Kornimate/medical-research-clean huggingface dataset:
measurement algorithm control, optimization, and performance evaluation of the vital usa glucosedetect

Conditions: Diabetes Mellitus

Summary: measurement algorithm control and optimization with subsequent performance evaluation of the vital usa glucosedetect™ during a standardized meal test in patients with diabetes mellitus type 1 and type 2

this study is a combined, open label, prospective, comparative single-center study. the study is separated in 3 consecutive study parts. the first 2 study parts include 16 patients each. in the third study part 16 additional patients will be enrolled. study part 1 and 2 will be used for optimization and validation of the measurement algorithms of the vital usa biosensor. during the third study part with enrolment of 16 additional patients, the precision and accuracy of the final vital usa biosensor algorithm will be demonstrated. the visit schedule for all participants of all 3 study parts will be exactly the same. in all groups of participants, the vital usa non-invasive monitoring biosensor will be individually introduced and assigned. during the experimental study visit, a standardized meal will be given to the participants. before and after the standardized meal, glucose, heart rate, and po2 will be measured using the vital usa monitoring biosensor at time-points -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. the glucose measurements will be compared to capillary blood glucose measurements by ysi stat 2300. parallel measurements of the heart rate and the po2 using a patient monitor will be compared to the device readings.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetic or healthy subject (50 % from each) * subjects who are able to complete informed consent form (by him/herself or by his/her guardian); * 18 years old and above; * anatomically suitable finger in discretion of the investigator exclusion criteria: * does not meet inclusion criteria; * any conditions that may hamper good visual contact between the finger or wrist and sensor, such as raised birthmarks, scars, tattoos; * pregnancy; * nursing mothers; * any skin scratch(es), damage, over dry, long nails on the measured finger; * unsuitable finger with the device might be excluded if recognized during the trial; * medication containing nitrates
database for the assessment of efficacy and safety of bph treatment

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Summary: this registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (bpe) and lower urinary tract symptoms associated with benign prostatic hyperplasia (bph-luts).

this registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (bpe) and lower urinary tract symptoms associated with benign prostatic hyperplasia (bph-luts). clinical, patient reported and imaging data that are assessed in clinical routine will be prospectively collected. all patients that are treated for bpe / bph-luts at our institution will be included if they provide written informed consent. this registry enables us to compare novel treatment option (e.g. prostatic artery embolization; pae) to established interventions (e.g., turp, holep, open prostatectomy, thulep, thulium laser vaporization, tuip) regarding safety and efficacy.

Eligibility criteria:
inclusion criteria: * all patients treated for bph / luts / prostatic obstruction at the urological department of kssg * patient age ≥ 18 years * informed consent provided exclusion criteria: -cognitive impairment not allowing informed consent or adequate data assessment.

Keywords: prostatic artery embolization transurethral prostate resection transurethral electroresection of prostate contact laser ablation of prostate laser enucleation of prostate open prostatectomy
quality of life in pediatric patients with acute lymphoblastic leukemia receiving maintenance chemotherapy

Conditions: Quality of Life

Summary: the purpose of the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (all) receiving maintenance chemotherapy.

health-related quality of life is an important outcome of cancer treatment which encompasses physical, psychological, social, and functional well-being. in addition, quality of life includes one's overall ability to become a productive member of society and achieve personal fulfillment. treatment of pediatric cancer is a highly stressful experience which can be challenging and disruptive to the lives of children and their families. pediatric oncology patients receiving chemotherapy often experience a decline in quality of life due to decreased activity, fatigue, and psychological distress such as depression or anxiety when compared to healthy individuals. preliminary data suggests that there is an association between physical activity and quality of life. exercise has been show to improve mood, increase energy levels, and reduce stress. although more research and clinical resources have been given to the effects of exercise on quality of life among adult cancer patients, there is a lack of research in these areas among children with cancer. the investigators know little about whether children with cancer would benefit from exercise. the investigators have added a blood sample for biomarkers. research in adult cancer patients have shown an association between different biomarkers and sleep quality which suggests that regulation of certain biomarkers may be affected through exercise in adults. measures of biomarkers may provide insight into potential mediators between pa, sleep quality, or fatigue levels.

Eligibility criteria:
inclusion criteria: * pediatric oncology patients with all in the maintenance phase of chemotherapy during the time of study * ages 8-18 years of either gender (age limits due to reliability and validity of outcome assessment surveys) * have no documented or observable psychiatric or neurological disorders that would interfere with study participation * capable of speaking and reading english * having no contraindications to participate in moderate physical exercise as determined by the research staff and the patient's pediatric oncologist * currently living with their parents/legal guardians * consent obtained from legal guardians and assent obtained from patients to participate in the study exclusion criteria: * not a pediatric oncology patient with all in maintenance * not receiving chemotherapy during the time of study * age less than 8 years or greater than 18 years * not english-speaking since not all outcome measures have been validated in spanish and other languages, only english-speaking patients will be included.

