cyrilzakka/clinical-trials huggingface dataset:
Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)

Validation of the French Version of the Score on Quality of Life in Hidradenitis Suppurativa. The French HiSQOL will be completed by 60 patients with hidradenitis suppurativa a first time, and a second time 1 week later.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patient with Verneuil disease
* Beneficiary of or affiliated to a social security insurance
* Participation agreement

Exclusion Criteria:

* Patients physically or mentally unable to complete questionnaires.
* Refusal to participate
* Patient under legal protection (guardianship, curatorship) or deprived of liberty
Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

The goal of this observational study is to validate the Creyos online cognitive assessment platform in individuals with mild cognitive impairment, or remitted major depressive disorder. The main objectives of this research are:

1. To confirm the feasibility of administering the Creyos cognitive battery to older adults with Mild Cognitive Impairment MCI) or Major Depressive Disorder in remission (rMDD).
2. To determine whether the Creyos battery can detect changes in cognition that are predictive of changes on paper-and-pencil neuropsychological testing ("gold standard") over up to five years.

Participants will complete both in-person neuropsychological testing yearly as well as the Creyos online battery quarterly for up to 5 years, to allow us to compare performance on these two batteries over time.


Eligibility Criteria:
General Inclusion Criteria:

* Ability to read and communicate in English
* Availability of a study partner who has regular contact with the participant

General Exclusion Criteria:

* Lifetime DSM 5 diagnosis of schizophrenia, bipolar disorder, or OCD
* DSM 5 diagnosis of alcohol or other substance use disorder within the past 12 months
* High risk for suicide
* Significant neurological conditions (e.g. stroke, seizure disorder, MS)
* Unstable medical illnesses (e.g. uncontrolled diabetes mellitus or hypertension)
* Taking anticonvulsants or other psychotropic medication that may interfere with cognitive testing that cannot be safely tapered and discontinued
* Current depressive symptoms defined as a MADRS score of 10 or above

Specific Eligibility Criteria for the MCI Group:

Inclusion:

* Aged 60 or older
* Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")

Exclusion:

* Having taken a cognitive enhancer within the past 6 weeks

Specific Eligibility Criteria for the rMDD Group:

Inclusion:

* Aged 65 or older
* Meets DSM 5 criteria for one or more major depressive episode(s) (MDE) during their adult life (i.e. 18 years of age or older) with: (a) an offset of 2 months to 5 years from the screening visit date, or (b) an offset of 5 years or more, with at least one MDE receiving medical attention (e.g. previously been on an antidepressant, saw a psychiatrist, primary care physician, or had a previous hospitalization

Exclusion:

* Having taken a cognitive enhancer within the past 6 weeks
* Having received electroconvulsive therapy (ECT) within 6 months of baseline neuropsychological testing

Specific Eligibility Criteria for the Control Group:

Inclusion:

* Aged 60 or older

Exclusion:

* Meets DSM 5 criteria for MDD at anytime during their lifetime
* Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
Exercise Capacity in Patients With Fontan Procedure

In literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing Fontan Procedure due to various factors related to surgery and underlying cardiac anomaly. Cardiopulmonary exercise test (CPET) was generally used to evaluate exercise capacity in children and adults with fontan circulation. The fact that CPET requires a clinically expert team and equipment and is more expensive does not always make it possible to perform routine cardiopulmonary exercise testing. In some cases, field tests evaluating submaximal and maximal exercise capacity may be more practical than cardiopulmonary exercise testing. Therefore, in this study, it is aimed to evaluate the exercise capacity of Fontan patients with 6-minute walking test and incremental shuttle walk test and to compare vital signs during the tests.


