Kornimate/medical-research-clean huggingface dataset:
evaluation of clinical outcomes following implantation of a sub-2mm hydrophilic mics intraocular lens

Conditions: Cataract

Summary: the objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (mics) and intraocular lens (iol) implantation. this study is evaluated in two phases * v4 (6m) endpoint: primary analysis * v5 (12m) and v6 (34m): epco score and nd yag incidence analysis


Eligibility criteria:
inclusion criteria: * subjects must have clear intraocular media other than cataract in the study eye. * subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye. exclusion criteria: * subjects with ocular malformation in the study eye. * subjects who have had previous surgery in the study eye. * subjects with uncontrolled glaucoma in either eye. * subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated * subjects using medications known to potentially complicate cataract surgery.
light therapy in end stage kidney disease

Conditions: End Stage Renal Disease

Summary: the goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. the main aim is to determine if light therapy decreases fatigue severity. participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment.

in a single site, 2-arm (bright light therapy group; dim light group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of bright light therapy compared to dim light therapy in subjects with end stage kidney disease who are receiving hemodialysis to treat fatigue. * to compare the effects of bright light therapy to dim light therapy on fatigue severity. * to explore the effects of bright light therapy to dim light therapy on salivary cortisol. * to compare the effects of bright light therapy to dim light therapy on insomnia, depression and quality of life. * to test the effects on bright light therapy to dim light therapy on physical activity levels.

Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to initiation of any study mandated procedure 2. male and female participants ≥ 18 years of age 3. diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month 4. fatigue severity scale (fss) \> 9 at enrollment 5. home refrigerator for salivary cortisol storage exclusion criteria 1. eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration) 2. participants with photosensitivity (e.g. epilepsy) 3. hospitalized or acutely ill
diagnostic study of patients with acute lymphoblastic leukemia or acute promyelocytic leukemia

Conditions: Leukemia; Acute Lymphoblastic Leukemia; Acute Promyelocytic Leukemia

Summary: this research trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute promyelocytic leukemia in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

objectives: 1. to perform quantitative pcr using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed apl and all and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome. 2. to evaluate the expression of novel genes or micrornas implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of patients with apl and all and to correlate expression level with other biological features and treatment outcome. 3. to evaluate the clinical significance of sequential quantitative mrd measurements using real-time quantitative pcr and/or flow cytometry during and following treatment of all and apl and correlate these findings with efficacy of novel treatment approaches and with other biological and clinical prognostic features. 4. to compare measurement of mrd in blood with bone marrow specimens in sequential remission specimens of patients receiving treatment on all and apl treatment trials.

Eligibility criteria:
* patients with a diagnosis of acute lymphoblastic leukemia (all) entered onto calgb treatment trials for previously untreated all must be enrolled on calgb 9862. entry on calgb 8461 is strongly encouraged. * patients with a diagnosis of acute promyelocytic leukemia (apl) enrolled on swog s0521 or s0535 must be enrolled on calgb 9862.
sexual function, body image, kinesiophobia and physical activity in pregnant women

Conditions: Pregnancy-Related Pelvic Girdle Pain

Summary: this study compares sexual function, body image, kinesiophobia and physical activity level in women with and without pregnancy-related pelvic girdle pain.

pelvic girdle pain (pgp) is a condition felt around the posterior iliac crystals, gluteal region and the sacroiliac joints, may spread to the back of the thigh, and may occur together or separately with pain in the symphysis pubis. pregnancy-related pgp causes problems in the sexual life of women. body image differs with the development of physical symptoms and changes in body size and shape during pregnancy. body dissatisfaction resulting from physical changes can cause problems in women's attitudes towards sexuality. sexual function is affected by physiological, anatomical and psychological changes that occur during pregnancy. sexual function during pregnancy has been associated with conditions such as body image, physical activity level, and pain. in the literature, there are studies evaluating the relationship between sexual function and body image in pregnant women and in different populations. however, in these studies, questionnaires specific to pregnant women were not used to evaluate sexual function and body image, and a comparison of these parameters was not investigate in women with and without pregnancy-related pgp. therefore, this study was planned to compare sexual function, body image, kinesiophobia and physical activity levels in women with and without pregnancy-related pgp. the outcome measures are pregnancy sexual response inventory (psri), body image in pregnancy scale (bips-turkish), tampa kinesiophobia scale (tks) and pregnancy physical activity questionnaire (ppaq). the clinical diagnosis tests are active straight leg rise, posterior pelvic pain provocation test, long dorsal sacroiliac ligament palpation, pelvic compression, pelvic distraction, patrick-faber test and gaenslen test.

