Kornimate/medical-research-clean huggingface dataset:
therapy online plus (top+) - comparing two online interventions for dealing with challenging life circumstances

Conditions: Mental Disorders; Online-Intervention

Summary: psychotherapy interventions can roughly be grouped into compensation-oriented strategies (compensating for and and modifying personal deficits of patients) versus capitalization-oriented strategies (building on patients' personal strengths). improvement of emotion regulation (compensation-oriented) as well as the activation of resilience (capitalisation-oriented) have been identified as important transdiagnostic factors in the treatment of mental disorders. the study aims to compare compensation vs. capitalization strategies by using two online programs, centered either on emotion-regulation ("remotion") or on activating resilience ("res-up!"). res-up! and remotion are administered as stand-alone intervention or as add-on treatment to standard psychotherapy. participants will be randomly assigned to three study conditions (res-up!, remotion, waiting control group). outcomes are assessed at baseline, after six weeks and after twelve weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of a mental disorder according to dsm-5 * recruited at the training centers of the german association for behavior therapy (deutsche gesellschaft für verhaltenstherapie, dgvt) at muenster, bielefeld and dortmund or at the center of mental health and psychotherapy, witten/herdecke university (all outpatients clinics exclusion criteria: * insufficient german language skills * current severe episode of major depression * psychotic disorder

Keywords: internet-based therapy resilience emotion regulation outcome research strengths psychotherapy
efficacy and safety study of msrd-100 in subjects with atopic dermatitis >=3 months of age and older

Conditions: Atopic Dermatitis

Summary: this is a double-blind, randomized, vehicle-controlled, multi-center, parallel group phase 3 study of msrd-100 in the treatment of atopic dermatitis in subjects aged 3 months and up.

this is a 4-week efficacy, safety and tolerability study of msrd-100 applied twice daily for 4 weeks compared to its vehicle among subjects ≥3 months of age in the treatment of atopic dermatitis covering ≥5% body surface area. the study will consist of up to 4 visits which includes screening - visit 1 (screening), baseline - visit 2 , visit 3 (day 14), and an end of treatment/final study visit - visit 4 (day 28). study ids m169981001 and m169981002 are two identical studies being run in parallel with different study sites.

Eligibility criteria:
key inclusion criteria: 1. subjects who are male or female, ≥3 months of age on the date of baseline visit. 2. subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the hanifin and rajka diagnosis criteria for atopic dermatitis. 3. subjects must have an investigator global assessment (iga) score of ≥2 at baseline. 4. subjects who have atopic dermatitis covering ≥5% body surface area (bsa) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants). 5. subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected. key exclusion criteria: 1. unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline. 2. concurrent conditions and history of other diseases. 3. used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study. 4. subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease.

Keywords: dermatitis, atopic eczema dermatitis pruritus genetic diseases, inborn hypersensitivity hypersensitivity, immediate immune system diseases skin diseases, eczematous skin diseases, genetic skin diseases itching rash steroid
pilot study investigating the use of the rebuilder to treat chemotherapy induced peripheral neuropathy in patients with breast cancer

Conditions: Peripheral Neuropathy

Summary: the purpose of this study is to investigate the effect of the rebuilder in the treatment of individuals with breast cancer and chemotherapy induced peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * patients with breast cancer referred to physical therapy for cipn * physical therapy examination indicates use of rebuilder for cipn * at least 18 years of age * signed informed consent for study population * willingness to complete study according to protocol exclusion criteria: * patients who do not have cipn * patients \<18 years of age * inability to or unwilling to sign informed consent * unable to read and understand the english language * preexisting sensory peripheral neuropathy from other comorbid conditions such as diabetes or alcoholism * more than three (3) prior rebuilder treatments; or rebuilder within the last 30 days, for sensory peripheral neuropathy

Keywords: rebuilder breast cancer chemotherapy induced
effect of cytoreductive chemotherapy and a ccr5 coreceptor antagonist on hiv-1 eradication

Conditions: HIV-1 Infection

Summary: effect on hiv-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of ccr5 coreceptors: a pilot, open, randomized, and controlled clinical trial.


