Kornimate/medical-research-clean huggingface dataset:
long-term follow-up safety of a single injection of gensci094 for ovarian stimulation using daily recombinant fsh as reference

Conditions: Infertility

Summary: the purpose of this study is to evaluate the safety of a single injection of gensci094 during controlled ovarian stimulation up to 1 year old of the infants from previous studies.

two previous rcts (a phase ii and phase iii studies of gensci094, one is nct06091436) investigated if a single injection of gensci094 was non-inferior to daily treatment with recfsh in initiating multi-follicular growth. the two studies followed 12 weeks after embryo transfer. this study is a follow-up to the above mentioned rcts. the purpose of this study is to follow-up with participants of the original study to determine the long-term effect a single injection of gensci094 during controlled ovarian stimulation might have on newborns until they are 1 year old.

Eligibility criteria:
inclusion criteria: 1. willing and able to sign informed consent 2. subjects who participated in phase ii or phase iii clinical trial of gensci094 and received at least one treatment with gensci094 or gonal-f ® 3. subjects who indentified an ongoing pregnancy in phase ii or phase iii clinical trial of gensci094 exclusion criteria: na
low-level laser therapy and flapless corticopuncture effect on accelerating six maxillary anterior teeth retraction

Conditions: Malocclusion, Angle Class II, Division 1

Summary: the long time needed for orthodontic treatment is considered one of the biggest obstacles that make patients refuse to undergo orthodontic treatment. it also has many disadvantages including higher caries rates, gingivitis, and root resorption. therefore, the purpose of this study is to evaluate the efficiency of two new noninvasive methods (low-level laser therapy and corticopuncture) in accelerating orthodontic tooth movement for the implant supported en-masse retraction of the six maxillary anterior teeth.

this study will be a randomized controlled trial with a 1:1:1 allocation ratio. sample size was calculated using minitab version 15. 36 participants recruited from patients attending the department of orthodontics and dentofacial orthopedics at damascus university with class ii division 1 malocclusion that indicates the extraction of first maxillary premolars will be randomly assigned into one of three groups: low-level laser therapy (lllt) group, flapless corticopuncture group, or control group. titanium mini-implants (1.6 mm diameter and 7 mm length) will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm height above the archwires below the mucogingival junction. after complete leveling and alignment of the maxillary dental arch, which will be defined by passive insertion of 19\*25 inch s.s. archwire, the retraction stage of the six maxillary anterior teeth will begin.

Eligibility criteria:
inclusion criteria: 1. patient age between (18 - 24) years. 2. class ii division 1 malocclusion that indicates extraction of two maxillary first premolars with the following parameters: anb: 5 to 10 degrees. overjet: 5 to 10 mm. growth pattern: normal or slightly vertical. 3. all upper teeth are existed (except for third molars). 4. mild to moderate crowding (3 mm or less). 5. patient dose not undergo any medical treatment that interfere with orthodontic tooth movement (cortisone, nsaids, ...). 6. good oral hygiene (plaque index \< 1). exclusion criteria: 1. any medical condition affecting orthodontic tooth movement. 2. poor oral hygiene (plaque index \> 1). 3. patient did not undergo previous orthodontic treatment. 4. patient lack of commitment toward follow-up appointments.

Keywords: orthodontic tooth movement acceleration
treatment study in patients treated with both insulin & hydrocortisone

Conditions: Diabetes Mellitus; Adrenal Insufficiency; Polyglandular Autoimmune Syndrome

Summary: the aim of ins.cort trial is, by studying glycemic variability in a well-defined patient group with both insulin \& hydrocortisone (patients with concomitant insulin-treated diabetes \& addison's disease) and collecting information about the administration -time point and doses- of insulin, hydrocortisone and food intake with the help of new technology to improve the treatment in all patients treated with both insulin \& glucocorticoids.


Eligibility criteria:
inclusion criteria: men and women at age 18 to 70 years, with bmi 18-32 kg/m2 and well-defined both insulin-treated diabetes \& addison's disease for \>12 months each, on insulin treatment and stable hydrocortisone replacement with once-daily dual-release hydrocortisone (20-30 mg/day) for \>3 months. exclusion criteria: * any medication with other glucose lowering agents than insulin * any additional underlying or intercurrent disease that may need regular or periodic pharmacological treatment with glucocorticoids during the study period, including infectious diseases * any medication with agents which in the investigator's judgement might interfere with the study drugs kinetics, including therapies affecting gastrointestinal emptying or motility * any medication with oral estrogen supplementation and/or regular dhea medication for the past 4 weeks * clinically significant renal dysfunction with a serum creatinine above 160 mmol/l * active malignancy * clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary/pancreatic disease which in the investigator's judgement may interfere with the study assessment * pregnant or lactating women * alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator.

