Kornimate/medical-research-clean huggingface dataset:
pilot-trial of emotion-focused cognitive behavior therapy for patients with schizophrenia

Conditions: Schizophrenia; Delusional Disorder; Schizoaffective Disorder; Brief Psychotic Disorder; Schizophreniform Disorder

Summary: the present study is a pilot single-blind randomized controlled therapy study. its aim is to assess the efficacy of an emotion-focussed form of cognitive behavior therapy that focusses on emotional processes that are involved in the formation and maintenance of delusions such as emotional stability, emotion regulation and self-esteem.

cognitive behavior therapy for psychosis (cbtp) is an effective treatment for patients with psychosis. several meta-analyses showed an effect of cbtp in addition to antipsychotic treatment of small to medium effect size with regard to positive symptoms, general psychopathology and depression. nevertheless, present research suggests that are especially emotional processes are closely related to positive symptoms and delusions, such as negative emotions, low self-esteem, depression and anxiety, whereas present interventions of cbtp focus often especially on cognitive interventions in order to change delusions as well as more cognitive risk factors for delusions such as reasoning biases and a dysfunctional causal attribution style. thus, the aim of the present single-blind randomized-controlled pilot therapy study was to assess the efficacy of a new form of emotion-focussed cognitive behavior therapy for psychosis with regard to change in positive symptoms and delusions in comparison to standard treatment. the main hypotheses are: - efficacy of cbt-e: patients with schizophrenia who receive cbt-e show a more pronounced reduction of delusions (primary outcome), as well as a more pronounced reduction of positive symptoms, depression and general psychopathology, a stronger improvement in general and social functioning and will receive lower doses of antipsychotic medication (secondary outcomes) at post-treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or brief psychotic disorder * positive and negative syndrome scale score in item p1 (delusions) of at least two * fluent in german language * agree to participate * estimated general intelligence of at least 70 (assessed with the german wortschatztest (mwt-b) * no present suicidality exclusion criteria: * acute suicidality * comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month * intake of benzodiazepines

Keywords: schizophrenia psychotic disorders cognitive behavior therapy emotion regulation self-esteem randomized-controlled trial
study to evaluate the safety,tolerability, pharmacokinetics and exploratory efficacy parameters of air dnase™in patients with cystic fibrosis previously treated with pulmozyme®

Conditions: Cystic Fibrosis

Summary: this study evaluates the safety,tolerability, pharmacokinetics and exploratory efficacy parameters of air dnase™in patients with cystic fibrosis previously treated with pulmozyme®.

this is a proof-of-concept, open label study, to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy of 2.5 mg air dnase tm administered once daily for 28 days via inhalation to cystic fibrosis subjects who have previously been treated with pulmozyme®. this multicenter study will be conducted in approximately 10 sites and will enroll up to 15 subjects.

Eligibility criteria:
main inclusion criteria: 1. age ≥ 12 years of age (inclusive) at the time of screening 2. weight ≥ 36 kg 3. prior confirmed diagnosis of cf 4. at least 4 months treatment with pulmozyme® prior to screening. 5. the subject is medically stable for at least one month prior to the screening visit. 6. stable inhaled regimen of either: antibiotics, steroids, hypertonic saline at least four months prior to screening visit. 7. fev1 of \>40% and \<90% and fvc ≥ 40% of predicted normal for age, gender, and height at screening . 8. female and male subjects whose co-partners are of child bearing potential must agree to use two medically acceptable methods of contraception, not including the rhythm method. 9. be willing and able to adhere to the study visit schedule and other protocol requirements 10. be willing and able to provide voluntary written informed consent main exclusion criteria: 1. has a history of lung transplantation. 2. female subjects who are pregnant or lactating. 3. history of severe or unexplained adverse reactions during aerosol delivery of any medicinal product. 4. history or presence of hypersensitivity or reaction to inhaled proteins. 5. participation in another clinical trial within 60 days prior to screening. 6. presence of any medical, emotional, behavioral or psychological condition that in the judgment of the investigator would interfere with the subject's safety or compliance with the requirements of the study. 7. have positive serology for human immunodeficiency virus (hiv) or hepatitis b or hepatitis c infection.

