cyrilzakka/clinical-trials huggingface dataset:
Lap-Band Surgery on Adolescents for Safety and Efficacy

This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.

STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss.

STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL).

DESIGN:Prospective, open-label, and single center

Eligibility Criteria:
Inclusion Criteria:

* Be at least 14 and less than 18 years of age at the time of enrollment into the study.
* Have a BMI of at least 40
* Have a history of obesity for at least 5 years, including failed attempts at diet and medical management of obesity.
* Confirmation by a psychologist or psychiatrist experienced with adolescents that the subject is sufficiently mature emotionally to comply with the study protocol.

Express willingness to follow protocol requirements.

•Assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception.

Exclusion Criteria:

* Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement.
* History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulopathy; hepatic insufficiency or cirrhosis.
* Presence of dysphagia or documented esophageal dysmotility.
* Patients with autoimmune connective tissue disorders
* Patients with acute abdominal infections
* Pregnancy or intention of becoming pregnant in the next 12 months.
* Presence of psychiatric problems or immaturity which would compromise cooperation with the study protocol.
* History of previous bariatric surgery, intestinal obstruction or adhesive peritonitis.
* Presence of localized or systemic infection at the time of surgery.
* Chronic use of aspirin and/or non-steroidal anti-inflammatory medications and unwillingness to discontinue the use of these concomitant medications.
* History of gastric or esophageal surgery.
* Use of weigh loss medications simultaneously
Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults

This is a randomized, double-blind, placebo-controlled, 2 arm crossover study conducted over 11 weeks, with participants randomised to a product for 4 weeks, followed by a 3-week washout period before completing the second product for 4 weeks, to study the effectiveness of a grape seed extract on circulatory measures in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Adults 25 years or older
* Generally healthy
* BMI 18 - 35kg/m2
* Able to provide informed consent
* Have prehypertensive blood pressure (systolic 120-139 mmHg and/or diastolic 80-89 mmHg)
* Agree to not change current diet and/or exercise frequency or intensity during entire study period
* Agree to not participate in another clinical trial while enrolled in this trial

Exclusion Criteria:

* Those with a history of myocardial infarction, angina or bleeding disorders
* Those who have uncontrolled thyroid diseases
* Currently taking dietary supplements for circulation (e.g. fatty acids, CoQ10, L-arginine, red ginseng, ginseng, natto, ginkgo) or use of these in the last 1 month
* Currently taking inflammation or circulatory associated medications (e.g. Pentoxifylline and vasodilators like nitroglycerin) or use of these in the last 1 month
* Currently taking statins medication including atorvastatin (e.g. Lipitor, Lorstat), fluvastatin (e.g. Lescol or Vastin), pravastatin (e.g. Pravachol, Cholstat), rosuvastatin (e.g. Cavstat, Crestor) or simvastatin (e,g, Lipex, Zocor, Zimstat).
* Currently taking Coumadin, Marevan (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy, or substrates of P-glycoprotein including (but not limited to) calcium channel blockers, cyclosporin, digoxin, erythromycin and protease inhibitors(1).
* Have a serious illness(2) e.g. mood disorders such as bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Have an unstable illness(3) (i.e., changing medication/treatment)
* Malignancy or treatment for malignancy within the previous 2 years (this excludes non-melanoma (e.g. BCC and SCC) skin cancers not requiring radiation or chemotherapy)
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
* Allergic to any of the ingredients in active or placebo formula
* Pregnant or lactating woman or women trying to conceive
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participated in another trial in the past 1 month

  1. Any participant that begins taking antiplatelet medication during the trial will be excluded from the study
  2. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
  3. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
Novel Candidate Genes for Treatment Response to Antipsychotics in Schizophrenia

Schizophrenia is a severe and chronic mental disorder. The lifetime risk of schizophrenia is around 1%. Its course is chronic and frequently disabling. The keystone of schizophrenia treatment is antipsychotic medications. The use of antipsychotics represents a huge public health and economic burden to society. Most of antipsychotics drugs are "metoo" drugs, directly or indirectly replicating dopamine D2 receptor blockade. Pharmaceutical companies have aimed to produce drugs with a general indication for all patients with schizophrenia with a "one-size-fits-all" strategy with no targeting or stratification. Second generation antipsychotics partly improve positive symptoms and are quite often associated to weight gain, metabolic changes and increased risk of cardiovascular diseases. Antipsychotics only achieve a certain degree of clinical improvement in a percentage of patients (45%) and 30% of the patients are treatment resistant. In light of the current deadlock, there is an urgent need to expand the horizon of pharmacological research by elucidating new mechanisms related to antipsychotic actions. An alternative strategy is the comparison of gene expression profiles in drug-naive accurately ill patients before and after antipsychotic treatment has been initiated. Our research group has a great experience in the field and has been working on this hypothesis in the latest years. We propose a continuation project to thoroughly explore the clinical implications (clinical response to antipsychotic drugs or emergence of metabolic side effects) of the variants in gene expression we have recently described in schizophrenia patients. This project takes advantage of an exceptional (regarding to the detailed knowledge of clinical outcome and side effect profile) longitudinal cohort of drug-naive patients with schizophrenia who had been followed up for three years at the University Hospital Marqués de Valdecilla.


