Kornimate/medical-research-clean huggingface dataset:
hypertension and diabetes mellitus community management center(had-come) project

Conditions: Hypertension; Diabetes Mellitus

Summary: to develop and implement quality improvement programs for the treatment and management of hypertension and diabetes,and preventing and controlling hypertension and diabetes-related diseases in chinese community. this program will use data collection, analysis, feedback, and process improvement to extend the use of evidence-based guidelines throughout the healthcare system and improve patient care of hypertension and diabetes in chinese community.

the aim of this project was to improving care for hypertension and diabetes mellitus in chinese community. study population including subjects who are hypertension and/or diabetes mellitus, of any race or ethnicity, any age.

Eligibility criteria:
inclusion criteria: * in accordance with the diagnosis of essential hypertension; * in accordance with the diagnosis of type 2 diabetes mellitus. exclusion criteria: * non-type 2 diabetes patients * secondary hypertension * non-hypertensive patients * type 1 diabetes or other types of diabetes
comparison of two types of artificial tears

Conditions: Dry Eye Disease

Summary: hyaluronic acid (ha), a natural component of the tear film, is a well-established active ingredient in artificial tears and has been reported to improve corneal and conjunctival staining in patients with ded. thealoz duo (laboratoires thea, clermont ferrand, france) is a novel artificial tear preparation containing two active ingredients: trehalose, a naturally occurring disaccharide with anhydrobiotic functions in many organisms, and hyaluronate, a widely distributed anionic glycosaminoglycan polysaccharide with lubricative and water-retaining properties in biological systems. the purpose of the current study is to investigate the effect of the hyabak and thealoz duo in treatment of ded.

the patients will be treated with thealoz duo (at least 3 times daily) in one eye and with hyabak (at least 3 times daily) in the other eye, based on randomization table. both hyabak and thealoz duo are preservative free. the doctors who examine the patients will not get any information about the choice of artificial tears in each eye. besides the artificial tears, if necessary, the patients will receive other treatments, for instance, steroids, cyclosporine etc., according to their dry eye severity.

Eligibility criteria:
inclusion criteria: * dry eye severity level (desl) 1-3 * equivalent between-eye desl exclusion criteria: * ocular infection and/or non-linked inflammation * corneal pathology (except ksp) * corneal refractive surgery or cataract surgery within 6 months prior to the study
individualization of nutritive sensory support of radiation therapy

Conditions: Radiotherapy; Complications; Head and Neck Cancer

Summary: nutritional deficiency and subsequent weight loss in patients with head and neck cancer is a common problem and a negative predictor of treatment outcomes and mortality, as well as quality of life. nutritional support for patients is a prerequisite for the successful management of cancer patients. sensory changes can be side effects of chemotherapy or ionizing radiation, which damages sensory receptors in the area of radiation, disrupts the function of the salivary glands, leading to hyposalivation and a decrease in taste. individual choice of nutrition based on sensory sensations can significantly improve the quality of life of patients and ensure timely correction of their eating behavior.


Eligibility criteria:
inclusion criteria: * age\> 18 years * the presence of morphological verification of squamous cell carcinoma of the head and neck * no history of anticancer treatment * ecog score 0 - 2 * life expectancy is more than 3 months * normal liver, kidney and bone marrow function * absence of severe uncontrolled concomitant chronic diseases and acute diseases (including infectious diseases) * absence of pregnancy, lactation * initial compliance of patients (according to the consultation of a psychologist and questionnaires) with a signed informed consent exclusion criteria: * simultaneous participation in another clinical trial * failure to meet inclusion criteria * the patient's condition is ecog ≥3, karnovsky ≤40%. * bleeding * decay / abscess in the area of tumor lesion * pregnancy or breastfeeding * refractory cachexia * allergy or intolerance to any of the components of ons

Keywords: nutritional support radiotherapy head and neck cancer complications
a clinical study to evaluate the safety and efficacy of elagolix in subjects with moderate to severe endometriosis-associated pain

Conditions: Endometriosis

Summary: a randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.

this is a phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. the study consists of 4 periods: 1) washout period (if applicable); 2) a screening period of up to 100 days prior to first dose; 3) a 6 month treatment period; and 4) a post treatment follow-up period of up to 12 months (if applicable). an electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. pregnancy testing will be performed monthly throughout the study.

