Kornimate/medical-research-clean huggingface dataset:
sublingual buprenorphine for chronic pain

Conditions: Chronic Pain

Summary: the purpose of this study is to develop and pilot test clinical guidelines for the use of buprenorphine for the treatment chronic pain among patients with substance abuse histories. buprenorphine, an opioid medication, holds promise as a treatment of chronic pain because, compared to most other opioid analgesics, it has a high safety profile, a low level of physical dependence, and mild withdrawal symptoms on cessation. moreover there are promising reports from europe of its use as a skin patch to treat chronic pain as well as clinical reports in the u.s. that it may be effective when used sublingually (placed under the tongue). this study will test the sublingual formulation.


Eligibility criteria:
inclusion criteria: undergoing treatment for moderate-severe chronic pain for at least six months at either an ambulatory practice of the department of pain and palliative medicine beth israel medical center in new york city or the the peter kruger clinic at the same institution. either 1. on opioid therapy (any dose) and observed to have had at least four of the aberrant drug-related behaviors described in (passik et al. clin j pain; 22(2):173-81 2006) during the past six months, or 2. considered a candidate for long-term therapy by the pain specialist and a history of a substance use disorder, as determined by dsm-iv criteria, but no longer meeting criteria for at least one year. age 18-70 exclusion criteria: * meets dsm-iv criteria for current opioid dependence or other substance use disorder including alcohol abuse. * currently being treated for opioid dependence with methadone. * currently maintained on naltrexone (e.g., for alcohol dependence). * taking benzodiazepines on a daily basis. * a history of moderate-severe cardiopulmonary disease or symptoms or signs consistent with moderate-severe cardiopulmonary disease. * elevated liver function test (lft) results (\> 2.5 above normal).

Keywords: pain chronic pain buprenorphine drug addiction
evaluation study of a management strategy for gastroesophageal reflux disease (gerd)

Conditions: Reflux; Heartburn; Regurgitation; Esophagitis

Summary: the aim of this project is to compare the gerd clinical outcomes in patients where a structured pathway using the gerdq questionnaire is implemented compared with the clinical outcomes of those treated without this implementation. this is a european project with 5 participating countries (austria, italy, norway, spain and sweden). due to different characteristics regarding the actual management of this disease in the 5 countries, each country had the flexibility to introduce design differences and changes in the study protocol.

in norway, it is developed as a clinical trial where a new structured pathway in the diagnosis and treatment of gerd is compared to the ordinary clinical pathway consisting of the endoscopic/ph-metry approach in patients referred from primary care to gi specialists. in italy, it is a pcp-level, cluster randomized, controlled trial comparing a structured clinical pathway versus usual care in patients with gerd. the implementation consists of training sessions on the clinical pathway with the selected pcps (implementation group). in sweden, it is a cluster-randomised interventional study performed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway in patients identified as having gerd. the participating pccs will be randomised (1:1) to implement the structured clinical pathway or handling the patients according to local clinical routines. in austria and spain, it is a cluster-randomized study to be developed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway on gerd patients . the evaluation study will take place subsequent to a prior implementation of a clinical pathway. the implementation consists of a detailed explanation by training-materials about the clinical pathway in a selected randomized pool of pccs. the implementation that will be evaluated is outside of the study procedures; it is the physician's decision whether to apply it or not.

Eligibility criteria:
inclusion criteria: * patients presenting with symptoms suggestive of gerd (heartburn or regurgitation as prevailing symptoms) of any severity * patient able to understand and complete the questionnaires exclusion criteria: * alarm symptoms (dysphagia/odynophagia, anorexia, anaemia, unintentional weight loss, abdominal mass, upper gi bleeding) * if the patient is participating in any clinical trial, he/she cannot take part on this study * any condition that, in the investigator's opinion, makes the patient's participation in the study difficult

Keywords: gastroesophageal reflux disease reflux, heartburn regurgitation acid control ppi antiacid primary care esophagitis
art as healing: a community-informed art-based programme (ciabp) for reintegrating ex-offenders into society in nigeria

Conditions: Trauma; Depression; Anxiety and Fear

Summary: the goal of this pilot experimental study is to test a community-informed art-based programme in improving community members trauma from crime and to aid the reintegration of ex-offenders into society. the main question it aims to answer are: • what is the feasibility in terms of recruitment, retention, adherence to the intervention and communities/victims' satisfaction with ciabp to promote healing and improve the successful reintegration of ex-offenders into society? participants will be randomly allocated into two groups. the first group, the intervention group, will receive the community-informed art-based programme (ciabp). the second group will receive government intervention involving media messages from the national orientation agency devoid of ciabp. the ciabp. sessions will cover relevant aspects of art, such as photo story, story telling, poetry, and drawing in tackling trauma and negative attitudes towards ex-offenders reintegration. researchers will compare ciabp group with the media orientation group to see if there are differences between a change in attitude towards ex-offenders' reintegration at base line, end of intervention and three months follow up.


