Kornimate/medical-research-clean huggingface dataset:
posterior fossa decompression with or without duraplasty for chiari type i malformation with syringomyelia

Conditions: Arnold-Chiari Malformation, Type 1; Chiari Malformation Type I; Type I Arnold-Chiari Malformation; Syringomyelia

Summary: the purpose of this study is to determine whether a posterior fossa decompression or a posterior fossa decompression with duraplasty results in better patient outcomes with fewer complications and improved quality of life in those who have chiari malformation type i and syringomyelia.

participants with chiari malformation type i and syringomyelia will be randomized to either have a posterior fossa decompression done with or without duraplasty. the participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: \< 6 weeks, 3-6 months, and 12 months. at these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete two quality of life questionnaires. a brain and cervical spine mri will be performed 12 months after the decompression.

Eligibility criteria:
inclusion criteria: 1. age ≤21 years old 2. chiari malformation type i ≥5 mm tonsillar ectopia 3. syrinx between 3 mm and 6 mm 4. chiari severity index (csi) classification 1 5. mri of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the data coordinating center exclusion criteria: 1. csi-2 or csi-3 classification 2. syrinx \<3 mm and/or ≥6 mm 3. neuro-imaging demonstrating basilar invagination 4. clival canal angle \<120° (signs of severe craniovertebral junction disease) 5. chiari malformation i + syringomyelia secondary to other pathology (e.g. a tumor) 6. unable to share pre-decompression mri of the brain and cervical and thoracic spine 7. patients who do not wish to participate
metformin in pregnant pcos women

Conditions: Polycystic Ovary Syndrome

Summary: to investigate the effect of metformin on pregnancy complications and pregnancy outcome in the ii. and iii. trimester of pregnancy in women with polycystic ovary syndrome.


Eligibility criteria:
inclusion criteria: * 18-45 years, * pcos diagnosis according to rotterdam criteria * single, viable, ultrasound verified fetus * if metformin was used at conception and early pregnancy, at least 7 days of "wash out" exclusion criteria: * known liver disease or alat \> 90 nmol/l * known renal disease or creatinine \> 110 micromol/l * diabetes mellitus * alcohol or drug abuse * peroral steroid treatment * cimetidine, anticoagulant or erythromycin treatment at time of inclusion * not suitable for other reasons

Keywords: pcos metformin pregnancy preeclampsia diabetes preterm delivery
time course of circulating myocardial biomarkers after a tash procedure.

Conditions: Cardiac Insufficiency

Summary: the study evaluates the released myocardial substances in blood of hocm patients after tash procedure (small "controlled" myocardial infarction). this helps to identify new pathomechanisms and biomarker and thus provides a better understanding of development and progress of cardiac insufficiency.

all patients who receive a tash procedure in the medical clinic i routinely receive routinely implementation of arterial pressure catheter for invasive blood pressure monitoring (usually arteria radialis) as well as a central venous catheter. directly after the procedure, the blood is taken through the central venous catheter. the operation is then terminated as planned. the postoperative treatment is performed according to the standard operating procedures (sops) of the medical clinic i -regular blood sampling is performed to monitor the patient's cardiac, renal and hepatic lab values. the patient is released on the 3-5th post-operative day. as part of a routine outpatient visit to the medical clinic i 1 week and 1 month after the tash procedure, an anamnestic record as well as a blood analysis is made. one month after the tash procedure, an echocardiographic follow-up of the hocm is routinely performed. adverse events or serious adverse events are documented, assessed and reported in accordance with gcp (good clinical practice).

Eligibility criteria:
inclusion criteria: * a clinical indication for tash procedure * an access to blood vessels * a person qualified for legal acts, mentally abte to follow the instructions of study stuff exclusion criteria: * patients with severe anaemia - hb \<8 mg/dl * patients with acute infectious diseases (e.g. pneumonia) * patients with acute myocardial ischaemia (e.g. angina pectoris or ecg alterations under strain) * patients with acute coronary syndrome in the last three months * patients that were hospitalized for acute heart failure during the last month and had to be treated by diuretics or inotropes * a pregnant and/or breastfeeding women * persons that are located by a court or administrative decision in an institution * persons with a relationship of dependency to investigator * persons with simultaneous participation in another clinical trial * administration of an investigational drug 30 days before start of the study

Keywords: fgf23, tash
electrical stimulation for spasticity in spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this study examines the immediate and long-term effects of lumbosacral tens on spasticity and residual voluntary force control in spinal cord injury in comparison to no tens. participants in the intervention group will receive 2 months of tens. participants in the control group will receive tens after a 2-month delay. modified ashworth score and pendulum test will be used to assess spasticity and force control. electrophysiological measures will be used to assess the activity profile of motorneurons.

