cyrilzakka/clinical-trials huggingface dataset:
Contribution of New Generation Oxford Nanopore-type High-throughput Sequencing in the Diagnostic Strategy of Neurogenetic Diseases.

Since 2012, NGS sequencing of long fragments or long reads has developed in various fields of research and today presents itself as a very promising alternative solution in the analysis of repeat amplifications. The Oxford Nanopore NGS automaton offers the prospect of bringing together 1st and 2nd line analyzes of all loci potentially indicated in neurogenetics at the same time. The project aims to compare the use of this new technology with methods currently used in reference laboratories.

The main objective is to evaluate the ability of next-generation high-throughput Oxford Nanopore-type sequencing (NEURONGS3) to diagnose 9 neurogenetic diseases compared to reference protocols via PCR (+/- Southern blot).

The secondary objective is to evaluate the repeatability of the NGS (intra-sample reproducibility) analysis in the diagnosis of 8 neurogenetic diseases.

Since 2012, NGS sequencing of long fragments or long reads has developed in various fields of research and today presents itself as a very promising alternative solution in the analysis of repeat amplifications. The Oxford Nanopore NGS automaton offers the prospect of bringing together 1st and 2nd line analyzes of all loci potentially indicated in neurogenetics at the same time. The project aims to compare the use of this new technology with methods currently used in reference laboratories.

Multicenter cross-sectional early phase diagnostic study on already existing biological collections. Analyzes with the new technique (NGS) will be carried out blinded to the results obtained with the current reference algorithm based on the sequential performance of PCRs The main objective is to evaluate the ability of next-generation high-throughput Oxford Nanopore-type sequencing (NEURONGS3) to diagnose 9 neurogenetic diseases compared to reference protocols via PCR (+/- Southern blot).

The secondary objective is to evaluate the repeatability of the NGS (intra-sample reproducibility) analysis in the diagnosis of 8 neurogenetic diseases.

Eligibility Criteria:
Inclusion Criteria:

* minors, adults and protected adults.
* Subject carrying an amplification of nucleotide repeats in one of the following 9 genes FMR1, DMPK, ZNF9, SCA2, JPH3, HD, FXN, C9ORF72, RFC1
* DNA available in sufficient quantity (5 to 10 µg)

Exclusion Criteria:

* DNA degraded or of medium size \<30kb,
* Patient objection to research - This patient objection must be reached to the center's investigator within 1 maximum period of 1 month after sending the information note.
AZD8683 Single Ascending Dose Study

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examinations
* Use any prescribed or non-prescribed medication
Effect of Family-Based Prevention on Children of Depressed Parents

This study will test the Protecting Families Program, a 10-week prevention program for depressed parents and their pre-teenage children, by comparing the effectiveness of the program versus parent training alone.

Children of depressed parents are at risk for developing social-emotional problems. Despite the fact that economic hardship is a strong risk factor for both maternal depression and poor child development, little research has been conducted to develop prevention programs for low-income urban families. This randomized, open-label study will address the research gap by developing and pilot-testing the Protecting Families Program (PFP), a family-based, multi-component prevention program. The PFP will offer its services to low-income, urban, depressed parents and their children between the ages of 9 and 14.

Prior to the interventional portion of the study, several small focus groups composed of mental-health care providers and depressed parents will meet. The purpose of these focus groups will be to gather information that will help maximize the effectiveness of the remainder of the study. The interventional phase will compare PFP combined with individual parent training versus parent training alone. Participants will be randomly assigned to one of these two intervention groups. The study will last a total of 10 weeks. Both groups will meet once each week. PFP will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child. Participants' symptoms, diagnosis, functional status, family functioning, cognitive factors, and parenting practices will be assessed at the study start date, immediately post-intervention, and 6 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Parent is currently in treatment
* Parent's primary DSM-IV diagnosis is major depressive disorder, dysthymia, or depression not otherwise specified
* Parent's child lives with him/her at least part time

Exclusion criteria:

* Parent has a history or current diagnosis of any psychotic disorder or organic brain syndrome
* Parent has history of bipolar or schizoaffective disorder
* Parent's IQ is below 70
* Parent has any serious medical or neurological disorder or condition that may prevent weekly participation
* Parent has chronic pain that may prevent weekly participation
* Parent or child is currently suicidal to the extent that it will interfere with outpatient treatment
* Parent has a current substance dependence
* Child is currently seeking psychological treatment
* Child is mentally retarded (determined by school and clinic records)
* Child has a clinically severe psychiatric diagnosis
Efficacy and Safety of Oral Probiotics on Ocular Symptoms and Gut Microbiome of Children with Vernal Keratoconjunctivitis

