Kornimate/medical-research-clean huggingface dataset:
the effects of acthar on synovial inflammation in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: patients will be assigned to receive either depo medrol or acthar treatment. a synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment.

patients will be assigned to receive either depo medrol or acthar treatment. a synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment. at screening visit, inclusion and exclusion criteria will be assessed. if assessments have not been completed to verify these criteria, they will be performed at this visit. after patients are confirmed to meet criteria, patient disease activity will be assessed and blood draw, synovial aspiration, and biopsy will be performed before first treatment injection. about 5 days after this first treatment injection, these assessment and samples will be performed again. about 5-6 weeks after first treatment injection, a final physician assessment will be performed. patients will have the option of consenting to allow storage of samples for future research.

Eligibility criteria:
inclusion criteria: * anti-cyclic citrullinated peptide positive rheumatoid arthritis * on a stable regimen of medications * moderate to severe disease activity as measured by the clinical disease activity index (cdai), or das28 (disease activity score) within 30 days of starting the study * patients must have at least one joint with the following features within 30 days of starting the study: 1. joint must be tender 2. joint must be swollen 3. joint must have +2 or +3 doppler signal by ultrasound exam 4. joint must have +2 or +3 gray scale synovitis by ultrasound exam e. joint must be amenable to synovial biopsy. f. clinician assessing the joint must conclude, with a reasonable degree of certainty, that the swelling and tenderness observed in the joint is caused by rheumatoid arthritis, and not by another arthritic condition such as osteoarthritis, crystal arthritis, or infection. exclusion criteria: * patients on anti-coagulation therapy * patients with an active infection * patients receiving oral corticosteroids within 5 days of enrollment, or parenteral corticosteroids within 3 weeks of enrollment (unless deemed able to taper off medication under investigator oversight and supervision) * patients with any history of joint infection * patients with a history of tuberculosis or coccidioidomycosis
a study of nemtabrutinib (mk-1026) in china participants with relapsed or refractory hematologic malignancies (mk-1026-005)

Conditions: Hematological Malignancies

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics (pk) and preliminary efficacy of oral nemtabrutinib in chinese participants at least 18 years of age who have relapsed/refractory hematologic malignancies.


Eligibility criteria:
inclusion criteria: * relapsed or refractory participants with a diagnosis of b-cell non-hodgkin's lymphoma (nhl), chronic lymphocytic leukemia (cll)/small lymphocytic leukemia (sll) or waldenström's macroglobulinemia (wm) who have received no more than 4 prior standard systemic therapies. participants must have failed or are intolerant to standard therapies and cannot be a candidate for standard salvage regimens and those with low grade lymphoma must be progressing and requiring treatment * must have received prior systemic treatment before joining this study * has an eastern cooperative oncology group (ecog) performance status of 0 to 1 * hbv/hcv viral load undetectable or no history of hbv/hcv * has adequate organ function * male participants agree to be abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 30 days after the last dose of the study intervention * female participant is not a women of child bearing potential (wocbp) or is a wocbp using contraception during the intervention period and for at least 30 days after the last dose of the study intervention exclusion criteria: * has a history of prior cancer within \<3 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other in situ carcinomas * has active primary tumor involvement of central nervous system (cns) disease * has an active infection requiring systemic therapy * has a known history of human immunodeficiency virus (hiv) infection * has an uncontrolled illness including but not limited to ongoing symptomatic congestive heart failure (new york heart association class iii or iv heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness * had immunotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product ≤4 weeks prior to treatment initiation * has any clinically significant gastrointestinal abnormalities that might alter absorption
gustatory modulators among a sample of depressed egyptian adults under anti-depressants therapy

Conditions: Taste Disorders

Summary: identify possible modulators for developing gustatory dysfunction among a sample of depressed egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using a questionnaire ( appendix) with a binary measuring unit (yes/no).

