Kornimate/medical-research-clean huggingface dataset:
effect of long term clarithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis in asian populations

Conditions: Bronchiectasis Adult

Summary: clarithromycin may reduce the exacerbations in middle-aged and elderly patients with non-cf bronchiectasis. the study is aimed to (a) investigate the etiologies and clinical features of patients with bronchiectasis, (b) compare the effect of clarithromycin 250mg daily on the frequency of exacerbations, quality of life and lung function, stratified according to the degree of bronchiectasis severity.


Eligibility criteria:
inclusion criteria: * patients aged 50 years or older * at least 2 or more exacerbation requiring antibiotic treatment in the past year clinically stable for at least 4 weeks prior to enrollment (defined as no symptoms of exacerbation, no requirement for supplemental antibiotic therapy) * diagnosis of bronchiectasis defined by high-resolution computed tomography (ct) scan exclusion criteria: * history of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis, * cigarette smoking within 6 months * a positive culture of non-tuberculosis mycobacteria in the past 2 years or at screening * macrolide treatment for more than 3 months in the past 6 months * oral or intravenous courses of corticosteroids within 30 days of screening * any antimicrobial treatment for lower respiratory tract infection in the last 2 weeks * unstable arrhythmia * history of coronary artery disease, or symptoms of heart disease * known allergy or intolerance to macrolides * patients with liver disease or with elevated transaminanse (aspartate aminotransferase (ast) and alanine aminotransferase (alt) levels equal to or greater than the upper limit of the normal) * concurrent medication: colchicine, calcium channel blocker, statins, amiodarone, amitriptyline, trazodone, citalopram, disopyramide, itraconazole, saquinavir, ritaonavir, atazanavir, sildenafil, tadalafil, vardenafil, theophylline, carbamazepine.
the use of earplugs on temporomandibular joint

Conditions: Ear Protective Devices; Temporomandibular Joint Disorders; Physical Therapy Modalities

Summary: the term temporomandibular joint disorder (tmd) refers to a group of disorders affecting the temporomandibular joint and/or muscles of mastication. typical symptoms are; joint noises, pain, and limited mouth opening. many therapeutic modalities have been advocated for the treatment of tmd as intraoral splints, laser, ultrasound, physical therapy, surgery, and medications with inconsistent reported results due to the multifactorial etiology of this disorder. although intraoral splints are the most widely used therapy, it has some drawbacks as being inconvenient for the patient due to their relatively large size interferes with eating and affects speech, therefore their use is mostly limited to sleeping time, which decreases its effectiveness. recently some commercial earplugs that claim to treat tmd have been introduced, however, there is no validated data regarding these appliances. thus, this study aimss to evaluate the possible effect of earplugs on myogenous tmd.


Eligibility criteria:
inclusion criteria: * pain in masticatory muscles for at least 3 months according to the dc/tmd * having a stable medication regimen for at least 1 month * age of 18-65 years * minimum pain intensity of 50 mm on a 100 mm visual analog scale (vas) * no concomitant systemic disease * natural posterior occlusion. exclusion criteria: * undergoing physical therapy * using muscle relaxants and/or nsaids * previous tmd treatment more recently than one year * major psychosocial problems * undergoing orthodontic treatment * wearing removable prosthesis * pregnancy * history of facial trauma.

Keywords: splints
alcon® ex-press® glaucoma filtration device in japanese patients

Conditions: Glaucoma

Summary: the purpose of this study is to assess the efficacy and safety of the alcon ex-press® glaucoma filtration device (ex-press) in japanese subjects with normal tension glaucoma.


Eligibility criteria:
inclusion criteria: * diagnosis of normal tension glaucoma. * indicated for filtration surgery using ex-press®. * understand and provide informed consent. * other protocol-defined inclusion criteria may apply. exclusion criteria: * women who are pregnant, lactating, or planning to be pregnant during the study period. * diagnosis of angle closure glaucoma or secondary glaucoma. * history of glaucoma surgery. * ophthalmologic surgery within the past 6 months. * difficulty with applanation tonometry measurement. * corneal dystrophy. * infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye. * severe blepharitis or dry eye. * history of metal allergy. * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma
sequential combination therapy with pd-1 antibody and peg-ifnα in chb patients

Conditions: Chronic Hepatitis B

Summary: this is a prospective study to evaluate the safety and efficacy of sintilimab (pd-1 antibody) in sequential combination with peg-ifnα-2b in na-supressed chb patients who had previously received peg-ifnα therapy.


