Kornimate/medical-research-clean huggingface dataset:
apol1 genotyping cta clinical performance study

Conditions: APOL1-mediated Kidney Disease

Summary: clinical performance study sp2024001, is a prospective, interventional study to assess the clinical performance of the apol1 genotyping clinical trial assay (cta) in the intended use population and environment. the study will use the apol1 genotyping cta to test deoxyribonucleic acid (dna) extracted from blood specimens to identify individuals who are homozygous or compound heterozygous for apolipoprotein l1 (apol1) high-risk genotypes (g1 and g2).the individuals who are identified as being homozygous or compound heterozygous for the apol1 high-risk genotypes are candidates for enrolment onto an pharmaceutical company-sponsored, phase 2b clinical trial which is investigating the safety and efficacy of a synthetic antisense oligonucleotide (aso) for the treatment of apol1-mediated kidney disease (amkd).


Eligibility criteria:
inclusion criteria: * study participants must be identified as a potential candidate for the pharmaceutical company- sponsored clinical trial by their physician based on the clinical trial inclusion criteria. * study participant has agreed to and signed the clinical trial informed consent form (inclusive of risks related to the apol1 genotyping cta). * the study participant's specimen must be distributed to the device test site accompanied by a complete test request form signed by the appropriate clinical trial site personnel. * all participant specimens must meet predetermined specifications (e.g., undamaged, appropriate volume, appropriate specimen type, appropriate disease indication) for acceptance for testing by the device test site in accordance with established procedures. exclusion criteria: * study participants will be excluded as a potential candidate for the pharmaceutical company -sponsored clinical trial by their physician based on the clinical trial exclusion criteria as assessed at screening visit 1. * the study participant has not agreed to and signed the (clinical trial) informed consent form. * the study participant's specimen is distributed to the device test site without a complete test request form. * the study participant's specimen did not meet predetermined specifications for acceptance for testing by the device test site in accordance with established procedures.
effects of pain neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome

Conditions: Wrist Injuries; Carpal Tunnel Syndrome

Summary: the aim of this study is to check the effects of pain neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.

in 2017 a stud assessed effectiveness of standard conservative protocol of cts and nerve mobilization along with and without pne and documented that standard conservative care seems to be the most appropriate option for pain relief, although neuroscience education might be a complementary option to accelerate recovery of function. more high-quality research is still necessary to determine its effectiveness and the subgroups of patients who may respond better to this treatment. in 2019 a study was done to assess the effect of pne and standard rehabilitation exercises on the 41 patients of cts. the experimenting group was given one session of pne plus exercises and the control group was given exercise therapy only. patients were randomly allocated and double blinded. the analysis of study showed better results with experimental group rather than control group. many studies have found the effects of standard rehabilitation of carpal tunnel syndrome and their results in controlling pain and dysfunction. however as per researchers' knowledge little literature is available on effects of pain neuroscience education and standard rehabilitation regime in carpal tunnel syndrome. therefore, this study6 is going to determine the effects of effectiveness of pain neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.

Eligibility criteria:
inclusion criteria: * age between 20_40 years old. * medical diagnosis of moderate to severe cts. * symptoms of cts since 1month * unilateral or bilateral symptoms * availability and access to the hospital. exclusion criteria: * inability to understand instructions, neurological conditions of the central nervous system (e.g. stroke, spinal cord injury) * patients on treatment with alternative therapies * previous participation in a research program * previous surgery on the affected upper limb

Keywords: carpal tunnel syndrome compression pain neuroscience education median nerve
real life experience of the use of isomers as alencal (levamlodipine) for evaluation of efficacy, safety and tolerability in the management of cardiovascular disease in colombian patients

Conditions: Hypertension

Summary: this is a phase 4, observational, open study in patients whom their doctor for clinical practice prescribes levamlodipine. no medication was provided by the sponsor. the planned observation time is 8 weeks. the 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8, or clinical practice.


Eligibility criteria:
inclusion criteria: * patients whose primary physician based on their clinical condition and locally approved use will be eligible to participate in this study, and have been prescribe with levamlodipine.

