Kornimate/medical-research-clean huggingface dataset:
safety study of hepastem for the treatment of urea cycle disorders (ucd) and crigler-najjar syndrome (cn)

Conditions: Urea Cycle Disorders; Crigler Najjar Syndrome

Summary: the purpose of this study is to assess the safety and to appraise the efficacy of one cycle of hepastem (heterologous human adult liver-derived progenitor cells, hhalpc) infusions in paediatric patients suffering from cn or ucd. the study duration: 12 months starting from the day of treatment: 6 months active surveillance and 6 months observation post-infusion.


Eligibility criteria:
general: 1. subject shows patency of the portal vein and branches, with normal flow velocity in the main portal vein as confirmed by doppler ultrasound and accessibility of the portal vein, or respectively, accessibility of the umbilical vein. 2. subject (if capable of signing) and parents or legal representative have provided a written informed assent/consent. 3. female subjects of childbearing potential need to have a negative pregnancy test and must agree to use an acceptable method of contraception throughout the study. main inclusion criteria crigler-najjar syndrome specific: * patient presents with crigler-najjar syndrome type 1. * patient presents with crigler-najjar syndrome type 2, poorly controlled under phenobarbital treatment, or experiencing serious impairment in quality of life. diagnosis must be confirmed by genetic mutation analysis if not available. urea cycle disorders specific: * diagnosis of one of the urea cycle disorders of which the disease is of such severity to warrant liver transplantation or alternatives despite full conservative therapy, * subject experiencing serious impairment in quality of life despite full conservative therapy. main exclusion criteria * the subject is 18 years or older at time of screening. * the subject presents acute liver failure, clinical or radiological evidence of liver fibrosis or cirrhosis, presents or has a history of hepatic or extrahepatic malignancy * the patient has a non-corrected cardiac malformation, has a known medical or family history of coagulopathy, had or has a renal insufficiency treated by dialysis. * the subject requires valproate therapy. * the subject has a thrombosis of the portal vein or persisting impairment of anterograde portal blood flow. * the subject has a porto systemic shunt or fistula assessed by doppler us. * patients with disease of such severity that liver transplantation is an absolute indication.

Keywords: cn, ucd
the efficacy of subconjunctival bevacizumab in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study evaluates the effects of subconjunctivally injected bevacizumab in patients with diffuse diabetic macular edema.

at baseline, the macular thicknesses of both eyes of the patients with persistant diabetic macular edema were measured by optical coherence tomography. after 3.75mg bevacizumab was injected into subconjunctival space of the eyes with diabetic macular edema. the measurements of the macular thicknesses were repeated by optical coherence tomography in 15th, 30th, 60th day after injections. the macular thickness measurements before and after injection were compared.

Eligibility criteria:
inclusion criteria: * having diffuse diabetic macular edema persisted at least 1 month * no intravitreal injection in last 3 months. * no retinal laser photocoagulation in last 6 months * not have any other macular disease causing macular edema exclusion criteria: * having ischemic macula * intravitreal injection in last 3 months. * retinal laser photocoagulation in last 6 months * have any other macular disease causing macular edema
prospective follow-up study of the aortic diameter in patients with giant cell arteritis

Conditions: Giant Cell Arteritis

Summary: giant cell arteritis (gca) is the most frequent vasculitis in patients above 50 years of age. the disease has limited mortality, mostly due to the development of aortic aneurysms, leading to dissection and rupture. the probability to develop this complication is 17 x higher at the level of the thoracic aorta and 2,4 x at the level of the abdominal aorta in patients with gca when compared with a control group. therefore, follow-up of the aortic diameter in patients with gca is part of good clinical practice. previous retrospective research showed a link between fdg-uptake at the level of the thoracic aorta, on positron-emission-tomography (pet) at the time of diagnosis, and the increase of diameter and volume of the thoracic aorta during follow-up (on computed tomography (ct)). the purpose of this prospective study is to follow-up on the aortic diameter, and to correlate these measures with fdg-pet uptake at diagnosis. ideally, this would allow us to define a group of patients at high risk to develop an aortic aneurysm, already at the time of diagnosis.

