cyrilzakka/clinical-trials huggingface dataset:
Surface Topography and Color Stability of Implant Supported 3D Printed Provisional Restorations

Patient attending the Outdoor Patient Department of the Department of Prosthodontics at Post Graduate Institute of Dental Sciences, Rohtak will be screened. The screening will include history taking and clinical examination of the partially edentulous patients. Patients will be selected according to the inclusion and exclusion criteria. Single stage endosseous implants will be placed. Two different Biocompatible 3D printed Polymethyl methacrylate resin will constitute two groups, Group A and Group B. 3D printed provisional poly methyl methacrylate resin crowns will be fabricated with Group- A and Group-B material followed by evaluation of surface topography and color stability after intraoral use.

Title: "Comparative Evaluation of Surface Topography and Color Stability of Implant Supported Provisional Restorations Fabricated using Two Different 3D Printing Materials in Mandibular Posterior Region: A Randomized Clinical Trial".

Rationale: The study needs to verify the surface topography and color stability of implant supported provisional restorations fabricated using two different 3D printing materials in mandibular posterior region.

Aim and objectives: To evaluate the surface topography and color stability of implant supported provisional restorations fabricated using two different 3D printing materials in mandibular posterior region.

Setting: Department of Prosthodontics and Crown \& Bridge, PGIDS Rohtak. Study Design: Randomised clinical trial. Population/Participants: Provisional restoration will be fabricated using two different 3D printing materials.

Sample Size: Total of 24 samples will be prepared (n=12 samples per test group).

Methodology: This is an in-vivo study and will be carried out in the Department of Prosthodontics and Crown \& Bridge, Post Graduate Institute of Dental Sciences, Rohtak with the purpose to evaluate the surface topography and color stability of implant supported provisional restorations fabricated using two different 3D printing materials in mandibular posterior region.

Outcome Measures: Measuring the surface topography using profilometer and color stability using spectrophotometer.

Statistical Analysis: Data obtained would be compiled on MS Office Excel Sheet (v 2010) and will be subjected to statistical analysis using statistical package for social sciences (SPSS v 21.0, IBM). Intergroup and intragroup comparisons will be done according to distribution of data.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects consented to participate in the study.
2. Subjects with maintainable oral hygiene.
3. Subjects with adequate edentulous space at the prospective implant site.
4. Subjects with availability of adequate quantity and quality of bone.

Exclusion Criteria:

1. Subject with presence of infection around proposed site of implant placement.
2. Subjects with any condition that would interfere with the soft tissue and bone healing.
3. Subjects in which surgical procedure is contraindicated for any reasons.
Exercise Testing to Screen for Unknown Coronary Artery Disease in Diabetic Patients: Does it Contribute to a Risk Reduction in Very High Risk Patients?

In the present study a cohort of diabetic patients without any symptoms and without known coronary artery disease (CAD) will be screened at the investigators' diabetes outpatients services. Those with intermediate or high risk will be asked to participate and enrolled. They will be seen and followed by the cardiologists in order to provide the best adherence to medical therapy. By mean of a randomization process, a group of patients will undergo an exercise electrocardiography (ECG) testing while the other group will continue to be regularly seen at the investigators' cardiology service. Those patients with a positive exercise ECG test will be study by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery. Both groups of patients will be seen every six-eight months for the next three years.


Eligibility Criteria:
Inclusion Criteria:

* Type two Diabetes Mellitus
* Cardiovascular risk equal or higher than 10% according to Italian risk score (www.cuore.iss.it)

Exclusion Criteria:

* Known coronary artery disease
* Symptomatic heart failure
* Objective inability to perform treadmill exercise
* Known or active malignancy, advanced renal failure (clearance \< 25 ml/mi/1.73m2), liver cirrhosis (child Pugh III); stroke within the past 30 days
* Presence of left bundle branch block or ST depression at rest greater than 0.9 mm
Transcranial Ultrasonography Using Linear 2D Imaging of the Brain

This study will use linear 2D ultrasound imaging to look at the brain of individuals diagnosed with autism and their siblings. This is called transcranial ultrasound (TUS). It is hypothesized that TUS will allow real-time imaging of the fluid spaces outside the brain and will further allow the imagining of brain areas important to language and social function.

TUS will be evaluated as a simple and low cost screening technique to evaluate the presence of increased extra-axial fluid (EAF)or(subarachnoid cerebral spinal fluid). A recent study (Shen et al. 2013) demonstrated increased EAF was predictive of risk of autism. We believe TUS is capable or rapid, safe, low cost, non-invasive measurement of EAF spaces. Where prior imaging, ie., MRI or CT exist they will be used as comparisons. Both individuals with autism and their siblings will be screened to create a database and standard for TUS measurements. It is further believed that TUS may be able to detect areas of cortical abnormalities called dysplasias. The procedure requires no sedation and only takes a few minutes to perform. If validated, this would make TUS an ideal screening test for autism risk and allow for early referral and more definitive imaging with MRI where necessary.

Eligibility Criteria:
Inclusion Criteria: Confirmed diagnosis of autism or the sibling thereof and willingness of a parent to consent and where applicable for the individual to assent or consent depending on age.

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Exclusion Criteria: Siblings must have no obvious health issues or developmental abnormalities.

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Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding

compare the chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques.


Eligibility Criteria:
Inclusion Criteria:

- Patients should have

1. Maxillary sound teeth and undergoing fixed orthodontic treatment.
2. Space problems ranging from spacing to mild crowding.
3. Good oral hygiene.

Exclusion Criteria:

1. Patients with partially erupted teeth in the maxillary arch .
2. Signs of caries, large restorations fluorosis, hypoplasia or abnormalities of crown morphology.
3. The need of banding.
4. Bad oral hygiene measures.
Listen to a Audio Book

This study investigates how listening to audiobooks affects agitation scores and respiratory parameters (like breathing rate, depth, and oxygen saturation) in patients receiving non-invasive mechanical ventilation (NIMV) for hypercapnic respiratory failure in an intensive care unit. Participants will listen to an audiobook of their choice during their 2-hour NIMV treatment. Their agitation levels and respiratory parameters will be measured before, during, and after NIMV application. The goal is to evaluate whether audiobooks can reduce patient agitation and improve respiratory outcomes, offering a low-cost, easy-to-use, and effective approach for better patient care.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 years or older Patients hospitalized in the Chest Diseases Intensive Care Unit Diagnosed with Hypercapnic Respiratory Failure Undergoing Non-invasive Mechanical Ventilation (NIMV) No hearing impairment Conscious and alert patients

Exclusion Criteria:

Patients unwilling to participate or wishing to withdraw from the study
Clinical Effects of a Nucleotides-Supplemented Infant Formula

The study hypothesis is that different concentrations of nucleotides' supplementation of an infant formula might affect differently growth and/or other clinical parameters in neonates.

Three groups of 50 newborn infants each, will be fed for 30 days an infant formula supplemented with either 4.9 mg/100 kcal or 10.6 mg/100 kcal of nucleotides or with no supplementation. Newborns will be monitored prospectively for the following outcome parameters:

* Growth percentiles.
* Behaviour and infantile colic.
* Bowel habits.
* Side effects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborns aged 0-30 days.

Exclusion Criteria:

* Prematurity
* Chronic illness
* Failure to thrive
* Milk allergy
Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.

Eligibility Criteria:
Inclusion Criteria:

* Central neuropathic pain
* Chronic pain with an average pain intensity is greater than or equal to 40/100
* Pain presents a daily or almost daily (at least 4 days out of 7)
* Pain presents for more than 6 months
* Patients who signed informed consent,
* Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study,
* Patients can be monitored for the duration of the study (29 weeks)
* Patients affiliated to a health insurance plan or entitled,
* Patients with a cerebral MRI T1.

Exclusion Criteria:

* Labor dispute or Accident,
* Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
* Abuse of drugs or psychoactive substances
* Peripheral Neuropathic Pain,
* Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
* Intermittent pain,
* Pain in less than 6 months,
* Presence of other pain more severe than that justify inclusion,
* Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session)
* Patients unable to understand informed consent, under guardianship,
* Patients refusing to stop or can not stop the prohibited treatment during the study,
* Patients participating in another research protocol involving a drug within 30 days before inclusion.
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks

Compare the fit of two pediatric face masks in children.

This is a prospective, randomized, open-label comparative observational study to be conducted in up to two (2) facilities with the healthy and non-healthy Subjects (4-12 years of age). The usage of face masks is common practice within hospitals, and masks may be evaluated outside of clinical facilities as well.

Eligibility Criteria:
Inclusion Criteria:

* 4 to 12 years of age
* conscious

Exclusion Criteria:

* able to wear a mask
* no previous allergic reactions to face masks
Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study

The investigators will perform a pilot study to gain insight into attitudes, barriers and facilitators for health behavior change in cancer patients and their partners. Results of this pilot will be used to design suitable questionnaires to investigate health behavior change in a larger cohort of patients and their partners. It will also direct future interventions to adequately target patients and, potentially, their partners to improve their lifestyle following a cancer diagnosis.

The investigators will perform semi-structured interviews with cancer patients and their partners in order to explore knowledge, attitudes, barriers and facilitators regarding health behavior change following cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years of age
* have completed adjuvant or curative chemotherapy (in BC and TC patients, respectively) or started adjuvant hormonal therapy alone (in BC patients) between 6 and 24 months previously
* have no signs or symptoms of recurrent disease
* be in follow-up at the Department of Medical Oncology of the UMCG.

Exclusion Criteria:

* signs or symptoms of recurrent disease
* mental disability
Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon

The aim of this study was to determine the effect of prone position on vital signs, arterial blood gases and blood values in 0-1 year old infants extubated after congenital heart surgery. The study was a randomised controlled experimental type study.

The sample of the study consisted of 40 infants aged 0-1 year who underwent surgery in the Cardiovascular Surgery Intensive Care Unit of a private hospital.Data collection tools consisted of "Data Collection Form", "Vital Signs Follow-up Form", "Arterial Blood Gas Follow-up Form", "Blood Values Follow-up Form" prepared by the researcher in line with the literature information and some measurement data used in the study (arterial blood sample obtained with the blood gas measurement device used in the NICU and blood gas parameters (PaCO2, pH, PaO2, Lac and SaO2) and bedside monitor).

The study was conducted in the Cardiovascular Surgery Intensive Care Unit of a private foundation university hospital. Infants between the ages of 0 and 1 year who had undergone congenital heart surgery and were extubated after surgery, who did not have any congenital anomalies of the lungs in addition to congenital heart disease, who did not have any condition that could affect cardiac, circulatory and respiratory functions or prevent positioning were included in the study. The infants to be included in the study were randomly selected to the control and study groups to avoid bias in the study. Which of the experimental or control groups the infants included in the study would be in was determined by using the address "https://www.calculatorsoup.com".

Eligibility Criteria:
Inclusion Criteria:

* To be between 0-1 years old
* Having congenital heart surgery
* Endotracheal intubation has been applied
* Being extubated after congenital heart surgery
* Obtaining permission from their parents to participate in the study

Exclusion Criteria:

* In addition to the diagnosis of congenital heart disease, congenital heart disease of the lungs with any of the anomalies,
* Position that may affect cardiac, circulatory and respiratory functions or surgical intervention that prevents ECMO (open sternum bone, ECMO support, etc.)
* Complications developed during the study,
* Infants whose parents did not agree to participate in the study were included in the study. is not recognised.
Comparison of Parameters Between a Frameless Brain Biopsy Method and the Standard Frame-based Stereotactic Biopsy

The purpose of the present study is to compare the characteristics, i.e. efficacy, duration, safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the standard frame-based stereotactic technique.

Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for open craniotomy.

Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless fiducial-less method using an optical based navigation system and a mini frame apparatus - trajectory guide.

The purpose of the present study is to compare the characteristics, i.e. efficacy, duration, safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the standard frame-based stereotactic technique, in order to apply a technique friendlier to the patient, more comfortable for the surgeon and more flexible concerning the overall hospital's function.

Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for open craniotomy.

Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless fiducial-less method using an optical based navigation system and a mini frame apparatus - trajectory guide.

The following parameters will be assessed: diagnostic yield, histological - cytological evaluation of the biopsy specimens, cerebral lesions' location, lesions' maximum diameter, duration of: the overall procedure, the preparatory steps overall, the preparation inside the OR, operation ("skin-to-skin"), the time spent inside the OR overall, neurologic morbidity, new abnormal findings in the postoperative head CT scan, length of hospitalization.

Eligibility Criteria:
Inclusion Criteria: Patients: 1) for whom no conclusive diagnosis could be settled in a noninvasive manner; and 2 who also had surgically inaccessible lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the probable diagnosis is a contraindication for craniotomy.

Exclusion Criteria: 1) Pediatric patients, 2) Coagulation abnormalities, 3) destructive comorbidities and very short life expectancy.
Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms

Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.

Duavee® which is the combination of the selective estrogen receptor modulator bazedoxifene and conjugated estrogen 0.45 mg) is an FDA approved drug for treatment of hot-flashes and prevention of osteoporosis in postmenopausal women. The investigators recently reported the results of a single arm pilot study suggesting that 6 months of Duavee® was associated with improvement in several risk biomarkers including benign breast tissue proliferation, mammographic fibroglandular volume, IGF-1, SHBG and progesterone in high risk women in late menopause transition. Prior to opening a randomized Phase IIB trial of 6 months of Duavee® vs placebo in high risk women with hot-flashes followed by open label Duavee®, the intent of this study is to assess probable uptake of such a trial design with a pilot of 6 months of Duavee® vs wait-list control in symptomatic women. Additional imaging biomarker information from MRI will be obtained. A finding on MRI of greater background parenchymal enhancement (BPE) in high risk women is positively associated with higher probability of developing breast cancer and is independent of fibroglandular volume. BPE is reduced by selective estrogen receptor modulators including tamoxifen. The investigators will investigate change in MRI BPE over time for women randomly assigned to either receive Duavee® or not (wait-list control). The investigators will also explore development of fully automated breast MRI volumetric density measures.

Eligibility Criteria:
Inclusion Criteria:

* Women who report vasomotor symptoms (hot flashes or night sweats)
* No menstrual periods for at least 3 months
* Must have at least one ovary (hysterectomy is permitted; bilateral salpingo- oophorectomy is excluded).
* BMI \<36 kg/m2
* Moderate risk of developing breast cancer based on having any one or more of the following:

  * First or 2nd degree relative with breast cancer
  * Known carrier of moderate to high penetrance germline mutation
  * Prior breast biopsy showing proliferative breast disease or multiple biopsies
  * High mammographic density (Volpara® categories c or d or BIRADs density assessment as heterogeneously or extremely dense (c or d).
  * IBIS Breast Cancer Risk Evaluation Version 8 10-year relative risk of \>2X that for the population for age group.

Exclusion Criteria:

* Risk: A prior biopsy showing LCIS, DCIS, or invasive breast cancer.
* Medical Conditions:

  * Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke
  * History of renal or liver disease
  * Prior invasive ovarian or endometrial cancer
* Medications

  * Current anticoagulant use other than low dose aspirin
  * Taking systemic hormones within two months (eight weeks) prior to baseline MRI and mammogram.
  * Taking tamoxifen, raloxifene, Duavee, or any selective estrogen receptor modulator, or an aromatase inhibitor within 12 months prior to baseline MRI and mammogram.
Standard Follow-up Program Neuro-oncology Patients (SFP Neuro-Oncology)

Standardised evaluation of baseline data regarding tumor-, patient- and treatment-characteristics as well as follow-up data regarding tumor- and clinical-outcome of neuro-oncology patients treated with radical/curative radiotherapy.

Motive:

Currently there is limited data on dose-effect relationships of tissues and structures in and around the brain. This lack of knowledge hampers patient selection for proton therapy, technique innovations, and accurate prediction of treatment outcome.

Goal:

To evaluate the selection for radiation treatment, obtain more knowledge on dose-effect relationships and enable insight in necessary treatment technique innovations that would improve treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patient with neuro-oncological cancer
* Patient receiving a radiotherapy dose XXX Gy

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria