Kornimate/medical-research-clean huggingface dataset:
pre-exposure option for reducing hiv in the uk.(proud)

Conditions: HIV

Summary: this study is looking at a new way to reduce the risk of catching hiv - truvada-prep. to find out whether a daily tablet, truvada, can safely reduce the risk of gay men catching hiv, we need to do a large trial in which half the men do not receive truvada for one year. we do not know if gay men at risk of hiv are interested in taking truvada, and if they are, whether they would be willing to wait a year before they can take it. the reason it may not be safe, is that taking truvada-prep may lead to an increase in risk behaviour. this could mean there was more chance of catching hiv and other infections. as well as finding out if a large trial would be possible, this study will looks at other factors including: * whether people using prep change the number of partners they have sex with * whether people using prep change how often they use condoms * whether prep leads to higher rates of other sexually transmitted infections (stis). this information on changes in sexual activity over time is one of the most important aspects of the study, because we have never collected this before in the uk. this means we don't know what happens to people's sexual activity without prep! in october 2014 an interim analysis of the proud study data showed that pre-exposure prophylaxis (prep) was highly protective against hiv for gay men and other men who have sex with men (msm) at high risk of infection. the proud trial steering committee announced that participants on the deferred arm of the study, who had not yet started prep, should be offered the opportunity to begin prep ahead of schedule. as a result, we changed the study design and offered all enrolled participants the opportunity to access prep. all study participants will be followed up until study closure in october 2016

intervention and control groups: arm a: immediate offer of truvada-prep arm b: deferred (12m) offer of truvada-prep method of randomisation: randomisation will be performed centrally using a computer algorithm based on random permuted blocks stratified by site.

Eligibility criteria:
inclusion criteria: * born to male gender, age 18 years or more * previously attended the enrolling clinic on at least one occasion * completed a screen for hiv and stis * hiv negative by a routinely used assay within 4 weeks prior to or on the day of randomisation * reported unprotected anal intercourse (uai) on more than one occasion within the 90 days prior to randomisation * likely, in the opinion of the volunteer, to have uai in the next 90 days * willing and able to comply with the visit schedule throughout the follow-up period * willing and able to provide written informed consent exclusion criteria: * an acute viral illness that could be due to hiv seroconversion * any contraindications to truvada according to the current package insert * treatment for hepatitis b infection indicated or ongoing * unlikely, in the opinion of the clinician, to comply with the randomised allocation

Keywords: hiv prevention truvada
description of the psychiatric care pathway of pregnant women after the early prenatal interview

Conditions: Psychiatric Disorder

Summary: pregnancy and postpartum are recognized as periods of psychic fragility. however, the psychiatric disorders of women that can emerge during these periods are underdiagnosed and have consequences in particular on the development of the child, his relationship with his parents. the need for an early diagnosis to allow appropriate treatment seems to be essential. the pregnancy monitoring is centered on the somatic and little on psychological evaluation of the mother and the father. in this context, the early prenatal interview (epp) was created through the perinatal plan of 2005-2007 in order to allow a more precise research of the factors of vulnerabilities likely to be predictive of a somatic, psychological or social disorder. however, until now, only few pregnant women benefited of this interview. in may 2020, epp became mandatory for all pregnant women. it now seems important to clearly identify the place, function, organization and usefulness of this interview in order to maximize its benefit in the monitoring of pregnancy

first, the investigators will describe the care pathway for pregnant women who have benefited of an early prenatal interview (epp) between march 2019 and march 2020, namely continued classic follow-up or referral to a child psychiatrist / psychiatrist. then, the investigators will define two subgroups within the women oriented towards psychiatric follow-up: those who had this follow-up and those who did not. then, the investigators will identify the factors of failure of this referral to psychiatric follow-up and describe the eventual difficulties encountered by the lack of this follow-up. finally, the investigators will try to study these observations made with the perspective of maximizing the benefit of the early prenatal interview in the monitoring of pregnancy.

Eligibility criteria:
inclusion criteria: * no opposition from women to participate in the study * women over 18 * women who had an epp at montpellier university hospital between march 2019 and march 2020 exclusion criteria: - age \< 18 years

Keywords: orientation to a psychiatric follow-up after epp early prenatal interview psychiatric disorder during pregnancy
a study to evaluate the impact of pre-procedural intracoronary nicorandil injection to prevent reduction of decreased timi flow in patients who undergoing percutaneous coronary intervention for the coronary artery disease

Conditions: No-Reflow Phenomenon; Coronary Artery Disease; Percutaneous Coronary Intervention

Summary: the aim of this study was to determine the effect of intra-coronary administration of nicorandil on the prevention of lowering of coronary blood flow for high-risk plaque lesions defined as the high value of lipid core burden index in patients with coronary artery disease who require stent treatment.


