cyrilzakka/clinical-trials huggingface dataset:
Nanosilver Fluoride to Prevent Dental Biofilms Growth

This study aims to evaluate the effectiveness of nanosilver fluoride for controlling the growth of S. mutans present in dental plaque of children.

The product will be apllied on cervical vestibular surfaces of incisors and canines healthy, with a total of 8 teeth, 4 upper and 4 below. Children will be instructed not to ingest any liquid or food within two hours after application. After a period of 7 days will be carried biofilm colect of cervical dental surfaces of incisors and / or canines upper and lower, with the aid of sterile spatulas. This material will be packaged in pre-weighed microfuge tubes containing 1.5 ml of buffered saline solution (0.9% sodium chloride), and transported under refrigeration immediately to the laboratory where analysis will be performed and the S. mutans colonies will be counted. The biofilm collect and posterior laboratorial analysis will be performed weekly.

Eligibility Criteria:
Inclusion Criteria:

* Have at least 4 upper teeth and 4 lower teeth deciduous;systemic health satisfactory; did not use antibiotics or nonsteroidal anti-inflammatory within one month before or during the study;do not use any other forms of chemical control of biofilm during the study period;not being a user of orthodontic devices or dentures;

Exclusion Criteria:

* Presenting oral lesions, supragingival calculus and severe malocclusion.
Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)

The purpose of this research study is to evaluate the safety and effectiveness of Neulasta® (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). This study is considered to be "investigational" because previous studies with Neulasta® used next day dosing and not same day dosing.


Eligibility Criteria:
Eligibility Criteria: - Age 18 years or older - Diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) - Have not received any prior chemotherapy - Have not received radiation therapy or undergone major surgery within the past 2 weeks
Comparison of Visual Field Assessments Between Three Perimeters

A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with best-corrected visual outcomes of 20/30 or better.

Exclusion Criteria:

* Unable to tolerate ophthalmic imaging
* Any ocular or systemic conditions, that could affect VF test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
HPV Vaccine Hesitancy Among Indiana Youth With Cancer and Blood Diseases

For the identified groups of patients (survivors of childhood cancer and youth with sickle cell disease) the investigators want to better understand the barriers to, and facilitators of, HPV vaccination. Through HCP interviews the investigators will also assess both attitudinal and logistical obstacles to HPV vaccination. Some subspecialty HCPs may believe, for instance, that it is the primary care provider's responsibility to vaccinate or they may be unfamiliar with the requirement to enter vaccination data into CHIRP. Also, in some cases HPV vaccine may not be readily available in subspecialty clinic locations and/or subspecialty HCPs may not be Vaccines for Children (VFC) providers. Participants: the investigators will focus on two patient groups: survivors of childhood cancer, which includes children aged 9-21 years who have completed active therapy for cancer and are eligible for vaccination, and sickle cell disease, which includes children aged 9-21 years with a diagnosis of sickle cell disease. The investigators will recruit parents of children aged 9-21 years and older adolescents aged 18-21 years. For pediatric patients, the investigators selected a lower age of 9 years because HPV vaccine is licensed down to 9 years of age, and an upper limit of 21 years, as that is considered the upper bound of adolescence by the American Academy of Pediatrics. For patients 9-17 years of age, only parents will be interviewed by video or phone because parents are the vaccine decision-makers. For patients 18-21 years of age, the investigators will interview both young adults and their parents, because, while the young adult has legal decision-making capacity, in reality, the decision is frequently made jointly by the young adult and parent, and older adolescents are frequently unwilling to go against their parents' wishes. All research procedures will be conducted in English. Participants will be excluded if they have an intellectual disability or severe medical illness such that they are unable to consent or to understand the questions.


Eligibility Criteria:
Inclusion Criteria:

* Age 9-21 years of age for patients with sickle cell disease or cancer.
* Caregiver of patient with sickle cell disease or cancer.
* Healthcare provider of patient with sickle cell disease or cancer.

Exclusion Criteria:

* n/a
Operating Check List During Consultation for Dental Implant

Various studies showed how extent elements not directly linked to the state of the patient were involved in the failures in particular in surgery. That's why it's common to use check list system to avoid human mistakes or any other situation which could impact on the surgery.

Here the study 's aim is to assess a tool set up by the Foundation for Oral Rehabilitation ; it's a check list which cover all the treatment phases concerning dental implant surgery.


