Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of talazoparib, parp inhibitor, in japanese patients with advanced solid tumors

Conditions: Neoplasms; Breast Neoplasms

Summary: this is a phase 1 study which consists of 2 parts; dose escalation part and expansion part. the dose escalation part is open-label, and evaluates safety, preliminary efficacy and pk of single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available. in the dose escalation part, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed dlts. the expansion part is designed to assess the efficacy, safety and pk of single-agent talazoparib at rp2d determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline brca1 or brca2 mutations. in the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary endpoint.


Eligibility criteria:
\[dose escalation part\] inclusion criteria: * histological or cytological diagnosis of locally advanced or metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available. * ecog performance status 0 or 1. * adequate bone marrow, renal and liver function. exclusion criteria: * patients with known symptomatic brain metastases requiring steroids. * current use of a strong p-gp inhibitor, strong p-gp inducer, or strong inhibitor of bcrp within 1 week or 5 half lives which ever is longer prior to the first dose of study treatment. * fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception. \[dose expansion part\] inclusion criteria: * histologically or cytologically confirmed carcinoma of the breast. * locally advanced breast cancer that is not amenable to curative radiation or surgery and/or metastatic disease. * documentation of a deleterious, suspected deleterious, or pathogenic germline brca1 or brca2 mutation by myriad genetics' bracanalysis cdx test. * no more than 3 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease. * have measurable lesion by the recist v.1.1. * ecog performance status 0-2. * adequate bone marrow, renal and liver function. exclusion criteria: * first-line locally advanced or metastatic breast cancer with no prior neoadjuvant and adjuvant chemotherapy. * prior treatment with a parp inhibitor. * objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease. * her2 positive breast cancer. * active inflammatory breast cancer. * central nervous system (cns) metastases. * current or anticipated use within 7 days prior to the first dose of study treatment, or anticipated use during the study of strong p-gp inhibitors. * fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception.

Keywords: phase 1 talazoparib pf-06944076 mdv3800 bmn673 parp inhibitor japanese solid tumors breast cancer c3441030
a 5-year observational follow-up study to describe treatment patterns in real world of hcv patients in china.

Conditions: Hepatitis C

Summary: a 5-year study to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in protocol ai452009 (i.e., the ccgenos cross sectional phase, clinicaltrials.gov identifier: nct01293279) and had their genotype characterized at diagnosis of hcv infection in a real world clinical practice in china.

a sample of 600 han ethnic chinese male or female who are ≥ 18 years old enrolled and completed in the study of ai452-009 (i.e., ccgenos cross sectional phase, clinicaltrials.gov identifier: nct01293279). in the ai452-009 study, all patients had a recent confirmation of anti-hcv-antibody positive and hcv rna positive but antiviral treatment naive from 28 university affiliated hospital in china. the primary objective of this study (ai452-018, ccgenos follow up phase, clinicaltrials.gov identifier: nct01293279) is to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in protocol ai452009 (i.e., the ccgenos cross sectional phase, clinicaltrials.gov identifier: nct01293279) and had their genotype characterized at diagnosis of hcv infection in a real world clinical practice in china.

Eligibility criteria:
inclusion criteria: * none. patients from ai452-009 study who accepted icf to be follow up exclusion criteria: * \< 18 years old not han ethnic not be willing to be followed up to 5 years

Keywords: hcv viral genotypes host genotypes il28b outcome follow-up itpa rna china
taichi for overweight/obese adolescent and young women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: the present study is a randomized pilot study, overweight/obese adolescent and young pcos subjects will be assigned into two groups: taichi arm and control arm. hormonal profile and metabolic profile will be determined.


Eligibility criteria:
inclusion criteria: * women aged between 19 and 35 years; * diagnosis of pcos according to the modified rotterdam criteria; * 2 years after menarche; * body mass index (bmi) equal to or greater than 23 kg/m\*m. exclusion criteria: * administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, gonadotropin-releasing hormone (gnrh) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers. * patients with other endocrine disorder including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected cushing's syndrome. * patients with known severe organ dysfunction or mental illness.

