Kornimate/medical-research-clean huggingface dataset:
treatment of dysmenorrhoea with the ova tens apparatus

Conditions: Dysmenorrhoea

Summary: dysmenorrhoea (menstrual pain) is a common complaint among women, leading to use of analgesics, reduced quality of life, and interference with daily activities such as going to work or school. transcutaneous electrical nerve stimulation (tens) is a well established method for treatment of pain. several clinical studies have shown tens treatment to be effective against dysmenorrhoea. a tens apparatus specifically developed for the treatment of dysmenorrhoea has now become commercially available (ova), but is has not been tested in clinical studies. this study will be done to evaluate the clinical utility of treatment with ova in women with primary dysmenorrhoea.

study aims: to compare perception of dysmenorrhoea with and without use of ova. design: prospective, clinical study lasting four months. the women will use the ova apparatus during every other menstruation. inclusion: 20 female volunteers with primary dysmenorrhoea. exclusion: pregnancy, either ongoing or planned during the study period. secondary dysmenorrhoea. consent: the participants will receive verbal and written information and will sign a consent form. randomisation: the participants are randomised to start with either active treatment or observation by drawing a closed, opaque envelope containing the forms for registration of perception of pain. registering pain: the participants will mark their perceived degree of dysmenorrhoea daily on 10 cm visual analogue scale (vas) during each menstruation. filling in forms: during each of the four menstruations throughout the study period the participants will respond daily to the questions on the form and note degree of pain on the vas. at the end of each menstruation they will mail the current form in a stamped and addressed envelope to the study coordinator. statistics: we assume that a difference of 2 vas-points is required for an effect to be of clinical interest. one-sided t-test for paired data will be used in the analysis. power calculation using the statistics program ssd v7.0 has shown that 16 participants is required to demonstrate a difference of 2 points at level of significance p=0.01, 90% power and assumed standard deviation of 2.

Eligibility criteria:
inclusion criteria: * primary dysmenorrhoea exclusion criteria: * pregnancy

Keywords: dysmenorrhoea women pain tens
phase 3 study of map0004 in adult migraineurs

Conditions: Migraine Disorders

Summary: this is a randomized, double blind, placebo controlled, parallel group study of map0004 in adult migraineurs. subjects will self administer study drug in the outpatient setting.


Eligibility criteria:
major inclusion criteria: * male or female between 18 and 65 years of age. * history of episodic, acute migraine (with or without aura) with onset prior to 50 major exclusion criteria: * known allergy or sensitivity or contraindication to study drugs or their formulations * history of chronic pulmonary disease, coronary artery disease (cad), liver disease, kidney disease, seizures, stroke, or major psychiatric condition. * any condition that, in the opinion of the investigator, would make the subject unsuitable for study participation

Keywords: migraine
day 3 fresh transfer followed by day 3 or day 5 vitrification of supernumerary embryos

Conditions: Subfertility

Summary: this monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh embryo transfer (et) on day 3 followed by cryopreservation of cleavage-stage (day 3) embryos versus blastocyst-stage (day 5) embryos. the primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. the secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.


Eligibility criteria:
inclusion criteria: * subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (ivf)/intracytoplasmic sperm injection (icsi) treatment * who are older than 18 and less than 38 years old * who have normal follicle stimulating hormone (fsh) and normal anti-mullerian hormone (amh) levels exclusion criteria: * treatment with donor oocytes or donor embryos * patients planned for pre-implantation genetic diagnosis (pgd) * patients with bmi\>30 * patients with endometriosis grade iii-iv
risk factors for concurrent endometrial carcinoma in patients with a curettage diagnosis of endometrial hyperplasia

Conditions: Endometrial Carcinoma

Summary: objective: to examine the risk factors for coexisting endometrial carcinoma in patients with endometrial hyperplasia. method: seventy-seven patients who received hysterectomy for endometrial hyperplasia were enrolled and divided into the non-endometrial carcinoma group (57) and the endometrial carcinoma group (20) depending on the final pathology. clinical variables were analyzed.

