cyrilzakka/clinical-trials huggingface dataset:
CGMIS 48-hour Feasibility Study

This is a single center, single arm non-randomized study of 48-hour CGMIS wear duration incorporating two meal-challenge tests to explore the performance of a single insertion combined glucose-sensing insulin delivery cannula.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes, present for at least 6 months. If there is lack of clarity regarding the type of diabetes, the PI will make the final decision based on medical records.
* Age 18-75
* Currently using a Tandem T-Slim or Medtronic 523/723 or newer series insulin pump to treat their diabetes.
* Hgb A1C between 5.8 and 10%
* Willingness to follow all study procedures and to attend all clinic visits.
* Willingness to sign informed consent and HIPPA documents.

Exclusion Criteria:

* Need for MRI/CT/Diathermy during study participation
* Current use of Hydroxyurea
* History of chronic kidney disease
* Inability to read pump or CGM display due to reduced visual acuity
* History of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
* History of chronic liver disease
* Active infection such as HIV or hepatitis
* Anemia defined by HCT at least 4 percentage points below lower limit of the reference range
* Dementia, Schizophrenia or other untreated mental illness
* Chronic substance abuse
* Chronic alcohol abuse
* Seizure disorder
* Major surgical operation within 30 days prior to screening
* History of bleeding disorder or treatment with anticoagulants.
* Allergy to acrylate-based skin adhesives
* Ongoing use of an investigational drug or device
* Female of childbearing potential who is pregnant or intending to become pregnant
* Diabetic ketoacidosis or hypoglycemia requiring hospitalization within the last 6 months
* Insulin resistance as defined by insulin requirement of more than 200 units per day
* Use of glucose-lowering medications other than insulin
* Need for uninterrupted treatment with acetaminophen
* Any other physical or mental condition judged by the PI as being exclusionary.
Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees

The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are:

* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation?
* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation?
* Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes?

Participants will:

* Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training.
* Complete a questionnaire prior to the workshop.
* Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy.

Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms.


Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* English speaking
* Able to sign an informed consent form
* Able to complete the self-report assessment
* Willing to be contacted to complete post and follow-up assessments

Exclusion Criteria:

* Pregnant
* Have plans to relocate within two months of protocol initiation
* Report psychotic symptoms or suicidal behavior within the past 2 weeks
* Are currently dependent on substances other than tobacco or caffeine
Evaluating Simplified Layered Consent for Clinical Trials

The goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of Staphylococcus aureus bloodstream infection (the SNAP trial).

The main questions it aims to answer are:

* Does use of a simplified layered consent form lead to an increased recruitment rate to the SNAP trial?
* Does use of a simplified layer consent form lead to increased participant understanding of the SNAP trial and increased participant satisfaction with the informed consent process?

Participants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. Research staff will use the assigned form to explain the SNAP trial to participants. After consent, participants will be evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* All inclusion criteria from the larger SNAP trial:

  1. S. aureus complex grown from ≥1 blood culture
  2. Admitted to a participating hospital at the time of eligibility assessment
* Specific additional inclusion criteria for SIMPLY-SNAP:

  1. Admitted to participating hospital of SIMPLY-SNAP
  2. Self-reported proficiency in English or French adequate to be able to participate in consent process carried out solely in English or French (as the supplementary consent materials required in the simplified consent process are currently only available in these two languages)

Exclusion Criteria:

* All exclusion criteria from larger SNAP trial:

  1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture
  2. Polymicrobial bacteremia, defined as more than one organism in the index blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician
  3. Patient currently being treated with a systemic antibacterial agent that cannot be ceased
  4. Known previous participation in SNAP
  5. Known positive blood culture for S. aureus between 72 hours and 180 days prior to the time of eligibility assessment
  6. Treating team deems enrolment in the study is not in the best interest of the patient
  7. Treating team believes that death is imminent and inevitable
  8. Patient is for end-of-life care and antibiotic treatment is considered inappropriate
  9. Patient \<18 years of age and paediatric recruitment not approved at recruiting site
* Specific additional exclusion criteria for SIMPLY-SNAP: None
A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome Radical Resection of Colorectal Cancer

1. Analysis of preoperative and postoperative metabolite changes: Through metabolomics technology, the changes of preoperative and postoperative metabolites in patients with colorectal cancer complicated with metabolic syndrome such as hypertension and diabetes were systematically analyzed, and the key metabolites related to postoperative remission were found.
2. Explore the influencing factors of postoperative remission of metabolic syndrome: Combined with clinical data, the association between various metabolites and the degree of postoperative remission was evaluated, and the main factors affecting postoperative remission were determined.

To reveal the mechanism of the remission of metabolic syndrome after surgery: To clarify the metabolic pathways and mechanisms involved in the remission of metabolic syndrome after surgery through multi-level metabolomics analysis, and to provide a new theoretical basis for the development of tumor metabolic surgery.

This study will continue for 2-3 years. All patients who meet the inclusion and exclusion criteria will be divided into hypertension group and diabetes group according to the type of metabolic syndrome, with 120 cases in each group. Blood and feces of all patients were collected before surgery, 3 days after surgery, 6 months after surgery, and 1 year after surgery. The collected samples will be subjected to untargeted metabolomics analysis, using NMR-IVDr technology to detect the dynamic changes of all small molecular metabolites (mainly endogenous small molecular compounds with relative molecular weight within 1000 Da) in blood and feces before and after stimulation or disturbance without bias. The differential metabolites of blood glucose, blood lipids, cholesterol, insulin, renin, aldosterone and angiotensin were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the potential physiological mechanism of postoperative hypertension, diabetes and other metabolic syndrome remission

Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>18 years old. 2. Patients with hypertension or diabetes for more than 1 year before surgery. 3. Patients who planned to undergo radical resection of colorectal cancer

Exclusion Criteria:

* 1. Emergency operation due to intestinal obstruction and intestinal perforation. 2. Tumor with distant metastasis. 3. Combined resection of other important organs. 4. Severe postoperative complications. 5. Patients who are using drugs that may significantly affect metabolic status (such as hormonal drugs, potent immunosuppressants, etc.). 6. Incomplete clinical data.
Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).

BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.


Eligibility Criteria:
Inclusion criteria:

Male and female chronic immune ITP patients

Exclusion criteria:

Any treatment of ITP excluded except for a stable dose of corticosteroids (up to 20 mg)
Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses

Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily digested carbohydrate).

* About two-thirds of adults in the United States are overweight or obese which can cause adverse health consequences for those individuals. Post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for Type 2 Diabetes. Controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. Resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. The investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations.
* Aim: To assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations.
* Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a beverage with maltodextrin (an easily digested carbohydrate).

Eligibility Criteria:
Inclusion Criteria:

* Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh \>110 pounds, with a BMI between 20.0 and 29.9.

Exclusion Criteria:

* Weight change \> 3kg in the past 3 months
* Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day
* Intestinal disorders including lipid mal-absorption or lactose intolerance
* Abnormal liver or kidney function tests; fasting blood glucose \>100mg/dL
* Smoking
* Drinking more than 2 alcoholic drinks per day
* Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
* Subjects must not be pregnant or lactating.
The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men

Dehydration is defined as the state of water deficit due to excessive water losses and/or small water intake. Underhydration is the result of inadequate water intake leading to activation of water hormonal homeostasis, characterized by elevated vasopressin, lower urinary output, and concentrated urine without any measurable changes in total body water. It is well established that dehydration (water deficit) decreases exercise performance and worsens mood, mainly in women. However, the impact of increased water intake in underhydrated individuals on their exercise capacity and mood is not known.

The aim of the proposed study is to investigate the impact of increased water intake in underhydrated individuals on aerobic exercise performance and mood in both women and men.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Residence in Arizona

Exclusion Criteria:

* Use of diuretics
* Use of anti-depressive medication
* Current pregnancy or lactation
* Current use of injectable insulin
* Diagnosed with irritable bowel syndrome
* Do not pass the Physical Activity Readiness Questionnaire for Everyone (PAR-Q) screening
Analysis of Blood and Bone Marrow to Detect Residual Disease in Patients With Previously Treated Hairy Cell Leukemia

RATIONALE: Diagnostic procedures that detect residual disease may predict disease relapse in patients who have hairy cell leukemia.

PURPOSE: Diagnostic trial to determine the effectiveness of analyzing blood and bone marrow to detect residual disease in patients who have previously treated hairy cell leukemia.

OBJECTIVES: I. Compare the sensitivity of flow cytometry, immunohistochemistry, and polymerase chain reaction in detecting minimal residual disease following therapy with cladribine in patients with hairy cell leukemia.

OUTLINE: Blood and bone marrow samples are obtained from patients at time of bone marrow biopsies to assess minimal residual disease using flow cytometry, immunohistochemistry, and polymerase chain reaction. Patients are followed for 2 years or until disease relapse.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study over 12-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Clinically documented hairy cell leukemia Active or in remission Must have received prior cladribine and be undergoing bone marrow biopsies as follow up

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy following prior cladribine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy

The purpose of this study is to test the ease of using a new device, called the GlowCap that reminds the patient to take their breast cancer hormone pill. The study will collect information about the experience with this device and what the patient thinks of its role in the daily pill taking routine.


Eligibility Criteria:
Inclusion Criteria:

* Early stage breast cancer patients taking adjuvant endocrine therapy (ie, tamoxifen, anastrozole, letrozole, exemestane).
* Age ≥ 60 years
* Must have broadband internet access at home (to enable the base for the system to communicate to the Vitality server).
* Must have a landline or mobile phone

Exclusion Criteria:

* Non-English speaking patients
Study on Patients With Rasmussen Encephalitis Treated With Adalimumab: Efficacy and Tolerance in the Short and Long Term

Since the initial study of cases reported between 2009 and 2015, adalimumab has become in France the immunomodulatory reference treatment used after failure of corticosteroids and immunoglobulins before a possible recourse to the hemispherotomy. This observational study is intended to document the long-term efficacy and safety of Adalimumab therapy in patients with Rasmussen encephalitis.

Rasmussen Encephalitis (ER) is a particularly severe chronic inflammatory brain disorder resulting in the progressive destruction of a hemisphere. It is a rare disease although at present no precise prevalence is available. It begins preferentially in children.

This inflammatory process is accompanied by a progressive loss of function of the affected hemisphere, associated with a pharmaco-resistant partial epilepsy. The diagnosis is based on a bundle of clinical, radiological and electroencephalographic arguments. CSF analysis directs diagnosis in 50% of cases.

No anti-epileptic treatment can stop seizures. Only hemispherotomy (surgical disconnection of a cerebral hemisphere) allows it but it is associated with definitive motor and cognitive deficits.

Over the last 20 years, new therapeutic trials have focused on immuno-modulatory treatments targeted at the T-lymphocyte pathway, including tacrolimus. Although they seem to be more effective than immunoglobulins or corticosteroids, it remains transient. In addition, the number of published cases is low. In this context, starting in 2009, it has been proposed to use adalimumab (Ab anti TNF) based on:

* 1 / study of a case index
* 2 / knowledge of the pathophysiology of Rasmussen Encephalitis. To date, very few data provide precise information on the efficacy or tolerance of the use of this product in the longer term. This information is essential to confirm the place of adalimumab in the therapeutic arsenal against Rasmussen encephalitis.

Thus, in the continuation of the work carried out previously (French study on the cases between 2009 and 2015), the aim of this research projet is to complete the follow-up of the patients who previously took part in in the first study and to establish the follow-up of the patients treated by adalimumab since then.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Rasmussen Encephalitis
* Patient aged more than 2 years
* Compliant treatment with adalimumab

Exclusion Criteria:

* Patient with a differential diagnosis
* Patient suffering from Rassmussen Encephalitis but not treated with adalimumab
* Patient who has not signed the informed consent
Outcomes of Low-Risk Endometrial Cancer with Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective, Multicenter, Cohort Study

This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer.

PRIMARY OBJECTIVE:

I. Evaluate whether patients with low-risk endometrial cancer and isolated tumor cells (ITC) will have worse recurrence-free survival (RFS) than a historical cohort of similar patients with negative nodes.

OUTLINE: This is an observational study.

Patients undergo tissue sample collection and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (\< 5 vessels involved) will be included.

  * Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging.
  * Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or \< 200 cells) identified in SLN.
  * Willingness to forego adjuvant treatment.
  * Research consent provided.

Exclusion Criteria:

* Prior neoadjuvant chemotherapy.

  * Planning to receiving adjuvant treatment.
  * Presence of synchronous cancer.
  * Extent of disease in SLN: micrometastasis (\> 0.2 to ≤ 2.0 mm) or macrometastasis (\> 2.0 mm).
  * Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology.
  * No prior invasive cancer diagnosis within 5 years of study entry.
A Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely

The purpose of this study is to determine whether the standard dosage of teicoplanin is adequate to produce timely the trough level \> 10 mg/L, which is considered to be effective in the treatment of methicillin-resistant Staphyllococcus aureus (MRSA) bacteremia.

In our hospital, the minimum inhibitory concentration of 100 MRSA isolates in 2003 for teicoplanin is 2 mg/L. Due to its time-dependant bacteriocidal effect, the trough level should exceed 10 mg/L, particularly in the elderly, for MRSA bacteremia. However, it is known that standard dosage of teicoplanin often produces inadequate serum trough levels, and MRSA infections may recurred. Therefore, to evaluate the loading dose required to achieve therapeutic concentration timely, we compare the trough levels between those given standard dose (6 mg/Kg) and those given increasing loading dose (12 mg/Kg). We also monitor the occurrence of adverse drug effects and clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 16 years of age who have blood culture-proven MRSA bacteremia and did not receive teicoplanin or vancomycin in the previous one month are enrolled.

Exclusion Criteria:

* Those who are allergic to teicoplanin or who have the need to use higher doses, 12 mg/kg/dose, such as endocarditis, osteomyelitis, septic arthritis and burn patients, are excluded.
Vertical Augmentation With Osteon at Dental Implant Placement

Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from the patient. Successful augmentation in the vertical direction has often proved difficult, however, the investigators have developed a technique to achieve this in the investigators patients using a synthetic bone substitute, Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another unnecessary surgical procedure.

Primary Objective

• To determine the success of dental implants in alveolar bone augmented in the vertical direction with Osteon.

Secondary Objectives • To determine the long term success of dental implants in this augmented bone.

Primary Endpoint

• Radiographically assessed vertical height of alveolar ridge formation following Osteon augmentation.

Eligibility Criteria:
Inclusion Criteria:

* missing one or two teeth
* bounded saddle
* healthy (ASA grade I \& II) adult

Exclusion Criteria:

* smoker
* significant medical problem (ASA III or above)