cyrilzakka/clinical-trials huggingface dataset:
Chatbot Intervention to Reduce Common Digital Addictions, Sedentary Behaviors and Mental Distress Among Adolescents

The goal of the study is to investigate the efficacy of a secondary low-intensity stage of change (SoC) and motivational interviewing (MI)-based Chatbot-assisted intervention in reducing digital addictions in adolescents with Internet gaming disorder (IGD) and/or social media addiction (SMA) by conducting a RCT.

Hypothesis: The intervention group will show a greater reduction in rates of IGD and/or SMA at post-treatment and 3-month follow-up than the control group.

Design and subjects: A two-armed RCT between the intervention group and psycho-educational control group for adolescents aged 10-19 with excessive screen time. Screening, baseline, post-programme, and 3-month follow-up evaluations will be conducted.

Participants will:

Be randomly assigned to online brief intervention or psycho-educational control

Complete questionnaires evaluating 1 ) Primary outcomes (IGD, SMA), 2) Secondary outcomes (sedentary lifestyle, mental distress, quality of life, eHealth literacy) and 3) Mediators/mechanisms (autonomy, competence)


Eligibility Criteria:
Inclusion Criteria:

* Students at grades 5-6 in primary schools or grades 7-12 in secondary schools,
* Positive screening results of IGD and/or SMA) based on the validated screening tools
* Using smartphone or Internet on a daily base, 4) students' and parental consent,
* Chinese speaking.

Exclusion Criteria:

* Current use of any psychotropic medication.
Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer

More than half of all pediatric cancer in Korea are solid cancer. For the treatment of solid cancer, multidisciplinary methods such as surgery, chemotherapy, and radiation therapy are applied, and with the development of the treatment method, the treatment performance has improved dramatically, and the 5-year survival rate of more than 80% is currently recorded. Due to the improvement in survival rate, interest in side effects caused by cancer treatment itself is gradually increasing, and efforts to reduce them are increasing. Accordingly, it aims to contribute to improving the quality of life of pediatric solid cancer survivors. by developing a Korean-type early diagnosis and follow-up protocol of ototoxic hearing loss, which commonly occurs in pediatric solid cancer who have undergone chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

① Solid cancer patients under the age of 19 receiving Platinum chemotherapy

② Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy

Exclusion Criteria:

① Those who have received chemotherapy or radiation in the past

* Those who have difficulty understanding the clinical trial due to mental retardation or unable to read the consent form, such as illiteracy or foreigners ③ Those who have difficulty in hearing test due to neurological factors, etc. ④ Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial
STIMPulseControl Ancillary Speech Study

Speech assessment is a substudy to the STIMPulseControl study (hereinafter referred to as the main study), where audio recordings of patients voices will be recorded as part of a speech analysis in the main study, for this optional ancillary study.

Speech of all study patients enrolled in the STIMPulseControl main study will be recorded at three points of time in a standardized way. Following this ancillary protocol, patients speech will be recorded at the baseline visit (preoperatively), at the 6-months visit and at the 12-months visit postoperatively.

For the baseline speech assessment the same protocol will be performed in chronic medication conditions. At 12-month follow up, we will repeat the speech protocol in chronic medication and stimulation condition. The recordings will be done in each centre in a decentralized way and the audio files will be produced according to a standardized protocol, and assisted by a step-by-step guided speech recording software.

Main aims and hypothesis for automated speech analysis study are safety measures for surgical interventions in PD assessment of parkinsonian (hypokinetic) motor speech features outcome after STN-DBS, assessment of dyskinetic (hyperkinetic) motor speech features outcome after STN-DBS, assessment of capsular speech features outcome after STN-DBS in PD emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD assessment of acoustic and linguistic speech features as proxy for behaviour and cognitive changes in PD, comparison of emotional and cognitive speech outcomes before and 1-year after STN-DBS + BMT vs BMT alone.

Eligibility Criteria:
Inclusion Criteria:

Please refer to main study (STIMPulseControl KKS-313)

Exclusion Criteria:

Please refer to main study (STIMPulseControl KKS-313)
PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

This study is to investigate retrospectively the effects of combination of immune checkpoint inhibitors anti-programmed death-1 antibody (PD-1 antibody) and radiotherapy for recurrent, metastatic and persistent advanced cervical carcinomas. Patients may or may not accept PD-1 antibody as maintenance therapy. Patients are followed up and the survival outcomes are evaluated. The primary endpoint are objective remission rate. The secondary endpoints are progression-free survival, overall survival and severe adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Confirmed of recurrent, metastatic, and persistent advanced cervical cancer
* Confirmed of subtypes of cervical squamous carcinoma, adenocarcinoma and adenosquamous carcinoma
* Accepting radiotherapy with concurrent anti PD-1 therapy
* With detailed follow-up outcomes

Exclusion Criteria:

- Not meeting all of the inclusion criteria
Text -Based Depression Screening Among Cancer Survivors

Depression is common among cancer survivors, but current screening methods are not always effective. To help improve depression screening for cancer survivors, this study will conduct a pilot randomized controlled trial (RCT) with 60 participants. The goal is to evaluate whether a text message-based approach to depression screening is feasible, acceptable, and potentially more effective than the current standard of care.

