Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness study of pre-operative artesunate in stage ii/iii colorectal cancer (neoart-v)

Conditions: Colorectal Cancer

Summary: this is a phase ii randomized, double-blind, placebo-controlled trial of neoadjuvant artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed stage ii/iii colorectal cancer (crc) awaiting surgical treatment with curative intent.

colorectal cancer (crc) is the third most common cancer worldwide and represents a significant health care burden with an incidence of one million new cases per year. in vietnam, colorectal cancer is the third most common cause of cancer deaths in men and fourth in women. artesunate is a safe and effective antimalarial with evidence of anticancer properties across a range of cancer cell lines. results from a pilot feasibility study in colorectal cancer patients in the uk showed that artesunate was safe and well tolerated. these findings provided the basis for a phase ii clinical trial investigating the effects of neoadjuvant artesunate on progression free survival and overall survival in stage ii/iii colorectal cancer in vietnamese patients. artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed stage ii/iii colorectal cancer (crc) awaiting surgical treatment with curative intent.

Eligibility criteria:
inclusion criteria: * aged 18 or over * histologically proven single primary site colorectal adenocarcinoma * stage ii/iii colorectal cancer planned for surgical resection and no clinical indication for neoadjuvant preoperative chemotherapy/chemoradiation therapy * who performance status 0,1 or 2 * adequate full blood count: white cell count (wcc) \>3.0 x 109 /l; platelets \>100 x 109/l; haemoglobin (hb) \>8g/dl * adequate renal function : glomerular filtration rate \>30ml/min by cockcroft-gault formula * adequate hepatobiliary function : bilirubin \< 3 x upper limit normal * female participants of child bearing potential must have a negative pregnancy test \< 72 hours prior to initiating study intervention and agree to avoid pregnancy using contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention * male participants with a partner of childbearing potential must agree to use contraceptive precautions during and for up to 6 weeks after the last dose of the study treatment intervention * patient able and willing to provide written, informed consent for the study exclusion criteria: * contraindication to the use of artesunate due to hypersensitivity * pregnancy or lactation * history of immunosuppression * history of hearing or balance problems * weight \ 110 kg * other planned intervention, apart from vietnamese standard of care * any other malignant disease diagnosis within the preceding 2 years with the exception of non-melanomatous skin cancer and carcinoma in situ * lactose intolerance
proof of concept study to evaluate safety and efficacy of lme636 in the treatment of acute anterior uveitis

Conditions: Acute Anterior Uveitis

Summary: the purpose of the study is to determine whether topical ocular administration of lme636 60 mg/ml is efficacious in resolving the ocular inflammation in the anterior chamber (ac) associated with acute anterior uveitis (aau).

eligible subjects will be randomized to lme636 or dexamethasone in a 3:1 ratio at the time they present to the trial site with the aau flare and will enter treatment for 28 full days. subjects with worsening disease from visit 2/day 4 onward or subjects without improvement after 14 days of treatment will be discontinued from treatment, unmasked and treated with a rescue regimen at the discretion of the investigator.

Eligibility criteria:
inclusion criteria: * provide written informed consent. * diagnosis of non-infectious aau in at least 1 eye. * anterior chamber cell score of 2+ or 3+ as per standardization of uveitis nomenclature (sun) in at least one eye. * able to communicate well with the investigator, to understand and comply with the requirements of the study. * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol. * ac cell score of 4+ (sun) or hypopyon. * onset of anterior uveitis more than 2 weeks prior to enrollment in the study. * presence of intermediate-, posterior-, or panuveitis in either eye. * administration of stable doses \>10 mg daily systemic prednisone or corticosteroids as described in the protocol. * recurrent corneal abrasion or ulceration in either eye (past or present). * tuberculosis (past or present). * other protocol-specified exclusion criteria may apply.

Keywords: acute anterior uveitis lme636
a community-health worker delivered hiv/sti prevention intervention for internally displaced women in leogane, haiti

Conditions: Risk Reduction Behavior; Interpersonal Relations; Mental Disorders

Summary: the investigators will develop, deliver and evaluate a solar powered tablet-based individual and group focused hiv/sti prevention intervention with internally displaced women in leogane, haiti. internally displaced women will be trained as community health workers to deliver the hiv/sti prevention intervention to other internally displaced women.

we will develop and field test a multi-component intervention that includes (1) solar-powered tablets with brief video-based educational messages and (2) 6 weekly peer-group sessions. the tablet will be programmed to analyze the data and to indicate incorrect hiv knowledge responses so the community health worker can immediately provide correct responses. this intervention involves 6 weekly women's health meetings that will cover a variety of issues pertinent to women's sexual health: hiv/aids, sexually transmitted infections, interpersonal relationships, communication and decision making, mental health and coping, creating social change.

