Kornimate/medical-research-clean huggingface dataset:
alk37-003: a study of rdc-1036 (alks 37) in adults with opioid-induced constipation (oic)

Conditions: Opioid-induced Constipation

Summary: the purpose of this study is to assess the safety and tolerability of rdc-1036 (alks 37) in adults with opioid-induced constipation (oic) following repeat dose administration

approximately 60 subjects will be enrolled in 1 of 2 cohorts. following a review of cohort 1 safety and tolerability data, subjects will then be enrolled into cohort 2, to explore additional doses. dose escalation will occur in both cohorts. there will be 18 visits over a 6-week period.

Eligibility criteria:
inclusion criteria: * 18 to 70 years of age * body mass index (bmi) of 19 to 35 kg/m2 at screening * receiving prescribed opioid medication for the management of chronic, non-cancer, pain * diagnosis of opioid-induced constipation (oic) * willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. the use of constipation rescue medication will be allowed during the study. exclusion criteria: * pregnancy and/or currently breastfeeding * clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed) * receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction * any gastrointestinal (gi) or pelvic disorder known to affect bowel transit, produce a gi obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars) * use of medical devices such as pacemakers, infusion pumps, or insulin pumps * use of naloxone, subutex or suboxone, revia, relistor, or entereg starting 15 days before the first study visit following screening until the end of the study * participation in a clinical trial of a pharmacological agent within 30 days before screening

Keywords: opioid-induced constipation rdc-1036 alks 37
abilify maintena pms in schizophrenia patients or bipolar 1 disorder

Conditions: Schizophrenia; Bipolar 1 Disorder

Summary: this is a post-marketing surveillance (pms) of abilify maintena® injections in accordance with korean regulations on new drug re-examination (i.e. new drug re-examination standards: ministry of food and drug safety(mfds) notification).


Eligibility criteria:
inclusion criteria: * adult patients with schizophrenia or bipolar 1 disorder * patients who are prescribed abilify maintena® injections treatment as per investigator's medical judgment * patients giving written authorization to use their personal and health data and starting abilify maintena® injections treatment after agreement is in place and investigators provide the explanation about objective and feature of the surveillance exclusion criteria: * patients with known hypersensitivity to aripiprazole or any excipients of abilify maintena® injections * elderly patients with dementia related psychosis * patients who have been treated with abilify maintena® injections * patients with score 0(not assessed) or 1(normal, not at all ill) in the clinical global impression-severity(cgi-s) * patients participating in other clinical trial * all patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance
intravitreal triamcinolone acetonide versus intravitreal bevacizumab for refractory diabetic macular edema (ibeme study)

Conditions: Diabetic Macular Edema

Summary: intravitreal triamcinolone has been effective for central macular thickness reduction and concomitant visual acuity improvement in patients with diabetic macular edema (dme). vegf is a very effective inducer of permeability, being 50.000 times more potent than histamine, and may exert its effect on retinal vascular permeability by altering tight-junctions proteins, such as occluding and ve-cadherin. based on these principles, there is a rationale for anti-vegf agents treatment of increased retinal capillary permeability conditions, such as diabetic macular edema. therefore, we conducted a randomized, prospective study to compare the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab injection for refractory diffuse dme.


Eligibility criteria:
inclusion criteria: * refractory diffuse dme (defined herein as clinically significant dme \[by biomicroscopic evaluation\] unresponsive to focal laser photocoagulation \[performed at least 3 months before evaluation\] and generalized breakdown of the inner blood-retina barrier with diffuse fluorescein leakage involving the foveal center and most of the macular area on fluorescein angiography), * snellen logarithm of minimum angle of resolution (logmar) bcva equivalent of 20/40 or worse, and 3) central macular thickness (cmt) greater than 300µm on optical coherence tomography (oct) exclusion criteria: * aphakic or pseudophakic eyes, * glycosylated hemoglobin (hb a1c) rate above 10%, * history of glaucoma or ocular hypertension, * loss of vision as a result of other causes, * systemic corticoid therapy,. * history of thromboembolic event (including myocardial infarction or cerebral vascular accident); * major surgery within the prior 6 months or planned within the next 28 days; * uncontrolled hypertension (according to guidelines of the seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure \[jnc-7\]);16 * known coagulation abnormalities or current use of anticoagulative medication other than aspirin; * severe systemic disease; or * any condition affecting follow-up or documentation

Keywords: bevacizumab diabetes intravitreal macular edema triamcinolone vegf
vasodilatory and metabolic effects of glucagon-like peptide-1 in periphery circulation in patients with and without type 2 diabetes mellitus

