cyrilzakka/clinical-trials huggingface dataset:
Testing of Cognitive Behavioral Therapy Resource of Turkish Version

This study aimed to evaluate the cognitive behavioral therapy source of Turkish version of the 'message to dentist' (MTD) with children attending two dental settings.

Children aged 5-16 years attending a dental faculty clinic and a private dental office were invited to complete the MTD form. Children were asked to report how worried they felt, their level of pain they anticipated and the actual level of pain they experienced on a scale of 1-10 (with 1 being the best outcome).

Eligibility Criteria:
Inclusion Criteria:

Having dental anxiety but not having negative experiences during dental treatment in childhood or adolescence

* Without any systemical and mental diasabilities
* Who volunteered to participate in the study and whose parental consent was obtained.

Exclusion Criteria:

* not have dental anxiety
* having any systemical or mental disability
* having negative experiences during dental treatment in childhood or adolescence
* and who did not volunteer to participate in the study and did not have parental consent for the study were excluded.
A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)

Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.

The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with moderate hepatic (liver) impairment.


Eligibility Criteria:
The main inclusion criteria include but are not limited to the following:

* All participants:
* Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing
* Has body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2
* Participants with moderate hepatic impairment:
* Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology

The main exclusion criteria include but are not limited to the following:

* All participants:
* Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
* Has a history of cancer (malignancy)
* Has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Participants with moderate hepatic impairment
* Has unstable electrolyte abnormalities or electrolyte abnormalities that are considered difficult to manage for participants with hepatic impairment
* Has a history of liver or other solid organ transplantation
PMS to Evaluate the Safety and Efficacy of Picato® Gel

This study is a mandatory post launch observational study in South Korea of 3.000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (Picato®), approved for topical treatment of actinic keratosis.

Each patient is observed for 8 weeks after treatment completion.

Picato® (ingenol mebutate) gel is a new topical therapy for Actinic Keratosis (AK) in adults which was approved by the Korean Ministry of Food and Drug Safety (MFDS) in December 2013. For AK in face or scalp the 0.015 percent gel is approved to be applied once a day for 3 consecutive days, and for AK in trunk or extremities the 0.05 percent gel is approved to be applied once a day for 2 consecutive days.

The re-examination period for Picato® runs from December 2013 to December 2019, during which at least 3,000 patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment must be documented in a standard Post Marketing Surveillance (PMS) study.

Each patient is to be observed for 8 weeks following application of ingenol mebutate gel. If a patient is unable to visit the PMS site, the investigator may contact the patient by phone to assess the safety.

Eligibility Criteria:
Inclusion Criteria:

Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel

Exclusion Criteria:

* Children and adolescents
Working Memory Training in Adults With Substance Abuse and Executive Function Deficits.

The purpose of this study is to evaluate the effects of a computerized working memory training program on substance abuse, psychosocial functioning, cognitive performance and psychiatric problems in adults with substance abuse and attention problems.

The primary aim of this study is to examine the effects of 5 weeks of computerized working memory training on substance abuse. Secondary aims are to explore whether effects are mediated by changes in executive functions and/or moderated by personality. Also, effects on measures of psychosocial functioning, depression, anxiety and attention will be explored. Follow-up assessment will be conducted at 6 months post training.

Eligibility Criteria:
Inclusion Criteria:

* Treatment seeking adults with substance abuse and executive function deficits.

Exclusion Criteria:

* Acute intoxication or abstinence symptoms of any substance.
* Psychosis.
Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy

This study compares the efficacy, safety, and patient satisfaction of the Buprenorphine 10 mg transdermal patch versus Tramadol for postoperative analgesia in shoulder arthroscopic surgery. The study hypothesizes that Buprenorphine provides superior pain relief with fewer side effects compared to Tramadol.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 65 years.
* Patients undergoing elective shoulder arthroscopy.
* Classified as ASA (American Society of Anesthesiologists) physical status I or II.
* Able to provide informed consent.
* Willing to comply with study protocols and follow-up assessments

Exclusion Criteria:

* Known allergy or hypersensitivity to Buprenorphine, Tramadol, or any related compounds.
* History of substance abuse, opioid dependency, or chronic pain requiring ongoing analgesic therapy.
* Pregnant or breastfeeding individuals.
* Presence of severe hepatic, renal, or respiratory disease.
* Any psychiatric or neurological condition that might interfere with pain perception or reporting (e.g., dementia, severe anxiety).
* Participation in another clinical trial within the last 30 days.
* Inability to apply or tolerate a transdermal patch (e.g., due to skin disorders or sensitivities).
* Contraindications to interscalene brachial plexus block, such as infection at the site, coagulopathy, or pre-existing neuropathy in the upper limb.
AZD5985 Single Ascending Dose Study

The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedure
* Healthy male subjects aged 18 to 45 years (inclusive)
* Have a body mass index (BMI) between 18 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:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
* Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2
Comparison of Alternative Embryo Culture Systems

This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.