Eligibility criteria:
inclusion criteria: 1. over 19 years old 2. patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information 3. patients who underwent nirs-ivus guided coronary stent surgery for coronary artery disease exclusion criteria: 1. patients with timi ≤ 2 before coronary intervention 2. subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel and contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.) 3. pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study 4. subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration 5. those whose surviving life is expected to be less than 1 year 6. subjects who visited the hospital due to cardiogenic shock and are predicted to have low survival probability based on medical judgment

Keywords: nicorandil no-reflow phenomenon lipid core burden index near-infrared spectroscopy
intracavernosal injection of botulinum toxin type a in the treatment of vascular erectile dysfunction

Conditions: Vasculogenic Erectile Dysfunction

Summary: evidence has been arising that botulinum toxin injections can relax smooth muscles fibers in the treatment of obesity and hyperactive bladder. would a similar effect on cavernosal smooth muscles help in the treatment of resistant erectile dysfunction not responding to medical and injection therapy, thus avoiding surgical treatment options. the treatment group will be injected intracavernously with 50 units of btx-a. the control group, 12 patients, will be injected with a normal saline injection.

24 males with will be included in the study. all will be subjected for full history taking, general and genital examination. penile duplex will be performed to assess a vascular etiology before the treatment and 2 weeks later. the patients will be randomized into a treatment group (12 patients) and a control group (12 patients). all patients will sign an informed consent. the treatment group will be injected ic with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color doppler assessment, followed, next day by 50 units of btx-a. the control group, 12 patients, will be injected with the trimix solution during penile color doppler assessment followed next day with a normal saline injection. the erection hardness score (ehs) will be assessed during the doppler exam. procedure: at least 1 day after the penile color doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. a rubber band will be applied to the base of the penis. the skin will be prepped with alcohol swabs followed by the ic injection of 50 units of btx-a. direct pressure will be applied for 2 minutes. the rubber band will be removed after 15 minutes. patients and controls will fill the sexual health inventory for men (shim) questionnaire and answer the the sexual encounter profile questions 1 and 2 (sep 2 \& sep 3), and the global assessment question (gaq) before and 4 weeks after treatment. the rational for selecting the minimum 2-weeks waiting period is to give a chance for the btx-a to reach its maximum effect. possible risks include pain and prolonged erections.

Eligibility criteria:
inclusion criteria: * 24 males will be included in the study recruited from andrology, sexology \& std's outpatient clinic, kasr el aini hospitals, cairo university, complaining of vascular ed proved by penile duplex. * unable to develop erections sufficient for intercourse. * failing to respond to first line and second line treatments for erectile dysfunction with surgery as the only remaining treatment option. * age between 40 to 70 years. exclusion criteria: * significant cardiovascular disease interfering with sexual activity
equivalency study of the teg and cora hemostasis systems

Conditions: Heart Disease; Focus is on Testing Performance of CORA Hemostasis System.

Summary: this study is being performed to obtain data about the cora system, a new device that is currently being tested and is not yet cleared for sale in the united state by the food and drug administration (fda). the purpose of the study is to validate the cora system by comparing the results of this test to that of the standard of care device called the teg system. both systems evaluate hemostasis, a highly complex and interactive process involving many protein and cellular elements, especially platelets, occurring in a series of interrelated phases, which results in either normal hemostasis or a tendency toward bleeding or clotting complications.

the study protocol specifies testing using multiple reagents which are similar for both the cora and teg systems. tests are run on blood samples taken from patients undergoing cardiovascular surgery and cardiology procedures, at two times throughout the procedure. the tests may be performed at three different pairs of times: pre-operation and post-protamine, or during operation (post-heparin) and icu, or pre-operation and icu. patients are selected at random for determination of which pair of times will be used, as long as the number of patients for each of the three groups is approximately the same. following the protocol defined in clsi standard ep09-a2, equivalence between the two systems will be demonstrated if the conclusions from the standard section 7, interpreting results and comparing to internal performance criteria, are found to be acceptable. the study protocol also specifies the testing of blood samples from normal, health volunteer subjects for the purpose of determining cora system reference ranges for all of the reagents used in the study. reference ranges will be constructed following the guidelines specified in clsi standard c28-a3c. all blood samples drawn for this study will use venous blood. whole blood is not used for these studies; only citrated or heparinized samples are used. all samples are repeated twice (run in duplicate tests). quality controls are run on both instruments at a frequency specified by the manufacturers. results obtained from this testing are not used to make treatment decisions.

