Kornimate/medical-research-clean huggingface dataset:
real-time interactive digital healthcare system in patients with breast cancer; randomized controlled trial

Conditions: Breast Cancer

Summary: this study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (uincare homeplus) in post-operative patients with breast cancer. this is prospective study. 100 breast cancer patients who underwent axillary lymph node diessection or breast reconstruction following mastectomy will be examined, and those with limited range of motion (rom) of affected shoulder will be enrolled in the study. shoulder rom, quick-dash, pain evaluation with nrs, quality of life evaluation with fact-b and eq-5d will be evaluated on enrollment, 4-week, 8-week, and 12-weeks after enrollment.

the limited range of motion (rom) of the shoulder occur often after receiving breast cancer surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and etc. due to this limited rom, the patients may have difficulty with activities of daily life and quality of life may be reduced. uincare homeplus is software manufactured in korea, which uses infrared, kinect camera and motion capture technology to track 3d motion of the patients' articulation. using this technology, the patients can receive feedback of their motion immediately. the objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (uincare homeplus) in post-operative patients with breast cancer.

Eligibility criteria:
inclusion criteria: * patients who underwent breast cancer surgery (axillary lymph node dissection or breast reconstruction following mastectomy) * limited active/passive range of motion of the affected shoulder (flexion \<160' or abduction \<160') * post-operative day not exceeding 8 week * patients who agreed informed consent exclusion criteria: * bilateral breast cancer surgery * patients with shoulder pain and limited rom before breast cancer surgery * those unable to perform exercise due to general deconditioning * those with communication difficulty
ipratropium or salbutamol sulphate alone or combination therapy salbutamol and ipratropium in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: study to compare the effects of nebulised salbutamol or ipratropium alone in patients with copd with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (sao2) and to characterise patients with copd (chronic obstructive pulmonary disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.


Eligibility criteria:
inclusion criteria: * male and female patients with moderate to severe stable copd: * patients with a diagnosis of chronic bronchitis and/or emphysema * fev1 \<65% of predicted value without regard to prior treatment * forced expiratory ration (fer = fev1/vc) \<70% of predicted value without regard to prior treatment * patients must not have had a respiratory infection or an exacerbation of copd during the four weeks immediately prior to entering the trial * patients must not have changed their normal treatment for copd during the four weeks immediately prior to entering the trial * patient aged ≥40 years * patients with a smoking history of ≥15 pack-years * patients must have given informed consent to participate in the trial exclusion criteria: * patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans * patients with any of the following: * untreated angle closure glaucoma * hypertrophic obstructive cardiomyopathy * tachyarrhythmia * recent myocardial infarction (within six months of screening visit) * severe organic cardiac or vascular disorder * untreated hyperthyroidism * diabetes mellitus (after approval of protocol amendment 1, the inclusion of well controlled diabetic patients was allowed) * patients who are pregnant, or who are planning a pregnancy, and nursing mothers * patients known to be hypersensitive to anticholinergic drugs or to β2 agonists * patients known to abuse drugs or alcohol * patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial * patients with a pao2 (arterial carbon dioxide tension) \<56 mmhg (7.5 kpa) at rest while breathing air without regard to prior treatment * patients with a sao2 ≤85% at rest while breathing air without regard to prior treatment * patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial * patients on home oxygen concentrator therapy * patients who have previously participated in the randomised phase of this trial
lymphatic mapping for image guided radiotherapy in patients with lacc - a feasibility study

Conditions: Locally Advanced Cervical Cancer

Summary: lymphatic mapping is a procedure in which all lymph nodes with drainage from the primary tumor, i.e. all nodes with potential (micro)metastases, can be imaged. these nodes are not necessarily suspicious on other imaging techniques. the goal of this feasibility study is to 1. investigate the feasibility of the lymphatic mapping procedure in locally advanced cervical cancer 2. study the agreement of the lymphatic map with the radiotherapy treatment plan including previous imaging (mri / ct / fdg-pet/ct)

