Kornimate/medical-research-clean huggingface dataset:
sodium channel mutations in patient with the anterior cutaneous nerve entrapment syndrome (acnes)

Conditions: Anterior Cutaneous Nerve Entrapment Syndrome; Nerve Entrapment Syndrome; Chronic Pain Syndrome

Summary: the goal of this observational study is to learn about sodium channel (nav) mutations in patients with the anterior cutaneous nerve entrapment syndrome (acnes). this study will give more insight into the pathophysiology of acnes, which is still largely unknown. the primary objective is to determine if there are mutations of nav1.7 and nav1.8 in patients with acnes. therefore, one blood sample will be drawn, in which the mutations will be analyzed.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a subject must be diagnosed with acnes and receive treatment at our outpatient clinic. additionally, subject has to meet one of the following criteria: * known to have a first- or second-degree relative with acnes; * have more than one recurrence of acnes after a pain free period or acnes at multiple locations in the abdominal wall; * persistent pain after posterior neurectomy. exclusion criteria: * inability to understand dutch language. * known neuromuscular or neurodegenerative disease.

Keywords: acnes sodium channel mutations
cognitive frailty in older adults: the role of technology in physical activity enhancement

Conditions: Mild Cognitive Impairment; Frailty

Summary: this study intends to determine if smart watches and mobile phone application prompts can complement physical activity as a preventive intervention by motivating participants to exercise, so as to improve their physical and cognitive outcomes. the investigators hypothesize that technology will help increase engagement in physical activity for the intervention group relative to the control group and subsequently improve cognitive and physical outcomes.

this study aims to explore the role of technology -- in the form of smart watches and mobile phone application -- in physical activity enhancement on cognitive frailty outcomes. cognitive frailty is defined here as having both physical frailty and cognitive impairment but does not satisfy criteria for major neurocognitive disorder. the investigators postulate that for older adults, such technology will help increase engagement in physical activity with subsequent improvement in cognitive and physical outcomes at follow up. this is with the aim of preventing this particular group from deteriorating to cognitive frailty because of the accompanying increased risk for adverse outcomes and morbidity. this pilot study will be a randomized control trial with 2 treatment arms. assessments will be done prior to and following the intervention period. during the period of intervention, the wearable will act as a tracking device and will be paired with a mobile application to issue prompts to the participant when necessary. the independent variable explored in the study is the use of the wearable while the levels of physical and cognitive improvements are the dependent measures. these will be tracked at baseline, 3 months and 6 months. additionally, the mediating variable measured is the levels of physical activity to ensure that the proposed outcomes are affected through an increased level of physical activity encouraged by the use of the device. if innovations like technology and the role of self-management proves efficacious, the future of healthcare in the context of a rapidly aging population will be more sustainable. furthermore, this supporting role of technology in positive behavioral modification amongst older adults can have a multitude of applications in subsequent healthcare interventions.

Eligibility criteria:
inclusion criteria: * older adults aged 60 to 85 years exclusion criteria: * engages in vigorous exercises as determined by having more than 0 minutes of vigorous exercise on the international physical activity questionnaire (ipaq). * has medical contraindications for exercising, including but not limited to: physical disabilities or heart conditions where the primary doctor disallows exercising at moderate intensity. * does not own an android phone which can support at least a version 6.0 operating system

Keywords: cognitive frailty physical frailty physical activity mild cognitive impairment technology
memantine and post-mastectomy neuropathic pain

Conditions: Neuropathic Pain

Summary: the aim of this study is to evaluate if memantine administered for four weeks starting two weeks before surgery induces a decrease in pain intensity at 3 months post-mastectomy.

this is a randomized, controlled, open-label study in patients undergoing mastectomy. patients included in this trial will receive memantine or not. for patients in the "memantine" group, the treatment will be given in titration (maximum dose of 20 mg/day). concerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment. whether it is the "memantine" group or the "usual care" group, visits will be scheduled under the usual following conditions of the participating center.

