Kornimate/medical-research-clean huggingface dataset:
dermoscopy in primary raynaud's phenomenon

Conditions: Raynaud Phenomenon

Summary: raynaud's phenomenon (rp) is very frequent in general population (up to 10%). nailfold capillaroscopy (nfc) is recommended for patients presenting rp, to eliminate systemic disease such as systemic sclerosis. nfc is not easily available in clinical practice. dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. however, no study has evaluated the performance of dermoscopy in primary rp. the objective is to determinate which items in dermoscopy are correlated with a normal nfc and predict with a good negative predictive value, a normal nfc in rp patients. the secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with rp.

raynaud's phenomenon (rp) is very frequent in general population (up to 10%). nailfold capillaroscopy (nfc) is recommended for patients presenting rp, to eliminate systemic disease such as systemic sclerosis. nfc is not easily available in clinical practice. dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. however, no study evaluated the performance of dermoscopy in primary rp. a preliminary study (tenon hospital) showed an interest of dermoscopy in primary and secondary rp, with a negative predictive value of dermoscopy of 100% for capillaroscopy. this is a prospective, multicentric french study comparing dermoscopy and capillaroscopy in patients attending dermatology or vascular medicine departments for the first evaluation of a rp. the objective is to determinate which items in dermoscopy are correlated with a normal nfc and predict with a good negative predictive value, a normal nfc in rp patients. the secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with rp. the main hypothesis is that a normal dermocopy on five items is highly predictive of a normal nfc. during a first consultation for rp, nfc will be realized with a clinical exam and a biological test (antinuclear antibodies), as official recommendations. dermoscopy of peri-ungueal area will be realized by another investigator, if possible during the same consultation. photographs of all fingers, except thumbs, will be made and will be reviewed by another investigator of another center. there will be no follow-up.

Eligibility criteria:
inclusion criteria: * age \> 18 years * first consultation for bilateral raynaud's phenomenon (rp) * bilateral raynaud's phenomenon affecting at least one finger of each hand defined by a paroxysmal syncopal phase on exposure to cold, * affiliated to the french health care systeme exclusion criteria: * age \< 18 years * presence of unilateral rp where the capillaroscopy is normal regardless of the cause

Keywords: dermoscopy nailfold capillaroscopy
fluvastatin 80 mg ret. vs combination with ezetimibe 10 mg in patients with high cardiovascular risk

Conditions: Hypercholesterolemia

Summary: patients with coronary heart disease (chd) or chd equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). besides, hypercholesterolemia is an evident risk factor for atherosclerosis. hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (hmg-co-reductase inhibitors) and ezetimib was investigated. this combination therapy should be more effective in reducing low density lipoprotein cholesterol (ldl-c) and total cholesterol levels compared to monotherapy.

ezetimibe, a cholesterol-absorption inhibitor, significantly lowers low-density lipoprotein cholesterol (ldl-c) when administered in addition to statin treatment. the effect of ezetimibe on the incidence and progression of vascular disease is elusive. therefore, our objective was to examine the effects of fluvastatin and fluvastatin plus ezetimibe on lipoprotein subfractions in patients with diabetes mellitus and/or coronary heart disease.

Eligibility criteria:
inclusion criteria: * patients with chd or chd equivalent with ldl 100-160 mg/dl * male or female sex * normal values of ck, ast and alt * normal kidney function exclusion criteria: * chd stage iii-iv * st. p. myocardial infarction or coronary artery bypass grafting * pregnancy or breastfeeding * premenopausal women without certain contraception * known hypersensitivity to hmg-coa reductase inhibitors or ezetimib
single ventricle reconstruction extension study (svr ii) - pediatric heart network

Conditions: Heart Defects

Summary: the single ventricle reconstruction (svr) trial looked at how infants with single ventricle heart defects did after the first stage of surgery (norwood operation). infants enrolled in the trial got one of two kinds of shunts during the norwood; a modified blalock-taussig shunt (mbts) or right ventricle to pulmonary artery shunt (rv-to-pa shunt). the purpose of this study is to learn if children (2-6 years of age) who were enrolled in the svr trial do better with one of the two shunts (mbts or rv-to-pa) in the years after surgery.

