Kornimate/medical-research-clean huggingface dataset:
the effect of transcranial direct current stimulation (tdcs) in addition to tinnitus retraining therapy (trt) for treatment of chronic tinnitus patients

Conditions: Tinnitus

Summary: the aim of this study is to evaluate the added effect of tdcs to trt within patients with chronic, non-pulsatile tinnitus. patients were randomised in two groups namely, trt and real tdcs and the second one is trt with sham tdcs. evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. subjective outcome measurements such as tinnitus functional index and visual analogue scales of loudness are the primary outcome measurement. secondary outcome measurements are the hospital anxiety and depression scale, hyperacusis questionnaire and psychoacoustic measurements.


Eligibility criteria:
inclusion criteria: * duration of tinnitus \> 6 months * maximum loudness of tinnitus on the vas ≥ 4 * tfi score ≥ 25 exclusion criteria: * pregnancy * psychiatric disorders * pace maker or defibrillator * pulsatile tinnitus * acoustic neurinoma * cva
aberrant gene expression prostate carcinoma

Conditions: Prostate Cancer

Summary: the goal of the study is to gain a better understanding of the molecular changes responsible for causing prostate cancer and that examination of tissue and blood samples will help in the development of improved screening and therapeutic approaches.

the goal of this study is to identify novel genetic elements that are aberantly expressed throughout prostatic neoplastic progression. the approaches proposed exploit the known familial arm of prostatic cancer, using established molecular genetic approaches, and extend these studies to sporadic prostatic cancer using a novel technique of differential display. application of the latter technique to colon cancer in the american population establishes this tumor type as a high priority for scientific investigation and this study is part of an initiative to address this problem. presently the studies in the field of prostate are under-represented. the collection of tissue samples from patients diagnosed with prostate cancer. patients will also provide a blood sample at the time of their surgery and potentially post-op from 6 mos to 5 years. samples will also be obtained from patients who's biopsy turns out to be non-prostate cancer. these samples will be obtained shortly following the biopsy out to 6 months after the biopsy.

Eligibility criteria:
inclusion criteria: * diagnosed prostate cancer undergoing prostatectomy * suspicion of prostate cancer undergoing biopsy - negative biopsy * health volunteer (control group) - blood sample for psa exclusion criteria: * patients not fitting the inclusion criteria

Keywords: prostate cancer
randomised trial of health coaching in secondary prevention of diabetes and heart disease

Conditions: Diabetes Mellitus, Type 2; Heart Failure; Coronary Disease

Summary: a randomised trial with individual patients as units of observation will be carried out. health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. a personal health coach is assigned to each patient and they are in weekly contact through telephone. the intervention lasts for 12 months. no intervention is offered to the patients in the control arm.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes (medication and hba1c\>7% and no cardiovascular disease), coronary artery disease (history of myocardial infarction or revascularisation) or heart failure (nyha ii-iii and admitted in a hospital for the condition within 2 years) * aged 45 years or older * resident in the päijät-häme health care district exclusion criteria: * classified as ineligible by primary care physician * unable to co-operate or participate in health coaching * major elective surgery planned within 6 months * history of major surgery within past 2 years * life expectancy \<1 year * pregnancy
comparative efficacy of an intensified re-vaccination scheme for hepatitis b virus infection among patients infected with hiv .

Conditions: Hepatitis B; HIV

Summary: hepatitis b virus infection is a common occurrence among patients with hiv. effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. the purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.


Eligibility criteria:
inclusion criteria: * older than 18 years of age. * patients infected with human immunodeficiency virus (hiv) * failed previous vaccination with a standard dose scheme of recombinant hepatitis b vaccine (20mcg at 0, 1 and 6 months). nonresponders will be considered as those patients presenting a hepatitis b surface antigen antibody titer lower than 10ui/ml 4 to 8 weeks after the last dose of the vaccine. * provision of informed consent. exclusion criteria: * proven hepatitis b virus infection (acute or chronic). * proven hypersensitivity to the vaccine or any of its components.

Keywords: vaccine primary prevention immunogenicity
effectiveness of adding subcutaneous long-acting detemir to insulin drip therapy compared with standard insulin drip therapy

Conditions: Diabetes

Summary: the investigators anticipate that the use of detemir will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and icu (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.