Keywords: cystic fibrosis cf air dnase™ digestive system diseases genetic diseases, inborn infant, new born, diseases lung diseases pancreatic diseases respiratory tract diseases
immunosuppressive medications for participants in itn005ct (nct00014911)

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this protocol is to provide continued acess to immunosuppressive medications to subjects from the completed/closed trial itn005ct (nis01,nct00014911). this protocol does not provide medicines to diabetes patients who did not participate in itn005ct.

study acronym: exiist - extended immunosuppression in islet transplantation islet transplantation is an experimental therapy in people with difficult to control type 1 diabetes (t1d). insulin producing cells (islets) are isolated from a pancreas. after the cells are prepared, the islets are put into the subject's liver. these transplanted islets may produce insulin that the subject's islets can no longer make. in order to help keep up the function of the transplanted islets, immunosuppressive medications must be given indefinitely or for as long as the study doctor determines is necessary. the medications serve to modify the immune system that normally tries to destroy (reject) new islets. participants in this study have received up to three islet cell infusions as a previous participant in the itn005ct (nis01) protocol. they also received a maintenance immunosuppressive treatment regimen consisting of a combination of orally administered drugs (tacrolimus (prograf®), sirolimus (rapamune®), mycophenolate mofetil (mmf, cellcept®), and/or mycophenolic acid (mpa, myfortic®).) this protocol provides a way to supply these immunosuppressive medications to subjects whose islets continue to function and make c-peptide. routine study follow-up visits will occur on an annual and -as warranted basis.

Eligibility criteria:
inclusion criteria: * participation in clinical trial itn005ct (reference: clinicaltrials.gov record nct00014911) at harvard university (massachusetts general hospital), washington university, or university of miami. * immunosuppressive regimen consisting of a single agent or some combination from among the following: tacrolimus, sirolimus, mycophenolate mofetil, and mycophenolic acid. * willingness of participants to use an approved method of contraception before, during, and 12 weeks after study participation. * peak c-peptide \>0.1 pmol/ml during a mixed meal tolerance test (mmtt) within 12 months of the screening visit. exclusion criteria: * inability to understand and sign the informed consent document for this study. * any medical condition which in the opinion of the investigator should preclude participation. * serum creatinine \> 1.6 mg/dl * insulin requirement \> 1.0 iu/kg/day * hemoglobin a1c (hba1c) result \> 12% * hypoglycemia unawareness defined as the absence of adequate autonomic symptoms at plasma glucose levels of \< 54 mg/dl requiring treatment with glucagon, outside assistance, or treatment in an emergency room or hospital within a 12-month period

Keywords: diabetes mellitus, type 1 t1d t1dm islets of langerhans transplantation pancreatic islets transplantation islet transplant tacrolimus sirolimus mycophenolate mofetil mycophenolic acid
effectiveness of a web-based nursing intervention in the reduction of postpartum depression and parenting stress.

Conditions: Depression, Postpartum

Summary: the purpose of the study is to determine whether a web-based nursing intervention delivered during the postpartum period will decrease symptoms of postpartum depression and parenting stress.

the purpose of this randomized, controlled trial is to determine whether receiving standardized messages (text or email) from a postpartum nurse four times/week for 6 months after delivery will decrease symptoms of postpartum depression and parenting stress. enrolled women will be randomized to one of three groups. the first group will receive the usual care, which is a phone call from a nurse within the first few weeks postpartum. the second group will receive four standardized messages each week, the content of which will include infant care, maternal self-care and inspirational material. the third group will receive the same four standardized messages each week, and in addition, two of these weekly messages will offer the option to respond with a request for a nurse to call them. baseline data will be collected during the postpartum hospitalization, and follow-up will occur by email at 3 weeks, 3 months and 6 months postpartum.

