Kornimate/medical-research-clean huggingface dataset:
effect of neuromodulation in patient with fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: this study was designed to examine the efficacy of neuromodulation therapy by using transcutanous electric nerve stimulation( tens) in patients with fms and to provide preliminary evidence regarding its effects on pain ,anxiety and qol by objectively measuring cortisol level in fms patients.

forty female patients with fm ( age : 20- 45 years ) participated in the study after suing the consent form . participants were randomly allocated assigned into 2 equal groups ( control group \[ g1 \] and low tens group \[g2 \] ) . group 1 received selected programs of physiotherapy including aerobic exercise and placebo low tens. group 2 received low frequency tens (10 hz).all participants were assessed for cortisol and pain level by using visual analogues scale also participants were assessed for qol by fibromyalgia impact questionnaire (fiqr) . treatment was done 3 sessions per weeks for successive 6 weeks pre and post assessment for all valuable were done.

Eligibility criteria:
inclusion criteria: women between 20-45 years old, (ii) diagnoses according to the 2016 american college of rheumatology criteria for fibromyalgia \[1\] - symptoms have been present at a similar level for at least three months (iii) absence of other disorders that causes similar symptoms: systemic lupus erethromatosis (sle), rheumatoid arthritis (ra) and lyme disease based on laboratory investigations (erythrocyte sedimentation rate (esr), anti anti-cyclic citrullinated peptide (anti ccp), antinuclear antibody (ana) and rheumatoid factor (rf)). exclusion criteria: * any medical, neurological, or psychiatric illness, use of strong opioids or other painkillers except paracetamol and/or ibuprofen, benzodiazepine, illicit drug or alcohol use, recent use of cannabis, pregnancy, breast feeding, and the presence of pain syndromes other than fm. presence of other autoimmune disorders e.g.: rheumatoid arthritis and systemic lupus erethromatosus
evaluation of the efficacy and safety of insulin glargine 300 u/ml in patients with type 2 diabetes mellitus uncontrolled on other kinds of insulin

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to assess the efficacy of gla-300 on glycemic control measured by hemoglobin a1c (hba1c) change in patients with type 2 diabetes mellitus (t2dm) uncontrolled with their current basal insulin following the switch to gla-300. secondary objectives: to evaluate the effects of gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (hcru) outcomes. to evaluate the safety of gla-300.

study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at week 27.

Eligibility criteria:
inclusion criteria : * participants with type 2 diabetes mellitus. * participants on "standard of care" basal insulin therapy administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without other antidiabetics approved for using with insulin. * glycated hemoglobin (hba1c) between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening. * fasting plasma glucose values above 130 mg/dl. exclusion criteria: * unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection, insulin doses \[variation more than ±20%\]). * treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin, fast acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
epidemiological approaches to the cardiovascular consequences of covid-19

Conditions: Acute Myocardial Infarction

Summary: the covid-19 pandemic highlights the importance of the prognosis of co-morbidities, such as coronary artery disease, which significantly increase the risk of mortality in patients infected with sars-cov2. investigators have recently studied the complex links between respiratory infections, particularly pneumonia, and type 2 myocardial infarction (mi) in many respects. the etiology of type 2 mi is based on an imbalance of myocardial oxygen supply/need in the absence of rupture/erosion of atheromatous plaques. based on the rico survey data, the investigators investigated whether covid-19-related sepsis and/or respiratory failure could be an underlying mechanism of mi2.


Eligibility criteria:
inclusion criteria: * patients hospitalized for a type 2 mi in ccu from chu dijon bourgogne with or without pneumonia * patients hospitalized for a type 2 mi in ccu from chu dijon bourgogne with or without covid 19 exclusion criteria: * none
change in gastrointestinal complaints after switch from oral parkinson's disease treatment to neupro® transdermal patch

Conditions: Idiopathic Parkinson's Disease

Summary: the study intends to collect data on gastrointestinal symptoms (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient satisfaction under everyday practice conditions after changing treatment to neupro® transdermal patch in patients suffering from idiopathic parkinson´s disease with gastrointestinal symptoms while being treated with oral antiparkinson drugs. the objective of the study is to ascertain whether switching therapy to neupro® transdermal patch can provide any relief in gastrointestinal symptoms.

routine treatment as per approved label in europe in accordance with the terms of the local marketing authorization for neupro®.

