Kornimate/medical-research-clean huggingface dataset:
female sexual function after cystectomy

Conditions: Sexual Activity

Summary: cystectomy with bladder replacement, with or without urinary diversion, is the preferred treatment option for benign pathologies responsible for neurogenic bladder or sphincter dysfunction after failure of conservative treatments. this surgery has both the objective of preventing urological complications and improving quality of life. we know that women are especially affected by these conditions, as demonstrated by the high prevalence of demyelinating diseases such as multiple sclerosis in this population. patients are often young and sexually active before the surgery. despite the existence of validated evaluation tools since the early nineties, there is poor data exploring effects of invasive procedures such as cystectomy on sexual activity and quality of sexual life in female patients. indeed, existing literature largely focuses on sexual function in male population after cystectomy for urothelial cancer. data on sexual function after stoma formation in women with colorectal cancer show a significant change after the surgery, partly due to body image issues. we can easily suppose that there's also an important impact of cystectomy that may affect sexual quality of life. thus, the objective of the study is to assess sexual function and determine factors that may influence sexual quality of life in female patients following cystectomy or urinary diversion.


Eligibility criteria:
inclusion criteria: * female patients aged from 18 to 75 years * with partial or total cystectomy and/or urinary diversion and/or urinary ostomy repair operations between 01/01/2007 and 15/12/2019 at the "lyon sud" hospital. * surgery was performed for urological disorders caused by a non-malignant disease * patients currently more than 6 months away from the last urological cystectomy/ urinary diversion/ urinary stoma repair surgery exclusion criteria: * patients deceased * patients who undergone a partial cystectomy without urinary diversion for endometriosis with bladder involvement * patients unable to complete the questionnaires
asc618 gene therapy in hemophilia a patients

Conditions: Hemophilia A

Summary: currently, hemophilia a patients are managed with prophylactic or on-demand replacement therapy with recombinant fviii or alternative therapeutics. the major challenges of current treatment regimens, such as the short half-life of hemophilia therapeutics with the need for frequent iv injections, encourage the current efforts for gene transfer therapy. this study will evaluate the safety and preliminary efficacy of asc618, an aav vector encoding b-domain deleted codon-optimized human factor viii under a synthetic liver-directed promoter


Eligibility criteria:
inclusion criteria: * male ≥18 years of age * severe or moderately severe hemophilia a (fviii activity ≤ 2 iu/dl) as evidenced by * medical history * received fviii prophylactic or on-demand replacement therapy for ≥ 150 accumulated * days (exposure days) * ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months * bmi ≤ 30 * agree to use double-barrier contraceptive until at least 3 consecutive semen samples are negative after asc-618 infusion exclusion criteria: * pre-existing immunity to aav8 vector as defined by aav8 total antibodies and neutralizing antibodies qualified tests. * current inhibitors, or history of high titer fviii inhibitors * presence of \> grade 2 liver fibrosis on elastography/fibroscan or comparable imaging methodology * history of chronic renal disease * active infection or any immunosuppressive disorder * history of cardiac surgery and need anticoagulant therapy * any cardiovascular / genetic risk factors for thromboembolic disorders * evidence of active hepatitis b, hepatitis c, human immunodeficiency virus (hiv)-1/2 or syphilis infection. * receipt of any vector or gene transfer agent * current antiviral therapy for hepatitis b or c
treating brain swelling in pediatric cerebral malaria

Conditions: Malaria, Cerebral

Summary: this study evaluates the effectiveness of two interventions in malawian children with cerebral malaria at high risk of death. one-third of the participants will receive treatment as usual, one-third will receive treatment as usual and be placed on a mechanical ventilator, and one-third will receive treatment as usual plus intravenous hypertonic saline.

an important mechanism of death in children with cerebral malaria is diffuse cerebral swelling, cerebral herniation, compression of the brainstem respiratory center, and respiratory arrest. in those who survive their illness without specific interventions, reversal of diffuse cerebral swelling is rapid. mechanical ventilation may help to preserve life while diffuse brain swelling diminishes. intravenous hypertonic saline may work as an osmotic diuretic, directly decreasing brain swelling.

