Kornimate/medical-research-clean huggingface dataset:
a clinical trail to compare pharmacokinetics of two peg-rhgh injections with different preparations

Conditions: Pediatric Growth Hormone Deficiency (PGHD)

Summary: the purpose of this study is to compare the pharmacokinetics of the two different peg-rhgh preparations after a single administration.


Eligibility criteria:
inclusion criteria: * healthy male aged ≥18 years old and≤45 years old; * the body mass index (bmi): 19-26 kg/m2 (inclusive), and body weight ≥50 kg; * normal results of physical examination, vital signs, laboratory tests, 12 lead-ecg, chest x-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above. exclusion criteria: * subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; * subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators; * subjects with severe infection, severe trauma, or major surgery prior to screening; * subjects who have received blood transfusions, had blood donors, or lost blood before screening; * subjects who have positive results of human immunodeficiency virus antibodies (hiv-ab), or hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv-ab), or syphilis specific antibodies (tppa); * subjects who have participated in clinical trials for medication or medical device prior to screening;etc.
long-term safety and efficacy of itopride hydrochloride (hcl) in patients suffering from functional dyspepsia

Conditions: Dyspepsia

Summary: itopride is a compound already marketed in japan and in some countries of eastern europe under the name of ganaton. it is used to treat symptoms of functional dyspepsia. patients suffering from this condition have difficulties digesting food. patients feel full after eating, they have bloating and have stomach pain. the goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

all patients having completed study itofd04-01 will be offered to continue to be treated with itopride for a period of up to one year in duration. a target of 300 patients will be followed up for 6 months. of these, a target of 100 patients will be kept on treatment for an additional 6 months. patients will need to come to the clinic for evaluations every 8 weeks during the trial. evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Eligibility criteria:
inclusion criteria: * patients must have completed the 8 week double-blind study itofd04-01 * female patients must not be pregnant (must have a negative serum pregnancy test) exclusion criteria: * patients with any newly occurring medical condition which was an exclusion criterion at itofd04-01 study entry

Keywords: abdominal symptom relief fullness bloating indigestion functional dyspepsia
the effect of intranasal oxytocin on emphatic abilities in patients with post traumatic stress disorder (ptsd)

Conditions: Post Traumatic Stress Disorder

Summary: oxytocin (ot) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a key mediator of complex social and affective behaviors, including emotional empathy. recently, several theoretical studies suggested that ptsd patients have abnormal functioning of the ot system. according to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes ptsd, and therefore intranasal ot may potentially relieve these symptoms. the main goal of this study is to examine the effects of administration of nasal ot on empathic abilities among ptsd patients. another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among ptsd patients.


Eligibility criteria:
inclusion criteria: * ptsd patients (dsm-iv criteria) * ability to provide written informed consent exclusion criteria: * suicidality * psychosis * arrhythmia * cardiac disease (arrythmia, heart failure) * hyponatremia * severe renal insufficiency * liver cirrhosis * pregnancy

Keywords: ptsd empathy oxytocin
burden of hepatitis d virus (hdv) infection in italy

Conditions: Chronic Hepatitis D

Summary: the circulation of the hepatitis d virus (hdv) has considerably diminished in italy, secondary to the control of the hepatitis b virus (hbv) with vaccination; this has led to the perception that hdv is vanishing and has reduced attention to the diagnosis of hepatitis d. however, migratory fluxes from hdv endemic areas, fostered by labour-forces globalization, are increasingly reconstituting the reservoir of hdv in the country and hepatitis d has not yet vanished in native italians but will remain an important medical issue for several years to come. as the epidemiologic and clinical features of hdv infection in migrant communities are largely unknown and the features of native italians with long standing hdv infections have not been updated, this project intends to establish the contemporary epidemiological and medical context of hdv in immigrants in italy and to determine the clinical characteristics and needs of the residual cohort of native hdv italians, through the analysis of all hdv cases recruited in 12 months in a coordinated network of 35 italian medical centers. the data will provide an appraisal of the burden of hepatitis d in the country and of its impact on the national health system. they will present the paradigm of the current trend of hdv infection in high-income countries in the world.


