Kornimate/medical-research-clean huggingface dataset:
low dose naltrexone in symptomatic inflammatory bowel disease

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Summary: the investigators will be looking at the efficacy of the use of once daily use of low dose naltrexone (4.5mg) in subjects with symptomatic inflammatory bowel disease.

the investigators will compare the use of daily low dose naltrexone (ldn) (4.5 mg) compared with placebo in subjects that have symptomatic inflammatory bowel disease (ibd). our subjects will be those with diagnosed with ibd and are symptomatic, defined by an inflammatory bowel disease questionnaire (ibdq) score \< 170. the subjects will be randomly assigned either placebo or ldn. they will take the ibdq prior to starting the trial, 6 weeks, 12 weeks and 6 months after starting the medication. participants have to remain on their current ibd regimen throughout the trial and cannot make any changes within 4 weeks of starting the trial. the investigators will have a safety phone call at 6 weeks and a follow up letter at 12 weeks after starting the trial. the participants will be given a card to keep with them with a phone number and email address if any adverse effects arise.

Eligibility criteria:
inclusion criteria: * patients with symptomatic crohn's disease or ulcerative colitis (defined as a response to the inflammatory bowel disease questionnaire less than 170) * confirmed crohn's disease or ulcerative colitis through radiographic, endoscopic and/or histologic criteria * on a stable dose of medication for ibd (i.e. no change in medication within 4 weeks of study enrollment) * age 18 or older exclusion criteria: * patients on opioids or immodium within 7 days of starting the investigational therapy * women who are breastfeeding, pregnant, or plan on becoming pregnant within the next year * patients on lomotil or opioid analgesics * patients already on low dose naltrexone * women of child bearing age not willing to use contraception or abstinence * a history of the following diseases or procedures: * acute hepatitis * liver failure * ileoanal anastomosis * short bowel syndrome * abnormal liver enzymes

Keywords: inflammatory bowel disease crohn's disease ulcerative colitis naltrexone low dose naltrexone inflammatory bowel disease questionnaire
study of vir-2218, vir-3434, and/or peg-ifnα in subjects with chronic hepatitis b virus infection

Conditions: Hepatitis B, Chronic

Summary: this is a phase 2 study in which participants with chronic hepatitis b virus (hbv) infection will receive vir-2218, vir-3434 and/or peg-ifnα and be assessed for safety, tolerability, and efficacy


Eligibility criteria:
inclusion criteria: * male or female ages 18 - \<66 years * chronic hbv infection for \>/= 6 months * on nrti therapy for \>/= 2 months at the time of screening exclusion criteria: * any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation * significant fibrosis or cirrhosis * history or evidence of drug or alcohol abuse * history of chronic liver disease from any cause other than chronic hbv infection * history of hepatic decompensation * history of anaphylaxis * history of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of vir-3434 * history of immune complex disease * history of known contraindication to any interferon product

Keywords: hepatitis b virus chronic hepatitis b hbv hepatitis
post-operative voiding after gynecological surgery trial

Conditions: Urinary Retention; Postoperative Complications; Surgery

Summary: to determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. methods: a single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to bladder drainage and foley catheter removal. primary outcome is time to first void, secondary outcomes include time to discharge, post-operative complications and patient satisfaction.


Eligibility criteria:
inclusion criteria: * women * undergoing elective laparoscopy for a gynaecological indication * plan for same day discharge * able to provide informed consent exclusion criteria: * pregnancy * undergoing procedure for pelvic organ prolapse, stress urinary incontinence, or nerve detrapment * prior hysterectomy, or incontinence/pelvic organ prolapse procedures * pre-existing voiding dysfunction * known recurrent urinary tract infections * known genito-urinary malformations * known for neuromuscular disorders such as multiple sclerosis * use of anticholinergic medication * intraoperative bladder related complications * need for discharge with indwelling foley catheter * patients requiring overnight admission for any reason

Keywords: laparoscopy, urinary retention
evaluation of a new eye-specific multivitamin formula in participants at risk of age-related macular degeneration (amd)

Conditions: Retinal Drusen; Age-related Macular Degeneration; Macular Degeneration

Summary: the aim of this study is to evaluate the clinical benefits in visual function from dietary supplementation of the lumega-z carotenoid liquid-supplement in participants with drusen and at risk of amd. the effects of lumega-z supplementation will be compared to an active comparator, the areds2 multivitamin.


