Kornimate/medical-research-clean huggingface dataset:
norwalk feasibility study

Conditions: Behavior Problem; Development Delay; Emotional Disturbances; Family Conflict; Relation, Mother-Child

Summary: the purpose of this study is two-fold: 1) to examine the feasibility of the drop-in model of family nurture intervention (fni); and 2) to collect pilot data concerning the mother's response to the drop-in model of fni and short term effects of participation. feasibility of the program will be measured through costs, staffing, space availability, and uptake. participation in the drop-in entails weekly visits for fni. the investigators hypothesize that the family nurture intervention will show feasibility through attendance and positive response to the drop-in format. the investigators also expect the family nurture intervention to improve mother's perceived well-being and mother-child emotional connection.

family nurture intervention (fni) is a novel family-based program that facilitates mother-child emotional connection and co-regulation. many current interventions aim at helping the child to self-regulate with or without the mother's help. however, the ability of the mother-child dyad to promote optimal development is dependent on their ability to co-regulate. the interactive co-regulation between the mother and the child shapes the behavior of both the mother and the child. this study aims to investigate the feasibility and short term effects of participation in the family nurture intervention for preschool aged children with developmental and behavior problems. mothers and children will be engaged by nurture specialists in comforting and calming interactions to co-regulate with each other during weekly group sessions with the support of study staff. intervention sessions will occur over the course of eight weeks, and each mother will decide how many sessions to attend.

Eligibility criteria:
inclusion criteria: * mother is fluent in english or spanish * mother is 18 years of age or older at the time of consent * mother-child pair does not demonstrate emotional connection as measured by the wecs * child is between the ages of 2 to 4½ years at date of enrollment (child must be younger than 4 years and 9 months at baseline assessment) or between 2 to 4½ at date of enrollment in study aaaq9547 * child resides with mother exclusion criteria: * the child has severe congenital anomalies or chromosomal anomalies including downs syndrome and cerebral palsy * the child has a diagnosis of autism spectrum disorder * the child has severe motor or physical disability * mother currently presents with psychosis or is currently taking antipsychotic medication * current maternal drug and/or alcohol abuse * mother is more than four months pregnant * mother and/or infant has a medical condition or contagion that precludes intervention components * mother is unable to commit to study schedule

Keywords: family nurture intervention martha g. welch md feasibility study preschool intervention co-regulation emotional connection multiple family group intervention
prevalence of anal sphincter defects after childbirth

Conditions: Fecal Incontinence; Childbirth Problems

Summary: the incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (ai) symptoms after childbirth may be as high as 40%. the present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-

the incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years. it is of great importance not only an early detection but to indicates the best possible management as soon as posible. the design is a prospective observational study including primiparous woman, without previous anal surgery.

Eligibility criteria:
inclusion criteria: * primiparous pregnant patients aged \>18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries. exclusion criteria: * non primiparous patients and patients with a history of anal surgery

Keywords: anal ultrasound fecal incontinence childbirth
the effect of education given to children with asthma

Conditions: Asthma

Summary: the aim of this study is to examine the effects of asthma education on asthma knowledge, control and quality of life of school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic.

asthma is among the most common chronic diseases in childhood. besides being one of the most common diseases, it is a preventable and controllable disease.in a study analyzing asthma data of children aged 0-17 by the centers for disease control and prevention (cdc), the prevalence of asthma was 8.7% in 2001, this rate increased to 9.4% in 2010, and decreased to 8.3% in 2016. in the same study, the prevalence of asthma was found to be 9.2% in boys and 7.4% in girls.asthma is also the leading cause of school absences in children ages 5 to 17, accounting for more than 14 million days of absence from school in 2013.these adverse effects of asthma can be minimized with appropriate education.studies have found an increase in the quality of life of asthmatic students after asthma education, a decrease in asthma exacerbations, school absences, parental workday loss and medical expenses, and an increase in adherence to treatment, asthma knowledge and correct inhaler use.these findings suggest that asthma management interventions increase children's knowledge about their disease and their self-management skills.based on this need, the aim of this study is to examine the effects of asthma education given to school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic on their asthma knowledge, control and quality of life.

