Kornimate/medical-research-clean huggingface dataset:
parent mentors to improve adherence to type i diabetes care regimen in adolescents

Conditions: Diabetes Mellitus, Type 1

Summary: the study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (mdi) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through hba1c. the study hypothesis is that trained parent mentors can help families with children who have poorly controlled t1dm improve adherence to their diabetes regimen and improve their metabolic control.

the study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (mdi) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through hba1c. diabetic knowledge, responsibility for diabetes care, degree of diabetes related family conflicts, and major complications of diabetes will also be collected during the patient's routine clinic visit. the study hypothesis is that trained parent mentors can help families with children who have poorly controlled t1dm improve adherence to their diabetes regimen and improve their metabolic control.

Eligibility criteria:
inclusion criteria for mentee families: * residing within 60 miles of a parent mentor * child diagnosed with t1dm greater than or equal to 1 year at the start of our study's data collection (february 2015) * on multiple daily injection regime or insulin pump therapy * mean hba1c between 8.5 - 12.5% over the last 2 clinic visits inclusion criteria for parent mentors: * child diagnosed with t1dm greater than or equal to 2 years at the start of our study's data collection * compliant with suggestions made by the diabetes care team * mean hba1c less than or equal to 8% over the last 2 clinic visits * no episodes of diabetic ketoacidosis, aside from initial episode at diagnosis, if applicable
a coordinated return to work program

Conditions: Back Pain

Summary: the aim of the study is to investigate the possibility that a diagnostic evaluation by a multidisciplinary team reduces the length of sick leave.

workers on sick leave due to back, neck or shoulder pain are randomized into 2 groups. individuals in the intervention group are offered an extra multidisciplinary diagnostic evaluation. the multidisciplinary team consists of an occupational physician, a physiotherapist, a chiropractor, a psychologist and a social worker. the result is a coordinated evaluation of the individuals problems with suggestions as to further actions. the focus is on evaluating, if and when the individual can return to work. no treatment is given. verbatim exemption from the local medical ethics board: "february 19, 2004 journal no. vf 20040030 jk/csf re: research project: a coordinated return to work program (kia) the the medical ethics committee of vejle and funen counties has reviewed this research project at its meeting on february 9, 2004. the entire committee decided that this project is an hta (health technology assessment) study and not a biomedical research project. therefore the committee decided that the project is not within the committee's legal competence areas, and is exempt from approval by a medical ethics committee before being carried out. the committee has no further comments to this case. on behalf of the committee sincerely erik laier jette krarup __________________________________________________________________________________________________________________________________________________ odense university hospital direct telephone: +45 6541 3425 kløvervaenget 10, 2.sal e-mail: vejle-fynkomiteen@ouh.fyns-amt.dk 5000 odense c fax: +45 6619 4392 denmark"

Eligibility criteria:
inclusion criteria: * on sick leave due to back, * shoulder or neck pain exclusion criteria: * pregnant, * other causes of sick leave

Keywords: back, neck, pain, sick leave
music listening to reduce pain and anxiety during leep

Conditions: Cervical Intraepithelial Neoplasia

Summary: loop electrosurgical excision procedure (leep) is the primary diagnostic and therapeutic procedure employed in women with high-grade intraepithelial neoplasia of the cervix. the procedure usually performed in the outpatient setting under local anesthesia. however, it could be associated with significant pain and anxiety. the aim of this study is to examine the effects of listening to music during the procedure in reducing pain and anxiety.


Eligibility criteria:
inclusion criteria: * women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix exclusion criteria: * allergy to local anesthetic agent (lidocaine) * pregnancy * previous major surgical procedures on cervix (conization, leep, laser therapy, cryotherapy) or uterus * using cardiac pacemaker or history of cardiac arrhythmia * neurological disorder affecting perception of pain * history of lower urinary tract cancer * coagulation defects * history of drug dependence * lower genital tract infection * apparent invasive cancer of the cervix * hearing difficulty
quantifyher: quantitative immunofluorescence and/or rt-qpcr for measuring her2 in her2-low metastatic breast cancer

Conditions: HER2-positive Metastatic Breast Cancer

Summary: this study will assess whether a quantitative, her2 assay can accurately and reliably discriminate between responders and non-responders among patients with her2 ihci+ metastatic breast cancer who are receiving t-dxd.