Eligibility criteria:
inclusion criteria: - patients with retinal drusen (as determined by clinical fundus photography examination) and dark adaptation recovery time of 6 to 10 minutes. exclusion criteria: * presence of congenital retinal pathologies that may impact data collection * prior history of retinal-detachment or vitreo-retinal surgeries with any complications * best-corrected visual acuity of 20/40 or worse

Keywords: lumega-z carotenoid supplement
doppler echocardiography versus clinical targets guided therapy on the outcome of postpartum septic shock.

Conditions: Doppler Echocardiography; Postpartum Septic Shock

Summary: postpartum sepsis is widely known as a preventable main cause of maternal morbidity and mortality. according to the world health organization, approximately 11% of the estimated maternal deaths worldwide were attributed to sepsis. recent global assessments indicate that obstetric infections rank as the third most prevalent cause of maternal death, with a prevalence mainly observed in low- and middle-income nations.

the management of septic shock is a major medical concern. early goal-directed therapy emerged as a novel approach for reducing sepsis mortality and was incorporated into surviving sepsis campaign guidelines in 2012. early detection of sepsis, rapid initiation of antibiotics and effective resuscitation with fluids, vasopressors, and inotropes were important concerns. however, many randomized trials were done to examine the effect of egdt on morbidity and mortality and showed that egdt was not associated with a significant reduction in mortality in patients with septic shock compared to usual care. that it wasn't addressed in recent guidelines in 2016 and 2021.

Eligibility criteria:
inclusion criteria: * postpartum women, within 6 weeks following delivery * meeting the third international consensus definitions for septic shock (2016) (sepsis-3): acute persisting hypotension requiring vasopressors to maintain mean arterial pressure (map) ≥ 65 mm hg and having a serum lactate \> 2 mmol/l (18 mg/dl) despite adequate volume resuscitation exclusion criteria: * patient refusal * history of any chronic cardiac disease * requirement for immediate surgery * hypotension attributable to another cause * do-not-resuscitate status * contraindication to central venous catheter placement * difficult transthoracic echocardiographic evaluation * primary cardiogenic cause of shock, instead of sepsis.
liquid somatropin formulation in children with growth hormone deficiency

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.


Eligibility criteria:
inclusion criteria: * growth failure due to growth hormone insufficiency (ghd) * turner syndrome: established diagnosis according to sex chromosome analysis, or * growth retardation in children with chronic renal disorders exclusion criteria: * pregnancy * breast feeding women * suspected or know allergy to trial product * participating in any other trial involving other investigational products within the last 3 months * previous participation in the trial * other daily injection therapy (non-growth hormone, e.g insulin-therapy)
sustainable early episode clinic study (seec)

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to describe relapse rates among participants receiving services in the seec program high intensity resource use. for purposes of this study, relapse will be defined as: psychiatric hospitalization; psychiatric emergency department visits; ambulatory acute services (partial hospitalization program, intensive outpatient program, crisis house stay).

schizophrenia is a severe mental illness that is one of the leading causes of long-term disability in the world. recognizing the need for improved early treatment for participants diagnosed with schizophrenia or schizoaffective disorder, a model was created for a "sustainable early episode clinic, seec." the goal of the seec model is to provide early intense intervention in 3 phases, with an ongoing maintenance phase, enabled by technology, resulting in improved participant outcomes and reduced long-term economic and social burden of schizophrenia. this study will last for up to a 36-month period.

