Kornimate/medical-research-clean huggingface dataset:
a study of subcutaneous c.e.r.a. for the treatment of anemia in pre-dialysis patients.

Conditions: Anemia

Summary: this single arm study will assess the efficacy, safety and tolerability of subcutaneous c.e.r.a. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with esa. eligible patients will receive c.e.r.a. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic renal anemia, with no need for dialysis expected in next 3 months; * adequate iron status. exclusion criteria: * previous epoetin therapy within 12 weeks prior to treatment; * transfusion of red blood cells during 2 months prior to screening; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * hemolysis; * folic acid and vitamin b 12 deficiency.
extension study for long term evaluation of sar153191 (regn88) in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: primary objective: * to assess the long term safety of sarilumab (sar153191/regn88) in participants with ankylosing spondylitis (as) secondary objective: * to assess the long term efficacy of sarilumab (sar153191/regn88) in participants with as

the maximum study duration per participant was to be 267 weeks (approximately 5 years) broken down as follows: * screening up to a maximum of 1 week; * treatment up to a maximum of 260 weeks; * follow-up of 6 weeks after treatment discontinuation.

Eligibility criteria:
inclusion criteria: * participant with as who participated and completed 12-week treatment in study dri11073-nct01061723. exclusion criteria: * adverse event(s) having lead to treatment discontinuation in the dri11073 study; * event or laboratory abnormality observed at the last treatment visit of dri11073 study that would have adversely affected participation of the participant in this study as per investigator judgment. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
study of combination of pigev before autologous stem cell transplant in patients with hodgkin's lymphoma

Conditions: Hodgkin's Lymphoma

Summary: study to assess maximum tolerated dose (mtd), safety, tolerability and activity of igev (ifosfamide, gemcitabine,vinorelbine, prednisolone) + panobinostat new combination in order to determine the recommended phase ii dose

patients will received 4 p-igev courses repeated every 3 weeks in the absence of unacceptable toxicity, whenever an objective response is observed at disease evaluation performed after ii cycle. eligible patients will be accrued in cohorts of 3 patients at each dose level and dose escalation will be performed following the standard 3+3 rule. three patients will be treated for each dose-level, starting from level 1, for one cycle: if no dose-limiting toxicities (dlts) will be recorded after the first cycle, treatment will be continued in those patients until study completion or unacceptable toxicity and three new patients will be treated at the next dose level. however, if one out of 3 patients will develop a dlt, the same dose-level will be administered to three additional patients for one cycle. if no one of those additional patients will experience a dlt, dose escalation will continue. if more than one over 3 or 6 patients will develop a dlt after the first cycle in any cohort, mtd will be reached. six further patients will be treated at the lower dose in order to obtain more information about the optimal dose for phase ii trials and to characterize pharmacokinetic profiles of this combination. if dlt will be found at level 1 (20 mg), 3 patients will be treated at dose -1 (10 mg). if no more than 1 patient experience toxicity, other 3 patients will be treated to assess more information about pharmacokinetic profiles and safety.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsed or refractory classical hl * measurable disease * one or two prior systemic lines of treatment * ps(ecog) 0-2 * absence of bone marrow infiltration * adequate laboratory values for bone marrow, liver and renal functionality exclusion criteria: * prior or concurrent treatment with a dac inhibitor including panobinostat * valproic acid therapy for any medical condition during the study or within 5 days prior to the first panobinostat treatment * previous autologous hematopoietic stem cell transplant * other concurrent therapy intended to treat the primary cancer including chemotherapy, investigational or biologic agents or other antitumor agents * impaired cardiac function or unstable af * known history of hiv seropositivity, chronic hepatitis, or other active viral infections * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection) * pregnant or breast feeding women

Keywords: hodgkin lymphoma
high level mobility training in ambulatory patients with acquired non-progressive central neurological injury

Conditions: Neurological Injury

Summary: brain injuries are a significant cause of loss of movement. it has been shown that physical therapy can help patients to regain movements. the purpose of this study is to see if it is possible to perform a new exercise program that will help patients regain movement. this new exercise program will involve practicing walking, stairs, jumping and running. participation in this study will involve physical therapy 1 to 2 times a week for 12 visits over 6 to 8 weeks.