transcutaneous electrical nerve stimulation (tens) has been used to control pain in stroke, ms, cerebral palsy and spinal cord injury (sci) and its effect on spasticity reduction, although not used clinically, has been examined recently. in the few sci studies done to date, the tens electrodes have been placed on the nerve to the muscle under study and initial reports show a consistent decrease in spasticity measures, like the modified ashworth score (mas) and reflexes, during or hours after the tens application. recently, study team members from the reyu recovery centre in edmonton have observed that when tens is applied with both electrodes over the lower back (lumbosacral tens), varying amounts of immediate and long-term spasticity relief are produced in both legs. the investigators have observed 3 clients from reyu and all have shown immediate reductions in spasticity for at least 2 joints in both legs. the effect of the lumbosacral tens varied from an immediate dramatic reduction to a more moderate reduction when applied over several days. this study will examine the immediate and longer-term (2 months) effect of using spinal tens in reducing spasticity of the lower limbs in a larger number of participants with sci. the investigators want to understand how spinal tens affects spinal circuits and motoneurons below the lesion to reduce spasticity to observe improvement in its effect in those with more moderate responses. lumbosacral tens has the potential for a non-pharmacological, on-demand control of sci spasticity to greatly improve the quality of life of those affected.

Eligibility criteria:
inclusion criteria: * sci adults 18 years and older * injury levels between c5-t12 exclusion criteria: * severe head injury * uncontrolled autonomic dysreflexia * other medical conditions precluding tens
mucinex exploratory cold study

Conditions: Common Cold

Summary: this is an exploratory, multicenter, randomized, blinded, placebo-controlled study of mucinex in patients with colds. patients will receive 7 days of treatment with either mucinex or placebo. the study will assess the effects of mucinex on sputum and cold symptoms.


Eligibility criteria:
inclusion criteria: * common cold symptoms * meet symptom severity * females of child-bearing potential must have negative pregnancy test and use effective birth control exclusion criteria: * chronic respiratory conditions * significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder * pregnant or lactating * known malignancy * participation in any other clinical trial within 30 days of baseline * related to another enrolled patient or persons involved directly or indirectly with the conduct of this study

Keywords: common cold
a study to find the best dosing schedule for delavirdine, zidovudine, and indinavir in hiv-positive patients

Conditions: HIV Infections

Summary: the purpose of this study is to see whether it is better to take delavirdine (dlv) plus indinavir (idv) plus zidovudine (zdv) twice a day or three times a day.

patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. group a receives zdv, dlv, and idv 3 times daily. group b receives zdv, dlv, and idv 2 times daily. patients are evaluated for changes from baseline in viral load and cd4 cell count.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * have a viral load (level of hiv in the blood) of at least 20,000 copies/ml. * have a cd4 cell count of at least 50 cells/mm3. * are at least 14 years old (consent of parent or guardian is required if under 18). exclusion criteria you will not be eligible for this study if you: * have ever taken an anti-hiv drug other than zdv. * have taken zdv for more than 1 month.

Keywords: drug therapy, combination zidovudine drug administration schedule hiv protease inhibitors cd4 lymphocyte count indinavir delavirdine reverse transcriptase inhibitors anti-hiv agents viral load
effect of a vegetarian meal on the physiology of insulin response in patients with type 2 diabetes mellitus and obesity

Conditions: Type2diabetes; Obesity; Diet, Healthy; Nutrition, Healthy

Summary: the role of diet in determining glucose intolerance and its progression towards t2dm has been extensively investigated. a 2017 meta-analysis showed that a vegetarian diet is inversely associated with the risk of developing diabetes. vegetarians, with the same baseline risk, are half as likely to develop t2dm than those following an omnivorous diet. therefore, vegetarian nutrition could have important clinical implications in the dietary management of diabetic patients.

the primary objective of the study is to evaluate the effect of two different isocaloric meals, one vegetarian compared to a conventional mediterranean-type one (vegetable protein source in the first case and animal in the second case), eaten at lunch, 1÷3 weeks apart, on the pathophysiology of glucose and insulin response. the two meals were elaborated in such a way as to have a superimposable composition. study population: 20 patients diagnosed with t2dm and bmi ≥ 30, belonging to the diabetes and clinical nutrition clinic of the irccs san raffaele hospital. study design: single-center, interventional, controlled, randomized crossover. procedures: the patients enrolled in the study, for each of the two meals, underwent serial blood tests, before eating lunch (t0) and every 30 minutes, up to 3 hours after the end of the meal itself (t2÷t6). collected variables: blood sugar, insulin, c-peptide, hba1c, total cholesterol, hdl cholesterol, ldl cholesterol, triglycerides, height, weight, waist circumference and blood pressure, visual analogue scale (0-10) for sense of hunger and satiety , meal satisfaction index (0-10).