Keywords: all cancer patients quality of life fitness
donidalorsen expanded access program for patients with hereditary angioedema

Conditions: Hereditary Angioedema

Summary: the purpose of the expanded access program is to provide pre-approval access of donidalorsen to eligible patients with hereditary angioedema (hae) who complete the isis 721744-cs3 clinical trial.

the expanded access program (eap) is intended to provide pre-approval access to donidalorsen for eligible patients with hae who complete the isis 721744-cs3 clinical trial.

Eligibility criteria:
inclusion criteria: * patients in the isis 721744-cs3 (open-label extension \[ole\] study) who have completed 205 weeks of treatment. * female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity. exclusion criteria: * any patient who is pregnant or plans to become pregnant. * any patient who was withdrawn from the isis 721744-cs3 ole study due to a serious adverse event (sae) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment.

Keywords: hae ionis pkk-lrx donidalorsen isis 721744
collagen scaffolds loaded with hucmscs for the improvement of erectile function in men with diabetes

Conditions: Erectile Dysfunction; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the intent of this clinical study is to answer the questions: 1) is the proposed treatment feasible; 2) is treatment effective in improving the disease pathology of patients with diagnosed diabetic erectile dysfunction.

intracavernous transplantation of stem cells has been shown to improve erectile function in some preclinical studies. however, inadequate cell homing to damaged sites limited its functions. the investigators explore the effect of hucmsc on improving erectile function of diabetic men, and whether collagen scaffolds contribute to long-term cell retention in the corpus cavernous and improves erectile function of diabetic men.

Eligibility criteria:
inclusion criteria: 1. type 1 or 2 diabetes,blood glucose controlled well, no effective with oral pde-5i; 2. have a consistent partner who is willing to engage in sexual activity more than twice per month during the study; 3. males age 20-65 years; 4. iief-5 score is under 16; 5. penile arterial insufficiency or venous leakage (doppler): psv \ 25 cm/sec, edv\>5cm/sec, ri\<0, 75; 6. hba1c is between 6.5% 10%; 7. physical examination with no abnormalities; 8. who is willing to consent to participate in the study follow-up; 9. willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters. exclusion criteria: 1. severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy; 2. positive for human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv) syphilis test; 3. testosterone level is less than 200ng/dl; 4. serum ast/alt \>3\*upper limit of normal or creatinine \>1.5\*upper limit of normal; 5. hba1c exhibit greater than 10%; 6. in the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery; 7. patients partner is trying to conceive during the trial period; 8. exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study; 9. unwilling and/or not able to give written informed consent.

Keywords: erectile dysfunction stem cell collagen scaffold
efficacy of diosmin and hesperidin on early rehabilitation after total knee arthroplasty

Conditions: Total Knee Arthroplasty; Venous Insufficiency of Leg

Summary: the goal of this clinical trial is to find out the efficacy of diosmin and hesperidin on postoperative early rehabilitation after primary total knee arthroplasty. the main questions it aims to answer are: does diosmin and hesperidin combined drug decreases the lower extremity swelling, pain and increases the range of motion after primary total knee arthroplasty surgery compared to standard therapy group? does diosmin and hesperidin combined drug decreases inflammation after total knee arthroplasty surgery. participants will take diosmin and hesperidin in addition to standard therapy for 14 days after total knee arthroplasty surgery. lower extremity swelling, pain and range of motion of the patients will be recorded in every visit.


Eligibility criteria:
inclusion criteria: * patients who underwent unilateral primary total knee replacement surgery * patients who are functionally asa 1, asa 2 or asa 3. exclusion criteria: * patients \>80 years or \<18 years of age * patients with liver insufficiency * patients with allergy to diosmin or hesperidin * patients which are not capable to communicate

Keywords: total knee arthroplasty lower extremity swelling inflammation venous insufficiency pain management
observe alternating hemiplegia of childhood (observ-ahc) study

Conditions: Alternating Hemiplegia

Summary: alternating hemiplegia of childhood (ahc) is a rare and serious disease that is in need of effective, and hopefully even curative, therapies. afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, and frequently severe developmental and psychiatric/psychological disabilities. based on the repeated input from family organizations and from professionals, as expressed at the london 2016 atp1a3 in disease meeting, there are urgent clinical research needs for ahc that are essential to better understand the disease, evaluate its treatment options and plan for future controlled clinical trials. the goal of the study is to evaluate different parameters involved in the evolution of the ahc. the investigating team's hypothesis is that the evolution is variable so it aims to evaluate the factors which could contribute to the progression of the disease.


