cyrilzakka/clinical-trials huggingface dataset:
Effect of Low-Level Laser Therapy Following Direct Pulp Capping on Postoperative Sensitivity by Thermal Stimulus

The aim of this study was to investigate the effect of low-level laser therapy (LLLT) on postoperative pain provoked by thermal stimulation in direct pulp capping. All the patients who received consent form in this retrospective study were retrieved from the records of patients attended for routine dental treatment at the Ordu University, Faculty of Dentistry, Department of Endodontics between 01.10.2017-01.10.2018. Study subjects were recruited from the pool of patients who performed direct pulp capping by a single operator. A total of 123 pre-treated teeth of 123 patients who referred to Ordu University, Faculty of Dentistry were examined. Follow-up examinations were carried out at postoperative 6th hours, 1st and 7th days with visual analog scale (VAS), and treatment outcome were assessed. Participants were allocated to the laser and control group which consist of 42 patients in each group. 6 patients were excluded from the study due to missing data in both groups. Thus, data from 72 patients who had been carried out direct pulp capping were assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Mandibular and maxillary permanent molars with pulpal exposure between 0.5-1.0 mm
2. Periodontally healthy teeth (no more than 3mm probing depth)
3. Pulpal exposure occurring only on the occlusal side of the tooth
4. Systemically healthy participant
5. Participants who signed the written consent form
6. Patients aged 15-45
7. Patients who have not used analgesic or antibiotic in the past two weeks
8. Patients whose data are fully and accurately recorded
9. Patients who do not use immunosuppressive drugs and do not need antibiotic prophylaxis

Exclusion Criteria:

1. Patients who need a second anesthetic
2. Presence of a previous restoration of the tooth
3. Patients using psychiatric or sedative medication
4. Patients who had a direct pulp capping treatment on several teeth
5. Patients with tooth pain and unable to localize this pain
6. Patients taking pain medication within 1 week after the procedures
7. Patients with a lack of data during follow-up
8. Treated teeth without following clinical procedures
Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women

Eliminating racial disparities in breast cancer is a top public health priority. African American (AA) women often present with more advanced and aggressive disease at the time of diagnosis and are more likely to die from breast cancer than any other racial/ethnic group in the United States. Mammogram screening significantly reduces breast cancer mortality by diagnosing cancer at an earlier stage where treatments are more effective. While some AA women do not schedule screening mammograms as recommended by current guidelines, others do not show up for their exams after scheduling them (no-shows). No-shows to cancer screening appointments impose an enormous strain on our limited healthcare resources with negative impact on other patients who could have secured earlier appointments, loss of revenue for hospitals or clinics serving underserved populations and delays in diagnoses and treatment for those who do not have screening. The investigators identified a high no-show rate for screening mammograms at our hospital. AA women were almost three times more likely to no-show for their mammograms compared to White women. Patient's social networks plan an important role in health promotion. In this study, we will pilot an intervention involving patient's social contacts (family, friends, neighbors, etc.) as healthcare facilitators to improve appointment attendance. The investigators seek to determine whether this intervention is feasible and acceptable to patients and whether this intervention will improve attendance rates for screening mammograms among AA women at our institution. If effective, the use of a patient's social contact person as a healthcare facilitator (similar to a patient navigator) would be a readily available and inexpensive resource for other institutions to implement.


Eligibility Criteria:
Inclusion Criteria for Patients:

* Female
* African American
* At least 40 years old
* Scheduled for a screening mammogram within 3 months following initiation of the study
* Willing and able to provide contact information for two adult social contacts (friends or family members)

Exclusion Criteria for Patients:

-Prior history of breast cancer

Inclusion Criteria for Social Contacts:

* At least 18 years old
* Selected by the patient as someone (family member or friend) who would be able to support her in keeping her mammogram appointment

Exclusion Criteria for Social Contacts:

-Less than 18 years of age
Reproducibility of a New Practical Newborn Behavioral Observation Scale

Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care.

However, a specific and individualized support to the development during the first weeks of this preterm patient has a positive effect on newborn development.

A new practical newborn behavioral observation scale has been developed by the investigators care unit in order to adapt care and individualized support to the development for each patient.

The goal of this study is to estimate the external reproductibility of this scale by experimented nurse in order to implement an individualized care program.


