Kornimate/medical-research-clean huggingface dataset:
mirocals: modifying immune response and outcomes in als

Conditions: Amyotrophic Lateral Sclerosis

Summary: mirocals is a phase ii study of ld-il-2 as a therapeutic agent for als. a randomized (1:1), placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-il-2 safety and clinical efficacy on survival and functional decline in newly diagnosed als patients treated for 18 months. randomization will be stratified according to (i) country (n = 2 levels: uk, france) and (ii) site of onset (n= 2 levels: bulbar vs limb onset). the primary objective to evaluate the clinical efficacy and safety of the experimental drug (ld il-2) over an 18 months period in order to establish the proof of concept (poc) that modifying immune responses through the enhancement of regulatory t cells modifies the rate of als disease progression.

the secondary objectives of mirocals are: to validate a new phase-ii study design to improve the efficiency of drug development in als with early determination of drug response using established biomarkers (bms). the aims of this new trial design are: (i) to shorten future trials duration in als using an early drug responding surrogate marker of disease activity; (ii) to establish the proof of mechanism (pom) of the tested drugs; (iii) to identify drug responder status. additional exploratory objectives are: (i) deep immune \& inflammatory phenotyping (ii) brain biomarkers (iii) genomics and transcriptomics

Eligibility criteria:
main inclusion criteria * patient is 18 years old and less than 76 years old * possible, probable, probable laboratory-supported or definite als as defined by el escorial revised als diagnostic criteria * disease duration \<= 24 months * slow vital capacity \>= 70% of normal * no prior or present riluzole treatment * lumbar punctures accepted by patient and done main exclusion criteria * other neurodegenerative disease that could explain signs or symptoms * contra indication for lumbar puncture (history of allergy to xylocaine, presence of contra-indicated treatment, or coagulation test abnormality, clinically significant coagulopathy or thrombocytopenia) * non authorized treatment * other disease or disorders that could preclude functional assessment, or life-threatening disorders * any documented, active, past or present, auto-immune disorders except asymptomatic hashimoto thyroiditis * using assisted ventilation * feeding through gastrostomy or nasogastric tube * women of child-bearing potential or sexually active man without contraception * pregnant or breast feeding woman * any clinically significant laboratory abnormality (excepting cholesterol, triglyceride, glucose, ck, ferritin) * history of documented symptomatic and treated asthma within the past 5 years

Keywords: interleukin-2 low-dose interleukin-2
a study to evaluate the effect of topiramate on clinical and electrophysiological parameters in subjects with diabetic peripheral polyneuropathy

Conditions: Diabetic Neuropathies; Diabetes Mellitus, Type 2; Polyneuropathies

Summary: the purpose of the study is to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. the study will also evaluate the safety of topiramate in this patient population.

this is a multicenter, double-blind, placebo-controlled study to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. patients will undergo the baseline phase when they are tapered off other pain medications, have diabetes controlled and eligibility reassessed. patients will then be randomized to receive either topiramate or placebo and enter the double-blind phase, which consists of titration period (topiramate dose will be titrated from 25mg/day to 200mg/day over 42 days) and maintenance period (study medication will be continued for 12 weeks). after the double-blind phase, study medication will be tapered off during the taper phase, whose duration will vary depending on each patient. the evaluations include electrophysiological assessment, quantitative sensory assessment, and clinical assessment such as subjective pain scales. safety evaluations (vital signs, clinical laboratory evaluations, physical and neurological examination, and evaluations of adverse events) will be conducted during the trial. during the first 42 days, doses of topiramate gradually increase to achieve the target dose (200mg daily by mouth), and then the dose is maintained for 12 weeks, after which the dose is slowly reduced and stopped over 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy * two sets of baseline nerve conduction studies and quantitative sensory testing * hba1c =\< 9% * diabetes controlled on stable regimen * female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) exclusion criteria: * diagnosis of type 1 diabetes mellitus * polyneuropathy due to other underlying causes * hospitalization within the past 3 months due to episodes of hyper/hypoglycemia * other unstable medical conditions * history of suicidal attempts * exposure to any other experimental drugs or device within the past 30 days

Keywords: diabetic peripheral polyneuropathy electrophysiology nerve conduction study neurological examination quantitative sensory testing topiramate
nimotuzumab in children with hgg

Conditions: High Grade Glioma

Summary: determination of efficiency of nimotuzumab in children with high grade glioma.

