cyrilzakka/clinical-trials huggingface dataset:
LAGB Versus VBG: 7-Year Results

The study aims to investigate the long term results of a randomized clinical single-centre trial comparing two standard operative techniques in bariatric surgery; laparoscopic adjustable gastric banding and vertical banded gastroplasty.

One hundred morbidly obese patients were included in the study. Randomization between the two operative techniques was performed using a computer model. Fifty patients were included in both groups. Weight loss, obesity-related comorbidity, long term complications, re-operations and conversions were all prospectively investigated for a mean period of 84 months.

Eligibility Criteria:
Inclusion Criteria:

* BMI of \> 40 kg/m2 or \> 35 kg/m2 with obesity-related comorbidities
* Failure to achieve sustainable weight loss with proven conservative measures

Exclusion Criteria:

* severe psychiatric and / or eating disorders
* unable to keep to a prescribed postoperative diet
* \< 18 or \> 60 years
* not eligible to bariatric surgery according to a member of the multidisciplinary team (psychologist, dietician, nurse practitioner, general practitioner and surgeon)
Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.

Ten consecutive subjects, ages 25-70 years, diagnosed with Chronic Subjective Dizziness (CDS) and ten healthy age and gender matched subjects will be asked to perform tests involving walking and balance while wearing the BalanceBelt. The BalanceBelt is a lightweight belt that will be worn under the clothes around the subjects waist and uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and motion.

Eligibility Criteria:
Subject population: 20 patients with diagnosis of Chronic Subjective Dizziness (CSD) and 10 normal volunteers.

Inclusion Criteria:

* Subjects will be 25-70 years of age inclusive and pregnant women may participate.
* Patients will have CSD as their primary diagnosis for the cause of their balance and dizziness complaints provided by the Behavioral Medicine Program for Dizziness, a division of the Department of Psychiatry \& Psychology.
* Normal volunteers will have a negative history of otologic \& neurologic disorders and no history of dizziness and balance problems.
* Normal volunteers will have normal findings on a screening office examination for peripheral and central vestibular system involvement (see methods for details of the examination) and screening for normal or symmetrical hearing loss of explainable origin.

Exclusion Criteria:

* Patients with positive indications from testing of peripheral and/or central vestibular system involvement that is felt to be influencing the symptoms reported beyond the CSD alone.
* Patients with mobility restriction that would prevent participating in the tests or the intensive therapy trials.
* Subjects with hearing impairment that interferes with oral communication.
A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People

The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Frail elderly individuals
* Able to understand and perform the study procedures

Exclusion Criteria:

* Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol)
* No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire)
* Use of anti-coagulation medication (except of Acetyl Salicyl acid)
* Presence of coronary heart disease (ECG)
* Renal insufficiency (eGFR \<60 mL/min/1.73 m2)
* Allergic or sensitive for milk proteins
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome

The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 10-18 years of age (both inclusive)
* Genetically confirmed diagnosis of Prader-Willi Syndrome
* Determined to be in nutritional phase 3 Prader-Willi Syndrome based on Miller et al, 2011

Exclusion Criteria:

* Known genetic, hormonal, or chromosomal cause of cognitive impairment other than Prader-Willi Syndrome
* Presence of currently active psychotic symptoms
* Presence of any cardiovascular disorders, epilepsy, frequent migraines or severe asthma
* Previous diagnosis of autism spectrum disorder by a qualified healthcare provider
* Prior or concomitant use of a selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI), antipsychotic medication, wakefulness-promoting drug, or thyroid hormone unless dosage has been stable ≥6 months at time of screening
Pulmonary Assessment in Thoracic Insufficiency Syndrome Patients

Thoracic insufficiency syndrome (TIS) is a complex condition that involves chest wall deformities that can affect normal breathing and lung growth. In most cases, children with TIS are also born with spine disorders such as scoliosis. The inability of the thorax to support normal respiration or lung growth can cause respiratory distress and even mortality. Investigators aim to validate MRI imaging sequences to use as an assessment tool for pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 6 to 18 years old diagnosed with thoracic insufficiency syndrome who are undergoing surgery

Exclusion Criteria:

* patients not diagnosed with thoracic insufficiency syndrome
Fluid Challenge and Plasma Volume, During Surgery

A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.

