Kornimate/medical-research-clean huggingface dataset:
lvn- ius versus oral megesterol acetate in treatment of atypical endometrial hyperplasia

Conditions: Atypical Endometrial Hyperplasia

Summary: this randomized controlled trial is aimed to compare the efficacy between megestrol acetate (ma) and the levonorgestrel intrauterine system (lng-iud) regarding the ability and duration to produce complete regression for cases with atypical endometrial hyperplasia.

up to 25% of cases with endometrial cancer and atypical hyperplasia occur in premenopausal women. the progressively increasing trend of delay in first conception increases such patients who wish to have children.3 the recommended treatment for eh without atypia is primarily hormonal, whereas the preferred treatment for eh with atypia is hysterectomy given the significant risk for both concurrent and subsequent development of endometrial carcinoma. a dilemma results when eh with atypia is diagnosed in women who wish to retain fertility or declining doing hysterectomy due to concomitant medical morbidities. in these women, a trial of hormone therapy can be considered.4,5 in recent years, progestin therapy has been successfully used to treat selected women with endometrial cancer and atypical hyperplasia who desire to preserve fertility or having severe medical co-morbidities precluding (immediate) surgery. the most common progestin regimens include megestrol acetate (ma) and the levonorgestrel intrauterine system (lng-iud).5-7

Eligibility criteria:
inclusion criteria: all cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy exclusion criteria: * cases with evidence of associated endometrial cancer. * cases with simple hyperplasia without atypia. * patients failed to collect at least 2 endometrial samples during treatment course.

Keywords: atypical endometrial hyperplasia levonorgestrel intrauterine system megestrol acetate partial regression
topical pdt cream without irradiation source in the acne treatment

Conditions: Acne, Photodynamic Therapy

Summary: in this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% butenyl ala cream formula without light source irradiation in the treatment of acne.


Eligibility criteria:
inclusion criteria: * mild to moderate acne vulgaris (leeds revised acne grading system score 2-7) at baseline. exclusion criteria: * known pregnancy * lactation * any medical illness that might influence the results of the study * a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment * use of topical acne medication within 4 weeks of study enrollment.
toads study: to assess death from septic shock.

Conditions: Septic Shock

Summary: the aim of this study is to assess the causes of death in patients with septic shock in french intensive care units. it is an epidemiologic and descriptive study .

the purpose of this epidemiologic study is to describe with accuracy the reasons and causes of death in patients with septic shock during patients stay in intensive care units. all deceased patients with primary diagnosis of septic shock will be included in this survey and patients baseline characteristics as well as the clinical and data at the time of patient's death will be recorded.

Eligibility criteria:
inclusion criteria: * adult patient * died of septic shock in the intensive care unit (icu) * at least 6 hours of vasopressors exclusion criteria: * legally protected adult patient. * less than 6 hours of vasopressors * opposition to participation in the study expressed by the patient, family or person of trust

Keywords: mortality
a phase 1 study of fisogatinib (blu-554) in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma (HCC)

Summary: this is a phase 1, open-label, first-in-human (fih) study designed to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and preliminary antineoplastic activity of fisogatinib (formerly known as blu- 554) administered orally in patients with fgf19 ihc+ hepatocellular carcinoma (hcc). the study consists of 3 parts, a dose-escalation part (part 1), an expansion part (part 2) exploring a once daily (qd) dosing schedule at the recommended phase 2 dose (rp2d), and a part 3 expansion of the qd dosing schedule at the rp2d in tki naive patients.


Eligibility criteria:
key inclusion criteria: * confirmed diagnosis of hcc by histological examination or by non-invasive criteria according to european association for the study of the liver (easl) or american association for the study of liver disease (aasld) guidelines (part 1, 2 and 3). * for part 1 and 2, the patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib. * for part 3, the patient has not received prior treatment with a tki. * child-pugh class a with no clinically apparent ascites * eastern cooperative oncology group (ecog) performance status of 0-1 * for part 1, willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator) * for part 2 and 3, all patients must have an fgf19 ihc result available. only fgf19 ihc+ hcc patients will be eligible for part 3. key exclusion criteria: * central nervous system metastases * platelet count \<75,000/ml * absolute neutrophil count \<1000/ml * hemoglobin \<8 g/dl * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>5x the upper limit of normal (uln) * total bilirubin \>2.5 mg/dl * international normalized ratio (inr) \>2.3 or prothrombin time (pt) \>6 seconds above control * estimated (cockroft-gault formula) or measured creatinine clearance \<40 ml/min