Eligibility criteria:
inclusion criteria: * peripheral p. falciparum parasitemia of any density * blantyre coma score ≤2 * no evidence of meningitis on lumbar puncture * consciousness not regained after correction of hypoglycemia (if hypoglycemia is present) * male or female whose age on the day of screening is between 6 months and 12 years old * severely increased brain volume on magnetic resonance imaging * provision of consent by guardian * willingness to return for 1, 6, and 12 month post-randomization follow-up visits exclusion criteria: * gross malnutrition as evidenced by peripheral edema, hair color changes, or severe wasting * advanced human immunodeficiency virus (hiv) disease - defined as known hiv positive status and evidence of severe wasting * evidence of recent head trauma by history or physical examination * pneumonia as evidenced by oxygen saturation on room air of \<85% * gastroenteritis and shock as evidenced by capillary refill \>3 seconds or skin tenting

Keywords: coma pediatrics
a trial of micronutrients and adverse pregnancy outcomes

Conditions: Pregnancy; Premature Birth; Infant, Low Birth Weight; Pregnancy Outcomes

Summary: the purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (hiv negative) women.

fetal loss, low birth weight and preterm birth are major public health problems worldwide, particularly in developing countries. birth outcomes are also major predictors of child health and survival in infancy and beyond. the purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (hiv negative) women. we also aim to determine whether the potentially protective effect of multivitamin supplements on the risks of low birth weight and preterm birth translate into a sustained reduction in infant mortality.

Eligibility criteria:
inclusion criteria: * hiv negative * 12-26 weeks gestational age at screening visit

Keywords: women pregnancy outcomes nutrition vitamins tanzania maternal and child health outcomes
insulin aspart vs. insulin lispro vs. regular insulin in paediatric population

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.


Eligibility criteria:
inclusion criteria: * pediatric patients with type 1 diabetes for at least one year * hba1c less than 12% * willing to administer at least 3 injections per day * willing to perform self monitored blood glucose (smbg) at least 4 times per day, includes subject and/or parent/guardian, as necessary
impact of gonadotoxic therapies on fertility

Conditions: Cancer; Fertility Issues; Fertility Preservation; Toxicity Due to Chemotherapy; Toxicity Due to Radiotherapy; Effects of Immunotherapy

Summary: the goal of this observational study is to learn how gonadotoxic treatments (chemotherapies, radiotherapies or immunotherapies) affect the fertility status of participants with cancer. the main questions it aims to answer are: * in females, if cancer therapies reduce the anti-müllerian hormone (amh) concentration (ovarian reserve); * in males, if cancer therapies reduce sperm concentration (sperm quality).

this is an international multicenter prospective exploratory study of fertility related data generated mostly routinely in fertility centers in switzerland belonging to the swiss network "fertisave" as well as in fertility centers in germany and austria belonging to the german-swiss-austrian network "fertiprotekt" and further international centers who are interested to participate. both networks include in total around 200 centers. the data, which are mainly part of the routine clinical care, will be collected by the physicians and added to the redcap study registry. patients will be coded by the center to be able to follow them up. each center will only have access to its own registry data set. access to the total data set is only permitted for the principal investigator and the specific sub-investigators. data collection before the start of gonadotoxic treatment will be performed for 5 years. data collection after the end of gonadotoxic treatment will be performed for 10 years (time points: at 12-15 months, at 5 years and at 10 years).

Eligibility criteria:
inclusion criteria: * patients with cancer or with benign reasons undergoing chemotherapy and/or radiotherapy of the pelvis (females) and the testicles (males) and/or immune therapy; * willing to participate; * austria: 14-50 years old (adolescents and adults), germany: 18-50 years old, switzerland: 14-50 years old (adolescents and adults); * serum hormone analysis before gonadotoxic therapy (females) or serum hormone analysis and sperm analysis before gonadotoxic therapy (males). exclusion criteria: * missing consent; * language barrier.

