Kornimate/medical-research-clean huggingface dataset:
intestinal microbiota survey of polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome is kind of disease with unclear etiology. recent studies on intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota maybe a novel theory for the development of polycystic ovary syndrome. hence, the investigators will compare the intestinal microbiota composition and diversity in pcos with age, bmi-matched control and then assess whether intestinal microbiota modification is associated with clinical and biological parameters.

the goal of this study is to investigate and compare the composition of the intestinal microbiota in patients with pcos and age, bmi-matched control. in addition, the investigators will investigate the relationship between alterations in the intestinal microbiota, clinical phenotype, biochemical analysis, body composition, inflammation and food consumption habit. the investigators hypothesize that alterations in the intestinal microbiota are associated with increased immune activation and progression of pcos. based on this hypothesis, the investigators propose the following aims: aim 1. identify and enroll cohort with pcos and age, bmi-matched control to study the role of intestinal microbiota on the development of pcos. 1. enroll participants at drum tower hospital. identify and classify participants through initial clinical evaluation, collect clinical metadata, obtain and process blood and stool samples for analysis. 2. characterize the intestinal microbiota through quantitative pcr and high throughput sequencing analysis of stool specimens in participants. aim 2. compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity and systemic inflammation.

Eligibility criteria:
inclusion criteria: 1. premenopausal between 18-40 years of age. 2. exclusion of other etiologies for infertility. exclusion criteria: 1. during the pregnancy and lactation period. 2. use of antibiotics within 3 months. 3. regular use of proton pump inhibitors, laxatives or pro-prebiotics. 4. previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder). 5. major changes in eating habits within the past 3 months.

Keywords: polycystic ovary syndrome intestinal microbiota
research of circulating tumor cells released during cervical cancer surgery

Conditions: Cervical Cancer Stage IA1; Cervical Cancer Stage IB1; Cervical Cancer Stage IA2; Cervical Cancer Stage IB2

Summary: cervical cancer is a rare pathology. recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. it could be explained by the spread of circulating tumor cells (ctc) due to tumor mobilization during different steps of the surgery. the primary goal is to evaluate the spread of ctc during surgery on peripheral blood samples. the secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively. 20 patients with early stage cervical (ia1 to ib2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

ctc detection could be a pronostic factor for cancer evolution. cervical cancer is a rare pathology with increased death rate. despite recommendations for coelioscopic treatment of \< 4cm cervical cancers, recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. it could be explained by the spread of circulating tumor cells (ctc) due to tumor mobilization during coelioscopic stadification and laparoscopic surgery. hypothesis : mobilization of the tumor during coelioscopy leads to ctc spread. this spread could explain the recurrence of cervical cancer. this pilot study will evaluate the possibility of ctc detection during surgery. the primary goal is to evaluate the spread of ctc during the different steps of surgery on peripheral blood samples. the secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively. 20 patients with early stage cervical (ia1 to ib2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

Eligibility criteria:
inclusion criteria: * woman \>18 years old * cervical cancer confirmed by histology * early stage eligible for immediate surgical treatment (or post-brachytherapy): stages ia1, 1a2, 1b1 and ib2 with or without emboli determined by mri performed as part of the treatment * histology : epidermoid carcinoma and adenocarcinoma * valid social security * wrote consent exclusion criteria: * advanced stage (stage ib3 and more) * concomitant cancer * pregnant or breastfeeding woman * vulnerable person (article l1121-6 of the public health code) * participation to other study with an exclusion period still in progress * participation to other study that may have an impact on the prognosis of cervical cancer

