Kornimate/medical-research-clean huggingface dataset:
aprotinin us special access protocol

Conditions: Postoperative Hemorrhage

Summary: this is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. the program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass graft (cabg) surgery requiring cardiopulmonary bypass (cpb) who are at increased risk of bleeding and transfusion when, in the opinion of the treating physician, the patients require it, there is no acceptable alternative therapy, and when there is a clearly favorable benefit-risk for the drug in that individual patient.


Eligibility criteria:
inclusion criteria: * patients 18 years of age and older * patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. these patients may include the following: * patients receiving preoperative antithrombotic drugs (e.g., clopidogrel, aspirin), * patients undergoing repeat cabg or complex cabg procedures, * patients undergoing urgent or emergent cabg procedures, * patients who refuse to receive allogeneic blood products for religious or other reasons, * patients undergoing primary cabg with advanced age or multiple comorbidities such as preoperative anemia, coagulopathies, diabetes mellitus, and peripheral vascular disease * the physician has determined that no acceptable alternative comparable therapy is available for the patient and that there is a clearly favorable benefit-risk for the drug in that individual patient * documented, signed, dated informed consent obtained prior to entry into the study exclusion criteria: * patients with a known or suspected previous aprotinin exposure during the last 12 months. aprotinin may also be a component of some fibrin sealant products, and the use of these products should be considered when evaluating previous aprotinin exposure * patients with a known or suspected allergy to aprotinin.

Keywords: cabg surgery requiring cpb and at increased risk of bleeding and blood transfusion
medium and long term outcome of total hip arthroplasty using accolade tmzf femoral stem

Conditions: Osteoarthritis of the Hip

Summary: this is a retrospective/prospective study evaluating the clinical and radiographic outcome of total hip arthroplasty (tha) performed using accolade femoral stem in a consecutive group of patients. all patients eligible for inclusion will be identified. the investigators hypothesize that the outcome of tha performed using accolade femoral stem is equal or superior to historical survivorship of tha using other types of collarless, proximally coated, tapered stems.


Eligibility criteria:
inclusion criteria: 1. all patients undergoing tha prior to 1/1/2003 using accolade femoral stem. 2. patients with hip fracture undergoing tha will also be included. 3. patients willing and able to comply with follow-up requirements and self-evaluations.
safety and clinical tolerability of hdmasit+tm peptides administered in hdm-induced allergic patients

Conditions: House Dust Mite Allergy

Summary: hdmasit+tm product is based on highly purified allergen fragments from house dust mites. the purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmasit+tm in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.


Eligibility criteria:
inclusion criteria: * a medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to aria (bousquet et al., 2001)) * a positive skin prick test to house dust mite dermatophagoides pteronyssinus * specific ige against house dust mite dermatophagoides pteronyssinus ≥ 0.7 ku/l * positive response to conjunctival provocation test (cpt) * being treated with anti-allergic medication for at least 12 months prior to enrollment * for asthmatic patients: confirmed diagnosis of controlled asthma according to global initiative for asthma (gina) guidelines (steps 1-3, gina 2014), fev1 ≥ 80% of the patient's reference value exclusion criteria: * previous immunotherapy with house dust mite allergens within the last 5 years * ongoing immunotherapy with house dust mite allergens or any other allergens * history of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc. * partly controlled or uncontrolled asthma according to gina guidelines (gina 2014) * chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (fev1) \< 80% of the patient's reference value (ecsc) * history of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
a phase 3, comparative study of asunaprevir and daclatasvir combination therapy versus telaprevir therapy in japanese hcv subjects

Conditions: Hepatitis C Virus Infection

Summary: the purpose of this study is to assess the anti-viral activity of bms-790052 and bms-650032 combination therapy in japanese subject. the purpose of this study is to compare the anti-viral activity of the co-administration of asunaprevir (asv) and daclatasvir (dcv) to telaprevir (tvr) included therapy in japanese hepatitis c virus (hcv) subjects

intervention model: parallel in the naive cohort and single group in the relapser cohort

Eligibility criteria:
inclusion criteria: * chronic hcv-1b infected patient * hcv ribonucleic acid (rna) \> 100,000 iu/ml at screening * ages 20 to 70 years (for the naive cohort), ages 20 to 75 years (for the relapser cohort) * treatment naive subjects to interferon (ifn) based therapy * subjects who had undetectable hcv rna at end of treatment with prior exposure to an ifn-containing regimen, but hcv rna detectable within 24 weeks of treatment follow-up exclusion criteria: * patients who have; * hepatocellular carcinoma * co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * severe or uncontrollable complication
non-interventional study in patients with ocular hypertension and open angle glaucoma treated with xalatan and xalacom

Conditions: Glaucoma; Ocular Hypertension

Summary: non-interventional study to obtain real life data from the treatment with xalatan and xalacom in germany and to assess the long-term efficacy and tolerability under routine conditions. data were entered into an electronic case report form.


