Kornimate/medical-research-clean huggingface dataset:
a study of apalutamide in participants with severe hepatic impairment compared with participants with normal hepatic function

Conditions: Hepatic Impairment

Summary: the purpose of this study is to characterize the single-dose pharmacokinetic (pk) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.


Eligibility criteria:
inclusion criteria: * participants must not have hepatic encephalopathy greater than or equal to (\>=) grade 3 (for participants with severe hepatic impairment) where the participant lacks the capacity to provide informed consent as judged by the investigator. mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted * participants with normal hepatic function must be in good health with no clinically significant findings from medical history, physical examination, vital signs, and laboratory evaluation, unless deemed not clinically significant by the investigator * participants with normal hepatic function must have serum creatinine within normal limits and creatinine clearance (crcl) greater than (\>) 60 milliliter per minute per 1.73 meter square (ml/min/1.73 m\^2) as calculated per chronic kidney disease epidemiology collaboration (ckd-epi) creatinine equation * participants with severe hepatic impairment must have a total child-pugh score of 10 to 15 inclusive, as determined by the investigator during screening and on day -1 prior to study drug administration. source documents to substantiate the clinical diagnosis (for example, ultrasonography, liver biopsy, liver/spleen scan, laboratory results or clinical findings), and medical history will be reviewed and signed by the investigator * participants with severe hepatic impairment must have crcl \>= 45 ml/min/1.73 m\^2 as calculated per ckd-epi creatinine equation exclusion criteria: * use of thyroid hormone replacement therapy * participants with normal hepatic function with presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function * participants with normal hepatic function who have hepatitis a immunoglobulin m positivity, hepatitis b surface antigen (hbsag) positivity, positive serology for hepatitis b or hepatitis c antibodies. hepatitis b surface antibody positivity is not exclusionary if participant can provide evidence of hepatitis b vaccination * participants with severe hepatic impairment who have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor * participants with severe hepatic impairment previously diagnosed with hepatocellular carcinoma
microcirculation in venoarterial extracorporeal membrane oxygenation life support

Conditions: Heart Failure; Respiratory Failure

Summary: extra-corporeal membrane oxygenation (ecmo) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. it can save time for these organs to recovery or for these patients to receive further management. however, many patients will die in spite of ecmo support. one of the key factor is whether the blood flow provided by the ecmo can meet the requirement of organ perfusion. the adequacy of macrocirculation may be determined by arterial pressure and minute blood flow of ecmo. however, the adequacy of microcirculation remains as a major unresolved clinical problem. this is a prospective observational clinical trial. the sublingual microcirculation will be examined with the incident dark field video microscope within 6 hours after venoarterial ecmo placement, and then at 24 h, 48 h, 72 h, and 96 h. the severity of multiple organ injury and clinical data will be recorded as well. the major parameters of microcirculation include total small vessel density, perfused small vessel density, and microvascular flow index. the sublingual microcirculation will also be examined before weaning off ecmo, within 6 hours after ecmo removal, and then at 24 h, 48 h, and 72 h. serum level of endothelial cell specific molecule-1 at specific time points will be examined. the data of 14-day mortality, 28-day mortality, duration of ecmo support, and intensive care unit stay will be recorded. this study aims primarily to investigate the relationship between microcirculation and prognosis of these patients. this study will also investigate the relationship among serum level of endothelial cell specific molecule-1, microcirculation, and prognosis of these patients. wish the results of this study can be applied in further research to help to improve the quality of ecmo care.


Eligibility criteria:
inclusion criteria: * patients who require venoarterial extra-corporeal membrane oxygenation (ecmo) life support exclusion criteria: * who can not take an examination of sublingual microcirculation within 6 hours after placement of venoarterial ecmo support * non-native speakers
for a better interpretation of quality of life scores of kidney transplant patients: determination of the minimum significant change retransqol

Conditions: Kidneys Transplantation

Summary: the project team developped and validated a french patient-based health-related quality of life instrument in kidney transplant: the qol retrans. the aim of the study is to determine the minimum significant change of the valdiated tool: retransqol


Eligibility criteria:
inclusion criteria: * patient with a transplant kidney exclusion criteria: * patient not able to answer survey
vaccine therapy in treating patients with stage ii melanoma that can be removed by surgery

Conditions: Melanoma (Skin)

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. it is not yet known what preparation of vaccine therapy is most effective for treating melanoma. purpose: randomized phase ii trial to study the effectiveness of tyrosinase/gp100 peptide vaccine in treating patients who have stage ii melanoma that can be removed by surgery.

