cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Guided Cannulation of Dialysis Fistulas

The investigators suspect that using ultrasound to guide insertion of needles for dialysis patients will make this process quicker and more accurate, thus reducing complications and reducing discomfort for patients.

Haemodialysis patients need to have two needles inserted into a large surgically altered vein (fistula) or surgical vascular graft/shunt for every dialysis session. Some fistulas or shunts may be more difficult to insert needles into than others. As such a system of colour coding or "traffic lighting" of patients is in place in most units. A "green light" patient is easy to "needle" with two needles and the majority of staff within the unit will be able to connect the patients to the dialysis machine. A "red light" patient is reserved for the more experienced staff within the unit who will often have to be timetabled to work specific times so that they are present to connect certain patients to the dialysis machines. "Amber light" fistulas lie between these two extremes.

Ultrasound (US) is routinely used in many hospitals and many dialysis units will have access to a machine to assess patients for problems. Indeed central venous line insertions for dialysis are now almost always performed under US guidance since two large studies in this area in 2002 provided strong evidence that US guided placement significantly reduces complications during catheter placement and a reduction in the number of attempts at insertion. In addition the National Institute of Clinical Excellence in the UK provided evidence that insertion time is quicker although this association was statistically less convincing.

Ultrasound offers the advantage of dynamic imaging without the risks of radiation exposure and can be done as an office based procedure using portable equipment.

Studies in emergency departments and particularly in paediatric care have suggested that US guidance can improve the speed and accuracy of cannulation in peripheral veins for intravenous access.

We suggest that US guided cannulation of fistulas might improve the cannulation rate of more difficult fistulas and potentially reduce the time required to commence dialysis and the number of local complications of cannulation (haematoma/aneurysm/infection).

To our knowledge US is not used in cannulation guidance in any dialysis units, although most units will have access to a machine as above. We therefore propose to perform a randomised controlled trial of US guided cannulation of fistulas versus current practice (blind cannulation) to assess the effectiveness of US controlled cannulation in a busy dialysis unit.

Eligibility Criteria:
Inclusion criteria:

1. Dialysis 3X per week
2. Dialysing via 2 needles in fistula
3. No deviation from routine dialysis protocol (additional or no heparin etc)

Exclusion criteria:

a. Active or recent fistula infection/thrombosis/intervention in 6/52 of study

Withdrawal criteria:

1. Patient request
2. Patient non compliance with study protocol
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia

Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients and their relatives. Despite treatment with second generation antipsychotics, negative symptoms and cognitive impairment often persist and determine an unfavourable course including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic treatment was demonstrated to be safe and was associated with improvement in negative symptoms in the majority of the small placebo-controlled trials.

The primary objective of the trial is to investigate the efficacy of high-frequency rTMS (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia compared to sham stimulation (placebo).


Eligibility Criteria:
Inclusion Criteria:

* Male or female in-patients and out-patients, 18 - 60 years of age
* Diagnostic criteria for schizophrenia according to ICD-10/DSM IV
* PANSS negative sum score \> 20 points, 1 of items N1 - N7 (range 1 to 7) ≥ 4 (at least moderate)
* Improvement in PANSS negative sum score less than 10 % in the last 2 weeks prior to study entry, stable antipsychotic medication
* Informed Consent

Exclusion Criteria:

* Clinically relevant psychiatric comorbidity, verbal IQ \< 85
* History of epileptic seizures, organic brain disease
* Instable medical comorbidity or condition
* Previous treatment by rTMS
* Factors not compatible with the use of TMS, e.g. cardiac pace makers or other metallic implants, pregnancy
Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects

The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured.

The origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality.

The CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.


Eligibility Criteria:
Inclusion Criteria:

* Child (aged 3 to 11) with critical MCC operated on for heart surgery during the first three months of life
* Parents and child affiliated with or benefiting from a social security or similar scheme
* Parents' and child's good understanding of the French language
* Free, informed and written consent of both parents for themselves and for the child
* Free, informed and written consent of the child aged 6 and over
* Biological parents

Exclusion Criteria:

* Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion
* Neurodevelopmental assessment not practicable
Chemotherapy in Treating Patients With Recurrent Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.

OBJECTIVES:

* Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine.
* Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma.

OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week.

Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional

3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients.

Patients are evaluated after every 6 week cycle.

PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven recurrent primary malignant glioma

  * Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance Status:

* Karnofsky at least 60%

Hematopoietic:

* Hematocrit greater than 29%
* ANC greater than 1,500/mm\^3
* Platelet count greater than 125,000/mm\^3

Hepatic:

* SGOT less than 1.5 times upper limit of normal (ULN)
* Bilirubin less than 1.5 times ULN

Renal:

* Creatinine less than 1.5 mg/dL
* BUN less than 25 mg/dL

Other:

* Not pregnant
* Effective contraceptive method must be used for the duration of the study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy within 6 weeks of study
* No prior topotecan or carmustine treatment failure
* No more than 1 prior chemotherapy regimen

Endocrine therapy:

* Patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level

Radiotherapy:

* No prior radiotherapy within 6 weeks of study

Surgery:

* No prior surgical resection within 3 weeks of study

Other:

* No concurrent medication that may interfere with study results
In-hospital Versus After-discharge Complete Revascularization

Patients with STEMI and multivessel disease in whom the culprit lesion has been successfully revascularized during prmimary PCI, will be randomized to in-hospital or after-discharge complete revascularization.

The purpose of this study is to evaluate the impact of these two different strategies in terms of hospital stay.

STEMI patients with mutivessel disease are, after successful primary angioplasty, randomized 1:1 ratio to either in-hospital complete revascularization or after-discharge complete revascularization strategy.

Eligible non-culprit coronary arteries must be \>2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses ≥70% or between ≥50% and \<70 in proximal segments can be randomized.

Patients in the in-hospital revascularization group will undergo to non-culprit percutaneous coronary intervention (PCI) at least 24 hours after ST-segment elevation myocardial infarction. On the other hand, patients in the after-discharge group will undergo to non-culprit PCI within 4-6 weeks after STEMI.

Eligibility Criteria:
Inclusion Criteria:

* Acute onset of chest pain \<12 hours duration.
* ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
* Culprit lesion in a major native vessel, with successful primary PCI.
* Presence of at least one non-culprit lesion more than or equal to 70% of stenosis in a vessel more than 2mm of diameter or more than or equal to 50% stenosis in proximal segments.
* The patient is able to give written consent for participation in the study.

Exclusion Criteria:

* Pregnancy.
* Significant left main stenosis.
* Stent thrombosis.
* Chronic total occlusion.
* Severe stenosis of non-culprit vessels with distal flow less than TIMI3.
* Significant non-culprit stenosis no candidate to revascularization.
* Presence of valvulopathy candidate for cardiac surgery.
* Cardiogenic shock status at admission.
* The patient is not able to give written consent for participation in the study.
Adapting the HOPE Online Support Intervention to Increase Uptake of Medications for Opioid Use Disorder

In a randomized controlled trial, with 3, 6-month and 1-year follow-up, this application aims to explore whether and how the HOPE intervention can be adapted to increase MOUD uptake among OUD patients, assess the effectiveness of using HOPE to increase MOUD requests, and analyze online community data to improve future intervention implementation and sustainability.

The proposed study is a low-risk, randomized control trial to assess the efficacy of the HOPE (Harnessing Online Peer Education) intervention, an evidenced-based peer-led social media/online community intervention (e.g., Facebook Groups), to increase self-reported requests for medications for opioid use disorder (MOUD) among patients with moderate to severe opioid use disorder (OUD). Participants will be recruited using a variety of recruitment methods including social media sites (e.g., Facebook), referral by physicians, medical records, research study websites (e.g., UCIMC Clinical Trials website), and study flyers disseminated at various venues, including clinics, group meetings, and shelters. Once enrolled, participants will be randomly assigned to an intervention or control group. Intervention group participants will be invited to join a private and hidden (unable to be viewed or searched for by others) group on Facebook, with approximately 6 peer leaders included in the group. Those in the control group will be invited into a Facebook group, but without peer leaders. The intervention will last 12 weeks. Study measures will be collected at the beginning of the study (baseline), after the completion of the intervention (3 months), with follow up surveys at 6 and 12 months after the study.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age;
2. Resident of CA, NV, AZ, OR, WA;
3. English speakers only;
4. Has moderate to severe OUD;
5. Is not currently prescribed MOUD;
6. Reports using social media at least 2x per week;
7. Has, or is willing to create a Facebook/social media account and accept a friend request and group invite from our study social media page

Exclusion Criteria

1. Anyone who does not fit inclusion criteria above
2. Was a participant in phase I of the study
3. Participants with active, unstable opioid, alcohol, sedative, or other substance use and/or unstable medical or psychiatric conditions as assessed by the study questionnaires will be reviewed by the study physician consultants and will be excluded and referred for acute care including detoxification, if needed.
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake

The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people


Eligibility Criteria:
Inclusion Criteria:

1. Sex: male/female
2. Age: 65 years or older
3. Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m²
4. Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days
5. Written informed consent

