cyrilzakka/clinical-trials huggingface dataset:
Personality Traits in Patients Seeking a Consultation for Treatment for Floaters

This study aims to assess if certain personality traits are move prevalent in patients seeking consultation for treatment of floaters, despite good visual acuity and no other ocular pathology compared to the normal population.

This study aims to assess if certain personality traits are move prevalent in patients seeking consultation for treatment of floaters, despite good visual acuity and no other ocular pathology compared to the normal population. A questionnaire utilising a validated personality trait assessment the 'Big Five Inventory' will collect information patients who have sought a consultation (or already had treatment in the form of vitrectomy) for floaters. We will also assess whether these patients are suffering from any degree of depression or anxiety using two validated screening questionnaires; the patient health questionnaire-9 to screen for depression, and the generalised anxiety disorder - 7 questionnaire to screen for anxiety. Identifying personality traits of patients who seek further help and potential therapeutic intervention, could help clinicians identify the individual factors that lead to this debilitating condition in some patients, despite having a healthy eye and may help determine future non-surgical minimally-interventional therapeutic approaches in the future

Eligibility Criteria:
Inclusion Criteria:

* • Patients aged 18 or over who have contacted an Ophthalmologist for a consultation for treatment for myodesopsia which has lasted for over 3 months

Exclusion Criteria:

* • Patients with co-existing ocular pathology e.g. uveitis, glaucoma, pathological myopia (refractive error \> -6D)

  * Patients with cognitive impairment or learning difficulties that would affect their ability to access and complete the questionnaire
  * Patients with known personality disorders
  * Patients must be able to read, speak and understand English so they can comprehend the patient information sheet and questionnaire
Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D

Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor.

The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection.


Eligibility Criteria:
Inclusion Criteria:

* Presence of anti-HDV in serum
* Presence of quantifiable HDV RNA in serum
* Elevated ALT \> ULN

Exclusion Criteria:

* Decompensated liver disease
* Patients with ALT levels greater than 10 times ULN (400 U/L)
* Pregnancy or inability to practice adequate contraception.
* Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR \<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease.
* Systemic immunosuppressive therapy
* Evidence of another form of liver disease in addition to viral hepatitis
* Active substance abuse, such as alcohol or injection drugs
* Hepatocellular carcinoma
* Concurrent hepatitis C infection or HIV coinfection
* Diagnosis of malignancy in the five years
* Concurrent usage of statins
* Concurrent use of any other drug known to inhibit NTCP
* Inability to understand or sign informed consent
Mobile EMA-based Peer Counselling for Youth Smokers

This pilot trial aims to examine the feasibility, acceptability, and preliminary effectiveness of EMA-based peer counseling for youth smokers.

Most smokers begin smoking during adolescence and early adulthood, a crucial period to prevent initiation and continuation of smoking. However, many proven smoking cessation interventions for adult smokers were not found effective in youth smokers, which may be partly explained by the vast differences in the pattern of tobacco use and determinants of quitting between adult and youth smokers. This calls for more research on novel intervention models to help young smokers quit.

The HKU Youth Quitline provides free smoking cessation support for smokers aged below 25 years since August 2005 in Hong Kong. The service provides multisession peer-led telephone counselling with an individualised quit plan devised for each young smoker according to their responses. Since the counselling model depends on the information retrospectively recalled by the smokers, it may be prone to recall and social desirability biases and fail to capture the variability of youth smoking patterns and momentary changes in personal (e.g., mood) and situational (e.g., peer smoking) antecedents of smoking episodes.

Recent advances in mobile technologies have enabled the use of more advanced and robust data collection approaches like ecological momentary assessment (EMA), which may benefit the counselling model by providing more ecologically valid data than traditional surveys. Previous studies have demonstrated the feasibility of using EMA to collect data on psychosocial processes and smoking behaviours in adolescent smokers. Therefore, we propose to develop and test a mobile EMA-based counselling intervention for youth smokers by conducting a pilot RCT.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 15 to 25 years
2. Have smoked in the past 30 days
3. Own a smartphone with an mobile instant messaging app installed
4. Can communicate in Chinese

Exclusion Criteria:

Youth smokers who are participating in other smoking cessation studies or program other than the HKU Youth Quitline
Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis

The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo on change from baseline in Total Lesion Symptom Score in subjects with mild to moderate atopic dermatitis

One of the causative factors for the inflammatory response observed in AD is the release of chemokines and other chemoattractant factors followed by recruitment of inflammatory cell subtypes (10). IL-16, a Langerhans cells (LC)-derived chemoattractant cytokine for CD4+ cells, RANTES, monocyte chemotactic protein (MCP-4) and eotaxin are overexpressed in epidermal keratinocytes from AD subjects and may contribute to the chemotaxis of eosinophils, macrophages and Th2-lymphocytes (11).

