Kornimate/medical-research-clean huggingface dataset:
an open study comparing the effects of moxaverine on ocular blood flow in patients with age- related macular degeneration, primary open angle glaucoma and healthy control subjects

Conditions: Macular Degeneration; Glaucoma; Regional Blood Flow

Summary: a number of common eye diseases such as age-related macular degeneration and glaucoma are associated with ocular perfusion abnormalities. although this is well recognized there is not much possibility to improve blood flow to the posterior pole of the eye in these diseases. for many years, moxaverine has been used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. this is based on a direct vasodilatatory effect of the drug, but also on the rheological properties of red blood cells. in a recent study the investigators have shown that intravenous moxaverine increases choroidal blood flow in healthy young subjects. the present study aims to investigate, whether moxaverine also improves blood flow in the diseased eye after systemic administration.


Eligibility criteria:
inclusion criteria: * men and women aged over 50 years * ametropia of less than 6 diopters and anisometropia of less than 2 diopters * clear non-lenticular ocular media amd patients: * patients with nonexudative amd * visual acuity in the study eye \> 20/60 glaucoma patients: * unilateral or bilateral primary open angle glaucoma * at least 3 reliable visual field testings * treated intraocular pressure \< 21 mmhg, * visual field mean deviation md \<10 (humphrey 30-2) healthy control subjects: * age- , gender- and sex- matched to the two patient groups, * matched with regard to smoking habits of the two patient group * no observable eye diseases exclusion criteria: * history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug * blood donation during the previous 3 weeks * abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study * known diabetes mellitus * presence of any ocular pathology that interferes with the aims of the present study * intraocular surgery within the last 3 weeks * hypersensitivity to moxaverine * acute gastric bleeding, massive cerebral hemorrhage related to stroke

Keywords: age-related macular degeneration glaucoma
interoceptive exposure for adolescents with low weight eating disorders

Conditions: Anorexia Nervosa

Summary: this project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) exposure-based family therapy (ie) vs. 2) family based therapy (fbt) for low weight eating disorders with 12 month follow-up. primary outcomes are expected body weight and clinical impairment. three mechanisms of change (autonomous eating, non-judgmental body awareness, and extinction learning) will be examined in a process mediation models of change.

a total of 120 individuals with anorexia nervosa ages 12-18 will be enrolled to either 20 sessions of outpatient exposure-based family therapy (ie) or family based therapy (fbt). the aims of the study are to test the comparative efficacy and primary mechanisms of change after 6 months of treatment and at one year post-treatment and to explore the mediators and moderators of the primary outcomes at these endpoints. all recruitment and study procedures will take place through the center of excellence in eating and weight disorders at the icahn school of medicine at mount sinai. assessments will take place at 2-, 4-, 6-, 12-, and 18-months following baseline.

Eligibility criteria:
inclusion criteria: * aged 12-18 * speak english * permission from pediatrician or equivalent to receive outpatient care * clinically significant restriction of food intake by eda-5 or evidence of persistent food avoidance from patient or guardians * evidence of the inability to maintain greater than minimally low body weight based on bmi for age percentiles and growth trajectories exclusion criteria: * comorbid psychotic or bipolar disorder * active suicidal ideation * current substance dependence * psychiatric medication initiated or dosage changes \<2 weeks from baseline * major medical illness (e.g., diabetes mellitus, crohn's disease, etc.)
detoxification and treatment of subjects with medication overuse headache

Conditions: Analgesic Rebound Headache

Summary: the purpose of this study is to assess the benefits of almotriptan used as a transitional therapy and topiramate in subjects with medication overuse headaches (moh.


Eligibility criteria:
inclusion criteria: * medication overuse headaches 18 years of age and older must have a diagnosis of probable medication overuse headache must have greater than fifteen headache days per month must be in generally good health female subjects must be postmenopausal or practicing an acceptable method of birth control exclusion criteria: * not overusing six or more tablets per day of compounds containing barbituates opioids no overuse of triptans previous failure or side effects with topiramate or almotriptan cannot be pregnant or lactating

Keywords: medication overuse
the effect of intermittent theta burst stimulation (itbs) in patients with alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: the aim of this trial is to investigate the efficacy of left dlpfc itbs in a population of alcohol use disorder patients, compared with the sham itbs. moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.

alcohol abuse and alcohol use disorder are important major health issues in our modern society. however, the treatment of alcohol addiction is currently limited to the treatment of acute withdrawal symptoms, but lacks effective interventions to reduce craving and prevent relapse. in an attempt to improve the treatment of substance dependence, non-invasive neuromodulation has gained attention as a new potential treatment option. the aim of this trial is to investigate the efficacy of left dlpfc itbs in a population of alcohol use disorder patients, compared with the sham itbs. moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.

