Kornimate/medical-research-clean huggingface dataset:
efficacy of artemisinin combination therapies for the treatment of uncomplicated p. vivax in pregnancy in brazil (paact-pv)

Conditions: Plasmodium Vivax Malaria

Summary: the current treatment recommendations for p. vivax in pregnant and non-pregnant individuals are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent relapse. as primaquine can not be used in pregnant women, these women remain at risk of relapse. as there is increasing concern about chloroquine resistant p. vivax in this region, there is a need to identify alternative treatment options. the artemisinin combination therapies are recommended for use against p. falciparum infections in pregnant women after the 1st trimester; additional data are needed to support the use of these drugs against p. vivax.


Eligibility criteria:
inclusion criteria: * gestational age \>16 weeks (determined by lmp and fundal height)- if there is discordance between the two, the more conservative estimate (i.e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus * normal fetal heart beat detected by doppler * presence of asexual p. vivax parasitemia ≤ 50,000 parasites/microliter (thick smear) * willing to sign or thumb print informed consent * willing to return for scheduled follow up visits for treatment and observation until delivery * willing to deliver in health facility exclusion criteria: * pregnancy \< 16 weeks * microscopically confirmed p. falciparum or mixed infection/ parasitemia (p. vivax and another species of plasmodium, i.e. p. vivax, p. ovale, or p. malariae) * history of allergy or hypersensitivity to interventional drugs * exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including al and ma) * patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin) * history or family history of epilepsy or psychiatric disorder * presence of signs and symptoms of severe malaria, severe illness, or danger signs * hemoglobin \< 7 g/dl * inability to tolerate oral medication (repeated vomiting, impairment of consciousness). * history of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, hiv/ aids, known hemoglobinopathy * participant's inability to return for follow up visits * age \<15 years

Keywords: plasmodium vivax malaria pregnancy brazil treatment
comparing t-stenting and minimal protrusion with external minicrush for treatment of complex coronary bifurcation

Conditions: Coronary Artery Disease; Ischemic Heart Disease; Chronic Coronary Syndrome; Acute Coronary Syndrome

Summary: nowadays, no studies compare the t-stenting and minimal protrusion (tap) and external minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

1. according to definition criteria, pci of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization (tvr) compared to provisional stenting 2. the double-kissing crush stenting (dk-crush) has been tested with the culotte and the classic crush techniques in the unprotected left main disease (ulmd) and in no-ulmd setting, respectively, showing better clinical outcomes. 3. however, due to its technical complexity and simultaneous improvement of the classic crush technique evolving in the external minicrush, it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation 4. the dk-crush technique has never been tested with the external minicrush, leaving the operators to choose one or the other according to their experience and preferences. 5. the t-stenting and minimal protrusion (tap) is a two-stent technique described to treat coronary bifurcation after provisional treating. compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting. 6. nowadays, no studies compare thetap and the external minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown. 7. the issue's importance is highlighted by higher rates of stent thrombosis (st) and in-stent restenosis (isr) of the two stent techniques compared to provisional stenting in treating coronary bifurcation8. 8. consequently, investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-pci tlr.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age * patients with an indication for pci, including chronic coronary syndrome and acute coronary syndromes (stemi, nstemi, unstable angina) * patients with at least one true coronary bifurcation according to the medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1 exclusion criteria: * patients who do not want or cannot sign the informed consent for the procedure. * patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe. * patients with a life expectancy of \<1 year. * patients with planned major surgery require prolonged discontinuation of antiplatelet therapy. * pregnant women. * patients who cannot take antiplatelet therapy for any reason.

Keywords: percutaneous coronary intervention (pci) coronary artery disease (cad) coronary bifurcation lesion (cbl)
korean post-marketing surveillance for sprycel®

Conditions: Leukemia, Myelomonocytic, Chronic; Leukemia-Lymphoma

Summary: the purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of sprycel® so that the regulatory authority can manage the marketing approval properly.