Eligibility criteria:
inclusion criteria: * patients who give written consent to participate in the study * age between 18 and 65 years old, included. * chronic hiv-1 demonstration of r5 viral tropism (use of ccr5 coreceptors) by genotyping in plasma samples stored * patients that are to be treated with intensive chemotherapy for non hodgkin lymphoma with or without stable antiretroviral therapy * patients that are able to understand the purpose of the study and be available for scheduled appointments. * both in the case of female and male patients, the patient agrees to use a double barrier method of contraception from the moment of signing the informed consent until 3 months after the end of their participation in the study. exclusion criteria: * to have planned antiretroviral treatment interruption during the participation in the study * hypersensitivity to products used in this study * to be involved in another clinical trial or received an investigational drug within 3 months prior to the study initiation * to have contraindications or limitations to perform leukapheresis

Keywords: hiv-1 ccr5 coreceptors maraviroc
nefazodone in the treatment of cocaine dependence and depression - 4

Conditions: Cocaine-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is the use of nefazodone in the treatment of cocaine dependence and depression comorbidity.

the objective of this study is to determine the safety and efficacy of nefazodone (serzone ) in depressed cocaine dependent subjects. this is a hypothesis-testing study which will explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a placebo control group.

Eligibility criteria:
inclusion criteria: dsm-iv diagnosis of cocaine dependence, depression score of 12 or above and history of depression. males and non-pregnant, non-nursing females 21-55 years of age. exclusion criteria: axis i diagnosis other than substance use disorder, major depression, anxiety of dysthymic disorder. physiological dependence on alcohol. significant medical or neurological history. abnormal ua, cbc or chem 23 (lft's may be up to 3 times normal). enrollment in an opiate-substitution treatment program within 45 days of enrollment in the present study.

Keywords: cocaine use disorders dependence depression
promoting cervical cancer screening for emergency department patients

Conditions: Cervical Cancer

Summary: the purpose of this study is to learn methods to encourage women to get recommended cervical cancer screening. cervical cancer screening is an important part of cervical cancer prevention. the study team will determine if the patient is currently up-to-date with cervical cancer screening recommendations. if the patient is not up-to-date, then they will be randomly assigned to one of two interventions. one intervention consists only of referral to a women's health care provider to obtain cervical cancer screening. the other intervention consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening.


Eligibility criteria:
inclusion criteria: * registered patient in the emergency department of the university of rochester medical center * women * age 21 - 65 exclusion criteria: * past hysterectomy with cervical removal * known infection with hiv (screening recommendations for women with hiv differ from the general population) * non-english speaking * inability to consent * lack of text-capable mobile phone and/or inability to use text function
the effects of a mediterranean diet in pediatric hyperlipidemia

Conditions: Hyperlipidemia

Summary: children with high cholesterol levels are especially vulnerable and are at high risk for early onset coronary heart disease (chd). endothelial dysfunction, the earliest phase of chd, is present in children with elevated cholesterol levels as early as 8 years of age. the long term objective of this study is to develop dietary interventions for the prevention and treatment of endothelial dysfunction in children with common lipid disorders including familial hypercholesterolemia (fh) and familial combined hyperlipidemia (fch). increasing evidence suggests that the mediterranean diet and ω-3 fatty acids found in fish have cardioprotective effects. the specific aims of the study are to: determine whether a mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves endothelial function; evaluate the effects of the dietary interventions on lipids and lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for oxidative stress and inflammation. this study is a randomized, double-blind, placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the mediterranean diet and ω-3 fatty acid supplements. a dietary educational behavioral intervention will be conducted over 6 months with individual counseling and group sessions. endothelial function will be measured noninvasively by high resolution ultrasound of the brachial artery at baseline, 6, 12, 18 and 24 weeks. this study is unique because it is a new intervention designed for children at high risk for early chd with a dietary component and supplementation with ω-3 fatty acids. if effective, this intervention would be broadly applicable in the community and lend valuable insight about dietary therapy to prevent the progression of chd in hyperlipidemic children.


