Kornimate/medical-research-clean huggingface dataset:
depression online assessment and therapy

Conditions: Depression

Summary: one aim of the current study is to better understand why some patients suffering from depression do not seek professional help by doctors but in the internet. furthermore patients with depression will receive online therapy for depression. aim of this part of the study is to investigate whether quality of life changes accordingly to improvement of symptoms after online therapy.

* german speaking patients can register online. there will be no side visits. * after screening: patients which meet inclusion criteria and no exclusion criteria can take part in online therapy for depression. * after 12 weeks 2nd online survey. after this survey patients can use the program the following 6 months (follow-up) * after 6 months 3rd and last online-survey. * according to the aims of the study cross-sectional as well as longitudinal data will be obtained and analysed

Eligibility criteria:
inclusion criteria: * german language * depression at least slight according bdi (beck depression inventory) and at least 2 weeks exclusion criteria: * severe depression according bdi * suicidal ideation * alcohol or drug dependency * history of psychotic symptoms * history of bipolar disorder or previous mania * current in-patient care or semi-residential treatment

Keywords: depression online therapy cognitive behavioural therapy quality of life alexithymia therapy expectation and satisfaction
norepinephrine transporter blockade as a pathological biomarker in neurogenic orthostatic hypotension

Conditions: Orthostatic Hypotension; Pure Autonomic Failure; Multiple System Atrophy; Parkinson's Disease

Summary: the autonomic or automatic nervous system helps control blood pressure. diseases of the autonomic nervous system may result in a drop in blood pressure on standing in many cases leading to fainting. diseases that affect the autonomic nervous system include pure autonomic failure, multiple system atrophy and parkinson's disease, and can present with very similar symptoms and it is sometimes difficult to determine an exact diagnosis. the purpose of the study is to find out if the blood pressure response from taking a single dose of the medication atomoxetine can help in the diagnosis of these diseases.

this is an observational, prospective three-year longitudinal study. the investigators will enroll participants with primary neurogenic orthostatic hypotension. all participants will undergo an extensive neurological and cardiovascular evaluation, including detailed autonomic testing and quality of life assessment. the investigators will then determine the magnitude of the pressor effect produced by 18 mg atomoxetine given orally, measured 1 hour after drug administration. participants will be followed annually or more often if there is a significant change in their clinical condition. during follow up at year 3, the investigators will repeat the initial neurological, cardiovascular and autonomic evaluation. the primary endpoint would be the final diagnosis made at year 3 after the initial evaluation (at the end of the follow-up period) or if they develop significant worsening of symptoms during follow-up phone assessments, based on specific clinical criteria.

Eligibility criteria:
inclusion criteria: * age 18-80 years old with neurogenic orthostatic hypotension, ≥30 mmhg drop in sbp within 5 minutes of standing * associated with impaired autonomic reflexes, as determined by absence of blood pressure overshoot during phase iv of the valsalva maneuver * absence of other identifiable causes of autonomic neuropathy * able and willing to provide informed consent exclusion criteria: * pregnancy * systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies * known intolerance to atomoxetine, pre-existing sustained severe hypertension (bp at least 180/110 mmhg in the sitting position) * clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months * any other significant systemic, hepatic, cardiac or renal illness * use of mao-i within 14 days * known closed-angle glaucoma or life-threatening arrhythmias

Keywords: orthostatic hypotension multiple system atrophy pure autonomic failure parkinson's disease
phase 3 study of sofosbuvir and ribavirin

Conditions: Hepatitis C

Summary: this study was to assess the safety and efficacy of sofosbuvir (gs-7977; psi-7977) in combination with ribavirin (rbv) administered for 12 weeks compared with pegylated interferon (peg)/rbv administered for 24 weeks in treatment-naive patients with hepatitis c (hcv) genotype 2 or 3. efficacy was assessed by the rate of sustained viral response (svr) 12 weeks after the discontinuation of therapy (svr12). this was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.


