Kornimate/medical-research-clean huggingface dataset:
relative bioavailability of palbociclib (pd-0332991) under fed and fasted conditions

Conditions: Healthy

Summary: a relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in phase 1 and 2 studies) under different fasting conditions.


Eligibility criteria:
inclusion criteria: * healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years. * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * any condition possibly affecting drug absorption.

Keywords: bioavailability bioequivalence auc cmax
the metabolic characteristics in sublobar areas of pre based on fdg-pet study

Conditions: Interictal FDG-PET Hypometabolism Patterns

Summary: epilepsy is a chronic brain disease that is caused by various factors and characterized by recurrent, episodic and temporary central nervous system dysfunction. in the past few decades, despite the continuous development of antiepileptic drugs, there are still 20%-30% patients with epilepsy progressing to pharmacoresistant epilepsy (pre), which leads to a significant increase in the morbidity and mortality of epilepsy. for those fraction of pre, surgical treatment may be the only possible way to cure epilepsy. accurate presurgical evaluation play an important role in making surgery decision and defining surgical extent and achieve better surgical outcome. imaging, especially interictal fluorine-18-fluorodeoxyglucose-positron emission tomography (fdg-pet) is widely used in preoperative evaluation, which is of great significance in the detection of epileptogenic foci. previous studies on fdg-pet have found that fdg-pet has a wide range of hypometabolism inpatients of pre varying from different epileptic origins. therefore, exploring the characteristics of glucose metabolism originating in different brain areas of resistant epilepsy can help to better interpret the results of fdg-pet and guide the preoperative localization of such patiens and better understand the potential mechanism of seizure propagation in pre.


Eligibility criteria:
inclusion criteria: (a) pharmacoresistant epilepsy may be defined by international league against epilepsy (ilae）as failure of adequate trials of two tolerated and appropriately chosen and used aed schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom (judged by two epileptologists); (b) conventional mri negative or nonspecific abnormalities; and (c) detailed information of long-term video-eeg, fdg-pet, high resolution mri (hr-mri) and neuropsychological assessment were acquired, (d) focal epilepsy defined by combining clinical, electrophysical and neuroimaging. exclusion criteria: (a) generalized or multifocal epilepsy or the patient's electroclinical features were inconsistent with pharmacoresistant epilepsy; (b) idiopathic focal epilepsy; and (c) unsatisfactory imaging quality. -
impact of physical exercise on quality of life in patients with inflammatory bowel disease - a pilot study.

Conditions: Quality of Life in Patients With Inflammatory Bowel Disease

Summary: patients with inflammatory bowel disease (ibd) suffer from a diminished quality of life compared to healthy adults. this is due to the chronic course of disease accompanied with diarrhea, stomach pains but also with psychological stress. it is known that physical education may improve course of disease and quality of life in a multitude of diseases. these include coronary heart disease, malignancies and also depression. the investigators believe that sport is as effective supportive tool in improving quality of life in ibd patients. but data is lacking with regard to controlled randomized clinical trials. because of the small amount of data available the investigators considered a feasibility study. our hypothesis is that ibd patients will cope with moderate exercise. the investigators further suspect that these patients improve their quality of life compared with patients in the control group.


Eligibility criteria:
inclusion criteria: * \>18 years * proven colitis ulcerosa (cu) * proven crohns disease (cd) * diagnosis \>= 1 year before start of the study * low or moderate disease activity exclusion criteria: * \< 18 years * high disease activity * regular exercise \> 2 hours per week * diagnosis of cu oder cd \< 1 year before start of the study

Keywords: inflammatory bowel disease ibd quality of life inflammatory bowel disease questionnaire
the prevalence, disease burden and prognosis of copd in patients with cardiovascular diseases

Conditions: Cardiovascular Diseases

Summary: this is a multi-center, prospective, and interventional study conducted in 3 types of cardiovascular diseases (cvd) subjects , including 3 cohorts which are patients with newly or previously diagnosed coronary heart disease ( chd), atrial fibrillation ( af) and chronic heart failure (chf).

the mainly purpose of this study is describe the prevalence of copd of the subjects with 3 types of cvd who are aged 40 years or older, and also observe the effect of cardiopulmonary co management on the short term prognosis of subjects with cvd and copd. this study will enroll approximately 3,000 subjects, with approximately 1,000 subjects in each cohort.