as standard care, all patients with a suspicion of gca undergo a biopsy of the temporal artery and a pet scintigraphy to evaluate the presence of large vessel vasculitis. patients with proven gca on biopsy and/or scintigraphy undergo a computed tomography (ct) of the aorta without the administration of contrast, at diagnosis and yearly thereafter (every 12 +/- 3 months) for 10 years. measurements include the diameter of the ascending aorta, aortic arch, descending aorta, suprarenal, juxtarenal and infrarenal aorta, and the volume of the thoracic and the abdominal aorta. these measurements are correlated with fdg-uptake at the level of the aorta on pet-scintigraphy at the time of diagnosis. all patients will be treated according to accepted guidelines and standard care in our center (methylprednisolone started at 32 mg/day, with slowly declining doses until stop after 1 to 1,5 years of treatment).

Eligibility criteria:
inclusion criteria: * patients with a first episode of biopsy and/or scintigraphy proven giant cell arteritis * patients with a previous diagnosis of giant cell arteritis, in whom a yearly computed tomography of the aorta is available can opt to participate in this study * informed consent form has to be signed by all patients exclusion criteria: * patients already treated with steroids before performance of pet-scintigraphy * earlier episodes of giant cell arteritis, without documentation of the aortic diameter at that moment
red rice yeast in low-density lipoprotein (ldl) lowering: an efficacy study

Conditions: Dyslipidemias; LDL Hyperlipoproteinemia

Summary: red yeast rice is a source of active compounds in reducing ldl levels with practically no side effects. molval fort is a natural product available in the lebanese market with a combination of red yeast rice extracts, epa/dha and coenzyme q10. the investigators are conducting this study to explore the effect of red yest rice extracts based product on ldl and its side effects in a sample of primary care lebanese patients.

red yeast rice is a source of active compounds in reducing ldl levels with practically no side effects. studies performed on american and chinese populations have shown positive results. these studies need confirmation in different populations. molval fort is a natural product available in the lebanese market with a combination of red yeast rice extracts, epa/dha and coenzyme q10. the investigators are conducting this study to explore the effect of red yest rice extracts based product on ldl and its side effects in a sample of primary care lebanese patients.

Eligibility criteria:
inclusion criteria: * adult patient (\>18 years) * indication to mild or moderate statin based on aha 2013 guidelines * treatment naïve exclusion criteria: * allergy to rice * renal or hepatic terminal disease * any contra indication to statin treatment * pregnancy wish during study period * familial hypercholesterolemia

Keywords: statins red rice yeast adverse effects cholesterol, ldl treatment outcome tolerability
evaluate the response to 2 induction courses (12 intravesical instillations) of bacillus calmette-guérin (bcg) for high risk superficial bladder cancer

Conditions: Bladder Cancer; High Risk Superficial

Summary: this is a phase ii study. this means that bcg therapy has already been found to be safe in humans. the investigators just want to see if using more treatments works better.


Eligibility criteria:
inclusion criteria: * patients must have high risk non-muscle invasive urothelial bladder carcinoma (tis, tahg, or t1) that is pathologically confirmed by the memorial sloan kettering department of pathology or a documented history of tahg or t1 non-muscle invasive urothelial bladder tumors. * 18 years and older * all visible papillary lesions must be macroscopically resected within 60 days of treatment initiation. * absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or biopsy) preferably within 12 months from the start of treatment. should the imaging or biopsy be performed outside this window it will be up to the physicians discretion to re-scan/biopsy. * patients who have received a single dose of mitomycin c following staging tur. exclusion criteria: * currently being treated or scheduled to have radiation treatment for bladder cancer during the study. * treatment with intravesical bcg or chemotherapy for a patient's current \<t2 tumor during the 12 months prior to the current diagnosis. * currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study. * currently being treated with or having been treated in the last 12 months with any investigational drug for high risk superficial bladder cancer. * previous muscle-invasive (i.e., stage t2 or higher) transitional cell carcinoma of the bladder. * currently being treated for metastatic transitional cell carcinoma. * scheduled to have surgery for bladder cancer during the study. * presence of clinically significant infections or congenital or acquired immunodeficiency.