Eligibility criteria:
inclusion criteria: * newly diagnosed with philadelphia chromosome-positive (ph+) chronic myeloid leukemia (cml) in chronic phase * adults with chronic, accelerated, or myeloid or lymphoid blast phase ph+ cml with resistance or intolerance to prior therapy including imatinib * adults with philadelphia chromosome-positive acute lymphoblastic leukemia (ph+all) with resistance or intolerance to prior therapy exclusion criteria: * according to warning/caution in local label
atelectasis formation: role of positive pressure breathing, hyperoxia, and hypobaria

Conditions: Pulmonary Atelectasis

Summary: the primary aim of this project is to get further knowledge of the physiology of flight atelectasis and its prevention. we seek to: 1) assess whether low levels of positive pressure breathing can prevent atelectasis formation in humans during exposure to hyperoxia and +gz-accelerations. 2) get further knowledge on the effects of hypobaria on regional ventilation and perfusion. a secondary aim is to evaluate the effect of anti g-trouser inflation on ventilation and regional perfusion.

the effect of positive pressure breathing on lung function is being studied, when applied during exposure to hyperoxia and +gz-accelerations. focus is on lung tissue compression, ventilation and regional perfusion. in addition, the influence of hypobaria on these parameters is assessed. this study is conducted in accordance with the amended declaration of helsinki. the ethics committee ile-de-france iii (ref. 3274) and the french national agency for drug safety ansm have approved the protocol (ref. id rcb 2015-a00485-44 and ansm 151046b-32). primary aim, item 1: experiments are conducted in a human centrifuge. the protocol mimics a routine peacetime flight in combat aircraft, and includes 1hr05 min at +1gz followed by 10-min exposure to +1.4 to +3.5gz . subjects are exposed three times to this sequence, breathing at positive pressure levels of 0, 5 or 10 hpa. two groups of sixteen healthy male non-smoking volunteers, wearing anti-g trousers, are studied and compared: group 1 breathes air, group 2 100% o2. primary aim, item 2: experiments are conducted in a hypobaric chamber. sixteen healthy male non-smoking volunteers are exposed to four conditions: 0 or 15,000 ft altitude, breathing air or 100%o2. protocol duration is 1h15min. positive breathing pressure can be applied depending on the results of the experiments of item 1. secondary aim: experiments are conducted in a human centrifuge. sixteen healthy male non-smoking volunteers are exposed to four conditions: uninflated or inflated anti-g trousers (175 hpa), +1 or +3.5 gz for 3 min.

Eligibility criteria:
inclusion criteria: * normal lung function checked by pulmonary function tests. * normal ecg * normal clinical examination aim 1 exclusion criteria: * smoking * myopia * past medical history of heart or lung disease * current medical treatment for heart or lung disease * past medical history of back pain or spine trauma or disease * otitis * bad tolerance to +gz accelerations (g-induced loss of consciousness, motion sickness) * claustrophobia in the centrifuge gondola aim 2 exclusion criteria: * smoking * past medical history of heart or lung disease * current medical treatment for heart or lung disease * otitis * bad tolerance to the altitude chamber (15,000 ft): ear pain, claustrophobia

Keywords: pulmonary ultrasound hypergravity human physiology oxygen lung ventilation lung perfusion computed tomography electrical impedance tomography altitude chamber
detection of plasma circulating tumor dna in gastric cancer

Conditions: Circulating Tumor DNA (ctDNA); Gastric Cancer

Summary: the aim of this study is to develop a protocol for detection of circulating tumor dna (ctdna) in plasma of patients with early stages of gastric cancer.

gastric cancer (gc) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. earlier detection of gc can dramatically increases the five-year survival rate up to \> 90%. the current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. additionally, most of serum-based biomarkers such as carcinoembryonic antigen (cea), carbohydrate antigen 19-9 (ca19-9), carbohydrate antigen 72-4 (ca72-4), and carbohydrate antigen 125 (ca125) are not recommended for detection of gc due to the limit of specificity and sensitivity in the early stages of gc. thus, it is essential to identify new biomarkers for diagnosis of early stages of gc. in this study, the investigators develop an ultradeep massive parallel sequencing (mps) assay to detect tumor derived mutations (tdm) in plasma of early stages of gc. this study provides proof-of-principle for eventual clinical employment of circulating dna, via liquid biopsy, for detection of early stages of gc.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18 years and older 2. histologically proven stage (i, ii and iiia) gastric adenocarcinoma 3. naivety to treatment. 4. no known other concomitant cancer diagnosis 5. signed informed consent exclusion criteria: 1. pathologically late stage (stage iiib and iv) or metastatic gastric adenocarcinoma 2. underwent any type of treatment 3. unable to undergo biopsy
percutaneous recanalization in ischemic stroke management in europe observational registry

Conditions: Ischemic Stroke

Summary: to determine the revascularization rate, clinical efficacy and safety of the ce-marked mindframe system in ischemic stroke patients

to determine the revascularization rate, clinical efficacy and safety in a "real-world setting" of the ce-marked mindframe system in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. target vessels include the basilar, internal carotid and middle cerebral (m1 and m2 segments) arteries.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy exclusion criteria: * intracranial hemorrhage

Keywords: stroke ischemic stroke revascularization mechanical thrombectomy neurothrombectomy
enhance - evaluating the implementation of head and neck cancer e-health

Conditions: Head and Neck Neoplasms

Summary: the nhs long term plan has an ambition to provide patients with digital services and tools to give them more control over their own health and care. guy's cancer centre in london (uk) is offering patients with head and neck cancer (hnc) the use of a smartphone cancer support app. few studies have evaluated the best way to implement apps to support patients with cancer, nor explored how they could help patients to self-manage. this is a hybrid implementation-effectiveness study to evaluate the implementation of a cancer-specific self-management app currently being used at guy's cancer centre. the purpose of the study is to assess the following: (1) key implementation outcomes, including acceptability and usability; (2) barriers and facilitators to patients and staff using the app; (3) the effectiveness of the app to support patients to self-manage during treatment for hnc. eligible participants include patients being treated for hnc, and their oncology clinical team. the study will be conducted at guy's cancer centre, a comprehensive cancer centre in london, uk. the study will employ mixed methods. data collection will involve questionnaires to measure the acceptability and usability of the app, and routinely collected patient-reported outcome measures. in addition, a sub-sample of participants will take part in semi-structured interviews to explore how the app was used and views about the implementation process. findings from this study will identify barriers and facilitators to using the app and context about how it may help patients to self-manage their condition. these findings will help to refine ongoing development of digital cancer services. findings will inform the development of recommendations for the integration of digital health in cancer services that can be shared with cancer alliances across the uk.


Eligibility criteria:
inclusion criteria: * individuals currently undergoing treatment for head and neck cancer, under the care of an oncologist, or * health professionals involved in the care of patients using the app, or involved in the implementation of the app exclusion criteria: * individuals who are not able to speak or understand english, due to no translation services available * patients with ecog performance status scale level 3 or 4 at baseline

Keywords: implementation digital health ehealth self-management cancer support apps
comparative evaluation of quadratus lumborum and transverses abdominis plane block for postoperative pain relief in lower abdominal surgeries

Conditions: Pain Relief to the Patient Following Abdominal Surgeries

Summary: two ultrasound guided techniques to give postoperative pain relief to the patients following abdominal surgeries would be compared using scoring systems for pain relief and scientific methods. while one technique is routinely used, other i.e quadratus lumborum has been recently described and relies on posterior deposition of the drug. both the techniques are safe and ultrasound imaging is to be used for guidance.


Eligibility criteria:
inclusion criteria: * patients undergoing lower abdominal surgery 18-60 yrs of age exclusion criteria: * none
"validation and reability of the munich shoulder questionnaire into turkish patients"

Conditions: Shoulder Impingement; Shoulder Pain; Shoulder Injury

Summary: the purpose of this study was to translate and culturally adapt the msq to turkish language and test the validity and reliability of turkish version of msq in shoulder dysfunction patients. and also, the ultimate goal was to facilitate international researches in shoulder problems as well as to serve the physicians for their clinical practice.

munich shoulder questionnaire (msq) is an innovative tool for self-assessment of shoulder function. it was especially designed for an effective follow-up of shoulder patients which were also allowing for a quantitative assessment of the constant, shoulder pain and disability index (spadi) and dash score consisting of a 30-items questionnaire. it based on subjective and objective parameters of shoulder function. standart questionnaire enable to follow patients on a close and regular base with manageable effort for both the disability and the patients.an optimal instrument for outcome measurement of shoulder problems should meet the following requirments: a) the instrument should be a self-assmment patient reporting tool, b) the questions must be easily comprensible, c) filling in should be finished less than 30 minutes, d) the results should provide calculation of several well established scoring system. msq can be completed at home and typical functional abilities about evaluation are explained with pictures so these can make it easy. as a result, we choose to translate the msq into turkish as it is less costly, practical and time consuming than developing a new tool. in addition, objective (normal joint movement and muscle strength) and subjective (pain, daily life activity, sport and leisure time activities) parameters in a single form to create the advantage in terms of ease of use and time. with these properties, msq may be preferred during follow-up of the results of conservative and / or surgical treatment.