60 patients scheduled for laparoscopic abdominal surgery, with a duration exceeding 90 minutes will be included in the study. These are randomized to three different groups (20 in each groups): The first group of patients will receive boluses of acetated Ringers 4 ml/kg body weight. The second albumin 4 ml/kg body weight and the third group albumin 20% 1 ml/kg body weight.

Hemoglobin, albumin and colloid osmotic pressure (COP) is sampled the day before surgery and in the morning directly prior to the anesthesia. Bioimpedance, urine osmolality and urine-creatinin are also measured. After induction of surgery a Cardio Q probe is inserted threw the nose into the esophagus, for circulatory measurements. Initial/baseline blood samples are taken after insufflation of carbon dioxide to the abdomen. Before every bolus of fluid and 5, (10), 15, 20, 30, 40, (50) and (60) minutes new blood samples are taken for determination of hemoglobin, albumin and COP. Artery blood gases are sampled 15 minutes after every infusion or depending on the clinical need.

Eligibility Criteria:
Inclusion Criteria:

* Written consent to participate in the study
* For women: relevant contraceptive, menopausal or a negative pregnancy test.
* ASA category I to III
* Laparoscopic abdominal surgery, with a duration of at least 90 minutes.
* 18 to 80 years

Exclusion Criteria:

* Patients with known cardiac failure
* \<18 or \>80 years
* known allergy to albumin
* extracellular hyperhydration or hypervolemia
* kidney failure
* pregnancy or planned pregnancy
Determination of Normal Measures of Optic Nerve Sheath Diameter in Children

The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children.

The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. For that, between 4 and 18 years old children will be selected. After taking of measurements, following parameters will be taken into account and measurements will be classified with those parameters .

1. Age
2. Gender
3. Length (cm)
4. Weight (kg)
5. Waist Circumference (cm)
6. Body Mass Index

Eligibility Criteria:
Inclusion Criteria:

• Children without cerebral edema.

Exclusion Criteria:

• Children with cerebral edema.
Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology

Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a monofocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this "mix-and-match" is well established, the aim of this study is to compare the monofocal lens cohort to the EDOF lens cohort and evaluate visual acuity and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patient age between 21-99 years
* signed consent form
* senile cataract LOCS III grading
* Cataract surgery with monofocal or premium lens implantation

Exclusion Criteria:

* missing signed consent form
* macular pathologies
* corneal pathologies
* irregular astigmatism
* pregnancy
Effectiveness of Contrast-Enhanced Ultrasound

The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.

Abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to detect and often lack external signs of injury on physical exam. The current gold standard imaging study is Computed Tomography (CT) with IV contrast, which is associated with radiation exposure. Contrast-enhanced ultrasound is a radiation-free alternative to detect abdominal injuries and has been studied primarily in adults and some older children, but evidence to support its use in young children is needed.

This is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal CT with IV contrast as part of their clinical care due to concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by CT. Investigators will additionally include retrospective data of children who underwent both abdominal CT and CEUS as part of clinical care.

Eligibility Criteria:
Inclusion Criteria for study CEUS

1. Males or females \< 8 years of age at time of enrollment
2. Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour)
3. Abdominal CT ordered or obtained
4. IV in place

Exclusion Criteria for study CEUS

1. Unable to obtain contrast-enhanced ultrasound within 72 hours after CT
2. History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na) palmitic acid)
3. Known congenital or acquired heart disease

Alternative Inclusion and Exclusion Criteria for children who have undergone or are undergoing CEUS as part of clinical care

Inclusion criteria:

1. Males or females \< 8 years of age at time of CEUS.
2. Clinical Team plans to perform CT or has performed CT as part of clinical care for abdominal trauma
3. Clinical Team plans to perform (or has performed) CEUS as part of clinical care
4. Date of CEUS after January 1, 2015

Exclusion Criteria: None
The Effect of Losartan on Emotional Processing in Healthy Volunteers

This experimental medicine study explores whether a single dose of losartan (50mg) versus placebo affects the processing of positive and negative stimuli, using fMRI.

Losartan has been shown to accelerate fear extinction in animals and to prevent the development of anxiety disorders in humans, emphasising its potential to possibly enhance exposure therapy in humans. This study explores the basic effects of losartan on emotional processing, to identify neural mechanisms by which the drug might have synergistic effects on psychological treatment in humans.