Keywords: observational colombia
efficacy of desonide (desonatetm) gel 0.05% in younger and older subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. desonate has been approved by the us food and drug administration (fda) for atopic dermatitis.

to assess the efficacy of a desonide hydrogel 0.05% in both young children (age \<13) and older subjects (ages 13 and up) with mild to moderate atopic dermatitis

Eligibility criteria:
inclusion criteria: * male or female, age 3 months or greater. * subjects must have diagnosis of mild to moderate atopic dermatitis by an investigator (a 2 or 3 on the iga scale). * subjects must have \>2% bsa involvement to be enrolled. * informed consent of participation must be given by parent or guardian if he or she is \<7 years old. children who are 7 to 18 years old will be given an assent form to sign. * moisturizers will be allowed during the study as long as the use remains stable from screening/baseline throughout the study. exclusion criteria: * known allergy or sensitivity to topical desonide hydrogel in the subject. * inability to complete all study-related visits. * introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. other than stable use of over the counter non-medicated moisturizers, all other topical treatments for ad must be stopped prior to study drug initiation. there will be no required washout for any topical therapies. stable use of systemic therapies may be continued throughout the study. * requiring \>130 gm of cream in a 4 week period. * pregnant women and women who are breastfeeding are to be excluded. women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control. use of desonide in pregnant subjects is controversial and is only to be used when benefits outweigh the risks.
evaluation of the modified atkins diet in young children with refractory epilepsy

Conditions: Refractory Epilepsy

Summary: the modified atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. this diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. modified atkins diet is of special importance in resource constraint settings with paucity of trained dieticians. however, there is paucity published data on the use of the modified atkins diet in refractory epilepsy in young children. this study aims to evaluate the efficacy and tolerability of the modified atkins diet in refractory epilepsy in young children.


Eligibility criteria:
inclusion criteria: 1. age: 9 months to 3 years. 2. seizures persisting at least three per week for \> 1 month despite the appropriate use of at least 2 anti-epileptic drugs. exclusion criteria: 1. known or suspected inborn error of metabolism, as evidenced by: clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination and/ or 2 or more of the following biochemical abnormalities high blood ammonia (\>80mmol/l), high arterial lactate (\>2 mmol/l), metabolic acidosis (ph \<7.2), hypoglycaemia (blood sugar \<40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests. 2. motivational or psychosocial issues in the family which would preclude compliance 3. systemic illness- chronic hepatic, cardiac, renal or pulmonary disease 4. severe acute malnutrition.

Keywords: refractory epilepsy dietary therapy non-pharmacological therapy modified atkin diet
culturally responsive person-centered care for psychosis

Conditions: Psychotic Disorders

Summary: this study will compare standard individualized care to person-centered care and community-integrating care for treating psychosis in adults of hispanic or african descent.

patient-centered care is a type of customized mental health care that is based on each individual's needs, values, and preferences. this type of care has become increasingly important, especially for members of ethnic minorities. however, although this type of care is, in theory, more effective than standard, less personalized care in treating psychotic disorders, there is a significant gap between theory and practice. research has shown that this gap is particularly evident in the treatment of psychotic disorders in individuals of ethnic backgrounds. this study will address these disparities by comparing the effectiveness of standard individualized care versus person-centered care and community-integrating care in treating psychosis in adults of hispanic and african descents. this open-label study will consist of two phases. in phase i, interview data on self-management of mental illness and treatment seeking behaviors will be collected and analyzed. in phase ii, participants from two urban mental health centers will be randomly assigned to receive one of three treatment combinations: standard care incorporating illness management recovery (imr); imr plus person-centered planning (pcp); or imr plus pcp and community integration (ci). imr will focus on nine topic areas: recovery strategies; facts about psychosis; a stress-vulnerability model; building social support; reducing relapses; effective use of medications; coping with stress; coping with problems or symptoms; and meeting health care needs. pcp will aid participants in discovering a vision of a desirable future and developing a plan for achieving that goal. techniques will include providing direction in the planning process, involving significant others, generating focus on assets and capacities, identifying and providing access to integrated community settings, and promoting acceptance of setbacks as part of the path to success. ci will include recovery group sessions and community integration activities. recovery groups will consist of 10 to 12 people per group, and will aid participants in asserting the skills they learned in imr and pcp. community integration activities will entail a variety of excursions and social and recreational activities in the community to promote community involvement and acquisition of social roles. all treatments will last a total of 6 months. assessments of psychiatric symptoms, social functioning, quality of life, and community integration will occur at month 6 and at a follow-up visit at month 18.

