Kornimate/medical-research-clean huggingface dataset:
intra-arterial microplasmin administration in patients with acute intracranial vertebrobasilar artery occlusion

Conditions: Stroke

Summary: the purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.

patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. during study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.

Eligibility criteria:
inclusion criteria: 1. patients with angiographically documented vertebrobasilar artery occlusion 2. initiation of study drug treatment within 24 hours of the onset of neurological symptoms 3. age 18-75 (inclusive). exclusion criteria: 1. patients with coma \> 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, vor, pupil reflexes) as measured at the last assessment before sedation/intubation 2. rapidly improving neurologic signs at any time before initiation of study drug administration. 3. known contrast agent-sensitivity 4. uncontrolled hypertension defined as a systolic blood pressure \> 180 mm hg or a diastolic blood pressure \> 100 mm hg on 3 separate occasions at least 10 minutes apart or requiring continuous iv therapy. 5. history of stroke within the previous 6 weeks.

Keywords: stroke vertebrobasilar basilar acute vertebrobasilar artery occlusion
multicenter itbs neuromodulation for ptsd treatment

Conditions: Posttraumatic Stress Disorder

Summary: the proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (itbs) targeting primary motor cortex (m1) as adjunct treatment for ptsd patients. the primary outcome measure includes changes in ptsd symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.

the proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (itbs) targeting primary motor cortex as adjunct treatment for ptsd patients. compared to traditional repetitive transcranial magnetic stimulation (rtms), itbs strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (mdd). through this adequately randomized and sham-controlled study of itbs for ptsd, this work will provide an alternative and potentially more potent stimulation target for clinical ptsd treatment. this study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in ptsd. the ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for ptsd patients.

Eligibility criteria:
inclusion criteria: * aged between 18 to 65 years old * right handedness * have a diagnosis of ptsd meeting dsm-5 criteria * caps-5 score\>35 * under stable medication for at least four weeks * capable of independently reading and understanding study materials and providing informed consent. exclusion criteria: * current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary cns tumors; 3) stroke; or 4) cerebral aneurysm. * primary psychotic disorder, bipolar i disorder, major depressive disorder, or personality disorders * lifetime history of attempted suicide or hamd-17 suicide item (item 3) ≥ 3 points * implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fmri * previous experience of rtms * pregnancy/lactation, or planning to become pregnant during the study * current under psychological or other physical treatments

Keywords: itbs ptsd
study targeting affect regulation

Conditions: HIV; AIDS; Substance Use Disorders

Summary: this phase ib pilot rct will examine the safety, feasibility, and acceptability of a multi-component intervention to address traumatic stress symptoms among hiv-positive, methamphetamine-using men who have sex with men (msm). following a baseline assessment, 56 participants will be randomized to receive either: 1) a 7-session intervention to address traumatic stress related to living with hiv/aids; or 2) a 7-session, attention-control condition. follow-up assessments will be administered at 1 and 3 months post-randomization.

in the multi-component intervention protocol, participants will complete expressive writing exercises where they will be asked to write about difficult life experiences. following expressive writing, participants will receive stress management skills training to assist them with managing any acute increases in distress that arise from the writing experience. participants in the attention-control condition will write about neutral topics and complete psychological measures. the overarching goals of this phase ib rct will be to: 1) examine the feasibility and acceptability of the intervention and attention-control; and 2) determine whether intervention participants report reductions in traumatic stress symptoms over the 3 months following randomization. findings from this phase ib trial will inform our efforts to implement a more definitive rct of this intervention with hiv-positive, methamphetamine-using msm.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * speak english * self-identify as a man who has sex with men * have been diagnosed with hiv for at least 3 months * provide evidence of hiv-positive serostatus * report using methamphetamine during the past 30 days exclusion criteria: * do not have the capacity to provide informed consent

Keywords: hiv/aids methamphetamine trauma
pathophysiology based therapy of early onset epileptic encephalopathies

