Kornimate/medical-research-clean huggingface dataset:
treatment for adolescents with deliberate self harm

Conditions: Intentional Self Harm

Summary: the purpose of the study is to evaluate the efficiency of dialectical behavior therapy (dbt) in treatment of adolescents with deliberate self harm compared to enhanced usual care (euc). eighty patients in the age of 12-18 yrs old will be included in the study. the main inclusion criterion is repetitive deliberate self-harm. the patients will receive 16 weeks treatment in outpatient clinics in oslo, after having been randomized to dbt or euc. they will be assessed on five different time-points: baseline (before starting treatment), 6 weeks (after start of treatment), 12 weeks, 16 weeks and 68 weeks. the main study hypothesis is: * dbt will be significantly more effective in treatment of self-harm behavior, as measured/indicated by reduction in number of self-harm episodes with or without intent to die, as well as reduction of number of emergency room visits. * it is also hypothesized that dbt will significantly reduce the level of suicidal ideation and depressive symptoms compared to euc.

power analysis: exact data on the repetition of self-harm over 16-20 week and 12 months observation periods for adolescents in outpatient psychiatric treatment are not available. building on previous clinical studies and rct studies in adults receiving dbt, we anticipate that the 16 week repetition rate will be 50% for adolescents who receive euc and 25% for adolescents who receive dbt. with an alpha error level of 5% 60 patients in each group is needed to provide 80% power with a two tailed test. we anticipate a drop out rate from research assessments of no more than 25%. to compensate for this attrition, it is calculated that 15 patients in each treatment group should be added, leading to a total number of 150 patients to be included in the trial. a more precise power analysis and determination of how many patients to include in the study will be based on data from the first 40 patients who have been included. a power analysis conducted on the basis of the first 40 patients showed that: 1. there had been no attrition from research assessments 2. with an alpha error level of 5% 40 patients in each group is needed to provide 80% power with a two tailed test a final number of patients to include was therefore fixed at 80.

Eligibility criteria:
inclusion criteria: * history of repeated deliberate self harm (last episode within last months) * satisfies at least 2 criteria of dsm-iv borderline personality disorder (as measured by scid-ii) in addition to the self-destructive criterion. or: satisfies at least 1 criterion + 2 criteria scored below threshold (score 2) of dsm-iv borderline personality disorder (as measured by scid-ii) in addition to the self-destructive criterion. exclusion criteria: * psychotic disorders * anorexia nervosa * substance dependence disorder * mental retardation (iq less than 70) * asperger syndrome/autism
glaucoma adherence study, spain

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Summary: the purpose of this study is to evaluate adherence to duotrav® when reinforced by the use of the travalert™ dosing aid.

this study was conducted in spain. an identical study was conducted in france, uk, italy, and netherlands under protocol id emd-07-01. a combined enrollment number is presented.

Eligibility criteria:
inclusion: * provide informed consent. * able to follow instructions and be willing and able to attend required study visits. * able to read and complete study questionnaires. * clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye. * intraocular pressure considered safe, in both eyes, assuring clinical stability of vision and the optic nerve throughout the trial. * currently treated with duotrav alone, dosed in the evening for at least for 30 days, at visit 1. * best corrected visual acuity of 20/200 snellen or better in each eye. * intraocular pressure ≤ 30 mm hg in both eyes. * evidence causing the investigator to consider the patient to be non-adherent, at some level, to their glaucoma medication. * agree that their adherence could be improved by the intervention with the dosing aid described in this study. * other protocol-defined inclusion criteria may apply. exclusion: * presence of other primary or secondary glaucoma not listed in inclusion criterion. * any abnormality preventing reliable applanation tonometry in the study eye(s). * any known opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of the study eye(s). * concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to visit 1. * risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment. * progressive retinal or optic nerve disease from any cause. * women of childbearing potential not using reliable means of birth control. * women who are pregnant or lactating. * a condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient. * participation in any other investigational study within 30 days prior to visit 1. * known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the principal investigator. * unwillingness to risk the possibility of darkened irides, eyelash changes or periocular pigmentation. * history of, or at risk for uveitis or cystoid macular edema (cme). * any physical disability which prevents the accurate use of the travalert™ dosing aid. * unable to accurately instill the travoprost/timolol fixed combination in the evening. * other protocol-defined exclusion criteria may apply.