Eligibility criteria:
inclusion criteria: * patient ≥18 years, * patient with a diagnosis of breast cancer, programmed for mastectomy with or without axillary dissection and neoadjuvant chemotherapy, * patient able to understand and willing to follow the study protocol, * acceptance to give a written consent. exclusion criteria: * patient with a contraindication to memantine administration (hypertension, severe cardiac or hepatic insufficiency, stroke), * patient with diabetes (type i and ii), * patient with renal insufficiency, * patient with drug treatments evaluated by the investigator to be not compatible with the trial, * patient treated with specific drugs (amantadine, ketamine, dextromethorphan, l-dopa, dopaminergic, anticholinergic agonists, barbituric, neuroleptic, imao, antispastic agents, dantrolen or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine), * patient with alcohol addiction, * epileptic patient or history of epileptic seizure or convulsions, * pregnant or nursing woman, * patient with a cooperation and an understanding that does not allow for a strict compliance under the conditions set out in the protocol, * patient participating in another clinical trial, or being in an exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial, * patient benefiting from a legal protection measure (curatorship, guardianship, protection of justice...),

Keywords: memantine post-mastectomy prophylaxis neuropathic pain cognitive-emotional parameters
body surface area-based vs concentration-based dosing of cisplatin for hyperthermic intraperitoneal chemotherapy (hipec) in women with advanced ovarian cancer

Conditions: FIGO Stage III Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Carcinoma

Summary: cytoreductive surgery (crs) with the addition of hyperthermic intraperitoneal chemotherapy (hipec) is used in current clinical practice in selected patients with advanced ovarian cancer. clinical evidence for the benefit of hipec in ovarian cancer comes from the pivotal phase 3 ovhipec trial. worldwide, two established strategies exist for dosing of hipec protocols, which follow either a body surface area (bsa)-based or a concentration-based approach. since both strategies result in different exposure to intra-peritoneal chemotherapy, we aim to compare the pharmacokinetics and safety of both strategies.


Eligibility criteria:
inclusion criteria: 1. signed and written informed consent 2. age ≥ 18 years 3. patients eligible for interval cytoreductive surgery 1. histological proven figo stage iii primary high grade serous ovarian, fallopian tube, or extra-ovarian cancer 2. when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry should be performed including keratin 7, keratin 20, p53, pax8 3. neo-adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel 4. following 2 cycles of chemotherapy no progression should occur 4. treated with optimal or complete interval cytoreductive surgery 5. fit for major surgery, who performance status 0-2 6. adequate bone marrow function (hemoglobin level \>5.5 mmol/l; leukocytes \>3 x 109/l; platelets \>100 x 109 /l) 7. adequate hepatic function (alt, ast and bilirubin \<2.5 times upper limit of normal) 8. adequate renal function (creatinine clearance ≥ 60 ml/min using cockcroft-gault formula or 24-hour measurement or ml/min/1,73 m2 using mdrd or ckd-epi) 9. able to understand the patient information exclusion criteria: 1. history of previous malignancy treated with chemotherapy 2. opting for fertility-sparing surgery
tcm clinical practice rehabilitation of post-stroke spasticity

Conditions: Stroke

Summary: the purpose of this study is to determine the effectiveness,safety and input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing.

a muti-center randomized controlled study with large samples to observe improvement of motor function,severity of spasm,adl(activity of daily lives),by standardized protocols of tcm techniques(massage and herbal bathing) combined with conventional rehabilitation on spasm after stroke in 1 month.modified ashworth scale,fugl-meyer index and modified barthel index were used for spasm,motor function and adl.and also the follow up research within 3 months and 6 months focus on the efficacy duration of tcm on spasm.try to find suitable timing for intervention on spasm by ctm(massage and herbal medicine bathing)and the connection between spasm severity and treatment efficacy.

Eligibility criteria:
inclusion criteria: * according to the diagnostic criteria of stroke and diagnosed by ct or mri * patient must be between the ages of 18 and 85 years. * all patients were examined at least 1 month after stroke and less than 12 months. * at least a set of spasmous muscles' level ≥1+ of dysfunctional extremities (modified ashworth scale) * body movement function decreased significantly. * the doses and kinds of anticonvulsant drugs should be used stable for more than 1 month if they are used * patient must understand and be willing, able and likely to comply with all study procedures. * patient must be able to give voluntary written informed consent. exclusion criteria: * significant cognitive defects(mmse\<16)，unable to finish the fugl-meyer scale,etc.. * other significant limb diseases such as fracture, severe arthritis,amputation * joint contracture formation * patients with significant pain and swelling suffering from complex regional syndrome after acute stroke * accept botulinum toxin or alcohol nerve block 3 months prior to the start of the experiment * patients need nerve block at any point of time during the whole experiment procedure. * serious cardiac,hepatic or renal insufficiency and patients with shock. * limb skin of patients who need medicated is visible wound. * patients with cancer or pregnancy * patients who participate in other clinical studies within 6 months

Keywords: stroke traditional chinese medicine rehabilitation
combining noninvasive brain stimulation and cognitive training on tobacco craving

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder.


