cyrilzakka/clinical-trials huggingface dataset:
Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults

In this study the investigators will compare a novel approach using daily financial incentives and a tiered sponsor network to motivate adolescents and young adults with type 1 diabetes to improve glycemic control.

Participants will be given daily glucose monitoring goals of ≥4 glucose checks per day with ≥1 readings within goal range (70-180 mg/dL) and provided with iHealth wireless glucometers. Half of the study participants will be randomized to the 3-month intervention arm on Way to Health. The intervention includes daily financial incentives ($60 in an account at beginning of each month with $2 daily loss if non-adherent) and a 2-level tiered sponsor network (youth select 2 people who will be notified of non-adherence after 2 and 5 consecutive days). The primary outcome will be HbA1c at 3 months compared to baseline. Secondary outcomes will include HbA1c at 6 months and the proportion of participants adherent to daily glucose monitoring goals. Exit interviews will elicit intervention feasibility and feedback from a youth perspective.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes
* HbA1c of 8 or greater
* Receiving care from the Childrens Hospital of Philadelphia Diabetes Center
* English-speaking
* Owns a smartphone

Exclusion Criteria:

* New diagnosis of type 1 diabetes within past year
* Unable to provide informed consent
* Already participating in another study to improve glycemic control
* Any medical conditions that would prevent completion of the study
Bempedoic Acid Pregnancy Surveillance Program

Bempedoic acid pregnancy surveillance program

A surveillance study of females exposed to bempedoic acid or bempedoic acid/ezetimibe fixed combination drug product (FCDP) during pregnancy. Observational outcome data will be collected on pregnant females through pregnancy and infants through the first year of life.

Eligibility Criteria:
Inclusion Criteria:

Exposure to at least 1 dose of bempedoic acid or bempedoic acid/ezetimibe FCDP at any time during pregnancy (from first day of last menstrual period \[LMP\] to pregnancy outcome

Exclusion Criteria:
A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT in Primary Hyperparathyroidism

The leading cause of primary hyperparathyroidism (pHPT) is a solitary adenoma (89%). The treatment of pHPT is generally surgical removal of the overactive parathyroid gland(s). Since a solitary adenoma is the predominant cause, parathyroid surgery is preferably performed through a minimally invasive parathyroidectomy (MIP) in which only the suspected adenoma causing the pHPT is resected in a focused manner. To facilitate the performance of a MIP, accurate preoperative imaging is pivotal. This study aimed to analyze the diagnostic performance of 11C-choline PET/CT after prior negative or discordant first-line imaging in patients with pHPT undergoing parathyroid surgery with an optimized imaging protocol.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion were ≥18 years old, diagnosed with biochemically confirmed pHPT, underwent a MIBI-SPECT/CT and/or cUS with negative or discordant results, and underwent a 11C-choline PET/CT followed by parathyroidectomy.

Exclusion Criteria:

Patients were excluded if they were known to have a germline mutation predisposing for familial hypocalciuric hypercalcemia (FHH).
Primary Care Beverage Study

This is a pilot randomized clinical trial of a brief educational intervention offered in primary care for Latino parents that promotes healthy beverage consumption by infants and toddlers. The control group will receive an educational intervention that promotes parents reading to children.

To use a randomized controlled trial (RCT) design to test the efficacy of a primary care-based intervention to promote Bright Futures recommendations for consumption of sugar-sweetened beverages and 100% fruit juice among Latino children ages 6 months to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Parents self-identify as Latino
* Parents speak English or Spanish
* Parents have a child between the ages of 6 months and 5 years

Exclusion Criteria:

* Parents who have participated in group educational sessions on nutrition offered through our obesity clinic or who have been newly referred to obesity clinic
* Parents whose child has a chronic condition which affects feeding (such as requiring tube feeds or being on a specialized diet for poor weight gain)
Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)

Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of various forms of dementia, such as Alzheimer's disease and its common precursor mild cognitive impairment (MCI). This project intends to assess the efficacy of cognitive rehabilitation in these patient populations. We will also use neuroimaging (functional magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following cognitive rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria (all patients):

* A minimum of 12 years of education or attainment of a Graduation Equivalency Diploma;
* All medications stable for approximately 3 months;
* No history of severe mental illness;
* No current untreated alcohol or substance abuse/dependence;
* English as native and preferred language;
* MRI-compatible if taking part in fMRI studies 7) Able to give informed consent.