Eligibility criteria:
inclusion criteria: * age 18-70 years * diagnosis of t2dm * in treatment with diet alone or single oral drug metformin * bmi ≥ 30 * hba1c between 6.0 and 9.0% (42-75 mmol/mol) * signature of the informed consent exclusion criteria: * history of acute/chronic pancreatitis * pancreatic cancer * pancreatic surgery * renal failure (any stage) * liver cirrhosis * thyroid disorders (hypothyroidism, hyperthyroidism) * patients with weight loss in the last 3 months equal to or greater than 5% of body weight * patients on therapy other than metformin monotherapy (insulin, glucagon-like peptide agonists, sulphonylureas, glitazones, dipeptidyl peptidase inhibitors, sglt2 inhibitors). * pregnant or breastfeeding women * history of severe allergic reaction to any food (anaphylaxis)

Keywords: nutrition meal insulin glycemia
intraaortic balloon pump in cardiogenic shock ii

Conditions: Myocardial Infarction; Shock, Cardiogenic

Summary: patients in cardiogenic shock complicating acute myocardial infarction (ami) are referred to a tertiary care center for percutaneous coronary intervention (pci) of the infarct related artery in this multicenter, ran-domized clinical trial. after checking in- and exclusion criteria computerized randomization is performed to either pci plus intraaortic balloon pump (iabp) insertion and medical treatment or pci plus medical treatment only. intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration. the iabp will be weaned after hemodynamic stabilization. primary outcome measure will be 30-day mortality. the secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.


Eligibility criteria:
inclusion criteria: cardiogenic shock complicating acute myocardial (stemi or nstemi) with * intended revascularization (pci or cabg) * systolic blood pressure \ 30 min or inotropes required to maintain pressure \> 90 mmhg during systole * signs of pulmonary congestion * signs of impaired organ perfusion with at least one of the following: * altered mental status * cold, clammy skin * urine output \<30 ml/h * serum lactate \>2mmol/l * informed consent exclusion criteria: * resuscitation \> 30 minutes * cerebral deficit with fixed dilated pupils * no intrinsic heart action * mechanical infarction complication * onset of shock \> 12 h * severe peripheral artery disease * aortic regurgitation \> ii.° * age \> 90 years * shock of other cause * other severe concomitant disease * participation in another trial

Keywords: acute myocardial infarction cardiogenic shock percutaneous coronary intervention intraaortic balloon counterpulsation acute myocardial infarction - cardiogenic shock
the molecular basis of inherited reproductive disorders

Conditions: Hypogonadotropic Hypogonadism; Reproductive Disorder; Kallmann Syndrome; Delayed Puberty

Summary: the goal of this study is to learn more about the genes that control puberty and reproduction in humans.

all study subjects will undergo the same activities. subjects will provide up to five tubes of blood for genetic analysis, complete a smell test, and answer questions about their health and family history.

Eligibility criteria:
participants must belong to one of the following categories: * failure to go through a normal, age-appropriate, spontaneous puberty and low sex steroid levels in the setting of low/normal gonadotropins or, * abnormally early development of puberty or, * normal puberty with subsequent development of low gonadotropin levels or, * evidence of a reproductive disorder with high gonadotropin levels or, * pre-pubertal individuals with features suggestive of hypogonadotropic hypogonadism or, * affected and unaffected family members of individuals that fit criteria above

Keywords: hypogonadotropic hypogonadism reproductive disorders kallmann syndrome kisspeptin delayed puberty
liposome bupivacaine interscalene total shoulder

Conditions: Acute Pain

Summary: this is a randomized prospective outcomes study comparing two groups of patients. one group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing total shoulder arthroplasty. the purpose of the study is to determine if lb plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

liposomal bupivacaine (lb) is a long acting local anesthetic. it is liposome encapsulated bupivacaine which allows for prolonged release of bupivacaine over a 72-hour period. bupivacaine is a medium acting local anesthetic which provides between 6 and 24 hours of analgesia when used in a peripheral nerve block. both medications are standard of care for use in interscalene blocks here at the u of mn. lb has not been adequately studied in peripheral nerve blocks and has yet to be studied for use in interscalene blocks for total shoulder arthroplasty (tsa) patients. it has been studied in rotator cuff repairs (rcr) surgery and showed superior analgesia compared to bupivacaine. the purpose of the study is to determine if lb plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Eligibility criteria:
inclusion criteria: * all adult patients aged greater than 18 years of age that are undergoing total or reverse total shoulder arthroplasty exclusion criteria: * patients with allergy to local anesthetics, daily use of opioids for more than 3 weeks prior to surgery, patient refusal, patient with coagulopathy, non-english speaking patients, and those who do not have access to a telephone.
peanut anaphylaxis predictors

