Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety and pharmacokinetics of aldurazyme® (laronidase) in mps i patients less than 5 years old

Conditions: Mucopolysaccharidosis I; Hurler Syndrome; Hurler-Scheie Syndrome; Scheie Syndrome

Summary: the main objectives of this study are to evaluate the safety and pharmacokinetics (pk) of enzyme replacement therapy with recombinant human alpha-l-iduronidase \[aldurazyme® (laronidase)\] in mucopolysaccharidosis i (mps i) patients less than 5 years old. efficacy measurements will also be evaluated in this study.


Eligibility criteria:
inclusion criteria: * written informed consent is required from the parent(s) or legal guardian(s) prior to any protocol-related procedures being performed. (a separate informed consent will be requested from the parent(s) for their genotyping, which is independent of the inclusion.) * be less than 5 years of age at the time of enrollment. * have confirmed iduronidase deficiency with a fibroblast or leukocyte alpha-l-iduronidase enzyme activity level of less than 10.0 % of the lower limit of the normal range, or below the detection range of the measuring laboratory. * have a clinical diagnosis of mps i based on genotyping. * documentation in his/her medical record that the parent(s) or legal guardian(s) have had counseling or a consultation regarding hsct in order to assure that the parent(s) or legal guardian(s) are fully informed regarding the risks and benefits of this alternative treatment for patients eligible for the trial and with the severe manifestations of mps i with neurodegeneration. exclusion criteria: * the patient is under consideration for or has undergone hematopoietic stem cell transplantation (hsct). * the patient has acute hydrocephalus at the time of enrollment. * the patient has a clinically significant organic disease (with the exception of symptoms relating to mps i) including: cardiovascular, hepatic, pulmonary, neurologic, or renal disease, other serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would preclude participation in the trial or potentially decrease survival. * the patient has received any investigational product within 30 days prior to trial enrollment. * the patient has known severe hypersensitivity to aldurazyme® (laronidase) or components of the delivery solution.
perfusion and diffusion mechanism of intervertebral disc-significance with age, degeneration, posture and stress loading.

Conditions: Spinal Cord Injury, Degenerative Spinal Disease.

Summary: the purpose of our study is to evaluate the perfusion of the ivds and their diffusion ability by using the dynamic contrast-enhanced mr perfusion technique and diffusion weighted image with adc value measurement, and to determine the relationship between these data and the degeneration of ivds, the different posture, and different stress-loading status.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of spinal cord injury and degenerative spinal disease * normal volunteers exclusion criteria: - patients with cancer and infection.
adjuvant cerebroprotection using normobaric hyperoxia in pre-hospital patients with suspected stroke

Conditions: Stroke Acute

Summary: the primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (nbo) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (aci) due to large vessel occlusion presenting within 6 hours of symptom onset.

stroke is a leading cause of death and disability globally, with acute ischemic stroke (ais) patients often benefiting from intravenous thrombolysis and endovascular therapies such as mechanical thrombectomy, which have been shown to improve reperfusion rates. however, despite reperfusion, the proportion of patients with large vessel occlusion achieving a favorable functional outcome, defined as a modified rankin scale score of 0-2 at 90 days, remains under 50%. normobaric hyperoxia (nbo) emerges as a compelling option for cerebral protection. its neuroprotective mechanisms are thought to include hypoxic tissue rescue, blood-brain barrier preservation, brain edema reduction, neuroinflammation alleviation, mitochondrial function improvement, oxidative stress mitigation, and apoptosis inhibition. nbo's diffusion properties allow it to reach the penumbra before reperfusion, enhancing aerobic metabolism and potentially reducing infarct volume. its advantages also include low cost, wide availability, and ease of use, making it accessible across various healthcare settings.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years old; * signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia); * no prior stroke; * the time from stroke onset/last seen well to randomization is within 6 hours; * paramedic-obtained fast-ed score \>= 3 (the enrollment of patients with a fast-ed score of 3 is prespecified to constitute no more than 10% of the total study population); * no significant pre-stroke disability (pre-stroke mrs 0-1); * signed informed consent from the patient or the legally authorized representative (lar). exclusion criteria: * endotracheal intubation in the field (prior to consent); * respiratory rate \ = 30 breaths per minute; * oxygen-dependence at baseline to maintain sao2 \> 95%; * known history of severe chronic obstructive pulmonary disease (fev1 less than 1.0), new york heart association (nyha) heart failure class iii, acute pulmonary infection or aspiration pneumonia, prior to enrollment; * seizure at stroke onset; * exhibiting symptoms of vomiting, severe headache, or unconscious; * known pregnancy: women of childbearing age (18 to 44 years old according to the cdc's division of reproductive health) will be asked about their pregnancy status. * participating in another clinical trial, or completed participation within prior 30 days; * receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide); * life expectancy \< 90 days due to comorbidities; * unlikely to complete the 90-day follow-up visit.