Eligibility criteria:
inclusion criteria: * patients with ocular hypertension or glaucoma, defined by smpc exclusion criteria: * defined by smpc

Keywords: xchange xalatan xalacom betablocker observational longterm
time to initiated antitumor therapy for tumor patients with covid19 infection

Conditions: Tumor; COVID-19

Summary: the goal of this observational study is to study the safety of initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with covid-19. the main questions aims to answer are: * whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with covid-19 increases adverse events related to antitumor therapy. * whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with covid-19 increases risk of re-infection of covid-19. * how initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with covid-19 affects qol of tumor patients participants will be asked to answer the question about: * the severity and duration of covid-19 symptoms * the date of diagnosis of covid-19 * the date of negative nucleic acid test * the qol of life before infection with covid-19, during infection of covid-19, after nucleic acid test negativity and receiving antitumor therapy


Eligibility criteria:
inclusion criteria: * tumor patients diagnosed with covid-19 infection at our center from december 1, 2022 to may 31. * covid-19 was confirmed by antigen testing or nucleic acid testing. * tumor was confirmed by pathology. * patients received systemic antitumor therapy after infected with covid-19. exclusion criteria: * covid-19 was not confirmed by antigen testing or nucleic acid testing * tumor was not confirmed by pathology * patients did not receive systemic antitumor therapy * patients died before receiving systemic antitumor therapy

Keywords: tumor patients covid-19 antitumor therapy
repetitive transcranial magnetic stimulation for chronic subjective tinnitus

Conditions: Tinnitus, Subjective

Summary: therapy of subjective chronic primary tinnitus could be challenging. repetitive transcranial magnetic stimulation (rtms) is currently being tested for suppressing the symptoms. however, effect of stimulation remains controversial. the aim was to uncover real effect of rtms stimulation for tinnitus treatment. there will be three groups, stimulation group, sham stimulation group and controlled group with medicament treatment. the investigators assume that combination of rtms stimulation of dorsolateral prefrontal cortex and primary auditory cortex at both sides will be more efficient. the investigators considered a 10% improvement in the tinnitus questionnaire score and in the tinnitus masking to be clinically relevant.

adult patients suffering from chronic subjective non-pulsatile primary unilateral or bilateral tinnitus for at least 6 months will be included in the study. patients will be randomly assigned using a random number generation randomization method into rtms stimulation group (group 1), sham stimulation group (group 2) and group with medicament therapy only (group 3). dorsolateral prefrontal cortex (frequency 25 hz; 300 pulses; 80% resting motor threshold=rmt) and primary auditory cortex on both sides (1 hz; 1000 pulses; 110% rmt) will be stimulated in patients in rtms stimulation group for 5 consecutive days. both the patients and outcome assessor were blinded to the intervention group in which the patients (rtms and shame stimulation group) belonged to. medicament therapy in group 3 will consist of ginkgo biloba extract egb 761 once a day for 6 months. there will be no medicament therapy for tinnitus in group 1 and 2. tinnitus reaction questionnaire (trq), tinnitus handicap questionnaire (thq), tinnitus handicap inventory (thi), beck depression inventory (bdi), pure-tone audiometry with fowler scoring of hearing loss and tinnitus analysis will be used for evaluation of tinnitus in all patients. data will be recorded on the day patient is included in the study, during follow-up after 1 month and 6 months. descriptive statistics, such as the arithmetic mean, standard deviation, and absolute and relative frequency tables, will be used for data processing. the pearson's chi-squared test, fisher's exact test, kruskal-wallis test and analysis of variance will be used for comparison. the statistical tests will be assessed using a significance level of 5%.

Eligibility criteria:
inclusion criteria: - subjective chronic non-pulsatile tinnitus lasting more than 6 months exclusion criteria: * head injury or brain surgery * epilepsy * organic brain lesion * meniere's disease or fluctuating hearing loss * cochlear or bone-anchored hearing device implantation * history of suicide * pregnancy * therapy with anticonvulsants * antipsychotic medication * heart pacemaker implantation * rtms performed in the past * not signing of the informed consent

Keywords: chronic tinnitus repetitive transcranial magnetic stimulation hypacusion depression treatment placebo medication therapy
single-dose study of a new formulation of biib061

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to assess the pharmacokinetic (pk) profile of biib061 in the new oral formulation in the fasted state in healthy male and female volunteers. the secondary objective of this study is to evaluate the safety and tolerability of biib061 in the new formulation in this study population.