Eligibility criteria:
inclusion criteria: * chronic genotype 2 or 3 hcv-infection * naive to all hcv antiviral treatment(s) exclusion criteria: * positive test at screening for hbsag, anti-hepatitis b core immunoglobulin m antibody (anti-hbc igm ab), or anti-hiv ab * history of any other clinically significant chronic liver disease * a history consistent with decompensated liver disease * history or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study. * participation in a clinical study within 3 months prior to first dose

Keywords: hcv genotype 2 (gt-2) hcv genotype 3 (gt-3)
bacterial load reduction by gentlewave and edgepro irrigation systems in mandibular necrotic molars

Conditions: Pulp Necroses

Summary: the purpose of this study is to compare the efficacy of gentlewave versus edgepro irrigation in the disinfection of infected root canals of human permanent teeth with necrotic pulp.


Eligibility criteria:
inclusion criteria: * permanent teeth that are diagnosed with pulp necrosis. * elected to have a permanent tooth nonsurgical root canal treatment * signed informed consent. exclusion criteria: * teeth with root fractures or previously root canal treated teeth. * teeth with severe loss of structure * teeth with vital pulps.

Keywords: root canal
single dose pharmacokinetics of prucalopride in paediatric subjects, with functional faecal retention

Conditions: Constipation

Summary: the purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged \>= 4 to \<= 12 years with functional faecal retention. hypothesis: pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile

this is a multicentre, open-label, single-dose pharmacokinetic trial. a minimum of 24 paediatric subjects (aged ≥ 4 to ≤ 12 years) with functional faecal retention (ffr) were administered a single dose of prucalopride in oral solution. all subjects who qualified to enter the trial received a single dose of 0.03 mg/kg prucalopride oral solution at hour 0 on day 1. one blood sample was drawn prior to dosing, and 13 samples were drawn over the 72-hour interval following the single dose or prucalopride. urine was collected quantitatively for the first 24 hours. plasma prepared from blood samples and urine samples were assayed for prucalopride concentrations. safety was monitored over the 72-hour interval following the dose of trial medication.

Eligibility criteria:
inclusion criteria: * subjects with a confirmed diagnosis of ffr, defined as a minimum 2-month history of faecal impaction, plus at least one of the following: * \< 3 bowel movements per week at the toilet; * a history of soiling; * male and female subjects ≥ 4 to ≤ 12 years of age, with a tanner stage 1 of 2 or less; * weight-height proportionality for age within the 5th and 95th percentile; * written informed consent, signed by the subject's legal guardian and by the investigator, and; * subject assent documented in the form of a note-to-file in the subject's source documentation. exclusion criteria: * requirement for any medication during the period of the trial; * evidence by examination or laboratory tests of abnormal growth; * an abnormal neurologic examination; * cystic fibrosis; * history of, or current anorectal malformations; * diagnosed chromosomal abnormalities (e.g., down's syndrome); * disease state or surgery known to significantly affect the gastrointestinal absorption of drugs, or the assessment of the trial drug's effect; * any history, clinical and/or biochemical evidence of clinically significant renal or liver disease or cirrhosis; * clinically significant anaemia; * use of any investigational drug within the 4-week period prior to administration of trial medication.
stabilizing training in degenerative disc disease

Conditions: Degenerative Disc Disease; Protrusion; Extrusion of Migrated Disc; Hernia

Summary: this study evaluates efficacy of stabilizing training of deep core muscles in the lumbar spine in degenerative disc disease subjects, considering the progression level of degenerative disc disease: protrusion or extrusion.

degenerative disc disease (ddd) is one of the causes of low back pain, and contributes to increasing the socio-economic problem. depending on the reason for the dysfunction, various classifications describing the level of advancement are used. literature on the subject commonly uses the division into protrusion and extrusion of the intervertebral disc, as approved by the american society of neuroradiology. stabilizing training is one of the forms of conservative treatment of lumbar pain, alongside manual treatment or techniques from the field of chiropractics or physiotherapy. it is thought that the proper stabilization of this region of the body is crucial for coping with pain. therefore, the aim of the study was to assess the effectiveness of stabilizing training of deep core muscles in the lumbar spine in subjects in the age of 20-35 years, considering the progression level of degenerative disc disease: protrusion or extrusion, on the basis of the clinical condition.

