Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of tamoxifen and its metabolites in breast cancer patients: the influence of a dose increase in phenotypic poor metabolizers of cyp2d6 (kinetam)

Conditions: Breast Cancer

Summary: all women on tamoxifen receive the standard dose of 20mg qd, irrespective of the use of potential cyp2d6 inhibitors, and are not tested for cyp2d6 polymorphisms prior to start of tamoxifen treatment.however cyp2d6 polymorphisms and/or the use of cyp2d6 inhibitors as co-medication may influence the treatment outcome of tamoxifen. the investigators propose a prospective study in women taking tamoxifen at a dose of 20mg qd. in each woman, information will be collected on endoxifen levels, cyp2d6 status, adherence and use of co-medication. in women who are phenotypically poor metabolizers of tamoxifen, a dose increase to 40mg qd will be applied and the effect of this intervention on tamoxifen pharmacokinetics will be evaluated after 4 weeks.

although already some information is available on the importance of cyp2d6 polymorphisms and/or the use of cyp2d6 inhibitors as co-medication that may influence the treatment outcome of tamoxifen, this information does currently not lead to a change in the management of this patient population. all women on tamoxifen receive the standard dose of 20mg qd, irrespective of the use of potential cyp2d6 inhibitors, and are not tested for cyp2d6 polymorphisms prior to start of tamoxifen treatment. in an attempt to at least resolve some of these issues we propose a prospective study in women taking tamoxifen at a dose of 20mg qd who are being followed at several large oncology clinics in the south-eastern part of the netherlands (nijmegen (cwz \& radboud), den bosch, harderwijk and arnhem). in each woman, information will be collected on endoxifen levels, cyp2d6 status, adherence and use of co-medication. in women who are phenotypically poor metabolizers of tamoxifen, a dose increase to 40mg qd will be applied and the effect of this intervention on tamoxifen pharmacokinetics will be evaluated after 4 weeks.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years at screening. * subject is able and willing to sign the informed consent form prior to screening evaluations. * subject is a female patient with (a history of) breast cancer and has been treated with tamoxifen 20mg qd for at least 4 weeks and is expected to be treated for at least another 4 weeks exclusion criteria: * inability to understand the nature and extent of the trial and the procedures required. * participation in a drug trial within 60 days prior to the first dose.

Keywords: breast cancer tamoxifen pharmacokinetics pharmacogenetics cyp2d6
pacific-fit: providing adults collaborative interventions for ideal changes focused intervention and tracking

Conditions: Overweight; Obesity

Summary: the pilot study will be a one group treatment program and will be utilized to refine the m+bwl program.

the investigators have developed a new model for the treatment of obesity, which emphasizes the role of memory on food consumption in an overweight population.the pilot study will be an open label trial of a memory+behavioral weight loss (m+bwl) group treatment. the treatment will be administered in 14 group sessions over 16 weeks. the investigators will recruit adults with overweight and obesity and will assess them at baseline (prior to treatment), during treatment, post-treatment (immediately following treatment), and follow-up (3 months after treatment). assessments will include body mass index (bmi), body composition, and binge eating over the course of treatment and follow-up. this study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.

Eligibility criteria:
inclusion criteria: 1. participant must be overweight (bmi between 25-45) 2. participant must be between the ages of 18-65 3. participant can read at a minimum of an 5th grade level in english 4. participant is willing to participate and to commit to 16 weeks of treatment and attendance at assessments 5. participants must consent to audio-taping of assessment interviews and treatment group sessions. 6. participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe. exclusion criteria: 1. participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires. 2. participants will not be moving out of the san diego area for the duration of their study enrollment (7 months). 3. participants will not be pregnant, planning to get pregnant during the 7-month study period or lactating. 4. participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance. 5. participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous, or would influence weight and eating, or cognitive functioning, such as attention, concentration, or mental status will not be included. 6. participants cannot have a history of bariatric surgery 7. participants cannot currently be enrolled in an organized weight control program.

Keywords: overweight obesity overeating body mass index weight treatment cravings intervention behavioral treatment
mind the gap - crossing borders study

Conditions: Emphysema; COPD; Hyperinflation Lung

Summary: rationale: a big step forward and great opportunity to improve overall efficacy of bronchoscopic lung volume reductioen is to combine treatment modalities aiming to close the dependent collateral channels and then proceed with ebv therapy to induce lobar collapse, and thus maximal treatment effect. objective: primary objective: 1. to investigate the feasibility of injecting aeriseal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. secondary objectives: 2. to investigate the safety of injecting aeriseal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. 3. to investigate the effectiveness of injecting aeriseal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.