Keywords: gonadotoxicity
hamburg city health study - a german cohort study

Conditions: Coronary Heart Disease; Stroke; Dementia; Cancer; Health Care; Vascular Diseases; Periodontal Diseases; Ocular Diseases; Respiratory Disease; Obesity

Summary: the hamburg city health study (hchs) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several risk and prognostic factors in major chronic diseases.

a random sample of 45.000 participants between 45 and 74 years of age from the general population of hamburg, germany, will take part in an extensive baseline assessment at a dedicated study center. participants undergo 13 validated and 5 novel examinations primarily targeting cardiac, arterio-venous and cerebral function and structure including extensive imaging examinations. the protocol includes self-ratings of life style and environmental conditions, , dietary habits, physical activity, professional life, psychosocial context, , digital media use, medical and family history as well as health care utilization patterns. the assessment is completed by genomic and proteomic characterization. beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to develop complex models predicting health outcomes based on a multitude of examination data, imaging data and behavioral assessments. participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia will be invited for a visit to conduct additional mri examination either of heart or brain. endpoint assessment of the overall sample will be completed through repeated follow-up examinations and data from involved health and pension insurances.

Eligibility criteria:
inclusion criteria: * inhabitant of the city of hamburg at the time of inclusion into the study (inclusion is time of written consent) * age 45 to 74 years * personally signed informed consent exclusion criteria: * insufficient knowledge of the german language, in order to understand study documents and computer assisted interview without translation * physical or psychological incapability to travel to the study center and to cooperate in the investigations

Keywords: epidemiology prospective cohort study nutrition prevention psychiatric and psychosomatic disorders
long-term follow-up of antithrombotic management patterns in acute coronary syndrome patients in russia

Conditions: Acute Coronary Syndrome

Summary: epicor-rus is a multi-centre, observational, prospective, longitudinal cohort study which will include patients, in a real-life setting, who are hospitalized for acute coronary syndrome (acs) within 24 hours of symptom onset and who have a final diagnosis of unstable angina (ua), st-elevation myocardial infarction (stemi) or non-st-elevation myocardial infarction (nstemi). patients will undergo clinical assessments and receive the standard medical care as determined by the treating cardiologist. patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the epicor-rus observational study.


Eligibility criteria:
inclusion criteria: * subject must be 18 years of age or older of either gender or race * diagnosis of stemi, nstemi or ua confirmed using the following definitions exclusion criteria: * ua, stemi and nstemi precipitated by or as a complication of surgery, trauma, or gastrointestinal (gi) bleeding or post-percutaneous coronary intervention (pci). * ua, stemi and nstemi occurring in patients already hospitalized for other reasons. * presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances). * already included in the epicor-rus study. * presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy. * current participation in a clinical trial.

Keywords: acute coronary syndrome antithrombotic management stemi nste-acs
effect of acupressure on constipation in community-dwelling spinal cord injury patients: a randomized controlled trial

Conditions: Spinal Cord Injuries; Traditional Chinese Medicine

Summary: spinal cord injury is a multi-sensory, motor and autonomic dysfunction, caused by various types of acute and chronic central nervous system injuries. and it will affect patient's ability to live normally and return to society. due to lack of physical activity and psychological and environmental factors, the feces remain in the intestine for too long, and there will be excessive water absorption and lead to dryness and difficulty in excretion and it will be constipation. chinese medicine, acupuncture and acupressure are the treatments of constipation in traditional chinese medicine. acupressure is a non- invasive intervention which is easy to learn and apply. we have carried out a number of studies on spinal cord injury rehabilitation support and acupressure to solve chronic problems such as constipation and anxiety. and this study aims to investigate the effects of acupressure combined with nursing intervention on constipation and quality of life in community-dwelling spinal cord injury patients.

this study will use an open-label, double-group, randomized controlled trial to compare the effect of the intervention group with the control group. study participants will be recruited from the "hong kong direction association for the handicapped, a non-governmental organization dedicated to serving severely disabled hong kong people such as sci. the sociodemographic data, disease status and outcome indicators of the study subjects were measured before the intervention, after the intervention and one month after the intervention. research assistants (ra1) were trained to evaluate data and data, blinded to group assignments. we will have the focus group interviews (semi-structured) with participants after the the intervention (post-intervention). the interviews will be conducted online to further understand the benefits and limitations of the research intervention.

