Kornimate/medical-research-clean huggingface dataset:
a study to understand how the study medicine dazukibart works in people with idiopathic inflammatory myopathies

Conditions: Dermatomyositis; Polymyositis

Summary: the purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \[dm\] or polymyositis \[pm\]). idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. there are several types of idiopathic inflammatory myopathies, including dm and pm. dm and pm involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. people with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. people with dm can also have a skin rash. these disorders negatively impact the quality of life and functioning of patients. in addition to the above, these disorders can affect how the lungs and heart work. this study is seeking participants who took part in a dm and pm study with dazukibart before. some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up. the study medicine will be given as an intravenous (iv) infusion (directly into the veins). this takes about 1 hour, every 4 weeks, from day 1 to week 48 (about 12 months) of the study. this will be followed by a safety follow-up period that lasts about 4 months after the last infusion. participants who receive study medicine will have about 18 study visits at the site over about 16 months. there will also be participants enrolled in this study who will not receive study medicine. such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. these participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.


Eligibility criteria:
inclusion criteria: * participants that completed a qualifying study through week 52. exclusion criteria: * any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation. * previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer). * current use of any prohibited concomitant medication(s). * active bacterial, viral, fungal, mycobacterial or other infections. * ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved. * investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
safety, tolerability and potential efficacy of avt001 in patients with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: this is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of avt001, and to assess avt001 as a potential treatment for type 1 diabetes (t1d). the trial will involve approximately 24 new-onset t1d subjects.


Eligibility criteria:
key inclusion criteria: 1. diagnosis of type 1 diabetes, within 12 months of first dosing, confirmed by positive lab result for one or more of the following types of autoantibodies: 1. glutamic acid decarboxylase (gad65) 2. insulinoma associated protein 2 (ia-2, also known as ica-512) 3. zinc transporter 8 (znt8). 2. age 16 or older and able to provide informed consent/assent. 3. if a participant is female with reproductive potential, willing to avoid pregnancy through the duration of the trial. 4. signed and dated written informed consent/assent. key exclusion criteria: 1. poorly controlled diabetes despite insulin therapy, who in the opinion of the investigator would not be a good candidate for participation in a clinical trial 2. screening hemoglobin \<10.0 g/dl; leukocytes \<3,000/ul; neutrophils \<1,500/ul; lymphocytes \<800/ul; platelets \<100,000/ul 3. screening urine albumin excretion \> 300mg/gmcr 4. screening egfr \< 60 ml/min/1.73m2 5. screening alt or ast \> 1.5x upper limit of normal (uln) 6. screening bilirubin \> 2.0 mg / dl, or \> 3.0 mg / dl for participants with gilbert's syndrome 7. current use of immunosuppressive or immunomodulatory therapies, including pharmacologic doses of systemic steroids. however, topical steroidal creams and inhaled steroids without large systemic absorption are allowed. 8. coincident medical condition likely to require immunosuppressive or immunomodulatory therapies. 9. coincident medical condition likely to limit short term (5 year) life expectancy (malignancy, symptomatic coronary artery disease, recent stroke) 10. prior radiation therapy, immunotherapy (within 1 year of screening), or chemotherapy 11. serologic evidence of current hiv-1 or hiv-2 infection 12. serologic evidence of hepatitis c infection 13. serologic evidence of acute or chronic active hepatitis b as measured by core ab positive and / or surface antibody antigen positive 14. subjects with other autoimmune conditions (except compensated or treated autoimmune thyroid, celiac, alopecia, or vitiligo diseases) 15. women who are pregnant (pregnancy testing during screening), breastfeeding, or planning pregnancy during the study period 16. inadequate venous access to support leukapheresis 17. any condition that in the opinion of the investigator(s) would preclude the subject from participating in a clinical trial. 18. abnormal screening ecg that in the opinion of the investigator or sponsor would pose a safety risk.
cardiac vascular reconstruction dynact for tavi procedures

Conditions: Aortic Valve Disease

Summary: the purpose of this work is to evaluate the feasibility of a new cardiac vascular reconstruction (cavarec, siemens medical systems, germany) image reconstruction algorithm for use during transcatheter aortic valve implant (tavi) procedures or interventional procedures to treat congenital or structural heart disease. cavarec utilizes the same x-ray projection images as currently acquired for clinical dynact. x-ray image acquisition to allow cavarec will occur during the interventional procedure after the tavi device, other valve, or stent is implanted. if the participants already have a surgically-implanted tavi device, stent or other device, and are having a cardiac catheterization, then an extra set of images will be acquired after your clinical care is complete, but before you leave the procedure room. the cavarec image processing algorithm will be implemented on an off-line workstation after the interventional procedure is complete. after the tavi procedure, cavarec images will be quantitatively and qualitatively compared to siemens dynact and cardiac ct images from radiology. the results of this study will be used to direct further development of cavarec toward the end goal of providing improved imaging capabilities to guide tavi, congenital heart, or structural heart treatment procedures.

1. compare utility of cavarec to standard dynact and cardiac ct for clinical assessment of the aortic valve and relevant, nearby anatomical structures. 2. investigate the utility of cavarec to assess calcification within and surrounding the native aortic valve. 3. investigate the utility of cavarec to assess procedural success, including prosthetic valve placement and annular anatomic correlates of paravalvular leak. 4. validate utility of cavarec for images acquired during normal sinus rhythm.