Eligibility criteria:
inclusion criteria: 1. give signed written informed consent to participate. 2. at least 40 years of age at baseline visit. 3. previous or newly diagnosed by at least one of the 3 types of cvd which are, * coronary heart disease ( chd ) * atrial fibrillation (af ) * chronic heart failure ( chf ) 4. subjects have no absolute contraindications to spirometry testing. 5. subjects have the cognitive ability to conduct questionnaires after e valuated by investigators. exclusion criteria: 1. significant diseases or conditions, which, in the opinion of the investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study. 2. women who are pregnant or lactating or are planning to become pregnant, or women of childbearing potential who are not using an acceptable method of contraception. 3. subjects who are not able to provide written informed consent. 4. treatment with investigational study drug or device in another clinical study within the last 30 days or five half lives prior to baseline visit , whichever is longer.
video assisted ablation of pilonidal sinus

Conditions: Pilonidal Sinus

Summary: the investigators supposed that the complete video assisted ablation of pilonidal sinus (vaaps) could be an effective minimally invasive treatment of pilonidal sinus. this new minimally invasive treatment allows the identification of the sinus cavity with its lateral tracks, the destruction and the removal of all infected tissue and the removing of any hair.


Eligibility criteria:
inclusion criteria: diagnosis of chronic pilonidal sinus exclusion criteria: inability to consent to the study recurrent pilonidal sinus after an outmidline technique
serratus plane block for the prevention of chronic pain after breast cancer surgery

Conditions: Breast/Surgery; Postoperative Complication; Chronic Pain

Summary: this study compare the "serratus block plane" (spb) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.

chronic pain after breast surgery may be severe, often requiring the use of morphine. the incidence of chronic pain varies from 27 to 50% depending on definitions. the infiltration of tissues by a local anesthetic is a simple, fast and low risk technique but of limited effectiveness. serratus the flat block, performed under ultrasound guidance, is minimally invasive and easy to perform. it allows anesthesia and analgesia to an extended part of the anterolateral chest wall and the axilla. this regional anesthesia technique provides good analgesia during and after breast surgery, but remains to be evaluated; beyond perioperative analgesia, the benefit-risk, post operative rehabilitation, and the impact on ambulatory and on chronic pain are fundamental objectives.

Eligibility criteria:
inclusion criteria: * women scheduled for elective breast neoplasm surgery * of asa classification 1, 2 or 3 * patients who provide written informed consent exclusion criteria: * minor patients * patients refusing to sign the consent * patients included in another protocol within 3 months * pregnant or lactating patients * patients with history of allergy to local anesthetics (ropivacaine) * patients with contraindication to regional anesthesia (coagulopathy, local infection ...) * patients with history of prior breast surgery (excluding diagnostic biopsy) * patients with history of chronic pain * patients with a history of psychiatric disorder
discontinuation of trimethoprim-sulfamethoxazole prophylaxis in adults on antiretroviral therapy in kenya

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome; Disease Progression; Immune System Diseases; Malaria; Parasitic Diseases; Pneumonia; Diarrhea; Infectious Disorder of Immune System

Summary: both antiretroviral therapy (art) and prevention of opportunistic infections (ois) have been associated with significantly decreased mortality in hiv-infected individuals. trimethoprim-sulfamethoxazole (tmp/smz), also known as bactrim, is a common antibiotic and used as prophylaxis for ois. for countries with high prevalence of hiv and limited health infrastructure, the who endorses universal tmp/smz for all hiv-infected individuals. notably, these guidelines were created prior to the scale-up of arts. following art and subsequent immune recovery, tmp/smz may no longer be required. in the us and europe, for example, tmp/smz is discontinued after patients show evidence of immune recovery. therefore, we propose a prospective randomized trial among hiv infected individuals on art with evidence of immune recovery (art for \> 18mo and cd4 \>350 cells/mm3) to determine whether continued tmp/smz prophylaxis confers benefits in decreasing morbidity (malaria, pneumonia, diarrhea), mortality, cd4 count maintenance, art treatment failure and malaria immune responses.

please see summary above.

Eligibility criteria:
inclusion criteria: * participants must be at least 18 years of age. * participants must be willing to participate and give written informed consent. * participants must be willing and able to return for the scheduled follow-up visits. * participants must have been on art for \> 18 months. * participants must have a cd4 count of \> 350 cells/mm3. * participants must not be suspected of art treatment failure. exclusion criteria: * participants must not be pregnant at enrollment (by urine hcg testing). * participants must not be breastfeeding at the time of enrollment. * participants must be on first-line art therapy as defined by kenyan national guidelines.

