Kornimate/medical-research-clean huggingface dataset:
open-label extension study with requip pr for subjects from study rop111528

Conditions: Parkinson Disease

Summary: this open label extension study allows assessment of the long term safety profile of requip pr in subjects who have completed 24 weeks of randomised treatment in study rop111528. subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous. subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.


Eligibility criteria:
inclusion criteria: 1. subjects must have completed 24 weeks of randomised treatment in study rop111528(and must have completed the one-week downtitration at the end of treatment/early withdrawal). 2. subjects must not have a break in medication between completing the downtitration phase for studies rop111528 and beginning treatment in this extension study. 3. women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (iud), or diaphragm in addition to spermicidal foam and condom on male partner, or systemic contraception (e.g. norplant system). 4. provide written informed consent for this study. 5. be willing and able to comply with study procedures. exclusion criteria: 1. patients with any ongoing clinically significant adverse events at the end of the study rop111528. 2. subjects with severe, clinically significant condition(s) other than parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma). 3. subjects with clinically significant abnormalities in laboratory or ecg tests at the end of the study rop111528. 4. subjects with severe dizziness or fainting due to postural hypotension on standing. 5. withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cyp1a2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce cyp1a2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period. 6. women who are pregnant or breast-feeding. 7. use of an investigational drug throughout the treatment period.
dual therapy with raltegravir and darunavir/ritonavir in hiv infected patients.

Conditions: Integrase Inhibitors, HIV; HIV PROTEASE INHIB

Summary: while 3-drug regimens remain standard of care, concerns exist regarding the safety of multi-drug regimens taken for a lifetime. problems with nucleoside analogue therapy prompted successful trials with ritonavir (rtv) boosted pi monotherapy, however long term safety and efficacy of such regimens remains unknown. clinical trials have shown raltegravir (ral) to have potent activity when patients have few active background drugs; it has a superior lipid profile compared with efv and lpv/rtv. darunavir/r (drv) is a potent, well tolerated pi with few gi side effects and lipid disturbances and with a high genetic barrier. the investigators hypothesized that ral/drv would be a well tolerated and effective regimen for those patients who are failing nucleoside reverse transcriptase inhibitors based regimens, due to poor tolerability or resistance. the investigators also would like to explore the plasma pharmacokinetics of raltegravir combined with darunavir in a sub-group of 12 hiv-infected patients.

hypothesis * nrti-sparing regimens are attractive options to avoid nrti-associated toxicity and to provide a full active regimen in patients with some extent of nrti resistance. * raltegravir (ral) and darunavir (drv) are potent "third drugs" and they provide a synergistic inhibition of 2 different steps in hiv replication. * drv has a high genetic barrier, and could be an excellent accompanying drug for raltegravir, providing a potent, safe and well tolerated dual therapy to patients who are failing nnrti based treatments. objectives: * to describe the safety, tolerability and efficacy of the combination of raltegravir and darunavir after 24 weeks of follow up in hiv infected patients failing a nrti based regimen. * to describe plasma pharmacokinetics of raltegravir when combined with darunavir 800mg qd in hiv-infected patients.

Eligibility criteria:
inclusion criteria: * documented hiv infection * naïve to raltegravir. * cd4 cell count above 200 cell/mm3. * no history of failure to pi containing regimens. * no evidence of pi mutations (ias-mutation list) by genotype test. * failing to a nrti based regimen. * the treating physician decides a nrti sparing regimen which includes drv/r 800/100 mg qd plus raltegravir 400 mg bid. * signed informed consent form * in opinion of the investigator, the patient should be considered clinically stable and could follow regular visits as scheduled per protocol. exclusion criteria: * patients receiving drugs considered contraindicated to raltegravir and drv/r. contraindicated drugs are: rifampin, fenitoin, phenobarbital in the case of raltegravir. pravastatin, astemizole, sildenafil, are contraindicated in combination with drv/r. * pregnancy * documented pi mutations

Keywords: pharmacokinetics, raltegravir, darunavir, nrti sparing regimen
cephalometric evaluation of a clear mandibular advancement appliance based on the twin-block design

Conditions: Skeletal Malocclusion

Summary: this study evaluates the cephalometric effects of a clear mandibular advancement appliance for the treatment of skeletal class ii growing patients suffering from mandibular deficiency.

a clear mandibular advancement appliance is constructed comprised of a clear dental splint of 1.5 mm thickness adapted on the patient's teeth. this is followed by the construction of acrylic bite ramps bonded over the splints. the bite ramps are constructed as such when the patient bites into occlusion, he/she has to advance the mandible to bring the two parts of the appliance together. lateral cephalometric radiographs were obtained pre and post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.