Eligibility criteria:
inclusion criteria: * community members with previous experience of trauma * aged 18+ years and are residents in areas including lagos/delta states and its environs. * able to give informed consent, * speak the english language, * able to partake in baseline, pre-, post- and three-month follow-up data collection. exclusion criteria: * the exclusion criteria are those not meeting the study's inclusion criteria.

Keywords: trauma anxiety and fear
early detection neurodevelopmental disorders of children and prevention of postnatal depression by mobile health app

Conditions: Development, Child; Postnatal Depression

Summary: the goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using malo on a regular basis. the main questions it aims to answer are : * the median age of possible neurodevelopmental disorders notification of infants * the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program participants will agree with use of their data


Eligibility criteria:
inclusion criteria: * youg parent with a minimum of 1 child under 10 years * user of the app (downloaded) * having given informed consent (in-app) exclusion criteria: * none

Keywords: early detection neurodevelopmental disorders postnatal depression mhealth real-world study smartphone
what do patients expect after scaphoid fractures?

Conditions: Expectations

Summary: this study will assess patients expectations pre-op and assess their views on their outcome at one year follow up

using trauma expectation factor and trauma outcome measure questionnaire. at fracture time and at one year post fracture analyse according to age, sex, fracture pattern, type of intervention

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of a scaphoid fracture * age \> 18 * consent for one year follow up exclusion criteria: * age \<18 * polytrauma (multiple systems/ multiple fractures) * ipsilateral fractures of the upper limb that may become distracting or affect rehabilitation * delayed presentation with higher risk of non-union or avascular necrosis
trial to evaluate the effect of plantago ovata husk in the remission of metabolic syndrome in children and adolescents

Conditions: Metabolic Syndrome

Summary: the metabolic syndrome represents a constellation of risk factors associated to the abdominal obesity that includes insulin resistance, lipids alterations, high blood pressure etc. several studies support the hypothesis that the intake of soluble fiber might have a positive effect in the improvement of such of these risk factors. so that, the aim of this study is to evaluate the efficacy of ispaghula husk in the remission of metabolic syndrome in children between 10 to 16 years old.

the prevalence of the metabolic syndrome is increasing in the last decade as well in adult people as in children and adolescents. the early diagnosis and treatment measures could be very important in order to reduce the cardiovascular risk in such populations. ispaghula husk could be efficacious to reach the remission of the syndrome due to its effects in several important lipidic parameters. the study will consist in the treatment with ispaghula husk during 4 months in patients with metabolic syndrome. the main variable is the remission of the metabolic syndrome following the idf(international diabetes federation) criteria specifics for children.

Eligibility criteria:
inclusion criteria: * children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the idf criteria: 1. waist circumference \> or equal to percentile 90 according the age. 2. presence of 2 or more of following factors: systolic blood pressure \> or equal 130 mmhg or diastolic \> or equal to 85 mmhg, or treated hypertension 3. cholesterol hdl \< 1.03 mmol/l or treatment with drugs to increase chdl 4. glucose blood levels \> 5.6 mmol/l or type ii diabetes diagnosed treated or no. exclusion criteria: * loss of body weight \> 3kg in the last 2 months * waist circumference 10 cm higher of 90 percentile according to the age * intake of fiber, aven supplements or phytosterols in the last 2 months * glycosylate haemoglobin \>7% in the time of inclusion * systolic blood pressure \> 145 mmhg or diastolic blood pressure \>95 mmhg.
a pilot study of nsicu assessment of seizure prophylaxis with lacosamide

Conditions: Traumatic Brain Injury

Summary: trial to determine if seizure prophylaxis with iv lcm in nsicu patients experiencing mental status changes due to severe traumatic brain injury (stbi) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (iv fpht) and will be at least as effective as iv fpht in preventing clinical and sub-clinical seizure activity.

the goals are to compare iv lcm and iv fpht for seizure prophylaxis in the neuro-critical care setting in terms of the following outcome measures: 1. the short- and long-term incidence of adverse events related to the anticonvulsant medication 2. the frequency of clinically-evident and sub-clinical seizures, as demonstrated by continuous eeg monitoring for the first three days and by clinical assessment for up to 6 months after initial admission. 3. intermediate and long-term outcomes as measured by standard outcome measures including extended glasgow outcome scale, disability rating scale, and resource utilization questionnaire