Eligibility criteria:
inclusion criteria: * women and men age \> 18 years * metastatic breast cancer, histologically- confirmed. any estrogen receptor (er) status is allowed. er status will be determined by local laboratory assessment utilizing asco/cap guidelines. * primary and/or metastatic tumor with 1+ level of expression of her2 by immunohistochemistry as determined by local laboratory assessment utilizing asco/cap guidelines. * measurable disease by cross-sectional imaging at the start of treatment. patients with measurable bone-only disease or active brain metastases are eligible. * archival tissue available for biomarker assessment. one specimen should be the most recent metastatic biopsy. if her2 1+ status was determined on a different specimen (either primary or metastatic tissue), that specimen is also required. samples obtained from bone metastases that were processed via decalcification methods are not eligible. * intention to initiate therapy with t-dxd (enhertu) at fda-approved dose and schedule as next line of therapy. if t-dxd was already initiated, patients must be registered within 30 days of initiation. * ability to provide informed consent exclusion criteria: * concurrent her2-overexpressing metastatic breast cancer (as confirmed by a metastatic biopsy with ihc 3+ or ihc 2+ with fish amplified as per standard asco/cap guidelines)
buprenorphine maintenance for cocaine abusing opioid addicts - 1

Conditions: Cocaine-Related Disorders; Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to compare the clinical efficacy of maintenance on low and high doses of buprenorphine with methadone for cocaine abusing opiate addicts.


Eligibility criteria:
please contact site for information.

Keywords: opioid-related disorders
effect of pulse width with spinal cord stimulation

Conditions: Pain; Chronic Pain; Back Pain

Summary: the primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.

this study will generate data which may allow precision scs devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. this study will extend anecdotal reports into a prospective analysis of outcome data. patients invited to participate in this study will have recently been implanted with the precision system, or will be eligible for scs therapy and will have already selected therapy with the advanced bionics precision system, independent of possible inclusion in this study.

Eligibility criteria:
inclusion criteria: * have chronic low back pain following spine surgery (failed back surgery syndrome), which is primarily located in the low back, with minimal lower extremity pain. * have been permanently implanted with a precision spinal cord stimulation (scs) system within 6 months, or be an appropriate candidate for scs and for the surgical procedures required for scs as determined by the physician and have independently selected scs with precision for treatment. * be 18 years of age or older. * be willing and able to comply with all study related procedures and visits. * be capable of reading and understanding patient information materials and giving written informed consent. exclusion criteria: * have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. * have any other chronic pain condition likely to confound evaluation of study endpoints.

Keywords: pain neurostimulation back pain chronic pain
efficacy and safety study of probucol in patients with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: this trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial. * screening period (4 week) * double blind treatment period (16 weeks)

1. usage: 16 week, bid, prescribed oral with the breakfast and dinner 2. dosage:placebo group: placebo 2 tablets, 16 weeks probucol 250mg group: probucol 125mg 2 tablets, 16 weeks probucol 500mg group: probucol 250 mg 2 tablets, 16 weeks

Eligibility criteria:
inclusion criteria: 1. the subject is male or female diagnosed with type 2 diabetes mellitus and must be aged 20 to 75 years at the time of screening visit 2. urinary albumin excretion \> 300 mg/g cr at screening visit 3. subjects administered acei or arb without changing dosage prior to 3 months at the screening visit (if subjects administered acei or arb) 4. subjects administered statins without changing dosage prior to 3 months at the screening visit(if subjects administered statins) or subjects have no plan to administered to statin(if subjects is not administered statin) 5. 15 ml/min ≤ egfr ≤ 90 ml min 6. subjects must be willing and able to give signed and dated written informed consent. exclusion criteria: 1. type 1 dm or gestational diabetes 2. subjects on renal replacement therapy or renal transplantation prior to screening visit 3. ventricular arrhythmia (multiple and multifocal premature ventricular contractions) 4. cardiac damage (abnormally levels of troponin i) 5. subject with medical history of cardiac syncope or primary syncope 6. has condition that may prolong qtc interval (for man qtc interval\>450msec, for woman qtc interval\>470msec) at screening 7. pregnant or lactating woman before randomization 8. inflammatory bowel disease (ulcerative colitis, crohn's disease) 9. cholestasis 10. congestive heart failure 11. subjects with a myocardial infarction, unstable angina, or cerebral infarction within the latest 6 months 12. subjects has a diagnosis of nyha grade iii-iv status 13. ast or alt is 3.0 times higher than the upper limit of the normal range 14. active hepatitis or liver cirrhosis 15. subjects with hyperkalemia (k\>5.5 meq/l) 16. subjects with renal artery stenosis 17. subjects with malignancy within the 5 years at the time of screening visit(except for treated basal cells carcinoma or squamous cell carcinoma) 18. urinary tract disease (urinary tract infection, neurogenic bladder) 19. kidney disease (nephritis, chronic glomerulonephritis or polycystic kidney disease) 20. has an allergic history to probucol 21. hba1c \> 9% 22. systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥ 100 mmhg 23. subjects taken probucol within 3 months prior to screening 24. the subject has received an investigational product or biological agent within 3 months prior to screening 25. subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial

Keywords: diabetic nephropathy albumin creatinine ratio probucol
prehabilitation and rehabilitation in breast cancer surgery patients - a pilot study

Conditions: Breast Cancer; Lifestyle; Rehabilitation; Prehabilitation; Surgery

Summary: prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.