Eligibility criteria:
inclusion criteria: 1. diagnosis of emphysema with a treatable target for endobronchial valves (zephyr). 2. subjects of both genders of at least 35 years of age at the time of the baseline visit. 3. understand and voluntarily sign a patient informed consent form. 4. 15 % predicted ≤ fev1 ≤ 50% predicted. 5. rv ≥ 175% predicted, and tlc ≥ 100% predicted and rv/tlc ≥ 55%. 6. 6mwd ≥ 140 meters. 7. dyspnea score of ≥2 on the mmrc scale of 0-4. 8. non-smoker \> 6 months prior to signing the informed consent. 9. chartis cv positive between target and ipsilateral lobe exclusion criteria: 1. evidence of active pulmonary infection. 2. evidence of clinically significant bronchiectasis. 3. history of more than 3 exacerbations with hospitalizations over the past 12 months. 4. myocardial infarction or other relevant cardiovascular events in the past 6 months. 5. prior lung surgery, lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy. 6. prior endoscopic lung volume reduction. 7. unstable pulmonary nodule requiring follow-up 8. pregnant of nursing women. 9. hypercapnia defined by paco2 \> 8.0kpa, or hypoxemia defined by pao2 \< 6.0kpa, both measured on room air. 10. any disease with high probability of mortality within 24 months. 11. patient is on an antiplatelet agent (such as plavix) or anticoagulant therapy (such as lmwh or coumarins), which cannot be stopped periprocedural. 12. patient was involved in other pulmonary drug studies within 30 days prior to this study. -
expert@work - effectiveness of a digital expert team on return to work

Conditions: Musculoskeletal Diseases; Mental Disorder

Summary: long-term sick leave is a challenge in norway, and the healthcare and labor- and welfare services are often not coordinated in helping the sick-listed employees return to work. in this study, the investigators want to evaluate the effectiveness of an intervention where an expert team provides advice for an individualized patient pathway based on information from a digital questionnaire and a video meeting with the sick-listed employee and the participant's general practitioner. the patient pathway should include both healthcare and labor- and welfare services measures. sick-listed patients with musculoskeletal- and/or common mental disorders are invited to join the study. they will receive a digital questionnaire and be randomized to either treatment as usual or personalized advice from an expert team. the team will be put together based on the response from the individual's questionnaire. the investigators will evaluate the effect on return to work and the use of health care services 12 months after the intervention.


Eligibility criteria:
inclusion criteria: * sick-listed minimum 50% between 11 and 20 weeks * musculoskeletal disorder and/or common mental disorder * living in the county of trøndelag or møre- og romsdal exclusion criteria: * specific conditions such as fracture, trauma, infections, malignancy, dislocations, etc. * serious mental conditions or another serious disease that makes participation difficult * most likely to return to work within 2 weeks * not speaking/reading norwegian
endothelial progenitor cells and pulmonary idiopathic arterial hypertension

Conditions: Pulmonary Idiopathic Arterial Hypertension

Summary: endothelial dysfunction ultimately represents an imbalance between the magnitude of injury and the capacity for repair. current evidence established that endothelial progenitor cells (epc) participate in several models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery disease, etc. however epc in the setting of pah is less well established. the target of this study is to demonstrate if the number of epc is increased in a mexican population of patients with pah.


Eligibility criteria:
inclusion criteria: * patients were included in the study if they were in the who functional class ii to iii, and had a mean pulmonary artery pressure \>30 mm hg on right heart catheterization. the ability to walk \>50 m during a standardized 6-min walk test. exclusion criteria: * pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, hiv infection, liver disease, major bleeding requiring blood transfusion,renal dysfunction, and evidence for malignant diseases were excluded.
scapular stabilization exercise on neck pain

Conditions: Neck Pain

Summary: neck pain is a very common problem in the population. most of the patients suffer from neck pain for long time and the problem becomes chronic. the investigators studied the effects of scapular stabilization exercise on mechanical neck pain.

neck is one of the most common musculoskeletal problem in the world. yet the problem still haven't been understood and solved completely. its incidence is also becoming higher and most people who have neck pain suffer from it for long time. several problems have been related to neck pain. hence, the investigators designed a study to see the effects of scapular stabilization exercise on neck pain.

