cyrilzakka/clinical-trials huggingface dataset:
Digital Versus Conventional Impression Techniques in Children

The impression is a necessary step for the orthodontic diagnosis. Digital impression has recently been introduced by means of intraoral optical scanners. To date, few studies have compared the conventional alginate impression with the digital impression with intraoral scanners. These studies have shown that digital impression could have some advantages in terms of satisfaction and less discomfort for the pediatric patient. Only one study is randomized and has analyzed patients between 10 and 17 years of age. There are, therefore, no randomized trials for patients under 10 years of age.

The objective of the study is to compare the conventional alginate impression with the digital impression of both dental arches in orthodontic patients between 6 and 10 years of age with a randomized crossover design. In particular, the preference, comfort, impression taking time and other subjective aspects will be analyzed. This is a monocentric, controlled, superiority, randomized, crossover, open study.

Inclusion criteria:

- Orthodontic patients between 6 and 10 years of age.

Exclusion criteria:

* Noncompliant patients
* patients with syndromes or systemic diseases
* patients suffering from cleft lip and palate. The patient will be asked which of the 2 dental arch impression procedures they prefer. In addition, patients will be provided with a questionnaire including VAS (Visual Analogue Scale) for comfort, pain, gag reflex and breathing difficulty. The VAS will consist of scales from 0 to 10.

As for the calculation of the sample size, this has been done by considering a null hypothesis for a proportion of 50% in the preference between the two treatments and an alternative hypothesis of 80%. For alpha set at 0.05, a power of 80% and a dropout rate of 10%, 24 patients are required.

Descriptive statistics will be performed for all variables (frequency and percentage for qualitative variables and mean and standard deviation for quantitative variables). For the primary endpoint variable, impression procedure preference, the test will be performed for one proportion and the 95% confidence interval will be calculated using the Clopper-Pearson method.

With regard to the secondary endpoint variables, duration of the procedure, comfort, pain, gag reflex, breathing difficulty, the 2 procedures will be compared with the t-test for paired data.

An Intention-To-Treat analysis will be performed. In case more than 5 deviations from the protocol will occur, a sensitivity analysis will also be performed per protocol.


Eligibility Criteria:
Inclusion Criteria:

* Orthodontic patients between 6 and 10 years of age.

Exclusion Criteria:

* Noncompliant patients
* patients with syndromes or systemic diseases
* patients suffering from cleft lip and palate.
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology

The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.

This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters.

Eligibility Criteria:
* Inclusion Criteria:

  1. Male or female, age \> or equal to 18 years or \< or equal to 89 years old;
  2. Capable and willing to give informed consent;
  3. English speaking;
  4. Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;
  5. Admitted to study area.

Exclusion Criteria:

1. Male or female, \< 18 years old or \> 89 years old;
2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
3. Previous venous grafts or surgery at the target vessel access site;
4. Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
EndoChoice's Fuse® Endoscopic System Performance In Routine Practice

The intent of this study is to evaluate the performance and usability of Fuse in routine practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy) gastrointestinal endoscopy procedures. The study is open label, prospective and Post Marketing study.

The intent of this study is to evaluate the performance and usability of Fuse in routine practice EndoChoice's Fuse system - Fuse is an FDA, CE and AMAR approved Endoscopic system (Gastroscope and Colonoscope).

Fuse® system The Fuse system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse system consists of camera heads, endoscopes, video system, light source and other ancillary equipment.

Fuse Colonoscopes in conjunction with the FuseBox™ processor are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects.

Fuse Gastroscopes in conjunction with the FuseBox™ processor are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ages 18 at least
* The subject has been scheduled for routine screening upper or lower endoscopy, diagnostic work up, or endoscopic surveillance.
* Signed informed consent

Exclusion Criteria:

* Subjects who are currently enrolled in another clinical study
Follow-up After Surgery for Colorectal Cancer

The currently developed implementation study aims to evaluate if a patient-led home-based follow-up approach is successful, improves quality of life, reduces anxiety and lessens fear of cancer recurrence during the years after surgical treatment of colorectal cancer (CRC).

As the available literature implies that intensive postoperative surveillance has no impact on (cancer-specific) survival outcomes in patients after curative intent surgery for CRC, critical appraisal of the current follow-up practice and guidelines is needed. Although patients in the referenced randomized controlled trials were included roughly 5 - 15 years ago, treatment for recurrent colorectal cancer has seen little to no change since then. Therefore, efforts to improve the current standard of follow-up in patients with CRC should focus on ameliorating quality of life and cost-effectiveness, rather than survival. It provides an opportunity to support patients emotionally, to evaluate treatment effects and complications, and to inform them on their individual prognosis. This is especially true considering the growing importance of value based healthcare and patient reported outcomes in medicine. The investigators therefore propose a patient-led home-based follow-up approach. This follow-up strategy primarily consists of carcinoembryonic antigen (CEA) level monitoring at home, but additional counselling/diagnostic testing remains possible if desired by patients. In this way the investigators hope to meet the individual needs of patients during follow-up and to improve quality of life outcomes, while achieving equal or greater societal cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago
* Scheduled or currently undergoing postoperative surveillance according to national guidelines
* Written informed consent by the patient

Exclusion Criteria:

* Patients with a severely complicated postoperative course, needing in hospital follow-up longer than 6 months postoperatively
* Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax
* Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent
* Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language
A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.

RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.

Overall Goals:

- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.

Primary Aim:

- to further evaluate effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.

Secondary Aims:

to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read and understand the informed consent document; must sign the informed consent;
2. Aged 18 to 75 years old , sex is not limited;
3. Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection;
4. Availability of at least 4 g tumor sample;
5. Patient must receive concurrent chemoradiotherapy (temozolomide chemotherapy and radiotherapy).
6. Karnofsky functional status rating \> or equal to 70.
7. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] ), and adequate renal function (BUN and creatinine \<1.5 times IULNs)
8. Agree to Surgical indications of Heart \& lung and without the coagulation system disease
9. Except for surgery and radiotherapy and chemotherapy before vaccine treatment, no other cancer treatment is received.

Exclusion Criteria:

1. Inability to comply with study-related procedures
2. Unavailability of at least 6 doses of vaccine
3. Severe allergies
4. Unstable or severe intercurrent medical conditions
5. Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
6. patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
7. any other clinical trials within 30 days pre-vaccination.
8. Female patients who are pregnant or breastfeeding
9. Carmustine extended release implant surgery within 6 months
10. Steroidal drugs are currently being used systemically.
Post-transplant Thrombotic Microangiopathy: Evaluation of Outcomes at the Bologna Kidney Transplant Centre

It is a retrospective-prospective, single-centre, non-pharmacological, retrospective tissue study carried out for scientific and health protection purposes. It involves the systematic collection of clinical information from patients diagnosed with PT-TMA

The primary objective is to calculate the incidence of PT-TMA in a large cohort of kidney transplant patients and to assess the association between PT-TMA and renal transplant outcome.

It provides for the systematic collection of clinical information of patients with a diagnosis of PT-TMA, starting from 01/06/2016 until the approval of the study by the Ethics Committee and the issuance of the authorisation by the Director General of the IRCCS; the evaluation of the prospective data will be carried out starting from the approval of the study by the Ethics Committee and the issuance of the authorisation by the Director General of the IRCCS and will continue for 10 years. Patients enrolled prospectively will be treated according to clinical practice, in accordance with the judgement of the Physician

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Living kidney transplant recipient, brain death cadaver donor, cardiac death cadaver donor, single kidney transplant, double kidney transplant, combined kidney transplant
* Acquisition of Informed Consent to participate in the study and to process personal, special and genetic data

Exclusion Criteria:

-
REASSURE-NIRS Registry

RESSURE-NIRS registry is designed to investigate clinical and pathophysiological characteristics of NIRS-derived lipid-rich plaque in patients with coronary artery disease. This is an on-going multi-center prospective registry in Japan.

NIRS imaging is an invasive intravascular imaging modality to quantitatively visualize lipid-rich atheroma in vivo. While NIRS-derived lipid-rich plaque has been shown to associate with cardiovascular events, there is limited clinical data about the association of this high-risk plaque with risk factors, medication use, prognosis and response of PCI. RESSURE-NIRS registry is an on-going multi-center prospective registry in Japan, which enroll subjects with coronary artery disease who received NIRS imaging to evaluate coronary atherosclerosis. The primary outcome is maximum 4-mm lipid core burden index at coronary lesions measured by NIRS imaging. Secondary major outcomes include entire lipid core burden index, plaque volume, plaque attenuation and echo-lucent area. The anticipated number of study subjects is 2000 cases.

Eligibility Criteria:
Inclusion Criteria:

patients with coronary artery disease clinical indication for coronary angiography and/or percutaneous coronary intervention visualization of coronary lesions with NIRS

Exclusion Criteria:

poor quality of NIRS images
"ISIS" Study of Sex Differences in Characteristics of Adiposity and Metabolism

The purpose of this study is to characterize differences in the structure and function of the body fat from two different parts of the body in young, healthy men and women. We will also compare how differences in metabolism relate to characteristics of body fat and its functions.

Following screening, the study comprises of a total of 3 clinic visits (2 outpatient visits, and 1 overnight stay) completed during a 2 week period. For the outpatient visits, body composition (by DEXA), visceral fat (by CT), ectopic fat (by MRS and CT) and aerobic fitness (by VO2max test) will be measured. Women will also have ovarian parameters (follicle size and number) measured during the MR scans. Following an overnight stay in the inpatient unit, insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes), abdominal adipose tissue oxygen content (Hunt and Direct Methods) will be measured and a subcutaneous fat biopsy of the abdominal and gluteo-femoral tissue will be collected. Women will complete all testing in the follicular phase of the menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic men and women ages 40 to 60, inclusive and healthy men and women ages 20 to 35, inclusive.
* Body mass index (a ratio of height to weight) less than 25 kg/m2 (lean group) or 27 to 35 kg/m2 (overweight/obese group).
* Not involved in regular physical activity (more than 3 times per week).
* Women must have regular menstrual cycles (1 menstrual bleeding each month).