Eligibility criteria:
inclusion criteria: * children (8-17 years old) * familial hypercholesterolemia or familial combined hyperlipidemia * able to read, write and understand english * parental consent and child assent * access to a computer and internet and literacy in the use of the internet * the attendance of a parent to each educational session. exclusion criteria: * chronic systemic illness with or without secondary hyperlipidemia * current smoking

Keywords: endothelial function lipids pediatrics
tepstabil - muscle function and dynamic and postural stability in patients receiving hip or knee arthroplasty

Conditions: Postural Stability

Summary: study 1 is to determine if muscle strength and dynamic and postural stability are compromised in patients with severe hip or knee osteoarthritis (oa) and in patients after tha and tka. study 2 is to quantify the effect of tha and tka on muscle strength and dynamic and postural stability.

postural stability is defined as the ability to maintain the body's centre of gravity within the limits of stability as determined by the base of support. it is further divided in static and dynamic stability involving the ability of maintaining a base of support while standing or completing a functional task. the importance of postural stability is accepted as a factor predicting falls and affecting the ability to perform activities of daily living. despite of reported strength deficits and the importance of balance, to date the potential contribution of strength deficits in patients before and after total hip arthroplasty (tha) or total knee arthroplasty (tka) to compromised balance ability is unknown. furthermore, the role of preoperative muscle function on functional outcome of tha and tka is poorly understood. a correlation between compromised preoperative muscular function and postoperative outcome would suggest that preoperative physical therapy may be critical for preserving the muscular status and may help explain reported poorer outcome after late treatment when muscular function has already deteriorated. the project includes two studies differing in design and primary and secondary objectives but with overlapping patient populations. study 1 will include all five groups, and there is only one visit by the participant (visit a). study 2 will include only patients from groups 3 and 4. three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3). visit 1 will be identical to visit a in study 1 in these two patient groups.

Eligibility criteria:
inclusion criteria: * patients with an unilateral tha or tka, which they received for the treatment of osteoarthritis (patient groups 1+2) * patients diagnosed with unilateral oa of the knee or hip planned for a treatment with tha or tka (patient groups 3+4) * age ≥ 30 years (healthy control group) exclusion criteria: * body mass index \> 35kg/m2 * use of walking aids * neuromuscular disorders affecting gait * inability to follow procedures due to psychological disorders or dementia * diagnosed hip or knee oa (healthy control group) * current pain in the lower extremities or lower back (healthy control group) * rheumatoid arthritis (healthy control group) * previous corrective osteotomy (healthy control group) * regular intake of pain medication (more than 4 times per week) (healthy control group)

Keywords: total hip arthroplasty total knee arthroplasty osteoarthritis muscle strength deficits dynamic stability
vaasa childhood obesity primary prevention study

Conditions: Childhood Obesity Pevention

Summary: this study aims to prevent childhood obesity with early life (pregnancy) intensified counselling. the recruited intervention group is pregnant mothers who are at risk to get gestational diabetes. lifestyle intervention (nutritional and physical activity) begins during pregnancy in maternity clinics and continues in child wellfare clinics until the child is 5 years of age.


Eligibility criteria:
inclusion criteria: * pregnant women who are at risk to get gestational diabetes. exclusion criteria: * foreigner with language problems * major psychosocial problems * diabetes mellitus type i or ii * physical disability, * major medical problems in pregnancy
mobile phone text for optimizing asthma treatment

Conditions: Asthma

Summary: the study aims at providing information on how the short message service (sms) tool influences self-management in asthma patients and to assess the resulting health related effect. a wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. the use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the sms tool influences the patient's self-management. objective: the objective of this study is to assess the health-related effects of a sms compliance and monitoring system for optimized asthma treatment in a controlled trial setting.


Eligibility criteria:
inclusion criteria: * asthmatics exclusion criteria: * below 18 and above 45 * copd patients * no mobile phone * not using the prescribed asthma inhalation medication
a study to assess the effect of creon® on pancreatic exocrine insufficiency in subjects with diabetes mellitus type 2

Conditions: Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Summary: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type ii


Eligibility criteria:
inclusion criteria: * signed informed consent * bmi \< 30 kg/m2 * history of type 2 diabetes mellitus as confirmed by: * onset of diabetes after 30 years of age and * no insulin treatment in the first year after diagnosis * subjects on insulin treatment or on insulin treatment in combination with oral antidiabetics * hba1c \> 6.5% in medical history within the last 6 months despite insulin treatment * not previously treated with any pancreatic enzyme supplementation inclusion criterion at visit 1: • fe-1 (fecal elastase 1) \<100μg/g of stool inclusion criterion at visit 2: • 13c mtbt of \<29% 13co2-crr (carbon dioxide-cumulative recovery rate) exclusion criteria: * treatment with systemic steroids for at least 3 weeks within past 6 months * patients with a known pancreatic exocrine insufficiency due to non-diabetic diseases, e.g., chronic pancreatitis, pancreatectomy, cystic fibrosis, celiac disease, shwachman-diamond syndrome, gastrectomy, etc. * any type of malignancy involving digestive tract in the last 5 years * any type of gastrointestinal surgery (except appendectomy and gallbladder resection) * short bowel syndrome * hemochromatosis * known late onset autoimmune diabetes in the adult * any history of drug abuse including alcohol * positive urine pregnancy test; lactation; females of child-bearing potential who are not using either an oral hormonal contraceptive or an intrauterine device * hypersensitivity to the active substance or to any of the excipients * intake of an experimental drug within 4 weeks prior to entry into this study * suspected non-compliance or non-cooperation * history of human immunodeficiency virus (hiv) infection