Eligibility criteria:
inclusion criteria: * 1. 18 - 65 years old; * 2.chronic hepatitis b patients with clear diagnosis of hematology, etiology and clinical (for example: hbsag positive for more than 6 months); * 3. in virologically suppressed (hbv dna below the lower detection limit) chb patients by nas treatment, hbsag decreased by less than 0.5log in the last 6 months of peg-ifnα therapy, and then discontinued peg-ifnα at least 6 months; * 4.patients with hbv dna negative, hbeag negative, hbsag quantification ≤ 200iu/ml at peg-ifnα discontinuation and enrollment. exclusion criteria: * 1. cirrhosis; * 2.platelet count \ uln (40u/l), total bilirubin \> 2uln; * 3.history of or suspicion of hepatocellular carcinoma * 4.patients received immunosuppressive therapy or other therapy influenced study within 12 months; * 5.hepatitis a, hepatitis c, hepatitis d, hiv infection or other active infections; * 6.alcohol or drug abuse/dependence; * 7.investigator judges that the participants are not suitable for this study.
a study of shr-1802 in patients with advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: to assess the safety and tolerability of shr-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (dlt)，recommended phase ii dose (rp2d) and assess objective response rate (orr) assessed by the investigator based on recist v1.1 criteria.


Eligibility criteria:
inclusion criteria: 1. evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; 2. eastern cooperative oncology group (ecog) performance status of 0-1; 3. has a life expectancy≥ 3 months; 4. at least one measurable lesion according to recist v1.1; 5. pathologically confirmed advanced solid tumor; 6. adequate bone marrow reserve and organ function. exclusion criteria: 1. have received prior therapy with camrelizumab, and famitinib; 2. received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment; 3. underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment; 4. have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites; 5. have known history of arterial/venous thrombosis within 6 months prior to the first dose of the treatment, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism; 6. grade ii-iv cardiac insufficiency as per the new york heart association (nyha) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the treatment; 7. have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.
the asap study - therapeutic efficacy of atovaquone-proguanil vs. artesunate-atovaquone-proguanil in cambodia

Conditions: Malaria

Summary: this is a two-arm, randomized, open label treatment study evaluating the therapeutic efficacy, safety, tolerability and pharmacokinetics of a three-day course of atovaquone-proguanil (ap) or a three-day course of atovaquone-proguanil combined with 3 days of artesunate (asap) in patients with uncomplicated plasmodium falciparum malaria at selected sites in cambodia. atovaquone-proguanil, soon to adopted as a first line antimalarial agent by the national malaria control program (cnm) in cambodia in provinces with confirmed multidrug resistance, will be given with or without artesunate (as) as a directly observed, standard three-day fixed dose combination treatment to all volunteers enrolled. the efficacy and safety of both drug combination as well as evidence for in vivo and in vitro resistance to their components will be monitored during the treatment period. all volunteers will receive a single dose of 15mg of primaquine as recommended by who with the first dose of ap or asap to block the transmission of malaria to mosquitoes. resistance to ap and asap will be assessed by a combination of clinical, pharmacologic, and parasitological parameters including genomic signatures of selection during careful weekly follow-up visits for 6 weeks. investigators will also be able to evaluate the effects of primaquine on the sexual stages of malaria (gametocytes).


Eligibility criteria:
inclusion criteria: 1. male or female with uncomplicated p. falciparum malaria (volunteers with mixed p. falciparum and p. vivax infections may be enrolled), 18-65 years of age 2. baseline asexual parasite density between 100-200,000 parasites/microl 3. able to provide informed consent 4. available and agree to follow-up for anticipated study duration including 3 day treatment course at the medical treatment facility, and weekly follow-up for the 42-day period. exclusion criteria: 1. allergic reaction or medical contraindication to atovaquone, proguanil, artesunate or primaquine, to include a calculated serum creatinine clearance estimate of less than 30ml/min 2. significant acute comorbidity requiring urgent medical intervention 3. signs/symptoms and parasitological confirmation of severe malaria 4. use of any anti-malarial within the past 7 days, or atovaquone-proguanil in the past 30 days 5. use of the following concomitant medications within 7 days, which may cause or be volunteers to significant drug-drug interactions with study drug - tetracycline, metoclopramide, rifampin, rifabutin, zidovudine or etoposide. 6. pregnant or lactating female, or female of childbearing age, up to 50 years of age, who does not agree to use an acceptable form of contraception during the study 7. judged by the investigator to be otherwise unsuitable for study participation
cellulose sulfate and hiv transmission among women