The primary goal of this study is to determine the effects of oral probiotics on the severity of ocular symptoms and the alterations of the gut microbiome of children (4-18 years old) with vernal keratoconjunctivitis. The current study will also assess the safety of oral probiotics among children with vernal keratoconjunctivitis. The main questions it aims to answer: 1- Does treatment with oral probiotics improve the severity of ocular symptoms in children with vernal keratoconjunctivitis? 2- Does treatment with oral probiotics alter the gut microbiome of children with vernal keratoconjunctivitis? Researchers will compare the ocular symptoms and gut microbiome between two groups receiving oral probiotics and placebo among children with vernal keratoconjunctivitis.

Participants The participants will receive the oral probiotics and placebo ever day for one month.

Record their regimen and keep a diary of their symptoms.


Eligibility Criteria:
Inclusion Criteria:1- Patients whose diagnosis of vernal keratoconjunctivitis is confirmed based on clinical criteria. 2-Patients with an age range of 4 to 18 years. 3-Patients who have not received drug treatment for vernal keratoconjunctivitis disease recently.

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Exclusion Criteria:1-Having other eye diseases (except refractive error) 2-Change in the diagnosis of the disease during the study 3-Antibiotics, anti-inflammatory drugs, immunosuppressive drugs 4-History of known gastrointestinal diseases (such as IBD, Celiac,...) 5- History of digestive problems in the last two weeks 6- Lack of consent to participate in the study 7- Having an eye infection in the last one month 8- People who were athletes or involved in intense physical activity 9- Smoking, alcohol and drugs. 10- Using drugs that affect appetite, bowel movements, and nutrient absorption 11- Using prebiotics, probiotics or synbiotics in the last 3 months 12- People who have been on a diet to lose or gain weight in the last 3 months 13- People who have undergone gastrointestinal surgery. 14- Changing the patient's diagnosis in the course of treatment 15- Failure to follow up the patient at the specified times for the visit and assessment of the patient's bed 16- Taking fat-reducing drugs 17-Oral hypoglycemic drugs, insulin, antihypertensive drugs-18- Diuretics, laxatives, antacids 19-Food supplements in the last 3 months.

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Secukinumab Open Label Roll-over Extension Protocol

The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).
2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
3. Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons).
4. Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement.
5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

Exclusion Criteria:

1. Participant has prematurely discontinued study treatment in the parent protocol.
2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).
Secondary Rupture of Aortic Aneurysm Post EVAR

Post-stent rupture of the abdominal aorta is a rare occurrence and with few publications: only 2 multicenter studies and one meta-analysis in 2017 listed this complication As well as a few cases reports This study, the first carried out in France, aims to describe the survival in patients with secondary rupture of the aneurysm despite initial treatment with EVAR.


Eligibility Criteria:
Inclusion Criteria:

* - Patient who had a ruptured aortic aneurysm between 01/01/1993 and 07/31/2020)
* Patients whose aortic aneurysm has been treated with EVAR

Exclusion Criteria:

* No
Effectiveness of a Community-based Multi-modal Tai Chi Rehabilitation Program for Patients After Total Knee Arthroplasty

The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is paramount to explore alternative strategies to enhance balance and physical functioning in post-TKA patients. As Tai Chi is a proven strategy for improving balance in older people, the proposed study aims to determine the feasibility and acceptability of a 12-week community-based post-TKA multimodal Tai Chi program and to collect preliminary data with respect to the efficacy of such a program in improving balance and physical functioning in post-TKA patients as compared to usual postoperative care.