we retrospectively reviewed the cases of seventy-seven patients who had hysterectomies for endometrial hyperplasia between january 1996 and september 2006 at the department of obstetrics and gynecology, national taiwan university hospital. a preoperative pathologic diagnosis of endometrial hyperplasia was obtained by d\&c (dilation and curettage) in all patients. twenty of them were diagnosed as having endometrial carcinoma in their hysterectomy specimens. all of the specimens were reviewed by a gynecologic pathologist. depending on the final pathologic reports of hysterectomy, we divided the seventy-seven patients into two groups - the non-endometrial carcinoma group and the endometrial carcinoma group. fifty-seven of the studied patients were in the non-endometrial carcinoma group and twenty were in the endometrial carcinoma group. as already mentioned above, we investigated them by clinical parameters including age, menopausal status, obstetrical history, medical history of diabetes and hypertension, bmi (body mass index) and preoperative pathology of d\&c. the clinical and pathologic characteristics of the twenty patients diagnosed as having endometrial carcinoma postoperatively were also reviewed. initial manifestation, histological grading of the carcinoma, the depth of myometrial invasion, with or without adjuvant radiotherapy and recurrence were included. the histological grading of endometrial carcinoma was based on figo ( international federation of gynecology and obstetrics ) definitions. the bmis of the patients with endometrial carcinoma were also analyzed by the receiver operating characteristic curve. the research and ethics committee of national taiwan university hospital approved this study. statistical analyses were performed with the independent-samples t test and the mann-whitney test. subsequently, multivariate analysis of risk factors was also employed with binary logistic regression model to obtain the adjusted odds ratio (or) and 95% confidence interval (ci) for selective variables. p\<0.05 was defined as significant.

Eligibility criteria:
inclusion criteria: * endometrial hyperplasia patient having hysterectomy with or without bilateral salpingo-oophorectomy exclusion criteria: * none

Keywords: endometrial hyperplasia hysterectomy endometrial carcinoma
a study to evaluate the pharmacokinetics and safety of yhd1119 in subjects with renal impairment and healthy subjects

Conditions: Healthy Volunteer; Renal Impairments

Summary: the purpose of this trial is to compare the pharmacokinetic characteristics and safety of yhd1119(pregabalin sr 75mg) and yhd1119(pregabalin sr 150mg) in subjects with renal impairment and healthy subjects. yhd1119 is sustained-release (sr) formulation which is made by yuhan corporation. primary endpoints are cmax and auclast and secondary endpoints are aucinf,tmax, t1/2, cl/f and v/f.


Eligibility criteria:
inclusion criteria: * 19\~75 years old, healthy volunteers and renal impairments * egfr \>= 60ml/min/1.73m2 * 60 ml/min/1.73m2 \> egfr \>= 30ml/min/1.73m2 * written informed consent exclusion criteria: * ast or alt \> 1.5 \* upper normal range * total bilirubin \> 1.5 \* upper normal range * blood cpk \> 1.5 \* upper normal range * total cholesterol \>1.5 \* upper normal range * woman who is pregnant or lactating * patients who are difficult to participate in cinical trials judged by investigators * have participated in other clinical trials within 180 days before ip intake
atomoxetine for treatment of weight gain in olanzapine or clozapine patients

Conditions: Schizophrenia

Summary: the study investigates the use of atomoxetine in combination with exercise and a diet support group (weight watchers)to treat weight gain associated with olanzapine or clozapine. all patients must be adults who have been diagnosed with schizophrenia or schizoaffective disorder.

the study is a 6 month double-blind trial of atomoxetine in combination with a weight watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. all participants should have been on olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a bmi of 27 or greater. in addition to the group support, participants are provided supervised exercise sessions and medical supervision. previous studies of the group process alone were successful in helping patients lose weight. it is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. all subjects will receive either atomoxetine or placebo during the 6 month study.

Eligibility criteria:
inclusion criteria: * schizophrenia or schizoaffective disorder * taking olanzapine or clozapine for at least 6 months * weight gain of 7% over baseline or bmi greater than or equal to 27 exclusion criteria: * current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine * treatment with other medications known to cause weight gain unless weight stable on medication for 6 months * current treatment with other medications for weight loss unless weight stable for 6 months * mental retardation * alcohol or substance dependence within the last 6 months * pregnancy * alcohol or substance abuse within the lat month * uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment

Keywords: weight loss support group exercise atomoxetine
humoral and cellular immunity in first-cycle sars-cov-2 vaccinated covid-19 patients

Conditions: SARS CoV 2 Infection; COVID-19

Summary: infection by the recent coronavirus (sars-cov-2) has generated at a pandemic level a new pathology, called covid-19, characterized by "flu-like" symptoms up to severe acute respiratory failure. the pathogenesis of the disease involves both humoral and cellular immunological responses; cell-mediated immunity is the first and most effective immune response to viral infection. to date, despite the extensive scientific research aimed at curing covid-19, there are few effective means to tackle sars-cov-2 infection and reduce its disease progression. among these, a first complete anti-sars-cov-2 vaccination course has been shown to significantly reduce the development of the disease towards the more severe forms requiring hospital and intensive care. on the other hand, over time the antibody response induced by vaccines against sars-cov-2 decreases, so much so as to indicate the need for a third booster dose. this translates into the fact that some patients who have undergone a complete first vaccination course, with third dose booster indications, develop severe critical disease, with the need for hospitalization. on the other hand, other patients with the same vaccination status do not develop the disease, although they are also positive for sars-cov-2. the investigators therefore hypothesized that the humoral and cell-mediated response among groups of patients may be radically different. for these reasons, the investigators designed this observational pilot study in order to analyze humoral and cell-mediated responses in sars-cov-2 positive first complete vaccination patients.


