Kornimate/medical-research-clean huggingface dataset:
the 6-minute pegboard and ring test in overweight and obese individuals

Conditions: Overweight or Obese Adults

Summary: the aim of our study is to investigate the validity and reliability of the 6-minute pegboard and ring test in overweight and obese individuals.


Eligibility criteria:
inclusion criteria: * body mass index ≥ 25 kg/m2 * volunteering for the study exclusion criteria: * having uncontrolled hypertension, diabetes mellitus * having comorbidities that may affect physical functions * failure to cooperate with tests to be performed * liver disease, kidney disease, cancer, lung diseases and serious cardiomyopathies, neurological diseases * pregnancy * having a history of bariatric surgery * presence of contraindications to exercise testing
a functional magnetic resonance imaging (fmri) study in overweight and obese men (0000-103)

Conditions: Obesity

Summary: this study will determine whether bold-fmri can be used to probe hunger and satiety states in healthy overweight or obese men and also whether fasted/fed fmri signals can be modulated by sibutramine.


Eligibility criteria:
inclusion criteria: * subject is a male between 18 and 45 years of age * subject has a body mass index (bmi) between 28 and 35 kg/m\^2 * subject does not weigh more than 140 kg (309 lbs) at the screening visit * subject is right-handed * subject is a non-smoker * subject is in generally good health * subject has normal or corrected to normal vision exclusion criteria: * subject works a night shift within 3 days of each treatment visit * subject has permanent cosmetic or metallic objects in his body * subject has attention deficit hyperactivity disorder (adhd) * subject has or had sleep apnea * subject has a history of neurological disorders * subject has a history of any clinically significant disease or condition * subject is vegan or vegetarian * subject has a history of eating disorders * subject has had previous bariatric surgery
predicting poor outcomes of cardiac surgery-associated acute kidney injury using novel biomarkers

Conditions: Acute Kidney Injury; Critical Illness

Summary: the aim of this study was to identify and validate novel biomarkers including functional tests for detecting aki, aki progression and other poor outcomes.

cardiac surgery-associated acute kidney injury (csa-aki) is the second most common type of aki after septic aki and is associated with increased mortality and morbidity. the progression of aki with multiple organ failure can result in poor outcomes. several novel biomarkers for earlier detection of aki, discrimination of etiologies, and prediction of outcomes were developed. however, the availability of these novel biomarkers may be limited by its expense or reimbursement issues in different countries. in present study, we conduct a large cohort to identify and validate novel biomarkers including functional tests for detecting aki, aki progression and other poor outcomes.

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery were prospectively enrolled. exclusion criteria: * history of end stage renal disease or on dialysis; * prior kidney transplantation; * patients with a dnr order; * patients without written informed consent; * pregnancy; * moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)

Keywords: acute kidney injury biomarker aki progression poor outcome furosemide stress test
clinical performance of a glass-ionomer restorative system: a 6-year evaluation

Conditions: Dental Caries

Summary: the aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class i and class ii cavities. a total of 140 (80 class i and 60 class ii) lesions in 59 patients were restored with a glass ionomer restorative system (equia) or a micro hybrid composite(gradia direct). restorations were evaluated at baseline and yearly during 6 years according to the modified-usphs criteria. data were analyzed with cohcran's q and mcnemar's tests (p\<0.05).

since the introduction of glass ionomers many modifications of these materials have been performed over the years. compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. so, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.

Eligibility criteria:
inclusion criteria: 1. a need for at least two but not more than four posterior toothcolored restorations; 2. the presence of teeth to be restored in occlusion; 3. teeth that were symptomless and vital; 4. a normal periodontal status; 5. a good likelihood of recall availability. exclusion criteria: 1. partly erupted teeth; 2. absence of adjacent and antagonist teeth 3. poor periodontal status; 4. adverse medical history; 5. potential behavioral problems.

Keywords: glass ionomer cement composite resin
a clinical study to evaluate the safety and efficacy of etx101, an aav9-delivered gene therapy in children with scn1a-positive dravet syndrome

Conditions: Dravet Syndrome

Summary: expedition is a phase 1/2 study in the uk to evaluate the safety and efficacy of etx101 in participants with scn1a-positive dravet syndrome aged 6 to \< 48 months. the study follows and open-label, dose-escalation design.


