Kornimate/medical-research-clean huggingface dataset:
cp-675,206 with neoadjuvant hormone therapy in patients with high risk prostate cancer

Conditions: Prostatic Neoplasms

Summary: this is a multi-center, open label, randomized study. patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: arm a: cp-675,206 + neoadjuvant hormone therapy (nht) or arm b: neoadjuvant hormone therapy. after randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). after completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the armed forces institute of pathology (afip) in washington, dc.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate, previously untreated * potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy * potential candidate for nht prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: high risk category: psa \>20 or gleason score 8 or ct2c/ct3 or intermediate risk category: psa \>10 and d20 or gleason score 7 or ct2b * no evidence of metastatic disease by physical examination, bone scan, and computed tomography, or mri, of the abdomen and pelvis * age \> 18 years * ecog performance status 0-1 * adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy * availability of prostatectomy specimen for histological analysis at the armed forces institute of pathology exclusion criteria: * prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer * history of, or significant risk for, chronic inflammatory or autoimmune disease * potential requirement for systemic corticosteroids before surgery based on prior history * history of autoimmune colitis or chronic gi conditions associated with diarrhea or bleeding, or current acute colitis of any origin * any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy * coexisting malignancies except basal or squamous cell carcinoma of the skin
multimodal pain package vs. regular formulation for pain management in ambulatory spinal surgery

Conditions: Spinal Disorder

Summary: the purpose of this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.


Eligibility criteria:
inclusion criteria: * adults: males or non-pregnant females. * patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics. exclusion criteria: * pregnancy * active severe liver disease * chronic kidney disease 3a-5 (moderate to severe) * chronic obstructive pulmonary disease with impaired pulmonary function * chronic steroid use * chronic opioid use * current use of narcotics * allergy to sulfonamides * allergy to nsaids * allergy to aspirin * allergy to tylenol * allergy to gabapentins * allergy to h2 blockers (cimetidine, famotidine) * allergy to steroid * current use of gabapentins for any medical condition * inability to be discharged home on the day of surgery * inability to swallow pills * myasthenia gravis * history of gastrointestinal ulcers or stomach bleeding * have any condition that, in the investigator's opinion, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.
effect of two iron preparations on protein in the urine

Conditions: Kidney Failure, Chronic; Anemia, Iron-Deficiency

Summary: this pilot study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein


Eligibility criteria:
inclusion criteria: * moderate to severe anemia * iron deficiency * moderate to severe chronic kidney disease * age ≥ 18 or greater and able to give informed consent exclusion criteria: * receiving dialysis * known sensitivity to sodium ferric gluconate complex in sucrose injection, iron sucrose usp, or any of their components * clinically unstable * indication of iron sufficiency
a rct to compare post-operative sensitivity of restorations with fill-up, a dual curing composite and conventional composite resin

Conditions: Postoperative Sensitivity of Existing Dental Filling Materials

Summary: the trial compares patient-reported postoperative sensitivity of 2 existing dental filling materials. the dental filling materials will be used according to manufacturer's instructions and within the existing ce marked licence. we are interested in investigating which licensed material confers the least postoperative discomfort to our patients in normal clinical use.


Eligibility criteria:
inclusion criteria: 1. patient is over 18 2. patient is under 70 3. patient is capable of informed consent 4. the tooth responds to sensitivity testing ('vitality test' with an electric pulp tester) 5. the cavity is suitable for composite restoration 6. the patient prefers composite to amalgam. 7. the restoration required involves 2 or more surfaces of the tooth exclusion criteria: 1. the tooth does not respond to an electric pulp test 2. the patient is suffering dental pain at the time of consent 3. the patient is currently taking long term analgesics 4. the patient is incapable of giving informed consent 5. the patient is a child under 18 6. the patient is unable to return the vas assessment sheets at the appropriate time 7. the tooth to be filled is periodontally involved (grade 2 or grade 3 mobile)
transform - observational cohort study of darbepoetin alfa use in european union (eu) hemodialysis patients switched from peg epoetin beta

Conditions: Anemia

Summary: to describe the time course of hemoglobin concentration in eu hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (peg epoetin beta; mircera) to darbepoetin alfa (aranesp).

this is a multi-centre, observational cohort study of eu hemodialysis patients whose erythropoiesis stimulating agent (esa) therapy has been switched from peg epoetin beta to darbepoetin alfa. data will be collected for the period spanning 14 weeks prior to switch through to 26 weeks post-switch.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age. ckd diagnosis, receiving hemodialysis * received peg epoetin beta for 14weeks prior to switching to darbepoetin alfa and received at least one dose of darbepoetin alfa.

