Kornimate/medical-research-clean huggingface dataset:
in the era of the hpv vaccine, what are the current hpv subtypes contributing to high grade cervical dysplasia, adenocarcinoma in situ, and early cervical cancer?

Conditions: HSIL, High-Grade Squamous Intraepithelial Lesions; Adenocarcinoma in Situ; Early Cervical Cancer

Summary: this study will look at cervical tissue samples in women with abnormal cervical cells to see if the frequency of the hpv 16/18 subtypes has changed in female populations today, after the introduction of the hpv vaccine. it will compare women who have been exposed to the hpv vaccine with those who have not.

the development of cervical dysplasia (precursor to cervical cancer) and cervical cancer requires infection with one of several cancer causing subtypes of the human papilloma virus (hpv). there are over 100 subtypes of hpv, and most are not cancer causing. in the past, north american data has shown that 70% of early cervical cancers were associated with hpv subtypes 16 and/or 18. the first hpv vaccines to be approved protected against the common subtypes of hpv 16 and 18. the traditional hpv vaccination consists of 3-doses administered over a 6 month period. since the 8 years after the introduction of the vaccine, there have not been any studies analyzing hpv subtype changes. it is important to determine if the prevalence of the hpv subtypes associated with precancerous and/or early cervical cancer have changed, and what preventative outcomes have arisen from the hpv vaccination. this will have implications regarding the importance and anticipated effects of immunization with the nanovalent vaccine that includes other oncogenic subtypes. this study will look at tissue samples to see if the frequency of the hpv 16/18 subtypes has changed in female populations today, after the introduction of the hpv vaccine. it will compare women who have been exposed to the hpv vaccine with those who have not.

Eligibility criteria:
inclusion criteria: * women ≥ 18 years old * presenting with cervical high grade intraepithelial dysplasia (hsil), adenocarcinoma in situ (acis), or early cervical cancer * fulfills one of the following two criteria: expected to have a cervical biopsy, loop electrosurgical excision procedure (leep), or cone biopsy as part of standard of care treatment or has already had a cone biopsy of leep and the archived tissue is located at sunnybrook health sciences centre and was taken within two years from the time of consent. exclusion criteria: * a history of hsil, acis, or early cervical cancer prior to 2010 * patients who are unable to provide consent * women who have had a previous leep or cone biopsy and tissue removed is greater than 2 years old, from the time of consent * women who have had a previous leep or cone biopsy and tissue is archived at an outside institution
effects of standard treatment of acute coronary syndromes on macrophage activity as measured by serum neopterin

Conditions: Acute Coronary Syndrome

Summary: this is a prospective observational study focused on monitoring the effects of various treatment options for acute coronary syndrome (acs) patients by measuring serum neopterin levels. serum neopterin is a marker for measuring macrophage activation. prior studies have illustrated that there are elevated serum neopterin levels in acs. patients enrolled are those with acs. blood samples are drawn at presentation, and at 72 hours after admission, or at office visits and at 72 hours later. neopterin levels are measured via a commercially available assay..

the study is a prospective observational study focused on monitoring the effects of various treatment options for acute coronary syndrome (acs) patients by measuring serum neopterin levels. serum neopterin is a marker for measuring macrophage activation. prior studies have illustrated that there are elevated serum neopterin levels in acs. the investigators' study focused on comparing different treatment arms with regard to their neopterin levels and correlating neopterin levels to the thrombolysis in myocardial infarction (timi) risk score. patients enrolled are those with acs. blood samples are drawn at presentation, and at 72 hours after admission, or at office visits and at 72 hours later. neopterin levels are measured via a commercially available assay.

Eligibility criteria:
inclusion criteria: * chest pain and either st segment elevation or depression \> 0.1 mv in at least 2 contiguous electrocardiographic leads as well as elevation in troponin levels. exclusion criteria: * history of medical conditions known to alter neopterin concentrations in blood. the exclusion criteria includes: * renal failure, * history of hiv, * transplant patients, * active infections, * history of autoimmune disease, * malignancy, * phenylketonuria, * immune mediated liver disease, and * patients taking immunomodulating therapy.

Keywords: neopterin macrophage inflammation
follow-up survey of patients who were treated for medulloblastoma or primitive neuroectodermal tumors of the central nervous in norway

Conditions: Brain Tumor

Summary: clinical follow-up survey of the norwegian material of paediatric patients who received therapy for medulloblastoma and cns-pnet from 1974 - 2013 with a focus on quality of life, education, work, family and children, delayed effects of tumour disease and treatment, endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.


