Kornimate/medical-research-clean huggingface dataset:
evaluation of the role of the noradrenergic system in pain perception in parkinson's disease

Conditions: Parkinson's Disease

Summary: patients suffering from parkinson's disease (pd) frequently experienced painful sensations that could be, in part, due to a central modification of nociception mechanisms. previous studies have shown that pain perception was altered in parkinson's disease (subjective and objective pain thresholds and pain-induced cerebral activity) and that administration of l-dopa normalized this alteration. in the central nervous system, l-dopa is converted in dopamine and in norepinephrine. apomorphine (a dopamine agonist) has no effect on pain threshold and pain-induced cerebral activity. therefore the noradrenergic system could be involved in pain alteration in pd. to assess the role of noradrenergic system in pain in patients with pd, we chose duloxetine (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients with pd. 36 patients will be enrolled in this study. we supposed that a chronic intake of duloxetine increase the pain perception level compare to the placebo. this increase would be the same than those observed with l-dopa.


Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of parkinson's disease according to the criteria of the ukpdsbb * parkinson's disease patients with a score ≤ 3 on the hoehn and yahr scale * patients treated with dopaminergic antiparkinsonian drugs (l-dopa, dopamine agonists, icomt...) * patients affiliated to a social protection program * women with efficacy contraception exclusion criteria: * patients suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies...) * parkinson's disease patients with a score \> 3 on the hoehn and yahr scale * depressed patients (madrs score \< 16) * patients suffering from a cancer * patients under tutelage, curatella or law protection * patients with a complete contraindication against apomorphine injections or duloxetine administration (selective serotonin reuptake inhibitor and monoamine oxydase inhibitors) * patients without any control of their arterial hypertension * patients with a neuroleptic treatment * pregnant women

Keywords: noradrenergic system and pain in parkinson's disease
study to evaluate the efficacy and safety in patients with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: to evaluate the efficacy and safety of combination therapy of agt and agz versus monotherapy of agt in patients with primary hypercholesterolemia.

a multi-center, randomized, double-blinded, active-controlled, factorial design phase 3 clinical trial

Eligibility criteria:
inclusion criteria: * patients with primary hypercholesterolemia exclusion criteria: * the subject not meet the specified ldl-c level
validation of 18f-miso-pet and 18f-flt-pet

Conditions: Head and Neck Neoplasms

Summary: hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. a promising non-invasive method of characterizing a tumor is the use of positron-emission tomography (pet). specific tracers can be used to detect hypoxia and proliferative activity. 18f-misonidazole is a tracer for hypoxia and 18f-thymidine is a tracer for proliferation. patients suffering from head and neck cancer and who will undergo surgery will be included in this study. one week before the surgery the patients will undergo a ct-scan and a pet-scan with either of the tracers. shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen. these markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation. the data collected by pet-scan will be analysed and compared to the results acquired by immunohistochemistry.


Eligibility criteria:
inclusion criteria: * stage ii-iv squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, planned for curative resection. * age \>18 years. * written informed consent. exclusion criteria: * pregnancy. * prior treatment for this tumor * women breast feeding

Keywords: head and neck cancer hypoxia tumor cell proliferation pet
a trial to evaluate the efficacy and safety of yh12852 in patients with functional dyspepsia

Conditions: Functional Dyspepsia

Summary: this is a multicenter, randomized, double-blind, placebo-controlled dose-finding phase 2 trial to evaluate the efficacy and safety of yh12852 in patients with functional dyspepsia.

eligible subjects will be randomized into one of 4 groups; yh12852 0.1 mg, 0.25 mg, 0.5 mg, or placebo at the same ratio and will be administered investigational products orally, twice daily for 4 weeks and followed up for 2 weeks.

