Kornimate/medical-research-clean huggingface dataset:
azd3293 thorough qt study in healthy male volunteers

Conditions: Alzheimer's Disease

Summary: a thorough qt study of azd3293

a single-center, randomized, double-blinded, placebo-controlled, 4-way cross-over study to assess the effect of a single oral dose of azd3293 administration on qtc interval compared to placebo, using open-label avelox (moxifloxacin) as a positive control, in healthy male subjects

Eligibility criteria:
inclusion criteria: 1. provision of signed, written and dated informed consent prior to any study-specific procedures 2. healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements 3. healthy male subjects aged 18 to 55 years 4. body weight ≥ 50 to ≤ 100 kg and body mass index (bmi) ≥19 to ≤30 5. clinically normal findings on physical examination in relation to age, as judged by the investigator. exclusion criteria: 1. history of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study 2. history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs 3. history of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder 4. history of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury 5. history of psychotic disorder among first degree relatives

Keywords: thorough qt study
sulodexide, vessel®, for the prevention of recurrent venous thromboembolism (the jason study)

Conditions: Venous Thromboembolism; Anticoagulant; Elderly

Summary: the study aims at optimizing extended management of elderly patients (\> 75 years) with at least one of the known bleeding risk factor, who suffered from first episode of venous thromboembolism of the lower extremity (proximal deep vein thrombosis with or without pulmonary embolism) (vte). patients were randomized to receive three different treatment: sulodexide 250 mg bis in die; sulodexide 500 bid in die or indistinguishable placebo to verify the efficacy and safety of extended treatment for 12 months with sulodexide (vessel®) in the secondary prevention of deep vein thrombosis / pulmonary embolism (dvt/pe) recurrence.

this prospective cohort study aims to assess the efficacy and safety of the extended treatment with sulodexide (vessel®) in the secondary prevention of dvt / pe recurrence in elderly outpatients (≥ 75 years old at the time of inclusion) ), with at least one of the known bleeding risk factor, who had a first episode of lower extremity proximal dvt and / or pe, idiopathic or associated with weak or removed risk factors, and who have received standard treatment with any oral anticoagulant drug lasting at least 3 months. the study seeks to verify the safety of the sulodexide therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not \> 3%).

Eligibility criteria:
inclusion criteria: 1. patients with a first event of proximal lower extremity dvt and / or pe, idiopathic or associated with weak or removed risk factors. 2. patients aged ≥75 years at the time of enrolment 3. patients with at least one of the known risk factors of bleeding (appendix 1): 1. hypertension 2. renal failure 3. thrombocytopenia 4. diabetes 5. antiplatelet therapy (asa maximum 140 mg/die) 6. frequent falls (\>2 /years) 7. nonsteroidal anti-inflammatory drug 8. liver failure 9. previous stroke 10. anemia 11. poor anticoagulant control 12. alcohol abuse 4. patients of both sexes. 5. patients who at the time of enrolment have already undergone a period of anticoagulant therapy (at, with any medication) of at least 3 months and the therapy has not been suspended for more than 30 days. 6. patients with no other at indications. 7. patients capable and able to provide informed consent exclusion criteria: 1. patients aged \<75 years at the time of the recruitment visit. 2. "provoked" index event, which occurred: * within 3 months of surgery or major trauma, * bed rest \> 4 days, * cast / immobility within 3 months. 3. index event represented by severe pe, with life threatening risk or treated with thrombolytic therapy. 4. index event represented by isolated distal dvt or superficial venous thrombosis. 5. thrombotic event in sites other than the deep proximal veins of the lower limbs. 6. anticoagulant therapy for less than 3 months at the time of enrolment. 7. discontinuation of anticoagulant therapy for over thirty days at the time of enrolment 8. recurrent episodes of dvt ± pe

Keywords: venous thromboembolism elderly sulodexide
intra-op vs pre-op transbronchial localization for small lung nodule

Conditions: Lung Cancer

Summary: comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.

using electromagnetic navigation bronchoscopy (enb), transbronchial localization can be performed in the operating room (or) under general anesthesia without extra radiation exposure, which is expected to reduce the discomfort for the patient during localization. this study will be carried out at the hsinchu branch of national taiwan university hospital. it is expected that 40 patients with pulmonary nodules will be randomly assigned into two groups. one group will receive bronchoscopic dye localization in the hybrid examination room equipped with cone-beam computed tomography, and the other group will receive enb-guided dye localization in or. the primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

Eligibility criteria:
inclusion criteria: a. one of each: lung nodule size less than 1 cm; depth more than 2 cm; ggo lesion b. 20\~90 years old c. sign permit exclusion criteria: a. previous emphysema, tb, copd b. previous ipsilateral thoracic surgery c. bleeding tendency d. heart failure, cirrhosis, ckd e. pregnancy or breast feeding f. immunocompromised g. severe infection h. unable to sign permit
efficacy and safety,long-term study of low-dose oral contraceptive pill to treat dysmenorrhea.