Keywords: ckd darbepoetin alfa dialysis hemodialysis anemia peg epoetin beta
dexmedetomidine use in szmn blocks for pediatric t&a pain control

Conditions: Postoperative Pain; Opioid Use

Summary: the suprazygomatic maxillary nerve (szmn) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures. however, it has not been studied for patients undergoing tonsillectomy and adenoidectomy (t\&a) procedures. the goal of this study is to determine whether the szmn block can be utilized to improve pain control and decrease morbidity in pediatric patients undergoing t\&a. an additional goal will be to determine whether the use of dexmedetomidine as a local anesthetic adjunct can prolong the analgesic effects of the szmn block to cover the entire duration of pain experienced.

patients between 6 months and 18 years undergoing t\&a surgical procedures will be reviewed for potential study enrollment. if participants agree to participate, they will be randomized into one of the three groups: * the suprazygomatic maxillary nerve (szmn) block treatment cohort * the szmn block with dexmedetomidine treatment cohort * the control cohort (standard of care). after anesthesia induction, patients randomized into the szmn-treatment group or szmn+dexmedetomidine treatment group will receive bilateral single injection szmn blocks under general anesthesia in the operating room. participants enrolled into the control group will receive the standard of care with no changes to their anesthetic or surgical care. this group will not receive the szmn block. postoperative pain scores and opioid consumption for all three groups will be collected in the pacu and for each postoperative day for a total of 14 postoperative days. we will also collect the following data: time to discharge readiness, postoperative nausea/vomiting, emergence delirium, oxygen desaturation and respiratory events, ability to tolerate oral intake, bleeding, hospital readmission, and adverse events related to the nerve block.

Eligibility criteria:
inclusion criteria: * ages 6 months - 18 years * give consent/parental consent to participate in study * patients undergoing tonsillectomy and adenoidectomy exclusion criteria: * participants who do not consent or have parental consent * patients who require urgent/emergent intervention * patients who undergo additional combined surgical procedures with separate incisions (in addition to the adenotonsillectomy) * patients with known difficult airway, clinical hemodynamic instability, coagulopathy, chronic pain history, chronic pain medication use, and unrepaired congenital heart disease * patients under age 6 months

Keywords: suprazygomatic maxillary nerve block tonsillectomy and adenoidectomy regional anesthesia dexmedetomidine pediatric
acute effects of ultra-processed versus unprocessed foods on glucocorticoid secretion in healthy individuals

Conditions: Glucocorticoids; Obesity and Overweight; Food Effect

Summary: the investigators aim to understand whether the acute cortisol response to food differs between differently processed foods. in this monocentric, randomized, cross-over, open-label study, 20 healthy volunteers will receive two differently processed meals of similar caloric content and composition. the study will primarily focus on changes in blood cortisol levels, but other metabolic parameters will also be compared.

obesity is one of the most serious health problems of the 21st century, with ultra-processed diets being a major driver of the current obesity pandemic. understanding how these diets affect body weight is critical to identifying new treatment targets. current evidence suggests that the degree of food processing may affect cortisol secretion, a hormone that plays a key role in body weight regulation by increasing with acute food intake and promoting energy storage in adipose tissue. however, whether ultra-processed foods enhance cortisol response has not been thoroughly investigated. here, the investigators aim to understand the reaction of gcs in response to different processed foods in healthy volunteers. no medication will be used in this study. participants will be asked to refrain from strenuous physical activity and alcohol consumption for 24 hours prior to the study. they will fast for 12 hours before consuming a high-calorie, low-processed meal. after fasting again, participants will consume a high-calorie, ultra-processed meal on a second study day. the order of the meals is not fixed. the study will include a screening visit and two study visits.

