Kornimate/medical-research-clean huggingface dataset:
effects of an adaptogenic extract on electrical activity of the brain in elderly subjects with cognitive impairment

Conditions: Cognitive Impairment, Mild

Summary: a randomized, double-blind, placebo-controlled, two arm cross-over study to determine whether a specific combination of andrographis paniculata and withania somnifera can be regarded as a safe and effective treatment for cognitive deficits.


Eligibility criteria:
inclusion criteria: * male and female volunteers suffering from cognitive deficits. * questionnaire-demtect. "demtect" (for pre-selection of subjects) - score values 8-12 are regarded as conclusive. * age between 60 and 75 years (both included). * subjects should be right-handed. * subject must be capable of giving informed consent. * acceptance of written consent to participate in the study after instruction in written and oral form (informed consent). exclusion criteria: * subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded. * acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination. * clinically relevant allergic symptoms. * detection of alcohol at the time of initial examination (day sc) or on study day a (positive alcohol test) or by case history. * consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history. * consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic). * presence of a rare, genetic disease such as fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency (anamnestic). * consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day). * detection of alcohol at the time of initial examination as well as on day a, b, c and d (alcohol test). * smoking in the study center on study days a, b, c and d. * result of the demtect questionnaire score \ 12. * participation in another clinical trial within the last 60 days. * bad compliance. * cancellation of informed consent.

Keywords: electroencephalography andrographis ashwagandha
prophylaxis for patients at risk to eliminate post-operative atrial fibrillation

Conditions: Atrial Fibrillation

Summary: after surgery on the lungs or esophagus, 12-46% of patients experience an irregular heart rhythm called atrial fibrillation. although usually transient, post-operative atrial fibrillation is associated with longer stay in hospital, greater complications, and increased risk of death. several medications have been shown to be effective at reducing the risk of atrial fibrillation after their surgery with the greatest effectiveness and safety demonstrated with amiodarone. nevertheless, amiodarone has potential side effects, and so it is only recommended in patients with increased risk of developing atrial fibrillation. a tool has been developed and validated to identify high-risk patients but no clinical trial has looked at the effectiveness of administering amiodarone in this high-risk group. this study aims to assess the feasibility and safety of conducting a clinical trial where patients are randomized to receive amiodarone or placebo. this is critical before considering a full-scale trial to assess the effectiveness of amiodarone in reducing atrial fibrillation after surgery on the lungs or esophagus.


Eligibility criteria:
inclusion criteria: * aged 18 years or greater * undergoing major non-cardiac pulmonary or esophageal surgery (including esophagectomy, pulmonary wedge resection, lobar resection, pneumonectomy, or gastrectomy) * poaf prediction score greater than or equal to 4 exclusion criteria: * aged less than 18 years * history of atrial arrhythmia (paroxysmal or persistent), or wolf-parkinson-white syndrome (wpw), or 2nd or 3rd degree heart block without a pacemaker * current antiarrythmic therapy (including amiodarone, propafenone, sotalol, flecainide, and dronedarone) * previous severe adverse reaction or contraindication to amiodarone (including pre-existing interstitial lung disease, or history of hepatotoxicity from amiodarone) * qtc interval longer than 450ms * serum alanine transaminase or aspartate transaminase over 3 times the upper limit of normal, or child-pugh class c * allergy to amiodarone
integrated health care for patients with frailty and heart failure

Conditions: Heart Failure; Frailty; Frail Elderly Syndrome; Symptom, Behavioral; Utilization, Health Care; Quality of Life

Summary: frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. the integrrated health care for patients with severe frailty and heart failure (intercare-hf) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. these teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. an open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical frailty score (csf) \>=5. a control-group (n=40) matched on age an clinical frailty scale score will be included. the overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.


Eligibility criteria:
inclusion criteria: * age \>18 years old * admitted to hospital with heart failure with symptoms of decompensation including dyspnoea in nyha class ≥ ii, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated nt-probnp concentrations at screening * clinical frailty score ≥5 * signed informed consent by patient and closest relatives\* and expected cooperation according to the protocol, ich/gcp and national/local regulations * although we preferably will recruit both patients and their relatives, participation from the next-of-kin will not be an exclusion criterium. exclusion criteria: * inability to comply with all study requirements, due to major co-morbidities or psychosocial issues, or a history of noncompliance, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures. * not being able to understand norwegian. * permanent nursing home and estimated to stay alive for less than 6 months
open label extension study to evaluate the safety and tolerability of oral fampridine-sustained release (sr) in canadian participants with multiple sclerosis who participated in acorda extension trials.

