Kornimate/medical-research-clean huggingface dataset:
value of follicular flushing. randomised controlled trial

Conditions: Infertility

Summary: the purpose of this study is to evaluate whether the addition of follicular flushing to the initial aspiration during oocyte retrieval increases the number of oocytes retrieved in women undergoing ovarian stimulation.

there is an ongoing debate regarding the effectiveness of follicular flushing during oocyte retrieval. currently published studies and metanalyses suggest that follicular flushing does not improve live birth rate, clinical pregnancy rate or the number of oocytes retrieved. however, currently published studies may be confounded by the types of needle used, aspiration pressures, number of times flushing is repeated, etc. additionally, follicular flushing should be examined in specific patient populations according to their response to ovarian stimulation. in the current study, each woman will have one ovary (right or left) randomly assigned to be aspirated with or without the addition of follicular flushing. this study design ensures that clinical and demographic characteristics of the couple will not affect the outcomes evaluated. the primary endpoints will be the number of oocytes retrieved per ovary assigned to each group. secondary outcomes will be the oocyte recovery rate (oocytes retrieved per follicle aspirated) oocyte maturation rate, fertilization rate, and embryo development per ovary assigned to each group. the study population will include three subgroups according to observed ovarian response to ovarian stimulation (poor responders, normal responders, hyper responders). assuming a minimum clinically significant difference in oocyte yield of 1 oocyte, a sample size of twenty patients per subgroup is required to yield 80% power. patients aged \ 11mm in each ovary on the day of triggering final oocyte maturation will be eligible for inclusion in the study. 60 patients (20 in each of the aforementioned subgroup) will be recruited and just prior to oocyte retrieval their left and right ovaries will be randomly allocated into flushing or the no-flushing group. in both ovaries all follicles greater than 11mm will be punctured by the same 16g double lumen needle, using the same aspiration pressure. in the flushing group, flushing will be performed up to a maximum of five times or until a cumulus oocyte complex (coc) is retrieved. in the control group all follicles greater than 11mm will be aspirated by the same double lumen needle and no flushing will be performed. all cocs will be grouped according to the ovary they originated from by the embryologists and their development will be recorded until day 3 following fertilization (number of mii oocytes, number of fertilized oocytes, number good quality day 3 embryos).

Eligibility criteria:
inclusion criteria: * presence of both ovaries * 18-43 years old * at least one follicle \>11mm present in each ovary on day of triggering final oocyte maturation. exclusion criteria: * ovarian surgery * monofolicular development

Keywords: follicular flushing oocyte retrieval
a study for patients with multiple sclerosis

Conditions: Secondary Progressive Multiple Sclerosis

Summary: to obtain additional safety data in subjects who have previously completed the mbp8298-01 study "a double blind placebo controlled multi-centre to evaluate the efficacy and safety of mbp8298 in subjects with secondary multiple sclerosis" dirucotide is generic name for mbp8298.


Eligibility criteria:
inclusion criteria: 1. subjects participating in this study must have completed treatment and all required evaluations in the previous mbp8298-01 study "a double blind placebo controlled multi-centre study to evaluate the efficacy and safety of mbp8298 in subjects with secondary progressive multiple sclerosis", 2. subject must be able and willing to give meaningful, written informed consent prior to participation in the trial in accordance with regulatory requirements, 3. in the investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations. exclusion criteria: 1. use of any concomitant disease modifying therapy for multiple sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. ivig) or immunosuppressive drugs including recombinant or non-recombinant cytokines. 2. any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements. 3. any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study. 4. females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.
safety and effectiveness of benlysta (belimumab) in systemic lupus erythematosus (sle) registry

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (aesi) and effectiveness in participants with active, autoantibody-positive sle treated with and without benlysta (belimumab). participants will be enrolled into 1 of 2 cohorts: (1) benlysta cohort: participants receiving or initiating benlysta plus standard of care (soc) at baseline; (2) comparison cohort: participants not receiving benlysta but receiving soc at baseline. after enrollment, changes in lupus medications, including starting or stopping benlysta, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. all participants will be assessed for aesi including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. data will be collected at enrollment and at 6 month intervals for 5 years. benlysta is a registered trademark of glaxosmithkline (gsk) group of companies.


