Kornimate/medical-research-clean huggingface dataset:
effect of food and formulation on the pharmacokinetics, safety, and tolerability of gns561 after one single dose (50 and 200mg) in healthy volunteers

Conditions: Primary Liver Cancer

Summary: gns561 is a drug used in preliminary phase 1b study for treatment of patients with primary and secondary liver cancer. the formulation used was oral capsule.the objective of this study in healthy volunteers is to compare pharmacokinetics, safety and tolerability of different formulations (tablets and capsules) and dosage (50 and 200mg) of gns561 after single oral administration in first part and to evaluate the food effect on pharmacokinetics in second part.


Eligibility criteria:
inclusion criteria: * bmi will be between 18 (inclusive) and 26 kg/m² (inclusive). * participants must be in good general health, with no significant medical history, have no clinically significant (cs) abnormalities on physical examination, vital signs, and 12-lead ecg at screening and/or before administration of the first dose of study drug * have a fridericia's correction factor for qt (qtcf) ≤ 450 ms for male participants and ≤ 470 ms for female participants on 12-lead ecg * women subjects of childbearing potential must have a negative serum/urine pregnancy test at screening and baseline * women subjects of childbearing potential and male subjects must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy * willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * able to understand and provide written informed consent. exclusion criteria: * pregnant or breast-feeding mothers * known allergic reaction to quinolone derivatives (e.g., quinine, choloroquine, mefloquine) * subjects with any clinically significant laboratory abnormality * history of qt prolongation (qtc ≥ 500 ms) or family history of long qt arrythmia or cardiac disease or bradycardia \< 50/mn or uncorrected hypokalemia * on going uncontrolled infection disease * history of pre-existing retinopathy or maculopathy * participation in any investigational clinical investigation ≤ 4 weeks prior to first planned dose of gns561 * malabsorption issues (e.g., gastric bypass or gastrectomy patients), current or history significant gastrointestinal diseases * patient with a mental or legal disability
thalidomide anti-angiogenesis therapy of relapsed or refractory leukemia

Conditions: Leukemia

Summary: the purpose of this study is to evaluate the efficacy and safety of thalidomide in patients with leukemia.

patients will take thalidomide tablets at bedtime daily until remission. the dose will be increased gradually and modified according to side-effects. the drug will be given daily up to the time of complete remission then as long as it is beneficial.

Eligibility criteria:
inclusion criteria: * diagnosis of refractory or relapsed leukemia: acute leukemia, cml, cllm and mds. * signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed * serum creatinine \< or = 2.5mg/dl * serum bilirubin\< or = 2.5mg/dl * negative pregnancy test * age 18 years or older * performance status \< or = 3 exclusion criteria: * pregnant or lactating women * concurrent treatment with cytotoxic chemotherapy, or radiation * history of seizures, neurotoxicity, or active cns disease * serious infections not controlled by antibiotics

Keywords: leukemia thalidomide relapsed
study of bgb-11417 in participants with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

Conditions: Leukemia; Lymphoma; Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Small Lymphocytic Lymphoma; Relapsed Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to evaluate the efficacy of bgb-11417 in participants with relapsed/refractory (r/r) chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)


Eligibility criteria:
key inclusion criteria 1. participants with a histologically confirmed diagnosis of cll/sll based on the international workshop on cll (iwcll) criteria: 1. treatment intolerance or failure during or after treatment with chemoimmunotherapy (cit) and btk inhibitors (btki) or 2. treatment intolerance or failure during or after treatment with btki for cit-ineligible participants as assessed by the investigator. 2. participants who require treatment based on the iwcll 2018 criteria 3. eastern cooperative oncology group (ecog) performance status score of 0 to 2 4. life expectancy of \> 6 month key exclusion criteria 1. prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (gleason score ≤ 6) localized prostate cancer 2. underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results 3. a known history of or currently suspected richter's syndrome 4. prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion) 5. prior allogeneic stem cell transplant note: other protocol defined inclusion/exclusion criteria may apply

Keywords: refractory chronic lymphocytic leukemia leukemia lymphoma small lymphocytic lymphoma
a first in human study of rt001 in patients with friedreich's ataxia

Conditions: Friedreich's Ataxia

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of rt001 in patients with friedreich's ataxia.

study rt001-002 is a randomized, double-blind, controlled, ascending dose study to evaluate the safety, tolerability, pharmacokinetic, disease state, and exploratory endpoints in patients with friedreich's ataxia after oral administration. the study includes 2 dose levels of rt001.