study population: aged ≥18 years, with locally advanced cervical cancer, that will be planned for radiotherapy. intervention (if applicable): lymphatic mapping will be performed on all study patients during the standard investigation under anaesthesia, to ensure painless injection of the radiopharmaceutical. patients will receive 6-8 depots of \[99mtc\]tc-nanocolloid peritumoral. planar and spect/ct gamma camera images will be made at the department of radiology and nuclear medicine 3 hours and 12-24 hours after administration of the radiopharmaceutical. all radioactive lymph nodes will be included in the lymphatic map. the radiation oncologist will determine the radiation therapy treatment plan blinded to the data of the lymphatic mapping. the lymphatic map will be compared to the radiation treatment plan and previous imaging (mri / ct / fdg-pet/ct). main study parameters/endpoints: 1. is it feasible to perform lymphatic mapping in locally advanced cervical cancer? is there visualisation of (multiple) lymph nodes in both sides of the tumor? 2. are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?

Eligibility criteria:
inclusion criteria: histologically proven locally advanced cervical cancer \[figo stage iib-iva\]. \>18 years old. treatment with curative (chemo)radiation. signed informed consent. exclusion criteria: pregnancy. administration of the radioactive tracer cannot be ensured properly due to obesity patients with tumors in which no circumferential injection of \[99mtc\]tc-nanocolloid is possible due to the size or position of the tumor.
retrospective digital computer analysis of keratoconus evolution - redcake

Conditions: Keratoconus

Summary: the purpose of this study is to create a database of keratoconic eyes with two or more corneal topographies/tomographies, at least 5 months apart

title: keratometry values such as k1, k2 and the angle between these two; value and location of the thinnest corneal point; pachymetry progression (radial change of pachymetry); is value (i.e., ratio of average curvature in superior and inferior sections) description: the primary endpoint is to obtain a database, containing at least two valid corneal biometry measurements (scheimpflug) recorded at least 5 months apart, for a predetermined number of suitable keratoconus patients. these data will be used to create a personalized three-dimensional model of the cornea at each time point, which permits classifying corneas according to shape and stage, as well as assessing the influence of patient age, gender, family history and ophthalmic habits (e.g. eye rubbing) on keratoconus progression. based on corneal changes over time, an estimate of the underlying biomechanical changes will be made. all these data will then be combined to develop software for automated keratoconus detection and progression risk assessment to help ophthalmologists decide when to perform crosslinking on their patients. the primary variables are the elevation parameters derived directly from the scheimpflug measuring device export files, along with the demographic and medical information (if available). time frame: 5 months once a predictive model for keratoconus progression speed based on multiple measurements, this can be improved to make predictions based on a single measurement. furthermore, the database obtained in this work will also be a valuable resource to analyse the variation in keratoconus shape, which may lead to an improved classification of keratoconus types

Eligibility criteria:
inclusion criteria: * age between 12-40 years. * clinically diagnosed mild or moderate keratoconus in one or both eyes * two or more scheimpflug measurements (type pentacam hr, pentacam axl, ziemer galilei, cso sirius) of good technical quality, separated at least five months apart. exclusion criteria: * corneal scarring present in both eyes. * known corneal or retinal pathologies, apart from keratoconus * known ocular procedures/ treatments (including crosslinking) * known systemic diseases (e.g. diabetes, ms, hiv/aids, hypertension,...), except allergies * change in contact lenses between measurements (e.g. start wearing lenses, change from corneal to scleral lenses, etc.) * fluorescein drops instilled into the eye before scheimpflug measurement.
thalamus seizure detection with a deep brain stimulator system

Conditions: Epilepsy; Seizure

Summary: the purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection. the sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-eeg monitoring collected in the in-patient setting (epilepsy monitoring unit), in 5 patients with drug resistant epilepsy.


Eligibility criteria:
inclusion criteria: participants must meet all of the inclusion criteria to participate in this study: * 18 years of age and older. * implanted with a clinical dbs system for epilepsy with brain recording capabilities (medtronic percept™ dbs). * subject or legally authorized representative is able to understand study procedures and to comply with them for the entire length of the study. exclusion criteria: all candidates meeting any of the exclusion criteria at baseline will be excluded from study participation: * health status or any clinical conditions (e.g., life expectancy, co-existing disease) that, in the opinion of the site investigator, would pose undue risk to undergo epilepsy monitoring unit evaluation for the purpose of seizure characterization. * women will verify not pregnant, and if applicable, have urine pregnancy test. * current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * inability or unwillingness of individual or legal guardian/representative to give written informed consent.
the safety, tolerability, pharmacokinetics, and preliminary efficacy of hmpl-523 in adult subjects with immune thrombocytopenia (itp)

