Kornimate/medical-research-clean huggingface dataset:
study in healthy volunteers to prove that two different formulations of rotigotine patches deliver equivalent drug amount to the body

Conditions: Healthy Volunteers

Summary: the major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two rotigotine patches of two different formulations


Eligibility criteria:
inclusion criteria: * healthy white, male volunteers between 18 and 55 years of age (inclusive). * bmi between 19 and 28 kg/m\^2 (inclusive) exclusion criteria: * previous participation in a clinical study with rotigotine * history or current condition of epilepsy and/or seizures * known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity * history of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis * history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease * clinically relevant abnormality in physical examination, ecg, vital signs or safety laboratory examinations * positive hiv, hepatitis b or c test or positive alcohol or drug test * relevant hepatic or renal dysfunction * intake of medication that might interfere with the test drug within 2 weeks prior to dosing

Keywords: rotigotine neupro® transdermal patch
chronic ankle instability and proprioception

Conditions: Chronic Ankle Sprains

Summary: the purpose of this investigation is to determine the effects of chronic ankle instability on cervical spine and knee proprioception as measured using joint position sense to investigate whether correlation can be drawn between the two.


Eligibility criteria:
inclusion criteria: * history of ankle instability * ages 20-65 yoa exclusion criteria: - recent surgery, have any unstable or fused joints of the cervical spine. * medications, prescription or herbal muscle stimulants, relaxants. * any previ

Keywords: sprain proprioception
clinical evaluation of a point-of-care (poc), sars-cov-2 (covid-19) igg antibody test in fingerstick whole blood

Conditions: SARS-Cov-2, Covid19

Summary: prospective, multi-center, observational, blinded clinical trial to compare a new point of care (poc) sars-cov-2 igg antibody test to a reference sars-cov-2 pcr test using fingerstick whole blood.

patients with pcr testing in outpatient setting will be screened and asked to participate in the study. subjects with a positive diagnosis of covid-19 confirmed by a positive, eua sars-cov-2 pcr test will be stratified by the number of days since first symptom onset (i.e. 0-7, 8-14, or \>15 days) in the positive cohort subjects with a negative diagnosis of covid-19 confirmed by a negative, eua sars-cov-2 pcr test within 0-7 days of pcr sample collection will be included in the negative cohort. treating clinicians, clinical research coordinators and study subjects will be blinded to the poc test results. quality assurance will be assured with site monitoring to check accuracy and completeness of data entered.

Eligibility criteria:
positive cohort inclusion criteria: * patients with high-sensitive eua pcr results (positive result) * previous diagnostic of sars-cov-2 * signed informed consent exclusion criteria: * missing pcr results * results from a non-high-sensitive pcr test negative cohort inclusion criteria: * patients with high-sensitive eua pcr results (negative result) * signed informed consent exclusion criteria: * missing pcr results * results from a non-high-sensitive pcr test * previous diagnostic of sars-cov-2 * history of a positive sars-cov-2 antibody test (igg, igm or total antibody) * negative sars-cov-2 pcr result that occurred \> 7 days from study visit

Keywords: igg point of care testing eua
a phase 3 trial of the effect of motavizumab prophylaxis on reduction of serious early childhood wheezing in infants

Conditions: Wheezing

Summary: the primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first rsv season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.

the primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (im) injection during the first rsv season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.

Eligibility criteria:
inclusion criteria: * male or female infants born at 32 \& 1/7 - 35 \& 0/7 weeks ga, determined according to available medical records * chronological age of \<6 months of age at randomization * in good health, in the opinion of the investigator * not more than one of the following aap-defined risk factors: 1. childcare attendance 2. school-aged siblings 3. exposure to environmental air pollutants (not including passive exposure to tobacco smoke) * ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures * written informed consent obtained from the subject's parent(s) or legal guardian exclusion criteria: * diagnosis of cld of prematurity (also referred to as bpd) or other chronic pulmonary diseases * diagnosis of hemodynamically significant chd, defined as requiring medication or supplemental oxygen for their chd * congenital abnormalities of the airways * severe neuromuscular disease, as determined by the investigator * previous or concurrent treatment with palivizumab or intravenous immunoglobulin (ivig) * eligible for prophylaxis based on local medical standards and guidelines at participating sites * known immunodeficiency * previous or current diagnosis of an upper or lower respiratory infection by a medical professional * previous or current diagnosis of wheezing, asthma, or other wheezing-related diagnoses * hospitalization at the time of enrollment (in case admitted to nursery as part of routine care, infant should only be randomized immediately prior to being discharged) * any illness or condition that would preclude long-term survival * participation in a trial or an investigational agent for rsv prophylaxis or therapy * inability to be followed through their 3rd birthday