objectives: i. determine immune reactivity in hla-a2 positive patients with resectable stage iia or iib melanoma treated with vaccine comprising tyrosinase peptide and gp100 antigen emulsified in montanide isa-51 (isa-51) alone or in combination with sargramostim (gm-csf). outline: this is a randomized, multicenter study. patients are stratified according to stage (iia vs iib). patients are randomized to 1 of 2 treatment arms: arm i: patients receive vaccine comprising tyrosinase peptide and gp100 antigen emulsified in montanide isa-51 (isa-51) alone subcutaneously (sq) once a week on weeks 0, 2, 4, 6, 10, 14, 18, and 26. arm ii: patients receive treatment as in arm i followed by sargramostim (gm-csf) sq for 5 days after each vaccination. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 50 patients (25 per arm) will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: histologically proven stage iia or stage iib resectable cutaneous melanoma rendered disease free clinically uninvolved lymph nodes by physical examination or pathologically uninvolved lymph nodes or sentinel lymph nodes after either complete node dissection or selective lymphadenectomy, respectively no evidence of metastatic disease within 28 days prior to definitive surgery hla-a2 positive patient characteristics: age: 18 and over performance status: ecog 0-1 hematopoietic: no coagulation disorders no significant hematologic abnormality hepatic: bilirubin no greater than 2.0 mg/dl no significant liver abnormality renal: creatinine no greater than 2.0 mg/dl no significant kidney abnormality cardiovascular: no major medical illness of the cardiovascular system pulmonary: no major medical illness of the respiratory system other: no known allergic reaction to montanide isa-51 or sargramostim (gm-csf) no major systemic infections not pregnant or nursing hiv negative hepatitis b surface antigen negative hepatitis c antibody negative no prior uveitis or autoimmune inflammatory eye disease no active autoimmune disease no other malignancy within past 5 years prior concurrent therapy: at least 1 month since prior adjuvant therapy or any other therapy for cancer biologic therapy: not specified chemotherapy: not specified endocrine therapy: no concurrent steroid therapy radiotherapy: at least 1 month since prior radiotherapy surgery: see disease characteristics

Keywords: stage ii melanoma
using mean ages on clothing size labels in revised advanced pediatric life support formulas for weight estimation

Conditions: Body Weight

Summary: weight calculation based on age could be performed according to apls (advanced pediatric life support) guideline recommendations in children requiring emergency treatment and intervention in the field or during resuscitation with no active weight and height measurements. the aim of the study is to investigate the suitability of weight calculation using mean ages on clothing size labels (acl) to the actual weight in real emergencies with no known actual age of the patient (aa).

weight calculation based on age could be performed according to apls guideline recommendations in children requiring emergency treatment and intervention in the field or during resuscitation with no active weight and height measurements. age formulas require only knowledge of the actual age of the child and widely used all over the world with being catchy. however, situations in which one has to intervene a child without having any patient data, including information on children's ages, especially in the field or during resuscitation are not uncommon. the objective of this study is to investigate the availability of age information contained in clothing size labels of children in weight calculation according to apls recommendations. usability of labels can protect victims from overdose and underdose problems in cases where the actual age is unknown and the measurements cannot be done

Eligibility criteria:
inclusion criteria: * all patients between 1-12 years of age who presented to the emergency department and agreed to participate in the study were consecutively included in the study exclusion criteria: * age under 1 years and over 12.99 years * no weighing in ed * no clothing size label information * refused to participate

Keywords: weight estimation emergency child
open-label study of ft-2102 with or without azacitidine or cytarabine in patients with aml or mds with an idh1 mutation

Conditions: Acute Myeloid Leukemia; Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Summary: this phase 1/2 study will evaluate the safety, efficacy, pk, and pd of ft-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. the phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of ft-2102 (olutasidenib) (single agent) and ft-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. the dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent ft-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. following the completion of the relevant phase 1 cohorts, phase 2 will begin enrollment. patients will be enrolled across 8 different cohorts, examining the effect of ft-2102 (olutasidenib) (as a single agent) and ft-2102 (olutasidenib) + azacitidine (combination) on various aml/mds disease states.