Eligibility criteria:
inclusion criteria: * being between 18 and 40 years-old, * being second or third trimester of pregnancy * being literate in turkish exclusion criteria: * having a pregnancy complication (preeclampsia, pregnancy-induced hypertension, diabetes, etc.), * having a known gynecological or urological problem that may mimic pgp * having neurological (multiple sclerosis, spinal cord injury, etc.), orthopedic (hip dislocation, etc.), cardiopulmonary (heart failure, chronic obstructive pulmonary disease, etc.) problems that affect sexual function and physical activity, * having situations in which sexual activity is contraindicated and should be restricted (placenta previa, risk of premature birth, cervical insufficiency, antepartum hemorrhage, premature rupture of membranes, genital infection, etc.), * having visual, auditory and cognitive problems that may prevent participation in the study.

Keywords: pelvic girdle pain sexual function body image fear of movement
sleep duration and blood pressure during sleep

Conditions: Blood Pressure; Hypertension; Elevated Blood Pressure; Sleep; Short Sleep Phenotype

Summary: the purpose of this study is to examine the impact that sleep duration has on blood pressure (bp) levels during sleep. the investigator will examine the effect of an 8-week sleep hygiene/extension intervention vs. control on sleep bp.

short sleep duration (ssd), defined as sleeping less than 7 hours per night, affects over 33% of us adults and is associated with increased mortality. ssd is a modifiable risk factor for obesity, type 2 diabetes, and htn. cross-sectional studies have demonstrated that ssd is associated with higher sleep bp levels. ssd is also associated with non-dipping bp which is primarily explained by higher sleep bp levels. however, many of the cross-sectional studies have included adolescent participants or have not used reference standard measures of sleep duration such as wrist actigraphy. manipulating sleep duration experimentally through sleep restriction or deprivation is associated with higher 24-hour and sleep bp levels. in contrast, there is scarce data on the effect of sleep extension on sleep bp levels among adults with ssd. eligible community individuals with short sleep duration will be randomized to sleep extension vs. control using 24-hour ambulatory blood pressure monitoring (abpm) and actigraphy in the naturalistic environment. individuals will be assessed throughout the study using questionnaires, activity monitoring via a fitbit device (for 8 weeks), blood pressure monitoring using a 24-hour abpm device, and heart rate variability monitoring for 24-hours.

Eligibility criteria:
inclusion criteria: * english speaking adults * age 18 and older * sleep duration \< 7 hours per night as assessed via daily self-report of sleep hours exclusion criteria: * inability to read or write in english * pregnant or plans to get pregnant within study period * arm circumference \>50 cm * lymphedema of the arm or unable to wear abpm device for 24 hours or wrist actigraphy for 8 weeks * end-stage renal disease (esrd) on dialysis * unreliable internet or phone/text access * high risk of obstructive sleep apnea (osa) (using the berlin questionnaire or diagnosis of osa or use continuous positive airway pressure device) * high risk of insomnia (using the insomnia severity index), or a known prior history of insomnia, and/or use of prescription sleep aides * high risk of depression (using the patient health questionnaire depression scale: phq-8) * perimenopausal women who have hot flashes (using the menopause rating scale (mrs) questionnaire, administered only to females age 45-65) * plan to travel out of state and/or internationally during the study period

Keywords: nocturnal hypertension short sleep duration cardiovascular disease
a comparison of tolerability and efficacy of different doses of duloxetine for the treatment of major depressive disorder