Keywords: adherence compliance glaucoma ocular hypertension
agili-c™ implant performance evaluation in the repair of cartilage and osteochondral defects

Conditions: Cartilage or Osteochondral Defects in the Knee

Summary: evaluate the performance of the agili-c™ in the repair of cartilage and osteochondral defects.

agili-c™ implant is a ce marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects. the agili-c™ implant will be implanted using the agili-kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the agili-c™ implant

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. up to 3 treatable cartilage lesions, icrs iiia - ivb on the femoral condyles or the trochlea, 3. symptomatic total treatable area 1-7 cm2. asymptomatic lesions will not be included in the calculation 4. koos pain score at baseline is not less than 30 and not more than 65 5. must be physically and mentally willing and able to comply with post- operative rehabilitation protocol and scheduled clinical and radiographic visits. 6. informed consent signing exclusion criteria: 1. bony defect depth deeper than 8mm, according to imaging articular cartilage lesions in the tibia or the patella, icrs grades iva and ivb 2. any previous ligamentous repair or malalignment correction in the index knee within the last 3 months 3. significant instability of the index knee according to ikdc knee examination form 2000, grade c (abnormal) or d (severely abnormal) 4. lack of functional remaining meniscus 5. meniscal transplantation in the past 6 months 6. malalignment more than 5 degrees varus or 5 degrees valgus according to standing x-ray 7. any known tumor of the index knee 8. any know history of infection of the index knee 9. any known history of inflammatory arthropathy or crystal-deposition arthropathy 10. any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta 11. body mass index \>35 12. osteoarthritis of the index knee graded as 4 according to the kellgren- lawrence scale 13. chemotherapy treatment in the past 12 months 14. any previous surgical cartilage treatment in the index knee within the last 6 months 15. history of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate 16. patient who is pregnant or intends to become pregnant during the study 17. history of any significant systemic disease, such as but not limited to, hiv infection, hepatitis infection or htlv infection; known coagulopathies, that might compromise the subject's welfare 18. known substance abuse or alcohol abuse 19. participation in other clinical trials within 30 days prior to the study or concurrent with the study 20. known insulin dependent diabetes mellitus 21. unable to undergo mri or x-ray
feasibility of an extended test battery and influencing factors for detecting frailty

Conditions: Frailty Syndrome

Summary: the aim of the prospective study is to assess the feasibility of a screening and baseline measurement protocol that is planned for a main study (präp-go) in a collective of 30 patients ageing 70+ scheduled for elective surgery. comprehensive geriatric assessment scores and modified fried frailty phenotype component evaluation are performed in all patients at baseline before elective surgery. the assessment of cognitive tests is conducted with a battery of neuropsychological tests, computer-based tests from the cambridge neuropsychological test automated battery \[cantab®\] and non-computer based tests. frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status. 10 patients without frailty, 10 patients with pre-frailty and 10 patients with frailty should be analyzed in this study and receive further comprehensive geriatric assessment testing up to seven days after surgery/discharge (before 7 postoperative days).


Eligibility criteria:
inclusion criteria: * age ≥ 70 years * male and female patients * patient eligible for inclusion: by the patient, preoperatively * elective surgery * expected anesthesia duration\> 60min exclusion criteria: * severe cardiological or pulmonary disease (nyha iv, gold iv) * intracranial interventions * moribund patients (palliative situation) * not enough language skills * non-consenting patients * participation in another prospective intervention study for study inclusion or throughout the study period.
monitoring the immuological toxicity of drugs

Conditions: Arthritis; Systemic Lupus Erythematosus; Rheumatoid Arthritis; Capillary Leak Syndrome; Hepatitis

Summary: several drugs and chemotherapies seem to have an impact on the immunological system. this study investigates reports of immunological toxicities, including the international classification of disease icd-10 codes m05, m32, i78 for treatments in the world health organization (who) global individual case safety report (icsr) database (vigibase).

several drugs and chemotherapies seem to have an impact on the immunological system and are responsible of a wide range of rare immunological side effects. those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. this study investigates the main characteristics of patients affected by rare immunological side effects (of which systemic lupus, immune arthritis, rheumatoid arthritis, hepatitis, capillary leak syndrome) imputed to drugs. a causality assessment according to the who-umc (world health organization - uppsala monitoring center) is systematically applied.

