Kornimate/medical-research-clean huggingface dataset:
hidradenitis suppurativa study of izokibep

Conditions: Hidradenitis Suppurativa

Summary: izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17a, to which it binds with high affinity. this study investigates izokibep in participants with active hidradenitis suppurativa (hs), including tumor necrosis factor-alpha inhibitor (tnfi) naïve participants, and those who had an inadequate response or intolerance to tnfi, or for whom tnfi is contraindicated.


Eligibility criteria:
inclusion criteria: general * participant has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (icf) and in protocol * 18 years of age or older * no known history of active tuberculosis unless adequately treated according to world health organization/center for disease control and prevention therapeutic guidance and determined to be fully recovered by a tuberculosis specialist type of participant and disease characteristics * diagnosis of hs for ≥ 6 months prior to first dose of study drug * hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is hurley stage ii or hurley stage iii * a total an count of ≥ 5 at screening and day 1 prior to enrollment/randomization * participant must have had an inadequate response to oral antibiotics or exhibited recurrence after discontinuation to, or demonstrated intolerance to, or have a contraindication to oral antibiotics for treatment of their hs * must agree to use daily or a minimum of 3 days a week over-the-counter topical antiseptics * participant must be willing to complete a daily skin pain diary exclusion criteria: medical conditions * draining fistula count of \> 20 * outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization * other active skin disease or condition that could interfere with study assessments * history of active inflammatory bowel disease (ibd) or symptoms within the last year that may be suggestive of ibd * chronic pain not associated with hs * uncontrolled, clinically significant system disease * history of demyelinating disease or neurological symptoms suggestive of demyelinating disease * malignancy within 5 years * the participant is at risk of self-harm or harm to others * active infection or history of certain infections * tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (exception: documented evidence of completed treatment and clinically resolved) * known history of human immunodeficiency virus (hiv) other protocol defined inclusion/exclusion criteria may apply
improving recovery after stroke via electrical stimulation of proprioceptors

Conditions: Chronic Stroke Survivors

Summary: the overall objective of the study is to test whether the use of small electrical currents to stimulate proprioceptors of the upper limb has potential for improving robot-assisted upper-limb rehabilitation in stroke survivors.

study participants will be instructed to perform upper-limb movements using a system designed for upper-limb rehabilitation (armeo spring by hocoma ag). the system provides subjects with unloading of the stroke-affected arm thus facilitating the performance of upper-limb movements. the system will be used to track the movements of the stroke-affected arm. simultaneously, a custom-designed system (a prototype developed by the investigators) will be used to deliver small electrical currents to the arm. we hypothesize that the currents delivered to the arm will improve the accuracy of the movements performed by study participants. to assess if delivering small currents to the arm has an effect on the accuracy of the movements performed by the study participants, they will receive actual stimulation for some trials and sham stimulation for other trials. because the investigators will deliver very small currents, study participants will be unable to perceive such currents and hence tell if they are performing the movements while receiving actual or sham stimulation. by comparing trials performed while subjects receive actual stimulation with trials performed while subjects received sham stimulation, the investigators will determine if the stimulation has an effect on the accuracy of the movements performed by the subjects. it is worth noticing that the investigators collected primary outcome data to assess changes associated with the use of actual stimulation vs sham stimulation. data during a follow-up session was also collected, but not for the purpose of collecting outcome measures.

Eligibility criteria:
inclusion criteria: * unilateral and cortical, subcortical, or cerebellar stroke * 6 months post-stroke * upper extremity impairments but able to move upper extremity against gravity 25% of the range * ability to understand directions and follow simple instructions * medically stable * upper extremity fugl-meyer between 28 and 55 * at least four (4) months since last botox treatment * mini-mental state examination (mmse) ≥ 23 exclusion criteria: * participation in other forms of therapy/ intervention for upper extremity motor recovery * upper extremity or trunk fractures * severe fixed contractures affecting the upper limbs * severe perceptual deficits or visual field impairments * severe cognitive deficits * pregnant women * presence of an implanted electrically operated medical device * evidence of more than one clinical stroke * serious medical or neurological illness * history of head trauma or cerebral infectious disease

Keywords: stroke electrical stimulation
use of diathermy versus blunt dissection in tep for inguinal hernia

