Kornimate/medical-research-clean huggingface dataset:
evaluation of the mixture myoinositol:d-chiro-inositol 3.6:1 in women with polycystic ovary syndrome

Conditions: Polycystic Ovarian Syndrome; Infertility

Summary: the aim of the present study is to evaluate the effect of increasing the proportion of d-chiro-inositol (dci) in a combination with myo-inositol (myo) in improving fertility in women with polycystic ovarian syndrome (pcos). sixty women diagnosed with pcos will randomly take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of d-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of d-chiro-inositol.

polycystic ovarian syndrome (pcos) is the most prevalent endocrinopathy in women of childbearing age. it affects 4-8% of the population and of them, approximately 74% present anovulatory cycles and, therefore, fertility problems. both myo-inositol and d-chiro-inositol are 2 natural substances that have been shown to improve ovarian function and metabolism in women with polycystic ovarian syndrome. the aim of the present study is to compare the effect of 2 ratios of myo-inositol /d-chiro-inositol on parameters related to the fertility of women with pcos. it is a multicenter, controlled, randomized, double-blind, parallel-group, 12-week clinical trial which will be conducted in 13 public and private hospitals from spain.

Eligibility criteria:
inclusion criteria: * being diagnosed with pcos according to rotterdam criteria. * being in in vitro fertilization treatment. * body mass index less than 30 kg/m2. * accept freely to participate in the study and sign the informed consent document. exclusion criteria: * contraindication to perform techniques of assisted reproduction or stimulation of ovulation. * advanced state of endometriosis (iii or iv). * classified as poor responder in fertility treatment. * premature ovarian failure. * severe male factor (cryptozoospermia). * few expectations of compliance and/or collaboration.

Keywords: polycystic ovarian syndrome d-chiro-inositol fertility
comparison trial of opa-15406 ointment in pediatric patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: to demonstrate the superiority of the investigational medicinal product (imp; 0.3% opa-15406 ointment, 1% opa-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in investigator's global assessment (iga) at week 4 as the primary endpoint in pediatric patients with atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * diagnosis of ad based on the japanese dermatological association's criteria * atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (bsa, excluding scalp) at the screening and baseline examinations * iga score of 2 or 3 at the screening and baseline examinations exclusion criteria: * subjects who have an ad or contact dermatitis flare-up defined as a rapid intensification of ad, within 28 days prior to the baseline examination
neonatal immunization with pneumococcal conjugate vaccine in papua new guinea

Conditions: Pneumonia; Meningitis; Otitis Media

Summary: the national health plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for papau new guinea. the papua new guinea (png) institute of medical research, the telethon institute for child health research and the department of paediatrics, university of western australia will collaborate to examine very closely the safety of neonatal vaccination, particularly with regard to impact on the development of immunity and response to other vaccines given to infants. this study will also provide a unique opportunity for training of png and australian scientists in both countries.

in order to obtain the earliest possible protection against invasive pneumococcal disease, achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate vaccine (pcv) immunization needs to be considered. this study in the png highlands will enrol 312 infants at birth, who will be randomised to receive pcv either at 1-2-3 months (infant schedule according to png national epi schedule) or 0-1-2 months of age (neonatal schedule) or receive only routine immunizations (controls). blood samples will be taken at birth-2-3-4 months of age, pre- and post-pneumococcal polysaccharide booster (23vppv) at 9-10 months of age (to assess immune memory) and at 18 months at study completion. carriage will be assessed weekly for the first month of life and at regular intervals thereafter. there will be ongoing surveillance for respiratory and other diseases throughout the study. in addition to serotype-specific igg, we will examine igg avidity, igg subclasses, mucosal iga and t-cell cytokine responses to pcv and pneumococcal protein antigens. to ensure immunological safety, particularly for neonatal pcv, immune responses to concomitant vaccines and viral and environmental antigens will also be examined as well as overall t-cell maturation.

