cyrilzakka/clinical-trials huggingface dataset:
Internet-delivered Therapy for Alcohol Misuse: Investigating Patient Preference for Self-guided or Guided Treatment

Internet-delivered cognitive behaviour therapy (ICBT) shows promise as a method of treating alcohol misuse. In this form of treatment, patients complete online lessons over several weeks that assist patients in developing skills to address alcohol misuse. ICBT can be offered to patients in a self-guided format or with guidance. Self-guided ICBT allows users to complete lessons by themselves without any contact with a guide. Guided ICBT involves having support from a guide in the form of emails, online messages and/or brief telephone calls. In some studies, guided-ICBT has shown greater reductions in alcohol consumption than self-guided ICBT. To date, there has been limited research on patient preferences for these varying levels of support when ICBT is offered as part of routine health care. This represents an important research direction as there is some past research showing that patients' treatment preferences can affect study enrollment, attrition, adherence, satisfaction, and outcomes.

This study will investigate patient preferences for self-guided ICBT versus guided-ICBT and compare enrollment, attrition, adherence, and outcomes of the two approaches when patients select their treatment preferences. The study will also explore the extent to which preferences are related to patient background variables (e.g., duration, severity of problems, treatment goals in terms of patients wanting to cut-down on alcohol use versus to abstain from alcohol use). Furthermore, this study seeks to identify how ratings of effort and helpfulness throughout treatment vary depending on whether patients select self-guided versus guided ICBT. This study represents a pragmatic observational trial conducted in routine care and aims to increase understanding of how to implement ICBT within routine care.


Eligibility Criteria:
Inclusion Criteria:

* Timeline Followback (TLFB; preceding week alcohol consumption) \> 13 drinks
* Alcohol Use Disorders Identification Test (AUDIT) \> 7

Exclusion Criteria:

* Suicidal ideation (measured by scoring \> 2 to question 9 of PHQ-9)
* Severe mental health or medical conditions
* Severe drug use problems (measured by scoring \> 24 on Drug Use Disorders Identification Test \[DUDIT\] or clinical assessment)
* Low motivation to do, or concerns regarding, online treatment
* Ongoing or impending significant mental health treatment
* Not residing in Saskatchewan Canada for the duration of treatment
* Lack of or inconsistent access to a computer and internet at home or private place for the duration of treatment
COL4A1 Gene Related Cerebra-retinal Angiopathy

This prospective multicenter cohort study aims to define the clinical, radiological and mutational spectrum of the disease related to COL4A1 gene.

150 index patients (children or young adult) will be prospectively recruited over three years according to eligibility criteria. Relatives will be also recruited.

Clinical, brain MRI-MRA and genetic testing (COL4A1 mutation screening) will be conducted for each included patient or asymptomatic relatives. 13 French investigating centres will be participating to the study.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the index patient :

* Children and young adult (\< 65 years)
* Intracranial hemorrhage of unknown etiology
* leukoencephalopathy
* Any associated signs (including retinal arteriolar tortuosity, intracranial aneurysm, porencephaly, Infantile Cerebral Palsy, juvenile cataract)

Exclusion criteria:

(for the index patient)

* Hypertension
* Diabetes
* Other (than COL4A1) genetic small vessel diseases of the brain
Role of Coenzyme Q in ADHD in Children

Role of Coenzyme Q in ADHD in Children

Role of Coenzyme Q in ADHD in Children: will it add a benefit?

Eligibility Criteria:
Inclusion Criteria:

* Patients with ADHD

Exclusion Criteria:

* Comorbidities like Autism, Anxiety, Obsessive compulsive disorder.
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment

PANGEA is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 7 days to 17 years inclusively and admitted to an ICU (ICU can be classified as general, cardiac, trauma, etc).
2. Children with acute or acute on chronic neurologic disease that occurred just prior to hospital admission or occurred during the hospital admission.
3. Acute neurologic disease is secondary to TBI, stroke, brain mass, hydrocephalus, cardiac arrest, status epilepticus, CNS infection/inflammation, or spinal cord injury.

