Kornimate/medical-research-clean huggingface dataset:
cohort study on people who inject drugs in senegal

Conditions: Drug Addiction; HIV/AIDS; Hepatitis C, Chronic; Hepatitis C, Acute; Hepatitis B, Chronic; Hepatitis B Acute; Tuberculosis; Sexually Transmitted Diseases; Psychiatric Disorder

Summary: the main purpose of the codisen cohort study is to propose a model of prevention and care for hiv and viral hepatitis adapted to the needs of people who inject drugs (pwid) in dakar, senegal.

the unodc estimated the number of consumers of injectable drugs at 1,02 millions in 2012 in africa among which 12,1 % lived with hiv. prevalences of hiv, chronic hepatitis c and b among people who inject drugs remain little documented in sub-saharan africa. the transmission of hcv in africa is mainly hospital-borne, bound to a precarious transfusional and therapeutic safety. however, the transmission by intravenous drug use emerges as a new stake in public health in urban areas. the report of a strong hiv prevalence in the population of pwid in the sub-region ( for example, in 2007, in the cape verde, prevalence of the hiv was 14 % in emprisoned pwid against 0,8 % in the general population) contributed to assert the reality of the use of intravenous drugs in the region and the vulnerability of this population. senegal, a country with an concentrated hiv epidemic \[0,5 % prevalence in 2012, who source\] is the first country of western africa to have measured prevalence of hiv (5,2 %), hbv (7,9 %) and hcv (23,3 %) in pwid (study anrs 12243). in view of these results, the senegalese authorities introduced from october, 2011 in dakar, activities of harm reduction by means of a mobile team of social workers and mediators allowing individual and collective activities of prevention, needle exchange program, references for care and follow-up, as well as a opioid substitution program in a methadone center (cepiad) located in dakar, first of its kind in western africa. the objective of the present research project thus is to estimate the impact of a strategy of " test and treat " of hiv and harm reduction initiatives on the prevalence and incidence of hiv, hbv and hcv infections in an population of injectable drug consumers followed in the methadone center ( cepiad) of dakar, senegal

Eligibility criteria:
inclusion criteria: * being aged greater than or equal to 18 years or emancipated minor, * being or have been an injecting drug user and followed at the cepiad (methadone program) * living in the dakar region for at least three months, * consenting to the study after individual information. exclusion criteria: * mental impairment making it difficult or impossible to consent to the study.
a randomized clinical trial of adipose-derived stem cells in treatment of non revascularizable ischemic myocardium

Conditions: Ischemic Heart Disease; Coronary Arteriosclerosis; Cardiovascular Disease; Coronary Disease; Coronary Artery Disease

Summary: the purpose of this study is to establish safety and feasibility of utilizing adipose derived stem \& regenerative cells (adrcs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia.

subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility in this study. eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which adrcs will be isolated from the lipoaspirate. according to randomization subjects will receive either adrcs or placebo. the outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 months post index procedure. long term follow-up will be conducted at 12, 18, 24 and 36 months after the procedure.

Eligibility criteria:
key inclusion criteria: * able to provide written informed consent * males or females 20 to 75 years of age, inclusive * coronary artery disease not amenable to any type of revascularization procedure (percutaneous or surgical) in the target area * hemodynamic stability * ability to undergo liposuction * ability to walk on a treadmill * negative urine pregnancy test (females only). key exclusion criteria: * unstable angina * serum creatinine \>2.5 mg/dl * planned or scheduled staged treatment of cad or other interventional or surgical procedures * cardiogenic shock * history of resuscitated sudden cardiac death; or symptomatic or sustained ventricular fibrillation or ventricular tachycardia. * vascular anatomy that precludes cardiac catheterization * peripheral artery disease that precludes insertion of an 8 fr sheath * severe valvular disease * pregnant or nursing females * known and relevant allergies or sensitivities * life expectancy \<1 year * participation in any other clinical research study that has not reached its primary endpoint or otherwise would interfere with the subject's participation in this study * any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Keywords: adrc stem cells chronic ischemia heart disease coronary artery disease inducible reversible ischemia
helmet non-invasive ventilation for covid-19 patients

Conditions: COVID-19; Acute Hypoxemic Respiratory Failure

Summary: study hypothesis: non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe covid-19 pneumonia and acute hypoxemic respiratory failure

this will be a pragmatic parallel randomized control trial that will compare helmet nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. the trial will be implemented in multiple centers.