Keywords: polycystic ovary sybdrome taichi
the accuracy of ultrasound in detecting rotator cuff tears in proximal humerus fracture patients

Conditions: Rotator Cuff Tear; Proximal Humeral Fracture

Summary: the aim of this study is to determine the diagnostic accuracy of ultrasonography (us) in detecting full-thickness (a lesion that extends through both the bursal and articular part of the tendon) rotator cuff tear in patients who have sustained a proximal humerus fracture, using operative examination as the golden standard.

although most of the focus concerning proximal humerus fractures is on the bony structures, injuries in the musculotendinous insertion regions of the rotator cuff musculature may also need attention in the treatment. ultrasound is a painless and non-invasive screening modality in patients with a suspected rotator cuff tear. it is a user-dependent modality and health professionals must possess the competence and training before using it. to the investigators knowledge, no studies have investigated the accuracy of ultrasound in detecting rotator cuff tears, in patients who sustained a proximal humerus fracture.

Eligibility criteria:
inclusion criteria: * displaced proximal humeral fracture * referred to operative treatment exclusion criteria: * younger than 18 years old * non-independent * does no understand written and spoken guidance in local language, danish, swedish or finnish * open fracture * isolated tuberculum fracture

Keywords: diagnostic ultrasound
a clinical study to investigate the effects of creatine supplementation on muscle energetics and cognitive function in young healthy male athletes and an ageing population

Conditions: Nutritional Status

Summary: this study will examine the impact of creatine supplementation on muscle function and cognitive performance in young and older subjects.

this is a randomised, double-blind study of the effects of creatine supplementation on muscle energetics and cognitive function, using 31p-mrs and fmri. 31p-mrs data will be acquired continuously during exercise phase and in the post-exercise metabolic recovery phase. participants will undergo a fmri scan of the brain to record changes in the blood oxygen level dependent (bold) signal during a series of cognitive tests. in addition, participants will undergo a resting state bold scan and a structural mri scan for localization of brain regions.

Eligibility criteria:
inclusion criteria: * healthy volunteer: group 1: male; group 2: male or female. * aged 18-35 years (group 1), or 50-70 years (group 2). * dietary protein intake at or near the current recommended daily amount (0.75 to 0.85 g protein/kg/day). * participation in regular physical activity (aerobic and resistance training) 2-3 times a week for at least 6 months before the study starts (group 1 only). * willingness to maintain a stable lifestyle throughout the study. exclusion criteria: * clinically relevant abnormal history, physical findings, ecg, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer. * presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous. * impaired endocrine, thyroid, hepatic, respiratory, neurological, or renal function, diabetes mellitus, cardiovascular disease, coagulation disorder, autoimmune disease, phenylketonuria, hyperlipidaemia, or history of any psychotic mental illness. * any impairment affecting mobility and muscle metabolism of the lower limbs (such as arthritis). * surgery (eg stomach bypass) or medical condition that might affect absorption of supplements. * inability to complete the structured exercise program. * blood pressure and heart rate in seated position at the screening examination outside the ranges 90-140 mm hg systolic, 40-90 mm hg diastolic; heart rate 35-100 beats/min (group 1) or 40-100 beats/min (group 2). * metal implants that may affect the mri scan, eg gold tooth or other metal dental devices (normal dental fillings are allowed), pacemaker, mechanical heart valve, replacement joint, shrapnel. if any metal in the body is identified, the investigators will make a decision, as to whether the subject should participate in the study. * history of claustrophobia or subject feels unable to lie still on their back for a period of 90 mins in the mri scanner, or subject unable to perform the required muscle exercise in the mri scanner.

Keywords: creatine functional magnetic resonance imaging (fmri) phosphorus-31 magnetic resonance spectroscopy (31p-mrs)
investigation of pharmacodynamic effects of dabigatran and ticagrelor and assessment of ticagrelor interaction potential with dabigatran

Conditions: Healthy

Summary: evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods


Eligibility criteria:
inclusion criteria: 1. healthy male subjects exclusion criteria: 2. any relevant deviation from healthy conditions
prevention of venous thromboembolism in patients undergoing elective total knee replacement surgery

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to examine the superiority of ym150 to the placebo and to evaluate the dose-dependent response of ym150 in patients undergoing elective total knee replacement surgery.