Conditions: HIV Infection

Summary: the purpose of the study is to determine the effect of cellulose sulfate on the transmission of hiv to women via vaginal intercourse. the secondary objectives are the effect on the transmission of gonorrhea and chlamydia via the same route. the study hypothesis is that there will be no effect.

despite the availability of an effective hiv prevention method, i.e. the condom, the epidemic continues growing. there is thus an urgent need for additional hiv prevention methods. one of the possibilities is the use of microbicides, i.e. chemical products which may be used in the vagina or rectum with the potential to prevent hiv infection. cellulose sulfate is an hiv entry inhibitor with an in vitro effect on n. gonorrhoeae (ng) and c. trachomatis (ct) and other sexually transmitted organisms. the study assess its effect on the vaginal transmission of hiv, ng and ct among women at high risk of heterosexual sti infection (defined as having had more than two partners in the last three months and an average of three sexual acts per week). the study is randomized, triple-blinded, placebo controlled.

Eligibility criteria:
inclusion criteria: * at least 18 years old * an average of at least three vaginal sex acts per week, at least three different partners in the last three months, expecting to continue this behavior * hiv negative * willing and able to comply with the protocol exclusion criteria: * pregnancy * allergy to latex or spermicides * intravenous drug user

Keywords: hiv prevention randomized controlled trial women sexually transmitted infections hiv seronegativity
anxiety depression and rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: anxiety and depression are highly prevalent in people with rheumatoid arthritis (ra).this study is to investigate the effect of anxiety and depression on treatment response in people with ra using observational longitudinal study design.


Eligibility criteria:
inclusion criteria: * people diagnosed with rheumatoid arthritis according to the american college rheumatology (acr) criteria 2010 exclusion criteria: * none

Keywords: rheumatoid arthritis anxiety depression
acoustic neuroma: assessing the quality of life by the scale panqol of patients operated or supervised

Conditions: Acoustic Neuroma

Summary: this study has investigated the quality of life of patients with vestibular schwannoma using this specific scale prospectively, whether treated surgically or monitored.

the panqol scale (penn acoustic neuroma quality-of-life) is a specific questionnaire containing 26 items interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. the score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. this score has been translated from french into english and validated according to the reverse translation rules by usual oddon et al. three questions for this score were added, evaluating quality of life parameters that seem particularly interesting: the first regarding the difficulties in driving, the second questioning the recovery of a "normal" life, and the third assessing difficulties in working life. the questionnaires are sent to the patient in the form of a custom web link generated on the online survey platform surveymonkey, and integrated into the body of an email sent from the mailbox of the investigator hospital. there is any identifying or indirectly identifying data on the questionnaire online, guaranteeing protection of the rights of the individual. only the principal investigator and co-investigator retain the link between the coded identity of persons undergoing research used to associate personal health data and their name (s) and name (s) (correspondence table retained securely to the paper).

Eligibility criteria:
inclusion criteria: * be in possession of an acoustic neuroma (or vestibular schwannoma) confirmed in mri, unilateral, unoperated * age over 18 years * patient insured or beneficiary of a social security scheme * free, informed and express exclusion criteria: * history of surgery of the angle ponto-cerebellar or otologic * neurofibromatosis type 2 * cons-indication to mri * psychiatric pathology * pregnant or breastfeeding women
oral melatonin plus zinc supplementation in chronic fatigue syndrome/myalgic encephalomyelitis (cfs/me)

Conditions: Fatigue Syndrome, Chronic; Myalgic Encephalomyelitis

Summary: the purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in cfs/me

chronic fatigue syndrome/myalgic encephalomyelitis (cfs/me) is a complex medical condition, characterized by severe disabling fatigue with no known cause, no established diagnostic tests, and no universally effective treatment. no studies have evaluated symptomatic treatment using oral melatonin plus zinc supplementation in cfs/me. the primary endpoint was to assess the effect of melatonin plus zinc supplementation on self-reported fatigue. secondary measures included self-reported outcomes of sleep problems, anxiety/depression, dysautonomia, qol and side-effects during treatment.

Eligibility criteria:
inclusion criteria: * cfs patient based on the 1994 centers for disease control and prevention/fukuda definition. * patient who provided signed informed consent. exclusion criteria: * patients who are participating in another clinical trial of the same or different nature previous 30 days prior to inclusion. * any subject that, in the judgment of the investigator, is not able to follow the instructions or to perform a good completion of the treatment. * subjects that do not provide signed informed consent. * patients who are receiving any of the drugs or products that may interfere with the results, and whose withdrawal could be a relevant medical problem. * patients receiving oral anticoagulants. * pregnancy or lactation * patients with hypersensitivity to melatonin and/or zinc.