Conditions: Type 2 Diabetes; Blod Pressure; Glucagon-like Peptide-1; Human Physiology; Blood Flow

Summary: diabetes and high blood pressure are risk factors for developing heart disease. an increase in the number of diabetes patients is expected. this increases the number of patients with heart disease, and since the vast majority with diabetes die from heart disease, it is extremely important to investigate how these diseases can be prevented and treated. studies in animals have shown that intestinal hormone glucagon-like peptide-1 (glp-1) can expand blood vessels, thus lowering blood pressure, but it is not known whether the effects is found in humans, which we will investigate. studies have also shown that glp-1 lowers blood sugar, but it is unclear whether this is solely due to increased insulin production, weight loss associated with glp-1 intake or glp-1 has an effect on the muscles which increases the uptake of sugar. we investigate whether glp-1 enhances the absorption of sugar in the leg. the investigators also examines whether these effects are greater in people with diabetes then in healthy.


Eligibility criteria:
inclusion criteria: * written informed consent * t2dm according to who's criteria (only t2dm subjects) exclusion criteria: * anemia * t1dm * severe liver or renal disease * severe heart disease * atrial fibrillation

Keywords: type 2 diabetes blod pressure glucagon-like peptide-1 human physiology blood flow
effect of vitamin d on morbidity and mortality of the covid-19

Conditions: COVID-19

Summary: patients diagnosed of covid-19 disease are randomized to receive a single dose of 100.000 iu of cholecalciferol (vitamin d arm) or no vitamin d (on top of the current medication used to treat covid 19). clinical, radiological and biochemical outcomes of covid 19 disease as well as mortality are evaluated.

efficacy parameters to compare both groups (vitamin d and no vitamin d). time to reach undetectable levels of sars cov2 infection. time of normalization of symptoms and clinical parameters. time of normalization of radiological images. time of normalization of biochemical markers. time of normalization of molecular inflammatory markers. transfer to the intensive care unit. mortality rate.

Eligibility criteria:
inclusion criteria: * \> 18 year * diagnosis of covid-19 * accept to participate in the study ( consent) exclusion criteria: * pregnancy * allergy to vitamin d * consumption of any form of vitamin d during the last 3 months * expected fatal outcome in the next 24 hours * cognitive deterioration
evaluation of a sensory-tonic stimulation on development of parent-infant interactions and social cognition in very premature children

Conditions: Very Preterm Birth

Summary: attachment is built primarily on the first interactions of the first 9 months of a baby's life. these first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others. extreme prematurity strongly modify these first interactions between parents and child. very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment. early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.

the aim of the study is to evaluate impact of a sensory-tonic stimulation on development of parent-infant interaction and on social cognition in very premature children.

Eligibility criteria:
inclusion criteria : * very preterm child (born before 32 weeks of amenorrhoea) * parents agreeing to participate to the study exclusion criteria : * child born before 25 weeks of amenorrhoea * child with a birth weight less than 600 grams * child with congenital malformation * child with hemodynamic instability
safety and tolerability of msi-1436c in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is a phase i, open-label, dose escalation study. msi-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle.

this is a phase i, open-label, dose escalation study. msi-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. subjects will be enrolled according to a standard phase i fibonacci design to receive msi-1436. drug infusions will last approximately 2 hours. if a subject has a dose-limiting toxicity (dlt) at any time during the study, msi-1436 will be held and either re-started or discontinued in that subject as per the dose adjustments and toxicities guidelines.

Eligibility criteria:
inclusion criteria: * signed, witnessed, and dated institutional review board (irb) approved informed consent form (icf). * pathologically confirmed metastatic breast cancer with measurable disease. metastatic sites must be measurable on ct, mri, or fdg-pet/ct as per the revised recist v1.1 criteria or measurable disease on physical examination. a metastatic site must be biopsy proven * life expectancy ≥3 months. * patients enrolled must have received 2 or more lines of therapy and all patients with her2 expressing tumors must have received her2 targeted therapy. * female age ≥18 years. * stable brain metastasis is permitted. this is not considered measurable disease. stable brain metastasis is defined as no change on ct scan or mri for minimum of 2 months and no change in steroid dose for a minimum of 4 weeks * a negative serum pregnancy test, if female of reproductive potential. reproductive potential defined as age \< 55 or with no menses for \< 1 year * screening laboratory values as follows: total bilirubin ≤1.5 times upper limit of normal (uln). aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase)≤ 2.5 times uln. serum creatinine ≤2.0 mg/dl or calculated creatinine clearance ≥60 ml/min. absolute neutrophil count \>1,500 cells/mm3. platelet count ≥100,000 plt/mm3. hemoglobin ≥ 8 g/dl. non-diabetic exclusion criteria: * pregnant or breast-feeding * ecog performance status greater than 2
craneofacial injuries in rink hockey athletes

