cyrilzakka/clinical-trials huggingface dataset:
Skin Manifestations Associated With Adhesives in Diabetes Technology Tools

The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place between 2 and 14 days. The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes.

The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place for between 2 and 14 days, or even longer, depending on the system under consideration. Unfortunately, an increase in skin reactions has been observed in diabetic patients using these new technologies, sometimes leading to discontinuation. The number of studies evaluating the cutaneous tolerance of the patches used by these technologies is limited, so the prevalence of these skin intolerances is unknown.

The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes. It will be implemented with the following design:

* observational, cross-sectional, multicentre study involving 4 Diabetology centres and over a period of 6 months.
* Establishment of an observatory on skin reactions to FreeStyle Libre® (FSL) and all other adhesive systems related to new technologies for the treatment of diabetes
* A questionnaire will be systematically proposed to the patients concerned, during the usual diabetes follow-up consultations made by all investigators.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women
* Adult (≥ 18 years old)
* All types diabetes (1, 2, other)
* Any patient who wears or has worn an adhesive system for the treatment of diabetes (insulin pump, and/or continuous glucose monitoring system) within the last 10 years.
* Seen consecutively in consultation
* Patient who was informed on the research and are not opposed to participation.

Exclusion Criteria:

* Illiteracy
* Refusal to participate in the study (refusals will be counted)
* Patient under guardianship or curatorship
Glasgow-Blatschford Score Validation in Digestive Hemorrhage

The purpose of this study is to validate the Glasgow-Blatchford score for the stratification of patients with upper gastro-intestinal hemorrhage. This score is easy to calculate. It is mainly based on the hemoglobin, blood pressure and blood urea. if the score is zero, the bleeding is very low risk and the gastrointestinal endoscopy may be delayed and performed as an outpatient.


Eligibility Criteria:
Inclusion Criteria:

* To be admitted in the university hospital for a gastrointestinal hemorrhage (vomiting of red or black blood or melena)

Exclusion Criteria:

* Age under 18
* Pregnancy
* Hemorrhage during hospitalisation
* red rectal bleeding
* No consent signed
Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

* To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
* To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
* To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

1. In good health.
2. Age: 19 to 55 years inclusive at Screening.
3. Satisfies one of the following

   * Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal, OR
   * Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose.
4. BMI: 18 to 30 kg/m2 at Screening.

Key Exclusion Criteria:

1. Clinically significant abnormalities in physical examination or vital signs.
2. Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
3. Clinically significant screening laboratory result as assessed by the Investigator.
4. The subject has a history of clinically significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
5. History or presence of malignancy with the past 5 years.
6. History of alcohol or substance abuse or eating disorder within 2 years, OR regular use of alcohol within 6 months (\>14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
7. Use of any investigational drug or participation in any investigational study within 30 days prior to screening. For dose levels 6 and 7 fed cohorts, subjects may participate who have taken part in the dose levels 4 and 5 fasted cohort.
8. Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc.
9. Any condition, disease, disorder or clinically relevant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment.
10. A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class.
11. Any clinically significant systemic infection within 3 weeks prior to screening.
12. Use of prescription medications within 30 days of screening.
Acceptance-Based Treatment for Prostate Cancer Distress

Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause of death in American men. Those diagnosed with localized prostate cancer encounter three sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3) the often life-altering side effects of treatment. In addition, patients who choose to undergo active surveillance which focuses on monitoring cancer in lieu of treatment, experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is an established psychosocial intervention that has been used extensively for mental health treatment and has shown benefits for various chronic conditions. ACT is a behavioral intervention that focuses on tolerating distress and improving function. This pilot study is designed to test the feasibility of ACT for distress reduction and improved quality of life in patients recently diagnosed with early-stage, localized PCa.


Eligibility Criteria:
Inclusion Criteria:

* Localized prostate cancer in Stages I or II
* Ability to give informed consent
* Age 18 to 80 years old
* Willingness to come in for a day long intervention

Exclusion Criteria:

* Acute psychosis
* Suicidal ideation
* Homicidal ideation
* Active substance abuse
* Dementia
Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars

evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin sealant in the pits and fissures sealing of the first permanent molars

GIC has a hydrophilic nature which makes it compatible with clinical situations when isolation may be difficult. It also sets rapidly, which can reduce sensitivity to moisture. Glass ionomers release fluoride, which promotes enamel remineralization and has an antimicrobial effect. Another benefit of using glass ionomers as sealants is that the tooth does not need to be etched to achieve chemical bonding to the tooth. Thus saving time which is critical in the case of young patients and patients with disabilities.

Eligibility Criteria:
Inclusion Criteria:

* • Children aged between 6 to 9 years

  * Children with deeply stained fissures of the first permanent molars.
  * First permanent molars are completely erupted
  * The patient's willingness to receive treatment

Exclusion Criteria:

* • Special child, a child with compromised systemic health.

  * First permanent molars covered by operculum.
  * Children with high salivary flow when isolation will be impossible
Diagnostic Accuracy of Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors

To compare the diagnostic ability of 64-detector MDCT coronary angiography with conventional invasive coronary angiography in patients with suspected coronary artery disease.

