Kornimate/medical-research-clean huggingface dataset:
heated and non heated ovarian aspiration needle protocol

Conditions: Infertility, Female

Summary: the success of ivf is influenced by factors as cause of infertility and age. furthermore, there is a large influence of external factors, from the laboratory environment, handling and cultivation of gametes and embryos. the existence of factors capable of affecting the success of the treatment lead to the need of a quality control to attenuate the unfavorable effects. after ovarian stimulation, follicular aspiration is performed. at this moment, factors such as aspiration technique, needle type and temperature are the main variables to be controlled. it is known that oocytes are the more sensitive cells to temperature fluctuations. currently, the standard protocol for follicular aspiration does not include the warming of the aspiration needle. however, due to the existing evidence in the literature, that the follicular fluid temperature drops during the aspiration procedure, this work aims to evaluate the influence of a pre warming of the aspiration needle as a new protocol.

the estimated sample was 600 oocytes for each group, totaling a minimum of 1200 oocytes, considering a fertilization rate of 65% in the control group and 73% in the study group, for a power of 80% and p alpha 5%, i.e. , an increase of more than 10% between groups. as there is no data in the literature, when the investigators have this sample an interim analysis to evaluate the data will be performed. the investigators consider 10% a reasonable difference that can (with this sample size) increase by 48 embryos and a possible increase of 7 pregnancies within this sample. bearing in mind that the average number of oocytes retrieved per patient is 6 oocytes, the investigators estimate that 200 patients will be needed to reach the calculated sample number. the warm-up protocol will be applied by the embryologists, which consists of heating the follicular aspiration needle to 37 celsius, overnight, the day before the day of the ovarian aspiration procedure. the variables that will be compared between the studied groups are the rates of oocyte retrieval, maturity (mii), fracture, atresia, fertilization rates and discarded embryos. continuous variables will be analyzed using student's t test if they have normal distribution, for comparison of means between two independent groups or the wilcoxon-mann-whitney u test if not parametric. differences between groups will be considered significant when p\<0.05.

Eligibility criteria:
inclusion criteria: * all women submitted to ivf cycles exclusion criteria: * women submitted to follicular aspiration due to oocyte cryopreservation * patients without oocyte retrieved * patients without mature oocyte retrieved * procedures with needle replacement
a study of orforglipron (ly3502970) in adolescent participants with obesity, or overweight with related comorbidities

Conditions: Obesity; Overweight

Summary: the main purpose of this study, performed under master protocol j4m-mc-pwmp, is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus placebo in adolescent participants with obesity, or overweight with related comorbidities. participation in the study will last about 18 months.


Eligibility criteria:
inclusion criteria: j4m-mc-pwmp * have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening. * obesity as defined by bmi equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[cdc-nchs, 2022\]); or * overweight as defined by bmi equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (cdc-nchs, 2022), and at least 1 weight-related comorbidity, * hypertension * type 2 diabetes (t2d) * prediabetes * dyslipidemia * obstructive sleep apnea * metabolic dysfunction-associated steatohepatitis (mash) or metabolic dysfunction-associated steatotic liver disease (masld) exclusion criteria: j4m-mc-pw01 * prepubertal (tanner stage 1) * have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening j4m-mc-pwmp * have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to: * gastric bypass * sleeve gastrectomy * restrictive bariatric surgery, such as lap-band® gastric banding, or * any other procedure intended to result in weight reduction. * have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes. * have type 1 diabetes or history of ketoacidosis, or hyperosmolar state. * have hba1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening. * have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
remote multichannel monitoring of patients with chronic diseases using speech technologies based on artificial intelligence

Conditions: Heart Failure; Diabetes Mellitus; Arterial Hypertension; Lymphoproliferative Disease; Total Knee Replacement

Summary: dialog is a study to assess the efficacy and safety of remote patient monitoring using virtual operator voice technologies and a business intelligence (bi) system for timely detection, prevention of early complications, worsening of the condition, and other adverse events in patients who have been discharged from the hospital.

