Kornimate/medical-research-clean huggingface dataset:
notus feasibility study: reducing chronic low back pain with mobile app intervention

Conditions: Low Back Pain

Summary: this feasibility study will investigate the feasibility of screening, recruiting, and delivering a mobile app intervention that involves pain education and clinical hypnosis to people seeking treatments for chronic low back pain (chronic lbp) in general practices in australia. this study aims to assess the recruitment strategy, the willingness of participants to be included in the proposed treatments, whether the intervention can be delivered as intended within the health care system and clinical setting, the adherence of participants to the proposed treatment, response rates to questionnaires, loss to the short-term follow-up, and the appropriateness and acceptability of the interventions. this feasibility study will inform possible modifications in the recruitment and treatments for the main clinical trial. a total of 60 participants will be randomised into two treatment groups.


Eligibility criteria:
inclusion criteria: * experiencing chronic lbp, defined as pain in the area between the 12th rib and buttock crease accompanied or not by leg pain for a minimum duration of 12 weeks. * lbp with or without leg pain (in case of leg pain, lbp is worse than leg pain). * currently attending general practice across australia. * mean pain intensity score on the nrs ≥ 3/10 in the past week. * a score of at least moderate on question 8 of the physical functioning component of the sf36 questionnaire. * access to a mobile device with minimal requirements to download the study app (300mb). * internet connection to access the mobile app functionalities. * able to understand english via reading and audio materials. * individuals who reported interest in participating in a clinical trial involving digital interventions after consultation with their general practitioners. * individuals whose general practitioners permitted them to receive information about the trial after the general practice consultation. exclusion criteria: * known or suspected back-specific (e.g., radiculopathy, fracture) or non-back-specific (e.g., tumour, infection) serious spinal pathology. * less than six months post-spinal surgery. * scheduled for major surgery during the program or the follow-up period. * known or suspected serious psychiatric condition not being treated by a health professional that would impact the adherence to the trial activities. * known or suspected sight or hearing problems that would limit access to the intervention components (reading and listening using headphones).
validation of an obstacle course used in patients with muscle tightness

Conditions: Stroke; Traumatic Brain Injury; Multiple Sclerosis; Spasticity; Healthy Controls

Summary: this study is being conducted to compare healthy patients versus patients with muscle tightness in their leg(s) after an acquired brain injury using walking trials time, a balance test, and foot pressure data. this data is obtained using foot pressure sensors, timers, and distance walked.

this study is being conducted to demonstrate the objective utility of the use of pedobarography as a tool to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ada based obstacle course.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age * must wear shoe size 5½ - 11 us womens or size 6 - 13 us mens * for treatment group be a clinical patient being treated for lower extremity spasticity exclusion criteria: * age matched controls must have no significant neurological or orthopedic disease that would effect their gait * clinical patients who are unable to walk for 1 minute
chromium and insulin resistance

Conditions: Insulin Resistance

Summary: chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance. chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes. accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. these subjects will be randomized to 16 weeks of therapy with either 500 mcg twice a day of chromium or placebo.

chromium is an essential nutrient for the maintenance of normal glucose tolerance and its deficiency causes insulin resistance. chromium administration has also been shown in several studies to lower glucose and insulin levels in patients with type 2 diabetes. moreover, studies in humans, animals and cell culture indicate that chromium enhances insulin signaling. while these studies suggest that chromium administration increases insulin sensitivity, it has not been directly demonstrated that chromium has an effect in well defined insulin resistant subjects independent of hyperglycemia. accordingly, we propose to perform a placebo-controlled study of chromium picolinate administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. the insulin sensitivity of 80 subjects will be measured by a euglycemic insulin clamp. approximately 40 insulin resistant subjects will be randomized to 16 weeks of therapy with either 500 ug twice a day of chromium picolinate or placebo. to quantitate the chromium-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, ogtt using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment. we believe these studies will (1) confirm the beneficial effect of chromium on insulin sensitivity; (2) further our understanding of the molecular mechanisms of chromium action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the metabolic syndrome, and coronary artery disease (cad), a demonstration of the beneficial effects of chromium on insulin action could ultimately have important public health consequences.

Eligibility criteria:
inclusion criteria: * not exercising regularly, healthy, non-diabetic. exclusion criteria: * diabetes, heart disease, hepatitis, hiv, impaired glucose tolerance, abnormal liver enzymes, abnormal tsh levels, other abnormal lab values.

