Kornimate/medical-research-clean huggingface dataset:
studies of a candidate aminoquinoline antimalarial (aq-13)

Conditions: Malaria

Summary: this is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in africa (plasmodium falciparum). this study will enroll 66 adult malian males with uncomplicated p. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (aq-13) by mouth over 3 days or the current standard treatment, which is 2 doses of coartem twice daily for 3 days. the hypothesis underlying this study is that aq-13 will be similarly effective to coartem for the treatment of uncomplicated p. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites. funding source - fda office of orphan product development (oopd).

this is an initial efficacy study (phase 2 proof of concept study) of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in africa (plasmodium falciparum). this study will enroll 66 adult malian males with uncomplicated p. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (aq-13) by mouth over 3 days or the current standard treatment, which is 80 mg of artemether and 480 mg of lumefantrine twice daily for 3 days. the hypothesis underlying this study is that aq-13 will be similarly effective to coartem for the treatment of uncomplicated p. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites.

Eligibility criteria:
inclusion criteria 1. adult malian males ≥ 18 years of age, 2. uncomplicated malaria with ≥ 2,000 asexual p. falciparum parasites per ul, and 3. informed consent obtained and signed. exclusion criteria 1. severe or complicated malaria (including temperature ≥ 40o c), 2. ≥ 100,000 asexual parasites per ul of blood, 3. anemia or other laboratory results (other than malaria) that require treatment (e.g., hb ≤ 7 gm/dl, k+ ≤ 3.5 millimolar (mm), bp ≥ 140/90), 4. seizures or impaired consciousness, 5. recent antimalarial treatment by history (within ≤ 2 weeks), 6. chronic medications (including inducers of cytochrome p450 3a4 \[cyp3a4\] activity such as rifampin and nevirapine), 7. ventricular or atrial arrhythmias, or second or third degree heart block on the screening ecg or holter recording, 8. infection with other plasmodial species on the blood smear (p. ovale, p. ovale, p. vivax).

Keywords: plasmodium falciparum pharmacokinetics antimalarials (antimalarial drugs) chloroquine (chloroquine-resistant) qt (qtc) interval
retrospective study on the efficacy and tolerability of liposomal irinotecan

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Summary: the aim of this retrospective study is to confirm the efficacy and safety results obtained in the napoli-1-study, when onivyde® in combination with 5-fu/lv is used in real-life practice in belgium. the data needed to do so will be obtained using information that is routinely collected as part of patient's medical care.

patients with pancreatic cancer have a poor prognosis with a 5-years survival of only 1-2%. this arises from the fact that it is typically diagnosed late, when curative resection is impossible. these patients are thus restricted to chemotherapy, with gemcitabine-based therapies being the standard of care for patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (mpdac). however, even after second or subsequent lines of therapy, disease progression is inevitable. therefore, the need for new treatment options is high. recently, the advantage of using nanoliposomal irinotecan (onivyde®) in combination with 5-fluorouracil and leucovorin (5-fu/lv) over the use of 5-fu/lv alone was demonstrated in a phase-3 randomized clinical trial (napoli-1 trial). as this study showed significant improvement on overall survival, progression-free survival, time to treatment failure, overall response rate and tumor marker ca19-9 response, on october 14 2016 this therapy was approved by the ema to be used for patients with mpdac previously treated with gemcitabine-based therapy. while randomized clinical trials, like the napoli-1 trial, are considered the reference standard for comparing the efficacy and safety of treatments, these studies do not always reflect the everyday clinical practice. therefore, the aim of this study is to evaluate the efficacy and safety of onivyde® in real-life practice in belgium. this information would be very valuable to determine the value of the drug and improve the knowledge of the actual use of onivyde® after marketing authorization.

Eligibility criteria:
inclusion criteria: * patient has diagnosis of pancreatic adenocarcinoma with documented metastatic disease. * patient progressed after gemcitabine-based therapy. * patient received at least one treatment cycle with onivyde® + 5-fu/lv 5fu in the context of post-gemcitabine based therapy of mpdac. exclusion criteria: * patient has not received at least one treatment cycle with onivyde® + 5-fu/lv. * previous irinotecan-based therapy in metastatic setting. * patientstarted the treatment with onivyde® + 5-fu/lv after 01/04/2021
capture of prostatic trans-rectal ultrasound scans for research

