Kornimate/medical-research-clean huggingface dataset:
centrimag failure-to-wean post approval study

Conditions: Heart Failure

Summary: the primary objective of this post approval study is to report the proportion of patients surviving to 30 days post centrimag support or to hospital discharge, whichever is longer. for subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.


Eligibility criteria:
inclusion criteria: * subject \>18 years of age * subject or legal representative has signed informed consent form (icf) * subject has centrimag circulatory support system implanted due to failure to wean from cardiopulmonary bypass exclusion criteria: • concomitant use of extracorporeal membrane oxygenation (ecmo) during centrimag circulatory support system implantation due to ftw from cpb
nexium 40mg once daily vs prevacid 30mg twice a day for control of severe gerd

Conditions: GERD

Summary: the purpose of this study is to determine if people taking lansoprazole two times a day to control severe gerd symptoms can be controlled just as well, if not better, by taking nexium just once a day.

approximately 20% of patients taking first generation proton pump inhibitors (ppis) are taking more than the standard approved dose. this dosing is required to attain adequate control of the gastric and intraesophageal ph in order to affect the desired clinical improvement. it is recognized that the b.i.d dosing strategy increases the intragastric ph control of \<4 from approximately 12 hours to almost 16 hours. the refinement of the s isomer of omeprazole (nexium)has led to a way to more effectively control acid exposure. comparative trials with all the ppis have shown significantly greater ph control of \<4 and head to head comparisons as well as a recent crossover study. one study suggests that nexium dosing contains approximately 16.5 hours of a ph control of \<4. conceivably, this duration of ph control suggests that b.i.d. dosing of other ppis might be avoided. furthermore, it suggests that patients currently taking b.i.d. ppis might be successful candidates for conversion to q.d. nexium. this would provide a considerable cost implication to health care plans and for patients who are responsible for paying for their ppi therapy. to date, esomeprazole has not been studied in comparison to b.i.d. dosing with other ppis. there is pharmacologic evidence to suggest, however, that it is comparable. in this proposed study, we believe that by beginning with patients who were well controlled should make for a cleaner definition and a higher likelihood to demonstrate efficacy.

Eligibility criteria:
inclusion criteria: * previous diagnosis of severe gerd. * male or female 18-80 years of age * ability to read, understand and provide informed consent * gerd is adequately controlled on bid lansoprazole as evidenced by gerd-hrql score of \</= 11 * females of childbearing potential must use an acceptable method of birth control for the duration of the study. exclusion criteria: * known contraindications to nexium * current or historical evidence of \>3 cm histologically confirmed barrett's metaplasia without current dysplasia, esophageal stricture or extraesophageal gerd symptoms. * previous esophageal gastric surgery * pregnant or nursing females * clinically significant abnormal laboratory values * medical condition that may be adversely impacted by participation in this study * history of or current drug or alcohol abuse * known malignancy * need for concurrent therapy with any acid suppressive therapy other than the study drug, antacids, alginates, nsaids, \>165 mg asa, prostaglandin analogs, prokinetic drug, antineoplastic agents, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, hiv protease inhibitors, rifampin, phenobarbital, or digoxin * use of investigational drug or experimental device within 30 days prior to screening

Keywords: reflux gerd
adult sma research and clinical hub

Conditions: Spinal Muscular Atrophy (SMA)

Summary: adult sma reach is a data collection study aiming to gain a better understanding of the impact of standards of care and new treatments on the natural history of spinal muscular atrophy (sma). this study is sponsored by the newcastle upon tyne hospitals nhs foundation trust. adult sma reach is funded by biogen and roche. currently, there are three drug treatments available for sma in the uk: zolgensma, nusinersen and risdiplam. zolgensma is the only approved drug - nusinersen and risdiplam are currently available as part of managed access agreements (maa).

spinal muscular atrophy (sma) is a genetic motor neuron disease with a broad spectrum of severity, affecting both infants and adults. advances in treatment, including nusinersen (spinraza), onasemnogene abeparvovec (zolgensma), and risdiplam (evrysdi), have significantly improved patient outcomes, highlighting the need for stronger clinical networks to monitor the long-term effects of these therapies. the adult sma reach study builds upon the success of sma reach uk, which has been instrumental in collecting natural history and treatment data for paediatric sma patients. the study benefits from collaboration with treat-nmd, the uk sma patient registry, and ismac, aligning with international efforts to harmonise sma data collection. by leveraging newcastle university's experience in global sma initiatives, adult sma reach aims to enhance patient care, inform clinical decision-making, and contribute to future sma research.