Eligibility criteria:
inclusion criteria: 1. gender: female subjects. 2. chronological age: all recruited subjects were between the ages of 8-12 years. 3. anteroposterior skeletal relationship: subjects with skeletal class ii malocclusion with normal maxilla and retrognathic mandible were selected. this was confirmed using lateral cephalometric radiographic analysis with the following parameters: decreased effective mandibular length (co-gn) according to mcnamara composite , snb\<78, sna=82+2. 4. dental characteristics: * angle class ii molar relationship ranging from edge to edge to full unit class ii. * overjet ranging between 5-10 mm. * absence of posterior crossbite and/or tendency for posterior crossbite. 5. skeletal maturation stage: the growth stage for all subjects was selected to be before or at the prepubertal growth spurt. this was confirmed by cervical vertebral maturation analysis from the lateral cephalometric radiograph. the cervical vertebrae maturation stage required was cervical vertebrae maturation stage 2-3 according to the cervical vertebrae maturation index by baccetti et al. allowing sufficient time before the end of the growth spurt. 6. no previous history of orthodontic treatment. 7. absence of systemic diseases affecting growth or craniofacial development. - exclusion criteria: -

Keywords: functional appliance skeletal class ii mandibular deficiency twin-block growing patients clear appliance aligner
mediterranean diet versus hypocaloric diet in pcos

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is the most common endocrinopathy of reproductive-aged women that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance. available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of pcos. thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely mediterranean diet and hypocaloric diet in pcos women.

pcos is the most common endocrine disorder of reproductive age women, that is often associated with chronic anovulation, hyperandrogenism and insulin resistance. the central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. no data are available for the best therapeutical approach for metabolic dysfunction of pcos. the new guidelines for the management of metabolic risk in pcos strongly recommended that overweight/obese women with pcos should lose weight changing their lifestyle. although calorie-restricted diets are currently recommended to reach the healthy weight, there are still unsatisfied data regarding the best dietetic regimen that should be suggested. in this study, our purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in pcos women.

Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome (using eshre/arsm 2007 criteria) * bmi \> 25 exclusion criteria: * age \ 35 years * bmi higher than 35 * pregnancy * hypothyroidism, hyperprolactinemia, cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months * subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea)

Keywords: polycystic ovary syndrome hypocaloric diet ovarian cysts ovarian diseases obesity mediterranean diet
milk and milk-produce to counteract the loss of muscle mass and function in exercising older adults.

Conditions: Sarcopenia

Summary: this project evaluates the use of different types of proteins from various food sources after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have low muscle mass). specifically, researchers want to: * examine the efficiency of protein intake after exercise on muscle mass and physical abilities; * examine the impact of exercise and proteins on blood lipids (ldl cholesterol, hdl cholesterol, total cholesterol and triglycerides); * examine the impact of exercise and proteins on liver enzymes; * examine the impact of exercise and proteins on a hormone that controls hunger; * evaluate the program's impact on the ability of the body to produce energy. all participants are exercising (resistance training) and ingest one of the 3 different sources of proteins, immediately after training: * milk proteins (from milk beverage) * essential amino acids (added to a soya beverage) * no protein (rice beverage - control group) our hypothesis is that proteins from milk will induce a gain in muscle mass and physical function equivalent to the essential amino acids (eaa). we anticipate that both milk proteins and eaa will be both superior to control group. this would represent an interesting finding since milk is more accessible, palatable and cheaper than essential amino acids commercial mix.