Keywords: liver cancer fgf19 gene amplification fgf19 overexpression fgf19 upregulation cyclin d1 (ccnd1) gene amplification cyclin d1 (ccnd1) copy number gain blu-554 fgfr4 hepatocellular carcinoma liver disease liver neoplasms
clinical assessment of the external sound processor worn by patients implanted with codacs

Conditions: Severe to Profound Mixed Hearing Loss

Summary: the purpose of this study is to evaluate the effect of the sound processor upgrade from the c-dacs investigational device freedom sound processor to the nucleus® cp810 sound processor for the codacs™ system on the speech reception threshold in noise, to evaluate the usability of the codacs™ fitting software, to evaluate the quality of life with the nucleus® cp810 sound processor for the codacs™ system, to collect long term data, to evaluate the acceptance criteria of the postoperative codacs™ system test and to evaluate the usability of the codacs™ test system.


Eligibility criteria:
inclusion criteria: * subjects implanted with a cochlear c-dacs investigational device exclusion criteria: * participation in another medical device study * unwillingness or inability of the subject to comply with the study requirements

Keywords: otosclerosis, cochlear implant, acoustic stimulation
chablis7.5: a study of the efficacy and safety of subcutaneous blisibimod in subjects with systemic lupus erythematosus with or without nephritis

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have seropositive, clinically-active systemic lupus erythematosus (sle) as defined by selena-sledai score ≥10, and positive for anti-double stranded dna and low complement (c3 or c4).


Eligibility criteria:
inclusion criteria: * fulfill at least 4 diagnostic criteria for sle defined by american college of rheumatology * active sle disease as defined by selena-sledai score ≥10 despite on-going stable corticosteroid therapy * positive for anti-double stranded dna (anti-dsdna) and low complement * subjects with stable nephritis may be enrolled * 18 years of age or older exclusion criteria: * severe active central nervous system lupus * malignancy within past 5 years * known to be positive for hiv and/or positive at the screening visit for hepatitis b, or hepatitis c * comorbidities that would interfere with evaluations of study drug effect * active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections * history of active tuberculosis or a history of tuberculosis infection * pregnant or nursing

Keywords: sle lupus lupus erythematosus, systemic autoimmune diseases a-623 blisibimod nephritis
duration of analgesia with dexmedetomidine and ropivacaine in brachial plexus block

Conditions: Analgesia; Pain, Acute; Peripheral Nerve Block

Summary: this is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for brachial plexus block and assessing the analgesia with vas pain scales(0-10), satisfaction scale by vas scale(0-10) and time to first analgesic consumption. this study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.

in our institute ropivacaine is used for all the peripheral nerve blocks. this a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. after screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator. adjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. sometimes patients have other added comorbidities along with high bmi with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(la) as well as the adjuncts. dexmedetomidine is proven to be better than clonidine in a recent study. also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. the investigators are evaluating whether adding dexmedetomidine to standard dose of ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.

Eligibility criteria:
inclusion criteria: * age-18years and above * both male and female patients * bmi-\>18 * elective subacute upper extremity fractures exclusion criteria: * chronic pain patients (pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.) * patients with drug abuse history in the past 6 months * esrd * hepatic failure

Keywords: upper extremity bone fracture
the effect of secondary prevention in patients with recurrent low back pain

Conditions: Low Back Pain, Recurrent

Summary: this study investigates the effect of a secondary intervention program for low back pain in patients with recurrent low back pain. one third of the subject will receive no therapy, one third wil receive 2 sessions of pain neuroscience education (pne) and one third will receive two sessions of pne and 5 sessions of exercise therapy over 6 weeks.

participants: 60 individuals with recurrent non-specific lbp were recruited through advertisement in sport facilities, social media and among friends and family. testing: the testing was performed before and after a six week period by three blinded 2nd master students of physiotherapy of university of ghent. the pre and post testing were almost identical and lasted 1 hour, only for the first testing an anamnesis was conducted to evaluate inclusion and exclusion criteria. the identical parts were tests for motor control, muscle performance and psychosocial factors. intervention: the subjects were divided into 3 groups, only group b and c were given treatment. group b had 2 sessions pne over a period of two weeks. group c received 2 sessions of pne and 5 sessions of exercise therapy over a period of six weeks. each of the sessions lasted 30 minutes and took place at the clinical practice room at the university of ghent. group c began the exercise therapy a week after the second session of pne.