Eligibility criteria:
inclusion criteria: 1. subjects must be willing and able to provide written informed consent. 2. bmi of \< 35 kg/m2 3. patients experiencing one or more of functional dyspepsia symptoms beginning at least 6 months prior according to rome iii criteria, with the symptom(s) evident over the last 3 months at the time of screening 4. patients with no evidence of organic lesions based on upper gi endoscopy, which could be the cause of dyspeptic symptoms 5. women of childbearing potential (wocbp) must have a negative pregnancy test result at the screening visit and use an adequate method of contraception to avoid pregnancy throughout the study exclusion criteria: 1. women who are pregnant or breastfeeding. 2. women with a positive pregnancy test result on enrollment or prior to investigational product administration. 3. subjects with a history of surgery that could affect gastrointestinal motility 4. subjects with inflammatory bowel disease 5. clinically significant chronic infection (eg. aids, etc), or significant medical or psychiatric illness. 6. serious cardiovascular disease (including qt prolongation defined as qtc interval ≥ 450msec) or respiratory disease 7. history of alcohol or drug abuse within the previous one year. 8. subjects with mental illness (e.g. schizophrenia, dementia etc) that may render the inability to complete the study 9. physical and laboratory test findings 10. administration of any other investigational product or participation in other clinical trials within 3 months prior to randomization.
implementation intentions to promote colon cancer screening in rural primary care practice

Conditions: Colorectal Cancer

Summary: to assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions.

although colorectal cancer (crc) is preventable and curable if detected early, a large portion of the population is not current with screening recommendations. many unscreened individuals 50 years of age and older do not receive health care system prompts to promote adherence to test preparation or completion. this study will assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions". the intervention will be delivered through a partnership between patients, rural primary care physicians, and trained crc information specialists (crc-is) and will focus on the 'recalcitrant' primary care population. a randomized design will test a comparison condition of a "no-partnership" system with generic information versus a "partnership" intervention system that specifically addresses each participants' crc screening "implementation intentions" (the "when," "where" and "how" screening details). the study will be conducted with 600 patients eligible for crc screening and recruited while presenting for care in a set of research network affiliated primary care clinics, or patient contact information gathered from in-house chart reviews. all participants who are not up-to-date on crc screening, or not at high risk for crc, will receive a baseline tablet pc-administered crc assessment, or a letter of invitation from their pc physician to go online to the healthy living kansas patient portal to complete the assessment. completion of crc screening at 60 days post index visit will be assessed through follow-up phone calls. those not completing crc screening after taking the assessment,(i.e., recalcitrant participants) then will be randomized to either c (comparison group-"no-partnership") or cpi2 (active intervention-crc-is/ physician/patient partnership and implementation intentions-based communication concepts). physicians will receive informational fax sheets summarizing all participant phone calls. a 120-day post randomization follow-up telephone call will assess the effects of implementation intentions communications and perceived crc screening barriers encountered. the primary outcome will be crc screening adherence at 120 days. secondary outcomes will assess 120-day perceived barriers and advancement in screening decisional stage. this intervention will provide information on the utility of embedding an "implementation intentions" based behavioral intervention for promoting crc screening among initially non-adherent primary care patients.

Eligibility criteria:
inclusion criteria: * 50 years of age or older * at average risk for colorectal cancer * not up to date with colorectal cancer screening exclusion criteria: * younger than 50 years of age * at high risk for colorectal cancer * up to date with colorectal cancer screening
phase 4 study in the elderly patients with t2dm

Conditions: Type 2 Diabetes Mellitus; Elderly

Summary: the study will assess the incidence of hypoglycemia: percent of patients presenting no hypoglycemia (confirmed events with smbg and severe episodes) over 6 months follow up in t2dm patients treated with a dpp-4 inhibitor or another oad as add-on therapy to metformin


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (dm) patients aged 65 to 80 years, willing to perform smbg in case of symptomatic hypoglycemia. * hba1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months. exclusion criteria: * age \> 80 yrs * bmi \< 22 and ≥ 45 kg/m2 * secondary t2 dm * hepatic failure, moderate/severe renal failure (cl \< 50 ml/min) and chf iii \& iv * asat / alat \> 3 uln, creatinine clearance \< 50 ml/min other protocol-defined inclusion/exclusion criteria may apply

Keywords: diabetes mellitus, vildagliptin, hypoglycemia, elderly
treatment of acute lymphoblastic leukemia (all) in younger adults