Eligibility criteria:
inclusion criteria: * participant has a predicted loss of function pathogenic or likely pathogenic scn1a variant * participant must have experienced their first seizure between the age of 3 and 15 months * participant must have a clinical diagnosis of dravet syndrome or the treating clinician must have high clinical suspicion of a diagnosis of dravet syndrome * participant is receiving at least one prophylactic antiseizure medication exclusion criteria: * participant has another genetic mutation or clinical comorbidity which could potentially confound the typical dravet phenotype * participant has a known central nervous system structural and/or vascular abnormality (indicated by an mri or ct scan of the brain). * participant has an abnormality that may interfere with csf distribution and/or has an existing ventriculoperitoneal shunt. * participant is currently taking or has taken antiseizure medications (asms) at a therapeutic dose that are contraindicated in dravet syndrome, including sodium channel blockers. * participant has experienced seizure freedom for a period of 4 consecutive weeks within the 90-day period prior to informed consent. * participant has previously received gene or cell therapy. * participant is currently enrolled in a clinical trial or receiving an investigational therapy. * participant has clinically significant underlying liver disease.
the role of the fto gene in reward system activation in obese and healthy subjects

Conditions: Obesity; Eating Behavior

Summary: in order to investigate if individuals, carrying genetic variants predisposing to obesity, respond differently to visual presented food images than non-carriers the investigators aim to screen 500 people for a common risk variant in the fto gene. from those 500 screened 40 subjects, 20 homozygous for the risk allele and 20 homozygous for a non risk allele will be selected for the second step in the study. this part involves the fmri technique to visualize the brain response, focus on reward system activation, when food images are visually presented in the scanner. factors regarding eating behavior, sleep, physical exercise and relation to food are investigated in the first part of the study as well as clinical parameters such as bmi.


Eligibility criteria:
inclusion criteria: * no medications (except contraceptives including estrogen) * no metabolic disorders/diseases * right handed * color vision * normal sleep-wake rhythm (eg. shift workers can not participate) exclusion criteria: * specific preferences of food, for example vegetarians * grandparents originating from country outside the nordic area * metallic implants
study of paclitaxel, carboplatin and oral metformin in the treatment of advanced stage ovarian carcinoma

Conditions: Epithelial Ovarian Carcinoma

Summary: initially, the prospect of metformin as a neoplastic treatment was considered for malignancies of the prostate, colon and pancreas. however, only select clinical studies involving the use of metformin in the treatment of ovarian cancer have documented improved survival rates. since no first line regimen has demonstrated compelling superiority in the management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin, and metformin is of particular interest given the triplet's prospect for achieving increased synergy without compromising patient tolerability.

a phase ii, open-label, non-randomized, pilot study assessing the safety, toxicity, and progression free survival of advanced stage ovarian carcinoma patients who underwent treatment with paclitaxel, carboplatin and metformin. an estimated 30 patients will be required for this study.

Eligibility criteria:
inclusion criteria: female gender age greater than 18 years advanced stage epithelial ovarian, fallopian tube, or primary peritoneal cancer adequate bone marrow function ecog performance score of 2 or greater patients must be able to swallow oral medication. exclusion criteria: subjects must not be taking metformin or have been on metformin in the past 6 months. subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas) subjects with concomitant malignancy or a previous malignancy within the past three years, melanoma skin cancer excepted
study evaluating the safety and efficacy of proellex® in the treatment of endometriosis-extension study

Conditions: Endometriosis

Summary: zpe-201 extension of treatment

this is an extension of the phase ii, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of proellex® was administered once-daily for four (4) months.