Eligibility Criteria:
Inclusion Criteria:

* Patients followed up for 3 years in the First Episode Psychosis Clinical Program (PAFIP).
* 15-60 years.
* Living in the catchment area.
* Experiencing their first episode of psychosis.
* No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks.
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder.

Exclusion Criteria:

* Meeting DSM-IV criteria for drug dependence.
* Meeting DSM-IV criteria for mental retardation.
* Having a history of neurological disease or head injury.
Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers - Protocol 4

Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research.

Urocortins are proteins that appear to increase blood flow and heart pumping activity. There has been particular interest in the role of Urocortins 2 \& 3 (subtypes of Urocortins) in heart failure.

In this study, we will examine the pharmacokinetics and pharmacodynamics (in particular the onset-offset of action and reproducibility of vasodilator effects) of Urocortins 2 \& 3 on forearm arterial blood flow healthy volunteers.

Utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between 18 - 65 years (inclusive)

Exclusion Criteria:

* Lack of informed consent- Age \<18 years \> 65 years
* Current involvement in a clinical trial
* Severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure
* Smoker
* History of anaemia
* Recent infective/inflammatory condition
* Recent blood donation (prior 3 months)
* Positive baseline urine test for drugs of abuse (including cannabinoids, benzodiazepines, opiates, cocaine and amphetamines)
Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

To evaluate patient function, radiographic changes and complication rates of acute coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an augmentation to repair.

Acromioclavicular (AC) joint dislocations comprise up to 12% of shoulder girdle injuries. Many methods of reconstructing the coracoclavicular ligaments, which provide vertical stability of the acromioclavicular joint, have been described. The use of tendon graft to augment the reconstruction provides improved biomechanical stability, less radiographic changes postoperatively including loss of reduction, and improved function. However, the use of a tendon graft necessitates larger drill holes in the clavicle when compared to suture-only repair constructs. The size and placement of these tunnels in the clavicle have been associated with a higher rate of complications.

It has been shown that repairs in the setting of acute injury demonstrate less complications including loss of reduction when compared with chronic dislocations. However, other reports describing repair of acute AC joint dislocations without graft augmentation have described significant changes in coracoclavicular distance with routine follow up radiographs, and up to 90% implant migration rates. While use of tendon graft would be expected to provide further stability, they may in turn cause an increased complication rate.

1. To determine complication rates in the reconstruction of AC joint dislocations with and without the use of tendon graft.
2. Determine patient satisfaction, the ASES, Constant, SF-12, SANE, SST scores of shoulders that undergo reconstruction of acute AC joint dislocations with and without the use of graft.
3. The investigation aims to determine whether or not graft should be used in the reconstruction of acute AC joint dislocations.

Eligibility Criteria:
Inclusion Criteria:

* Displaced acromioclavicular joint dislocation sustained within 3 weeks of surgery
* recommended for operative fixation
* age 18 years or older

Exclusion Criteria:

* Open dislocation
* previous acromioclavicular surgery
* unable to follow study protocol
* concomitant injury requiring surgery (rotator cuff repair, biceps tenotomy/tenodesis)
* active infection
* unable to follow postoperative rehabilitation guidelines
* reconstruction with coracoclavicular screw or hook plate.
Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

The research team will evaluate pupillary dilation from vagal nerve stimulation of Arnold's Nerve, a branch of the vagus nerve, during routine cochlear implantation surgery.

The objective of this study is to determine if electrical stimulation of Arnold's Nerve, a branch of the vagus nerve, can result in vagal nerve response through the measurement of pupillary dilation

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing cochlear implantation:

* will be undergoing surgery for a cochlear implant
* is over the age of 18
* is willing to participate in the study

Patients undergoing vagal nerve stimulator implantation:

* will be undergoing implantable vagal nerve stimulation
* is over the age of 18
* is willing to participate in the study

Exclusion Criteria:

Patients undergoing cochlear implantation:

* is under the age of 18
* has history of prior ear surgery, congenital ear malformation, or cochlear implantation
* pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
* medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:

  * One vagus nerve
  * Receiving other concurrent forms of brain stimulation
  * Heart arrhythmias or other heart abnormalities
  * Dysautonomias (abnormal functioning of the autonomic nervous system)
  * Lung diseases or disorders (shortness of breath, asthma, etc.)
  * Ulcers (gastric, duodenal, etc.)
  * Vasovagal syncope (fainting)
  * Pre-existing hoarseness