after ensuring that the patient\&#39;s characteristics meet the inclusion and exclusion criteria and confirming the patient\&#39;s ability to use the \&#34;voice assistant\&#34;, as provided in the research protocol, patients who have completed the briefing will be able to use the voice assistant at home. during the month, robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a bi system will be conducted for five groups of patients (chf, dm, ah, lpd, and patients who underwent total knee replacement) who have been discharged from the hospital. the system developed allows for quick surveys, collection of data on patient conditions, and convenient transfer of this data to the physician. the physician will receive information on patient status in a graphical form using a traffic light system. in the event of any red flags, the physician will contact the patient for further discussion on treatment strategies. the study will evaluate the efficacy and safety of utilizing the \&#34;voice assistant\&#34; by assessing the achievement of target values for controlled parameters, evaluating patient satisfaction and adherence to treatment, reducing the number of repeat hospitalization, and reducing overall mortality and cardiovascular-related mortality.

Eligibility criteria:
inclusion criteria: * disease diagnosed according to the latest clinical practice guidelines * stable condition at the time of discharge from the hospital * written informed consent to participate in the study non-inclusion criteria: * diagnosed dementia or severe cognitive impairment * the inability to use automatic devices to register blood pressure at home, a blood glucose meter * alcohol or drug abuse * inability to contact a voice assistant and other study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures exclusion criteria: * unwillingness of the patient to continue participating in the study * the development of conditions related to the criteria of non-inclusion

Keywords: heart failure diabetes mellitus arterial hypertension lymphoproliferative diseases knee replacement remote monitoring mhealth telemedicine voice assistant
pws outcomes assessment study

Conditions: Prader-Willi Syndrome

Summary: this is a longitudinal study during which qualitative interviews will be conducted with caregivers of soleno c601/c602 study subjects. there is an additional option for caregivers to collect video data of pws patients doing specific activities of daily life. the purpose of this study is to understand the real-world and nuanced impact of a potential therapeutic on individual pws patients. the results of this study will complement the outcomes being captured during the soleno c601/c602 clinical studies. there is no treatment or intervention associated with this study.


Eligibility criteria:
inclusion criteria: key inclusion criteria for interviews: eligible caregivers must: * be willing and able to provide informed consent in english * care for a c601/c602 trial subject or potential trial subject * have access to a smartphone or the internet * be able to converse in english key inclusion criteria for video capture: eligible pws participants for the optional daily life video capture must: * be willing and able to provide informed consent or assent. * be enrolled in the c601/c602 trial * be able to converse in english * have a caregiver who has access to an apple or android smartphone or has internet access and is willing to use a wi-fi-only device to record and upload videos * have a caregiver who is willing and able to record activity videos exclusion criteria: * n/a

Keywords: prader-willi syndrome pws
to evaluate clinical outcome and injection compliance of scilin

Conditions: Diabetes Mellitus, Type 2

Summary: this is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-scilin n, scilin r and scilin m30 (alone or in combination) in routine clinical practice. the term study insulins will be used in this protocol for these drugs and combinations.


Eligibility criteria:
inclusion criteria: * based on physicians' clinical judgement, subjects who are treated with scilin n, scilin r and scilin m30 ( alone or in combination) will be eligible to be included in this clinical study. exclusion criteria: subjects with one of the conditions listed below will be excluded: women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months subjects who have to be treated with other insulins simultaneously subjects who are participating in other diabetes clinical studies at the same time

Keywords: recombinant human insulin t2dm safety efficacy
inflammatory bowel disease and thromboembolic events

Conditions: Inflammatory Bowel Diseases; Thromboembolism; Coagulation Disorder

Summary: the main objective was to demonstrate the existence and importance of hypercoagulability in patients with ibd, by determining the prevalence of changes in coagulation parameters and evaluating the impact of these changes on the occurrence of thromboembolic events.