Eligibility criteria:
inclusion criteria: * 18 years of age or over (both groups) * age, gender, ace and disease state documented (both groups) * in good health (reference ranges group only) exclusion criteria: * subjects/patients under the age of 18 (both groups) * on medications affecting hemostasis (reference ranges group) * having conditions or undergoing treatments affecting hemostasis (reference ranges group)

Keywords: hemostasis thromboelastography coagulation teg
a research study investigating nnc0247-0829 for weight management in people with overweight or obesity

Conditions: Overweight; Obesity

Summary: this study looks at nnc0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. the study looks at how nnc0247-0829 works in the body. participants will either get nnc0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. nnc0247-0829 is an experimental medicine which has not been approved by the us fda. participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. the study will last for about 18 months, but participation will last from 11 to 23 weeks. this will depend on the group participants are in. participants will attend 8 to 14 visits at the clinic with the study staff. some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. others will have two 2-day, 1-night visits. at all visits except one, participants will have blood tests and other checks. they will be asked about their health, medical history and habits including mental health questionnaires.


Eligibility criteria:
inclusion criteria: * female not of childbearing potential (cbp) or male, aged 18-60 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 27.0 and 34.9 kg/m\^2 (both inclusive) in the sd cohorts and between 27.0 and 39.9 kg/m\^2 (both inclusive) in the md cohorts at screening. overweight or obesity should be due to excess adipose tissue, as judged by the investigator. exclusion criteria: * male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception. * any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. * use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. mild painkillers are permitted until 24h prior to screening.
lifscreen : evaluation of whole body mri for early detection of cancers in subjects with p53 mutation (li-fraumeni syndrome)

Conditions: Li Fraumeni Syndrome

Summary: the purpose of this study is to compare the diagnostic efficacy of two follow-up schedules for the early detection of cancers in the population under study on cancer incidence at 3 years.


Eligibility criteria:
inclusion criteria: * p53 mutation

Keywords: patients with li fraumeni syndrome
therapeutic plasma exchange as an adjunctive strategy to treat coagulopathy and inflammation in severe covid-19

Conditions: Severe Covid-19

Summary: randomized controlled trial to analyse adjuvant therapeutic plasma exchange (tpe) in severe covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (soc). a total of three tpes (d1, 3, 5) will be performed in the intervention group. primary endpoint is the reversibility of relative adamts13 deficiency (indicated by the change in adamts13 / vwf:ag ratio from day 1 to 7).


Eligibility criteria:
inclusion criteria: * proven sars-cov2 infection * severe covid-19 (indicated by respiratory failure requiring invasive mechanical ventilation) * evidence of coagulopathy (indicated by d-dimer \> 10 mg/l) * evidence of systemic inflammation (crp \> 100 mg/l , ferritin \> 500 ng/ml) exclusion criteria: * • participation in another study with investigational drug within the 30 days preceding and during the present study, * previous enrolment into the current study. * extra corporeal membrane oxygenation (ecmo)
vascular subphenotypes of lung disease in hiv & copd

Conditions: Pulmonary Artery Hypertension

Summary: this study is looking for high blood pressure in the lungs (pulmonary artery hypertension pah) in hiv and copd patients.

the goal of the project is to identify and characterize populations at risk for developing pulmonary arterial hypertension (pah). the project will establish a pah subphenotype core cohort (core) to evaluate mechanistic pathways and test novel therapeutic agents. this core cohort serves as a resource for the translational program project grant, vascular subphenotypes of lung disease (mark gladwin, pi). in order to construct the core, we have chosen to recruit copd and hiv patients, two populations with advanced lung and systemic diseases that are enriched for pah. we have selected these as prototypic conditions because: a) both copd patients and hiv-infected patients develop pah at a rate significantly greater than the general population, b) morbidity and mortality are greatly increased in dually-affected persons, c) mechanisms responsible for development of the pah "subphenotype" are not well-understood, d) clinical and genetic characteristics of the subgroup with pah are not known, and e) effects of pah therapies in subphenotypes are incompletely studied. there is also some overlap between copd and hiv, with hiv-infected patients having accelerated copd even with effective antiretroviral therapy. participants with copd, hiv, or hiv-uninfected controls will be recruited to the study based on entry criteria of elevated n-terminal pro-brain natriuretic peptide (nt-probnp) and/or an abnormal echocardiogram. these subjects will then undergo a 6-minute walk test, blood collection, questionnaire, medical record review, and echocardiography (if not previously performed). selected subjects will then be recruited to undergo right heart catheterization. the goals of the study are to establish a pulmonary hypertension cohort for translational investigations, to determine the utility of nt-probnp as a biomarker of pah, to determine clinical characteristics and relationship of lung function to pah in copd and hiv, and to establish a biorepository for mechanistic studies of pah phenotypes.