Eligibility criteria:
inclusion criteria: * having neck pain at least 6 months * having score of at least 10 points from neck disability index * having type-1, type-2 or type-3 scapula from kibler's four types rating system * no previous shoulder or neck surgery * no accompanying shoulder problem exclusion criteria: * no complying to the rehabilitation * if patient wants to finished and don't want to complete study, they were excluded

Keywords: scapula neck pain therapy kinematic
stockholm myocardial infarction with nonobstructive coronaries study 3

Conditions: Myocardial Infarction with Nonobstructive Coronary Arteries

Summary: the present pilot study will investigate the prevalence of cmd in an unselected cohort of patients with the working diagnosis minoca and to study if the diagnostic yield can be improved by adding adenosine to the cmr investigation. patient will be their own controls.


Eligibility criteria:
inclusion criteria: * a suspected diagnosis of minoca or takotsubo syndrome with coronary angiography without diameter stenosis ≥50% * age 35-80 years * reading and writing proficiency in swedish exclusion criteria: * claustrofobia * arrythmia and/or pacemaker (atrial fibrillation and av-block i- iii) * asthma or severe chronic obstructive lung disease * egfr \< 30 ml/min * spontaneous coronary artery dissection * acute pulmonary embolism * acute myocardial infarction type 2 * cardiomyopathy other than takotsubo syndrome * a previous myocardial infarction due to cad
fluid optimization in liver surgery

Conditions: Cancer of Liver

Summary: the purpose of this study is to analyze hemodynamic changes, in patients undergoing liver resection, through the vigileo/flotrac system.

to reduce bleeding, hepatectomies are performed with low central pressure (cvp) combined with extrahepatic control flow. this management can lead hemodynamic instability and reduction in oxygen delivery so an advanced monitoring should be used. this study analyzes hemodynamic changes, in patients undergoing liver resection, through the vigileo/flotrac system.

Eligibility criteria:
inclusion criteria: * asa i-iii exclusion criteria: * cirrhosis * systolic ventricular contractility or diastolic relaxation alterations * ischemic or valvular diseases * absence of sinusal rhythm * impaired renal function

Keywords: intraoperative monitoring fluid management
efficacy and safety study of bhv-7000 monotherapy in major depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine the efficacy and safety of bhv-7000 in participants with major depressive disorder (mdd)


Eligibility criteria:
key inclusion criteria: 1. subjects experiencing a moderate to severe episode of depression. 2. subjects experiencing a current episode of depression for at least 2 months. 3. subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study. 4. male and female participants 18 to 75 years of age at the time of consent. 5. body mass index (bmi) must be ≥ 18 kg/m2 and ≤ 35 kg/m2. key exclusion criteria: 1. subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit. 2. subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study. 3. subjects with a history of medical conditions that may interfere with the conduct of the study. 4. females who are pregnant, breastfeeding or planning to become pregnant.

Keywords: depression depressed depressive disorder major depression major depressive episode antidepressant
study of muraglitazar versus pioglitazone in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare muraglitazar and pioglitazone in patients with type 2 diabetes. both the safety and blood sugar lowering effects of these treatments will be studied.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c \> = 8.0% and \< = 12.0% * serum triglyceride concentration \< = 600 mg/dl * fasting c-peptide \> = 1.0 ng/ml * body mass index \< = 41 kg/m2 * drug naive patients exclusion criteria: * history of mi (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (tia), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related chf (congestive heart failure) within six months prior to screening and during the lead-in phase. * women of child bearing potential * uncontrolled hypertension, chf defined as new york heart association (nyha) class ii, iii and iv, exacerbation of previously stable chf (any nyha class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the lead-in phase. * history of renal disease, bladder cancer, pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Keywords: type 2 diabetes
perinatal outcomes and hematologic parameters in covid-19 pregnancies

Conditions: Pregnancy, Infections in; Covid19

Summary: complete blood count parameters are routinely evaluated cost-effective markers in diagnosis and clinical follow-up of infectious diseases.there is increasing number of studies to report the course of covid-19 in pregnancy. the current study aimed to elucidate the changes in hematologic parameters in response to sars-cov-2 infection and whether there was an increase in adverse perinatal outcomes such as increased neonatal intensive care unit admission and lower apgar scores in pregnancies with covid-19.

the objective of this study is to evaluate the relationship between coronavirus disease 2019 (covid-19) in pregnancy and adverse perinatal outcomes. the secondary aim is to analyze the diagnostic value of hematologic parameters in covid-19 complicated pregnancies.the current study is conducted in a high volume tertiary obstetrics center burdened by covid-19 pandemics, in turkey, between march 20 and july 25, 2020. the study included a pregnant women cohort who had been regularly followed up and delivered in our clinics. the cohort was divided into two groups to reveal the impact of covid-19 on the complete blood count cell indices and unfavorable obstetric and early neonatal outcomes in pregnant women. the clinically confirmed diagnosis of covid-19 cases were included in study group (n=39) the healthy pregnant women without covid-19 were included in control group (n=69). the study achieved a power of 0.89 and 0.98 with a 5% level of significance.