Eligibility criteria:
inclusion criteria: * pathologically proven acute myeloid leukemia (aml) (except acute promyelocytic leukemia \[apl\] with the t(15;17) translocation) or intermediate, high-risk, or very high risk myelodysplastic syndrome (mds) as defined by the world health organization (who) criteria or revised international prognostic scoring system (ipss-r) which is relapsed or refractory (r/r) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy. * patients must have documented idh1-r132 gene-mutated disease as evaluated by the site * good performance status * good kidney and liver function exclusion criteria: * patients with symptomatic central nervous system (cns) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy * congestive heart failure (new york heart association class iii or iv) or unstable angina pectoris. previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Keywords: aml mds idh1 idh
evaluation of the diagnosis performances of dec lts-2 skin patch for onchocerciasis in central africa

Conditions: Onchocerciasis; Loiasis; Diagnoses Disease; Neglected Diseases

Summary: this study aims at evaluating the diagnosis performances of the lts-2 dec patch for onchocerciasis compared to the gold standard which are the skin snips. this study will be conducted in cameroon in two different areas : ngog-mapubi and bafia health districts (one area only endemic for onchocerciasis, and one area endemic for both loiasis and onchocerciasis).


Eligibility criteria:
inclusion criteria: * all voluntary adults exclusion criteria: * general acute infection (temperature ≥ 38,5°c) * impaired general condition * ivermectin taken in the 6 last months * known allergies to one of the component of the patch * dermatological acute infection (bacterial, atopic, prurigo, or zona)

Keywords: health public
pharmacokinetics and tolerability of rufinamide in healthy chinese subjects

Conditions: Seizures

Summary: the purpose of this study was to determine the pharmacokinetic (pk) and safety profile of single and multiple doses of rufinamide. the effects of food and sex on the pk properties of rufinamide in these chinese volunteers were also evaluated.

this single- and multiple-dose, randomized, open-label study was conducted in healthy chinese subjects. in the single-dose study, volunteers were randomly assigned to 4 dose groups and received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasted condition. an additional food effect study was performed in the 200-mg dose group by assessing changes in pk parameters after high-fat diet. in the multiple-dose study, 10 subjects were administered 200-mg rufinamide formulation twice daily for 6 consecutive days. lc-ms/ms method was applied to determine plasma concentration of rufinamide. tolerability was assessed based on investigator inquiries, spontaneous reports, and clinical evaluations such as standard laboratory tests, vital signs, physical examinations and 12-lead electrocardiography.

Eligibility criteria:
inclusion criteria: * body mass index between19 and 24 kg/m2 * negative for hiv and hepatitis b * had no clinicallyimportant findings on health tests * thorax radiography and ecg with no abnormalities * normal blood pressure values * heart rate exclusion criteria: * any drug treatment within 2 weeks before starting the study * participation in another clinical study within the previous 3 months * alcoholism and smoking * pregnancy * breast-feeding * hypocalcemia * blood donation or participation in other clinical trials within 3 months before enrollment in the study * sitting blood pressure \ 140/100 mm hg * a ventricular rate \ 100 beats/min at rest

Keywords: pharmacokinetics food effect sex effect tolerability
using re-inforcement learning to automatically adapt a remote therapy intervention (rti) for reducing adolescent violence involvement

Conditions: Violence; Substance Use; Criminal Behavior; Violence in Adolescence

Summary: this study will use a randomized control trial (rct) design to administer two versions of a multisession remote behavioral intervention for youth seeking emergency department care for a violent injury with the goal to reduce their violence involvement and associated negative behaviors and consequences. the study examines two versions of the remote therapy intervention - a standard rti (s-rti) and an artificial intelligence rti (ai-rti). the application of a just-in-time adaptive strategy to address youth violence is an important and novel direction for this research, particularly given the need to understand best practices for delivering behavioral interventions among lower-income populations.

the specific aims for the proposed study are to refine the remote therapy intervention (rti) for delivery using a standardized remote therapy package (s-rti; 1 ed + 5 remote sessions) based on a piloted rti and an adaptive rti that optimizes bi-weekly dose and intervention intensity between four levels of therapy (remote therapy+, remote therapy; automated electronic tailored therapy; none) based on a reinforcement learning (rl) algorithm \[ai-rti\]. a total of 750 youth (age=14-24) seeking ed care for a violent injury will be enrolled and randomly assigned (stratified by age/gender) to the s-rti (n=250), ai-rti (n=300), and a control (euc; n=200) condition. in addition to the randomized assignment, all youth will take a daily assessment over the course of the intervention timeline. outcomes will be assessed at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * youth will be eligible if they screen is positive for seeking treatment in the ed for a violent injury, age 14-24, and report ownership of a smartphone with texting capability and internet access. exclusion criteria: * youth will be excluded if they do not understand english, cannot provide informed consent due to mental incompetence, incarceration or medical instability (unstable patients will be recruited if they stabilize within 72 hours), are 14-17 years old and presenting without an accessible parent/guardian, are presenting for suicide attempt/intent, sexual assault, and/or child abuse (due to high intensity of social services needed for such patients during their ed visit).
alcohol and tobacco consumption in patients with head and neck or lung cancer : interest of an addiction treatment