Conditions: Seroma; Hernia, Inguinal

Summary: there is a long debate whether monopoloar or blunt dissection should be adopted in tep to minimise the chance of seroma formation. this study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial.

there is a long debate whether monopoloar or blunt dissection should be adopted in tep to minimise the chance of seroma formation. this study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial. all male and female patients presented with first occurrence, unilateral inguinal hernia anticipated for laparoscopic tep are included into study after informed consent. patients are randomized into "diathermy-preferred" (dp) group and "blunt dissection-preferred" (bdp) group just before commence of operation after general anaethesia. surgeons are instructed to use monopolar energy as main dissection method for whole operation if possible (dp), where as blunt dissection is the preferred choice in bdp group but it is allowed to use monopolar energy if needed. total energy time is measured by a specially designed device attaching to the monopolar pedals as accurate as to millisecond (ms). pre-peritoneal drains are inserted for drainage and removed 23 hours after operation. energy time, drainage output, ultrasonic seroma sizes at day 1, day 6, 1 month post-operations, recurrence are compared between 2 groups.

Eligibility criteria:
inclusion criteria: * age above 18 and below 90 * male or female patients * unilateral inguinal hernia * first occurrence hernia * consent to laparoscopic hernioplasty for inguinal hernia exclusion criteria: * inguino-scrotal hernia * recurrent inguinal hernia * incarcerated hernia * bilateral inguinal hernia * bleeding tendency * on anti-platelet agent or anti-coagulant * significant co-morbidies * patients with pacemaker * decline or not consent to
pharmacokinetics of sildenafil orally disintegrating tablet formulation versus to viagra® oral tablet.

Conditions: Erectile Dysfunction

Summary: this study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.


Eligibility criteria:
inclusion criteria: * otherwise healthy male subjects age 45 years or older with or without erectile dysfunction. body mass index (bmi) of 17.5 to 32.5 kg/m2. signed and dated informed consent document. exclusion criteria: * evidence or history of clinically significant abnormalities * have baseline orthostatic hypotension * positive drug screen, excessive alcohol and tobacco use

Keywords: bioequivalence oral dissolving tablet
transversus abdominis plane (tap) block using liposomal bupivacaine in metabolic and bariatric surgery patients

Conditions: Morbid Obesity; Bariatric Surgery Candidate

Summary: to investigate if laparoscopic transversus abdominis plane (tap) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. the study will see if the plain bupivacaine group will be equivalent in terms of length of stay, morphine milligram equivalents, pain scores and patient satisfaction, but cost less.

compared to only bupivacaine administered via tap block, the study will investigate the analgesia effects to patients undergoing metabolic and bariatric surgery receiving tap block with a liposomal bupivacaine mixture. to determine if patients undergoing metabolic and bariatric surgery receiving tap block with a liposomal bupivacaine results in pain scores, as measured by visual analogic scale (vas), that are equivalent compared to patients receiving tap block with bupivacaine only. compared to tap block with bupivacaine only, the study will compare opioid consumption, and other effect differences to patients undergoing metabolic and bariatric surgery receiving tap block with liposomal bupivacaine. the study will explore other effects, including pain score at 48 hours, and 72 hours after surgery, total opioid consumption required post op during their one-week post op visit as measured in morphine equivalences.

Eligibility criteria:
inclusion criteria: * age \> 18 years * participants who can give written informed consent and willing to comply with all study-related procedures. * patients undergoing primary sleeve gastrectomy or roux-en-y gastric bypass exclusion criteria: * patients undergoing duodenal switch procedures * patients undergoing concomitant hiatal hernia repair or ventral hernia repair or cholecystectomy at time of primary metabolic surgery * patients with chronic opioid use

Keywords: transversus abdominis plane (tap) block bupivacaine liposomal bupivacaine
medically-graded honey supplementation formula to preterm infants

Conditions: Prebiotics; Honey; Premature Infants; Intestinal Microbiota

Summary: honey is a natural product that contains multiple nutrients; it is composed of fructose, glucose and fructooligosaccharides that can potentially serve prebiotic functions. it also contains more than 180 substances including amino acids, vitamins, minerals and enzymes. investigators hypothesized that supplementation of enteral feeds with honey would produce a bifidogenic effect and stimulate the immune response in preterm infants. investigators randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2 weeks and measured their effect on stool colonization, systemic immune parameters and anthropometric measurements.