Conditions: Immune Thrombocytopenia; Blood Platelet Disorder; Hematologic Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorder; Thrombotic Microangiopathies; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Primary Immune Thrombocytopenia; ITP - Immune Thrombocytopenia

Summary: this is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of hmpl-523 in adult subjects with itp.

this study is a phase 1b, open-label, multicenter, single-arm study to evaluate the safety, tolerability, and preliminary efficacy of hmpl-523 in adult subjects with primary itp diagnosed at least 3 months prior to enrollment or randomization. in the dose escalation stage (part 1), subjects will receive one of 3 dose levels of hmpl-523 to determine the recommended dose of hmpl-523 for the randomized dose optimization- stage (part 2). at the end of part 1, 2 dose levels will be selected to be used in the dose-optimization stage (part 2) of the study. in part 2 of the study, subjects will be randomized in a 1:1 ratio between the 2 dose levels to better understand the exposure/efficacy/toxicity relationship. at the end of part 2, the recommended phase 3 dose (rp3d) of hmpl-523 will be determined based on the safety, efficacy and pk data.

Eligibility criteria:
inclusion criteria: subjects may be enrolled in this study only if they satisfy all the following criteria: 1. adult male or female subjects ≥18 years of age 2. diagnosis of itp, with a duration of disease of at least 3 months prior to randomization or enrollment 3. intolerance or insufficient response or recurrence after at least 1 prior itp treatment (excluding splenectomy) 4. response (defined as achieved a platelet count ≥50 × 109/l) to at least 1 prior itp therapy (including splenectomy) 5. adequate hematologic, hepatic and renal function exclusion criteria: subjects are not eligible for enrollment into this study if any one of the following criteria are met: 1. evidence of the presence of secondary causes of itp 2. clinically serious hemorrhage requiring immediate adjustment of platelets 3. known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor t-cells (car-t) therapy 4. splenectomy within 12 weeks prior to enrollment 5. presence of active malignancy unless deemed cured by adequate treatment. 6. history of serious cardiovascular disease corrected qt interval (qtcf) ≥450 ms 7. uncontrolled hypertension 8. being unsuitable to participate in this study as considered by investigators

Keywords: itp sovleplenib
efficacy study between two different dosages of an antiparasitic in patients with crusted scabies

Conditions: Gale; Severe Forms of Scabies; Oral Parasitic Drug; Ivermectin

Summary: severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. however, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).


Eligibility criteria:
inclusion criteria: patients ≥ 18 years old, diagnosed with severe forms of scabies 1. clinical criteria : cutaneous lesions of scabies * crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or * profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis 2. paraclinical criteria: * positive parasitological test * and/or dermoscopic exam with signs of scabies effective contraception for women in age of pregnancy written consent from patient or his/her legal representant, trustworthy person or family member affiliated to a social security scheme exclusion criteria: * pregnant and/or breastfeeding women * intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream * use of anti parasitic drug (ivermectin or albendazole) within the past 7 days * abnormal liver test results: alt and/or ast \>3n within the past 7 days (within 6 months if no hepatic history) * participation in other biomedical drug research * patient deprived of freedom * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Keywords: gale severe forms of scabies oral parasitic drug ivermectin
a study to investigate mechanisms of resistance to breast cancer therapies

Conditions: Breast Cancer

Summary: this study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (her2) positive, hormone receptor (hr) positive or triple negative breast cancer.