Exclusion Criteria:

1. Children with acute perinatal neurologic disease.
2. Children with isolated chronic brain injury and no acute neurologic disease.
Role of Residual Urine and Asymptomatic Prostatitis in the Development of Urinary Tract Infections in Spinal Cord Injury

The purpose of this prospective study is to investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (\>2 /year) symptomatic urinary tract infections in patients suffering from chronic (\> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization.

The following hypotheses will be tested:

1. The amount of residual urine after intermittent catheterization is significantly greater in SCI patients suffering from frequent (\>2 /year) urinary tract infections compared to those without.
2. The incidence of asymptomatic bacterial prostate infections is significantly higher in SCI patients suffering from frequent (\>2 /year) urinary tract infections compared to those without.

To investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (\>2 /year) symptomatic urinary tract infections in patients suffering from chronic (\> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization, patients perform self-catheterization twice (before and after urodynamic testing. After each catheterization, residual urine is assessed by ultrasound. Prior to urodynamic testing, prostate massage is performed, bacterial cultures of the fluid and the urine are initiated and the results of these cultures will be analysed .

Eligibility Criteria:
Inclusion Criteria:

* male patients with chronic (\> 1 year) spinal cord injury
* bladder management by intermittent catheterization

Exclusion Criteria:

* symptomatic urinary tract infection
* prostate pathology
* immunodeficiency
* antibiotic therapy
* missing informed consent
Iron Bioavailability of Fortified Oat Drink

This study will follow a double blinded randomized controlled study design to enroll 20 apparently healthy 6 year old children. The children will be fed with two different nutrient fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA). Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for stable isotope measurements and iron absorption will be calculated.


Eligibility Criteria:
Inclusion Criteria:

* 6 year old children (inclusive)
* Normal BMI for age (WHO standard: 15.3-15.5 kg)
* Apparently healthy, no metabolic or gastrointestinal disorder; non-anemic (Hemoglobin values not less than 11.5 mg/dL -WHO cut-off for respective age)
* No medication or vitamin/mineral supplement will be consumed during the study; intake of vitamin/mineral supplement will be discontinued 2 weeks before the start of the study
* Parents demonstrate an understanding of the given information and ability to comply with the study procedure
* Obtained parental or legal representative's informed consent

Exclusion Criteria:

* Known gastrointestinal or metabolic disorder or experiencing blood losses over the past 6 months;
* Children taking medication
* Children who are anemic (Hemoglobin values less than 11.5 mg/dL - WHO cut-off value for this age)
* Currently participating or having participated in another clinical trial during the past 3 months prior to the beginning of the study
Ultrasound-guided Versus Landmark-guided Percutaneous Dilational Tracheostomy in Pediatric Patients

Percutaneous dilatational tracheostomy is one of the most common procedures performed in pediatric intensive care units. The investigators aimed to compare traditional landmark-guided percutaneous dilatational tracheostomy (PDT) and ultrasound-guided percutaneous dilatational tracheostomy in pediatric patients in terms of location, duration, and potential complications related to the procedure.

Tracheostomy, one of the most common procedures performed in intensive care units (ICU), refers to creating a stoma in the anterior wall of the trachea to maintain airway security. Tracheostomy can be formed via a surgical or percutaneous dilatational technique (1). The surgical technique requires the transportation of the patient to the operating theatre, while the percutaneous dilatational technique can be performed in the ICU. Thus, ICU practitioners commonly prefer the percutaneous dilatational technique.

Percutaneous dilatational tracheostomy can be performed via three approaches: landmark, ultrasound (USG), or bronchoscopy guided. Although landmark-guided PTD is a practical approach, there are growing concerns regarding the location of the second and third tracheal rings and injuries to vascular structures and the thyroid gland. USG may be helpful to establish the anatomy of the airway and the vascular and glandular structure of the area.

The investigators aimed to compare traditional landmark-guided percutaneous dilatational tracheostomy and USG-guided percutaneous dilatational tracheostomy in pediatric patients in terms of location, duration, and potential complications related to the procedure.

Eligibility Criteria:
Inclusion Criteria:

* healthy pediatric patients
* between 5 and 13 years old

Exclusion Criteria:

* neck anomalies
* syndromic patients
Parents Matter!: Interventions to Promote Effective Parent-Child Communication

Parents Matter is a community-based project whose goal it is to develop and test an intervention designed to promote effective parent-child communication about sexuality in order to promote sexual health among adolescents.

