cyrilzakka/clinical-trials huggingface dataset:
Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance

The purpose of this study is to determine whether patients with repaired congenital heart disease show differences in size or function of their heart atria compared to normal controls and depending on the nature of their heart disease.

Atrial function is important for good ventricular filling and function. In patients with impaired cardiac function, atrial contraction is even more important. So far, the size and function of the atria have been assessed two-dimensionally by angiography and by echocardiography. However, these do not allow exact characterization of the volumetric changes of the atria during the cardiac cycle. Recently, cardiac magnetic resonance (CMR) has been used to assess size and function of the left atrium in adults. Little data are available about function and volume of the atria in children and the role of the atria in congenital heart disease (CHD).

The study will recruit patients with CHD (n=40) and normal controls (n=10). The patient group will be composed by patients suffering from the following conditions: coarctation of the aorta (n=10), tetralogy of Fallot (n=10), transposition of the great arteries after atrial switch (Senning procedure) (n=10), transposition of the great arteries after arterial switch operation (n=10).

The study consists of measurements of sizes and function of the right and the left atrium, respectively, by examining three-dimensional volume changes across the heart cycle, and of phase contrast measurements of blood flow across the valves of the heart.

Eligibility Criteria:
Inclusion Criteria:

* Ability to perform repetitive breath holds of 10-15 seconds each
* Written informed consent of the patients or their legal guardians

Exclusion Criteria:

* Patients requiring general anaesthesia
* Residual cardiac findings which might potentially influence the size and function of the atria
Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients

The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake, social isolation, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory.

This study is a randomized clinical trial conducted in a Department of Geriatrics of a tertiary public hospital with 35 beds allocated. Hospitalized patients who meet the inclusion criteria will be randomly assigned to intervention or control group. Patient recruitment will begin in the first 48 hours of admission to the ward, which will be identified through the list of patients admitted to the hospital and assigned to the Department of Geriatrics. The doctor who decides the inclusion in the intervention or control group will not be the attending physician. Patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. Randomization will be performed by applying http://www.randomizer.org/. The information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 3, 6 and 12 after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age 75 years and older
* Able to tolerate exercise
* Able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair
* Able to communicate
* Non-elective admission to hospital

Exclusion Criteria:

* Severe dementia (GDS 7)
* Duration of hospitalization \<72 hours
* Unwillingness to either complete the study requirements or to be randomized into control or intervention group
* Unstable cardiovascular disease or other unstable medical condition
* Terminal illness
Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma

Recent studies addressing the role of adjuvant chemotherapy in cholangiocarcinoma (CCA) have been published; however, there are challenges in generalizing the findings due to different prognostic characteristics depending on tumor location and resectability. Therefore, the aim of this study was to investigate the role of AC in distal cholangiocarcinoma, a common tumor subtype of CCA.


Eligibility Criteria:
Inclusion Criteria:

* Patients with distal cholangiocarcinoma who underwent surgery

Exclusion Criteria:

* Who underwent neoadjuvant treatment
* Who underwent R2 resection
* Non-adenocarcinoma patients in final pathology report
* Insufficient data
* Death within 90days of surgery
Comparing Menghini-type Needle and Franseen-type Needle in EBUS-TBNA for Sarcoidosis

This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis, as defined by improved sample quality for pathological diagnosis compared to the conventional Menghini-type needle.

This study is a prospective randomized control trial. More than 370 lymph nodes from approximately 128 patients with enlarged mediastinal and/or hilar lymph nodes (≥10 mm short-axis diameter on CT scan) and suspected sarcoidosis will be enrolled in this study. This is a single-center study conducted at the Toronto General Hospital.

If consent is obtained, patients will be considered enrolled. The patients will then be assigned to either Menghini-type (the standard needle type in Toronto General Hospital) or Franseen-type needles in a 1:1 ratio with stratified randomization by the availability of rapid on-site cytology evaluation. An automated randomization program will be used to generate the randomization scheme for the study. Samples from mediastinal and hilar lymph nodes will be obtained by EBUS-guided Menghini-type or Franseen-type needle biopsy. Post-procedural assessment will take place in the endoscopy recovery room and will include, but not limited to, monitoring of vital signs, signs of bleeding, and pulmonary status. As EBUS-TBNA is an outpatient procedure, patients will be discharged home after the procedure.

Specimens (cell pellet and/or tissue fragment) will be assessed by pathologists as per their usual practice. The pathologists will remain blinded to the allocated needle. Specimens will be classified by their adequacy for histological assessment and diagnostic yield. In addition, total procedure time and mean number of needle passes to obtain tissue samples will be compared between the two study arms.

Eligibility Criteria:
Inclusion Criteria:

* -Any adult patient aged 18 years or older with enlarged mediastinal and/or hilar lymph nodes
* (≥10 mm short-axis diameter on a CT scan), suspected as having sarcoidosis based on clinical
* history, physical exam, and other investigations, and booked for EBUS-TBNA.

