Kornimate/medical-research-clean huggingface dataset:
effect of rimonabant on weight gain and body composition in adults with prader willi syndrome

Conditions: Prader-willi Syndrome

Summary: the purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1 blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects with prader-willi syndrome (pws). this will be a double blind placebo controlled clinical trial involving a total of 18 young adults aged 18 to 35 years with pws. patients will be divided in to the two groups of control and intervention, and treated with either placebo (inactive drug), or rimonabant 20 mg once a day for a total duration of 6 months. body weight, fat distribution, objective and subjective assessment of the hunger, fasting blood sample for measurement of ghrelin and leptin (two hormones regulating appetite), serum lipids , igf-1(growth hormone related protein), insulin and glucose concentrations will be measured upon enrollment, at 3 months, and at the end of the study. the proportion of body fat to muscle will be determined using a radiological technique, whole body dual-energy x-ray absorptiometry (dexa) scan, and also by measurement of skin fold thickness, waist and hip circumference at the enrollment prior to the intervention, and at the end of the study.


Eligibility criteria:
inclusion criteria: 1. subjects will be selected if they have prader willi syndrome previously confirmed by standard genetic testing (the dna methylation test) or meet the clinical diagnostic criteria as follows :the presence of at least four of the six principal characteristics of pws syndrome including 1) infantile hypotonia, 2) abnormal pubertal development, 3) obesity after early infancy, 4) dysfunctional central nervous system performance, 5) dysmorphic facial features, and 6) short stature. in addition, they must have one or more of the following characteristics commonly associated with pws: 1) small hands and feet, 2) skin problems, 3) behavioral problems related to food, and 4) decreased pain sensitivity. 2. subjects must be 18 to 35 years of age and fairly cooperative with the study protocol. 3. subjects must have a bmi of at least 30 or more. exclusion criteria: 1. presence of pulmonary disease. 2. presence of any other abnormal endocrine findings, including abnormal thyroid function. 3. presence of significant behavioral problems or psychiatric illness including anxiety disorder and depression, interfering with the follow up of protocol. any degree of depression and moderate to severe anxiety will be exclusion criteria for this study. 4. subjects with prader willi syndrome who are on other medications including growth hormone therapy, anti epileptic medications, or antipsychotic medications. 5. the presence of moderate to severe renal or liver disease. mild elevations of liver enzymes are not exclusive. 6. subjects who are on any other research or weight loss medication

Keywords: body weight, fat mass, growth hormone, ghrelin
protocol for high-risk assessment, screening, and early detection of pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to find out whether endoscopic ultrasound (eus) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. ultrasound refers to an imaging technique that uses sound waves to produce pictures. eus in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.


Eligibility criteria:
inclusion criteria: * patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer * if only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened * if there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened * patients at least 40 years old or 10 years younger than the youngest affected individual * peutz-jeghers syndrome (pjs) patients age\>30 * hereditary pancreatitis patients * patients with familial atypical multiple mole melanoma syndrome (fammm) * patients with brca2 mutation and at least one first or second degree relative with documented pancreatic cancer * willingness to undergo (eus) with possible fine needle aspiration (fna) * willingness to undergo surgical evaluation for abnormal eus/fna finding * willingness to undergo radiographic evaluation if screening findings are abnormal exclusion criteria: * medical contraindications to undergoing endoscopy or obstruction of the gi tract that precludes passage of the endoscope * personal history of pancreatic adenocarcinoma * previous partial or complete resection of the pancreas for adenocarcinoma * prior partial or total gastrectomy with billroth ii or roux-en-y anastamosis * previous computed tomography (ct) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (mri/mrcp) or eus of the abdomen in the past 3 years * coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (aids/hiv) * life expectancy less than 5 years * pregnancy

Keywords: pancreas high-risk
angelman natural history study - fast spain

Conditions: Angelman Syndrome

Summary: the goal of this study is to conduct a prospective, longitudinal study to observe the natural clinical progression and disease outcome of as patients receiving no disease-modified intervention, with the purpose of obtaining data that will be useful for future clinical trials.

the overall goal is to increase our understanding of the long-term natural history of angelman syndrome and to identify and validate objective and sensitive outcome measures, which could serve as endpoints for outcome measures that can be used in clinical trials.