Keywords: insulin treatment hydrocortisone treatment opposing effects on glucose metabolism randomized controlled trial
reconstruction following pancreaticoduodenectomy: a randomized clinical trial of pancreaticojejunostomy vs pancreaticogastomy

Conditions: Pancreas Cancer; Periampullary Cancer

Summary: pancreaticoduodenectomy (pd or whipple procedure) involves the removal of the head of the pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from the common bile duct, ampulla of vater, duodenum, neuroendocrine cells of the pancreas, and most commonly the exocrine pancreas). in canada, cancer of the pancreas is the 11th cancer in terms of new cases/year, and the 5th leading cause of cancer related deaths/year. following pd the remaining pancreas is re-connected to a portion of the gastrointestinal tract; the pancreas is very soft and difficult to sew and connect safely. the primary cause of complications following pd is related to leak occurring at this connection. of patients that develop a leak, over half need a second operation, and up to 40% will die. the two main organs that the pancreas may be re-connected to are the jejunum or the stomach. the investigators will compare the rates of pancreatic leakage in two groups of patients randomized to reconnection to either the jejunum or stomach following pd. the goal of this study is to determine which of these methods is safer. the results may change practice patterns across north america and the world. it may in the future prevent many cases of avoidable leakage and the resulting morbidity of this including death. this will therefore reduce the morbidity and mortality of this group of cancer patients.


Eligibility criteria:
inclusion criteria: * suspected pancreatic or periampullary neoplasm that appears to be resectable based on preoperative imaging (ct scan and/or mri) and are deemed medically fit to undergo pd. exclusion criteria: * patients less than 18 years of age will be excluded. * as well, patients with distant metastasis, local unresectability, and/or gastric involvement will be excluded. other exclusion criteria include: * female subjects who are pregnant or nursing * current use of an investigational drug * currently receiving chemotherapy or radiotherapy.

Keywords: whipple pancreas reconstruction leak fistula
effectiveness of an active lifestyle promotion program for patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: patients with parkinson's disease (pd) are heavily inclined towards a sedentary lifestyle. this is caused by a combination of physical impairments and cognitive dysfunction. however, regular physical activity in pd is highly desirable, for two reasons. first, physical activity has positive generic effects in preventing complications such as cardiovascular diseases, type ii diabetes mellitus, osteoporosis and certain cases of cancer. secondly, physical activity has additional disease-specific merits in pd such as depression, sleep disturbances and constipation. these effects lead to raised quality of life. furthermore, animal studies suggest that physical activity could slow down disease progression. simply informing patients about the importance of physical activity is not enough to initiate and maintain an adequate level of physical activity. we propose to develop a physical activity promoting program for sedentary patients with pd in order to raise their level of daily physical activity. objective: the first aim of the study is to investigate whether a physical activity promotion program will result in an increase in physical activity in sedentary patients with pd. the second aim is to demonstrate an increase in physical fitness and quality of life.

no extensive description

Eligibility criteria:
inclusion criteria: * idiopathic pd * hoehn and yahr stage i-iii * between 40 and 75 years old * not meeting the norm for healthy physical activity: the latter being defined according to international standards as either five days a week 30 minutes of moderate-intensity physical activity, or 3 days a week 20 minutes of vigorous-intensity physical activity exclusion criteria: * wheel chair bounded * severe co-morbidity (e.g. orthopaedic disorders or chronic hart failure) * severe cognitive decline, defined as mini mental state examination \< 24

Keywords: parkinson physical therapy physical activity
neurogenic myocardial and lung injury in sah patients

Conditions: Myocardial Injury; Lung Injury; Subarachnoid Hemorrhage

Summary: up to this day, little is known whether the extent of brain damage in patients with sah correlates with the degree neurogenic myocardial injury and neurogenic lung injury. this is a prospective observational study designed to asses relationship between catecholamine surge and development of myocardial and lung injury in subarachnoid haemorrhage patients.

multiple forms of brain damage, primarily, subarachnoid haemorrhage (sah) are frequently accompanied by neurogenic myocardial injury with changes in the electrocardiogram, accompanied by the release of markers of myocardial injury. this form of cardiac dysfunction is thought to be mediated by cellular toxicity associated with catecholamine release. central nervous system damage in the course of intracranial haemorrhage may, in a similar pathogenic pathway, lead to neurogenic lung injury. up to this day, little is known whether the extent of brain damage in patients with sah correlates with the degree of neurogenic myocardial injury. moreover, it remains unknown what is the full clinical picture and duration of this type of myocardial injury and how often it co-occurs with neurogenic lung injury. such analysis is a fundamental and most important step in optimising the treatment of these patients. methods: in this prospective observational study the authors aim to recruit 30 patients with subarachnoid haemorrhage, requiring hospitalization in the intensive care unit. the patients will be monitored for elevation in cardiac damage markers (hs-tnt, cpk, ck-mb, nt-probnp) and worsening of respiratory conditions, defined by need for more invasive ventilation parameters, and subsequent changes in arterial blood gas. the above mentioned parameters will be assessed every 12 hours. additionally, the patients will be screened for an elevation in catecholamine metabolite (metanephrine) concentration in 12-hour urine collection. hypothesis to be tested: myocardial and lung injury in sah patients is timely-associated with an increase in metanephrine concentration in urine.