Eligibility criteria:
inclusion criteria: 1. male or female 18 to 50 years of age 2. medical history consistent with the symptoms of frda at ≤ 25 years of age 3. homozygous for gaa repeat expansions in the frataxin gene in the affected range for frda 4. fars-neurological score of 20-90 points 5. ambulatory (with or without assistive device) and capable of performing assessments/evaluations 6. body mass index ≤ 29.9 kg/m2 7. agrees to dietary restrictions and agrees to receive calls from a dietary coach 8. signed the informed consent form prior to entry into the study 9. agrees to spend the required number of overnight clinic days 10. able to provide the necessary repeated blood samples exclusion criteria: 1. received treatment with other experimental therapies within the last 30 days prior to the first dose 2. known point mutation in the fxn gene 3. history of malignancies (other than basal cell carcinomas) 4. impaired renal function at screening 5. alanine transaminase (alt) or aspartate transaminase (ast) laboratory values \> 2 x upper limit of normal (uln) at screening 6. known hepatitis b surface antigen (hbsag)-positive, or known or suspected active hepatitis c infection, or is known to be human immunodeficiency virus (hiv) positive 7. female who is breastfeeding or has a positive pregnancy test 8. male participant or female participant of child bearing potential, who is sexually active and unwilling/unable to use a medically acceptable and effective double barrier birth control method throughout the study 9. unwilling or unable to comply with the requirements of the protocol 10. clinically significant cardiac abnormalities at screening that, in the opinion of the investigator, would make the patient unsuitable for enrollment 11. diabetes mellitus (type 1 or 2) 12. suicidal ideation as determined by the columbia-suicide severity rating scale 13. history, within the last 2 years, of alcohol abuse, significant mental illness, or physical opioid dependence 14. cannot adhere to the dietary guidance required to be followed by the protocol 15. cannot take the medication due to impairment in swallowing capsules
assessment of different disinfection protocols on regenerative potential of mature teeth

Conditions: Apical Periodontitis

Summary: regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. the aim of this study is to assess the regenerative potential of mature permanent teethwith necrotic pulps after disinfecting the root canal using diode laser andcompare it with dynamic agitation of xp-endo finisher and conventionaltriple antibiotic paste


Eligibility criteria:
inclusion criteria: patients with mature teeth. patients with periapical periodontitis. maxillary anterior teeth only will be involved. patients should be free from any systemic disease that may affect normal healing and predictable outcome. patients who will agree to the consent and will commit to follow up period. exclusion criteria: * patients with immature roots. - immuno-compromised patients, including patients who self-reportedto be a carrier of hiv, hepatitis, undergoing steroid therapy, thosewho self-reported with genetic or systemic diseases that could resultin a reduced immune response.- all patients who respond positive to allergic patch test \[tripleantibiotic paste\] and drugs.- pregnant and lactating women.- patients who could/would not participate in a 1-year follow-up.- teeth with previous endodontic therapy performed. - teeth with periodontal involvement. - teeth with calcified canals.- presence of external or internal root resorption.- teeth with root fractures (checked with pre-operative radiographsusing horizontal and vertical angulations)
immunochemotherapy, zevalin, and bone marrow transplant for follicular lymphoma

Conditions: Follicular Lymphoma

Summary: follicular lymphoma has historically been considered an incurable lymphoma. by combining multiple effective treatments, the investigators believe that prolonged disease-free survival is achievable in this disease. the investigators goal is to have at least 60-70% of our patients in first continuous complete remission 15 years from initiation of treatment.

patients will receive six cycles of combination chemotherapy, c-mopp-r, typically through a subcutaneous port. this combination chemotherapy will last six months. after the last dose of chemotherapy, patients will have a 2 month treatment holiday prior to undergoing stem cell mobilization from peripheral blood with subcutaneous injections of neupogen and mozobil. patients then receive zevalin radioimmunotherapy, and this is followed after recovery of blood counts, typically 3 months later, by an autologous stem cell transplant.

Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * follicular lymphoma, newly diagnosed or previously treated but no more than 2 previous regimens * relapse of disease must be greater than 6 months after last chemotherapy * stages ii, iii or iv * eastern cooperative group (ecog) performance status of 0 or 1. if ecog 2-4, poor performance must by due to lymphoma as judged by study investigator. * patient signed written informed consent * adequate renal function defined as a glomerular filtration rate (gfr) \> 60 ml/min * adequate blood counts (absolute neutrophil count ≥ 1,500, platelets ≥100,000), unless low due to lymphomatous involvement of the bone marrow. * no known allergies to the chemotherapeutic agents * no other major disabling co morbidities * adequate pulmonary function, defined as corrected dlco greater than 70% of predicted and fev1 (forced expiratory volume in one second, a test of respiratory function) greater than 50% of predicted. * adequate hepatic function as assessed by study investigator * adequate cardiac function, defined as baseline muga (multiple gated acquisition, a test of heart function) \>50% exclusion criteria: * stage i follicular lymphoma * ecog performance status ≥ 2, unless due to lymphoma * patient refuses to sign written informed consent * poor renal function defined as gfr \<60ml/min * abnormal liver function as assessed by study investigator * poor bone marrow reserve (absolute neutrophil count \<1,500 and/or platelets \< 100,000) not attributable to lymphomatous involvement of the bone marrow. * hypersensitivity to the chemotherapeutic agents * major disabling co morbidities like uncontrolled severe htn (hypertension), active coronary artery disease, liver cirrhosis. * previously diagnosed malignancy other than basal or squamous cell carcinoma of the skin diagnosed \<5 years prior. * central nervous system disease * history of advanced cardiac disease (active angina, congestive heart failure with a lvef (left ventricular ejection fraction) \<50%).

Keywords: follicular lymphoma radioimmunotherapy rituximab c-mopp-r autologous transplant
laryngeal mask airway in laparoscopic hernia repair

Conditions: Inguinal Hernia; Inguinal Hernia, Indirect; Inguinal Hernia Bilateral; Inguinal Hernia Unilateral

Summary: this prospective randomized study will evaluate the effectiveness of laryngeal mask airway (lma) versus endotracheal intubation (ett) for patients undergoing laparoscopic inguinal hernia at cmh.

this study aims to evaluate the effectiveness during general anesthesia of laryngeal mask airway versus endotracheal tube for laparoscopic inguinal hernia repair. there are limited pediatric literature evaluating the use of laryngeal mask airway for laparoscopic procedures compared with traditional endotracheal intubation. this study aims to add to this literature in providing information comparing the two techniques. the rationale for this study is to show that general anesthesia with laryngeal mask airway is an effective and non-inferior technique compared with general anesthesia with endotracheal intubation in pediatric patients undergoing laparoscopic inguinal hernia repair and may offer benefits in terms of efficiency of care and respiratory complications.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic inguinal hernia repair. * ages 12 months to 8 years of age * american society of anesthesiologists physical status classification asa 1 or 2 * asa 1- a normal, healthy patient * asa 2- a patient with mild systemic disease * elective with appropriate npo status * english speakers * spanish speakers exclusion criteria: * patients with current gastroesophageal reflux * obesity (cdc \>= 95th %ile) * contraindications to study protocol medications
a phase ii trial of weekly alternating sequential administration of bibf 1120 and bibw 2992 in patients with advanced colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of bibf 1120 and bibw 2992 in patients with metastatic crc based on the recist criteria.


Eligibility criteria:
inclusion criteria: 1. age over 18 years. 2. signed informed consent. 3. histologically proven colorectal adenocarcinoma 4. history or presence of metastatic colorectal cancer (stage iv) 5. measurable (\>1 cm) or evaluable tumour deposit (according to recist criteria) 6. documented progression or unacceptable toxicity on the last therapy 7. progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin 8. progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan 9. if patients have been previously exposed to cetuximab or other egfr inhibitor, they must have shown progression or unacceptable toxicity 10. if patients have been previously exposed to bevacizumab or other vegf inhibitor, they must have shown progression or unacceptable toxicity 11. life expectancy of at least 12 weeks. 12. who (ecog) performance status \ 75 years. 13. adequate hepatic function 14. adequate renal function exclusion criteria: 1. prior treatment with small molecule egfr, her2 or vegfr tyrosine kinase inhibitors 2. treatment with standard chemotherapy or cetuximab within the last 14 days 3. treatment with bevacizumab within the last 28 days 4. history of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. patients with adequately treated basal or squamous cell skin cancer are generally eligible. 5. serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality 6. significant cardiovascular diseases 7. history of haemorrhagic or thrombotic event in the past 12 months. known inherited predisposition to bleeds or to thrombosis. 8. patient with history or clinical or radiological evidence of cns disease or brain metastases. 9. pregnancy or breast-feeding
vertebral body sparing craniospinal irradiation for pediatric patients with cancer of the central nervous system