This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary efficacy of a text message-based depression screening approach for cancer survivors. A total of 60 adult cancer survivors will be enrolled and randomly assigned to either the text message intervention or the usual care depression screening. The intervention involves sending text messages one week before scheduled oncology appointments, inviting participants to complete a depression screening using the PHQ-2, followed by the PHQ-9 for those who screen positive.

The study will assess the feasibility of implementing text message-based screenings, participant acceptability, and compare the efficacy of this method to traditional in-person depression screenings during clinical visits. The primary outcome is feasibility, measured by the proportion of participants completing the screening via text, while secondary outcomes will include acceptability (assessed through participant surveys) and preliminary efficacy (measured by screening completion rates and depression detection).

Eligible participants will be English-speaking cancer survivors aged 18 or older with an upcoming oncology appointment at the Hollings Cancer Center or associated clinics. The study aims to improve current depression screening methods and address challenges such as logistical and system-level barriers in screening cancer survivors for depression.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* diagnosis of cancer
* upcoming appointment in an HCC or HCN oncology clinic within 14 days
* English proficiency
* ownership of a cellphone with SMS text capability.
Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder

Overactive bladder is a clinical diagnosis affecting up to 17% of women. The existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. Studies on TENS have shown a real impact on patients quality of life and encourage its use in routine clinical practice. TENSI+ medical device is a treatment for overactive bladder. It is non-invasive, placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin. Discreet and without side effects for users, this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications. The aim of this study is to assess the quality of life of patients using this device, both before use and after at least 3 months of use.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated for overactive bladder
* Patients using the TENSI+ for at least 3 months

Exclusion Criteria:

* Neurological disease that may explain overactive bladder
* Patient having received anticholinergic drug treatment during neurostimulation.
* Have one or more contraindications to wearing the device: pacemaker, defibrillator, wearing a mechanical implant near the electrode placement area, ankle joint problems, damaged skin, cognitive impairment.
COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study

The COVID-19 coronavirus has led to a global pandemic of respiratory diseases with an increase in hospitalization and death risk. To keep COVID-19 manageable for healthcare, early treatment is urgently needed to avoid hospitalization. Dexamethasone can dampen the exaggerated cytokine response to COVID-19 and is a promising agent for preventing disease aggravation, hospitalization and death. However, the evidence on the effectiveness, safety and cost-effectiveness of dexamethasone treatment in primary care is inconclusive.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* A positive test for SARS-CoV-2
* A GP consultation for deteriorating COVID-19 symptoms

Additional inclusion criteria in order to be eligible for randomization to the trial:

- Exercise-induced desaturation, defined as SpO2\<92% (\<90% for COPD patients) and/or an absolute drop of ≥4% in SpO2 after a 1-minute sit-to-stand test

OR

- SpO2\<92% (\<90% for COPD patients) in rest with GP's and patient's shared decision to keep patient at home despite this in itself being an indication for referral to hospital

Exclusion Criteria:

* Inability to understand and sign the written consent form
* Inability to perform saturation measurements or sit-to-stand test
* Not willing to be admitted to hospital
* On the discretion of the recruiting clinician if he or she deems a patient not eligible

The following criterion will be used to exclude patients from randomization to the trial:

* Contra-indication for dexamethasone
Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.

The objective of the study will be to evaluate the efficacy of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) in order to reduce or stabilize the atrophic progression in dry Age-related Macular Degeneration (AMD).

Patients will undergo intravitreal injections of CB-PRP (Cord Blood Platelet-rich Plasma) according to three different treatment regimens, and the efficacy and safety of CB-PRP in an in vitro model of lipopolysaccharide (LPS)-induced degeneration in hTERT RPE-1 and ARPE-19 model cell lines derived from retinal pigmented epithelium (RPE) will be evaluated.

The purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of CB-PRP and the response of photoreceptors in the macular region in dry-AMD. Microanatomical changes in the retina induced by intravitreal CB-PRP therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* Bilateral dry-AMD
* ETDRS-corrected visual acuity between (or equal to) 1/10 and 4/10
* No concomitant ocular pathology (e.g., Glaucoma, amblyopia) or systemic pathology that would result in a BIAS for primary goal assessment
* Signature of informed consent

Exclusion Criteria:

* Age \< 65 years
* Pregnancy
* Previous inflammatory/infectious events involving the eyes
* Eye trauma, diabetes, or disease potentially damaging to the visual system, even in the absence of impairment at the time of intake
* Previous intravitreal treatments.
* Refusal to sign informed consent.
Investigation of the Effects of Pilates Training in Parkinson Patients

This study was planned to examine the effects of Pilates training in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn \& Yahr Stage 1-2.5. Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. It was concluded that Pilates training performed to Parkinson's patients 3 times a week for 8 weeks was effective on "core" stability, thickness of "core" muscles, functional exercise capacity, motor functions, freezing, fatigue and QOL.

