatment
* Children who have used any painkillers during the treatment
Capacitive Diathermy in the Lumbopelvic Pain

Objective: To determine the effectiveness of the capacitive diathermy in the mechanosensitivity, morphological, functional and contractility changes in patients with lumbopelvic pain.

Design: A pilot study, single blind, randomized controlled clinical trial, approved previously by The Princess University Hospital Ethics Committee (Feb 11, 2016) and the European University clinical intervention review board (CIPI/054/15).

Setting: Faculty of Health Sciences, Exercise and Sport. European University of Madrid.

Patients and intervention: A sample of 20 patients with bilateral lumbopelvic pain, between 18 and 60 years old, will be recruited and randomized into 2 intervention groups. The instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+ T-CaRe®on; n = 10) and the instrumental manual therapy with the switched off capacitive diathermy electrode (IMT+ T-CaRe®off; n = 10) will be bilaterally treated for 4 weeks (1 treatment per week during 10 minutes) in the lumbopelvic region.

Outcome measurements: Control variables such as the age, sex, height, weight, body mass index, Borg scale physical activity and distress respiratory test will be measured at the beginning of the treatment. Dependent variables such as the pain intensity, the pressure pain threshold, the contractility, the stiffness, the adverse effects, the Oswestry and Schöber test, as well as the ultrasound imaging cross sectional area and thickness of the skin, subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus anterior, externus oblique, internal oblique and transversus abdominis) will be assessed before and after each intervention by a blinded examiner.

Analysis data: The statistical analysis will be performed with a 95% confidence interval and the Statistic Package Social Sciences (SPSS) 22.0.


Eligibility Criteria:
Inclusion Criteria:

* bilateral lumbopelvic pain for 6 weeks

Exclusion Criteria:

* neuromuscular conditions
* negative straight leg raise test
* respiratory or congenital conditions
* surgeries
* neurologic signs
* lower extremities conditions
* skin alterations
* cognitive disorders
* body mass index higher than 31 kg/cm2
* skin alterations
* pregnancy
* intensive physical activity
* Nijmegen test higher than 24
Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units

The goal of this study is to explore if Virtual Reality helps patients in the cardiothoracic ICU move more and feel better. Participants will be asked to answer a survey about anxiety, depression, and loneliness. The study team will teach participants how to use the VR device and how to play the game. Participants will play the game at least once per day, but can play as much as they want. Study activities include nurse facilitated patient use of VR applications that involve upper body movement (e.g., using arms and hands to dance or hit objects in a virtual reality environment).

Patients who survive critical illness and prolonged intensive care unit (ICU) stays are at risk for debilitating physical (deconditioning, skin injury, and infection), and mental health impairment (depression, anxiety and PTSD). Early mobility improves these deleterious outcomes but is challenging to implement in patients on prolonged bedrest. The purpose of this study is to compare a nurse-led implementation of a Virtual Reality (VR) experience in the Cardio-Thoracic Intensive Care Unit (CT-ICU) to standard of care to improve mobility for patients on prolonged bedrest. The investigators hypothesize that nurse-led implementation of VR experiences in the CT-ICU, in combination with engineering-led patient-centered customization of the VR applications, will improve both the physical and psychological function of ICU patients on prolonged bedrest.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* English speaking
* 3+ days ICU admission with limited mobility

Exclusion Criteria:

* Pregnancy
* Blind/severe visual impairment
* History of seizures
* Intubation/sedation
* Special enteric contact isolation
Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis

Dermatomyositis (DM) are rare and heterogeneous systemic autoimmune diseases, characterized by the association of muscle inflammation, skin inflammation and vasculopathy. DM concern both adults and children. DM can be life-threatening (interstitial lung disease, infectious complications) and responsible of significant functional disability (muscle weakness). Age of onset appear to be an independent prognostic factor. Juvenile-onset DM is characterized by a higher frequency of calcinosis, skin ulceration and digestive vasculitis. In adults, interstitial lung disease and cancer are more frequent with higher mortality. Data concerning the comparison of the initial severity between juvenile and adult-onset DM are limited.

The main objective is to compare global severity between juvenile DM and adult-onset DM at initial diagnosis.

Secondary objectives are:

* to compare organ-specific severity between juvenile DM and adult-onset DM at diagnosis.
* to compare damage during follow-up and at last follow-up between juvenile DM and adult-onset DM.
* to compare activity at the last follow-up between juvenile DM and adult-onset DM.
* to compare iatrogenic complications between juvenile DM and adult-onset DM.