Keywords: ischemic stroke
a prospective, multi-center, real-world study of ovarian metastatic colorectal cancer patients

Conditions: Ovarian Metastasis; Colorectal Cancer

Summary: this prospective, multi-center, real-world study is conducted to investigate the impact of different treatment strategies (systemic chemotherapy combined with oophorectomy or with other local treatment or chemotherapy alone) on the prognosis of ovarian metastatic colorectal cancer patients.

this study prospectively collects data of patients diagnosed with ovarian metastatic colorectal cancer, meeting inclusion criteria and signing the informed consent. patients' treatment strategies and survival outcome in the real world will be faithfully recorded.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal adenocarcinoma; 2. histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs; 3. women ≥18 years of age; 4. eastern cooperative oncology group performance status score ≤2; 5. available imaging data if the disease is measurable according to recist criteria version 1.1; patients are eligible if there is no measurable lesion. 6. complete medical records; 7. informed consent form signed. exclusion criteria: 1. not ovarian metastatic colorectal cancer confirmed by radiology or histology; 2. drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study; 3. other conditions that would influence patient compliance; 4. pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.
effectiveness of kaltenborn mobilizations versus muscle energy technique in adhesive capsulitis.

Conditions: Adhesive Capsulitis of Shoulder

Summary: total of 30 patients are selected according to inclusion criteria by convenient sampling and randomly allocated by sealed envelop method into two groups. group 1 is treated with muscle energy technique(post isometric relaxation) and group 2 is treated with grade ii,iii kaltenborn mobilizations and both groups also receives conventional therapy in form of codman exercise and wall ladder exercises.data will be collected at baseline then after 2 weeks and after 4 weeks of intervention.

the purpose of study is to determine effectiveness of muscle energy techniques(post isometric relaxation) and kaltenborn mobilizations and to compare the effectiveness of both techniques on pain and functional disability in patients with adhesive capsulitis.several studies about the effects of maitland mobilizations and muscle energy technique have been conducted. evidence regarding the comparison of kaltenborn mobilizatuons and post isometric relaxation is sparse. there has been no work regarding effectiveness of these two techniques in improving pain and functional disability in patients of adhesive capsulitis. kaltonborn mobilizations involves the application of a passive sustained stretch technique to enhance joint mobility without articular surface suppression. the forces applied to increase joint mobility are graded from i-iii. grade i applies a distraction of minor intensity that hardly causes stress within the joint capsule; it is often used to decrease pain. grade ii refers to a force that stretches the periarticular tissue; such stimulus is colloquially referred to as "taking up the slack." finally, grade iii force causes enough distraction or gliding so that joint capsule can sufficiently stretch; it is often used for enhancing rom. met is unique in its application as the client provides the initial effort while the practitioner facilitates the process. one of the main uses of this method is to normalize joint range, rather than increase flexibility, and techniques can be used on any joints with restricted range of motion (rom) identified during the passive assessment. the main effects of met can be explained by two distinct physiological processes: post isometric relaxation (pir) and reciprocal inhibition (ri). post isometric contraction decrease muscle tone in single group of muscle after brief period of submaximal isometric contraction of same muscle.

Eligibility criteria:
inclusion criteria: * age between 20 and 60 years. * duration of complaint for more than 3 months. * gender: both male and female. * patients with idiopathic frozen shoulder * patients having restriction in more than 2 ranges * patients with diabetes exclusion criteria: * shoulder dislocation, fracture or labral tear. * shoulder girdle motor control deficit associated with neurological disorder. * any bony deformities acquired or congenital in glenohumeral joint. * patients with language barrier.