Eligibility criteria:
key inclusion criteria: * males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone \[fsh\] levels determined at screening to be in the postmenopausal range) or surgically sterile females. * all male subjects must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. all male subjects must also be willing to refrain from sperm donation for at least 3 months after their dose of study treatment. * must be in good health and have normal vital signs as determined by the investigator, based on medical history and screening evaluations. * body mass index of 18.0 to 30.0 kg/m2, inclusive. key exclusion criteria: * history of or positive test result at screening for human immunodeficiency virus, hepatitis c virus antibody, or hepatitis b virus (defined as positive for hepatitis b surface antigen \[hbsag\] or hepatitis b core antibody \[hbcab\]). * prior exposure to biib061. * history of any clinically significant cardiac, endrocrinologic, hematologic, hepatic, gastric, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the investigator. * treatment with any prescription medication within 28 days prior to and throughout the duration of the study. * use of any over-the-counter products, including herbal or alternative health preparations within the 14 days prior to the study * enrollment in any interventional clinical study in which an investigational drug, biologic, device, or approved therapy for investigational use is administered or used within 30 days prior to the study * any live or attenuated immunization/vaccination given within 30 days prior to the study or planned to be given during the study. * blood donation within 30 days prior to the study * surgery within 3 months prior to the study note: other protocol defined inclusion/exclusion criteria may apply

Keywords: oral remyelination
a pilot trial in a sleep laboratory setting to observe night time bladder function of subjects with overactive bladder (oab)

Conditions: Bladder Function

Summary: this is an observational, pilot, non-treatment study to evaluate and develop clinical variables for distinguishing female oab subjects that have detrusor overactivity positive (do+) nocturia from female oab subjects that have detrusor overactivity negative (do-) nocturia utilizing a sleep laboratory setting.


Eligibility criteria:
inclusion criteria: * subject must have confirmed diagnosis of oab and oab symptoms for ≥ 3 months * subject must have documented detrusor overactivity * subject must not be taking any oab medication for at least 14 days * subject has no sleep related conditions (other than nocturia) exclusion criteria: * subject has active urinary tract infection (uti) * subject has significant stress incontinence or mixed stress/urge incontinence * subject has nocturnal polyuria * subject has history of sleep apnea * subject has indwelling urinary catheterization within 4 weeks * subject using medication that effects urinary and sleep function * subject is unable to refrain from alcohol or smoking during the sleep night stay * subject has an unstable medical or psychiatric disorder * subject has a history of cardiovascular concerns * subject is pregnant, breastfeeding or plans to become pregnant

Keywords: oab nocturia bladder function cystometry polysomnography
prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo

Conditions: Cystoid Macular Edema

Summary: prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.


Eligibility criteria:
inclusion criteria: * subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens. exclusion criteria: * previous uveitis (\<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to nsaids
study of postoperative icc analgesia

Conditions: Postoperative Analgesia

Summary: this study is to examine the analgesic effectiveness of continuous loco-regional analgesic application (ropivacaine) through surgically placed intercostal catheter (icc) and to establish correctly this method as a possible standard of care in the postoperative analgesia after video-assisted thoracoscopic surgery (vats) anatomical lung resection.

good control of the pain without excessive use of opiates supports the benefits of minimally invasive surgical procedure. this study is to examine the efficacy of continuously via surgically placed intercostal catheter administered ropivacaine at a flow rate of 6-8 ml/h of 2 mg/ml on post-operative pain (nrs) and pulmonary function (fev1, pef) during a maximum of 72 ± 2 hours after skin closure. patients undergoing video-assisted thoracoscopic anatomical resection of the lung under general anaesthesia with confirmed or anticipated stage i lung cancer will be included. the study will be conducted as superiority, double-blind, placebo-controlled, randomized. the efficacy of loco-regional administered ropivacaine will be compared to placebo (nacl, 0.9%) administration. the whole study period per participant is expected to be 6 months. in the follow-up, 6 months after surgery, the impact of ropivacaine on long-term pain (nrs, mcgill) and pulmonary function (fev1, pef) shall be evaluated.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * patient undergoing video-assisted thoracoscopic anatomical resection of the lung under general anaesthesia for confirmed or anticipated stage i lung cancer (uicc 8th edition) * american society of anesthesiologists (asa) physical status classes i to iii exclusion criteria: * nrs while coughing \> 0 * previous ipsilateral thoracotomy or sternotomy * abdominal or contralateral thoracic surgery up to 6 months preoperatively * contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product * contraindications to self-administration of opioids * women who are pregnant or breast feeding * chronic steroid therapy (e.g. prednisone \> 10mg/day for more than last 2 weeks before surgery) * chronic, daily pain therapy * congestive heart failure * liver insufficiency * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * participation in another study with investigational drug within the 30 days preceding and during the present study, * enrolment of the investigator, his/her family members, employees and other dependent person

Keywords: surgically placed intercostal catheter (icc) minimally invasive anatomical lung resection ropivacaine loco-regional analgesia thoracic analgesia video-assisted thoracoscopic surgery (vats)
effects of myofascial induction therapy on pressure pain and ankle range of motion.