Eligibility criteria:
inclusion criteria: 1. premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent. 2. clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into washout (if applicable) or screening. 3. agrees to use required birth control methods during the entire length of participation in the study. 4. subject has a composite pelvic signs and symptoms score total score of ≥ 6 at screening with a score of at least 2 for dysmenorrhea and at least 2 for non-menstrual pelvic pain. 5. subjects must have at least two menstrual cycles 24 to 38 days within the screening period, prior to day 1 exclusion criteria: 1. subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the screening period. 2. subject has a history of previous non-response to gonadotropin-releasing hormone (gnrh) agonists, gnrh antagonists, depot medroxyprogesterone acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary). 3. subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain. 4. clinically significant gynecologic condition identified on screening transvaginal ultrasound or endometrial biopsy. 5. subject has a history of osteoporosis or other metabolic bone disease. 6. subject has a current history of undiagnosed abnormal genital bleeding.

Keywords: gonadotropin-releasing hormone antagonist endometriosis associated pain dysmenorrhea (dys) non-menstrual pelvic pain (nmpp) elagolix
post marketing study in haemophilia b patients using nonafact® (human coagulation factor ix)

Conditions: Hemophilia B

Summary: in this postmarketing study, the safety of nonafact® (human coagulation factor ix) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia b.

the clinical efficacy and safety of nonafact® has been shown in two pre-authorisation studies. marketing authorisation for the eu was granted 3 july 2001. the post marketing study, which evaluates the clinical efficacy, immunogenicity and safety of nonafact®, is set up according to cpmp/bpwg /198/95, rev. 1 (final, london, 19 october 2000) 'note for guidance on the clinical investigation of human plasma derived factor viii and ix products'

Eligibility criteria:
inclusion criteria: * haemophilia b (mild, moderate or severe), haemophilia b leyden or symptomatic carriers of haemophilia b and haemophilia b leyden * above the age of six, at the moment of inclusion * tested positive for hav and hbv antibodies, induced by infection or vaccination, and negative for hbsag * informed consent signed by the patients or his legally accepted representative exclusion criteria: * under the age of six, at the moment of inclusion * tested negative for hav and hbv antibodies

Keywords: haemophilia b factor ix product surveillance, postmarketing plasma products
eccentric exercise in epicondylitis

Conditions: Tendinopathy

Summary: there is more and more evidence of the importance of the role of kinesitherapy in the management of epicondylitis, specifically (but not exclusively) of eccentric exercise. since eccentric kinesitherapy, when applied in a systematic way by a physiotherapist, consumes time and human resources in a significant way, and in the case of such a prevalent pathology, it is frequent that strategies of training the patient are addressed so that this is who perform the exercises after learning them. however, it is not proven that the efficacy and safety of this approach is equivalent to treatment applied by a physiotherapist. a randomized single-blind controlled trial is conducted that compares both treatment approaches for epicondylitis (eccentric exercises applied directly by a physiotherapist for 10 sessions, and eccentric exercises applied by the patient during the same time) in terms of efficacy against pain, functionality and patient satisfaction, all this within the framework of the public health system.

the main objective of this study is: to compare the efficacy of an eccentric exercise program applied to patients with epicondylosis by a structured manual program in ten sessions and by an illustrated booklet. the specific objectives of this study are: compare the effectiveness of the above-cited approaches in terms of pain compare the effectiveness of the above-cited approaches in terms of function compare the effectiveness of the above-cited approaches in terms of satisfaction

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years old * epicondylosis of three or more months of evolution. * acceptance of the voluntary participation in the study and signature of the informed consent. exclusion criteria: * generalized musculoskeletal pain. * rheumatological affections involving of the upper limb. * cervicobrachialgia. * previous trauma in upper limb. * neurological or other pathology that may interfere with the function of the upper limb. * being out of work or in litigation due to the pathology of the upper limb.