Keywords: bacillus calmette-guérin (bcg) 14-174
treatment of obesity and binge eating: behavioral weight loss versus stepped care

Conditions: Obesity; Binge Eating

Summary: this controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with binge eating disorder (bed). the major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.

the stepped-care arm of this study included an obesity medication intervention. at the start of the study, the active medication was sibutramine and was compared to a placebo control. on 10/8/2010, abbott laboratories withdrew their obesity drug sibutramine (meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. in response to this event, the investigators submitted an irb amendment to change the active obesity medication from sibutramine to orlistat. the irb amendment was approved on 11/4/2010. the pi received approval from nih/niddk program officer robert kuczmarski to enact this change.

Eligibility criteria:
inclusion criteria: * obese (bmi\>=30) exclusion criteria: * medication regimen that represents medical contraindication to sibutramine * serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine * pregnancy

Keywords: experimental comparator
exploration of high frequency otoacoustic emissions and developmental language disorders

Conditions: Language Development Disorders

Summary: among the objective non-invasive audiological explorations the distorsion products of otoacoustic emissions (dpoae) allow to quickly assess the function of the cochlear outer hair cells (without the active participation of the subject). this technique is used in newborn screening. while humans are able to perceive sounds in a frequency range of 20hz to 20khz, routine clinical audiological assessment is only concerned with frequencies between 1-4khz. this obscures the importance of high frequencies (hf) which can be easily assessed by dpoaes. in young children, the perception of these high frequencies could also play an important role in language acquisition. the main objective of this study is to evaluate the relationship between subtle high-frequency hearing impairment, as assessed by the dpoae (non-invasive, rapid and simple audiological test), and language delay or difficulties in a pre-, peri- and school-age pediatric population.


Eligibility criteria:
inclusion criteria for case (children with language disorder): * normal hearing (after an audiometry test, even if an ent consultation has been carried out beforehand and if the doctor has not found any hearing problem, as defined in the nf en iso 70292017-04 standard, and according to an average hearing loss calculated according to the biap \<20db hl) * free and informed consent of the parental authority and the patient * affiliated to the social security system * presenting a developmental language acquisition disorder (score according to the evalo / evaleo test) * for children between 15 and 17 years of age, completion of the evaleo test before their 16th birthday inclusion criteria for control (children without language disorder) : * normal hearing (after an audiometry test, even if an ent consultation has been performed beforehand and if the doctor has not found any hearing problem, as defined in the nf en iso 70292017-04 standard, and according to an average hearing loss calculated according to the biap \<20db hl) * free and informed consent of the parental authority and the patient * enrolled in the social security system exclusion criteria: * hearing disorder identified during the inclusion visit (presence of cerumen or foreign body in the earwax plug or foreign body in the external auditory canal, tympanometry suggesting a middle ear disorder, audiometry with thresholds outside the normal thresholds outside the normal range (0-20db hl), absence of responses in (0-20db hl), absence of responses in acoustic otoemissions or acoustic distortion products) on conversational frequencies between 500hz and 4khz. * declaration by the parents of an ent follow-up for a hearing disorder and/or a speech therapy for a language disorder * refusal of participation evoked by the subject

Keywords: language development disorders otoemisions child high frequencies hearing
an efficacy and safety study of palonosetron in preventing chemotherapy-induced nausea and vomiting (cinv) in the chinese cancer patients

Conditions: Chemotherapy-Induced Nausea and Vomiting

Summary: this clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed cinv and was also well tolerated in the chinese cancer patients.


Eligibility criteria:
inclusion criteria: * male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease * naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one * karnofsky index more than 70% and anticipated survival time more than 90 days * scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study day 1 and the chemotherapy should be accomplished on study day 1 * no emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration * adequate organ functions(no impairment to renal, hepatic, cardiac or bone marrow function ) * use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit * provision of written informed consent exclusion criteria: * inability to understand or cooperate with study procedures * receipt of investigational drugs 30 days before study entry * scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment * contraindications to 5-ht3 receptor antagonists * woman patient with pregnancy or lactation * diagnosed with hypertension or severe infectious diseases * obstructive symptom of gastrointestinal tract * symptomatic brain metastasis or mental dysfunction * baseline qtc \> 500 ms
platelet reactivity in patients on a thienopyridine and awaiting coronary artery bypass grafting

Conditions: Complication of Coronary Artery Bypass Graft; Peri-operative Hemorrhage or Hematoma; Post Operative Bleeding

Summary: the primary objective of this exploratory cohort study is to describe levels of platelet reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (cabg).