Eligibility Criteria:
Fontan Group Inclusion Criteria

* be between the ages of 8-50
* Having undergone Fontan operation in our hospital or another center
* Clinical stability of the patients (preserved ventricular function),
* No change in ongoing drug therapy that adversely affects clinical stability,
* At least 1 year after the operation and to be followed in the Pediatric Cardiology Polyclinic of our hospital

Fontan Group Exclusion Criteria:

* Inability to access the patient's medical data
* Neurological and/or genetic musculoskeletal disease
* Having orthopedic and cognitive problems that prevent testing
* The patient's and/or family's unwillingness to participate in the study

Control Group Inclusion Criteria:

* Not have cardiovascular, neurological and/or genetic musculoskeletal disease
* Not having orthopedic and cognitive problems that prevent testing
* The patient's and/or family's willingness to participate in the study
Characteristics of Pain in Women With Lipoedema

This observational study will seek to investigate the following questions in women with lipoedema:

* pain characteristics, intensity and patterns of pain
* the relationships between the characteristics, intensity and patterns of pain and age, ethnicity, location, employment status, levels of anxiety/depression, walking ability, ability to work, relations with other people, impact on sleep and quality of life.
* the impact of pain treatments or medications on the intensity of pain. The information will be collected via an online survey and participants will be recruited through social media platforms.

Lipoedema is a chronic adipose tissue disorder that occurs almost exclusively in women and affects approximately 11% worldwide. Pain is a recurring feature described by people with lipoedema (pwL) with a recent study reporting 88.3% of patients indicating pain as a clinical feature. It has been suggested, with chronic long-term conditions, that the pain people experience can be moulded by a myriad of elements.This includes biomedical, psychosocial (e.g. patients' beliefs, expectations, and mood), and behavioural factors (e.g. context, responses by significant others). PwL often experience significant impairment in their daily activities and quality of life. It has further been found that psychological and the biomedical consequences of lipoedema can increase the chances of anxiety and depression which can subsequently further impact on quality of life and pain experience.

This observational study will seek to investigate the following questions in women with lipoedema:

* pain characteristics, intensity and patterns of pain
* the relationships between the characteristics, intensity and patterns of pain and age, ethnicity, location, employment status, levels of anxiety/depression, walking ability, ability to work, relations with other people, impact on sleep and quality of life.
* the impact of pain treatments or medications on the intensity of pain. INformation about pain characteristics, demographics, mood, functional ability and quality of life will be collected via an online survey and participants will be recruited through social media platforms.

Eligibility Criteria:
Inclusion Criteria:

* Women with lipoedema
* 16 years and older

Exclusion Criteria:

- Inability to provide consent
The ASAP Study - Therapeutic Efficacy of Atovaquone-proguanil vs. Artesunate-atovaquone-proguanil in Cambodia

This is a two-arm, randomized, open label Treatment Study evaluating the therapeutic efficacy, safety, tolerability and pharmacokinetics of a three-day course of Atovaquone-Proguanil (AP) or a three-day course of Atovaquone-Proguanil combined with 3 days of Artesunate (ASAP) in patients with uncomplicated Plasmodium falciparum malaria at selected sites in Cambodia. Atovaquone-proguanil, soon to adopted as a first line antimalarial agent by the National Malaria Control Program (CNM) in Cambodia in provinces with confirmed multidrug resistance, will be given with or without artesunate (AS) as a directly observed, standard three-day fixed dose combination treatment to all volunteers enrolled. The efficacy and safety of both drug combination as well as evidence for in vivo and in vitro resistance to their components will be monitored during the treatment period. All volunteers will receive a single dose of 15mg of primaquine as recommended by WHO with the first dose of AP or ASAP to block the transmission of malaria to mosquitoes. Resistance to AP and ASAP will be assessed by a combination of clinical, pharmacologic, and parasitological parameters including genomic signatures of selection during careful weekly follow-up visits for 6 weeks. Investigators will also be able to evaluate the effects of primaquine on the sexual stages of malaria (gametocytes).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female with uncomplicated P. falciparum malaria (volunteers with mixed P. falciparum and P. vivax infections may be enrolled), 18-65 years of age
2. Baseline asexual parasite density between 100-200,000 parasites/microL
3. Able to provide informed consent
4. Available and agree to follow-up for anticipated study duration including 3 day treatment course at the Medical Treatment Facility, and weekly follow-up for the 42-day period.