peco * p population: depressed egyptian adults under anti-depressants therapy * e1 exposure 1: commonly prescribed tricyclic antidepressants (imipramine, amitriptyline, clomipramine hcl) * e2 exposure 2: commonly prescribed selective serotonin re-uptake inhibitors antidepressants ( fluoxetine, fluvoxamine, sertraline, citalopram, paroxetine) * c control (non exposure) : non-pharmacological treatment ( psychotherapy) * o outcome: identify possible gustatory dysfunction modulators among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Eligibility criteria:
inclusion criteria: * • depressed egyptian adults under antidepressants therapy for at least 3 months/non-pharmacological treatment( psychotherapy) * age from 20 to 50 years old exclusion criteria: * antipsychotics * hypnotics * anticonvulsants * ages other than the mentioned • olfactory dysfunction * chemosensory dysfunction
predicting risk factors of postoperative hypocalcemia after total thyroidectomy

Conditions: Hypoparathyroidism

Summary: with increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia. the aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or pth levels can predict hypoparathyroidism.

our study consists of analyzing the calcium (mmol/l) and pth (pmol/l) levels on the first postoperative day. postoperative treatment with calcium and vitamin d and the length of hospital stay is also taken into consideration. we also analyze post-operative complications.

Eligibility criteria:
inclusion criteria: • total thyroidectomy exclusion criteria: * concomitant parathyroidectomy for primary hyperparathyroidism * lobectomy only * completion thyroidectomy * central and lateral neck dissection * patients with calcium and/or vitamin d supplementation prior surgery * patients with known and significant osteoporosis and renal failure

Keywords: thyroidectomy hypocalcemia hypoparathyroidism discharge pth
bedrest, feeding pattern, and insulin sensitivity

Conditions: Atrophy, Disuse; Insulin Resistance

Summary: in the present study, the investigators will assess the impact of two different feeding patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following bedrest.

in the present study, the investigators will assess the impact of two different feeding patterns on insulin sensitivity and muscle mass following bedrest. healthy, young males will be fed in a continuous (no breaks in food supply) or intermittent (in boluses throughout the day) manner.

Eligibility criteria:
inclusion criteria: * bmi between 18.5 and 35 * recreationally active exclusion criteria: * type 2 diabetes * performing progressive resistance training in 6 months prior to study * back/knee/leg problems * hypertension * use of certain anticoagulants * all co morbidities interacting with mobility and muscle metabolism of the lower limbs * blood donation in past 3 months
treatment with peripheral nerve stimulation of the pudendal nerve in patients with erectile dysfunction

Conditions: Erectile Dysfunction; Electric Stimulation; Pudendal Nerve

Summary: erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether of organic, psychogenic or relational cause. in this case the pudendal nerve is addressed, since it has its origin in the sacral plexus, deriving from the s2, s3 and s4 nerve branches. its fibers have different innervation, being the pudendal nerve a mixed nerve, and estimating that it has 30% of autonomic innervation, and 70% of somatic innervation (50% sensory and 20% motor). peripheral percutaneous nerve stimulation (proposed treatment) is performed with a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings of the deeper tissues.

the study corresponds to an experimental, prospective, multicenter, randomized, prospective clinical trial. according to the granmo program, it has been calculated to recruit 72 subjects with erectile dysfunction, recruited from different leading urology and andrology centers such as clínica lyx (instituto de urología de madrid). patients will voluntarily accept to be part of the study, and will be able to ask the principal investigator any questions they may have at any time. the intervention will be performed at the lyx clinic (urology institute).

Eligibility criteria:
inclusion criteria: * men * ages 18-60 years old * primarily organic cause diagnosed by doppler: peak-systolic velocities (psv). tele-diastolic velocity (dtv). resistance index (ir) * initial iief-ef questionnaire scores: 1-25 points (mild, moderate or severe erectile dysfunction). * active sex life (more than 4 attempts per month). exclusion criteria: * pelvic surgeries * history of peyronie's disease * penile surgeries, except circumcision or frenuloplasty * priapism * pelvic radiation * women

Keywords: erectile dysfunction percutaneous electrical neurostimulation pudendal nerve
pre-exposure prophylaxis (prep) uptake and adherence intervention for women with trauma-related conditions

Conditions: Substance Use

Summary: the investigators have previously developed an integrated bio-behavioral intervention to promote prep uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for hiv. the intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to prep care. the purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. the hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater prep uptake and adherence.