Eligibility criteria:
inclusion criteria: * males or females age 18 years or older. * have a clinical diagnosis of active sle. * current or history of autoantibody-positive sle. * must be treated with sle therapy including benlysta and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics). * have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures. exclusion criteria: * treatment with an investigational drug within one year of enrollment. investigational drug applies to any drug not approved for sale in the country it is being used. * currently enrolled in a placebo-controlled benlysta (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent. * participants who have a history of benlysta exposure, but are not currently receiving benlysta. * participants only receiving an anti-malarial for sle. * participants only receiving steroids for sle.

Keywords: belimumab benlysta systemic lupus erythematosus autoimmune disease autoantibodies
clinical utility of the spyglass system in primary sclerosing cholangitis (psc)

Conditions: Sclerosing Cholangitis

Summary: this study aim to prospectively evaluate the clinical utility of spyglass in sclerosing cholangitis patients undergoing endoscopic retrograde cholangiopancreaticography (ercp). fifty patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ercp from september 2008 and onwards will be investigated with peroral cholangioscopy using spyglass direct visualization system. clinical data on all patients will be collected at time of the ercp including information on the primary sclerosing cholangitis (psc) and inflammatory bowel disease (ibd), serum liver function tests and indication for ercp. a structured data collection form including information on majoie score, macroscopic features of the bile ducts at cholangioscopy, quality of the investigation, technical difficulties, and an overall judgment of whether any abnormalities observed were benign or malignant was completed by the endoscopist in conjunction with the procedure.


Eligibility criteria:
inclusion criteria: * sclerosing cholangitis with indication for ercp * over 18 year * informed consent exclusion criteria: * not able to sign informed consent

Keywords: sclerosing cholangitis spyglass endoscopic retrograde cholangiopancreaticography
effects of teas on pocd

Conditions: Post-operative Cognitive Dysfunction

Summary: patients undergoing elective orthopedics, urology, and general surgery will be included and randomly allocated to teas group or control group . after routine anesthesia induction and tracheal intubation, patients in teas group will receive electrical stimulation of acupoints at neiguan and shenmen points. for patients in the control group, the electrodes will be only attached to the corresponding sites, with no teas electrical stimulation given during the operation. the primary outcome is the incidence of pocd at day 7 after surgery. the secondary outcomes include the incidence of pod during post-operative days 1-7, the incidence of pocd at day 30 after surgery, and the serum levels of cytokines, including il-1β、il-6、tnf-α、mmp9 on day 1 after surgery.

this study will enroll 110 patients who are older than 60 years old and will have elective orthopedics, urology, or general surgeries under general anesthesia. patients will be randomly assigned to teas group and control group. after routine anesthesia induction and tracheal intubation, patients in teas group will receive electrical stimulation of acupoints at neiguan and shenmen points for 30min every hour. in other words, the patients will receive teas stimulation for 30min, then no stimulation for 30min, then stimulation for another 30min, etc, until the end of the surgery. for patients in the control group, the electrodes will be only attached to the corresponding sites, with no teas electrical stimulation given during the operation. the primary outcome is the incidence of pocd at day 7 after surgery. the secondary outcomes include the incidence of pod during post-operative days 1-7, the incidence of pocd at day 30 after surgery, and the serum levels of cytokines, including il-1β、il-6、tnf-α、mmp9 on day 1 after surgery.

Eligibility criteria:
inclusion criteria: 1. ≧ 60 years old; 2. communicate normally； 3. asa physical status 1-2; 4. patients will have elective orthopedics, urology or general surgeries under general anesthesia; 5. with an estimated surgery time of more than 2h; 6. agree to participate the trial. exclusion criteria: 1. patients with brain diseases or history of brain diseases; 2. preoperative diagnosis of cognitive impairment by subtle mental state (mmse) less than 24 points; 3. patients with history of neurological and psychological disorders including ad, stroke, and psychosis; 4. severe hearing or visual impairment, illiteracy; 5. preoperative systolic blood pressure \>190mmhg, or diastolic blood pressure \>100mmhg; 6. disagree to participate in this research; 7. have used other medical electronic devices.
a phase 2 extension of study gcs-100-cs-4003

Conditions: Chronic Kidney Disease

Summary: the primary objective of this study is to determine the safety and tolerability of extended dosing with a fixed dose of gcs-100 3 mg iv push in patients with chronic kidney disease (ckd).

galectin-3 contributes to fibrosis, is elevated in patients with esrd, and correlates with adverse outcomes (de boer et. al., 2011, dang et. al., 2012, fernandes bertocchi et. al., 2008, henderson et. al., 2008). animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney (dang et. al., 2012, fernandes bertocchi et. al., 2008, henderson et. al., 2008). gcs-100 is a galectin-3 antagonist that has been shown to reduce fibrosis pre-clinically. based on the role of galectin-3 and fibrosis in kidney disease, the sponsor believes gcs-100 may be effective at treating patients with ckd. this study will consist of a fixed dose of gcs-100 3mg iv push at least every 30 days for a total of 1 year with a follow-up 4 weeks after the last dose is administered.