Eligibility criteria:
inclusion criteria: * of hispanic and/or african origin * dsm-iv diagnosis of an axis i psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic features) exclusion criteria: * n/a

Keywords: person-centered care recovery disparities culturally responsive care psychosis
safety and tolerability of memantine in moderate to severe alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe alzheimer's disease.

memantine is a moderate affinity, uncompetitive n-methyl-d-aspartate (nmda) receptor antagonist. pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. results from clinical trials in patients with moderate to severe alzheimer's disease (ad) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline. the purpose of this 24-week open-label extension study was to collect additional long-term safety and tolerability data on memantine in patients who completed the lead-in double-blind placebo-controlled study 10158. in agreement with health canada the study was prematurely terminated due to recruitment difficulties in the lead-in study 10158. patients ongoing in the study when the decision to terminate was taken were allowed to complete it.

Eligibility criteria:
inclusion criteria: * ambulatory outpatients with moderate to severe dementia of the alzheimer's type who have completed the 24-week study 10158 and who have a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study. exclusion criteria: * diseases/medication which judged by the investigator could interfere with the assessments of safety, tolerability or efficacy.

Keywords: alzheimer's disease
a study of the safety and effects of adh-1 given intravenously as a single agent

Conditions: Neoplasms

Summary: n-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. adh-1 blocks n-cadherin. this study will test the safety and effects of adh-1 in subjects with specific incurable, solid tumors with a protein biomarker called n-cadherin. this study will examine the clinical activity of adh-1.


Eligibility criteria:
inclusion criteria: * signed written informed consent * male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists * histologically proven advanced and/or metastatic solid tumor of one of the following histologies: * non-small cell lung cancer (squamous or non-squamous histology), * gastroesophageal carcinoma (squamous or adenocarcinoma histology), * renal cell carcinoma, * hepatocellular carcinoma, * adrenocortical carcinoma * measurable disease * immunohistochemical evidence of n-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue * adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ecg) exclusion criteria: * receipt of adh-1 prior to this clinical study * chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry * history of spinal cord compression, or history of primary brain tumor(s) or brain metastases (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months * history of tumors that have shown clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks before study entry * stroke, major surgery, or other major tissue injury within 30 days before study entry * history of: * uncontrolled congestive heart failure, * coronary artery disease, or life threatening arrhythmias; * myocardial infarction less than 12 months prior to study entry; * significant ecg abnormalities; or * known hypercoagulable states

Keywords: cancer; tumors; neoplasms; anticarcinogenic agents; antineoplastic agents cadherins; non-small-cell lung carcinoma; esophageal cancer; gastric cancer; renal cell carcinoma; hepatocellular carcinoma; adrenocortical carcinoma
exeantide in type 2 diabetes on insulin

Conditions: Type 2 Diabetes

Summary: exenatide has been shown to result in better glycemic control in type ii diabetes patients. obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss. the purpose of this study is to determine if the addition of exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.


Eligibility criteria:
inclusion criteria: * males or females 20-75 years of age inclusive. * type 2 diabetes * on insulin therapy * hba1c ≥7.5% and ≤ 9% * bmi ≥ 30 kg/m2 * subjects on statins, ace inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. exclusion criteria: * coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks * pregnancy * hepatic disease (abnormal lft's) * use of dpp4 inhibitors. * renal impairment (serum creatinine \> 1.5) * participation in any other concurrent clinical trial * any other life-threatening, non-cardiac disease * uncontrolled hypertension (bp \> 160/100 mm of hg) * congestive heart failure. * use of an investigational agent or therapeutic regimen within 30 days of study

Keywords: type 2 diabetes obesity
impact of short-term fructose-enriched diet on serum metabolome by normal- and over-weighed women.