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to evaluate the long-term safety and tolerability of biib041 (fampridine-sustained release (sr)) treatment in canadian participants with multiple sclerosis (ms) who previously participated in the registrational and extension studies conducted by acorda. those studies include nct00654927 (ms-f202ext), nct00648908 (ms-f203ext) and nct00649792 (ms-f204ext).


Eligibility criteria:
key inclusion criteria : 1. previously enrolled in 1 of the 3 acorda-sponsored studies (ms-f202ext, ms-f203ext, and ms-f204ext) and continuing to receive fampridine-sr. 2. willing to comply with the required scheduling and assessments of the protocol. 3. female subjects of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test, and must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment. key exclusion criteria: 1. discontinued prematurely from the preceding study ((ms-f202ext, ms-f203ext, or ms-f204ext). 2. any prior history of seizure, epilepsy, or other convulsive disorder. 3. any clinically significant abnormal laboratory values. 4. new history of moderate or severe renal impairment. 5. new history of angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the investigator. 6. any significant change in overall health that would preclude subject's participation in the study, in the opinion of the investigator. 7. known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-sr tablet 8. received an investigational drug, except fampridine-sr under the preceding study (ms-f202ext, ms-f203ext, or ms-f204ext), within the last 30 days, or the subject is scheduled to enroll in an investigational drug at any time during the study. 9. a history of drug or alcohol abuse within the past year. 10. treatment with other forms of fampridine or 4-ap (e.g., compounded formulation of 4-ap) or 3,4-diaminopyridine (3,4-dap). note: other protocol defined inclusion/exclusion criteria may apply.
a clincal study of max-40279-01 in patients with advanced colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.

this study is a study of max-40279-01 in patients with advanced colorectal cancer. this study include two parts, the part 1 will assess the safety and efficacy of the preset two dose level of max-40279-01, and recommend a dose level of max-40279-01 for stage 2. the part 2 is a randomized, controlled study ,and designed to compare the efficacy and safety of max-40279-01 to regorafenib or best support care(bsc) in pretreated advanced colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. males and/or females over age 18 2. histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma. 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. expected survival \>3 months. 5. previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological vegf inhibitor, and, if ras wild-type, an egfr inhibitor. patients with msi-h/mmr-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. in addition, patients with braf mutant tumors must also have received a braf inhibitor, if available and approved. 6. signed informed consent form. exclusion criteria: 1. known uncontrolled or symptomatic central nervous system metastatic disease. 2. adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade \>1 (national cancer institute common terminology criteria \[nci ctcae\] v.3.0) at the time of randomization. 3. inadequate organ or bone marrow function. 4. medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product. 5. pregnant or breast-feeding woman. 6. known allergies, hypersensitivity, or intolerance to max-40279-01 the excipients of these treatments the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: metastatic colorectal cancer pretreated
the effect of dash diet on the cardiometabolic risks and hepatic function among type 2 diabetic patients

Conditions: Type 2 Diabetic Patients

Summary: the investigators are not aware of any study regarding the effect of dash eating pattern on different cardiovascular risks among type 2 diabetic patients. the investigators assumed that dash eating pattern could reduce the cardio-metabolic risks and improve the hepatic function among type 2 diabetes.


Eligibility criteria:
inclusion criteria: * having type 2 diabetes exclusion criteria: * having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy

Keywords: dietary approach to stop hypertension weight coagulation dash eating pattern.
cbt for anxiety disorder in children with co-morbid asd

Conditions: Randomized Treatment Study

Summary: children with autism spectrum disorder (asd) often have other difficulties as a result of the disorder. up to half of the children with asd are thought to suffer with anxiety in a way that interferes with their wellbeing and every day functioning. in this project the investigators will study the effect of the group program the cool kids anxiety program: autism spectrum disorder adaptation (cool kids asd) - an anxiety treatment program specific developed for children with asd. the investigators expect a decrease in the overall anxiety level together with an increase in the ability of handling anxiety.

the primary objective is to investigate the effect of a manualised cognitive behavioural therapy (cbt) programme the cool kids anxiety program: autism spectrum disorder adaptation (cool kids asd) for anxiety disorder adapted to children with autism spectrum disorder (asd) in a waitlist controlled design. the investigators will investigate treatment effects on anxiety diagnosis and anxiety symptoms. further, the investigators will investigate outcomes related to general functioning, co-morbid psychiatric disorders (obsessive-compulsive disorder (ocd), hyperkinetic disorder and depression) and level of asd symptoms (social and communicative skills).

