Kornimate/medical-research-clean huggingface dataset:
an observational pregnancy safety study in women who were exposed to the drug nifurtimox during pregnancy to learn about the risk of pregnancy complications and about the mother's and baby's health

Conditions: Chagas Disease

Summary: this is an observational study in which data from women with chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. chagas disease is an inflammatory, infectious disease caused by the parasite trypanosoma cruzi. this parasite is mainly spread by insects called triatomine bug. if chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. nifurtimox has been used for more than 50 years to treat chagas disease in children and adults. it is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. currently, there are not enough data to know if this is also the case in humans. in this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. to do this, researchers will collect the following information: * birth defects (abnormal and problematic structures or functions, a child is born with) * pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) * certain health problems of the child up to 12 months of age * certain health problems of the women experienced during pregnancy the data will be collected from different sources including telephone calls with the women or their doctor, crfs (case reprt forms) or from medical records the researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. the study will run for approximately 10 years.


Eligibility criteria:
inclusion criteria: * females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period / time of conception to pregnancy outcome). * written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent/legal guardian). exclusion criteria: * none
comparison between invasive pressure flow study and non-invasive penile cuff test

Conditions: Bladder Outlet Obstruction; Pressure Flow Study

Summary: to provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (boo) in men with benign prostatic hyperplasia. 1. penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level of accuracy without the morbidity and expense of invasive pressure flow study. 2. penile cuff test may be particularly useful in the counseling of patients prior to benign prostatic hyperplasia operation. patients diagnosed as obstructed following a penile cuff test can be reassured that surgery has a high chance of resulting in symptomatic benefit


Eligibility criteria:
inclusion criteria: 1. male patients with low urinary tract symptoms over 6 months. (international prostatic symptom score \>= 12) 2. patients scheduled to have pressure flow study. 3. able to give fully informed consent exclusion criteria: 1. patients with urologic malignancies such as prostate cancer and bladder cancer 2. patients underwent urethral, prostate surgery 3. patients with urethral stricture or bladder diverticulum or bladder neck contracture 4. seems not to be appropriate to this study by the decision of investigators because of any other reasons

Keywords: penile cuff test
the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes

Conditions: Amniocentesis; Video Information

Summary: the goal of this clinical trial is to assess the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes

amniocentesis is the most commonly used invasive prenatal diagnostic test. this study aimed to investigate the effect of video-based multimedia information (mmi) on the anxiety and pain levels of patients undergoing amniocentesis. all consecutive women aged 18-45 years scheduled for amniocentesis were included in this prospective randomized controlled study. subjects were assigned to receive video-based mmi or traditional written information (controls). anxiety levels were assessed at the first admission using the state and trait anxiety inventory-state (stai-s). after mmi and written information, stai-s was repeated before the procedure. a standard amniocentesis procedure was performed on all patients by the same perinatology physicians. after amniocentesis, a likert scale was used to evaluate the ease of the procedure and patient satisfaction, and a visual analog scale was used to evaluate pain. pregnancy results and amniocentesis results were noted

Eligibility criteria:
inclusion criteria: * all consecutive women aged 18-45 years scheduled for amniocentesis exclusion criteria: -

Keywords: video-based information, amniocentesis
the natural history study of mitochondrial neurogastrointestinal encephalopathy (mngie)

Conditions: Mitochondrial NeuroGastroIntestinal Encephalopathy (MNGIE)

Summary: this is a multi-center natural history study of mitochondrial neurogastrointestinal encephalopathy (mngie). patients will be followed over time to assess clinical symptoms. the investigators hope to learn more about the disease of mngie as well as develop useful measures of disease status for use in future clinical trials. additional clinical centers will be listed as they become available.

the investigators will examine a total of 20 patients at six month intervals for up to five years. the investigators will evaluate gastrointestinal function, lean body mass, neuropathy, neuropsychological capability, quality of life, nutrition, motor function and biochemical parameters.