Keywords: epicondylitis tennis elbow eccentric exercise
how accurate infanib is among hospitalized preterm infants

Conditions: Preterm Infants

Summary: reliability of infant neurological international battery (infanib) among hospitalized preterm infants will be checked. this study will mainly focus on test-retest reliability.

background: nicu is a specialised intensive care unit that treats and cares for premature or critically ill newborn babies. a special category of high-risk babies consists of premature infants. their motor growth differs from that of healthy full-term infants and their occurrence of motor disorders is greater. the outcome of neuromotor disorders can be substantially changed by treatments during the first year of life. so in order to detect these neuromotor disorder there must be a reliable screening tool present. hence, in this study we will check reliability of infanib. purpose: reliability of infanib among hospitalized preterm infants. methodology: it will be an observational study and will be carried out in neonatal intensive care unit (nicu). the study will recruit preterm infants that are stable and are present without any respiratory assistive devices. infanib screening tool will be performed on these infants. it has 20 items that measure the state of the infant for body tone and posture, primitive reflexes and french angles in the supine, prone, sitting, standing and suspended position upto 18 months. but we will take only preterm infants so only 14 items will be assessed and infants will be scored accordingly. the main focus will be on test- retest reliability. discussion: a similar research has been carried out in iran and china, that established that reliability of infanib is excellent. another research was carried out in india that stated infanib's reliability to be low. so this study is required to be carried out in india to know the actual results.

Eligibility criteria:
inclusion criteria: 1. preterm neonates. 2. stable neonates. exclusion criteria: 1. unstable neonates. 2. neonates on respiratory assistive devices.

Keywords: neonatal preterm nicu newborn infanib
extension study to evaluate safety and efficacy of jaktinib in patients with active ankylosing spondylitis(as)

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to determine if jaktinib is safe and effective in participants with active ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: * the investigators concluded that the participants continued to benefit from treatment with jaktinib. * the participants have been fully informed and voluntarily signed informed consent. * the participants completed the zgjak029 study for 16 weeks of treatment and visitation and had good compliance. * the interval between the participants' first dose and the last dose of zgjak029 ≤ 4 weeks. exclusion criteria: * there were any grade ≥3 adverse events within 4 weeks prior to enrollment and no return to grade 1 or normal. * within 4 weeks prior to enrollment, participants had the following infectious diseases: tuberculosis infection requiring treatment; hiv-positive, syphilis, hbv infection, hcv infection. * the investigators considered participants unsuitable for this study.
esophageal dysmotility and dilatation after laparoscopic gastric banding

Conditions: Esophageal Motility Disorders

Summary: the purpose of this study is to determine whether esophageal dysmotility and dilatation is an important complication in the long term follow-up following laparoscopic gastric banding for morbid obesity.

using a yearly barium swallow the diameter of the esophagus will be monitored over the period.

Eligibility criteria:
inclusion criteria: * bmi more than 40 exclusion criteria: * bmi below 40

Keywords: laparoscopy adjustable gastric banding morbid obesity esophageal motility esophageal dilatation
mechanisms of lv remodeling in hypertensive patients working on a rotational expeditionary basis in the arctic

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: the main goal of our investigation is to study the mechanisms of formation of left ventricular remodeling in patients with hypertension, working on a rotational expedition basis in the arctic.

hypothesis: in patients with hypertension working in the conditions of the arctic shift, the combination of climatic and geographical factors and rotational expeditionary method of labor contributes to the increase in the left ventricular remodeling processes and leads to the formation of heart failure with preserved ejection fraction.

Eligibility criteria:
inclusion criteria: * the patient signed the informed consent exclusion criteria: * valvular pathology of the heart * past cardiac or cerebral complications * identified heart rhythm disturbances * coronary heart disease * patients with severe somatic pathology, whose prognostic survival rate does not exceed 1 year * the presence of a mental disorder of organic origin

Keywords: hypertension arctic rotational shift work echocardiography
safety study of gsk biologicals' dtpa-ipv/hib (infanrix™-ipv/hib)

Conditions: Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria; Tetanus; Poliomyelitis

Summary: this study will evaluate the safety and reactogenicity of infanrix-ipv/hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.