Conditions: Leukemia, Lymphocytic

Summary: this study is a multicenter trial of treatment for young all patients. all all patients will receive the same steroid pre-phase in order to evaluate sensitivity or resistance. then, patients will be included into 3 specific trials according to biological features (immunophenotype, cytogenetics, and molecular biology). group for research on adult acute lymphoblastic leukemia (graall) 2005: * t all or b all non ph (n=810 patients planned). * graall 2005 r: b all non ph cd20+ (n=220 patients planned). * graaph 2005: all ph+ (n=270 patients planned)

graall 2005: t all or b all non ph randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification. (n=810 patients planned) graall 2005 r: b all non ph cd20+ randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification. randomization between mabthera (rituximab) or no mabthera during all induction and consolidation courses.(n=220 patients planned) allogenic transplantation will be performed depending on unfavourable risk factors. graaph 2005: all ph randomization between an imatinib-based induction and a chemotherapy + imatinib induction. (n=270 patients planned) allogenic transplantation will be systematically performed in the presence of related or unrelated donors. autologous transplantation could be performed in the absence of a donor in case of molecular residual disease (mrd) ≤ 10-4. consolidation therapy will be performed in the absence of a donor in case of mrd \> 10-4.

Eligibility criteria:
inclusion criteria: * 18-59 years * all newly diagnosed (blast \< 20%) * central nervous system (cns) positive or negative * signed written informed consent * for graaph trial only: t(9;22) or bcr- abl positive exclusion criteria: * lymphoblastic lymphoma * all 3 * chronic myeloid leukemia * severe organ condition

Keywords: all, young patients, chemotherapy, mabtera, imatinib, allogeneic transplant
detection of colonic polyps via a large scale artificial intelligence (ai) system

Conditions: Colonic Polyp

Summary: colonoscopy is the gold standard for detection and removal of precancerous lesions, and has been amply shown to reduce mortality. however, the miss rate for polyps during colonoscopies is 22-28%, while 20-24% of the missed lesions are histologically confirmed precancerous adenomas. to address this shortcoming, the investigators propose a new polyp detection system based on deep learning, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy. the investigators dub the system deep: (deep) detection of elusive polyps. the deep system was trained on 3,611 hours of colonoscopy videos derived from two sources, and was validated on a set comprising 1,393 hours of video, coming from a third, unrelated source. for the validation set, the ground truth labelling was provided by offline gastroenterologist annotators, who were able to watch the video in slow-motion and pause/rewind as required; two or three specialist annotators examined each video. this is a prospective, non-blinded, non-randomized pilot study of patients undergoing elective screening and surveillance colonoscopies using deep. the aim of the study is to: assess the: 1. number of additional polyps detected by the deep system in real time colonoscopy. 2. safety by prospective assessment of the rate of adverse events during the study period attributed or not to the use of the deep system. 3. stability of the deep system by measuring the rate of false positives (false alarms) per colonoscopies 4 and to examine its feasibility and usefulness of in clinical practice by assessing the colonoscopist user experience while using the deep system in a 5 point scale.


Eligibility criteria:
inclusion criteria: * healthy subjects undergoing routine screening or surveillance colonoscopy in an ambulatory non urgent setting. * able to understand the study protocol and sign inform consent. exclusion criteria: * previous surgery involving the colon or rectum * known diagnosis of colorectal cancer * known history of inflammatory bowel disease * known or suspected diagnosis of familial polyposis syndrome

Keywords: colonoscopy performance
effects of sleep duration on eating and activity behaviors

Conditions: Sleep; Obesity

Summary: the purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake. fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study. for 1 week each, children will be asked to sleep their typical amount, increase their sleep by 1-½ hours, and decrease their sleep by 1-½ hours. half of the children will be asked to increase their sleep first and half to decrease their sleep first. during each week, the following will be gathered: sleep duration (measured by actigraphy, which is a small device that measures sleep), levels of hormones measured through blood draws, self-reported hunger and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are to eat (measured using a computer activity), and child height and weight. we believe that when children sleep less they will show changes in hormones associated with hunger and appetite, report being hungrier, be more motivated to eat, and eat more food.


Eligibility criteria:
inclusion criteria: * age 8-11 years old * bmi for age and gender \> 5th percentile (but no greater than 100% overweight) * sleep approximately 9-10 hours nightly * attend elementary school * like at least 1 food and 1 activity used in the reinforcement paradigm * able to understand and complete the reinforcement paradigm exclusion criteria: * existence of a diagnosable sleep disorder * medical or psychiatric condition that could influence sleep or weight * onset of menarche * inability to complete study materials, including diagnosed disabilities * dietary restrictions/allergies to foods used in the study that preclude them from study participation

Keywords: sleep obesity children eating behaviors activity leptin ghrelin
a bioequivalence study comparing camoquin® suspension (pfizer) to flavoquine® tablets (sanofi aventis) in healthy subjects

Conditions: Falciparum Malaria

Summary: the purpose of this study is to determine bioequivalence of amodiaquine suspension ( pfizer) and the who approved reference product flavoquine® tablet ( sanofi aventis).