Eligibility criteria:
inclusion criteria: 1. thymidine phosphorylase (tp) defect: 1. homozygous or 2. compound heterozygous mutations in the tymp gene, and/or 3. tp enzyme activity of \<20% of normal. 2. increased plasma thd \> 3 micromole/l 3. increased plasma durd \> 7.5 micromole/l 4. age requirement of at least 5 years of age. exclusion criteria: 1. participation in an interventional (study medication or other experimental intervention) study (within 1 month of participation in this study). 2. unable to travel to site for research visits. 3. unwillingness to sign informed consent form. 4. substance abuser

Keywords: mngie mitochondrial mitochondrial neurogastrointestinal encephalopathy
development of a pelvic cavity characterization algorithm through the acquisition of mri images and pressure measurement by an intravaginal probe

Conditions: Pelvic Floor Disorders

Summary: the conditions such as childbirth or endometriosis can lead to a change in the mobility of the pelvic organs (bladder, vagina, rectum and uterus). the purpose of the study is to study in a personalized way each woman the characteristics of the tissues of their pelvis and to be able to personalize the treatments (surgery, injection, rehabilitation, etc.). women requiring pelvic mri may participate in the study. the pelvic dynamic mri will be done with an intravaginal probe which will be inserted by the patient herself as well as gel in the anus and vagina which will allow to obtain the data on the characteristics of the pelvic tissues of each woman with a 3d reconstruction.


Eligibility criteria:
inclusion criteria: all: * understanding of the french language * signature of informed consent * insured social patient for pregnant women: * primiparous women * with no severe maternal-fetal pathology * with no scheduled caesarean section at the time of the mri for women with prolapse: - requires pelvic mri exclusion criteria: * minor * person who does not have social security * person with ongoing vaginal infection * pregnant woman during the first or third trimester of pregnancy * pregnant woman with broken water pocket * bi-cicatricial uterus * ivf * person wearing a pace maker or any intra-body metal implant (if "tube" mri) * claustrophobic person (if "tube" mri)

Keywords: geometrical reconstruction pelvic floor disorders fe models pelvic system mri
esophageal and gastric registry and biorepository

Conditions: Gastro Esophageal Reflux

Summary: the evaluation of the foregut, the esophagus and stomach, has come a long way over the past two decades, and continues to experience exciting discoveries in the clinical evaluation of foregut physiology. assessing esophageal peristalsis has relied for the past several decades on high resolution manometry (hrm), however it has recently become known that even though hrm is an extremely effective tool, that there are certain subsets of patients in which additional information is required. additionally, the assessment of esophageal reflux disease has relied on ph impedance for the last two decades. however, this procedure requires a catheter to be passed through a nostril and remain in place for at least 24 hours. novel techniques, already fda approved, including endoflip for esophageal peristalsis and mucosal integrity (mi) for reflux disease, have emerged as time-of-endoscopy assessments. both involve the placement of a balloon through the scope at time of upper endoscopy (standard first line assessment for both dysphagia and reflux symptoms) and are quick and pose little-to-no additional risk or discomfort for patients. however, data regarding normal esophageal parameters are poorly defined for both endoflip and mi. additionally, endoflip has increasingly been used to assess the pylorus, and scarce data exists there regarding how a tool originally envisioned for esophageal assessment can be used more distally in the gi tract. we will recruit healthy, asymptomatic volunteers to undergo testing with mi and flip (esophageal and pyloric). the data obtained will help establish the benchmark from which assessments can be made in patients.


Eligibility criteria:
inclusion criteria: * age 18-85 * no prior surgical history * asymptomatic according to gastroesophageal and gastric questionnaires * not currently taking any medications that affect acid secretion or gut motility * no history of malignancy * no mental health issues precluding informed consent * no smoking history * no excessive or daily alcohol use * bmi \< 30 * no known hiatus hernia * no known medical illness (autoimmune, neurological) that could be associated with altered esophageal or gastric function * not allergic to fentanyl or versed * no history of eating disorder * no history of autoimmune disorders exclusion criteria: * minors * surgeries involving the gi tract * medication use affecting acid secretion or gut motility * personal history of malignancy * mental health issues precluding informed consent * symptoms on standard clinical questionnaires * pregnant - the effect that pregnancy has on esophageal and gastric motility is not well defined, but we will need to eliminate this as a confounding factor * nursing women - although the investigations are fda approved and part of standard clinic practices, they are time consuming and involve medication administration that might affect the ability of a mother to nurse