Eligibility criteria:
inclusion criteria: * hbsag-positive subjects * 18 years or older * anti-hd-positive
morphological and functional evaluation of buttock lipoatrophy treatment with macrolane

Conditions: Atrophy

Summary: the study is being undertaken to establish the effectiveness and safety of macrolane volume restoration factor 30 (vrf30) when used for treatment of hiv-infected subjects with buttocks lipoatrophy.


Eligibility criteria:
inclusion criteria: * have buttocks lipoatrophy and is unable to remain seated for more than 30 minutes due to pain. * have undergone hiv treatment for more than 2 years. * have rna copies less than 50/ml. * have cd4 more than 200 cell/mm3. exclusion criteria: * active infections. * active skin disease, inflammation or related conditions. * perineal pathology. * condition that may affect pain assessment. * skin with underlying fibrous tissue. * bmi less than 19. * insufficient tissue cover in the area to be treated. * concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 14 days prior to treatment, or a history of bleeding disorders. * permanent implant placed in the treatment area. * other injectable implant, liposuction or other surgical therapy in the treatment area. * presence or history of connective tissue diseases. * tumors or pre-malign tissue disorder near or on the area to be treated. * contraindications for mri * previous hypersensitivity to hyaluronic acid, or to the local anesthetic or antibiotic used in the study.

Keywords: lipoatrophy buttock treatment
procalcitonin-guided detection of streptococcal acute tonsillitis

Conditions: Streptococcal Acute Tonsillitis

Summary: the primary purpose of the present study is to investigate the usefulness of procalcitonin as a supplement to the streptococcal antigen test and centor criteria in the differential diagnose making between streptococcal and non-streptococcal acute tonsillitis. furthermore, the investigators aim to examine procalcitonin as a diagnostic marker in acute tonsillitis due to fusobacterium necrophorum.

acute tonsillitis is based on typical symptoms (sore throat, pain on swallowing, and fever) and clinical findings of tonsillar exudate and hyperemia. 10-20% of patients seen by their family physician, have acute tonsillitis due to streptococci group a. in denmark, centors criteria and the streptococcal antigen test (strep. a-test) are gold standard in the diagnostic process of streptococcal acute tonsillitis. although the sensitivity and specificity of the strep. a-test is biochemically high, its clinical reliability is reduced due to several influential factors. moreover, studies suggest that 4-10% of patients are tested false-negative based on clinical criteria and the strep a-test. fusobacterium necrophorum are suspected to be the cause of acute tonsillitis in teenagers and young adults (5-15%). however, there is no rapid test available for this bacterium. since tonsillar surface swab is not included in the diagnostic standard, family physicians get no information about infection due to fusobacterium necrophorum or other pathogens. c-reactive protein, leukocyte count and absolute neutrophil count as diagnostic markers are examined with variable results. procalcitonin is a relatively new marker of bacterial infection, which has the advantage of more rapid and specific induction compared to the other markers.

Eligibility criteria:
patients with acute tonsillitis: inclusion criteria: * age between 15 and 40 years. * subjective and objective signs of acute tonsillitis + presents of 2-4 centor criteria. * participation accept after verbal and written information. exclusion criteria: * antibiotic treatment within the last month. * other infection within the last month. * inadequate tonsil swabs due to lack of cooperation. * suspicion of peritonsillar abscess control patients: inclusion criteria: * age between 15 and 40 years. * participation accept after verbal and written information. exclusion criteria: * antibiotic treatment within the last month. * infection within the last month. * tonsillectomy * more than 2 cases of acute tonsillitis within the last 12 months.

Keywords: acute tonsillitis procalcitonin streptococcal antigen test centor criteria infection marker
researching the useful of barb suture in obese patients undergoing posterior cervical surgery

Conditions: Cervical Spinal Stenosis; Posterior Cervical Spine Surgery; Barbed Suture

Summary: through a single-center, exploratory clinical study, the safety and effectiveness of using barb wire in the incision and suture of posterior cervical surgery in obese patients were evaluated, providing a basis for its wide clinical application in posterior cervical surgery.