Eligibility criteria:
inclusion criteria: * patients with a complete first-cycle vaccination against sars-cov-2 performed 4 to 7 months before. exclusion criteria: * presence of malignancy under chemotherapy * patient with previous transplantation * patient receiving immuno-modulatory or immunosuppressive drugs * patient receiving corticosteroid therapy since more than 10 days * pregnancy * consent withdrawal
follow-up efficacy and safety of alitretinoin in severe chronic hand dermatitis

Conditions: Hand Dermatoses

Summary: patients who have been treated in study protocol bap089 may have responded to treatment, and subsequently relapsed to \>75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.


Eligibility criteria:
inclusion criteria: * previous participation in protocol bap089 * response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease exclusion criteria: * female patients who are pregnant or who want to become pregnant * female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception

Keywords: patients who have been enrolled in study protocol bap089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed
prevention of severe sars-cov-2 infection in hospitalized patients with covid-19

Conditions: Confirmed Coronavirus Disease

Summary: the primary purpose of this study is to evaluate if adding rhc1-inh to standard of care (soc) in patients admitted for stage ii covid-19 infection may reduce the risk of disease progression, i.e. ali requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to soc alone.

patients fulfilling all eligibility criteria will be randomized in a 2:1 ratio in an open-label controlled design to treatment with rhc1-inh in addition to soc or soc only starting on day 0. the first rhc1-inh treatment will be administered on the same day and continued for a total of 4 days.

Eligibility criteria:
inclusion criteria: * age 18-85 years, * admitted to the hospital because of confirmed positive sars-cov-2 (covid-19 infection). * evidence of pulmonary involvement on ct scan or x-ray of the chest, * symptom onset within the previous 10 days and at least one additional risk factor for progression to mechanical ventilation: 1) arterial hypertension, 2) \>50 years, 3) obesity (bmi\>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) c-reactive protein of \>35mg/l, 7) oxygen saturation at rest in ambient air of \<94% exclusion criteria: * contraindications to the class of drugs under study (c1 esterase inhibitor); * history or suspicion of allergy to rabbits; * women who are of childbearing potential and not using methods of contraception during the entire study period; * pregnant or breastfeeding females or has a positive serum β-human chorionic gonadotropin (hcg) pregnancy test at screening; * chronic liver disease (any child-pugh score b or c); * currently admitted to an icu or expected admission within the next 24 hours; and * currently receiving invasive or non-invasive ventilation
study to evaluate the efficacy of covid19-0001-usr in patients with mild/or moderate covid-19 infection in outpatient

Conditions: SARS-CoV-2 Infection

Summary: determine the efficacy and safety of covid19-0001-usr in the treatment of sars-cov-2 infection in mild to moderate manifestations administered via nebulization/inhalation.

this is an interventional, randomized controlled, double-blind study (i.e., active and passive control), 1 intervention group will be randomized with covid 19-001-usr, and a control group to receive a placebo intervention to assess efficacy, tolerance, and decrease viral load and clinical manifestation on patients infected with sars-cov-2. this will be a self-administered study drug 3 times a day for 7 days

Eligibility criteria:
inclusion criteria: * provide written consent before being included in the essay. * positive cases of covid-19 (based on polymerase chain reaction or positive antigen test for sars-cov-2), * being diagnosed with mild to moderate sars-cov-2 disease (covid19) * symptomatic or asymptomatic patient, with good clinical appearance, sat o2 at rest \> 94% with room air, and without desaturation with ambulation, and without tachypnea, * respiratory rate \< 20. * suspected cases of covid-19, based on 3 criteria: * fever \> 38 degrees celsius * o2 saturation ≤94 * abnormal laboratory indicators, any of them: * lymphopenia \<1500 cells/m3 * c reactive protein \>2 mg/l * ferritin \>300g/l exclusion criteria: * existing decompensated conditions such as diabetes mellitus, hypertension, coronary insufficiency, coronary artery disease, chronic obstructive pulmonary disease (or any chronic or severe lung disease), chronic kidney disease, cancer, immunosuppression, mood change * respiratory frequency \> 20 / min, pulse \> 120 bpm, systolic \< 90 mmhg, diastolic \< 60 mmhg * the patient seems toxic and distressed, or, o2 at rest \<93% in ambient air, or desaturation when ambulating * being diagnosed with severe sars-cov-2 disease (covid19) * patients with low oxygen saturation levels, need for icu entry, need or likelihood of invasive mechanical ventilation * patients requiring bronchodilator treatment * patients with a known history of asthma and/or lung disease * patients with severe decompensated chronic obstructive pulmonary disease * patients who are unable to give consent or who are unable to follow up on the test group will be excluded