This study was planned to examine the effects of Pilates training, which is a "core" stability based exercise method that improves body alignment, postural control and balance, on "core" stability, the thickness of the "core" muscles, functional exercise capacity, motor functions, freezing, fatigue and daily life activities (ADLs) in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn \& Yahr Stage 1-2.5. The patients were randomly divided into two groups as as Pilates (n: 17) and control (n: 17). Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. The "core" power with the "sit-ups" and the modified "push-ups" tests, the "core" endurans with lateral bridge, trunk flexor endurance and "prone bridge" tests, the thickness of the "core" muscles by ultrasonography, functional strength of the lower limbs with 5 Times Sit Up Test (5TSST), balance with the Berg Balance Scale (BBS), functional mobility; with the Timed Up and Go Test (TUG), functional exercise capacity and walking with the 6-Minute Walk Test (6-MWT), motor impairment with the United Parkinson's Disease Rating Scale (UPDRS)-III, freezing with Freezing of Gait Questionnaire (FOGQ), fatigue with Parkinson's Fatigue Scale (PFS-16), ADLs with UPDRS-II, quality of life (QOL) with Parkinson's Disease Questionnaire-39 (PDQ-39) were evaluated before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* After providing information about the research, agreeing to participate in the research
* Being 40 years or older
* Being diagnosed with '' Idiopathic Parkinson's Disease '' by a specialist
* To be between 1-2.5 values according to Hoehn and Yahr (H\&Y) Scale

Exclusion Criteria:

* Standardized Mini Mental Test score is less than 24
* Presence of cardiovascular, pulmonary, orthopedic or other medical conditions that limit participation in Pilates training
THRIVE in Pediatric Laryngeal Microsurgery

Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios, however its use in spontaneously breathing pediatric patients undergoing tubeless airway surgery has not been described. This is a physiologic study that evaluates the feasibility of THRIVE during pediatric airway surgery under self-respiration.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation

Exclusion Criteria:

* Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation
Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study

Meningitis, defined as inflammation of the meninges caused by different pathogens, is a serious infection associated with high morbidity and mortality. It occurs more commonly in the neonatal period than in any other age group. Neonatal meningitis is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality. In this study, we aimed to evaluate epidemiology, treatment and prognosis of neonatal meningitis in a large-scale retrospective multicenter cohort study.

The main objectives of this study were to assess the incidence, temporal trend, risk factors, causative organisms, and short term outcomes of neonatal meningitis in a large national cohort of newborn infants admitted to Turkey NICUs.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a positive cerebrospinal fluid culture/PCR of bacterial pathogen.
* Subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥20 /mm3.

Exclusion Criteria:

* Major congenital anomalies
* Cultures positive for coagulase-negative staphylococci (CONS) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.
Levels of Interleukin-6 andTransforming Growth Factor Beta in HCV Patients Sera

Hepatitis C virus (HCV) infection is associated with significant morbidity and mortality owing to progression of a high percentage (85%) of HCV infected patients to chronic hepatitis, which might lead to the development of liver cirrhosis or hepato cellular carcinoma..

Egypt has possibly the highest HCV prevalence in the world, 10-20% of the general population .

Currently, second-generation direct-acting antiviral agents have been used for chronic hepatitis C treatment. The association of sofosbuvir with daclatasvir or simeprevir , with or without ribavirin , directly inhibits viral replication .

Sofosbuvir (400 mg once per day) and daclatasvir (60mg once per day) or simeprevir (150 mg once per day) for 3 months treatment regimens.

Sofosbuvir-based antiviral therapy guarantees efficacy in HCV eradication in approximately 90% of cases and is associated with mild to moderate adverse effects.

Overall, studies describe an increase in serum cytokine levels in chronic hepatitis C patients, when compared with healthy individuals. ,interleukin-6(IL-6) is produced mainly by kupffer cells and induces the production of the acute phase proteins, C-reactive protein and haptoglobin .

Previous studies reported that serum Interleukin-6 levels were increased, compared with healthy individuals, in patients with some liver diseases.Previous results suggest that baseline levels of Interleukin, as well as their decrease during treatment .Transforming growth factor beta (TGF-β) is a cytokine that has been assigned a key role in epithelial repair. Injury to the liver elicits a rapid increase in its expression. HCV -infected hepatocytes produce (TGF-β) which may stimulate T-regulatory cells.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 70 years.
* HCV RNA positivity .
* Any Body Mass Index(BMI).
* Treatment-naive or treatment experienced.
* all fibrosis stages.

Exclusion criteria:

* Direct serum bilirubin greater than 2 mg/dl.
* Serum albumin less than 2.8 g/dl.
* International normalization ratio (INR) greater than or equal to 1.7
* Platelet count less than 50 000/mm3.
* Ascites or history of ascites.
* Hepatic encephalopathy or history of hepatic encephalopathy.
* Hepatocellular carcinoma.
* Serum creatinine greater than 2.5 mg/dl .
* Pregnancy.
Clinical Study of Approved and Investigational Contact Lenses

This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 18 to 40 years of age at the time of consent.
4. The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
5. The subject's refractive cylinder must be ≤1.00D in each eye.
6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
7. The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
8. The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
9. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
5. Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
8. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
9. Any ocular infection.
10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
12. History of binocular vision abnormality or strabismus.
13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report).
14. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)