Conditions: Dysmenorrhea

Summary: the purpose of this long-term study is to determine whether combination oral contraceptive pill of norethindrone \& ethinyl estradiol is effective in the treatmentof dysmenorrhea associated with endometriosis.


Eligibility criteria:
inclusion criteria: * dysmenorrhea associated with endometriosis exclusion criteria: * severe hepatopathy * pregnant woman
efficacy of metformin and diane-35 on pcos patients,a randomized, controlled, prospective clinical trial

Conditions: Polycystic Ovary Syndrome; Insulin Resistance

Summary: polycystic ovary syndrome (pcos) is one of the most common endocrinopathies in reproductive-age women, and it affects 5-7% of this group. it is characterized by disturbed menstrual cycle, ovulatory dysfunction and hyperandrogenism. over 40% of pcos women might become the patients with impaired glucose tolerance or type 2 diabetes. it has been confirmed that insulin resistance (ir) is a common feature in pcos and adipokines might play roles in the pathogenesis of ir and pcos, because these adipokines have wide-ranging effects on carbohydrate and lipid metabolism. the present clinical trial intends to compare the effects of metformin and oral contraceptives on pcos patients, focusing on the insulin sensitivity, ovulation, and menstrual cycle etc. the investigators also aim to study the effects of metformin on serum adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in pcos patients.


Eligibility criteria:
inclusion criteria: with at least two of the following features : (i) oligo-amenorrhea or chronic anovulation; (ii) clinical and/or biochemical hyperandrogenism; (iii) ultrasound appearance of polycystic ovaries exclusion criteria: - other known causes of hyperandrogenemia and ovulatory dysfunction, including 21-hydroxylase deficiency, congenital adrenal hyperplasia, cushing's syndrome, androgen-secreting tumors, thyroid disease, and hyperprolactinemia. use of hormone medications (including oral contraceptives) within the past month and the use of medicines that affect insulin sensitivity (e.g., metformin or thiazolidinediones) within the past three months

Keywords: polycystic ovary syndrome insulin resistance
a 2 week blinded study for pain due to arthritis of the knee

Conditions: Osteoarthritis

Summary: the primary aim is to assess if pf-00592379 is able to reduce pain in patients with osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * male or female of any race * between the ages of 18 and 75 years * knee pain due to osteoarthritis exclusion criteria: * pregnant * participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline * history of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year
hope social media intervention for hiv testing and studying social networks

Conditions: HIV

Summary: this study \[hope: harnessing online peer education\] seeks to determine the efficacy of using online social networks to scale peer community leader models to increase hiv prevention within african-american and latino men who have sex with men. the peer community leader model, which teaches community popular opinion leaders about how to disseminate behavior changes messages throughout the community, has been proven to increase hiv prevention behaviors. social media and online communities, such as facebook, may be a cost-effective platform for scaling these models. primarily upper middle-class white populations used the internet in its early years, however, internet use within african-american and latino households has recently increased dramatically, especially on social media. people using the internet may be at the highest risk for contracting hiv and are using novel internet approaches to find sex partners, such as through social media. this is the first study to examine the effectiveness of the hope social media intervention to increase hiv testing among at-risk groups in the united states.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * male * sexually active with another man in the last 12 months * willing and capable of understanding and assenting to an online informed consent form * has (or willing to create) a social media page. exclusion criteria: * does not satisfy inclusion criteria
angiogenic factors in the conservative management of gestational hypertension

Conditions: Gestational Hypertension

Summary: hypertensive disorders of pregnancy (hpt) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. the only cure for the is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. one of the most controversial scenarios is gestational hypertension, a group of hypertensive disorders considered the mildest form of the pre-eclamptic spectrum, where current recommendations indicate termination of pregnancy at 37 weeks. however, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known. the purpose of the study is to use angiogenic factors as a guide to decide the most appropriate gestational age for termination of pregnancy in patients diagnosed with gestational hypertension.


Eligibility criteria:
inclusion criteria: * pregnant women between 24 and 40 weeks of gestation. * diagnosis of gestational hypertension based on acog criteria * index sflt-1/pigf equal or below 33 exclusion criteria: * multiple gestation * maternal vasculitis * previous cesarean section (3 or more) * neurological conditions * chronic renal disease * purpura * heart disease * index sflt-1/pigf of 34 or more

Keywords: gestational hypertension angiogenic factors
understanding the differences in the management of patients with arthritis of the knee or hip

Conditions: Osteoarthritis; Arthritis, Degenerative; Osteoarthritis, Hip; Osteoarthritis, Knee

Summary: the purpose of this study is to examine cultural and clinical context factors in african-american and white veterans with knee or hip osteoarthritis with a focus on how these factors may be potentially modifiable determinants of willingness to consider joint replacement.

the study focuses on identifying potentially modifiable determinants of patients� willingness to consider joint replacement as a treatment option for osteoarthritis of the knee or hip. this line of research is informed by not only our prior work but also recent studies on health disparities and patient decision-making. our long-term goal is the development and evaluation of interventions to target these determinants of willingness in order to eliminate ethnic disparities in joint replacement. the study findings will assist in laying the groundwork for the design of such interventions for patients with osteoarthritis.