high grade malignant gliomas are tumors grade iii and iv according to who classification, that originate from oligodendroglia and astrocytes, where the latter are also known as anaplastic astrocytoma(who grade iii) and glioblastoma(who grade iv). this also includes intrinsic pontine gliomas of adolescents, which are usually not documented histologically due to their localisation, but they have a similar clinical progress when compared to high grade malignant astrocytic tumors. among various molecular alterations, malignant gliomas overexpress egfr (epidermal growth factor) in nearly 50% of cases, which is particularly pronounced in glioblastoma.(schlegel 2003) standard therapy consists of radical surgery as extensive as medically responsible followed by radiotherapy dose of 60 gy, which is aimed at the area with a safety margin. the long-term efficacy of additional chemotherapy has been a subject for controversy for several decades. the combination of all three treatment modalities in grade iii tumors can lead to median survival times of 3-5 years in adults. for this treatment group reports of 5 year recurrence free periods in 33-50% of cases have been reported in children and adolescents. for glioblastoma(who grade iv) 5year recurrence free periods are 3% in elderly patients and 10-20% for adolescents.(schlegel 2003) in german speaking territories chemotherapy with cisplatin, etoposid and ifosfamid is used as a postoperative treatment option for adolescents and this disease.(wolff hit-gbm) in case of recurrence therapy choices are even more limited, thus if medically feasible the enrolment in clinical trials is an option. in this study the aim is to use an antibody directed against the egf-receptor to effect the proliferation of the tumor cells negatively. pilot studies conducted in adults indicate that the median survival time for patients with malignant glioma can be prolonged by the antibody treatment.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of high grade glioma (who iii und iv) \[not needed for intrinsic pontine glioma\] * progressive patients under primary therapy or first and second radiologically confirmed recurrence(mri not older than 2 weeks) of high grade gliomas between the age of \> 3 years \< 20 years * lack of curative standard therapy which is currently under investigation in a national gpoh-therapy optimization study * sufficient haematological, renal and hepatic function (ctc grad ≤ 2) * disease measurable radiologicaly in at least one dimension * life expectancy \> 4 weeks * written declaration of consent of the parents/legal guardians and if possible of the child after prior information exclusion criteria: * curative therapy with an alternative method after diagnosis of progression and during this study * prior administration of human or murine antibody * pregnancy in girls of child-bearing age

Keywords: astrocytoma, glioblastoma, intrinsic pontine glioma
social and clinical aspects of pelvic pain in turkey

Conditions: Chronic Pelvic Pain Syndrome

Summary: chronic pelvic pain (cpp) is a common medical condition with a complex treatment due to different variables that influence its clinical course.there is a growing literature which discussing the effect of ethnicity and culture on pain. it was aimed to invesitigate whether there is a considerable difference in the presentation and experience of pelvic pain in women from a different societies and cultures.

chronic pelvic pain (cpp) is a common medical condition with a complex treatment due to different variables that influence its clinical course.there is a growing literature which discussing the effect of ethnicity and culture on pain. it was aimed to invesitigate whether there is a considerable difference in the presentation and experience of pelvic pain in women from a different societies and cultures. the study includes randomly selected 45 females who completed a comprehensive set of questions derived from international pelvic pain society (ipps), pelvic pain assesment form. character and intensity of pain, sexual abuse and harresment, coping with pain, physical activites (exercising) and comorbidities were evaluated. the mcgill pain questionnaire short form was used to evaluate pain. sexual abuse items in the questionnaire (modified) to assess patients' sexual abuse status.

Eligibility criteria:
inclusion criteria: * women aged 18-65 years with pelvic pain ≥6 months were eligible. exclusion criteria: * patient who have had pelvic surgery * gynecological female patients with problems other than pelvic pain
pilot study of exercise and peripheral nerve function in people with diabetes - enrgy2 addendum

Conditions: Diabetic Neuropathy

Summary: this is an amendment to study posting nct00970060. based on preliminary results from that study is was determined there needs to be a follow-up exercise intervention study. this study has two additional aims than the original study. the objectives are to determine is a prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness positively impact people with diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * age 40-70 * type 2 diabetes * peripheral neuropathy exclusion criteria: * serious cardiac pathology such as recent myocardial infarction or heart surgery, uncontrolled cardiac arryhthmia, hypertrophic cardiomyopathy symptomatic aortic stenosis or heart failure, unstable angina, acute pulmonary embolus or myocarditis, conduction abnormalities, or mitral valve prolapse * serious musculoskeletal problems that would limit ability to exercise * skin conditions, circulatory insufficiency, or open wounds in the leg that would interfere with healing from the biopsy * open wounds on the weight bearing surface of the feet * not able to ambulate independently * stroke or other central nervous system pathology * stage 2 hypertension (resting blood pressure \> 160 systolic or \> 100 diastolic) * lidocaine allergy * anticipated difficulty with blood clotting due to coumadin(warfarin) use or blood clotting disorder * body weight \> 450 lbs * inadequate cognition and communication abilities, defined as \< 24 on the mini mental status exam (mmse) * pregnant or planning on becoming pregnant in the 18 weeks following enrollment

Keywords: pain fitness diabetes aerobic exercise
to evaluate the efficacy and safety of hsk16149 capsule in chinese patients with diabetic peripheral neuropathic pain

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: investigate the efficacy and safety of hsk16149 capsules in chinese diabetic peripheral neuropathic pain (dpnp) following 13 weeks treatment in comparison to placebo.


Eligibility criteria:
inclusion criteria: 1. signed informed consent; 2. males or females aged 18-75 years of age inclusive; 3. diagnosis of diabetic peripheral neuropathic pain (dpnp) and diabetic peripheral neuropathy (dpn) pain ≥ 6 months; 4. hba1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening; 5. at screening, pain scale (vas) of ≥40 mm and \<90 mm. exclusion criteria: 1. peripheral neuropathy or pain unrelated to dpn that may confuse the assessment of dpnp. 2. skin conditions in the area affected by neurupathy that could alter sensation. 3. chronic systemic diseases that may affect subjects' participation in the study. 4. severe hematologic, hepatic or renal dysfunction, the subject will be excluded if: 1. neutrophils \< 1.5 × 10\^9/l, or platelet \< 90 × 10\^9/l, or hemoglobin \< 100 g/l, or 2. ast/alt \> 2.5 × upper limit of normal (uln), or tbil \> 1.5 × uln, or 3. estimation of glomerular filtration rate (egfr) \< 60 ml/min / 1.73 m\^2, or 4. creatine kinase \> 2.0 × uln. 5. history of substance abuse or alcohol abuse. 6. acute complications of diabetes in the 6 months prior to screening. 7. any active infections at screening. 8. hbsag or hcv ab positive, or hiv ab positive, or serum tp ab positive. 9. inability or unwillingness to discontinue any other prohibited concomitant medications (see section 6.3). 10. failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of dpnp. 11. history of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds. 12. history of suicidal behavior or attempted suicide. 13. pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of icf signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period. 14. participated in another clinical study within 30 days prior to screening. 15. other conditions of the subjects who are unlikely to comply with the protocol. 16. could potentially affect a subject's safety.
evaluation of the analgesia nociception index vs. surgical pleth index under general and regional anaesthesia

Conditions: Pain; Stress; Monitoring

Summary: there is a lack of sufficient analgesia monitoring apart from surrogate parameters. the analgesia nociception index (ani) shall be evaluated under general and regional anaesthesia.

while sophisticated haemodynamic monitoring as well as depth of neuromuscular block and sedation are established in daily clinical routine monitoring of analgesia remains poorly represented. the surgical pleth index (spi) algorithm takes into account both central and peripheral sympathetic tone via the normalised heart beat interval and the plethysmographic pulse wave amplitude and has been described before. a more detailed investigation on the spi and its behaviour under a posture maneuver shows the limitation of the device. another device developed calculates the "analgesia nociception index" (ani) by heart rate variability and was launched into the market in 2010. however, the effect of posture - to our knowledge - has not yet been studied. the change of body positioning during surgery is regularly necessary in order to improve surgical access to anatomic structures. these alterations in positioning are known to be accompanied by changes in haemodynamic parameters. the aim of this study was to evaluate the ani in patients undergoing elective surgery in lithotomy position.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * body mass index (bmi) \< 35 kg m2 * american society of anesthesiologists (asa) status i-iii * elective urology and gynaecology surgery in lithotomy position * 15 healthy volunteers were included in the study as a control group exclusion criteria: * age \< 18 years * asa status iv or higher * bmi ≥ 35 kg m2 * chronic heart rhythm disorders * implanted pacemakers * patients with a history of chronic pain and emergency surgery
the effectiveness of anti-resistance exercise on lower limb lymphoedema among gynecological cancer

Conditions: Gynecological Cancer; Lower Limb Lymphedema

Summary: background: the incidence of lower limb lymphedema (lll) after gynecological cancer surgery with lymphadenectomy is about 10-46%. lower limb lymphedema results in limited physical mobility and reduced patients' quality of life. a hospital -based complete decongestive therapy has been recommended to patients with lll, including exercise, manual lymphatic drainage, compression therapy, and skin care. however, the inconvenience of the hospital-based rehabilitation program limit the availability for those patients lll. home-based exercise program may be feasible instead of the hospital-based program. few studies have evaluated the effectiveness of the home-based lower extremity exercise on reliving lll and improving quality of life in patients with lll. research purposes: the main purpose of the study is to evaluate the effectiveness of a home-based exercise program for relieving lower extremity lymphedema, including circumference measurement, bioimpedance spectroscopy (bis), lower limb muscle strength, quality of life related to cancer \& lll, and fatigue. methods: this study is a two- year project with a single-blind randomized clinical trial. the participants are women with gynecological cancer surgery, aged of 20-75 years and currently have lower extremity lymphedema. a sample of 76 participants will be stratified randomly assigned to an experimental group or a control group. the experimental group is to carry out a home-based anti-resistance exercise with elastic band other than a routine care of complex decongestive physiotherapy; while the control group is to carry out a routine care of complex decongestive physiotherapy. the home-based program is a 12-week exercise program. data collections will be conducted before exercise (baseline), during exercise (second months), and exercise program after completion. measures includes (1) physical examination: limb leg circumference measurement, bioimpedance spectroscopy (bis), lower limb muscle strength, (2) questionnaires: functional status of lymphatic edema of lll, fatigue, and eortc-qlq-c30. anticipated outcomes: findings from this study could provide a reference of home-based exercise guideline and be integrated into the care of activities for women following gynecological surgery with lll.


Eligibility criteria:
inclusion criteria: * women with gynecological cancer surgery * aged of 20-75 years * currently have lower extremity lymphedema. exclusion criteria: * heart failure * kidney failure * dvt * limb surgery

Keywords: women's health home-based anti-resistance exercise
evaluation of a novel method of contrast volume quantification - avert plus 2.0

Conditions: Acute Kidney Injury

Summary: purpose: to evaluate the accuracy of the avert plus to monitor contrast volume used during angiographic procedures. this will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.

research design: the avert plus is an fda 510k cleared device which consists of 1) a contrast delivery modulator designed to reduce unnecessary contract dye delivery to the patient during angiography (coronary or peripheral) and 2) a concomitant contrast monitoring system to precisely measure contrast volume delivered to the patient. this will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.

Eligibility criteria:
inclusion criteria: * patients undergoing clinically indicated coronary or peripheral angiography exclusion criteria: * none
parkinson's research: the organized genetics initiative

Conditions: Parkinson Disease

Summary: the purpose of this trial is to study genetic and other risk factors that may be important in the development of parkinson's disease.

the the parkinson's research: the organized genetics initiative, also known as progeni, is a multi-center study involving 2000 people throughout north america who are affected, or possibly affected, with parkinson's disease (pd). the goal of the initiative is to study the genetic and other risk factors which may be important in the development of pd. in order to better understand the genetic factors leading to pd, researchers will study families having 2 or more members diagnosed with pd. using dna samples from each participant, researchers hope to identify genes that may cause a person to be at higher risk for developing pd. each participant in the study will be asked to complete a family history questionnaire, providing information about the history of pd in the family. participants also will be asked to discuss the symptoms they have experienced and their responses to pd medications. this information will be used by study personnel to determine further eligibility for the study. those eligible for further participation will be asked to undergo a study visit at the site closest to their residence, during which they will be asked to complete questionnaires regarding pd symptoms, medical history, places of residence, occupations, mood, mental status, and activity level. a blood sample will be drawn for dna extraction. the study visit will take about 2 hours.

Eligibility criteria:
inclusion criteria: * to be eligible to participate in this study participants must be diagnosed with or have symptoms of pd. in addition, they must also have a family history of pd in other relatives. exclusion criteria: * subjects cannot have participated in any other genetic research project for parkinson's disease.

Keywords: parkinson disease parkinson's disease pd genetics genes siblings family