Eligibility criteria:
inclusion criteria: * patients with 18 years of age or older, diagnosed with ibd, followed at a gastroenterology consultation at centro hospitalar tondela-viseu, between november 2016 and april 2017. exclusion criteria: * individuals with other risk factors for te (severe hepatic or renal failure, valvular heart disease, atrial fibrillation, heart failure or cardiomyopathy, pregnancy, and oral anticoagulants or heparin at the baseline).
a safety and efficacy study for infliximab (remicade) in patients with active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the effectiveness and safety of infliximab (remicade) in patients with ulcerative colitis.

this is a study designed to investigate the safety and effectiveness of a medication called infliximab (the active drug in (remicade®) in adult patients with active ulcerative colitis. the purpose of this study is to see if the symptoms of ulcerative colitis are lessened with this medication, infliximab, and what dose is needed to do that safely. patients will receive infusions of either 5mg/kg, 10 mg/kg or placebo at weeks 0, 2, 6, and then once every 8 weeks thereafter through week 46 for up to 3 years. safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. patients will receive infusions of either 5mg/kg, 10 mg/kg or placebo at weeks 0, 2, 6, and then once every 8 weeks thereafter through week 46 for up to 3 years.

Eligibility criteria:
inclusion criteria: * patients who have had ulcerative colitis of at least 3 months' duration at screening * patients who have ulcerative colitis confirmed by the biopsy taken at screening * patients must have active colitis confirmed during the screening sigmoidoscopy * patients must have active disease. exclusion criteria: * patients must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study * patients must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage

Keywords: ulcerative colitis infliximab remicade infusion
treatment of relapsed/refractory multiple myeloma (rrmm) with pomalidomide in clinical practice

Conditions: Multiple Myeloma

Summary: there is a high unmet medical need for an anti-myeloma therapy for rrmm patients previously treated with lenalidomide and bortezomib, due to poor prognosis. this observational study focuses on the collection of data concerning the safe and optimal usage of pomalidomide, a new therapy option for rrmm patients, thereby increasing the knowledge about optimal ae management. beside this, further analysis of tolerability, dosage and efficacy will be performed. this knowledge could lead to a optimization of pomalidomide usage and treatment.

there is a high unmet medical need for further anti-myeloma therapy in patients with rrmm who have previously been treated with lenalidomide and bortezomib containing regimens that is both active and tolerable, as these patients have a poor prognosis. hands-on experience with pomalidomide is very limited in austria and a non-interventional study enhances the attention paid to safe use and handling of the product as well as increase knowledge about optimal adverse event (ae) management substantially. a detailed record of the medical history including. co-morbidities and pre-treatment regimens will allow analysis of the impact there of on tolerability, dosage and efficacy. beside the collection of data on efficacy and tolerability this observational drug utilization study could give insight into the clinical practice and the routine use of pomalidomide.

Eligibility criteria:
inclusion criteria: * signed ic * age ≥ 18 years * relapsed/refractory mm * cohort a (combination pomalidomide und dexamethasone): ≥2 antimyeloma treatments (including lenalidomide and bortezomib), induction therapy followed by asct and consolidation or maintenance therapy is considered as 1 antimyeloma treatment * cohort b (combination pomalidomide, bortezomib and dexamethasone): ≥1 antimyeloma treatments (including lenalidomide) induction therapy followed by asct and consolidation or maintenance therapy is considered as 1 antimyeloma treatment * refractory to last antimyeloma treatment * adequate contraception according to rmp * adequate thrombosis prophylaxis exclusion criteria: 1. pregnant or lactating females 2. known hypersensitivity to imnovid

Keywords: relapsed multiple myeloma refractory multiple myeloma pomalidomide imnovid non-interventional
dual mobility cup versus unipolar cup

Conditions: Dislocation, Hip

Summary: the general purpose of this study is to examine whether the dual mobility cup (novae® serf) reduces the number of hip dislocations after total hip replacement, both early dislocation (≤1 year) and late dislocation (\>1 year) after primary thr compared with a conventional cup design (trabecular metaltm modular acetabular system).

surgery with thr for arthritis and other hip disorders has long been one of the most successful orthopedic surgical treatments. the majority of the patients gain pain relief and experience improved hip function. in 2017, a total of 10,691 thrs were implanted in denmark (annual report 2018). hip dislocation is a known complication after thr. it is a painful condition which may have far-reaching consequences for the patient, who may experience both physical and mental discomfort. ultimately, multiple hip dislocations may result in reoperation. in the literature, the incidence of hip dislocation is reported at 2-6 %, and a more recent review reports a risk of 0.5-10 %. in denmark, recurrent hip dislocation is the cause of 21 % of the reoperations per year according to the danish hip arthroplasty register. according to the british national joint registry (njr) and the australian register (aoanjrr), hip dislocation is the cause of 15.5 % and 21 %, respectively, of the reoperations. the best method to avoid reoperation due to instability is to choose the correct implant for the individual patient and thereby spare the patient of having to endure a painful complication and yet another procedure. there are multiple risk factors for instability after thr, and increased use of dual mobility cups (dmc) is already documented.