Eligibility criteria:
inclusion criteria: * males aged 18 to 40 years * bmi 18.5-29.9 kg/m2 exclusion criteria: * severe acute or chronic disease * lactose intolerance * severe food allergy * casual smoking (more than six cigarettes per day) * frequent, heavy alcohol consumption (more than 30g/day) * frequent, heavy caffeine consumption (more than 4 caffeinated drinks/day) * regular physical exercise (more than 4hrs per week) * shift work * previous enrollment in a clinical trial within the past two months * intake of any steroid-containing drugs, including topical steroids and inhalers, within four weeks of the study initiation * contradictions to undergo the investigated intervention * inability or unwillingness to provide informed consent
correlation between creatine phosphokinase and pelvic floor muscle strength in postnatal women

Conditions: Pelvic Floor; Rupture, Old (Postpartum)

Summary: the purpose of this study is to determine the correlation between creatine phosphokinase and pelvic floor muscle strength in post-partum women.

pelvic floor disorders (pfds) are complex conditions affecting women's quality of life, including issues like pelvic organ prolapse, urinary incontinence, and pelvic pain. these disorders are prevalent, with 2.6-28.7% of women experiencing urinary incontinence and 20-50% suffering from pelvic organ prolapse. accurate diagnosis requires a comprehensive understanding of pelvic musculoskeletal components and the interaction of multiple body systems. creatine phosphokinase (cpk) activity can be elevated in various conditions, including muscle diseases, burns, and after strenuous exercise. during childbirth, increased serum cpk levels have been observed, attributed to enzyme release from the uterus and placenta. cpk levels typically return to normal within six weeks postpartum. to date, no study has explored the correlation between cpk levels and pelvic floor muscle strength in postnatal women. this research aims to fill this knowledge gap, potentially benefiting medical services and expanding understanding in women's health physical therapy.

Eligibility criteria:
inclusion criteria: * post-partum women who delivered vaginally. * their ages will range from 25 to 35 years old. * their body mass index (bmi) will be \<30 kg/m2. * cpk will be measured within the first six weeks (2nd-5th weeks) after delivery for all women. exclusion criteria: * any dysfunction or associated injury or any pathological conditions which may affect the result of the study as cardiac abnormalities, thyroid dysfunction recurrent urinary tract infections, uncontrolled hypertension or diabetes mellitus. * history of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease, any hormonal abnormality and any psychological problem. * pelvic floor dysfunction: genital prolapse, incontinence. * previous surgical operations as hysterectomy. * inability to understand the written and verbal instructions.

Keywords: pelvic floor strength creatine phosphokinase postnatal women
prevention of noise-induced damage by use of antioxidants

Conditions: Noise-induced Tinnitus; Noise-induced Hearing Loss

Summary: the current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (nihl) and noise-induced tinnitus (nit). the antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100db for at least 30 minutes.


Eligibility criteria:
inclusion criteria: * age: 18-25 years old * temporary tinnitus after noise exposure: loudness \>5 on a vas exclusion criteria: * middle ear problems * allergy for magnesium or n-acetylcystein * use of hearing protection when going out

Keywords: prevention noise-induced tinnitus noise-induced hearing loss young population
strataxrt versus aquaphor for the prevention and management of radiation dermatitis

Conditions: Radiation Dermatitis

Summary: the aim of this study is to assess the efficacy and safety of strataxrt® in comparison to standard of care (defined using the common terminology criteria for adverse events \[ctcae\], version 5.0) by assessing the severity of inguinal rd in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.


