Kornimate/medical-research-clean huggingface dataset:
evaluation of the best treatment in terms of quality of life for patients having a brain metastasis

Conditions: Quality of Life; Brain Metastases

Summary: main goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion. second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol

a patient with a brain metastasis may have the choice between surgery and focal radiosurgery of the surgical site and only hypofractionned radiosurgery on the lesion. no previous study has focused on quality of life regarding these two treatments options.

Eligibility criteria:
inclusion criteria: * eligible for both treatments options oms status \<3 primary cancer with no evolution brain metastasis \< 3cm ou giving symtoms patient with informed consent patient affilated to french social security exclusion criteria: * oms \> 3 more than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery

Keywords: brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery
nad supplementation to prevent progressive neurological disease in ataxia telangiectasia

Conditions: Ataxia Telangiectasia

Summary: the study investigates the effect of dietary supplementation of nicotinamide ribonucleoside (nr) in children with ataxia telangiectasia (at), with main focus on neurological symptoms.

ataxia telangiectasia (at) is a genetic disease, where patients are born with mutations in the ataxia- telangiectasia mutated (atm) gene. the gene codes for the atm kinase, which is required for repair of dna double-stranded breaks and dna damage response signalling. there is no treatment available for the neurological manifestations of at. the study investigates the effects of nr (300 mg/day) during 2 years.

Eligibility criteria:
inclusion criteria: * clinically and molecular verified classical a-t disease exclusion criteria: * less than 2 years of age * participation in other on-going study * pregnancy * liver failure * other severe medical conditions considered to set patient at risk

Keywords: ataxia telangiectasia nicotinamide ribonucleoside louis-bar syndrome
hybrid persistent atrial fibrillation ablation in heart failure

Conditions: Atrial Fibrillation; Heart Failure

Summary: pilot, randomized, unblinded, feasibility and proof of concept clinical trial randomizing 50 patients in a 1:1 ratio to hybrid ablation or catheter ablation

to determine if a hybrid convergent ablation procedure with atrial appendage clip is superior to catheter ablation in the management of heart failure patients with persistent and longstanding persistent af. hypothesis: hybrid convergent ablation procedure with atrial appendage clip is superior to catheter ablation in the management of heart failure patients with persistent and longstanding persistent af in terms of mortality and worsening heart failure, af rhythm control and improvement in lvef, quality of life, and 6-minute walk distance.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following criteria: * be \>18 years of age * provide signed written informed consent * persistent or longstanding persistent af * heart failure with lv systolic dysfunction (defined as ef\ 30% vs \<30% to ensure balanced enrollment) * moderate or severe left atrial enlargement (left atrial diameter\>45 mm and not exceeding 60 mm; or indexed la volume \>40 ml/m2 and not exceeding 110 ml/ m2) * ability to complete 6 minute walk test * negative pregnancy test for female patients of child bearing potential. * be eligible for ablation and anti-arrhythmic drugs exclusion criteria: subjects must meet none of the criteria: * very severe left atrial enlargement with diameter \>60 mm or indexed la volume \>110 ml/m2 * stroke or myocardial infarction within the preceding 3 months * reversible causes of af such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma * presently with valvular heart disease requiring surgical intervention * presently with coronary artery disease requiring surgical or percutaneous intervention * early post-operative af (within three months of surgery) * history of avn ablation * liver failure * renal failure requiring dialysis * social factors that would preclude follow up or make compliance difficult. * contraindication to the use of appropriate anticoagulation therapy * enrollment in another investigational drug or device study. * patients with severe pulmonary disease * documented intra-atrial thrombus, tumor, or another structural abnormality which precludes ablation
comparative study of recovery characteristics between remimazolam anesthesia with flumazenil and desflurane anesthesia for closed reduction of nasal bone fracture

Conditions: Anesthesia

Summary: the goal of this prospective, randomized study is to compare recovery characteristics between remimazolam anesthesia with flumazenil and desflurane anesthesia in patients undergoing closed reduction of nasal bone fracture. the main question this study aims to answer is: * is there statistically significant difference in time from discontinuation of the anesthetic agent up to patient's response to verbal command between these two groups? participants will receive either remimazolam or desflurane for the maintenance of general anesthesia. when the surgery ends, the anesthetic agent will be stopped. for remimazolam group, flumazenil will be administered as an antagonist of remimazolam.


