Kornimate/medical-research-clean huggingface dataset:
efficacy of trapeziectomy versus sham surgery in the treatment of osteoarthritis at the base of the thumb

Conditions: Thumb Osteoarthritis

Summary: a multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. the primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.

a multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (cmc1). the primary outcome is patient reported wrist and hand evaluation (prwhe) at 6 months after the randomization to treatment group. secondary measures include prwhe at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.

Eligibility criteria:
inclusion criteria: 1. primary thumb basal joint (cmc1) osteoarthritis (eaton glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living 2. indication for surgical treatment of thumb basal joint (cmc1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (nsaids or paracetamol, implemented for at least three months. 3. thumb pain in use of at least 4 on a 0 to10 numerical rating scale (nrs, 10=worst pain) 4. age \> 45 years 5. asa-classification i-ii (american society for anesthesiologist's physical status classification system) 6. ability to speak, understand and read in the language of the clinical site 7. provision of informed consent from the participant exclusion criteria: 1. patients' main complaint is due to some other problem than primary thumb basal joint (cmc1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy 2. neurologic condition affecting the function or symptoms of the upper extremity 3. \<6 months from other surgical procedure of the upper extremities 4. rheumatoid arthritis or other inflammatory joint disease 5. bilateral thumb basal joint (cmc1) osteoarthritis in which patient requests treatment for both sides 6. previous operation due tothumb basal joint (cmc1) osteoarthritis for either side 7. \>45 degrees of hyperextension in the thumb mp joint in resting position (zig zag deformity) 8. patient is unable to continue his/her current job due to thumb pain
high intensity laser therapy in the treatment of hemiplegic shoulder pain

Conditions: Hemiplegia

Summary: high intensity laser therapy (hilt) has been considered as a treatment option for shoulder pain. to our knowledge, the effectiveness of hilt in patients with hemiplegic shoulder pain (hsp) with partial thickness rotator cuff tear (ptrct) is unknown. in this study, we intended to investigate the effectiveness of hilt on pain, disability, function and quality of life in patients with hsp accompanied by ptrct.

the study was designed as prospective, randomized, controlled trial. patients with hsp accompanied by ptrct (n=44) were randomly assigned to hilt and control groups. group 1 (hilt group, n=22) received 3 sessions of hilt per week for 3 weeks in addition to the exercise program which performed 5 sessions per week for 3 weeks. group 2 (control group, n=22) received an exercise program for hsp of 5 sessions per week for 3 weeks. participants were evaluated with visual analog scale (vas), passive range of motion (rom), shoulder pain and disability index (spadi), nottingham health profile (nhp), functional independence measure (fim) and ultrasonographic ptrct size.

Eligibility criteria:
inclusion criteria: * patients with hsp (at least 4/10 points from vas) aged 18-75 years with hemiplegia duration\> 6 months, suffered a stroke resulting in unilateral hemiplegia for the first time, and who had partial thickness rct after ultrasonographic evaluation due to shoulder pain exclusion criteria: * cases who had inflammatory rheumatic disease, cervical radiculopathy, diabetes mellitus, thyroid disease, coronary heart disease, cardiac pace-maker, neurological disease, shoulder surgery, and shoulder injection in the last 3 months

Keywords: hemiplehic shoulder pain rotator cuff tear high intensity laser therapy exercise ultrasound
benzac 5% gel in combination with cosmetic products in acne vulgaris

Conditions: Acne Vulgaris

Summary: the aim of this study is to evaluate a complete acne regimen consisting of a medication (benzaknen® 5% gel), and 2 cosmetic products dermotivin® soft liquid soap and cetaphil® dermacontrol moisturizer spf30 in patients with acne.

the main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising benzaknen® 5% gel in association with 2 cosmetic products including a foam soap, dermotivin® soft liquid soap, and a non comedogenic moisturizer, cetaphil® dermacontrol moisturizer spf30, in patients with mild to moderate acne, after 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * male or female subject of any ethnic background of 12 years or older. * subject with mild or moderate facial acne vulgaris defined as an investigator global assessment (iga) score at 2 or 3 on a 0-4 scale. * subject with any skin phototype according to t.b. fitzpatrick skin phototype definitions. exclusion criteria: * subject with severe acne (iga\>3) with nodules, cysts, scars or extra-facial lesions, * female subject who is pregnant, lactating or planning a pregnancy during the study, * subject susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face,
at278 and novorapid® in glucose clamp study

Conditions: Diabetes Mellitus, Type 1

Summary: a phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. the study compares the pharmacodynamic, pharmacokinetic and safety characteristics of at278 and novorapid® in male participants with type 1 diabetes.


