Kornimate/medical-research-clean huggingface dataset:
safety study of nebivolol for copd patients

Conditions: High Blood Pressure

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the study drug nebivolol, in people who suffer with high blood pressure with chronic obstructive pulmonary disease (copd).

the study would be a randomized, placebo-controlled trial of 60 hypertensive patients with documented copd greater than age 40.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of high blood pressure and chronic obstructive pulmonary disease (copd) exclusion criteria: * asthma; heart failur; * end stage kidney disease; * acute myocardial infarction,unstable angina, stroke or tia within the past year; * females who are pregnant, lactating or women of childbearing potential who are not using approved method of contraception.

Keywords: chronic obstructive pulmonary disease
study to evaluate the efficacy, safety and tolerability of photodynamic therapy(pdt) with chlorin-e6 in treating moderate to severe acne

Conditions: Acne; Photodynamic Therapy

Summary: this study aims to evaluate the clinical efficacy, safety and tolerability of a photodynamic therapy(pdt) based on a new photosensitizer, chlorin-e6, in the treatment of moderate to severe acne. the hypothesis is that the therapy has good efficacy, safety and tolerability.

the acne clinical guidelines all recommend pdt as an alternative therapy for moderate to severe acne based on the excellent performance of ala-pdt in the treatment of acne vulgaris. photosensitizers including porphyrin and chlorin have also proved to play a positive role in reducing the number of skin lesions and microbial load. researchers have successfully provided basic evidence that chlorin-e6 induces inflammation inhibition through ap-1, nf-κb, mapks and other pathways of propionibacterium acnes and increases collagen expression in hacat cells, which undoubtedly further indicates: as a new type of photosensitive material, chlorin-e6 derivatives have excellent performance in the face of moderate and severe acne with high levels of inflammation and high risk of scar.

Eligibility criteria:
inclusion criteria: 1. subject is male or non-pregnant female 18 years of age and younger than 50 years of age. 2. subject has moderate to severe facial acne vulgaris. 3. subject has provided written informed consent. exclusion criteria: 1. people who are taking photosensitive drugs; 2. allergic to any component of the photosensitizer; 3. porphyrins or allergies to porphyrins, with a history of photosensitivity; 4. pregnant or lactating women and those planning to become pregnant within 3 months; 5. oral or topical antibiotics, retinoids, glucocorticoids, peroxybenzoyl and other drugs within the past 1 month; 6. have a history of exposure to sunlight in the past 1 month, have received photoelectric treatment in the past 3 months, or have received facial grinding treatment in the past six months; 7. are using vasodilators (such as nitroglycerin, etc.), beta blockers (such as metoprolol, etc.), anticoagulants (such as warfarin, etc.) and other drugs that easily cause facial capillary dilatation; 8. patients with facial rosacea, atopic dermatitis, hormone-dependent dermatitis and other facial skin-related diseases; 9. abnormal blood and urine routine, liver and kidney function, diseases of important organs and hematopoietic system that researchers believe are not suitable for clinical trials; 10. patients participating in other clinical trials at the same time.
impact of the organization of the first responders in the remote areas on cardiac arrest victim survival

Conditions: Cardiac Arrest, Sudden

Summary: emergency medical services (ems) provide emergency care not only in the urban but also in the remote areas which could be up to 40 minutes from the ems station. thus, a cardiac arrest victim in those remote areas has a low likelihood to survive the cardiopulmonary resuscitation. therefore, we have organized first responders (who are mostly volunteer fire-fighters) in the remote areas and taught them how to perform basic life support (bls) with use of an automated external defibrillator (aed). in the case of a cardiac arrest the medical dispatcher activates simultaneously the ems and the first responders, who perform the bls with the use of an aed before the arrival of ems. the aim of the study is to analyze and compare the survival of the cardiac arrest victims in remote areas in the time period when the first responders were not organized yet compared to the time period when the first responders were activated to perform bls.