Eligibility criteria:
inclusion criteria: 1. male or female between 3 months and 99 years of age. 2. clinical diagnosis of angelman syndrome and molecular confirmation of the diagnosis. 3. the participant has an acceptable guardian capable of giving consent on behalf of the participant, 4. willingness and ability of their guardians to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: 1. patients with any comorbidity that, in the clinical judgment of the principal investigator, may affect the results of the study. any confirmed chronic or acute condition or illness affecting any system(s) that could interfere with study results and/or compliance with study procedures is included. 2. patients who are participating in parallel studies with investigational drugs. 3. unwillingness or inability of their guardians to follow the procedures outlined in the protocol.
omega-3-polyunsaturated fatty-acids (n3-pufa) in patients with severe chronic heart failure

Conditions: Chronic Heart Failure

Summary: to investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.


Eligibility criteria:
inclusion criteria: * chronic heart failure of non-ischemic origin * age ≥18 years * nyha functional class iii-iv * lvef \< 35 % * optimized heart failure therapy * plasma nt-bnp \>2000pg/ml exclusion criteria: * current treatment with omacor or other fish oil products * known hypersensitivity to the study drug * ischemic cardiomyopathy * uncorrected significant valvular heart disease * heart failure due to congenital heart disease * restrictive cardiomyopathy * alcoholic heart disease * acute myocarditis * continuous i.v. therapy for heart failure * mechanical assist device * life expectancy \<1 year due to non-cardiac causes * inability to perform bicycle testing * women of childbearing potential not practicing a save contraception method * current participation in another intervention study * participation in another study with an intervention within the last 3 months.
childhood schistosomiasis: a novel strategy extending the benefits/reach of antihelminthic treatment

Conditions: Schistosomiasis

Summary: objective and hypotheses: this project has the overall objective of implementing and evaluating new approaches to reducing the current and future burden of urinary schistosomiasis in young children using the antihelminthic drug praziquantel. the project aims to (1) determine the operational health benefits of treating schistosome infections early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome structure (species diversity or abundance) is a risk factor for s. haematobium infection or morbidity, and (3) elucidate the factors and underlying mechanisms mediating the reduction/reversal of schistosome-related morbidity and resistance against infection/re-infection in young children.

this study aims to refine current paediatric treatment of schistosomiasis using the drug praziquantel (pzq) to improve the current and future health of pre-school children and infants. praziquantel is cheap, highly efficacious and safe, presenting a realistic opportunity of using a pre-existing tool in a modified way to benefit child health and development. the study will focus on children aged 3 to 5 years of age, comparing the impact of early vs. later treatment with pzq on the current and future health status of the children. by killing worms pzq stops the morbidity related to the presence of worms and eggs such as anaemia, abdominal pain, diarrhoea and blood in the urine as well as induced immune responses associated with reduced re-infection rates. therefore the study will investigate the immediate health benefits of treating pre-school children and infants and the effects of treatment on re-infection rates.

Eligibility criteria:
inclusion criteria: 1. lifelong residents of the area 2. have provided at least 2 urine and 2 stool for parasitological examination 3. have given a blood sample before and after each treatment episode 4. be negative for schistosomes, hookworm, trichuris and ascaris 5. have frequent contact with infective water exclusion criteria: 1. clinical signs of tuberculosis or malaria 2. presenting with fever 3. have had a recent major operation, illness or vaccination 4. have previously received antihelminthic treatment 5. are infected with any helminths

Keywords: paediatric schistosomiasis morbidity immunology
cervical transforaminal injection of steroids guided by ultrasound

Conditions: Cervical Radiculopathy

Summary: cervical transforaminal epidural steroid injections (tfesi) are indicated in cervical radicular pain resistant to conservation therapy, by which steroids can be delivered into anterior epidural space surrounding target spinal nerve roots to help alleviate pain in the upper limb or neck. cervical tfesi is traditionally commended to perform with guidance of fluoroscopy or ct. as fluoroscopy can not monitor the injection route whether it pass vessel or not, many serious neurological complications caused by inadvertent intra-arterial injection have been reported2. here, the investigators will introduce a novel cervical tfesi guided by ultrasound, which incidence of inadvertent vessel injury or injection might be lower than those guided by fluoroscopy.