Eligibility criteria:
inclusion criteria: * whose who has been treated for medulloblastoma og cns-pnet between 1974 and 2013 exclusion criteria: * other brain tumours
fertility after myomectomy versus uterine artery embolization for symptomatic uterine fibroids

Conditions: Leiomyoma

Summary: purpose of this study: to establish the superiority of myomectomy versus uterine artery embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.

background: the use of uterine artery embolization (uae) to treat symptomatic fibroids in women seeking future fertility remains a matter of debate, because of possible adverse effects on ovarian reserve and embryo implantation. in women with associated infertility factors, not eligible for myomectomy, poor fertility was obtained after uae. on the other hand, fertility of women eligible for surgical myomectomy, deciding to have a uae, compares favourably with the fertility obtained after myomectomy. study design: eligible women will be explored to pull out any other infertility factors such as: * tubal factors (no hydrosalpinx at mri, tubal permeability assessed by hysterosalpingography and/or negative serology of for chlamydia) * endometriosis (clinical history and examination, mri) * ovarian factors (normal amh dosage, and antral follicular count) * male factors (normal spermogram of the partner if possible) women will be treated with fertility sparing ultra selective uterine artery embolization, or surgical removal of multiple myomas. a six months convalescence/cicatrisation period will be respected, then women will be allowed to intend to conceive. several elements will be prospectively followed: * spontaneous pregnancy from 6 months to 18 months after treatment * pregnancy outcomes * symptoms and quality of live with ufs-qol and whq questionnaires, at 3, 6, 12 and 18 months after treatment * uterine size with mri, before and 3 months after treatment. * aspect of the uterine cavity with hysteroscopy before and 3 months after treatment. * ovarian reserve with amh dosage, and antral follicular count before and 3 months after treatment. * volume and molecular pattern of the endometrium at the implantation window before and 3 months after treatment (optional). * treatment's adverse effects.

Eligibility criteria:
inclusion criteria: * women aged ≥ 18 and ≤ 43 years old * at least one interstitial fibroid more than 3 cm on mriat mri) * with symptoms: genital bleeding, chronic pelvic pain or heaviness, anemia, or infertility \> 1 year. * with immediate desire to conceive * without assisted reproductive indication: no tubal infertility, menstrual irregularities, hydrosalpinx, endometriosis, adenomyosis, or male infertility. * patient with health insurance, who can read and understand french and who has given written consent exclusion criteria: * ongoing regnancy * emergency situation * contraindication to surgery or uterine embolization: allergy to contrast medium , renal failure, immunodeficiency, contraindication to anesthesia, subserosal or submucosal pedunculated fibroids, fibroids with largest diameter inside of the uterine cavity

Keywords: leiomyoma uterine artery embolization surgery childbearing age fertility noninferiority trial
pilot study to investigate the association between acid control and heartburn symptoms after proton pump inhibitor treatment

Conditions: Heartburn

Summary: the purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (ppi) drug esomeprazole in frequent heartburn patients.


Eligibility criteria:
inclusion criteria: * confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, h2 receptor antagonists (h2ras) and/or ppis). * heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days. * when heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription h2ras, or short term non prescription or prescription ppis at approved doses but complete resolution of heartburn was not achieved. exclusion criteria: * a history (past or present) of erosive esophagitis verified by endoscopy. * the need for continuous treatment with h2ras, ppis, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy). * subjects requiring continuous intervention by a physician for the treatment of gerd (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
a clinical study of sph7485 tablets in the treatment of advanced solid tumors.