Eligibility criteria:
inclusion criteria: * referred to physical therapy with an acquired non-progressive central neurological injury (traumatic brain injury, stroke, brain tumor, spinal cord injury) for 3 months or more * capacity to consent * ability to read and write english at the sixth grade level * able to walk twenty meter without physical assistance or an assistive device, however they can use a brace. * self-selected gait speed of 0.6 m/s or greater when performing 10 meter walk test. exclusion criteria: * adults subjects diagnosed with a progressive central or peripheral neurological disorder or an acute non progressive central neurological disorder (less than 3 months) * subjects who require physical assistance or an assistive device to walk twenty meters or demonstrate self-selected gait speed less than 0.6 m/s * subjects who are already able to run independently in the community * participants who are unable to complete the 12 physical therapy visits at prescribed skill level as established by protocol * participants who reports \>4/10 on nprs with lower extremity weight bearing.

Keywords: non-progressive central neurological injury
evaluation of adherence, persistence and efficacy of treatment with pcsk9 inhibitors in italy

Conditions: Hypercholesterolemia

Summary: evaluation of adherence, persistence and efficacy of treatment with pcsk9 inhibitors in a real-life italian population.


Eligibility criteria:
inclusion criteria: * patients under pcsk9 inhibitor treatment. exclusion criteria: * age \ 80 years; * patients who refuse to participate and to sign informed consent.
quality of life among survivors of hodgkin lymphoma

Conditions: Hodgkin's Disease

Summary: the purpose of this study is to collect information on the long-term side effects of treatment for hodgkin lymphoma. we hope to study about 500-800 survivors of hodgkin lymphoma. we plan to use the findings from this study to better understand hodgkin lymphoma survivors' health and quality of life.


Eligibility criteria:
inclusion criteria: * biopsy-proven hl participation in irb-approved protocols for the first-line treatment of hl between 1975-2000 (irb #75-104, #75-103, #79-17, #81-103, #90-44, #91-69). * english speaking exclusion criteria: * none

Keywords: survivors quality of life
phase iii study of the safety and efficacy of cl-108 in the treatment of moderate to severe pain

Conditions: Pain; Nausea; Vomiting

Summary: this is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of cl-108 (hydrocodone 7.5 mg/apap 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth. a positive control ( norco, a commercial formulation of hydrocodone 7.5 mg/apap 325 mg) was included to determine the anti-emetic effects of cl-108. the efficacy of cl-108 was also evaluated to placebo for the relief of pain.


Eligibility criteria:
inclusion criteria: * determination of being likely or possibly nausea-prone. * male or non-pregnant and non-lactating female. * surgical extraction of at least 2 impacted third molar teeth * a female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is using an acceptable method of birth control. * surgical extraction of at least 2 impacted third molar teeth. * presence of at least moderate post-operative pain. exclusion criteria: * medial condition, presence of a serious medical condition. * active local infection. * drug allergy history of hypersensitivity to an opioid, promethazine, acetaminophen. * caffeine use since midnight before the operation. * use of an ind drug within past 30 days. * previous participation in this study. * pregnant or lactating. * employee of the pi,sub-investigator or charleston labs or relative of an employee.

Keywords: pain nausea vomiting
delirium reduction with ramelteon

Conditions: Delirium

Summary: the overall purpose of this study is to identify a medication that might treat and/or prevent delirium in intensive care unit (icu). currently, there is no proven medical therapy for prevention or treatment of delirium. ramelteon is a medication approved for insomnia. we hypothesize that ramelteon may help regulate the day/night cycle and decrease icu delirium.

melatonin is an endogenous hormone that regulates the sleep-wake cycle along with several other physiological functions. it is reported that melatonin secretion may be impaired in icu patients, and there is some question whether this may be a contributing factor to delirium occurrence. ramelteon is a melatonin agonist with three to six times increased affinity for mt1 and mt2 receptors versus melatonin. it is fda approved for the treatment of insomnia, and some studies suggested some benefit with ramelteon for delirium prevention. there is limited prospective research data assessing the efficacy of ramelteon for delirium treatment. the goal of this study therefore is to assess the efficacy of ramelteon versus placebo on the prevention and treatment of delirium in icu patients.

Eligibility criteria:
inclusion criteria: * medical or surgical icu patient * ability to take oral or nasogastric tube within 48 hours of admission to icu * expected icu length of stay and life expectancy at least 48 hours * patient or poa capable of signing informed consent within 48 hours of icu admission exclusion criteria: * past medical history includes cirrhosis * active alcohol withdrawal * patients taking fluvoxamine prior to admission * self-reported hypersensitivity to ramelteon * incarcerated patients * pregnant patients * patients with acute neurological conditions including brain abscess, head bleed, meningitis * patients who are transferred from an outside hospital where they have resided for greater than 4 days * non-english speaking patients * hearing-impaired patients requiring sign language for communication * visually-impaired patients
effects of comedy therapy on pain and comfort levels in liver transplant recipients