Eligibility criteria:
inclusion criteria: * diabetic ketoacidosis (dka) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (npo), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip. * patients with type 1 and type 2 diabetes mellitus (dm) will be included. * patient with both types of diabetes will be among those treated with insulin drip while being npo, having severe concomitant illness or receiving enteral and parenteral nutrition * patients will be of age 19 to 80. exclusion criteria: * inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, levemir allergy, and concurrent sulfonamide treatment

Keywords: diabetes
phage safety retrospective cohort study

Conditions: Bone and Joint Infection; Prosthetic Joint Infection

Summary: the aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.


Eligibility criteria:
inclusion criteria: * patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event exclusion criteria: -

Keywords: bone and joint infection phagotherapy adverse event prosthetic joint infection
bi 44370 ta in acute migraine attack

Conditions: Migraine Disorders

Summary: the objective of this trial is to assess the safety, tolerability, and efficacy of three doses of bi 44370 ta in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator.


Eligibility criteria:
inclusion criteria: * adult migraine patients with or without aura, diagnosed according to the ich. * established migraine diagnosis greater than or equal to 1 year. * age at first migraine onset latest at 50 years of age. * medical history of migraine with headache of moderate to severe intensity and migraine frequency of 2-8 times/ month. * patient has provided written informed consent in accordance with ich-gcp and local legislation. exclusion criteria: * history of hemiplegic, ophthalmoplegic or basilar migraine, or cluster headache. * history of treatment-resistant migraine attacks. * other pain syndromes possibly interfering with study assessment or use of any pain medication \> 10 days / month. * use of migraine and other restricted medication, or other restrictions as per protocol. * pregnancy or breast-feeding. female of childbearing potential who do not use contraception. * clinically significant cardiovascular, peripheral vascular, hepatic, respiratory, haematological, gastrointestinal, renal, metabolic, immunological, hormonal, neurological and psychiatric disorders. * patients in whom unrecognised coronary artery disease is likely, or who are at risk of coronary artery disease indicated by the presence of risk factors. * persistent liver enzyme elevation such as alt, ast or ap \> 2x uln. * known history of hiv, or history of cancer within the last 5 years. * dsm-iv-defined-history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine, but including alcohol or benzodiazepines.
efficiency of manual therapy on central sensitization in patients with nonspecific chronic back pain

Conditions: Central Sensitization; Manual Therapy

Summary: central sensitization (cs) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. cs has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (lbp). the aim of this study is to investigate the effect of manual therapy on central sensitization in patients with nonspecific chronic lbp.

a total of 40 lbp patients aged between 24-64 with css will be randomized into two groups. the manual therapy group will receive a 4-week manual therapy (two sessions/week) plus the conventional physiotherapy program, while the control group will only receive conventional physiotherapy. before and after the interventions pain intensity (vas), and scores of three questionnaires: oswestry disability index (odi), central sensitization inventory (csi), and the 36-item short form health survey questionnaire (sf-36) will be recorded.the outcomes of the study will be analyzed by appropriate statistical methods.

Eligibility criteria:
inclusion criteria: * non-spesific low back pain patients with pain longer than 12 weeks * aged between 20-64 years male and female participants exclusion criteria: * concomitant disease that would interfere with treatment * pregnancy * have had any spinal surgery or fracture

Keywords: central sensitization manual therapy non-specific low back pain
the early diagnosis and warning role of erectile dysfunction

Conditions: Erectile Dysfunction; Endothelial Dysfunction

Summary: 1. find the early diagnostic markers of erectile dysfunction; 2. study the warning role of ed in some diseases.


Eligibility criteria:
inclusion criteria: 1. male and at least 18 years of age. 2. provide signed informed consent. 3. have a history of erectile dysfunction (ed: defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) . 4. have a stable monogamous relationship with a female partner. to some subjects with poor sexual experience, re-evaluation would be conducted after a 4-weeks sex education. 5. make at least four sexual intercourse attempts with the female sexual study partner during the 4-week therapeutic period without medication. 6. agree not to use any other ed treatment for at least 4 weeks. exclusion criteria: 1. severe diseases (such as congestive heart failure, arrhythmia, significant renal or hepatic dysfunction and anemia); 2. had clinically noteworthy penile deformities, pelvic surgery or trauma of perineal region; 3. had received long-term pharmacotherapy (including antioxidant agents, vitamins and traditional chinese drugs). 4. an addiction problem (with a history of injection or administration of opium, poppy, heroin, hemp, morphine, cocaine, caffeine, ketamine and meperidine etc.)
impacts of touch-massage on the experience of patients with chronic pain: a mixed study.

