cyrilzakka/clinical-trials huggingface dataset:
Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes

The investigators are hoping to figure out how youth with type 1 diabetes can best control their blood glucose levels after meals, by determining whether accurate carbohydrate dosing or the timing of the bolus is more important. There is evidence to suggest that each strategy is important for blood glucose control. Unfortunately, for some people, prebolusing is difficult, because they may not know how much they are going to eat. To give an exact dose of insulin 20 minutes before a meal can be difficult. In this study, the investigators would like to show that taking even just part of the insulin bolus 20 minutes before the meal is preferable to waiting until mealtime and taking the entire bolus. To do this, the investigators will have 24 patients in the study, who will each spend 4 mornings at The investigators clinic. The order of the visits will be selected randomly. The visits will include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking ½ bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. At each visit, the person will eat the same meal, but the timing and amount of the bolus will be different. The investigators will measure the blood glucose levels with a blood glucose meter, and also with a laboratory test called YSI. The investigators will also be measuring the glucose levels under the person's skin with a continuous glucose monitor. The investigators will compare the area under the curve for the different visits, as well as the glucose levels at different points after the meal.


Eligibility Criteria:
Inclusion Criteria:

* Ages 7-21, inclusive
* Diagnosis of type 1 diabetes for \>1 year
* Using carbohydrate counting to dose mealtime insulin
* Using an insulin pump and continuous glucose monitor to control diabetes
* HbA1c \<10%

Exclusion Criteria:

* Celiac disease or other GI abnormality
* Severe hypoglycemia in the past 6 months
* Pregnancy
* Documented hypoglycemia unawareness
Precision Dosing of Metformin in Youth With T2D

The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).

Based on the investigators previous studies of young people who take metformin, the study team found that young people's bodies process metformin faster than older people and young people may need higher doses of metformin for the best treatment outcomes. The purpose of this study is to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).

Eligibility Criteria:
Inclusion Criteria:

* Age 10-21 years
* Provider diagnosis of T2D
* Stable medication regimen for 2 weeks before screening visit (No addition or removal of medications and no more than 20% change in insulin dose)
* ≥ 1 month from T2D diagnosis
* Taking regular metformin (not extended-release formula)
* Ability to wear CGM for a total of 6 weeks while in the study.
* English or Spanish speakers.
* Willing to abide by recommendations and study procedures.
* Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
* Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
* Known history of ongoing renal or hepatic disease.
* Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
Safe Indoor Temperature Limit for Fans

Extreme heat events are a significant global threat to health and wellbeing, and result in more morbidity and mortality than all other natural disasters combined. Thus, a key priority is identifying effective and accessible heat resilience solutions to protect individuals from the potentially fatal consequences of heat stress. Within a range of ambient conditions, a fan has been recognized a low-cost heat resilience solution. However, when ambient temperatures exceed skin temperatures (e.g., above 35°C), a fan will incur greater dry heat gain which may be counterbalanced with evaporation of sweat from the skin surface. However, at a critical indoor temperature, the rate of heat gain will exceed the rate of evaporation resulting in net heat gain. The critical indoor temperature has yet to be determined. The purpose of this present study is to identify the indoor temperature at which a fan results in greater cardiovascular and thermal strain relative to still air in young adults using a simulated heat wave scenario of a warming room.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index less than 30
* male or female
* ability to tolerate hot environments for a prolonged period (e.g. \&gt;2 h)

Exclusion Criteria:

* Any respiratory disease
* Any cardiovascular disease, including hypertension
* Diabetes
* not currently on any medication (except oral contraceptives)
Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial sepsis probably caused by Coagulase-negative staphylococcus.

The investigators hypothesized that newborn infants with the presumptive diagnosis of nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome not inferior to that of those treated with vancomycin.


Eligibility Criteria:
Inclusion Criteria:

* Newborn infants older than three days of life with suspected bacterial sepsis and according to attending physicians, with an indication for initial treatment with vancomycin and at least one blood culture taken prior to receiving the antimicrobial treatment.

Exclusion Criteria:

* previous treatment with vancomycin during the week before,
* infants referred from other hospitals and, upon admission, were being treated with antibiotics.
A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement

The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged between 18 and 75 years (inclusive).

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use.
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.

OBJECTIVES:

* Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
* Assess the toxicity of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.

* Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
* Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed localized adenocarcinoma of the prostate
* Candidate for prostatectomy

PATIENT CHARACTERISTICS:

Age:

* 21 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.4 mg/dL
* AST no greater than 3 times normal

Renal:

* Creatinine no greater than 2.0 mg/dL
* Calcium no greater than 10.2 mg/dL
* No idiopathic urinary calcium stone disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No prior hormonal therapy for prostate cancer
* No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins

Radiotherapy:

* No prior brachytherapy or external beam radiotherapy for prostate cancer

Surgery:

* See Disease Characteristics

Other:

* At least 7 days since prior vitamin D therapy or calcium supplements
* No other concurrent vitamin D analogues or calcium supplements
* No concurrent magnesium-containing antacids
* No concurrent thiazide-containing diuretics
* No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

The purpose of this study is to test the safety of a new plan for treating glioblastoma. The usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. In this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. Our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. This study will look at what effects, good or bad, this approach has on the patient and the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of glioblastoma or grade IV glioma.
* Tumor volume should be less than 60 cc (approximately 5cm maximum diameter).
* Age \> or = to 18
* KPS ≥70
* Granulocyte count \>1.5 X 10 9/L
* Platelet count \>99 X 10 9/L
* SGOT \< 2.5X upper limit of normal (ULN)
* Serum creatinine \< 2X ULN
* Bilirubin \< 2X ULN
* All patients must sign written informed consent

Exclusion Criteria:

* Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
* Any prior experimental therapy for glioma.
* Multicentric glioma
* Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
* Serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment.
* Pregnant or breast feeding women.
* Refusal to use effective contraception
* Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg)
* Prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction or unstable angina within 12 months prior to Day 1
* History of stroke or transient ischemic attack
* Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
* History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
* History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening
* Known hypersensitivity to any component of bevacizumab
Measuring Deep and Superficial Multifidus and the Activation Pattern During Dynamic Task Correlating With Trunk Stability Ability and Functional Performance in Different Ages Asymptomatic and Unspecific Low Back Pain Adult

The first propose of the study is to understand the contraction of deep and superficial multifidus in patients with non-specific low back pain and the elderly. The second purpose of the study is to understand the relationship between the multifidus and the functional performance in patients with non-specific low back pain and the elderly. The hypothesis is that the patients with non-specific low back pain and the elderly have less ability to contract the deep multifidus then asymptomatic adults and younger adults. Besides, the multifidus is correlated to the functional performance.


Eligibility Criteria:
Inclusion Criteria:

* age 20-90
* have lumbar region discomfort in the past three months, and the discomfort is more than one day
* have diagnosis of non-specific low back pain

Exclusion Criteria:

* have received surgery of lumbar or lower extremities
* neurological symptom (eg. numbness of lower extremities)
* have no ability to stand and walking independently
* cancer
* systemic disease (eg. ankylosing spondylitis, rheumatoid arthritis, Systemic lupus erythematosus)
* pregnancy
Feasibility of 11C-MET PET/MRI Imaging in Pediatric Brain Fossa Tumors

Brain tumors are the most common solid tumors in children and are the second most common cause of cancer-related death among this population. Posterior brain fossa tumors represent about 50% of children brain tumors.

Recently, knowledge in molecular biology has permitted to identify different tumors subgroups of very different prognosis. Today, surgery removal of the tumor is the mandatory. Neuro-oncological treatment differs depending on the histological and molecular subgroup. With classical Magnetic Resonance Imaging (cMRI), distinction between different types of posterior fossa tumors remains difficult.

Positron Emission Tomography combined with MRI (PET/MRI) has proven its benefits for the management of brain tumors. The direct spatiotemporal correlation makes possible the assessment of metabolic, anatomical and functional information. PET/MRI would provide precisions on the pre-therapeutic characterization of tumors, which could permit to modify the patients' care.

L- \[methyl-11C\] methionine (11C-MET) is currently the gold-standard tracer used in neuro-oncology, but few data exists in children. 11C-MET PET/MRI assessment seems promising, but has not been studied enough. To the best of our knowledge, there is no specific study on primary brain tumors of the posterior fossa in children using 11C-MET PET/MRI.

The primary objectives of this first pilot study is to evaluate the practical feasibility of 11C-MET PET/MRI imaging (machine accessibility and imaging interpretability) before surgery in a population of children older than 5 years old with posterior fossa tumors.

The secondary objectives aim to describe :

* the PET/MRI parameters of the different tumors studied,
* and the patient's participation acceptation.

This feasibility study will allow us to standardize the PET/MRI measurements; this could allow us to discriminate, in a larger study, the different tumor subgroups before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 5 years old and \< 18 years old at enrollment,
* with primary posterior brain fossa tumor, metastatic or not,
* hospitalized in the Department of Pediatric Neurosurgery of Femme-Mère-Enfant Hospital, and for whom a surgery is scheduled,
* covered by national health insurance,
* patient's parents or legal guardians who have provided written informed consent prior to participation in the study.

Exclusion Criteria:

* Patients with contraindication for MRI (claustrophobia, carrying metallic object)
* Patients with contraindication for Gadolinium injection (including pregnancy and breastfeeding)
* patient with recurring posterior brain fossa tumor
* patient with brain stem infiltrative tumor
Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers

The purpose of this study is to develop and test a new communication training intervention called Hematolo-GIST to help oncologists communicate with patients about their lymphoma diagnosis and advance care planning.


Eligibility Criteria:
Inclusion Criteria:

Hematologists

* Currently a hemotologic oncologist providing care to patients with DLBCL

Patients

* Per medical record, is being treated by a hematologic oncologist participating in this study
* Per medical record, has a diagnosis of DLBCL including DLBCL-transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) which are histologically similar and clinically treated as large-cell lymphoma
* Per medical record, relapse/ refractory disease within 12 months of 4 cycles of first line therapy OR relapse after 2 cycles of later line therapy or autologous stem cell transplant (ASCT)
* Self-identify as Black and/or White
* Per medical record, 18 years of age or older
* Per self-report, fluent in English\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study:

  1. How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
  2. What is your preferred language for healthcare? (must respond English)

Exclusion Criteria:

Hematologists

* Per self-report, planning to leave the cancer center in the next 12 months

Patients

* Cognitively impaired as demonstrated by (Blessed Orientation- Memory- Concentration (BOMC) score of ≥ 11
* Per research staff judgment and/or self-report, too ill or weak to complete study procedures
* Per medical record or self-report, receiving hospice care at the time of enrollment
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin

The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

* 19\~45 years healthy male
* Body weight is over 55kg, BMI measurement 18.0kg/m\^2\~ 27.0kg/m\^2
* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
* Researchers determined suitable volunteers through physical examination, laboratory tests

Exclusion Criteria:

* History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
* Sitting SBP\>150mmHg or \<100mmHg, sitting DBP\>100mmHg or \<60mmHg, after 3 minutes break
* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
* Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
* Donated blood within 60 days prior to the first administration day in this study.
NeoCart Phase 2 Clinical Trial

The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent.

Exclusion Criteria:

* Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.
Nutrition Care Process in Mexican Older Adults

The aim of this clinical trial is to determine the efficacy at 12 months of the application of the nutrition care process in the eating habits of older adults in the state of Colima, Mexico compared to a conventional nutritional intervention.

The main questions it aims to answer is: what is the efficacy of the application of the nutrition care process vs. a conventional nutritional intervention on the eating habits of older adults in the state of Colima, Mexico after 12 months of follow-up?

Participants will be two study groups. Group 1 will apply the nutritional care process and Group 2 will use standard care. The Structured Survey of Food Quality of the older adult will be applied to classify eating habits as good and bad; as well as the reduction of malnutrition in the study participants, in addition, the 24-hour reminder and the food consumption frequency questionnaire will be evaluated before and after the nutritional intervention, an eating plan will be determined according to the needs and later, follow-up will be given for 8 weeks, finally monitoring will be done at 3, 6 and 12 months in order to detect changes in eating habits.

The financial resources will be financed by resources own in the Social Coexistence Center for the older adults in the metropolitan area of Colima, Mexico. Group experience: there are health professionals specialized in patient care.

The protocol has the approval of a local research ethics committee (CEICANCL220223-NUTRICIA-02).

Eligibility Criteria:
Inclusion Criteria:

* Older adults ≥ 60 years old
* female or male
* who voluntarily agree to participate in the study.

Exclusion Criteria:

* People who have a specific treatment determined by another health professional
* people with chronic kidney disease and hemodialysis or dialysis treatment.
* adherence less than 80% in the nutritional intervention
* incomplete data collection, participants who decide to leave the project
* people who are hospitalized or die.