Eligibility criteria:
inclusion criteria: * symptoms and signs of the patients were typical. mri showed single or multiple central herniation of c3-c7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis. * preoperative routine tests and examinations showed no contraindications. * bmi≥28 * informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery. exclusion criteria: * a history of wasting diseases associated with malignancy and chemoradiotherapy that may interfere with wound healing * history of dermatosis * history of immune system diseases * history of blood diseases * skin injury or defect at the back of the neck * severe hypersensitivity * cold, fever, trauma or other infections in the week before surgery * infectious disease * psychosis could not cooperate with follow-up
cardiovascular risk markers in polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: women with polycystic ovary syndrome (pcos) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. it is not know whether it is the overweight and insulin resistant component of pcos, or pcos per se which leads to the greater cardiovascular disease risk. the aim of this study was to examine cardiovascular risk markers in women with pcos versus a control population matched for body mass index (bmi), and or, insulin resistance


Eligibility criteria:
inclusion criteria: * had a positive diagnosis of pcos as defined according to the nih criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. clinical criteria included hirsutism with a ferriman-galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (dheas) greater than the laboratory reference range. * were between the ages of 18 and 40 exclusion criteria: * were under 18 years or greater than 40 years old, * were non-caucasian * were pregnant, lactating or trying to conceive * had a body mass index (bmi) \ 50kg/m2 * had a recent illness or any chronic illness likely to influence results * were taking hormonal contraception

Keywords: pcos
breast density and the role of preoperative mammography, ultrasound, elastography and mri

Conditions: Breast Cancer

Summary: to determine the sensitivity, specificity, and accuracy of preoperative ultrasound, elastography, mammography and breast mri in women with dense breast tissue diagnosed with breast cancer; to test whether elastography or mri can improve upon routine mammogram and conventional ultrasound in women with dense breast tissue.


Eligibility criteria:
inclusion criteria:- patients must have a suspicious breast lesion detected by a physical exam, mammography or u/s . that has not been surgically resected and is being considered to undergo biopsy if clinically indicated. * patients must be \>= 18 and \< 80 years of age, and female. * patients must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria:- patients who have already had primary surgical excision of the suspicious finding * \ 80 years of age * pregnant or lactating women
myocardial effects in patients with attrv with polyneuropathy treated with patisiran or vutrisiran

Conditions: Transthyretin Amyloidosis; Amyloidosis, Hereditary

Summary: attrv amyloidosis is a systemic disease with two clinical forms, neurological and cardiological, which are sometimes combined (so-called mixed forms). patisiran and vutrisiran have shown protective effects on the progression of neurological damage. the effects of patisiran or vutrisiran on the heart remain incompletely understood. the aim of this study is to better understand the morphological and functional cardiac consequences in attrv patients with stage 1 or 2 polyneuropathy with a mixed form treated with patisiran or vutrisiran

attrv amyloidosis is a systemic disease with two clinical forms, neurological and cardiological, which are sometimes combined (so-called mixed forms). patisiran and vutrisiran have shown protective effects on the progression of neurological damage. the effects of patisiran or vutrisiran on the heart remain incompletely understood. during their therapeutic management, including the prescription of patisiran or vutrisiran, the routine examinations carried out at the inclusion, one and two year later will allow us to observe the consequences on myocardial activity during the routine consultation after 1 and 2 years of treatment. examinations are : clinical and biological exams, ekc, echocardiography, cardiac mri and scintigraphy. data at the start of treatment and at 1 and 2 years will be collected, especially cardiac function assesment in addition, during these two consultations, a life quality questionnaire, a dysautonomia questionnaire and a functional walking test will be carried out specifically for the study. the aim of this study is to better understand the morphological and functional cardiac consequences in attrv patients with stage 1 or 2 polyneuropathy with a mixed form treated with patisiran or vutrisiran.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * patients with hereditary transthyretin amyloidosis (attrv) with stage 1 or 2 polyneuropathy * patient not previously treated for attrv * patients for whom treatment with patisiran or vutrisiran has been initiated by a hospital neurologist in accordance with recommendations for a minimum of 24 months. * patients with nyha stage 1 and 2 cardiac disease. * beneficiary of a social security scheme * person who does not object to his/her participation in the research exclusion criteria: * patients treated with tafamidis simultaneously with patisiran or vutrisiran * adults under legal protection (legal guardianship, curatorship, guardianship), persons deprived of liberty. * contraindications to the explorations provided for in the protocol: claustrophobia, metallic implant contraindicating mri, woman of childbearing age

Keywords: patisiran vutrisiran
safety and efficacy of lansoprazole in patients with reflux disease

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.

lansoprazole is currently approved in germany for the treatment of erosive reflux esophagitis and active duodenal and gastric ulcer disease, and for long-term treatment including maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of pathological hypersecretory conditions such as zollinger-ellison syndrome. this study was conducted to evaluate the safety, efficacy and quality of life of patients receiving up to five years of treatment with lansoprazole.