Eligibility criteria:
inclusion criteria: * the decision to prescribe neupro® must have been made by the physician before and independently of his/her decision to include the patient in the study * the patient's treatment must be in accordance with the terms of the local marketing authorization (ma) for neupro® * the patient must have a diagnosis of idiopathic parkinson's disease * the patient must have signed the consent form regarding study information, data transfer and use * patient suffering from gastrointestinal symptoms while being treated with oral parkinson's medication exclusion criteria: not applicable

Keywords: rotigotine neupro® parkinson's disease gastrointestinal switch from oral therapy to patch
oxygen titration protocol for exertion of copd patients by an automated adjustment device

Conditions: COPD; Chronic Respiratory Insufficiency

Summary: the aim of our study is to assess if an automated titration of oxygen flow during exertion can be a useful tool to determinate the level of oxygen required by copd patients that are using oxygen therapy during exercise.

all patients referred to our centre of oxygen titration during exertion will be offered to participate in our study. after baseline assessments, patients will have an oxygen titration using two different methods in random order: * usual titration protocol will include an manual oxygen increase during a titration 6 minutes walk test * automatic titration protocol that will use the automated oxygen titration device to adjust oxygen flow rate during a titration 6 minutes walk test. after each titration protocol, the efficacy of the titration will be assessed in 3 validation 6 minutes walk tests during which oxygen flow will be set at: * the manually determined flow rate * the 95th percentile flow rate of the automatic titration * the median flow rate of the automatic titration during validation 6 minutes walk test, oxygen saturation, dyspnea, walked distance and heart rate will be recorded.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 85 years * copd patients at the stage of crf under ltot or desaturating at exercise * written and signed consent exclusion criteria: * patients under guardianship or curatorship. * pregnant women * patients with non-weaned smoking. * patients using technical assistance to move * inability to perform 6mwt due to locomotor disorders. * inability to understand 6mwt due to cognitive disorders * patients exacerbating * unstable angora * myocardial infarction \< 1 month * hr at rest \> 120 bpm * systolic blood pressure \> 18 and/or diastolic blood pressure \> 10

Keywords: copd long-term oxygen therapy six minutes walk test exertion rehabilitation
efficacy of perifosine alone and in combination with dexamethasone for patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase 2 study of perifosine in patients with multiple myeloma. patients will receive perifosine 150 mg at bedtime (qhs) daily. patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks.

treatment: patients will take three 50 mg tablets of perifosine qhs daily with food. all patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. progressing patients will have dexamethasone 20 mg twice per week added to the perifosine. patients who experience toxicity may continue on treatment with doses delayed or reduced. evaluations: serum and/or urine-electrophoresis will be evaluated for progression or response at 3 week intervals. this study will enroll a total of up to 64 patients.

Eligibility criteria:
inclusion criteria: major criteria: 1. plasmacytomas on tissue biopsy. 2. bone marrow plasmacytosis (\> 30% plasma cells). 3. monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin g (igg) \> 3.5 g/dl or immunoglobulin a (iga) \> 2.0 g/dl; kappa or lambda light chain excretion \> 1 g/day on 24 hour urine protein electrophoresis. minor criteria: 1. bone marrow plasmacytosis (10 to 30% plasma cells) 2. monoclonal immunoglobulin present but of lesser magnitude than given under major criteria 3. lytic bone lesions 4. normal immunoglobulin m (igm) \< 50 mg/dl, iga \< 100 mg/dl or igg \< 600 mg/dl. any of the following sets of criteria will confirm the diagnosis of multiple myeloma: 1. any two of the major criteria. 2. major criterion 1 plus minor criterion b, c or d. 3. major criterion 3 plus minor criterion a or c. 4. minor criteria a, b and c or a, b and d. exclusion criteria: 1. renal insufficiency (serum creatinine levels \> 3 mg/dl). 2. patients who present with either alt or ast ≥ 2.5 x upper limit of normal. 3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine). 4. concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to day 1. nitrosoureas must be discontinued 6 weeks prior to day 1. 5. subjects with a hemoglobin \< 8.0 g/dl. 6. any condition, including laboratory abnormalities, that in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study. 7. women of childbearing potential (wcbp) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded. 8. plasma cell leukemia.