Eligibility criteria:
inclusion criteria: * spontaneous pregnancy, * singleton pregnancy, * clinically diagnosed covid-19 (sars-cov-2 positivity in real time-polymerase chain reaction) exclusion criteria: * chronic maternal diseases (rheumatological diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, hypo-hyperthyroidism, congenital hematological disorders), * acute inflammatory conditions (acute pancreatitis, acute appendicitis), * pregnancy complications (gestational diabetes, pprom, preeclampsia), * multiple pregnancies, * anticoagulant medication.

Keywords: covid-19 pregnancy complete blood count perinatal outcome monocyte/lymphocyte ratio (mlr)
physical inactivity and appetite regulation

Conditions: Overweight

Summary: the goal of this parallel-group, two-arm, assessor-blinded, randomised clinical trial is to investigate the effects of reducing physical activity on food intake and satiety in physically active and healthy males, 40-55 years of age. the main questions it aims to answer are: * does physical inactivity affect glp-1 stimulated food intake? * does physical inactivity affect food preferences, satiety and other mechanisms supporting appetite regulation? participants will be randomised (1:1) to two weeks of either no intervention (control group) or inactivity. inactivity will be implemented as cessation of active commuting and all other structured exercise. furthermore, steps will be reduced to a maximum of 1500 steps/day. researchers will compare the inactivity group to the control group to see if physical inactivity impairs appetite regulation.


Eligibility criteria:
inclusion criteria: 1. male 2. age ≥ 40 years and ≤ 55 years 3. body mass index (bmi) \> 20 and \< 25 kg/m2 4. physical activity level should as a minimum include: active commuting by biking a minimum of 10 km, four days per week or an equivalent amount of other physical activity four days per week. 5. healthy (based on self-reporting, pre-study medical examination and biochemical screening) 6. can adhere to two weeks of inactivity (refrain from running, cycling and all other exercise while reducing steps to max. 1500 pr. day) 7. caucasian 8. no change in body weight \> 5 kg within the last 6 months 9. eats breakfast and lunch daily 10. does not follow specific dietary restrictions 11. no disliking of spaghetti bolognese 12. no diagnosis of psychiatric disorder or treatment with anti-depressant or anti-psychotic medication 13. no history of suicidal behavior or ideations. 14. no previous surgical treatment for obesity 15. no cardiovascular disease 16. no rheumatologic disease 17. no metabolic/endocrine disease 18. no liver disease (asat or alat \>2x upper normal range) 19. no other chronic disease 20. no elite sports 21. no frequent or chronic use of medications affecting bodyweight, physical performance, or inflammation (nsaids, dmards, corticosteroids) 22. no current infection 23. no history of cancer 24. no anemia (hematocrit \<33%) 25. no smoking 26. no participation in other research intervention studies exclusion criteria: 1. clinical or biochemical signs of disease 2. hba1c \> 39 mmol/mol 3. unable to allocate the needed time to fulfill the intervention 4. language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions
methadone/buprenorphine cross-over study - 4

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to explore ways to cross patients over from methadone to buprenorphine.


Eligibility criteria:
inclusion criteria: m/f ages 21-50. opiate dependence according to dsm-iv critera. self-reported use within the last 30 days. agreeable to conditions of study and signed informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nursing women. dependence on etoh or benzodiazepines or other sedative-hynotics. acute hepatitis. other medical conditions that deem participation to be unsafe.
a multicenter, phase 3 randomized, double-blind, vehicle-controlled study evaluating the safety and efficacy of qtorin 3.9% rapamycin anhydrous gel in the treatment of pachyonychia congenita

Conditions: Pachyonychia Congenita

Summary: this study evaluates the safety and efficacy of qtorin 3.9% rapamycin anhydrous gel in the treatment of adults with pachyonychia congenita. this study includes a screening period, baseline period and 6-month treatment period.


Eligibility criteria:
key inclusion criteria: * adult patients, 18 years or older (16 years or older in the uk) * diagnosed with pachyonychia congenita (pc), genetically confirmed key exclusion criteria: * any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications. * any significant concurrent condition (including conditions involving or inferior to the ankle) that could adversely affect the patient's participation and/or the assessment of the safety and efficacy in the study. * participation in any other interventional clinical research trial within 30 days prior to the screening visit or during the patient's participation in this study