The "Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors" or "CorE-64" study was designed to evaluate the diagnostic accuracy of multislice spiral CT angiography using 64 detector rows for identifying coronary artery stenosis in patients with suspected or known coronary artery disease. The study was designed as a prospective, multi-center, international, blinded study examining the diagnostic accuracy of 64-slice CT in comparison with CCA. The primary hypothesis of the study is that 64-slice CT coronary angiography will be able to detect significant coronary artery disease in a patient with acceptable diagnostic accuracy as compared to CCA. Significant CAD is defined as ≥ 50% stenosis as determined by quantitative analysis of CCA (QCA). The diagnostic parameters is per-patient sensitivity and specificity compared with CCA, with both point estimates and continuous measurements of diagnostic accuracy. Eligible patients will first undergo MDCT (calcium scanning and MDCTA)prior to clinically indicated conventional coronary angiography. Patients with CAC 600 or less will be included in the primary analysis. Patients will be followed for clinical events including revascularization.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, age 40 years or greater.
* Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
* Suspected coronary artery disease (i.e. symptoms, signs) with a clinical indication for coronary angiography; and planned coronary angiography within the next 30 days.
* Able to understand and willing to sign informed consent.

Exclusion Criteria:

* Known allergy to iodinated contrast media
* History of contrast-induced nephropathy
* History of multiple myeloma or previous organ transplantation
* Elevated serum creatinine (\> 1.5mg/dl) OR calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula
* Atrial fibrillation or uncontrolled tachyarrhythmia, or heart block
* Evidence of severe symptomatic heart failure; moderate or severe aortic stenosis
* Previous coronary artery bypass or other cardiac surgery
* Coronary artery intervention within the last 6 months
* Intolerance or contraindication to beta-blockers
* Body Mass Index \> 40.
Cryoablation for Benign Gastrointestinal Anastomotic Strictures

Anastomotic stricture is a common complication following foregut surgery. The standard of care for these benign foregut anastomotic strictures is balloon dilatation. However, re-stenosis of strictures is also common, requiring frequent repetition of balloon dilatation. Cryotherapy is a novel therapy that may improve clinical outcomes following dilatation. The purpose of the present study is to conduct a randomized controlled trial to characterize the impact of cryotherapy on clinical outcomes and complications for benign anastomotic strictures following esophagectomy, gastrectomy, and bariatric surgery.


Eligibility Criteria:
Inclusion Critieria

* History of esophagectomywith primary anastomosis
* History of gastrectomy with primary anastomosis
* History of bariatric surgery with primary anastomosis
* History of anastomotic stricture
* History of balloon dilatation at Keck Hospital of the University of Southern California

Exclusion Critieria

* Patients treated at medical centers other than Keck Hospital of the University of Southern California
* History of anastomotic stent placement
The Impact of 8 Weeks of a Digital Meditation Application on Work Stress

The aim of this study is to test the effects of a digital meditation intervention in a sample University of California, Irvine (UCI) employees who report mild to moderate stress. UCI employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

The aim of this study is to test the effects of a digital meditation intervention in a sample UCI employees who report moderate to high stress. UCI employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

Participants assigned to the intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. All study participants will be asked to fill out short (no longer than 25 minutes) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone).

Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. The entirety of the study is digital and there are no in-person assessments. Adherence will be tracked remotely. The goal is to recruit as many as 2000 participants (1000 per condition).

Eligibility Criteria:
Inclusion Criteria:

You may join if you:

* Have access to a smartphone or computer every day
* Are fluent in English
* Are a UCSF employee
* Report mild to moderate levels of stress
* Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and has received a signed and dated copy of the informed consent
* Are at least 18 years of age

Exclusion Criteria:

* You may not join if you are an experienced meditator or have participated in a formal meditation practice in the last 6 months (defined as once or more per week for a duration of 20 minutes or more at each practice)
Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

The concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. This study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.

Cancer is accompanied by increased oxidative stress and induction of polymorphic cytochrome P- 450 mixed oxidase enzymes (CYP). Both processes affect the abundance of volatile organic compounds (VOCs) in the breath because oxidative stress causes lipid peroxidation of polyunsaturated fatty acids in membranes, producing alkanes and methylalkanes which are catabolized by CYP.

In the Technion labs, a new system for breath samples diagnosis, is being developed. The system is based on Nanoparticles technology.

The current study will try to identify colon and breast cancer patients through their breath samples and discriminate them from healthy individuals.

Men and women coming for colonoscopy or breast biopsy will be recruited for the study. Breath samples will be taken from all volunteers before the medical test. Subjects with positive cancer results by biopsy will be the test groups for both diseases, all others will be the control.

The research goal is to test the NaNose system ability to discriminate between healthy and sick.

Eligibility Criteria:
Inclusion Criteria:

* Men and women attending Rambam medical center for either breast biopsy or colonoscopy.
* Suspicious finding on breast imaging requiring a biopsy.
* Complaints indicating the possibility of colon cancer: Blood in stool, weight loss, constipation, anemia, family history of colon cancer.

Exclusion Criteria:

* Other known active malignancy.
* History of malignant disease and treatments.
RECOVER-ENERGIZE Platform Protocol_Appendix B (Structured Pacing (PEM))

This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).

The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.

Study interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix. Study intervention appendices may be added or removed according to adaptive design and/or emerging evidence.

The platform protocol enrolls participants who meet study eligibility criteria. After completing initial screening assessments, eligible participants are assigned to one of the study intervention appendices that are actively enrolling. Participants must meet certain criteria within a specific appendix in order to be included in that appendix. Once assigned to an appendix, eligible participants are randomized to either the study intervention group or a control group.

Eligibility Criteria:
• See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix

Additional Appendix B (Structured Pacing (PEM)) Level Inclusion Criteria:

1. Participant identifies new PEM following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
2. Score of 2 or greater for both frequency and severity for any of the first 5 questions on the Screening mDSQ-PEM AND Answer of YES to either item 7 or 8 on Screening mDSQ-PEM, and response of \>14 h in item 9.

or Score of 3 or greater on any severity question(regardless) and answer of YES to either item 7 or 8 on the Screening mDSQ-PEM, and response of \>14h in item 9.

Additional Appendix B (Structured Pacing (PEM)) Level Exclusion Criteria:

1. Inability to attend in-person screening visit or participate in weekly visits (in-person \[≥ 1\] and remote)
2. Participant was previously enrolled in Appendix A of this protocol and has NOT completed the full study follow-up period of Appendix A
Nutritional Management in Respiratory Critically Ill Patients -an Observational Study in Mainland China

The important role of nutritional management in the treatment of ICU patients has been paid more and more attention. Reasonable nutritional management can improve the nutritional status of patients, reduce the risk of malnutrition, shorten the length of ICU stay, improve the quality of life of patients, and reduce the mortality of patients, thereby improving the prognosis. Many studies have investigated the nutritional status and implementation of ICU patients. It is generally believed that the nutritional status of ICU patients is not good, and the implementation of standardization needs to be improved.The data on the nutritional status and implementation of RICU patients in mainland China is rare. Therefore, the main purpose of this study is to investigate the implementation and compliance of nutritional support treatment for RICU patients in mainland China.

Respiratory critically ill patients have their own disease metabolism and treatment methods. However, RICU medical staff generally do not pay enough attention to nutrition support treatment. The data on the nutritional status and implementation of RICU patients in China is rare. But the data plays an important role in carrying out nutrition-related research, formulating the goals of continuing education programs for nutrition support treatment, guiding the introduction of medical insurance policies and the revision of consensus. Therefore, the main purpose of this study is to investigate the implementation and compliance of nutritional support treatment for RICU patients in tertiary hospitals in mainland China, so as to lay the foundation for further relevant work.

Eligibility Criteria:
Inclusion Criteria:

* patients aged \>18 years
* the length of RICU stays \>48 hours

Exclusion Criteria:

* patients aged ≤18 years
* the length of RICU stays ≤48 hours
* patients who were admitted to RICU due to or combined with severe trauma or surgery
Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac

The main objective of the study is to estimate the proportion of children, born between the 01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before and after the third MenBvac vaccination.


Eligibility Criteria:
Inclusion Criteria:

* children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated twice by MenBVac
* parental authority(ies)assent

Exclusion Criteria:

* no parental authority(ies)assent
* no blood sample during the third vaccination
* impossibility of third vaccination
Aromatherapy Versus Gum Chewing on Preoperative Anxiety

Investigators hypothesized that the use of blend aromatherapy and gum chewing before surgery would reduce preoperative anxiety as assessed by the Speilberger State-Trait Anxiety Inventory (STAI) questionnaire and provide non pharmacological methods to decrease postoperative sore throat, postoperative nausea \& vomiting and postoperative pain.

A written informed consent will be taken from the patients.patients will be assigned randomly to three groups (30 subjects each) either with preoperative aromatherapy (Group A) or gum chewing (Group G) or control group (Group C) to assess the preoperative anxiety and postoperative sore throat, nausea \& vomiting and pain control between the three studied groups.

Eligibility Criteria:
Inclusion Criteria:

* Educated adult females
* American Society of Anesthesiologists (ASA) physical status I-II
* Listed for elective gynecological laparoscopy surgery under general anesthesia and endotracheal tube (ETT)

Exclusion Criteria:

* Impaired pharyngeal or esophageal function
* Phenylketonuria (contraindication to the sweetener aspartame in chewing gum)
* A fall upper or lower denture (not feasible to chew gum)
* A history of preoperative sore throat, upper respiratory tract illness
* Using steroid or analgesia within the last 48 hour
* Chronic smokers
* Receiving warfarin, heparin, full dose 325 mg aspirin, or clopidogrel
* A history or diagnosis of bleeding diatheses
* Any known allergies to ginger or lavender
* Having head or neck surgery
* History of difficult intubation
* Pregnant women