Eligibility criteria:
inclusion criteria: * evidence of a cervical radiculopathy involving 1 spinal nerve of at least 1 month's duration refractory to medical treatment * symptoms of cervical pain radiating to the upper limb * and signs of altered sensations, ab- normal reflexes, or motor weakness caused by degenerative spondylosis and/or disk herniation as documented at ct or mr imaging and a current mean pain vas score of six. exclusion criteria: * evidence of vertebral fracture, tumor, or infection of the cervical spine * treatment with cervical corticosteroid injections within the past 3 months * coagulopathy * allergy to iodinated contrast media.

Keywords: ultrasound cervical transformational epidural steroid injection
prospective study of hiv infection in hemophiliacs

Conditions: Acquired Immunodeficiency Syndrome; HIV Infections; Blood Disease; Hemophilia A; Hepatitis, Viral, Human; Blood Transfusion; Cytomegalovirus Infections

Summary: to examine mechanisms of individual differences in the progression of hiv infection in hemophiliacs.

background: in the late 1980s, hemophiliacs were transfused with a variety of blood products, including large amounts of cryoprecipitate. in comparison to other cohorts, hemophiliacs are cmv(-), resulting in a comparison group for the study of this virus as a potential cofactor. in contrast, non a, non-b hepatitis is common in comparison to other cohorts, and preliminary data prior to 1990 suggested that this chronic disease predisposes to more rapid progression of hiv infection. design narrative: disease-free survival rates were determined in hiv-infected hemophiliacs. the effects of co-factors such as intensive transfusion, concomitant cytomegalovirus or chronic nanb hepatitis infection were ascertained. host-virus interaction was assessed through the use of plasma cultures, specific antibody titers, and markers of immune changes detected by flow cytometry and immune function assays. the immunology of asymptomatic stable infection was investigated. the safety of volunteer donor blood products was determined in seronegative patients exposed to over 50,000 donors yearly and the risk of sexual transmission of hiv to spouses of seropositive patients was monitored.

Eligibility criteria:
no eligibility criteria
national project to implement mesenchymal stem cell for the treatment of perianal crohn's fistula (the prime study)

Conditions: Safety; Efficacy, Self

Summary: darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with crohn's disease. safety and efficacy of the procedure has been sufficiently demonstrated and the spanish agency of medication approved its application a few months ago. being aware about the difficulties to a proper application and management of the stem cells the spanish stem cell therapy group devised, in a joint activity with the spanish group germ (grupo español de rehabilitacion multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. the objective is to get a homogeneous implementation in all hospitals in spain that have being baked to use this biological therapy.


Eligibility criteria:
inclusion criteria: * adults aged 18 years or older who have complex perianal crohn ﬁstula * non-active or mildly active luminal crohn's disease for at least 6 months. * the ﬁstula had to have been draining for at least 6 weeks before inclusion. exclusion criteria: • patient with recto-vaginal ﬁstula; rectal or anal stenosis; or active severe proctitis.
lamictal as add on treatment in mixed states of bipolar disorder

Conditions: Bipolar Disorder

Summary: * to evaluate the efficacy and safety of lam+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder. * to evaluate the efficacy and of a combination of lam+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

1. to evaluate the efficacy and safety of lam+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder. 2. to evaluate the efficacy and of a combination of lam+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