Eligibility criteria:
inclusion criteria: * subjects is scheduled for elective primary total knee replacement surgery * written informed consent obtained before screening exclusion criteria: * subject has history of deep vein thrombosis and/or pulmonary embolism * subject has a hemorrhagic disorder and/or coagulation disorder * subject has had clinically important bleeding occurred within 90 days prior to the screening visit * subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia * subject is receiving anticoagulants/antiplatelets

Keywords: ym150 thrombosis vte knee replacement anticoagulant fxa inhibitor
feasibility, acceptability, and preliminary effects of istdp for personality disorders in a specialized psychiatric clinic

Conditions: Personality Disorder

Summary: the primary objective of this study is to evaluate the feasibility and acceptability of a 25-week combined group and individual therapy program using intensive short-term dynamic psychotherapy (istdp) for patients diagnosed with personality disorders. the secondary objective is to investigate preliminary effects of the treatment in terms of reducing symtoms of depression, anxiety and emotion regulation difficulties.

the investigators vill investigate a 25-week treatment with istdp that consists of both weekly group- and individual therapy for patients diagnosed with personality disorder in a psychiatric clinic specialized on depression, anxiety and ptsd. the feasibility and acceptability and preliminary effects will be evaluated using a within-group design with repeated measures and qualitative interviews. patients will be recruited from the clinic and the main inclusion criteria is that the patient have a personality disorder diagnosis.

Eligibility criteria:
inclusion criteria: personality disorder diagnosis (clinical assessment using stip-5) speaks swedish fluently exclusion criteria: autism or intellectual disability borderline, antisocial or narcissistic personality disorder diagnosis need for interpreter urgent social misery psychotic disorder high suicidality

Keywords: personality disorder istdp intensive short-term dynamic psychotherapy
reviving early diagnosis of cardiovascular disease in the utrecht health project

Conditions: Coronary Artery Disease; Atrial Fibrillation; Heart Failure; Valvular Heart Disease

Summary: the goal of this randomized trial is to compare the diagnostic yield of a screen-like early diagnosis strategy to usual primary care to detect coronary artery disease (cad), atrial fibrillation (af), heart failure (hf), and/or valvular heart disease (vhd) in community people aged 50-80 years who participate in the utrecht health project. the diagnosis strategy consists of a questionnaire with questions related to symptoms suggestive of cad, af or hf, a focused physical examination, laboratory testing, electrocardiography, and echocardiography.


Eligibility criteria:
inclusion criteria: * aged 50-80 years * being a participant of lrgp * having indicated in the lrgp informed consent to be interested in participating in further research. exclusion criteria: * diagnosed with coronary artery disease and atrial fibrillation and heart failure. * undergoing major (cardiovascular) surgery, and/or revascularisation therapy and/or transplantation treatment within 3 months after enrolment. * not willing to give written informed consent for red-lrgp. * not allowing incidental findings to be reported to him/herself or their own gp.

Keywords: early diagnosis cardiovascular diseases cohort study primary health care
study evaluating ski-606 (bosutinib) in subjects with breast cancer

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: the purpose of this study is to determine if ski-606 (bosutinib) is effective in the treatment of advanced or metastatic breast cancer. patients must have current stage iiib, iiic or iv breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.


Eligibility criteria:
inclusion criteria: * stage iiib, iiic or iv breast cancer not curable with available therapy. * patients must have progressed after 1 but not more than 3 prior chemotherapy regimens. * life expectancy of at least 16 weeks. * ability to swallow whole capsules. exclusion criteria: * use of or requirement for bisphosphonates within 8 weeks prior to screening. * any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ * uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc. * recent or ongoing significant gastrointestinal disorder

Keywords: advanced breast cancer
analgesic efficacy of valdecoxib in patients following bunion surgery

Conditions: Pain, Post-surgical

Summary: to assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.