Conditions: Non-Alcoholic Fatty Liver Disease; Obesity

Summary: the purpose of this study is to investigate how a high-fructose diet, either by high fructose intake from complex, natural foods or by fortifying the diet with corn syrup, affects the metabolism. furthermore, it will be investigate if there are differences between obese and normal weight participants.


Eligibility criteria:
inclusion criteria: * healthy adults, aged between 20 and 30 years * normal weighted (bmi ≤ 25 kg/m2) and obese (bmi 35-50 kg/m2) * written informed consent at initial medical examination an anamnesis, physical examination, blood sample collection (10 ml) was performed to check for eligibility. furthermore, a hydrogen breath test was performed to detect potential fructose intolerance exclusion criteria: * smoking, * fructose intolerance/ -malabsorption, * pregnancy * chronic gastrointestinal diseases (e.g. chronic inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.), * operation on the gastrointestinal tract (exclusively appendectomy) * anemia, * hepatic or renal disease * diabetes mellitus * consuming illnesses (e.g. cancer, acquired immunodeficiency syndrome (aids)) - drug intake affecting lipid or glucose metabolism (cholesterol- or glucose reducing or antihypertensive drugs, steroids, l-thyroxin, antidepressants, weight reducing drugs).
practice change with drug-coated balloon in patients with multivessel coronary artery disease

Conditions: Coronary Artery Disease; Multi Vessel Coronary Artery Disease

Summary: this study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (dcbs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (mvd), as opposed to the default strategy of using only drug-eluting stents (des). the investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (des and dcb) and its effects on clinical outcomes.


Eligibility criteria:
inclusion criteria: 1. age 19 or older 2. multivessel coronary artery disease patients requiring coronary intervention * stenosis of 2 or more major coronary arteries or major coronary artery branches (vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization * having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm 3. capable of understanding the risks and benefits of participating in the study and providing informed consent exclusion criteria: 1. incapable of voluntarily providing informed consent 2. allergy or contraindication to aspirin, p2y12 inhibitors, or components of drug-eluting stents 3. cardiogenic shock or cardiac arrest patients 4. patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 5. patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention 6. patients with severe valvular heart disease requiring open heart surgery 7. pregnant or lactating women

Keywords: coronary artery disease multivessel coronary artery disease percutaneous coronary intervention drug-coated balloon drug-eluting stent
culture and well-being for latinos

Conditions: Social Isolation; Loneliness; Suicidal Ideation

Summary: the proposed k23 study is an intervention study using an experimental therapeutics approach. this pilot rct asks: "does social-engage increase cultural-social engagement and decrease suicide risk among spanish-speaking adults?" we will first optimize a behavioral intervention - social engage (s-engage) - for target engagement using human-centered design approaches with spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot rct (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of s-engage with this population. the ultimate goal is for s-engage to be offered as a suicide prevention program for hispanics at risk for suicide.


Eligibility criteria:
inclusion criteria: * identify as hispanic/latino adult (age 18+); * primary spanish-speaker; * patient in the ur health system; * low cultural-social engagement (i.e., score ≤ 2 on the adapted berkman-syme social network index); * elevated suicide risk (i.e., presence of passive or active suicide ideation in the past month on the columbia-suicide severity rating scale \[c-ssrs\]). exclusion criteria: * medical or psychiatric comorbidities that impair ability to consent (e.g., active psychotic or manic episode, cognitive impairment).
effectiveness study of a computer-based colorectal cancer screening decision aid

Conditions: Colorectal Cancer; Health Literacy

Summary: the purpose of this study is to determine whether a multimedia educational computer program can increase colorectal cancer screening rates in low and adequate literacy patients.

results will be stratified by low/marginal and adequate literacy as determined by the rapid estimate of adult literacy in medicine instrument.

Eligibility criteria:
inclusion criteria: * english-speaking * scheduled to see an internal medicine provider * no recent colorectal cancer screening exclusion criteria: * personal history of colorectal cancer * family history of colorectal cancer * blood seen in stools within last month * obvious cognitive or physical impairment that would prevent participation

Keywords: colorectal cancer screening health literacy patient education computer assisted instruction