This is a single-blinded 2-arm RCT. TKA participants will be randomized to either a 12-week community-based rehabilitation program starting at 12 weeks after TKA, or usual post-operative care without outpatient physiotherapy. A third group of asymptomatic controls will be recruited to provide comparisons at various time points. All post-TKA participants will undergo five clinical assessments: 1 week before TKA, and at 6, 12, 24 and 52 weeks after TKA. The untreated asymptomatic controls will be assessed at baseline, and 12 and 52 weeks from baseline

Eligibility Criteria:
Inclusion Criteria:

1. 60 years or above;
2. candidates for primary unilateral TKA who are placed on the TKA waiting list for less than 1 month before their surgery;
3. living independently in the community

Exclusion Criteria:

1. living in assisted living facilities, requiring nursing care, or planning to reside away from the hospital district within 1 year.
2. unstable medical conditions,
3. fracture of lower limbs,
4. malignancy in the last five years,
5. lower limb prosthesis/amputation,
6. congenital defect that is considered to cause the present complaint,
7. systemic inflammatory and autoimmune diseases,
8. previous osteotomy,
9. neurological diseases (e.g. Parkinson's disease, stroke),
10. blindness, revision TKA,
11. complications after primary TKA,
12. cognitive impairment with a Mini-Mental State Examination score \< 19
13. prior experience in practicing Tai Chi exercise for at least 3 months
A Feasibility Open Trial of App-Enhanced Brief CBT for Suicidal Inpatients

The purpose of this study is to evaluate the feasibility of integrating Brief Cognitive-Behavioral Therapy (BCBT) counseling with a software application (app) to prevent future suicidal thoughts and behaviors.

Participants will provide written informed consent. Participants will complete up to 4 sessions of BCBT (depending on length of stay) incorporating the use of a SmartPhone app. This study treatment will be completed in addition to usual care in an open trial design. Assessments will be completed at intake, discharge, and 1-, 2-, and 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* History of suicide attempt (lifetime) AND active ideation (with or without plan or intent) on admission
* Own and have access to their phone (iPhone or Android with capability to download apps) during their inpatient stay
* Ability to understand the nature of the study and provide written informed consent
* Willing and able to provide at least two verifiable contacts for emergency or tracking purposes
* Expected length of stay long enough to complete the entire treatment protocol

Exclusion Criteria:

* Not fluent in English
* Experiencing current mania or psychosis
* Have lifetime history of schizophrenia spectrum disorder, intellectual disability, or organic brain illness
* Inpatient treatment plan includes detox protocol or electroconvulsive therapy
* Any other psychiatric or medical condition that in the investigator's opinion would preclude informed consent or participation in the trial
Efficacy Assessment of Gluten Free Cupcakes

Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). After consumer acceptance against various attributes of aglutenic cupcake, the product will be provided in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2 cupcakes for each day) providing approximately 20% daily value (DV) of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group. Further product will be provided on follow-up visits. The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire (FFQ).

Raw Material/ Preparation of flour blends for aglutenic (gluten free) cupcakes:

Sorghum, chickpea, Flaxseed and Almond rich in healthy nutrients will be purchased from the local market. All these ingredients was ground into fine powder using uncontaminated grinder. Different flour blends was prepared by substituting whole wheat flour with Sorghum, Chickpea, Flaxseed and Almond flour at different replacement levels.

The efficacy study protocol was approved by the Bioethics Committee for randomized controlled trial (RCT). Written informed consent was obtained by the parents of children or their legal guardian.

Target population: Celiac Disease/gluten sensitive patients (n= 70, 35 control + 35 intervention) was recruited according to European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria.

Inclusion criteria:

In accordance with the inclusion criteria, boys and girls suffering from celiac disease was recruited:

* Positive trans-glutaminase antibody (tTG) as currently recommended test is the serum Immunoglobulin A (IgA) tissue trans-glutaminase antibody (tTG). The test has a sensitivity and specificity of greater than 90%.
* Clinical response to gluten free diet
* In the age range of 3-8 years

Exclusion Criteria:

* Patients on any other designed diet
* Taking vitamins and mineral supplements
* Individuals presenting with any other intestinal inflammatory disease, malignant diseases, chronic infections, thyroid, renal or hepatic alterations
* Taking drugs known to effect lipid and /or carbohydrate metabolism will be excluded from the study.

Effect of interventional product on nutritional status of participants will be assessed through anthropometric measurements, gastrointestinal complaints and following hematological indices;

* Complete Blood Count (CBC) WBCs, RBCs, MCV, Hb. , Hct. , Platelets
* Total Protein
* Lipid Profile HDL, LDL, VLDL, Cholesterol
* SGPT, SGOT
* Serum Electrolytes (Na ,Ca, K)

Eligibility Criteria:
Inclusion Criteria:

* Positive tissue trans-glutaminase antibody (tTG)
* Clinical response to gluten free diet

Exclusion Criteria:

* Vitamins and mineral supplements
* Intestinal inflammatory diseases
* Malignant diseases of intestines
* Chronic infections,
* Thyroid, renal or hepatic alterations
* Celiac patients with diabetes
* Taking drugs known to effect lipid and /or carbohydrate metabolism
D-serine in Schizophrenia

This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments.