Keywords: relapsed multiple myeloma refractory multiple myeloma
adherence to preventive care for cervical cancer

Conditions: Cervical Cancer; Cervical Precancer; Adherence

Summary: in the united states, the highest incidence of cervical cancer occurs in inner city urban centers, rural areas, the deep south, appalachia and the u.s.-mexico border. the goal of this study is to study predictors of adherence among patients seeking care at an inner city medical center in new york city and the u.s. mexico border for cervical cancer prevention, namely, pap smears and colposcopy exams.

because there are multiple pathways through which a person is influenced to seek and receive care, the investigators will conduct interviews with patients seeking care for cervical cancer prevention at an inner city medical center. the investigators will ask questions related to previous screening, diagnostic, and treatment practices as well as barriers experienced in seeking such care. the investigators will also explore patients' level of resiliency and coping as predictors of adherence to timely care. furthermore, among immigrants, questions about acculturation and discrimination will be asked. additional measures of socioeconomic status, such as education, income and occupation will also be collected.

Eligibility criteria:
inclusion criteria: * women who are at least 21 years old * are seeking care for a pap smear exam * are seeking care for a colposcopy exam for the first time * are not pregnant by self-report * are able to provide informed consent exclusion criteria: * women who do not meet the above eligibility criteria * women who have no prior history of a hysterectomy * women who have previously participated in this study
evaluation of respiratory specimens for bacterial and viral pathogens by real-time pcr

Conditions: Cough; Fever

Summary: community acquired pneumonia(cap) is a common cause of morbidity and mortality. the diagnosis of cap from the microbiology perspective has been challenging. recent reports suggest the utility of real-time pcr for rapid and accurate diagnoses of these pathogens. real-time pcr tests, using the lightcycler instrument, will be performed on excess or additional specimens after extraction of nucleic acid.

excess patient specimens normally collected for routine microbiologic testing for cap and in some cases additional specimens (i.e.,blood, urine, throat swab) will be evaluated using real-time pcr tests developed in our laboratory. specimens will be performed on patients suspect for cap. test will be directed at variety of pathogens including but not limited to m.pneumoniae, c. pneumoniae, legionella pneumophila, streptococcus pneumoniae, b. pertussis, influenza viruses, adenovirus, and metapneumovirus. the ultimate goal is to have a panel of highly accurate and rapid (same day) tests that can be orderable and performed in short period time for cap cases. real-time pcr tests, using the lightcycler instrument, will be performed on excess or additional specimens after extraction of nucleic acid. real-time pcr tests, using the lightcycler instrument, will be performed on excess or additional specimens after extraction nucleic acid. these tests will include the organisms listed above. as nucleic acid extracts will be archived, other pathogens can be tested in the future should we develop additional real-time pcr tests. all results obtained by real-time pcr will be compared to results for conventional testing as listed above. sensitivity, specificity and predictive values will be calculated. in cases where discordant results occur, additional pcr testing and or medical history review will be conducted.

Eligibility criteria:
greater than 18 years of age. cough present greater than one day and a history of fever and chills or documented fever in the emergency department
trial for surgical treatment of reducible atlantoaxial dislocation

Conditions: Atlantoaxial Dislocation

Summary: the management of reducible atlantoaxial dislocation associated is challenging. direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. in 2020, we modified this technique and proposed a posterior intra-articular distraction technique. the intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. however, its superiority has not been proven. therefore, we design a rct study to compare the reduction rate and fusion rate of different strategies.


Eligibility criteria:
inclusion criteria: * ct indicated atlantoaxial dislocation agree with the operation plan agree to be followed up exclusion criteria: * the pathology is traumatic or ra underwent operations in occipital-cervical region before with mortal diseases without ability to sign papers
assist registry studying various operator techniques

Conditions: Ischemic Stroke

Summary: the purpose of this registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (lvo).

assist is a prospective, global, consecutive enrollment registry of anterior circulation acute ischemic stroke patients with an lvo who undergo treatment with one of the interventional techniques using stryker neurovascular devices for the first pass. the purpose of this registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (lvo) in the anterior circulation. data will be collected on the use of stryker market-released neurovascular mechanical access and mechanical thrombectomy devices that are commercially available or that may be approved for commercial use during the conduct of the registry. this registry will also collect data, including time-to-treatment and quality of life measures, to allow for subset analyses.