Eligibility criteria:
inclusion criteria: * age ≥16 years (when patients will begin the transition process to adulthood) * genetically confirmed diagnosis of 5q sma * signed informed consent to take part in the study exclusion criteria: * non-5q sma * no genetic confirmation * \<16 years of age * no signed informed consent or consent withdrawn

Keywords: sma data collection adult sma sma reach data collection study spinal muscular atrophy, spinal real-world data
heart failure and anemia

Conditions: Heart Failure; Anemia

Summary: the purpose of this study is to determine whether increasing hemoglobin concentration in patients with heart failure and anemia will improve the patients' functional status, including exercise tolerance and new york heart association (nyha) classification.


Eligibility criteria:
inclusion criteria: - at least 21 years of age - symptomatic chf for at least 3 months - limited exercise tolerance on a treadmill - reduced left ventricular ejection fraction - stable heart failure medication - hemoglobin concentration between 9.0 and 12.5 g/dl exclusion criteria: - hypertension - unstable angina pectoris or recent myocardial infarction - likely to receive cardiac transplant - unable to do cardiopulmonary exercise testing - major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - recent or current treatment for malignancy - systemic hematologic disease - anemia due to acute or chronic bleeding - recent epogen or darbepoetin alfa therapy - recent blood transfusion
genomic analysis to identify a predictive biomarker for immunotherapy

Conditions: Lung Cancer

Summary: this study is designed to identify the predictive biomarker for immunotherapy using patient samples (tumor tissue, blood, fecal material) who treated with immune checkpoint inhibitor.

\[sample acquisition\] * informed consent is waived for those who agree to donate samples left over from other clinical trials or acquired for other purposes to be used for other research by the sign to master agreement in advance. * the study will be conducted based on the purposes indicated in the master agreement signed by tissue donator \[clinical data acquisition\] * baseline demographics: sex, birth date, expire date (last follow-up date for the survivals) * lung cancer treatment history: diagnosed date, treatment history (surgery, radiation therapy, chemotherapy, immunotherapy treatment history, and responses), general performance, metastatic sites * lung cancer histologic information: pathology, histologic subtype, egfr mutation profile, alk-rearrangement result

Eligibility criteria:
inclusion criteria: 1. aged above or equal to 18 2. histologically confirmed lung cancer patients 3. patient treated with immune checkpoint inhibitor exculsion criteria: na
the bioseal vascular study

Conditions: Cardiovascular Bleeding; Vascular Bleeding; Hemorrhage

Summary: to evaluate the clinical utility of bioseal as an adjunct to control bleeding during elective vascular surgery.


Eligibility criteria:
inclusion criteria: 1. subjects between 18 and 75 years of age; 2. undergoing elective vascular surgical procedures and with the presence of an appropriate target bleeding site (tbs) requiring an adjunct to achieve hemostasis as identified intra-operatively by the surgeon ; 3. able and willing to comply with procedures required by protocol; 4. signed and dated written informed consent prior to any study related procedures. exclusion criteria: 1. subjects with any intra-operative findings that may preclude conducting of the study procedures; 2. intended use of fibrin sealants (including autologous fibrin sealants) other than bioseal on the tbs; 3. subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products; 4. subjects with known allergies to or previously used porcine derived products; 5. female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period. 6. the subject, in the opinion of the investigator, would not be suitable for participation in the study. 7. subjects who participated in another trial within 30 days prior to the planned start of treatment.
comfort comparison of intravitreal injection eyelid retraction techniques

Conditions: Intravitreal Injection; Pain

Summary: this study evaluated the discomfort associated with eyelid retraction during intravitreal injections. participants had eyelid retraction with one of three methods: eyelid speculum, unimanual eyelid retraction method or with a cotton tipped applicator eyelid retraction technique. all participants were given a pain survey immediately after the injection to evaluate their discomfort level.

comfort is an important factor in compliance and satisfaction during medical care with the millions of intravitreal injections done each year, even small improvements in participants' experiences could lead to significant benefit. during the process eye injections, the method of eyelid retraction has been shown to be one of the most significant sources of discomfort. many ophthalmologists use an eyelid speculum to retract the eyelids, but potentially more comfortable methods exist. the purpose of our study was to test the comfort eyelid retraction with an eyelid speculum to that of the unimanual eyelid retraction method and a cotton tipped applicator eyelid retraction technique.