Keywords: diabetes insulin resistance chromium healthy volunteers
transferrin saturation and asthenia in hemochromatosis

Conditions: Hemochromatoses, Genetic

Summary: observational study.

the linked hfe genetic hemochromatosis (c282y mutation in the homozygous state) is the most common form of genetic iron overload. its treatment is based on bloodletting, and takes place in 2 phases, according to the recommendations of the high authority of health (has). the first phase, called induction, aims to achieve ferritinemia \<50 by performing weekly bleeds. the second phase, called maintenance, aims to maintain this ferritinemia \<50 by performing bleeding every 1 to 6 months depending on the case. the treatment is therefore according to the current recommendations only adapted according to ferritinemia, and not according to the effectiveness on the functional symptoms. however, some patients report persistent asthenia during maintenance treatment, despite ferritin levels \<50. this could reflect an incomplete control of their disease, and leads us to raise two points: * it is known that in some subjects, the transferrin saturation coefficient remains high, despite ferritinemia \<50; it is also known that this elevation of the transferrin saturation coefficient may be accompanied by a rise in circulating free iron, which is toxic for the organism1. * the asthenia observed in some patients in the maintenance phase could be linked to a high rate of transferrin saturation coefficient. our objective is to evaluate, in patients homozygous c282y in maintenance phase, the association between quality of life and transferrin saturation coefficient .

Eligibility criteria:
* inclusion criteria: * homozygous c282y ; * in the maintenance phase for at least 6 months ; * follow-up at rennes university hospital ; * patient who has not expressed his opposition to participate in the study. * exclusion criteria: * permanent: any cause of modification of the cst unrelated to hemochromatosis (chronic inflammatory disease, excessive consumption of alcohol ...) ; * temporary: infectious syndrome within 7 days before bleeding.
phase iv clinical study of benvitimod cream in the treatment of mild to moderate psoriasis in adults

Conditions: Psoriasis

Summary: this is a multi-center, prospective post-approval clinical phase iv study to evaluate the safety and efficacy of benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will use the benvitimod cream at the skin with psoriasis for 12 weeks.

this is a multi-center, prospective post-approval clinical phase iv study to evaluate the safety and efficacy of benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will apply the benvitimod cream on the skin with plaque psoriasis for maximum 12 weeks. all participants will complete follow-up visits at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks and continuing up to one year.

Eligibility criteria:
inclusion criteria: * male and female participants ages at least 18 years. * the participant with diagnosis of mild to moderate stable psoriasis vulgaris. * bsa involvement \<10%. * capable of giving written informed consent. exclusion criteria: * planned ultraviolet (uv) light therapy or prolonged exposure to natural or artificial sources of uv radiation during the study period. * known allergies to the active ingredient or excipients of the drug. * pregnant females, lactating females. * the patients who were considered unsuitable to participate in the study by the investigators.

Keywords: benvitimod cream psoriasis topical treatment
thyroid hormones effect on brown adipose tissue

Conditions: Hyperthyroidism

Summary: brown adipose tissue (bat) is important in energy expenditure through thermogenesis although the regulatory factors are not well known in humans. there is evidence suggesting that the thyroid hormones affect bat functions in lower mammals, but the effects of the thyroid hormones on bat activity in humans are still unclear. the objective of this study was to investigate the effects of thyroid hormones on glucose metabolism of bat and other organs in humans.

twenty consecutive patients with graves'-caused hyperthyroidism who are newly diagnosed and untreated will be studied at the endocrine department of huashan hospital, fudan university. all subjects are screened and examined by two senior investigators. putative bat activity is determined by the integrated 18f-fluorodeoxyglucose (18f-fdg) pet-ct. after the first pet scan, hyperthyroid patients will be treated with methimazole following clinical guidelines. none of them uses beta adrenergic blockade. the initial dose of methimazole employed is 10mg thrice a day. during follow-up, the thyroid hormone levels (free triiodothyronine and free thyroxine) will be measured every twenty days. the pet-ct scans and assessments will be repeated when the symptoms have disappeared and the thyroid hormone levels return to normal range. then the dose of methimazole will be adjusted accordingly.

Eligibility criteria:
inclusion criteria: * newly diagnosed and untreated hyperthyroid patients * informed consent was obtained exclusion criteria: * history of other endocrine diseases * useing beta adrenergic blockade * pregnant women * pacemaker implantation
interferon-free antiviral treatment of hcv-positive genotype 1b related indolent non-hodgkin lymphomas

Conditions: Hepatitis c

Summary: interferon-free antiviral treatment of hcv-positive genotype 1b related indolent non-hodgkin lymphomas patients using daclatasvir and asunaprevir: a pilot study

prospectively collect cases with nhl (n=10), having hcv genotype 1b related nhl, who will be treated with asv (200 mg twice daily) + dcv(60 mg once daily) for 24 weeks the patients will be observed and followed to determine whether there is regression of nhl after antiviral treatment. conventional chemotherapy should be initiated shortly in cases without regression.