Eligibility criteria:
inclusion criteria: * cardiac arrest in adult victims exclusion criteria: * cardiac arrest in pediatric population

Keywords: cardiac arrest cardiopulmonary resuscitation automated external defibrillator first responders
management of obstetrical pain: " 7 days survey of obstetric analgesia/anesthesia in france"

Conditions: Birth

Summary: obstetric analgesia is a requirement of our times. the different applicable methods vary in effectiveness. the essential part is represented by epidural analgesia which remains one of the most effective methods. it is important to know other methods to respond to all requests. the applications of these methods, patient satisfaction and psychic experience, complications or incidents remain poorly or partially evaluated in france. the main objective is to describe the different techniques of anesthesia/analgesia actually used in france for the management of pain during vaginal deliveries and cesarean sections on a representative sample of all maternity hospitals at a given time(7 days per maternity hospital, 63 maternity hospitals (levels i,ii,iii), so about 2500 births). secondary objectives will be multiple : * describe the results of analgesic methods on the physical pain of patients during labor by a global visual analog scale * describe the feeling of pregnant women relative to the different anesthesic and analgesic techniques, by an analysis of the questionnaire responses * describe the frequency of adverse events of birth


Eligibility criteria:
inclusion criteria: * all patients hospitalized in a maternity hospital for delivery during the 7 days defined for the study will be included exclusion criteria: * patients under 18 years old * lack of understanding of the french language

Keywords: birth obstetric analgesia obstetric anesthesia
angiotensin converting enzyme (ace2), brain, gut dysbiosis in pulmonary hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary arterial hypertension (pah) is fatal with right heart failure due to raised pulmonary vascular pressure. gut dysbiosis was identified in animals with pulmonary hypertension. deidentified human samples will be tested for gut dysbiosis in pah, circulating bacterial metabolites and markers of inflammation and gut leakiness. the gut microbiome and circulating metabolites, markers of inflammation and gut leakiness of pah patients and healthy subjects will be compared in deidentified fecal samples and blood.

stool samples will be collected from people with no, mild-moderate or severe pulmonary arterial hypertension. bacterial dna will be extracted from the feces and sequenced by whole genome sequencing (shotgun sequencing). the dna sequences will be used to identify the bacteria present in the feces, and to model the functions of the gut microbial community in each of the three groups. this will test for gut dysbiosis in pulmonary arterial hypertensive patients compared to healthy subjects. gut dysbiosis is a condition where the gut bacterial communities are unbalanced and has been implicated in disease processes. in subjects recruited in the usa, blood samples will be tested for markers of gut leakiness and inflammation as well as gut bacterial metabolites found in the circulation.

Eligibility criteria:
inclusion criteria: * severe, mild-moderate or no pulmonary arterial hypertensive subjects exclusion criteria: * patients with pulmonary hypertension due to left heart disease, lung diseases and / or hypoxia, chronic thromboembolic pulmonary hypertension, and pulmonary hypertension with unclear multifactorial mechanisms.
icp versus intracranial compliance guided management in sah

Conditions: Subarachnoid Hemorrhage (SAH)

Summary: the purpose of this study is to determine whether treatment guided also by icp mean wave amplitude improves outcome compared to international standard care in patients with sah.

in this study sah-patients are randomized to treatment based on international standard care (icp/cpp guided therapy) or intracranial compliance (icp mean wave amplitude) guided therapy in addition to icp/cpp guided therapy. main outcome variables are survival and neurological outcome after 3 and 12 months.

Eligibility criteria:
inclusion criteria: * subarachnoid hemorrhage, acute * intracerebral pressure monitoring device inserted exclusion criteria: * no intracranial pressure monitoring * age \< 18 years

Keywords: subarachnoid hemorrhage intracranial hypertension intracranial pressure diagnostic techniques and procedures compliance treatment outcome intensive care, surgical
randomized clinical trial to assess the efficacy and safety of concomitant use of rifampicin and efavirenz 600 x 800mg

Conditions: Tuberculosis; HIV Infections

Summary: rifampicin is a potent inducer of the cyp450 and decrease the plasmatic concentration of nnrti and protease inhibitors. in our study we are going to compare the 600 an 800mg doses of efavirenz concomitant of rifampicin use to treat tuberculosis. the hypothesis is that the 800 mg dose would be more adequate than the 600mg

the study consist in a open label randomized clinical trial comparing efavirenz 600mg qid versus efavirenz 800mg qid in patients with tuberculosis (treated with regimens including rifampicin) and aids diagnosis. the total duration of the study is 6 months for each patient. all eligible patient will be treated with a fist line regimen for tuberculosis according to brazilian guidelines: rifampicin (600mg qid); isoniazid (400mg qid) e pyrazinamide (2g qid) during 6 months for a weight of 45 kg or more and adapted doses for persons with less than 45 kg. for patients with previous history of tb therapy etambutol 1.200mg qid will be added to the regimen. both groups will receive nucleoside reverse transcriptase inhibitors (nrti)and a non nucleoside transcriptase inhibitor (nnrti) to treat hiv. the itrn of first choice will be zidovudine and lamivudine association. patients presenting contra indication for the use of those drugs will receive others nrti. the nnrti is efavirenz (800 or 600mg). antiretrovirals will be initiated 30 days after stable tb therapy. in case of adverse events during tb therapy that lead to treatment interruption, the study drugs will be delayed until the 30th day after triple therapy for tb. during hiv therapy nrti can be changed in case of intolerance