Eligibility Criteria:
Inclusion Criteria:

* patient with dental implant surgery

Exclusion Criteria:

* refusing the participation
The Prevelance of Pulmonary Manifestation in Patients With Inflammatory Bowel Disease

Bronchopulmonary manifestations signs and symptoms are variable extraintestinal manifestations of IBD.

Several cases like bronchiactsis, bronchitis, tracheobronchitis and broncholitis. None of this complications are specific for either crohns or ulcerative , however the majority of cases are related to ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:All patients diagnosed ulcerative colitis and crohns disaese on conventional treatment and biological treatment -

Exclusion Criteria:no exclusion criteria

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Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment

Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.

This study recruits young adults with childhood adversity; enrolled subjects either receive an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the intervention. MRI and a battery of self report questionnaires will be administered before and after the intervention; subjects on the waiting list will undergo the same research procedures at the same time as subjects in the intervention group. Primary hypotheses include improved hippocampal plasticity, increased mindfulness and reduced stress and related psychological symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Experience of childhood maltreatment
* With current age between 19 to 35 years old
* With current symptoms of depression or anxiety or PTSD or significant general stress.

Exclusion Criteria:

* History of psychiatric disorders with psychotic features
* Suicidal attempts during the past six months
* Neurological disorders
* And common MRI exclusion criteria
* Prior history with the mindfulness based stress reduction program or other systematic meditation programs.
Institut Paoli Calmettes Colorectal Cancer Database

Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with a colorectal cancer diagnosis

Exclusion Criteria:

* Non applicable
Shared Decision Making for Antipsychotic Medications

This study aims to provide an evidence-based shared decision making intervention for antipsychotic medications, the Antipsychotic Medication Decision Aid (APM-DA), for individuals experiencing early psychosis and provide, for the first time, an understanding of the shared decision making mechanism of action.

The investigators will conduct a cluster RCT of the APM-DA intervention at 6 OnTrackNY clinics, with 3 clinics implementing APM-DA as part of their psychiatric visits and 3 randomized to serve as control offering treatment as usual (TAU). The planned sample size is 120 OnTrackNY clients with first episode psychosis (FEP). This real-world pilot cluster RCT will assess the feasibility of the APM-DA intervention in FEP care, providing the first evidence for the effectiveness of the APM-DA compared with TAU and understanding of the SDM intervention's mechanism of action.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified/unspecified schizophrenia spectrum and other psychotic disorders (ICD-10-CM Diagnosis Code F20.x)
* Current/past experiences with antipsychotic medications (APM; e.g., currently taking any antipsychotic medication, stopped taking, or considering stopping).
* Receive FEP treatment in one of OnTrackNY clinics/sites randomized to intervention or treatment as usual (TAU) - Willing to participate in research interviews after each APM visit during the study period (3 months)

Exclusion Criteria:

* Unable to provide informed consent
* No experience with APM
* Not fluent (speaking, reading, writing) in English
Ventilatory Efficiency in Critically Ill COVID-19 Patients

The new severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2) causes the illness named COVID-19, which is primarily characterized by pneumonia. As of 27 December, there have been over 79.2 million cases and over 1.7 million deaths reported since the start of the pandemic. In many cases, pneumonia evolves to acute respiratory distress syndrome (ARDS) with the need for mechanical ventilation and patient admission to intensive care unit, determining a marked increase in the need for intensive care beds worldwide.

Pulmonary involvement causes predominantly hypoxemic respiratory failure. Although COVID-19 pneumonia often falls within the diagnostic criteria of ARDS, it differs from it for some peculiar pathophysiological characteristics. In particular, patients with ARDS secondary to COVID-19 often have the compliance of the respiratory system within the normal range. A significant role in the pathophysiology of hypoxemia seems to depend on vascular alterations such as altered pulmonary vascular self-regulation, pulmonary capillary leakage, and microvascular thrombosis in a complex process known as "immunothrombosis". All together they act by altering the relationship between ventilation and perfusion and increasing the dead space, which ultimately results in impaired efficiency of the pulmonary ventilation. Among the various markers associated with the prognosis of patients with COVID-19, D-dimer is linked to both the inflammatory state and thrombotic phenomena and could help to identify patients at greater risk of developing early ventilation-perfusion changes.