Eligibility criteria:
inclusion criteria - participants * participants must be at least 18 years or older * participants within 5 years of a clinical diagnosis of schizophrenia or schizoaffective disorder made by a clinician with understanding of the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for these disorders * participants must be able to speak, read, and understand english * participants must sign an informed consent form inclusion criteria - caregivers * caregivers must be 18 years or older caregivers must also be willing to attend the multi-family psychoeducation group series (phase i) * caregivers must be willing to participate in monthly family therapy and/or monthly phone contact with staff for the duration of the study * caregivers must sign informed consent form exclusion criteria - participants * co-occurring developmental disabilities * receiving electroconvulsive therapy * primary substance use disorder * on permanent conservatorship * unable to complete baseline assessments due to acuity of psychiatric symptoms exclusion criteria - caregivers * caregivers who refuse to participate in the psychoeducation series of phase 1 * caregivers who refuse monthly family therapy/phone contact with staff will be excluded * caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by treatment team * caregiver is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employee or the investigator
metronidazole pharmacokinetics (pk) in premature infants

Conditions: Serious Systemic Infections; Necrotizing Enterocolitis

Summary: yearly in the united states over 500,000 newborns are delivered prematurely. this population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. infants with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk of mental retardation. metronidazole is an antibiotic that is often administered to infants with suspected or confirmed necrotizing enterocolitis. unfortunately, the appropriate dose of metronidazole in premature infants has not been established and it is likely to be different from older children and adults. the investigators will investigate the appropriate metronidazole dose in very premature infants by: 1) determining how premature infants eliminate metronidazole from the body and 2) determining the safest and most effective dose of metronidazole in premature infants. the investigators hypothesis are: 1) the rate of removal of metronidazole will increase with infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary drug levels to treat bacteria involved in necrotizing enterocolitis.


Eligibility criteria:
inclusion criteria: * gestational age \<32 weeks at the time of enrollment. * postnatal age \<91 days at the time of enrollment. * sufficient venous access to permit administration of study medication. * infant suspected to have a serious infection and from whom a blood culture has been obtained within 96 hours of study entry. exclusion criteria: * history of anaphylaxis to metronidazole or other nitroimidazole derivatives (e.g., tinidazole). * previous exposure to metronidazole in the week prior to study. * previous participation in the study.

Keywords: metronidazole neonate premature sepsis necrotizing enterocolitis
dose-escalation, and safety study of lde225 and gemcitabine in locally advanced or metastatic pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: this phase ib study includes two phases: dose escalation phase and safety expansion phase. during the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of lde225 administered on a continuous once daily (qd) dose in combination of gemcitabine. this phase of the study will determine the maximum tolerated dose (mtd) and/ or recommended dose for expansion (rde) of lde225 administered in combination with gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma patients. during the safety expansion phase, once the mtd of lde225 is established, additional patients will be enrolled and treated at the mtd of lde225 in combination with gemcitabine in order to further evaluate its safety, tolerability and explore the potential efficacy of the combined treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.


Eligibility criteria:
inclusion criteria: * patients with locally advanced or metastatic pancreatic adenocarcinoma that have not been previously treated or have progressed despite chemotherapy * performance status of 0 or 1 per who classification * adequate hematologic , renal and liver function * adequate blood creatine kinase value (ck \< 1.5uln) exclusion criteria: * treatment with prior radiotherapy * pancreatic cancer that is potentially curable by surgery * women of childbearing potential unless they are using highly effective method of contraception other protocol-defined inclusion/exclusion criteria may apply other protocol-defined inclusion/exclusion criteria may apply.

Keywords: metastatic pancreatic cancer lde225 gemcitabine locally advanced adenocarcinoma
a study of jnj-68284528 out-of-specification (oos) for commercial release in participants with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (oos).


Eligibility criteria:
inclusion criteria: * eligible for treatment with cilta-cel per united states prescribing information (uspi) or locally approved label * participant is suffering from serious or life threatening multiple myeloma per uspi (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator * has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (oos) * meets the criteria to receive lymphodepleting chemotherapy * a woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hcg\]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine exclusion criteria: * history of active uncontrolled infection or condition where an administration of cilta-cel oos constitutes serious health risk to the participant * known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel oos including dimethyl sulfoxide (dmso), dextran 40, or residual kanamycin per uspi * hepatitis b infection * hepatitis c infection defined as (anti hepatitis c virus \[hcv\] antibody positive or detectable hcv ribonucleic acid \[rna\]) or known to have a history of hepatitis c * seropositive for human immunodeficiency virus (hiv) * uncontrolled autoimmune disease
to assess the efficacy and safety of scd-044 in the treatment of moderate to severe atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: this is a phase ii, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.

this is a phase ii, randomized, double-blind, placebo-controlled study to determine the effect of scd-044 in subjects with moderate to severe atopic dermatitis.

