Kornimate/medical-research-clean huggingface dataset:
proof of concept (bone resorption/bone mineral density) study (0429-005)

Conditions: Post-Menopausal Osteoporosis

Summary: a study to asses the safety and efficacy of mk0429 in postmenopausal women with osteoporosis.


Eligibility criteria:
inclusion criteria: * person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis exclusion criteria: * person has had a previous fracture * person has rheumatoid arthritis. person has has certain types of cancer * person has donated blood or has been in another investigational study within the last 4 weeks
osteoporosis prevention: changes to exercise and diet in children

Conditions: Osteoporosis

Summary: the purpose of this study is to determine whether educating parents about health and behavior management techniques will increase physical activity, calcium intake, fitness, and bone density in their children.

in recent years, osteoporosis has become a major public health problem in the united states. osteoporosis can best be prevented by optimizing bone mineral gain and reducing bone loss. because the rate of bone development reaches its peak during adolescence, fostering bone health in childhood is of critical importance. although there have been many studies of exercise and nutritional factors that influence bone mass in adults, few randomized, prospective studies have been conducted in children. this study will determine whether parent training is effective in increasing children's calcium intake, strength, and frequency of aerobic exercise. families will be randomly assigned to either the physical activity and nutrition intervention group or to the injury prevention control group. families in both groups will undergo training during 9 weekly classes. the intervention training will emphasize health topics, principles of behavior, and contingency management techniques. post-training coaching procedures will be provided periodically for 9 months. coaching procedures will assist parents with problem solving and help them refine and maintain parenting skills. all families will be assessed prior to training and at months 3, 9, and 12. outcome measures will include 24-hour recall estimates of change in diet and change in physical activity. total bone calcium, bone density, body composition, and skeletal age will also be assessed.

Eligibility criteria:
inclusion criteria * participates in organized sports less than 3 days a week and less than 9 months per year * parent willing to attend weekly training sessions exclusion criteria * serious medical illness * spends less than 4 days a week with the parent willing to attend classes * body mass index \> 32

Keywords: bone density children adolescents behavior health education health promotion physical fitness diet parent training injury control
to evaluate the efficacy and safety of shr0302 tablet in subjects of active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this study is a phase 3 study,to evaluate the efficacy and safety of different doses of jak1 inhibitor shr0302 in subjects with active psoriatic arthritis.


Eligibility criteria:
inclusion criteria: 1. provide signed informed consent； 2. diagnosis of psa fulfillment of the classification criteria for psa (caspar) criteria with symptom onset at least 6 months prior to the screening visit； 3. active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints； 4. diagnosis of active plaque psoriasis or documented history of plaque psoriasis. exclusion criteria: 1. history of other autoimmune diseases; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases； 2. non-plaque forms of psoriasis (with exception of nail psoriasis)； 3. previous treatment with cytotoxic drugs; jak inhibitor or bdmards within 6 months of randomization.
effect of home based swallowing exercise in stroke patients with dysphagia

Conditions: Dysphagia Following Cerebrovascular Accident

Summary: dysphagia is a common problem in post-stroke patients and greatly impaired quality of life. among them, the strength of tongue and lip muscles played a key role in the oral phase of swallowing and many stroke survivors suffered from these muscles weakness. iowa oral performance instrument (iopi) is a standardized portable device that can be used to quantify tongue muscle strength, thus allowing the clinician to set the level of resistance necessary to achieve optimal gains in strength, and also providing visual feedback of performance to the patients to guide training. in this study, we use videofluoroscopic swallowing study (vfss) to screen for the stroke patient suffering from dysphagia and recruited them into the trial. they then participated in a home based resistance-training program using the tongue depressor, 1 time everyday and each time consisted of 30 repetitions, totally 4 weeks. various tongue strength variables and subjective scale were obtained before and after the intervention. the purpose of the study was to evaluate the effect of the home based swallowing therapy in the post stroke dysphagia patients.


Eligibility criteria:
inclusion criteria: * acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities * mini-mental status examination \>20, could cooperate swallow therapy exclusion criteria: * already known dysphagia before stroke event * malocclusion or severe facial palsy * localized oral lesion interfering swallowing

Keywords: dysphagia ischemic stroke intracranial hemorrhage
a phase 2 study to evaluate the safety of apixaban in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to assess the effect of two doses of apixaban (2.5 mg bid and 5 mg bid) versus warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.