Eligibility criteria:
inclusion criteria: 1. able to speak and read english 2. access to a device which can receive text or email messages exclusion criteria: 1. non-english speaking, 2. no access to a device which can receive text or email messages 3. age younger than 18 -

Keywords: postpartum nursing follow-up
is caffeine an environmental modifier in huntington's disease?

Conditions: Huntington Disease

Summary: the aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest hd.


Eligibility criteria:
inclusion criteria: * hd mutation carriers (\>36 cag) * premanifest (total motor uhdrs \< 5) * estimated time to diagnosis between 3 and 10 years * adults older than 21 years (in order to exclude juvenile patients who begin the disease before 21 years) * informed consent signed * with a social protection exclusion criteria: * mri contraindication * pregnant and lactating women * people under guardianship, trusteeship, deprive of freedom
real world data analysis: impact of high-frequency ren treatments as migraine preventive therapy in adolescence

Conditions: Migraine

Summary: this is a post-marketing study investigating the safety and efficacy of the ren device (nerivio by theranica, israel) in adolescents with migraine. the data analysis will test the ability of frequent use of ren for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months, suggesting potential preventive benefits.

the ren device (nerivio by theranica, israel) is a neuromodulation device approved by the fda for acute and/or preventive treatment of migraine in patients of 12 years old and above. it is a wearable device applied to the upper arm. it stimulates c and aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs, modulated frequency of 100-120 hz, and up to 40 ma output current which the patient can adjust. the ren device is operated by a designated app that is downloaded to the user's phone prior first use of the nerivio device. as part of the sign-up process to the nerivio app, all patients accept the terms of use which specify that providing personal information is done by their own free will and that their de-identified data may be used for research purposes. users are not obligated to provide personal information and could treat without providing any feedback. the app includes a secured, personal migraine diary, which enables patients to record and track their migraines and other headaches. at the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (no limitation, some limitation, moderate limitation, severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window. this post-marketing rwe study investigates the potential of high usage of nerivio for the acute treatment of migraine on migraine prevention, using the following outcomes: 1. - reduction in mean monthly migraine treatment days (mmtd), 2. - acute treatment efficacy measured 2 h post-treatment 3. - improve in functional disability 4. - device safety together, these objectives may provide a comprehensive evaluation of the impact of the high usage of nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population.

Eligibility criteria:
inclusion criteria: * patient age is 12 years to 18 years * patient is using the nerivio device for acute treatment of migraine * patient treated at least 10 treatments in his first month of using nerivio and at least 3 treatments in each of the two consecutive months (months 2 and 3 exclusion criteria: * treatments shorter than 30 minutes

Keywords: migraine prevention headache nerivio ren
comparison of two hydroxy-apatite coated hip stems

Conditions: Hip Osteoarthritis

Summary: in this study, the investigators propose to randomize 80 subjects to receive either the avenir cementless hip stem or a competing, ha-coated hip stem (corail, depuy-synthes) and follow these patients for a period of 2 years post-surgery. the investigators aim to determine if the avenir cementless hip stem has equivalent or better fixation and clinical outcomes compared to a predicate hip stem with longer clinical history.

this is a multi-center, randomized controlled trial of patients undergoing primary total hip arthroplasty. this study will be focused on enrollment at a single site with possible expansion to additional centers should patient enrollment occur at a slower than expected rate. decision to expand the study to additional centers will be mutually agreed upon by both the clinical site and the study sponsor. patients will be randomized to two study groups: 1. zimmer avenir cementless, ha-coated femoral hip stem with matching trilogy it cup; 2. depuy-synthes corail cementless, ha-coated, non-collared femoral hip stem with matching pinnacle cup patient allocation to the study groups will occur following a randomized 4-block design.