Eligibility criteria:
inclusion criteria: * being between the ages of 7-11, * medically diagnosed with asthma and being followed up in the outpatient clinic * family and child agreeing to participate in the study * ability to use a smartphone, computer or tablet * having internet access * children who can read and understand turkish exclusion criteria: * children who do not have a medical diagnosis of asthma * children who do not agree to participate in the study and their parents * children who do not complete the training and tests

Keywords: asthma children education randomized control
systematic hereditary pancreatic cancer risk assessment and implications for personalized therapy

Conditions: Pancreatic Cancer

Summary: this research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations

this research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. a patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision. the investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool. the investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. to do so, the investigators will offer all patients with pancreatic cancer in the dana-farber gastrointestinal oncology clinic referral for genetic evaluation. at the cancer genetics and prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.

Eligibility criteria:
inclusion criteria: * diagnosis of pancreatic ductal adenocarcinoma * signed initial informed consent * participant agrees to genetic counseling exclusion criteria: * prospective participant unable to sign informed consent based on referring physician recommendation. * patient has neuroendocrine pancreatic tumor

Keywords: pancreatic cancer
a study of nasal pyy3-36 and placebo for weight loss in obese subjects

Conditions: Obesity

Summary: the purpose of this study is to determine the effect of nasal pyy3-36 on weight loss post 24 weeks of treatment.

this is a multi-center, phase 2 double-blind, randomized, placebo-controlled trial in healthy obese patients. the primary objective of the study is to evaluate the effect of increasing nasal pyy3-36 dosing on weight loss post 24 weeks of treatment. secondary objectives: * to evaluate the safety of three nasal pyy3 36 dose groups compared to nasal placebo * to compare the weight loss post 12 and 24 weeks of treatment for each of the three nasal pyy3 36 dose groups versus the nasal placebo group * to compare the proportion of patients who lose at least 5% and 10% of the baseline body weight post 12 and 24 weeks of therapy for each of the three nasal pyy3 36 dose groups versus the nasal placebo group * to compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus capsule placebo * to compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with nasal placebo versus capsule placebo * to compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus the nasal pyy3 36 dose groups * to evaluate the effect of 12 and 24 weeks of treatment with nasal pyy3 36 and sibutramine on fasting lipid profile, plasma glucose, insulin, blood pressure and pulse, waist circumference and bmi * to evaluate the effect of 24 weeks of treatment with nasal pyy3 36 and sibutramine on hba1c levels

Eligibility criteria:
inclusion criteria: * male or female patients 18 and 65 years, inclusive; * bmi 30-43 kg/m2, inclusive; * in good health, determined by medical history and physical examination, as well as normal 12-lead ecg and vital signs; * non-smoker and no use of tobacco or nicotine products for at least 3 months; * females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following study completion be willing to use an approved method of contraception; * has normal nasal mucosa. exclusion criteria: * previous surgical treatment for obesity; * serious medical condition * serious psychiatric illness * organic causes of obesity (e.g. untreated hypothyroidism) * type 1 or type 2 diabetes; * presence of uncontrolled hypertension * on prohibited concomitant medication

Keywords: weight loss dieting
a dose ranging escalation study of tramadol hydrochloride in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (hcl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).

this is a randomized (study drug assigned by chance), sequential-cohort (time lagged), double-blind (neither the participant or the study doctor will know the name of the assigned treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of 3 treatment groups), single-center, phase 1 study of multiple ascending doses of tramadol hcl in healthy adult volunteers. thirty participants (15 men and 15 women) will be sequentially assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). participants in each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol hcl or placebo, in the ratio of 4:1. the study includes a screening phase and a double-blind treatment phase. the treatment phase will consist of 3 treatment periods separated by a 5-day safety review period before the next ascending dose of study drug is administered to the next group. participants in each group will be confined to the study center for a total of 5 days, the total duration of each subject's participation will be up to 33 days, including the screening phase. the total duration of the study (completion of all 3 treatment cohorts) will be up-to-approximately 2 months.

Eligibility criteria:
inclusion criteria: * body mass index between 18 and 30 kg/m², inclusive * body weight not less than 50 kg * have a normal electroencephalogram under basic and stimulated conditions * have a 12-lead ecg that is consistent with normal cardiac conduction and function * have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration exclusion criteria: * any personal or family history of epileptic seizures or convulsions * have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection * have suffered from loss of consciousness of unknown origin * drowning or sudden infant death syndrome in a first degree relative

Keywords: healthy pain tramadol hydrochloride tramadol hcl analgesic qt prolongation rwj-26898-002
molecular epidemiology of benzene-exposed workers.