Eligibility criteria:
inclusion criteria: * currently undergoing mental health treatment; * have a history of trauma; * hiv negative; * sexually active with an opposite sex partner within the past 6 months; * not using prep for hiv prevention at the time of screening; * eligible for prep based on having at least one centers for disease control and prevention (cdc)-defined criteria for prep; * fluent in english; * own or have regular access to a smart phone. exclusion criteria: * hiv positive; * concurrently participating in another hiv prevention program; * have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy; * have psychological distress that would prohibit them from participating in the study; * be unable or unwilling to meet study requirements.

Keywords: pre-exposure prophylaxis women hiv prevention
comparative study of biologic mesh versus repair with component separation.

Conditions: Ventral Hernia

Summary: the purpose of this study is to compare open abdominal incisional hernia repair using xenmatrix biologic mesh versus repair with their own tissue. this study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.

this study will involve comparison of open abdominal incisional hernia repair with xenmatrix biologic graft versus repair with native tissue. the current study seeks to evaluate xenmatrixtm, an fda approved biologic graft for repairing contaminated abdominal wall defects. this study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.

Eligibility criteria:
inclusion criteria: 1. is an adult ≥ 18 years old of either gender 2. will undergo a planned open abdominal incisional hernia repair 3. has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm) 4. contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus 5. infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh 6. has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam 7. is considered a clean-contaminated or contaminated case per surgical site infection risk guidelines 8. is willing and able to return for all scheduled and required study visits 9. is willing and able to provide written informed consent for study participation exclusion criteria: 1. has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh 2. is a clean or dirty case per surgical site infection risk guidelines 3. has conditions that would adversely affect subject safety as per product labeling 4. will undergo a laparoscopic hernia repair 5. has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh 6. has conditions which preclude abdominal imaging at a standard imaging facility 7. has an anticipated survival of \< 24 months 8. care plan is to perform a staged repair over 45 days 9. is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair) 10. is asa class 4 or 5 11. bmi over 45 12. is pregnant

Keywords: infected ventral hernia contaminated incisional hernia
validation study of a computer pharmacokinetic tool to assist in the follow up care of haemophilia a patients

Conditions: Haemophilia A

Summary: optims is a non interventional validation study of the calculator developed by bayer for clinician's use in the prophylactic treatment by factor viii of patients with severe or moderate haemophilia a with a severe clinical profile. the study takes place during a single visit, at the time of patient enrollment in the study


Eligibility criteria:
inclusion criteria: * patient with severe haemophilia a defined as residual factor viii activity \< 1% * or patient with moderate haemophilia a (residual factor viii activity \>1% and \<5%) with severe clinical profile * patient treated in prevention with the same plasma or recombinant factor viii for at least 6 months * patient whose inclusion visit is performed during a routine visit including a measurement of plasma residual factor viii :c level * in the medical file (retrospective data) the pharmacokinetic parameters are available and have been obtained from a pk analysis of factor viii level performed with the same anti haemophilic factor than the one used on the inclusion day exclusion criteria: * patients with haemophilia b

Keywords: haemophilia a factor viii pharmacokinetic computer tool validation
a trial of shr-1210 in combination with apatinib in patients with unresectable hcc

Conditions: Hepatocellular Carcinoma

Summary: this is a phase ii , open-label , investigator-initiated trail of shr-1210 (an anti-pd-1 inhibitor) in combination with apatinib in patients with unresectable hepatocellular carcinoma. this study aims to evaluate the safety and efficacy of shr-1210 combination with apatinib as a preoperative treatment of unresectable hcc.


Eligibility criteria:
inclusion criteria: * subjects voluntarily participate in this study and sign informed consent . * men or women aged 18-75 years * patients with unresectable hcc confirmed histologically or cytologically or clinically，at least one measurable lesion that meets the recist v1.1 criteria without local treatment. * the patients can swallow pills normally. * ecog score was 0 or 1. * have a life expectancy of at least 12 weeks. * the functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : neutrophils≥1.5 x 109/l, hb≥9g/dl; plt≥90 x 109/l, alb≥3g/dl, tsh≤uln(upper limit of norma), tbil ≤ 1.25 x uln, alt and ast ≤ 1.5 x uln, akp≤ 2.5 x uln, cr≤ 1.5 x uln * female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment. exclusion criteria: * subjects had any active autoimmune disease or history of autoimmune disease. * subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. it is still in use within 2 weeks before enrollment. * subjects with severe allergic reactions to other monoclonal antibodies. * the subjects had a central nervous system metastases of clinical symptoms. * a heart condition or disease that is not well controlled. * subjects had active infections. * other clinical trials of drugs were used within 4 weeks prior to the first administration. * the subjects have received other pd-1 antibody therapy or other immunotherapy for pd-1 / pd-l1 or cdk4/6 inhibitor treatment in the past. * there are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
n-acetylcysteine in non-acetaminophen pediatric acute liver failure