Conditions: Depressive Disorder

Summary: the purpose of this study is to compare the tolerability and efficacy of different doses of duloxetine in patients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * outpatients at least 18 years of age (male and/or female) who meet criteria for major depressive disorder (mdd) as defined by the diagnostic and statistical manual for mental disorders fourth edition text revision (dsm-iv-tr). patients may have comorbid anxiety disorders, except for obsessive compulsive disorder * tests negative for pregnancy at the time of enrollment based on a serum pregnancy test and agrees to use a reliable method of birth control (for example, use of oral contraceptives or norplant a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of study drug. * hamilton depression rating 17 item scale (hamd-17) greater than 15 at visits 1 and 2. exclusion criteria: * have any current axis i disorder other than major depressive disorder (mdd), dysthymia, or any anxiety disorder; however, obsessive-compulsive disorder is excluded. * have any previous or current diagnosis of bipolar disorder, obsessive-compulsive disorder, schizophrenia, or other psychotic disorders. * lack of response of the current episode of major depression to two or more adequate courses of antidepressant therapy at clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression. * dsm-iv-tr-defined history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine. * patients judged to be at serious suicidal risk in the opinion of the investigator.
comparison of the revlite electro-optic q-switched neodymium-doped yttrium aluminium garnet (eo qs nd:yag) laser to a fractionated laser system

Conditions: Photodamage; Irregular Pigmentation; Acne Scars

Summary: the purpose of this study is to compare the results of treatment between the side of the face treated with the revlite laser and the side of the face treated with a fractionated laser system.


Eligibility criteria:
inclusion criteria: * fitzpatrick skin type i-vi and wrinkle class i * between the ages of 25-65 * evidence of bilateral dyschromia exclusion criteria: * pregnant, lactating, or is planning to become pregnant * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical or systemic therapy * coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy) * any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study * currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days * unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function * unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits * accutane within 6 months * need to be exposed to artificial tanning devices or excessive sunlight during the trial * prior treatment with parenteral gold therapy * diabetes type 1 or 2 * does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or ipl treatment, chemical peel) or injected fillers/other substances (e.g., restylane, botox) that might affect the treatment area for the duration of the study * artificial tanning within 1 month * (micro)dermabrasion within 3 months * other laser or ipl to the face within 6 months * chemical peel within 1 month * injectable fillers within 3 months * topical retinoids within 3 months * over-the-counter anti-aging products (e.g., those containing peptides, hyaluronic acid, or agents specifically advertised as having anti-aging or age-inhibiting properties) within 1 month * history of keloids or hypertrophic scarring * evidence of compromised wound healing * history of cold sores, chickenpox or shingles and unwilling to take a prophylactic course of valtrex/acyclovir * allergy to acyclovir
pharmacokinetics, safety, and tolerability of rhegf eye drops in healthy male subjects

Conditions: Dry Eye Syndromes

Summary: a randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the pharmacokinetics, safety, and tolerability of rhegf eye drops in healthy male subjects

primary objective: to evaluate safety and tolerability of rhegf eye drop/ secondary objective: to evaluate pk of rhegf eye drop

Eligibility criteria:
inclusion criteria: * healthy male aged from 20 to 51 at screening test * weight 50kg \~100kg bmi 18-27 * those who are fully understood, voluntarily decided to participate and signed prior to screening * those who are deemed suitable for participating in clinical trial due to lab tests, physical exam etc exclusion criteria: * those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)
a cadaveric and radiologic study of sacral erector spinae plane block (espb)

Conditions: Nerve Block

Summary: the goal of this cadaveric study is to learn about the distribution of contrast agent in ultrasound-guided sacral espb. the main questions it aims to answer are 1. which nerves are affected by this block. 2. which approach is the best for optimal analgesia in human

4 embalmed cadavers will be divided into groups of 2 and sacral espb will be made with 2 different methods. the cadavers will be removed from the solution 48 hours before and will be placed in the prone position, there will be no history of trauma or surgery in the sacral region of the cadavers, and no dissection will be performed from the sacral regions. in the median approach, the probe will be placed on the cadaver, which was previously placed in the prone position, using a 12-18 megahertz high-frequency linear probe with ultrasound to form a right angle to the sacral crest. after being placed parallel to the sacrum and observing the median crest, a 50 mm echogenic needle will be inserted by advancing the implant towards the second sacral level. after touching the crest, the distribution will be observed by retreating 1mm and making 1 cc of serum physiologic. then all 40 ml of methylene blue and radiocontrast solution will be given. in the intermediate approach; from the second sacral level, 20 ml of red acrylic dye and a solution containing radiocontrast will be given to the right and left by entering the sulcus between the median and intermedian crests with the same technique, using the same technique, under the guidance of ultrasound. after the procedure, sacral tomography will be performed on the cadavers. the spread of radiocontrast material will be observed and their reconstruction will be performed. later, anatomical dissection will be performed on the cadavers and the spread of the dyes given will be observed. which of the sacral intervention methods is more effective in clinical practice will be evaluated. estimated durations of the study; 1. removing the cadavers from the solution 48 hours before, performing the block, going to the radiology and performing the ct scan, coming to the anatomy laboratory and performing the dissection: 3 days 2. reconstruction and interpretation of radiology images: 1 week 3. interpretation of anatomical dissection: 1 week 4. evaluation and writing of the study: 1 month

