Kornimate/medical-research-clean huggingface dataset:
combined behavioral/pharmacological therapy for insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: this study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

long-term insomnia is a common and significant health problem. two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia. during the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires. participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (ambien), behavioral therapy plus placebo, or behavioral therapy alone. during treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires. after 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study. after the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.

Eligibility criteria:
inclusion criteria: * be between 21 and 75 years of age * have a mean total nocturnal wake time of \> 60 min./night * have a history of insomnia \> 6 months * have a history of one or more poor sleep hygiene practices such as taking 3 or more naps/week, varying bed times or wake times by \> 2 hrs. from day to day, or routinely lying in bed awake for periods \> 30 min exclusion criteria: * pregnant women * the terminally ill * individuals with other medical conditions (e.g. chronic pain disorders, etc.) that compromise sleep * individuals with major psychiatric diagnoses * persons with hypnotic-dependent insomnia * subjects on antidepressants or anxiolytics * subjects with evidence of sleep apnea

Keywords: sleep deprivation insomnia sleep disorders
efficacy and safety study of procaterol hydrochloride to treat patients with cough variant asthma (cva)

Conditions: Cough Variant Asthma

Summary: the purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (cva).

this is a 8-week, double-blind, randomized, placebo-controlled study, the patients with cva will be randomized to experimental or placebo control group. during the screening period, eligible patients will be evaluated by cough symptom score and lcq life quality score. after 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and lcq life quality score respectively. adverse events will also be captured at every visit.

Eligibility criteria:
inclusion criteria: * male or female patients,18-75 years old; * cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom; * without wheeze and fever; * without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years; * without rales from lung; * no obvious abnormalities from chest x-ray; * bronchial provocation test: positive. exclusion criteria: * patients with chronic pulmonary disease; * patients who are allergic to ß2 receptor agonist; * patients taking ß2 receptor agonist for long time; * severe heart, renal and hepatic disease; * unable to comply with the protocol; * pregnant, breast feeding, and childbearing potential women; * patients improper to the trial according to the investigators' judgment.

Keywords: cough variant asthma procaterol hydrochloride
an efficacy and safety study of reslizumab subcutaneous in patients with oral corticosteroid dependent asthma and elevated blood eosinophils

Conditions: Asthma; Elevated Blood Eosinophils; Oral Corticosteroid Dependence

Summary: the primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (ocs)-dependent asthma and elevated blood eosinophils, without loss of asthma control.


Eligibility criteria:
inclusion criteria: 1. the patient is male or female, 12 years of age and older, with a previous diagnosis of asthma. 2. written informed consent is obtained. 3. the patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening. 4. the patient has a documented elevated blood eosinophils at screening or during the previous 12 months. 5. the patient has required high dose ics plus another asthma controller for at least 6 months prior to screening. 6. the patient has fev1 reversibility to inhaled saba or historical reversibility within the previous 24 months. * other criteria may apply, please contact the investigator for more information. exclusion criteria: 1. the patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety. 2. the patient has another confounding underlying lung disorder. 3. the patient has a known hypereosinophilic syndrome. 4. the patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers. 5. the patient is pregnant or intends to become pregnant during the study or is lactating. 6. the patient required treatment for an asthma exacerbation within 4 weeks of screening. 7. the patient is a current smoker or has a smoking history ≥10 pack-years. 8. the patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance ocs for the treatment of asthma. 9. the patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer. 10. the patient was previously exposed to benralizumab within 12 months of screening. 11. the patient was previously exposed to reslizumab. 12. the patient has a history of immunodeficiency disorder including human immunodeficiency virus. 13. the patient has current suspected drug and/or alcohol abuse. 14. the patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening. 15. the patient has a history of allergic reactions or hypersensitivity to any component of the study drug. * other criteria may apply, please contact the investigator for more information.