Conditions: Chronic Pain

Summary: the main purpose of this study is to evaluate the impacts of toucher-massage on the experience of patients with chronic pain. the study takes place in two rehabilitation internal medicine services of the university hospitals of geneva at 2 inpatients units with 78 participants (39 per group).

this is a monocentric study with a design of non-randomized cluster trial with an exploratory qualitative part. the treatment is assigned to one of two care units and subjects are allocated to the care unit not according to a randomization process but based on administrative basis. the main purpose of this study is to evaluate the impacts of toucher-massage (tm) on the experience of patients with chronic pain hospitalized in two rehabilitation internal medicine services. the main objective is to measure the effects of tm on the global impression of change of the perception of pain. the secondary objectives are: 1. measure the effects on 1. the severity and impact of pain 2. anxiety/depression 3. caregiver-patient interaction 2. explore the experiences of patients benefiting from tm 3. explore perceptions, resistance, barriers and facilitators regarding the proposed interventions with the health care teams of the units. the population is patients suffering from chronic pain in two units of the internal medicine rehabilitation service at beau-séjour. the two units are similar in terms of care intake and populations cared for. the required sample size is 78 participants (39 per group)

Eligibility criteria:
inclusion criteria: * hospitalized for a minimum of two weeks * suffering from chronic pain for more than 3 months * having sufficient command of french in reading, writing or speaking exclusion criteria: * documented cognitive impairments, and jeopardizing their ability to discern * diagnosed with cancer that does interfere with foot massage (extremities metastases) * dermatological conditions that interfere with foot massage * suffering from major polyneuropathy * taking anticoagulants or bleeding disorders * being pregnant * having a pacemaker

Keywords: toucher-massage well-being gratitude
glycemic control, brain structure and cognition in youth with type 1 diabetes (t1dm)

Conditions: Type 1 Diabetes Mellitis; Cognition

Summary: lo5 study: the investigators are inviting a new group of youth (ages 7-16) who have been recently diagnosed with type 1 diabetes and their non-diabetic siblings. these youth will complete cognitive tests and a mri scan of the brain. this scan uses strong magnets to obtain pictures and does not involve any radiation or injections. the investigators will recruit patients within three months of their diagnosis date. the study entails 1 study visit that lasts 3.5 hours. evening and weekend times are available. the investigators plan to enroll 135 participants. hy5 study: the investigators are inviting a cohort of youth and young adults (ages 9-21) with type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already completed. this group of people will complete several memory and thinking tests along with several mri scans of their brain, just as they did at their previous visits. the investigators plan to enroll 150 participants.


Eligibility criteria:
lo5: inclusion criteria for participants with type 1 diabetes: * between the ages of 7 and 16 * diagnosed with type 1 diabetes within 3 months inclusion criteria for participants without type 1 diabetes: * between the ages of 7 and 16 exclusion criteria for participants with type 1 diabetes: * pregnant or lactating * chronic disease other than t1dm, well-controlled asthma, or hashimoto's thyroiditis * other current serious medical illness * psychiatric illness * psychoactive drug dependence * neurological illness (except t1dm-related): stroke, seizure, major loss of consciousness, head injuries, encephalitis, or hydrocephalus, blindness, deafness * use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed) * use of dopamine depleting agents or stimulants such as ritalin, cylert, adderall * pre-maturity at birth of more than 4 wks early with complications (e.g. on respirator at nicu) * inability to complete mri scan (e.g. claustrophobia, metal implants) * full set (top and bottom) of orthodontic braces (half set braces, fillings, and retainers are ok) exclusion criteria for participants without type 1 diabetes: * same as above (except cannot have type 1 diabetes) hy5: must have been a participant in our earlier study.

Keywords: type 1 diabetes mellitis youth hypoglycemia hyperglycemia cognition memory brain growth & development magnetic resonance imaging
effect of transcutaneous electrical nerve stimulation in peripheral artery disease tens-pad study / tens-aomi

Conditions: Peripheral Artery Disease

Summary: purpose: the investigators team recently carried out a proof of concept study testing the efficacy of one single 45-minute session of 10 hz tens prior to walking, versus placebo. in this randomized study, the investigators found that tens significantly delayed pain onset and increased the pain-free walking distance in patients with class ii pad. from these encouraging results, the investigators now seek to assess the efficacy of an intervention that includes the daily use of tens for 3 weeks (5 days a week) on walking distance in pad (leriche-fontaine stage ii). methods/design: prospective multicentre study / randomized controlled trial / double blinding.

interventions (2 groups): experimental group (tens group): the treatment will consist of stimulation of the leg (frequency of 10 hz, biphasic, with a pulse width of 200 µs, maximal intensity below motor threshold), 45 minutes per day, in the morning before the exercise rehabilitation programme, for 3 weeks, 5 days per week. control group (group sham): the stimulation placebo will be delivered according to the same modalities as for the tens group but with a voltage level that vanishes automatically after 10 seconds of stimulation. 15 days of interventions (tens or sham) between j0 and j23, end of study for patient at j24-j25, two days for the last analyses who are the same of inclusion's visit j0. primary outcome: walking distance (metres) measured on a treadmill with a standardized protocol. secondary outcomes: transcutaneous oxygen pressure (tcpo2) measured during a strandness exercise test, peak oxygen uptake (vo2 peak) (ml.min.kg-1), endothelial function (endopat®), ankle-brachial pressure index, body mass index, lipid profile (ldl-c, hdl-c, triglycerides), fasting glycaemia, hba1c, welch questionnaire.

Eligibility criteria:
inclusion criteria: * unilateral leriche stage ii pad, admitted to cardiovascular rehabilitation unit * men or women * able to take part in an out-patient rehabilitation programme * clinically stable * sedentary * provided informed consent to participate in the study exclusion criteria: * ward of court * walking disorders related to orthopaedic or neuromuscular disease * participation in a structured physical reconditioning programme in the month before the study * renal insufficiency requiring dialysis * known and documented myopathy * progressive cancer * associated progressive disease causing a deterioration in general health * participation in another research protocol * skin disorder making it impossible to use tens * absolute contra-indication to physical activity * presence of pacemaker / defibrillator * pregnant women in the 1st trimester / 12 weeks

Keywords: peripheral artery disease transcutaneous electrical nerve stimulation walking ability endothelial function
the effect of carnitine supplementation on cardiac function and lipid profile in patients with drug resistant epilepsy on ketogenic diet

Conditions: l Carnitine With Ketogenic Diet

Summary: primary aim: demonstrating the effect of carnitine supplementation on lipid profile and cardiovascular functions in patients with dre on kd. secondary aim: to highlight the effect of carnitine supplementation on efficacy of kd in seizure control.

the kd, a strict diet high in fat and low in carbohydrates, increases the ketone body concentrations that could lead to an enhancement of inhibitory neurotransmission and thereby possibly reducing the seizure frequency (seo et al., 2007). carnitine plays a major role in the degradation of fatty acids. as a trimethylated amino acid, it facilitates translocation of fatty acids into the mitochondrion and is therefore an essential cofactor in fatty acid oxidation and ketogenesis (longo et al., 2016). carnitine transports dietary fat to the mitochondria to be oxidized into ketones, which are used for energy when sufficient carbohydrate is not available (coppola et al., 2006; mcnally \& hartman, 2012). levocarnitine can improve cardiac function effectively through improving albumin, high sensitivity crp, brain natriuretic protein, troponin, and left ventricular end diastolic dimension (zhao et al., 2020). due to the high fat intake, children following kd may have an increased demand for carnitine and therefore, may be at an increased risk for carnitine deficiency (neal eg et al.,2008). although total carnitine decrease over the first few months of kd treatment, and in some patients, dip into the deficiency range, it then normalizes with no evidence of a continued decline (berry-kravis et al., 2001; coppola et al., 2006). few studies was performed to evaluate carnitine effect in epileptic children and adolescents treated with old and new antiepileptic drugs with or without ketogenic diet coppola et al., 2006). the kd is mostly associated with gastrointestinal (gi) disturbances, such as nausea, vomiting, diarrhea, and constipation, also were frequently noted, sometimes associated with gastritis and fat intolerance (armeno et al., 2018).

Eligibility criteria:
inclusion criteria: - all aged from 1 month till 16 years old with dre on kd. exclusion criteria: * patients who are already on kd and carnitine supplements.
evaluation of the effect of neuroprotective drug on treatment result in patients after traumatic brain injury

Conditions: TBI (Traumatic Brain Injury)

Summary: traumatic brain injury tbi is one of the most common causes of death and recovery failure worldwide. each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. more and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with tbi. in our trial we stated the hypothesis that cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. in retrospective analysis we divided the patients into two groups : with and without cerebrolysin. we also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (icp) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. we also analyzed if there is any change in the results of treatment after combining cerebrolysin with another neuroprotective drug : amantadine. we also analyzed the influence of craniotomy combined with cerebrolysin treatment. in an observational study, we collected information on 56 patients.


Eligibility criteria:
inclusion criteria: * tbi diagnosis * admission to icu * age \>18 y exclusion criteria: * initially lethal injury * age \<18 y

Keywords: tbi neuroprotective treatment cerebrolysin neuromonitoring nirs icp onds