Keywords: coronavirus infections covid-19 sars-cov-2
a prospective, randomized comparison of drainage techniques after one- or two-level open posterior lumbar decompression or decompression and fusion

Conditions: Complications, Postoperative

Summary: this project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.

the primary objective is to prospectively evaluate drains used in lumbar spine surgery in patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion for the relative risk of return to the operating room within 90 days.

Eligibility criteria:
inclusion criteria: * one or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis exclusion criteria: * infection, tumor, or trauma * prior lumbar fusion surgery * lumbar fusion surgery at more than 2 levels * anterior lumbar surgery * perioperative anticoagulation treatment * intraoperative incidental durotomy * intraoperative or postoperative cerebrospinal fluid leakage * intraoperative ebl greater than one liter

Keywords: lumbar spine surgery drain postoperative complications
n3 pufa and muscle-disuse atrophy in young women

Conditions: Muscle Atrophy

Summary: this study will examine the influence of n3 pufa supplementation on the rate of muscle atrophy in women undergoing 2 weeks of unilateral limb immobilization. assessments in skeletal muscle strength and skeletal muscle volume will also me made before, after and in recovery from immobilization.

biological aging is associated with the loss of skeletal muscle mass and strength resulting in compromised metabolic function and mobility. throughout life, individuals will also experience periods of reduced physical activity/muscle disuse that independently lower muscle mass and strength accelerating the aging process. the losses in muscle mass with aging and disuse are underpinned by feeding-induced declines in rates of muscle protein synthesis. thus, strategies to enhance muscle protein synthesis could have clinical implications for those who wish to maintain metabolic health and function during times of muscle disuse. supplementation with n3 pufa-enriched fish oil has been shown to potentiate rates of muscle protein synthesis in response to simulated feeding in both younger and older adults. fish oil supplementation also has been efficacious in enhancing skeletal muscle strength during a period of resistance exercise training. however, no study has examined the impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in muscle mass/strength during a period of immobilization.

Eligibility criteria:
inclusion criteria: * female * aged 18-30 years exclusion criteria: * take any analgesic or anti-inflammatory drugs(s), prescription or non-prescription, chronically will be excluded * a history of neuromuscular problems or muscle and/or bone wasting diseases * any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires * use medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications) * fish allergy

Keywords: n3 pufa
a monocenter, cross-sectional study to compare different type of cognitive impairment in multiple sclerosis patients and cerebrospinal fluid biomarkers (beta amyloid, total tau protein and tau-phosphorylated protein).

Conditions: Disseminated Sclerosis

Summary: in multiple sclerosis (ms) sub cortical cognitive impairments are frequently reported. nevertheless, cortical cognitive troubles, with hippocampic memory troubles have been described. besides inflammatory damage, early cortical and degenerative damage are well known. in neurodegenerative diseases, three biomarkers of the cerebro spinal fluid (csf), reflecting lesional mechanisms, are measured: the beta amyloid peptide, the tau total protein, and the phospho tau protein. preliminary studies shown increased level of tau in ms. no study compare cognitive impairment and biomarkers of csf.the aim of this study is to measure in the csf of ms patients these three biomarkers (beta amyloid peptide, tau total and phosphotau) in order to establish correlations between a profile of biomarkers and a pattern of cognitive troubles, cortical or subcortical.the possibility to show, in ms patients with memory hippocampic troubles, a profile of biomarkers closed from the one encountered in ad, could argue in support of the degenerative hypothesis in ms and lead to discuss the interest of the use of ad treatment in ms.


Eligibility criteria:
inclusion criteria: * groups 1 and 2 -patients ms - edss\<7 group 3- patients with first clinical inflammatory symptom exclusion criteria: * pregnant or not taking contraceptive * contraindication for lumbar puncture * contraindication for nmr

Keywords: multiple sclerosis cognitive deterioration biomarkers cerebrospinal fluid alzheimer disease