Conditions: Head Injury; Face; Concussion, Brain

Summary: to collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season.

to collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season, while collecting athlete´s exposure and specifical injury characteristics (burden, mechanism, situation, etc)

Eligibility criteria:
inclusion criteria: * compete in a spanish rink hockey league * play at least in one game during ther regular season exclusion criteria: * do not accept the participation in the study

Keywords: rink hockey injury epidemiology burden
dietary protein intake and rehabilitation from anterior cruciate ligament surgery

Conditions: ACL Injury

Summary: protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (rt) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. protein supplementation could be useful to improve clinical outcomes.

protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (rt) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. despite this, no studies have investigated the role of protein provision in the context of physical therapy (pt) or musculoskeletal rehabilitation, including following surgical interventions. survey data of americans in the highest protein consuming age range (19-30 year old consuming 91 g/kg body weight/day), show they have an adequate protein intake to maintain nitrogen balance at baseline (85 g/kg). however, if patients under consume protein, as apparent in older adults (mean intake of 66 g/kg) these individuals will require more during times of tissue healing or could benefit with more in attempting to build back their strength through rt or pt. thus, protein supplementation could be useful to improve clinical outcomes.

Eligibility criteria:
inclusion criteria: * participants with a complete acl tear and received a hamstring autograft acl repair surgery (within 8 months of injury) and plan to complete physical therapy and follow up treatment with wfbh at d1 outpatient rehabilitation * subjects must have a smartphone capable of running the nutrition tracking app (my fitness pal) exclusion criteria: * subjects must not have other ligamentous involvement, or complications during the surgical procedure. * they must not have had a concurrent meniscal repair (debridement is acceptable). * they must not have post-operative limitations that interfere with rehabilitation. * patients determined by the referring surgeon to be poor candidates for the study for any medical (including history of eating disorder, phenylketonuria, maple syrup urine disease, food allergies, lactose intolerance, kidney or liver disease) or other reasons that deem them inappropriate to complete the intervention (driving distance from facility, work schedule that prohibits therapy treatments, dietary restrictions) will be excluded. * females who are pregnant will not be permitted in the study.

Keywords: protein nutritional guidance acl surgery
low-dose rituximab and high-dose dexamethasone as first line treatment for itp

Conditions: Immune Thrombocytopenic Purpura

Summary: the purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab and high-dose dexamethasone in the treatment of adult immune thrombocytopenic purpura.

itp is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction and bleeding. corticosteroids increase the platelet count in about 80 percent of patients.however, many patients have a relapse when the dose of corticosteroid is reduced. debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. rituximab, a chimeric anti-cd20 monoclonal antibody, has been shown to be effectively raise the platelet count in some patients with itp and there is clinical and biological evidence to suggest that, if given early, rituximab may prevent itp relapses. rituximab 375 mg/m2 weekly for four weeks has significant activity in patients with immune thrombocytopenia. furthermore, using lower dose rituximab the level of b-cell depletion and the response rates appear similar to those previously observed with standard dosages in a population of itp. the purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab (100mg iv days 1,8, 15 and 22) and high-dose dexamethasone (40mg po days 1,2,3,4) in untreated adult patients immune thrombocytopenic purpura. a complete platelet response is defined as an increase in platelet counts to \>150×109/l on two consecutive occasions. a partial response is defined as an increase in the platelet count to between 50 and 150×109/l on two consecutive occasions, 1 week apart. duration of response is considered from the day of the initial infusion to the first time of relapse (platelet count \<30×109/l)or to time of analysis.

Eligibility criteria:
inclusion criteria: * clinically confirmed immune thrombocytopenic purpura (itp) platelet count less than 30,000/mm3 on two occasions. platelets \>30000/mm3 with bleeding. * normal to increased numbers of megakaryocytes on bone marrow examination in patients ≥ 60 years * subject is ≥ 18 years * subject has signed and dated written informed consent. * no sepsis or fever * no active infection requiring therapy * no active chronic viral infection * hiv negative * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception exclusion criteria: * performance status above or equal to 2. * previous treatment with rituximab * immunosuppressive treatment within the last month * previous splenectomy * presence of malignant haematological disease * connective tissue disease * autoimmune hemolytic anemia * pregnancy and lactation * not willing to participate in the study. * expected survival of \< 2 years * known intolerance to murine antibodies.