Eligibility criteria:
inclusion criteria: * age between 19 and 75 years * american society of anesthesiologists physical status (asa ps) of i-ii * patients undergoing elective closed reduction of nasal bone fracture exclusion criteria: * patient who cannot understand the process of this study * cognitive, visual or hearing impairment * chronic use of antipsychotic medications or medications for sleeping problem * use of benzodiazepine * patient with kidney or liver disease * body mass index (bmi) \>30 kg/m\^2
eu: a multicenter compassionate use program of daclatasvir (bms-790052) in combination with sofosbuvir with or without ribavirin for the treatment of subjects with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the primary objective of this program is to provide daclatasvir in combination with sofosbuvir with or without ribavirin to subjects with chronic hepatitis c who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.


Eligibility criteria:
this program is conducted in the eu (germany, austria, norway, the netherlands, sweden and united kingdom only) for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * patients chronically infected with hepatitis c * patients at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options exclusion criteria: * patients who are \<18 years old * patients who have contraindications to either daclatasvir (dcv) or sofosbuvir (sof) * patients who are pregnant * creatinine clearance (crcl) ≤ 30 ml/min (as estimated by cockcroft and gault formula) * patients who are pregnant or women of child bearing potential who are not using required contraception
observational study in bariatric surgery

Conditions: Obesity; Neostigmine; Residual Neuromuscular Blockade

Summary: obesity in the world represents a growing share of the general population. at hospital, the management of these patients could be problematic especially when calculating the drug dosage. according to the french guidelines, neostigmine, a cholinesterase inhibitor, should be used to reverse a residual neuromuscular blockade at a dose of 0.4 mg/kg of total body weight in non-obese patients. in morbidly-obese patients, with the modification of the fat/lean mass ratio, the optimal dose of neostigmine is non-consensual. to calculate the dose of neostigmine, some anesthesiologists use the total body weight, others use the ideal body weight and others use the adjusted body weight. due to this practice variability, it may be useful to observe the mean time to recovery of neuromuscular blockade and side effects after pharmacological reversal according to the dosage of neostigmine.


Eligibility criteria:
inclusion criteria\*: * adult obese patients (≥ 18 years and bmi ≥ 35 kg/m²), both sexes * any elective bariatric surgery * neuromuscular blockade with rocuronium * maintenance of anesthesia with a halogenated agent * free patient, without guardianship or subordination * patients with a social security coverage * no opposition given by the patient after clear and fair information exclusion criteria\*: * patients with hypersensitivity to the active substance or to other derivatives, or to any of the excipients of neostigmine, * emergency surgery, * severe renal and / or hepatic insufficiency, * persons benefiting from enhanced protection, namely pregnant women, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally sick people in emergency situation.
expanded access to abbv-787

Conditions: Acute Myeloid Leukemia

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to abbv-787 prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: - the participant must not be eligible for an abbv-787 clinical trial.

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme
a safety and effectiveness study of intraspinal gabapentin (mdt2004) for the treatment of chronic pain

Conditions: Chronic Intractable Pain

Summary: the purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.


Eligibility criteria:
inclusion criteria: * chronic pain below the neck present for a minimum of one year. * diagnosis of at least one of the following: * back pain with or without leg pain, * post-herpetic neuralgia, * complex regional pain syndrome (crps) 1 or 2, * diabetic neuropathy, * or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.
(∆pi) to predict post-spinal anesthesia hypotension

Conditions: Spinal Anesthesia Hypotension

Summary: we aimed to evaluate the change in femoral artery pulsatility index as a predictor to post-spinal anesthesia hypotension

after spinal anesthesia, hypotension is a common effect that occurs in between 15 and 30% of patients therefore it is essential to prevent such effect. number of variables were utilized for estimating post spinal hypotension, such as assessing heart rate variability, perfusion index, inferior vena cava collapsibility index; however, the majority of these indices needs advanced equipment. investigator of current research decided to study the role of ultrasound derived index namely pulsatility index to predict post spinal anesthesia hypotension.