Eligibility criteria:
inclusion criteria: 1. subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent 2. subject was enrolled in gcs-100-cs-4003. exclusion criteria: 1. subject experienced a grade 3 or worse adverse event related to gcs-100 in clinical study gcs-100-cs-4003. 2. systolic blood pressure ≤90 mmhg and ≥160 mmhg and diastolic blood pressure ≤40 mmhg and ≥100 mmhg at screening 3. subject has clinical laboratory values of: * hemoglobin: ≤9 g/dl * total bilirubin: \>1.5x the upper limit of normal (uln) * alt and/or ast: \>2.5x uln 4. subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk. 5. subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.
effect of maitland mobilization with low level laser therapy in treatment of patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: background: osteoarthritis is a common cause of chronic pain and disability in elderly people. objective: to evaluate the efficacy of low-level laser therapy (lllt) in combination with maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis. design: pre-test post-test randomized control trial.

knee oa is associated with pain and disability, high treatment costs, decreased productivity, and absence from work and thus has a substantial and growing burden on society objective: to evaluate the efficacy of low-level laser therapy (lllt) in combination with maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis. participants: seventy five subjects of both genders with age range from 50 to 65 years, with proven bilateral knee oa diagnosed and referred by orthopaedist were recruited for the study and randomly assigned into three groups.

Eligibility criteria:
inclusion criteria: subjects with proven bilateral knee oa with age range 50- 65 years according to the american college of rheumatology criteria. 2- only patients with x-ray stages ii and iii osteoarthritis selected according to kellgren \& lawrence classification system. 3- bmi equal to or less than 30 . 4- patients with knee pain lasted at least 6 months with intensity at least 3 on vas scale in activities such as going up-and downstairs, sitting and squatting. 5- patients with normal mental state. 6- patients who are not participating in physical therapy in the recent 3 months. . exclusion criteria: 1. patient with history of gout, infection, tumour, autoimmune diseases, trauma or other causes of knee pain or knee deformities. 2. patient with neurologic dysfunction, or with history of chronic disease that may affect the study. 3. patient with history of knee intra-articular injection in the past 6 months.
bioequivalence study of torrent pharmaceuticals ltd's felodipine extended-release tablets under fasting condition

Conditions: Healthy

Summary: objective: primary objective of the present study was to compare the single dose bioavailability of torrent's felodipine extended-release tablets usp 10 mg and innovator's (mylan pharmaceuticals inc., usa) felodipine extended-release tablets usp 10 mg. dosing periods were separated by a washout period of 17 days during fasting study. study design: open-label, randomised, two period, two treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: * healthy males within the age range of 18 to 50 years. * a body mass index within 18-25 kg/m2. * given written informed consent to participate in the study. * absence of diseases markers of hiv 1 \& 2, hepatitis b \& c virus and rpr. * absence of significant disease or clinically significant abnormal laboratory * values on laboratory evaluation, medical history and physical examination during the screening. * a normal 12-lead ecg. * a normal chest x-ray. * comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol. * no history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites. * no history of allergic rash. * no history of significant systemic diseases. * no history of psychiatric disorders or addiction to any recreational drug or drug dependence. * no donation of blood within 56 days prior to study check-in. * no participation in any clinical study within the past 56 days. * no receipt of any prescription drugs or otc products, with in two weeks prior to study check-in. * no history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in. * no family history of neurological disorders. * not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in. * negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period. * not consumed grape fruit juice within the 48 hours prior to study check-in. exclusion criteria: * blood pressure systolic\> 140 mm hg and \ 90 mm hg * history of seizures * history of alcohol consumption for more than 2 units/day. * high caffeine or tobacco consumption * history of difficulty with donating blood or difficulty in accessibility of veins. * any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons. * used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study
diabetes and social issues: evaluation of a diabetes education module