Eligibility criteria:
inclusion criteria: * had gastro esophageal reflux disease with or without oesophagitis. * had a history of heartburn at least for 5 days per week during the past 6 months or was receiving long-term treatment with a proton pump inhibitor and during two weeks (without proton pump inhibitor treatment) prior to enrolment. exclusion criteria: * history of surgery of stomach or oesophagus. * gastric ulcer (can be included after healing of gastric ulcer). * duodenal ulcer (can be included after healing of duodenal ulcer). * bleeding (melena, hematemesis). * severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases). * barrett oesophagus with dysplasia. * complicated esophagitis (oesophageal strictures or ulcers). * treatment with proton pump inhibitor or histamine receptor 2 (h2)antagonists within the previous two weeks. * pregnancy, wish to become pregnant, breast feeding. * treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic acid (aspirin) \> 100 mg/day.

Keywords: gerd gastroesophageal reflux disease drug therapy
routine bladder catheterisation through fast-track hip and knee replacement - what are the consequences?

Conditions: Postoperative Urinary Retention

Summary: to describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (kad) for up to 24 hours of fast-track tha and tka

postoperative urinary retention (pour) is a well known complication of fast-track total hip (tha) and knee arthroplasty (tka), and even though medical options have been attempted, bladder catheterisation remains the only well-documented capacity to prevent and / or treat pour. it was previously standard to use fixed urinary catheter (kad), the first 24-48 hours postoperatively to prevent pour by tha and tka, while more recent studies now recommend intermittent urinary catheterization in the postoperative period. however, there are no detailed studies with adequate follow-up, describing the consequences of using either one or the other treatment regimen of pour by fast-track tha and tka. purpose: to describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (kad,catheter a demure) for up to 24 hours of fast-track tha and tka end points: 1. the number of patients in need of re-catheterization due pour 2. the number of patients in which the removal of kad was not carried out within 24 hours. 3. the number of urinary tract infections from surgery to postoperative day (pod) 30 4. the number of patients with new-onset urinary discomfort at pod 30 (increase in ipss score). 5. the number of urological-related readmissions (including urosepsis) within pod 30

Eligibility criteria:
inclusion criteria: * patients must meet all the following criteria to be eligible to enroll in the study: * age \>50 years. * patients scheduled for primary tha or tka. * patients who have given verbal consent to participate in the study. exclusion criteria: * patients who meet one or more of the following criteria may not be included in the study: * patients who can not cooperate with the study. * patients who do not understand or speak danish. * patients who are permanent catheter carriers or use disposable bladder catheterisation. * patients on hemodialysis. * urine derivative patients. * pregnancy or childbirth within 6 months.
fluoxetine for motor, aphasia, and neglect recovery after ischemic stroke

Conditions: Stroke

Summary: this pilot study will recruit 25 subjects to assess the feasibility of replicating the flame study (chollet, et al. lancet 2011), a randomized controlled trial (rct) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an american sample of post-acute stroke patients. this trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. the results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an american post-acute environment. there are two additional substudies: the first will use mri to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.


Eligibility criteria:
inclusion criteria: * ischemic infarction within 15 days * admission nihss item 5 score equal to or \>2 -able to give informed consent, with surrogate consent acceptable- exclusion criteria: * pre-stroke modified rankin scale score equal or .3 * pregnant or lactating * taking an ssri on admission to srh * taking a medication likely to have adverse interaction with an ssri * unable to return for follow-up testing days 90,180 * concurrent medial condition likely to worsen patient's functional status over next 6 months * unable to competently participate in testing for 45min-2hrs with rest breaks * for mri substudy: contraindication to mri

Keywords: stroke recovery fluoxetine aphasia neglect motor