Patients undergoing vagal nerve stimulator implantation:

* is under the age of 18
* has history of prior ear surgery, congenital ear malformation, or cochlear implantation
* pregnant or breastfeeding
* medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:

  * One vagus nerve
  * Receiving other concurrent forms of brain stimulation
  * Heart arrhythmias or other heart abnormalities
  * Dysautonomias (abnormal functioning of the autonomic nervous system)
  * Lung diseases or disorders (shortness of breath, asthma, etc.)
  * Ulcers (gastric, duodenal, etc.)
  * Vasovagal syncope (fainting)
  * Pre-existing hoarseness
Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)

The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are able to speak Danish \> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
* Normal EKG, blood pressure and pulse
* Signed informed written consent

Exclusion Criteria:

* Medical reason that contraindicates physical activity
* Patients diagnosed with a symptomatic cardial disease
* Documented bone metastasis
* Cognitively or emotionally unstable
* Unable to read or write in Danish
* Patients unable to carry out baseline tests
Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response

This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator (PENFS) in adolescents with functional nausea. A neurostimulator is applied to the outer ear and stimulates several nerves that are thought to be involved in transmission of nausea and vomiting signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.

By stimulating branches of several cranial nerves in the outer ear, this study aims to improve symptoms and quality of life in adolescents with functional nausea.

The study has the following specific aims:

1. To define adolescent functional nausea into subtypes based on clinical characterization and physiologic testing.
2. Evaluating the efficacy of auricular neurostimulation via PENFS for functional nausea. Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They will receive either an active or non-active (sham group) device for 5 days each week x 4 weeks total. Those who do not improve will receive an additional 4 weeks of therapy with active stimulation.
3. Investigate possible brain functional connectivity changes induced by auricular neurostimulation compared to patients with irritable bowel syndrome and healthy controls

Eligibility Criteria:
Inclusion Criteria:

* Meeting pediatric Rome IV criteria for functional nausea
* English-speaking and able to verbalize their condition and concerns about nausea, pain and other symptoms
* Lack of other explanation for symptoms
* Intact external ear that is free of infection or severe dermatological conditions, - - No currently implanted electrical device

Exclusion Criteria:

* Medically complex and/or suffering from medical condition that may explain symptoms
* Taking a medication that may explain symptoms
* Significant developmental delays
* Patients treated with a new drug affecting the central nervous system within 4 weeks of study start
* Infection or severe dermatological condition of ear
* Currently implanted electrical device
* Patients with a history of severe allergy to adhesives
Emergency Contraception - User's Profile

Retrospective analysis of requests of emergency hormonal contraception using pharmacy protocols registered in 2003 and 2006.

In 2002, Levonorgestrel was introduced in Switzerland for emergency hormonal contraception (EC) without prescription ('pharmacist only'). In 2003, a first analysis of requests of EC showed that the dispensing of EC through pharmacies could successfully be implemented (Lemke et al 2004).

This study was repeated three years later with the aim to explore whether the user's profile has changed after introduction of a low threshold access to EC.

Eligibility Criteria:
Inclusion Criteria:

* women seaking emergency hormonal contraception

Exclusion Criteria:

-
A Study of Different Types of Fatty Acid on Risk Factors for Heart Disease

Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and insulin sensitivity but the impact of NEFA composition is unknown.

The objective was to test the effect of acute elevation of NEFA enriched with either saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3 PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.

To investigate potential diet-gene interactions, potential subjects (n=370) were prospectively genotyped for the eNOS Glu298Asp polymorphism, of which 35 were Asp298 and 150 were Glu298 homozygotes. Three subjects in the Asp298 group were unable to participate, two were unsuitable according to selection criteria and one subject subsequently withdrew from the study. Subjects homozygous for Asp298 (n=29) and Glu298 (n=30) were therefore selected, balanced for gender, age and BMI.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Either homozygous for eNOS Glu298 (wildtype)or eNOS Asp298 (variant)

Exclusion Criteria:

* Smokers
* Raised fasting blood lipids
* Taking excessive fish oil supplements (\>1g EPA/DHA per day)
* Taking medication known to influence blood lipids, blood pressure or blood clotting
Tympanoseal (Tympanic Membrane Device) Clinical Study

The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.

This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients over 2 years of age at enrollment
* Documentation of a retained tympanostomy tube or persistent perforation less that 5 mm.
* Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study

Exclusion Criteria:

* Active otorrhea or otitis media
* History of cholesteatoma
* Perforations on the edge of the tympanic membrane
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Subject is taking systemic corticosteroids
* Subject requires continued use of any type of topical otic medication