Kornimate/medical-research-clean huggingface dataset:
study to evaluate different regimens of vaniprevir (mk7009) for the treatment of chronic genotype 1 hepatitis c virus infection in treatment-naive patients (mk-7009-019)(withdrawn)

Conditions: Chronic Genotype 1 Hepatitis C Virus Infection

Summary: this study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-ifn) and ribavirin (rbv) to treat treatment-naive genotype 1 hepatitis c virus (hcv)-infected patients.


Eligibility criteria:
inclusion criteria: * patient has chronic genotype 1 hcv infection * patient has had a liver biopsy without evidence of cirrhosis * patient has had an eye exam prior to the start of study * female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study exclusion criteria: * patient has had previous treatment with: 3 or more doses ifn, peg-ifn, and/or rbv; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for hcv * female patient is pregnant or breastfeeding * patient has chronic hepatitis not caused by hcv * patient has evidence of cirrhosis of the liver * patient has hiv * patient has active hepatitis b infection * patient has non-genotype 1 hcv infection * patient consumes excessive amounts of alcohol
the effect of baby massage on postpartum depression and maternal attachment

Conditions: Depression, Postpartum; Maternal Behavior; Attachment

Summary: this study was conducted to determine the effect of baby massage on postpartum depression and maternal attachment in the postpartum period.

the transition to motherhood is one of the life stages that brings about stress and change. primiparous mothers, who will experience motherhood for the first time due to anxiety about the unknown, may experience more stress and their communication with their babies may deteriorate. in this process, the mother's seeing, touching and interacting with her baby positively affects her perception of her baby. the easiest and most natural way to do this is baby massage. touching and massaging the baby maintains the baby's body contact, which strengthens the baby's sense of trust and supports the mother's development of attachment behavior. it also reduces mothers' levels of stress hormones such as cortisol and relieves depressive symptoms.

Eligibility criteria:
inclusion criteria: * primiparous, * cesarean section, * having a single baby, * between the ages of 19-35, * literate * effective communication. exclusion criteria: * having a premature baby, * mother and baby have a disease that prevents massage, * loss of vision and hearing.

Keywords: primiparous mother baby massage postpartum depression maternal attachment
non-invasive device for the screening and diagnosis of sleep apnea syndrome

Conditions: Obstructive Sleep Apnea

Summary: this prospective study aims to establish and evaluate a predictive model to diagnose osa with maxillofacial characteristics 3d acquisition.

polysomnography is the gold-standard for obstructive sleep apnea (osa) diagnosis. however, osa is still undiagnosed. maxillofacial profile can influence osa severity. morphological characteristics can be identified but are not enough measurable and analysable by physicians. 3d acquisition of maxillofacial characteristics with a user-friendly tool, quick and low-priced could be used to obtain a predictive model as an osa risk indicator. thus, the aim of this study is to establish and evaluate a predictive model to diagnose osa with maxillofacial characteristics 3d acquisition.

Eligibility criteria:
inclusion criteria: * bmi \< 35 kg/m² * caucasian men * patients from the sleep laboratory (chu grenoble alpes) admitted for a polysomnography * patient who has given free and informed consent in writing exclusion criteria: * history of maxillofacial surgery * dental malocclusion * patient involved in another clinical research study * patient not affiliated with social security * patient deprived of liberty or hospitalized without consent

Keywords: sleep apnea diagnosis 3d acquisition
effect of mouthwashes on oral wound healing and microbiome

Conditions: Wound Heal; Oral Microbiome

Summary: the purpose of this clinical research study is to investigate if mouthwashes to be tested can affect oral mucosal wound healing and change the oral microbiome (bacteria colonization) or expression of selected biomarkers.


Eligibility criteria:
inclusion criteria: 1. male or female volunteers 18-45 years of age. 2. good general health. 3. must sign informed consent form. 4. minimum of 17 natural uncrowned teeth (excluding third molars) must be present. exclusion criteria 1. oral pathology, chronic disease, or history of allergy to testing product. 2. medical condition which requires pre-medication prior to dental visits/procedures 3. moderate or advanced periodontal disease (gum disease) or periodontal probing depths greater than 4 mm. 4. five (5) or more decayed untreated dental sites at screening (cavities). 5. impaired salivary function. 6. use of medications that can currently affect salivary flow. 7. use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, antibiotics, antimicrobial, anti-inflammatory medication or daily analgesics within 30 days prior to the start of the study or scheduled to start such intake during the course of the study. 8. ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) 9. pregnant or nursing women. 10. participation in any other clinical study within 1 week prior to enrollment into this study. 11. use of any tobacco products. 12. subjects who must receive dental treatment during the study dates. 13. presence of an orthodontic appliance that interferes with required clinical assessments. 14. history of allergy to common dentifrice ingredients. 15. subjects who wear night guard, denture retainers 16. not willing to abstain from eating crunchy (eg. granola bars, popcorns, nuts etc) or spicy and hot foods/liquids during the study period; 17. not willing to abstain from drinking citrus fluids, alcohol, and tea during the study period 18. non english-speaking subjects
lung protection in ards using neurally adjusted ventilatory assist