Since the activation of SHIP1 by AQX-1125 results in the inhibition of inflammatory cell chemotaxis and reduction of pro-inflammatory cytokine synthesis, this study hypothesized that AQX-1125 would improve AD.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged from 18 to 65 years old
2. Confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin and Rajka criteria
3. At least a 6 months history of atopic dermatitis.
4. Body Surface Area (BSA) covered with atopic dermatitis of 1% or more
5. Mild or moderate atopic dermatitis (IGA score of 2 or 3).
6. TLSS of 5 or more at Day 0.
7. Subject must use a non-medicated emollient daily for at least (≥) 7 days prior to Day 0 and should continue using that same emollient, at the same frequency, throughout the study.

Exclusion Criteria:

1. Female subject who is pregnant or breast-feeding
2. Unstable or clinically infected atopic dermatitis
An Artificial Intelligence Algorithm for Identifying Gynecologic Cancer Patients in Need of Outpatient Palliative Care

This clinical trial tests an artificial intelligence (AI) algorithm for its ability to identify patients who may benefit from a palliative care consult for gynecologic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A significant delay in referral to palliative care often occurs among patients with cancer. This delay can lead to poorer symptom management, decreased quality of life, and care that does not align with patient goals or values. AI algorithms are computer programs that use step-by-step procedures to solve a problem. In this trial, an AI algorithm is applied to patients' medical records in order to identify patients with a high burden of disease. Information gathered from this study may help researchers learn whether this AI algorithm is useful for identifying patients who could benefit from outpatient palliative care consultation.

PRIMARY OBJECTIVE:

I. To pilot an oncology risk prediction model to identify patients who may benefit from outpatient palliative care consultation to improve symptom management and goal-concordant care in this population.

OUTLINE:

Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm once a week (QW) for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient in Enhanced, Electronic health record (EHR)-facilitated Cancer Symptom Control (E2C2) with a diagnosis of advanced gynecologic malignancy (International Classification of Diseases \[ICD\] codes C51 through C58)
* Weekly the reviewers will select patients by looking at patients in sorted order starting with the highest score and proceeding down the list and evaluating each patient for exclusion criteria

Exclusion Criteria:

* Patients that have been seen by palliative care will be excluded for 75 days
* Patients under the age of 18 years
* Patients currently enrolled with hospice
Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors

This phase II, randomized pilot trial studies the effect of the consumption of foods made with resistant starch compared to foods made with corn starch on biomarkers that may be related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods made with resistant starch may beneficially influence markers of inflammation, insulin resistance, and the composition of gut bacteria in colorectal cancer survivors.

Participants are randomized to 1 of 2 groups.

GROUP I (INTERVENTION GROUP): Participants eat a diet consisting of resistant starch foods daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.

GROUP II (CONTROL GROUP): Participants eat a diet consisting of regular corn starch foods daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.

Eligibility Criteria:
Inclusion Criteria:

* History of diagnosed American Joint Committee on Cancer (AJCC) stage I-III colorectal adenocarcinoma.
* Completed all treatment of colorectal adenocarcinoma within past 4-36 months.
* Current Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (per physician).
* Ability to consent and follow study protocol.

Exclusion Criteria:

* Active cancer.
* Prior diagnosis of diabetes that is currently uncontrolled (defined as hemoglobin \[Hgb\] A1c \> 8.0).
* Active inflammatory bowel disease (i.e., patients who are symptomatic despite medical therapy). This includes irritable bowel syndrome, Crohn's disease, or any other inflammatory bowel disorder.
* Known food allergy/intolerances to wheat, gluten, dairy or eggs.
* Use of antibiotic(s) within the last 3 months prior to enrollment.
* Women who are pregnant and/or breastfeeding.
* Current body mass index (BMI) \< 18.5 kg/m\^2.
* Uncontrolled constipation.
* Inability to speak and fully understand English.
Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage

Rational: The main danger with intracranial aneurism is its rupture conjugated with subarachnoid hemorrhage (SAH) occurrence. SAH is a severe pathology leading not only to neurological but also extra cerebral disorders. The major cause of morbidity and mortality when developing a SAH is the secondary development of a delayed cerebral ischemia consecutive to a prolonged vasospasm of cerebral arteries. The understanding of the pathophysiological mechanisms of SAH complication, such as vasospasm which is the more frequent, is essential.