Eligibility Criteria:
Inclusion Criteria:

* term of birth between 24 and 33 weeks of amenorrhea
* weight less than 1500g birth;
* postnatal age between 1 and 60 days
* consent form of parent in order to film their baby

Exclusion Criteria:
Is PNF Application Effective on Temporomandibular Dysfunction

The goal of this clinical trial is to compare effects of Rocabado exercises which is conventional physiotherapy treatment alone vs. combine it with proprioceptive neuromuscular facilitation (PNF) in people with temporomandibular dysfunction (TMD) with forward head posture. The main question aims to answer:

- Does adding neck and jaw PNF techniques to the treatment affect the pain and functional status of the jaw compared to Rocabado exercises alone?

Participants will be randomized into two groups (Group 1: only Rocabado exercises, Group 2: Rocabado + PNF) and perform 8 weeks long exercises. They will be assessed in the beginning of the study and at the end of the 8th week.

Infrared heat will be applied to the neck and face areas for 15 minutes for individuals with TMD with forward head posture in both groups. Then Group 1 will perform Rocabado exercises only, and Group 2 will perform PNF exercises in addition to Rocabado exercises. Exercises will be demonstrated and applied by a physiotherapist at the university clinic.

Pain intensity, pain threshold, TMJ functions, joint range of motion and Mandibular Function are among the parameters to be evaluated. All evaluations will be made by a blinded evaluator at baseline (baseline t=0), before exercise and after exercise (post-exercise, t=8.week).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of TMD according to the diagnostic criteria for temporomandibular disorders (RDC/TMD),
* Presence of trigger points in the relevant muscles,
* Presence of pain

Exclusion Criteria:

* Intra-articular or degenerative joint disorders and subluxation requiring urgent treatment;
* History of temporomandibular joint (TMJ) or cervical region surgery in the last 3 months;
* Treatment history from relevant areas;
* Presence of rheumatic diseases, including TMJ diseases;
* TMJ instability or fracture;
* Presence of perception-cognition disorder;
* Presence of chronic pain such as trigeminal neuralgia
* Orthopedic, neurological or rheumatological cervical disorders affecting jaw movements
* History of surgery in the jaw, head and neck area
* Presence of vertigo that prevents head movements during exercise
General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients

The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous closure of atrial septal defect on hemodynamic changes.

Atrial septal defect (ASD) is one of the most common types of congenital heart defects, occurring in about 25% of children General anaesthesia is usually obtained with tracheal intubation and mechanical ventilation or spontaneous breathing, the depth of anesthesia required to tolerate the presence of a tracheal tube will invariably lead to some reduction in myocardial contractility and alteration of respiratory mechanics. The goal of anesthetic technique is to provide sedation and analgesia during cardiac catheterization to ensure immobility and hemodynamic stability.

Ketamine is an N-methyl-D-aspartate receptor (NMDA) antagonist with sedative, analgesic, and sympathomimetic effects. Among its benefits ,it has the ability to protect airway reflexes with minimal effect on ventilatory drive.

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist with sedative, anxiolytic, and analgesic effect, it also blunts the sympathetic nervous system response to surgical stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 3-8 years old.
* Both genders.
* American Society of Anesthesiologists (ASA) physical status II-III
* Pediatric patients scheduled for elective transcatheter atrial septal defect closure.

Exclusion Criteria:

* Patients with multiple congenital anomalies.
* Patients with congestive heart failure
* Patients with Organ dysfunction liver or renal disease or pulmonary disease.
* Recent chest infection.
* Airway abnormalities.
Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound

This prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (HD-IVUS) as guidance for primary percutaneous coronary intervention (PCI) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with ST-elevation myocardial infarction (STEMI).

Objectives:

* To assess clinical outcomes after IVUS-guided primary PCI in STEMI patients.
* To assess IVUS-guided optimization in STEMI patients.
* To assess culprit lesion plaque characteristics in STEMI patients with HD-IVUS.
* To assess and quantify thrombus in STEMI patients with HD-IVUS.
* To explore HD-IVUS derived predictors for clinically relevant aspiration thrombectomy.

The SPECTRUM study is an investigator-initiated, single-center, prospective, single arm, observational cohort study investigating the safety and efficacy of (HD)-IVUS as guidance for primary PCI in 200 patients with STEMI. This study enables the assessment of culprit lesion plaque characteristics and thrombus morphology with a 40-60 MHz HD-IVUS catheter.