Eligibility criteria:
inclusion criteria: * patients with subarachnoid haemorrhage (both aneurysmal and non-aneurysmal) with acute consciousness disturbances (glasgow coma scale \< 8 pts) requiring intubation and mechanical ventilation, hospitalized in the icu for over 24 hours exclusion criteria: * severe prior pulmonary diseases * severe prior cardiac diseases * death in the first 72 hours of icu stay * need for any extracorporeal life-saving techniques

Keywords: myocardial injury lung injury sah subarachnoid haemorrhage metanephrine catecholamine-induced injury intensive care unit neurocritical care
platelet resistance with ticagrelor or standard-dose clopidogrel among ckd and acs patients

Conditions: Acute Coronary Syndrome; Chronic Kidney Disease; End-Stage Renal Disease

Summary: a 4 week-duration cross-over study on ticagrelor and clopidogrel for the acute coronary syndrome (acs) and chronic kidney disease (ckd) subjects, focusing on the platelet inhibition and safety observation.

acute coronary syndrome is a high mortality and costly disease. antiplatelet therapies, including aspirin and p2y12 antagonist, play important roles at the acute and subacute stage treatment for acute coronary syndrome, especially after coronary stent implantation. patients with decreased estimated glomerular filtration rate (egfr) experience higher cardiovascular morbidity and mortality. clopidogrel, one of p2y12 receptor antagonists, inhibits the receptor's activation by blocking its interaction with adp. however, the efficacy of clopidogrel shows substantial variation and residual platelet reactivity, which is related to adverse cardiovascular outcome, especially in impaired renal function. our study aims to check the platelet inhibition rate comparing both medication with a cross-over study among ckd subjects and acs condition.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. female and male, age between 20-75 years 3. stage 3-5 chronic kidney disease (egfr\<60ml/min) patients or esrd 4. taking standard treatment dose of clopidogrel (75mg/day) for more than 1 week 5. patients were eligible for enrollment if they were hospitalized for an acute coronary syndrome, with or without st-segment elevation, with an onset of symptoms during the past 6 months. 6. for patients who had an acute coronary syndrome without st-segment elevation, at least two of the following three criteria had to be met: st-segment changes on electrocardiography, indicating ischemia; a positive test of a biomarker, indicating myocardial necrosis; or one of several risk factors (age ≥60 years; previous myocardial infarction or coronary-artery bypass grafting \[cabg\]; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease). 7. for patients who had an acute coronary syndrome with st-segment elevation, the following two inclusion criteria had to be met: persistent st-segment elevation of at least 0.1 mv in at least two contiguous leads or a new left bundle-branch block. exclusion criteria: 1. oral anticoagulation therapy that cannot be stopped 2. increased risk of bradycardia 3. concomitant use of strong cyp3a inhibitor/inducers 4. unwilling to sign inform consent 5. allergic or contraindicated to any study medications

Keywords: acute coronary syndrome chronic kidney disease end-stage renal disease egfr ticagrelor clopidogrel
energy expenditure in breast and bottle feeding preterm infants fed their mother's breast milk

Conditions: Preterm Infants

Summary: objective. neonatologists consider early feeding at the breast to be too tiring for preterm infants, although there is no evidence that this is actually the case. it is also not known whether the method of feeding affects energy expenditure. we hypothesized that resting energy expenditure (ree) would be higher after breastfeeding than after bottle feeding. patients and methods. preterm ( \>32 weeks ga) stable infants who are nourished entirely by their mothers' breast milk will be studied when fed expressed breast milk either by bottle or at the breast. ree will be measured for 20 minutes after feeding. breast milk quantity is evaluated by pre- and post feeding weighing.

most vlbw infants cannot be fed at the breast upon birth, and expressed breast milk by gastric tube is thus recommended. sucking skills mature at around 34 weeks when nipple-feeding is introduced. in the absence of evidence-based data to decide the best timing to introduce breastfeeding, many clinicians use empiric criteria, such as the infant's weight, gestational age, and the ability of infants to bottle feed as proxies of readiness to breastfeed. despite some evidence of physiological benefits of preterm infants feeding at the breast, many neonatologists consider direct breastfeeding to be too fatiguing for preterm infants. it is not known, however, whether preterm infants who are breastfed expend more energy than bottle-fed infants