among critical congenital heart lesions, hypoplastic left heart syndrome (hlhs) and related single right ventricle (rv) anomalies are associated with the highest morbidity and mortality. the first stage in palliation for patients with these defects is the norwood procedure. the essential components of the norwood procedure include (1) an atrial septectomy, (2) anastomosis of the proximal pulmonary artery to the aorta with homograft augmentation of the aortic arch, and (3) establishment of a source of pulmonary blood flow, with either a modified blalock-taussig shunt (mbts) or the right ventricle to pulmonary artery (rv-to-pa) shunt. in may 2005, the pediatric heart network began a multi-center, randomized trial, the single ventricle reconstruction (svr) trial, comparing outcomes in subjects with hlhs or other single rv anomalies palliated using the norwood procedure with either a mbts or the rv-to-pa shunt. the primary outcome of this trial was freedom from death or cardiac transplantation by 12 months post-randomization. the single ventricle reconstruction extension (svr ii) study is an extension of the svr trial that compares clinical outcomes and rv performance following the rv-to-pa shunt versus mbts modifications of the norwood procedure in subjects at 6 years post-randomization. data is collected annually between ages 2 and 6 years, as well as before and after the fontan surgery. vital status and medical history is ascertained annually until the last enrolled subject is 6 years old. data is obtained through medical record review, phone interview with the parent or guardian, electrocardiography (ecg), core laboratory analysis of echocardiographic images and holter monitors, and completion of questionnaires regarding neurodevelopmental outcomes, behavior, health-related quality of life, and family functioning. the primary outcome variable in svr ii will be freedom from death or cardiac transplantation at 6 years post-randomization. all subjects who were randomized in the svr trial will be included in analysis of this endpoint.

Eligibility criteria:
inclusion criteria: * randomized subject in the single ventricle reconstruction trial exclusion criteria: * no subjects enrolled in the the original svr trial will be excluded from analysis of the primary endpoint
agitation in the acute psychiatric department

Conditions: Mental Disorders

Summary: agitation is associated with a number of acute psychiatric conditions, and frequent in acute psychiatric admissions. it is associated with violence towards others, and strongly associated with in-patient suicides. the main aims of the study are to assess different clinical presentations of agitation at admittance, and to assess the consequences of these different clinical presentations during the first three days of the stay.

the patients are assessed with three rating scales (components of agitation, the panss-ec, the brøset violence checklist) measuring agitation at admittance and day three thus providing a measurement of the differences during three days of in-patient stay. therapeutic measures and interventions taken are assessed daily with a 18-item checklist. threatening and violent incidents are recorded with the soas-r. blood samples for immunological parameters are taken at admittance and discharge giving opportunity to assess changes through the acute psychiatric condition. urine and blood samples are taken at admittance to assess substance use and medications. the patients are assess with two self-rating vas-scales at discharge assessing the suicidal intentions they have had during the stay, aspects of clinical history and assessment for personality disorders.

Eligibility criteria:
inclusion criteria: * all consecutive acutely admitted in-patients are asked for participation. exclusion criteria: * patients not willing to sign informed consent form. * patients not speaking english or norwegian.

Keywords: emergency services, psychiatric psychomotor agitation suicide violence
an open label study of l059 intravenous (iv) in japanese epilepsy subjects with partial onset seizures

Conditions: Epilepsy; Partial Onset Seizures

Summary: to evaluate the safety of levetiracetam iv 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with partial onset seizures after switching from the equivalent levetiracetam oral dose.


Eligibility criteria:
inclusion criteria: * subject is a male or female aged ≥ 16 years * subject has partial onset seizures that are classifiable according to the 1981 international league against epilepsy (ilae) classification of epileptic seizures * subject weighs ≥ 40 kg * subject is currently taking levetiracetam (lev) as an adjunctive antiepileptic oral treatment with 1 to 3 other antiepileptic drugs (aeds) exclusion criteria: * subject has problems with venous accessibility * subject has participated in another clinical/pharmacological study during the last 4 weeks prior to the screening visit * subject is pregnant or lactating * subject has a history of suicide attempt(s) or presents with current depressive signs, current suicidal ideation, and/or behavior * subject has clinically significant electrocardiogram (ecg) abnormalities according to the investigator

Keywords: levetiracetam infusion epilepsy partial onset seizures
research on new regimens for retreatment pulmonary tuberculosis

Conditions: Reinfection Pulmonary Tuberculosis

Summary: multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients. to obtain optimized short-course regimen, decrease treatment cost and improve success rate.

china is the country with the second highest tuberculosis (tb) burden in the world. most of the retreatment tb patients may develop multi-drug resistant. the resistant rate of any of the anti-tb drug is 35.9%, and the multi-drug resistant rate is 15.4%. retreatment tb becomes one of the factors which inhibit the decrease of morbidity and mortality of tb. it is also a tuff work in tb control. at present the standardized regimen for retreatment tb is 2shrez/6hre or 3hrez/6hre. the drugs in the regimen are all first-line anti-tb drugs which are unsuitable for the high drug resistance prevalence, because the cure rate of this regimen is low and the adverse reaction is severe. our study is a national multi-center, prospective trail to investigate the efficacy of a new super-short regimen for retreatment tb patients. the new regimen consists of 5 drugs lasting 5 months. the cure rate and success rate of the new regimen is compared with standardized regimen usually 8-9 months in order to obtain the optimized regimen.