Eligibility criteria:
inclusion criteria: * asd * anxiety (not necessary diagnosed) exclusion criteria: * iq under 70 * not meeting diagnostic criteria for primary anxiety diagnosis on adis * active psychosis * untreated adhd * families not able to follow program
using digital technology versus conventional relining procedure for correction of loose maxillary complete denture

Conditions: Dental Diseases; Dental Trauma; Bone Remodeling Disorder

Summary: this study aimed to evaluate the use of computer added designning / computer added manufacturing (cad/ cam ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues.

twelve edentulous patients suffering from loose maxillary complete dentures were selected, the dentures were adjusted for taking the relining impressions, the impressions were scanned and the stl files were used for milling new dentures (group a), then the relining impression went through the conventional laboratory steps of processing (group b). both groups were evaluated regarding patient's satisfaction by a specially designed questionnaire, retention values were measured by a digital force gauge at denture insertion appointment and two weeks later, finally dentures adaptation to the oral tissues were compared using geomagic software.

Eligibility criteria:
inclusion criteria: * patients with completely edentulous maxillary and mandibular ridges with a normal skeletal relationship (class i) have a moderate-to-highly well-rounded maxillary edentulous ridge without severe undercuts to minimize the effect of undercuts on retention values. * patients' main complaint was a loose or "falling" denture, but with proper esthetics, centric relation and the correct vertical dimension of occlusion (vdo). exclusion criteria: * patients with significant skeletal problems (class ii or iii) or who went through severe osseous surgery or any hereditary or acquired osseous abnormality find it challenging to place the denture properly on the supporting ridge. * if the patient suffers from xerostomia, excessive flabby ridges, any pathology of the oral mucosa, or any inflammatory changes, candidiasis, hyperplasia, neurological disorders and malignancies * if the denture creates a major speech problem, poor esthetics, or an unsatisfactory jaw relationship.

Keywords: relining upper denture digital denture denture retention denture adaptation. cad/cam milling
acupuncture treatment for improving alzheimer's dementia

Conditions: Cognitive Deficits; Alzheimer Disease

Summary: evaluate cognitive improvement pre amd post acupuncture treatment in patients with probable alzheimer's dementia as measured by moca score and also per form a( measure of patient's personal information). also caregiver input.

patient's with diagnosis of probable mild to moderate ad will be enrolled in this study. patient will undergo neurological examination including moca. examiner will also fill out form a at the time of initial evaluation. patient will then undergo series of acupuncture treatments 2 per week for 6 weeks(12 acupuncture treatment). at end of this intervention patients will be reassessed using same testing(moca and form a) data collected will be assessed via statistical analysis to see if there is any statistically significant improvement. acupuncture points used in this trial will stay the same for all subjects and throughout the course. the points will be si shen chong, st36, 37, lv 2,3,6, gb 34, 39, xia san huang, li 11, li 4.

Eligibility criteria:
inclusion criteria: * mild to moderate ad exclusion criteria: * severe ad

Keywords: acupunture
short course radical cure of p. vivax malaria in nepal

Conditions: Malaria; Malaria, Vivax; Malaria,Falciparum

Summary: this study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course pq treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (g6pd) normal patients with p.vivax and p falciparum to reduce the risk of subsequent p.vivax episodes.

plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. recurrent infections can be associated with a febrile illness, cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite. in co-endemic areas, there is a very high risk (up to 50%) of patients representing with p.vivax malaria following treatment of p falciparum. hence, in co-endemic regions there is a strong rationale for eradicating p.vivax hypnozoites from the liver in patients presenting with uncomplicated p. falciparum infections. the recently completed multicentre improv study compared the efficacy of a 7 day pq regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). the 7 day pq regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing p.vivax recurrence than the control. this study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course pq treatment (3.5mg/kg total dose given over 7 days) in g6pd normal patients with p.vivax and p falciparum to reduce the risk of subsequent p.vivax episodes.

Eligibility criteria:
inclusion criteria: * p. falciparum and/or vivax infection * fever (axillary temperature ≥37.5⁰c) or history of fever in preceding 48 hours * age \>1 years * g6pd normal by rapid diagnostic test (rdt) as per national guidelines * written informed consent * able to comply with all study procedures and timelines exclusion criteria: * general danger signs or symptoms of severe malaria * anaemia, defined as hb \<8g/dl * pregnant women as determined by urine β-hcg pregnancy test * breast feeding women * known hypersensitivity to any of the drugs given * regular use of drugs with haemolytic potential * blood transfusion within the last 4 months
improving weight loss maintenance through alternative schedules of treatment

Conditions: Obesity

Summary: this project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.


Eligibility criteria:
inclusion criteria: * at least 21 years-old * body mass index (bmi) = 28.0 - 45.0 kg/m2 * willing to provide informed consent and accept randomization exclusion criteria: * bmi \>45 kg/m2 * illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported hiv); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity. * conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read english at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.

Keywords: weight loss