Eligibility criteria:
inclusion criteria: * subject with traumatic brain injury admitted to the hospital less than 24 hours prior to randomization * gcs score 3-8 (inclusive) or gcs motor score of 5 or less and abnormal admission ct scan showing intracranial pathology * hemodynamically stable with a systolic bp \> 90 mmhg * at least one reactive pupil * age at least 18 years * signed informed consent and hipaa authorization for research form * patients will not be excluded because of race, gender, educational status or occupation exclusion criteria: * no venous access * spinal cord injury * history of or ct confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage * hemodynamically unstable * suspected anoxic events * other peripheral trauma likely to result in liver failure * age less than 18 years of age * known hypersensitivity to any anticonvulsant * any treatment, condition, or injury that contraindicates treatment with lacosamide (lcm) or fos-phenytoin (fpht) * inability to obtain signed informed consent or hipaa authorization for research

Keywords: lacosamide fosphenytoin traumatic brain injury glasgow coma scale disability rating scale resource utilization questionnaire continuous eeg seizures
efficacy and safety of different concentrations of mapracorat ointment over 4 weeks in atopic dermatitis (ad)

Conditions: Atopic Dermatitis; Eczema

Summary: the purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * signed written informed consent * diagnosis of atopic dermatitis according to hanifin and rajka criteria * willingness of subject to follow all study procedures * willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight exclusion criteria: * pregnancy and breast-feeding * clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results * clinically manifested immunosuppressive disorder or known history of malignant disease * history of relevant drug and/or food allergies
can a relaxometer improve cognitive impairment of fibromyalgia patients

Conditions: Fibromyalgia Syndrome; Fibromyalgia; Pain, Chronic; Impairment; Cognitive Impairment

Summary: the aim of the study is to evaluate the differences in cognitive performance and quality of life, after a cycle of treatment with the relaxometer, between a group of patients affected by fibromyalgia and a control group.

the relaxometer is a device designed for the physical rehabilitation of patients with functional problems of upper limbs. it works by moving passively the patient's fingers in a gradual way (with different speeds) in all directions of space, which is innovative compared to similar machines already on the market. the device consists of an electrical supply unit and two handling units made of 10 silicone tips of different sizes for the placement of fingers and it works with a six-minute pre-set program. it has obtained patent and certification mark and it has been used in the rehabilitation of patients with joint stiffness induced by specific working activities, as musicians. after the treatment these patients reported a remarkable improvement of motor skills and articulation of fingers, in addition to a parallel improvement of cognitive abilities such as concentration, visual acuity and mnemonic learning. in sight of this, the aim of the study is to establish whether the application of this treatment in a small group patients affected by fibromyalgia and cognitive impairment is able to improve some aspects of the cognitive dysfunction measured with appropriate functional tests and comparing the results with a control group of patients not affected by this condition.

Eligibility criteria:
inclusion criteria: * fibromyalgic syndrome diagnosed according to the criteria of american college of rheumatology 2016 (acr 2016) * moderate-severe cognitive impairment according to the symptoms severity score (ss) * informed consent gathered exclusion criteria: * contraindication to passive handling of fingers (severe arthritis, fractures or unconsolidated traumatic outcomes, not healed wounds, finger amputations, contact allergies to substances contained in the relaxometer) * informed consent not gathered * drug addiction * brain stroke withdrawal from study * withdrawal of informed consent * treatment non completed

Keywords: relaxometer mini mental state examination fibromyalgia impact questionnaire cognitive impairment rehabilitation fingers
dose-finding study of empegfilgrastim for neutropenia prophylaxis in patients with breast cancer

Conditions: Chemotherapy-induced Neutropenia

Summary: the purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.

bcd-017-2 is an open-label randomized phase ii clinical study to compare the incidence of ctcae grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (extimia®) at a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.

Eligibility criteria:
inclusion criteria: * signed informed consent form; * histologically verified diagnosis of stage iib/iii/iv breast cancer; * age of 18-70 years inclusive; * if the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study; * ecog performance status of 0, 1 or 2, not increasing within during 2 weeks before randomization; * anc level of 1500/μl and more at the beginning of the study * platelet count of 100 000/μl and more at the beginning of the study * hemoglobin level of 90 g/l and more * creatinine level \<1.5 mg/dl * total bilirubin level \<1.5 × the upper limit of normal (uln) * alt and/or ast levels \<2.5×uln (5×uln for patients with liver metastases); * alkaline phosphatase \<5×uln; * left ventricular ejection fraction \>50% and more; * if the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 500 mg/m2 for doxorubicin or 500 mg/m2 for epirubicin; * ability of the participant to follow the protocol requirements, according to the investigator's opinion; * patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior randomization and for 6 months after the last administration of the study drug. exclusion criteria: * patient has received two or more chemotherapy regimens for the metastatic breast cancer; * documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, pegylated drugs, recombinant proteins. * pregnancy or breastfeeding; * systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration; * concomitant radiotherapy (except selective radiotherapy of bone metastases); * surgery, radiotherapy (except selective radiotherapy of bone metastases), administration of any experimental drugs within 30 days prior randomization; * history of bone marrow/stem cell transplantation; * conditions limiting the patient's ability to follow the protocol; * ctcae grade 2/4 neuropathy * hiv, hcv, hbv, t.pallidum infection(s); * acute or active chronic infections.

Keywords: empegfilgrastim pegylated filgrastim neutropenia febrile neutropenia chemotherapy-associated neutropenia breast cancer docetaxel doxorubicin
an investigational study to evaluate bms-986165 in participants with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this study will investigate bms-986165 to assess its effects in participants with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * systemic lupus erythematosus (sle) disease diagnosed ≥ 24 weeks before the screening visit * meets the systemic lupus international collaborating clinics (slicc) classification criteria for sle * one of the following: elevated antinuclear antibodies (ana) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsdna) (positive includes indeterminate results) or positive anti-smith (anti-sm) as determined by the central laboratory * total systemic lupus erythematosus disease activity index 2000 (sledai-2k) score ≥ 6 points and clinical sledai-2k score ≥ 4 points with joint involvement and/or rash \[score must be confirmed by central review services (crs)\] * men and women must agree to follow specific methods of contraception, if applicable exclusion criteria: * drug-induced sle, certain other autoimmune diseases, and active, severe lupus nephritis * sle overlap syndromes such as scleroderma and mixed connective tissue disease * clinically significant abnormalities on chest x-ray or electrocardiogram (ecg) * history of any significant drug allergy other protocol defined inclusion/exclusion criteria apply
the profile of fatigue and discomfort - sicca symptoms inventory

Conditions: Primary Sjögren's Syndrome

Summary: primary sjögren's syndrome (pss) is a chronic, systemic autoimmune disease characterized by disorders of the lacrimal and salivary glands. the disease can be seen in systemic involvement by affecting any organ. it may result in skin, lung and kidney involvement as well as symptoms such as vasculitis and neuropathy. patients with pss often report fatigue as an important symptom to manage. fatigue, defined as an overwhelming feeling of fatigue, lack of energy, and exhaustion, is associated with poor health and functional impairment. fatigue is a common symptom of pss. this symptom is the most important cause of loss of function in patients. it is thought that as a result of fatigue in pss, decrease in mental health related to physical activity level and quality of life in patients, sleep problems, depression and loss of ability to work. several mechanisms have been proposed to explain the occurrence of fatigue among sjogren patients, but its underlying physiological basis has not been adequately defined. therefore, it is a complex, multifaceted and poorly understood symptom. in population-based studies, approximately 20% of healthy adults report experiencing fatigue, and this rate rises to 60%-70% among patients with autoimmune disorders. fatigue is the most common non-exocrine symptom in pss, and the prevalence of fatigue disability among patients with pss has been reported to be approximately 70%.

in order to evaluate fatigue in primary sjögren's syndrome patients, questionnaires such as facit fatigue scale, sjögren's syndrome eular patient reporting index, fatigue severity scale, fatigue multidimensional assessment scale and short form-36, which are also used in many disease groups, are used. although the importance of the effect of fatigue on pss patients has been demonstrated in studies, most of the fatigue assessment questionnaires used are not pss specific. for this reason, bowman et al. they developed the fatigue and discomfort profile - sikka symptoms scale (profad-ssi) to assess multidimensional fatigue in patients with pss, considering disease symptoms. profad-ssi is scored from 0 to 7 on an 8-point likert scale. the 19-item scale evaluates patients in 8 different dimensions: somatic fatigue, mental fatigue, arthralgia, vascular dysfunction, oral dryness, ocular dryness, cutaneous and vaginal dryness.

Eligibility criteria:
inclusion criteria: * diagnosed with primary sjögren's syndrome * patients between the ages of 18-65 * being literate exclusion criteria: * having cognitive disorders * having another rheumatological diseases

Keywords: sjogren validity reliability fatigue sicca symptoms