Kornimate/medical-research-clean huggingface dataset:
effects of robotic-assisted gait training in non-ambulatory patients after guillain-barré syndrome

Conditions: GBS

Summary: this study investigates the effects of robotic-assisted gait training in non-ambulatory patients after guillain-barré syndrome.the participants are randomly divided into two groups.patients of the treatment group receive robotic-assisted gait training,while the contorls receive conventional rehabilitation.

guillain-barré syndrome (gbs) is an acute autoimmune disease of the peripheral nervous system, which may lead to rapidly developing motor deficits, sensory deficits, autonomic dysfunction and respiratory failure. approximately, 20.3% of patients cannot walk unaided at 4 weeks of symptom onset and 18.0% at 6 months. so, restoration and improvement of independent walk are one of major goals of gbs rehabilitation. for severely affected neurological patients, gait training using conventional therapy is technically difficult due to their motor weakness and balance problems. robotic-assisted gait training （ragt）is an effective alternative to treadmill therapy with partial body weight in intense gait rehabilitation after some neuropathy. and the proven reliability and safety of ragt suggest that it may be effective for treating non-ambulatory patients after some neuropathy. in our study, we investigated the anti-inflammatory effects of ragt in non-ambulatory patients of gbs.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of gbs; * age between 18 and 65 years; * period of gbs is between 4 and 8 weeks; * severe walking disabilities, defined as a gbs disability score of 2-4; exclusion criteria: * an unstable phase of disease; * disorders preventing ragt(eg, unstable cardiovascular, respiratory disease ,orthopedic, or neurological condition, unhealed decubitus, orthostatic hypotension etc.) ; * severe cognitive impairment preventing meaningful communication; * body weight more than 100 kg; * pregnancy;
a double-blind study on adjunctive use of pemf in the treatment of 5th metatarsal non-union fractures

Conditions: Nonunion of Fracture of Fifth Metatarsal

Summary: the purpose of this study is to analyze the effect of pemf in surgical reconstruction of 5th metatarsal non-union fractures.

the investigators hypothesize: 1. that treatment of 5th metatarsal non-union fracture with pemf will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures. 2. pemf will stimulate increased expression of critical growth factors (i.e. bmp-2, bmp-4, bmp-7 as well as tgfb, igf-1, fgf-2 and vegf) at the non-union site to facilitate osseous healing of 5th metatarsal non-union fractures.

Eligibility criteria:
inclusion criteria: 1. subject has been diagnosed with a 5th metatarsal delayed or non-union. 2. subjects with duration of a 5th metatarsal fracture for a minimum of 3 months. 3. male or female between ages of 18 and 75 years old, inclusive exclusion criteria: 1. subject has synovial pseudarthrosis. 2. subject has a fracture gap of larger than 5mm as measured on ct scan. 3. subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma. 4. if female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating. 5. subject has an implanted unipolar pacemaker. 6. subjects who have previous malignant or connective tissue disorder. 7. subjects who use medication such as steroids or anticoagulants. 8. subjects who have an underlying osseous infection (osteomyelitis) and/or open wound.

Keywords: nonunion fracture
a study investigating the efficacy and safety of lbl-007 plus tislelizumab in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine in participants with unresectable or metastatic colorectal cancer

Conditions: Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

Summary: this is a phase 1b/2 study to investigate the efficacy and safety of lbl-007 plus tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine, and lbl-007 in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine to participants with colorectal cancer.


Eligibility criteria:
inclusion criteria: * participant must have measurable disease as defined per recist version 1.1 * has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (stage iv as defined by american joint committee on cancer \[ajcc\] 8th edition) * no prior systemic therapy for colorectal cancer (crc) in the metastatic setting except for the induction treatment of first-line therapy. note: local regional treatment performed during induction systemic treatment is allowed * participants who have completed the first-line induction treatment, with an overall response of stable disease or better. the duration of induction treatment should be completed within approximately 6 months. the first dose of study treatment needs to occur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeks after day 1 of the last cycle of induction therapy exclusion criteria: * participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible * progressive disease occurred less than 6 months from completion of any prior neoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvant therapy (ie, chemotherapy with or without radiotherapy), whichever occurred later * participants who have been treated with anti-epidermal growth factor receptor (egfr) antibody in the induction treatment * any prior therapy targeting t-cell stimulation or checkpoint pathways * participants with b-raf proto-oncogene, serine/threonine kinase (braf)v600e mutations * have locally or centrally confirmed microsatellite instability-high (msi-h) by polymerase chain reaction (pcr) method or dmmr by immunohistochemistry (ihc) method note: other protocol defined criteria may apply.

Keywords: colorectal cancer microsatellite stable mismatch repair proficient maintenance therapy
axis length and its relationship with refractive error in chinese university students

Conditions: Refractive Error - Myopia Axial

Summary: to investigate the relationship between axis length (al) and refractive error. eyes of low hyperopia to emmetropia subjects, comprising eyes with moderate to high myopia (-11.00d ≤ se ≤ -4.00d) were analyzed in this cross-sectional study. cycloplegic refractive error was measured with the autorefractor, al was measured with the iol master. association between al and refractive error were evaluated by linear regression analysis. the mean of al and its correlation with se, sex, and age were evaluated.

to investigate the relationship between axis length (al) and refractive error (re). 894 eyes with low hyperopia to emmetropia (-0.50d ≤ spherical equivalent (se) ≤ +2.00d), comprising 1007 eyes with moderate to high myopia (-11.00d ≤ se ≤ -4.00d) were analyzed in this study. cycloplegic re was measured with the autorefractor, al was measured with the iol master. association between al and refractive error were evaluated by linear regression analysis. the mean of al and its correlation with se, sex, and age were evaluated.

Eligibility criteria:
inclusion criteria: with moderate to high myopia (se ≤ -4.00d) without myopia (-0.50d ≤ spherical power ≤ +2.00d) no concurrent eye disease best corrected visual acuity is 1.0 exclusion criteria: significant systemic illnesses congenital myopia, media opacity uveitis glaucoma intraocular surgery refractive surgery neurologic diseases retinal disease

Keywords: china high myopia hyperopia emmetropia
use of pet/mr imaging in chronic pain

Conditions: Chronic Pain

Summary: the investigators are studying the ability of pet/mr imaging (using the pet tracer \[18f\]fdg) to objectively identify and characterize pain generators in patients suffering from chronic pain.

the diagnosis and management of chronic and neuropathic pain syndromes remains a major clinical challenge, and this failure is partly attributed to our inability to identify the hypersensitive and inflammatory changes in the pain-sensing part of our nervous system that is thought to contribute to these syndromes. the lack of a specific, objective diagnostic test for chronic and neuropathic pain syndromes can result in a delay of diagnosis and suboptimal management decisions. this delay in diagnosis is quite unfortunate since the early diagnosis and treatment of a disease is attributed to the highest probability of remission in certain chronic pain syndromes. additionally, identifying the correct source of pain is of paramount importance since the clinical course and therapeutic interventions are different depending on cause. evidence in the literature points strongly toward an active inflammatory component in chronic pain. for example, soft tissue and bony inflammation is known to be an important pathophysiological mechanism for the symptoms of certain neuropathic pain syndromes. similarly, individuals suffering from chronic sciatica or radiculopathy may suffer from a combination of inflammation and compression of lumbar or cervical spinal nerves. it is also established that inflammatory lesions have increased metabolism and energy requirements and, therefore, are more glucose-avid than normal tissues, showing increased uptake of radiolabeled glucose analogs, such as \[18f\]fluorodeoxyglucose (\[18f\]fdg). correspondingly, \[18f\]fdg positron emission tomography-magnetic resonance imaging (pet/mri) represent leading fda-approved clinical imaging modalities to longitudinally study metabolic changes in the nervous system and non-neural tissues (e.g., muscle, blood vessels, joints, bone, scar tissue, etc.) in patients with chronic pain conditions. one of the goals of the study is to determine whether \[18f\]fdg pet/mri can identify sources of inflammation with greater sensitivity, accuracy and objectivity than current diagnostic methods.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * chronic pain lasting greater than 2 months. for example: low back pain, sciatica, complex regional pain syndrome, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, and migraine. * provides informed consent * on a typical day, pain level of at least 4/10 on a 0-10 comparative pain scale * covid vaccination status: vaccinated or unvaccinated subjects who received a negative test result from the covid test within 72 hours of the scan. exclusion criteria: * mri-incompatible * diabetes * pregnant or nursing * non-english speaker * claustrophobic

Keywords: positron emission tomography magnetic resonance imaging pet/mri fluorodeoxyglucose fdg pain chronic pain neuropathic pain inflammatory pain nociceptive pain
randomized controlled trial of a e-intervention to help patients newly diagnosed with cancer cope better: pilot study

Conditions: Head and Neck Cancer

Summary: informed by a previous trial in general cancer patients, the investigators aim to conduct a multi-centre phase iii explanatory rct to demonstrate a significant impact of ptsd coach on levels of anxiety in head and neck cancer (hnc) patients, including saliva and hair cortisol as bio-immunological indicators for stress. however, prior to proposing a larger trial requiring 267 patients, the investigators aim to demonstrate feasibility of recruitment and compliance with protocol procedures in a phase ii pilot of 60 newly diagnosed hnc patients. the eg will receive ptsd coach + usual care, compared to two control groups (uc and ac). ac will be comprised of a game app (e.g., tetris, candy crush, or solitaire) and will be structurally equivalent to the eg to control for distraction (attention on something pleasant or a task) and the human factor involved in usage prompting (i.e., same exposure time + contacts with personnel), since either distraction or the human contact with staff may, alone, lower anxiety. from a resource allocation perspective, it is important to know if the positive effects of ptsd coach are due to the intervention itself or to the use of an app and its usage prompting. the investigators believe that ptsd coach will be even more effective at reducing anxiety in hnc patients, as it teaches specific cbt techniques and uses psychoeducation already found to be more effective than distraction alone.

see above

Eligibility criteria:
inclusion criteria: 1. newly diagnosed with hnc (all hnc sites; tnm classification system); first occurrence, progression or recurrence \<4 weeks at referral. 2. willing to complete ptsd coach or game app within 3 weeks as they await treatment onset. 3. \>18 years old 4. alert and capable of giving free and informed consent according to referring clinician. exclusion criteria: 1. karnofsky performance status (kps) score \< 60 (rated by referring oncologists/nurses or research coordinator) or expected survival \<6 months according to clinical judgment of physicians and/or nurses. 2. suicidal. present a score of ≥2 on the beck depression inventory (bdi) suicide item. 3. known diagnosis of schizophrenia or schizoaffective disorder.
ahus observational long term follow-up

Conditions: Atypical Hemolytic Uremic Syndrome

Summary: there is growing but limited information on the long term clinical status of ahus patients who have previously received or are continuing to receive treatment with eculizumab. this study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with ahus.


Eligibility criteria:
inclusion criteria: * ahus patients who participated in any one of the ahus-eculizumab clinical studies. * ahus patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database. exclusion criteria: * not applicable.

Keywords: atypical hemolytic uremic syndrome ahus eculizumab
efficacy of intracoronary infusion of different medicine in stemi patients with csfp

Conditions: ST Segment Elevation Myocardial Infarction; Coronary Slow Flow Phenomenon

Summary: the study intends to evaluate the efficacy of different medicine delivering by targeted perfusion catheter in coronary administration on coronary blood flow in stemi patients with csfp.

the goal of stemi therapy is to successfully restore epicardial blood flow. pci has been documented as being the most effective method for restoration of epicardial blood flow. however, stenting does not necessarily equate to epicardial blood flow; not every patient achieves timi 3 flow after successful pci. currently, there are two main types of interventions to improve epicardial blood flow. one is the mechanical method, which included thrombus aspiration catheter and the distal protective devices. it has been confirmed that the mechanical method can effectively improve epicardial and myocardial perfusion in patient with part of large vessels and high burden thrombus. but for patients with small vessels and no obvious visual thrombus, the efficacy is not significant. the other intervention is medicine which included gp iib/iiia receptor antagonist, adenosine, sodium nitroprusside, verapamil etc. part of the drugs have some effect but the overall clinical efficacy is still not satisfied. the study intends to use targeted perfusion catheter to deliver drug to the distal targeted blood vessels. tfg and ctfc are applied to evaluate the efficacy of treatment with alprostadil or nitroglycerin on coronary blood flow in stemi patients with csfp.

Eligibility criteria:
inclusion criteria: patents with myocardial infarction who have symptom onset within 12h before randomization; ecg: ≥2 mm st-segment elevation in 2 contiguous precordial leads or ≥1 mm st-segment elevation in 2 contiguous extremity leads ; corrected timi frame counted (ctfc) measured from the final angiographic imaging after pci exceeding 40 frames; signed informed consent form prior to trial participation. exclusion criteria: coronary artery bypass surgery (cabg) history; failed in stents implanting; severe heart failure; cardiogenic shock.

Keywords: stemi csfp alprostadil targeted perfusion microcatheter
a study of herceptin (trastuzumab) in women with metastatic breast cancer

Conditions: Breast Cancer

Summary: this 2 arm study will assess the efficacy and safety of intravenous herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with herceptin for her2-positive early breast cancer.patients will receive either herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). the anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * at least 10 months of herceptin treatment for her2-positive early breast cancer; * metastatic breast cancer \>=12 months after discontinuation of herceptin; * measurable disease. exclusion criteria: * previous chemotherapy for metastatic breast cancer; * brain metastases; * invasive malignancy other than metastatic breast cancer.
safety, efficacy and pharmacokinetics of ald518 in patients with non-small cell lung cancer-related fatigue and cachexia

Conditions: NSCLC; Fatigue; Cachexia

Summary: the purpose of this study is to asses the safety and efficacy of ald518 in patients with non-small cell lung cancer-related fatigue and cachexia (weight-loss).

this is a phase ii, double-blind, randomized, placebo-controlled study of ald518 in patients with nsclc related fatigue and cachexia. it is estimated that a total of 120 patients will be randomized to ald518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio. a total of eight visits (excluding the screening visit) will take place over a period of 24 weeks: day 1, weeks 2, 4, 8, 12, 16, 20, and 24. enrolled patients will be screened within a 4 week period (day 35 to 7). randomization to treatment will be within a 12 day period (day 14 to 3), before initial dosing on day 1. patients will receive treatment eight weeks apart (on day 1, and weeks 8 and 16). all patients will remain at the clinic for at least 4 hours from the time the infusion is started. follow-up visits will occur four and eight weeks after the last dose of study drug, at weeks 20 and 24, respectively.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of nsclc incurable by other treatments including surgery * a ≥5 % loss of body weight in the preceding 3 months * a c-reactive protein (crp) concentration ≥ 10 mg/l * life expectancy of at least 12 weeks exclusion criteria: * treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days * ast/alt ≥ 3 x uln at screening * hemoglobin \< 8 g/dl at screening * history of or active diagnosis of tuberculosis

Keywords: lung cancer fatigue cachexia
a randomized, placebo-controlled trial of modafinil for methamphetamine dependence

Conditions: Methamphetamine Dependence

Summary: the proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. in this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly motivational enhancement therapy sessions. this study will be conducted at the addiction \& pharmacology laboratory in san francisco, ca, and at the new leaf treatment center in lafayette, ca, and is expected to last one year.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * patient is agreeable to conditions of study and signs consent form

Keywords: meth methamphetamine addiction methamphetamine treatment modafinil
melatonin for prevention of radiation induced oral mucositis

Conditions: Oral Mucositis (Ulcerative) Due to Radiation

Summary: the main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.

the study was designed as randomized, controlled, clinical trial. patients who were undergoing chemoradiation were divided into two groups: group i: was given conventional treatment. group ii: was given melatonin therapy in combination with the conventional treatment. all patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity. in addition, the total antioxidant capacity of the melatonin was evaluated at the start of the radiotherapy and six weeks later.

Eligibility criteria:
inclusion criteria: * patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy. * patients whose radiotherapy treatment planned dose is between 60-70 gy. * patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy. exclusion criteria: * patients under anticoagulants such as warfarin, heparin, or aspirin. * patients under fluvoxamine (luvox) and nifedipine medications. * patients whose radiotherapy treatment planned dose is lower than 60 gy. * pregnant and lactating women. * patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction) * patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Keywords: melatonin
efficacy and safety study of topical capsaicin in painful diabetic neuropathy

Conditions: Diabetic Polyneuropathy

Summary: painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. this is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. after one week wash-out period, patients will be switched to the other group for 8 weeks. outcome will be assessed by visual analog scale, neuropathic pain scale, sf-mpq, sf-36. safety and tolerability will be recorded.

Eligibility criteria:
inclusion criteria: * history of type 2 diabetes mellitus * peripheral neuropathy * stabilized on pain medication for at least one month * no previous invasive intervention for pain relief exclusion criteria: * local wound or skin abnormality in the applicable area * allergic to capsaicin * refuse to participate or give consent * has other significant disease or receive medication that may worsen neuropathy

Keywords: capsaicin placebo trial diabetic polyneuropathy neuropathic pain