This study aims at measuring the ventilatory efficiency, assessed by Ventilatory Ratio, in critically ill, mechanically ventilated, COVID-19 patients and its correlation with plasma D-dimer and quasi-static respiratory compliance.


Eligibility Criteria:
Inclusion Criteria:

All of the following:

* confirmed SARS-CoV-2 infection by RT-PCR on a nasopharyngeal swab
* severe hypoxemia due to COVID-19 who meets the diagnostic criteria of ARDS (Berlin's definition)
* invasive mechanical ventilation
* patients receiving neuromuscular blocking drugs

Exclusion Criteria:

* history of preexisting severe hypoxemia (i.e. primary pulmonary hypertension, COPD in therapy with O2 supplementation, pulmonary fibrosis, etc.)
* severe haemodynamic instability defined as:

  * Mean arterial pressure \< 65 mmHg despite the infusion of norepinephrine, or epinephrine, or dobutamine, or levosimendan
  * severe left ventricular dysfunction with ejection fraction \<20%
  * right ventricular failure due to pulmonary embolism
Primary Cesarean Section in Primigravida and Muligravida in Sohag and Al Balyana Cities

cesarean section and vaginal delivery are two methods of delivery, cesarean section somtimes indicated for obstetrical reason but primary cesarean section especially in primigravida might have a preference of the mode of delivery


Eligibility Criteria:
Inclusion Criteria:

* all primigravida with gestational age more than 28 weeks and above who have come for delivery
* multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery
* women between 18 and 45 years

Exclusion Criteria:

* primigravida women \<28 weeks
* multigravida \<28 weeks
* patient having previous history of myomectomy or hystrotomy
* gravida 5 and more
Pentoxifylline for the Prevention of PEP

Between December 2016 and June 2017, 110 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be recruited for the study. Patients were randomized using opaque, sealed envelopes containing random numbers assigning them to treat with pentoxifylline (pentoxifylline group) or Placebo (placebo group) for preventing ERCP pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, age \> 18 years.
2. Normal amylase level before undergoing ERCP.
3. Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

1. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
2. Patients involved in other study within 60 days.
3. Billroth II or Roux-en-Y anatomy
4. Acute pancreatitis.
5. a history of previous ERCP
6. Pregnancy or history of allergy to pentoxifylline
7. Patient treated for arterial hypertension
8. Patient with severe coagulopathy
9. Patient with hyper sensibility of pentoxifylline
10. Nursing mothers
Tai Chi Mind-Body Therapy for Chronic Heart Failure

The purpose of this study is to determine the effects of a tai chi exercise program on functional capacity and health-related quality of life in patients with chronic heart failure (HF). This study will also examine the way tai chi influences mental, physical, and social functioning.

HF is a major public health problem in the United States, affecting approximately 5 million adults. Despite recent advances in pharmacologic therapy and technologic devices, HF is the most common reason for hospitalization among Medicare patients and is reaching epidemic proportions as the population ages. New and inexpensive interventions that can improve functional capacity and quality of life and can delay disease progression are needed. Tai chi is a popular mind-body exercise that is a potential treatment for heart disease. This exercise incorporates both gentle physical activity and meditation, and it may be particularly suited to frail patients with HF. This study will examine the effects of a tailored tai chi program on functional capacity and quality of life in patients with HF.

Participants will be randomly assigned to either a tai chi program or heart health education for 12 weeks. Participants in both groups will undergo a bicycle stress test at study entry and will receive weekly training sessions of their assigned intervention. Self-report scales and questionnaires will be used to assess participants at study start and at the end of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic HF
* Percentage of blood pumped from the left ventricle (ventricular ejection fraction) less than 40% for at least 1 year prior to study entry
* Stable medical regimen, defined as no major changes in medication, in the 3 months prior to study entry
* New York Heart Association Classification of Class I (no activity limitations), Class II (slight activity limitations), or Class III (marked activity limitations)
* English-speaking

Exclusion Criteria:

* Unstable angina, myocardial infarction, cardiac resynchronization, or major cardiac surgery within 3 months prior to study entry
* History of cardiac arrest or diagnosis of peripartum cardiomyopathy within 6 months prior to study entry
* Unstable ventricular arrhythmias or structural valvular disease
* Current participation in a conventional cardiac rehabilitation program
* Inability to perform a bicycle stress test at study entry
* Lower extremity amputation or other inability to walk due to conditions other than HF
* Severe cognitive dysfunction preventing informed consent and understanding of tai chi concept
* Current regular practice of tai chi
* Current participation in a tai chi pilot study or other studies
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology

The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period. The device is a foot mat, which can detect changes in foot temperature that may predict foot ulceration in patients with diabetes mellitus. This mat, the Podimetrics Smart Mat, is FDA cleared.