Eligibility criteria:
inclusion criteria: 1. being hong kong residents between the ages of 18 or older, 2. having an sci diagnosis for over 6 months and living in the community, 3. demonstrating the willingness and ability to learn and engage in acupressure (or having a caregiver to assist if self-operating is not feasible), 4. experiencing difficulties with defecation or having concerns related to defecation. exclusion criteria: 1. currently undergoing other tcm treatments or receiving interventions related to defecation or bowel functions, 2. being unable to attend the training sessions due to personal reasons, 3. having a history of gastrointestinal organic disease, 4. having severe metabolic diseases, cardiovascular, cerebrovascular, or mental illnesses

Keywords: spinal cord injury acupressure community-dwelling traditional chinese medicine
root caries prevention using fluoride varnish fortified with sbgc

Conditions: Dental Caries of Root Surface; Root Caries

Summary: the goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without strontium-doped bioactive glass (sbgc) on root caries development in community-dwelling older adults.

this 36-month, double-blind, two-arm randomized controlled trial is aimed to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without strontium-doped bioactive glass (sbgc) on root caries development in community-dwelling older adults. participants will be divided in to two groups, the main question it aims to answer is: is fluoride varnish with sbgc more effective than that without sbgc on prevention root caries in community-dwelling older adults? participants will be divided into two groups, experimental group and controlled group after randomization. subjects in the experimental group will receive fluoride varnish with sbgc quarterly, and subjects in the controlled group will receive fluoride varnish without sbgc quarterly. it is hypothesized that community-dwelling older adults who receive quarterly fluoride varnish applications containing sbgc will develop fewer root caries.

Eligibility criteria:
inclusion criteria: * adult \> 60 years old * good collaborative relationships exclusion criteria: * less than 8 natural teeth * have severe medical conditions * are in use of high fluoride toothpaste

Keywords: strontium-doped bioactive glass ceramic fluoride varnish older adults root caries dentine prevention
skin self-examination education during mammography

Conditions: Melanoma

Summary: the skin self-examination for melanoma (sse) educational materials were developed with the input provided by women undergoing screening mammograms. the investigators seek to evaluate the performance of sse by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. the purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. the investigators specifically aim to evaluate the performance of sse by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.

the proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. the initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the lynn sage comprehensive breast center of northwestern medicine/ prentice women's hospital. the investigators seek to evaluate performance of skin self-examination (sse) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. in the second phase, a more intensive intervention in which women will not only receive information about sse, but will also receive a reminder to perform sse one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. the number of women who perform sse at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about sse alone. the hypothesis is that women who receive more the intensive educational intervention will be more likely to perform sse at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. this project builds upon robinson's successful sse training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations.

Eligibility criteria:
inclusion criteria: * women 18 years of age or older * waiting to have a mammogram exclusion criteria: * male

Keywords: melanoma skin self-examination mammogram
pre-hospital post rosc care: are we achieving our targets?

Conditions: Out-Of-Hospital Cardiac Arrest; Post Cardiac Arrest Syndrome; Emergency Medical Services

Summary: rational: out of hospital cardiac arrest is a devastating event with a high mortality. survival rates have increased over the last years, with the availability of aed's and public bls. previous studies have shown that deranged physiology after return of spontaneous circulation (rosc) is associated with a worse neurological outcome. good quality post-arrest care is therefore of utmost importance. objective: to determine how often prehospital crews (with their given skills set) encounter problems meeting optimal post-rosc targets in patients suffering from ohca, and to investigate if this can be predicted based on patient-, provider- or treatment factors. study design: prospective cohort study of all patients attended by the ems services with an ohca who regain rosc and are transported to a single university hospital, in order to identify those patients with a rosc after a non-traumatic ohca who had deranged physiology and/or complications from ohca ems personnel was unable to prevent/deal with in the prehospital environment. study population: patients, \>18 years, transported by the ems services to the ed of the university hospital groningen (umcg) with a rosc after ohca in a 1 year period main study parameters/endpoints: primary endpoint of our study is the percentage of ohca patients with a prehospital rosc who arrive in hospital with either a deranged physiology or with complications from ohca ems personnel was unable to deal with.


Eligibility criteria:
inclusion criteria: * non-traumatic ohca (as confirmed in notes of ambulance crew) with rosc obtained before transport to hospital * age \> 18 exclusion criteria: * traumatic cause of arrest (nb asphyxia due to hanging, electrocutions and drowning are not considered as traumatic arrests in this study, as normal als algorithms (special circumstances) are followed for these patients * no rosc before leaving ohca * age \<18 * informed opt out of medical research of patient