Kornimate/medical-research-clean huggingface dataset:
study of the effect of sr57667b on the progression of symptoms in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the primary objective is to assess the effect of sr57667b at the dose of 4 mg/d on the progression of parkinson symptoms in patients with early pd. the primary outcome will be the time to progression of disability warranting initiation of l-dopa or a dopamine agonist. secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.

multinational, multicenter, randomized, parallel-group, double-blind, phase ii study.

Eligibility criteria:
inclusion criteria: * male or female outpatients. * age \>=35 years at screening.· * diagnosis of parkinson's syndrome, on at least two of the three key parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity. * duration of the disease of less than 3 years since diagnosis· * modified hoehn and yahr stage \<= 2.5. * untreated patients. * generally healthy and ambulatory. * patient has given his informed written consent and is capable of following study procedures. exclusion criteria: * any indication of forms of parkinsonism other than pd. * severe resting tremor. * presence of either dyskinesia, fluctuations, or loss of postural reflexes· * treatment with l-dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (comt ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa. * electroconvulsive therapy (ect). * use of cyp3a4 strong, and moderate inducers or inhibitors. * participation in another clinical trial with an investigational drug within two months prior to randomization. * dementia, uncontrolled depression, psychotic disorder. * history of substance-related disorders including alcohol or other substance use disorders. * females of child bearing potential. * evidence (detected by history, physical examination and/or laboratory/ecg tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. * alterations of laboratory tests or ecg findings of potential clinical significance.

Keywords: parkinson disease levodopa dopamine agonists
high resolution retina imaging

Conditions: Retinitis Pigmentosa; Maculopathy, Age Related; Macular Dystrophy; Macular Edema; Retinal Degeneration; Diabetic Retinopathy; Occlusion Retinal Vein; Hypertension

Summary: to increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera


Eligibility criteria:
inclusion criteria: * persons over 12 years of age, of both sexes, presenting with retinal pathologies. * beneficiaries of the health insurance exclusion criteria: * any abnormality preventing good quality oa imaging on both eyes * major under guardianship or curatorship
risk factors for falls and fall-related injuries associated with mild neurocognitive disorders

Conditions: Old Age; Fall Injury; Neurocognitive Disorders

Summary: this study evaluates the risk for incident falls and fall-related injuries at the onset of neurocognitive disorders in older adults participating in the canadian longitudinal study

falls are frequent events in adults over age 65 (up to 30% each year in canada). they are a major canadian public health concern, which negatively impacts health and quality of life of fallers, and health care system. neurocognitive disorders are strongly associated with falls and fall-related injuries. several clinical characteristics, identified previously as risk factors for falls in the older population and in older adults with neurocognitive disorders are selected in the canadian longitudinal study on aging. the performance criteria of different statistical models will be compared for the association of neurocognitive disorders with falls and fall-related injuries. six linear statistical models (i.e., logistic regression, discriminant analysis, bayes network algorithm, decision tree, random forest, boosted trees), factor mixture models and two different artificial neural network (i.e., multilayer perceptron and the neuroevolution of augmenting topologies).

Eligibility criteria:
inclusion criteria: * people who are 65 years and over * men and women who live in canada exclusion criteria: * people who do not live in canada * a fall resulting from acute medical event and/or an external factor * moderate to severe dementia
outcomes of antipsychotic medication used in the emergency department

Conditions: Agitation,Psychomotor

Summary: to review records of patients treated with antipsychotics (including adasuve, geodon, haldol) in order to evaluate outcomes.

a retrospective chart review will be performed for all patients presenting to the ed with agitation and subsequently given antipsychotic therapy for treatment. identification of patients will be through chart review of patients presenting with agitation. data to be recorded include patient age, gender, medical history, time of presentation, time of treatment, co morbidities, use of restraint, time to disposition and patient outcome. inclusion criteria include all patients over age 18 presenting to the ed with agitation and treated with antipsychotics. no patients will be knowingly excluded from analysis. we will compare resulting outcomes of patients treated for agitation to see if adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.