Keywords: mucosal integrity functional luminal imaging probe
dose response study of a topical formulation of nitroglycerin for the treatment of raynaud's phenomenon

Conditions: Raynaud's Disease

Summary: the purpose of this clinical study is to determine the response to two different dosage strengths of a topical nitroglycerin gel in patients with raynaud's phenomenon. patient fingers will be monitored for changes in blood flow and skin temperature. symptoms of pain, tingling and numbness will also be monitored.

it is the intention of this protocol to study, in a controlled manner, the response of fingers of patients with raynaud's phenomenon to two dosage strengths of a fast acting topical formulation of nitroglycerin, mqx-503. patients may have moderate to severe primary raynaud's phenomenon or raynaud's phenomenon secondary to autoimmune diseases such as scleroderma. quantitative changes in blood flow in the fingers of the non-dominant hand will be measured after the clinical induction of constriction of blood vessels by exposure to local cold temperatures. secondarily, the quantitative reduction in skin temperature recovery time and symptoms of pain, tingling and numbness associated with raynaud's phenomenon will be evaluated using a patient hand symptom analog assessment score. the frequency and severity of adverse events associated with mqx-503 will be assessed.

Eligibility criteria:
inclusion criteria: * patients with raynaud's phenomenon * patients who are willing to discontinue any current therapies for raynaud's phenomenon exclusion criteria: * the use of any medication containing nitroglycerin or known to interact with nitroglycerin * patients with a history of migraine or other severe headaches * open skin lesions or skin conditions in the area where medication is to be applied * pregnant or nursing women or those wishing to become pregnant.

Keywords: raynaud's phenomenon raynaud's disease raynaud's disease secondary to scleroderma raynaud's phenomenon secondary to autoimmune disease
internal bracing following acl reconstruction

Conditions: ACL Injury

Summary: the purpose of this study is to assess anterior cruciate ligament (acl) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following acl reconstruction with quadriceps graft with and without internal bracing.

the primary objective is to compare functional outcomes at one year in patients who underwent aclr with or without internal bracing. the secondary outcomes are to characterize the evidence of acl healing at 1 year by mri imaging of the knee and obtain data on clinical and patient reported outcomes at 1 year follow-up.

Eligibility criteria:
inclusion criteria: • history of acl injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy. exclusion criteria: * patients who underwent concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy. * history of blood-borne diseases including hiv, hbv, hcv, htlv, and syphilis.
clinical and imaging biomarkers associated with plasma ad cellular determinants of cardiovascular disease at the time of covid 19

Conditions: Cardiovascular Diseases

Summary: acute and chronic cardiovascular complications of pneumonia are common and result from various mechanisms, including relative ischemia, systemic inflammation, and pathogen-mediated injury. however, there is only limited published data regarding on cardiovascular desease (cv) submissions in the wake of viral outbreaks. data collected during the covid-19 pandemic highlighted a number of possible determinants of adverse outcome in these patients, particularly with reference to cardio-respiratory complications.

the risk of death increases substantially after age 60, in men and in overweight patients. cardiac involvement, characterized by elevation of cardiac troponin i and brain-like natriuretic peptide, is frequent in covid-19 patients and is associated with a worse prognosis. finally, right ventricular (rv) dilatation and dysfunction is the most common echocardiographic abnormality in patients with covid-19, at least in part due to a substantial incidence of pulmonary thromboembolism (pte). cardiac abnormalities in covid-19 patients include changes in heart rate and cardiac autonomic modulation, as well as systemic activation of inflammatory processes, with endothelial damage and involvement of the cv and respiratory systems. the research program will examine imaging and clinical biomarkers associated with plasma and cellular determinants of cardiovascular disease, taking into account the potential effects of covid-19 infection. this will make it possible to re-evaluate the cardiovascular risk profile of subjects with cardiovascular diseases.

Eligibility criteria:
inclusion criteria: * women and men between the ages of 45 and 90; * patients diagnosed with cardiovascular disease; * patients with diabetes; * patients with dyslipidemia; * patients with hypertension, myocardial infarction (pre-existing or acute stemi or nstemi event) chronic stable angina, peripheral vascular disease, stroke or tia exclusion criteria: * inflammatory diseases and/or infections (except for the ima-covid-19 group); * tumors, immunological and/or hematological disorders; * ejection fraction less than 40%; * treatments with anti-inflammatory drugs, with the exception of low-dose aspirin, and antibiotic therapies up to 1 month before enrolment.