Eligibility criteria:
inclusion criteria: 1. diagnosis of type 1 diabetes for at least 12 months 2. receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months 3. hba1c concentration ≤8.5% at screening 4. weight within the range 75kg - 100kg (both inclusive) exclusion criteria: 1. known or suspected hypersensitivity to investigational medicinal products 2. clinically significant concomitant disease or abnormal lab values 3. supine systolic bp outside range 95-140mmhg and/or diastolic bp greater than 90mmhg
effect of u-health service in stroke patients

Conditions: Stroke

Summary: provides mobile programs for occupational and speech therapy to patients with stroke.


Eligibility criteria:
inclusion criteria: * stroke confirmed by brain imaging study * impairment in upper extremity function or speech * native speaker of korean exclusion criteria: * previous history of aphasia * psychiatric or psychotic problem * severe cognitive dysfunction * severe hearing or visual loss * cannot sit with devices
platelet-rich plasma in acute muscle injuries

Conditions: Muscle Injury

Summary: objective: to evaluate the effect of platelet rich plasma (prp) injection in muscle injuries. the investigators check football players in the acute phase of hamstrings or quadriceps injuries. efficacy and safety are evaluated. there are two intramuscular infiltration of prp (ortho pras ® system) or a homeopathic product (traumeel ®) in each of the football players. the number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.

study design: randomized clinical trial. methods: 41 football players are included in the study. it is used randomly prp injection or a homeopathic product in muscle injuries (hamstring), in the early stage (first 48-72 hours). one week later, the investigators do a second infiltration with the same product, always ultrasound guided. 3-4 weeks after the injury, different variables are evaluated: the injurie with ultrasounds , self-perception test, muscle strength, flexibility, jump and run. it is compared the elapsed time in days in each of the groups: return to play. furthermore, the pain, recurrence rate and adverse reactions are evaluated.

Eligibility criteria:
inclusion criteria: * over 18 years old. * acute muscular injury type 3a-3b (múnich classification) in hamstring muscles * informed consent signed exclusion criteria: * hamstring injury (last 6 months). * previous infiltration in hamstring.

Keywords: platelet-rich plasma hamstrings cuadriceps football players
hypertension and retinal microvascular dysfunction

Conditions: Hypertension

Summary: hypertension is a worldwide health care burden that affects the structure and function of the macro- and microcirculation. non-invasive vascular biomarkers are essential to timely diagnose end organ damage to improve cardiovascular (cv) risk stratification and medical decision making. the "hypertension and retinal microvascular dysfunction" (hypervasc) trial will investigate macro- and microvascular impairments in hypertensive patients and healthy controls to investigate hypertension-induced end organ damage by using gold-standard methods as well as newly developed and unique retinal microvascular biomarkers. additionally, this trial will investigate the reversible effects of an eight weeks supervised and walking based high-intensity exercise intervention on blood pressure as well as macro- and microvascular health, compared to a control group with standard physical activity recommendations. secondary outcomes will be cardiorespiratory fitness, physical activity, microalbuminuria, hypertensive retinopathy, and classical cardiovascular risk marker. the results of the hypervasc trial will improve the understanding of hypertension-induced vascular impairments and will push the development of non-invasive vascular biomarker to screen end organ damage in general cv risk stratification.


Eligibility criteria:
inclusion criteria: * men and women between 40 and 70 years of age * hypertension (≥90 mmhg diastolic or ≥140 mmhg systolic bp during 24h monitoring or hypertensive medication) or normal blood pressure (≤85 mmhg diastolic and ≤130 mmhg systolic bp during 24h monitoring and no hypertensive medication). exclusion criteria: * any cardiovascular (cv) medication (accept for hypertensive medication in the hypertensive group) * history of cv, pulmonary, or chronic inflammatory disease * active smoking status * any chronic eye disease.
fibromyalgia outcome research trial evaluating synergistic suppression of hsv-1

Conditions: Fibromyalgia

Summary: randomized, double-blind, placebo-controlled, 16-week study designed to explore the safety and efficacy of imc-1 for the treatment of patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * the patient is female, 18 to 65 years of age, inclusive. * the patient has a diagnosis of primary fm as defined by the 2016 revisions to the 2010/2011 fibromyalgia diagnostic criteria (american college of rheumatology preliminary diagnostic criteria) * the in clinic 7-day recall vas scale average daily pain intensity score at screening visit within protocol defined range. exclusion criteria: * any underlying medical or psychiatric condition that could impact their safe participation per protocol.