Conditions: Liver Transplant; Complications; Pain, Postoperative; Care Acceptor, Health

Summary: this study was conducted to investigate the effects of watching excerpts from classical turkish comedy films on pain and comfort levels in liver transplant recipients during the postoperative period. h1-0: watching classical turkish comedy films has no effect on postoperative pain in liver transplant recipients. h1-1: watching classical turkish comedy films reduces postoperative pain in liver transplant recipients. h2-0: watching classical turkish comedy films has no effect on postoperative comfort levels in liver transplant recipients. h2-1: watching classical turkish comedy films increases postoperative comfort levels in liver transplant recipients.

intervention group a patient introduction form, numerical rating scale and general comfort scale were applied as a pre-test after transplantation surgery. after patients came to the clinic after transplantation surgery and their condition was stable, 10-minute turkish comedy films prepared by the researchers were shown. after the intervention, a numerical rating scale and general comfort scale were applied as a post-test. while patients watched the comedy films, a quiet and calm environment was provided in the patient room. control group a patient introduction form, numerical rating scale and general comfort scale were applied as a pre-test after transplantation surgery. no intervention was made to the control group patients outside of the clinical protocol. after patients came to the clinic after liver transplantation and their condition was stable, the numerical rating scale and general comfort scale were applied again.

Eligibility criteria:
inclusion criteria: * being over 18 years of age, * being a liver transplant recipient, * data obtained after transplantation, * not having any visual or auditory problems. exclusion criteria: * being under 18 years of age, * having any visual/auditory problems, * not accepting to participate in the study/wanting to leave, * not providing hemodynamic instability (sudden change in vital signs, etc.)

Keywords: pain comfort transplant liver post-operatif
expanded access for ljpc-501

Conditions: Catecholamine Resistant Hypotension (CRH); Distributive Shock; High Output Shock; Sepsis; Vasodilatory Shock

Summary: the primary objective of the study is to provide access to ljpc-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

primary objective the primary objective of the study is to provide access to ljpc-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy. secondary objective the secondary objective of the study is to assess the safety of ljpc-501.

Eligibility criteria:
inclusion criteria: * patients must be adults ≥ 18 years of age who remain hypotensive despite fluid therapy and vasopressor therapy and who received or are receiving a total sum norepinephrine (ne) equivalent unit dose of \> 0.2 µg/kg/min for at least 2 hours prior to ljpc-501 infusion. * patients must have central venous access and an arterial line present, which is expected to remain for the duration of the ljpc-501 infusion. * patients must be adequately volume resuscitated in the opinion of the treating investigator. * patients must have clinical features of distributive shock documented by either estimated or measured ci \> 2.3 l/min/m\^2 determined by echocardiogram or another cardiac output monitoring modality or a concurrent cvp \> 8 mmhg and scvo2 \> 70%. * patient or legal surrogate is willing and able to provide informed consent per local guidance and patient/legal surrogate is willing to comply with all protocol requirements. exclusion criteria: * patients with a map \> 80 mmhg. * patients diagnosed with acute occlusive coronary syndrome requiring intervention. * patients who have been on ecmo \< 6 hours. * patients in liver failure with a meld score ≥ 30. * patients not mechanically ventilated with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators. * patients with acute mesenteric ischemic or history of mesenteric ischemia. * patients with raynaud's phenomenon, systemic sclerosis, or vasospastic disease. * patients with an expected lifespan of \< 24 hours. * patients with active bleeding and an anticipated need for transfusion of \> 4 units prbcs within 48 hours of the initiation of ljpc-501. * patients with active bleeding and hemoglobin \< 7 g/dl. * patients with an anc \< 500 cells/mm\^3. * patients with a known allergy to mannitol. * patients who are currently participating in an investigational interventional trial. * women who are known to be pregnant at the time of screening or have a positive serum or urine β-hcg, if of childbearing potential.
autoantibodies in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: evaluate the autoantibodies, such as glutamic acid decarboxylase (gad65), tyrosine phosphatase (ia-2 or ica125), islet autoantibodies (iaa) and other associated autoimmune autoantibodies: microsomal antibodies, thyroglobulin antibodies, gastric parietal cell antibodies in patients with type 1 dm.