Eligibility criteria:
inclusion criteria: * age ≥ 20 years outpatient (regardless of sex) * patients diagnosed as non-valvular atrial fibrillation (nvaf) * one or more following risks of stroke. exclusion criteria: * recent cerebral infarction (includes tia) within 4 weeks of week 0. * subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (dic), congenital platelet dysfunction and von willebrand disease (those suspected from the family history are included). * subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the warfarin therapy.
cardiac surgery: in vivo titration of protamine

Conditions: Bleeding

Summary: safe use of cardiopulmonary bypass (cpb) requires massive doses of intravenous unfractionated heparin. at end-cpb, residual heparin is neutralized with intravenous injection of protamine sulfate. this prospective, randomized, controlled study will be conducted in 82 voluntary subjects admitted for elective, first intention, cardiac surgery requiring cardiopulmonary bypass. each will be randomly assigned to one of two groups. the control group will be submitted to a standard protamine infusion of 1.3mg :100u of the total heparin dose given during bypass. the test group will receive an infusion of protamine (over 15 minutes) until activated clotting time (act) values (determined every 3 minutes) depict a plateau, sign that the optimal protamine to heparin ratio has been attained. the investigators hypothesize this new in vivo titration method to be as efficient as the standard protocol (adequacy of heparin neutralization, % heparin rebound, bleeding, and transfusion), and potentially safer by its ability to prevent protamine overdose and its deleterious impact on platelet function.15 principal objective evaluate a new in vivo method of titration of protamine sulfate. secondary objective evaluate the impact of this method on the adequacy of heparin neutralization by measuring: 1. platelet count 2. postoperative bleeding 3. transfusion exposure a 4. incidence of heparin rebound

protamine sulfate is administered to reverse the anticoagulant effects of heparin upon completion of cardiopulmonary bypass (cpb). in most cases, protamine is given in amounts sufficient to neutralize the total dose of heparin.9 this dose is usually calculated with a ratio of 1.3mg protamine for every 100u heparin given.10 in the literature, reported doses of intraoperatively administered protamine range from 0 to 8mg per 100u of heparin. given in excess, protamine can, in addition to complement activation and hemodynamic instability,11 induce platelet dysfunctions.12-16 the latter significantly increases both the cost and morbidity of cardiac interventions as it is one of the main causes of postoperative bleeding. the optimal protamine/heparin ratio is difficult to individualize for each patient because of the great interpatient variability in heparin's metabolism4-7 and of the absence of correlation between act and heparin's plasma concentration.8 consumption of heparin may vary from 0.01 to 3.86u/kg per minute during cpb.30 the exact concentration of remaining circulating heparin at the end of bypass is not easily obtained.

Eligibility criteria:
inclusion criteria: * first intention, elective, cardiac surgery: either coronary artery bypass graft (cabg)or valve repair/replacement. * patients on preoperative aspirin, clopidogrel or heparin will be included. exclusion criteria: * combination of cabg and valve surgery * second intention cardiac surgery * asa 5 patients * pre-existing hemostatic disorder (as evidenced by history) * pregnancy * plavix \< 5 days before de surgery

Keywords: titration of protamine exact dose protamine neutralize heparin
a study to test the safety and effectiveness of nivolumab combined with daratumumab in patients with pancreatic, non-small cell lung or triple negative breast cancers, that have advanced or have spread

Conditions: Advanced Cancer

Summary: the purpose of this study is to determine whether a combination of nivolumab and daratumumab is safe and effective when treating pancreatic, non-small cell lung or triple negative breast cancers, that have advanced or have spread.


Eligibility criteria:
inclusion criteria: for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com * patients with metastatic or advanced solid tumors * women with histologically or cytologically confirmed triple negative breast carcinoma * participants with histologically or cytologically confirmed pancreatic adenocarcinoma * participants with histologically or cytologically confirmed non small cell lung cancer (nsclc) exclusion criteria: * active brain metastases or leptomeningeal metastases. * any serious or uncontrolled medical disorder * prior malignancy active within the previous 3 years other protocol defined inclusion/exclusion criteria could apply

Keywords: non-small cell lung cancer (nsclc) triple negative breast cancer (tnbc) pancreatic cancer (pac)
reset trial - part 1 - a phase 3 trial in subjects with sjögren-larsson syndrome (sls)

Conditions: Sjogren-Larsson Syndrome

Summary: a phase 3 randomized, double-blind, vehicle-controlled, parallel group trial to evaluate the safety and efficacy of adx-102 1% topical dermal cream in subjects with sjögren-larsson syndrome (sls).