Eligibility criteria:
inclusion criteria: 1. subjects who experienced acute ischemic stroke (ais), eligible for restoration of blood flow using stryker neurovascular market-released products in the neurovasculature to remove thrombus 2. occlusion of intracranial anterior circulation vessel 3. subject or subject's legally authorized representative (lar) has signed the informed consent form prior to or within 48 hours post-procedure 4. subject is willing to comply with the protocol follow-up requirements 5. the intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per instructions for use (ifu): technique category/devices: sr classic/sr + bgc, sr combination/sr + asp cath ± pump + bgc or ls, direct aspiration/asp cath ± pump + bgc or ls, exclusion criteria: the subject is participating in another device trial or any other clinical trial where the study procedure or treatment might confound this study's endpoint.
liquid biopsy monitoring of cholangiocarcinoma for treatment response and prognostic outcomes (morocco)

Conditions: Cholangiocarcinoma

Summary: this study explores the potential value of a new blood test approach to detect measurable residual disease or early recurrence/progression in patients with cholangiocarcinoma.

primary objectives: i. to estimate the association of puma levels from peripheral blood with disease progression (radiographically or clinically) in patients that are candidates for curative surgical intervention of cholangiocarcinoma. ia. pre- and post-neoadjuvant-treatment puma levels will be associated with treatment response to neoadjuvant therapy (short term progression). ib. pre-surgical and post-surgical puma levels will be associated with progression free survival. ii. to estimate the association of puma levels from peripheral blood with postoperative survival in patients treated for cholangiocarcinoma. outline: this is an observational study. patients undergo collection of blood samples and have their medical records reviewed on study. patients also undergo collection of archived tissue samples on study.

Eligibility criteria:
inclusion criteria: * patient has a suspected or clinical diagnosis cholangiocarcinoma and under evaluation for surgical intervention with intent to cure * age ≥ 18 years exclusion criteria: * patient has metastatic disease involving other organs (excluding lymph node) * patent has known primary cancer outside of the bile ducts within the last 3 years prior to blood collection (not including basal cell or squamous cell skin cancers, indolent cancer not requiring treatment within 3 years i.e. kidney, prostate or thyroid being observed) * patient has had surgery to remove current target pathology completely or partially * patient has undergone any prior radiation therapy to target lesion prior to blood collection * patient has received chemotherapy class drugs in the 3 years prior to blood collection * patient has had any transplants prior to blood collection * current target pathology is a recurrence
the effects of laf237 on gastric function in type 2 diabetes

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: administration of the incretin hormone, glucagon-like-peptide-1 (glp-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. in addition, glp-1 also delays gastric emptying and has been shown to enhance gastric accommodation. these characteristics make glp-1 an ideal therapy for type 2 diabetes (t2d). however, because of its rapid breakdown by dipeptidylpeptidase iv (dpp iv), glp-1 has to be administered by continuous intravenous infusion. this would be a drawback in clinical usage. laf237 is a synthetic inhibitor of dpp iv which has been shown to raise glp-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. however, the effects of laf237 on gastric emptying and satiety are at present unknown. the investigators propose to study the effects of laf237 on gastric emptying, gastric volume and satiety in patients with t2d in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.


Eligibility criteria:
inclusion criteria: * type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents
metformin, vitamin d, and depression in polycystic ovary syndrome (pcos) trial

Conditions: PCOS; Depression; Vitamin D Deficiency; Insulin Resistance

Summary: open-label randomized clinical trial assessing the efficacy of metformin versus vitamin d in improving symptoms of depressed mood in polycystic ovary syndrome.

this is a single center, open-label, randomized, pilot clinical trial. women with polycystic ovary syndrome and depressed mood, who are insulin resistant and vitamin d insufficient are eligible. subjects are randomly assigned to one of two interventions: vitamin d versus metformin. subjects are followed with questionnaires and a final wrap-up clinic visit with a physician. the study duration is 12 weeks.

Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome diagnosis (rotterdam criteria) * vitamin d insufficiency (serum vitamin d \<30 ng/ml) * insulin resistance * mild or greater severity of depression by beck depression inventory-ii exclusion criteria: * current metformin use * vitamin d supplementation of \> 50,000 iu following confirmation of vitamin d insufficiency * insulin-dependent diabetes mellitus * pregnancy or breastfeeding * untreated hypothyroidism * current active substance abuse * other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data

Keywords: pcos depression vitamin d insulin resistance anxiety quality of life mood disorders