Eligibility criteria:
inclusion criteria: * suspected or confirmed covid-19 * aged ≥14 years old at the participating icu. icus that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years) * acute hypoxemic respiratory failure based on pao2/fio2 ratio \ 10 l/min or above * intact airway protective gag reflex * able to follow instructions (e.g. squeeze hand on command, eye contact with care provider, stick out tongue on command, etc.) exclusion criteria: * prior intubation during this hospital admission * cardiopulmonary arrest * glasgow coma scale \<12 * tracheostomy * upper airway obstruction * active epistaxis * requirement for more than one vasopressor to maintain mean arterial pressure \> 65 mm hg * pregnancy * imminent intubation * patients with do not intubate orders or equivalent * enrolled in another trial for which co-enrolment is not approved including trials on mechanical ventilation * patients already treated with helmet * patients with chronic carbon dioxide retention (paco2 \>45) * previous enrolment in this trial * the primary cause of respiratory failure is not heart failure as judged by the treating team

Keywords: helmet nonivasive ventilation
novel endpoints in cough challenge testing

Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Healthy; Chronic Cough; Smokers

Summary: the sensitivity of a person's cough reflex can be measured by getting them to breathe in (inhale) irritant chemicals. there are different methods by which subjects are asked to inhale these chemicals, either by taking one deep breath in, or by asking them to just continue to take a number of breaths. the purpose of this clinical research study is to see if the coughing responses are different in healthy people and people with respiratory problems that make them cough when they are given these chemicals in these two methods.


Eligibility criteria:
inclusion criteria: * adult subjects aged 18 and over. meet criteria for subject groups as outlined below: healthy volunteers: * must be non smokers. * no history of respiratory disease. healthy smokers: * current smokers with at least 10 pack year history of smoking. * spirometry within normal limits i.e. fev1 \> 80% predicted and fev1/fvc ratio of \> 75% predicted. asthma: * physician diagnosis of asthma * stable asthma. * airway hyperresponsiveness to methacoline; pc20\< 16mg/ml. * non smokers or ex-smokers with smoking history of less than 10 pack years. copd: * physician diagnosis of copd * ex smokers with smoking history of at least 20 pack years * spirometry demonstating evidence of airflow obstruction i.e. fev1/fvc ratio of \< 70% chronic cough: * history of dry cough for at least 8 weeks. * normal chest x ray. * non smokers or ex smokers of less than 10 pack years history of smoking. exclusion criteria: * symptoms of upper respiratory tract infection within the last 4 weeks. * participation in another clinical trial of an investigational drug within 4 weeks. * use of medication likely to alter cough reflex sensitivity i.e. ace inhibitors, codeine phosphate, morphine sulphate. * patients with severe respiratory disease i.e. fev1 \< 1.0 litre. * use of steroid tablets in previous 2 months or taken more than 3 courses of steroid tablets in the preceding 12 months in subjects with asthma or copd. * change in asthma treatment in the preceding 6 weeks in asthma group * significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, parkinson's disease, multiple sclerosis etc.

Keywords: copd asthma healthy volunteers chronic cough smokers cough challenge cough challenge testing.
in-home use test of the new modified diprobase formulation to assess the safety and tolerability in infants and children under physician's control

Conditions: Atopic Dermatitis

Summary: to investigate the safety and tolerability of the modified diprobase formulation over 14 days in infants and children with a history of atopic dermatitis (ad).