Eligibility criteria:
inclusion criteria: * 18 and over * capable of providing informed consent * internally displaced (living in tent or camp) * female exclusion criteria: * male * under 18 years old * not able to provide informed consent

Keywords: hiv prevention sexually transmitted infection prevention hiv knowledge relationship power depression coping social support internally displaced persons community health worker hiv/sti educational video substance use women's health
face-to-face versus distance learning of basic suturing skills

Conditions: Educational Problems

Summary: the main objective of this study is to determine the acceptability and effectiveness of distance learning (dl) of basic suturing skills in novice learners. a prospective randomized controlled trial involving 118 pre-medical and medical students with no previous experience in suturing was conducted. participants were randomized into two groups for learning simple interrupted suturing: f-f and dl groups (59 students in each group) . evaluation was conducted by two independent assessors. agreement between the assessors was calculated, and performance scores of the participants were compared between the two groups. all the participants demonstrated their ability to place three interrupted sutures, with no significant difference in the performance between the two groups. all the respondents positively rated the teaching sessions, found them useful and enjoyable. distance learning of basic suturing is as effective as the face-to-face approach in novice learners

at our hospital, during the initial lock-down period in march and april 2020, all medical students' clinical clerkships were temporarily cancelled, and their educational activities switched to web-based remote learning, utilizing teleconferencing and commercially available web-based interactive clinical modules. teaching surgical technical skills, such as basic suturing, presented itself as a more challenging component of the clinical education under these unusual circumstances as compared to teaching cognitive skills and knowledge, which raised questions and concerns around the effectiveness and acceptability of distance learning of basic surgical skills. in this study, the investigators aimed to compare the effectiveness and retention of distance learning to the traditional face-to-face learning of basic (simple interrupted) suturing in novice learners. this study entails a prospective randomized trial involving two arms (traditional face-to-face versus distance learning of basic simple interrupted suturing) in pre-medical students as well as first and second year medical students at the american university of beirut (aub). immediately after the teaching session as part of research, two independent surgeons assessed the students' simple interrupted suturing performance using a validated checklist and osats global rating. the difference in performance was used to determine the effectiveness of distance learning of basic suturing as compared to the traditional instructional method. in addition, the students in both groups were asked to complete a questionnaire (immediately after the teaching session) to investigate their satisfaction and confidence.

Eligibility criteria:
inclusion criteria: * pre-medical, first, and second-year medical students with no previous experience in suturing. exclusion criteria: * previous experience in suturing.refusal of enrolment.

Keywords: medical education suturing skills face-to-face learning distance learning pandemic
protective effect of thymosin α1 against negative immune dysregulation and organ dysfunction after acute aortic dissection surgery (panda ii)

Conditions: Acute Aortic Syndrome; Aortic Dissection Type a

Summary: systemic inflammatory response syndrome (sirs) and multiple organ dysfunction syndrome (mods) are the major causes of death in patients with acute aortic syndrome (aas). therefore, the prevention of sirs and mods is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. this study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of aas will result in a reduced incidence of sirs and mods.


Eligibility criteria:
inclusion criteria: * the patients are conformed to 2010 acc/aha guidelines for the diagnosis and treatment of thoracic aortic disease (tad) within two weeks of onset; * patients with acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled. * the patients' age between 18 \~90 years old. * agree to participate in the study and sign the informed consent. exclusion criteria: * patients allergic to thymosin α1; * lactating women and pregnant women; * patients with mental diseases, drug and alcohol dependence; * refuse to participate in this study and refuse to sign the informed consent.
clinical evaluation of genetron tert/braf pcr kit in thyroid cancer patients

Conditions: Thyroid Cancer

Summary: the purpose of this trail is to evaluate the performance of genetron tert/braf pcr kit in thyriod cancer patients using real-time pcr method.

this trial follows the principle of synchronous blinding. the enrolled cases are coded, and the enrolled samples are detected with genetron tert/braf pcr kit and sanger sequencing method. the results were determined independently according to the cutoff values or interpretation requirements provided by each method. the safety and effectiveness of this kit are confirmed and evaluated.

Eligibility criteria:
inclusion criteria: 1. patients with clinical diagnosis of suspected thyroid cancer who underwent fine-needle aspiration (fna) 2. the sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc. 3. subjects who can provide a complete fna sample 4. subjects who agree to provide follow-up diagnosis and treatment information exclusion criteria: 1. the investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps. 2. samples with incomplete information required. 3. the amount of dna extracted is not enough to complete the samples tested by the assessment reagent or comparative method.
promus™ element™ everolimus-eluting coronary stent system european post-approval surveillance study

Conditions: Coronary Heart Disease

Summary: the goal of the promus™ element™ everolimus-eluting coronary stent system european post- approval surveillance study is to evaluate real world clinical outcomes data for the promus™ element™ coronary stent system in unselected patients in routine clinical practice.


Eligibility criteria:
inclusion criteria: * according to instructions for use exclusion criteria: * contraindications according to instructions for use

Keywords: coronary stenting drug-eluting stent post-market surveillance study promus element stent
a comparison of valdecoxib 20 mg twice daily and 40 mg daily and placebo in the treatment of sore throat

Conditions: Pharyngitis

Summary: the study was performed to evaluate the analgesic efficacy, safety, and tolerability of valdecoxib 20 mg twice daily (bid), valdecoxib 40 mg once daily (qd), and placebo in patients with moderately to severely painful symptomatic sore throat over a 24-hour period. in addition, the study was to validate a new scale and criteria for measuring pain in sore throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore throat pain on pain score and efficacy of analgesics. the study also examined what type of medications are commonly used for sore throat and whether this information has relevance to analgesic efficacy.


Eligibility criteria:
inclusion criteria: * included patients had moderate to severe pain, as measured by the sore throat pain intensity scale (stpis) on swallowing ≥66 mm on a 100-mm visual analogue scale (vas) and a minimum of 4 points on the 10-point tonsillo-pharyngitis score (tps) but who were not coughing or experiencing any evidence of mouth-breathing. exclusion criteria: * patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to nsaids, cox-2 specific inhibitors, sulfonamides, or acetaminophen were excluded.

Keywords: pharyngitis, sore throat
serplulimab combined with chemotherapy for early-stage hr+/her2- breast cancer

Conditions: HR+/HER2- Breast Cancer

Summary: the neoadjuvant treatment options commonly used for hr+/her2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice. the aim of this study was to explore the efficacy and safety of the serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of hr+/her2- breast cancer


Eligibility criteria:
inclusion criteria: 1. age\>=18 years old 2. ct2 - ct4d, or ct1c with axillary lymph node metastasis confirmed clinically and pathologically； 3. pathologically proven hr+/her2- breast cancer: defined as: * positive for er or pr (ihc nuclear staining \>1%) * her-2 negative (ihc 0, 1+ without fish, or ihc 2+ with no amplification by fish)； 4. has clinically measurable lesions:measurable lesions on ultrasound, mammography, or mr (optional) within 1 month before randomization； 5. organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy； 6. cardiac ultrasound ef value ≧55%； 7. females of childbearing age, with a negative serum pregnancy test 14 days before randomization; 8. ecog score≤1 point; 9. sign informed consent； exclusion criteria: 1. the patient has evidence of metastatic breast cancer； 2. for this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received; 3. the patient has a second primary malignancy other than adequately treated skin cancer; 4. the patient has been treated with anti-programmed cell death protein 1 (anti-pd-1), anti-programmed death ligand 1 (anti-pd-l1) or anti-pd-l2 drugs, or other immunotherapy； 5. the patient has been diagnosed with immunodeficiency disease or autoimmune disease; 6. the patient has severe lung or heart disease; 7. the patient has active hepatitis b and c; 8. the patient has a history of organ transplantation or bone marrow transplantation; 9. pregnant or breastfeeding women; 10. the investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
patient- and caregiver-reported symptoms and outcomes with levodopa/carbidopa intestinal gel for the treatment of advanced parkinson's disease

Conditions: Parkinson's Disease

Summary: patient reported outcomes (pro) have become an important endpoint assessed in clinical trials. it is important to understand the relationship between medication and patients' symptomatology, quality of life and well-being. we predict levodopa/carbidopa intestinal gel (lcig; duodopa) will significantly improve quality of life and emotional well-being compared to baseline in patients with advance parkinson disease (apd) not well controlled with conventional treatment.


Eligibility criteria:
inclusion criteria: * patients with advanced levodopa-responsive parkinson's disease, with at least, 2 hours "off" time or 2 hours of dyskinesia based on clinician's/investigator's medical judgment * patients with advanced parkinson's disease with severe motor fluctuations and dyskinesia when combination of conventional pd treatments was unable to satisfactory control symptoms. * patients with advanced parkinson's disease who meet the criteria for use of levodopa/carbidopa intestinal gel (lcig) established in the summary of product characteristics, spanish neurology society (sen) guidelines, local/regional directories (ccaa) or site's protocols for use of lcig in common clinical practice. * the decision to treat with lcig is made by the physician prior to any decision to approach the patient to participate in this study. * patients with a cognitive level enough to complete the questionnaires, confirmed by a mini-mental state examination (mmse) score of at least 26 points, according to the recommendation of the movement disorder society (mds) task force on dementia in parkinson's disease (pd) exclusion criteria: * lcig's contraindications included in the summary of product characteristics (product label)

Keywords: duodopa advanced parkinson's disease levodopa/carbidopa intestinal gel
acute health effects of low temperature exposure

Conditions: Cardiovascular System; Respiratory System; Cognitive Function

Summary: this is a randomized controlled human exposure crossover study. investigators aims to assess the acute effects of low temperature exposure and the underlying mechanisms.

the investigators will conduct a randomized controlled human exposure crossover study among about 50 healthy young adults in shanghai, china. each subject will be exposed twice: once to the low temperature (16#) and once to the moderate temperature (22#) in a chamber for about 2-2.5 hours. during the exposure session, each subject will be requested to rest. health examinations will be conducted immediately prior to exposure (within 1 hour before the exposure session), during the period of exposure, and after exposure (within 2 hours after the exposure session). health examinations include spirometry, holter monitoring, blood pressure tests, cognitive function tests, symptom questionnaires, and magnetic resonance imaging. investigators plan to collect blood, urine, exhaled breath condensate, and oropharyngeal swabs samples.

Eligibility criteria:
inclusion criteria: * living in shanghai during the study period; * body mass index \> 18.5 and ≤ 28; * right-handed; * receiving or having received higher education; * with the ability to read and understand chinese smoothly. exclusion criteria: * smoking and alcohol abuse; * current drug and dietary supplements intake; * subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy; * subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension; * subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease; * subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease; * subjects who have a history of major surgery due to cardiovascular, cerebrovascular, respiratory, or neurological diseases; * subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia; * abnormal spirometry (fev1 and fvc ≤ 75% of predicted and fev1/fvc ≤ 0.65); * subjects with color vision disabilities.

Keywords: low temperature randomized controlled trial cardiopulmonary effects cognitive function
performance of 18f-fluorodeoxyglucose positron emission tomography (fdg-pet) in the diagnosis of indeterminate adrenal tumors on conventional imaging: a french prospective multicentric study

Conditions: Adrenal Tumors

Summary: this is a prospective study which aims to validate a new diagnostic approach in the tissue characterization of adrenal tumors indeterminate on conventional imaging. for this purpose, it is not necessary to have a control group since the diagnostic accuracy in a well defined subset of patients. visit 0 : enrollment, eligibility. visit 1 : fdg-pet. visit 2 : postoperative visit. visit 3 : 6 months post-pet. visit 4 : 12 months post-pet.

primary objective the primary objective is to assess the diagnostic accuracy of fdg-pet, particularly the suvmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging. secondary objectives * to assess the diagnostic accuracy of the tumor suvmax, and suvmax of the tumor/mean suv of the liver. * to evaluate the relationship between suvmax tumor/liver ratio and weiss score. * to evaluate the impact of the use of fdg-pet on the treatment options. * to evaluate the economic impact of fdg-pet in the management of indeterminate adrenal tumors (ancillary study).

Eligibility criteria:
inclusion criteria: * adult ≥ 18 yrs, male or female; * indeterminate adrenal tumor (6.3.1.). the ct must include the calculation of sd and contrast washout and should have been performed within the 30 days before the inclusion visit (visit 0) ; * patient insured with public health care system ; * patient who accept to participate to the study and to sign the consent document form. exclusion criteria: * technical inability to perform fdg-pet. * patient's death before final diagnosis.