Exclusion Criteria:

1. Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition
2. Subjects with galactosaemia or similar metabolic disorders
3. Subjects with severely impaired gastrointestinal function or complete failure
4. Subjects with insulin-requiring diabetes
5. Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day)
6. Subjects reporting frequent occurrence of migraine attacks
7. Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia)
8. Existing mouth abnormalities, which cause impaired gustatory sense
9. Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication)
10. Subjects passing through chemotherapy (last cycle \< 2 months ago)
11. Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS
12. Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator
13. Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition
14. Subjects with need of a special diet contradicting the intake of the ONS
15. History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
16. Subjects with dysphagia or with high aspiration risk
17. Enrolment in another clinical study
18. Administration of any investigational medicinal product during the last month prior to individual enrolment of the subject
19. Subjects who are not able to self-report GI-problems and compliance
20. Subjects who report a general dislike of the ONS flavour
21. Subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned
22. Subjects suspected or known not to follow instructions
23. Subjects unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical study
Validation of Saliva in the Esoterix Genetic Laboratories Fragile X Assay

The purpose of this research is to determine if saliva samples can be used as an alternate sample type to test for fragile X. By using saliva instead of blood, it would be easier for patients to have fragile X testing.

Saliva samples will be prospectively collected from subjects who have previously been tested by Esoterix Genetic Laboratories, LLC using blood specimens and diagnosed as fragile X intermediates, premutations (carriers) or full mutations (affected). Results from fragile X testing with saliva will be compared to results from the blood sample that was previously submitted to Esoterix Genetic Laboratories for testing.

Data from this study will be used for regulatory submissions.

Eligibility Criteria:
Inclusion Criteria:

* Subject has previously been identified through molecular testing at Esoterix Genetic Laboratories as a Fragile X intermediate, premutation (carrier) or full mutation (affected).
* In the opinion of the subject's physician, the subject is medically stable and able to provide the required quantity of saliva.
* If Subject is at least 18 years of age:
* Subject must be willing to give written informed consent
* Subject must be willing to comply with the collection procedure
* If Subject is under 18 years of age, the legally authorized representative must give written informed consent and agree to comply with study procedures.

Exclusion Criteria:

* Subject has been determined to be an individual with a normal FMR1 gene.
* Subject has a known medical condition that would cause risk to the donor or, if relevant, the fetus as a result of saliva collection.
Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure

The development of the abdominal aorta aneurysm is multifactorial. Through use of magnetic resonance imaging without contrast, this study will look closely at flow, the stresses hereby induced, as well as signs of inflammation in the vessel wall.

The etiology of the abdominal aorta aneurysm is complex and multi-factorial. Biomechanic and hemodynamic stress contributes to aneurysmal growth, and the relevance of inflammation is gaining in terms of pathological influence. The technical advances of imaging now enable one to utilize magnetic resonance in reconstructing aortal blood flow. Newer post-imaging software then enables one to perform complex data analysis, wherein shear and wall-stress can be calculated. The goal of this study is to analyze the aneurysms of twenty patients. Values will be obtained for shear and wall stress. Additionally, the utilization of short tau wave inversion recovery (STIR) sequences will be performed to evaluate the presence or absence of acute edema and inflammation of the region. It should also be noted that particular attention will be placed on the so-called "neck" of the aneurysm, where the aneurysm typically tapers into what is often regarded as normal aortic tissue. This region is important for both the placement of a surgical bypass prosthesis or a deployed stent graft.

Eligibility Criteria:
Inclusion Criteria:

* Infrarenal abdominal aorta aneurysm (AAA)

Exclusion Criteria:

* Lack of signed, informed consent
* Pacemaker or other implanted metal prostheses
* Claustrophobia
* Dementia
* Diabetes Mellitus
* Thoracoabdominal aorta aneurysm, per Crawford/Safi criteria
* Ehlers-Danlos, Marfans, or other diagnosed connective tissue disease
Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession

The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.


Eligibility Criteria:
Inclusion Criteria:

* Gingival recession type 2 according to Cairo et al (2011).
* Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).
* Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)
* Clinically thick gingival biotype (1mm \&lt; gingival thickness).
* Anterior esthetic zone.

Exclusion Criteria:

* Patients with gingival recession types 1 and 3 according to Cairo et al.
* Inadequate amount of attached gingiva (AG \&lt; 2 mm).
* Uncooperative patients.
* Smoking more than 10 cigarettes per day.
* Patients with known systemic conditions or taking medications that may affect soft tissue healing.
* Pregnant and lactating women.
* Patients with parafunctional habits.