Exclusion Criteria:

1. Allergic reaction or medical contraindication to atovaquone, proguanil, artesunate or primaquine, to include a calculated serum creatinine clearance estimate of less than 30mL/min
2. Significant acute comorbidity requiring urgent medical intervention
3. Signs/symptoms and parasitological confirmation of severe malaria
4. Use of any anti-malarial within the past 7 days, or atovaquone-proguanil in the past 30 days
5. Use of the following concomitant medications within 7 days, which may cause or be volunteers to significant drug-drug interactions with study drug - tetracycline, metoclopramide, rifampin, rifabutin, zidovudine or etoposide.
6. Pregnant or lactating female, or female of childbearing age, up to 50 years of age, who does not agree to use an acceptable form of contraception during the study
7. Judged by the investigator to be otherwise unsuitable for study participation
Use of NAC in Alleviation of Hangover Symptoms

This will be a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21 to consume beer on hospital property in a safe environment to ensure immediate availability to medical attention and to security if needed. Volunteers will be recruited from residency programs, hospital employees, emergency medical personnel, and friends of study investigators. The volunteers will drink to a BAC of 0.1 as checked with a breathalyzer. They will wear a tag around their neck with their study number, which will be hole-punched with every beer consumed, which will be collected at the end of the night for an accurate count of beers consumed per person. They however will not be forced to drink anymore if they are uncomfortable with the amount of alcohol they are consuming and can withdraw from the study at any time. All participants will be required to be driven home by a sober driver once the participant's BAT is 0.02 or less. At the end of the night, the volunteer will be breathalyzed to determine BAC, and given 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participate will fill out a Hangover Symptom Score questionnaire, evaluating each hangover symptom on a 0 - 4 point Hangover Symptom Severity scale. A random number generator will be used to determine Placebo or NAC first, then the participant will be given the other treatment at their subsequent encounter. The study will be conducted over the series of many months, and data can be analyzed by self-control comparing the participant's hangover symptom severity as determined by the hangover symptom scale data when using NAC compared to placebo. The data will be analyzed using the numerical values of each category for hangover classification and compare the placebo data to the control data.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers over age 21 years

Exclusion Criteria:

* Volunteers will be excluded from the study if they suffer from any of the following conditions:
* Alcoholism,
* Pregnancy,
* Reactive Airway Disease,
* Diabetes,
* Kidney or bladder stones,
* Kidney disease,
* Liver disease,
* Stomach ulcer,
* Organ transplant patients,
* Dialysis patients,
* and patients with alcohol, egg, milk or wheat allergies.

Volunteers taking the following medications will not be able to participate:

* activated charcoal,
* ampicillin,
* carbamazepine,
* cephaloridine,
* cloxacillin,
* methicillin,
* nitroglycerine,
* oxacillin,
* penicillin G,
* or quinacillin.
Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva

The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy volunteers
* Age between 20-45 years
* Presence of minimum 24 permanent teeth
* No evidence of gingivitis or periodontitis (CPITN= 0)
* No presence of untreated caries at the start of the study

Exclusion Criteria:

* Smoker or ex-smoker
* Presence of dental protheses or orthodontic appliances
* Antibiotic treatment and/or routine use of oral antiseptics in the previous three months
* Presence of any systemic disease that could alter saliva production or composition
Immune Checkpoints in Colorectal Cancer

Colorectal cancer (CRC) ranked the first in cancer incidence in Hong Kong and it is frequently lethal with heterogeneous drug responses and survival outcomes. Immune-based approaches targeting to enhance tumor-specific responses have been actively under investigation as therapeutic strategies. Currently, PD1 and PD-L1 blockade has shown promising results in clinical trials especially in colorectal cancer patients with microsatellite instability. This study aims to examine the role of PD-L1/PD1 in immune cell-mediated cytotoxicity in colorectal cancer patients.

Aim: To examine the role of PD-L1/PD1 in immune cell-mediated cytotoxicity in colorectal cancer patients.

Objectives: 1. Comprehensive investigation of PD-L1/PD1 in colorectal cancer in association with chemotherapy responses and immune activities; 2. Examine the functional role of PD-L1/PD1 targeting in immune cell-mediated cytotoxicity.

Hypothesis: It is hypothesized that PD-L1/PD1 has pivotal role on the immune cell-mediated cytotoxicity in colorectal cancer.

Significances: The current study will elucidate the significance of PD-L1/PD1 on chemo-resistance and the effect on immune cells and their functional properties. The study will enhance the understanding on chemotherapy response and immune evasion. The long-term goal is to provide the crucial information on oncoimmunology to improve efficacy of immunotherapy in cancer treatment.