Eligibility criteria:
all the subjects undergo imaging examination in the form of mri, whose results will be interpreted by a radiologist. each person will be classified according to the current damage to the intervertebral disc as recommended by the american society of neuroradiology: protrusion or extrusion of the intervertebral disc. inclusion criteria: * disc disease located in the lumbar region of the spine confirmed by the mri * subacute stage of the disease * age 20-35 years exclusion criteria: * advanced degenerative-deformatory changes of the spine * previous fracture of the spine * neurologic deficits in lower limbs or pelvis * spondylolisthesis * transitional vertebra * rheumatic diseases

Keywords: degenerative disc disease stabilizing training protrusion extrusion
study of irofulven in patients with hormone-refractory prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (hrpc) whose disease has progressed following taxotere based regimens.

for every five patients randomized, two will receive treatment number 1 (irofulven + prednisone), two patients will receive treatment number 2 (irofulven + capecitabine (xeloda®) + prednisone), and one patient will receive treatment number 3 (mitoxantrone + prednisone). this is not a blinded study, so both the patient and doctor will know which treatment has been assigned.

Eligibility criteria:
inclusion criteria: to be included in the study, patients must meet the following criteria: 1. cancer of the prostate confirmed by a biopsy sample. 2. 18 years of age or older. 3. disease must have spread beyond the prostate as proven by chest x ray, abdominal and pelvic computed tomography (ct) scan, bone scan or clinical examination. 4. at least one prior hormonal treatment with documented disease progression during hormone therapy. 5. one previous line of chemotherapy that included taxotere® (as monotherapy or in combination). this could be in addition to estramustine single agent therapy. 6. disease progression during prior taxotere-based therapy or within 3 months of discontinuing. 7. recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery. 8. recovered from any toxic effects associated with other investigational drugs, if applicable. 9. signed informed consent obtained prior to initiation of any study-specific procedures or treatment. exclusion criteria: patients cannot participate in the study if any of the following apply: 1. unable to use prednisone. 2. prior treatment with irofulven, capecitabine (xeloda), continuous/protracted infusion 5-fu (5-fluorouracil) (infusion duration greater than or equal to 24 hours), other fluoropyrimidines or mitoxantrone. 3. ongoing treatment with a corticosteroid at a prednisone-equivalent dose \> 10 mg/day. 4. more than 1 prior treatment with either 153sm or 89sr, or radioisotope treatment within 8 weeks prior to entering this study. 5. initiation of treatment with bisphosphonate agents (e.g., pamidronate, etidronate) within 2 months of entering the study. pre-existing treatment with bisphosphonate agents is to be continued during this study. 6. treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period. please note: there are additional inclusion/exclusion criteria. the study center will determine if patients meet all of the criteria. if patients do not qualify for the trial, study personnel will explain the reasons. if patients do qualify, study personnel will explain the trial in detail and answer any questions. patients can then decide if they wish to participate.

Keywords: irofulven docetaxel taxotere
comparison between recombinant versus urinary hcg for ovulation induction in high responders

Conditions: Infertility

Summary: the purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rhcg) and urinary hcg (uhcg) in patients undergoing ivf cycles.

urinary human chorionic gonadotrophin (u-hcg) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. recombinant technology has allowed the production of r-hcg inj which all urinary contaminants are absent. hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. this study will investigate the effectiveness of the recombinant hcg compared to the currently used urinary hcg.

Eligibility criteria:
inclusion criteria: * at least 14 follicles \>11mm on the day of triggering final oocyte maturation * pretreated with gnrh antagonist protocol exclusion criteria: * poor responders * women with 25 or more follicles on the day of trigger

Keywords: recombinant hcg urinary hcg
gemcitabine, capecitabine, and erlotinib in treating patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. purpose: this phase i trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.

objectives: primary * determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer. secondary * analyze the limiting toxicities according to ctc. * analyze the toxicity according to ctc. * determine the recommended dose. * determine the pharmacokinetic dosages of the three drugs. * analyze interactions between the drugs. outline: this is a multicenter study. patients receive one course of chemotherapy comprising gemcitabine hydrochloride iv over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the pancreas * advanced disease * no standard curative therapy available * must have received prior first-line chemotherapy * no brain metastasis patient characteristics: * who performance status 0-2 * life expectancy ≥ 8 weeks * anc ≥ 1.5 x 10\^9/ l * platelet count ≥ 130 x 10\^9/ l * hemoglobin ≥ 10 g/dl * liver transaminases ≤ 1.5 times upper limit of normal (uln) (≤ 5 times uln in the presence of liver metastases) * bilirubin ≤ 1.5 times uln * creatinine ≤ 130 mmol/l or creatinine clearance \> 30 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no intolerance or hypersensitivity to any of the drugs being tested * no history of interstitial lung disease * no history of severe cardiac disease * no serious uncontrolled infection * no rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome * must not be deprived of liberty or under guardianship * must not be on probation prior concurrent therapy: * see disease characteristics * no prior erlotinib hydrochloride * no concurrent potent inducers or inhibitors of cytochrome p450 or cyp3a4 * more than 14 days since participation in another clinical trial