Keywords: cervical cancer circulating tumor cell coelioscopy disease-free survival laparoscopy
a trial comparing efficacy and safety of insulin degludec/insulin aspart and biasp 30 in insulin naïve subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia and europe. the aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and biasp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject) * type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening * current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (oads): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (visit 2) with the minimum doses stated: - metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - dpp-iv inhibitor: minimum 100 mg daily or according to local labelling, - alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose * insulin naïve subject; allowed is: previous short term insulin treatment up to 14 days * insulin naïve subject; allowed is: treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days) * hba1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis * body mass index (bmi) below or equal to 40.0 kg/m\^2 exclusion criteria: * treatment with thiazolidinediones (tzds) or glucagon like peptide 1 (glp-1) receptor agonists within 12 weeks prior to visit 1 (screening) * anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and mao inhibitors * anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits * cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure nyha (new york heart association) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial * previous participation in this trial. participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period * known or suspected hypersensitivity to trial products or related products
characteristics of patients with thymoma in chulalongkorn hospital

Conditions: Thymoma Staging; Clinical Presentations; Associated Disorders; Laboratory Findings

Summary: the purpose of this study is to study characteristics of patients with thymoma in chulalongkorn hospital between 2003-2007.

to study characteristics of patients with thymoma undergone thymectomy in chulalongkorn hospital between 2003-2007 in terms of clinical manifestations, associated diseases, and laboratory findings.

Eligibility criteria:
inclusion criteria: * patients with histocytological proved thymoma undergone thymectomy in chulalongkorn hospital between 2003-2007 exclusion criteria: * none

Keywords: thymoma autoimmune diseases immunodeficiency
24 vs 48 hours of cefazolin or cefuroxime as prophylaxis

Conditions: Surgical Site Infection

Summary: a randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (cefazolin) or 2nd generation cephalosporin (cefuroxime).

a prospective randomized controlled patient blinded study with 2x2 factional design. it aims to study optimal duration of antibiotic to reduce surgical site infections following cardiac surgery in adults 24 or 48 hours using 1st generation cephalosporin (cefazolin) or 2nd generation cephalosporin (cefuroxime). patients shall remain on either medicines for 24 or 48 hours. the primary endpoints of the study are:(1) 48 hours antibiotic prophylaxis is superior to 24 hours in adult cardiac surgery (2) cefuroxime is superior to cafazolin as a prophylactic antibiotic in adult cardiac surgery. secondary endpoints include; organisms causing surgical site infections, length of hospital and icu stay, and worsening in renal function.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent * planned to undergo a cardiac surgical procedure exclusion criteria: * patients on antibiotics on the day of surgery or those who received any within 7 days for any reason * patients taken to operating room as salvage * patients who are allergic to either cefuroxime or cefazolin * patients for lvad or ecmo * patients who are known mrsa carriers * patients receiving steroid therapy
trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: oral and systemic versus systemic antibiotics

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.

the use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. but the rout of administration should be systematic, oral, or both is controversial. furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. we compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.

Eligibility criteria:
inclusion criteria: * colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection exclusion criteria: * ecog performance status \>=2 * age\<20 * any organ dysfunction * ileus * preoperative infectious disease * antibiotic administration before surgery * steroid administration before surgery * neo-adjuvant radiation and/or chemo therapy * severe diabetes mellitus * pregnancy/lactational woman * severe allergy

Keywords: antibiotic prophylaxis colorectal surgery laparoscopy
changes in cerebral blood flow with spinal manipulative therapy vs. voluntary motion

Conditions: Vertebral Artery Dissection; Cerebrovascular Accident; Cerebrovascular Stroke

Summary: the investigators are performing a study to determine whether changes in blood flow occur in the neck and back of the brain following a series of head positions and a manipulation of the upper neck. each participant will be asked to undergo a series of mri's to evaluate whether there are any changes in blood flow resulting from any of the head positions or manipulation. the study will be conducted over a period of 1 day and each participant can anticipate the testing to take approximately 120 minutes.

the goal is to further investigate the cerebrovascular hemodynamic consequences of cervical spine positions, including rotation and manipulation in-vivo under clinically relevant circumstances using two advanced forms of mri technology on the va and posterior cerebral vessels. according to the knowledge of the investigators, a study utilizing mri and functional blood oxygen level dependent (fbold) imaging to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these vessels has yet to be conducted.