Eligibility criteria:
inclusion criteria: * thermally stable infants were nursed in an open and unwarmed bassinet. * all fed solely by their mothers' breast milk equivalent to at least 150 cc/kg/day divided into eight meals and growing steadily exclusion criteria: * infants with congenital anomalies and infants who had either more than five daily episodes of apnea of prematurity or any apnea requiring assistance or methylxanthine therapy

Keywords: metabolic rate indirect calorimetry oral feeding
sarah exercise program in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the aim of this study is to investigate the effectiveness of the sarah home exercise program to be applied for 12 weeks on wrist proprioception and hand functions in adult patients with rheumatoid arthritis.

finger/hand/wrist joints can be affected in the early period in patients with ra, and as the disease progresses, it can significantly limit the patient's functionality. damage to articular and periarticular structures seen in inflammatory arthritis may affect the sense of proprioception by destroying mechanoreceptors located in these areas. hand functions may worsen as a result of the worsening of the sense of proprioception, which can be defined as being aware of body parts. sarah (strengthening and stretching for rheumatoid arthritis of the hand) home exercise program, which is a widely preferred approach in the case of hand involvement in patients with rheumatoid arthritis (ra), includes exercises to increase hand-wrist strength and mobility. although the effectiveness of this program on pain, muscle strength, and range of motion has been demonstrated in large patient groups, its effect on proprioception and hand functions, which may be caused by inflammatory arthritis, has not been studied. therefore, this study aims to investigate the effectiveness of the sarah home exercise program on wrist proprioception and hand functions in adult patients with rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: 1. ra diagnosis according to 2010 acr/eular ra criteria 2. being between the ages of 18-65 3. being able to follow turkish instructions 4. volunteering to participate in the study exclusion criteria: 1. being in an acute disease exacerbation period 2. ongoing physiotherapy/occupational/exercise treatment regarding hands within the last 6 months 3. history of steroid injection, surgery, or trauma to the upper extremity in the last 6 months

Keywords: hand proprioception exercise
examination of act implementation in a vivax / falciparum co-endemic area

Conditions: Malaria; Fever

Summary: in areas of which are co-endemic for vivax and falciparum malaria, treatments for the two diseases often differ and this may lead to mistreatment. this places an emphasis on diagnosis at the health service provision level. diagnosis is also important when malaris endemicity is low - most fevers are not caused by disease. these two issues mean that most malaria and fevers are not adequately treated, even though the drugs may be effective; many patients who do not have malaria are treated for the disease, and patients with malaria may get the wrong treatment for their species. the study aims to test the effectiveness of employing rapid diagnostic tests and will study the effect on correct treatment.

the study will randomly assign diagnostic methods, either with clinical diagnosis, field microscopy or rapid diagnostic tests. the study will take place in 22 clinics in eastern and northern afghanistan, both areas with low transmission of predominantly vivax malaria. they differ in their locations and their current standard diagnostic methods. the study will examine the result of the diagnostic test in the clinic against the result of reference slides and pcr to estimate the number of cases correctly treated in each arm. this will be a measure of the effectiveness of diagnosis (and the physicians response to the diagnosis) and be influential in considering modalities for diagnostic delivery

Eligibility criteria:
inclusion criteria: * any patient where the clinician\* considers malaria in the diagnosis - either prescribing an antimalarial or would request a malaria test if available or referring for diagnosis of malaria elsewhere. * patient, or parent/guardian, gives informed consent to the study. exclusion criteria: * patients with a result from another facility * patients referred on for diagnosis in the private sector * patients the clinician decides to treat presumptively without requesting a test (defined as treating prior to randomisation) * where the clinician requests microscopy specifically due to clinical need prior to randomisation will not be randomised in the trial, but will be noted as part of the study and a reference slide and clinical information will be taken following consent.

Keywords: malaria rapid diagnostic tests afghanistan non-specific fever
bladder cancer patient-reported outcomes

Conditions: Bladder Neoplasms

Summary: the purpose of this study is to identify aspects of the bladder cancer (blca) survivorship experience that differ by clinical risk at diagnosis. the investigators will collect cross-sectional data from persons with blca to identify aspects of health-related quality of life (hrqol) and symptom management. the study originally enrolled only nonmuscle-invasive bladder cancer survivors but has been expanded to include survivors with any stage disease. information from this study will be used to develop a new patient education and counseling intervention.


Eligibility criteria:
inclusion criteria: * \> 18 years * diagnosed with blca within the past 4 years * able to read, speak, and understand english * able to provide informed consent. exclusion criteria: * younger than 18 * diagnosed blca longer than 4 years ago * unable to read, speak, and understand english * unable to provide informed consent.

Keywords: cross-sectional survey health-related quality of life symptom management