Eligibility criteria:
inclusion criteria: * sputum confirmed diagnosis of retreatment pulmonary tuberculosis * must be able to swallow tablets * must be able to sign written informed consent form exclusion criteria: * extra-pulmonary tuberculosis * diabetes * allergy to any of the medications in the regimen or pregnancy * liver disease * renal disease * metabolic disease * immune system disease * hematological disease * nervous system and mental disease * endocrine disease * malignant disease * receiving immunosuppressive therapy * hiv/aids * alcohol addiction
hydrus® microstent new enrollment post-approval study

Conditions: Primary Open Angle Glaucoma

Summary: the purpose of this post-approval study is to evaluate the rate of hydrus microstent malposition and associated clinical sequelae occurring within 24 months post-operation. qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (iol), followed by implantation of the hydrus microstent.

qualified subjects will attend a screening visit, a surgical visit (day 0), and 8 scheduled postoperative visits at day 1, day 7, month 1, month 3, month 6, month 12, month 18, and month 24. this study was initiated by ivantis, inc. ivantis was acquired by alcon research, and alcon assumed sponsorship of the study in november 2022.

Eligibility criteria:
inclusion criteria: * an operable, age-related cataract with best corrected visual acuity (bcva) of 20/40 or worse; * diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications; * optic nerve appearance characteristic of glaucoma; * medicated iop less than or equal to 31 millimeters mercury (mmhg); other protocol-defined inclusion criteria may apply. exclusion criteria: * closed angle forms of glaucoma; * congenital or developmental glaucoma; * secondary glaucoma; * use of more than 4 ocular hypotensive medications; * previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery; * prior surgery with implanted device or other surgery involving the trabecular meshwork or schlemm's canal; * other protocol-defined exclusion criteria may apply.
clinical and microbiological efficacy of systemic ayurvedic immunomodulator septilin in the treatment of chronic periodontitis

Conditions: Chronic Periodontitis

Summary: the present clinical trial was designed to investigate the clinical and microbiological effectiveness of systemic ayurvedic immunomodulator septilin as an adjunct to scaling and root planing (srp) in the treatment of chronic periodontitis (cp)

objective: the present clinical trial was designed to investigate the clinical and microbiological effectiveness of systemic ayurvedic immunomodulator septilin as an adjunct to scaling and root planing (srp) in the treatment of chronic periodontitis (cp). design: sixty five subjects presenting at least twelve teeth with probing depth (pd) ≥4 mm were selected. 33 subjects were randomly assigned to full-mouth srp + septilin (group 1) and 32 subjects were assigned to full-mouth srp + placebo (group 2). the clinical outcomes evaluated were plaque index (pi), gingival index (gi), clinical attachment level (cal), pd and % of sites with bleeding on probing (%bop) at baseline (b\\l), 10 days, 1, 3 and 6 months interval and percentage of sites positive for a. actinomycetemcomitans, p. gingivalis and t. forsythia were recorded at b/l, 3 and 6 months using polymerase chain reaction.

Eligibility criteria:
inclusion criteria: * age 30 to 50 years * atleast 12 scorable teeth with a probing depth (pd) ≥ 4 mm not including third molars * teeth with orthodontic appliances bridges, crowns, or implants * radiographic evidence of bone loss. exclusion criteria: * pregnancy or lactation * smokers * systemic diseases like diabetes mellitus, immunocompromised patients * systemic antibiotics taken within the previous 6 months * use of non-steroidal anti-inflammatory drugs * sub-gingival srp or surgical periodontal therapy in the previous year.