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs). * an informed consent document signed and dated by the subject or a legally acceptable representative. exclusion criteria: * a history of drug induced agranulocytosis and history of liver and hematological problems while taking amodiaquine. * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen.

Keywords: amodiaquine suspension flavoquine tablets bioequivalence study
comparison of standard of care guidelines for mycoplasma genitalium infections among men with non-gonococcal urethritis

Conditions: Mycoplasma Genitalium Infection

Summary: the purpose of this protocol is to determine the difference in clearance of mycoplasma genitalium (mg) when using the australian management protocol versus the current centers of disease control (cdc) treatment guidelines for us standard of care (soc), to determine the proportion of men from the deep south, with ngu attributable to mg, and to determine the proportion of mg cases that harbor the macrolide-resistance associated with mutation.

mycoplasma genitalium (mg) has been associated with non-gonococcal urethritis (ngu) in many populations and the prevalence of mg strains with macrolide-resistance associated gene mutations is increasing . while no mg diagnostic assays have fda clearance in the united states (us), treatment for ngu is primarily focused on managing potential infection with chlamydia trachomatis (ct) using single dose 1 gm azithromycin (a macrolide class of drug). without testing for mg that might alter ngu treatment strategies, the current paradigm may be contributing to selective pressure resulting in increased macrolide resistance in mg. in australia, awareness of the prevalence of mg and macrolide resistance-associated mutations has been facilitated by an approved diagnostic test manufactured by speedx. ltd. as a result of the epidemiologic information generated by this diagnostic tool \[mg resistanceplus (mrp) assay\], the australian sexual health alliance, who publish the australian sexually transmitted infection (sti) management guidelines for use in primary care, have revised the management of men with ngu and mg infection. the new management guidelines include initial treatment of ngu with doxycycline, and concomitant testing for mg and macrolide resistance, with subsequent treatment for mg infected patients according to resistance results. we propose using the mrp assay in a population of men with ngu to determine the clinical impact of the australian treatment strategy compared to the current standard of care for ngu on clearance of mg infection.

Eligibility criteria:
inclusion criteria: * presenting with symptoms of urethritis (dysuria and/or urethral discharge) exclusion criteria: * non-english speaking

Keywords: mycoplasma genitalium urethritis ngu treatment
magnetic apnea prevention(magnap) device to treat obstructive sleep apnea:first-in-human study of feasibility and safety

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to determine the safety and feasibility of the magnap magnetic device in the treatment of obstructive sleep apnea (osa).

magnap is a magnet-activated treatment for obstructive sleep apnea (osa) designed to be less invasive than reconstructive surgery, more tolerable than positive airway pressure, and more effective than non-invasive therapies for osa. the magnap device consists of a neodymium-iron-boron rare earth magnet with a ferromagnetic directional back-plate encased in titanium. the device will be implanted surgically on the hyoid bone. following surgery, the patient is fitted with a custom, removable external neck accessory containing a second magnet, which is worn during sleep and prevents airway collapse by attracting the internal hyoid magnet with sufficient force to keep the airway open .

Eligibility criteria:
inclusion criteria: * patient is between 21 and ≤70 years of age * subject has moderate to severe obstructive sleep apnea (defined as apnea-hypopnea index of 15-50 events/hour on baseline/screening polysomnogram) * subject is intolerant of positive airway pressure therapy (defined as \<2 hours of sleep time with use per night for at least 5 nights per week as measured objectively by evaluation of continuous positive airway pressure (cpap) machine memory chip and interpreted by the study sleep medicine specialist) * subject signs and dates a written informed consent form and indicates understanding of the study procedures and risks exclusion criteria: * any evidence that apnea is not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction) * any condition likely requiring mri or has a metal implant * any factor that, in the surgeon's judgment, would pose a risk to surgery or placement of a long-term implanted device * any factor that, in the surgeon's judgment, would make the subject unlikely to respond to magnap treatment * congenital anomalies of the larynx, pharynx, or trachea or any other anatomical abnormality of the head, neck, or chest that would be a contraindication to placement of the magnap device and usage of the external device * there are no exclusion criteria based on gender, race or ethnicity

Keywords: apnea sleep apnea magnetic sleep apnea device hyoid bone