MCI Inclusion Criteria:

* Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;
* 55 years of age or older.

TBI Inclusion criteria:

* History of a mild to moderate TBI;
* No history of other neurological disease or injury;
* A minimum of 6 months and maximum of 5 years post-onset of TBI;
* 18 - 45 years old.

Exclusion Criteria:

* History of neurological disease or injury (other than TBI)
* History of severe mental illness
* Current untreated alcohol or substance abuse
* Other conditions may exclude; please discuss with contact
Enteral Formula Tolerance in Pediatric Patients

The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.

In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 1 - 13 years of age
* Currently tolerating enteral feeding
* Has enteral access
* Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days
* Having obtained his/her and/or his/her legal representative's informed consent

Exclusion Criteria:

* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
* Judged to be at risk for poor compliance to the study protocol
* Lack of informed consent
* Currently participating in another conflicting clinical trial
Cardiac Simulator for Surgical Planning

The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:

To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.

To aid surgeons in envisioning different surgical approaches for each individual patient.

To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.

Participants will:

Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.

Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group.

The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are pediatric patients ages 0-17 with a congenital heart disease (CHD) diagnosis of 1) congenitally corrected transposition of the great arteries (cc-TGA) with ventricular septal defect (VSD), 2) double outlet right ventricle (DORV) with remote VSD, or 3) other single ventricle conditions.

Exclusion Criteria:

* Adult patients with CHD.
PERFECTED: Caring for Patients With Hip-fracture & Memory Difficulties

This qualitative study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR) funded research programme. PERFECTED's overall aim is to develop and pilot an evidence-based intervention to improve the hospital care of patients living with dementia who have fractured their hip. The findings from this particular study will support PERFECTED's other activities by exploring stakeholder (lay and professional) views of the hospital care experiences of hip-fracture patients who are experiencing memory difficulties. Best practices and priorities, including attention to cost-consequences will be explored.

Semi-structured interviews will be conducted with 15-30 hip-fracture patients with mild memory difficulties recently discharged from acute hospitals in Norwich, Nottingham and Bradford. Equal attention will be given to those patients discharged directly home and those discharged to community hospitals for further rehabilitation. Interviews will be conducted with 15-30 recognised carers of hip-fracture patients with moderate/severe memory difficulties who have recently been discharged from acute hospitals in the same three regions. Semi-structured interviews will also be carried out with a nominated dementia lead in each region. Finally, in each region, small focus groups, face-to-face or telephone interviews will be conducted, with clinical staff of various grades and professions, hospital managers and with NHS commissioners. This study will enable a range of topics and perspectives to be explored and potential components for PERFECTED's intervention to be identified.

As part of PERFECTED's on-going commitment to Public Patient Involvement (PPI), lay researchers will be trained to assist in interviewing recognised carers of hip-fracture patients with moderate/severe memory difficulties. Interviews and focus groups will be recorded, transcribed and analysed thematically. Resulting data will address the pre-defined aims of the current study and feed into findings reported across the whole of Work Package 1 of PERFECTED.


Eligibility Criteria:
Inclusion Criteria:

* A hip-fracture patient recently discharged (within a month) from an acute hospital in one of the study locations.
* 60 years or older
* Having some memory difficulties as recognised by a relevant member of their care team - supported by an AMT score of 5-8 if required
* Has the cognitive ability to engage with a research interview as determined by a relevant member of their care team

Exclusion Criteria:

* Lacks mental capacity
Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons

ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or higher) by the use of proton therapy. Secondary endpoints contain assessment of quality of life, biochemical recurrence and recurrence free survival as well as overall survival and economic comparison between photon and proton therapy.

The hypothesis of the study is a 7.5% decrease of combined genito-urinary and intestinal side effects from 15% with photon therapy to 7.5% by the use of protons. With an alpha of 0.05 and 80% power it is therefore necessary to treat 131 patients with protons to detect such difference. With an estimated drop-out rate of 10% 146 patients have to be recruited to the proton arm. As randomization to photon or proton therapy is not possible in a multicenter setting with only few proton facilities available patients treated with photons will be prospectively matched to their proton counterparts. Stratification criteria will include: Age, high dose volume, androgen deprivation, history of surgery, obstructive disease, increased risk for rectal bleeding, socio-economic criteria and use of rectal balloon during radiotherapy. Comparison of the primary endpoint will be restricted to patients without irradiation of lymphatic drainage.

Eligibility Criteria:
Inclusion Criteria:

* life expectancy ≥ 10 years
* adenocarcinoma of the prostate confirmed by punch biopsy
* locally limited to locally advanced adenocarcinomas without evidence of distant metastases i.e. T1-3b N0-1 M0
* stage-related indicated neoadjuvant / adjuvant androgen deprivation possible (neoadjuvant ≤ 6 months)
* good general condition (ECOG performance status 0 - 1)
* marker seed implantation before irradiation (optional) or possibility of Image-guided Radiation Therapy (IGRT) by CT
* adequate compliance for follow-up
* written informed consent

Exclusion Criteria:

* distant metastases
* previous radiotherapy of the lesser pelvis
* previous or concomitant other malignant disease except when there is no impact on treatment or follow-up of the prostate cancer
* participation in another clinical study, if it's excluded by the study protocols
Pain in Women With Chronic Pelvic Pain

Chronic pelvis pain is very common between adult women. Significant progress is made in clarifying the multifactorial model of chronic pain pathogenesis, but a more complete assessment is important in order to improve the therapeutic approach. The purpose of this study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.

Chronic pelvic pain is defined as non-menstrual or noncyclic pelvic pain with duration of at least 6 months. This pain interfere with habitual activities and requires clinical or surgical treatment. It is a complex interaction between the gastrointestinal, urinary, gynecologic, musculoskeletal, neurologic and endocrine systems influenced by psychological factors. Its prevalence range between 3 and 8% among women aged 15-73 years, ranging from 14 to 24% among women of reproductive age. It is very important a multidimensional approach in order to stablish a more specific profile.

Eligibility Criteria:
Inclusion Criteria:

* Women.
* Clinical diagnosis of chronic pelvic pain.
* More than eighteen years.
* Non-menstrual or noncyclic pelvic pain.
* Duration of pain of at least 6 months.

Exclusion Criteria:

* Duration of pain less than 6 months.
* Women who were pregnant in the last 12 months
Adherence to Fluid Intake Recommendations in Kidney Stone Patients

The cumulative risk of stone recurrence rate is up to 14% at 1 year, 35% at 5 years, and 52% at 10 years. Low urine volume caused by insufficient fluid consumption is one of the most crucial risk factors for kidney stone formation. According to the guidelines, a copious fluid intake to maintain a urine volume of at least 2.0 to 2.5 L/24 h is recommended for most kidney stone formers. Patients often find it difficult to follow the recommendations in fluid intake, which leads to stone recurrence. Therefore, there is a need to improve patient compliance and adherence to following the instructions on keeping water balance. For this purpose we developed a mixed educational program including two parts. The first is the mobile application called "StoneMD: Kidney Stones". The second is the "School for Patients" with kidney stones, which is responsible for the stone clinic effect.

The aim of the study is to test the hypothesis that using mixed educational program additionally to standard recommendations in patients after the first stone surgery episode helps to achieve better adherence to daily fluid intake recommendations than the using standard recommendations alone given at the day of discharge.

Eligibility Criteria:
Inclusion Criteria:

* Low risk recurrence group patients;
* Patients after the first stone surgery;

Exclusion Criteria:

* Recurrent cases of stone formation;
* Patients, who do not have smartphones;
* Patients, who can't visit "Schools for Patients" with kidney stone disease;
S-1 and Photodynamic Therapy in Cholangiocarcinoma

In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. But most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the combined effect of photodynamic therapy and S-1.

In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. But most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the combined effect of photodynamic therapy and S-1.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of cholangiocarcinoma
* Not eligible for curative surgery
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
* No serious or uncontrolled concomitant medical illness
* Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧75,000/ul)
* Consent this study in letter

Exclusion Criteria:

* Another neoplasia
* Porphyria
* Pregnant or breastfeeding women
Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years

Elderly people are more prone to develop infection with a poorer prognosis compared to young people. Physicians may encounter difficulties regarding antimicrobial agents administration route. In fact, poor venous access and behavioral disturbance are frequent issues. The subcutaneous (SC) route may be a safe alternative, but sparse data are available in the literature. The present study aims to describe Pharmacokinetics (PK) / Pharmacodynamics (PD) characteristics of antibiotics (amoxicillin/clavulanate, ceftriaxone and piperacillin/tazobactam) subcutaneous administration in patients aged over 65.

Antibiotic administration through subcutaneous (SC) injection is common practice in France, especially in Geriatrics as an alternative to intravenous (IV) route in case of poor venous access or delirium (Forestier et al. CMI 2015). Whereas tolerance of such a practice seems to be reasonable (Roubaud-Baudron et al. Age and Ageing 2017), sparse PK/PD data are available. Most PK/PD studies include young and healthy subjects, yet elderly patients often have multimorbidity , poly medication, renal insufficiency and cachexia which may disturb antibiotics PK/PD. Compared to intravenous (IV) route, SC route is less painful and less frequently associated with infectious or thrombotic complication. A recent study carried out in Bordeaux University Hospital comparing PK/PD data on ertapenem SC or IV administrations in patients aged over 75 showed that area under the curve (AUC) and probability to maintain free ertapenem concentration above the Minimum inhibitory concentration (MIC) during at least 40% of time (fT\>MIC\>40%) were not significantly different (manuscript in progress).

The investigator's hypothesis is that SC administration of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam has favorable pharmacokinetics and acceptable tolerance compared with IV infusion in elderly patients.

Patients receiving one of the three antibiotics by IV or SC route will be included at steady state (depending on antibiotic treatment) for several blood tests (3 or 4 depending of routes choice) and followed until 15 days after completion of antibiotic treatment in order to evaluate tolerance and efficacy of antibiotic treatment. Physicians in charge of patients will decide antibiotic prescription including administration route. The study will not influence these choices because patients will be included after antibiotic initiation.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 65
* To receive ceftriaxone (1g daily) or amoxicillin-clavulanate (1g/0.2g every 8h) or piperacillin-tazobactam (4g/0.5g every 8h) by SC or IV infusion (30-60minutes) at steady state (48h, 24h and 24h respectively)
* Free, written and informed consent signed by the participant or by a proxy in case of delirium

Exclusion Criteria:

* criteria for legislation (justice protection, subject participating to another research including a period of exclusion)
* previous inclusion in this study
Study of ADH-1 Given Intravenously to Patients With Solid Tumors

N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.


Eligibility Criteria:
Inclusion criteria:

* Signed written informed consent
* Male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists. Study currently enrolling only patients with non-small cell lung cancer or advanced ovarian cancer to the safety expansion phase.
* Clinically or radiologically documented measurable disease.
* Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
* Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)

Exclusion criteria:

* Receipt of ADH-1 prior to this clinical study
* Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
* History of primary brain tumors or brain metastases (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months. History of spinal cord compression. History of tumors that have shown clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks before study entry.
* Stroke, major surgery, or other major tissue injury within 30 days before study entry
* History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states