Conditions: Peanut Hypersensitivity; Anaphylaxis

Summary: peanut allergy can be life-threatening. current diagnostic techniques for peanut allergy have high sensitivity, but not high specificity. this clinical trial will test the validity of a novel blood biomarker (compared with current testing) as a diagnostic predictor of anaphylaxis to peanut.

children aged 2-17 years with suspected peanut allergy will be invited to participate in the study. they will have a questionnaire, a skin prick test to peanut, 2 breathing tests (spirometry and fraction of exhaled nitric oxide (feno)), and a blood test (specific peanut antibodies, allergic immune responses - including the novel blood biomarker - and genetic testing to identify novel potential molecular and genetic markers of food allergy in the future. the genetic testing component will be optional). the breathing test is not required for those under 6 years. the final step is an open label peanut food challenge with incremental doses of peanut, (routine practise) as per the australasian society of clinical immunology and allergy (ascia) food challenge protocol.the endpoints in the food challenge will be signs of allergy or anaphylaxis as per practicing allergology (practall) consensus report for oral food challenges or completion of the ascia food challenge protocol. outcome: the primary outcome of the project is to confirm that a novel blood biomarker has a higher diagnostic accuracy as compared to current best testing in predicting anaphylaxis at open label peanut challenge. secondary outcome: will be to determine the value of the biomarker, feno and ara h2 specific immunoglobulin e (sige) (individually and in combination) at predicting anaphylaxis or clinical allergy at open label peanut challenge.

Eligibility criteria:
inclusion criteria: * children aged 2 - 17 years with an allergy to peanut and require peanut challenge to confirm peanut allergy. exclusion criteria: * children with peanut skin prick test (spt) wheal size greater than 10mm as these children are likely to have clinical peanut allergy (no clinical indication for food challenge).
learning oriented physiotherapy - a new approach

Conditions: Agitation; Anxiety; Dizziness; Pain; Numbness; Depression; Fatigue; Sleep Disturbances

Summary: outpatients that suffer from different anxiety disorders may have physical ailments that negatively affect daily life functioning and quality of life. lof is a physical therapy approach focusing on the link between bodily and mental balance and through defined, but simple movements, patients are expected to learn how to cope and reduce health complaints. this study aims to investigate the short- and longterm effect of lof compared to other standardized psychiatric treatments given in the clinic on levels of anxiety and depression, health related function and quality of life.


Eligibility criteria:
the study population will be recruited among patients referred to three norwegian psychiatric outpatient clinics for anxiety-like conditions. the same criteria for inclusion and exclusion will be applied for the experimental and active comparator group. inclusion criteria: participants should be * 18 years or older * able to read, write and speak norwegian * understand the project information and consent exclusion criteria: participants should not * have ongoing substance abuse or addiction. * be psychotic.

Keywords: ownership of body bodily and mental balance learning body image sensations expectations
the clinical course and factors for the progression of uninvestigated dyspepsia to functional dyspepsia

Conditions: Dyspepsia

Summary: dyspepsia is one of the most common gastrointestinal diseases. this disease was defined as predominant epigastric pain lasting for at least 1 month, which can be accompanied with other symptoms, such as epigastric fullness, and early satiety. despite dyspepsia symptoms lasting for ≥1 month represented clinical problem, a longer duration of 6 months or more after first-onset symptom was required for the diagnosis of functional dyspepsia based on rome iv criteria. it was unclear about the natural procession of first-onset dyspepsia to functional dyspepsia assessed by rome iv or asia criteria and possible factors associated with this progression.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years old who had first-onset dyspepsia with one or more symptoms of epigastric pain, epigastric burning, postprandial fullness, early satiation and that has lasted for more than 1 month to 3 months. exclusion criteria: 1. patients with local or systemic diseases which may cause dyspeptic symptoms: known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc. 2. known acute or chronic injury of liver or kidney 3. obvious hematological abnormality, or endocrine and metabolic diseases 4. known malignancy; obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc. 5. other conditions which may be associated with dyspeptic symptoms (such as nsaids associated dyspepsia) 6. organ failure defined by marshall standard or severe psychiatric illnesses 7. pregnancy or lactation 8. unable to provide consent

Keywords: functional dyspepsia uninvestigated dyspepsia