Eligibility Criteria:
Inclusion Criteria:

* Patient with dermatomyositis according to 2017 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification

Exclusion Criteria:

* Patient with cancer-associated dermatomyositis (within 3 years before or after diagnosis of dermatomyositis)
* Patient with antisynthetase syndrome
Cuirass Fitting Study - Time for Mounting and Ventilation

Non-invasive biphasic cuirass ventilation (BCV) has recently been described for ENT surgery (ref 1-2). The clinical experience is however still sparse and further study is required.

The purpose of the study is to descibe 1) mounting time and fitting of the cuirass shell on voluntary participants and 2) time to visible ventilation

The purpose of this study is to evaluate the the fitting of the Cuirass shell on healthy volunteers. Even though there is growing knowledge of Cuirass ventilation in anaesthesia, (ref. 1-2) there is sparse experiences with the time required for fitting the Cuirass shell and the time to start of ventilation. This knowledge is paramount before even discussing the potential use of Cuirass ventilation in acute settings in the future.

In addition to the invitation to the Copenhagen Airway Management course in Copenhagen Denmark on 30th of November 2023, all participants have been invited an has accepted to participate in the study.

In total 60 to 65 participants will all have the Cuirass shell fitted and will be awake ventilated with Biphasic Cuirass Ventilation. All participants have given consent to being video filmed.

The study will register the time it takes to fit the Cuirass shell and the time before visible ventilation is obtained.

All participants will be in their habitual state i.e..no sedation is required since the product was originally designed for home use in awake patients.

Eligibility Criteria:
Inclusion Criteria:

* participants of the airway course

Exclusion Criteria:

* Recent surgery in thoracic or abdominal compartments
* participants with pace-maker
A Stage-matched Intervention Based on Transtheoretical Model of Change in Changing the Videogaming Behavior

A Stage-matched randomized controlled trial seeks to change the problematic digital gaming behavior among high school male students.

The researchers will use two groups (study and control) in which participants will be randomly selected and assigned in each of the study and control groups using simple random sampling.

The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.

A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.

Eligibility Criteria:
Inclusion Criteria:

* High school male students who do not experience any psychiatric-mental disorder.

Exclusion Criteria:

* High school male students who experience any psychiatric-mental disorder.
Aromatherapy Using a Nasal Clip After Surgery

The purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively.

The primary hypothesis of the study is that post-operative patients who meet eligibility criteria and report nausea and receive a blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils while using a nasal clip to facilitate inhalation will have more relief from nausea than those who receive normal saline inhalation using the same delivery system.

The secondary purposes of the study is to determine the duration of effectiveness of the essential oil blend as compared to the saline in the relief of post-operative nausea and to investigate the degree of comfort participants report using the nasal clip delivery system for aromatherapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* cognitively able to give consent based on nurse's assessment,
* having gynecological or other abdominal surgery
* not allergic to peppermint, spearmint, cardamom or ginger
* not receiving blood thinning medications

Exclusion Criteria:

* less than 18 years old
* unable to cognitively give consent
* allergic to ginger, peppermint, cardamom or spearmint.
* receiving warfarin (Coumadin) or any antiplatelet drug (heparin, 325 mg Aspirin, clopidogrel (Plavix) or other) or a diagnosis of bleeding diatheses (predisposition to abnormal blood clotting/hemorrhage) will not be included in this study.
* all surgeries other than gynecological or abdominal surgery
Exercise Program Among Lung Cancer Dyads

Pilot study of an exercise program among patients with all stages of lung cancer examining feasibility and acceptability. Preliminary outcomes include objective measures of physical function, depression, adherence to lung cancer treatments, Quality of Life (QOL), and social support.

PRIMARY OBJECTIVE:

I. Determine the feasibility and acceptability of a progressive exercise program initiated after lung cancer diagnosis among patient partner dyads.

SECONDARY OBJECTIVE:

I. Examine the preliminary effects of partnered exercise on physical function, depression, adherence to lung cancer treatments, QOL and social support .

OUTLINE:

Participants attend supervised group exercises classes twice per week during weeks 1-6 and once per week during weeks 7-12. Participants also attend home-based unsupervised exercise sessions via an instructional DVD once per weeks over for 30 minutes during weeks 1-6 and twice per week during weeks 7-12.

Eligibility Criteria:
Inclusion Criteria:

* Mild depression symptoms
* Able to participate in exercise program per physician approval
* Available partner/spouse to participate with patient

Exclusion Criteria:

* Persistent severe depression symptoms
* Inability to participate in exercise
* Life expectancy less than 1 year