Keywords: exocrine pancreatic insufficiency
improvement of communicational skills between health workers and oncological patients during medical consultative conversations

Conditions: Prostate Cancer

Summary: the aim of the study is to identify the specific patterns of communication between doctors and oncological patients during medical consultations and develop recommendations to improve its effectiveness.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed prostate cancer; 2. psa up to 10 ng / ml; gleason (3 + 3) = 6 (isup 1); the stage of the tumor t2a (low- risk according to the d'amico scale); exclusion criteria: 1. failure of the recording device; 2. unsatisfactory audio quality.
comparison of glycaemic fluctuation and oxidative stress between two short-term therapies for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for type 2 diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.

this study was a single-center, randomized, controled and prospective trial. type 2 diabetic patients were randomized into 2 groups (group a and group b). subjects in group a would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group b would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets). after achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days. then a medtronic dynamic blood glucose meter would be applied to the subjects for 72 hours. the clinical data, such as demographic information, present history, past history, personal history and so on were collected in the 1st day. in the 2nd day and the last day of the trial, the blood samples of the patient were collected for the laboratory measurements: cr, uric acid, aminotransferase, lipid profiles, white blood cell count, n%, fasting plasma glucose, fasting c-peptide, insulin, hba1c and standard meal test (0.5h-postprandial and 2h-postprandial blood glucose levels, c peptide and insulin, et al. the parameters of b-cell function and glycemia fluctuation were calculated and then analyzed by spss 13.0.

Eligibility criteria:
inclusion criteria: 1. investigator diagnosed type 2 diabetes( 1999 who diagnosis criteria). 2. diagnosed as type 2 diabetes in the first time without drug therapy, or type 2 diabetes does not accept insulin in the near 3 month and duration is shorter than 10 years 3. fasting plasma glucose ( fpg ) ≥11.1mmol/l or glycated haemoglobin (hba1c )≥9%. 4. agree to participate the study and sign the informed consent. exclusion criteria: 1. obvious failure of heart, hepatic, kidney function. 2. severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug. 3. women in pregnancy or planning to get pregnancy.

Keywords: glargine continuous subcutaneous insulin injection blood glucose control blood glucose fluctuation oxidative stress
assessing the effectiveness and efficacy of the myhealthypregnancy application

Conditions: Pregnancy Related; Preterm Birth

Summary: one in ten births will occur prior to 37 weeks of gestation leading to serious complications such as problems with lung, heart and brain function and an increased risk of infant mortality. solutions exist to treat risk factors related to preterm birth but these solutions require timely identification of the risks which is often not possible within regular prenatal care. this study will evaluate myhealthypregnancy, an application that monitors for common risks associated with preterm birth and recommends solutions to the expectant mother and care team.

myhealthypregnancy (mhp) is an application that was developed using behavioral decision science principles. this study seeks to evaluate the effectiveness and efficacy of the application. myhealthypregnancy was offered to expectant mothers at the university of pittsburgh medical center in conjunction with usual prenatal care. the primary objective is to compare the reduction in gestational age at birth between mhp and usual care cohorts. secondary objectives include comparing births occurring prior to 37 weeks of gestation, depression rates, anxiety rates, referrals to behavioral health, referrals to social workers, preeclampsia rates, gestational weight gain, number of prenatal appointments attended, and percent of required prenatal appointments attended between the mhp and usual care cohorts.

Eligibility criteria:
inclusion criteria: * offered a prescription for myhealthypregnancy * 18+ years of age * pregnant * seeking care at a upmc hospital * delivered at a upmc hospital