Keywords: good health
vitrectomy for optic disc pit maculopathy

Conditions: Optic Disc Pit Maculopathy

Summary: the purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or laser photocoagulation to the margin of the optic nerve, for the treatment of macular detachment associated with optic disc pits and to characterize retinal manifestations during treatment of optic pit maculopathy using optical coherence tomography (oct). vitrectomy with induction of a pvd at the optic disc without gas tamponade or laser photocoagulation appears to be an effective method of managing macular detachment due to optic disc pits. oct scanning pre- and postoperatively suggests that peripapillary vitreous traction with the passage of fluid into the retina through the pit is the cause of the schisis-like separation seen in optic disc pit maculopathy.


Eligibility criteria:
inclusion criteria: * eyes with optic disc pit maculopathy exclusion criteria: * eyes without macular elevation associated with optic disc pit

Keywords: optic disc pit retinal detachment retinoschisis vitrectomy posterior vitreous detachment
multidetector computed tomography (mdct) evaluation of obstructive jaundice: a cross-sectional study from a tertiary hospital of nepal

Conditions: Obstuctive Jaundice; Radiological Correlation of Obstructive Jaundice

Summary: this study was done to evaluate the diagnostic statistics of mdct and its features in the assessment of obstructive jaundice in reference to surgical or histopathological diagnosis.

we did a cross-sectional study among 30 participants of obstructive jaundice at bp koirala institute of health sciences (bpkihs), dharan, nepal. the sensitivity and the negative predictive value of mdct for non-neoplastic cause to detect obstructive jaundice were 100% (95% ci 79.41-100.00) and 100% (95% ci 75.29-100.00), while the specificity and the positive predictive value for neoplastic cause to detect obstructive jaundice were 100% (95% ci: 79.41-100.00) and 100% (95% ci: 75.29-100.00). similarly, the accuracy for either non-neoplastic or neoplastic cause was 96.67% (95% ci: 82.78-99.92). the most common cause for obstructive jaundice was choledocholithiasis (33.34%) followed by cholangiocarcinoma (20%), ampullary carcinoma (13.33%) and choledochal cyst (13.33%). the diagnostic accuracy of individual etiology of common causes of obstructive jaundice ranged from 82.78 to 100%. biliary obstruction was most frequently observed in the periampullary region (83.33%), followed by the proximal common bile duct (6.67%), hilar region (6.67%), and intrahepatic region (3.33%).the mdct could serve as the initial, cost-effective, easily available, and time-efficient imaging modality for diagnosing various causes of obstructive jaundice. it can differentiate non-neoplastic from neoplastic causes of obstructive jaundice.

Eligibility criteria:
inclusion criteria: * any patient referred for ct scan with findings suggestive of obstructive jaundice with pertinent histopathological and post-surgical findings . exclusion criteria: * patients with contraindications for contrast-enhanced ct, those with non-obstructive cases of jaundice, and patients experiencing recurrent malignancy causing obstructive jaundice.
prostate ablation registry and database for information, surveillance, and evaluation (paradise)

Conditions: Prostate Cancer

Summary: prostate cancer (pca) is the most commonly diagnosed non-cutaneous cancer of men in the world. in 2023 alone, it is estimated that 288,300 us men will be diagnosed with prostate cancer and 34,700 will die from the disease despite the approval of multiple systemic agents. due to advances in screening and imaging technology, pca is now detected much earlier in its disease course. prostate gland ablation for prostate cancer might provide the option for a "middle" ground between active surveillance (as) and radical therapy by destroying prostate cancer in a minimally invasive or non-invasive fashion and thus limiting the morbidity. this treatment strategy is increasingly being offered to patients due to low morbidity but the data on long term oncologic efficacy and side effect profile is lacking for such a treatment strategy. the purpose of this study is to create a database and prospective registry for data collection on patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. patients with biopsy-proven prostate cancer of any gleason grade will be entered into the registry as long as prostate ablation is used as the prostate cancer management modality. historical data from 2017 to the present time will be added through chart review. current and future patient data will be collected through chart review during the subject's clinical care. only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. no biospecimens will be collected, and there are no physical risks from study participation.