Eligibility criteria:
inclusion criteria: 1. aged at least 18 years. 2. males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at screening and baseline based on eichenfield revised criteria of hanifin and rajka. 3. moderate to severe atopic dermatitis at screening and baseline exclusion criteria: 1. female subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study. 2. known organ complications of diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy. 3. history or presence of uveitis -
identification of oxygen desaturation in patients admitted following adenotonsillectomy'

Conditions: Obstructive Sleep Apnea

Summary: sleep apnea has become exceedingly recognized in children. the primary treatment for sleep apnea in children is surgery in the form of adenotonsillectomy. the majority of children that undergo adenotonsillectomy are discharged following their immediate recovery in the post anesthesia care unit.

based on national and international consensus statements, institutional practice has developed at texas children's hospital as to which patients require overnight observation following adenotonsillectomy for continuous pulse oximeter monitoring to assess for desaturation events. there is insufficient evidence to suggest which patients need to stay for pulse oximeter monitoring which has led to many patients being admitted unnecessarily. therefore, the aim of this study is to capture data prospectively on pulse oximetry in children admitted overnight following adenotonsillectomy to identify risk factors for post operative oxygen desaturation.

Eligibility criteria:
inclusion criteria: * adenotonsillectomy surgery * patient meeting institutional guidelines for postoperative admission (e.g, admitted following surgery from recovery room). exclusion criteria: * parental refusal * airway surgery in addition to adenotonsillectomy * patient psychological limitations, precluding wearing device (e.g. autism). * patient not meeting institutional guidelines for postoperative admission (e.g, discharged following surgery from recovery room).
evaluation the efficacy between botox injection and combination pharmacotherapy in patients with detrusor overactivity

Conditions: Urinary Bladder, Overactive; Urodynamics; Effect of Drug

Summary: to investigates the effects of botulinum toxin type a bladder injection compared to combined pharmacotherapy with mirabegron and solifenacin.

patients with detrusor overactivity who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study. patient were divided in two groups, intradetrusor onabotulinumtoxina injection and combined pharmacotherapy with mirabegron and solifenacin. incontinence-related symptoms distress and impact on quality of life were evaluated by short form of urinary distress inventory, (udi-6), incontinence impact questionnaire (iiq-7) and overactive bladder symptom score (oabss). objective outcomes include changes from baseline in daily urgency episodes, urinary incontinence episodes, maximum cystometric capacity, maximum detrusor pressure (pdetmax) at first involuntary detrusor contraction and volume at first involuntary detrusor contraction were measured.

Eligibility criteria:
inclusion criteria: * patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. those who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study exclusion criteria: * postvoid urine retention before treatment

Keywords: detrusor overactivity urodynamic study combined pharmacotherapy botulinum toxins effectiveness
optimization of fluid therapy in sepsis by a passive leg raising test

Conditions: Shock, Septic

Summary: a randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department. hypothesis: a passive leg raising test, will reduce weight gain by day 3 by 30%.


Eligibility criteria:
inclusion criteria: all patients \>18 years admitted to the icu diagnosed with circulatory shock due to suspected sepsis or pancreatitis. circulatory shock is defined as map\<70 mm hg or need for norepinephrine despite resuscitation with ≥30 ml/kg of crystalloid fluids. exclusion criteria: \> 12 hours have passed after onset of shock. the patient has contraindications for an arterial femoral/axillary line. elevated icp. patients who have had a femoral amputation. elevated intraabdominal pressure\>20 cm h2o. suspension criteria: the patient has developed pulmonary oedema during plr test. life threatening bleeding. serious adverse events: trombosis in arteria femoralis. death during the study period.

Keywords: shock, septic hemodynamics algorithms