Conditions: Prostate Cancer; Prostate Neoplasm

Summary: through this study the investigators seek to build up a repository of prostate ultrasonography videos and prostate mri scans to enable research into novel anatomical registration techniques. these data will facilitate the development of improved technology that enables targeting of tumours seen on mri using free-hand biopsy techniques, without the need for a gantry or overlaid perineal grid.

the purpose of this study is to explore whether mathematical and computational modelling techniques can be used to enable anatomical based real-time image registration for guiding prostate biopsies. this would lead to the ability to perform free-hand trans-perineal biopsy without the need for supporting gantries or a biopsy grid placed over the perineum. this will significantly decrease costs of trans-perineal biopsy, reduce the number of puncture sites through the perineal skin - reducing pain and bleeding - and reduce the procedure time. alongside locally developed local-anaesthetic transperineal biopsy techniques it will allow targeted biopsy to be taken in the outpatient setting, improving patient convenience, and helping health services to meet growing demands on targeted biopsies. the investigators aim to create a new method of mapping the prostate using free-hand ultrasound, without any additional physical equipment. this may require collaborations with approved international groups with particular skills in relevant mathematical or engineering techniques.

Eligibility criteria:
inclusion criteria: * subjects undergoing trans-perineal prostate biopsy under general anaesthesia who have had an mri of their prostate within the preceding 12 months. * male. * age 18-100. exclusion criteria: * those unable to provide informed consent. * any medical condition, vital sign or laboratory value that, in the opinion of the investigator or responsible anaesthetist makes any prolongation of general anaesthesia unsafe to the participant. * patients unable to have an mri

Keywords: transperineal biopsy prostate cancer transrectal ultrasound fusion biopsy techniques
quantitative dynamic contrast enhanced breast mri

Conditions: Breast Cancer

Summary: the purpose of this study is to see if dynamic contrast enhanced (dce) mri imaging makes it possible to distinguish benign conditions of the breast from malignant tumors and provide better information than can be obtained with regular mri. dce mri uses a new way of collecting and analyzing the images or pictures which provides doctors extra information not available with standard imaging methods. this includes information about the blood vessels of different breast diseases. pictures produced this way look just like the regular mri pictures. the dce mri adds another imaging sequence (another scan) to the mri examination ordered by your physician to evaluate your breast lesion, thus increasing the exam time (extra 10 min). the information gained from doing the new test, the dce mri, will not be used in your treatment and will not affect the type of care you receive for your breast lesions.

our aim is to perform dynamic contrast enhanced (dce) mri on 150 patients during their routine breast mri examination at mskcc. this will add extra 10 min scanning time to the routine examination. high resolution (submillimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the dce mri data. these results will be correlated with pathology to determine new pharmacokinetic threshold so that the negative predictive value for benign lesions is close to 100%. the improvement in diagnostic specificity may help to reduce unnecessary biopsies in the future.

Eligibility criteria:
inclusion criteria: · scheduled for breast mri interventional procedure for a known breast lesion. exclusion criteria: * patients who would be normally excluded from undergoing an mri examination patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field. * patients who are unable to cooperate for an mri, and/or have known reaction to gadolinium contrast agent.

Keywords: breast lesion lesion breast cancer 05-091
impact of "asap" multidisciplinary optimization care protocol on clinical outcome in elderly inpatients for hip fracture

Conditions: Hip Fractures

Summary: to compare the impact of asap protocol (geriatric advice, early surgery, loco-regional anesthesia and pharmacological adaptation) on elderly patients with hip fracture and clinical outcome.

retrospective double cohort analysis for asa physical status 1, 2 and 3 elderly patients \>65 years old, scheduled to undergo surgery for hip fracture between january 1st 2017 and december 31st 2022. the investigator want to confirm the better outcome on 30-days mortality after surgery in patients where the asap protocol was applied, starting from 1 january 2020. asap protocol follow the latest international guidelines about hip fracture in elderly patient. the investigator focuses the research about the impact of asap protocol on clinical outcome: geriatrician's advice, impact of loco-regional techniques on intra-operative and postoperative pain control, chronic pharmacological therapy's adaptation and 30-days postoperative mortality.