Conditions: Hematologic Diseases

Summary: the purpose of this study is to investigate the health effects of benzene exposure in workers in shanghai, china.

the purpose of this study is to investigate the dose-response relationship between benzene exposure and blood diseases in shanghai workers and to characterize genetic polymorphisms that are associated with increased risk of developing benzene hematotoxicity.

Eligibility criteria:
inclusion criteria: worked for at least one year in a monitored environment have at least one physical examination recorded - exclusion criteria: history of cancer, radiation exposure, chemotherapy -

Keywords: hematologic diseases benzene genetic polymorphisms
treatment of prednisone plus cyclophosphamide in patients with advanced-stage iga nephropathy

Conditions: IgA Nephropathy

Summary: treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage iga nephropathy.


Eligibility criteria:
inclusion criteria: * biopsy-proven primary iga nephropathy; * 18-70 years old; * elevated serum creatinine and less than 3.0mg/dl; * with a written consent from participants to receive prednisone and/or cyclophosphamide exclusion criteria: * diabetes; * contraindications for the treatment of prednisone and/or cyclophosphamide; * any treatment with steroids or immunosuppressive drugs prior to this study; * acute deterioration of renal function(including those of glomerular origin)

Keywords: iga nephropathy cyclophosphamide prednisone
music in reducing distress in participants with cancer during chemotherapy treatment

Conditions: Caregiver; Malignant Neoplasm

Summary: this trial studies how well music works in reducing distress in participants with cancer during chemotherapy treatment. music in participants receiving cancer treatment such as infusion treatment and caregiver may reduce pain, anxiety, and distress and improve participant's psychological and physiological wellbeing.

primary objectives: i. to test the effect of patients? listening to music on level of distress during cancer treatment. secondary objectives: i. to explore the influence of covariates (patients? sociodemographics, musical background, and clinical variables) on the association between patients? listening to music and level of distress during cancer treatment. ii. to explore the interdependence of adjustment among patients and their caregivers on the association between. outline: participants and caregivers are randomized to 1 of 2 groups. group i: participants and caregivers listen to music of their choice for up to 60 minutes during infusion session. group ii: participants and caregivers do not listen to music during infusion session and are placed on music waitlist.

Eligibility criteria:
inclusion criteria: * able to speak, read, write and understand english * have sufficient hearing capacity to hear music exclusion criteria: * patients with cognitive or perceptual disturbances will be excluded
observational study on the efficacy and safety of novoseven® during "real-life" usage in germany

Conditions: Congenital Bleeding Disorder; Congenital FVII Deficiency; Glanzmann's Disease; Acquired Bleeding Disorder; Acquired Haemophilia

Summary: this non interventional observational study is conducted in europe. the primary aim is to observe the haemostatic efficacy of novoseven® treatment during routine practice in german clinics. the observational study observes patients with congenital haemophilia with inhibitors to coagulation factors viii or ix, acquired haemophilia, congenital fvii deficiency, or glanzmann's thrombasthenia who have received at least one dose of novoseven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication exclusion criteria: * due to the non-interventional observational character of the study, there are no exclusion criteria.
longitudinal study of haart, social networks, & adherence

Conditions: Acquired Immunodeficiency Syndrome

Summary: our study is a randomized controlled trial that aims to evaluate the effectiveness of modified directly observed therapy (mdot) to (1) increase both short and long term adherence to haart treatment, and (2) improve clinical outcomes associated with haart therapy. our hypothesis is that modified directly observed therapy (mdot) during the initial 6 weeks of haart, supervised primarily by hiv-positive lay activists, will improve adherence and clinical outcomes compared with those that do not have supervised mdot. we also hypothesize that the benefits of mdot will be achieved through a variety of mediators that will result from the social interactions the patients will have with the activists. these mediators include improved social support, improved knowledge about haart, reduced stigma, and improved self-efficacy.

to test this hypothesis, we intend to randomize 350 arv naïve patients starting haart to either receive mdot for the initial 6 weeks of treatment or standard adherence support. both intervention and control groups will receive standard hiv care that includes haart medications free of charge, clinical and laboratory follow-up, psychosocial adherence support by a trained social worker, and referral to community-based peer support groups. patients in the intervention group will in addition to stand care, receive their morning weekday dose of a twice-daily haart regimen under dot in clinic for 6 weeks. nighttime and weekend doses are self-administered. a group of hiv-positive dot activists, who are trained and paid lay-clinic personnel, will be primarily responsible for the direct observation of treatment in the mdot group. in addition to observing treatment, dot activists will provide counseling, education, and emotional support to patients, and will also locate patients not presenting for dot on the same day. although the hiv activists may also provide psychosocial and adherence support to specific patients in the control group, this support will only be a daily and formalized part of care in the group randomized to mdot.