Eligibility criteria:
inclusion/exclusion criteria 1. enrolled and matriculated as a student in the canadian memorial chiropractic college. 2. healthy asymptomatic male patients who would otherwise receive cervical manipulation on a regular basis as a part of their normal learning experience and will have had a cervical manipulation in the last 3 months. 3. sufficient english language ability to complete study questionnaires (see appendix). 4. no history of disabling neck, arm or headache pain within the last 6 months. 5. no current or prior history of neurological symptoms including, facial or extremity weakness, abnormal sensation to the face, body or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing. 6. subjects will have had no prior history of head trauma or prior history of surgery to the neck region. 7. no history of claustrophobia, metallic implants or tattoos to ensure compatibility with mri requirements.
study of hepatoma treated by perfusing cinobufacin through hepatic artery combining embolotherapy

Conditions: Hepatoma; Cinobufacin Injection

Summary: cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas. compared with transarterial chemoembolization (tace) , the clinical effect of cinobufacini is non-inferior/ equivalent.compared with tace, cinobufacini is superior in security .

inclusion criterion : 1. the sex does not limit, age:18-70 years old . 2. the patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation\< 70 % 3. the patients have failure in surgical intervention or resection operation recidivist 4. hepatic function child-pugh a、b 5. all the cases have the definite final diagnosis of imageology results such as mri、ct 、b ultrasonic or cytology results 6. the patient's prediction of live time\>6 months, who can tolerant of tace and has quality of life ecog score\<3 7. the patients participate the clinical trial voluntarily and have already signed informed consent exclusion criterion : 1. main portal vein was obstructed completely. 2. the occupation of tumor are 70 % or more than 70 % in the whole liver 3. the patient has tace or other antineoplaston 4. after carcinosectomy the patient has the prophylactic 5. the patient is with renal inadequacy: cr≥133 umol/l 6. severe cardiovascular disease 7. the patient is with other diseases to influence the proposal

Eligibility criteria:
inclusion criteria: 1. the sex does not limit, age:18-70 years old ; 2. the patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation\< 70 %; 3. the patients have failure in surgical intervention or resection operation recidivist; 4. hepatic function child-pugh a、b; 5. all the cases have the definite final diagnosis of imageology results such as mri、ct 、b ultrasonic or cytology results ; 6. the patient's prediction of live time\>6 months, who can tolerant of tace and has quality of life ecog score\<3; 7. the patients participate the clinical trial voluntarily and have already signed informed consent. exclusion criteria: 1. main portal vein was obstructed completely; 2. the occupation of tumour are 70 % or more than 70 % in the whole liver; 3. the patient has recepted tace or other antineoplaston; 4. after carcinosectomy the patient has the prophylactic; 5. the patient is with renal inadequacy: cr≥133 umol/l 6. severe cardiovascular disease; 7. the patient is with other diseases to influence the proposal; 8. all over the body generally have metabasis or be with other malignant neoplastic disease; 9. in the process of participation of other medicinal trial; 10. gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.

Keywords: transcatheter arterial embolization cinobufacin injection hepatoma
journey of patients with vasculitis from first symptom to diagnosis

Conditions: Vasculitis; Systemic Vasculitis; Behcet's Disease; CNS Vasculitis; Cryoglobulinemic Vasculitis; Eosinophilic Granulomatous Vasculitis; Temporal Arteritis; Giant Cell Arteritis; Granulomatosis With Polyangiitis; Wegener Granulomatosis; Henoch Schonlein Purpura; IgA Vasculitis; Microscopic Polyangiitis; Polyarteritis Nodosa; Takayasu Arteritis; Urticarial Vasculitis

Summary: this study seeks to understand the journey that patients eventually are diagnosed with vasculitis experience in the period prior to their formal diagnosis by a healthcare provider. data elements of interest include average time from the onset of the first symptoms to the time a diagnosis of vasculitis is confirmed. other aims include identifying factors associated with the time to diagnosis. these factors will be divided into: a) intrinsic factors, or so-called "patient-related factors", such as the type of vasculitis symptoms, patient demographics, socioeconomic status, patients' beliefs regarding the etiology of their symptoms, and other factors, and b) extrinsic factors, or "professional/health system factors", such as healthcare access, referral patterns, testing patterns, and other factors. understanding such factors can guide future efforts to shorten delays in diagnosis and thereby improve outcomes. all analyses will be done for the population of patients with vasculitis as a whole and by individual types of vasculitis.