Innovations toward the prevention of diabetic foot ulcer (DFU) are needed. Early detection of changes in the foot that predict the development of DFU could allow timely intervention to prevent the limb damage that occurs with advanced DFU.

Studies have demonstrated that increased temperature in the foot presage the development of DFU. Temperature changes can accurately be detected by home monitoring devices and predict impending ulceration. Here the study team will test the uptake of novel foot temperature monitoring technology for a future intervention study to determine if a home monitoring device could prevent the occurrence of severe DFU for patients at Montefiore Medical Center (MMC).

The investigator team will conduct a longitudinal study to determine the adherence to an FDA cleared device, Podimetrics, which has been tested in other populations and shown to 1) decrease the risk of severe DFU, and 2) decrease the utilization of health care resources in high risk patients with a history of DFU.

For this study, the study team will identify and enroll patients who are at high risk for DFU. These participants will be identified from the electronic medical record (EMR) and have case report form filled out.

After providing informed consent, study participants will receive the foot mat and obtain training remotely from Podimetrics, which provides a standardized training program.

Participants briefly stand on the mat daily (20 seconds), and the temperature data is automatically sent for analysis to Podimetrics to interpret the information. The participants will be evaluated over a six-month period to measure:

1. Daily use of the technology
2. Secondary outcomes: occurrence of DFU and use of health care resources.

Study participants will be contacted every month by the Einstein investigators to assess foot health. Study participants will be instructed to contact the study team during the study period to inquire if development of any changes in the foot such as the diagnosis of DFU, or if a foot cast is required for offloading, or if participants have any concerns about their feet.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 or Type 2 diabetes mellitus
2. Prior treatment of DFU within 24 months
3. Subject had at least one outpatient follow up with a provider after treatment for DFU
4. No active ulcer at time of enrollment
5. Male or female, aged 18-75 yrs
6. Presence of Neuropathy
7. Ambulatory
8. Provision of signed and dated informed consent form
9. Stated willingness to adhere with all study procedures and availability to participate for the duration of the study

Exclusion Criteria:

1. Active diabetic foot ulcer (DFU)
2. Unable to comply with study requirements
3. Prior above-knee amputation (AKA) or below-knee amputation (BKA)
Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

A neutrophil elastase inhibitor may have effect on suppression of the lung injury after thoransthoracic esophagectomy. The investigators hypothesized that postoperative complication, particularly respiratory complication may be reduced by neutrophil elastase inhibitor after esophagectomy.

The aim of this study was to clarify the usefulness of perioperative administration of sivelestat sodium hydrate, a selective inhibitor of neutrophil elastase in the pulmonary function, systemic inflammatory response, and the postoperative clinical course following video-assisted thoracoscopic esohpagectomy for esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Thoracic esophageal squamous cell carcinoma

Exclusion Criteria:

* Preoperative chemoradiotherapy
* Cardiovascular disease with NYHA grade III or IV
* Pulmonary disorder with Hugh-Jones classification II, III, IV, or V, preo
* Liver cirrhosis
* Renal failure
Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing

Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of our study is to confirm these observations.

Besides its main function in erythropoiesis, EPO has also shown tissue protective effects. The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.

Currently, renal tissue hypoxia is the only widely accepted trigger for erythropoietin (EPO) production. However, previous studies in healthy subjects have demonstrated that a sudden and sustained decrease in tissue oxygen level, aside from an absolute low level of tissue oxygen tension, could also act as a trigger for EPO production. To confirm these observations and to clarify an eventual role of free oxygen radicals and antioxidants, hypobaric pure oxygen will be administered to healthy subjects.

The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.

The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.

Eligibility Criteria:
Inclusion Criteria:

* healthy non-smokers; patients undergoing CABG under cardiopulmonary bypass

Exclusion Criteria:

* Subjects with a pulmonary disease; subjects who have stayed at high altitude since at least 3 months; healthy subjects taking medication; patients undergoing a redo or combined cardiac surgery; patients with renal insufficiency; any emergency CABG; Patients with pulmonary disease