Eligibility criteria:
inclusion criteria: * over 65 years old patients with hip fractures between january 1st 2017 and december 31th 2022 exclusion criteria: * fracture without indication for surgery * death before surgery * intensive care's or polytrauma patients (\> 2 fracture sites) or under pharmacological coma needed before and after surgery.
positron emission tomography guided therapy of aggressive non-hodgkin's lymphomas

Conditions: Lymphoma, High-grade

Summary: the main purpose of the petal trial is to determine whether patients with aggressive non-hodgkin's lymphomas with a persistently positive pet scan after two cycles of chemotherapy benefit from a change of the treatment protocol.

positron emission tomography performed after two cycles of (r-)chop chemotherapy (interim-pet) has been shown to predict long-term outcome in patients with aggressive non-hodgkin's lymphomas. patients with early normalization of pathological pet findings have an excellent prognosis, while patients with a persistently pathological pet scan have a high risk of non-response or relapse. patients with a negative interim-pet scan (part a of the trial) will be randomized to receive either another four cycles of the (r-)chop regimen (arm a1) or four cycles of the (r-)chop regimen plus two additional doses of rituximab (arm a2). randomisation in part a of the trial was stopped when the number of patients required was reached (128 patients in each treatment arm). since then patients have been uniformly treated according to arm a2. patients with a persistently positive interim-pet scan (part b of the trial) will be randomized to either continue treatment with another six (r-)chop cycles (arm b1) or switch to an alternative protocol used for the treatment of burkitt's lymphoma (arm b2: six blocks according to the so-called b-all protocol of the german all study group). patients refractory to or relapsing within two years after treatment according to parts a or b of the trial will receive age-adapted salvage protocols (patients \ 60 years: (r-)eshap protocol)(part c of the trial).

Eligibility criteria:
inclusion criteria: * aggressive b-cell or t-cell non-hodgkin's lymphoma * pathological pre-treatment pet scan * performance status ecog 0-3 * age 18 - 80 years * ability to understand the purpose of the study and act accordingly * willingness to use adequate contraception * informed consent exclusion criteria: * burkitt's lymphoma * primary central nervous system lymphoma * previous chemo- and/or radiotherapy * other cancer within preceding 5 years * hiv infection, active viral hepatitis or other uncontrolled infection * other medical conditions precluding administration of planned therapy * pregnancy or lactation

Keywords: aggressive non-hodgkin's lymphoma positron emission tomography chemotherapy
influence of tidal volume on postoperative pulmonary function

Conditions: Pulmonary Function

Summary: lung function impairment is common after abdominal surgery. few preventive strategies exist against postoperative lung function impairment. a new potential preventive strategy against postoperative lung function impairment comes from research on critically ill patients with severe respiratory failure. in this field research has long focused on influence of breathing volume (= tidal volume) during mechanical ventilation on outcome. it has been shown, that low tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes. therefore, we propose a patient and investigator blinded randomised trial to test the hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to high tidal volumes reduces postoperative lung function impairment in high risk patients.


Eligibility criteria:
inclusion criteria: * written informed consent * age ≥ 50 years and asa classification ≥ ii * elective upper abdominal surgery of at least 3 hours duration * general anaesthesia plus epidural anaesthesia. exclusion criteria: * \< 18 years of age * impaired mental state * unwillingness to participate * pregnancy * duration of surgery \< 3 hours * asa physical status ≥ iv * increased intracranial pressure * neuromuscular disease that impairs spontaneous breathing

Keywords: tidal volume predicted body weight lung function respiratory outcome respiratory function tests surgery
short arc multifidus study

Conditions: Multifidus Disuse Atrophy

Summary: patients will be performing logan short arc banding protocols to see the effect on multifidus size

the subjects will initially be scanned by diagnostic ultrasound by to assess the cross sectional area of their lumbar multifidi. then they will perform 3 sets of 30 second periods of logan short arc banding on the atm machine twice a week for 4 weeks and then they will be scanned again using diagnostic ultrasound to assess the effects of the rehabilitation exercise.

Eligibility criteria:
inclusion criteria: * male or female ages 18-54 exclusion criteria: * asymptomatic of: low back pain, previous spinal injury, surgery or other condition affecting the spine, local infection, injury or malignancy; pregnancy or any condition affecting muscle reaction time.
prevelance of molar incisor hypomineralization among a group of egyptian children

Conditions: Child Development Disorder

Summary: the purpose of this study is to find out the prevalence of molar incisor hypomineralization among a group of egyptian children

molar incisor hypomineralization is frequent in many population throughout the world and a wide variation of molar incisior hypomineralization 2.4_40% has been reported.to the best of our knowledge,there is no sufficient information regarding the prevalence of molar incisor hypomineralization in egyptian children therefore the aim of this study is to assess the prevalence of molar incisor hypomineralization among a group of egyptian children.