the recent emergence of platelet reactivity testing as a potential option for evaluating the degree of platelet inhibition promises to add another level of understanding to our concept of cabg-related bleeding. there is an emerging literature that links high levels of platelet reactivity with adverse clinical events, primarily in patients on clopidogrel. for example, studies of the verifynow p2y12 platelet function assay have shown that platelet reactivity units (pru) \> 235-240 in patients on clopidogrel therapy appears to predict cardiovascular events.15,16 there is a paucity of literature, however, on the use of platelet reactivity testing to predict bleeding events and complications. in other words, if excessively high levels of platelet reactivity predict ischemic events, do excessively low levels of platelet reactivity predict bleeding events? this is an especially relevant question, given the emergence of prasugrel as a therapeutic option. the investigators therefore propose an exploratory cohort study of patients receiving a thienopyridine (clopidogrel or prasugrel) and undergoing cabg, in order to describe levels of platelet reactivity in such patients by using a variety of platelet function tests.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years old from both genders. 2. taking maintenance thienopyridine therapy within 5 days of surgery or received a loading dose of thienopyridine therapy within 48 hours of surgery for cabg. 3. referred for cabg (which is scheduled to be performed during the current admission). exclusion criteria: 1. known allergies to aspirin, clopidogrel, or prasugrel. 2. use of a glycoprotein (gp) iib/iiia inhibitor within 8 hours of initial platelet reactivity testing. 3. patient known to be pregnant or lactating. 4. patient with known history of bleeding diathesis or currently active bleeding. 5. platelet count \<100,000/mm the day of initial blood draw. 6. hematocrit \<25% the day of initial blood draw. 7. on warfarin therapy at the time of initial blood draw. 8. known blood transfusion within the preceding 10 days of the blood draw. 9. patients treated with non-steroidal anti-inflammatory drugs (nsaids) within the previous 5 days. 10. plan for patient to be discharged before undergoing cabg. 11. any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Keywords: platelet reactivity cabg perioperative and in hospital bleeding
evaluation of the effects of cannabidiol (cbd) compared to delta-9-tetrahydrocannabinol (thc) and alprazolam

Conditions: Cannabis Use Disorder

Summary: the purpose of this study is to evaluate the abuse potential of cbd to determine whether it should remain as a schedule i drug under the controlled substances act, or be recommended for decontrol.

this is a single-dose, randomized, double-blind, placebo- and active-controlled crossover study that evaluates cbd in comparison with thc, alprazolam, and placebo in healthy recreational drug users.

Eligibility criteria:
inclusion criteria: * must understand and provide written informed consent prior to the initiation of any protocol-specific procedures. * male or female subjects 18 to 55 years of age, inclusive. * body mass index (bmi) within the range of 19.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg. * healthy, as determined by no clinically significant medical history, physical examination, * 12-lead ecg, vital signs or laboratory (including hematology, clinical chemistry biochemistry, urinalysis, and serology) findings at screening, as judged by the investigator. * must be a recreational drug user, defined as meeting all of the following criteria: * ≥10 lifetime non-therapeutic experiences (i.e., for psychoactive effects) with cns depressants (e.g., benzodiazepines, barbiturates, zolpidem, eszopiclone, propofol/fospropofol, gamma-hydroxy-butyrate). * ≥10 lifetime non-therapeutic experiences with cannabinoids (e.g., cannabis, hashish, thc, nabilone). * at least 3 non-therapeutic uses of a sedative, and at least 3 non-therapeutic uses of a cannabinoid, within the 3 months prior to screening. * must pass qualification phase eligibility criteria. * female subjects of childbearing potential who are not abstinent must be using and willing to continue using medically acceptable contraception throughout the trial and for 30 days after last dose. in the context of this trial, highly effective methods of contraception are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. such methods include hormonal contraceptives, intrauterine devices/hormone-releasing systems, double-barrier methods, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. abstinence is only acceptable as true (total) abstinence, when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * non-vasectomized male subjects must agree to a highly effective method of contraception with female partner(s) of childbearing potential and may not donate sperm throughout the trial and for 90 days after the last study drug administration. * able to speak, read, and understand english sufficiently to allow completion of all study assessments. * must be willing and able to abide by all study requirements and restrictions. exclusion criteria: * contact site directly for more information