Kornimate/medical-research-clean huggingface dataset:
to compare the efficacy and safety of ins068 and insulin glargine in subjects with type 2 diabetes mellitus treated with basal insulin.

Conditions: Type 2 Diabetes Mellitus

Summary: the study aims to evaluate the efficacy and safety of ins068 once daily (qd) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin glargine qd for 26weeks.


Eligibility criteria:
inclusion criteria: 1. diagnosed with type 2 diabetes≥ 6 months; 2. hba1c 7.0% \~ 10.0% (both inclusive) at screening; 3. treated with basal insulin ≥10u /day for at least 8 weeks prior to screening. exclusion criteria: 1. known or suspected allergy or intolerance to investigational medicinal products or related products. 2. hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months. 3. potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months. 4. received premixed insulin, mealtime insulin, or insulin pump therapy within 8 weeks prior to screening. 5. participated in clinical trials of any approved or unapproved investigational drug/treatment within the previous 1 month or 5 half-life period, whichever is longer, prior to screening. 6. women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential are reluctant to use appropriate contraception during the trial and for at least 14 days after the last dose of the investigational medicinal drug; anycircumstances that the investigator judges might not be suitable to participate in the trial..
assessment with gait analysis of robotic total knee arthroplasty using inverse kinematic alignment

Conditions: Osteoarthritis, Knee

Summary: postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after tka procedurs. implant positioning and component alignment are determining factors in patient outcome. currently, different alignment strategies in tka surgery are used such as mechanical alignment (ma) and kinematical alignment (ka). recently, a new and individualized alignment strategy (inverse kinematic alignment/ika) was introduced. preliminary 1-year results of ika are promising, however, clinical and functional outcome on the medium and longterm should be investigated. this project aims to compare patients with ika tka with ma tka on clinical, functional and biomechanical outcomes.


Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained prior to any screening procedures 2. received a primary total knee replacement (incl. patella) robotically-assisted 3. male or female 4. age between 50 and 80 5. able to walk independently exclusion criteria: 1. revision surgery 2. patient with a history of neurological, psychiatric or neurodegenerative disease 3. any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. 4. other musculoskeletal lesions that may affect the gait pattern

Keywords: total knee arthroplasty robotic surgery alignment inverse kinematic alignment mechanical alignment gait analysis performance testing
renal cancer detection using convolutional neural networks

Conditions: Kidney Cancer

Summary: we aim to experiment and implement various deep learning architectures in order to achieve human-level accuracy in computer-aided diagnosis (cad) systems. in particular, we are interested in detecting renal tumors from ct urography scans in this project. we would like to classify renal tumor to cancer, non cancer, renal cyst i, renal cyst ii, renal cyst iii and renal cyst vi, with high sensitivity and low false positive rate using various types of convolutional neural networks (cnn). this task can be considered as the first step in building cad systems for renal cancer diagnosis. moreover, by automating this task, we can significantly reduce the time for the radiologists to create large-scale labeled datasets of ct-urography scans.

we aim to experiment and implement various deep learning architectures in order to achieve human-level accuracy in computer-aided diagnosis (cad) systems. in particular, we are interested in detecting renal tumors from ct urography scans in this project. we would like to classify renal tumor to cancer, non cancer, renal cyst i, renal cyst ii, renal cyst iii and renal cyst vi, with high sensitivity and low false positive rate using various types of convolutional neural networks (cnn). this task can be considered as the first step in building cad systems for renal cancer diagnosis. moreover, by automating this task, we can significantly reduce the time for the radiologists to create large-scale labeled datasets of ct-urography scans.

Eligibility criteria:
inclusion criteria: * all patient with rcc, who underwent surgery exclusion criteria: * patients with rcc, who did not underwent surgery

Keywords: renal cancer machine learning
autonomic cardiovascular neuropathy in recently diagnosed dm2 patients (acndm2)

Conditions: Dysautonomia

Summary: the investigators are studying the initial autonomic alterations in participants recently diagnosed with dm2 and in those patients classified as pre-diabetes, mainly focused on the baroreceptor sensitivity and on the peripheral sympathetic innervation.

until now the autonomic dysfunction in diabetes mellitus type 2 (dm2)has been broadly studied in long term patients. thus, clinical features as cardiac autonomic neuropathy (can) and the lack of the baroreceptor reflex were widely described in patients with a long standing diabetes. however, there hasn´t been a description of the initial autonomic imbalance in both pre-diabetes and recently diagnosed dm2 patients. this is the goal of the present research study, to assess the autonomic dysfunction among these sets of patients. yet can is finding mostly happening in late stages of dm2 and so the lack of baroreceptor reflex sensitivity there are other subtle indicators of dysautonomia which hasn't been extensively analyzed. in fact, rest tachycardia and orthostatic intolerance may point to an early dysautonomia. a description of the impairment of the cardiovascular autonomic regulation is still missing. therefore, the investigators intend to evaluate this regulation through the means of a task force system.