Conditions: Fascia; Trigger Point Pain, Myofascial; Range of Motion; Pain

Summary: in this study, it will be assessed if there are changes in ankle dorsiflexion and pressure pain after performing the myofascial induction technique in the calf.


Eligibility criteria:
inclusion criteria: * subjects with no pain and with 18 to 30 years old. exclusion criteria: * (1) diagnosis of lower limb injury, including any tendinopathy, bursitis, ligamentous involvement or fasciitis , * (2) history of lower limb surgery , * (3) participants were required not to have undergone ankle stretching or any other treatment, * (4) diabetes due to possible alteration of arterial distal circulation, * (5) deformities of the toes, such as hammer toes and hallux valgus. all subjects signed an informed consent form before participating in the study
enhanced cue exposure therapy for negative emotional eating

Conditions: Disordered Eating Behaviors; Binge Eating

Summary: the current study aims to evaluate the efficacy of enhanced cue exposure therapy (e-cet) in reducing negative emotional eating (nee), compared to an active control intervention, behavioral lifestyle intervention (bli), in a parallel-group, participant-blinded, randomized controlled trial. the secondary aim is to evaluate whether changes in conditioned stimulus-unconditioned stimulus (cs-us) expectancies mediate the changes in nee.

participants will be randomly assigned to either the experimental treatment or control bli group. participants in the experimental group will receive 6 weeks of e-cet treatment and those in the control group will receive 6 weeks of behavioral counselling integrating behavioral strategies for making changes related to diet and exercise. outcomes will be assessed at baseline, posttreatment, and 3- and 12-month follow-ups. research question 1: is e-cet an efficacious intervention for reducing nee? hypothesis 1: e-cet will lead to greater reductions in nee at posttreatment and follow-up compared to bli. research question 2: does e-cet work via the violation of the cs-us expectancies? hypothesis 2: changes in the believability of cs-us expectancies will mediate the treatment effects of e-cet on nee.

Eligibility criteria:
inclusion criteria: * aged 18 or over * a score \>3.25 on the emotional eating subscale of the dutch eating behavioural questionnaire lasting for three months or longer * confirmed to have, on average, two or more nee episodes per week using ecological momentary assessments (emas) exclusion criteria: * active suicidal intent or plan * psychiatric illnesses except mood disorders, anxiety disorders, and eating disorders because mood and anxiety disorders and symptoms are common in those with nee * currently receiving psychotherapy, or adjusting to changing psychiatric medication * substance abuse * any conditions or circumstances that prevent the participant from receiving all treatment sessions

Keywords: emotional eating eating disorders obesity exposure and response prevention behavioral therapy randomized controlled trial violation of expectancy inhibitory learning habituation mechanism of change
act-mbc: a study of circulating tumor cells (ctcs) in metastatic breast cancer (mbc)

Conditions: Metastatic Breast Cancer

Summary: act-mbc prospectively assesses the impact of ctcs on treatment decisions, response assessment and prognosis in mbc patients.


Eligibility criteria:
inclusion criteria: 1. invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease 2. er+/her2- patients prior to starting 2nd line therapy or beyond or er/progesterone receptor (pr)/her2-negative (triple negative) patients prior to starting any line of therapy 3. measurable and/or non-measurable disease is allowed 4. male or female breast cancer is allowed 5. age \> 18 years 6. willingness to provide mandatory blood specimens 7. willing to return to enrolling institution for follow up imaging at least once exclusion criteria: 1. life expectancy of ≤ 6 months 2. inability to provide blood samples based on the judgment of the treating provider
interest of serum periostin dosage in patients with bone fibrous dysplasia

Conditions: Bone Fibrous Dysplasia

Summary: fibrous dysplasia is a rare bone disease which can cause pain and fractures. it has been shown that periostin is over expressed in fibrous component in patients bones ; but periostin has never been measured out in serum of patients, although it is easy to assess. this study aims to show whether serum periostin is elevated in serum of patients with fibrous dysplasia, and if it is more elevated in patients with severe forms of the disease.


Eligibility criteria:
inclusion criteria: * patients with fibrous dysplasia of the bone * access to social security * informed consent exclusion criteria: * no informed consent * pregnancy * patients with a history of conditions known to increase periostin serum (stade iv cancer, severe asthma, pulmonary fibrosis...)