Conditions: ARDS, Human; Mechanical Ventilation Pressure High

Summary: the aim of this study is to investigate the use neurally adjusted ventilatory assist (nava) as lung protective strategy in patients with acute respiratory distress syndrome (ards).

background： acute respiratory distress syndrome (ards) should ventilated with a tidal volume of 4-6 ml/kg according to the ardsnet recommendations. due to the lack of clinical evidence of the potential role of neurally adjusted ventilatory assist (nava) in ards, investigators would like to conduct a study comparing the two modes from a lung protective point of view. investigators believe it may have a great value in defining guidelines for improved lung protection. study design： this is a prospective, pilot-randomized controlled trial n a single intensive care unit from one hospital. the study is expected to close the case a year (2018.08.01-2019.07.31). methods： fifty patients with ards according to the berlin definition will enroll to this study. patients are randomized after fulfilling inclusion and none of the exclusion criteria (25 participants will divide into study group and the other 25 participants will be control group). patients are studied twice daily with collection of data and blood tests. all data are collected and analysis. effect： tidal volumes in ards patients ventilated with nava will show tidal volumes clearly within the safe range. ards patients on nava mode will show improvements in oxygenation, gas distribution and inflammatory markers while requiring less sedatives and hemodynamic support. key words： acute respiratory distress syndrome; neurally adjusted ventilatory assist; lung protective strategy.

Eligibility criteria:
inclusion criteria: * diagnosis of ards by berlin definition * p/f ratio between 100-300 * completed the case enrollement within 48 hours exclusion criteria: * less than 18 years old * pregnancy * participants with tracheostomy * unable to insert the ng-tube

Keywords: acute respiratory distress syndrome neurally adjusted ventilatory assist lung protective strategy
red light ptosis proof-of-concept

Conditions: Mitochondrial Diseases; Blepharoptosis

Summary: this study tests a new treatment to help with droopy eyelids (ptosis) and eye movement problems (squint) in children and young people with genetically confirmed mitochondrial conditions - using red-light. we use a torch to shine a red light through the closed eyelid for 3 minutes a day. the study will run for 18 months. we believe that this treatment could help strengthen the muscle in the eyelid to make it easier to open the eyes, and could also help some children with squint.


Eligibility criteria:
inclusion: age 3 to less than 18 years genetically confirmed diagnosis of primary mitochondrial disease (known pathogenic mutation(s) in mitochondrial or nuclear dna known to cause primary mitochondrial disease) ptosis exclusion: genetic diagnosis not consistent with primary mitochondrial disease. no genetic diagnosis unable to cooperate with light treatment or ophthalmological assessments.
comparison of nt vs body weight supported tt along with ct on lower extremity in chronic stroke patients

Conditions: Chronic Stroke

Summary: to determine the effect of neurodevelopment treatment vs body weight supported treadmill training along with conventional therapy on lower extremity among chronic stroke patients.


Eligibility criteria:
inclusion criteria: * application of m-cog test for checking patients cognition. * chronic ischemic stroke patients. * both male and female patients. * patients of 35 or above years of age. exclusion criteria: * patients with history of recurrent stroke. * patients with lower limb fractures or dislocations. * patients with peripheral vascular disease * patients with skin discoloration or skin ulcers.
efficacy and safety study of a percussion device to mobilise sputum from respiratory passage

Conditions: Chronic Bronchiectasis; Chronic Obstructive Pulmonary Disease (COPD)

Summary: a malaysian company by name formedic technologies sdn bhd has devised a hand held machine which is supposed to mimic the chest percussion performed by professional physiotherapist to mobilize sputum through the respiratory passage. the aim of this study is to compare the effectiveness and safety of this mechanical percussion device in the treatment of airway clearance with conventional chest physiotherapy carried out by qualified physiotherapists in patients suffering from bronchiectasis or chronic obstructive pulmonary disease (copd).

this study will compare the amount of sputum expectorated during the two procedures and not intended to look at the clinical improvement of the patient.