Eligibility criteria:
inclusion criteria 1. woman with a confirmed breast cancer diagnosis 2. planned surgical treatment of breast cancer 3. age 18 years or older 4. provision of written informed consent exclusion criteria 1. severe mental retardation, which limits the ability to follow instructions independently 2. severe psychiatric problems, which limits the ability to follow instructions independently 3. legal incapacity 4. language barrier: if we cannot find a lifestyle coach who speaks the patient's language, unfortunately we cannot offer the lifestyle coaching in its entirety, and this option will be omitted for the patient.
peripheral nerve responses to focal vibration and implications in pain and mobility for patients with diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: the purpose of this study is to characterize the changes in peripheral nerve functions (sensory and motor) in patients with diabetic peripheral neuropathy, and examine the relations between the changes in nerve functions and changes in pain and mobility using focal vibration.

peripheral nerve impairments are highly prevalent in patients with diabetic peripheral neuropathy (dpn) and are associated with pain and poor mobility. while peripheral sensorimotor nerve function is implicated in neuropathy, the mechanism associated with both pain and mobility is not well understood. even less understood is the interplay between, and responses to, sensory and motor fibers of the affected peripheral nerve. in our previous study, focal vibration (fv) was effective in reducing pain and improving mobility for only a subgroup of participants with dpn. because fv stimulates both motor and sensory peripheral nerve fibers, when combined with nerve conduction testing, it offers a unique opportunity to study both the sensory and motor peripheral nerve performance and their contribution to pain and mobility in patients with dpn. we are proposing a single group, repeated measured study to: characterize the changes in sensory and motor peripheral nerve functions; examine the association(s) between these changes and changes in pain and mobility, using fv. if successful, this study will provide us with a better understanding of the role played by sensory and motor nerve impairments in pain and mobility for dpn, and support larger clinical studies to optimize nerve function performance and the fv parameters. we will also explore how changes in the peripheral nerve function associate with severity of dpn.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes for at least one year; * diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested; * age 45-80 years old; * able to ambulate independently without assistive devices (e.g., walker or crutches) for 30 feet; * no evidence of neurological (other than peripheral neuropathy) or orthopedic conditions; * able to understand english instructions; * have normal or corrected vision. exclusion criteria: * with other non-diabetic causes of neuropathy by history; * symptomatic peripheral vascular disease, joint pain, swelling and/or limited range of motion in the lower extremities that interfere with walking; * other systemic or local diseases that could interfere with walking assessment * amputation in the lower extremities; * clinically diagnosed with dementia greater than mild (screened using montreal cognitive assessment (moca) \<24)

Keywords: focal vibration wearable nerve conduction study pain mobility
evaluation of the pico® negative pressure dressing system on the fibula free flap donor site's skin graft.

Conditions: Carcinomatous Resections; Violent Trauma

Summary: a fibula free flap can be used for the reconstruction of a mandible or a maxillar when the lack of bonne exceeds 3cm. this flap is made of the fibula bone, some muscle around, the fibular vascular pedicle and a skin paddle to reconstruct the gum. once this flap has been taken and transposed on the face, the leg is closed with a split thickness skin graft to replace the skin paddle. but the healing on this site is often a problem: this is partly due to the high rate of early graft's loss due to local devascularization (3 to 55% of loss). the skin grafting is generally improved by the application of a dressing sewn and left in place during 5 to 7 days postoperative (standard method). this study will evaluate the efficiency of a portative miniature negative pressure dressing system named pico® on the split-thickness skin graft of fibula free flap donor sites, compared to the standard method. a prospective randomized evaluation will be done, comparing the pico® to a conventional dressing. the main aim of the study is the evaluation of the impact of this portative system on the healing of the skin grafted donor site, in terms of rate of skin take, time of healing, complications and medical costs. the patients will be seen preoperatively to decide on their inclusion in the protocol. they will be reviewed at day 10 to evaluate the engraftment and possible local complications on the donor site. they will then be reviewed at day 20 and day 30 and until complete healing. the follow up will be of 12 months maximum. a medical cost evaluation will be done comparing the costs generated by the care on the donor site in the 2 groups.