Participants in the intervention are African American parents or guardians who have children in the 4th or 5th grade that are 12 or younger. Recruitment was done through schools, housing authorities, community based organizations, and churches. Participants were randomly assigned to participate in one of three interventions delivered by community based interventionists. The enhanced sexuality communication intervention consists of five 2.5 hour sessions conducted over 5 weeks with booster sessions at 12 and 24 months post-intervention. The full sexual communication intervention focuses on general parenting skills and sexual communication skills using a variety of presentation modalities: group discussion, video, and role-plays. The brief sexual communication intervention consists of a single 2.5 hour session in which parents are provided with information on general parenting skills and sexual communication skills. Thus, this intervention seeks to provide the same information as the full sexual communication intervention but in a condensed format with little group participation. The control intervention is a single 2.5 hour session focusing on general child health issues such as diet and exercise rather than parenting and sexual communication.

Eligibility Criteria:
Inclusion Criteria:

The eligibility criteria for the parent-child dyad are as follows:

* The parent or guardian must be African-American
* The parent or guardian must be the primary caregiver for a child in 4th or 5th grade who is 12 or younger at the time of the 1st assessment.
* The parent or guardian and the child must have lived together continuously for at least the past 3 years and the child must spend most nights (5 or more) with the parent or guardian.
* The parent or guardian and the child must both speak English.
The Ohio State University Sepsis Registry

Specific Aim #1: To collect follow-up information about patients with sepsis in the OSUMC MICU who survive to hospital discharge for future retrospective IRB-approved studies.

Specific Aim #2: To collect a registry of patients who would be interested in hearing more information about future prospective IRB-approved studies for survivors of sepsis.

Specific Aim #3: To collect a blood sample from patients with sepsis admitted to the OSUMC MICU for future retrospective IRB-approved studies.

There are several goals of the Ohio State University Sepsis Registry and Blood Bank. First, we hope that, by collecting a cohort of patients with sepsis, we will provide information for future studies with data of specific relevance to sepsis (the Clinical Registry). Second, by following survivors of sepsis for a more prolonged period than prior studies, we will better understand the disease process and the duration of recovery (the Follow-up Registry). We will contact hospital survivors every six months to assess their vital status, living situation and employment. Furthermore, subjects will have the opportunity to find out about new studies as they arise. Finally, we will ask subjects for permission to collect a blood sample (10 cc) to use for future studies analyzing genetic and protein data. There will be a step-wise consent process that will allow subjects to opt out of any or all parts of the study.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to OSUMC MICU, ≥ 18 years, have consensus criteria for sepsis (infection plus two of four systemic inflammatory response syndrome \[SIRS\] signs \[tachycardia, tachypnea, fever or hypothermia, leukocytosis or leukopenia\]).

Exclusion Criteria:

* Consent not available or declined, prisoner, died before discharge (excluded from Follow-up Registry only), died before blood collected (excluded from Blood Bank only), onset of sepsis more than 24 hours prior to ICU admission. Patients who have sepsis onset more than 24 hours prior to ICU admission but spent the ENTIRETY of the current admission in the OSUMC ED will be eligible.
Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation

In this study, it was aimed to evaluate whether or not NMES in front of the mirror brings an additional benefit to mirror therapy alone or NMES alone on upper extremity motor and functional development, spasticity, anxiety, depression, cognitive function and activities of daily living, and neuropathic pain.

Cerebrovascular diseases are the general name given to clinical neurological pictures that occur as a result of pathological changes in the blood vessels of the primary lesion and / or in the properties of the blood passing through them. Many complications develop in the acute and chronic periods in patients with stroke, and the rate of complication development has been reported to vary between 40-96% in different studies. The aim of hemiplegic upper extremity rehabilitation is to prevent complications and improve lost motor-sensory control. Upper limb rehabilitation is less successful than lower limb rehabilitation because the upper limb is more functional and more complex.

For muscle reeducation, NMES is used to strengthen inhibited muscle groups, facilitate voluntary isolated muscle contraction, prevent muscle atrophy, increase metabolism and enzyme activity, change the contractile properties of the muscle, maintain or increase the normal range of motion of the joint, develop voluntary movement and functional gains. NMES has been used in hemiplegia rehabilitation since 1960 for the purpose of functional retraining of muscles. The purpose of this treatment is to enable the muscles with impaired neural function of the electrical current to perform a functional and useful movement.