Eligibility criteria:
inclusion criteria: * only subjects treated in the zpe-201 study will be allowed to enter the extension study. * subjects who withdrew from zpe-201 due to lack of treatment efficacy will also be invited to participate. exclusion criteria: * all other subjects

Keywords: endometriosis pelvic pain oral progesterone blocker
trial of pdna cmv vaccine (vcl-ct02) followed by towne cmv vaccine (towne) challenge

Conditions: Cytomegalovirus Infection

Summary: objectives of this trial are to: evaluate the kinetics and magnitude of the cmv-specific immune response post-towne challenge (3000 pfu) in healthy cmv-seronegative volunteers who receive vcl ct02 administered (1 mg weekly x 3) 3 months previously compared to randomized controls who do not receive vcl ct02 as measured by: 1. antibody titers for gb; 2. t-cell ifn-g elispot; 3. t-cell proliferation assays for ie1, pp65, and/or gb; and 4. cytokine and phenotypic flow cytometry responses to pp65, ie1, and/or gb. evaluate the safety safety of towne challenge in healthy cmv-seronegative adult subjects who have previously been immunized with a trivalent pdna cmv vaccine (vcl-ct02) administered intramuscularly. our hypothesis is that the immune response to towne vaccine 3000 pfu challenge after vlc-ct02 priming will be greater than that after towne vaccination alone.

this is a phase 1, single-center, randomized, open-label trial of the live, attenuated towne cmv vaccine administered as a "challenge" to healthy, cmv-seronegative, adult subjects who previously receive the cmv immunotherapeutic trivalent pdna-based vaccine, vcl-ct02, given by intramuscular route at days 1, 7 and 14 or who receive no vcl-ct02. up to 12 healthy, cmv-seronegative subjects will be enrolled. if a subject consents and meets all eligibility criteria, the subject will be randomized to the vcl ct02 (n=6)or control (n=6) groups. vcl ct02-assigned subjects will receive vcl ct02 (1 mg weekly x 3) and then on day 77 will received towne vacine (3000 pfu subcutaneously). control-assigned subjects will receive towne alone. safety will be monitored and both antibody to cmv gb and t-cell responses to cmv antigens will be measured at specified intervals for 252 days post towne challenge.

Eligibility criteria:
inclusion criteria: * 18 to 45 years of age * normal lab values at study entry * good general health * negative cmv igg antibody test exclusion criteria: * cmv seropositive * recent vaccination(s) * immunodeficiency * vaccination with investigational cmv vaccine(s) * pregnant or breast-feeding

Keywords: cytomegalovirus vaccine t cell antibodies
a research study to assess the effectiveness and safety of different doses of oral pf-00489791 in the treatment of adult patients with pulmonary arterial hypertension

Conditions: Hypertension, Pulmonary

Summary: study will assess pf-00489791 efficacy and safety in pulmonary arterial hypertension (pah)

pfizer decided to stop this trial early upon stage 1 completion due to change in pf-00489791 development and not as a result of safety concerns for pf-00489791. date of termination (lslv) occurred on july 28, 2010.

Eligibility criteria:
inclusion criteria: * idiopathic or familial pulmonary arterial hypertension (pah) * mean pap at least 25 mm hg, pcwp \< 15 mm hg at rest * for females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion * signed and dated informed consent * willingness to comply with the study plan and procedures exclusion criteria: * pulmonary arterial hypertension (pah)other than idiopathic or familial * for females, pregnancy or lactation * use of specific pah treatments, potent cyp3a4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study * change of dose or class of standard background pah therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study * large shift in altitude (defined as \>5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit * subjects with intracardiac shunts and/or serious heart, lung or other health conditions * hiv positive subjects * subjects participating in another clinical trial with an investigational drug or device * subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy * allergies and previous intolerance of pde5 inhibitors * alcohol or drug abuse * blood donation during the study, or 1 month before or after the study

Keywords: pah pulmonary hypertension pulmonary arterial hypertension
capecitabine in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of capecitabine in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.