Eligibility criteria:
inclusion criteria: * patients over 18 years old * any patient requiring a fibula free flap with skin paddle * theoretical need of a skin graft for the closure of the donor site (evaluated by the surgeon in charge of the patient at the time of inclusion) and performed at the same time as the fibula flap * signature of informed consent. exclusion criteria: * contraindication to making a fibula free flap: * anesthetic contraindication, * atheroma in the leg arteries obstructing more than 60% of the arterial lumen (objectified by ct angiography of lower limbs) * contraindication to the setting up of a negative pressure therapy: * allergy to one of the pico® components * infection in the donor area * cutaneous lesions of the lower limb preventing the placement of an occlusive dressing or making it impossible to seal the device * no affiliation to a social security scheme. * minor or major patients who are protected or unable to give their consent (according to article l1121-8 of the public health code (phc)) * pregnant or lactating women (according to article l1121-5 of the phc) * vulnerable people (according to article l1121-6 of the phc)

Keywords: fibula free flap skin graft
mk0767 added to insulin therapy in patients with type 2 diabetes (0767-030)

Conditions: Diabetes Mellitus, Type 2

Summary: this study will look to see if mk0767 works better than placebo in controlling blood sugar in patients with type 2 diabetes who are taking insulin but do not have adequate control of their blood sugar. this is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * type 2 diabetes with inadequate glycemic control * patient is on stable insulin therapy alone or with one oral antidiabetic agent * male or non-pregnant female 21 years or older * total daily dose of insulin must be less than or equal to 30 but not greater than or equal to 200 units/day exclusion criteria: * have a history of type 1 diabetes mellitus * history of ketoacidosis who are being treated with insulin * are taking 2 or more antidiabetic agents in combination with insulin
the efficacy of tendoactive, eccentric training, and the combination of both as a treatment of achilles tendinopathy

Conditions: Achilles Tendinopathy

Summary: the purpose of this study is to determine whether tendoactive, eccentric training, or the combination or both could be effective in the treatment of achilles tendinopathy.


Eligibility criteria:
inclusion criteria: * patients suffering from a gradually evolving painful condition in the achilles tendon located at the midportion for at least 3 months (diagnosis based on clinical examination showing a painful thickening of the achilles tendon located at a level of 2 to 6cm above the tendon insertion, and confirmed by ultrasonography: local thickening of the tendon, irregular tendon structure with hypoechoic areas and irregular fiber orientation). * men and non-pregnant women aged 18-70 years * be informed of the nature of the study and provide written informed consent. exclusion criteria: * clinical suspicion of insertional disorders (pain at the site of the insertion of the achilles tendon on the calcaneum) * clinical suspicion of an achilles tendon rupture (thompson test abnormal and palpable "gap") * clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance) * clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve) * clinical suspicion of peroneal subluxation * suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis. * condition that prevents the patients from executing an active exercise programme * patient has already performed eccentric exercises, according to the schedule of alfredson et al (12 weeks) * patient has already received an injection of prp for this injury * patient does not wish, for whatever reason, to undergo one of the two treatments * known presence of a pregnancy * condition of the achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins

Keywords: achilles tendinopathy tendoactive eccentric training
a study of pressure and flow characteristics during inspiration and expiration using breathemax® in healthy subjects

Conditions: Healthy Subjects

Summary: the aim of this study are to explore the characteristics of mean airway pressure, oscillatory amplitude and power spectral density (psd) of oscillatory airway pressure that generate by various loaded and flow rate during expiration and inspiration in healthy subjects and to explore the best loaded and flow rate for airway secretion clearance using the breathemax® device

for inspiratory group, the resistive load 3, 4, 5, 6 and 7 cm h2o were test with three flow rate: 0.2, 0.4, and 0.6 l/sec in each load. in each flow rate, the subjects were instructed to inspire as deeply as possible with steady flow rate for 3 seconds with end-inspiratory pause for 2-3 seconds through the inspiratory circuit and follow by passive exhalation. for expiratory group, the resistive load and flow rate were test similar inspiratory group. in each flow rate, the subjects were instructed to inspire as deeply as possible through the nose with end-inspiratory pause for 2-3 seconds and partially forced exhalation with reach to 1/3 of expiratory reserve volume (erv) for at least 3 seconds through expiratory circuit

Eligibility criteria:
inclusion criteria: * the healthy subjects * able to breathe against resistive load with the breathemax device * good conscious and cooperation exclusion criteria: - fever