Eligibility criteria:
inclusion criteria: * adult patient undergoing infra-umbilical surgeries. exclusion criteria: * coagulopathy peripheral vascular disease contraindication to spinal anesthesia
vitamin d improves depression in liver patients

Conditions: Depression; Chronic Liver Disease

Summary: this study evaluates the efficacy of vitamin d replacement therapy in reducing depressive symptoms in patients with chronic liver disease and vitamin d deficiency. patients with normal vitamin d levels will be monitored as controls, and they will not receive any intervention.

patients with chronic liver diseases regularly suffer from vitamin d deficiency and depression. a recent meta-analysis reported an inverse correlation between depression and vitamin d levels. indeed, vitamin d receptor is present and genomic and nongenomic vitamin d receptor-mediated signalling has been described in brain. this intervention study investigates whether vitamin d therapy ameliorates depressive symptoms in chronic liver disease patients. the investigators hypothesise that depressive symptoms will improve upon vitamin d replacement therapy.

Eligibility criteria:
inclusion criteria: * men and women * over 18 years of age * chronic liver disease exclusion criteria: * severe hepatic encephalopathy (cff \<35 hz) * interferon treatment * hypercalcaemia (\>2.7 mmol/l) or hypercalciuria (\>8.0 mmol/d) with or without hyperparathyroidism (\>65.0 pg/ml) * history of calcium-containing kidney stones * allergy or hypersensitivity to any of the supplement ingredients: peanuts, soy, gelatin * sarcoidosis * stage iv or v chronic kidney disease * pregnancy

Keywords: mood vitamin d deficiency adjuvant treatment
a safety and efficacy study of the dynalink®-e everolimus eluting peripheral stent system

Conditions: Atherosclerosis; Peripheral Vascular Disease

Summary: the purpose of this first-in-man study is to evaluate the safety and performance of the dynalink®-e everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal lesions. abbott vascular is ceasing data analysis of the strides clinical trial after 2 years. the decision to discontinue the study is not related to any safety concern. the rationale for this proposal is based on the following considerations: the performance of dynalink-e from strides shows no device- or procedure-related deaths and no stent fractures, and the rate of additional revascularizations has been stable since approximately 14 months after the procedure. evaluations of the bare metal nitinol dynalink and absolute stents in the clinical literature show low rates of death, reintervention and stent fracture, which are consistent with strides and demonstrate the safety of the nitinol stent platform of the dynalink-e. long-term animal studies show no concerns with the drug or polymer coating of dynalink-e - everolimus tissue concentration drops below the quantifiable limit by approximately 17 months after implant, and vascular response to the coating is normal with widely patent lumens and struts incorporated into vessel tissue. the safety and performance of the dynalink-e has been substantiated by its clinical and pre-clinical data, and by the clinical data of similar products. given the demonstrated mechanical integrity of the stent along with the evidence of a healthy long-term vascular response, there is a reasonable expectation of continued low event rates.

a prospective, non-randomized, single-arm, multi-center, clinical study to evaluate the safety and performance of the dynalink®-e, everolimus eluting peripheral stent system for the treatment of atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal artery lesions.

Eligibility criteria:
inclusion criteria: * rutherford becker category 2-5 * single de novo or restenotic lesion in the superficial femoral or proximal popliteal artery * disease segment length 30-170 mm * \>50% diameter stenosis or total occlusion * target reference vessel diameter 4.3-7.3 mm exclusion criteria: * target lesion previously treated with stent or surgery * rutherford becker category 0, 1, or 6 * immunosuppressive disorder or currently receiving immunosuppressive agents * serum creatinine \>2.5 mg/dl
a study on the angioarchitecture of hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: hepatocellular carcinoma (hcc) is one of the commonest solid malignancies in hong kong as well as globally. transarterial therapy has been playing an important role in the treatment algorithm for patients with hcc. the primary purpose of transarterial therapy is eradication of the viability of the targeted tumors. the treatment outcomes have been variable among the various treatments, in general, there is still much room for improvement, especially for large size tumors. from the studies on transarterial chemoembolization (tace), it is known that the treatment outcome is affected by the nature and the formulation of therapeutic agents that are delivered, which is related to the angioarchitecture of the tumor. knowledge on the angioarchitecture of hcc is essential for the understanding of the requirements for effective transarterial treatment of hcc. this prospective study is aimed to study the angioarchitecture of hcc.

embolization is performed within 2 weeks before the scheduled date of partial hepatectomy. the purpose of the timing is two folded, it allows observation of the embolization effect to be differentiated among the various embolic agents, it also allows time for the patient and the liver to recover from the embolization. the patient then receives partial hepatectomy within 2 weeks unless the result of liver function tests shows contraindication to surgery, in which case the liver function test is further evaluated on a weekly basis until the findings are acceptable, and surgery is scheduled accordingly.