Eligibility criteria:
inclusion criteria: * preterm infants with gestational age ≤ 34 weeks * postnatal age \> 3 days * no previous enteral feeding, and * parental wish to use milk formula with no intention to use breast milk or breastfeed. exclusion criteria: * infants with major chromosomal abnormalities * infant with major congenital anomalies of the cardiovascular, pulmonary or central nervous system; including neuromuscular disorders and neural tube defects * infants with intestinal atresia, tracheoesophageal fistulas, omphalocele, gastroschisis, and other major congenital gi anomalies, and * infants with sepsis, either before or during enrollment
pilot study: urea cycle disorders practice patterns and outcomes assessment

Conditions: Urea Cycle Disorders

Summary: the purpose of this study is to determine if patients participating in "the longitudinal study of urea cycle disorders" are different than participants in the urea cycles disorders consortium (ucdc) rare diseases clinical research network (rdcrn) contact registry and to determine if patients are a good source of medical information.

participants enrolled in the rdcrn ucdc contact registry will receive an email inviting them to participate in the study. interested participants will be directed to the informed consent document. after agreeing to participate, participants will be directed to the study web portal. the study web portal will be developed and maintained by the data management and coordinating center at the university of south florida (usf). participants will complete several questionnaires about their urea cycle disorder including diagnosis and treatment information and quality of life.

Eligibility criteria:
inclusion criteria: * enrollment in ucdc rdcrn contact registry * patient reported diagnosis of one of the eight ucds or ucd diagnosis highly likely/pending. exclusion criteria: * cases of hyperammonemia caused by an organic acidemia, lysinuric protein intolerance, mitochondrial disorders, congenital lactic acidemia, fatty acid oxidation defects and primary liver disease. * individuals with rare and unrelated serious comorbidities, e.g., down syndrome, intraventricular hemorrhage in the newborn period, and extreme low birth weight (\<1,500 grams). * inability to provide informed consent and complete surveys
the effects of polyphenol-rich berry juice on blood pressure in hypertensive subjects

Conditions: Pre-hypertension; Hypertension

Summary: the purpose of this study is to investigate the effects of berry juices containing different levels of polyphenols on blood pressure and other cardiovascular risk factors. the study is a 12 week double blinded randomized controlled intervention trial. the subjects will be divided in three groups where one receives a placebo juice while the two other will consume 0.5 liter of juice containing different levels of polyphenols. blood pressure will be monitored and blood samples will be taken.


Eligibility criteria:
inclusion criteria: * pre-hypertension or hypertension systolic blood pressure in the 130-179 mmhg range and/or diastolic blood pressure in the 85-109 mmhg range) * bmi 20-35 kg/m2 * stable weight (change \<4 kg previous 12 weeks) exclusion criteria: * regular use of blood pressure lowering agens * diabetes type i or ii * smokers * allergy to grape, cherries, blueberries/bilberries, black currant, aronia * supplements for weight loss * changes in pharmacological treatment of hyperlipidemia or hyperglycemia (initiation, termination or changes in dosage) last 30 days prior to inclusion or during the study period (run-in and intervention) * participation in a drug trial during the previous 30 days
abca3 gene and rds in late preterm and term infants

Conditions: Respiratory Distress Syndrome, Newborn

Summary: respiratory distress syndrome (rds) is the most common respiratory cause of mortality and morbidity in very preterm infants, but it also could be seen in late preterm and term infants. some genetic mechanisms were involved in the pathogenesis of rds in late preterm and term infants. atp-binding cassette transporter a3 (abca3) is essential for the production of pulmonary surfactant, whose mutation is the most common monogenetic cause of rds in newborns. it also takes a vital role on unexplained rds (urds) in late preterm and term infants. some previous studies showed that urds with homozygous or compound heterozygous abca3 mutations had high mortality, while different mutation types could lead to different outcomes. however, most of the study focused on urds with abca3 gene mutations, and there is no evidence that urds without confirmed gene mutations have relatively better or worse outcomes. furthermore, all the population in previous study are non-asian races, which indicated that all the study conclusion is not applicable in asia. based on the next-generation sequencing technology, exome sequencing has been widely used in the clinic. in our neonatal intensive care unit (nicu), a clinic exome sequencing was usually performed in infants with fatal urds. the present study was designed to compare the urds with abca3 gene mutations with those without confirmed gene mutations and to establish the relationship between various abca3 gene mutations and variant rds severity and outcomes.