Keywords: asthma elevated blood eosinophils oral corticosteroid dependence reslizumab
calligraphy writing for cognitive and emotional enhancement among older mci people

Conditions: Mild Cognitive Impairment

Summary: this study is aimed to investigate the efficacy of an 12-week chinese calligraphy training program for enhancing cognitive and emotional functions of older adults with mild cognitive impairment. participants are tested with several cognitive tests and electroencephalography (eeg), psycho-physical parameters and brain activities are recorded. results are compared at pre-intervention, post-intervention, and 6-month post-intervention to provide evidence of benefits of chinese calligraphy practice.

participants are older adults with mild cognitive impairment, who will be recruited from several community elderly centers in hong kong according to selective criteria. the participants are randomly assigned to an experimental or a control group. the experimental group is invited to participate in 16 sessions of structured chinese calligraphy program over 12 weeks. each session lasts for 1.5 hours. the control group is invited to participate in an ipad learning program with navigating the internet. the ipad program is also consisted of 16 sessions of 1.5 hours each over 8 weeks. cognitive tests and physiological measures are conducted immediately before and after intervention and at 6-month post-intervention follow-up. statistical analysis are performed to investigate the significant differences and interactions among the three time points. the association of cognitive performance and emotional calmness is also investigated. selected participants are invited to take part in a eeg session while doing some computer tasks related to chinese calligraphy. eeg results of are used to explore neural activities associated with visuospatial working memory and to provide evidence for neural changes at functional level as a result of chinese calligraphy training and practice.

Eligibility criteria:
inclusion criteria: * meeting petersen's criteria for mild cognitive impairment * being able to read simple chinese characters * community-dwelling * clinical dementia rating score of 0.5 * no substantial prior experience of calligraphy writing * willing to write using a brush and willing to participate exclusion criteria: * presence of musculoskeletal problems preventing participants from writing * known chronic cardiovascular (e.g. systolic bp \> 140mmhg) or pulmonary conditions requiring long-term medication * presence of severe mental disorder such as psychosis or depression.

Keywords: mild cognitive impairment cognitive training calligraphy emotional calmness working memory
a study of tace combined with camrelizumab plus rivoceranib (apatinib) in patients with incurable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: a study to evaluate efficacy and safety of transarterial chemoembolization (tace) in combination with camrelizumab and rivoceranib (apatinib) therapy in patients with incurable hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. voluntarily participate in this study and sign informed consent. 2. subjects diagnosed with hcc or clinically diagnosed with hcc by histopathology / cytology. 3. baseline imaging examination has at least one measurable lesion. 4. child-pugh liver function rating was grade a within 7 days before randomization. 5. ecog ps score within 7 days before randomization: 0 or 1. other protocol defined inclusion criteria could apply. exclusion criteria: 1. known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and lamellar cell carcinoma. 2. subjects who are ready for or have previously received organ or allogeneic bone marrow transplantation. 3. has any active autoimmune disease or a history of autoimmune disease and may relapse. 4. suffering from hypertension and can not be well controlled by antihypertensive drugs. 5. with clinical symptoms or diseases of the heart that are not well controlled. 6. previous or current central nervous system metastasis. 7. the subject has congenital or acquired immune deficiency (such as hiv infection). 8. thrombotic or embolic events occurred within 6 months prior to the start of study treatment. 9. a history of gastrointestinal hemorrhage or a clear tendency to gastrointestinal bleeding within 6 months prior to the start of study treatment. 10. abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to the start of study treatment. 11. severe, unhealed or cracked wounds and active ulcers or untreated fractures. 12. known genetic or acquired bleeding or thrombotic tendencies. 13. severe infection occurred within 4 weeks prior to the start of study treatment. 14. received live attenuated vaccine treatment within 28 days prior to the start of study treatment. 15. other investigational drugs were received within 28 days prior to the start of study treatment. 16. according to the assessment of investigator, the subject has other factors that may interfere with the results of the study or cause the forced termination of the study. other protocol defined exclusion criteria could apply.
food effect study of codeine sulfate

Conditions: Pain

Summary: the study was designed to assess the effect of food on the absorption of codeine from roxane laboratories' 60 mg codeine sulfate tablet


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to codeine sulfate or any comparable or similar product.
the effect of conbercept injection through different routes for neovascular glaucoma