Keywords: melatonin zinc myalgic encephalomyelitis chronic fatigue syndrome sleep pain
extracorporeal shock wave therapy for pain-relief after arthroscopy for osteochondral lesions of the talus

Conditions: Osteochondral Lesion of Talus

Summary: arthroscopic surgery is effective in treating osteochondral lesions of the talus. however, there are still some patients with postoperative ankle pain. this study aims to investigate the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy and to provide basis for further popularization and application.

arthroscopic surgery is effective in treating osteochondral lesions of the talus. however, there are still some patients with postoperative ankle pain. this study was conducted to investigate the clinical efficacy of shock wave therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy. patients with osteochondral lesions of the talus treated by arthroscopic microfracture surgery and still complained ankle pain three months after surgery were enrolled. radial extracorporeal shock wave therapy was used to give energy to the injured region of the talus and the adjacent area.treatment was done once a week for 5 consecutive weeks. after shock wave therapy,the patients were followed by visual analogue scale (vas), the american orthopaedic foot and ankle society ankle-hindfoot scale(aofas-ahfs) , and followed finally by magnetic resonance imaging(mri) of the ankle.

Eligibility criteria:
inclusion criteria: 1. for arthroscopy: * ankle pain, aggravated after exercise or weight-bearing activity, accompanied by lameness, joint stiffness and dysfunction for at least 3 months * no talar collapse * talar cartilage injury cases before stage ⅳ of hepple classification 2. for shock wave therapy: * patients with micro-fractures treated with arthroscopic treatment of talar cartilage injury and were treated with routine rehabilitation training after arthroscopy * patients who till complained obvious ankle pain 3 months after surgery exclusion criteria: * severe cardiovascular and cerebrovascular diseases * hemorrhagic diseases, coagulation disorders * bone immaturity * thrombosis * use of anti-immune agents * various types of tumor patients * pregnant women * history of mental illness * patients who could not be followed * patients with other lower extremity injuries after surgery and were unwilling to participate in the study

Keywords: extracorporeal shock wave therapy osteochondral lesions of talus arthroscopy pain-relief
magnesium is associated with qol in copd: a cross-sectional study

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of this study was to investigate the associations between serum concentrations of vitamin d, magnesium and calcium in chronic obstructive pulmonary disease patients and the potential impact of these parameters on lung function and quality of life.

attention is enhancing worldwide on the increasing tendency of insufficient 25-hydroxyvitamin d serum levels. new insights into the role of vitamin d and distribution of its receptors in the human body have been revealed. presumably, this entails implications concerning disease and treatment that go far beyond the well-known field of bone-metabolism. vitamin d deficiency is common in patients with chronic obstructive pulmonary disease (copd), and reductions in vitamin d serum levels have formerly been perceived as a consequence rather than a cause of copd. yet, there is a lack of consensus concerning the role of vitamin d on the decreasing lung function in copd. some trials have revealed a high degree of co-variation between the grade of airway obstruction, intake of vitamin d and reduction of serum-vitamin d. other claim that vitamin d appears to be capable of inhibiting pulmonary inflammatory responses. vitamin d interacts with calcium and magnesium and this subtle balance might be highly relevant in the progression of inflammatory diseases like copd. presumably, mg inhibits contraction and relaxes smooth muscles in airways due to blocking of calcium-ion-flux across the cell membrane. the aim of this study is to investigate the status of vitamin d, magnesium and calcium in copd, and to study the relationship and impact of vitamin d, magnesium and calcium in copd-patients. the hypothesis of this study is that copd-patients with vitamin d-, magnesium- and calcium supplement have a better lung function and quality of life, than those who have vitamin d-, magnesium- and calcium deficiency.

Eligibility criteria:
inclusion criteria: * copd-patients * unchanged medical treatment for copd for the last 4 weeks * outpatients * adults over 40 years exclusion criteria: * copd exacerbation, which resulted in hospitalization and/or modification of medical treatment within 4 weeks * patients with other lung diseases, such as active tuberculosis, lung cancer, sarcoidosis and pulmonary fibrosis * diseases affecting vitamin d and/or calcium and/or magnesium distribution * previous lung resection * treatment with systemic steroids * known addiction problems with alcohol and/or drugs

Keywords: vitamin d calcium magnesium copd qol