Eligibility criteria:
inclusion criteria: * adults with tuberculosis diagnosis, hiv positive. * agreement to avoid not allowed drugs during the trial, agreement to participate in the study (informed consent) exclusion criteria: * active liver disease * pregnancy or breast feeding * cd4 counts \>350

Keywords: efavirenz tuberculosis aids rifampicin efficacy safety treatment naive
internet-delivered cbt for adolescents with obsessive-compulsive disorder - a pilot study

Conditions: Obsessive-Compulsive Disorder

Summary: the main goal of this trial is to study the feasibility and effectiveness of internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder.


Eligibility criteria:
inclusion criteria: * a primary diagnosis of ocd as defined by dsm-iv tr * a total score of above 15 on the cy-bocs * age between 12 and 17 years * ability to read and write swedish * daily access to the internet * a parent that is able to co-participate in the treatment * participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment * signed informed consent exclusion criteria: * diagnosed autism spectrum disorder, psychosis or bipolar disorder * suicidal ideation * ongoing substance dependence * subject not able to read or understand the basics of the icbt self-help material * completed cbt for ocd within last 12 months (defined as at least 5 sessions cbt including exposure and response prevention) * ongoing psychological treatment for ocd or another anxiety disorder

Keywords: cognitive behavior therapy pediatric obsessive-compulsive disorder internet-delivered cognitive behavior therapy
intravenous ketamine effects on functional neuroanatomy

Conditions: Depression

Summary: the purpose of this study is to investigate the neuroanatomical effects of ketamine treatment on patients with treatment-resistant depression. the investigators will compare the neuroimaging of patients several days before and after injection in order to assess the more durable changes induced by ketamine. in addition, changes in perfusion will be analyzed, in addition to changes in neurovascular coupling, and functional connectivity that are correlated with psychiatric measures.

the present study is designed as a prospective data analysis of patient response to the use of ketamine to treat treatment-resistant depression. for phase i trail, 10 patients of any gender with an age range of 18 to 70 who have undergone the outlined procedure will be recruited for inclusion. patients will be examined by the principle investigator. all patients must be diagnosed with persistent treatment-resistant depression and prescribed ketamine. patients will be accepted regardless of if the depression coincided with anxiety and/or pain. patient status will be assessed using the beck depression inventory, beck anxiety inventory, and brief pain inventory. patients must have a beck depression inventory score of 10 or above. these scores will be used as baseline data. patients will be offered the option of participating in the study and provided informed consent for neuroimaging before and after the ketamine treatment. a week before the scheduled ketamine treatment, the patients will have fmri scans, including structural t1, arterial spin labeling, and resting bold. the scans take around 30 minutes at no charge to the patients. the ketamine will be injected per the doctor's orders to achieve a dissociative state; dosages varies between 75mg - 1000mg depending on every individual's unique treatment plan. the same scans will be taken two days after treatment.

Eligibility criteria:
inclusion criteria: * in order for a subject to be considered for this study, the patient must have been diagnosed with treatment-resistant depression, meaning the patient failed three medications and has been suffering from moderate treatment-resistant depression for over 6 months, indicated by a beck depression inventory score of 10 or above. the patient must have been prescribed ketamine as part of their treatment plan, completely independent of any research. the patient must be willing to comply with the study protocol. exclusion criteria: * in order for a subject to be considered for this study, he/she may not have any of the following: * advanced stages of any terminal illness or any active cancer that requires chemotherapy * hepatic impairment * significant cytopenia * cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis * women who are pregnant, may become pregnant, or are breastfeeding * any counter indications to ketamine * subjects unable to give informed consent or in vulnerable categories, such as prisoners

Keywords: intravenous ketamine treatment-resistant depression
yoga as a therapy for traumatic experiences

Conditions: Post-Traumatic Stress Disorder

Summary: the purpose of the proposed research is to conduct a feasibility study of yoga as an adjunctive therapy for the treatment of posttraumatic stress disorder (ptsd) in 15 military personnel at the walter reed army medical center (wramc) in washington, dc. participants will complete 10 weeks of yoga training, in addition to the continuing their usual and customary care for ptsd at wramc. the style of yoga chosen for this study, yoga nidra, uses deep relaxation, deep breathing and meditation to systematically reduce physical, emotional, mental, and even subconscious tension. after a diagnostic mental health assessment at baseline, participants will attend a total of 18 classes taught over a 10-week period and will practice daily at home using a compact disk provided by the instructor. baseline measures will include the patient health questionnaire, pd-hat trauma questions, ptsd symptom scale - interview, fear of loss of vigilance scale, and expectation of efficacy. the primary outcome measure will be the ptsd checklist. changes in health status, locus of control, and pain will be assessed over the course of the study. an additional goal of this study is to gather preliminary data on the anticipated effect size and feasibility of conducting a larger clinical study of the adjunctive use of yoga for the treatment of ptsd symptoms in enlisted military personnel.


Eligibility criteria:
inclusion criteria: * active duty military personnel * aged 18 and over * a minimum score of 40 on the posttraumatic stress disorder checklist (pcl-m), a brief, self-report instrument used to assess ptsd severity. exclusion criteria: * active suicidal or homicidal ideation * severe cognitive impairment or history of cognitive disorder * serious surgical procedures within the last two months or planned * treatment for refractory pain * new or dose adjusted psychotropic medication (i.e. ssris and anxiolytics) in last month * unwilling or unable to practice yoga nidra at home * amputation of any body part

Keywords: post-traumatic stress disorder yoga nidra
safety and efficacy of aliskiren + hydrochlorothiazide (± amlodipine 5 mg) in patients with moderate hypertension

Conditions: Hypertension

Summary: this study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (hctz) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. there was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus hctz 25 mg.

title of study extension: an open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus hctz 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg

Eligibility criteria:
inclusion criteria for core study: - patients with mean sitting diastolic blood pressure ≥ 100 mmhg and \< 110 mmhg inclusion criteria for the extension: - mssbp ≥ 140 mm hg and/or msdbp ≥ 90 mm hg at visit 5 of the core study exclusion criteria for core study: * patients with mean diastolic blood pressure ≥ 110 mmhg or mean systolic blood pressure ≥ 180 mmhg * patients with prior stroke, hypertensive encephalopathy or heart attack * patients with type 1 diabetes mellitus * patients with type 2 diabetes mellitus with poor glucose control exclusion criteria for the extension: * premature discontinuation in the core study or failure to comply with the core study protocol * history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the smpc (particularly amlodipine 5 mg), e.g. severe hypotension, shock - including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis) * any patient that the investigator decides should not participate in the extension study for medical reasons other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: hypertension aliskiren cardiovascular diseases
a comparative study between anterior glenoid block with sub-omohyoid suprascapular block versus interscalene block in shoulder arthroscopy

Conditions: Shoulder Pain

Summary: the patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group a, b. group a: patients will receive anterior glenoid block combined with suprascapular nerve block. group b: patients will receive conventional interscalene block. in group a, the patient will be supine for anterior glenoid block. the suprascapular nerve will be identified as it branch off from the superior trunk and will be traced until it courses beneath the inferior belly of the omohyoid muscle. in group b, interscalene brachial plexus block will be performed. the primary outcomes will be as follows: (1) 11-point (0-10) numeric rating scale (nrs) pain score immediately before surgery starts and after surgery; (2) degree of preserved diaphragmatic function (dpdf): the ratio of postoperative to pre-block (baseline) diaphragmatic excursion amplitude will be assessed in the holding area using a curvilinear probe (sono site, transportable fuji m-turbo ultrasound system).;(3) degree of preserved handgrip strength (dphs): the ratio of postoperative to pre-block (baseline) handgrip strength (the maximal force patients exerted when instructed to squeeze the dynamometer handles as tightly as feasible). measurements will be done before surgery, immediately postoperative, 4, 8, and 24 hours postoperatively. and (4) recording of the complications which are: hematoma, nerve injury, allergy to any of the used drugs.


Eligibility criteria:
inclusion criteria: 1. patients american society of anesthesiologists' physical status (asa) i to ii. 2. aged 18 to 65 years. 3. both sexes. 4. patients scheduled for shoulder arthroscopy. exclusion criteria: 1. patient refusal 2. asa physical status iii or more. 3. patients with known allergy to any of the study drugs. 4. infection at the site of injection. 5. patients with history of cardiovascular disease. 6. patients with renal disease. 7. patients with hepatic disease. 8. patients with neuromuscular disease. 9. presence of any coagulopathy. 10. chronic opioid, gabapentin or pregabalin use. 11. patients with history of any psychiatric disorder.