Eligibility criteria:
inclusion criteria: * being between 18-65 years old, * having unilateral or bilateral shoulder dysfunction, * ability to read and complete the self-assessment questionnaires exclusion criteria: * have neurological, psychological and cardiovasculer diseases or injuries

Keywords: cultural adaptation validation responsibility shoulder
muscle pressure estimation with artificial intelligence during mechanical ventilation

Conditions: Respiratory Failure

Summary: the goal of this diagnostic study is to validate estimation of inspiratory muscle pressure by an artificial intelligence algorithm compared to the gold standard, the measure from an esophageal catheter balloon, in patients under assisted mechanical ventilation. the main questions it aims to answer are: • are inspiratory muscle pressure estimates from an artificial intelligence algorithm accurate when compared to the direct measure from an esophageal balloon? participants will be monitored with an esophageal balloon and with an artificial intelligence algorithm simultaneously, with inspiratory muscle pressure estimation during assisted mechanical ventilation with decremental levels of pressure support.

this is a diagnostic study to validate estimation of inspiratory muscle pressure during assisted ventilation from an artificial intelligence algorithm integrated in a mechanical ventilator (fleximag, magnamed, brazil) compared to direct measure of muscle pressure from esophageal catheter balloon (gold standard). this is a novel non-invasive method to estimate inspiratory muscle pressure. after obtaining informed consent, participants will be monitored simultaneously with the esophageal balloon and the artificial intelligence algorithm, with decremental levels of pressure support (20 to 2 cmh2o, in steps of 20 minutes). esophageal balloon will be removed after completing the last pressure support step. the investigators estimated a sample of 50 participants, considering 3 cmh2o as a clinically relevant discordance between methods and 10% of missing data. concordance analysis and correlation analysis will be performed. procedures will follow a specific standard operating procedures and participants inclusion data will be inserted in redcap.

Eligibility criteria:
inclusion criteria: * patients under assisted or assist-control mechanical ventilation exclusion criteria: * contraindication to esophageal catheter insertion (esophageal cancer or bleeding, esophageal fistula, skull base fracture, uncontrolled coagulopathies) * contraindication to transient neuromuscular blockade * bronchopleural fistula (persistent air leak) * hemodynamic instability (norepinephrine \> 1mcg/kg/min) * gestation * current sinus infection * refusal from patient's family of attending physician * palliative care

Keywords: mechanical ventilation artificial intelligence
skin sensitization test (modified draize-95 test)

Conditions: Skin Sensitisation

Summary: skin sensitization test (modified draize-95) to support a low dermatitis potential claim for a blue non sterile powder free nitrile examination gloves. to evaluate whether residual chemical additives at a level that may induce type iv allergy in the unsensitized general user population are present in a finished rubber containing medical device.

1. to evaluate whether residual chemical additives at a level that may induce type iv allergy in the unsensitized general user population are present in a finished rubber containing medical device. 2. to meet requirements for claim: this product demonstrated reduced potential for sensitizing users to chemical additives as described in guidance for industry and fda staff - medical glove guidance manual9. supporting test data: a negative skin sensitization test (modified draize-95 test) on a minimum of 200 non-sensitized human subjects.

Eligibility criteria:
inclusion criteria: * subjects must be aged 18 and 65 years, inclusive; * subjects who have not participated in other voluntary testing for at least 30 days; * subjects must be capable of understanding and following directions. * female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the tiral. exclusion criteria: * subjects who are in ill health; * subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the tiral; * subjects who have used topical or systemic corticosteriods, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiationor during their participation on this tiral; * femable subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactaticn during the tiral; * subjects who have a history of adverse reactions to cosmetics, otc drugs, or other personal care products; * subjects who introduce the use of any new cosmetic, toiletry or personal care products during the trial; * subjects with any visible skin disease that might be confuesd with skin reactions caused by the test material; * subjects with any knowledge or indication of existing type iv allergy (delayed hypersensitivity) to natural rubber chemical additives; * subjects with a history of frequent irritation; or * subjects who have received endogenious or exogenious immunosuppressive treatment (r prolonged exposure to sun).