Eligibility criteria:
inclusion criteria: * patients who have not suffered hypertension, parkinson diseae, parkinsonic syndrome, guillain-barré disease, myocardial infarction, obesity nor ischemic stroke exclusion criteria: * those older than 55 years old, or younger than 18 years old. * those who have suffered hypertension, parkinson diseae, parkinsonic syndrome, guillain-barré disease, myocardial infarction, obesity or ischemic stroke

Keywords: diabetes autonomic cardiovascular
pectin supplemented enteral feedings in critically ill patients

Conditions: Enteral Nutrition; Dietary Fiber

Summary: the current study will enroll critically ill patients who are going to require enteral nutrition support and randomize them to standard formula enteral nutrition or pectin-supplemented enteral nutrition in 7 days. the occurrence of enteral nutrition-related complications will be recorded and compared between groups. the study is trying to assess whether the use of pectin will improve the enteral nutrition-related complications in critically ill patients.


Eligibility criteria:
inclusion criteria: * patients aged 18-80 years old, with informed consent to participate; * critically ill patients who require enteral nutrition support exclusion criteria: * patients with lung infection at admission * condition which contraindicates enteral feeding (i.e. intestinal obstruction) * lack of enteral access * any condition that would contraindicate use of the enteral nutrition * require enteral nutrition support for less than 1week or more than 4 weeks from enrollment
screening for tb in pregnancy. on hiv-infected pregnant women

Conditions: Tuberculosis

Summary: pregnant women who develop active tuberculosis (tb) are at increased risk of poor maternal and infant outcomes. our data from south africa show that up to 3% of hiv-infected pregnant women have active tb , many with advanced disease, contributing to the 40% of maternal mortality associated with tb or hiv in south africa . screening for tb in pregnant women in this setting is therefore essential to reduce maternal mortality. symptom-directed screening for tb has been recommended by the world health organization and by the south african national department of health; however, no implementation framework is in place to operationalize the guidelines. symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. in soweto, we found that 0.7% (700/100,000) of hiv-infected women had active tb when a symptom-based strategy was employed once, but in klerksdorp we found that 3.3% (3,300/100,000) had active tb when universal testing, regardless of symptoms, was performed; most tb cases were newly diagnosed among women who reported no symptoms .


Eligibility criteria:
inclusion criteria: 1. hiv seropositive by two rapid tests, or documented history of a positive enzyme immunoassay eias, or hiv rna \>1000 copies/ml 2. pregnancy confirmed by urine pregnancy test or clinical exam 3. estimated gestational age of 13 weeks or older 4. age 18 years or greater 5. willing to provide verbal consent exclusion criteria: 1. currently diagnosed with tb 2. completed tb treatment within the last 6 months 3. inability to communicate in one of the study languages. 4. lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.
longitudinal follow-up in women with endometrial hyperplasia without atypia

Conditions: Female

Summary: this study will prospectively enroll a total of 1000 patients (200 per year) simple hyperplasia/complex hyperplasia (sh/ch) without atypia. all subjects will receive education for exercise and weight control and be randomized 1:1 to with or without metformin intervention. at the end of this 3-year project, an interim analysis will be performed. since long-term follow-up is intended, therefore for the 4th to 6th year a new grant support will be looked for. the long-term occurrence of endometrial cancer (up to15 years) data will be acquired from national cancer registry, which permission is addressed in the informed sent.

the first year: (1) the cumulative progression rate of sh/ch without atypia to endometrial cancer (ec) of the 1989-2011 cohort will be investigated by linking with national health databases from health and welfare data science center (hwdc); (2) prospectively enroll 200 patients with sh/ch without atypia and deliver education for exercise and weight control and collect the related biospecimens and data; (3) 1:1 randomized to with or without metformin intervention. the 2nd year: (1) analyze the whole genome sequencing (wgs) data of those progressed and non-progressed ; (2) analyze the metabolomic data in relation to exercise and weight control data. the 3rd year: (1) validate microrna (mir) panel in tissues and sera selected by cmrpg3g1511-3; (2) analyze data of mir panel, degree of exercise/weight control, clinical lab data, and demographic data on ec progression rate; (3) incremental predicting proficiency of the model including metabolomics data and wgs.