objectives: i. determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with oral capecitabine. ii. determine the tolerability and safety of this regimen in these patients. outline: patients receive oral capecitabine twice daily for 14 days. treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 14-35 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed recurrent ovarian epithelial carcinoma, fallopian tube cancer, or primary peritoneal cancer previously treated with at least one cisplatin based chemotherapy regimen prior repeat treatment with a taxane and/or platinum agent allowed prior repeat treatment with other chemotherapy agent allowed once recurrent disease defined as: at least one site of measurable disease by radiograph and/or a rise of ca-125 over a minimum of 3 samples to a level of at least 50% of upper limit of normal patient characteristics: age: not specified performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 2.0 times upper limit of normal (uln) sgot less than 2.0 times uln alkaline phosphatase less than 2.0 times uln renal: creatinine no greater than 1.5 mg/dl other: must be able to take oral medication prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics no prior fluorouracil based chemotherapy endocrine therapy: not specified radiotherapy: not specified surgery: not specified

Keywords: recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer
validation of the french version of the fatigue score "brief fatigue inventory ( bfi)".

Conditions: Fatigue Symptom

Summary: fatigue, or asthenia, is an important symptom for the diagnosis and follow-up of patients in routine as well as research oriented clinical practice. various questionnaires measuring fatigue have been developed, but few have been validated in french. mfi (multidimensional fatigue inventory) has been validated in french in only one study. bfi (brief fatigue inventory) has been translated but never validated in french language. the main purpose of this study is to validate psychometrically the french version of bfi.


Eligibility criteria:
inclusion criteria: * consultation for fatigue as symptôme principal ( isolated or asociated with other symptomes). exclusion criteria: pregnancy psychosis. unable to complete questionnaire phsyiological fatigue due to effort and reversible rest. post-traumatic stress disorder -

Keywords: fatigue brief fatigue inventory (bfi) primary care general practitioners
asian phase 2 study for treatment of pain associated with diabetic peripheral neuropathy

Conditions: Pain; Diabetic Peripheral Neuropathy

Summary: the purpose of this study is to investigate the effectiveness and safety of ds-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * painful distal symmetric polyneuropathy * average daily pain score is great than or equal to 4 exclusion criteria: * hba1c greater than 9.0

Keywords: pain diabetic peripheral neuropathy
proximal humerus fractures: randomized study between locking nails and locking plates for neer 2 and 3 parts

Conditions: Humerus; Proximal Humeral Fracture; Fractures, Bone; Humeral Fractures; Wounds and Injuries; Arm Injuries

Summary: the hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the constant score.


Eligibility criteria:
inclusion criteria: * fracture with less than 21 days; * fractures of the proximal humerus classified as 2 or 3 parts of neer, with involvement of the humeral head and one of the tuberosities; * fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of neer neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm; * closed fractures; exclusion criteria: * characteristics of the fracture: * fracture between the greater tubercle and the smaller, independent of the deviation; * isolated fracture of the greater or lesser tuberosity * 4-part fractures of neer; * fracture involving the articular surface of the humeral head; * fracture-dislocation of the proximal humerus * other criteria: * neurological injuries in the affected limb; * previous surgery on the affected shoulder; * associated fractures in the affected limb; * pathologic fractures; * lesions of the rotator cuff tendons previously diagnosed; * psychiatric illnesses or inability to understand preoperative questionnaires; * active infection or previous infection on the shoulder;

Keywords: humerus fracture nail plate tuberosity
fluid status and t1-mapping by cmr

Conditions: Heart Diseases; Heart Failure; Valvular Heart Disease

Summary: it is unclear to what extent systemic fluid overload has an impact on t1-mapping results by cardiovascular mangetic resonance imaging. in this study, patients will undergo body composition monitoring assessing systemic fluid overload and t1-mapping using molli by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.


Eligibility criteria:
inclusion criteria: * written informed consent * patient undergoing cardiovascular magnetic resonance imaging exclusion criteria: * unwillingness to participate * pregnancy
parallel arm trial of ad109 and ad504 in patients with osa

Conditions: OSA - Obstructive Sleep Apnea

Summary: this is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of ad109 and ad504 to atomoxetine or placebo in obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * between 18 to 65 years of age for men and 18-75 for women, inclusive, at the screening visit. * mean ahi 10 to 45 events/h, inclusive * pgi-s: \>1 exclusion criteria: * current clinically significant sleep disorder other than osa * clinically significant craniofacial malformation. * clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control). * participants with a history of using devices for osa treatment, including cpap, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first psg and are not used during participation in the study