Conditions: Upper Aerodigestive Tract Neoplasms; Lung Cancer

Summary: this is a multicenter, interventional, randomized study among patients with a first lung or head \& neck cancer who are still active smokers ± alcohol misusers.the study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (arm a), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (arm b)

* study proposal at the first medical consultation for therapeutic management of a first upper aerodigestive tract cancer or lung cancer. * selection criteria validation * collection of an informed consent * randomization : arm a: experimental arm : addiction consultation to the overall cancer treatment arm b: standard of care the completion of questionnaires , the measurement of exhaled carbone monoxide rate using a co tester for all patients, and the integrated addiction treatment among patients randomized in arm a will not interfere with the medical treatment of cancer.

Eligibility criteria:
inclusion criteria: * patients with a first upper aerodigestive tract cancer or a lung cancer * initial cancer treatment * aged ≥ 18 and ≤65 years * living within a radius of 20 km from the chru de lille/oscar lambret center * patient with tobacco addiction: regular smoker = at least 7 cigarettes /week or 1 cigarette/day or short-term ex-smoker = regular smoker who has stopped smoking for less than 1 year from the inclusion date * performance status (ecog/who) ≤ 2 * registered with a social security system * informed and signed consent collected before initiation of any study procedures exclusion criteria: * previous lung cancer or upper aerodigestive tract cancer * previous other cancer \< 5 years, evoluting or treated at the inclusion (except uterine cervical carcinoma, basal cell or squamous cell skin carcinoma ) * mesothelioma and esophageal cancer * occasional smoker (less than 7 cigarettes/week or less than 1 cigarette/day) * long-term ex-smokers who have stopped smoking for more than 1 year from the inclusion date * impossibility to comply with the study procedures due to geographic, social or mental reasons * patient under guardianship or tutorship * pregnant or breastfeeding women

Keywords: alcohol and tobacco consumption addiction treatment
efficacy (induction of response/remission) and safety study in patients with moderate to severe crohn's disease

Conditions: Crohn Disease

Summary: the purpose of this study is to evaluate if leukine can induce clinical response or remission in patients with crohn's disease.

on 29 may 2009, bayer began transitioning the sponsorship of this trial to genzyme. note: this study was originally posted by sponsor berlex, inc. berlex, inc. was renamed to bayer healthcare, inc.

Eligibility criteria:
inclusion criteria: * stable but active crohn's disease at the time of screening * must be able to self-inject or have another person who can help with the injection exclusion criteria: * not have a colostomy or ileostomy * not be taking prohibited medications as defined in the protocol * not have had gi surgery or a bowel obstruction in the last 6 months or planned surgery for the next months * not have ever taken this drug or drugs of similar type in the past

Keywords: morbus crohn sargramostim phase iii placebo controlled
paracetamol toxicity in septic patients

Conditions: Fever; Sepsis

Summary: the investigators will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. the investigators will monitor blood glutathione and liver enzymes to look for potential toxicity.

paracetamol is metabolized in liver using the glutathione system. this detoxification system is depressed during severe illness such as sepsis, trauma etc. the study will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. we believe that during sepsis, paracetamol metabolites are not fully detoxified and therefore are toxic to the patient. patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. the investigators will monitor blood glutathione (as a surrogate marker for liver glutathione), liver enzymes and various clinical data (such as length of hospitalization) to look for a potential toxicity.

Eligibility criteria:
inclusion criteria: * age\>18y * hospitalized to int. med. dept. or icu * body temp\>38 and one or more from the following: 1. pulse\>90 bpm 2. resp. rate\>20/min or paco2\<32 mmhg 3. wbc\>12000 or \<4000 * one of the following: 1. hypotension 2. disturbed end-organ perfusion (confusion, oliguria, lactic acidosis etc.) exclusion criteria: * acute / chronic liver disease * acute cns disorder * current isoniazid treatment * alcoholism * active malignancy * pregnancy * tpn or ppn

Keywords: fever in severe sepsis