Eligibility criteria:
inclusion criteria: * 65-75 years * francophone or understanding french * muscle mass index \< 10.75 kg/m2 (janssen et al, 2004) * body mass index \<30kg/m² * weight stable (\< 2 kg) for 6 mo * no resistance exercise for 3 years * controlled blood pressure for at least 6 months exclusion criteria: * major physical disability * medical treatment influencing metabolism * statin treatment * diagnosis or any sign of kidney disease

Keywords: sarcopenia physical capacity muscle force muscle quality milk proteins essential amino acids proteins resistance training exercise
raas and arterial stiffness in sci

Conditions: Arterial Stiffness; Renin Angiotensin Aldosterone System; Orthostatic Hypotension; Spinal Cord Injury; Hypotension

Summary: the study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls.

the study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls. arterial stiffness and blood pressure will be collected in the laying down position. a blood sample of norepinephrine and plasma renin will also be collected. the participant will tilt to 30, 45 and 60 degrees for 10 minutes at each angel. blood pressure and heart rate will be monitored at each angle. another blood sample of renin and norepinephrine will be collected at the end of 10 minutes at 60 degrees.

Eligibility criteria:
inclusion criteria: * sci participants: * injured between c1-t1 and t6-t12 * wheelchair dependent * ais classification a, b or c * injured occurred more than 1 year ago exclusion criteria: * currently have an illness or infection * current smoker of at least 1 year * controlled or uncontrolled hypertension or diabetes mellitus * neurological condition other than sci (alzheimer's disease, dementia, stroke, multiple sclerosis, parkinson's disease) * cardiovascular disease (coronary heart disease, congestive heart failure, peripheral artery disease)
effect of cerebral and cerebellar rtms in stroke patient

Conditions: Stroke; Repetitive Transcranial Magnetic Stimulation; rTMS; Motor Recovery

Summary: this study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. this study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rtms) is effective in improving motor function compared to the conventional cerebral rtms in stroke patients.


Eligibility criteria:
inclusion criteria: * hemiplegic stroke patients within 1 month after onset * moderate to severe motor impairment (fugl-meyer assessment \<85) * cognitive and language functions to perform more than one step of command * more than 19 years old exclusion criteria: * contraindicated to rtms * progressive or unstable stroke * pre-existing and active major neurological disease or major psychiatric disease * a history of advanced liver, kidney, cardiac or pulmonary disease, a terminal medical diagnosis consistent with survival \<1 year
empower the heart of patients with terminal cancer using cardiac medicines trial

Conditions: Pre-terminal Cancer

Summary: the pathophysiological implications of various cancer diseases and anti-cancer therapies is the occurrence of a cardiac disease-like phenotype with cardiac dysfunction, cardiac wasting, and cardiac homeostasis changes (incl. fibrosis and apoptosis) in end-stage cancer patients, causing heart failure like syndrome with development of congestion, dyspnoea and severely reduced physical functioning. the present trial aims to evaluate, if a heart failure medication improves the self-care ability and self-reported health care status of patients with pre-terminal cancer in palliative care.


Eligibility criteria:
inclusion criteria: basic criteria: * patients with solid cancer in union internationale contre le cancer (uicc) stage 4 (in palliative care) * 3-6 months expected survival (minimum 4 weeks) as assessed according to local standards * patients under optimised analgetic therapy group 1 criteria: * heart rate \>70 bpm * nt-probnp \>600 pg/ml * elevated high-sensitive troponin (\>99th percentile of respective test) * lvef \<55% * heart failure with preserved ejection fraction (hfpef) likelihood medium or large * evidence of left ventricular (lv) mass reduction \>15% since start of cancer * iron deficiency (id) with transferrin saturation (tsat) \<20% group 2 criteria: * 4 m walking time (\>=6.0 secs for 4m - test will be performed twice and the average time is calculated) or not able to walk 4m at all. * not being able to wash oneself in at least 3 of the last 7 days * presence of shortness of breath (sob) (nyha iv) requirement for inclusion: at least two fulfilled criteria of group 1 plus at least one fulfilled criterion of group 2 exclusion criteria: * previous participation in this trial. participation is defined as randomised * ongoing haemodialysis * patients currently on intravenous iron * acute sepsis with at least 2 points at the quick sequential organ failure assessment (qsofa) score. the use of i.v.-antibiotics is permitted in patients with a lower qsofa score. * ongoing acute exacerbation of chronic obstructive pulmonary disease (copd) acute st elevation myocardial infarction (stemi) or severe pulmonary embolism (pe) or severe deep vein thrombosis (dvt) (currently or in last 4 weeks) * current uncontrolled cerebral metastasis * impaired neurological status, precluding the ability to walk * unable or unwilling to give written informed consent * participation in other interventional trials using investigational products in randomised settings
imaging and treatment planning for cardiac radioablation