Vasospasm is defined as a reversible shrinking of an artery lumen diameter in the subarachnoid space, beginning generally between 4 and 12 days after the hemorrhage. Such a vasospasm could have a huge clinical impact leading to delayed neurological ischemic deficiency in 17 to 40 % of cases. Up to day, mechanisms involved in vasospasm occurrence are not well described.

Disposing of well-established genetics and transcriptomics databases along with cerebral ischemia and inflammation is essential to unravel the mechanisms leading to vasospasm occurrence on SAH patients. It will enable researchers to better comprehend SAH pathology and elaborate an efficient and individualized therapeutic strategy to SAH acute phase in order to reduce the risk of vasospasm occurrence.

Aims: 1) Constitute DNA and RNA Biobank via blood proofing oh SAH patients 2) Constitute a database grouping clinical and biological data 3) Look for genetic and transcriptomic early markers via genomic approaches 4) Correlate these different markers with vasospasm occurrence and clinical evolution of the patients

Study: Patients inclusion will be done following their admission (D1) in the " unité de réanimation neurochirurgicale" of Pitié-Salpètrière Hospital. After obtaining of the informed consent, blood proofing will be realized daily during 12 days: one daily 2.5ml tube for the transcriptomic study and a single 10ml EDTA tube for genetic analyses. Clinical and biological follow-up will be performed as usual.

200 patients will be initially included during 2 to 3 years for the transcriptomic study of which 1/3 will develop vasospastic complication. The transcriptomic study will thus be performed by comparing patients developing or not developing this complication

Expected Results: Unravel vasospasm early genetic markers.


Eligibility Criteria:
Inclusion Criteria:

* Patient entering the neurosurgical unit in the 48 hours following an aneurismal sub-arachnoid hemorrhage and treated in the 96 first hours (embolization or surgery)
* Aged more than 18
* Caucasian origin
* Affiliated to a social care service
* Having (or one of is related if he is comatose) given its informed consent

Exclusion Criteria:

* Subjects which do not have a social care protection
* Subjects (or one of is related if he is comatose) refusing to sign the consent
* Subjects being under a protective juridical system for adults
A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)

Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency) and explore the optimal dosage


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis)
2. The patients who can not be treated by surgical resection, conventional radiotherapy and chemotherapy or molecular targeted drugs treatment failure, not willing to accept, or intolerance to radiotherapy and chemotherapy or molecular targeted therapy.
3. The TCM Syndrome diagnosis of Qi-Deficiency.
4. Aged 18-75 years, both male and female.
5. ECOG performance status 0-2.
6. Expected to survive more than 3 months.
7. Joined in the test voluntarily and signed the Informed consent by GCP regulation.

Exclusion Criteria:

1. Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr).
2. Patients with significant cachexia.
3. Untreated symptomatic brain metastases.

4 .Allergic constitution, or for a variety of drug allergy.

5 .Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath.

6. Participated in other clinical trial within 3 months.

7. Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.

8. Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.

9. Not fit for the clinical trial judged by the investigator.
Zika Virus Infection's Pregnancy Consequences in French Department of America

The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy. This study is meant to collect, within usual care practices, clinical and paraclinical information which will allow the precise description of the consequences of ZIKV infection occurring during pregnancy.

This is a prospective observational, non-interventional study that has been integrated into the usual standard of care practices. All information and biological samples collected during the course of this project will be done through the new medical standard of care which has been put in place during the ZIKV epidemic in the DFAs; this new standard of care is a result of existing recommendations from medical professionals and/or public health authorities. Outside of these recommendations, no invasive procedure will be done simply to satisfy an objective of this study.