Eligibility criteria:
* children with normal or dry skin and a history of mild to moderate ad, but without any signs or symptoms within the last month prior to enrollment * skin type i - vi according to fitzpatrick skin classification * aged 6 months to 48 months
efficacy study of ipilimumab versus placebo to prevent recurrence after complete resection of high risk stage iii melanoma

Conditions: High Risk Stage III Melanoma

Summary: the purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage iii melanoma


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * age ≥ 18 years * complete and adequate resection of stage iii melanoma with histologically confirmed melanoma metastatic to lymph node * disease-free * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 * randomization within 12 weeks of surgery exclusion criteria: * prior therapy for melanoma except surgery * auto-immune disease
executive reaction time test in assessment of cognitive dysfunction after aortic valve procedures

Conditions: Neurobehavioral Manifestations

Summary: up to 50% of patients undergoing surgical aortic valve operation suffer from some level of post-operative cognitive dysfunction (pocd). frontal lobes of the brain, where executive functions are located, are highly susceptible to trauma caused by possible blood malperfusion to these areas of the brain during surgery. conventional and established neuropsychological test methods are poor in distinguishing these kinds of trauma, as they are isolated, structured tests that do not require multitasking and processing of multiple stimuli at the same time. the phase 1 goal of this study is to employ an experimental executive reaction time (rt) test to see if this method could improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone electic aortic valve replacement (avr) surgery. phase 2 of the study will concentrate on patients undergoing transcatheter aortic valve implantation (tavi).


Eligibility criteria:
inclusion criteria: * undergoing elective aortic valve stenosis surgery (phase 1) or transcatheter aortic valve implantation (phase 2) exclusion criteria: * previous neurological or psychiatric disorder. * significant visual problem * problems with upper arm/hand use

Keywords: pocd executive reaction time test aortic valve surgery cognitive functions transcatheter aortic valve implantation
high dose icotinib with sequential srs for nsclc patients harboring egfr mutation with brain metastases

Conditions: Non-small Cell Lung Cancer; Brain Metastases

Summary: this trail is designed to assess the efficacy and safety of high dose iconitib combined with srs for nsclc patients harboring egfr mutation with brain metastases.

the long-term control of brain metastases becomes a clinical challenge. whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. egfr-tkis like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits to brain metastases patients.

Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of non-small cell lung cancer (nsclc); * diagnosis of brain metastases on a gadolinium-enhanced mri. * less than 10 sites of intracranial metastases, or the longest diameter of the intracranial lesion is less than 4cm. * positive egfr mutation（ex19del or 21l858r）. * life expectancy ≥3months. * have one or more measurable encephalic lesions according to recist. * the patient has not received radiotherapy for the head or extracranial target lesions before. * adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. * adequate renal function: serum creatinine ≤1.5 x uln, or ≥ 50 ml/min. * adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases. * female subjects should not be pregnant. * all human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications. * written informed consent provided. exclusion criteria: * previous usage of egfr-tki or antibody to egfr: gefitinib, erlotinib, herceptin, erbitux. * csf or mri findings consistent with metastases of spinal cord, meninges or meningeal. * allergic to icotinib. * lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. * pregnancy or breast-feeding women. * participate in the other anti-tumor clinical trials in 4 weeks. * have quit from the trail before. * any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Keywords: egfr-tki nsclc icotinib srs radiotherapy
preoperative oral carbohydrate drink for elective cesarean delivery and the effect on insulin sensitivity

Conditions: Insulin Sensitivity

Summary: preoperative fasting and surgery can cause metabolic stress and insulin resistance. oral carbohydrate loading has been shown to attenuate the development of insulin resistance in the non-pregnant population undergoing many different types of surgery. pregnant women have an increase in insulin resistance and therefore may further benefit from a preoperative carbohydrate load prior to cesarean delivery. although woman in the uk receive a carbohydrate drink prior to elective cesarean delivery, the metabolic effects of these drinks on the mother and neonate have not been evaluated.