Keywords: pain
the effect of white noise in patients undergoing lumbar disc herniation surgery

Conditions: Disc Herniation

Summary: the aim of this clinical trial is to determine the effectiveness of listening to white noise on the sleep quality, comfort level, satisfaction level of patients after lumbar disc herniation surgery. the main hypotheses are: * is there a difference between the sleep quality of patients who listen to white noise and those who do not? * is there a difference between the comfort levels of patients who listen to white noise and those who do not? * is there a difference between the satisfaction levels of patients who listen to white noise and those who do not? the main tasks that the participants will be asked to do will be explained and their informed consent will be obtained. the two research groups will be compared.

this study will be conducted with a total of 60 patients who underwent surgery for lumbar disc herniation at a hospital in istanbul. participants in the study who had lumbar disc herniation surgery will be divided into two groups: intervention (n = 30) and control group (n = 30), according to the randomization method created with computer-based random numbers. on the 0th and 1st postoperative days, patients in the intervention group will listen to white noise with a bluetooth headset for 30 minutes before going to sleep, and they will be kept under observation during this time.patients in the control group will be monitored according to their routine clinical procedures. since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed. patients in the control group will also be followed up at the same times and with the same forms. descriptive characteristics form, informed consent form, the richards-campbell sleep questionnaire, general comfort questionnaire,visual analog scale for satisfaction level will be used in data collection.

Eligibility criteria:
inclusion criteria: * underwent lumbar disc herniation surgery * hospitalized for at least 48 hours * agreed to participate in research exclusion criteria: * chronic sleep problems and taking medication * not filling out the questionnaire

Keywords: lumbar disc herniation white noise sleep quality comfort level
aspirin in immune thrombocytopenia patients with cardiovascular disease

Conditions: Purpura, Thrombocytopenic

Summary: the incidence of immune thrombocytopenia increases with older age. this population is at risk for arterial thrombosis. due to an increased turn-over of platelets, low-dose aspirin once daily may be insufficient in this population to protect against arterial thrombosis. this study is aimed at assessing the pharmacodynamics of aspirin once daily on platelet function in these patients.

the incidence of immune thrombocytopenia increases with older age. about 20% of patients who develop immune thrombocytopenia are exposed to low-dose aspirin for arterial thrombosis prophylaxis. moreover, immune thrombocytopenia patients have an increased risk for developing arterial thrombosis as compared with matched controls from the general population. because itp patients have an increased turn-over of platelets and aspirin is an irreversible inhibitor of cyclooxygenase-1, aspirin taken once daily may be insufficient to provide stable inhibition of platelet function. this has been demonstrated in myeloproliferative neoplasms with a higher platelet turn-over as well; aspirin is given twice daily to these patients. in immune thrombocytopenia, epidemiological findings sustain this assumption because aspirin is not associated to an increased risk of bleeding. the primary aim of this study is to assess the residual platelet function after 75 mg aspirin intake (h24). secondary objectives are to assess the kinetics of platelet function after daily 75 mg aspirin intake and the relation with arterial thrombosis.

Eligibility criteria:
inclusion criteria: * adult patients * non-treated immune thrombocytopenia or immune thrombocytopenia with stable treatment (at least 1 month) * treated with aspirin daily for a cardiovascular disease; stable platelet count \< 100 x 109/l * at least one month following an arterial thrombosis * no other antiplatelet drug and anticoagulant * female patient with childbearing potential must have acceptable method of birth control * affiliated or benefiting from public health insurance exclusion criteria: * opposition to participate * adults under guardianship or other legal protection * deprived of their liberty by judicial or administrative decision * pregnancy or breastfeeding

Keywords: immune thrombocytopenia aspirin pharmacodynamics proof-of-concept study
protopic ointment in adult atopic eczema of the face

Conditions: Dermatitis, Atopic

Summary: patients with facial atopic eczema and a poor response to topical corticosteroid applied either protopic or fluticasone ointment twice a day for 3 weeks. they could continue during 3 more weeks once a day if needed or change for the other ointment.

treatments were to be applied twice daily over all lesions on the face (except for the eyelids) until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. in the event of a flare-up the treatment was to be resumed twice a day until the end of the study.