Eligibility criteria:
inclusion criteria: * male sex * ≥22 years of age * histologic diagnosis of prostate cancer * scheduled to undergo or have already undergone ablation of the prostate as part of routine clinical care or any ongoing clinical trials * prostate ablation performed with any of the following energy sources: cryotherapy, high-intensity focused ultrasound, irreversible electroporation, laser, microwave, radiofrequency ablation, or photodynamic therapy. newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins exclusion criteria: * under 21 years of age.
performance and safety of hyalo gyn gel on the treatment of vaginal atrophy in postmenopausal women

Conditions: Vulvovaginal Atrophy

Summary: this clinical investigation evaluates the performance and safety of hyalo gyn, a hyaluronic acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.


Eligibility criteria:
inclusion criteria: * postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum fsh levels \>40 iu/l), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen). * women between 18 and 75 years of age. * vaginal ph ≥5. * vulvovaginal atrophy with vhi \< 15. * at least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity. * women with active sex life. * patients who give written informed consent to participate in the trial. exclusion criteria: * treatment with another investigational product within the previous 3 months. * previous participation in any clinical study with hydeal-d based investigational products. * patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week * patients in previous treatment with either oral or topical hormonal products within 1 month. * patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (bv); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen. * patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors. * positive history of hypersensitivity hyaluronic acid or to any component of the medical device. * any condition in the investigator's opinion not suitable for the inclusion of the patient.

Keywords: hyaluronic acid post-menopause
pilot study of of renal arterial sympathetic denervation by cryotherapy

Conditions: Hypertension

Summary: non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. during surgery the renal arteries are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. another 5 patients that are not subjected to the freeze therapy serve as controls. main outcome is change in ambulatory blood pressure levels.

non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. during the surgery the renal arteries at both sides are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. renal arterial blood flow is checked by doppler after the freezing procedure, during the surgery. another 5 patients that are not subjected to the freeze therapy serve as controls. main outcome is change in 24h ambulatory blood pressure levels and of course safety parameters such as creatinine levels.

Eligibility criteria:
inclusion criteria: * planned prophylactic surgery for abdominal aortic aneurysm exclusion criteria: * hypotension, * inability to understand study protocol
pretreatment of patients expecting bariatric surgery with the glp-1 analogon liraglutid

Conditions: Obesity

Summary: the aim of this study is to investigate the effect of the treatment with the glp-1 analogon liraglutide on the lipid metabolism an inflammation in adipose tissue.

the aim of this study is to investigate the effect of the treatment with the glp-1 analogon liraglutide on the lipid metabolism an inflammation in adipose tissue. as glp-1 is presumed to improve insulin sensitivity and associated parameters the investigators hypothesize that this might be due to changes in lipid metabolism which might be involved in the regulation of insulin sensitivity. therefore the investigators intend to investigate changes of metabolic pathways before and after treatment with the glp-1 analog liraglutide that could play a crucial role in pathogenesis as well as regulation of insulin sensitivity and atherogenic dyslipidemia such as: de novo lipogenesis and reverse cholesterol transport

Eligibility criteria:
inclusion criteria: * bmi 35-55 kg/m2 * fasting blood glucose \>140mg/dl * planned bariatric surgery * diabetic medication (metformin, sulfonylurea, insuline) exclusion criteria: * known hypersensitivity against liraglutid * pretreatment dpp-4 inhibitors or glp-1 analogue the last 3 months * hba1c \>10%
dapa - egypt study