Eligibility criteria:
inclusion criteria: - patient seeks dental care in paediatric dentistry and dental public health department in cairo university * positive patient acceptance for participation in the study * children with at least one of four permanent molars erupted or partially erupted exclusion criteria: * uncooperative children * children with appliance * children with systemic diseases
a phase 3 study of ranolazine in subjects with type 2 diabetes who are inadequately controlled on metformin alone

Conditions: Type 2 Diabetes Mellitus

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (t2dm) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.


Eligibility criteria:
inclusion criteria: * documented history of t2dm * metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to screening * body mass index (bmi) 25 to 45 kg/m\^2, inclusive, at screening * hba1c within specified ranges at screening and at the end of the qualifying period based on current metformin dose * c-peptide ≥ 0.8 ng/ml at screening * fasting serum glucose (fsg) ≥ 130 mg/dl (7.2 mmol/l) and ≤ 240 mg/dl (13.3 mmol/l) at screening and at the end of the qualifying period exclusion criteria: * type 1 diabetes mellitus * history of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma * history of severe hypoglycemia * any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to screening * history of congestive heart failure * corrected qt interval (qtc) \> 500 msec by ecg at screening, a personal or family history of qtc prolongation, congenital long qt syndrome, or individuals who are receiving drugs that prolong the qtc interval, such as class ia or class iii antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone) * serum creatinine concentration ≥ 1.5 mg/dl for males or ≥ 1.4 mg/dl for females at screening * active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (ast) \> 3 x upper limit of the normal range (uln) and/or alanine aminotransferase (alt) \> 3 x uln and/or serum total bilirubin \> 2.0 mg/dl * use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to randomization * treatment with chronic insulin within 24 weeks prior to screening (except for one temporary period of daily insulin injections no longer than 7 days) * treatment with strong or moderate cytochrome p450 3a (cyp3a) inhibitors or p-glycoprotein (p-gp) inhibitors within 14 days prior to randomization * treatment with cyp3a inducers or p-gp inducers within 14 days prior to randomization * treatment with simvastatin or lovastatin at a dose \> 20 mg or \> 40 mg daily, respectively, within 14 days prior to randomization
efficacy and tolerability of zoledronic acid with radiotherapy in pts with advanced osteolytic bone lesions

Conditions: Pain; Neoplasm Metastasis; Cancer

Summary: it is the aim of this multicentric clinical study to assess the efficacy and tolerability of zoledronic acid in combination with radiotherapy in patients with advanced osteolytic bone lesions in terms of the reduction of pain and analgesic consumption.


Eligibility criteria:
inclusion criteria: * diagnosis of at least one cancer-related bone lesion in cancer patients, confirmed by x-ray, mrt or computer tomography * severity of pain ≥ 5 on item 3 of the bpi which is caused by the bone lesion(s) and requires radiotherapy * adequate liver function - serum total bilirubin concentration less than 1.5 x the upper limit of normal value * expected survival time ≥ 6 months * if the patient is of child-bearing potential: negative pregnancy test at screening * ecog performance status of 0, 1 or 2. * written informed consent exclusion criteria: * prior treatment with an oral bisphosphonate for more than 3 months or more than 3 intravenous (i.v.) bisphosphonate applications * bisphosphonate treatment within 6 months before study start * previous radiotherapy of the painful areas to be irradiated. an initiation of radiotherapy for the target area(s) up to 3 days at maximum prior to the first infusion is allowed. * skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication. * initiation of a new chemotherapeutic treatment regimen during the last 2 weeks prior to the first infusion of trial medication * abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute. creatinine clearance (crcl) is calculated using the cockcroft-gault formula: crcl = \[140-age (years)\] x weight (kg) {x 0.85 for female patients} \[72 x serum creatinine (mg/dl)\] * corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l) or ≥ 12.0 mg/dl (3.00 mmol/l). * patients with clinically symptomatic brain metastases * history of diseases with influence on bone metabolism such as paget's disease and primary hyperparathyroidism * pregnancy and lactation * women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, intrauterine device \[iud\], vaginal diaphragm or sponge, or condom with spermicide) * current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures. * recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pain bone metastasis analgesic consumption cancer patients cancer patients with painful bone metastasis