Eligibility criteria:
inclusion criteria: * patients with hip arthritis who are amenable to surgery with thr and age ≥ 65 years referred to the department of orthopedic surgery at either section farsø, frederikshavn hospital or aalborg university hospital. patients who are willing to participate in the trial and who give their written, informed consent after receiving oral and written information. exclusion criteria: * patients who do not wish to participate. * sequelae of calvé-legg-perthes' disease, caput necrosis, epiphysiolysis. * proximal femoral or acetabular fracture. * hip dysplasia with subluxation crowe types iii and iv. * earlier hip bone surgery (excluding arthroscopic surgery). * elective bilateral surgery. * if the patient's bone morphology is unsuitable for a cemented exeter® femoral stem. * patients with no e-mail.

Keywords: dislocation, hip thr dual mobility cup
a study comparing sb5 to humira® in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy

Conditions: Rheumatoid Arthritis

Summary: this is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of sb5 compared to humira® in subjects with moderate to severe ra despite mtx therapy.

investigational product: sb5 40 mg (0.8 ml of 50 mg/ml) indication studied: rheumatoid arthritis

Eligibility criteria:
inclusion criteria: * are male or female aged 18-75 years at the time of signing the informed consent form. * have been diagnosed as having ra according to the revised 1987 american college of rheumatology (acr) criteria for at least 6 months but not exceeding 15 years prior to screening. * have moderate to severe active disease despite mtx therapy defined as: 1. more than or equal to six swollen joints and more than or equal to six tender joints (from the 66/68 joint count system) at screening and randomisation. 2. either erythrocyte sedimentation rate (westergren) ≥ 28 mm/h or serum c-reactive protein ≥ 10 mg/dl at screening. * must have been treated with mtx for a total of at least 6 months prior to randomisation and must have been on both: a stable route of administration (oral or parenteral) and stable dose of mtx (10-25 mg/week) for at least 4 weeks prior to screening. * female subjects who are not pregnant or nursing at screening and randomisation and who are not planning to become pregnant from screening until 5 months after the last dose of ip. exclusion criteria: * have been treated previously with any biological agents including any tumour necrosis factor inhibitor. * have a known hypersensitivity to human immunoglobulin proteins or other components of humira or sb5. * have a positive serological test for hepatitis b or hepatitis c or have a known history of infection with human immunodeficiency virus. * have a current diagnosis of active tuberculosis (tb), have been recently exposed to a person with active tb, or are considered to have latent tb. * have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to randomisation. * have a history of chronic or recurrent infection. * have any of the following conditions: 1. history of congestive heart failure (new york heart association class iii/iv). 2. history of acute myocardial infarction or unstable angina within the previous 12 months prior to screening. 3. history of demyelinating disorders. 4. history of any malignancy within the previous 5 years prior to screening. 5. history of lymphoproliferative disease including lymphoma. 6. any other disease or disorder which, in the opinion of the investigator, will put the subject at risk if they are enrolled. * have physical incapacitation (acr functional class iv or wheelchair-/bed-bound).

Keywords: rheumatoid arthritis, adalimumab
a study conducted over 3 periods to look at the drug in the body

Conditions: Type 2 Diabetes Mellitus

Summary: a study conducted over 3 periods to look at the drug in the body.


Eligibility criteria:
inclusion criteria: * provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in cyp3a5 * suitable veins for cannulation or repeated venepuncture * subjects should have a body mass index (bmi) between 18 and 30 kg/m2 exclusion criteria: * abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator * prolonged qtcf \>450 msec or shortened qtcf \<350 msec or family history of long qt syndrome * suspicion of known gilbert's disease * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Keywords: type 2 diabetes mellitus healthy