Kornimate/medical-research-clean huggingface dataset:
effectiveness of using interactive consulting system to enhance informed choice

Conditions: Age-related Cataract

Summary: to compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. the chatbot was built based on large language models, and could generate medical expert-level responses.

cataract surgery is the only way to treat age-related cataract. for patients at early or moderate stages, cataract surgery is an elective surgery without objective indications. therefore the patients are uaually not aware whether they should receive the surgery. the number of trained and qualified ophthalmologists are limited in china and lots of patients cannot have detailed consultation with ophthalmologists. as a result, many patients still have doubts about whether they should receive cataract surgery or not. in this study, we aim to assess the effectiveness of an interactive chatbot based on large language models versus senior ophthalmologists to enhance informed decisions made by cataract patients.

Eligibility criteria:
inclusion criteria: 1. individuals aged 45-80 years who have been resident in the selected study district for more than six months; 2. a definite diagnosis of age-related cataract; 3. having not received cataract surgery; 4. willing to participate the study and provide informed consent. exclusion criteria: 1. bilateral blindness (presenting distance visual acuity worse than 3/60); 2. having ocular, hearing or mental disorders precluding reading or telephone interview; 3. ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery; 4. having cataract surgery contraindication.
rapid benzodiazepine detoxification using flumazenil - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to verify the hypothesis that the benzodiazepine antagonist, flumazenil, will reduce acute benzodiazepine withdrawal.


Eligibility criteria:
please contact site for information.

Keywords: substance-related disorders
long-term safety and efficacy extension trial of bimatoprost sr

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: this study will evaluate the long-term safety and efficacy of bimatoprost sustained release (sr) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 phase 3 bimatoprost sr studies (192024-091, -092, -093, or -095) and received bimatoprost sr or who received commercial durysta (bimatoprost sr) in the open-label phase 4 argos study (med-ma-eye-0648) and completed (or exited early from) the study.


Eligibility criteria:
inclusion criteria: * participants who completed 1 of the 4 bimatoprost sr phase 3 studies (192024-091, -092, -093, or -095) and received bimatoprost sr. * participants who completed (or exited early from) the open-label phase 4 argos study with no ongoing safety concerns, and received durysta. exclusion criteria: * female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study. * concurrent or anticipated enrollment in another investigational drug or device study during the present study. * any condition which would preclude the participant's ability to comply with study requirements, including completion of the study. * participants who were randomized to receive timolol eye drops in the study eye (control group) during the phase 3 bimatoprost studies 192024-091 and -092. * for patients from the argos lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.

Keywords: open-angle glaucoma ocular hypertension bimatoprost durysta
minimally invasive surgery versus traditional open surgery in the treatment of single level lumbar stenosis

Conditions: Intervertebral Disc Degeneration; Lumbar Spinal Stenosis

Summary: the purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis


Eligibility criteria:
inclusion criteria: * age 18 to 75 years; * patient has single level degenerative lumbar spinal stenosis and an indication for a single level instrumented lumbar fusion for the treatment; * symptoms persisting for at least three months prior to surgery; * given written informed consent; * able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements. exclusion criteria: * prior lumbar spinal fusion at any level; * other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study; * any condition that cannot be treated with mini-invasive unilateral decompression and fusion; * history or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis); * previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
study of gemcitabine/platinum +/- cetuximab as first-line treatment for patients with advanced/metastatic non-small cell lung cancer

Conditions: Non-Small-Cell Lung Carcinoma

Summary: the primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.


Eligibility criteria:
inclusion criteria: * must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy. * must not have received cetuximab or any medications that target the same pathway as cetuximab (such as iressa or tarceva). * must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease. * must be able to carry out work of light or sedentary nature (e.g. light house work, office work). * it must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest. exclusion criteria: * women who are pregnant or breastfeeding. * women with a positive pregnancy test on enrollment or prior to study drug administration. * any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial). * symptomatic or uncontrolled metastases in the central nervous system (cns). * peripheral neuropathy. * inadequate hematologic function defined by an absolute neutrophil count (anc) \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or a hemoglobin level \< 9g/dl. * inadequate liver function. * inadequate kidney function.