Eligibility criteria:
inclusion criteria: * in remission during testing * recurrent low back pain (rlbp) \>6months * 2 or more episodes in the past year * pain flare of ≥24 hours, characterized by an increase of ≥2 on an numeric rating scale (nrs) scale and/or ≥5 on the roland morris disability questionnaire * followed by a pain-free episode of ≥1 month, characterized by a 0/10 on an nrs scale and/or \<2 on the roland morris disability questionnaire * non-specific rlbp (no cause for low back pain (lbp); \>3y post discus herniation) * 1 year or more post-natal exclusion criteria: * use of antidepressants or analgesics (except for nsaids or paracetamol), taken 2 weeks before the testing * neurologic, respiratory, circulatory, or severe orthopedic diseases * pregnancy * specific lbp causes * a history of cognitive exercise therapy and/or specific motor control training * current treatment or new therapies starting \<6 weeks before baseline assessment

Keywords: low back pain recurrent non-specific secondary prevention pain neuroscience education exercise therapy
reducing wound infections using bioelectric wound dressings

Conditions: Surgical Site Infection

Summary: the purpose of this study is to compare the outcomes of using bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.

the standard of care for enhance recovery after surgery (eras) protocol uses chlorhexidine alcohol base prep as the way to clean the skin preoperatively to decrease bacterial flora before sterile prep at the or. under eras protocol there is no recommendations on any post-operative dressing. biolelectric wound dressing has been introduced, used and proof to decrease wound infection in orthopedic extremity clean surgery for years. the purpose of this study is to compare the outcomes of using bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.

Eligibility criteria:
inclusion criteria: 1. elective diverticular, benign polyp, or colon cancer resection 2. age 18-90 years old 3. all patients must receive some kind of bowel prep (su- prep, pills, go-lytely, milk of magnesia, etc....) 4. must be off antibiotics for more than 2 weeks before surgery 5. surgery must be laparoscopic, hand assisted or robotic 6. skin will be closed in layers and subcuticular interrupted fashion 7. just one dose of preoperative antibiotics (invanz or equivalent if patient is allergic) 8. patients will have a primary anastomosis, no colostomy. 9. patient must be compliant with dressing care 10. ability to provide informed consent exclusion criteria: 1. active infections before surgery -example: intra-abdominal abscess not drained or actively on antibiotics on the day of surgery, skin infections 2. inability to take intestinal bowel preparation 3. hgba1c \>8 4. bmi \>40 5. immunosuppression 6. need of steroid stress dose pre-op 7. patient receiving active chemotherapy 8. need of stoma (end ostomies after resection protective stoma included) 9. need of blood transfusion during surgery 10. use of irrigation with antibiotics or irriseptr during surgery 11. any standard contraindication to anesthesia and/or surgery 12. pregnancy or lactating women 13. inability to provide informed consent 14. inability to follow instructions for dressing care 15. sensitivity or allergy to silver or zinc

Keywords: surgery outcomes bioelectric dressing,
sapien 3 ultra system pmcf

Conditions: Aortic Valve Stenosis

Summary: a post-market study of the edwards sapien 3 ultra system in subjects with symptomatic, severe, calcific aortic stenosis.

to monitor and review device performance and outcomes of the sapien 3 ultra system in subjects with symptomatic, severe, calcific aortic stenosis.