Exclusion Criteria:

* For men in the overweight/obese group, you have a waist circumference less than 102cm (40 inches).
* You smoke.
* You have liver, kidney, thyroid or heart diseases, or cancer.
* You are claustrophobic.
* You have metal objects in your body such as implanted rods or surgical clips.
* If you are not diabetic and you are taking steroids, protease inhibitors, statins, antihypertensives or medications known to alter glucose or lipid metabolism.
* If you are diabetic and you are taking steroids, protease inhibitors, or injectable antihyperglycemic medications (oral diabetic meds are allowed.)
* If you are a woman, you are pregnant or breast feeding or trying to become pregnant (women who become pregnant throughout the study will be excluded).
* If you are a woman, you are using hormonal contraceptives or have anovulation, androgen excess or irregular menstrual cycles (less than 1 cycle per month).
* You have previously had a BMI \>35 kg/m2.
* You are not able to eat the foods provided by PBRC.
* If your weight has not been stable.
Perceive and Calculated CV Risk

Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making. Research has focused on refining the accuracy of these CV risk calculators for different populations, relatively little has been done to understand how patients perceive their own ASCVD risk. Accurate perception of a patient's risk by both the patient and the doctors is important because this is an important determinant of health-related behaviour. Patients often show optimistic bias when considering their own CV risk and consistently underestimate it.

We aim to determine patient perceived versus actual risk of ASCVD in a Chinese population. We aim to better understand the degree to which patients underestimate or overestimate their ASCVD risk and whether patients are better or worse at estimating their ASCVD risk relative to their peers of the same age and sex. Finally, we aim to evaluate patients willingness to follow guideline recommended CV prevention and specifically lipid-lowering therapy.

Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making. Research has focused on refining the accuracy of these CV risk calculators for different populations, relatively little has been done to understand how patients perceive their own ASCVD risk. Accurate perception of a patient's risk by both the patient and the doctors is important because this is an important determinant of health-related behaviour. Patients often show optimistic bias when considering their own CV risk and consistently underestimate it.

We aim to determine patient perceived versus actual risk of ASCVD in a Chinese population. We aim to better understand the degree to which patients underestimate or overestimate their ASCVD risk and whether patients are better or worse at estimating their ASCVD risk relative to their peers of the same age and sex. Finally, we aim to evaluate patients willingness to follow guideline recommended CV prevention and specifically lipid-lowering therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 40 years and above
2. Consent to complete questionnaire
3. Lipid profile within 12 months

Exclusion Criteria:

1. Known ASCVD defined as history of coronary heart disease (i.e. obstructive coronary disease, prior myocardial infarction, or prior coronary revascularization); cerebrovascular disease (i.e. stroke or transient ischemic attack); and peripheral arterial disease (i.e. obstructive peripheral disease, prior vascular amputation or prior revascularization)
2. Other chronic illness with life-expectancy \<12 months
Nature Video to Improve Older Adult Health: A Feasibility Study.

Background: Exposure to nature has a positive impact on a multitude of health-related outcomes such as stress, attention, recovery after surgery, and overall well-being. There is growing interest in determining the impact of vicarious nature experiences delivered through multimedia platforms on the well-being of persons at high risk for poor psychosocial outcomes, as is the case in older adults diagnosed with mild cognitive impairment (MCI) or mild dementia.

Objectives/Purpose: The primary purpose of this study is to assess the feasibility of providing an immersive nature-based multimedia experience to older adults with MCI or mild dementia. A secondary purpose is to identify the potential health benefits of this intervention.

Methodology: A convenience sample of 40 older adults (65+ years old) with and without mild cognitive complaints will be recruited from a Los Angeles senior service partner. Participation will include three visits. The first visit will include the consent process, cognitive testing, and questionnaire completion. The second and third visits will consist of a video session followed immediately by a group discussion regarding the content in the videos. The two video sessions will be administered in a randomized and counterbalanced manner one week apart. One video involves a 15-minute immersive nature-based experience and the other includes a 15-minute clip that presents emotionally "neutral" educational content. Both sessions will be immediately followed by a group discussion of the content in the videos and how it relates to past experiences.

Outcomes and Analysis: Process evaluation data associated with recruitment, screening eligibility, involvement of personnel, assessment administration, and retention will be collected to determine overall study feasibility. Additionally, selected assessments will be administered at each multimedia experience during key time points to examine potential short-term health benefits.


Eligibility Criteria:
Inclusion Criteria:

* Speaks and understands English
* Mild cognitive impairment/mild dementia or normal cognition
* Minor complaints with thinking or memory
* Demonstrate the cognitive capacity to understand and consent to research procedures and to communicate his/her decision

Exclusion Criteria:

* Self-reported phobias that could be triggered by nature-based videos
Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, through the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
* Subjects who are displaying clinically significant homicidality or suicidality
* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.