All study patients will have a protocolized pre-intervention IVUS pullback directly after recanalization (so before any lesion preparation, i.e. balloon dilatation, aspiration thrombectomy or stent placement) and a post-intervention IVUS pullback. Subsequently, if IVUS-guided optimization is performed, a final pullback is highly recommended and considered as the post-optimization IVUS pullback.

The primary study outcomes are target vessel failure at 12 months and incidence of IVUS-guided optimization. More information on outcome measures is provided in the section below.

Eligibility Criteria:
Inclusion Criteria:

* Native coronary artery culprit lesion, angiographically
* Culprit vessel reference diameter ≥ 2.25 mm, angiographically

Exclusion Criteria:

* Cardiogenic shock
* Presentation \> 12 hours after symptom onset
Sinovuyo Caring Families Project - Pilot Trial

This pilot feasibility trial will evaluate the Sinovuyo Caring Families Program in a small-scale randomized controlled trial in Cape Town, South Africa (n=60 families). The pilot study will use a mixed-methods approach to intervention evaluation. Self-report and observed quantitative data for intervention and control groups will be collected at pre-test and post-test evaluation. Primary outcomes will include parent-reports and observations of child behavior problems. In addition, as an exploratory study, this phase will examine initial pre-post intervention effects for potential mediating factors of parenting behavior, parental stress, parental depression, and perceived social support. However, this phase will not test mediation effects due to small sample sizes. Quantitative assessments will also collect data on program fidelity, exposure/adherence, participant engagement, and satisfaction. Furthermore, qualitative focus groups with intervention participants and group leaders will examine issues of program feasibility, content, deliver, and satisfaction. Randomization will be done on an individual level and include a wait-list control group that will receive the intervention 3 months after the post-test evaluation. Results from the feasibility pilot study will be shared with intervention partners and advisory groups. If necessary, final program adjustments will be made prior to further testing. Results will also be disseminated to community forums, local organizations, government stakeholders, and via academic conferences.

Research hypotheses:

Hypothesis 1: Children in the intervention group will demonstrate reduced observed and parent-reported child behavior problems in comparison to the control group.

Hypothesis 2: Parents in the intervention group will demonstrate increased observed and self-reported positive parenting outcomes and decreased observed and self-reported harsh and inconsistent parenting outcomes in comparison to the control group.

Hypothesis 3: Parents in the intervention group will demonstrate decreased parental depression and parental stress outcomes and increased perceived social support outcomes in comparison to the control group.

Hypothesis 4: The Sinovuyo Caring Families Program will be implemented with an acceptable degree of program fidelity, exposure/adherence, and participant satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* isiXhosa-speaking adults above the age of 18
* primary guardians of children aged 3-8 from Khayelitsha, Cape Town
* reside in the same household as child for at least 4 nights per week
* Score 11 or more on Eyberg Child Behavior Inventory Problem Scale

Exclusion Criteria:

* Severe mental health problems on Beck Depression Inventory
* Evidence of severe child maltreatment
Continuous Evaluation of Diaphragm Function

Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction"

Aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (DiaMon, Respinor AS, Oslo, Norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement.

A secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators.

In particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims:

1. to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to standard mechanical indices of respiratory effort such as the pressure-time product (PTP)
2. to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to the ultrasonographic assesment of muscle function performed by an expert operator.


Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode.
* Positive end-expiratory pressure (PEEP) lower than 10 cmH2O
* Pressure support level between 4 and 10 cmH2O
* Ratio between PaO2 and FiO2 \>200 mmHg
* Resolution of the cause of respiratory failure

Exclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Pregnancy
* Circulatory failure
Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis

The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Positive skin prick test to house dust mite,
* Positive RAST test to house dust mite,
* Positive provocation test result to house dust mite,

Exclusion Criteria:

* Serious chronic diseases,
* Other perennial allergies
Description of a Retrospective Cohort of Patients With Transthyretin Cardiac Amyloidosis (ATTR-CA) in Internal Medicine

In 2024, the prevalence of TTR cardiac amyloidosis is difficult to determine precisely. Indeed, the disease has long been underdiagnosed due to a lack of effective treatment and non-invasive diagnostic methods. The prevalence of ATTRwt is estimated at 155 to 191 cases per million person-years, with an incidence of 36 cases per million person-years. Both incidence and prevalence increase with age.

The most common presentation of TTR cardiac amyloidosis is heart failure with preserved ventricular ejection fraction (LVEF).

The natural history of TTR cardiac amyloidosis is progression to restrictive heart disease with all the complications described above.

The median time between diagnosis and the first cardiac symptoms was 39 months. Currently, the median survival in France is approximately 3.5 years, but survival appears to be improving, with a mortality rate of 73.5% at 30 months between 2002 and 2006, compared to 15% at 60 months between 2017 and 2022.

The number of patients diagnosed with TTR cardiac amyloidosis appears to be increasing. The overwhelming majority of available data concerns patients treated in cardiology. However, the issue of TTR cardiac amyloidosis concerns all specialists caring for patients with heart failure, particularly in internal medicine due to the high number of admissions from emergency departments, with a significant proportion of patients suffering from cardiac decompensation.


Eligibility Criteria:
Inclusion Criteria:

* Sujet majeur (≥18 ans)
* Diagnostic d'amylose à TTR suite à une hospitalisation en médecine interne aux HUS entre 01/01/2013 au 31/12/2023.

Exclusion Criteria:

* Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes.
* Type of amyloidosis other than ATTR after review of the medical record (immunological assessment, imaging assessment, expert report).
A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children

To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female constipated outpatients between the ages of 4 and 16
* Currently taking a dose of PEG 3350 powder up to a maximum of 17g per day that has been consistent for at least 4 weeks, or if less than 4 weeks, the investigator testifies that the patient is stable
* Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents
* Are otherwise in good health, as judged by a physical examination
* If female and of childbearing potential, patient must be using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so for the duration of the study
* In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

* Patients who are impacted at baseline exam
* Patients with known or suspected perforation or obstruction
* Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy
* Patients with a known history of organic cause for their constipation
* Patients currently using medications known to cause constipation (these include opiates, antidepressants, SSRI's, antimotility agents and anticholinergics)
* Patients who are breastfeeding, pregnant, or intend to become pregnant during the study
* Female patients of childbearing potential who refuse a pregnancy test
* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure
* Patients with known allergy to PEG or PEG containing medications
* Patients who, within the past 30 days have participated in an investigational clinical study
CBT4CBT for Women in Residential Treatment for Substance Use Disorders

This project examines computer-delivered cognitive-behavioral intervention (CBT4CBT) as an adjunct to residential treatment for women with substance use disorders (SUD). The project will conduct a 2-arm randomized clinical trial (RCT) comparing post-discharge relapse rates for treatment as usual (TAU) with access to the CBT4CBT program vs. TAU in a residential sample of women with SUDs.

Women with substance use disorders face unique barriers to substance use treatment, and as a result, are less likely to seek treatment for substance use than their male counterparts. Women's residential treatment settings have been shown to have higher rates of treatment completion and better outcomes; however, relapse rates for substance use are high, with estimates ranging from 40-60%. Cognitive behavioral therapy (CBT) has been identified as an evidence-based treatment known to improve relapse rates by teaching clients how to recognize and respond to their cues for substance use. Women may particularly benefit from CBT, as their relapse risk factors include depression, interpersonal stress, and relationship conflict.

Despite the effectiveness of CBT, its dissemination is hindered due to limited availability of trained clinicians, cost, and limited resources. Computer-based training for cognitive behavioral therapy (CBT4CBT) offers an opportunity to improve the quality and reach of treatment services that is both feasible and cost-effective. Studies to date have demonstrated the utility of CBT4CBT in outpatient settings; however, it has not yet been evaluated as an adjunct to residential treatment for SUDs.

The specific aims are to: 1) Examine feasibility for use of CBT4CBT in a residential treatment program for women with SUDs; 2) Conduct a small RCT comparing TAU with access to the CBT4CBT program (CBT4CBT; intervention) vs. treatment as usual (TAU; control) using relapse rates and days of use as primary treatment outcomes; 3) Exploratory analyses will identify other correlates (e.g., coping strategies, depression) of relapse at 4 and 12 weeks post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Female
* Meet DSM-5 criteria for a SUD (current)
* Own a smartphone
* Can return to facility for the 4 and 12-week follow-up visits.

Exclusion Criteria:

* Pregnant
* Cognitive or psychiatric impairment
* Language barriers that preclude informed consent