Eligibility criteria:
inclusion criteria: 1. age above 18 years 2. hcc suitable for partial hepatectomy 3. child-pugh a or b cirrhosis 4. eastern cooperative oncology group performance score 0 or 1 5. barcelona clinic liver cancer (bclc) staging a or b 6. hcc diagnosed by typical enhancement patterns on cross sectional imaging or histology 7. massive expansive tumor morphology with measurable lesion on ct (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions) exclusion criteria: 1. previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy), 2. evidence of tumor invasion of portal vein or hepatic vein 3. history of acute tumor rupture presenting with hemo-peritoneum 4. infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules) 5. serum creatinine level \> 150umol/l
art therapy in acute schizophrenia

Conditions: Schizophrenia

Summary: randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual. \*main hypothesis: art therapy has no impact on clinical symptoms and the course of remission compared to tau. \*exploratory hypotheses: art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to tau.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia according to dsm-iv-tr * age 18-64 yrs * sufficient german language competency * written informed consent exclusion criteria: * axis-i mental disorders other than schizophrenia * comorbid antisocial personality disorder, relevant substance abuse, * relevant severe somatic disease * acute suicidal tendencies or aggression * incapability to tolerate group settings
metabolic consequences of cpt-1 deficiency

Conditions: Carnitine Palmitoyl Transferase Type 1A (CPT1A) Deficiency

Summary: the purpose of this study is to learn more about how long children with cpt-1 deficiency can wait between meals without developing low blood sugar or symptoms of low blood sugar. the other purpose is to learn more about how much fat is stored in the liver of a child with cpt-1 deficiency.

with the advent of enhanced screening (via tandem mass spectroscopy, ms/ms), the northwest regional newborn screening program (nwrnsp) has identified a high incidence of carnitine palmitoyl transferase type 1a (cpt1a) deficiency in alaska native infants. since october of 2003 approximately 80 alaska native infants have been identified with this condition; previously only 30 published cases were known worldwide. all of the infants are homozygous for a c.1436c-t sequence variant in the cpt1a gene, which results in the substitution of a leucine for proline at amino acid position 479 (p479l), and an approximately 80% reduction of cpt1a activity (non-classic cpt1a deficiency) (7). the clinical implications of this very restricted level of enzyme activity are not known. however, patients with more severe reductions of cpt1a activity (as the result of other mutations) are known to be at high risk for hypoketotic hypoglycemia, liver dysfunction, and sudden unexplained death (1). hepatomegaly with micro- and macro-vesicular steatosis is also common (16). currently the treatment of alaska native infants and children with cpt1a deficiency is based on data from patients with more severe forms of cpt1a deficiency and other fatty acid oxidation (fao) disorders. our ultimate goal is to establish evidence-based guidelines for treatment of the form of cpt1a deficiency prevalent in the alaska native population. this pilot study addresses two specific questions and will provide the first glimpse of the physiologic effects of homozygosity for the c.1436c-t sequence variant in the cpt1a gene. these data will aid in the development of strategies for clinical management that can be evaluated in future prospective studies, and provide preliminary data required for applications for nih funding for more in-depth characterization of the clinical consequences of this condition.

Eligibility criteria:
inclusion criteria: * cpt-1 deficiency * homozygous for the c.1436c-t sequence variant * greater than 6 kg * otherwise healthy * siblings must be free of cpt-1 deficiency but heterozygous for c.1436c-t sequence variant and otherwise healthy exclusion criteria: * liver dysfunction * diabetes * renal disease * metal plate in body

Keywords: cpt1a steatosis deficiency metabolic response fasting