Conditions: Neovascular Glaucoma

Summary: the neovascular glaucoma (nvg) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. it has been confirmed high levels of vascular endothelial growth factor (vegf) in nvg. conbercept is an anti-vegf agent，its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of nvg.

the neovascular glaucoma (nvg) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. it has been confirmed high levels of vascular endothelial growth factor (vegf) in nvg. conbercept is an anti-vegf agent，its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. the intravitreal injection of anti-vegf agent has shown its therapeutic potential for the early stage of nvg, but not for the late stage. intracameral injection maybe used as an alternative way for administration. investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of nvg.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of neovascular glaucoma (stage 1-2-3) * individuals who are ages 20-80 years old; male or female of chinese * visual acuity of light perception or better in the study eye * willing and able to comply with clinic visits and study-related procedures * provide signed informed consent exclusion criteria: * use of intraocular anti-vegf agents in the study eye in the past 3 months. * active ocular or periocular infection in the study eye * uncontrolled blood pressure * thromboembolism * congestive heart failure * renal failure * history of myocardial infarction * history of stroke * pregnant or breast-feeding women * participation in another simultaneous medical investigator or trial
prospective study assessing two scales for identification of complex elderly patients in the emergency department

Conditions: Geriatric

Summary: with the help of medical progress, life expectancy has increased in our country, resulting in an increase in the number of elderly people and especially so-called complex patients. these complex elderly patients present with a combination of poly pathology, locomotor disorders and loss of autonomy, which leads to increased risks of hospitalization, re-hospitalization or difficulty in remaining at home. these risks could be reduced by early adapted care specific to this type of patient. to do this, it is necessary to identify these complex elderly patients as early as possible in their care pathway. screening complex elderly patients in the emergency department would require trained and educated staff, or the use of a simple, rapid and reliable diagnostic scale. the purpose of this study is to compare two scales for the screening of complex elderly patients, whose use is adapted to the hospital emergency department environment. this study assess the diagnostic performance of the isar and socoloc scales for complex elderly patients.

the assumption of the study is that at least one of these two scales (isar or socoloc) is adapted to the constraints of hospital emergencies and that it presents good performances for the screening of elderly patients in complex medico-social situations (sensitivity ≥ 90% and specificity ≥ 50%).

Eligibility criteria:
inclusion criteria: * patients over 75 years of age * patient presenting to the "emergency department" of the annecy genevois hospital, whatever the reason for consultation, from monday to friday between 8:00 a.m. and 8:00 p.m. * patient informed of the study and not opposed to participation exclusion criteria: * patients under guardianship or curatorship * patients under the safeguard of justice * patient presenting for a life-threatening emergency * patient unable to answer the questions on the scales * patient does not speak french * patients who have already been included in the study: any patient already included in the study and making another trip to the emergency department cannot be included a second time.
investigation of biomarkers in susac syndrome

Conditions: Susac Syndrome

Summary: susac syndrome is a rare disease and the establishment of the diagnosis is often difficult. the aim of this investigation is to identify relevant biomarkers and to elucidate the pathogenesis of susac syndrome

susac syndrome is a rare disease characterized by encephalopathy, branch retinal artery occlusion and sensorineural deafness. the pathogenesis is not yet clear, an autoimmune endotheliopathy is discussed. because of the variable and often incomplete clinical presentation, the establishment of the diagnosis is often delayed or even completely missed. the aim of this study is to identify biomarkers that facilitate the reliable and prompt establishment of the diagnosis. patients with a definite diagnosis of susac syndrome and healthy subjects as controls are investigated. furthermore, the correlation of serological markers with structural retinal and cerebral changes will contribute to clarification of the pathogenesis of susac syndrome.

Eligibility criteria:
inclusion criteria: * adult male and female patients with definite susac syndrome or matching healthy control subjects * ability to provide informed consent exclusion criteria: * pregnancy
phase iii study of gr1802 injection in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, pk, pd and immumogenicity of gr1802 injection in comparison to placebo in patients with atopic dermatitis. patients will receive gr1802 injection or placebo every 2 weeks.