Eligibility criteria:
inclusion criteria: - patients who fit the aicardi alternating hemiplegia of childhood clinical criteria of any age. the aicardi criteria are six : * paroxysmal hemiplegia episodes. * bilateral hemiplegia or quadriplegia episodes. * other paroxysmal manifestations, such as abnormal eye movements, nystagmus, strabismus, ataxia, dystonia, choreoathetosis, tonic spells, or autonomic disturbances. * evidence of permanent neurological dysfunction, which can manifest as cognitive impairment, developmental delay, and/or persistent motor deficits such as spastic diplegia/quadriplegia, hypotonia, ataxia, choreoathetosis, or dystonia. * sleep relieves symptoms, although attacks may resume soon after awakening. * first signs of dysfunction occur prior to the age of 18 months. exclusion criteria: * patients who do not have a mutation of the atp1a3 gene and having only some of the above criteria * patients and / or their parents / legal guardian having provided their opposition to the study. * incapacity of patient / parent or other referent adult to participate in the prospective phase of observation of different paroxysmal events of the disease and in the scoring of the vineland ii adaptive behavior scales. * diagnosis of another disease, which could explain the presence of symptoms mentioned in the criteria of aicardi.
bci for hemiparetic upper extremities in patients due to stroke

Conditions: Stroke; Brain Computer Interface

Summary: non-invasive brain-computer interface (bci) technology is one of the new training approaches to achieve motor restoration through a closed-loop system from brain activity through event-related desynchronization (erd) after motor imagery (mi) or movement attempt to peripheral feedback triggered by an external hepatic device. often, it is unclear whether the bci intervention itself or the assistance of the external device leads to neural responses and functional gains. this study adopts a closed-loop bci system involving erd induced by mi. functional electrical stimulation (fes) and virtual reality (vr) are simultaneously delivered as feedback. the aim is to investigate the efficacy of closed-loop bci training combined with fes and vr on the recovery of the hemiparetic upper extremity of individuals with chronic stroke. chronic stroke survivors are being recruited and randomly allocated into 3 groups: (1) bci-fes-vr - participants look at an external screen displaying the vr avatar participant's arms while performing wrist dorsiflexion mi in random order (left or right). the bci system detects the erd of the motor area corresponding to correct mi. then, visual feedback with the vr and motor-tactile feedback with the discharge of the fes is delivered; (2) bci-fes - same procedure as group 1, but the difference is that the participant's hands replace the vr system; (3) bci-vr - same procedure as group 1, but the fes is removed. each session requires 240 mi trials with a training duration of 10 sessions in a 3-week interval. motor and mi assessments are being conducted at post-assessment and at a 3-week follow-up. the findings of this study will provide significant new information regarding neurophysiological motor relearning mechanisms, which could inform the development and evaluation of bci-based treatment for individuals with stroke and impact the field of translational neuroscience.


Eligibility criteria:
inclusion criteria: 1. have a diagnosis of ischemic or hemorrhagic stroke to unilateral hemisphere, confirmed by neuroimaging examinations, i.e., brain ct or mri; 2. chronic phase of stroke, i.e., time after stroke onset more than 6 months; 3. between 18 and 64 years old; 4. with severe to moderate levels of hemiparetic upper limb impairment due to stroke, i.e., from levels 1 to 4 in the functional test for the hemiplegic upper extremity (fthue) 5. able to give informed written consent to participate in the study. exclusion criteria: 1. previous diagnosis of any neurological disease excluding stroke; 2. presence of any sign of cognitive problems (abbreviated mental test \< 6) 3. modified ashworth score \> 2 in wrist extensor muscle in the hemiparetic upper extremity after stroke (bohannon and smith, 1987) or with severe pain that hinders upper extremity movement 4. with other notable impairments of the upper extremity not caused by stroke (e.g., fracture, rheumatoid arthritis, or congenital deformity, etc.)

Keywords: stroke brain computer interface neurorehabilitation event related desynchronization
myocardial dysfunction evaluation in lower extremity arterial disease patients with deformation analysis

Conditions: Peripheral Artery Disease; Heart Failure

Summary: single centre observational study to assess lower extremity arterial disease (lead) patients' cardiac dysfunction with strain analyses and to assess connections between cardiac dysfunction, metabolomic changes and target organ damage in lead.