Eligibility criteria:
inclusion criteria: * a male or female infant between, and including, 60 and 90 days of age at the time of the first study visit. * born after a gestation period of 36 to 42 weeks inclusive. * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis b vaccine. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or hib disease. * previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or haemophilus influenzae type b diseases. * history of seizures or progressive neurological disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. the following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: • current febrile illness or axillary temperature \> 37.0 ºc or other moderate to severe illness within 24 hours of study vaccine administration.

Keywords: combined vaccine
diagnosis et treatment of asthma in athlete : boundary between disease and doping

Conditions: Asthma

Summary: this study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise.


Eligibility criteria:
inclusion criteria: * patient who hold a license in a sport federation, and do at least 8 hours of sport each week * asthmatic patient exclusion criteria: -

Keywords: asthma athlete
a study to evaluate the effect of sage-718 on cognitive function in participants with huntington's disease (hd)

Conditions: Huntington's Disease

Summary: the primary purpose of this study is to evaluate the effect of sage-718 on cognitive performance and functioning in participants with hd.


Eligibility criteria:
inclusion criteria: 1. meet all the following criteria for hd at screening (days -28 to -2): 1. genetically confirmed disease with huntingtin gene cag expansion ≥36. 2. at screening, uhdrs-total functional capacity (tfc) score \&amp;gt;6 and \&amp;lt;13 suggesting no more than a moderate level of functional impairment. 3. no features of juvenile hd. 2. score of 15 to 25 (inclusive) on the montreal cognitive assessment (moca) at screening indicating the presence of cognitive impairment. 3. be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study. 4. be ambulatory (use of assistance devices such as a walker or cane is acceptable, as is occasional use of wheelchair, as judged by the investigator. individuals requiring a wheelchair on a regular basis are excluded), able to travel to the study center, and, as judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study. 5. completion of huntington's disease cognitive assessment battery (hd-cab) trail making-b test in less than 240 seconds at screening (days -28 to -2). exclusion criteria: 1. have participated in a previous clinical study of sage-718, have previous exposure to gene therapy, have participated in any hd investigational drug, biologic, or device trial within 180 days, or a non-hd drug, biologic, or device trial within 30- days or 5-half-lives (whichever is longer). (note: participants with confirmation of enrollment in the placebo arm of these trials would not be excluded.) 2. have a diagnosis of an ongoing neurodegenerative condition other than hd, including but not limited to alzheimer's disease, vascular dementia, dementia with lewy bodies, or parkinson's disease.
non-invasive brain stimulation and occupational therapy to enhance stroke recovery

Conditions: Stroke; Cerebrovascular Accident; CVA; Acute Stroke; Acute Cerebrovascular Accident; Apoplexy

Summary: the purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tdcs) combined with traditional physical-occupational therapy (ot) will improve motor function in patients with chronic stroke. the aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tdcs to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. our research in normal subjects has shown that motor skills can be enhanced if tdcs is applied to the brain's motor region during motor learning. the effects after a single session of tdcs can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. furthermore, single sessions of tdcs applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. patients enrolled in this trial will be randomized to receive either real tdcs or sham tdcs in combination with pt-ot once a day for 5 days. assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. patients are also blinded as to whether they are receiving real or sham tdcs. we hypothesize that real tdcs applied to the motor regions in combination with pt-ot results in a subsequent improvement in motor function of the recovering hand over sham tdcs in combination with pt-ot.


Eligibility criteria:
inclusion criteria: * first time clinical ischemic stroke or cerebrovascular accident * at least 5 months out from first ischemic stroke prior to study enrollment exclusion criteria: * more than 1 stroke (older strokes) * significant pre-stroke disability * a terminal medical illness or disorder with survival of less than 1 year * co-existent major neurological or psychiatric diseases (e.g., epilepsy) * use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents * active participation in other stroke recovery trials testing interventions

Keywords: stroke ischemia infarction cerebrovascular disorder central nervous system diseases brain infarction brain ischemia rehabilitation recovery neurorehabilitation plasticity