Eligibility criteria:
inclusion criteria: * case reported in the who's pharmacovigilance database till 02/01/2018 * adverse event reported were including the meddra terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome. exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: adverse event arthritis systemic lupus erythematosus capillary leak syndrome hepatitis
eustachian tube growth and development

Conditions: Otitis Media

Summary: this study is to measure over time (from 3 years until 13 years of age) eustachian tube function (the way the eustachian tube works) and facial growth in groups of children with two types of middle-ear disease and with little past middle-ear disease. these measures will be used to determine if facial growth is related to improved eustachian tube function, to see if the better function explains why young children who have middle-ear disease outgrow it as they get older, and to determine if these measures are different for the children in the three groups defined by disease history.

the existing literature documents an important role for the eustachian tube (et) in the pathogenesis and/or persistence of otitis media (om). cross-sectional studies report a lower prevalence of om in older children, a better et pressure-regulating function in older children and age-related differences in et form, length and width, and the vector orientation of the paratubal musculature. these growth-related changes in et structural relationships are demonstrably predictive of increasingly more efficient et function (etf) and, because the et and paratubal musculature are intimately related to the cranial base, the vector orientation of the et system can be reconstructed from osteological or radiographic data. together, these observations suggest that measurable, age-related changes in et-paratubal muscle vector relationships are reflected in more efficient etf and, by consequence, a decreased om risk. the overall goal of the proposed longitudinal study is to evaluate the validity of this hypothesis.

Eligibility criteria:
inclusion criteria: * 3 years of age * history of middle ear disease must fit into one of the 3 categories of ear history * with or without patent tympanostomy tubes at time of entry * generally good health exclusion criteria: * cleft palate or other syndromes predisposing to otitis * history of significant orthodontic treatment or plan for such * cholesteatoma or other past ear surgery other than tubes * unable to cooperate for testing

Keywords: otitis media ear acute otitis middle ear eustachian tube recurrent acute otitis media chronic otitis media with effusion no significant history of otitis media
evaluating the efficacy and compatibility of efinaconazole 10% solution (jublia) for the treatment of toenail onychomycosis in patients wearing toenail polish compared to those without polish

Conditions: Onychomycosis of Toenail

Summary: this study will test how well efinaconazole solution (jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not.

topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality for toenail onychomycosis. this study will examine the compatibility of topical efinaconazole and nail polish in patients with distal and lateral subungual onychomycosis (dlso). it is hypothesized that the treatment of dlso with efinaconazole 10% solution will not be adversely affected by the application of nail polish.

Eligibility criteria:
inclusion criteria: * female age 19-70, as 19 is the legal age in alabama * dlso affecting at least 1 great toenail diagnosed with positive potassium hydroxide microscopy and culture of a dermatophyte * suitable for application of topical antifungal therapy, in the opinion of the investigator * target toenail thickness of 3 mm or less as measured by digital caliper, as thickness greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this was the criteria used in the pivotal trial using topical efinaconazole for onychomycosis * women of childbearing potential will be required to use birth control and a negative urine pregnancy test must be documented prior to initiating treatment exclusion criteria: * history of immunosuppression or concurrent use of immunosuppressant drugs * history of uncontrolled diabetes mellitus * history of psoriasis or any other condition that might interfere with the toenail evaluation * three or more dermatophytomas (streaks) on the target nail * severe dlso of the target nail * patients who cannot refrain from wearing gel or plastic based polishes that are used in salons and that require curing
aerobic exercise in patients receiving chemotherapy for cancer

Conditions: Cardiac Toxicity; Chemotherapeutic Agent Toxicity; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health. purpose: this randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer.

objectives: * to determine if patients with cancer can exercise safely and routinely, under supervision, while receiving anthracycline chemotherapy. * to determine the magnitude of the change in the peak ventilatory oxygen uptake (vo2) before and after completion of anthracycline chemotherapy with concurrent exercise versus without exercise in patients with cancer. outline: patients are randomized to 1 of 2 intervention arms. * arm i (exercise): patients undergo supervised aerobic exercise (walk or bicycle) 3 days a week concurrently with standard anthracycline-based chemotherapy for approximately 18-24 weeks. * arm ii (non-exercise): patients receive standard anthracycline-based chemotherapy for approximately 18-24 weeks. patients undergo peak ventilatory oxygen uptake (vo_2) by exercise bike test with gas exchange analysis at baseline and at 2 weeks after completion of anthracycline-based chemotherapy.