Conditions: Advanced Solid Tumor

Summary: to evaluate the efficacy and safety of sph7485 tablets in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed advanced solid tumors； 2. at least one extracranial measurable lesion; 3. ecog (eastern cooperative oncology group) performance status score of 0 or 1; 4. subjects whose laboratory examination indicators meet the prescribed standards during the screening period; 5. life expectancy≥3 months; 6. subjects whose toxic reactions to previous antitumor therapy returned to baseline or ctcae≤grade 1; 7. female subjects whose pregnancy tests are negative; male subjects agree not to donate sperm; subject and partner agree to use reliable contraception; 8. volunteer to participate in clinical research; fully understand and know the study and sign the informed consent; subjects willing to follow and able to complete all test procedures. exclusion criteria: 1. subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose; 2. subjects who have received previous drugs with the same target; 3. subjects with active infections requiring systemic treatment; 4. subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods; 5. subjects with uncontrolled or severe cardiovascular disease; 6. severe lung disease; 7. subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug; 8. subjects taking strong/moderate inhibitors or inducers of cyp3a4; 9. subjects who use or require long-term use of hormonotherapy before screening; 10. subjects who have had other malignancies within the past 5 years; 11. subjects with symptomatic cns metastasis, pial metastasis, or spinal cord compression due to metastasis; 12. subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery; 13. abnormal virological examination during screening; history of immune deficiency; 14. uncontrolled systemic diseases; 15. subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose; 16. subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose; 17. subjects with a history of severe allergy or known allergy to this product and its excipients; 18. subjects who cannot follow the study protocol to complete the required study visit and dosing; 19. subjects with a history of alcohol or drug abuse; 20. lactating female patients; 21. subjects with a clear past history of neurological or psychiatric disorders. subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator; 22. subjects deemed unsuitable for this clinical study by the investigator for other reasons.
biograph vision 600 versus biograph vision.x pet/ct

Conditions: Cancer; Alzheimer Disease

Summary: the main purpose is to evaluate initial clinical experiences and to explore whether the vision.x system yields improved image quality and diagnostic performance compared to vision 600.


Eligibility criteria:
inclusion criteria: * written inform consent to participating. * 18 to 85 years of age * willing and able to comply with the requirements of the study, as judged by the investigator exclusion criteria: * women in pregnancy * patients unable to lie still for the duration of the examination

Keywords: pet/ct vision image quality diagnostic performance
a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of e5501 old tablet formulation under fasted conditions and a new tablet formulation under fed and fasted conditions in healthy subjects

Conditions: Healthy Subjects

Summary: this study will be a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of e5501 old tablet formulation under fasted conditions and a new tablet formulation administered under fed and fasted conditions in healthy subjects.


Eligibility criteria:
inclusion criteria: * normal healthy adult males and females (age 18-45 years) * body mass index (bmi) greater than or equal to 18 and less than or equal to 32 at the time of screening * all females must have a negative serum human beta-chorionic gonadotropin test result or negative urine pregnancy test result at screening and baseline. females of child-bearing potential must use a medically acceptable method of contraception throughout the entire study period and for 30 days after study drug discontinuation. postmenopausal women and women who have been surgically sterilized or are proven sterile are exempt from this requirement. all women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation. * male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of child-bearing potential must use, or their partners must use, a highly effective,method of contraception starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days after the last dose of study drug. * willing and able to comply with all aspects of the protocol * provide written informed consent exclusion criteria: * standard selection criteria typically used in all protocols * clinically significant abnormal laboratory test results, including platelet count and electrolyte abnormalities at screening and at each baseline
extracorporeal shock wave therapy in osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the present study has examined the effectiveness of extracorporeal shock wave therapy along with conventional physical therapy on functional ability in grade iv knee osteoarthritis. intervention program was performed for four weeks. conventional physical therapy included ultrasound therapy, isometric quadriceps, straight leg raising (slr) and isometric hip adductor strengthening exercises. functional ability was assessed using the lower extremity functional scale (lefs) score.


Eligibility criteria:
inclusion criteria: * grade iv primary knee osteoarthritis (oa) diagnosed by an orthopaedic surgeon based on the kellgren-lawrence score exclusion criteria: * secondary knee oa, * rheumatoid arthritis, * psoriatic arthritis, * the presence of any red flags (metastatic growth, thrombophlebitis), * neurologic or psychiatric impairments, * tissue injuries of the knee joint, * previous knee joint replacement or other surgeries in the knee joint, * already received eswt, * intra articular injection * unable to walk independently

Keywords: physical therapy lower extremity functional scale score ultrasound therapy exercises quadriceps
integrating care after exacerbation of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this clinical trial is designed to determine whether an intervention that provides information to primary care providers about gaps in care for their patients recently discharged from hospital for copd can reduce hospital re-admissions and mortality and improve their patients' quality-of-life.