Eligibility criteria:
inclusion criteria: 1. chronic, frequent knee or hip pain based on the national health and nutrition examination survey 2. age \>50 and \<80 (at least 50 but not to exceed 79 years of age) 3. severe or extreme knee or hip oa on the western ontario and mcmaster universities osteoarthritis index (i.e., score greater than or equal to 39) exclusion criteria: 1. prior history of knee or hip joint replacement 2. terminal illness (i.e., end-stage cancer, chf, copd, etc.) 3. physician-diagnosed inflammatory arthritis 4. dementia 5. prosthetic leg

Keywords: racial/ethnic health disparities attitudes osteoarthritis management patient perceptions
registry for chronic obstructive pulmonary disease with pulmonary thromboembolism in china

Conditions: COPD; PTE - Pulmonary Thromboembolism

Summary: chronic obstructive pulmonary disease (copd) is closely related to venous thromboembolism (vte). but it is difficult to identify vte in copd patients in clinical practice. therefore, the prevalence data of pte in copd is limited. pulmonary thromboembolism (pte) is an important factor effecting patients outcomes, but existing researches only have short follow-up time less than 1 year. this study aim to develop an early detection system of pte in copd and explore the disease course and prognosis.


Eligibility criteria:
inclusion criteria: * patients hospitalized for chronic obstructive pulmonary disease (copd) exacerbation exclusion criteria: * stable copd patients * copd hospitalized for definite causes other than pulmonary thromboembolism * patients with malignant tumor * patients with contraindications for ct pulmonary angiography * psychopath
68ga-pentixather and 68ga-pentixafor pet/ct in multiple myeloma

Conditions: Multiple Myeloma

Summary: chemokine receptor-4 (cxcr4) is overexpressed in multiple myeloma (mm) cells. 68ga-pentixafor is a radio-labled tracer for cxcr4 . 68ga-pentixafor pet/ct has shown good diagnostic performance in mm. but an exchange of ga3+ by lu3+ or y3+ will lead to a significant loss of cxcr4 affinity. investigators conduct this prospective study to evaluate the diagnostic performance of 68ga-pentixather compared with 68ga-pentixafor, in order to parallel 68ga-pentixather and 177lu/90y-pentixather in theranostics of mm.

multiple myeloma (mm) is a malignant plasma cell disorder which is characterized by clonal proliferation of plasma cell in bone marrow microenvironment. chemokine receptor-4 (cxcr4) is overexpressed in mm cells, and has been identified as a potential therapy target. 68ga-pentixafor is a radiolabeled ligand with high affinity for cxcr4. 68ga-pentixafor pet/ct has been reported with better diagnostic performance than 18f-fdg pet/ct. however, considering both diagnostic and therapeutic applications, an exchange of ga3+ by other m3+ ions (lu or y) will lead to a significant loss of cxcr4 affinity. thus, pentixather was developed as the precursor of 177lu-pentixather or 90y-pentixather, which can be used in cxcr4-targeted peptide receptor radionuclide therapy (prrt). investigators conduct this prospective study to evaluate the diagnostic performance of 68ga-pentixather compared with 68ga-pentixafor, in order to parallel 68ga-pentixather and 177lu/90y-pentixather in theranostics of mm.

Eligibility criteria:
inclusion criteria: 1. suspected or confirmed untreated multiple myeloma (mm), relapsed mm, mm in remission 2. signed written consent exclusion criteria: 1. pregnancy 2. breastfeeding 3. known allergy against pentixather or pentixafor 4. any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.

Keywords: multiple myeloma cxcr4 68ga-pentixather pet/ct 68ga-pentixafor
perinatal attentional retraining intervention for smoking for minority women

Conditions: Postpartum Smoking Relapse

Summary: the proposed research intends to randomize 50 abstinent pregnant black or hispanic smokers to receive either the attentional retraining (ar) or control vp task. participants will be asked to carry around a smartphone as they go about their daily lives for 2 weeks in their last month of pregnancy (phase 1). the smartphone will sound an alert randomly during the day, at which time participants will be asked to respond to a short set of questions assessing subjective states; this will be followed by a request to complete the ar (or control) procedures. this same procedure will be repeated for 2 weeks immediately after delivery (phase 2). women will undergo a follow-up visit 3 months after the end of phase 2, and complete an unmodified vp and follow-up assessments.

there are 2 specific aims that this study intends to address. specific aim 1: to examine whether ar delivered on a smartphone can modify attentional bias to smoking-related stimuli and craving for tobacco cigarettes. specific aim 2: to examine whether ar delivered on a smartphone can modify attentional bias to stress-related stimuli and reduce perceived stress.