Eligibility criteria:
1. subject meets the criteria per the indication and contraindications according to the current ifus. * indication for use: the edwards sapien 3 ultra thv, the edwards sapien 3 thv, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a heart team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the sts risk score and other clinical comorbidities unmeasured by the sts risk calculator). * contraindications: evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; inability to tolerate anticoagulation/antiplatelet therapy. 2. subject has provided written informed consent to comply with all study procedures and follow-up visits

Keywords: transcatheter aortic valve implantation transcatheter aortic valve replacement sapien 3 ultra
high-frequency vs. low-frequency vs. sham dmpfc-rtms for bulimia and anorexia nervosa

Conditions: Bulimia Nervosa; Anorexia Nervosa

Summary: this trial will compare the efficacy and tolerability of 10 hz vs. 1 hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered once daily over 30 days, in patients with a diagnosis of bulimia or anorexia nervosa binge-purge subtype. the trial will include structural and functional mri, and behavioral measures obtained before, during, and after treatment.


Eligibility criteria:
inclusion criteria (patient): * voluntary and competent to consent * mini confirmed diagnosis of bulimia nervosa or anorexia nervosa, binge/purge subtype * outpatient * between the ages of 18-65 * have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening * must adhere to research schedule. * pass the tms safety screening questionnaire. * failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode. exclusion criteria (patient): * have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump * have active suicidal intent * are pregnant * have a lifetime mini diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms * have a mini diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than the ed * have received rtms for any previous indication due to the potential compromise of subject blinding.

Keywords: brain stimulation rtms
efficacy, safety and tolerability of acz885 in pediatric patients with the following cryopyrin-associated periodic syndromes: familial cold autoinflammatory syndrome, muckle-wells syndrome, or neonatal onset multisystem inflammatory disease

Conditions: Cryopyrin-associated Periodic Syndromes; Familial Cold Autoinflammatory Syndrome; Muckle-Wells Syndrome; Neonatal Onset Multisystem Inflammatory Disease

Summary: this trial will provide long-term safety, efficacy and tolerability of acz885 in caps patients that completed the cacz885d2307 study


Eligibility criteria:
inclusion criteria: 1. patients who completed the core cacz885d2307 study (a patient is defined as having completed the core study if they completed the study up to and including the eos visit with no major protocol deviations in the core). 2. male and female patients that are ≥ 1 year of age at the time of the roll-over visit. 3. parent or legal guardian written informed consent must be obtained before any assessment in the extension cacz885d2307e1 study is performed. exclusion criteria: 1. patients for who continued treatment in the cacz885d2307e1 extension study is not considered appropriate by the treating physician. 2. patients who discontinued from the core cacz885d2307 study other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cryopyrin-associated periodic syndromes (caps) familial cold autoinflammatory syndrome (fcas) muckle-wells syndrome (mws) neonatal onset multisystem inflammatory disease (nomid) children, systemic autoinflammatory disease cias-1 gene nalp-3 nlrp3 acz885 canakinumab human monoclonal anti-human interleukin-1 antibody autosomal dominant familial autoinflammatory syndrome childhood immunizations vaccinations
balloon tamponade vs b-lynch in placenta previa

Conditions: Placenta Previa

Summary: patients were allocated to group a and b. in group a, balloon tamponade (using foley catheter 28 fr) was used intra-operatively to prevent post-partum hemorrhage. in group b, b lynch suture was used intra-operatively to prevent post-partum hemorrhage.

after approval from hospital ethical committee, patients fulfilling the inclusion \& exclusion criteria were recruited after taking informed written consent for surgery. patients were allocated to group a and b using computer generated random sample allocation. in group a, balloon tamponade (using foley catheter 28 fr) was used intra-operatively to prevent post-partum hemorrhage. post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in foley balloon tamponade bag, in milliliters. in group b, b-lynch suture was used intra-operatively to prevent post-partum hemorrhage. post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.

Eligibility criteria:
inclusion criteria: 1. singleton pregnancy 2. late third trimester pregnancy (35+ weeks to 39 weeks) 3. placenta previa confirmed by ultrasonography 4. elective caesarean section. exclusion criteria: 1. multiple gestation 2. placenta accreta spectrum (accrete/increta/percreta) 3. bleeding diathesis 4. other causes of post-partum hemorrhage i.e. uterine atony, genital tract tears, retained products of conception etc. 5. serious medical or surgical diseases.