Eligibility criteria:
inclusion criteria: * all patients given antipsychotic therapy for acute agitation exclusion criteria: * none

Keywords: bipolar 1 disorder schizophrenia
relypsa for ed acute hyperkalemia control and reduction (reduce)

Conditions: Kidney Failure, Chronic

Summary: the investigator hypothesize that a single dose of patiromer will lower serum potassium levels in less than 6hrs. since a dosage of 30g/day for a period of 4 weeks has been studied in at least two multicenter randomized controlled trials, the investigator further hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic patients in the emergency department setting. the fda approved dosage of 25.2g is appropriate for this study because the research staff will enroll patients with moderate (k greater than 6 meq/l) to severe hyperkalemia, and the higher dosage has typically been used in this population for more effective control.

this is an open label pilot study. thirty patients with esrd who qualify for emergent dialysis on the basis of serum potassium greater than 6meq/l will be randomly assigned, using a random number generator in blocks of sixes, to standard-of-care (standard care) or patiromer group. patients in the patiromer group will be given a single dose of 25.2g of patiromer in addition to standard-of-care treatment after randomization. standard-of-care is defined as intervention or care provided by clinical provider according to individual practice pattern or hospital protocol. each group of 15 patients will be observed with telemetry monitoring for 10 hours or till hemodialysis units become available for treatment (whichever comes first). blood draws and electrocardiograms (ecgs) will be performed at enrollment and at 1, 2, 4, 6, 8 and 10hrs thereafter. serum will be analyzed for basic metabolic panel and magnesium. medications, including potassium lowering agents, administered during this period will be documented. 1. informed consent will be obtained. 2. subject will be randomized. 3. a. randomized to standard of care (soc): data will be collected on soc treatment. 3. b. randomized to patiromer group: subjects will receive a single dose of 25.2g of patiromer. soc data will be collected. 4. all subjects will have blood drawn and ecgs (1 12 lead ecg and 1 lead i rhythm strip) done at baseline, 1, 2, 4, 6, 8 and 10 hours. blood will be analyzed for basic metabolic panel and magnesium. 5. crf completion-soc data will be recorded in addition to current medications. 6. after subjects have received hemodialysis or reach the 10 hour study period, whichever comes first, the subject will be completed on the study.

Eligibility criteria:
inclusion criteria: * esrd patients with serum potassium greater than or equal to 6.0 meq/l * emergent dialysis not expected to be available for 6 hours exclusion criteria: * new clinically significant arrhythmia on initial ecg * patiromer is contraindicated * have received sps
casein phosphopeptide--amorphous calcium phosphate on human enamel subjected to in vivo acid attacks

Conditions: Dental Erosion

Summary: 40 specimens were prepared from fresh-extracted human molars and further embedded using the acrylic resin. specimens were randomly divided into 2 groups according to the treatment before in vivo erosion (n=20): cpp-acp for 3 min (cpp-acp group) and deionized water for 3 min (control group). 10 healthy volunteers were recruited and customized maxillary appliance containing 4 specimens (2 from cpp-acp group and 2 from control group) was fabricated for each volunteer. participants were instructed to drink 150 ml cola in 5 min using the gargling method after placing appliances intraorally for 2 h. the in vivo attacks were performed 4 x 5 min with 1-h interval daily over 7 d. the surface microhardness and surface microstructure of the specimens were evaluated at the baseline and after the treatment. the data were statistically analyzed using three-way anova and post hoc tests. data were considered statistically significant at a level of p \<0.05.


Eligibility criteria:
inclusion criteria: * 18 to 60 years of age and in good general health * dental erosion and wear degree is 0-1 exclusion criteria: * systemic diseases or oral mucosal disorders * current orthodontic treatment * pregnancy * known allergies to the experimental drink * had been given drugs which lead to dry oral more regularly within half a year
comparison of pregabalin versus venlafaxine xr and placebo in the treatment of generalized anxiety disorder

Conditions: Anxiety

Summary: the purpose of the study is to compare pregabalin to venlafaxine xr and placebo in the treatment of generalized anxiety disorder.