Keywords: stage iii pancreatic cancer stage iv pancreatic cancer adenocarcinoma of the pancreas recurrent pancreatic cancer
feasibility and safety of the routine distal transradial approach

Conditions: Vascular Access Complication; Radial Artery; Coronary Artery Disease; Puncture; Coronary Angiography

Summary: the distal transradial approach (dtra) via the anatomical snuffbox is hypothesized to be more beneficial than the conventional transradial access (ctra) in patients undergoing coronary procedures. this prospective single-center randomized trial was designed to investigate the safety, efficacy, and various ultrasound parameters of dtra.

transradial approach (tra) has emerged in most countries as a default strategy in urgent and elective coronary procedures. the advantages of tra compared to the transfemoral access encompass a reduction of mortality, complications, and cost as well as improvement of patient's comfort. the aim of the present study (antares, distal vs conventional transradial access for coronary procedures study) was to assess the feasibility, safety and various ultrasound parameters of dtra in the anatomical snuffbox as the first-line strategy, in comparison with ctra, in patients undergoing coronary angiography (cag) and percutaneous coronary intervention (pci). the study is a non-inferiority, randomized controlled trial. there are two arms: distal transradial access and conventional transradial approach. 400 patients were enrolled.

Eligibility criteria:
inclusion criteria: * patients referred for cag and/or pci exclusion criteria: * st-elevation myocardial infarction * sudden cardiac arrest * hemody-namic instability * chronic kidney disease (stages 4-5) * forearm artery occlusion * previous unsuccessful ipsilateral tra * unfavorable ra diameter * ultrasound unavailability

Keywords: radial artery distal transradial approach access complication anatomical snuffbox
progressive web app about individualized patient decision aid for nsclc stage i-ii

Conditions: Lung Cancer Stage I; Lung Cancer Stage II

Summary: studies indicate that the majority of early-stage non-small cell lung cancer (nsclc) patients find it important to be involved in treatment decision making. however, in a recent study it has been reported that about 40% of the participants experienced decision conflict and feel uninformed(1). the investigators therefore developed a patient decision aid (pda) for stage i-ii nsclc patients, that informs and empowers patients to help decide between stereotactic radiotherapy (sbrt) and surgery.

a pilot study in which semi-structured interviews will be conducted (qualitative research).in addition, patients will be asked to fill in a questionnaire about the usability of the prototype. a small group of patients (n=15) that have been treated for early stage nsclc in the past will be asked to participate. the persons involved in this pilot are asked to assess a patient decision tool and will be interviewed only once. after the interview they will be asked to fill in a questionnaire. the burden of the pilot study is very low. no medical examinations or procedures will be carried out. pilot study in lung cancer patients treated in the past with radiotherapy or surgery. the participants will all give informed consent. the investigators are using a qualitative design. semi-structured interviews will be carried out. in addition the investigators will ask the participants to fill in a questionnaire with 35 questions. no age limits are defined. the pilot study will be carried out in stage i-ii nsclc patients who were treated with radiotherapy or surgery, at least 6 months ago. patients should currently be free of disease, no disease progression. the semi-structured interview consists of 17 open questions and text recorded, in order to be able to analyze the date afterwards. the interviews will take place when the patients come to the hospital for a regular follow-up appointment. after the interview, the patient is asked to fill in a questionnaire about the usability of the decision aid. in total, the expected duration is about 2 hours.

Eligibility criteria:
inclusion criteria: early stage non-small cell lung patients, treated with curative intent minimum 6 month ago, max 5 years. doctors it exclusion criteria: others

Keywords: ipda shared decision making patient decision aids progressive web app