type 1 diabetes mellitus (dm) is a common disease in pediatric endocrine clinic and epidemiological studies showed the racial variation in the incidence, with the highest of 35 cases per 100000 in finland. the incidence of type 1 dm in taiwan is reported to be 1.5 per 100000 for the population less than 30 years old. while the diagnosis is made, the residual islet cell function is only about 20% of normal population. therefore, the principle therapy in these patients is insulin therapy lifelong. the pathogenesis of type 1 diabetes mellitus is multifactorial and controversial, involving the genetic and environmental factors. type 1 dm is an autoimmune disease, which is t cell mediated islet cell destruction. ninety percent of patients with type 1 dm express at least one of the autoantibodies to the islet. antibodies to glutamic acid decarboxylase 65 (gad65) were observed in 60-80% of such patients, which were considered the most important autoantigens. the autoantibodies disappeared successively after diagnosis and decreased in concentrations over time, but titers of antibodies to gad65 had been observed fluctuated in patients with type 1 dm. the prevalence of gad antibodies, insulin autoantibodies, ia-2 (tyrosine phosphatase) were reported as 45-67%, 23-67% and 49%, respectively in taiwan. other associated autoimmune disease, such as autoimmune thyroiditis were reported as 13-24%. such differences may be caused by the enrolling criteria and different age population. therefore, we want to elucidate the role of autoantibodies in the pathogenesis of type 1 dm.

Eligibility criteria:
inclusion criteria: * pediatric patients with type 1 diabetes
cesarean scar defect (csd); prevalence, risk factors and possible associated symptoms

Conditions: Cesarean Section Complications

Summary: the study aims to detect the incidence of cesarean scar defect (csd) in women undergoing cs in women health hospital (whh), assiut university, to identify risk factors for development of csd and identify the possible gynaecological symptoms related to csd.

all eligible women, who will undergo cs in women health hospital (whh) will be seen on regular visits to detect the presence of csd by ultrasound and identify its characters and a questionnaire will be fulfilled by the candidates about the gynecological symptoms related to csd and appeared after cs.

Eligibility criteria:
inclusion criteria: * all women who will undergo transverse lower segment cesarean section after 28 weeks gestational age (electively and emergency), after counseling and written consent exclusion criteria: 1. rupture uterus (unscarred or scarred). 2. upper segment cs. 3. vertical lower segment cs.

Keywords: niche
study of preoperative chemotherapy for early triple negative or her2-positive operable breast cancer

Conditions: Breast Cancer

Summary: the investigators research aim to explores the optimal comprehensive treatment for tnbc and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of rfs.

neoadjuvant chemotherapy (nct) is a standard treatment of patients who hope breast-conserving therapy (bct) with locally advanced inoperable breast cancer or large tumor size. it is beneficial to degrading the tumor stage, increasing the rate of surgical resection or the bct.people who are pathological complete response (pcr) after nct have an improvement in disease-free survival (dfs) and overall survival (os), as well as better prognosis. currently, breast cancer are entering into the era of molecular classification. different molecular subtype of breast cancer showed a significant difference in prognosis; triple negative breast cancer (tnbc) and her2 positive breast cancer are clinically relevant terms referring to a specific subtype of breast cancer with high malignant characteristics, early recurrence and metastasis, but sensitive to primary chemotherapy, proportion of which are 15% and 20% respectively. a meta analysis shows that tnbc and her2 positive breast cancer have a higher pcr than luminal a/b, and the increasing in pcr rate means improvement in survival. the investigators previous study indicates that paclitaxel plus carboplatin with or without trastuzumab can improve pcr and prolong rfs in tnbc and her2 positive breast cancer comparing to adjuvant chemotherapy. the investigators research aim to explores the optimal comprehensive treatment for tnbc and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of rfs.

Eligibility criteria:
inclusion criteria: 1. invasive breast cancer confirmed by pathology evaluation of core biopsy 2. tumors must be er/pgr status negative (immunohistochemistry（ihc） \< 10%) and lack of her2/neu overexpression or amplification as measured by local hospital pathology laboratory (ihc +/- fluorescence in situ hybridization (fish) and ihc \< 3+, and fish \< 2.2) as described in the nccn guidelines 3. female between18 to 70 years of age, eastern cooperative oncology group(ecog) performance status 0 or 1 4. early-stage tnbc or her2 positive breast cancer according to the american joint committee on cancer (ajcc) staging manual clinical stage iia or iib, stage iiia operable breast cancer 5. previously untreated 6. adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µl; hemoglobin \> 9 g/dl, platelets \> 100,000/µl.) 7. adequate hepatic function: total bilirubin ≤ upper limit of normal (uln), serum albumin ≥≥ 3.0 g/dl, alanine aminotransferase and aspartate aminotransferase ≤ 1.5 x uln. exclusion criteria: 1. ich:er/pgr status positive 2. her2 positive breast cancer patients with reduced ejection fraction \<50% are not eligible 3. patients with second malignancies 4. patients with bilateral breast cancer 5. allergic constitution