Eligibility criteria:
inclusion criteria: * 20-60 years old * smoking \> 15 cigarettes per day * tobacco use disorder according to diagnostic and statistical manual v criteria exclusion criteria: * contraindications to noninvasive brain stimulation * psychiatric or neurologic condition
controlled-release oxycodone for postoperative analgesia after video-assisted thoracic surgery

Conditions: Anesthesia Recovery Period; Pain, Postoperative

Summary: the main hypothesis of this study is that preoperative administration of controlled-release (cr) oxycodone may reduce acute postoperative pain and improve time to discharge from the post-anesthesia care unit in patients undergoing video-assisted thoracoscopy for spontaneous pneumothorax. the study drug will be compared with intravenous morphine administered 30 minutes before the end of anesthesia.

although spontaneous pneumothorax may be treated conservatively by simple observation or chest tube insertion, up to 50% of patients treated conservatively may experience recurrence in subsequent months or years. video-assisted thoracic surgery (vats) is a minimally-invasive surgical approach to treat spontaneous pneumothorax and reduce the risk of recurrence. compared to open thoracotomy, vats may facilitate a faster recovery and lead to earlier home discharge. totally-intravenous anesthesia (tiva) with propofol and remifentanil is a useful anesthetic technique for vats, as the drugs are rapidly eliminated after the end of the procedure, leading to fast recovery from anesthesia. one drawback of ultra-short-acting opioid remifentanil is residual hyperalgesia after the end of the infusion, particularly after vats, which is associated with relatively short but intense pain after surgery. intravenous morphine, administered just before the end of anesthesia, is the typical choice for pain relief after tiva. however, this drug may require repeated titration and may be associated with postoperative nausea and vomiting, itchiness or drowsiness in the early postoperative period. oxycodone, another opioid, is available in an oral controlled-release (cr) formulation which grants relatively constant plasma levels of the drug after 1 h of administration. the investigators hypothesize that administration of cr oxycodone 20 mg 1 hour before surgery may lead to better recovery parameters in the post-anesthesia care unit, thus granting earlier discharge to the surgical ward.

Eligibility criteria:
inclusion criteria: * patients scheduled for video-assisted thoracic surgery for clinical diagnosis of spontaneous pneumothorax * must be able to swallow tablets 1 h before surgery * american society of anesthesiologists (asa) physical status class i or ii exclusion criteria: * known allergy or other contraindications to study drugs * acute myocardial infarction ≤6 months before enrollment * serum creatinine \> 2 mg/dl * body mass index (bmi) \> 30 * diagnosis of psychiatric disorders * known or possible pregnancy * epilepsy * chronic opioid therapy or abuse

Keywords: care, postoperative analgesia analgesics, opioid morphine remifentanil oxycodone anesthesia, regional anesthesia, intravenous preanesthetic medication analgesia, patient-controlled
phase i study of intravenous lipotecan® (tlc388 hcl for injection) in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to find a safe and tolerable dose of lipotecan® when administered to patients with advanced solid tumors.

lipotecan® is a drug product of tlc388 hcl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines in vitro and anti-tumor activities in several xenograft models with human tumor cell lines. structurally, tlc388 hcl is related to other camptothecins, but it has been chemically modified to improve stability and potency, and to minimize toxicities.

Eligibility criteria:
inclusion criteria: * adult patients defined by age ≥18 years. * pathologically confirmed advanced solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective * evaluable disease, either measurable on imaging or with informative tumor marker(s), by recist (response evaluation criteria in solid tumors) criteria. exclusion criteria: * pregnancy or lactation. women of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment. male and female patients of childbearing potential must agree to use appropriate birth control (barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records). * previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry. * receipt of more than 3 prior regimens of chemotherapy. * chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to baseline. receipt of radiotherapy to \>25 % of bone marrow. major surgery within 4 weeks prior to baseline. * concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents which are potent inhibitors or inducers of cytochrome p450 enzymes unless approved by the sponsor. * uncontrolled intercurrent illness that would jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the investigator.
ankle foot orthosis on muscle activity in cerebral palsy

Conditions: Cerebral Palsy Spastic Diplegia

Summary: to compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (gross motor functional classification scale iii).

few studies have examined muscular activity via electromyography (emg) during quiet standing in children with cp. a few studies have examined the benefits of ground reaction ankle foot orthosis, showing that it could effectively reduce or eliminate the crouch position in children with spastic cerebral palsy however little is known about the benefits of grafos on postural control mechanisms in static standing in children with cp. previous studies suggested that appropriate tuning of ankle foot orthosis properties may reduce muscle demand for children with cp. so, this study may be a guide in management of postural instability in children with spastic diplegic cerebral palsy in standing position.

Eligibility criteria:
inclusion criteria: * spasticity level ii in lower limb muscles according to modified ashworth scale. * able to follow order. * aged from 6 to 12 years old. exclusion criteria: * visual or obvious detected vestibular sensory disorders or cerebellar disease. * botox injection in the last 6 months. * cognitive deficits or disturbed conscious level.
comparing artificial intelligence for assisted diagnosis of diabetic retinopathy

Conditions: Diabetic Retinopathy; Diabetic Macular Edema

Summary: this study plans to compare the accuracy of artificial intelligence (ai)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (oct) and fundus fluorescence angiography (ffa) in the diagnosis of diabetic retinopathy and diabetic macular edema.

this study plans to compare the accuracy of artificial intelligence (ai)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (oct) and fundus fluorescence angiography (ffa) in the diagnosis of diabetic retinopathy and diabetic macular edema. this study was conducted as a prospective study. participants meeting eligibility criteria will be recruited from sites staffed by trained photographers. after assessing eligibility and obtaining informed consent, fundus photographs will be taken using a non-dilated fundus camera. and optical coherence tomography or fundus fluorescence angiography will be performed.

Eligibility criteria:
inclusion criteria: 1. diagnostic for diabetes: type 1 diabetes of a lest 5 years of evolution; or type 2 diabetes; 2. obtaining informed consent; 3. patient age 18 or above. exclusion criteria: 1. patients under 18 years of age; 2. failure to obtain informed consent; 3. presence of other retinal diseases; 4. a patient who has already undergone the treatment.

Keywords: diabetic retinopathy diabetic macular edema artificial intelligence
polarization sensitive optical coherence tomography

Conditions: Myopia

Summary: the purpose of the study is to use the polarization sensitive optical coherence tomography (ps-oct) developed by singapore eye research institute, to evaluate the potential oct scleral biomarkers capable of predicting risk of myopia progression.


Eligibility criteria:
inclusion criteria: (adult cohort) * aged 21 and above * ability to provide informed consent * 42 normal controls: no diabetes and free from clinically relevant eye disease that interferes with the aim of the study i.e. glaucoma, diabetic retinopathy, age-related macular degeneration, uveitis, or vascular occlusive diseases * 76 subjects with pathological myopia (up to -12 dioptres) or staphyloma (children cohort) * aged 10 to 18 * 23 subjects with low to moderate myopia (-0.75 to -6 dioptres) * 23 subjects with high myopia (more than -6 dioptres) * ability of legal representative and subject to provide informed consent exclusion criteria: (adult cohort) * unable to give consent * subjects with visual acuity worse than 6/12 * diagnosis of clinically relevant eye disease that interferes with the aim of the study (e.g. diabetic retinopathy, hereditary macular disease, glaucoma, uveitis, or vascular occlusive diseases) or conditions that may potentially result in poor quality imaging scans (severe cataract, corneal haze/opacity)
dyslipidemia in type 2 diabetes (0767-034)

Conditions: Diabetes Mellitus, Type II; Dyslipidemia

Summary: the purpose of the study is to compare the lipid-altering effects of mk0767, glipizide, and pioglitazone after 12 weeks of treatment. this is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * men and non-pregnant females * age greater than or equal to 21 years * stop current diabetes therapy (if applicable) * stop current statin therapy (if applicable) exclusion criteria: * history of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin * patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks * patients requiring treatment with corticosteroids for more than 14 consecutive days * patients taking warfarin or warfarin-like anti-coagulants * patients undergoing surgery within 30 days of visit 1 * patients with hepatitis b, hepatitis c, active liver or gallbladder disease * patients with history of pancreatitis or uncontrolled high blood pressure