Eligibility criteria:
inclusion criteria: * adult participants receiving an intravitreal injection exclusion criteria: * iodine allergy * prior ocular surgery other than uncomplicated cataract surgery

Keywords: discomfort visual analog scale speculum eyelid retraction cotton tipped applicator eyelid speculum unimanual eyelid retraction
weight loss diet in obesity with metabolic syndrome

Conditions: Obesity; Diet Modification

Summary: concomitant interventions included lifestyle modification with a personally tailored program of diet as detailed below and physical activity adjusted for age and specific physical limitations, targeting engagement in physical activity of at least 150 minutes/week. lipid lowering and or blood pressure lowering drugs were prescribed as needed according to guideline-assisted medical practice. patients were seen by a physician every 3 month. the dietitian had a weekly meeting with the patients for the first three months, every other week during months 4-6, once a month during month 7-9 and every 6 weeks during the last three months of the study.


Eligibility criteria:
inclusion criteria: - fulfilled the diagnostic criteria for the metabolic syndrome as defined by the third report of the adult treatment panel (atpiii). exclusion criteria: * diabetes * the presence of current or recent pregnancy or intention to conceive within the trial's period * chronic renal or liver disease * past bariatric surgery * current participation in any dietary/ medical program with current continuous weight loss.
pet imaging characteristics of c11-acetate in patients with recurrent prostate carcinoma

Conditions: Prostate Cancer

Summary: positron emission tomography (pet) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

the goal of this project is improved imaging of prostate cancer by positron emission tomography (pet) with use of the radiopharmaceutical c-11 acetate, utilizing state-of-the-art pet/ct camera technology and processing algorithms. a successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. this study is designed to generate data to add to the understanding of the effectiveness of c-11 acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy. the study is designed to expand on the database of c11-acetate pet imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in psa), and to evaluate the relationship between detection on c11-acetate pet imaging, psa (trigger, velocity and doubling time) and fdg pet imaging. specific questions to be addressed: 1. what is the yield of current state-of-the-art pet/ct with c-11 acetate in detecting recurrent disease in this patient population? 2. how does the performance of pet with c-11 acetate compare with that of pet using f-18 fluorodeoxyglucose (fdg-pet), sodium f18 pet bone scans and with that of ct? 3. what is the optimal imaging protocol in terms of imaging time after injection?

Eligibility criteria:
inclusion criteria: * recurrent prostate cancer (detectable psa following radical prostatectomy or rising psa in patients with radiation therapy as the primary treatment) exclusion criteria: * \< 18 years old * claustrophobic patients

Keywords: recurrent prostate carcinoma sodium acetate c11 pet prostate cancer rising psa psa recurrence biochemical recurrence
study to evaluate the use of ultrasound in the diagnosis of hemophilic joint disease

Conditions: Inherited Bleeding Disorders

Summary: the purpose of this study is to see whether power doppler sonography (pds) can be used to diagnose synovitis in patients with inherited bleeding disorders.

aim #1 - to determine if pds can be used to diagnose synovial hypertrophy and inflammation in joint disease associated with inherited bleeding disorders. mri will be used as a reference standard. aim #2 - to determine if pds can be used to assess therapeutic response to treatment. aim #3 - to determine if pds can be used as a screening tool for diagnosing early synovitis.

Eligibility criteria:
inclusion criteria: * diagnosis of inherited bleeding disorder for aim 1: * age of at least 6 years * history of at least 4 bleeds in the same joint in the preceding 6 months * joint swelling, synovitis or deformity for aim 2: * meet inclusion criteria for aim 1 and will be having a synovectomy for aim 3: * age of at least 1 year * have had at least 2 joint bleeds exclusion criteria: * not meeting inclusion criteria

Keywords: hemophilia factor deficiency synovitis sonogram
compromised microcirculation in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the scientific aims of the study are to determine how peripheral microcirculatory responsiveness is altered in obese women with polycystic ovary syndrome (pcos) during local heating and to determine the mechanism for testosterone effects on peripheral microcirculatory responsiveness in women with pcos.

in these studies, we propose to use the skin as a relatively non-invasive model to examine cardiovascular and endothelial function in obese women with and without pcos. data have indicated an important role for testosterone in influencing the peripheral microcirculation. while testosterone can lead to vasodilation in the peripheral microcirculation in both men and in women without pcos, testosterone appears to induce vasoconstriction in women with pcos. the differential response between women with and without pcos, and between men and women may be the result of differential et-1 actions in the vessel, and regulated by the receptor subtype is involved in these actions.

Eligibility criteria:
inclusion criteria: * obese women (18-35) years with and without pcos exclusion criteria: * conditions that would preclude safe use of hormones

Keywords: skin blood flow microcirculation
cost effectiveness of linezolid in central america

Conditions: Ventilator Acquired Pneumonia

Summary: the therapy with linezolid (lin) represents better cost-effectiveness vs. vancomycin (van) for the treatment of nosocomial pneumonia associate to ventilator (vap).