Eligibility criteria:
inclusion criteria: * subject is aged 3 years or older * subject has a genetically-confirmed diagnosis of sls. * subject has active ichthyosis that is grade 2 or higher on the visual index ichthyosis severity (viis) score. * females of child-bearing potential: negative pregnancy test at screening and baseline visits. exclusion criteria: * subject has evidence of a serious active infection. * systemic or topical retinoids or other topical medications, not including emollients, within the past 30 days baseline visit 1. * subject has received an investigational systemic or topically administered drug within the past 30 days prior to baseline visit 1. * subject is currently receiving immunosuppressive therapy, including intermittent or low-dose systemic corticosteroids. * subject has a known allergic reaction to any ingredients of study drug formulation. * subject has any clinically significant laboratory test abnormalities or a history of any other condition that, in the opinion of the investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the study results.

Keywords: adx-102, sjögren-larsson syndrome
therapist-guided vs self-guided cbt for ad: non-inferiority trial

Conditions: Atopic Dermatitis

Summary: the study aims to test the hypothesized non-inferiority of a self-guided digital intervention compared to a therapist-guided variant for people with atopic dermatitis (ad). both interventions are based on cognitive behavioral therapy. participants will be recruited from advertisements in social media. measurements of ad symptoms and psychological well-being will be conducted at pre-treatment, post-treatment as well as 6-month and one-year follow-up.

background: digital self-care based on cognitive-behavioral therapy (cbt) could be an effective alternative to guided cbt for people with atopic dermatitis (ad) and has the theoretical potential to significantly increase access to psychological treatment for patients with ad, whilst being cost-effective for health care organizations. aim: to investigate whether a shortened digital self-care intervention is noninferior to, and cost-effective compared with, a comprehensive and therapist-guided cbt treatment for ad. intervention: participants randomized to guided care will receive internet-delivered cognitive behavior therapy for 12 weeks. participants randomized to digital self-care will have access to a self-guided intervention for 12 weeks_ design, setting, and participants: this is a single-blind, randomized clinical non-inferiority trial at karolinska institutet, a medical university in stockholm, sweden. 174 adult participants with ad will be recruited through self-referral. participants will be randomized 1:1 to the two experimental conditions. at post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. cost-effectiveness will be explored at 1-year follow-up. potential mediators will be investigated. data will be analyzed intention-to-treat.

Eligibility criteria:
inclusion criteria: * self-reported ad diagnosed by physician (potential participants will disclose the circumstances of their diagnosis) * no new types of medications introduced for six months prior, with no intention of future change * able to understand swedish * access to the internet and a smartphone exclusion criteria: * other disease or condition that has immediate treatment priority over ad. this could be an ongoing demanding treatment of a severe somatic or psychiatric condition. no specific diagnoses are inevitably a cause for exclusion, as potential participants will rather be evaluated on a case-to-case basis.

Keywords: cognitive behavioral therapy self-guided intervention digital intervention exposure therapy
a long-term prospective randomized controlled study using repetitive education at six-month intervals and monitoring for adherence in heart failure outpatients - the remadhe study

Conditions: Heart Failure

Summary: recent meta-analysis reported reduction in mortality and hospitalization of hf patients.however, important issues in dmp for hf remain to be resolved. dmp are not homogeneous concerning methodology and in general included only elderly patients; most were tested in high-risk hf patients discharged from hospital; quality of life results are controversial; few reports included long-term results; some protocols had limited enrollment of screened patients, and it was suggested that could be less effective when patients are already followed by hf specialist.improved survival was associated with cardiologist care as well with multidisciplinary teams providing specialized follow-up.whether both together could benefits hf is not well defined. also, no studies reported the long-term effects of a cyclic repetitive reeducation program.we tested whether a dmp that consisted of a long-term repetitive education program associated with a telephone monitoring could benefit hf outpatients in usual ambulatory care already under care of cardiologist with experience in hf


Eligibility criteria:
inclusion criteria: * eligible patients on ambulatory care were aged 18 years or older with irreversible chronic heart .failure with at least 6 months duration, and non planned surgical procedure or other procedure that could influence the follow-up in the next 6 months exclusion criteria: * impossibility for attendance of education sessions and monitoring based on non corrected limitations of transport, or unfavorable distance, or social, or of communication; myocardial infarction or unstable angina within 6 months before randomization; cardiac surgery or angioplasty within 6 months randomization; hospitalized patients or recent discharged patients; severe renal/hepatic/neurological/pulmonary or any systemic disease that could confuse the interpretation of results and impair expected survival; and pregnant women or women of childbearing potential.