Conditions: Malignant Central Nervous System Neoplasm

Summary: this trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.

primary objectives: i. to demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children. ia. to report the dose received to the vertebral bodies and the dose gradient/heterogeneity within the vertebral body. ib. to document, using weekly cone beam computed tomography (ct) of the cervical and lumbar spine, delivered dose in comparison with planned dose after accounting for any errors in patient positioning. ii. to evaluate acute toxicity of vertebral body sparing (vbs) craniospinal irradiation (csi). iia. to report absolute lymphocyte counts over time and occurrence of grade 3-4 hematological toxicity. iib. to report the incidence and severity of any grade esophagitis during or within 4 weeks of radiation therapy. iii. to evaluate the feasibility of magnetic resonance imaging (mri) imaging during csi therapy as in vivo proton range verification. iiia. to demonstrate the feasibility of completing interim non-contrast mris of the spine during treatment. iiib. to characterize the earliest time point at which radiation induced bone marrow changes can be detected in children receiving proton csi. outline: patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo mri over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity. after the completion of study treatment, patients are followed up at 4 weeks and then every 3-12 months thereafter.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation. * signed informed consent and assent when indicated. exclusion criteria: * any contraindication to undergoing mri (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). metal fragments, shrapnel, or tattoos near the eye. * any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements. * pregnant females are excluded. females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.

Keywords: craniospinal proton therapy pediatric
a clinical trial to evaluate the pharmacokinetics and safety/tolerability of fimasartan and linagliptin in healthy volunteers

Conditions: Hypertension; Diabetes

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of fimasartan/linagliptin and when co-administrated fimasartan and linagliptin.

this is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of fimasartan/linagliptin and co-administration of fimasartan and linagliptin.

Eligibility criteria:
inclusion criteria: 1. male 19-50 years of age. 2. body mass index (bmi) ≥ 18 and ≤ 27 kg/m2 at screening. 3. understands the study procedures in the informed consent form (icf), and be willing and able to comply with the protocol. 4. medically healthy with no clinically significant medical history. exclusion criteria: 1. history or presence of clinically significant medical or psychiatric condition or disease. 2. positive results at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv). 3. seated blood pressure is less than 100/55 mmhg or greater than 140/100 mmhg at screening. 4. plasma donation within a month prior to the first dose of study drug. 5. participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Keywords: fimasartan linagliptin
analysis of rv-dysfunction in fallot patients

Conditions: Tetralogy of Fallot

Summary: in the presented study tdi will be used as a modern technique to characterize rv-function in fallot patients at rest and during different exercise conditions.

tissue doppler imaging (tdi) presents a modern technique to depict the velocity of tissue motion within a distinct area of the myocardium providing amendatory characterization of diastolic and systolic function of the heart. tdi is hypothesized to be of additional value in the evaluation of adult congenital heart disease, especially tetralogy of fallot (tof), which is one of the most common conditions. in particular, fallot patients are at risk of developing right ventricular (rv) dysfunction due to pulmonary valve defects or alterations of the outflow tract. it is pivotal to recognize this progression at an early stage before irreversible changes occur. aim of the study is to test feasibility of tdi in fallot patients as a new technique that provides new parameters to characterize rv dysfunction, more precise than common methods. additionally tdi is performed at rest and during different endurance testings (passive leg raising (plr), handgrip (hg) and cardiopulmonary exercise (cpx), as certain changes might be compensated at rest, first apparent during exercise.

Eligibility criteria:
inclusion criteria: * patients with corrected tetralogy of fallot * adult healthy controls without cardiovascular disease or other relevant systemic diseases with written consent exclusion criteria: * inability to give written consent, incapable of cycling or handgrip exercise due to cognitive or orthopedic limitation, poor echocardiographic image quality

Keywords: tetralogy of fallot tissue doppler imaging exercise testing