Keywords: adhesive capsulitis,mobilizations, muscle energy technique
study of clozapine for the treatment of psychosis in patients with idiopathic parkinson's disease

Conditions: Parkinson Disease

Summary: objectives: i. determine the efficacy and tolerability of clozapine in ameliorating psychosis in patients with idiopathic parkinson's disease (pd). ii. determine the adverse effects of clozapine on motor function in this patient population. iii. determine the safety of clozapine in psychotic pd patients taking multiple anti-pd medications. iv. describe the phenomenology of drug induced psychosis in pd.

protocol outline: this is a randomized, placebo controlled, double blind study, followed by an open label treatment of all patients. patients are stratified according to the institutional investigator and age. in the first phase of the study, patients receive either clozapine or placebo. the drug is taken orally at night, approximately 30 minutes before retiring. therapy continues for 4 weeks unless psychosis becomes unmanageable without hospitalization, parkinsonism worsens, or other adverse effects occur. it is possible that the dose may be escalated. in the second phase of the study, all patients are treated with open label clozapine. therapy continues for 3 months unless psychiatric status or parkinsonism progress. dose escalation is also possible during this phase. patients are followed weekly during the first phase of the study, and monthly during the second phase. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- presumed idiopathic parkinson's disease presence of three of the cardinal features: rest tremor rigidity bradykinesias/akinesia postural and balance abnormalities absence of alternative explanations for the syndrome absence of atypical features psychosis of at least 4 weeks duration requiring treatment --prior/concurrent therapy-- chemotherapy: no concurrent chemotherapy other: no use of any dopamine blocking drug within the past 3 months no use of depot neuroleptic within the past 12 months no change of antidepressant or anxiolytic dose within the past 1 month no prior clozapine for psychosis anti-pd medications stable for at least 7 days before study entry --patient characteristics-- hematopoietic: no history of leukopenia no active blood dyscrasia other than mild anemia renal: no active problems with urinary retention cardiovascular: no symptomatic orthostatic hypotension no uncontrolled angina no myocardial infarction within the past 3 months other: fertile patients must use effective contraception no uncontrolled seizures (i.e., 1 or more seizures per month over the past 6 months) no dementia precluding accurate assessment on psychiatric assessment battery no aids no other illness that would make use of clozapine potentially hazardous no narrow angle glaucoma no systemic factor contributing to the psychosis (e.g., urinary infection, liver disease, renal failure, anemia, infection, etc.)

Keywords: parkinson disease neurologic and psychiatric disorders rare disease
investigation of the efficacy of non-invasive vagus nerve stimulation and physiotherapy in unilateral vestibular hypofunction patients

Conditions: Vestibular Diseases; Vestibular Vertigo; Vertigo

Summary: the purpose of this study: to investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with unilateral vestibular hypofunction (uvh).

it was planned to include 40 patients diagnosed with uhv in the study. patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).

Eligibility criteria:
inclusion criteria: * he learned about unilateral peripheral vestibular hypofunction with videonystagmography * being able to communicate well exclusion criteria: * having cognitive impairment * presence of central neurological disease * lack of cooperation * previous ear surgery * accompanied by benign proxysmal positional vertigo * having acute meniere's disease * finding pathology in temporal bone mri * having a lower extremity disorder that prevents walking * evidence of central pathology in videonystagmography results

Keywords: unilateral vestibular hypofunction non-invasive vagus nerve stimulation balance vestibular rehabilitation
low frequency deep brain stimulation of the subthalamic nucleus in parkinson's disease

Conditions: Parkinson Disease; Cognitive Impairment

Summary: prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced parkinson's disease. all study participants have undergone dbs implantation surgery as part of their routine care for motor manifestations of parkinson's disease. in this study, a temporary low frequency period of stimulation will be applied to determine its effects on cognition.

in this randomized cross-over pilot study, our primary aim was to determine the effect of theta (5 hz), and gamma (130 hz) frequency stimulation in the ventral stn on cognitive control in patients with pd. this study provides a first look at frequency dependent modulation of cognitive function and provides important insights into the utility of dbs for non-motor symptoms of pd and other neuropsychiatric disorders.

Eligibility criteria:
inclusion criteria: * parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms. exclusion criteria:
perioperative hyperglycaemia in primary total hip and knee replacement

Conditions: Knee Replacement; Hip Replacement; Hyperglycemia

Summary: the purpose of this study is to analyze how common stress hyperglycaemia (abnormally high blood glucose) is in primary hip and knee replacement surgeries and which factors predispose to hyperglycaemia.

postoperative infections remain one of the most frequent reasons of failure of hip and knee prostheses. diabetes increases the risk of infections. in other fields of surgery, hyperglycemia induced by surgical stress (stress/perioperative hyperglycemia) has been associated with higher rates of postoperative infections and complications. such studies have not yet been performed in the field of joint replacement surgery. unlike several other risk factors of infected joint replacements, hyperglycemia is potentially modifiable and therefore its prevalence, predisposing factors and association with postoperative infections are of interest.

Eligibility criteria:
inclusion criteria: * diagnosis of osteoarthritis * scheduled for primary hip or knee replacement exclusion criteria: * arthritis other than osteoarthritis * medication affecting glucose metabolism (excl. antidiabetic agents) * not undergoing hip or knee replacement

Keywords: knee replacement hip replacement hyperglycemia diabetes osteoarthritis
lupus and observance

Conditions: Systemic Lupus, Skin Lupus

Summary: a poor therapeutic observance is described between 3 and 76% cases in systemic lupus. it is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis. new treatment protocols exist and are indicated in second intention in case of good compliance. an assessment of therapeutic adherence is therefore essential. patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with plaquenil (hydroxychloroquine), will be included in the study. the study primary objective is to determine risk factors for non-observance the secondary objectives are to: * measure the observance rate of patients with systemic lupus in martinique. * describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. systemic lupus defined according to the diagnostic criteria of the american college of rheumatology " 1997, diagnosed for at least 6 months; or skin lupus 3. consultation or hospitalization at the university hospital of martinique, in either services of internal medicine, rheumatology or dermatology. 4. prescription of hydroxychloroquine (plaquenil®) for at least 6 months 5. affiliate or beneficiary of a social security scheme. 6. patient not opposed to participate in the study exclusion criteria: 1. age \<18 years or patient under guardianship 2. patient not speaking and / or not understanding french 3. no prescription and/or contraindication to hydroxychloroquine 4. systemic lupus outbreak with neurological impairment defined by sledai score by a psychosis (disruption of normal activity in relation to a severe alteration of the perception of reality. includes: hallucinations, incoherence, impoverishment of the content of thought, illogical reasoning, bizarre behavior, disorganized or catatonic) or brain damage (with impairment of mental functions with impaired orientation, memory or other brutal appearance and fluctuating evolution). 5. history of psychiatric disorders: personality disorders, psychoses, severe depression 6. hospitalization with a life-threatening clinical condition that does not allow to answer questions 7. non affiliated patient or beneficiary of a social security scheme. 8. patient refusing to participate in the study

Keywords: systemic lupus erythematosus observance hydroxychloroquine dosage risk factors of non-observance slicc score sledai score
effects of melatonin and massage after third molar surgery

Conditions: Melatonin

Summary: lymphatic drainage massage is an important practice, especially for reducing edema. it is a very gentle, monotonous, slow, rhythmic massage applied to the skin surface. it accelerates the flow of lymph fluid and provides comfort by minimizing swelling. lymphatic drainage massage, which is frequently used after impacted third molar surgery, helps reduce edema and increases patient comfort during the postoperative period. melatonin, a hormone produced by the pineal gland, is a neurochemical substance that works in harmony with the body's natural rhythm. in addition to the brain, it is found in the retina, bone marrow, intestines, skin, and various blood cells. conditions such as insomnia or jet lag may benefit from melatonin supplements. besides contributing to sleep quality, melatonin may also assist in regulating the immune system, body temperature, blood pressure, and cortisol hormone levels.

another important function of melatonin is that it is a very powerful free radical scavenger. melatonin can neutralize both reactive oxygen species and reactive nitrogen species. it is also known to capture highly toxic hydroxyl radicals, peroxynitrite anions, and peroxyl radicals. in some cases, melatonin inhibits nitric oxide synthase, a prooxidant enzyme. additionally, it stimulates the mrna levels of superoxide dismutase enzyme and is known to activate glutathione peroxidase, glutathione reductase, and glucose-6-phosphate dehydrogenase. after reacting with the hydroxyl free radical (oh•), melatonin transforms into an indolyl cation radical, which is noted to capture the superoxide radical (o2 · -) in the environment and exhibit antioxidant activity. due to this powerful antioxidant property, its effects on pain and edema have been investigated in some studies. in these studies, pre-op/post-op melatonin application has been shown to reduce postoperative pain and accelerate sensory healing due to melatonin's antioxidant effects.

Eligibility criteria:
inclusion criteria: 1. patients need for removal surgery of impacted third molars. 2. patients without systemic diseases. exclusion criteria: 1. presence of systemic diseases affecting general health. 2. presence of a malignant disease in the head and neck region. 3. patients with any bleeding disorders. 4. patients with cardiovascular diseases or those undergoing anticoagulant or antiplatelet therapy.

Keywords: edema tooth removal melatonin