Keywords: rituximab dexamethasone low-dose itp
an study of patients with ph- chromosome-negative relapsed or refractory acute lymphoblastic leukemia in the us

Conditions: Relapsed/Refractory Acute Lymphoblastic Leukemia

Summary: a retrospective chart review study of philadelphia chromosome-negative r/r all patients in the us.


Eligibility criteria:
inclusion criteria -medical records of patients initiating treatment for ph- r/r all at participating clinical centers in the us between january 2013 and march 2019 will be eligible for inclusion. exclusion criteria * medical records of patients with ph+ all will be excluded. * if informed consent is required, medical records of patients who do not provide informed consent will be excluded.
prgn-2009 in combination with pembrolizumab versus pembrolizumab in patients with recurrent or metastatic cervical cancer

Conditions: Cervical Cancer; HPV-Related Carcinoma; HPV-Related Malignancy; Recurrent Cervical Carcinoma; Metastatic Cervical Cancer

Summary: this randomized trial will evaluate the efficacy and safety of prgn-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.

this is a randomized, two-arm study of prgn-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. patients meeting all eligibility criteria who consent to participate in the study will be randomized 1:1 to receive a combination of prgn-2009, plus pembrolizumab, or to receive pembrolizumab alone.

Eligibility criteria:
inclusion criteria: * age 18 years and older. * recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant. * must have been treated with pembrolizumab, either as monotherapy or in combination * patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting * tumors are confirmed positive for pd-l1 and hpv16/18 * measurable disease that can be accurately measured by recist v1.1 criteria * eastern cooperative oncology group (ecog) performance status of 0 or 1. * life expectancy ≥ 12 weeks from the time of enrollment. * must have adequate organ function * negative serum pregnancy test. women of child-bearing potential (wocbp) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment. * all patients must have the ability to understand and willingness to sign a written informed consent. exclusion criteria: * patients with presence of other active malignancy within 1 year prior to study entry * known central nervous system (cns) disease * has severe hypersensitivity (≥grade 3) to pembrolizumab and/or any of its excipients. * known history of active tuberculosis (tb, bacillus tuberculosis). * pregnant and lactating women are excluded from this study. * patients with a history of solid organ transplant. * patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment. * patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.

Keywords: human papilloma virus cervical cancer pembrolizumab therapeutic vaccine cervix cancer resistance to checkpoint inhibitors
cyclosporine 0.1% eye drops as prophylactic treatment in cataract surgery

Conditions: Ocular Surface Disease; Ocular Inflammation

Summary: use of cyclosporine 0.1% eye drops as prophylactic treatment in cataract surgery

to asses ocular discomfort symptoms and signs and inflammatory biomarkers after preoperative topical cyclosporine 0.1% eye drops therapy in high risk elder population after a specific insult such as cataract surgery.

Eligibility criteria:
inclusion criteria: * \>18 years old * postmenopausal women for whom cataract surgery has been scheduled * stage n2-3; c1-2 according (lens opacities classification system) locs * willing to sign informed consent and fully participate to all length of the study * patients without any previous medical history of ocular and/or systemic inflammatory, autoimmune or auto inflammatory disease * patient with no history of ocular surgery * patients without any previous or concomitant ocular diseases exclusion criteria: * patients under topical or systemic anti- inflammatory drugs patients with a concomitant diagnosis of glaucoma, or on therapy with antiglaucoma drugs * patients on systemic or local therapy with drugs that alter the secretion of the tear film (beta blockers, antidepressants and psychotropics) * patients with a history of allergic, congenital, autoimmune systemic diseases * patients who have undergone previous eye surgery * ocular or peri-ocular malignancies or premalignant conditions * active or suspected ocular or peri-ocular infection. * complicated cataract surgery * patients with a positive pregnancy testallergy or reaction history to study drug * patients who participated in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug

Keywords: ocular surface disease
transient infrared imaging for early detection of skin cancer

Conditions: Skin Cancer

Summary: the hypothesis or study goal is to determine whether functional dynamic infrared imaging can be used for melanoma and other skin cancer screening and/or diagnosis.


Eligibility criteria:
inclusion criteria: * all lesion in easily accessible places * lesion less than 3.5 cm exclusion criteria: * any minors * lesion close to vital organs