Eligibility criteria:
inclusion criteria: * patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) requiring open manipulation of bone with periosteal elevation under regional anesthesia (mayo block) * patients had a baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a vas exclusion criteria: * patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone * patients treated with patient controlled analgesia (pca) subsequent to the end of anesthesia * patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space * patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids

Keywords: hallux valgus
main pancreatic duct diameter

Conditions: Pancreatic Duct Dilatation

Summary: the maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts: * pancreatic head * pancreatic neck * pancreatic body * pancreatic tail

all patients without pancreatic or biliary disorders undergoing upper-gi endoscopic ultrasound (eus) are eligible for the study. the maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound in millimeters at four different parts: * pancreatic head * pancreatic neck * pancreatic body * pancreatic tail

Eligibility criteria:
inclusion criteria: * patients undergoing eus for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper gi-tract * indication for eus is undependent from the study * written informed consent * age ≥18 years exclusion criteria: * pancreatic diseases (chronic or acute pancreatitis, pancreatic tumor, pancreatic cyst, etc.) * disorders of papilla duodeni major/minor (adenoma/carcinoma of papilla duodeni major or minor) * biliary disorders (bile duct stones, cholangio carcinoma, cholangitis) * elevated bilirubin and/or lipase
phase iii randomized, placebo-controlled, crossover study of soy protein isolate for hereditary hemorrhagic telangiectasia

Conditions: Hereditary Hemorrhagic Telangiectasia

Summary: objectives: i. evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia. ii. assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients.

protocol outline: this is a randomized study. one group of patients is treated with soy protein isolate for 12 weeks. the control group receives a placebo for 12 weeks. patients cross to the alternate group following a 4-week washout.

Eligibility criteria:
* hereditary hemorrhagic telangiectasia (hht) with 2 of the following: * first-degree relative with hht * history of recurrent epistaxis or gastrointestinal bleeding * three or more skin telangiectasia * migraine headache meeting international headache society criteria 3 or more times a month for more than 1 year * no pattern of daily headaches * no severe head trauma * no onset of headaches after 50 years of age * at least 1 month since migraine prophylaxis * at least 1 month since any of the following medications: beta blockers; calcium channel blockers; divalproex sodium; tricyclic antidepressants; selective serotonin re-uptake inhibitors * concurrent regular treatment for migraine and gastrointestinal hemorrhage allowed * creatinine no greater than 2.5 g/dl * no allergy to soy * no pregnant women * no women with intent to become pregnant

Keywords: genetic diseases and dysmorphic syndromes hematologic disorders hereditary hemorrhagic telangiectasia rare disease
impact of intravitreal aflibercept injections on capillary non-perfusion

Conditions: Central Retinal Vein Occlusion; Proliferative Diabetic Retinopathy

Summary: the purpose of this study is to look at how effective, safe, and well tolerated intravitreal aflibercept injection is in subjects with central retinal vein occlusion (crvo) or proliferative diabetic retinopathy (pdr).

protocol available upon request.

Eligibility criteria:
inclusion criteria: 1. diagnosis of one or more of the following: proliferative retinopathy (pdr) macular edema secondary to crvo proliferative disease secondary to crvo (anterior segment or posterior segment neovascularization). 2. be in need of iai treatment, whether previously treated or treatment-naïve. 3. age \> 18 years. exclusion criteria: 1. subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy. 2. subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible. 3. presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc. 4. active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye. 5. uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmhg despite treatment with anti-glaucoma medication). 6. history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye. 7. participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study. 8. intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline. 9. history of vitrectomy surgery in the study eye. 10. subjects with 12 or more anti-vegf injections within 24 months prior to screening. 11. subjects who received anti-vegf therapy within 30 days of screening or received steroid or laser therapy within 90 days of screening. 12. subjects allergic to fluorescein, povidone iodine (betadyne) or aflibercept 13. pregnant or breast-feeding women.