In a double-blind between-groups design, 30 healthy volunteers will be randomised to a group receiving a single dose of losartan (50mg) versus placebo, and this study will measure the effects of probing renin-angiotensin function on emotional information processing, using functional magnet resonance imaging (fMRI). Such knowledge will ultimately be essential for the development of more effective pharmaco-psychological treatment approaches for anxiety disorders.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to provide informed consent
* male or Female, aged 18-50
* body mass index (BMI) of 18-30 kg/m2
* fluent English skills
* non- or light-smoker (\< 5 cigarettes a day)

Exclusion Criteria:

* Female participant who is pregnant or breast-feeding
* central nervous system (CNS) active medication during the last 6 weeks
* Current blood pressure/other heart medication (esp. aliskiren or beta blockers)
* Intravascular fluid depletion
* Past or present DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) axis-I diagnosis
* Alcohol or substance abuse
* First-degree family member with a history of a severe psychiatric disease
* Impaired liver or kidney function
* Lifetime history of epilepsy or other neurological disease, systemic infection, or clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, metabolic, endocrine or pulmonary disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Insufficient English skills
* participated in another study involving certain medication during last 6 weeks
* Contraindication to magnet resonance imaging (MRI) scanning (e.g. pacemaker)
Modified BFM-95 Regimen as First-Line Chemotherapy in Adults With T- Lymphoblastic Lymphoma

This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to modified BFM-95 regimen for acute lymphoblastic leukemia.

All patients received a modified BFM regimen which was derived from the NHL-BFM-95. The differences were as follows: (1) during the course of high-dose methotrexate therapy (HD-MTX), citrovorum folinate (CF) was used for rescue at 36 h after the administration of HD-MTX;(2) Pirarubicin was used instead of daunorubicin (3) Pegaspargase was used instead of L-asparaginase for patients.All patients received induction phase 1 and phase2, followed by the protocol M, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate \[MTX\] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. CNS-positive patients received two additional doses of intrathecal MTX at days 18 and 27 of induction and received CRT after reinduction therapy. The dose was 18 Gy.Patients with identifiable blasts in CSF-cytospin preparation but less than 5cells/uL in CSF were not considered CNS positive but received two additional doses of intrathecal MTX at days 18 and 27. For men with testicular involvement,orchiectomy was not performed, and irradiation (20 Gy) of testes was to be confined to biopsy-proven persistent infiltration of testis after protocol M.Response to treatment was evaluated on day 33 and at the end of induction in Modifed BFM-95.Sufficient response was defined as at least 70% tumor regression, less than 5% BM blasts, and no CNS disease on day 33 and complete remission detected by PET / CT at the end of induction.For patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial ALL-BFM95, with local radiotherapy (30 Gy) and allogeneic blood stem-cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosedT-LBL
* age:18-65years
* Ann Arbor stage IEto stage IVE
* at lease one measurable lesion
* receive no chemotherapy or radiotherapy before
* Adequate renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

* mismatch the inclusion criteria
* systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
25gr. Glucomedics vs 25gr. Zusto

Objective: to compare blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink)

This is an experimental study enrolling 10 healthy female subjects. The study compares the blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink). Subjects need to be fasted for at least 8 hours before all visits. At visit 1, five women will consume the solution with 25gr Zusto®, the other five will have the solution with 25gr Glucomedics®. On visit 2, groups will be switched. Visit 1 and 2 will be performed within approximately one week interval.

Both drinks will be identical in amount of water and only be different by the use of 25gr Glucomedics® and 25gr Zusto®.

Before intake of the drink, vital signs, weight and bedside blood glucose and baseline blood samples - 15' and 0' for glucose, insulin and C-peptide will be taken at visit 1 and 2. Both drinks will be consumed within 5 minutes and time of start and end of intake of Zusto® / Glucomedics® will be documented.