Eligibility criteria:
inclusion criteria: * a dsm-5 diagnosis of alcohol use disorder * age between 18 and 65 * can return to the research center for successive visits. exclusion criteria: * severe cognitive impairment * current dsm-5 diagnosis of schizophrenia or another psychotic disorder * current other substance abuse (except nicotine) * severe organic diseases * rtms contraindications (such as a history of epileptic seizures, metal implants near the head).

Keywords: alcohol use disorder intermittent theta burst stimulation alcohol dependence
improving neuroprotective strategy for ischemic stroke with sufficient recanalization after thrombectomy by intra-arterial cocktail therapy (insist-ct)

Conditions: Ischemic Stroke

Summary: thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. although sufficient recanalization after thrombectomy is more than 80%, hermes study indicated that nearly half of the ischemic stroke patients under thrombectomy suffered obvious disability. artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon are among the most important reasons of poor prognosis of acute ischemic stroke patients. the investigators speculate that a combination of argatroban, edaravone, and glucocorticoid may be helpful in preventing artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon. this study intends to explore the safety, feasibility and efficacy of thrombectomy with sufficient recanalization bridged by intra-arterial cocktail therapy in acute ischemic stroke patients.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy. 3. sufficient recanalization （tici 2b-3）within 7 hours of stroke onset. 4. the availability of informed consent. exclusion criteria: 1. insufficient recanalization（tici \< 2a）after endovascular treatment; 2. hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage. 4. coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3）. 5. severe hepatic or renal dysfunction, increase in alt or ast (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis. 6. severe uncontrolled hypertension (systolic blood pressure over 200mmhg or diastolic blood pressure over 110 mmhg). 7. patients with contraindication or allergic to any ingredient of drugs in our study. 8. unsuitable for this clinical studies assessed by researcher.
a study of gfs101a in combination with toripalimab in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: the purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of gfs101a in combination with toripalimab in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. voluntarily participate in this clinical trial, and are willing to sign informed consent forms. 2. male or female aged from 18-75 years old (inclusive). 3. diagnosed with histologically or cytologically confirmed advanced solid tumors. 4. evaluable lesions defined by recist v1.1. 5. eastern cooperative oncology group performance status of 0 to 1. 6. subjects or their legal representatives are able to communicate well with investigators and are willing to comply with the protocol and complete the study. exclusion criteria: 1. with clinically significant cardiac diseases 2. with clinically significant digestive disorders. 3. other severe disease. 4. pregnant or lactating women. 5. other unfavorable situations for subjects to participate in the study judged by investigators.
peripartum cardiomyopathy in nigeria registry

Conditions: Peripartum Cardiomyopathy

Summary: peripartum cardiomyopathy (ppcm) is a global disease with significant morbidity and mortality, and nigeria probably has the highest burden of the disease in the world. unfortunately, much about the disease including its aetiology, epidemiology and treatment is not yet well described. this will be a prospective, national, multicenter cohort study, conducted in centres in nigeria. it is expected that approximately 500 patients with ppcm and 500 apparently healthy pregnant women will be recruited over a 6-month period with follow-up at 3-monthly intervals for 18 months.

peripartum cardiomyopathy (ppcm) is a global disease with significant morbidity and mortality, and nigeria probably has the highest burden of the disease in the world. unfortunately, much about the disease including its aetiology, epidemiology and treatment is not yet well described. this will be a prospective, national, multicenter cohort study, conducted in centres in nigeria. it is expected that approximately 500 patients with ppcm and 500 apparently healthy pregnant women will be recruited over a 6-month period with follow-up at 3-monthly intervals for 18 months. the objectives of the study are: i. to describe the burden and demographic, social and clinical characteristics of ppcm in nigeria. ii. to describe the ventricular remodelling and outcomes (rehospitalisation rate, cardio-embolic events and survival) of ppcm in nigeria. sub-study: iii. to study the relationship between selenium deficiency, oxidative stress and ppcm in nigeria. iv. to describe the prevalence of selenium deficiency and its relationship with cardiac function in apparently healthy pregnant women in nigeria. v. to study the impact of sodium selenite supplementation on cardiac function among selenium deficient ppcm patients who have not recovered left ventricular function at 6 months after the diagnosis. this will be the largest systematic evaluation of ppcm in nigeria, and it is hoped that the information will assist in developing locally applicable treatment guidelines, policies and interventions for this seemingly deadly disease.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ppcm * ppcm patients with hf symptoms at the time of recruitment * asymptomatic pregnant women attending antenatal clinic (anc) * sub-study: open-label randomised trial: non-pregnant ppcm patients with all of the following: lvef \<35% and/or lveddi≤33.0 mm/m2 at 6 months postpartum and selenium deficiency * written informed consent exclusion criteria: * asymptomatic ppcm patients at the time of recruitment * ppcm patients who are not expected to survive at least 6 months from recruitment * pregnant women with any medical condition other than ppcm * subjects who are considered not likely to attend follow up reviews regularly, because of lack of patient's and close relative's phone numbers, or long distance from the study centre, etc * refusal or withdrawal of consent

