cyrilzakka/clinical-trials huggingface dataset:
UK Prevalence of Mental Health After SCI

Mental health decline after Spinal Cord Injury (SCI) is commonly reported but minimally investigated in the United Kingdom. The current study aims to explore the prevalence and impact of mental health challenges after SCI to establish population norms in the UK. Additionally the current study will aim to identify barriers to and facilitators of mental health support seeking in people with SCI.

A four-phase mixed methods research study will be undertaken. Phase One will be a cross-sectional online survey designed to determine the prevalence of mental health conditions in adults with SCI in the UK assessing resilience, anxiety, depression, pain, life satisfaction, PTSD and coping self-efficacy.

Phase Two will consist of in-depth semi-structured online interviews conducted with approximately twenty people with Spinal Cord Injury who, in the first study, indicated either that the participants had accessed, or had wanted to access mental health services. The two-part interview schedule will be undertaken, covering: 1) core themes surrounding the causes of, changes in, and management of mental health after SCI; and 2) questions relating to participant hopes for and experiences of satisfaction with, access to and efficacy of mental health services, in the context of the mental health service providers which participants currently use or have attempted to access.

Phase Three will consist of in-depth semi-structured online interviews held with approximately twenty 'significant others' (partner/family/friend) of people with Spinal Cord Injury whose family member/partner/friend experience mental health problems. The interview schedule will cover two core themes surrounding: 1) perceptions of the causes and impact of mental health difficulties after SCI on 'significant others'; 2) their experiences of current mental health services provided for participants' partner/family/friend and perceived recommendations and hopes for better management of mental health in participants' family member/partner.

Phase Four will recruit twenty-five people with high resilience (\>30 on the CD-RISC-10) to participate in an in-depth semi-structured online interview. This will review participants' thoughts and perceptions about resilience and how it is possible to maintain a high level of resilience whilst living with spinal cord injury.

Eligibility Criteria:
Inclusion Criteria: Phases 1 and 2 (survey and SCI interviews)

* Adults with spinal cord injury
* Adults with cauda equina syndrome

Exclusion Criteria:

* Difficulty with written or verbal English Language comprehension

Inclusion Criteria: Phase 3

- Partner, Spouse, Family member or carer of a person with Spinal Cord Injury

Exclusion criteria:

- Difficulty with verbal English Language comprehension

Inclusion Criteria: Phase 4

- Adults with Spinal Cord Injury who screen as having resilience higher than 30 on the Connor-Davidson Resilience Scale (CDRS-10).

Exclusion Criteria: Phase 4

* Adults with Spinal Cord Injury with resilience lower than 30
* Adults with Spinal Cord Injury who choose not to complete the CDRS-10.
Checking the Usability of a Virtual Reality System in Children With Brain Injury

The purpose of this study is to check the usability of Virtual Reality (VR) Video Capture Projected System in children with acquired brain injury(ABI)and comparing their performance to the performance of normally developing children. The trial shall include 15 subjects in each group, aged 6-12 years old. ABI subjects are hospitalized at the hospital's Pediatric Rehabilitation Department Each subject will experience 3 different virtual environments. The subjects in the trial group will practice 3 experiences (3 times in 3 different days) during a period of a week to 10 days, to check the practice effect.In addition, all subjects will be tested in three tests: "PEDI" - to evaluate the functional abilities of daily living (dressing, eating...),The "Melbourne Assessment" - to evaluate functional movements of upper extremities, and the TEA-ch - to evaluate different attention abilities. Performance correlations will be tested between these tests and the performance in the VR first experience.

The purpose of this study is to check the usability of Virtual Reality (VR) Video Capture Projected System in children with acquired brain injury(ABI) comparing their performance with the performance of normally developing children, matched by age, gender,sector and parents' education. subjects' age: 6 - 12 years old. The trial shall include 15 subjects in each group. ABI subjects are hospitalized at Sheba Hospital's Pediatric Rehabilitation Department.

Each subject will experience 3 different virtual environments. The subjects in the trial group will practice 3 experiences (3 times in 3 different days) during a period of a week to 10 days, to check the practice effect. In addition, all subjects will be tested in three tests: "PEDI" - to evaluate the functional abilities of daily living (dressing, eating...),The "Melbourne Assessment" - to evaluate functional movements of upper extremities, and the TEA-ch - to evaluate difference attention abilities.

Correlations between those tests to the performance in the VR experiences will be checked with Pearson's statistical correlation tests. The differences between the trial group (ABI children) and the control group will be checked with Independent t-tests.