Blood samples for glucose, insulin and C-peptide will be taken at 15', 30', 60', 90', 120' and 180' after start of intake 25gr Zusto® and 25gr Glucomedics®.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects
* Age between 30 and 50 years
* BMI between 20 and 30 kg/m²

Exclusion Criteria:

* No first degree relatives with mellitus type 1 or type 2
* No intake of medication with influence blood glucose levels
* Pregnant, breast feeding or planning to become pregnant during the study
* Employer of the investigator or study center with direct involvement in the proposed study or other studies under the direction of the investigator or study center
Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

In patients with out-of-hospital cardiac arrest in Singapore, investigators aim to assess the benefit of introducing a resuscitation protocol including the use of intravenous (IV) access and/or intraosseous (IO) vascular access in the pre-hospital setting.

The assumption is that low vascular access rates could be due to difficulty of setting IV cannulas in the field due to certain factors like poor lighting or space constraints. Thus, by introducing a protocol including IO access for difficult IV cases, success rates for vascular access will be higher and this might lead to higher survival rates.

This will be a study comparing 'IV+IO' and 'IV alone' protocols in patients with cardiac arrest managed by Singapore Civil Defence Force (SCDF) emergency ambulance service. The trial will recruit 400 patients over 1 year. Each of the 30 SCDF ambulances will provide both 'IV+IO' and 'IV alone' treatments in 2 consecutive phases of 6-months in order to allow for all ambulance crew a chance to be trained on usage of IO. Currently, IO insertion is the accepted standard of care in Singapore General Hospital, Department of Emergency Medicine.

Primary objectives:

In adult and paediatric patients with Out-of-Hospital Cardiac Arrest (OHCA) in Singapore, investigators aim to evaluate the incremental benefit of introducing a resuscitation protocol including the use of intravenous (IV) access and/or intraosseous (IO) vascular access compared to protocols with only intravenous (IV) access by SCDF paramedics in the pre-hospital setting on the return of spontaneous circulation (ROSC) rates.

Secondary Objective:

* To compare the success rates of vascular access with IV access and/or IO insertion compared to that with intravenous (IV) access alone by SCDF paramedics in the pre-hospital setting.
* To compare the rates of successful 1st dose adrenaline given in the field to cardiac arrest patients in IV+IO and IV groups and whether this translates into a higher survival rate at 30 days.
* To determine the cost benefit of introducing IO access to the emergency ambulance service for OHCA.

Hypothesis:

In adult and paediatric patients with Out-of-Hospital Cardiac Arrest (OHCA) in Singapore, the hypothesis is that low vascular access rates could be due to difficulty of setting IV cannulas in the field due to certain factors like poor lighting or space constraints. Thus, by introducing a protocol including IO access for difficult IV cases, success rates for vascular access will be higher and this might lead to a higher ROSC and survival rates.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest (medical or traumatic)
* Intravenous fluids or medications needed

Exclusion Criteria:

* Adult needle (weight ≥ 40 kg)
* Paediatric needle (weight 3 - 39 kg)
Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging

Old age (\> 60 years) is at high risk to develop major depression disorders (MDD). MDD doubles the risk for subsequent cognitive disorders and dementia. Apathy (i.e. the lack of motivation) is a core problem in depression in older age and is frequently associated with cognitive decline in people who have mild cognitive disorders. The investigator propose here to combine actimetry (the measurement of motor activity using a simple device worn at the wrist) and brain imaging to show that it's possible to measure apathy using actimetry in a population of elders with MDD. Having shown that apathy can reliably be measured with actimetry and that it is associated with brain abnormalities, the investigator will be able to test whether actimetry can predict cognitive decline in elders with MDD and can be routinely used in a day-to-day medical practice.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* 60 years and above
* Major depressive disorder (either late-onset or early onset)
* Ambulatory settings
* Both uni and bipolar depression will be considered Healthy controls
* 60 years and above
* No psychiatric disorders, including no major depressive disorder
* No non-inclusion criteria

Exclusion Criteria:

* Patients and healthy controls
* Major cognitive disorders (\< 125 on the Mattis dementia rating scale and a major cognitive disorders diagnostic according to the DSM5 (Diagnostic and Statistical Manual of Mental Disorders) criteria).
* Other neurological conditions (stroke, Parkinson's disease and seizures), severe and inflammatory disorders (ex: severe arthroses which limits movements, spondylarthritis)
* Severe sarcopenia: speed walk \< 1 meter/second
* Extrapyramidal syndrome
* High suicidal risk
* Anti-psychotic prescription
* Participant who are unable to provide clear consent, under legal protection
* MRI contra-indication