Eligibility criteria:
inclusion criteria: * hiv+ persons initiating haart * adults and children over the age of 18 * reside in or around beira mozambique * willing and able to provide consent to participate exclusion criteria: * physically or mental incapable to make daily clinic visits * psychotic or demented

Keywords: acquired immunodeficiency syndrome antiretroviral therapy, highly active randomized controlled trials africa adherence treatment naive
the foot in your nose study: links between nasal staphylococcus aureus colonies and diabetic foot lesion infections

Conditions: Diabetic Foot; Staphylococcus Aureus

Summary: the presence of s aureus in the nasal passages of diabetic patients may be a risk factor for diabetic foot lesion infections. our aim is to compare the genetic profiles of s aureus strains found in the noses and on the foot lesions of diabetic patients. the investigators are also studying the virulence of these strains, the prevalance of s aureus at either site, and whether or not the quantity of s aureus found in the nose affects the risk for infection in foot lesions. the investigators also use this study to test the sensitivity and specificity of the genexpert system.


Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetic patients * patients consulting or hospitalized in the diabetology departments of one of the participating centers * grade 2-4 ulcer on the foot or ankle (both primo and recurrent events are acceptable) exclusion criteria: * patient refuses to participate * pregnant, parturient or breastfeeding women * patient does not have diabetic foot or arteritic * diabetic ulcer is located elsewhere than the foot or ankle * the ulcer is non-swabbable * patient does not have social-security coverage * patient is under any type of guardianship

Keywords: diabetic foot
shockwave therapy of chronic achilles tendinopathy

Conditions: Chronic Inflammatory Disorder

Summary: chronic achilles tendinopathy is a painful condition with frequently unsatisfactory results of conservative treatment. extracorporal shock wave therapy (eswt) has been introduced in the management of various soft tissue conditions. the objective of the study was to investigate the effect of supplementary eswt versus placebo to conservative treatment of chronic achilles tendinopathy.

chronic achilles tendinopathy is a common disability of the foot during walking and running. avoiding of painful activities, correction of malalignment by arch support, stretching exercise and eccentric training combined with non-steroidal anti-inflammatory pain killers are the standard treatment regimen (wilson 2005). however, evidence to support these modalities is sparse (mclauchlan 2001). extracorporal shock wave therapy (eswt) originally used for treatment of renal stones became popular in the last decade for treatment of different soft tissue disorders including calcifying tendinopathy in the rotator cuff, humeral epicondylitis and plantar fasciitis (haake 2001, ogden 2001, chung 2002, gerdesmeyer 2003, speed 2004). it is now worldwide employed and fda-approved for the treatment of plantar fasciitis. however regarding both calcifying tendinopathy in the rotator cuff, humeral epicondylitis and plantar fasciitis the results are conflicting (rompe 1996, boddeker 2001, hammer 2002, schmitt 2002, gross 2003, haake 2003, pleiner 2004, chung 2005). a series of randomized studies on eswt for soft tissue disorders have been reported (rompe 1997, krishek 1998, loew 1999, rompe 2001, haake 2001, hammer 2002, schmitt 2002, gerdesmeyer 2003, gross 2003, haake 2003, pleiner 2004, chung 2005, costa 2005) only four reporting significant effect of eswt (rompe 1997, krishek 1998, loew 1999, gerdesmeyer 2003), and only one randomised studies for chronic achilles tendinopathy (costa 2005). two uncontrolled (perlick 2002, lakshmanan 2003) and one controlled (furia 2005) series introduce eswt for chronic achilles tendinopathy. the results of these papers are seriously conflicting. some authors include training and others not. since eccentric training has documented effect (alfredson 2000) other conservative treatments should be introduced as a supplement. we investigated in a double blind randomized trial the supplementary effect of eswt to enhance recovery of achilles tendinopathy. we investigated, firstly, the effect on aofas score and secondly the effect on pain.

Eligibility criteria:
inclusion criteria: * chronic achilles tendinopathy exclusion criteria: * recent surgery in area

Keywords: chronic achilles tendinopathy