Eligibility criteria:
inclusion criteria: * at least 18 years of age or older * eastern cooperative oncology group (ecog) performance status of 0-2 * life expectancy of at least 6 months * biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions * patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 gy in 1.8-2 gy fractions using photon or proton therapy * no known allergy to studied products * able to give written informed consent, or have written consent given on their behalf * patients who are able and willing to attend the post-radiation weekly skin assessment appointments * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. abstinence is acceptable if preferred by patient. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. exclusion criteria: * patients with gross cancer involvement of either or both inguinal regions. * patients who have received prior pelvic and/or inguinal radiation therapy. * patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study. * patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis. * patients with existing rashes or wounds in either inguinal region at baseline. * planned inguinal dissection within 90 days after completion of radiation therapy on this study. * female patients who are pregnant or breast feeding. * patients who are unable to give written informed consent, or are unable to have written consent given on their behalf.
getting malaria "off the back" of women and children in western uganda

Conditions: Malaria

Summary: this is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of p. falciparum malaria among infants in a rural area of western uganda. participants will be recruited from four villages immediately adjacent to the bugoye level iii health centre (bugoye, kanyanamigho, izinga, rwakingi 1a) in the kasese district of western uganda. the purpose of the study is to assess the feasibility and tolerability of using insecticide-treated lesus to reduce the incidence of p. falciparum malaria infection among infants.

this is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of p. falciparum malaria among infants in a rural area of western uganda. participants will be recruited from four villages immediately adjacent to the bugoye level iii health centre (bugoye, kanyanamigho, izinga, rwakingi 1a) in the kasese district of western uganda. the first phase will consist of a series of focus group sessions with mothers of young children and their male partners to gain further insight into lesu use, to include location of purchase and frequency of washing, as well as exploring initial perceptions of insecticide-treated clothing and inform the protocols for the open-label study. the second phase will consist of a prospective, open-label study. twenty-five (25) mothers and their young children will be provided with insecticide-treated lesus and twenty-five (25) controls who will be provided untreated lesus. after an initial visit, bi-weekly follow up, including finger-prick blood collections will continue for a period of twelve (12) weeks. collected blood spots will be transported to epicentre for real-time pcr to identify sub-microscopic parasitemia and to the french research institute for development (https://en.ird.fr) in marseille, france for quantification of the mosquito salivary antigen (gsg6-p1 peptide). remaining samples will be stored for future analysis.

Eligibility criteria:
inclusion criteria: * adult women (age greater or equal to 18 years) with a healthy child between the ages of 6 months to 18 months from one of four eligible villages exclusion criteria: * mother or child with hiv (and thus taking cotrimoxazole prophylaxis)

Keywords: malaria p. falciparum permethrin rapid diagnostic test
performance of artificial intelligence tools and ultrasonographers with different skills

Conditions: Ileocolic Intussusception

Summary: artificial intelligence versus different skilled sonographers.

comparison of artificial intelligence and ultrasonographers with different skills in diagnosing intussusception in children and identifying indications for surgery.

Eligibility criteria:
inclusion criteria: * children aged 3-36 months with suspected ileocolic intussusception exclusion criteria: * children younger than 3 months or older than 36 months with suspected ileocolic intussusception
study and management of cystic complications in autosomal dominant polycystic kidney disease

Conditions: Polycystic Kidney Diseases

Summary: autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. while the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. to date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. diagnosis of these complications is often complicated, and their management has not been codified. the latest international recommendations (kdigo) provide only low-level recommendations. for the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.

autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. while the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. to date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. diagnosis of these complications is often complicated, and their management has not been codified. the latest international recommendations (kdigo) provide only low-level recommendations. for the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.

Eligibility criteria:
inclusion criteria: * patient with autosomal dominant polycystic kidney disease (apkd) participating in the genkyst study * patient with at least one cystic complication. the cystic complications retained are the following: * acute or chronic cyst-related pain requiring analgesic treatments * cyst infection * intracystic haemorrhage * urinary lithiasis * functional complaints related to the cystic mass: digestive disorders with eating disorders, undernutrition, diaphragmatic compression phenomena, portal hypertension, umbilical or linea alba hernias, ventrations * need for a cystic reduction procedure: puncture, marsupialization, open surgery (including preparation for grafting) exclusion criteria: * patients who have expressed their opposition to taking part in the study * patient under legal protection (guardianship, curatorship, etc.)