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 Schizophrenia criteria, able and willing to give informed consent, and comply to study procedure, adequate contraception, post-menopausal or abstinent, PANSS Total Score equal or greater than 70, score of 4 or greater on two psychotic items

Exclusion Criteria:

* clinically significant, uncontrollable or unstable medical condition, mental retardation or severe organic brain syndrome, significant risk of suicide or violent behavior
Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After BR or RCHOP or R2: a Multicenter Clinical Study

This multi-center clinical study will evaluate the efficacy of Rituximab maintenance treatment of newly diagnosed follicular lymphoma after induction therapy of BR, RCHOP or R2.

Follicular lymphoma (FL) is a lymphoma of B cells in follicular center. It is a common pathological subtype of lymphoma, and its incidence rate is only next to diffuse large B cell lymphoma (DLBCL). The initial remission rate is high, but the tumor generally recurrent, making it difficult to be completely cured. This study attempts to explore the efficacy and safety of rituximab monotherapy maintenance after BR, RCHOP, R2 regimen induction therapy in the treatment of follicular patients, and to find the best way to maximize survival benefit and reduce treatment toxicity for FL patients. The study can improve the quality of life, prolong the survival and avoid the transformation to invasive lymphoma in patients with follicular lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
* Treatment naive
* Age ≥ 18 years
* Indications for treatment confirmed
* Must has measurable lesion in CT or PET-CT prior to treatment
* Considered suitable for RCHOP, BR or R2 regimens
* Informed consented

Exclusion Criteria:

* Transformed follicular lymphoma or 3B follicular lymphoma;
* HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
* Central nervous system or meninges involved
* Any drug contraindication in the treatment plan
* Patients judged by other researchers to be unsuitable for inclusion in the study
Address Tobacco Use Among Adolescents in Hong Kong

This study will examine the effectiveness of a social norms campaign in correcting smoking misperceptions, reducing smoking susceptibility and changing smoking-related behaviours in Hong Kong adolescents.

The study involves a behavioural intervention with social norms approaches to correct smoking misperceptions, reduce smoking susceptibility and change smoking-related behaviours in Hong Kong adolescents. A 2-arm stratified clustered randomised controlled trial (RCT) will be conducted to evaluate the effectiveness of the intervention. A total of 18 secondary schools will be randomly selected from the 5 regions in Hong Kong and invited to the RCT. The schools will then be randomly allocated to intervention or control group in the ratio of 1:1. Secondary 1 to 5 (US Grade 7 to 11) students will be invited. Students in both intervention and control group will complete a baseline survey, and the intervention group will receive the intervention after the baseline. Intervention materials includes posters and table tents at school, flyers to students, and online banner on school website. The intervention adopts social norms approaches, and will highlight the prevalence of adolescents who do not smoke and have no intention to smoke. It will last for 2 months. Both intervention and control groups will complete follow-up surveys at 3 and 9 months. The control group will receive the intervention materials after the RCT.

Eligibility Criteria:
Inclusion Criteria:

* Local secondary schools that cover grades 1-6

Exclusion Criteria:

* International secondary schools
* Special schools for adolescents with visual, hearing or other physical impairments or disabilities
Acupressure for COVID-19 Related Quality of Life and Stress

This study is being conducted to evaluate the efficacy of acupressure in promoting health and well-being among healthcare workers during the COVID-19 pandemic. The investigators hypothesize that providing participants with a remote and standardized self-acupressure training program will improve HRQOL and the perception of stress. In the event that the study demonstrates acupressure to be safe and effective for this indication, the training could be scaled up and deployed at low-cost nationally and internationally.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (18 years of age and over) who are health care providers according to self-report will be eligible for participation with the exception of subjects meeting exclusion criteria as below.

Exclusion Criteria:

* Exclusion criteria includes subjects who are physically unable to participate (e.g., from severe arthritis) or cognitively unable to participate (e.g., from dementia) will be excluded. Patients unable to provide their own informed consent will be excluded. Patients under the age of 18 years will be excluded. Pregnant women will be excluded. Patients who have previous training in acupressure will be excluded.