Eligibility criteria:
inclusion criteria: 1. women aged ≧ 20 years 2. histological diagnosis of sh/ch without atypia 3. not taking metformin for diabetes mellitus currently 4. adequate kidney function 5. provided informed consent within 3 months of diagnosis 6. no previous history of breast cancer with tamoxifen use 7. willing to be followed for 5 years exclusion criteria: 1. atypical hyperplasia or ec found within 3 months after enrollment 2. history or concurrent gynecologic cancers or cervical intraepithelial neoplasia 3. pregnancy test positive 4. history of intolerance to metformin 5. family history of hnpcc

Keywords: simple hyperplasia metformain
registry of patients treated with plerixafor (mozobil®) for haematopoietic stem cell mobilization before autologous transplantation

Conditions: Bone Marrow / Autologous Transplants

Summary: the aim of this registry is to provide information, in day-to-day practice, on plerixafor prescription modalities in france, over a 13-month period in order to address the health authorities' request.


Eligibility criteria:
inclusion criteria: * patients treated with plerixafor for autologous transplantation between november 2011 and november 2012 * patients who have been informed and who have given their written consent for the access to their medical file exclusion criteria: * patients already included in a plerixafor ongoing clinical trial.

Keywords: autologous stem cell transplantation lymphoma multiple myeloma
feasibility study of the self-care immediate stabilization procedure (isp) ® after a traumatic experience

Conditions: Post-traumatic Stress Disorder; Acute Stress Disorder

Summary: the study aims to assess the feasibility of an online intervention platform based on the immediate stabilization procedure (isp®). this intervention targets early trauma reactions, aiming to reduce the risk of future ptsd.

the primary objective of this study is to assess the effectiveness and feasibility of an immediate stabilization procedure adapted for online self-usage. this procedure relies on the eye movement desensitization and reprocessing (emdr) treatment, a well-known approach for post-traumatic responses. it involves bilateral stimulation of the brain's hemispheres through tapping on the body (i.e., the 'butterfly hug') and positive therapist statements during the tapping process. key advantages of this protocol include: 1) prevents long-term post-traumatic symptoms; 2) short intervention - takes 5-20 minutes on average; 3) simple procedure that does not require recalling traumatic memories; 4) could be administered by non-mental health experts. the isp® protocol was found effective and safe in israel (face-to-face) and the ukraine (remote). in addition, online variations of the protocol for self-usage have been utilized globally. the on-going state of war emphasizes the critical need for immediate emotional support. a collaborative group involving researchers, mental health clinicians, and software engineers adapted the isp® protocol for online self-usage. the current study aims to evaluate the efficiency of this intervention.

Eligibility criteria:
inclusion criteria: 1. hebrew speakers 2. age 18 years or older 3. have been in israel since october 7th 2023 (the start of the war) 4. were exposed to traumatic events during the war (alarms, participated in battles, were attacked by terrorists, etcetera) 5. access to pc/smartphone 6. basic technological skills, ability to use the internet and email. exclusion criteria: 1. diagnosed with psychotic conditions. 2. diagnosed with ptsd or complex ptsd. 3. diagnosed with alcohol use disorder or drug abuse disorder. 4. suicidal ideation 5. treated with medication, psychotherapy, or any other mental treatment about 10 randomly selected subjects will perform the intervention while recorded via zoom in the presence of a research assistant. this will allow us to assess the way subjects utilize this intervention.

Keywords: post-traumatic stress disorder (ptsd) emdr (eye movement desensitization reprocessing) immediate stabilization procedure [ips(r)] the 'butterfly hug' acute stress disorder
influence of gender specific differences of saliva composition on the development of dental erosion - an in-situ study

Conditions: Dental Erosion

Summary: healthy volunteers are observationally wearing an intraoral device with bovine tooth samples once for two hours. afterwards, calcium release from the bovine enamel and dentin samples is measured after extraoral erosion. total protein concentration within the formed salivary pellicles on the bovine samples is determined. further salivary parameters (unstimulated and stimulated saliva flow rate, ph, buffer capacity, albumin and total protein content as well as concentration of inorganic calcium, phosphate and fluoride) are being measured. the aim of this study is to investigate whether gender differences in the salivary composition correlate with predisposition to erosion.