preoperative fasting and surgery can cause metabolic stress and insulin resistance. perioperative insulin resistance results in hyperglycemia which can lead to increased infectious complications, morbidity, and mortality.2,3 significant research has occurred in the non-pregnant population utilizing preoperative oral carbohydrate loading to attenuate the development of insulin resistance. in a recent meta-analysis, awad and colleagues 2 found that a preoperative carbohydrate drink may be associated with reduced length of stay and a reduction in postoperative insulin resistance in patients undergoing major abdominal surgery. approximately 1.3 million women undergo cesarean delivery (cd) annually in the united states. 4 cd is the most common inpatient surgery in the united states. in the uk, there are recommendations to implement enhanced recovery after obstetric surgery. implementation of enhanced recovery supports the national health service quality, innovation, productivity, and prevention programme with the aim of improving quality of care while reducing costs. as part of the enhanced recovery pathway, pregnant women are receiving a preoperative carbohydrate drink. there is a paucity of research looking at the metabolic effects of this carbohydrate load in the pregnant woman and her neonate.

Eligibility criteria:
inclusion: * asa physical status ii-iii women presenting for scheduled, elective cesarean delivery under neuraxial anesthesia * singleton gestation at term (37-42 weeks) * ages 18-50 exclusion: * preexisting diabetes (gestational diabetes, type i dm, type ii dm) * taking insulin-sensitizing or other medications known to influence glucose or fatty acid metabolism. * kidney, heart, or liver disease. severe lipid disorders. * history of bariatric surgery * pre-pregnancy bmi \>40 * prolonged period of time (\>4 hours) between ingestion of carbohydrate drink and surgery * four or more repeat cesarean sections
patient-reported outcome measures after post-anesthesia care unit delirium

Conditions: Delirium; Neurocognitive Disorders

Summary: to assess self-reported cognitive function and health-related quality of life in patients with and without early postoperative delirium

neurocognitive disorders including postoperative delirium are a serious complication after surgery and anesthesia in the elderly. postoperative delirium is an acute-onset diffuse brain dysfunction that is characterized by a fluctuating course of confusion, disorganized thinking, inattention, irritability, disturbances of the circadian rhythm, and disorders of consciousness. post-anesthesia care unit (pacu) delirium occurs immediately after emergence from anesthesia and affects up to 45% of patients after elective surgery. it is unclear, whether pacu delirium is associated with intermediated or long-term adverse outcomes including neurocognitive disorders or mortality. the aim of this prospective observational was to assess self-reported cognitive function and health-related quality of life in patients with and without pacu delirium three months after radical prostatectomy.

Eligibility criteria:
inclusion criteria: * elective radical prostatectomy * \>60 years * fluent in german exclusion criteria: * preexisting cognitive impairment * cerebrovascular disease
clinical data collection in breast tomosynthesis (cobris)

Conditions: Breast Cancer

Summary: the purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment

after being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. one additional mammography view will be obtained with the investigational application and analyzed. subject participation is expected to last no more than 30 minutes. after the mammography examination, subjects will be followed according to the hospital standard of care.

Eligibility criteria:
inclusion criteria: * women aged 35 years or older; * women referred for unilateral or bilateral 2d and 3d mammography; * women able and willing to comply with study procedures; * women able and willing to participate in this study who have signed and dated the informed consent form; and * women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test exclusion criteria: * women who have been previously included in this study; or * be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or * women with brca 1 or brca 2 gene mutation
safety of cultured allogeneic adult umbilical cord stem cells exosomes for trigeminal neuralgia

Conditions: Peripheral Neuropathy; Trigeminal Neuralgia

Summary: this trial will study the safety and efficacy of instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of trigeminal neuralgia.

this patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (uc-mscs) exosomes for the treatment of trigeminal neuralgia. patients will receive an intranasal instillation of uc-mscs exosomes. the total dose will be approximately 800 billion exosomes split evenly between both nasal cavities via tian syringe through 4 ccs of alloex. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. for patients with more severe disease an autologous effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility criteria:
inclusion criteria: * diagnosis of trigeminal neuralgia or peripheral neuropathy * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: peripheral neuropathy trigeminal neuralgia stem cell treatment