Eligibility criteria:
inclusion criteria: * male and female outpatients with diagnosis of generalized anxiety disorder. exclusion criteria: * any serious or uncontrolled medical condition. * current diagnosis of depression, dysthymia, obsessive-compulsive disorder.
acupuncture feasibility trial for dyspnea in lung cancer

Conditions: Lung Cancer; Dyspnea

Summary: this is a single arm clinical trial to establish the feasibility of conducting a clinical trial of acupuncture in reducing dyspnea among lung cancer survivors who have completed chemoradiotherapy. twelve subjects with dyspnea will be recruited to this clinical trial. up to 10 sessions of acupuncture will be delivered over the course of 8-10 weeks. the primary outcome will be dyspnea as measured by the english version of the cancer dyspnea scale at the completion of the intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of lung cancer (non small cell and small cell both eligible) * completion of concurrent crt at least 6 months prior to randomization. * dyspnea which worsened after chemoradiotherapy, leading to a ats dyspnea score greater than or equal to 2 (walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on level) * ability to understand written english -willingness to adhere to all study-related procedures * age 18 years old * ecog performance status 1-3 exclusion criteria: * current receipt of therapy for treatment related pneumonitis for 3 weeks. * surgical resection of this lc (lobectomy or pneumonectomy) * another organic cause of dyspnea necessitating treatment (eg pleural effusion appropriate for thoracentesis, rapidly progressive intrathoracic recurrence, symptomatic pulmonary embolus after crt, untreated anemia with hemoglobin8 g/dl) * current bleeding disorder by history * life expectancy of 12 weeks, as assessed by primary oncologist

Keywords: concurrent chemotherapy concurrent radiation
evaluating isradipine for cognitive enhancement in schizophrenia and schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.

the purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder. incomplete treatment response can be common in these disorders. while there are medications that are effective at treating positive symptoms, some other symptoms of the disorders are often left only partially treated (cognitive impairment and negative symptoms). this study will begin to address if the medication isradipine might help to treat some of the cognitive problems associated with schizophrenia and schizoaffective disorder. isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. it is currently approved by the fda for hypertension.

Eligibility criteria:
inclusion criteria: * age 18-60 * dsm-iv schizophrenia or schizoaffective disorder diagnosis * residual phase of illness criteria met at screen and baseline as defined by item scores of equal to or less than 4 on each of the brief psychiatric rating scale (bprs) hallucinatory behavior, unusual thought content, conceptual disorganization items * hamilton rating scale for depression (hrsd) equal to or less than 12 * baseline clinician administered scale for mania (cars-m) score of less than 5 * simpson angus scale (sas) total score equal to or less than 6 * treatment with at least one but no more than two stably-dosed second-generation antipsychotic medication (other than clozapine) for equal to or greater than 2 months and no changes planned over the 4-week study period exclusion criteria: * history of cns trauma, neurological disorder, adhd, mental retardation, learning disability, or other non-schizophrenic cause of cognitive impairment * dsm-iv diagnosis of substance abuse/dependence within 3 months * pregnant women or women of childbearing age who are not using a medically accepted means of contraception * women who are breastfeeding * active, unstable medical problem that may interfere with cognition * current treatment for hypertension * uncontrolled hypertension * any drug known to interact with isradipine * history of gi strictures * history of heart disease * abnormal lab or ecg at screen * significant suicidal ideation at baseline (hrsd item 3\>2) * ect treatment within 12 months

Keywords: cognition schizophrenia schizoaffective disorder
animal-assisted therapy in pediatric autism spectrum disorders

Conditions: Pediatric Autism; Developmental Delay (Disorder); Behavioral Concerns

Summary: the purpose of this research is to evaluate the effect of animal-assisted therapy (aat) on prosocial behavior and emotional regulation in children with developmental delay, behavioral concerns, or autism spectrum disorder. service dog use in the pediatric population who have these concerns is increasing and more studies are indicated to determine best practice for incorporating canines into traditional therapy sessions to enhance therapeutic outcomes. the hypothesis for this study is that inclusion of the canine will enhance therapy sessions and produce a lasting effect on prosocial behavior and emotional regulation after aat sessions have concluded.

investigators are determining if a child's verbality affects interaction with the canine or changes the effect of animal-assisted therapy on prosocial behavior and emotional regulation in autistic children.