Eligibility criteria:
inclusion criteria: * evidence of a legally acceptable representative signed and dated informed consent document indicating that him or her has been informed of all pertinent aspects of the study. * adult (18 years old or older) men and women with confirm diagnosis of vap treated on icu with lin or van; on the selected institutions. exclusion criteria: * adult men or women with nosocomial pneumonia not associated to a ventilator.

Keywords: cost effectiveness linezolid ventilator acquired pneumonia central america
infection rates between using of vancomycin versus gentamycin in primary aclr

Conditions: Anterior Cruciate Ligament Injuries

Summary: the purpose of the study is to compare the efficacy of vancomycin versus gentamycin , in reducing infection rates following anterior cruciate ligament reconstruction .

there has been a marked increase in the number of cases of anterior cruciate ligament reconstruction (aclr) worldwide. aclr helps in the restoration of knee instability. but infection following aclr is a big complication(1) .it may require multiple reoperations in the form of irrigation and debridement, prolonged use of antibiotics, removal of the graft, and sometimes graft revision surgery. it also has increases the risk of early osteoarthritis, and causes graft failure (2,3) . there are a number of contributing factors that can lead to infection, like the presence of comorbid conditions like diabetes or concomitant open surgical procedures, use of larger incisions, longer tourniquet time, and use of drain are other contributing factors(4) .some studies have reported increased chances of infection with hamstring autografts in comparison to patellar tendon autografts and drain application(5,6). the harvested graft is prone to infection from skin flora, and an adequate concentration of antibiotics to inhibit bacterial growth can be achieved with the local application of antibiotics over the graft(7) .the most common pathogen after aclr is staphylococci, accounting for 90% of cases of septic arthritis (8,9). vancomycin is commonly used locally in the surgery in orthopaedics because of the relative safety for local use in high dosis, and bactericidal action against organisms like staphylococcus aureus (10) on the other hand there are concerns about its use because of antibiotic resistance, high cost, and graft toxicity(11) . several studies evaluated the effect of gentamicin solution on aclr(7). gentamycin offers an advantage in terms of activity against staphylococci, gram-negative pathogens, and pseudomonas, along with being cost-effective(7). the objective of the present study is to compare the infection rate with pre-soaking of harvested grafts in vancomycin vesus gentamycin during aclr.

Eligibility criteria:
inclusion criteria: * 1) any patient for aclr exclusion criteria: * 1) revision acl surgery 2) previous knee surgery 3) associated knee operations other than meniscal surgery (eg.hto) 4) open acl reconstruction 5) immune suppressed patients (eg. diabetic and patients taking steroids )
study of danicopan in participants with paroxysmal nocturnal hemoglobinuria with inadequate response to eculizumab

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: to determine the effectiveness of ach-0144471 (also known as danicopan and alxn2040) in improving anemia when given with eculizumab for 24 weeks in participants with pnh. danicopan dose may be increased within each participant, to a maximum of 200 milligrams (mg) three times daily (tid) based on safety and efficacy at protocol-specified time points.

the purpose of this study is to determine the effectiveness of danicopan in improving anemia, as measured by increased blood hemoglobin, when given with eculizumab (a drug commonly used for treatment of pnh) for 24 weeks in participants with pnh. the 24-week treatment period was followed by a long-term extension phase. in the extension phase, participants received the same danicopan dose plus eculizumab as they were receiving at the end of 24-week treatment phase. results are reported for the 24-week treatment period.

Eligibility criteria:
key inclusion criteria: * diagnosed with pnh * have received at least one red blood cell transfusion within last 12 weeks * anemia with adequate reticulocytosis * must be on a stable regimen of eculizumab * platelet count ≥ 40,000/microliter without the need for platelet transfusions * documentation of vaccination for neisseria meningitidis, haemophilus influenza, and streptococcus pneumoniae or willingness to receive vaccinations based on local guidelines * willingness to receive antibiotic prophylaxis * female participants must use highly effective birth control to prevent pregnancy during the clinical trial and for 30 days after their last dose of study drug * male participants must use a highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 90 days after the last dose of study drug key exclusion criteria: * current evidence of bone marrow failure or aplastic anemia requiring treatment * history of a major organ transplant or hematopoietic stem cell/marrow transplant * received another investigational agent within 30 days or 5 half-lives of the investigational agent prior to study entry, whichever is greater * documented c5 complement protein mutations * known or suspected complement deficiency * contraindication to any of the required vaccinations * active bacterial infection or clinically significant active viral infection, a body temperature \>38°c, or other evidence of infection * history of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection * history of hypersensitivity reactions to commonly used antibacterial agents note: additional inclusion/exclusion criteria may apply, per protocol.

Keywords: pnh paroxysmal nocturnal hemoglobinuria ach-0144471 danicopan eculizumab alxn2040