Eligibility criteria:
inclusion criteria: new born babies with birth weight \>2000 g (2 kgs) and parents giving consent exclusion criteria: 1. acute neonatal infection; 2. severe congenital abnormality; 3. children of mothers known to be hiv positive will be excluded; 4. serious asphyxia at birth; 5. intended migration in the next 2 years; 6. parents withdraw consent;

Keywords: pneumococcal vaccine antibody responses cellular immunology th1/th2 immune responses paediatric neonatal infectious diseases papua new guinea
pufa augmentation in treatment of major depression

Conditions: Major Depression

Summary: the purpose of this study is to determine if omega-3 fatty acid epa will enhance and speed up response to antidepressant therapy with celexa (citalopram) in people suffering from major depressive disorder. all patients will receive celexa, 50% will receive epa, 50% placebo epa.

as per brief summary

Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for current major depression, and have a ham-d (21 item) score of \> 17 * male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence * age between 18 and 65 * capable of giving informed consent exclusion criteria: * diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders * current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months * unstable medical or neurological conditions that are likely to interfere with the treatment of depression * history of allergy to citalopram or proepa, finfish or shellfish * history of failure of response to citalopram, as documented by an adequate trial of the medication \[defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks\] * history of seizure disorder * pregnancy * currently on psychotropic medications including antidepressants or neuroleptics * active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study * exposure to treatment with fluoxetine or maois in the previous two months * patients on anticoagulant therapy * patients with a dietary intake of \> 3.0g total omega-3 pufa/day at baseline

Keywords: depression citalopram celexa polyunsaturated fatty acids omega-3 epa antidepressants
pivotal, clinical study for the accuracy evaluation of the identiclone dx igh assay

Conditions: B-Cell Lymphoproliferative Disorder

Summary: this protocol describes the pivotal accuracy study for the identiclone dx igh (ic igh dx) assay. the intent of the accuracy study is to demonstrate agreement between the results of the ic igh dx assay and a predicate devise or assay on retrospective and residual de-identified dna extracted from peripheral blood (pb) samples from individuals with suspected b-cell lymphoproliferations. the predicate device will be the lymphotrack dx igh (fr1/fr2/fr3) assays - miseq (lt dx igh-ce-ivd), which is a ce-ivd assay with a similar intended use as the ic igh assay on the same sample type.


Eligibility criteria:
inclusion criteria: 1. dna extracted from peripheral blood (pb) with edta as anticoagulant with minimum total dna ≥ 2 µg with concentration at ≥ 50ng/µl 2. dna extracted from pb specimens no more than 7 days 3. dna stored at -15°c to -30°c up to 5 years 4. donor age: ≥ 18 5. for positive sample, dna from pb of subjects diagnosed (at the time the specimen was drawn) with lymphoproliferative disease, with: 1. icd 10 codes: c8300, c8330, c8510 or other b-cell leukemia/lymphoma diagnosis 2. b-cell lymphoproliferative disease diagnosis per collection site procedure (i.e. snomed) 6. for negative sample, dna from pb of subjects suspected of lymphoproliferative disease exclusion criteria: 1. pb specimens that have been frozen prior to extraction
evaluation of neuromuscular disease

Conditions: Healthy; Neuromuscular Disease; Peripheral Nervous System Disease

Summary: the peripheral nervous system is the portion of the nervous system outside of the brain and spinal cord. it includes the 12 pairs of cranial nerves, 31 pairs of spinal nerves and their branches, nerves responsible for sensation and maintenance of normal body functions (sympathetic and parasympathetic nerves). years of research using clinical examinations, microscopic examinations, and electrophysiology have made the peripheral nervous system the best-studied and most available portion of the nervous system. however, even with all of the extensive studies conducted on the peripheral nervous system, many conditions remain unclassified. the emg laboratory at the nih concentrates on studying disorders of the peripheral nervous system. this protocol was designed to allow the emg laboratory to; i) learn more about established diseases of the peripheral nervous system ii) identify and characterize new diseases of the peripheral nervous system iii) assess current techniques in the diagnosis of diseases of the peripheral nervous system iv) refine old methods and develop new ones for the diagnosis of diseases of the peripheral nervous system.

combined with careful clinical examination, electrophysiology and histopathology have rendered the peripheral nervous system the best studied and most accessible level of the nervous system. but even after intensive diagnostic evaluation of peripheral neuropathies in large diagnostic centers, 24 to 70% of disorders remain unclassified. analogous statistics for disorders of muscle and neuromuscular transmission are not known but probably similar, if not worse. clearly, detailed diagnostic characterization of disorders of the peripheral nervous system is the first stage in clinical intervention. currently, the emg laboratory at the nih offers complete clinical, electrophysiologic, and, when appropriate, pathologic evaluations on all referrals from the other branches and institutes. since these referrals come primarily from within the nih, most disorders are secondary to other systemic disease. this protocol is designed to extend the services to direct referrals of primary disorders of the peripheral nervous system. the purposes are first, to learn more about established diseases; second, to identify and characterize new diseases; third, to assess current methodologies and technologies; and fourth, to refine old methods and develop new ones. under this umbrella protocol, individual cases and clinical series can be investigated.

