cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of an Online Religiously-integrated Cognitive Behavioral Therapy-based Intervention on Death Anxiety

There has been growing awareness of the importance of death anxiety (DA) in pathological anxiety. DA is defined as a persistent and unreasonable fear of death and thoughts, fears, and emotions associated with the end of life. DA has been suggested as a core fear that underpins the emergence and perseverance of numerous anxiety disorders. However, previous DA-based treatment studies focus on the elderly, the patients, or health professionals who care for the terminally ill. Therefore, there is a need to examine the effect of psychological interventions on DA and current disorder symptoms in a clinical sample through randomized controlled trials. The current study aims to develop a novel Religiously Integrated Cognitive Behavioral Therapy (RCBT)-based intervention on DA in individuals diagnosed with an anxiety disorder and to compare the effectiveness of RCBT-based intervention with classical CBT-based intervention.

Religion facilitates the pursuit of symbolic immortality by providing individuals with purpose and hope in both life and death. Those who believe in an afterlife also see their world as fairer, which results in lower levels of psychiatric symptoms. Previous CBT-based death anxiety interventions did not consider the assumption of an afterlife. RCBT is an approach that integrates spiritual or religious beliefs into the therapeutic process. RCBT is an approach that recognizes the importance of spirituality or religion in a client's life and aims to use these beliefs and practices positively within the context of evidence-based CBT. Briefly, no intervention studies have investigated the effect of RCBT on DA. This will be the first study to develop an RCBT-based intervention for DA.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* A score of \> 26 on the Turkish Death Anxiety Scale
* Diagnosed with one of the anxiety disorders
* Believing in life after death

Exclusion Criteria:

* Diagnosed with schizophrenia, schizophreniform disorder, schizoaffective disorder, and delusional disorder
* Being in an active manic episode
* Possessing a mental disorder that interferes with completing measures or understanding the exercises conducted during sessions
* Extreme symptoms of depression (score of \> 20 on the Patient Health Questionnaire (PHQ-9), and \>1 on the item assessing suicidality)
* Currently receiving therapy.
Nevoid Basal Cell Carcinomas in Gorlin Syndrome

The overall aim of the project is to gain knowledge about the expected course of nevoid basal cell carcinomas and the usefulness of dermatoscopy in young individuals with Gorlin syndrome.

Clinical experience and some case-reports suggest that nevoid basal cell carcinomas have an indolent course with slow growth and that they can sometimes regress. However, no systematic research has previously been performed.

Increased knowledge about nevoid basal cell carcinomas and the use of dermatoscopy could be of great clinical value in the follow-up and treatment of individuals with nevoid basal cell carcinoma syndrome.


Eligibility Criteria:
Inclusion Criteria:

* The individual has Gorlin syndrome (clinically and/or genetically diagnosed)
* The individual is minimum 6 years and maximum 17 years
* The individual has at least three skin lesions clinically compatible with nevoid basal cell carcinomas

Exclusion Criteria:

* The patient has a psychiatric disorder not compatible with completion of the study examinations
* The patient has received topical treatment (imiquimod, 5-fluorouracil, photodynamic therapy and/or cryotherapy) of nevoid basal cell carcinomas during the last three months
UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD)

This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept.

Free plasma VEGF-A level was measured in this study .


Eligibility Criteria:
Key Inclusion Criteria

* Newly diagnosed Age-related Macular Degeneration (AMD)
* No previous treatment received for diagnosed AMD
* Visual Acuity 6/7.5 to 6/96

Key Exclusion Criteria:

* standard exclusion criteria for anti-VEGF treatment
* Visual Acuity \<6/96
* nAMD in both eyes, or any condition in other eye which may have required anti- VEGF treatment during study period
* other disease in candidate eye which could have compromised visual acuity or required medical/surgical intervention during study period
* participation to other clinical study with 'not approved' treatment within a year prior to UNRAVEL study participation.
Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy

Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients receiving 3-day cisplatin-based chemotherapy.

Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2015 V1).The patient should receive a 3-day cisplatin-based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant(125 mg po at day1, 80 mg at day2-3) combination with palonosetron and dexamethasone(5mg iv at day1-3, 3.75mg po at day4-5). In placebo group patients would receive palonosetron and dexamethasone(5mg iv at day1-3, 7.5mg po at day4-5).During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patient who was confirmed lung cancer by pathologic histology or cytology.
2. Males or females aged ≥18 years, \<80 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.
4. Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
5. Patients with asymptomatic, treated brain metastases are eligible for trial participation.
6. Adequate bone marrow, renal, and liver function are required.
7. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
8. Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

1. History of sensitivity/idiosyncrasy to aprepitant or excipients
2. Condition that might interfere with drug absorption, distribution metabolism or excretion.
3. Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
5. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
6. Female subjects should not be pregnant or breast-feeding.
7. Inadequate hematological function.
8. Abnormal liver and renal function.
9. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)


Eligibility Criteria:
Inclusion:

* Diagnosis of Crohn's disease
* CDAI score at baseline of between 220 and 450
* Normal laboratory parameters
* Willing and able to give informed consent

Exclusion:

* Diagnosis of ulcerative colitis
* Women cannot be pregnant or breastfeeding
* No previous use of infliximab or other anti-TNF antagonists
* No previous history of tuberculosis or listeria infection
* No previous history of cancer other than successfully treated skin cancer
Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).