Keywords: peripartum cardiomyopathy ventricular remodelling survival selenium oxidative stress nigeria
health and justice: a continuum of care for hiv and su for justice-involved young adults (phase 2)

Conditions: HIV/AIDS; HIV Infections; Substance Use; Substance Abuse; Substance Use Disorders; Sexually Transmitted Diseases

Summary: this research study proposes to embed hiv testing outreach workers from a young adult focused medical and hiv treatment program into an alternative sentencing program to deliver a new service delivery model (link2care) that integrates evidence-based protocols for justice-involved young adults to: a) promote hiv and sti testing, and hiv and su risk screening, b) provide onsite intervention, and c) cross-system linkage to hiv, sti, and su care. phase 1 has already been completed. in phase 1, the intervention components were adapted for use among justice involved young adults and the resulting protocols were piloted with justice involved young adults, finalizing the resulting 4-session link2care intervention. in phase 2, we will test link2care among n=450 justice-involved young adults enrolled at the alternative sentencing program and conduct process evaluations with n=15 alternative sentencing program staff.


Eligibility criteria:
young adults inclusion criteria: * between 18-24 years of age * currently enrolled at the alternative to sentencing program * conversant in english * engaged in any unprotected or vaginal sexual activity (in the past 12 months) exclusion criteria: * cognitively unable to complete the interview * hiv positive alternative to sentencing staff inclusion criteria: * currently employed at the alternative to sentencing program * between ages of 18-80 exclusion criteria: * none
the effect of the mindfulness-based childbirth and parenting program

Conditions: Pregnancy Related

Summary: the aim of this study is to determine the effect of mindfulness-based childbirth and parenting program on prenatal attachment and depression, stress and anxiety levels of pregnants. the study will be carried out in two different groups. after the pregnants are evaluated in terms of eligibility criteria for the research, the pregnants who are eligible will be informed about the research and written informed consent will be obtained from the pregnants who accept. the random distribution of pregnants to the study groups will be carried out random. the following applications will be made to the groups.


Eligibility criteria:
inclusion criteria: * being at 20-30 weeks of gestation * being nulliparous exclusion criteria: * history of psychiatric illness * follow-up in the risky pregnancy clinic * not completing the study
proof: protein overfeeding effect on body weight

Conditions: Obesity

Summary: this study is designed to determine the effects of dietary protein content on overfeeding.

when body weight increases, the expenditure of energy increases as a mechanism to dissipate the excess calories. the role of diet composition in over-feeding/energy dissipation in humans is unknown. we propose that: 1. high and low protein diet will result in less weight gain as compared to a moderate protein diet during a 56d high fat overfeeding. 2. increase in energy expenditure and spontaneous physical activity, adjusted for lean and fat mass will be greater in the high and low protein diets as compared to a moderate protein diet. 3. the average size of the fat cells and the pattern of genes expressed in the adipose tissue, skeletal muscle, and peripheral blood mononuclear cells will "predict" which group of subjects will gain the most weight (and fat mass) independent of the level of the protein in the diet.

Eligibility criteria:
inclusion criteria: * have a bmi of 19-30kg/m2 a cutpoint of 26kg/m2 will be used to allocate treatment across the three diets. see the statistics section for more detail. * are willing to eat all of the study foods even when full * are willing to eat only foods provided by pennington and all of the foods provided * are willing to live at pennington for 10-12 weeks possibly without leaving the metabolic unit the entire time * are willing to avoid exercise while in the inpatient phase of the study * age 18 - 35 exclusion criteria: participants are ineligible to participate in the study if they... * smoke * have diabetes * have claustrophobia * have a fasting blood sugar \>110 * have a history of cardiovascular disease * have an average screening blood pressure \>140/90 * have a history of a major psychiatric, addictive or eating disorder or any psychosocial or scheduling factors that could impede study outcomes * post obese (self-reported bmi) must never have had a bmi greater than 32 * exercise more than 2 hours per week * unable to complete vo2 max test. * weight gain or loss of \> 3kg in the last 6 months * have significant renal, hepatic, endocrine, pulmonary or hematological disease, or a history of gout * have had previous gi surgery, obstructive disease of the gi tract, hypermotility disorder or a history of problems of impairment of the gag reflex. * corticosteroid use in the last 2 months * you are pregnant or breastfeeding * have irregular menstrual cycles * use depo-provera, hormone implant or estrogen replacement therapy * have an allergy to paba (a component of a b-vitamin often found in sunscreen)
d-chiro-inositol in overweight type 1 diabetes patients