Eligibility criteria:
inclusion criteria: 1. diagnosed with ad according to williams criteria with a history of at least 12 months before screening, with below requirements: 1) easi score ≥16 at screening and baseline; 2) iga score ≥3 at screening and baseline; 3) ≥10% bsa of ad involvement at screening and baseline; 4) pruritus nrs average score ≥4 at baseline. 2. inadequate response or intolerance to topical glucocorticoid therapy for ad within 6 months prior to screening. exclusion criteria: 1. not enough washing-out period for previous therapy. 2. concurrent disease/status which may potentially affect the efficacy/safety judgement. 3. abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial. 4. women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study. 5. other
diabetic macular edema severity at diagnosis

Conditions: Diabetes Mellitus; Diabetic Retinopathy; Macular Edema

Summary: the purpose of this study is to identify the severity level distribution at the moment of diagnosis, in diabetic patients with macular edema from a mexico city sample, and to identify the rate with severe macular edema that needed immediate treatment.

the international severity scale grades macular edema as mild, moderate or severe, according to the distance of the thickening from the center of the fovea; however, this scale does not define the distances which fulfill the criteria of "distant from" or "approaching" the center of the macula; a quantitative and reproducible tool, such as optical coherence tomography (oct), could be more accurate to grade severity, by localizing thickening in a standardized way. as far as we know, distribution of clinically significant macular edema at the moment of diagnosis, according to the international scale has not been described. a study was conducted to identify the rate of eyes that had severe macular edema at the moment of diagnosis, whose risk of visual loss could be higher and required immediate treatment.

Eligibility criteria:
inclusion criteria: * type 2 diabetic * regardless of diabetes duration and retinopathy severity level * one or both eyes with csme exclusion criteria: * media opacities that prevented an adequate fast macular map from being acquired * a thickened posterior vitreous * any additional retinal disease

Keywords: clinically significant macular edema diabetic macular edema optical coherence tomography diabetic retinopathy severity
impact of oral dyglomera™ on body fat and blood lipids of overweight and obese adults

Conditions: Body Fat Disorder

Summary: the extract of dichrostachys glomerata (dyglomeratm), has been reported to be effective in weight reduction in obese patients with metabolic syndrome. this plant has been shown to have many biological properties and has been reported to have no toxic or adverse side effects in animals. the purpose of this human study was to prove that the effect of reducing body fat percentage (%) after 12 weeks of intake was superior to that of the control group.

this is a 12-weeks randomized double-blind placebo controlled trial. 120 number of subjects are planned. each subject will be administered a single dose of the investigational product once daily, before lunch or dinner, consisting each time of 400 mg of the test product or placebo. subjects will be assigned to the test group or placebo group in random order. evaluations will be taken at baseline and at the beginning of each of the 5 study visits. screening data will be reviewed to determine subject eligibility. subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. the following investigational products will be used: * test product: dichrostachys glomerata extract (dyglomera™) at a dose of 400 mg * control product: placebo at a dose of 400 mg in this human study, starting with visit 2, the duration of participation in the human study will be 12 weeks (84 days) in total. the study period will be planned to be 8 months from the date of approval of the human study. the screening visit of the first subject will be conducted at the max specialty hospital, and the first subject will be enrolled thereafter. the last subject will complete the study within about 5 months.

Eligibility criteria:
inclusion criteria: * patients aged from 19 to 65 years old, * patients with a bmi ranging between 25 and 34.9 kg/m2, * patients available for the entire period of study . exclusion criteria: * patients that has an age below 19 years old and greater than 65 years old, * patients not available for the study period, * specific exclusion criteria included: morbid obesity (bmi \> 34.9 kg/m2); diabetes mellitus requiring daily insulin management; pregnancy/lactation; active infection; and systemic disease such as hiv/aids, active hepatitis or clinical signs of active malignancy within the past 5 years. other exclusion criteria will include having taken any other medications or any natural health product within 1 month prior to the screening visit.

Keywords: body fat dyglomera blood lipids