Eligibility criteria:
patients with disorders of the peripheral nervous system, including neuropathies, myopathies, or defective neuromuscular transmission. normal age-matched volunteers, including some from within a neurologic population.

Keywords: nerve conduction studies emg normal volunteer electrophysiology peripheral neuropathies myopathies
pet imaging and olanzapine treatment in borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: the overall design of the study is to perform both a pet and mri scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with pet.

the primary objective of this proposed study will be to compare the baseline pet scan to the endpoint scan in 15 bpd patients who have been treated with olanzapine. the comparison of the scans will be done through a statistical image analysis, using a pixel-by-pixel group mean subtraction strategy with appropriate correction for multiple comparisons. in an exploratory fashion we will compare frontal and temporal regions of interest to address hypotheses of which areas of the brain might show changes with olanzapine treatment. a secondary objective is to use a normal database to compare the baseline pet scan of the 15 patients in a medication free state to normal subjects. the advantage of this strategy is the ability to closely match subjects by gender and age. as noted earlier, dr. pardo has data on 35 control subjects studied on the same scanner we plan to use for this study.

Eligibility criteria:
inclusion criteria: 1. age 18-45 years 2. diagnosis: borderline personality disorder by dsm-iv criteria 3. gender: female 4. may have history of substance use and other axis ii disorders exclusion criteria: 1. axis i diagnosis of schizophrenia, schizoaffective disorder, or bipolar i disorder during the subject's lifetime. no current major depression or ptsd. 2. treatment with psychotropic medication in the previous month. 3. medical disorder that would influence outcome of the study - e.g. epilepsy, thyroid disease, hiv, etc. 4. medical disorder that would not allow use of olanzapine 5. active substance abuse or dependence 6. previous adverse reaction to olanzapine 7. females whom are pregnant or nursing

Keywords: borderline personality disorder bpd pet olanzapine brain
postoperative vocal cord palsy between double-lumen endobronchial tube and bronchial blocker for robot-assisted esophagectomy

Conditions: One Lung Ventillation (OLV)

Summary: the goal of this clinical trial is to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.

esophagectomy is a challenging surgery that usually requires one lung ventilation, and double-lumen endobronchial tubes and bronchial blockers are commonly used for one lung ventilation. successful resection of recurrent laryngeal nerve lymph nodes during esophagectomy is important to survival and prevention of cancer recurrence, but there is a risk of postoperative vocal cord palsy due to the recurrent laryngeal nerve injury during the resection. compared to a double-lumen endobronchial tube, the use of a bronchial blocker is expected to reduce the incidence of recurrent laryngeal nerve injury; however, few clinical studies compare the two devices in terms of the incidence of postoperative vocal cord palsy in robot-assisted esophagectomy. therefore, the researchers aimed to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.

Eligibility criteria:
inclusion criteria: * adults aged 19 or older * american society of anesthesiologists physical status i - iii * elective robot-assisted esophagectomy * any clinical stage of esophageal cancer * patients who need recurrent laryngeal nerve lymph nodes resection exclusion criteria: * patients who diagnosed vocal cord palsy or damage before surgery * patients who need specific airway device due to airway problem * history of thoracic surgery * emergency surgery * combined surgery with other department * pregnant or nursing women

Keywords: robot-assisted esophagectomy double-lumen endobronchial tube bronchial blocker vocal cord palsy
biomarker monitoring of prostate cancer patients with rsi mri (prosrsi)

Conditions: Prostate Cancer

Summary: adult male patients with high-risk, localized prostate cancer and planning to undergo radiation therapy (rt) with androgen deprivation therapy (adt) will undergo an advanced magnetic resonance imaging (mri) examination called restriction spectrum imaging (rsi-mri) to evaluate whether rsi-mri can predict treatment response.

participants will undergo rsi at three time points: before therapy (mri #1), after neoadjuvant adt (mri #2), and after radiotherapy (mri #3). treatment response will be assessed primarily by absence of biochemical recurrence (psa ≥2 ng/ml greater than nadir) within 3 years of completing radiotherapy. change in rsi cellularity index from mri #1 to mri #2 will be evaluated for prediction of participants who will experience biochemical recurrence within 3 years, using area under the receiver operating characteristic curve. we hypothesize that rsi cellularity index will be an early biomarker for treatment effectiveness in prostate cancer treated with adt and radiotherapy.