Eligibility criteria:
inclusion criteria: * healthy probands aged between 20 and 40 years who are able to give written consent exclusion criteria: * non-fulfillment of the inclusion criteria * smoking * hyposalivation / xerostomia (unstimulated saliva \< 0.3 ml/min, stimulated saliva \< 0.7 ml/min) * intake of any medication (except contraceptives in women) * pregnant or lactating women * known allergies to substances used in the study * orthodontic treatment or malfunction which doesn't allow to wear an intraoral device
acrysof® toric natural t9 intraocular lens (iol)

Conditions: Bilateral Cataract

Summary: the purpose of this study is to describe rates of spatial distortions related to intraocular lens (iol) misalignment for acrysof® single-piece toric natural iol model sn60t9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. subjects were implanted with the model sn60t9 in the first operative (study) eye and either model sn60t9 or model sn60t8 in the second operative eye.


Eligibility criteria:
inclusion criteria: * adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts; * calculated lens power is within the available range; * willing and able to complete all required postoperative visits; * planned cataract removal by phacoemulsification; * potential postoperative visual acuity of 0.2 logmar or better in study eyes; * preoperative astigmatism of 4.11 - 4.62 diopter (d) of predicted crossed cylinder as calculated by the study specific web-based alcon® toric iol calculator in the first operative eye. corneal incisions made to reduce astigmatism will not be allowed during the course of the study; * preoperative astigmatism of 3.60 - 4.62 d of predicted crossed cylinder as calculated by study specific web-based alcon® toric iol calculator in the second operative eye; * clear intraocular media other than cataract; * able to comprehend and sign a statement of informed consent; * preoperative best corrected distance visual acuity (bcdva) worse than 0.2 logmar; * pupil size greater than or equal to 6 mm after dilation; * the subject must be able to undergo second eye surgery within 30 days of first eye surgery. exclusion criteria: * irregular corneal astigmatism; * keratopathy/keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana; * any inflammation or edema (swelling) of the cornea, including but not limited to the following; keratitis, keratoconjunctivitis, and keratouveitis; * previous corneal refractive surgery; * subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logmar; * amblyopia; * clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy); * diabetic retinopathy; * extremely shallow anterior chamber, not due to swollen cataract; * microphthalmos; * previous retinal detachment; * previous corneal transplant; * recurrent severe anterior or posterior segment inflammation of unknown etiology; * rubella or traumatic cataract; * iris neovascularization; * uncontrolled glaucoma; * aniridia; * optic nerve atrophy; * pregnancy; * any subject currently participating in another investigational drug or device study that may confound the results of this investigation.

Keywords: astigmatism cataract corneal astigmatism iol acrysof
helmet niv in acute respiratory failure

Conditions: Acute Respiratory Failure

Summary: non-invasive ventilation (niv) is a form of respiratory support that has been shown to prevent invasive mechanical ventilation and reduce mortality. this study will investigate the feasibility of performing a larger study examining whether a new modality of niv, the helmet, is superior to the current face mask in reducing mortality in patients with sudden respiratory failure.


Eligibility criteria:
inclusion criteria: * 1) patients who are admitted to the adult icu * 2) deemed to require niv, as per the clinical team, for acute respiratory failure. exclusion criteria: * 1) with impending cardiac arrest or need for intubation * 2) glasgow coma scale \<9 * 3) tracheostomy or upper airway obstruction * 4) elevated intracranial pressure * 5) untreated pneumothorax * 6) who refuse endotracheal intubation (do not intubate order documented) * 7) facial trauma * 8) are unable to wear the helmet or facemask * 9) who use niv chronically

Keywords: non-invasive ventilation helmet non-invasive ventilation
pt001 mdi versus spiriva® in patients with moderate to severe copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the overall objective of this study is to determine an optimal dose and dosing regimen of pt001 mdi for further evaluation in later stage studies.

the primary objective of this study is to assess efficacy relative to placebo of gp mdi in subjects with moderate to severe chronic obstructive pulmonary disease (copd) within the range of doses evaluated in this protocol. to this end, each dose of gp mdi will be compared to placebo with respect to the primary efficacy endpoint, fev1 auc0-12 relative to baseline.

Eligibility criteria:
inclusion criteria: * signed written informed consent * 40 - 80 years of age * clinical history of copd with airflow limitation that is not fully reversible * females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods * current/former smokers with at least a 10 pack-year history of cigarette smoking * a measured post- bronchodilator fev1/fvc ratio of \< or = 0.70 * a measured post- bronchodilator fev1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * able to change copd treatment as required by protocol exclusion criteria: * women who are pregnant or lactating * primary diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * active pulmonary diseases * prior lung volume reduction surgery * abnormal chest x-ray (or ct scan) not due to the presence of copd * hospitalized due to poorly controlled copd within 3 months of screening * clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ecg, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * cancer that has not been in complete remission for at least 5 years * treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives other inclusion/exclusion criteria as defined in the protocol

Keywords: copd