Eligibility criteria:
inclusion criteria: 1. men and women 2. 18 to 70 years of age 3. who had chronic hcv genotype 1b infection 4. an hcv rna level of 105 iu per milliliter or higher 5. being diagnosed to be low grade b cell non-hodgkin lymphoma exclusion criteria: 1. patients with hepatitis b virus infection, 2. other liver diseases 3. hiv infection, 4. pre-existing hcv variants in the ns5a domain included q30r, l31 m/v, and y93c/n 5. evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results.
study of zoladex given every 12 weeks versus given every month in advanced breast cancer (abc) pre-menopausal women

Conditions: Advanced Breast Cancer

Summary: the primary objective is to evaluate whether zoladex 10.8 mg (12-weekly) is non-inferior to zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks. secondary objectives are to compare the safety and tolerability profile of zoladex 10.8 mg and zoladex 3.6 mg by assessment of adverse events (aes)and to assess goserelin pk in japanese and caucasian participants who have received zoladex 10.8 mg by assessment of goserelin plasma concentration time profiles recruitment into the study has been permanently stopped as of 24 december 2007 due to slow recruitment. 98 (vs the planned 260) patients were randomised into the study and will be followed as per protocol for 2 years


Eligibility criteria:
inclusion criteria: * pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (er +ve) breast cancer * world health organization (who) performance status of 0, 1, or 2 * provided written informed consent exclusion criteria: * treatment with tamoxifen or other hormonal therapies as early breast cancer (ebc) adjuvant in the previous 24 weeks * received radiotherapy within the past 4 weeks * history of systemic malignancy other than breast cancer within the previous 3 years * estimated survival less than 24 weeks

Keywords: oncology cancer breast cancer
sleep, breathing and psychomotor performance at altitude: a physiologic study in healthy subjects

Conditions: Healthy Men

Summary: this study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects.

sleep is essential for well being and performance. sleep disturbances by recurrent apnea and hypoxia in patients with obstructive sleep apnea syndrome impair quality of life, cognitive and cardiovascular functions. similar consequences occur in healthy subjects exposed to hypoxia at altitude due to periodic breathing with recurrent central apnea. this project will investigate effects of altitude on sleep, breathing, psychomotor performance and on the cardiovascular system in healthy subjects and patients with sleep apnea. the results will help to better understand mechanisms of sleep disturbances and psychomotor impairment induced by hypoxia and to prevent adverse effects of altitude exposure.

Eligibility criteria:
inclusion criteria: * healthy men * residence at \<800m exclusion criteria: * any active disease requiring treatment * requirement for regular use of medication * smoking, regular intake of alcohol or drugs * body mass index \ 30 kg/m2 * previous intolerance of moderate altitude (\<3000m)

Keywords: hypoxia altitude sleep sleep apnea periodic breathing vigilance psychomotor endothelial function
emurmur id - clinical performance evaluation

Conditions: Heart Murmurs; Pathologic Murmurs; Innocent Murmurs; Congenital Heart Defect; Systolic Murmurs; Diastolic Murmurs

Summary: the differentiation between innocent and pathologic murmurs through traditional auscultation can often be challenging, which in the end makes the diagnosis strongly dependent on the clinitians experience and clinical expertise. with the development of technology it is now possible to help diagnose heart murmurs using computer aided auscultation systems (caa). emurmur id is an investigational caa system (not fda cleared) and the investigators hypothesize that it can distinguish between aha class i (pathologic murmurs) and aha class iii heart sounds (innocent murmurs and/or no murmurs) with a sensitivity and specificity not worse compared to a similar fda cleared caa system on market.