Applications in front of the mirror are thought to trigger the neuronal connections in the motor cortex associated with the imagined movement. Findings obtained from studies with functional magnetic resonance support this theory. Compared to conventional PR, applications in front of the mirror are thought to have more and longer-lasting effects.

Eligibility Criteria:
Inclusion Criteria:

* Subacute hemiplegia
* Patients who can communicate well, are motivated enough and are willing to participate in the study
* Patients' medical conditions are stable
* Initiation of voluntary extension movement in the wrist (lower limit)

Exclusion Criteria:

* The presence of more than one previous cerebrovascular disease (except transient ischemic attack).
* Presence of flaccid hemiplegia.
* Presence of a previous neurological disease causing a decrease in strength in the affected extremity.
* Presence of deformity due to a previous fracture, inflammatory arthropathy, etc. in the affected extremity.
* Presence of more than grade 3 spasticity in upper extremity according to Modified Ashworth Scale
* Use of cardiac pace maker
* Presence of fatal cardiac arrhythmia
* Presence of seizure history within 2 years.
In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp

The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use.

Additional objective of this clinical in-use study was to evaluate the cosmetic features and the acceptance of the product by means of a questionnaire at the end of the 4-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* age: ≥ 18 years
* with chronically itchy scalp
* normal to dry scalp or scalp prone to neurodermatitis

Exclusion Criteria:

* any deviation from the above-mentioned criteria
* users of sour hair conditioner
* subjects who wash their hair more than once a day
* other dermatological disorders (scars, moles) on the scalp
* known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
* topical medication in the test area within 1 month prior to study start
* systemic medication with anti-inflammatory agents and antibiotics within two weeks prior to starting of the study
* systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within four weeks prior to starting of the study
* severe internistic disease that leads to pruritus
Confirmatory Study of NeoCart in Knee Cartilage Repair

This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.


Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years old
* symptomatic articular cartilage lesion of the femur and/or trochlea

Exclusion Criteria:

* prior surgical intervention other than debridement
* arthritis
* clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO

This was an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort enrolled patients with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). The results of the second cohort are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14 days of completion of the 24 month treatment phase of the previous study.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Completion of the treatment phase (through Month 24) of a Genentech-sponsored ranibizumab study for AMD (FVF2598g, FVF2587g, or FVF2428g) (Cohort 1)
* Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

Exclusion Criteria:

* Previous subfoveal focal laser photocoagulation in the study eye
* Previous pegaptanib sodium injection in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 of this extension study
* History of submacular surgery or other surgical intervention for AMD in the study eye
* History of glaucoma filtering surgery in the study eye
* History of corneal transplant in the study eye
* Concurrent use of systemic anti-EGF agents
* Use of AMD treatments not approved by the FDA
* Use of intravitreal Avastin(R) (bevacizumab) in the study eye and/or fellow eye
* CNV in either eye due to other causes than AMD, such as ocular histoplasmosis, trauma, or pathologic myopia for Cohort 1
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)
* Pregnancy or lactation
* Premenopausal women not using adequate contraception
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
* Current treatment for active systemic infection
* Inability to comply with study or follow-up procedures
PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy

The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.

This research intends to prospectively enroll patients with prior negative biopsies, a PI-RADS score ≤ 3, and persistent PSA or PHI elevation, randomly assigning them to the PSMA PET/MRI group (experimental group) and the TRUS-guided transperineal saturation biopsy group (control group). The research aims to evaluate the application of PSMA PET/MRI in clinically suspected prostate cancer patients with prior negative biopsies, comparing the differences in csPCa detection rates between PSMA PET/MRI-TRUS guided prostate targeted biopsy and TRUS-guided saturation biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Serum PSA \> 4 ng/mL
* At least one prior negative prostate biopsy
* At least two consecutive increases in PSA and/or PHI
* Negative digital rectal examination
* Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3

Exclusion Criteria

* Age ≤ 30 years or \> 85 years
* Concurrent presence of other malignant tumors
* Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)
* Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.)
* Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)
* Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)
* Incomplete clinical or pathological data