Keywords: septiline, chronic periodontitis, immunomodulator, microbiology
clinical study to assess the efficacy and safety of g238 compared to clotrimazole otic solution in the treatment of otomycosis

Conditions: Otomycosis

Summary: the purpose of this study is to evaluate the safety and efficacy of g238 for the treatment of otomycosis


Eligibility criteria:
inclusion criteria: * 18 years or older. * clinical diagnosis of otomycosis where topical treatment is indicated. exclusion criteria: * other ear diseases.
preoperative chemoradiotherapy with capecitabine plus irinotecan in rectal cancer

Conditions: Rectal Neoplasm; Neoadjuvant Therapy

Summary: this study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer

this study is an open-label, single center, nonrandomized phase ii study. daily fractions of radiotherapy at 1.8 gy to total of 45 gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 gy to the tumor were delivered concurrently with chemotherapy. chemotherapy starts at day 1 of radiotherapy. capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (monday to friday) every week during radiotherapy. irinotecan 40 mg/m2 is given intravenously once a week (d 1, 8, 15, 22 \& 29). six ± 2 weeks after completion of chemoradiotherapy, curative surgery is performed. post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery. capecitabine 1,250 mg/m2 twice daily on days 1-14 every 21 days will be administered for 18 weeks.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the rectum * distal margin of tumor located from 0 to 8 cm from anal verge * tumor must be clinically resectable by surgery and r0 resection must be most likely * ecog performance status 0-2 * no prior chemotherapy, radiotherapy to pelvis, and immunotherapy * adequate organ functions * patients must sign an informed consent exclusion criteria: * malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease * any unresected synchronous colon cancer * any distant metastasis * intestinal obstruction or impending obstruction, but decompressing colostomy is permitted * any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix * any other morbidity or situation with contraindication for chemoradiotherapy * patients have history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine * pregnant or lactating women or patients of childbearing potential not practicing adequate contraception

Keywords: rectal neoplasm neoadjuvant therapy radiotherapy combination chemotherapy irinotecan capecitabine
personality and drug use

Conditions: No Conditions Study Focus on Substance Use and Personality

Summary: this is an observational, naturalistic study that aims to assess whether people with different histories of recreational or therapeutic illicit substance use (or no history at all) will differ in terms of their personalities.

the study aims to assess the association between the use of various substances (including psychedelic and non-psychedelic drugs) and personality profiles. specifically, the study will investigate if people with different histories of drug use differ in personality profiles. as psychedelics were found to influence changes in personality over time, the investigators sought to measure both the current personality profile (via the big five inventory-44 (bfi)) and perceived retrospective changes in personality (via a self-constructed retrospective personality scale (rps). to investigators' knowledge, no study has explored the diversity of substance use histories in relation to individual current and retrospective personality traits and aggregate personality profiles. the investigators aim to survey a large number of participants from all around the world, using a mobile app-based survey. the remote character of the study will increase its accessibility and diversity, which are common shortcomings in the psychedelic line of research. additionally, a remote and anonymous study setup with no face-to-face interactions might help overcome any potential concerns participants may have regarding the sharing of sensitive information (e.g., reports on illicit substance use). to increase scientific transparency and for educational purposes (comparing personalized results with the aggregated results of participants with similar socio-demographic profiles), investigators plan to share personalized results summaries with participants of the study, which might be an additional motivating factor for study completion. in conclusion, this large-scale, low-budget, naturalistic, retrospective, observational study aims to shed light on the aforementioned gap in the literature and lay a foundation of evidence for further research.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * full legal and mental capacity * access to a smartphone with internet to fill in the study measures (available for ios and android) exclusion criteria: * lack of proficiency in english * visual impairments (not able to use mobile devices) * illiteracy

Keywords: personality substance use psychedelics drugs
supplemental effects of eldoa in addition to thoracic manipulation on upper back pain, thoracic kyphosis and forward head posture in thoracic hypomobility

Conditions: Forward Head Posture; Thoracic Hypomobility; Upper Back Pain

Summary: the purpose of this study is to determine the supplemental effects of eldoa in addition to thoracic manipulation on upper back pain, thoracic kyphosis and forward head posture in thoracic hypomobility.


Eligibility criteria:
inclusion criteria: * both male and females * adults (19-44 years) * upper back pain or discomfort * forward head posture * thoracic hypomobility * thoracic hyperkyphosis exclusion criteria: * ankylosing spondylitis * history of spinal fusion or spinal surgery (discectomy/laminectomy etc.) * degenerative disc disorders, facet joint syndrome * cervical radiculopathy, scoliosis * spinal stenosis or myelopathy * recent fracture or surgery * tb of spine, spondylolisthesis * not able to attend regular therapy appointments * fibromyalgia/myofascial pain syndrome