Keywords: non-small lung cancer
acupuncture for pain during injection of local anaesthetic

Conditions: Pain; Distress; Satisfaction

Summary: stimulation of acupoint li4 has been shown to result in analgesic effects in patients experiencing acute pain. we aimed to determine whether li4 acupuncture could reduce pain and distress in children receiving an injection of a local anaesthetic (la). children scheduled for dental treatment using local anesthesia as a standard treatment, received bilateral acupuncture at li4 using indwelling fixed needles. during the treatment, the parents of the patients stimulated the needles by massage. two different treatment regimes were compared: a standardized la injection given 5 minutes after acupuncture, and an la injection without acupuncture. the order of treatment was randomised, with the two treatments performed on different days. pain intensity during la injection, assessed by the patient with the verbal rating scale or faces pain scale (0-10), was used as the primary endpoint. parent- and dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction with the received therapy were also recorded.


Eligibility criteria:
inclusion criteria: * children with an american society of anesthesiologists (asa) physical status of i or ii * scheduled for at least two dental treatments for caries requiring local anaesthesia exclusion criteria: * history of analgesic medication, psychiatric disease, or local or systemic infection * necessity to change their treatment schedule

Keywords: injection pain local anesthesia acupuncture
efficacy and safety of ainuovirine treating with aids patients

Conditions: HIV/AIDS

Summary: ainuovirine is the third generation of non nucleoside reverse transcriptase inhibitors(nnrtis), for the treatment of hiv-1 infected adults. the existing clinical studies show that ainuovirine is safe and potent, it solves the problem from the first-generation nnrtis such as efavirenz with large side effects and the second-generation like rilpivirine not suitable for high viral load, but there are no relevant data or reports on the efficacy and safety of ainuovirine in hiv-infected patients in china so far. this project aims to explore the efficacy and safety of art regimens containing ainuovirine for hiv-infected patients in real clinical environment, in further to guide clinical application.

this study is an open-label, multicentered, single-arm and phase iv clinical trial. 450 hiv-infected patients who received ainuovirine regimen (150mg, oral, qd) were included. at day 1 (1st collection as day 1), 3rd, 6th, 9th, 12th month, the rate of viral suppression and cd4+t cell count were calculated against baseline. in addition, the safety and drug compliance were also monitored. other indicators: demographic data (including gender, ethnicity, age, height, education level, occupation, route of infection), past medical history, smoking history, drug abuse history, hepatitis b markers, hepatitis c antibody, b ultrasound, chest x-ray, electrocardiogram, pregnancy test (females of childbearing age): day 1 (1st collection as day 1), 1 time in total. vital signs (heart rate, blood pressure), body weight: 5 times on day 1 (the 1st collection was taken as day 1), 3rd, 6th, 9th, and 12th months.

Eligibility criteria:
inclusion criteria: diagnosis of hiv infection 18-60 years old patients who are prescribed to take ainuovirine regimen . sign informed consent exclusion criteria: 1. patients who are participating in other interventional clinical trials; 2. patients who previously participated in the acc007 study.

Keywords: ainuovirine therapy;real world study;hiv-1-infected patients
evaluation of difficulty score for robotic pancreatoduodenectomy

Conditions: Pancreatic Neoplasm

Summary: robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. the ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. this study aims to provide a difficulty score (ds) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.

our robot difficult score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. based on the univariate and multivariate analysis, the elevated bmi, asa 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of "difficulty" in the robotic pancreatoduodenectomy. the robot addict score will be calculated in all cases of the international consortium on minimally invasive pancreatic surgery (i-mips; www.i-mips.com).

Eligibility criteria:
inclusion criteria: * pathology of the head of pancreas requiring surgery exclusion criteria: * pathology of the head of pancreas not requiring surgery
clinical development of a tool for optimized self- and hetero-diagnosis of stroke using artificial intelligence: stage1- collection of video-clinical data in a pragmatic situation.

Conditions: Stroke, Cerebrovascular

Summary: the study authors aim to form a collection of video-clinical data in a pragmatic situation to enable the development of relevant ai algorithms (for both hetero- and self-diagnosis modes). the aim is to optimize management through early diagnosis (self- and hetero-diagnosis) and thus to reduce sequelae disability. the study authors hypothesize that some stroke patients will be able to successfully perform a self-test consisting of a few exercises dictated by an application on a smartphone or tablet and recorded on video.


Eligibility criteria:
inclusion criteria: * patients treated in the emergency department or hospitalized in the nicu at the chu de nîmes for suspected stroke or transient ischemic attack in the acute phase (\<72h), with or without motor deficit * patient to be seen again in consultation within 4 months * patient has given free and informed consent and signed the consent form. if the patient is not in a position to give consent, it must be obtained, prior to filming the first video, from the designated trusted support person or relatives present. in this case, data will not be used until the patient is able to sign the consent (cnil). * patient affiliated or beneficiary of a health insurance scheme exclusion criteria: * patients who do not speak or read french. * patient in a period of exclusion determined by another study. * patient under court protection, guardianship or curatorship. * pregnant, parturient or breast-feeding patients.

Keywords: artificial intelligence data bank video recording
an open-label, dose escalation study to evaluate the safety and the pharmacokinetics of oral prx-112

Conditions: Gaucher Disease

Summary: this is an open-label, dose escalation study to evaluate the safety of oral prx-112 and pharmacokinetics of gcd in subjects with gaucher disease naive to enzyme replacement therapy. the dose levels of prx-112 are 50 units, 100 units, 200 units and 400 units gcd. subjects will receive once daily oral administrations of prx-112 for 5 consecutive days at each dose level with a 2-day washout period between doses.


Eligibility criteria:
inclusion criteria: * male or female age 18 or older * historical diagnosis of gaucher disease by low leukocyte gcd activity level * haemoglobin ≥ 10 g/dl * body mass index (bmi) of 18 kg/m2-30 kg/m2 inclusive * subject is able to provide written informed consent * female subjects of child bearing potential must not be pregnant or lactating with a negative urine pregnancy test result at the screening visit. * female subjects of child-bearing potential and male subjects with female partners of childbearing potential must use two methods of contraception at all times during the study, one of which must be a barrier method. acceptable methods of contraception are oral contraceptives, barrier methods (male condom, female condom, diaphragm, cervical cap, spermicide or intrauterine device), surgical sterility (documented doctor's report of vasectomy, hysterectomy and/or bilateral oophorectomy) and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or subject report). * negative laboratory tests for hiv, hbsag and hcv at the screening visit * naïve to any previous ert or have received the last ert treatment 12 months before signing ic exclusion criteria: * presence of a gastrointestinal (gi) disease affecting motility or absorption * subjects with any history of allergic response to biological drugs or other allergies deemed clinically significant by the investigator * reported history of alcohol or drug abuse * subject has donated blood in the 3 months prior to screening or subject has received plasma derivatives in the 6 months prior to screening * use of any investigational drug or participation in another clinical trial in the 3 months prior to screening (subject report) * subjects who have previously received ert with positive anti-human plant recombinant gcd (prgcd) antibodies * clinical evidence of any active significant disease that could potentially compromise the ability of the investigator to evaluate or interpret the effects of the study treatment on safety assessment, thus increasing the risk to the subject to unacceptable levels * presence of any medical, emotional, behavioural or psychological condition that, in the judgement of the investigator, would interfere the compliance requirements of the study * subject has used any medication (excluding acetaminophen or dyprione) within 7 days of screening, including laxatives, teas and food additives known to be used for the treatment of constipation or diarrhea
comparing bubble and ventilator nasal cpap in preterm infants

Conditions: Respiratory Distress Syndrome

Summary: there are various methods to generate the pressure needed for nasal cpap. some neonatal intensive care units (nicu) use an underwater bubbling system and others use a ventilator to generate the pressure. there is no right or wrong way to generate the pressure and both methods are approved and accepted. the aim of this study is to compare the two systems of nasal cpap by placing the baby on each for a defined time period and reviewing the infant's vital signs. the investigators expect that the pressure generated by bubble cpap will be better and lead to improved vital signs.

there are various methods to generate the pressure needed for nasal cpap. some neonatal intensive care units (nicu) use an underwater bubbling system and others use a ventilator to generate the pressure. there is no right or wrong way to generate the pressure and both methods are approved and accepted. the aim of this study is to compare the two systems of nasal cpap by placing the baby on each for a defined time period and reviewing the infant's vital signs. the investigators expect that the pressure generated by bubble cpap will be better and lead to improved vital signs.

Eligibility criteria:
inclusion criteria: * neonates between 26-32 weeks gestational age who have been on nasal cpap for at least 48hrs on fraction of inspired oxygen (fio2) of \< or = 0.3. parental consent will be obtained prior to enrollment. exclusion criteria: * infants with severe congenital anomalies, such as airway or chest wall deformities, pulmonary hypoplasia, congenital heart disease, neurologic abnormalities including severe intraventricular hemorrhage (ivh) and need for surgery eg. for necrotizing enterocolitis will be excluded from the study. any infants with genetic/chromosomal abnormalities will be excluded.
music based caregiving in patients with pain and dementia

Conditions: Pain; Dementia; Music; Activity, Motor; Quality of Life

Summary: the main objective of this study is to evaluate the pain-relieving effect of a well-characterized non-pharmacological treatment program, music-based caregiving (mbc), to patients in nursing homes with dementia and pain. patients with dementia disease will be recruited from nursing homes in trondheim and oslo, and each ward at the nursing homes will be cluster randomized into intervention - or control wards. then the health care personnel in the intervention wards will receive education in mbc and perform the intervention during eight weeks. the hypothesis is that this non-pharmacological intervention will reduce pain intensity and improve general activity, as well as reduce other symptoms in nursing home patients with dementia and pain compared to baseline.

this is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at eight nursing homes. 1. about 12 nursing homes are selected to participate in trondheim and in oslo. 2. all patients at the included nursing homes will be screened with respect to dementia and pain (see screening tools later). if patients have dementia and report pain (≥3 on mobid 2) they will be included in the intervention part of the study (n=240). 3. the included patients will then have a clinical examination of pain and pain management by expert physicians (see below). evaluation of the use of analgesics and psychopharmacological medication will be performed. inappropriate medication (both too much and too little) will be corrected in collaboration with the nursing home doctor. 4. in addition to the clinical examination of pain, the investigators will measure total daily physical activity, adl, qol, and neuropsychiatric symptoms on all included patients. 5. after the pre-test - a randomization of the wards into intervention wards or control wards will be performed. 6. about five staff members at each of the wards randomized to the intervention group will receive education in the mbc before intervention. 7. a post-test just after the intervention has ended, pain, total daily physical activity, adl, qol, and neuropsychiatric symptoms will be measured.

Eligibility criteria:
inclusion criteria: * all patients living in one of the included nursing homes in oslo or trondheim will be included in the first descriptive phase * patients will be included in the intervention part if they report moderate pain or more (≥3 on mobid) and mild dementia or more (≥1 on cdr). exclusion criteria: * they will not be included if they have lived in the nursing home less than four weeks, have short (less than eight weeks) expected lifetime (judged by the nurses),or if they do not understand the norwegian language.
administration of oral extended release minocycline for assessment of skin and plasma concentrations of minocycline

Conditions: Acne

Summary: the primary objective of this study is to evaluate the skin and plasma concentrations of minocycline in subjects undergoing treatment of acne vulgaris with oral extended release minocycline. acne lesion counts and safety/tolerance of the treatment will also be evaluated.

this will be an open label, non randomized, interventional pilot study evaluating the plasma and skin levels of minocycline in 10 subjects with moderate to severe acne vulgaris. subjects with non inflammatory acne of nodular acne will not be enrolled. subjects will be on an oral extended release minocycline regimen of up to 2mg/kg once a day for 4 weeks. steady state levels of minocycline in plasma and skin will be determined.

Eligibility criteria:
inclusion criteria: * otherwise healthy male and female subjects 14 to 40 years of age * moderate to severe inflammatory facial acne vulgaris (egsa score of 3-5) * subjects not using oral or topical antibiotic products for at least 30 days prior to study entry and willing to refrain from use of oral and topical antibiotics for the duration of study participation * subjects not currently using and willing to refrain from use of other topical acne products for the duration of study participation exclusion criteria: * mild, non-inflammatory or nodular acne vulgaris * have current or previous skin cancer * have a history of skin disease or presence of skin condition the pi believes would interfere with the study * females who report that they are pregnant, planning a pregnancy during the study period or breastfeeding * have conditions or factors that the pi believes may affect the response of the skin or the interpretation of the results * participation in any clinical study within the previous 30 days or plan concurrent participation in other studies