Subjects: Only those patients for whom colorectal cancer is the indicated clinical diagnosis will be recruited in the current study. Possible participants will be patients undergoing tumor resection or endoscopic examination at the Department of Surgery, Prince of Wales Hospital, Shatin, Hong Kong. Specimens will be collected from sixty-eight colorectal cancer patients. The estimated duration for collection of all the necessary samples will be two years. With at least one year of follow-up information, the proposed study should be completed in three years. For the current study, single blood sample (10 ml of peripheral blood in EDTA) will be drawn before the operation or endoscopic session. A small portion of the tumor and non-tumor tissue tissues from resected specimens or biopsy tissues will be collected for histological evaluation, primary culture and for comparison of the genetic and protein components in the blood specimen.

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer patients undergoing resection or endoscopic examination at the Department of Surgery, Prince of Wales Hospital, Shatin, Hong Kong

Exclusion Criteria:

* patients who do not consent
Evolut PRO China Clinical Study

Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).

The study is targeting 6 centers with a maximum of 8 centers in China and estimating 65 subjects with a maximum of up to 70 subjects with attempted implants including 50 subjects with an attempted implant in primary study population and the first two attempted subjects at each site for roll-in population. The subjects will follow the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6 months, 1 year, and annually through 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Aortic valve area (AVA) \< 1.0 cm2 (or indexed AVA \<0.6 cm2/m2) OR mean gradient \> 40 mmHg, OR max aortic velocity \> 4.0 m/sec
2. High risk for SAVR defined as STS-PROM score ≥ 8% AND ≤ 15%, OR documented Heart Team agreement of high risk for AVR due to frailty or comorbidities
3. Symptoms of aortic stenosis and NYHA ≥ II

Exclusion Criteria:

1. Age is less than 65 years old
2. Non-calcified aortic valve
3. Bicuspid aortic valve with no raphe or 2 raphes (Sievers classification type 0 or type 2)
4. Ascending aortic diameter \> 4.5 cm
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of JNJ-42165279 in Healthy Male Participants

The purpose of this study is to assess the effects of repeated administration of 200 mg of itraconazole on the single-dose pharmacokinetics of JNJ-42165279 in healthy male participants.

This is an open-label (all people know the identity of the intervention), study in healthy male participants. This study will consist of a screening phase (between 21 and 2 days prior to the first dose administration of JNJ-42165279), a 2-period (Period 1: Day 1 to Day 3 and Period 2: Day 4 to Day 10) open-label treatment phase, and a follow-up phase (within 7 to 14 days after the last dose of JNJ-42165279). A single 30-mg dose of JNJ-42165279 will be administered on Day 1 of Period 1. During Period 2, the administration of oral itraconazole 200 mg once a day will start on Day 4. A second single oral 30-mg dose of JNJ-42165279 will be administered on Day 8 together with the dose of 200 mg itraconazole. Sixteen healthy participants will be enrolled in this study. Safety assessments will include assessment of adverse events, supine vital signs, 12-lead electrocardiogram, clinical laboratory testing and physical examinations. The maximum study duration for each participant will be approximately 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 30 kg/m2 inclusive (BMI = weight/height2)
* Nonsmoker (not smoked for 3 months prior to screening)
* During the study and for 3 months after receiving study medication, must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception), always use a condom during sexual intercourse and to not donate sperm
* Participants must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions

Exclusion Criteria:

* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
* Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram at screening or on Day 1, predose
* History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection. History of epilepsy or fits or unexplained black-outs
* Drinks, on average, more than 8 cups (more than or equal to 150 mL) of caffeine containing beverages per day
* Clinically significant acute illness within 7 days prior to study drug administration
* Has a contraindication to the use of itraconazole or any antifungal azoles
Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)

Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.

Eligibility Criteria:
Inclusion Criteria:

1. infant less than 28 days
2. diagnosis of ARDS
3. informed parental consent has been obtained

Exclusion Criteria:

1. major congenital malformations or complex congenital heart disease
2. transferred out of the neonatal intensive care unit without treatment