Eligibility criteria:
inclusion criteria: 1. diagnosis of a systemic vasculitis: the v-pprn includes patients with self-reported behçet's disease, central nervous system vasculitis, cryoglobulinemic vasculitis, eosinophilic granulomatosis with polyangiitis (churg-strauss syndrome, css), giant cell (temporal) arteritis (gca), granulomatosis with polyangiitis (wegener's, gpa), iga vasculitis (henoch-schönlein purpura), microscopic polyangiitis (mpa), polyarteritis nodosa (pan), takayasu's arteritis (tak), and urticarial vasculitis. 2. language requirements: questionnaire will be in english only exclusion criteria: 1. inability to provide informed consent and complete survey in english 2. patients with a diagnosis of "other" type of vasculitis 3. patients with a "missing" diagnosis -
safety and efficacy study of oral fispemifene for the treatment of sexual dysfunction in hypogonadal men

Conditions: Secondary Hypogonadism; Sexual Dysfunction; Erectile Dysfunction

Summary: to evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.

this phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week run-in and an 8-week treatment period. it will assess the safety and tolerability of fispemifene, and the effects of treatment on the sexual side effects seen in this patient population using pro endpoints.

Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of secondary hypogonadism * mild to moderate erectile dysfunction * ability to read, understand and complete diaries and questionnaires * ability to safely make sexual attempts during the course of the study exclusion criteria: * primary hypogonadism * hypogonadism as a result of surgery, trauma, tumors or radiation of the hypothalamus or pituitary * history or current diagnosis of breast cancer, prostate cancer and/or psa level above ≥3.5 ng/ml * poorly controlled blood pressure, type 2 diabetes, thyroid disease; sleep apnea * elevated prolactin level * hemoglobin \>17 g/dl or hematocrit \>50% * use of transdermal or oral testosterone within 4 weeks, intramuscular testosterone therapy within 6 weeks, and testosterone pellets within 6 months prior to screening and at any time throughout the study * use of another serm or past participation in a trial with fispemifene * use of medications known to alter the hpg axis * clinically significant findings on physical exam, screening labs, or other findings which would prevent safe participation in the study * participation in another clinical study in the last 30 days

Keywords: secondary hypogonadism sexual dysfunction erectile dysfunction
team study to improve depression care in rural cbocs

Conditions: Depression

Summary: we adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.

background / rationale: implementing collaborative care for depression in small rural primary care (pc) practices without on-site mental health specialists presents unique challenges. we adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by pc providers in small rural practices. the telemedicine enhanced antidepressant management (team) collaborative care intervention was implemented by offsite personnel and all intervention components were implemented using telemedicine technologies. objective(s): specific aim 1: determine whether the team intervention improves quality and outcomes compared to usual care. specific aim 2: determine whether the team intervention will be cost-effective in routine practice settings. methods: seven visn 16 cbocs participated in the study. cbocs were included if they 1) treated \>1,000 and \<5,000 unique veterans, 2) had no on-site psychiatrists, and 3) had interactive video equipment. matched cbocs were randomized to receive the intervention or usual care. of the 24,882 clinic patients, 73.6% (n=18,306) were successfully screened and 6.9% screened positive for depression (phq9 =12). of those eligible for the study, 91.3% agreed to participate, and 91.9% of those attended their appointment and were consented. over an 18-month period, 395 patients were enrolled, and 91.1% (n=360) were followed-up at six months. telephone research interviews were conducted at baseline, six and twelve months. effectiveness was tested using an intent-to-treat analysis. cost-effectiveness analysis was assessed from the perspective of the va. costs included intervention costs, encounter costs, and medication costs. quality adjusted life years (qalys) were calculated using the quality of well being scale.

Eligibility criteria:
inclusion criteria: phq9 score \> or = to 12 exclusion criteria: a diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment