cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance of Fiber Reinforced Composite Versus Microhybrid Composite Restorations

Clinical performance of direct fiber reinforced resin composite restorations versus direct microhybrid resin composite restorations in endodontically treated molars will be evaluated over 12 months using modified USPHS criteria.

Restoration of endodontically treated teeth is one of the main challenges in restorative dentistry. There are structural changes in endodontically treated tooth: dehydration of dentin, mutation of collagen due to the effect of irrigation and reduction of hardness. This alteration together with loss of tooth structure inflicts a negative impact on long term prognosis of the endodontically treated tooth increases incidence of dental fracture.

Endodontically treated teeth were restored traditionally by crown but this approach is invasive with many technical and clinical steps that prolong the time of treatment. Adhesive philosophy and resin composite were developed and enhanced within the last thirty years that give clinician conservative option also strengthen, protect the tooth against fracture and changed the doctrine of devitalized tooth must be restored by crown. Current studies encourage applying conservative approach and restoring endodontically treated teeth with bonded restorations, so a lot of classic indications of crown in restoring endodontically treated teeth are questioned now.

Microhybrid resin composite restorations permit application of conservative approach that preserves remaining sound tooth structure. Fiber reinforced resin composite improved strength, toughness and fracture resistance of conventional resin composite and restored teeth.

Fiber reinforcement of conventional resin composite is introduced aiming to improve their physical, mechanical properties and tooth fracture resistance. The improvement of the properties was interpreted due to the rule of fibers in stopping crack propagation and transferring stress from matrix to fibers, also it was suggested that fiber Reinforced Resin Composites decrease polymerization shrinkage and shrinkage stress. fiber-reinforced resin composites are used as a dentine substitute combined with conventional resin composites as an enamel replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Good oral hygiene.
* Co-operative patients approving to participate in the study.
* Endodontically treated molar with minimum to moderate loss of tooth structure.
* Presence of antagonists

Exclusion Criteria:

* Patients with advanced periodontal disease.
* Patients with parafunctional habits.
* Patients with temporomandibular joint disorders.
* Teeth with failed endodontic therapy or extensive caries.
* Pregnant female
Virtual Mentorship to Support Maternal and Infant Health and Wellbeing: Assessing the Impact and Efficacy of NurturePA

The primary objective of this study is to determine whether the NurturePA text-based mentorship program reduces maternal stress and depressive symptoms, increases maternal knowledge, and increases engagement in language and literacy practices among new mothers relative to the control condition of periodic informational texts at the four-month data collection point.

Context: New parents in the US are typically offered little if any support with the transition to parenthood, despite the difficulty many families experience during this time and the importance of positive early parent-child interactions to children's future school and life outcomes.

Objectives: This study seeks to evaluate the impact of the NurturePA text-based mentorship program on maternal and infant health and wellbeing.

Study Design: Randomized control trial Setting/Participants: Participants will be recruited from the West Penn Hospital Maternity Ward. 200 participants (100 treatment, 100 control) will be recruited. They must be first or second time mothers of a focal infant of full term gestational age and normal birthweight. They must be current residents of Allegheny County and plan to remain in Allegheny County for the next two years.

Study Interventions and Measures: Treatment participants will be enrolled in the NurturePA text-based mentorship program and assigned a mentor with whom they can communicate. Control participants will receive periodic texts from NurturePA with information about child safety and health.

This study will measure maternal mood and stress, engagement in parent-child language and literacy activities, maternal knowledge, and child developmental outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Resident of Allegheny County
2. First time mother or mother of one other child
3. Gestational age of focal infant at birth is at or above 34 weeks
4. Birthweight of focal infant at or above 4 pounds (1814 grams)
5. Focal infant leaving hospital with mother (e.g. no extended NICU stay)
6. Planning to remain living in Allegheny County for at least two years
7. No more than one other child living full time and being cared for in the home (including non-biological children)

Exclusion Criteria:

1. History of substance abuse disorder
2. Parents/guardians who, in the opinion of the Investigator, may be non-adherent with study schedules or procedures.
Axillary Reverse Mapping in Breast Cancer

The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.

Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.

In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.

HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.

Eligibility Criteria:
Inclusion Criteria:

Patients who will undergo ALND in the treatment of breast cancer:

* cT4a, cT4c and cT4d.
* cT4b with extensive involvement of the skin.
* cN0 with SLNB positive (pN+) that need to associate ALND:

  * cT3-T4b.
  * \>2 lymph node macrometastasis if cTis, cT1 and cT2.
  * Patients who underwent mastectomy and it is not possible associate adjuvant radiotherapy.
* cN1:

  * If primary surgery treatment.
  * After neoadjuvant systemic treatment, if there is not a clinical-radiological complete response and/or SLNB positive (ypN+).
* cN2:

  * If primary surgery treatment.
  * After neoadjuvant systemic treatment, if luminal tumours or there is not a clinical-radiological complete response in triple negative or HER2 overexpressed tumours.
* cN3.

Exclusion Criteria:

* Patients with previous axillary surgery (except sentinel node biopsy)
* Patients who did previous axillary radiotherapy treatment.
* Patients who do not wish to participate in the study.
Explore Biomarkers Associated With Prognosis of Recurrent and Metastatic CRC After Surgery by Multi-omics Methods

This project is the first application, which is applied as a single center project and applied according to the screening quantity. This project is a multi-omics approach to explore biomarkers associated with prognosis after secondary radical resection of recurrent and metastatic colorectal cancer.

Main research objectives: 1. To detect DNA mutation and methylation in tumor tissues by NGS detection technology (the methylation dimension should be detected in adjacent tissues at the same time), and to explore specific molecular markers related to prognosis; 2. Using NGS test technology of blood in patients with preoperative and postoperative blood ctDNA mutations and methylation double dimension testing, respectively, to explore the preoperative and postoperative ctDNA mutations and the correlation between methylation status and recurrence, including but not limited to predict patients with recurrence of sensitivity, specificity, positive predictive value, negative predictive value and recurrence warning time and other indicators.

Main contents: This study intends to include single site for the first time/organ metastasis after radical treatment and surgical indications again in patients with colorectal adenocarcinoma (including but not limited to spread to the liver, lung metastasis, peritoneal metastasis, lymph node metastasis and other organ metastasis), collected in patients with preoperative peripheral blood and tissue samples, tissue adjacent to carcinoma and postoperative peripheral blood, NGS detection technology was used to detect DNA and mutation in the relevant samples, combined with clinical treatment and prognosis information of patients, and then explore biomarkers for predicting recurrence risk.


Eligibility Criteria:
Inclusion Criteria:

1. Colorectal cancer patients with first recurrence and metastasis after previous radical resection
2. Single site/organ metastasis is indicative of reoperation
3. Adenocarcinoma diagnosed by histology or cytology
4. At the time of signing the informed consent, the applicant must be 18 years old or older
5. Life expectancy is at least 12 weeks
6. ECOG score 0\~1

Exclusion Criteria:

1. Currently participating in the intervention study treatment, or receiving other drugs or study devices within 4 weeks before enrollment
2. Concurrent with other malignant tumors
3. The investigator determined that the patient had other serious diseases that might affect follow-up and short-term survival
4. Cardiac function NYHA class III or IV heart disease
5. The presence of definite peripheral nerve disease
6. There is definite hearing loss
7. Other researchers think it is not suitable for inclusion
A Study to Investigate a Transdermal Continuous Glucose Monitoring System in Diabetic Patients for a Period of 28 Days

Single-centre, open label (unblinded). A maximum of 48 patients will be enrolled in 4 Cohorts of 10 patients and 2 potential replacements each. Diabetic patients (type 1 and 2). Duration up to 11 weeks: up to 6 weeks of screening phase (42 days); 4 weeks of treatment/measurement phase (28 days, depending on sensor functionality) and 1 week of follow up (7 days)

This study is an investigational study, which will be conducted only at one site in Germany. The investigators, the patient and the sponsor will be unblinded.

The eligibility of the patient is determined in up to two steps, a screening (see inclusion criteria) and in case of women of childbearing potential a urine pregnancy test at the day of sensor insertion (independent of any re-screening). Women of childbearing potential are only enrolled after a negative outcome of the urine pregnancy test. The screening results are valid up to 42 days. Within that time the first measurement visit including the insertion of the device should be performed. If the first measurement visit is delayed a re-screening has to be performed. Should the patient not pass the re-screening, the patient is considered as a screening failure and must be excluded.

The trial is structured into three phases, the screening/enrolment phase, the insertion/measurement phase and the follow-up phase.

Screening/Enrolment Phase: Up to 6 weeks (42 days), 1 visit

Insertion/Measurement phase: Up to 4 weeks (28 days), up to 6 in-house measurement visits

Follow-up Phase: 1 week (7 days), 1 visit

Eligibility Criteria:
Inclusion Criteria:

* Body mass index within the range of 19-40 kg/m2, inclusive
* Diabetes type 1 and 2
* Females (if of childbearing potential) must agree to abstain from sexual intercourse or use reliable forms of contraception e.g. condom or diaphragm with spermicide or oral contraceptives to prevent pregnancy during the study
* Negative urine pregnancy test immediately before sensor insertion (only women of childbearing potential)
* Signed written Informed Consent

Exclusion Criteria:

* Inability to follow the protocol schedule
* Participating in another clinical trial
* Pregnant or lactating females, , including positive urine pregnancy test immediately before sensor insertion
* Any known hypersensitivity to any of the products used in the study, including preservatives etc. Especially hypersensitivity against legumes
* Tattoos at the abdominal or upper arm skin area where the fiber sensor is supposed to be placed
* Malignancies requiring therapy during the study
* Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study
* Acute severe infection disease at the time of enrolment
* Alcohol and/or drug addiction
* Vulnerable patients (e.g. persons kept in detention)
* Poorly controlled diabetes mellitus with hemoglobin A1C higher than 10%
Investigating Usability of c-SIGHT in the Homes of Brain Injury Survivors

A brain injury can damage the brain, so that it no longer receives information about the space around one side of the world. If this happens, people may not be aware of anything on one side, usually the same side they also lost their movement (the most affected side). This severe condition is called spatial neglect. Currently there is no recommended diagnostic test or clinically-proven treatment for the condition. In a recent study, the investigators found a long-lasting reduction in neglect if people practiced picking-up an object with their unaffected hand. This intervention is called Spatial Inattention Grasping Home-based Therapy (SIGHT). It requires people to lift wooden rods of different lengths. Once a person is familiar with the task, they can practice on their own at a time convenient to them in their homes. The investigators have developed the first computerized version of SIGHT (c-SIGHT) as well as a novel diagnostic test for neglect using portable low-cost motion-tracking technology that can be used in the patient's home. In the proposed study, the investigators will investigate how usable and acceptable this technology is in people's homes. Stroke survivors (recruited from community settings) will undergo a 7-day self-led training at their homes with c-SIGHT. At the end of the intervention, 1:1 semi-structured interviews will be carried out with both stroke survivors and carers to investigate usability and acceptability of c-SIGHT. Moreover, spatial neglect, carer burden and motor function will be assessed pre- and post-completion of c-SIGHT.


Eligibility Criteria:
Inclusion Criteria:

* +18
* suffered brain injury
* have TV with around 2 meters in front of it to be able to run the therapy
* live in the Norfolk, Suffolk, Essex or Cambridgeshire (UK)
* no other pre-existing neurological disorders (such as dementia)
* no language impairment (able to follow 1-stage command)
* mental capacity to consent
* no known learning disability
* no major psychiatric illness
* no history of substance abuse
Choroidal Changes Post Short Term Exposure To Virtual Reality Devices

This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display compared to a control (standard) VR display. The hypothesis is that there will be less choroidal thinning in the eye viewing the test VR screen compared to the eye viewing the control VR screen.


Eligibility Criteria:
Key Inclusion Criteria:

* Is at least 13 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Visual Acuity of +0.20 logMAR or better in each eye;
* Is willing and able to follow instructions and maintain the appointment schedule.

Key Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is amblyopic in either eye;
* Has a colour vision abnormality;
* Commonly experiences motion sickness.
The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research

This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.

The study was designed to answer some of the most important questions about the treatment modalities of acromegaly, the relevance of these treatment modalities to patients' clinical outcomes and the economic impact of treatment programs on patients. These answers may be of great help to the treatment of these populations and may also help to make treatment and related health decisions in the future.

This study only collects the patient's medical information during the study and does not interfere with the patient's treatment. Each patient will be assigned a unique patient identification number for the study. The sites will maintain a confidential decode list that enables the study staff at the site to link the assigned patient identification number with the patient's medical records for extraction of study-required data. These registries will be maintained following International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and the respective local privacy laws and requirements.

Eligibility Criteria:
Inclusion Criteria:

1. Be able and willing to sign the informed consent form (ICF)
2. Male, female, age 18-75 years old (including 18 years old and 75 years old).
3. Compliance with acromegaly diagnostic criteria:

   * At least one laboratory or medical record shows that the patient is random GH ≥ 2.5 μg / L
   * At least one checklist or medical record shows radiographic evidence that the patient has a pituitary tumor

Exclusion Criteria:

1. Ectopic secretion of GH or pituitary cancer
2. The patient is diagnosed with other complicated malignancies, or has previously been diagnosed with another malignancy, and there is currently evidence of lesion residue.
3. Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study.
4. Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* vitreous haemorrhage
* tractional retinal detachment
* active proliferative diabetic retinopathy.

Exclusion Criteria:

* neovascular glaucoma
* cataract
* combined traction and rhegmatogenous RD
Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

A study comparing 2 different investigational formulations of pantoprazole in healthy adults.

open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study

Eligibility Criteria:
Inclusion Criteria

* Men or women aged 18 to 50 years.
* Healthy as determined by the investigator.

Exclusion Criteria

* History or active presence of clinically important medical disease.
* History of drug or alcohol abuse.
Testing Strategies to Improving Warfarin Adherence

We are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin. Individuals from an anticoagulation clinic are being asked to participate in order to see if a lottery which provides the opportunity to win money in combination with the use of the Med-eMonitor might be useful in helping patients to achieve better control of their anticoagulation therapy. Half of the participants will be enrolled in the lottery arm and the other half will be a control group who will receive the Med-eMonitor only.


Eligibility Criteria:
Inclusion Criteria:

* 21 years old age or older
* On warfarin managed at the AC clinic
* Target INR 2.0-3.0 or 2.5-3.5
* At maintenance phase of therapy (defined as stable INR with stable warfarin dosing over at least 2 consecutive visits)

Exclusion Criteria:

* Do not have access to telephone line
* Unwillingness to participate or to sign a consent form(refusal)
* Inability to participate because of advances dementia, advanced Alzheimer's disease or other impairment affecting ability to provide informed consent and/or quality data or utilize the Med-eMonitor
* Participation in a current study that does not permit participation in another study
* End stage or terminal illness with anticipated life expectancy of 6 months or less
* INR over the upper limit for the individual's range at the time of enrollment (e.g.,\>3.0 or \>3.5, depending on the target range)
* Diagnosed with antiphospholipid antibody syndrome or abnormal INR prior to starting warfarin