Eligibility criteria:
inclusion criteria: * infants ≥34 weeks' gestation * meet the fatal respiratory distress syndrome as following: (1) manifestations and chest radiograph are compatible with rds; (2) at least 7days on invasive ventilation with fio2 ≥60%, or persistent hypoxemic respiratory failure on fio2 100% regardless of duration of invasive ventilation * undergone exome sequencing exclusion criteria: * culture-positive sepsis * cardiopulmonary malformations * pulmonary hypoplasia * known surfactant mutations such as sftpb, sftpc, chpt1, lpcat1 and pcyt1b were excluded.

Keywords: respiratory distress syndrome abca3 gene exome sequencing
assessing folic acid in high-risk pregnancy for neural tube defects

Conditions: Neural Tube Defects; Folic Acid

Summary: aim of this study is to investigate and statistically reveal the prevalence and awareness of folic acid usage in pregnant women who have at least one of the risk factors for neural tube defects, to express the level of knowledge of the determined population on this subject and to present ideas to increase awareness in the society.


Eligibility criteria:
inclusion criteria: * over 18 years * under 45 years of age * having at least one of the risk factors for neural tube defects (family history, mthfr gene mutation, birth defect with aneuploidy, history of gdm or known dm) for case group. * singleton pregnant women exclusion criteria: * under 18 years old * above 45 years old * multiple pregnancies

Keywords: neural tube defects folic acid awareness perinatology pregnancy
steroid injections given at the "level of mri pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other.

Conditions: Radiculopathy; Spinal Stenosis; Intervertebral Disc Displacement

Summary: patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection. low back pain has a tremendous impact on the individual and society. it not only affects the individuals quality of life, it also contributes to lost productivity and increased health care costs. epidural steroid injections (esis) are a common treatment option for many forms of low back pain. they have been used for low back problems since 1952 and are still being used as a non-surgical form of treatment for low back pain. the goal of the injections is reduction of pain, increased quality of life and improved function. this study is being conducted to determine the outcomes of injections given at the "level of mri pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other and to learn more about the characteristics of the two different injections.


Eligibility criteria:
inclusion criteria: * diagnosis of single level spinal stenosis. * single level radiculopathy with mri findings at a different level than clinical pattern. * chronic low back pain with radicular symptoms of \> 4 weeks, but \< 6 months. * failure of conservative therapy to include physical and pharmacotherapy. * patient is at least 21 years of age. * patient is willing to be blinded to treatment until after the 3-month follow up visit. * patient is willing and able to review and sign the study's informed consent form. exclusion criteria: * patient has a mental or physical condition that would invalidate evaluation results. * patient has had prior lumbar surgery at any level. * patient is pregnant. * patient has systemic infection or infection at the proposed injection site.
a safety, tolerability, pharmacokinetic study of shr-6934 injection in healthy subjects

Conditions: Heart Failure

Summary: this study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase ⅰ clinical trial. six dose groups were planned for the sad part of the study and four dose groups were planned for the mad part. a total of 88 healthy subjects were included.


Eligibility criteria:
inclusion criteria: 1. understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (icf); 2. male or female aged 18-60; 3. females must have a negative pregnancy test at the screening visit; 4. body mass index (bmi) between 19 and 28 kg/m2; 5. normal electrocardiogram (ecg); 6. men and women of childbearing potential must agree to take effective contraceptive methods. exclusion criteria: 1. history of any clinically important disease or disorder; 2. history of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug; 3. prior history of risk factors for torsades de pointes, such as unexplained syncope, definite long qt syndrome (including family history), heart failure, myocardial infarction, angina pectoris; 4. systolic blood pressure (sbp)≥140 mmhg or \<90 mmhg, diastolic blood pressure (dbp) ≥90 mmhg or \<60 mmhg; 5. patients with orthostatic hypotension; 6. positive results of hepatitis b surface antigen, hepatitis c antibody, syphilis antibody and human immunodeficiency virus antibody.