Eligibility criteria:
inclusion criteria: * all age groups of patients will be included from 1day old * patients who are being followed for known congenital heart disease and are returning for follow up * patients referred for a suspected heart murmur exclusion criteria: * mismatch between the expert physician's diagnosis (auscultation based) and the diagnosis resulting from echocardiography (independently read by a cardiologist blinded to the auscultation results). note: both, the expert physician and echocardiography results must independently reach the same diagnosis, which is then accepted as the gold standard reference diagnosis to which both devices are compared to. this is necessary because not every pathology visible on an echocardiogram causes an audible murmur, and not every murmur heard by a medical expert might correlate to pathology. * patient whose behaviour does not allow for a standard auscultation by the physician (e.g. a screaming fit).
relationship between circulating sclerostin and bone lesions in patients with mastocytosis

Conditions: Mastocytosis; Bones

Summary: mastocytosis is very rare and highly heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs and tissues. bones are the most frequent localization of systemic mastocytosis. the aim of our research was to explain the potential role of sclerostin in the pathogenesis of bone disease in mastocytosis.

mastocytosis is a heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs, such as the skin, bone marrow or liver. the skeleton is the most frequent localization of systemic mastocytosis (sm). bone involvement occurs in approximately 70% of sm patients. pathogenesis of mastocytosis bone disease is poorly understood. the aim of our research is to explain the potential role of sclerostin, a recently discovered bone tissue protein, in the pathogenesis of bone changes in patients with mastocytosis. the study group consists of adult patients with mastocytosis divided according to their clinical variants of disease (aggressive systemic mastocytosis - asm, systemic mastocytosis with an associated hematological neoplasms sm-ahn, smouldering systemic mastocytosis - ssm, indolent systemic mastocytosis - ism and cutaneous mastocytosis - cm; and group of healthy volunteers. the concentration of sclerostin, bioactive sclerostin and expression of the sost gene in human plasma and hmc-1.2 human mast cell culture supernatants is assessed. the real-time pcr method is used to evaluate the expression of sclerostin at the mrna level, while the concentration of the sclerostin protein and its bioactive form is assessed using the enzyme immunoassay elisa method. the obtained results are correlated with selected demographic, clinical, laboratory and radiological findings. low-dose ct scan is used to assess bone changes. these preliminary results could serve that sclerostin may be a new therapeutic target in patients with mastocytosis.

Eligibility criteria:
inclusion criteria: * age \> 18 years * mastocytosis defined according to who criteria * known kit mutation status exclusion criteria: * history of organ transplant * inability to give informed consent * pregnancy, breastfeeding * vulnerable patient, defined as: patient with another uncontrolled severe disease; patient under juridical protection

Keywords: bones mastocytosis osteolysis osteosclerosis sclerostin
a phase 2 study of immunogenicity, safety and tolerability of csl412 in elderly participants

Conditions: Influenza

Summary: current influenza vaccines have a reduced efficacy in the elderly. this study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 to ≤ 45 or ≥ 60 * ability to provide pre-vaccination venous blood sample exclusion criteria: * history of clinically significant medical conditions * immunomodulative therapy * acute infection
patient reported outcomes in stroke care

Conditions: Stroke

Summary: the presented study is an explorative prospective study. first, it focusses on the longitudinal analysis of outcome quality in stroke treatment (12 months). particularly, it addresses patient reported quality of life after inpatient stroke treatment and influencing factors. second, it focusses on the feasibility and acceptance of a standard set of measures capturing outcome quality of medical care in stroke patients.

with a shift in focus to patient-centered health care and a constant effort to improve the quality of treatment, the role of the patient's perception of his/her medical care becomes essential. patient reported outcome measures (proms) are among the most adequate instruments for assessing the patient's perspective on symptom load, functional status, and quality of life. after stroke, patients not only suffer from objectively scaled and measurable symptoms and impairments but also experience dramatic changes in everyday routine and quality of life. in this project, a standardized outcome measurement, including proms, for stroke patients is used. this stoke standard set was developed by the international consortium for health outcomes measurement (ichom; www.ichom.org); an international, interdisciplinary and inter-professional expert group with the contribution of patient representatives, aiming to create a comprehensive tool for measuring the most important outcomes and risk factors applicable to a broad variety of diseases. main objective of this study is the analysis of quality of life 90 and 360 days after stroke and its association with stroke specific risk factors and complications, also measured within the scope of the ichom tool. furthermore, the process and success of the implementation of the ichom stroke standard set within the stroke unit of the university medical centre hamburg- eppendorf (uke) will be studied and evaluated.

Eligibility criteria:
inclusion criteria: * patients in inpatient care in the stroke unit of the uke with the following diagnoses (icd-10): * ischemic attack (i63), * transient ischemic attack (g45) * intracerebral hemorrhage (i64) * written informed consent exclusion criteria: * substantially impaired communication capacity due to aphasia or dementia

Keywords: stoke patient-reported outcomes (pros) quality of life morbidity mortality functional status patient-centered care ichom treatment quality