Eligibility criteria:
inclusion criteria: * moderate to severe ad (rajka \& langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term ad * at least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated * female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study * informed consent * therapeutic washout for atopic dermatitis treatments exclusion criteria: * genetic epidermal barrier defect, such as netherton's syndrome, or suffering from erythroderma * seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin * clinical infection due to the vzv virus (varicella, zona), hsv1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum * superinfected eczema * known hypersensitivity to macrolides or to any other excipient in tacrolimus 0.1% ointment * known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation * ulcerated lesions, of whatever type * moderate to severe acne or rosacea * patients who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study * any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up * serologically-proven hiv positivity

Keywords: dermatitis, atopic dermatologic agents topical drug administration tacrolimus calcineurin corticosteroid fluticasone propionate face
time-restricted eating and interval training with digital follow-up

Conditions: Overweight and Obesity

Summary: this study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. participants in the intervention group will complete the intervention remotely and will receive weekly follow-up through online platforms (telephone, video call). before and after the intervention, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. secondary sub-analyses of sex differences in the responses to the intervention will be performed.


Eligibility criteria:
inclusion criteria: * body mass index ≥ 27 kg/m² * able to walk or ride a bike \> 60 min exclusion criteria: * on-going pregnancy * lactation within 24 weeks of study commencement * high-intensity exercise ≥ 1/week * habitual eating window ≤12 hours/day * taking hypertension, glucose-, or lipid-lowering drugs * body mass variation ≥ 4 kg three months prior to study commencement * known diabetes mellitus (type 1 or 2) or cardiovascular disease * working night shifts

Keywords: time-restricted eating high-intensity interval training exercise diet body composition
effects of human leptin replacement

Conditions: Obesity; Metabolic Syndrome; Diabetes

Summary: this study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.

the study aims to elucidate the role of leptin in the regulation of human endocrine function approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world so far who are leptin-naive due to a functional leptin gene mutation. a study of leptin-naive subjects avoids all confounding factors and pitfalls, because the only bioactive leptin to which they will be exposed is the exogenously administered recombinant protein. thus, this proposal will permit us to ascertain the endocrine effects of human leptin.

Eligibility criteria:
inclusion criteria: * congenital leptin deficiency (these are only 3 adult individuals in the world that have been identified as leptin-naïve thus far). exclusion criteria: * pregnant, trying to become pregnant, breast-feeding an infant or sexually active women, not using contraception. * subjects with hemoglobin levels below 12 g/dl. * subjects whose body contains a ferromagnetic implanted device that might produce a safety hazard during fmri.

Keywords: congenital leptin deficiency obesity metabolic syndrome diabetes
eradication rates of helicobacter pylori and its affecting factors

Conditions: Helicobacter Infections

Summary: the purpose of this study is to investigate the trend of eradication rates of first-line triple therapy for helicobacter pylori in recent ten years and clinical factors that affect the eradication in korean.

a ppi triple regimen combining a proton pump inhibitor(ppi) with two antibiotics (amoxicillin and clarithromycin) is currently considered the gold standard therapy for eradication of h. pylori. however, recently the eradication rate with first-line treatment has a tendency to decrease because of increasing antibiotics resistance. in addition, ppi is mainly metabolized by cytochrome p450 2c19 (cyp2c19) in the liver and several reports have suggested that differences in th cyp2c19 genotype are associated with h. pylori eradication failure. thus, the first aim of this study is to investigate the trend of eradication rates of first-line triple therapy in recent ten years. and the second aim is to analyze the antibiotics resistance rate for h. pylori by using culture minimal inhibitory concentrations(mics) result and to analyze the association between cyp2c19 genotype and eradication rate of h.pylori. and also investigate the other clinical factors (age, gender, underlying disease, cigarette smoking and alcohol use) that affect the eradication rate.

Eligibility criteria:
inclusion criteria: * patients who proven h. pylori infection by invasive or non-invasive h. pylori test * patients treated with first-line triple therapy (ppi + amoxicillin + clarithromycin) exclusion criteria: * previous eradication therapy for h. pylori * follow-up loss patients after eradication therapy * other treatment regimen * poor medication compliance (\<80%)