Eligibility criteria:
inclusion criteria: * embalmed cadaver exclusion criteria: * none of the cadavers had a history of trauma or surgery in the sacral region

Keywords: cadaver study erector spinae plane block anatomic dissection
telerehabilitation in copd

Conditions: COPD

Summary: the prevalence of chronic obstructive pulmonary disease (copd) in turkey is 10%. patients with copd have a decreased physical capacity. decreased physical activity in copd patients causes an increase in all-cause mortality. pulmonary rehabilitation contributes to increasing physical capacity and quality of life in copd patients. however, a limited number of patients have access to pulmonary rehabilitation. some of the patients drop out of pulmonary rehabilitation due to reasons such as transport difficulties, low social support, and low professional support. in addition, disruption of daily routine is one of the important reasons for this situation. telerehabilitation can enable more patients to access pulmonary rehabilitation. education and exercise programs can be followed with telerehabilitation in patients with copd. an increase in exercise capacity and a decrease in dyspnea have been achieved with telerehabilitation in copd patients. different technologies such as telephone, video conferencing or web sites can be used for telerehabilitation. also, mobile phone was used to telerehabilitation. to make pulmonary telerehabilitation completely patient-based, we have developed an application suitable for smartphones. the application contains videos which showing how to perform pulmonary rehabilitation exercise videos, and it allows the participants to follow up compliance with pulmonary rehabilitation daily. the application will be downloaded to the smartphones of the participants, and it will be shown how to use the application. participants will not be shown pulmonary rehabilitation exercises. this study aims to evaluate the effectiveness of telerehabilitation with the application program on physical capacity, quality of life, and dyspnea perception in copd patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * being diagnosed with copd * not have previously participated in pulmonary rehabilitation * to able to use smartphone exclusion criteria: * under age 18 * pregnancy * have previously participated in pulmonary rehabilitation * having any malignacy * having any disorder that limit exercise

Keywords: copd pulmonary rehabilitation telerehabilitation
a study to determine safety & efficacy of autologous human platelet lysate (hpl) in facial wrinkles(nasolabial folds)

Conditions: Facial Wrinkles (Nasolabial Folds)

Summary: this is a multicentre, open label, pilot study to evaluate safety and efficacy of autologous human platelet lysate (hpl) in subjects with facial wrinkles (nasolabial folds). the study is being conducted at 2 centers in india. the primary endpoints are improvement in wrinkle severity rating scale ( wsrs ) as per atlas photographic grading at rest and on full smile and global aesthetic improvement scale (gais). the secondary endpoints are improvement in photographic assessment, physician's assessment scores, patient's assessment scores form enrollment to end of study.


Eligibility criteria:
inclusion criteria: * subjects (male and female), aged 18 to 40 years (both inclusive). * subjects willing to refrain from any other treatment for nasolabial folds. * subjects who are willing to give informed consent and adhere to the study protocol. exclusion criteria: * subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. botox, fillers etc * subjects with history of connective tissue disease * subjects with autoimmune diseases * subjects unwilling to or unable to comply with the study protocol. * subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days
safety, tolerability and pharmacokinetics of multiple doses of zgn-433 in obese female volunteers

Conditions: Obesity

Summary: the purpose of this study is to assess whether multiple doses of zgn-433 is safe and well tolerated in obese female subjects. the study will also provide information on how much zgn-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.

this protocol is designed to test the safety and preliminary efficacy of a drug called zgn-433. it is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.

Eligibility criteria:
inclusion criteria: * obese, otherwise healthy females * post menopausal or infertile * weight ≥ 50 kg * bmi ≥ 32 and ≤ 45 kg/m2 exclusion criteria: * use of weight loss agents in the past month * history of eating disorder * history of diabetes or other endocrine disorder * history of gastric bypass * current smokers * unstable body weight during the past 3 months

Keywords: obese obesity overweight