Eligibility Criteria:
Inclusion Criteria:

* preterm infants less than 32 weeks of gestational age
* intubated more than 48 hours after birth
* subjected to extubation with minimal ventilator setting (mean airway pressure \< 7cmH2O + peak inspiratory pressure \< 13 cmH2O + FiO2 \< 0.4 + respiratory rate \< 35/min)
* with informed consent from parents

Exclusion Criteria:

* with major congenital anomalies
* use of sedative or anesthetic drugs
* hemodynamic instability
* grade 3 or higher intraventricular hemorrhage
* phrenic nerve palsy
Cost-utility Analysis of the Use of the Paro Robotic Seal by Elderly Patients With Moderate or Severe Cognitive Disorders in Institutions: a Randomised Study.

Many residents from establishments for dependent elderly people (EHPAD) have memory disorders with behavioural problems such as agitation, aggression and anxiety, which make it difficult to assist them on a daily basis.

Studies have proven the beneficial effect of the therapeutic seal robot PARO® in behavioural disorders. The present project aims to complement these data with a medico-economic study. At present, the only study of this type has been carried out in Australia, and is not transposable to France.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 70 years of age
* With moderate or severe neurocognitive disorders of any etiology (Mini Mental State Examination (MMSE) less than or equal to 20, or not feasible)
* Resident in EHPAD (establishment for dependent elderly people) or USLD (long-term care unit ) in permanent accommodation for more than 1 month at inclusion

Exclusion Criteria:

* Patient with presumed life expectancy of less than 3 months
* Mini Mental State Examination (MMSE) not feasible for any reason other than cognitive impairment (e.g. stroke aphasia), without dementia
* Known carrier of multi-drug resistant bacteria
* Carrier of Pace-maker (precautionary advice from manufacturer)
* Refusal to participate to the study (trusted person, guardian or curator or patient depending on the patient's mental state)
* Patient under court protection
* Prior inclusion in an interventional study that may alter the interpretation of the results of the analysis
* Patient not affiliated to a social security system or beneficiary of such a system
Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis

Background:

PDA is viewed as a standout amongst the most widely recognized congenital heart defects in children and its closure is responsible for many hemodynamic changes that require intervention and care.

Methods:

A retrospective study included fifty children with isolated PDA treated by surgical ligation from June 2015 to June 2018. Their mean age was 15.78 ± 7.58 months and 72% were females. The LV dimensions and systolic function were assessed by two-dimensional echocardiography pre PDA ligation. The mean duct size was 4.08 ± 1.25 mm.

Methods:

Study population Fifty children with PDA, for whom surgical PDA ligation was done from June 2015 to June 2018. All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital. Their mean age at intervention was 15.78 ± 7.58 months, body surface area (BSA) 0.43±0.03 and 32 (72%) were females. The mean duct diameter was 4.08 ± 1.25 mm. The study conforms to the ethical standards of the Helsinki Declaration and approval was obtained from the institutional ethics committee of Qena Faculty of Medicine.

Surgical technique PDA ligation was performed under general anaesthesia after pre-operative anaesthetic evaluation. After single endotracheal tube anaesthesia induction; children were placed on the right lateral recumbent position fixed with adhesive plaster and a pad under the chest, the left arm raised above the head. A left mini-thoracotomy incision is done parallel to the medial border of the scapula and entrance to the thoracic cavity was via the third or fourth intercostal space. Cautiously, the ductus is identified and dissected carefully. Then it was doubly ligated with silk ligature (2/0 or 0). An intercostal tube inserted during operation and removed within 48 hours if no drainage presents.

Descriptive statistical analysis Data were arranged and analyzed utilizing Version 20 of the SPSS program (Statistical Package for Social Sciences). Continuous variables were compared using the Student paired t-test and are expressed as mean values ± standard deviation. Pearson Chi-Square tests were used to detect differences among groups for categorical variables. The relationship between PDA size and changes in echocardiographic parameters was verified using the Pearson linear correlation and the linear regression analysis. P-value of \<0.05 was considered of significance.

Eligibility Criteria:
Inclusion Criteria:

* All cases had clinical as well as echocardiographic proof of hemodynamically critical PDA.

Exclusion Criteria:

* Patients with silent PDA.
* irreversible pulmonary vascular disease.
* those who had associated hemodynamically significant congenital heart disease (CHD).
Effect of Baby Massage on Oral Motor Skills of Premature Babies

This experimental research was conducted in a single-blind, block randomized controlled design type.

The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.

As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20).

Comparative results were evaluated statistically.

The Effect of Baby Massage on Oral Motor Coordination Ability in Prematures Purpose: The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.

Method: The research was a single-blind, block randomized controlled design type and data was collected between September 2021 and May 2023. Baby massage was applied to the intervention group (n=20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (n=20). The applications were applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale. Descriptive statistical methods, Fisher test, chi-square analysis, dependent and independent t test, Mann Whitney U test, one-way analysis of variance, Kruskal Wallis test, Pearson and Spearman correlations were used to evaluate the research results.