Eligibility criteria:
inclusion criteria: * male/female 18-80 years of age. * subject has been previously enrolled in pact/mac/ecrc study. * must have recent probnp test \>120pg/ml or abnormal echocardiogram (right ventricular systolic pressure \>or=40mmhg) without evidence of left sided heart failure. exclusion criteria: * previous diagnosis of congenital heart failure. * if evidence of left ventricular systolic or diastolic dysfunction, echo will be reviewed by the pi on a case by case basis. * creatine clearance \<60ml/min per 1.73 m2. * undiagnosed chest pain or myocardial infarction, stroke or cardiovascular event within 3 months. * pregnancy. * subjects receiving chronic anticoagulant. * inability to complete the 6 minute walk test.

Keywords: hiv copd pulmonary disease
hipec for peritoneal surface malignancies including carcinomatosis or sarcomatosis - data registry

Conditions: Peritoneal Neoplasms; Neoplasm Metastasis; Adenocarcinoma; Sarcoma

Summary: in this registry study the investigators will collect data about patients' disease, treatment, and response to treatment to include in both our local and national databases. these can then be used by investigators to answer questions about cytoreductive surgery/hipec such as how well-tolerated or effective it is in specific populations.

patient selection: the sole inclusion criteria for this study will be those consenting patients who are to undergo cytoreductive surgery followed by hipec. data collection and use plan: for those patients who provide informed consent, data listed below will be collected during and after treatment. this will be entered into the pi's local database for future use and, after being de-identified, will be shared with a national database (held by the american society of peritoneal surface malignancies) to bolster the amount available for researchers looking at efficacy and outcomes such as overall survival rates, progression-free survival, and tolerability in certain populations. data collected (as applicable): age, primary tumor, dates of prior surgeries, prior chemotherapy with dates and whether it was neoadjuvant in nature, length of disease status, comorbidities, peritoneal surface disease severity score, peritoneal cancer index as determined prior to surgery, peritoneal cancer index as determined during surgery, completeness of cytoreduction score, ascites present, blood products used, complications, length of stay in icu and in hospital, where discharged, death within 30 days, readmission and reason, date of recurrence, treatment of recurrence, and time from procedure to death. for the hipec surgical procedure itself, data collected will be: date, duration, chemotherapeutic used and dose, duration of circulation, fluid temp, and flow rate.

Eligibility criteria:
inclusion criteria: * eligible to undergo cytoreductive surgery followed by hipec performed by the pi at edward hospital * provides consent by signing informed consent form exclusion criteria: * not eligible for surgery or for potential cytoreductive surgery and/or hipec as determined by the pi * does not consent to participate

Keywords: metastasis carcinomatosis carcinosis sarcomatosis crs cytoreductive surgery hipec heated intraperitoneal chemotherapy intra-abdominal sugarbaker technique mitomycin c cisplatin doxorubicin oxaliplatin melphalan
swallowing and voice outcomes after thyroidectomy

Conditions: Functional Voice and Swallowing Outcomes

Summary: impairment in voice and swallowing functions are common after thyroidectomy. the investigators aimed to evaluate the objective functional voice and swallowing outcomes in a series of patients undergoing thyroidectomy. according to the study, even in the absence of recurrent laryngeal nerve injury, subjective and objective swallowing and voice alterations do occur after thyroidectomy.

a total of 43 consenting patients who underwent thyroidectomy were prospectively recruited. subjective evaluation of swallowing was assessed with 'swallowing impairment score' and 'md anderson dysphagia inventory'. fiberoptic endoscopic evaluation of swallowing (fees) was applied for objective evaluation. also, functional oral intake scale (fois) and functional outcome swallowing scale (foss) were used for swallowing assessment. voice evaluation was assessed with videostrobolaryngoscopy (vsl) and 'the multi-dimensional voice program (mdvp)' was used for capturing and analyzing the voice samples. all evaluations were performed preoperatively and on 1st day, 2nd week and 6th months postoperatively.

Eligibility criteria:
inclusion criteria: * patients undergoing thyroidectomy exclusion criteria: * patients who were diagnosed with thyroid carcinoma preoperatively * having history of previous neck surgery, * history of radiotherapy at head and neck region, * vocal cord paralysis, * neuromuscular dysfunction, * larynx, esophagus and chest pathology * who did not want to be involved in the study

Keywords: thyroidectomy voice swallowing problems dysphagia