Keywords: heart failure, disease program management, treatment, education
evaluation of the pharmacokinetics of antituberculosis drugs and tuberculosis treatment outcomes

Conditions: AIDS With Tuberculosis

Summary: tuberculosis (tb) is a leading cause of death in hiv-infected individuals. there are insufficient data correlating concentrations of anti-tb drugs with treatment response. we hypothesize that sub-therapeutic concentrations of anti-tb drugs are associated with inadequate tb treatment response to mycobacterium tuberculosis.

during the study periodic monitoring will be conducted to ensure that the protocol and good clinical practices (gcps) are being followed.the monitors may review source documents to confirm that the data recorded on crfs is accurate. the study site may be subject to review by the institutional review board (irb) and/or appropriate regulatory authorities. a crf will be completed for each included subject and will be signed by the investigator or by an authorized staff member to attest that the data is true. any corrections to entries made in the crfs, source documents must be dated, initialed and explained (if necessary) and should not obscure the original entry. qualit assurance will as also be performed regularly on the crfs. the primary end point will be analyzed using time to event (cure, death, relapse etc)analysis and failure rates and hazard ratios will be calculated accordig to categorical drug concentrations with proposed cutt offs. secondary end points will be analysed using time to event for occurence of toxicities which will also be corelated to the drug concentrations.

Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * age of ≥18 years * first episode of pulmonary tb i.e. proven or highly suspected tb considered for tb treatment qualifying for 6 months anti-tb drugs regimen * confirmed hiv-1 infection exclusion criteria: * unable to provide informed consent * documented or highly suspected tb infection of any organs/systems other than the lung requiring tb treatment longer than 6 months * previously treated for a mycobacterial infection (tb or atypical mycobacterial infection, active or latent) * pregnancy or planned pregnancy within the next year * unwillingness to perform pregnancy test * decompensated liver disease and/or aminotransferases \>5x uln * gfr \< 50 ml/min * co-morbidities reducing life expectancy to \<1 year (e.g. cancer) * patient wishes to take part in another interventional study

Keywords: hiv tuberculosis antituberculosis drugs
the safety of remote dbs programming system

Conditions: Parkinson Disease

Summary: remote programming has significant advantages over conventional programming methods on some issues. this research will test the safety of sceneray remote and wireless dbs programming system.

programming is a crucial aspect of deep brain stimulation (dbs), directly influences the final success of dbs. optimal programming helps patients achieve maximized control of clinical symptoms and higher life quality. however, there are a number of inadequacies in conventional programming methods. first, the programming probe must come into close contact with the implantable pulse generator (ipg) and test stimulator to complete programming. and during initial postoperative programming, only the parameters of one patient can be ascertained. in addition, the same frequency is typically used in the left and right brain for dual channel ipg. the patient also need to repeatedly travel between their home and the hospital, leading to increased time and expense. therefore, the investigators developed the sceneray wireless and remote dbs system to address the outline issues. this system has significant advantages over conventional programming methods on all the issues above. this research will test the safety of this remote and wireless dbs programming system.

Eligibility criteria:
inclusion criteria: * primary pd patients volunteered to receive dbs surgery with sceneray wireless and remote dbs system, * age 18-75 years, * achieved optimal control of clinical symptoms after coventional programming for 3-12 months, * significant difference in motor function when dbs is switched on/off, * good compliance and easy to follow-up, exclusion criteria: * no significant improvement or clinical efficacy in symptoms after surgery, * severe cognitive impairment due to dementia (mini-mental state examination score: illiteracy \<17, elementary school \<20, junior high school or above \<24) or inability to accurately record in a diary, * active psychosis or a history of psychosis, * serious heart, liver, or kidney diseases, * severe hypertension or orthostatic hypotension, severe diabetes, or diabetes accompanied by brain and cardiovascular diseases, * malignant cancer, brain injuries, epilepsy, or other unstable medical conditions, * severe alcohol dependence or drug abuse, * any situation that may jeopardize the patient's safety or lead to a failure to participate in the study (medical, psychological, social, or georational factors) at present or in the future, * participating in other clinical trials, * other factors that researchers think may not be suitable for research.