Eligibility criteria:
inclusion criteria * symptomatic osteoarthritis of the hip undergoing primary total hip arthroplasty * between the ages of 18 and 79 inclusive * patients willing and able to comply with follow-up requirements and self-evaluations * ability to give informed consent exclusion criteria * requires specialty implant (e.g., suspected metal allergy, coxa vera implant) * avascular necrosis * unresolved infection of the hip * hip fracture * hip dysplasia * at risk for loss to follow-up * prior surgery to the ipsilateral hip * severe proximal femoral deformity preventing the use of standard proximal press-fit femoral components * medical condition precluding major surgery * current or pending patient incarceration
visual function after implantation of bilateral acrysoft restor aspheric iol

Conditions: Cataract

Summary: this study will involve up to 20 bilateral patients per surgeon. patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.


Eligibility criteria:
inclusion criteria: * 21 years or older; * need spherical correction between 10-30 diopters (d); * corneal astigmatism less than 0.75d as measured by keratometry; * willing to sign an informed consent form and complete all visits; * pupil dilation greater than 6mm; * expected visual acuity (measured in logmar)=0.3 or better exclusion criteria: * women of childbearing potential; * irregular corneal astigmatism; * keratopathy/keratectasia; * cornea inflammation or edema; * cornea reshaping surgery; * corneal dystrophy;corneal transplant; * amblyopia; * glaucoma; * retinal pigment epitheliopathy (rpe)/macular changes; * proliferative diabetic retinopathy

Keywords: acrysof restor aspheric iol cataract
screening for prostate cancer using high resolution micro-ultrasound versus multiparametric magnetic resonance imaging.

Conditions: Prostate Cancer Screening

Summary: the purpose of this study is to compare whether the fda and health canada approved microus is as effective as the currently used option (mri) for imaging the prostate gland. participants will be randomized into two groups to compare the imaging results of the current standard of care mri and the new microus. the study is looking to identify the most effective imaging modality to help guide whether you progress to have a prostate biopsy.


Eligibility criteria:
inclusion criteria: 1. male sex; 2. age 50-70; 3. psa 3-20 and/or abnormal dre; 4. biopsy naïve. exclusion criteria: 1. prior personal history of prostate cancer; 2. prior prostate imaging using microus or mri; 3. contraindication to microus or mri; 4. testosterone replacement therapy within last 12 months; or 5. androgen deprivation therapy within last 12 months.
the efficacy of transcutaneous electrical nerve stimulation on luts: one prospective study.

Conditions: Pelvic Organ Prolapse

Summary: the study is a prospective study at a single institution. investigators create strict inclusion and exclusion criteria, selecting 126 patients who undergo the pelvic reconstructive surgery. 63 patients in the intervention group accept 10 times of the transcutaneous electrical nerve stimulation.

all the patients have severe pelvic organ prolapse and undergo the pelvic reconstructive surgery. investigators evaluate all patients' lower urinary tract symptoms, quality of life score, overactive bladder questionnaire, maximal rate and residual urine volume, at 1, 3, 6 and 12 months after the surgery.

Eligibility criteria:
inclusion criteria: * severe pelvic organ prolapse(pop-q:3/4 stage) * accept pelvic reconstructive surgery exclusion criteria: * dominant stress urinary incontinence * serious medical problems * mental disease * infectious disease

Keywords: transcutaneous electrical nerve stimulation;
surgical resection versus percutaneous local ablative therapy for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma With CSPH

Summary: the aim of this study is to compare the operative complication and short-/long-term therapeutic effects of percutaneous local ablative therapy (plat) versus surgical resection(sr) on small hepatocellular carcinoma(hcc) patients with clinically significant portal hypertension(csph) so as to lend clinical and theoretical basis of the therapeutic schemes for the disease.