Keywords: hiv co-infections malaria pneumonia diarrhea
jakarta acute coronary syndrome registry

Conditions: Acute Coronary Syndrome

Summary: jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to the emergency department of all health centers in jakarta and the surrounding area.

the jac registry is an ongoing prospective, multi center, observational study that aims to enroll acs patients who admitted to the emergency department (ed) of all health centers in jakarta and the surrounding area. the registry has been collecting data since 2007, and used extensively since 2014. currently, the jac registry is the main source of data for measuring the performance of the stemi network in the region, namely jakarta cardiovascular care unit network system. the stemi network in jakarta has been introduced as an integral part of the government project since 2010/2011. stemi was diagnosed based on the typical chest pain and st segment elevation on two or more contiguos leads. the number of primary pci, fibrinolytic therapy and non-reperfused patients were recorded.

Eligibility criteria:
inclusion criteria: * stemi patients that was diagnosed based on the presence of typical chest pain and st-segment elevation in two or more contigious leads on the initial ecg exclusion criteria: * stemi patients that was under 18 years

Keywords: system of care acute myocardial infarction registry primary pci fibrinolytic therapy
guided discontinuation versus maintenance treatment of sirolimus in pediatric patients with kaposiform hemangioendothelioma

Conditions: Kaposiform Hemangioendothelioma; Kasabach-Merritt Syndrome

Summary: this randomized controlled trial aims to compare guided discontinuation with maintenance treatment of sirolimus in pediatric patients with khe.

kaposiform hemangioendothelioma (khe) is a rare vascular tumor that occurs in infants and children. khe is characterized by sheets of spindle cells with an infiltrative pattern in the dermis, subcutaneous fat, and muscle. it is locally aggressive and can cause kasabach-merritt phenomenon, a serious life-threatening coagulopathy characterized by profound thrombocytopenia and hypofibrinogenemia. sirolimus, one of the mtor inhibitors, has become a new and very effective treatment, which is especially reliable for khe with kmp and has acceptable side effects. however, there is yet no strong evidence on the best practice of treatment length of sirolimus. this randomized controlled trial aims to compare guided discontinuation with maintenance treatment in pediatric patients with khe in order to provide a basis for the optimal treatment duration of sirolimus, as well as the clinical characteristics of pediatric patients who can safely reduce the dose till withdrawal.

Eligibility criteria:
inclusion criteria: * participant diagnosed with khe with or without kmp * participant age 0-12 years * participant with detailed medical records of the disease at the time of screening * participant with at least two years of remission of khe and no previous toxicity or adverse events * participant with normal liver and kidney function * participant with signed and dated informed consent from the guardian(s) exclusion criteria: * participant with other hematological diseases * participant with other solid tumor * participant with general disease such as hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency. * participant with infectious diseases * unwilling participant

Keywords: kaposiform hemangioendothelioma kasabach-merritt syndrome sirolimus rapamycin
study evaluating sirolimus in kidney transplant recipients

Conditions: Graft vs Host Disease; Kidney Transplantation

Summary: the purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.


Eligibility criteria:
inclusion criteria: * kidney transplantation * donor must be at least 60 years old. exclusion criteria: * current systemic infection * unstable angina or treatment for serious arrhythmia. * cancer within the previous 5 years.

Keywords: kidney transplant
standard motorcycle child safety helmet initiative (mchi) program

Conditions: Head Injuries

Summary: the main aim of this intervention study is to test the hypothesis if helmet initiative program will significantly increase helmet usage in primary school students. the secondary aim of this intervention is to evaluate the behavioral change in standard child safety helmet usage among the parent/adult riders. the study was conducted in 23 primary school in selangor from 1st january 2016 to 31st december 2018 in three different phases.

in malaysia, the road traffic plans estimated that the number of death on road traffics might increase almost 23% from 2014-2020 (royal police of malaysia, 2017). the main road crash involved the motorcyclist and the main cause of death was due to the severe head injuries. previous study in malaysia had reported only 20% of proper helmet usage among the adult riders (malaysian institute of road safety research, 2015). this highlights the need to transfer the knowledge to the parent/adult riders on the importance, proper usage and availability of the standard child safety helmet and hence increase the prevalence of standard helmet usage for the pillion riders especially for the children.