Conditions: Type-2 Diabetes

Summary: approximately 39 million people of adults aged 20-79 are living with diabetes in mena region in 2017, egypt is number 8 in the top 10 countries in number of adults with diabetes (8.2 million), where egypt represents 21% of the diabetics in mena region. metformin is used as 1st line oral anti-diabetic drug in most cases. sulfonylureas (su) are used as frequent first add-on after failure of metformin monotherapy. sodium glucose co-transporter 2 (sglt2) inhibitors are a newer class of therapy which has a lower incidence of hypoglycemia and in addition helps in weight and bp reduction. in egypt, sglt2 inhibitors were introduced in 2016. it is not yet widely used for various reasons including lack of wide clinical experience in egyptian patients and safety concerns particularly related to infections and some rare diabetic ketoacidosis (dka). also, usage of sglt2 inhibitors is limited in the early stage of diabetes as they are usually preferred as 3rd or 4th add-on therapy. the existing dapagliflozin phase-3 clinical trial program on sglt2 inhibitors didn't include subjects from egypt. there is no study available which evaluates the effect of dapagliflozin in real world scenario in egypt. key opinion leaders in diabetes in egypt have also identified the need for study on egyptian subjects to observe the usage pattern and effect of dapagliflozin, a sglt2 inhibitor, in this specific real world setting. therefore, there is a need for data on real world setting across egypt. with this aim in mind, the present study has been planned.


Eligibility criteria:
inclusion criteria: 1. male or female patients with 18 years and above. 2. patients who provide written informed consent. 3. patients with previously diagnosed type-2 diabetes mellitus 4. patients with inadequately controlled diabetes (hba1c\>7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment. 5. patients who initiated dapagliflozin at least 3 months prior to the date of study start. 6. patients who are having past medical records for demographic information, weight, blood pressure, hba1c value, and concomitant medications at the time of dapagliflozin prescribed. exclusion criteria: 1. patients with type-1 diabetes mellitus. 2. patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study 3. pregnant or lactating women 4. patients with other severe conditions/elements which require / may require hospitalization, during study participation period
morphometric study of the muscles of the skin in mri 3 tesla in patients with facial paralysis.

Conditions: Facial Paralysis

Summary: the problem posed is the possibility of objectively assessing facial muscle mobility. today, in patients with facial paralysis, the assessment of the deficit is carried out using a subjective scale such as the house brackman \[1\] or emg scale of the facial nerve but does not distinguish each muscle individually . objective measurements of skin muscles such as thickness and volume, in preoperative assessment of a facial paralysis rehabilitation surgery, would be useful in order to choose the most appropriate surgical technique. indeed, too much amyotrophy will contraindicate hypoglosso-facial anastomosis (vii-xii) and it will be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap. similarly, it would be useful to be able to objectively evaluate the recovery of muscle function after facial allo-transplantation. although electromyography has been developed since the work of duchenne de boulogne, little research has been carried out on the development of noninvasive methods to objectively characterize in vivo skin muscles (variation, position, orientation, morphometry). the main morphometric data of the skin muscles come from anatomical dissections. imaging of the skin muscles has not been specifically developed. some studies have been carried out to visualize these muscles in mri 1.5 tesla in pathologies such as myasthenia gravis, facial paralysis, and labio-alveolo-palatine clefts for example. the originality of the project is to develop a method allowing to establish a quantitative correlation between the movements of the face and the muscular changes. this correlation will be achieved by associating muscular morphological data derived from mri acquisitions and cutaneous deformations resulting from clinical examinations. this non-invasive approach should make it possible to establish objective and reproducible indicators in patients with facial paralysis sequelae.


Eligibility criteria:
inclusion criteria: * subject, for which a diagnosis of facial paralysis has been made, female or male, over 18 years of age. exclusion criteria: * pregnancy and lactation, * a patient with a contra-indication to mri (claustrophobia, pace maker, neurosurgical clips, vascular clips, cardiac valves, v.peritoneal valves, cochlear implant, neuro-stimulator, intra-orbital metal shards (articular prosthesis, dental prosthesis, contact glass, insulin pumps, intrauterine device, tattoo, piercing / implants.))

Keywords: muscle skin irm 3 tesla