Keywords: covid 19 pneumonia
a natural history study in participants with congenital myasthenic syndromes (cms) due to mutations in dok7, musk, agrn, or lrp4

Conditions: Congenital Myasthenic Syndrome

Summary: participants will attend up to 4 study visits to collect clinical assessments. the assessments will evaluate participants' symptoms and quality of life to understand disease activity in patients with cms due to mutations in dok7, musk, agrn, or lrp4.


Eligibility criteria:
inclusion criteria: * can understand the requirements of the study and can provide written informed consent/assent, and willingness and ability to comply with the study protocol procedures * is male or female and aged ≥2 years at the time of providing informed consent/assent * has a diagnosis of cms due to biallelic pathogenic mutations in dok7 or any pathogenic mutations in musk, agrn, or lrp4 * has a total quantitative myasthenia gravis (qmg) score of ≥3 (applies only to participants aged ≥6 years) * for participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine), participant must have been receiving the medication for ≥3 months before screening/baseline exclusion criteria: * known medical condition that would interfere with an accurate assessment of cms, in the investigator's opinion * is currently participating in any interventional clinical study with a study drug at the time of providing informed consent/assent * diagnosis of cms due to mutation of any gene other than dok7, musk, agrn, or lrp4
immune persistence after the whole vaccination shcedule with recombination quadrivalent hpv vaccine

Conditions: HPV Infections; Cervical Cancer Stage IIa; Vaginal Cancer; Genital Wart; CIN1; CIN2; CIN3

Summary: to access the immune persistence of chinese women aged 9-45 years after receiving quadrivalent hpv vaccine with the immunization schedule of 0, 2 and 6 months.


Eligibility criteria:
inclusion criteria: * subjects who participated in the phase iii clinical trial of non inferior efficacy of hpv tetravalent vaccine of yangchun center for disease control and prevention (protocol no.: 4-hpv-3001), completed three doses of hpv quadrivalent vaccine and provided blood sample at months 7; or subjects who have participated in the bridging study of hpv quadrivalent vaccine of mianyang center for disease control and prevention (scheme no.: 4-hpv-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7; * the subjects aged 9 to 17 years old at mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification; * the subject voluntarily agrees to enroll in this study. if the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form; * be able to understand the study procedures and promise to participate in regular follow-ups under the requirements. exclusion criteria: * enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at mianyang site are still in the post exemption safety follow-up stage of the 4-hpv-3002 trial); * suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.); * according to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.

Keywords: human papillomavirus vaccine cervical cancer
topical use of vancomycin in reducing sternal wound infection in cardiac surgery (swi trial)

Conditions: INFECTION

Summary: the purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.

during open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. the sternum is held open throughout the surgery so that the doctors can reach the heart. sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates. the purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. the results of this study could provide important information to guide new standards of practice in cardiac surgery. the ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.

Eligibility criteria:
inclusion criteria: * able to sign informed consent and release of medical information form * age ≥ 18 years * undergoing cardiac surgery with complete sternotomy (including re-operations) exclusion criteria: * evidence of active infection (any culture positive or blood positive infection) * undergoing organ transplantation * patients with known hypersensitivity to vancomycin * pregnant or nursing women * mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study
a survey to evaluate diabetes management, control, chronic complications, psychosocial aspects of diabetic subjects in indonesia

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in asia. further perceptions and practices of physicians and subjects about diabetes management in asia will be evaluated.


Eligibility criteria:
inclusion criteria: * diabetic patients registered in the particular centre for more than 12 months. * patients should have visited the centre at least once in the last 3-6 months before the initial study visit. * patients willing to sign informed consent form. exclusion criteria: * repetition of any patient as patients should not be included twice for any reason. * unwilling to participate or unable to comply with protocol requirements.

Keywords: diabcare asia 2008, cross-sectional survey, glycemic control, psychosocial well-being, diabetic complications, quality of life.