Eligibility criteria:
inclusion criteria: 1. adult patients \> 18 years of age 2. chronic sputum expectoration-(producing \>30ml/day of sputum at baseline) 3. clinical diagnosis of bronchiectasis or copd 4. not carrying out regular chest physiotherapy (for the purposes of this study this will be defined as less than two occasions per week) 5. clinically stable disease (defined as no requirement for antibiotics in the 4 weeks preceding study entry). 6. fev1 of \> 35% of the predicted value in copd patients exclusion criteria: 1. primary diagnosis of asthma; 2. active sarcoidosis 3. active pulmonary tuberculosis. 4. history of brittle bones, 5. history of broken ribs in the past one year. 6. history of severe osteoporosis 7. bleeding from the lungs or haemoptysis 8. experiencing intense pain in the thoracic region 9. clinical suspicion of increased intracranial pressure. 10. have head or neck injuries 11. have collapsed lungs or a damaged chest wall; 12. recent myocardial infarction, unstable angina and stroke (within 6 months prior to enrollment) 13. have a pulmonary embolism or lung abscess; 14. have an active hemorrhage 15. have injuries to the spine 16. have open wounds or burns in the thoracic region 17. have had recent surgery (within six months prior to enrollment.) 18. any systemic steroids within 4/52 prior to enrollment 19. any antibiotics within 4/52 prior to enrollment

Keywords: manual percussion mechanical percussion chronic bronchiectasis chronic obstructive pulmonary disease wet sputum weight dry sputum weight
mind body intervention for chronic lower back pain

Conditions: Chronic Lower Back Pain

Summary: this pilot study will evaluate the feasibility of having a non-behavioral health provider deliver a combination of manual therapy (mt) and cognitive behavioral therapy for pain (cbt-p). in addition, we will evaluate differences in outcomes in patients undergoing the combined intervention of cbt-p and mt and those undergoing mt alone.

given that this is a pilot study we will use simple descriptive statistics for patient characteristics, including age, sex, bmi and baseline scores on outcome measures. in addition we will assess the inter-rater reliability of the scoring of the delivery of the cbt-p by the two trained practitioners utilizing kappa statistics. we will perform data analyses using spss.

Eligibility criteria:
inclusion criteria: * 18 to 69 years of age with clbp who are * "high risk" for poor prognosis based on sbst * currently undergoing chiropractic care. exclusion criteria: * contraindications to either mt or cbt-p. * patients who are currently undergoing cbt-p * who have been treated for substance abuse in the past year.

Keywords: chronic lower back pain manual therapy cognitive behavioral therapy
an evaluation of healthy ankle motion and morphology

Conditions: Healthy Ankle

Summary: determine motion and morphology of the healthy ankle during simulated gait.

healthy volunteers will undergo weight-bearing, cone beam ct scans of their foot/ankle during 3 phases of simulated gait. motion and morphology of the foot and ankle will be quantified and analyzed.

Eligibility criteria:
inclusion criteria: 1. the subject self-reports having a right healthy ankle. 2. the subject agrees to comply with the requirements of the study and complete the study measures. 3. the subject is between the ages of 18 and 65. 4. the subject is willing to provided written informed consent. exclusion criteria: 1. the subject is pregnant. 2. the subject reports having been diagnosed with any form of diabetes. 3. the subject reports having surgery on the right foot, right ankle and/or right knee. 4. the subject reports a history of repeated ankle sprains or injuries to the right ankle. 5. the subject reports a history of instability of the right ankle. 6. the subject reports chronic or recurring pain of the right ankle. 7. the subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, and/or known abuser of alcohol and/or drugs.

Keywords: ankle
application ct and mri in cerebral venous sinus thrombosis

Conditions: Magnetic Resonance Imaging; Cerebral Venous Sinus Thrombosis; Computer Tomographgy

Summary: cerebral venous thrombosis (cvt) is a rare disease, and with poor prognosis. computed tomography (ct) andmagnetic resonance imaging (mri) are the most commonly used image modalities for patients with non-specific neurologic symptoms. we are going to assess the accuracy of ct and mri in the differential diagnosis of cvt and cerebral venous sinus thrombosis (cvst).


Eligibility criteria:
inclusion criteria: a. the patients were diagnosed with cerebral venous thrombosis or cerebral venous sinus thrombosis; b. the patients completed at least cranial ct or mri examination upon admission;c. the patients complete at least one of the ctv, mrv or dsa examination. exclusion criteria: a. patients with severe cardiopulmonary insufficiency;b. patients lost to follow-up;c. patients with incomplete access to imaging data;d. patients with cerebral venous sinus thrombosis that was not diagnosed at discharge.
evaulation of interaction between herbal products and anticoagulants

Conditions: Coagulation Disorders

Summary: the purpose of this study is to determine if the use of herbal products interferes with normal anticoagulation, leading to either excessive thinning of the blood and bleeding problems or inadequate thinning of the blood and clotting problems. many patients who are on long term anticoagulation, or blood thinning, for a variety of medical problems, also take herbal products. it is not yet known whether use of herbal products interferes with this anticoagulation, and puts patients at risk for bleeding or clotting. this study will carefully monitor patients who are taking herbs and anticoagulants to determine if their laboratory tests show signs of being affected by the herbs. the study will ask all patients about their herbal product use, so all reported herbs will be included and monitored.