Eligibility criteria:
inclusion criteria: * referred to the program for asd diagnostic evaluation based on their development and behavior. could have asd, developmental delay, or behavioral concerns. exclusion criteria: * afraid or allergic to canines

Keywords: animal-assisted therapy canine-assisted therapy pediatric autism spectrum disorder verbality prosocial behavior emotional regulation
ultrasonic perfusion imaging in post-mastectomy irradiated patients

Conditions: Breast Reconstruction; Radiation Dermatitis; Radiation Fibrosis; Fat Grafting

Summary: the purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).


Eligibility criteria:
inclusion criteria: * breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy * have undergone mastectomy exclusion criteria: * patients who are unwilling to participate
to evaluate the efficacy and safety of hsk16149 capsule in chinese patients with herpetic neuralgia

Conditions: Herpetic Neuralgia

Summary: investigate the efficacy and safety of hsk16149 capsules in chinese herpetic neuralgia following 4 weeks treatment in comparison to pregabalin.


Eligibility criteria:
inclusion criteria: * signed informed consent; * males or females aged 18 years and older ; * patients must have herpetic neuralgia; * at screening, pain scale (vas) of ≥ 40 mm; * at screening, pain scale (nrs) of ≥ 4. exclusion criteria: * patients have pain present for more than 1 months after the healing of the herpes zoster skin rash; * ast/alt \> 2 × upper limit of normal (uln), or tbil≥1.5 × uln; * serum creatine \> 176μmol/l; * any active infections at screening; * history of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds; * participated in another clinical study within 30 days prior to screening; * pregnant or breastfeeding at screening ; * other conditions unlikely to participate in this trial.
the comparison of tace-lenvatinib with tace-lenvatinib-ablation for intermediate recurrent hepatocellular carcinoma

Conditions: Recurrent Hepatocellular Carcinoma; Lenvatinib; Local Therapy; Ablation; Systemic Therapy

Summary: studies have shown that combination therapy of tace with lenvatinib could achieve better survival outcomes than tace alone for hepatocellular carcinoma (hcc) at bclc b stage. however, whether patients could benefit from the ablation for intermediate recurrent hcc (rhcc) is still need high quality clinical evidence. this study is to evaluate the efficacy of ablation combined with tace and lenvatinib for the intermediate-stage rhcc.

the evidence of ablation combined transarterial chemoembolisation (tace) and lenvatinib for intermediate-stage recurrent hepatocellular carcinoma (rhcc) is limited. patient responses to this treatment vary because of the heterogeneous nature of rhcc. thus, it is important to identify patients who are most likely to benefit from this three regimes therapy. the aim of this study is to comparison of tace-lenvatinib with tace-lenvatinib-ablation for intermediate rhcc.

Eligibility criteria:
inclusion criteria: 1. 18-75 years; 2. rhcc diagnosed by imaging; 3. intermediate-stage rhcc (two to three lesions which at least one was \>3 cm in size or more than three tumors); 4. the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm; 5. absence of extrahepatic metastasis or macrovascular invasion; 6. child-pugh class a or b; 7. tace as initial treatment after tumor recurrence and showed no tumor progression after tace. 8. life expectance \>3 months; exclusion criteria: 1. under 18 years or over 75 years of age; 2. primary intermediate-stage hcc; 3. rhcc with more than six tumors, or single rhcc (5) rhcc \>5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;

Keywords: lenvatinb hepatocellular carcinoma microwave ablation radiofrequency ablation cryoablation
a comparison of duloxetine hydrochloride, marketed comparator, and placebo in the treatment of generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: this study will examine duloxetine compared with placebo and an active comparator in the treatment of generalized anxiety disorder.


Eligibility criteria:
inclusion criteria: * male and female outpatients at least 18 years of age, presenting with generalized anxiety disorder (gad) based on the disease diagnostic criteria. must suffer from gad and not from an adjustment disorder or anxiety disorder not otherwise specified. the symptoms of gad should not be situational in nature. exclusion criteria: * any current and primary dsm-iv axis i diagnosis other than gad, including: * patients diagnosed with major depressive disorder within the past 6 months; or * patients diagnosed with panic disorder, or post-traumatic stress disorder within the past year; or * patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetimes. * the presence of an axis ii disorder or history of antisocial behavior, which, in the judgement of the investigator, would interfere with compliance with the study protocol.