Eligibility Criteria:
Inclusion Criteria:(trial group)

* acquired brain injury as a result of brain tumor excision intervention, traumatic brain injury, infection, vascular disorders, metabolic disorders or anoxia.
* ability to move at least one of the upper extremities against gravity in a partial range of motion (MMT: -3)

Exclusion Criteria: (trial group)

* Significant visual limitations
* Premorbid, progressive mental disorder or neurological injury
* Premorbid learning disability

Inclusion Criteria (control group):

* healthy subjects

Exclusion Criteria (control group):

* developmental disorders
* significant medical problems
* neurological disorders
Micro-Randomized Trial to Optimize Digital Oral Health Behavior Change Interventions

The study will involve a 10-week Micro-Randomized Trial (MRT) to inform the delivery of prompts (via mobile app push notifications) designed to facilitate adherence to an ideal tooth brushing protocol (2x2x4; 2 sessions daily, 2 minutes per session, all 4 quadrants).

The goal of the MRT is to investigate whether delivering (vs. not delivering) a prompt that contains engagement strategies grounded in decision science is beneficial in terms of promoting proximal oral health behavior (OHB) score, which reflects adherence to the 2x2x4 brushing protocol (Primary Aim) and also mobile health engagement (mHealth; Secondary Aim). Additionally, Exploratory Aims will concern (a) comparing different types of prompts in terms of proximal OHB score and mHealth engagement, (b) investigating the conditions in which prompts should be delivered to most effectively promote proximal OHB and mHealth engagement; and (c) investigating whether the effect of the engagement prompts (vs. no prompt) on OHB score varies across components of the 2x2x4 brushing regimen (i.e., frequency, duration, or coverage).

Participants will receive an electronic toothbrush (eBrush) and a mobile app (Oralytics) that contains well-established behavior change strategies (e.g., goal setting, monitoring adherence, and feedback). Participants will be randomized twice per day - in the morning and the evening - to receive either (a) a push notification containing one of three (randomly selected) engagement strategies or (b) no notification.

During the 10 weeks of the study, a Bayesian algorithm will iteratively adjust the probability of receiving a prompt or no prompt in any given randomization window, using prior behavioral data collected through the eBrush and mobile app. Data patterns suggesting positive effects of the prompts on adherence to brushing protocol, especially duration, will result in higher subsequent probabilities of receiving the prompts, whereas patterns suggesting null or negative effects will result in lower probabilities of receiving the prompts.

Study results will inform the implementation of a smartphone-delivered behavior change intervention that further adapts the delivery of engagement prompts based on passively collected information from an eBrush and the mobile app.

Eligibility Criteria:
Inclusion Criteria:

* Adults, age 18 or older.
* Fluent in English
* Dentulous/partially edentulous (18+ teeth; at least 2 teeth in each quadrant)
* Possess a smartphone (iOS or Android) with a data plan.
* Willing to allow the passive collection of data on tooth-brushing activities in the home setting for 10 weeks.

Exclusion Criteria:

* Not fluent in English
* Edentulous
* Unable to use a mobile device due to cognitive or physical impairments
Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice

This study is designed as a retrospective, multi-center study. The study population consist of subjects who received one or more OsseoSpeed EV implants during the period January 1st 2015 to December 31st 2016. Two hundred subjects will be enrolled, approximately 25-30 subjects per site. The study includes retrospective data collection from subjects' medical records and data collection from one prospective study visit with a clinical examination.


Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 18 years at time of implant installation.
* Subject signed and dated the informed consent form.
* Having installed one or more OsseoSpeed EV implants between January 1st 2015 and December 31st 2016.

Exclusion Criteria:

* Unlikely to be able to comply with study procedures, according to Investigator's judgement.
* Subject is not willing to participate in the study or not able to understand the content of the study.
* Involvement in the planning or conduct of the study.
* Simultaneous participation in another clinical study that may interfere with the present study.
* Severe non-compliance to Clinical Investigation Plan (CIP) as judged by the Investigator and/or Dentsply Sirona Implants.
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users

Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).

The main purpose for this study is to determine whether dimebon exhibits abuse potential.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years.
* Recreational polydrug user with a history of CNS depressant use.

Exclusion Criteria:

* History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
* A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
* Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
* History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.
Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose parents or guardians can issue informed consent
* Patients aged over 7 and less than 16 at the baseline
* Patients confirmed to show type I allergy
* Patients with allergic conjunctivitis
* Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)

Exclusion Criteria:

* Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis
* Patients having retinal detachment, diabetic retinopathy or progressive retinal disease
* Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury
* Patients having received continuous treatment with corticosteroid within 3 months
* Patients having received immunotherapy
* Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product
* Patients having undergone ocular laser therapy within 3 months
* Unilaterally blind patients (best corrected visual acuity: below 0.01)
* Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride
* Patients necessitating the use of contact lens during the study period
* Other patients judged by the attending physician as inappropriate for study
Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)

This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective measures (Hb and iron parameters).

Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.

Randomized patient-blind placebo controlled study. Hb level of 10 g/dl will be used as a cut-off value for our study based on the guidelines published by American Society of Clinical Oncology and the American Society of Hematology for the treatment of cancer-related anemia, recommending Hb\<10 g/dl as a treatment threshold.

Ferinject® to be administered based on Hb and body weight per approved summary of product characteristics (SmPC).

5 - 7 days after gastrectomy for gastric cancer, consented patients with 7g/dl≤Hb\<10g/dl will be administered Ferinject® or placebo (normal saline) based on the results of randomization.

• Study Group Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50Kg .

Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight \<50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value \<15ng/mL at week 4 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)

• Control Group Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight \<50 Kg.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 20 years old
* 7g/dl ≤ Hb \< 10g/dl at 5 - 7 days after gastrectomy for gastric cancer
* signed written informed consent

Exclusion Criteria:

* a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
* hypersensitivity to any component of the formulation
* active severe infection/inflammation
* History of transfusion, erythropoietin, \> 500 mg intravenous iron administration within 4 weeks prior to screening.
* History of acquired iron overload.
* Pregnancy or lactation.
* Decreased renal function (defined as creatinine clearance \< 50 mL/min calculated by Cockcroft-Gault)
* Chronic liver disease or increase of liver enzymes (ALT, AST) \> 3 times the upper limit of normal range.
* Participation in any other interventional study within 1 month prior to screening.
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR
* Willingness and ability to comply with scheduled visits, treatment plan, and procedures

Exclusion Criteria:

* Requires precaution against suicide
* Not in generally healthy medical condition
* Poor compliance with study drug or study procedures during participation in study B2061032
Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing LDD in Turkish Population

This study aims to show the association between the Interleukin-1β (rs 1143627 T/C) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility.

Background: Lumbar disc degeneration (LDD), a complex process characterized by phenotypic and genotypic changes, causes low back pain.

Aims: This study aims to show the association between the Interleukin-1β (rs 1143627 T/C) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility.

Method: A hospital-based case-control study included 50 LDD patients and 44 healthy controls. In this study, Taqman allelic discrimination analysis was performed for the genotype of the Interleukin-1β (rs 1143627 T/C) gene polymorphism. Differences in Interleukin-1β allele frequencies and genotypes were evaluated between patients and controls. Relationships between allele presence/genotype and disease risk are reported as odds ratios (ORs) with 95% confidence intervals (CIs). The Pfirrmann classification was used to grade the level of disc degeneration on MRI scans, and the McNab's classification was used to classify disc displacements. The pain levels of the patient group were evaluated with VAS and their functional disability with ODI. Spinal flexibility was evaluated using the Modified Schober method and a digital inclinometer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic low back pain (over 3 months
* Aged 18-60 years old
* With magnetic resonance imaging (MRI) evidencing LDD with Pfirrmann classification

Exclusion Criteria:

* Cauda equina syndrome
* Lumbar spinal stenosis
* Spinal deformities (scoliosis, kyphosis, spondylolisthesis)
* Vertebral fractures
* Inflammatory rheumatic diseases
* Diabetic neuropathy
* Pregnancy
* Drug and alcohol dependence
* Psychiatric illness
* Oncologic diseases
* Who refuse to sign the consent form and donate a blood sample for analysis of genomic DNA.
Lidocaine for Pain After Urodynamic Testing

Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2 phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours after testing). Additionally, the investigators will record any adverse effects (such as an allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after testing.

Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it contains no active drug. The assigned study regimen will be chosen by chance, like flipping a coin. Participants will have an equal (50/50) chance of being given either study regimen. Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting. Additionally, a member of the study team will ask participants about their pain level before and after the testing. The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study.

Eligibility Criteria:
Inclusion Criteria:

• All female patients between the ages of 40-80 undergoing urodynamic testing.

Exclusion Criteria:

* Urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks
* History of urinary retention
* Known or suggested history of urethral syndrome or painful bladder syndrome
* Prior anti-incontinence surgery
* Prior pelvic surgery with placement of transvaginal mesh
* Known urethral or bladder anomaly including urethral diverticulum or congenital anomalies of the bladder or urethra
* History of genital herpes outbreak within the past 3 months
* Defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations, or lacerations
* Neurologic disease affecting urethral sensation
* Chronic pelvic pain
* Contraindication or allergy to topical anesthetic
* Pregnancy
* Syncopal episode during preparation for or execution of uroflowometry