Eligibility criteria:
inclusion criteria: * taking longer-term (\>6 months) anticoagulation * enrolled in one of kaiser permanente northern california anticoagulation clinics

Keywords: herbal medicine alternative medicines anticoagulation side effects bleeding clotting
paracetamol versus ibuprofen for pda closure

Conditions: Patent Ductus Arteriosus

Summary: comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of patent ductus arteriosus (pda) in premature infants

a pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct. ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.

Eligibility criteria:
inclusion criteria: 1. gestational age ≤ 35 weeks 2. aged 2-7 days with color doppler echocardiographic evidence of pda 3. urine output more than 1 ml/kg/hr 4. creatinine concentration level less than 1.8 mg/dl exclusion criteria: neonates who have one or more of the following criteria were excluded from the study: 1. congenital heart diseases of any type including * pulmonary stenosis * anomalus in pulmonary venous drainage * ventricular septal defect 2. major congenital anomalies as hydrops fetalis 3. low platelets count (less than 60, 000/mm3)

Keywords: efficacy safety paracetamol ibuprofen pda preterms
safety and efficacy study of mehd7945a + folfiri versus cetuximab + folfiri as second line therapy in participants with kras wild-type metastatic colorectal cancer (mcrc)

Conditions: Colorectal Cancer

Summary: this open-label, randomized, multicenter, phase 2 study will evaluate the safety and efficacy of mehd7945a when combined with folfiri (folinic acid \[leucovorin\], 5-fluorouracil \[5-fu\], and irinotecan) chemotherapy as compared to cetuximab plus folfiri in participants with kirsten rat sarcoma viral oncogene homolog (kras) wild-type mcrc who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. participants will be randomized to receive folfiri chemotherapy plus either mehd7945a or cetuximab. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with kras wild-type status * progressive disease on or after first-line oxaliplatin-containing regimen for mcrc; participants must have received oxaliplatin-containing chemotherapy for greater than or equal to (\>/=) 3 months; no more than one prior chemotherapy regimen for metastatic disease is allowed * measurable disease per modified response evaluation criteria in solid tumors version 1.1 (recist v1.1) * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic and end-organ function exclusion criteria: * prior treatment with irinotecan * prior treatment with an investigational or approved human epidermal growth factor receptor (her)-targeted agent * last anti-tumor therapy within 4 weeks prior to cycle 1, day 1 * leptomeningeal disease as the only manifestation of the current malignancy * active infection requiring intravenous antibiotics * active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs * current severe, uncontrolled systemic disease * known human immunodeficiency virus (hiv) infection * untreated/active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) * pregnant or lactating women * malignancies other than colorectal cancer within 5 years prior to randomization, except for adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
prevention of pneumonia in nursing home

Conditions: Pneumonia

Summary: infections in nursing home are associated with high morbidity and mortality. pulmonary infections are known to be the most problematic. in our incur observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. on average, the extra cost of pneumopathies was 4,467 euros / patient for the long-term care facility and 3,044 euros for the hospital.

the pneumopathies in nursing home are the main cause of hospitalization of residents. depending on the series, 9 to 50% of residents with pneumonia should be transferred. this reflects the difficulties faced by nursing home care teams in these situations. the respiratory symptomatology of nursing home residents is difficult to grasp and the prescribed antibiotic therapy is often considered inappropriate (25% to 75% of cases). prevention of resident pneumonia, such as vaccination against pneumococcus remains poorly practiced, influenza vaccination teams or vitamin d supplementation. in addition to the risk of mortality, lung diseases are often the cause of a rapid functional decline. preventing pneumonia in nursing homes is therefore an important issue in the prevention of dependence, the quality of life, the health care system (use of hospitalization and transfer to emergencies) and health expenditure. in this vulnerable population, a prevention intervention seems particularly relevant. in this research project, the investigators hypothesize that a multi-domain prevention intervention for pneumonia carried out by nursing teams in nursing homes can reduce the incidence of pneumonia. they also believe that this action would reduce emergency transfers and health expenditures.

Eligibility criteria:
inclusion criteria: * living in a nursing home for at least 30 days at the start of inclusions, * having received information concerning the study and having not expressed opposition to participate, * for which an agreement in principle of the attending physician has been obtained. exclusion criteria: * refusal of the resident (or of his legal representative) or of his treating physician after given information, * resident at the end of life (life expectancy evaluated within one month by the coordinating physician), * resident whose attending physician is already involved in the piano study under a resident of another nursing home.

Keywords: nursing home prevention