Eligibility criteria:
inclusion criteria: * primary school students from selected school * aged 7 - 12 years old * travel to school by motorcycle. * the adult rider able to speak/read malay and english exclusion criteria: * students who are travelling to school using mode of transport other than motorcycle. * pre school students

Keywords: standard motorcycle child safety helmet chinstrap toy/game helmet
profiling and targeting epigenetic marks to improve diagnosis and therapeutic approaches in head and neck cancer

Conditions: Head and Neck Cancer

Summary: investigators have recently shown that epigenetic remodelling enzymes, such as hdac inhibitors, are feasible drugs in hnc (8, 9). preliminary data are indicating some deregulated epigenetics marks suggesting the corresponding histone modifiers as possible targets for the treatment of hnc, providing an attractive and feasible option to build upon. our overarching hypothesis is that unique histone marks distinguish hpv+ and hpv- hnc and that specific histone modifiers are novel mediators of hnc tumorigenesis in an hpv specific manner

head and neck cancer (hnc) is a highly heterogeneous disease, involving diverse anatomical sites including oral cavity, larynx and oropharynx. hnc risk factors include tobacco smoking and alcohol consumption and, especially for the subtype of oropharyngeal cancers (opc), human papillomavirus (hpv) infection

Eligibility criteria:
inclusion criteria:• age: adults aged ≥ 18 years diagnosed with hnc * sex: both male and female * human papilloma virus (hpv) test: both positive and negative. * tumor: primary tumors, treatment naïve, squamous cell carcinoma * cancer stage: i-iv * anatomic location: oral cavity, larynx, oropharynx * tumor fragments not required for diagnostics exclusion criteria: * previous radiotherapy, chemotherapy or immunotherapy for hnc * unable to provide written informed consent

Keywords: profiling and targeting epigenetic marks head and neck cancer
the noergaard technique for anterior shoulder dislocation

Conditions: Anterior Shoulder Dislocation

Summary: in this paper we describe and evaluate the results of the noergaard technique through a retrospective analysis of patients admitted and treated for anterior shoulder dislocation at the ed of copenhagen university hospital hvidovre, denmark, in a 1-year period.

introduction in this article the investigators describe the noergaard technique for reduction of anterior shoulder dislocations. this is an atraumatic reduction method that has proven successful through several years of practice. the investigators describe and evaluate the results of this technique through a retrospective analysis of patients admitted and treated for anterior shoulder dislocation at the emergency department (ed) of copenhagen university hospital hvidovre, denmark, in a 1-year period. methods in the noergaard technique the patient is placed standing bend over forwards in front of the rail on a hospital bed, resting the forehead on the back of the non-affected forearm, which is put on the rail. the affected arm should now be relaxed and stretched, hanging straight down toward the floor. the patient is then instructed to attempt to relax and make pendular and circular motions with the affected arm hanging down.

Eligibility criteria:
inclusion criteria: - patients have had a closed shoulder reduction performed at the emergency center of hospital of hvidovre between 1st of january 2014 and the 31st of december 2014. exclusion criteria: * patients with diagnosed severe arthrosis in the shoulder joint. * patients with malignancy in the humerus or scapula. * patients who have had a total shoulder arthroplasty performed at the same side as the lunation. * patients with more than four previous shoulder reductions performed. * patients who have undergone operations on the same shoulder, but at different hospitals.

Keywords: shoulder dislocation noergaard reduction
intraoperative aromatherapy versus placebo for port-a-cath placement under monitored anesthesia care. a randomized controlled trial

Conditions: Cancer Pain

Summary: this is a prospective, controlled, randomized trial. primary objective is to compare the time to readiness for discharge (minutes) from post-anesthesia care unit (pacu) after port-a-cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. 70 eligible subjects will be identified from within the patient population of the study site. there will be no advertisements for study subjects.

primary objective: to compare the time to readiness for discharge (minutes) from post-anesthesia care unit (pacu) after port-a-cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. secondary objective: to evaluate the following secondary outcomes: * anxiety score (hads) in preoperative holding area * midazolam use intraoperatively (mg) * itraoperative opioid use (morphine equivalents) * intraoperative anti-emetic use * time to first occurrence of postoperative nausea or vomiting (ponv) in pacu * rate and intensity of ponv in pacu * antiemetic use in pacu * opioid use in pacu (morphine equivalents) * pain intensity in pacu (0-10 numerical rating scale) * patient satisfaction in pacu

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) * port-a-cath placement under monitored anesthesia care * signed informed consent exclusion criteria: * patients undergoing other surgical procedures during port-a-cath placement (including explantation of a port-a-cath or other previous vascular access device) * patients requiring general anesthesia or those not eligible for mac