Eligibility criteria:
inclusion criteria in lead group: * fontaine i-iv class symptoms * confirmed diagnosis of lead inclusion criteria in control group: * age 35-85 * has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes exclusion criteria: * age \ 85 years * bmi ≥40 kg/m² * known heart failure in history * any acute or chronic autoimmune or rheumatic disease * cardiac structural disease in history: inflammatory, infiltrative diseases, nonischemic cardiomyopathies * acute coronary syndrome in last 3 months * moderate to severe cardiac valvular disease * cardiac valvular disease operative/invasive treatment in history * cardiac implantable electronic device (cied) * transitory ischemic attack or stroke in last 3 months * severe copd (gold c or d) * moderate to severe asthma (according to gina 2022 criteria) * untreated hypertension (noninvasive blood pressure measurement ≥180/110 mmhg during recruitment) * chronic severe kidney dysfunction (egfr \<30 ml/min/1,73 m²) * malignant tumor with radiation treatment to thorax, oncologic or biologic treatment in history * chronic hematologic disease (except for anemia) * severe liver dysfunction * malignant tumor with \<5 years of remission * acute or chronic infectious disease * anemia with hemoglobin \<80 g/l
active pharmacovigilance study of adsorbed covid-19 (inactivated) vaccine

Conditions: SARS-CoV-2 Acute Respiratory Disease

Summary: this is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the adsorbed covid-19 (inactivated) vaccine sinovac / institute butantan.

. this is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the adsorbed covid-19 (inactivated) vaccine sinovac / institute butantan. * the immunization schedule is two doses intramuscular injections (deltoid) with a 14-28 days interval. * there will be 900 participants (300 health care professionals between 18 and 59 years old); 300 participants 75 years old or more; 300 participants between 60 and 74 years old. all participants must be allowed to receive the adsorbed covid-19 (inactivated) vaccine according to the brazilian immunization national plan. * for safety analysis , the incidence of adverse events after receiving the adsorbed covid-19 (inactivated) vaccine that needed health assistance until 42 days after two-doses immunization schedule. * the total period of participation in the study will be approximately 60 days after completing the two-dose schedule of the vaccine. * active pharmacovigilance studies are essential to assess the safety profile of the vaccine in subgroups that will be included as target populations in the immunization program.

Eligibility criteria:
inclusion criteria: * adult allowed to receive the adsorbed covid-19 (inactivated) vaccine according to the immunization national plan. * informed consent form signed by participant. * show voluntary intention to participate in the study and availability throughout the study. exclusion criteria: * history of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine. * history of fever (axillar temperature ≥ 37,8º c) 72 hours before the vaccine * be unavailable during the study period. * any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.

Keywords: covid-19 adsorbed covid-19 vaccine (inactivated) pharmacovigilance
the comparison efficacy of azithromycin with doxycycline in the treatment of acne vulgaris

Conditions: Acne

Summary: a comparison of efficacy and adverse side effects occurrence of doxycycline and azithromycin in the management of moderate acne vulgaris


Eligibility criteria:
inclusion criteria: * between 18 to 30 year old * moderate facial acne(at least 10 inflammatory lesions with maximum 3 nodules and pseudocysts exclusion criteria: * pregnancy * breast feeding * acne fulminant * acne conglobate * isotretinoin therapy within past 6 months * topical treatment in last 2 weeks * use of systemic antibiotic in the last month * hyperandrogenism symptoms * menstrual irregularity

Keywords: acne azithromycin doxycycline
a study to evaluate the antiviral activity and safety of hh-003 injection in subjects with chronic hepatitis b and hepatitis d co-infection

Conditions: Chronic Hepatitis B and Hepatitis D Co-infection

Summary: this is an open-label phase iia study of hh-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis b and hepatitis d co-infection. hh-003 is a human monoclonal antibody targeting the pre-s1 domain of the hbv large envelope protein. it blocks engagement of pres1 with sodium taurocholate co-transporting polypeptide (ntcp), the cellular receptor for hbv/hdv.


Eligibility criteria:
inclusion criteria: * signed informed consent form; * male or female subjects aged from 18 to 70 years inclusively; * 18 kg/m2≤bmi≤32 kg/m2, body weight ≥45 kg for men and ≥40 kg for women; * positive hbsag, anti-hdv igg antibody and hdv rna at screening; * women of childbearing potential or male subjects with female partners of childbearing potential should agree to use an adequate and highly effective contraceptions from screening to the end of study or until 12 weeks after last dose of the study drug (whichever is longer). exclusion criteria: * be pregnant or lactating at screening; * subjects with decompensated liver cirrhosis; * subjects with liver dysfunction (including but not limited to ascites, hepatic encephalopathy and upper gastrointestinal bleeding) within 3 months prior to screening; * average daily alcohol consumption \>40g for men and \>20g for women or drug abuse within 6 months prior to screening; * subjects with other serious diseases that is inappropriate for study participation per the investigator's or the sponsor's discretion (including but not limited to serious cardiac or pulmonary disease, chronic or recurrent urinary disorders, uncontrolled diabetes and autoimmune diseases, epilepsy requiring treatment); * history of hepatocellular carcinoma (hcc) or hepatocellular carcinoma suggested by liver histopathology or liver imaging; * interferon antiviral therapy within 1 year prior to screening.