Conditions: Diabetes Mellitus

Summary: this study is a multi-center, randomized prospective trial with a 6-month follow up. a newly developed treatment and education module will be tested compared to a waiting-list control group. the module covers the topic "diabetes and social issues". primary outcome variable is diabetes-specific empowerment regarding diabetes and social issues. secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

the module consists of one lesson (duration: 90 minutes). the module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: primas (nct01220557). the module is designed as a group session held by a trained diabetes educator. patients are randomized either to the immediate participation in the module or to the control group. control group is a waiting-list control group. patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

Eligibility criteria:
inclusion criteria: * intensive insulin treatment * specific interest in "diabetes and social issues" * wish to participate in group education * informed consent * fluent in reading and speaking german language exclusion criteria: * diabetes duration \< 4 week * severe organic disease (e.g. terminal renal disease, cancer with poor prognosis) * current treatment of a mental disease * cognitive impairment * dementia * pregnancy

Keywords: diabetes education randomized prospective
a study of combination treatment with an hcv polymerase inhibitor (ro5024048) and an hcv protease inhibitor (ro5190591/danoprevir) in genotype 1 chronic hepatitis c patients

Conditions: Hepatitis C, Chronic

Summary: this 7 cohort study will evaluate the efficacy and safety of combination treatment with an hcv nucleoside polymerase inhibitor(ro5024048)and an hcv protease inhibitor(ro5190591/itmn-191/danoprevir) in patients with chronic hepatitis c, genotype 1.cohorts a,b,c,d and g will be treatment-naive patients, cohort e will be treatment-experienced excluding null responders, and cohort f will be null responders. cohorts a and b will evaluate doses of 500mg po bid ro5024048 and 100mg po q8h ro5190591, alone or in combination, for up to 7 or 14 days. cohort c will evaluate combination treatment with either 1000mg po bid ro5024048 and 100mg q8h ro5190591 or 500mg po bid ro5024048 and 200mg q8h ro5190591 for 14 days. cohort d will evaluate 1000mg po bid ro5024048 and 200mg q8h ro5190591 for 14 days.cohort e will evaluate 1000mg ro5024048/600mg ro5190591 po twice daily for 14 days, and cohorts f and g will evaluate 1000mg ro5024048/900mg ro5190591 po twice daily for 14 days. cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.following the last dose of study medication patients have the option of continuing treatment with standard of care therapies. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age; * chronic hepatitis c, genotype 1. exclusion criteria: * decompensated liver disease, or impaired liver function; * presence or history of non-hepatitis c chronic liver disease; * hbsag or hiv infection; * history of cancer within 5 years, other than localized or in situ cancer of the skin.
operative treatment of ankle fractures

Conditions: Ankle Fracture, Trimalleolar; Ankle Fracture - Lateral Malleolus; Ankle Fracture, Bimalleolar

Summary: patients who underwent operative treatment of an ankle fracture with or without following removal of the osteosynthetic material are examined by a specific ankle provocation test, a questionnaire and x-rays to evaluate the clinical, functional and radiological outcome compared to a healthy control group

the study includes all patients operated from 09.12.2012 to 31.12.2020. patients will undergo an x-ray at least two years after primary surgery or at least one year after removal of the osteosynthetic material. the patients operated from 09.12.2012 to date are therefore a retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. this method is used to achieve the highest possible number of patients in a define period of time with no alteration of surgical technique. all patients in the retrospective cohort are contacted at least 2 years after surgery (or 1 year after removal) via phone call or letter, informed about the study and asked to participate. in case of informed consent, they are invited to the study site. they are asked to complete the questionnaires and they undergo x-ray of the affected and the non-affected ankle. all patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic. in case of informed consent, they are invited to the study site at least 2 years after surgery. they are asked to complete the questionnaires and they undergo na x-ray of the affected and non-affected ankle.

Eligibility criteria:
inclusion criteria: * age older than 18 and younger than 51 years * operative treatment of an ankle fracture * time operation to follow up: at least 2 years * time removal of osteosynthetic material to follow up: at least 1 year * time operative treatment to removal of the osteosynthetic material: at least 9 months * informed consent as documented by signature (appendix: informed consent form) exclusion criteria: * other pathologies of the lower limb of the affected and/or non-affected side (fractures, pre-existing arthrosis or operative treatment of the affected and/or non-affected limb) * pre-existing vascular (peripheral arterial disease, diabetes) or neurological diseases of the lower extremities * women who are pregnant * prevalence of an infection of the implanted osteosynthetic material