Eligibility Criteria:
Inclusion Criteria:

* Being between 28-33 weeks of gestation,
* Not having a congenital disease,
* Clinical findings are stable and normal,
* It meets the readiness criteria for oral feeding,
* Being fed at full dose via Oral/Nasogastric tube and having never attempted oral intake before,
* It must weigh between 1000-2000 grams
* Parents give their consent to participate in the research and record video.

Exclusion Criteria:

* Premature babies of parents who did not give consent to participate in the study,
* Premature babies of parents who gave up participating in the study at any stage of the study,
* Physiological stability was impaired during the data collection process; Premature babies who require oxygen support and/or mechanical respirators,
* Conditions that disrupt clinical stability such as intracranial bleeding, necrotizing enterocolitis, neonatal sepsis are included in the process.
Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years

Primary care offers a promising setting for promoting parenting practices that shape healthy eating and physical activity behaviors of young children. This study assessed the impact of a parent-based, primary care intervention on the feeding habits, health behaviors, and body mass index (BMI) of 2-5 year olds with elevated or rapidly-increasing BMI. Four private pediatric offices in West Michigan were assigned as control (n=2) or intervention (n=2) sites based on patient load and demographics. Treatment families were recruited at well-child visits to receive physician health-behavior counseling and four visits with a registered dietitian nutritionist (RDN) over a 6-month period. Outcomes included percent of the 95th BMI percentile (%BMI95), the Family Nutrition and Physical Activity survey (FNPA), and the Feeding Practices and Structure Questionnaire (FPSQ).


Eligibility Criteria:
Inclusion Criteria:

* Age between 2 and 5 years
* BMI ≥85th percentile for age and sex, using the 2000 CDC growth chart, or BMI percentile increase within the past year equivalent to crossing at least two growth chart lines per year on a standard CDC growth chart, excluding the 5th percentile (e.g., 10th \& 25th, 25th \& 50th, 50th \& 75th, 75th \& 85th). This rate of increase is equivalent to ≥0.67 standard deviations per year (BMI z-score), and, when occurring in this age group, has been shown to increase risk of adult obesity

Exclusion Criteria:

* Known disorder of the HPA axis
* Use of glucocorticoid medication
* Non-English speaking
Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF

Ceftazidime-avibactam is used for treatment of invasive Gram-negative bacterial infections among critically ill patients, including those on continuous venovenous hemodiafiltration . However, dosing of ceftazidime-avibactam for these patients remains undefined. The purpose of this study was to evaluate the pharmacokinetics of ceftazidime and avibactam among critically-ill patients, including those receiving CVVHD. This is a registration of Dr. Shields' exempt project under IRB approved research study STUDY19040363

Patients who received ceftazidime-avibactam as part of their clinical care were consented. EMR data was collected as well as PK sampling around their dosing to include the following samples immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, and 8 hours. Blood samples were collected in lithium-heparin tubes from a central venous catheter that is not being used for the continuous venovenous hemodiafiltration. The tubes were centrifuged at 2500 rpm for 10 minutes within 1 hour from collection and the samples will be frozen at 80°C. The total concentrations of ceftazidime and avibactam were determined simultaneously from plasma by using a validated HPLC-tandem MS assay. Noncompartmental pharmacokinetics were calculated using the linear-up and logarithmic-down trapezoidal method, based on the assumption of first-order elimination.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients receiving ceftazidime-avibactam as standard care

Exclusion Criteria:

* Less than 18 years-old
Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine

Cocaine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce cocaine use, however, these interventions are not universally effective and treatment effects diminish over time. Development of a pharmacotherapy that enhances the efficacy of these interventions is a priority for the National Institute on Drug Abuse. This study proposes to determine the impact of buspirone maintenance on self-administration of cocaine and alternative reinforcers. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects of cocaine and increase the reinforcing effects of alternative reinforcers.


Eligibility Criteria:
Inclusion Criteria:

* Recent cocaine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine or buspirone
Comprehending Atopic Risk Elements

Skin barrier impairment and familial atopy have been implicated as crucial risk factors for the development of atopic dermatitis (AD). Additional risk factors have been explored, including gestational weight, height, age, familial smoking habits, proximity to urban centers and others. However, a comprehensive study focusing on the entire spectrum of risk factors has yet to be undertaken. Such a study could enable predictive capabilities able to inform medical professionals as to a newborn's inherent risk to develop AD, and potentially recommend appropriate preventative modalities to prevent or delay disease onset.


Eligibility Criteria:
Inclusion Criteria:

1. A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment \& less than 120 hours prior to enrollment
2. Term and near term newborns born between 34+0 and 42+0 weeks gestational age
3. Mothers must be aged \>18 years
4. Parents' ability to complete questionnaire(s) at defined times throughout study duration
5. Parents or legal guardian provide informed written consent

Exclusion Criteria:

1. Preterm birth prior to 34+0 weeks gestation
2. Less than 12 hours out of the incubator
3. Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
4. Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
5. Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
6. Neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial
7. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety