cyrilzakka/clinical-trials huggingface dataset:
Family Routines Enhancing Adolescent Diabetes by Optimizing Management

A three month randomized study to examine the potential benefits of sleep extension in tandem with clinical trial on diabetes management in youth with type 1 diabetes.

Type 1 Diabetes (T1DM) is one of the most common chronic medical conditions that occur in children. More than two-thirds of these young patients struggle to maintain optimal glycemic control. On a seemingly unrelated front, insufficient sleep has become a public health crisis as less than 30% of youth achieve the recommended number of hours on school nights. Prior research has supported that sleep disturbances contribute to elevated glucose levels and have a significant impact on memory, attention, and planning. These skills are essential to effective diabetes management. Despite the link between sleep and diabetes, no research has examined the benefits of an intervention to help these youth achieve a healthy sleep duration. To that end, our primary objective is to determine the effect of sleep extension on glycemic control and psychosocial functioning. Our secondary objective is to determine mediators and moderators of effect. The central hypothesis is that an increase in sleep duration will lower glucose levels and improve behavioral ratings (internalizing, externalizing, and classroom behaviors). Our primary study aims are to (1) Test if lengthening sleep improves glycemic control and psychosocial function in youth with T1DM; (2) Assess putative mechanisms for the effects of sleep extension on glucose and psychosocial function; and (3) Examine the possible moderating effect of pre-existing sleep parameters and sociodemographic variables that modify the impact of sleep extension. A secondary aim is exploratory to examine additional pre-selected mediators and moderators. In the proposed randomized study, up to 175 youth with T1DM will be assigned to a Sleep Extension or a supportive routines condition. The Sleep Extension lengthens youth's time in bed to allow for a healthy sleep duration on a consistent basis, whereas the supportive routines condition reinforces daytime and nighttime activities. We will test the impact of sleep extension on key indices of glycemic control (average glucose levels and % time hyperglycemia using continuous glucose monitors and HbA1C) as well as putative mechanisms of effect (e.g., heart rate variability and salivary cortisol levels) and participant characteristics that might mitigate the benefits of sleep extension (e.g., sleep-disordered breathing, adherence, and SES). Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes

Exclusion Criteria:

* neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation
* not hospitalized within the previous month prior to enrollment
CPAP on Acute Stroke and OSA

Stroke affects 16.9 million individuals each year and is the second leading cause of death worldwide. Despite advances in pharmacologic therapy, morbidity , mortality and rates of hospitalization for stroke remain high. These data emphasize the importance of identifying all treatable conditions that could aggravate stroke. One such condition is obstructive sleep apnea (OSA).

Sleep-related breathing disorders, including obstructive and central sleep apnea, often coexist with stroke. Compared to the general population, in whom OSA is the most common form of this breathing disorder with recent prevalence estimates of 22% of male and 17% of female , in the stroke population, the prevalence of OSA is much greater at 70% . Several randomized controlledtrials on OSA patients with stroke in acute or sub-acute stage showed that treating OSA with continuous positive airway pressure (CPAP) improved motor and functional outcomes, accelerated neurological recovery.Apart from the benefits in better neurological outcomes, secondary analyses of SAVE study suggested that CPAP treatment potentially help to reduce recurrence of stroke. Nevertheless, we don't have evidence yet from randomized control studies to prove CPAP treatment would reduce the recurrence of cardiovascular or cerebrovascular events.

Traditionally, recurrence of cardiovascular or cerebrovascular events uses documented mortality, morbidity or hospitalization for heart failure, acute coronary syndrome or stroke as clinical endpoints. Recently, several studies showed that enlarged left atrium (LA) can serve as a predictor for recurrent stroke or cardiovascular events. On the other hand, a growing body of studies demonstrated that CPAP treatment reduce size of LA in those with OSA. Notably, all of these studies above are observational or retrospective in nature. To date, there are no prospective longitudinal randomized controlled trials reporting the effect of CPAP treatment of OSA on the change of size of LA. We therefore will undertake a randomized , controlled trial involving patients with stroke to test the primary hypothesis that treatment of OSA with CPAP would reduce the size of LA.


Eligibility Criteria:
Inclusion Criteria:

1. Time from onset of stroke symptoms to hospital arrival \<2 weeks .
2. Stroke is documented with brain magnetic imaging or computed tomography
3. Competency to provide informed consent.
4. Moderate to severe obstructive sleep apnea being established with the use of a home sleep-study screening device (ApneaLink).
5. Epworth sleepiness scale≦10.

Exclusion Criteria:

1. Having received CPAP for obstructive sleep apnea prior to admission.
2. History of pneumothorax or brain surgery.
3. Coexisting heart failure or renal failure or persistent atrial fibrillation.
4. Unable to wear a nasal or nasal-oral mask.
5. Concomitant uncontrolled infection.
6. Swallowing difficulty or episodes of choking due to stroke
7. Coexisting central nervous diseases such as dementia
FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors

The primary objectives of this study are:

1. Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone.
2. Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI.

A secondary objective of this study is:

1) Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must have a known or suspected primary brain tumor with a non-enhancing component with planned standard of care surgical resection. Patients with newly diagnosed or recurrent brain tumors are eligible.
2. Tumors with non-enhancing regions will be defined as T2/FLAIR hyperintensity extending at least 0.5 cm beyond areas of enhancement as assessed by MRI.
3. Patient must be 18 years of age or younger at the time of study enrollment.
4. Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
5. Patient must have a life expectancy greater than 8 weeks.
6. Patient must be able to undergo FET-PET/MRI without sedation.
7. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration FET. Females who have not reached menarche will not require pregnancy testing.

Exclusion Criteria:

1. Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.
2. Patient must not have received radiation therapy within the past 6 months.
3. Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).
4. Patient must not be pregnant or breast feeding.
5. Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
6. Patients must not have a history of brain metastases.
The Turkish Cross-Cultural Adaptation, Validity and Reliability of VMPCI

This study was planned to adapt the Vanderbilt Multidimensional Pain Coping Inventory into Turkish, to investigate its cultural adaptation, validity and reliability. The study was completed with 352 volunteers who fulfilled the criteria to be included in the Rheumatology Clinic of Istanbul Haydarpaşa Numune Training and Research Hospital. Data collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used.

Rheumatoid arthritis (RA) is a chronic, progressive, inflammatory, autoimmune disease of unknown etiology, mainly affecting synovial joints, causing loss of function. The main reason that directs RA patients to medical treatment is pain. Chronic pain causes limitation of movement, sleep problems, fatigue, stress and depression, as well as physiological and psychological problems that cause negative effects on the quality of life of the individual. The patient's thoughts, expectations, and methods of coping with pain are effective in pain control. In order to identify and treat the painful condition, individual coping methods of the patient and the effectiveness of these methods should be evaluated. This study was planned to adapt the Vanderbilt Multidimensional Pain Coping Inventory into Turkish, to investigate its cultural adaptation, validity and reliability. The study was completed with 352 volunteers who fulfilled the criteria to be included in the Rheumatology Clinic of Istanbul Haydarpasa Numune Training and Research Hospital. Data collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used. The language validity of the Turkish form of the scale was provided by the translation-back translation method. Expert opinion was obtained for scale of validity. In order to evaluate the reliability of the Turkish version of the scale; internal consistency coefficient, test retest and parallel form methods were used. After all these analyzes, the reliability and validity of the Turkish version of the VMPCI scale was obtained. In addition to this study, the descriptive characteristics of the sample, SF-36 scale, Mcgill and Melzack Pain Questionnaire results were examined alone and together with the sub-dimensions of the scale.

Eligibility Criteria:
Inclusion Criteria:The study included individuals whose native language is Turkish, who are literate, over the age of 18, diagnosed with rheumatoid arthritis, without cognitive impairment and communication problems, and who want to participate in the study.

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Exclusion Criteria:

* Individuals who do not meet the inclusion criteria are excluded from the study.
Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial

The "Cardiovascular Risk Reduction-Diet in Pregnancy" (CARRDIP) - is a randomised controlled trial with dietary intervention during pregnancy. The participants were enrolled in Norway 20 years ago and consisted of 269 pregnant, healthy mothers. The participants were randomised 1:1 to either intervention-diet or control. The intervention diet was build upon an anti-atherogenic principle and was a so called "Mediterranean diet". The participants were monitored during pregnancy, and mother and child participated in a follow-up study 1 year after birth. The current "CARRDIP20" trial is a follow-up of the same participants, both mother and offspring, 20 years after the original intervention to measure and analyse the cardiovascular health and compare the intervention group to the control group.


Eligibility Criteria:
Inclusion Criteria from original CARRDIP-trial:

* Non-smoking pregnant women
* BMI 19 to 32 kg/m2 at inclusion
* Age 21 to 38 years
* Carrying a single foetus

Exclusion Criteria:

* Previous pregnancy complications
Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)

The study aims at optimizing extended management of elderly patients (\> 75 years) with at least one of the known bleeding risk factor, who suffered from first episode of venous thromboembolism of the lower extremity (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients were randomized to receive three different treatment: Sulodexide 250 mg BIS in die; Sulodexide 500 BID in die or indistinguishable placebo to verify the efficacy and safety of extended treatment for 12 months with Sulodexide (Vessel®) in the secondary prevention of Deep Vein Thrombosis / Pulmonary Embolism (DVT/PE) recurrence.

This prospective cohort study aims to assess the efficacy and safety of the extended treatment with Sulodexide (Vessel®) in the secondary prevention of DVT / PE recurrence in elderly outpatients (≥ 75 years old at the time of inclusion) ), with at least one of the known bleeding risk factor, who had a first episode of lower extremity proximal DVT and / or PE, idiopathic or associated with weak or removed risk factors, and who have received standard treatment with any oral anticoagulant drug lasting at least 3 months. The study seeks to verify the safety of the Sulodexide therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not \> 3%).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
2. Patients aged ≥75 years at the time of enrolment
3. Patients with at least one of the known risk factors of bleeding (APPENDIX 1):

   1. Hypertension
   2. Renal failure
   3. Thrombocytopenia
   4. Diabetes
   5. Antiplatelet therapy (ASA maximum 140 mg/die)
   6. Frequent falls (\>2 /years)
   7. Nonsteroidal anti-inflammatory drug
   8. Liver failure
   9. Previous Stroke
   10. Anemia
   11. Poor anticoagulant control
   12. Alcohol abuse
4. Patients of both sexes.
5. Patients who at the time of enrolment have already undergone a period of anticoagulant therapy (AT, with any medication) of at least 3 months and the therapy has not been suspended for more than 30 days.
6. Patients with no other AT indications.
7. Patients capable and able to provide informed consent

Exclusion Criteria:

1. Patients aged \<75 years at the time of the recruitment visit.
2. "Provoked" index event, which occurred:

   * Within 3 months of surgery or major trauma,
   * Bed Rest \> 4 days,
   * Cast / immobility within 3 months.
3. Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy.
4. Index event represented by isolated distal DVT or superficial venous thrombosis.
5. Thrombotic event in sites other than the deep proximal veins of the lower limbs.
6. Anticoagulant therapy for less than 3 months at the time of enrolment.
7. Discontinuation of anticoagulant therapy for over thirty days at the time of enrolment
8. Recurrent episodes of DVT ± PE
The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp

Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy.

Shared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process.

This is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically verified malignant colorectal polyp removed endoscopically and CT-scan (and MRI if the malignant polyp was situated in the rectum) shows N0, M0 disease.

Exclusion Criteria:

* Inability to provide informed consent
* Inoperable due to comorbidity
* Known residual tumor left in situ after local resection, \>N0 or \>M0
Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL

The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent an isolated Anterior Cruciate Ligament (ACL) reconstruction or a combined ACL and anterolateral ligament reconstruction (Extra Articular Plasty) between January 1, 2011 and March 31, 2012.
* Patients affiliated or beneficiaries of a social security scheme
* Patients who have given their express consent.

Exclusion Criteria:

* Patients with pediatric ACL reconstruction technique
* Patients with a complex associated gesture such as osteotomy or ligamentoplasty other than extra articular plastic surgery.
* Contraindication to a radio control (pregnancy)
* Patient's refusal to participate in the study
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma

This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Male or female, at least 18 years old
* Documented medical history of asthma (diagnosis at least 6 months ago)
* Non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
* Able to conduct a technically acceptable spirometry, methacholine and neurokinin-A provocation test.
* At visit 1: PC20 methacholine ≤ 8 mg/ml AND ≤ 3.3x10-7 mol/ml for the neurokinin-A provocation test.
* At visit 1: forced expiratory value in one second \>= 80% of the predicted value.
* Female subjects may not get pregnant and should be using adequate contraception.

Exclusion Criteria:

* Airway infection within 6 weeks prior to first study visit.
* Other respiratory diseases (eg COPD, lung cancer, etc.)
* Participating in another clinical trial.
* Clinically relevant systemic diseases, other than asthma.
* Clinically significant laboratory deviations.
* Alcohol or drug abuse.
* Female subjects who are lactating.
Effect of Bile Acid Secretion and Sequestration on GLP-1 Secretion

Accumulating evidence suggests that bile acids in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile acids can lead to changes in gut hormone secretion and consequently affect glucose homeostasis.

The current study is a human interventional randomized controlled cross-over study including four study days for each participant. As a tool to sequester bile acids we will use sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with chronic kidney disease. Surprisingly, sevelamer has been shown to improve glycaemic control in patients with chronic kidney disease and type 2 diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The aim is to examine how (and if) bile acid sequestration can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2 diabetes.

The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in gut hormone secretion. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion and glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 3 months (diagnosed according to the criteria of the World Health Organization (WHO))
* Men and postmenopausal women
* Metformin applied as the only anti-diabetic drug
* Caucasian ethnicity
* Normal haemoglobin
* Age above 40 years and below 70 years
* BMI \>23 kg/m2 and \<35 kg/m2
* Informed and written consent

Exclusion Criteria:

* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* Nephropathy (serum creatinine \>150 µM and/or albuminuria)
* Hypo- and hyperthyroidism
* Hypo- and hypercalcaemia
* Hypo- and hyperphosphataemia
* Active or recent malignant disease
* Treatment with medicine that cannot be paused for 12 hours
* Treatment with oral anticoagulants
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Any condition considered incompatible with participation by the investigators
Dynamic Mediterranean Prospective Cohort: the SUN Project

Dynamic prospective cohort of Spanish university graduates. The main objective is to evaluate the associations between nutrition and lifestyle and chronic diseases.

The SUN Project (University of Navarra Follow-Up Study) began in 1999, and currently more than 20,500 people participate. The Project is permanently open to new volunteers, and around 2,000 new participants are invited each year.

A new questionnaire is sent to participants every two years. The questionnaires are named with the letter "Q," followed by the number of years that have passed since the participant first volunteered. The first questionnaire is titled "Q0" and is followed by "Q2","Q4", etc.

The cohort is "dynamic" thanks to the fact that it is permanently open to new volunteers. Although the Project was created by the Department of Preventive Medicine and Public Health of the University of Navarra, it now counts on the invaluable collaboration of other Spanish university centers.

Thanks to the invaluable collaboration of our participants, the investigators are able to research cardiovascular diseases, depression, fertility, arterial hypertension, and car accident injuries, among other areas.

Eligibility Criteria:
Inclusion Criteria:

* Spanish university graduates

Exclusion Criteria:

* not Spanish university graduates
Serratus Anterior Plane Block Versus Erector Spinae Plane Block. for Thoracotomy in Pediatric Patients

This randomized controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients.


Eligibility Criteria:
Inclusion Criteria

* Age 1 to 10-year-old
* ASA I, II, and II

Exclusion Criteria

* Patients whose parents or legal guardians refusing to participate.
* Preoperative mechanical ventilation.
* Preoperative inotropic drug infusion.
* Known or suspected coagulopathy.