Eligibility criteria:
inclusion criteria: in order to be included in the study patient must meet criteria a, c, d, e, f, g plus any 1 of the 3 criteria listed in section b. a. patients meeting dsm-iv diagnosis of bipolar disorder, i or ii b. 1. patients meeting dsm-iv diagnostic criteria for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three dsm-iv depressive symptoms excluding psychomotor agitation or 2. patients meeting dsm-iv symptomatic criteria for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three dsm-iv depressive symptoms excluding psychomotor agitation or 3. patients meeting dsm-iv criteria for a depressive episode associated with at least three dsm-iv manic/hypomanic symptoms c.madrs of ≥14 d.ymrs of ≥ 14 e. age 13years to 75 years f. male or female g. outpatient exclusion criteria: 1. illness precluding the use of lam 2. alcohol/drug dependence in the past one month 3. patients with a history of a rash on lam 4. cns neoplasms, demyelinating diseases, degenerative neurological condition or active cns infection 5. history of seizure, known eeg with frank paroxysmal activity, known ct of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma 6. patients currently taking lam

Keywords: mixed mania lamotrigine
development of a nanosecond pulsed electric field system to treat skin cancer

Conditions: Basal Cell Carcinomas

Summary: human basal cell carcinomas (bccs) can be ablated by treating them with nanosecond pulsed electric fields (nspef)

the purpose of this study is to determine if low energy, non-thermal, 100 ns pulses can ablate bccs. the investigators consider this a non-significant risk study because our pulsecure system only applies 0.4 watts to the skin compared to the 40 watts applied by the currently used electrosurgical unit to remove skin lesions, the hyfrecator. since the pulsecure applies 1/100 of the energy and does not even heat the skin significantly, it represents a non-significant risk to the patient. our study will provide the first data on the response of bccs to these 100 ns pulses. the investigators will first treat three bccs on bcns patients with different pulse numbers to determine the pulse number needed to ablate. once the investigators have the optimal pulse number, the investigators will use it to treat 20 normal patients with sporadic bccs on their trunks. this should provide sufficient data to conclude whether or not nspef can ablate bccs on normal individuals.

Eligibility criteria:
inclusion criteria: 1. study subjects must have had diagnosed at least one bccon their trunk 2. the subject is from 18-75 years of age, inclusive. 3. the subject must sign and date all informed consent statements. exclusion criteria: 1. the subject is exhibiting signs of a bacterial or viral infection, including fever. 2. the subject is unwilling to allow a biopsy of a malignant lesion for histological analysis. 3. the subject has a pace maker or other electronic device implanted

Keywords: basal cell carcinoma basal cell nevus syndrome electric field nanosecond pulse
overcoming high on-treatment platelet reactivity (hpr) during prasugrel therapy with ticagrelor

Conditions: Coronary Artery Disease

Summary: the primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg ld/ 90mg bid) at 2, 4 hours and 14 days in stable coronary artery disease (cad) patients who exhibit high-on prasugrel platelet reactivity defined as vasodilator stimulated phosphoprotein-phosphorylation (vasp-p) \>50%.


Eligibility criteria:
inclusion criteria: 1. male or female; age ≥ 18 and \< 75 years 2. weight ≥ 60 kg 3. currently on asa therapy and eligible to reduce asa dose to 81 mg daily if on higher dosing 4. on stable prasugrel maintenance dose for ≥1 month 5. stable cad patients defined as: subjects with documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization (defined as either a prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery). a minimum of 1 month must have elapsed between a subject's enrolment and any acute event, revascularization procedure or hospitalization for chest pain for that subject. 6. if female, may be enrolled if one of the following 3 criteria are met: 1)had a hysterectomy or tubal ligation at least 6 months prior to signing icf, 2)post-menopausal for at least 1 year, 3)if of childbearing potential, will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy. 7. able and willing to provide written informed consent before entering the study exclusion criteria: 1. subject plans to undergo coronary revascularization at any time during the trial 2. presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (tia); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry) 3. history of refractory ventricular arrhythmias with an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (av) block or bradycardic-related syncope) 4. history or evidence of congestive heart failure (new york heart association class iii or above ≤ 6 months before screening 5. severe hepatic impairment defined as alt\> 2.5 x uln 6. uncontrolled hypertension, or systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 110 mmhg at screening 7. severely impaired renal function (glomerular filtration rate \< 30 ml/minute) or on dialysis 8. concomitant use with parenteral or oral anticoagulants 9. platelet count \<100 x103

Keywords: coronary artery disease anti-platelet medications platelet-aggregation inhibitors