Eligibility criteria:
inclusion criteria: * women with a history of smoking 5+ cigarettes per day that have achieved abstinence during pregnancy by 32 weeks gestation. * the ability to speak and write english. * an edinburgh postnatal depression scale (epds) score \<10. exclusion criteria: * current substance abuse (e.g., alcohol, benzodiazepines, marijuana). * current major depressive disorder, minor depression or dysthymia, or history of any of these disorders in the last 6 months. * the presence of an axis i psychotic disorder. * plans to relocate out of the area. * imminent incarceration. * planned inpatient hospitalization during study period. * plans to breastfeed. women who plan to breastfeed will be excluded since this is a powerful, independent motivation for remaining abstinent and may decrease the relapse event rate.
extension study of intrathecal enzyme replacement for cognitive decline in mps i

Conditions: Mucopolysaccharidosis I; Cognitive Decline

Summary: this is a five-year extension study of the pilot study, "intrathecal enzyme replacement for cognitive decline in mps i". participants must have completed the pilot study to participate in this study.


Eligibility criteria:
inclusion criteria: 1. the subject has completed the mirc-002 study of intrathecal enzyme replacement therapy for cognitive decline in mucopolysaccharidosis i 2. age six years or older. 3. subject and/or guardian willing and able to provide written informed consent. 4. negative urine pregnancy test at screening (non-sterile females of child-bearing potential only) 5. currently using two acceptable methods of birth control as determined by the investigator and willing to continue to use acceptable birth control during their participation in the study (non-sterile females of child-bearing potential who are sexually active only) 6. willing and able to comply with study procedures. for example, the subjects must be able to complete written and computer-based testing. the subjects must be able to lie still in the mri scanner for at least 40 minutes without sedation. exclusion criteria: 1. the subject has undergone hematopoietic stem cell transplantation 2. recent initiation of intravenous aldurazyme® therapy with less than 6 months of therapy. subjects who have been receiving aldurazyme® therapy for more than 6 months, and those who have never received aldurazyme® therapy, will be allowed to enroll 3. pregnant or lactating, or considering pregnancy 4. receipt of an investigational drug or procedure other than intrathecal aldurazyme® within 30 days of enrollment 5. a condition, medical or other, that prevents participation in the study, including severe auditory or visual impairment, significant lumbar pathology, lumbar catheter, or recent major surgery within 6 weeks that would preclude their ability to participate. 6. infusion reactions to intravenous or intrathecal aldurazyme® therapy that are life-threatening or require emergent intervention such as epinephrine, cardiopulmonary resuscitation, or hospitalization 7. the subject has severely impaired spinal csf flow, demonstrated by failure of appearance of radionuclide in the basal cisterns by 4 hours after intra-lumbar administration. 8. the subject has a coagulopathy, as identified by a platelet count of less than 50,000, an inr of 1.5 or greater, or a ptt that is 1.5 times the upper limit of normal for the laboratory from which it was drawn.
a phase 2a study to evaluate the safety and efficacy of azx100 in trocar sites of arthroscopic shoulder surgery patients

Conditions: Scar Prevention; Scar Reduction

Summary: the purpose of this study was to determine the safety of azx100 drug product and to determine whether it was effective in preventing or reducing scars that were made from trocars following arthroscopic shoulder surgery.


Eligibility criteria:
inclusion criteria: * scheduled for an arthroscopic shoulder surgery that will result in at least 3 trocar sites * healthy male or non-pregnant female 18-75 years old * non-diabetic * body mass index 18-35 * no clinically significant abnormal values on blood test * non-smoker for previous 6 months exclusion criteria: * history of acute or chronic disease * cancer within previous 5 years, except for removed skin cancer * hypersensitivity reaction * allergy to general anesthesia, lidocaine, or epinephrine * current skin disorder other than folliculitis or acne * on therapy with steroids * on therapy with a drug that affects collagen synthesis * positive for hiv or hepatitis * positive urine test for nicotine * positive blood test for anti-azx100 antibodies * participated in another clinical study within 60 days before enrollment * gave blood within 7 days before dosing * gave plasma within 3 days before dosing * tattoo on the shoulder area * applied any prescribed or over the counter agents to the shoulder within 14 days before dosing, or intend to use any scar improving product * visited a tanning salon within 14 days before dosing * history of drug addiction or excessive use of alcohol

Keywords: azx100 patient and observer scar assessment scale posas visual analog scale vas trocar scarring scar reduction scar prevention