Eligibility criteria:
general inclusion criteria: * willingness to undergo a procedure to obtain tumor tissue (e.g. biopsy) and blood draw * diagnosis of her2+, hr+ (for cohort r1) or triple negative breast cancer (for cohort t1) as per local assessment * availability of an archival tumor tissue (most recent pre-treatment tumor tissue is preferred) * unequivocally growing tumor lesion (progressive lesion) that is accessible for resection, excision or core needle biopsy * discontinuation of prior anti-cancer treatment outlined below should not be longer than 4 weeks from participation in this study inclusion criteria for participants in the cohorts studying acquired resistance * participant had undergone regular monitoring for disease progression as per local practice (preferably every 3-6 months) while on most recent breast cancer therapy * accessible tumor lesion that newly appeared or a lesion that started to regrow while the participant was at least 6 months on therapy inclusion criteria for participants in the cohort studying primary resistance * accessible tumor lesion that continued to increase in size or a newly appearing lesion (as confirmed by routine tumor assessment) while treated for at least 4 weeks but less than 6 months on therapy exclusion criteria: * any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g. bleeding disorders) * any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study * participant has started treatment with subsequent anti-cancer therapy * participants whose progressive tumor lesion that is targeted for biopsy/resection is in the bone * discontinuation of treatment was due to a reason other than disease progression
efficacy of high-dose dual therapy vs bismuth-containing quadruple therapy for first-line treatment of hp infection

Conditions: Helicobacter Pylori Infection

Summary: up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (hddt) and bismuth-containing quadruple therapy (bqt) as 1st-line regimens for h. pylori eradication. the aims of this study are: 1. to compare the efficacy of hddt, and bqt as 1st-line regimen in h. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence h. pylori eradication by these treatment regimens.

participants, aged ≥ 20, having h. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. all undergo endoscopy with biopsy for rapid urease teat, histology, and bacterial culture before treatment. four to eight weeks after termination of treatment, h. pylori infection status will be examined by the 13c-urea breath test. the cyp2c19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (pcr-rflp) method. a computed generated random numbers sequence will be blocked into two subgroups, say a, and b. if the participants did not receive anti-h. pylori therapy previously, they will be invited to enter this study for evaluated the efficacy of these 1st-line regimens. participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens: group a- hddt (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group b- bqt ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days); all participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. post-treatment, the participants will be followed up at the outpatients clinic to investigate patient adherence and adverse effect of treatment.

Eligibility criteria:
inclusion criteria: participants having h. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy. exclusion criteria: 1. pregnant or nursing woman 2. serious concomitant illness and malignant tumor of any kind 3. history of hypersensitivity to test drugs 4. serious bleeding during the course of the ulcer 5. previous gastric surgery 6. receiving bismuth salts, ppis, or antibiotics in the previous month.

Keywords: helicobacter pylori high dose dual therapy bismuth-containing quadruple therapy antibiotic resistance
erector spinae plane block versus thoracic paravertebral block for pain control in modified radical mastectomy

Conditions: Breast Surgery; Thoracic Paravertebral Block; Post-operative Pain Control; Erector Spinae Plane Block; Opioid Use

Summary: the aim of the study is to compare the effectiveness of the erector spinae plane (esp) block versus thoracic paravertebral (tpv) block in the post-operative pain control after radical mastectomy.

primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, esp block and tpv block, in the post-operative pain-control after radical mastectomy. we will also evaluate both intra and post-operative opioid consumption, the incidence of ponv, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 85 * american society of anesthesiologists classification i - iii * signature of consent to participate in the study exclusion criteria: * coagulopathies and / or use of antiplatelet / anticoagulant drugs * infections and/or lesions at the puncture site, * bmi ≥40 * allergies and / or contraindications to the administration of the drugs used in the study, * use of chronic opioid therapy

Keywords: breast surgery thoracic paravertebral block erector spinae plane block mastectomy post-operative pain control
a study to identify markers in blood and tissue of hpv clearance

Conditions: HPV Infections

Summary: this is a research study looking at gene characteristics in blood and pap smear samples in hopes of identifying markers that will predict if the hpv infection is present or not.

because infection with high-risk human papillomavirus is a necessary cause of cervical cancer, hpv testing has many potential uses in cervical cancer screening. unfortunately, like cytology, it suffers from a lack of specificity when used for population-based screening. given that hpv testing detects more cases of cin3+ than cytology and that it would probably be more practical in developing regions, finding a biomarker that would increase specificity has been the goal for much research on hpv and cervical cancer. the goal of this study is to explore potential predictors of viral clearance, specifically rna levels of candidate genes in cervical swabs and host genetic polymorphisms, in the context of genotype-specific infection data.

Eligibility criteria:
inclusion criteria: * hpv positive exclusion criteria: * negative for hpv

Keywords: women of the state of alabama cin 1 negative biopsy normal colposcopy hpv