Exclusion Criteria:

* -Patients that are unable to provide informed consent

  - Patients with lymphadenopathy strongly suspected to be secondary to other diseases based on
* clinical history, physical exam, and/or other investigations (e.g., lung cancer, lymphoma,
* infection).
The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs

Objective: This study aimed to determine the effect of face-to-face and video-based education for fistula care on hemodialysis patients' self-care behaviors.

Methods: The study was conducted as a randomized controlled experimental study. Fistula care training was given to the patients in the control group using face-to-face education technique. Fistula care training was given to the patients in the experimental group using a video based technique.

Experimental group: The researcher provided the patient education the on fistula care. In this training, the researcher first verbally explained fistula care to the patients. After the verbal training, a video recording about fistula care was shown to the patients. The patients watched the video recording during dialysis using the TV unit at the bedside. The training took 20 minutes. Patients were allowed to watch the training video twice, at a one-week interval, when they came for hemodialysis treatment after the condition of the patients on dialysis stabilized.

Topics: Video recordings on of fistula care was done by the researchers in the vocational skills laboratory. The video flow plan included the introduction of the materials to be used in fistula care as well as the researcher's presentation of how to manage the fistula. Fistula care steps were performed on the simulation model. In addition, the precautions to be taken during the application and what to do in case of possible complications were also shown.

Literature review, research results, clinicians' opinions, and experts and practices were used in editing the content of verbal training and video recording,

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* Receiving hemodialysis treatment for more than 6 months,
* Having arteriovenous fistula,
* Being able to read, understand and speak Turkish,
* Not having any physical, mental or mental disability restricting daily activities,
* Having no visual-hearing impairment, perception and psychiatric problems,
* Volunteering to participate in the study

Exclusion Criteria:

* Not having arteriovenous fistula,
* Declining to participate in the study
Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus

The purpose of this study is to determine whether levetiracetam is safe and well tolerated by patients while suffering a status epilepticus. Levetiracetam is added to the standard treatment of patients with this disease.

Status epilepticus (SE) is a disorder with high mortality and morbidity. There are strong indications that ongoing seizure activity substantially reduces the chances on a good outcome. This implies that optimal treatment of SE should start as soon as possible. Unfortunately, treatment options are limited and often based on little evidence. Besides, current treatment options are hampered by serious side-effects like respiratory depression and impaired consciousness. Therefore, the advent of new and effective anti-epileptic drugs (AEDs) is of great potential interest for the treatment of SE. Presently, the newer AEDs are mainly used in later stages of SE at a time when the disease is often more difficult to control. The characteristics of one of these recently introduced anticonvulsants i.e. levetiracetam seems to provide a number of fortunate properties for application as first-line treatment of SE. The complicating side-effects of "classical" AEDs, like a decrease in cardiorespiratory function or in level of consciousness are hardly present. Besides, levetiracetam may lower the need for benzodiazepines, reducing chances on respiratory depression by benzodiazepines at higher doses. Due to a remarkable synergism with first-line administered benzodiazepines, levetiracetam may therefore reduce the need for intubation or ICU treatment. Besides, it may enhance the immediate cessation of seizures, prolong the anti-seizure activity of benzodiazepines and provide neuroprotective properties. The sustained efficacy of levetiracetam would suggest that long term sequelae secondary to neurological damage, may also be reduced. Levetiracetam IV has recently been shown to be safe in healthy volunteers, and becomes available for iv application in clinical practice, early 2006. To date, there are hardly any data available on its applicability in medical emergencies like SE. We propose as a first step the executing of a phase II study on tolerability and safety of intravenous levetiracetam in patients with SE. Current first-line treatment of SE consists of standardized administration of benzodiazepines. For the study we propose to apply this regimen together with the iv administration of levetiracetam as add-on therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years of age
* All types of SE, diagnosed by the medical examiner according to the predefined definition. Absence SE has to be confirmed by EEG.
* Woman: 18-50 years of age of whom is known, from anamnesis or hetero-anamnesis (first line relative), that she is not pregnant.

Exclusion Criteria:

* Woman \< 50 years of age, without information on pregnancy
* Known pregnancy
* Known allergy for levetiracetam
* Daily dose levetiracetam of more than 2000mg/day
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis

This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells.

PRIMARY OBJECTIVE:

To demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions per week.

OUTLINE: This is a dose-escalation study.

Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks.

After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic proven diagnosis of solid tumor malignancy
* One brain metastasis or brain metastasis resection cavity with maximal diameter ≥ 3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.)
* Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) ≥ 70%

Exclusion Criteria:

* Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target volume would have received more than 12 Gy
* RPA class III (KPS \< 70%)
* Brain metastasis or resection cavity volume \< 3 cm or \> 6 cm
* Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
* Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)
* Evidence of leptomeningeal disease by magnetic resonance imaging (MRI) and/or cerebrospinal fluid (CSF) cytology
* Current pregnancy
* More than 8 weeks between resection and radiosurgical procedure
* Metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic apparatus (optic nerves and chiasm)
* Inability to undergo MRI evaluation for treatment planning and follow-up
Vitamin/Mineral Supplement for Children and Adults With Autism

The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:

1. improvement of nutritional status in some children/adults with autism, and
2. reduction of some of the symptoms of autism in some children

The major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. The study design is a randomized, double-blind, placebo-controlled. Blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. Then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.