Qualifying and consenting IVF patients will have approximately half of their developing embryos cultured in droplets covered with oil. The other approximate half of their embryos will be cultured in small enclosed containers. Embryo assignments will be at random. Regardless of culture system, all embryos will be cultured from the bipronuclear stage to the blastocyst stage in the same (Global) media, without the usual refreshing of media on day 3.

Eligibility Criteria:
Inclusion Criteria:

* Female age 18 to 40, seeking IVF treatment
* Ability to understand English (to obtain informed consent)
* Use of an oocyte donor, sperm donor, gestational carrier, and/or genetic testing (with blastocyst biopsy only) are allowed.

Exclusion Criteria:

* Diminished ovarian reserve as evidenced by either elevated cycle day 3 follicle stimulating hormone (FSH) level (≥10 IU/L) or low antral follicle count (\<8 antral follicles)
* Fewer than five (5) bipronuclear oocytes
* Day 3 embryo biopsy for any reason
* No minors may enroll
Digital Behavioral Therapy for Sleep Problems

Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 diagnosis of insomnia disorder
* Aged 18 years or older
* Reliable Internet access using either computer or smartphone
* Ability to read and understand English

Exclusion Criteria:

* High risk of obstructive sleep apnea
* Diagnosis of restless legs syndrome
* Severe health issues requiring hospital admission
* Currently receiving psychological treatment for insomnia
* Reporting current suicidal ideation
A Network Intervention for Prevention of HIV Infection in Chennai, India - 1

The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners in Chennai India.

The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. Furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.

Eligibility Criteria:
Inclusion Criteria:

* drug users
* network members
Comparison Between Sensory and Motor Transcutaneous Electrical Nervous Stimulation on Electromyographic and Kinesiographic Activity of Patients With Temporomandibular Disorder: a Controlled Clinical Trial

Background The purpose of the present controlled clinical trial was to assess the effect of a single 60 min application of transcutaneous electrical nervous stimulation (TENS) at sensory stimulation threshold (STS), compared to the application of motor stimulation threshold (MTS) as well as to untreatment, on the surface electromyographic (sEMG) and kinesiographic activity of patients with temporomandibular disorder (TMD). Methods Sixty female subjects, selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in remission were assigned to MTS, STS or untreatment. Pre- and post-treatment differences in the sEMG activity of temporalis anterior (TA), masseter (MM), digastric (DA) and sternocleidomastoid muscles (SCM), as well in the interocclusal distance (ID), within group were tested using the Wilcoxon test, while differences among groups were assessed by Kruskal-Wallis test; the level of significance was set at p ≤ 0.01.


Eligibility Criteria:
Inclusion Criteria:

* age less than 30 years;
* female gender
* right-handed (7-10 points in Edinburgh inventory);
* presence of complete permanent dentition, with the exception of the third molars;
* normal occlusion;
* diagnosis of unilateral arthrogenous TMD on the Research Diagnostic Criteria for TMD (RDC/TMD), Axis I, groups II and III

Exclusion Criteria:

* having pacemaker or other electrical devices
* previous experience of TENS or biofeedback
* systemic diseases
* history of local or general trauma
* neurological or psychiatric disorders
* muscular diseases
* cervical pain
* bruxism diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding
* pregnancy
* assumption of anti-inflammatory, analgesic, antidepressant or myorelaxant drugs
* fixed or removable prostheses
* fixed restorations that affected the occlusal surfaces
* previous or concurrent orthodontic or orthognathic treatment
Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

The study compares the effect of a group-based activity with an individual work-out activity on work participation.

The study is an RCT comparing the effect of a group-based intervention with an individual work-out intervention on work participation. The target group is persons who are at risk of leaving the work force due to health issues, and people currently outside the work force. The interventions have a time-span of 3 months. Survey data will be collected at baseline, after three months (after intervention has ended), and after 15 months. Survey data include information on lifestyle, self-reported health, subjective health complaints and readiness for work. Register data on employment and welfare benefits will be collected from two years in advance of inclusion, and five years after inclusion. According to power calculations, the study will need 322 participants.

In addition to the effect evaluation, a process evaluation will also be performed. The process evaluation will examine content quality and adherence to guidelines, as well as feasibility of the group intervention. The process evaluation will consist of some survey data as well as interviews with service providers and participants.

Eligibility Criteria:
Inclusion Criteria:

* Desire to work
* Understand Norwegian sufficiently to complete surveys

Exclusion Criteria:

* Not able to participate in the interventions due to personal or health-related constraints.
PRP vs PRP+IVC for Severe nPDR

The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.

This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.

Eligibility Criteria:
Inclusion Criteria:

Type II diabetic patients, 18 years and older, were included if the participants had:

1. severe non-PDR in either eyes with/without diabetic macular edema;
2. ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
3. no previous treatment (of any type) in either eye.