Conditions: Acute Liver Failure; Hepatic Encephalopathy

Summary: we have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (iv) n-acetylcysteine (nac) vs. placebo for the treatment of non-acetaminophen alf. the purpose of this study is to examine the safety and efficacy of intravenous nac in children with alf for whom no antidote or other specific treatment is available. inclusion in the nac study required enrollment in the pediatric acute liver failure (palf) study registry.

the pediatric acute liver failure (palf) study group to identify, characterize, and develop management strategies for infants, children and adolescents who present with acute liver failure. the palf study group includes 20 sites (17 in the united states, 2 in the united kingdom, and 1 in canada). the primary objective of the pediatric acute liver failure (palf) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with alf, including information derived from biospecimens. patients enrolled in the palf study registry were able to enroll in the nac study providing they met the additional required inclusion/exclusion criteria.

Eligibility criteria:
inclusion criteria: * meet entry criteria for and be enrolled in the pediatric acute liver failure prospective database. * able to be evaluated and initiate treatment within the first 24 hours of hospitalization * patients transferred from referring hospitals to the study site may be considered for enrollment, provided that no other treatment protocol has begun, and that no liver support device (bal, extracorporeal liver assist device, transgenic pig perfusion) has been used or is contemplated. * use of fresh frozen plasma infusions will not disqualify patients from participation. exclusion criteria: * older than 18 years of age * pregnancy * alf that is secondary to acute acetaminophen toxicity, mushroom poisoning, or a known malignancy. * patients who exhibit signs of cerebral herniation, have intractable arterial hypotension, require inotropic drugs, or demonstrate signs of sepsis (temperature ≥ 39.5o c or bacteremia) at the time of enrollment * no exclusion will be made on the basis of race, ethnic group or gender. * criteria for inclusion of females and minorities will be those established in the nih guidelines

Keywords: acute liver failure hepatic encephalopathy acetaminophen toxicity n-acetylcysteine
long-duration stimulant treatment study of adhd in young children

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this study will evaluate if ritalin la™ is safe and effective for adhd treatment in 4-to-5-year olds.

this is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (b-mph), also known as ritalin la™. b-mph is a fda-approved medication for children 6 years and older with attention-deficit/hyperactivity disorder (adhd), but there are no studies of its use in preschoolers. this study will evaluate the safety and effectiveness of b-mph for adhd treatment in 4-to-5-year old children. total study duration is approximately 5 weeks. it includes a screening evaluation and 4 weeks of b-mph treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). the study doctor will conduct parent-training sessions during the treatment visits.

Eligibility criteria:
inclusion criteria: 1. parents/guardians and children must speak english and/or spanish; parents/guardians must sign consent form; children must verbally assent. 2. boys and girls from 4-5 years old (inclusive) at screening. 3. children who meet the dsm-iv criteria for a primary diagnosis of adhd (combined or hyperactive subtype), with symptoms present for at least 9 months. 4. children who demonstrate adequate need for treatment due to adhd symptom-severity and clinical impairment. 5. children with iq of at least 70 confirmed by valid iq test. 6. children who are in educational settings (pre-school, kindergarten, or elementary school program) with at least 8 same-age peers for at least two half days weekly. 7. parents and children who can attend weekly study visits. 8. children who are naïve to adhd medications; received adhd medications in the past but are not currently treated; or on adhd medications but finding them inconvenient (due to short duration of action) or not very helpful exclusion criteria: 1. children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist. 2. children taking excluded medications. 3. children with history of intolerance to mph/stimulant medications or no response to adequate stimulant trials. 4. children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders. 5. children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some adhd symptoms. 6. children with screening abnormalities deemed clinically significant by child psychiatrist.

Keywords: adhd attention-deficit/hyperactivity disorder (adhd)