Eligibility Criteria:
M1:

Inclusion Criteria:

* On-going pregnancy regardless the presumed date of birth
* Clinical signs suggestive of ZIKV infection
* Whatever the RT-PCR analysis

Exclusion Criteria:

* Minor
* No consent

M2:

Inclusion Criteria:

* Head circumference \< 5th percentile
* Other brain morphological abnormality
* Hydramnios
* Intrauterine growth restriction (IUGR)

Exclusion Criteria:

* Minor
* No consent

M3:

Inclusion Criteria:

* Pregnant woman during epidemic period of ZIKV

Exclusion Criteria:

* Minor
* Opposition

M4:

Inclusion Criteria:

* Delivery during epidemic period of ZIKV

Exclusion Criteria:

* Minor
* No consent

M5:

Inclusion Criteria:

* Spontaneous abortion or fetal death in utero during epidemic period of ZIKV

Exclusion Criteria:

* Minor
* No consent
Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy

Recently, the treatment of Cystic Fibrosis (CF) incorporated new modulators/enhancers of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). It is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. For this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with CF treated with these new generation CFTR modulators. They will be randomly assigned to two groups (exercise and control group). The effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and miRNAs. After completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed.

Specific objectives

1. To determine the effects of a strength exercise intervention in a group of children and adolescents with cystic fibrosis treated with new generation CFTR modulators on: (1.i) peripheral muscle strength; (1.ii) respiratory muscle strength; (1.iii) muscle mass and (1.iv) biomarkers of muscle damage.
2. To determine the effects of a strength exercise intervention in a group of children and adolescents with cystic fibrosis being treated with new generation CFTR modulators on: (2.i) cardiorespiratory fitness; (2.ii) body composition and (2.iii) lung function.
3. To determine the effects of a strength-based exercise intervention in a group of children and adolescents with cystic fibrosis treated with new-generation CFTR modulators on: (3.i) biomarkers of inflammatory status and (3.ii) expression of associated miRNAs.
4. To determine the effects of a strength-based exercise intervention in a group of children and adolescents with cystic fibrosis treated with the new generation CFTR modulators on the levels of Elexaxcaftor/Ivacaftor/Tezacaftor and their metabolites.
5. To assess the clinical evolution and adherence to exercise after 6 months of the programme in children and adolescents with cystic fibrosis treated with the new generation of CFTR modulators.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with CF.
* patients between 6-20 years of age.
* patients receiving treatment with new CFTR protein modulating medication
* reading, acceptance and signing of the informed consent form.

Exclusion Criteria:

* CF patients with symptoms of pulmonary exacerbation during the last four weeks.
* with a diagnosis of other cardiorespiratory lung diseases progressing to a symptom of persistent respiratory dysfunction.
* CF patients with musculoskeletal alterations that influence assessments.
* CF patient who is pregnant during the time of the study
* CF patient with cognitive impairment;
* CF patient with incomplete dosing of modulator therapy;
Lymphatic Mapping for Image Guided Radiotherapy in Patients With LACC - a Feasibility Study

Lymphatic mapping is a procedure in which all lymph nodes with drainage from the primary tumor, i.e. all nodes with potential (micro)metastases, can be imaged. These nodes are not necessarily suspicious on other imaging techniques.

The goal of this feasibility study is to

1. investigate the feasibility of the lymphatic mapping procedure in locally advanced cervical cancer
2. study the agreement of the lymphatic map with the radiotherapy treatment plan including previous imaging (MRI / CT / FDG-PET/CT)

Study population:

Aged ≥18 years, with locally advanced cervical cancer, that will be planned for radiotherapy.

Intervention (if applicable): Lymphatic mapping will be performed on all study patients during the standard investigation under anaesthesia, to ensure painless injection of the radiopharmaceutical. Patients will receive 6-8 depots of \[99mTc\]Tc-nanocolloid peritumoral. Planar and SPECT/CT gamma camera images will be made at the department of Radiology and Nuclear medicine 3 hours and 12-24 hours after administration of the radiopharmaceutical. All radioactive lymph nodes will be included in the lymphatic map.

The radiation oncologist will determine the radiation therapy treatment plan blinded to the data of the lymphatic mapping. The lymphatic map will be compared to the radiation treatment plan and previous imaging (MRI / CT / FDG-PET/CT).

Main study parameters/endpoints:

1. Is it feasible to perform lymphatic mapping in locally advanced cervical cancer? Is there visualisation of (multiple) lymph nodes in both sides of the tumor?
2. Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?

Eligibility Criteria:
Inclusion Criteria:

Histologically proven locally advanced cervical cancer \[FIGO stage IIB-IVA\]. \>18 years old. Treatment with curative (chemo)radiation. Signed informed consent.

Exclusion Criteria:

Pregnancy. Administration of the radioactive tracer cannot be ensured properly due to obesity Patients with tumors in which no circumferential injection of \[99mTc\]Tc-nanocolloid is possible due to the size or position of the tumor.