chronic obstructive pulmonary disease (copd) exacerbations are common among veterans admitted to hospital, lead to worsening health-related quality of life, and are important drivers of health care expenditures. as many as half of patients discharged for copd are readmitted within 6 months. an intervention to improve copd care is needed, not only to treat patients for copd and their accompanying comorbidities, but also to redesign the care delivery system. the goal of this clinical trial is to test an intervention to improve patient care during the transition from hospital to outpatient setting for patients discharged for copd. the investigators are targeting the intervention to patient aligned care team (pact) providers who are randomized to receive the intervention or not receive the intervention. for the intervention, study clinicians, consisting of experienced primary care providers and pulmonary specialists, reviewed the medical record for each patient discharged from hospital for copd. the team looked for gaps in care for copd and key co-morbidities such as obesity, hypertension, diabetes, and cardiovascular disease. they focused on immediate care processes associated with the hospital admission and comorbid disease treatment. for providers in the intervention group, the team placed any patient care recommendations into the medical record using a non-visit consult note and pre-filled order sets. the patient's provider then accepted, modified, or declined any or all of the recommendations based on personal knowledge of the patient's history. the investigators hypothesize that the intervention will: 1) improve patient quality of life; and 2) decrease hospital readmission and mortality after hospital admission for copd exacerbation.

Eligibility criteria:
inclusion criteria: providers: * primary care provider (md, np, pa) from va puget sound or boise va. * willingness to participate in the informed consent process and complete interviews and questionnaires. patients: * having a provider that is participating in this clinical trial. * discharged alive with either a primary discharge diagnosis of copd or acute respiratory failure with a secondary diagnosis of copd. * willing and able to participate in the informed consent process and complete interviews and questionnaires. exclusion criteria: providers: none patients: * having previously participated in the study. * significant cognitive dysfunction, language barrier, or severe psychiatric disorder that would preclude completing the questionnaires.

Keywords: randomized controlled trial quality of life patient readmission mortality patient satisfaction intervention studies multicenter study
assessment of the educational experiences for patients newly diagnosed with nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: the purpose of this study is to learn about patient, caregiver and healthcare worker perspectives on educating patients with newly-diagnosed nephrotic syndrome. all patients enrolled in the contact registry with nephrotic syndrome will be invited via email to participate in this study.

the survey included questions addressing the following areas: 1.) information that is important to know when learning to manage nephrotic syndrome. 2.) preferred resources for the education of patients and caregivers with newly-diagnosed nephrotic syndrome. 3.) the time frame required to acquire confidence in the management of nephrotic syndrome. 4.) disease-specific information such as diagnosis, length of disease duration, medications used, need for kidney biopsy, dialysis and/or transplant. 5.) demographic data such as race/ethnicity and educational background. the survey data is stored by the rare diseases clinical research network's data management and coordinating center (dmcc) at the university of south florida. the data is de-identified. names or other personal health information were not collected. upon conclusion of the study period, the data will be sent to the neptune consortium lead at the university of michigan.

Eligibility criteria:
inclusion criteria: patient and patient caregiver: * 18 years or older * english literate * history of nephrotic syndrome \> 3 months or caregiver of a child diagnosed with nephrotic syndrome \> 3 months prior to enrollment * informed consent healthcare worker inclusion criteria: * age \> 18 years * english literate * provides medical care for children or adults with nephrotic syndrome * informed consent exclusion criteria: * inability to provide informed consent and complete survey * other criteria as specified by consortium and based on the data we collect in the contact registry
study to evaluate the safety and tolerability of tirabrutinib (ono/gs-4059) given as monotherapy in participants with relapsed/refractory nhl and cll

Conditions: Non Hodgkins Lymphoma; Chronic Lymphocytic Leukaemia

Summary: the primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ono/gs-4059) given as monotherapy to participants with relapsed/refractory non-hodgkin's lymphoma (nhl) and chronic lymphocytic leukemia (cll).


Eligibility criteria:
key inclusion criteria: 1. males or females with a confirmed diagnosis of and documented history of relapsed or refractory malignant disease (b-cell lymphoma and/or cll) for which no therapy of curative or high priority exists and for whom treatment with a btk inhibitor may be deemed appropriate. 2. age ≥ 18 years. 3. eastern cooperative oncology group (ecog) performance status of ≤ 2. key exclusion criteria: 1. central nervous system (cns) lymphoma. 2. women who are pregnant or lactating. note: other protocol defined inclusion/exclusion criteria may apply.