Conditions: Ventricular Tachycardia, Monomorphic; Ventricular Tachycardia (V-Tach); Ventricular Tachycardia (VT)

Summary: the purpose of this study is to (1) determine whether computed tomography (ct) imaging can be used to identify areas of ischemic scar, which are often used as radiation targets for cardiac radioablation, just as well as mri can, and (2) to determine how best to deliver cardiac radioablation treatment to a patient, for example, which treatment machine should be used and how to limit the effect of chest movement during treatment. participants will undergo two separate imaging appointments: one ct imaging appointment, where they will undergo scans including perfusion scans, late enhancement scans, and radiation therapy treatment planning scans; and one mri appointment, where they will undergo scans including a late enhancement scan. the overlap in areas of ischemic scar as identified in ct scans and mri scans will be quantified. using radiation therapy treatment planning ct scans, the safety and feasibility of different treatment and motion management techniques will be evaluated. treatment plans will be created using these different techniques and will be compared to one another. these plans will also be evaluated for compliance with dose constraints.


Eligibility criteria:
inclusion criteria * ischemic cardiomyopathy with monomorphic vt * referred by cardiologists * 18 years of age or older exclusion criteria * polymorphic ventricular tachycardia * ventricular fibrillation * pregnant or breastfeeding or planning to become pregnant or breastfeed during the study * estimated glomerular filtration rate ≤ 30 ml/min/1.73m2 * unable to undergo mri due to metal implants * previous allergic reaction to ct contrast agent

Keywords: cardiac radioablation stereotactic arrhythmia radioablation ischemic fibrosis late iodine enhancement ct ct perfusion late gadolinium enhanced mri
immunogenicity of rotavirus vaccine

Conditions: Rotavirus Gastroenteritis

Summary: rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. two vaccines against rotavirus, rotarix® and rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented who from making a universal recommendation of their use until recently. this study will be conducted in pakistan and will look at two objectives: 1. to compare the immunogenicity of rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life. 2. to compare the immunogenicity of rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.


Eligibility criteria:
inclusion criteria: * 6 weeks 0 days to 6 weeks 6 days age at the time of enrollment. * healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study. * written informed consent obtained from the parents or guardians. exclusion criteria: * hypersensitivity to any of the vaccine components. * use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study. * use of any immunosuppressive drugs. * previous intussusception or abdominal surgery. * enrolment in any other trial (simplified antibiotic therapy for neonatal sepsis trial, management of omphalitis trial). * birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days. * immunoglobulin and/or blood products use since birth or during the study period.

Keywords: rotavirus rotavirus vaccine dosing schedule immunogenicity breast feeding pakistan
puberty suppression and cardiometabolic health

Conditions: Transgenderism; Insulin Sensitivity/Resistance; Endothelial Dysfunction; Vascular Stiffness

Summary: this observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.


Eligibility criteria:
inclusion criteria: * identify as a transgender female or cisgender male * age 9-14 years at the time of enrollment * tanner stage 2-3 baseline pubertal development * plan to start gonadotropin releasing hormone analogue clinically in \< 2 months (for transgender females only) exclusion criteria: * cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures * type 1 or 2 diabetes (by medical history) * on any medications that affect insulin sensitivity (e.g. metformin, antipsychotics) * hypertension (resting bp ≥ 140/90 mm/hg) * weight \> 400 lbs * on estrogen- or progesterone-containing medications at baseline * \>3 hours of moderate-to-vigorous physical activity on the 3dpar at the screening visit