Eligibility criteria:
inclusion criteria: * male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate * high-risk prostate cancer (any of: psa ≥20 ng/ml or ct3-t4 stage or gleason score ≥8) * intended treatment and follow-up according to standard of care for prostate cancer * planning to undergo definitive radiotherapy with neoadjuvant and concurrent androgen deprivation therapy * in good general health as evidenced by medical history and ecog performance status 0-2 * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: * prior radiotherapy to the pelvis * prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy) * hip prosthesis * contraindication to mri, per institutional requirements * technetium-99 bone scan showing no clear evidence of distant metastasis * mri or ct scan of the pelvis showing no clear evidence of bone or distant metastasis * another malignancy, unless in remission or unlikely to impact the patient's survival or ability to receive standard care for prostate cancer (e.g., cutaneous basal cell carcinoma) * patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
epicardial ablation in brugada syndrome. an extension study of 500 brs.patients

Conditions: ECG Brugada Pattern

Summary: this study represents an extension of a previous study (nct02641431) on the acute and long-term benefit of epicardial ablation on elimination of both brs-ecg pattern and vt/vf inducibility in 500 consecutive brs patients.

according to previous protocol (nct02641431), 300 additional consecutive selected patients having an icd implantation will be enrolled up to a total of 500 brs patients. echocardiography with cardiac deformation analysis, three-dimensional color-coded voltage, activation and duration electroanatomical maps before and after ajmaline (1mg/kg in 5 minutes) wiil determine the site and the size of the arrhythmogenic substrate as characterized by abnormally prolonged fragmented ventricular potentials and potential wall motion abnormalities. primary endpoint will be identification and elimination of this electrophysiological substrate by rf applications leading to ecg pattern normalization and vt/vf non-inducibility before and after ajmaline. patients will be followed up to 10 years after ablation by sequential 12-lead ecg and holter recording, echocardiography, icd interrogation, vt/vf inducibility patterns before and after ajmaline test.

Eligibility criteria:
inclusion criteria: * symptomatic brs patients with typical brs-related symptoms (cardiac arrest or syncope) or without typical brs-related symptoms (dizziness, palpitations, presyncope, dyspnea) icd implantation, spontaneous or ajmaline-induced type 1 br pattern. exclusion criteria: * age \< 18 years, prior epicardial ablation, pregnancy, co-morbidities.
outcome of percutaneous mechanical thrombectomy to treat acute deep venous thrombosis

Conditions: Deep Venous Thrombosis

Summary: the purpose of this study was to compare the efficacy of percutaneous mechanical thrombectomy (pmt) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.

the conventional treatment of acute deep vein thrombosis (dvt) is anticoagulation therapy, as recommended in the international guidelines. anticoagulation prevents recurrent venous thrombosis, pulmonary embolism, and death. early thrombus removal is now considered as the standard of medical care for deep vein thrombosis (dvt). early thrombus removal can offer the potential for early restoration of venous patency and preservation of valve function. percutaneous mechanical thrombectomy (pmt) uses a number of catheter-based mechanical devices to deliver the thrombolytic agent as well as to produce some combination of thrombus fragmentation, distribution of thrombolytic drugs throughout the thrombus, and/or thrombus aspiration. the purpose of this study was to compare the efficacy of percutaneous mechanical thrombectomy (pmt) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.

Eligibility criteria:
inclusion criteria: * proven acute deep venous thrombosis, less than 21 days and who were referred to the interventional radiology department. exclusion criteria: * presence of subacute or chronic dvt more than 21 days in duration, inability to lie in the prone position required for intervention, terminal systemic disease requiring palliative treatment, active bleeding (from a gastric/duodenal ulcer or the cerebrovascular system), a haemorrhagic stroke within the previous year, an impaired bleeding-clotting profile, and any haemophilic disorder, or pregnancy.

Keywords: deep venous thrombosis percutaneous mechanical thrombectomy