Conditions: Seizure, Epileptic

Summary: genetic epileptic encephalopathies (ees) are a group of very rare and severe, pharmaco-resistant epilepsy forms characterized by an early onset, e.g. first years of life, and an often severe developmental delay. genetic defects were found in different ion channels such as potassium or sodium channels explaining well the pathological neuronal hyperexcitability leading to seizures. further mutations were also found in proteins relevant for cell structure, dna/rna processing or the synaptic vesicular metabolism. specific and individualized therapies have not been established neither in the clinical routine nor in controlled studies. the goal of this monocentric non-blinded non-placebo controlled phase iib study is the evaluation of the effectivity of anticonvulsive drugs specifically working on the ion channels defective in some subtypes of ees in order to establish a standard and individualized therapy for these rare diseases based on the specific genetic defect.

during the study, the sodium channel blockers phenytoin and lacosamide and the potassium channel blocker kinidinsulfate will be given under standardized conditions to patients with an early onset and pharmaco-resistant genetic epilepsy with and without mutations in the potassium channels kcnt1 and kcnq2 and the sodium channel gene scn2a. the primary endpoint will be a significant seizure reduction under trial medication compared to baseline. secondary endpoints will be the improvement of electroencephalographic characteristics of the respective ees.

Eligibility criteria:
inclusion criteria: * highly active epilepsy (≥ 1 seizure per day) * epilepsy with onset 0-3 months of age * pharmaco-resistant epilepsy (2 or more standard anticonvulsive medications tried before) * recently max. two stable anticonvulsive drugs for minimum 4 days before study start * patients under continuous monitoring control * patients younger than 1 year of age exclusion criteria: * high grade cardial rhythm disorders * severe liver, renal and electrolyte blood parameter changes * metabolic or lesional origin of epilepsy (metabolic screening results and cranial mri available) * parallel participation in other studies (must be finished two month before study start) * missing informed consent
double blind study of thymopentin effects on patients with hiv-1 infection

Conditions: HIV Infections

Summary: examine the ability of thymopentin (timunox) to: reduce the amount and/or frequency of virus isolation. stimulate the immune system and alter the clinical findings in patients infected with hiv who do not yet have aids.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * aerosolized pentamidine. prior medication: allowed: * aerosolized pentamidine. exclusion criteria co-existing condition: patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded. concurrent medication: excluded within 90 days of study entry: * zidovudine (azt). prior medication: excluded within 30 days of study entry: * immunomodulatory or experimental therapy. * excluded within 90 days of study entry: * zidovudine (azt). patients must not have: * hemophilia a or b or other hematologic disorders requiring current or previous administration of blood products. * aids as defined by the cdc (except for those with hiv "wasting syndrome"). * significant hepatic disease. * thrombocytopenia (\< 75000 platelets/mm3). patient must voluntarily sign consent and be seropositive for hiv-1 (elisa assay) confirmed by western blot. * hiv-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (pbmc) on two separate occasions. * patients with hiv "wasting syndrome" are included. intravenous drug abuse.

Keywords: thymopentin acquired immunodeficiency syndrome
a comparative investigation of standard of care (soc) and episil® in combination versus soc alone on oral mucositis

Conditions: Oral Mucositis

Summary: to compare the performance of standard of care (soc) + episil® versus soc alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (hsct). the primary variable will be the area under the curve (auc) of oral mucositis scores defined by the world health organisation (who) oral toxicity scale assessed daily by the investigator over the 28-day study period.

this was multicentre, open-label, randomised parallel-group study. patients were randomised to one of two parallel treatment groups: episil® in combination with soc or soc alone. the study was originally planned to be conducted in several sites in the following countries: denmark, israel, poland, and sweden. following a country-specific amendment on 20-feb-2013 and a german ethical committee (ec) approval in 07-may-2013, germany was added to the list of countries where the study would be conducted. no study sites were initiated in denmark. the study design was aimed to facilitate direct comparison of the performance of soc + episil® versus soc alone. the study was conducted in an open-label manner that is common in trials involving cancer patients, as this takes into the account the ethical issues involved in this indication and patient population. to reduce the likelihood of bias, assignment to study treatment was randomised. soc as control group is appropriate and widely used, especially in trials involving cancer patients. in this particular study, basic oral hygiene consisting of brushing, flossing, rinsing and moisturising was taken as the soc used as control group. .

Eligibility criteria:
inclusion criteria: 1. is at least 18 years of age. 2. has a confirmed diagnosis for which he/she is scheduled for hematopoietic stem cell transplantation (hsct) of either type of transplant (autologous or allogeneic). 3. is due to undergo treatment with myeloablative conditioning (radiation-based or non radiation based) before hsct. exclusion criteria: 1. will undergo reduced intensity conditioning before hsct. 2. has got known allergy to any ingredient in the study product or to peanuts, peppermint oil, or soya. 3. is pregnant or breast feeding. 4. has any other concurrent medical condition that, in the opinion of the investigator, would increase the risk to the patient, compromise evaluation of the investigational device, or interfere with the conduct of the study. 5. has an unstable condition (eg, a psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying with the study requirements. 6. is undergoing treatment with parenteral opioids at enrolment. 7. uses treatments that promote mucosal healing (eg, palifermin). 8. uses electrolyte mouthwashes (eg, caphosol®) or other topical oral treatments (eg, tantum verde® (benzydamine), gelclair®, fungicidin (nystatin)).
gender solutions natural knee post-market study

Conditions: Osteoarthritis; Inflammatory Arthritis; Post-traumatic Arthritis; Rheumatoid Arthritis; Osteonecrosis; Varus or Valgus Deformities

Summary: this is a prospective multicenter study of the gender solutions natural knee flex system when used in primary total knee arthroplasty. the purpose of the study is to obtain short-, mid-, and long-term clinical outcomes and implant survivorship data for the gender solutions natural knee flex system.

survival and outcome data on the gender solutions natural knee flex system will be done by an analysis of standard scoring system, radiographs and adverse event records. survivorship will be evaluated by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. outcomes will be measured by comparing the overall pain and function performances (based on the knee society scoring system), survivorship, subject quality of life and radiographic parameters of study subjects receiving the gender solutions natural knee flex system.

Eligibility criteria:
inclusion criteria: * patient 18-75 years of age, inclusive; * patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: osteoarthritis, inflammatory arthritis, post-traumatic arthritis, rheumatoid arthritis, or valgus, varus, or flexion deformities; * patient has undergone a study related informed consent process; * patient is willing and able to provide written consent; * patient is willing and able to cooperate in the required post-operative therapy; * patient is willing and able to complete scheduled follow-up evaluations. exclusion criteria: * patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint; * insufficient bone stock on femoral or tibial surfaces; * skeletal immaturity * neuropathic arthropathy * osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb; * stable, painless arthrodesis in a satisfactory functional position; * severe instability secondary to the absence of collateral ligament integrity; * patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater; * patient has known sensitivity or allergy to one or more of the implanted materials; * patients pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)

Keywords: arthritis
examination of efficacy and safety of baricitinib in ra patients

Conditions: Rheumatoid Arthritis

Summary: the aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients: 1. baricitinib treatment for 12 months 2. biologics treatment for 12 months 3. tofacitinib treatment for 12 months


Eligibility criteria:
inclusion criteria: * ra patients exclusion criteria: * not ra patients * ra patients who are allergic to the drugs, refused to do this research, or who are pregnant
urban health study ii

Conditions: HIV

Summary: the study will test an intervention to help hiv-positive people achieve consistency of hiv care while transitioning in and out of jail.

the study has two research objectives: (1) to expand access and options for hiv testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (idus) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (haart) among hiv-positive persons in this population, by implementing a promising intervention focused on continuity of hiv care, and evaluating it using a rigorous experimental design. hiv-positive persons will be identified through the testing activities described in objective 1. they will then be offered enrollment in a randomized controlled trial (rct) of an intervention designed to engage and maintain hiv-positive people with criminal justice involvement in medical care. the intervention, project bridge, has shown great promise but has not yet been rigorously evaluated. the rct will assess the efficacy of project bridge compared with a usual care arm. our hypotheses are that, at quarterly data collection visits: (1) intervention participants will have lower hiv viral load than usual care participants 2b: (2) intervention participants will be more likely to be in hiv care than usual care participants (3) intervention participants will be more likely to be on haart than usual care participants. the study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. this change was approved by the nimh program officer and the rti irb in june, 2012.

Eligibility criteria:
inclusion criteria: * age 18 or older * hiv antibody positive * not currently receiving hiv care exclusion criteria: * already in care * unable to provide informed consent

Keywords: drug users criminal justice hiv care haart incarceration
effects of kinesiotherapy exercises with cervical mobilization in cervicobrachial neuralgia

Conditions: Cervico-Brachial Neuralgia

Summary: to evaluate the effects of kinesiotherapy exercises with cervical mobilization in cervicobrachial neuralgia.

cervicobrachial neuralgia is characterized by pain and discomfort in the arm, specifically in conjunction with pain in the cervical spine. it has been observed that a significant number of patients seeking therapy for cervical spine diseases are affected by this type of pain. when an illness is chronic, it has a tendency to manifest as a persistent or recurring issue that has a negative impact on an individual's mental and physical well-being. it is a randomized clinical trial. 30 patients fulfilling the inclusion and exclusion criteria will be recruited by non-probability convenience sampling and then randomly divided in two groups using lottery method. group a will receive the strengthening and kinesiotherapy exercises along with brugger's relief position training with 10 minutes per session and cervical lateral glide mobilization, 3 times a week. and the group b will receive the cervical lateral glide mobilization. pain levels will be measured using a visual analogue scale and goniometer will be used to measure neck ranges.the data will be analyzed by using spss version25.

Eligibility criteria:
inclusion criteria: * both male and female * age: 30-50 years * positive upper limb neurodynamic test * patients having neck pain radiating to upper limb and limited rom with articular dysfunction. exclusion criteria: * patients diagnosed with fibromyalgia * surgery of cervical/thoracic spine * limited glenohumeral joint movement * presence of neurological disease (stroke, multiple sclerosis)

Keywords: kinesiotherapy exercises cervical mobilization
transcutaneous mechanical nerve stimulation in the treatment of incontinence

Conditions: Stress Urinary Incontinence; Urge Urinary Incontinence

Summary: during transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. in a subsequent study it was demonstrated that transcutaneous mechanical nerve stimulation (tmns) in women could induce pressure increment of the external urethral sphincter. a pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. another pilot study has shown promising effect on the overactive bladder syndrome. the present study aims to treat urinary incontinence and includes 2 groups of patients with 30 patients in each group: women suffering from urinary stress incontinence and women suffering from urge incontinence. a medical vibrator is used and in each group the subjects will be randomized to vibration treatment or no vibration treatment. all patients will receive pelvic floor training and all women suffering from urge incontinence will receive anticholinergic medications. the stimulation will be performed at the perineum every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 hz. results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests. if the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing a normal function of the pelvic floor muscles and bladder function in incontinent patients.


Eligibility criteria:
inclusion criteria: * women suffering from stress incontinence or women suffering from urge incontinence /overactive bladder syndrome * ongoing anticholinergic treatment in the urge incontinence/overactive bladder syndrome group * patient capable of understanding protocol and performing treatment exclusion criteria: * on going pregnancy or breast feeding * treatment with anticholinergic medications in the stress incontinence group * treatment with diuretic drugs * acute illness (including infection, trauma and haematuria) * fibromyalgia * faecal incontinence * known neurological disease * bladder pain syndrome * genital prolaps \> stage 2 on the pelvic organ prolapse quantification system pop-q * previous treatment with neuromodulation or botox * previous pelvic floor surgery or radiation

Keywords: stress incontinence urge incontinence overactive bladder syndrome vibration nerve stimulation