Eligibility criteria:
disease characteristics: * patients with cancer scheduled to receive 4-6 courses of an anthracycline-based chemotherapy patient characteristics: * able to pedal a stationary bicycle * no severe hypertension (systolic blood pressure \> 220 mm hg or diastolic blood pressure \>120 mm hg) * no atrial fibrillation with an uncontrolled ventricular response * no ventricular arrhythmias * no unstable angina * no acute myocardial infarction within the past 28 days of enrollment * no severe valvular heart disease * no severe (exercise-limiting) peripheral vascular disease * no severe pulmonary disease prior concurrent therapy: * see disease characteristics

Keywords: cardiac toxicity chemotherapeutic agent toxicity unspecified adult solid tumor, protocol specific
a study to determine the safety and efficacy of autologous human platelet lysate for treatment of androgenetic alopecia

Conditions: Androgenetic Alopecia

Summary: this is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human platelet lysate (hpl) in subjects with androgenetic alopecia. the study is being conducted at 2 centers in india. the primary endpoints are improvement in caliber \& density of hair and improvement in photographic assessment from randomization to end of study. the secondary endpoints are physicians and patients self assessment score.


Eligibility criteria:
inclusion criteria: * male subjects, aged between 18 to 50 years (both inclusive) and in general good health * subjects willing to refrain from other aga treatments during the entire study duration * subjects who are willing to give informed consent and adhere to the study protocol. exclusion criteria: * subjects aged \ 50 years * subjects with dermatological disorder of scalp that might interfere with study evaluation * subjects on anti-coagulant therapy * subjects with clinically significant medical or psychiatric disease as determined by the investigator. * subjects with dermatological disorder of scalp that might interfere with study evaluation * subjects unwilling to or unable to comply with the study protocol.
patient-centered implementation trial for single embryo transfer

Conditions: Male Infertility; Female Infertility; Pregnancy

Summary: background: the number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (ivf) and intracytoplasmic sperm injection (icsi). ivf or icsi with transferring only one embryo, elective single embryo transfer (eset), will reduce this incidence remarkably. unfortunately, former research has documented that cycles with set maintain lower pregnancy rates compared to double embryo transfer (det). implementation of eset will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. this trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy. objective: the main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eset) in in vitro fertilisation (ivf) and intracytoplasmic sperm injection (icsi), between usual care and a combined patient-centred strategy. study design: a randomised controlled trial study population: couples with a female age less than 40 years ongoing an ivf/icsi treatment in 2 of the 13 dutch ivf centres and their 4 satellite/transport centres. intervention a combined patient centred implementation strategy for eset in ivf/icsi. the strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eset in the first 2 cycles. primary study parameters/outcome of the study: the eset occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy. secondary study parameters/outcome of the study: * patient knowledge * patient decisional conflict * patient satisfaction * ivf/icsi treatment outcome.

see above

Eligibility criteria:
inclusion criteria: * female age \< 39 years * in first cycle minimum of two embryos available for transfer exclusion criteria: * medical necessity for single embryo transfer

Keywords: implementation single embryo transfer icsi ivf prevention
traveler's constipation

Conditions: Constipation; Travel-Related Illness

Summary: the occurence of traveler's constipation is sparsely covered in the medical litterature. this study aims to determine the gastrointestinal-related discomforts related to traveling on a trip to turkey.

traveler's constipation, which is characterized by the more hard and less frequent stools, is sparsely covered in the medical litterature. only a few studies have examined this problem and the actual occurrence and extent of this problem is not known. hypotheses about why travel constipation occurs are, among other things, about changed circadian rhythm due to jet lag, changed schedules and tight sanitary conditions. other factors such as dehydration, change in cabin pressure and the content of the in-flight food in connection with flights have not been investigated. the research project aims to clarify changes in the test subjects' bowel habits as well as other gastrointestinal-related discomforts in connection with a flight abroad with only an hour's time difference and without the consumption of flight food.

Eligibility criteria:
inclusion criteria: * can understand danish and is able to answer the questionnaires * given written consent exclusion criteria: * history of intestinal resection * medically treated intestinal disease * ibs at baseline