hcc is a major health problem worldwide, with an estimated incidence ranging between 500,000 and 1,000,000 new cases annually. it is the fifth most common cancer in the world and the third most common cause of cancer-related death,especially in east-asia countries.sr remains the first therapeutic option for a cure but is suitable only for 9%-27% of patients.the presence of significant background cirrhosis often precludes liver resection for hcc.even though these hcc patients undergo sr，the incidence of posthepatectomy liver failure(phlf) and death would be high，especially to hcc patients complicating csph，whose corresponding risk of phlf and persistent phlf were 59.02%and 14.75%respectively in our past study. it is extremely urgent to search a safe and effective means in this subgroup of hcc patients.plat, a recently developed local ablative technique, has attracted the greatest interest and popularity because of its effectiveness and safety,with a 3-year survival rate of 62-77%,a low treatment complication rate of 8-9% and a low treatment mortality rate of 0-0.5%.however, there is still debate on whether plat or sr is the most suitable therapy for hcc.to our knowledge,there have been no study on the therapy of hcc complicating csph.

Eligibility criteria:
inclusion criteria: 1. 18 years \< ge ≤ 70 y,kps ≥ 70 2. a solitary hcc ≤ 5cm in diameter,or multiple hcc(≤3) ,each ≤3cm in diameter without evidence of radiologically definable vascular invasion or extrahepatic metastasis. allowing to both sr and plat 3. child-pugh class a or b,without history of encephalopathy,ascites refractory to diuretics,or variceal bleeding 4. no previous treatment of hcc 5. platelet count\>40,000/mm3；prothrombin time prolongation of no more than 3 seconds 6. patients who can understand this trial and have signed information consent exclusion criteria: 1. metastatic liver cancer 2. patients with apparent cardiac,pulmonary,cerebral and renal dysfunction,which may affect the treatment of hcc 3) patients with other diseases which may affect the treatment mentioned 4） patients participating in other clinical trials 5） patients with a medical history of other malignant tumors 6) pregnant and breast-feeding women

Keywords: hepatocellular carcinoma csph hepatectomy percutaneous local ablative therapy (plat) randomized controlled trials(rcts)
development of a novel disease-specific quality of life questionnaire for gastroesophageal reflux disease (gerd) patients in chinese population

Conditions: Gastroesophageal Reflux Disease

Summary: a questionnaire composed of items addressing psychological, emotional and social aspects of gerd is developed for chinese population. we plan to conduct a validation study on this novel disease-specific quality of life (qol) instrument. this study aims to evaluate various indicators of validity and reliability, which include criterion validity, test-retest reliability, responsiveness, internal consistency reliability and discriminant validity. after initial pilot testing of face validity and content validity, two hundred gerd patients from the gastroenterology and ulcer clinics of cluster nte hospitals will be invited to complete a revised 18-item version of gerd-qol questionnaire. the data from gerd qol will be evaluated using exploratory factor analysis to identify appropriate items and domains and the internal consistency of the domains will be determined and further refinement of questionnaire will follow. 100 gerd patients will complete gerd-qol, sf-36 health survey and the visual analog scale (vas) questionnaire for criterion validation. 100 gerd patients with stable symptom profile will repeat gerd qol two weeks after the first administration for evaluation of test-retest reliability. another 26 patients who are receiving maintenance acid suppressive therapy and in remission of symptom will be recruited as controls for comparison with active reflux patients. the ability to distinguish active patients from controls in remission is known as discriminant validity.


Eligibility criteria:
inclusion criteria: * patients presenting with 1 attack of heartburn and/or acid regurgitation per week as chief complaint in recent 6 months exclusion criteria:patients with * gerd as gi involvement of systemic disease e.g. scleroderma, sle, thyrotoxicosis, chronic intestinal pseudo-obstruction * cause of esophagitis other than gerd e.g. drug induced, infection, nasogastric tube injury * previous gastrointestinal or hepatobiliary surgery (including cholecystectomy) * organic pathology of upper gi tract that may present as reflux / dyspeptic symptom e.g. peptic ulcer, gastric cancer, gastric outlet obstruction * presence of alarm symptom that does not suggest functional gi disorder * use of nsaid in recent 4 weeks (low dose aspirin \< 300 mg is allowed) * pregnant woman or lactating female * illiterate patient (who cannot administer questionnaire) * known hypersensitivity to ppi