Conditions: Type 1 Diabetes

Summary: the purpose of this pilot study was to evaluate the effect of d-chiro-inositol (dci) oral supplementation in addiction to folic acid compared to folic acid alone on glycaemic control as assessed by hba1c in overweight or obese t1d patients undergoing intensive insulin therapy. a 24 weeks, prospective, randomized control trial was carried out in t1d patients, aged 17-50 years (13 males, 13 females), with disease duration \> 1 year and bmi \>25, attending as outpatients the endocrinology and diabetes unit of university campus bio-medico in rome


Eligibility criteria:
inclusion criteria: * t1d patients * aged 17-50 years * disease duration \> 1 year * bmi \>25 exclusion criteria: * learning disabilities * presence of chronic conditions potentially able to influence daily activities (visual or auditory disability, motor impairment for neurological or orthopaedic problems). * t1d patients affected from diabetic complications * pregnancy

Keywords: d-chiro-inositol, type 1 diabetes
incidence, predictors and validation of risk scores to predict myocardial infarction after noncardiac vascular surgery

Conditions: Complication of Surgical or Medical Care

Summary: evaluate the incidence and predictors of post-operative mortality after noncardiac vascular surgery and compare the performance of existing risk scores.


Eligibility criteria:
inclusion criteria: * elective arterial vascular surgery * patients \> 18 years exclusion criteria: * urgent/emergent surgery * patients \< 18 years
feasibility study of modified atkins ketogenic diet in the treatment of newly diagnosed malignant glioma

Conditions: Glioblastoma

Summary: the purpose of this research study is to see if people can produce ketones in their blood with the modified atkins diet. modified atkins diet is a diet that produces ketones in your blood by restricting carbohydrates to \<20 grams per day. ketones are substances that are produced in the blood when fat is being broken down. ketones may help radiation work better and may starve your tumor because it is thought that some brain tumors can not use ketones to grow and can only use sugar or glucose to grow.


Eligibility criteria:
inclusion criteria: * histologically confirmed primary malignant glioma, grade iii or iv * no uncontrolled infection or other active malignancy or chronic systemic immune therapy. * ecog performance status \< 3. * life expectancy \> three months. * adequate labs exclusion criteria: * diagnosis of genetic disorder of fat metabolism. * type 2 diabetes diagnosed with a hemoglobin a1c \> 6.4 * allergic to dairy or lactose intolerance

Keywords: brain tumor
safety and efficacy study of neovasculgen (pl-vegf165) gene therapy in patients with peripheral nerve injury

Conditions: Peripheral Nerve Injury

Summary: the purpose of this study is to determine safety and efficacy of pl-vegf165 ("neovasculgen") for regeneration of peripheral nerve. pl-vegf165 ("neovasculgen") is the permitted in russian federation angiogenic medication that induce growth of new vessels and included in a complex therapy for patients with peripheral arterial diseases in russia. it has also been shown to enhance nerve regeneration and muscle reinnervation in animals but these properties have not previously been studied in patients. moreover, currently there is no method in clinical use to speed the rate of recovery after nerve injury. the objective of this study is to explore the ability of pl-vegf165 to benefit the treatment of patients with peripheral nerve injury. the investigators hypothesize that treatment with intraneural injections with pl-vegf165 after peripheral nerve reconstruction will accelerate nerve regeneration, reduce the period of denervation and improve muscle reinnervation and recovery in patients with peripheral nerve injury.

all patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. patients after nerve injury classified as neurotmesis will receive surgical repair of injured nerves what will be added by intraneural injections of pl-vegf165. safety and efficacy of gene therapy will be assessed by physical examination, comprehensive laboratory tests over next 18 month after surgical nerve reconstruction.

Eligibility criteria:
inclusion criteria: * patients with confirmed transection injury between shoulder and wrist * isolated injury of ulnar or median nerve (not mixed injury of several nerves) * nerve injuries which are amenable to direct end-to-end repair * length of the gap between of stumps of transected nerve no longer than 3,5 centimeters * early delayed (secondary) repair performed between 2 to 6 weeks after nerve injury exclusion criteria: * length of the gap between of stumps of transected nerve more than 3,5 centimeters * simultaneous injury of several peripheral nerves * localization of nerve injury beyond of forearm * presence of neurological deficit preceding to nerve injury * systemic disease of connective tissue * myopathy * large surgical procedures planned for next one and a half year * presence of oncological diseases * pregnancy and breastfeeding * alcohol and drug addiction * patient ability to adhere strictly to the rules of the current clinical trial protocol

Keywords: peripheral nerve injury neurotmesis gene therapy plasmid nerve regeneration therapy