Eligibility Criteria:
Inclusion Criteria:

1. age 3-60 years old;
2. Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
3. Control Group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of Attention Deficit Disorder by parent report

Exclusion Criteria:

1. Usage of a vitamin/mineral supplement in the last 2 months
2. Current use of any chelation treatment
Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer

The main objective of the CanMoRe study is to evaluate the impact of a standardized and individually adapted exercise intervention in Primary Health Care aiming at improving physical function (primary outcome) and habitual physical activity, health related quality of life, fatigue and psychological well-being in patients undergoing radical cystectomy due to urinary bladder cancer.

The most common treatment for solid cancer tumours is surgery, often in combination with chemo- and/or radiotherapy. To minimise the postoperative complications is important in today's health care. Early mobilisation at the ward and physical activity at home after discharge, have been shown to be important parts to reduce complications. Common complications after abdominal surgery are postoperative pulmonary complications and venous thrombosis. One of the conditions that suffers the most from different kinds of postoperative complications is radical cystectomy due to urinary bladder cancer. Complications after radical cystectomy could be direct related to the patients' high age and also high degree of comorbidity.

There is today strong evidence that physical activity has a positive impact on health, survival and quality of life. Patients who have been treated for urinary bladder cancer are not sufficiently physical active and suffer from readmissions to hospital due to complications. Therefore, there is a need for developing and testing a physical rehabilitation programme to support patients who have a radical cystectomy, in the early postoperative period.

The CanMoRe study is a randomized controlled trial with a single-blinded design evaluating an exercise intervention in Primary Health Care as part of the CanMoRe programme. In addition, a qualitative study (interviews) on patient's experience of the programme will be conducted as well as data gathered on factors that might influence the implementation of the programme.

Then CanMoRe programme consists of preoperative information, the Activity Board used for enhanced mobilization during hospital stay, a 12-week, (1 h, 2 times/week) standardized and individually adapted exercise intervention in Primary Health Care and behavioral support for daily physical activity. The CanMoRe programme is evaluated in two steps, i.e. the in-hospital intervention using the Activity Board (published) and the exercise intervention in Primary Health Care reported herein.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned for a robotic assisted laparoscopic radical cystectomy due to urinary bladder cancer at the Karolinska University Hospital Solna will be included in the trial. The patients should be able to talk and understand Swedish, live in the Stockholm County Council area and be mobile with or without walking aid.

Exclusion Criteria:

* Patients who will undergo radical cystectomy on a non-curative basis will not be included.
Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery

Intracorporeal suturing and knot tying during robotic prostatectomy and laparoscopic and robotic renal surgery have historically been considered the most technically challenging and time consuming aspects of these procedures. With improved operative technique as well as the use of innovative surgical devices, vascular control during these surgeries is often less cumbersome as compared with traditional techniques. Current standard methods of hemostasis include the use of clips, of which the most popular design is the Hemolock, a locking, nonabsorbable plastic clip, or the use of the very expensive endomechanical stapler. Unfortunately while they are associated with time savings in the operating room, there is a great deal of disposable costs associated with these various devices as well as a not insignificant device malfunction rate reported in the literature. The aim of this case-controlled study is to evaluate the Aesculap U-clip device compared to our current technique of vascular control using the Teleflex Hemolock clip device during minimally invasive genitourinary surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients ≥ 18 years old with genitourinary malignancy either prostate cancer or kidney renal masses undergoing minimally invasive genitourinary organ removal will be included in this small pilot study.
Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults

This study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV administration.


Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination
* Females, of childbearing potential, and males must agree to utilize protocol specific contraception methods
* Screening laboratory evaluations must be within defined thresholds

Exclusion Criteria:

* Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
* Pregnant and lactating females
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual treatment and/or adherence to the protocol
Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

Patients with traumatic brain injury are likely to present with cognitive, psychological, emotional and behavioral problems during different periods, all of which affect patients' life quality seriously. The aim of this study was to assess cognitive and psychosocial outcome in patients with mild traumatic brain injury, and to determine the risk factors associated with cognitive and psychological outcome. Mini-mental state examination (MMSE), activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and mental health symptom checklist (SCL-90) were used to assess the cognitive performance and psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's exact tests and Logistic regression analysis were used to analyze the risk factors.


Eligibility Criteria:
Inclusion Criteria:

* 18 \~ 60 years old
* Education: primary school and above, who could understand the content of psychological test
* History of brain trauma
* No taking of antipsychotic or any other drugs affecting central nervous system before the test
* Glasgow coma score (GCS) was 13-15

Exclusion Criteria:

* History of craniocerebral injury, brain disease, mental disease
* With mental retardation
* with other serious body diseases
* History of drug and alcohol dependence
* With color-blind or color weakness
* Who had severe visual and auditory disorders after brain injury
* Who failed or failed in completing the test effectively
* With cognitive impairment caused by the damage of the unilateral frontal or bilateral lobes, or with language dysfunction caused by temporal lobe damage