Exclusion Criteria:

1. history of prior laser treatment or vitrectomy in the study eye;
2. history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
3. major surgery within the prior 6 months or planned within the next 28 days;
4. history of glaucoma or ocular hypertension;
5. loss of vision as a result of other causes;
6. history of systemic corticosteroid therapy within the last 3 months;
7. severe systemic disease other than diabetes mellitus;
8. known coagulation abnormalities or current use of anticoagulative medication other than aspirin
9. any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).
Digital Health Interventions for Obsessive Compulsive Disorder (OCD)

The investigators are testing two digital health interventions for obsessive compulsive disorder (OCD). The investigators hope that these digital health programs will increase access to treatment for OCD.

The primary aims of this study are to test the feasibility, acceptability, and efficacy of two digital health interventions for adults with OCD recruited nationally. Eligible subjects (N=120) will be randomly assigned (50/50 chance) to 12 weeks of app-based CBT on their personal Smartphone or 12 weeks of web-based health and well-being education in addition to completing clinical assessments and questionnaires from home. All participants will have access to a coach to help guide them through their assigned program. Total participation time for the study is approximately 6 months, and all study appointments (5 total) occur over secure phone or video conference call.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Current diagnosis of primary obsessive compulsive disorder (OCD), based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Mini International Neuropsychiatric Interview (MINI)
* Currently living in the United States

Exclusion Criteria:

* Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
* Past participation in ≥4 sessions of cognitive behavioral therapy (CBT) for OCD
* Past use of a CBT for OCD app
* Current severe substance use disorder
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥2 on the suicidal ideation subscale of the Columbia Suicide Severity Rating Scale (C-SSRS).
* Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology, self-report version (QIDS-SR), total score ≥ 21
* Current post-traumatic stress disorder (PTSD)
* Concurrent psychological treatment
* Does not own a supported mobile smartphone with a data plan
* Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

A phase 2, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of Allopregnanolone as a regenerative therapeutic for Alzheimer's disease.

This is a proof-of-concept phase 2 clinical trial to investigate the long-term safety and efficacy of Allo to function as a regenerative therapeutic to restore structural integrity and cognitive function of the brain in participants with mild Alzheimer's disease (AD) dementia. Study participants will be male and female, APOE ε4 positive diagnosed with probable AD, Mini-Mental State Exam (MMSE) 20 to 26, ages 55 to 80 years old.

After a 2-4-week screening period, participants will be randomized to 4 mg Allo (administered intravenously over 30 minutes, once per week, in clinic) or matching placebo, 1:1 allocation, for a period of 12 months. After 12 months, all participants in the placebo group will be crossed-over to receive Allo for the remainder of the study (6 month open-label phase). Brain imaging to evaluate the primary endpoint will be conducted at baseline, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women
* Age 55 to 80 years old
* Meets NIA-AA criteria for probable AD dementia
* MMSE of 20-26
* APOE ε4 positive
* Geriatric Depression Scale short form (GDS-S) score of ≤ 6
* No medical contraindications to participation
* Capacity to provide informed consent at screening

Exclusion Criteria:

* Dementia other than probable AD
* Use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the GABA-A receptor complex
* History of stroke with a modified Hachinski Ischemic Scale score \>4
* History of seizure disorder, focal brain lesion, traumatic brain injury
* History within the last 5 years of a primary or recurrent malignant disease
* Unstable or clinically significant cardiovascular, kidney or liver disease
* MRI indicative of any other significant abnormality, including but not limited to one or more significant ARIA-E or macro-hemorrhage findings, or multiple microhemorrhages (\>8), or Fazekas score of 3; encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions
* Any conditions that would contraindicate MRI studies.
Value of Diaphragmatic Motion Measurement at Ultrasonography to Predict Poor Prognosis in Emergency Department Patients With Acute Respiratory Failure

Acute respiratory failure is one of the most common diagnosis in patients admitted in the Emergency Department. Acute respiratory failure is associated with morbidity and mortality. Fifteen percent of patient will require ventilatory support and among them 40% will die.

Measurement of diaphragmatic motion (excursion) at ultrasonography is a noninvasive measure, allowing to assess diaphragm dysfunction. It could be useful in predicting poor prognosis in ED patients with respiratory failure .

In this study the investigators will compare the prognostic value of diaphragmatic excursion measurement at ultrasonography to that of the National Early Warning Score (NEWS) 2 in patients presenting with acute respiratory failure in the ED

The Investigators made the hypothesis that measurement of diaphragmatic excursion in ED patients with acute respiratory failure could be of value in predicting the need for ventilatory support or mortality within 28 days from ED admission

Diaphragmatic dysfunction can be explored by measuring diaphragmatic excursion using ultrasonography in spontaneous ventilation patients.

Patients in spontaneous ventilation will undergo both diaphragmatic excursion measurement at ultrasonography and assessment of the News2 score as part of standard care.

Eligibility Criteria:
Inclusion criteria:

* Age equal or over 18 y.o
* Signs of acute respiratory failure defined by RR equal or over 25 br/min and/or signs of increased work of breathing
* Patients on spontaneous breathing

Exclusion criteria:

* Medical history of diaphragmatic dysfunction including stroke or diaphragmatic paralysis
* Patients on ventilatory support at ED admission or prior to inclusion
* Patients treated with curare
* Trauma patients