Eligibility criteria:
inclusion criteria: * patients may either be scheduled for a tavi procedure or scheduled for a cath lab appointment at any time after a tavi procedure, or scheduled for device implant to treat congenital or structural heart disease. exclusion criteria: * patient enrolled in research protocol with exclusions from simultaneous participation in another protocol * lack of research consent.
therapy of peri-implantitis: scaling versus low abrasive powder

Conditions: Peri-implantitis

Summary: in the last decade, the number of dental implantations continuously increases. however, at the same time, the prevalence of peri-implantitis increases, too. although both surgical and non-surgical interventions are available for the therapy, there is no efficient and satisfying therapy option resulting in an adequate improvement of this disease. an innovative, low abrasive powder has been introduced for the therapy of periodontitis. however, the powder might be suitable for the peri-implantitis therapy, also, and could improve the effectiveness of the therapy. the usage of this powder in peri-implantitis patients has not been assessed in a clinical trial although the effectiveness in natural teeth has been demonstrated. the aim of this prospective, randomised, multi-centre trial is to assess the effectiveness of the aforementioned powder in peri-implantitis patients.


Eligibility criteria:
inclusion criteria: * mild to moderate peri-implantitis * age ≥18 years * capacity to contract * no subgingival debridement within the last six months * informed consent exclusion criteria: * pregnancy * subgingival debridement within the last six months * bleeding tendency * usage of antibiotics within the last three months * insufficient restorations (including caries etc.) * diabetes mellitus * smoker * implantats with platform switch
evaluating mechanical properties of post-mastectomy skin flaps to estimate reconstruction risks, the empower study

Conditions: Breast Carcinoma

Summary: this study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.

primary objective: i. characterize the nanomechanical properties of the skin and adjacent soft tissue removed at the time of postmastectomy implant reconstruction. outline: this is an observational study. patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.

Eligibility criteria:
inclusion criteria: * \* age 18 and older * female sex * patient with history of mastectomy with tissue expander placement * tissue expander in place at time of study enrollment * patient plans to undergo surgery to exchange tissue expander for permanent breast implant within the next 3 months of signing the informed consent * ability to understand and provide written informed consent in accordance with institutional policies
cirrhosis readmission telehealth project

Conditions: Cirrhosis

Summary: this is a 2 year research study to study if post discharge phone calls can help lengthen time to hospital readmissions for patients with encephalopathy.

the purpose of this randomized prospective pilot study is to decrease hospital readmissions for patients with hepatic encephalopathy. patients who were admitted at ynhh with hepatic encephalopathy will be enrolled. patients will then be randomized to one of two groups upon discharge. the control group will receive usual standard of care for hepatic encephalopathy (encephalopathy education, cirrhosis brochure, stool chart, and routine follow up with their primary care provider and hepatologist). the intervention group will receive usual standard of care as discussed above and phone calls for a 3-month period after their hospitalization.

Eligibility criteria:
inclusion criteria: * age of at least 18 * patients with known cirrhosis * current hospitalization for overt hepatic encephalopathy as categorized by west haven encephalopathy score of 2 or more * current hospitalization found no precipitants triggering encephalopathy as determined by the primary team * encephalopathy resolved at time of enrollment * has a telephone * able to obtain medications exclusion criteria: * altered mental status unrelated to cirrhosis * acute liver failure * expectation of liver transplant within 1 month after enrollment * chronic kidney disease with cr \> 2 mg/dl * respiratory insufficiency:moderate to sever copd on pulmonary function test * electrolyte imbalances not corrected at enrollment * sodium less than 125 mmol/l * calcium greater than 10mg/dl * potassium \< 2.5mmol/l * unable to give legal consent * deafness * infection, spontaneous bacterial peritonitis, gastrointestinal bleeding
combining chest x-ray and arterial blood gas findings to predict need for mechanical ventilation in critically ill patients

Conditions: Respiratory Failure; Critical Illness; Mechanical Ventilation

Summary: this prospective cross-sectional study aims to develop and validate a machine learning model that combines chest x-ray findings with arterial blood gas (abg) analysis to assess the necessity for mechanical ventilation in critically ill adult patients. conducted at zagazig university hospitals, the study seeks to improve clinical decision-making by integrating radiological and biochemical data using artificial intelligence. the model's predictive performance will be evaluated against standard clinical assessments.

the study is a prospective cross-sectional investigation conducted at zagazig university hospitals, aiming to develop a machine learning model that integrates chest x-ray findings and arterial blood gas (abg) analysis to assess the necessity for mechanical ventilation in critically ill adult patients. while current clinical decision-making relies on separate interpretation of radiologic and biochemical data, this study proposes a novel model that synthesizes both sources of information using artificial intelligence to improve predictive accuracy and reduce subjectivity. a total of approximately 2,160 patients will be enrolled over a 6-month period. data collected will include demographic and clinical characteristics, abg parameters (e.g., ph, pao2, paco2, hco3), and radiological features (e.g., infiltrates, effusions, consolidation). patients will be categorized based on whether they require mechanical ventilation. the machine learning model will be trained on 70% of the dataset and validated on the remaining 30%. performance metrics such as accuracy, r-squared values, and root mean square error (rmse) will be used to assess predictive capacity. the study will adhere to ethical guidelines and has obtained irb approval from the faculty of medicine at zagazig university (approval no. 1138). by combining imaging and laboratory data, this study seeks to deliver a practical decision-support tool that enhances the objectivity and efficiency of critical care management.

Eligibility criteria:
inclusion criteria: critically ill adult patients aged 18 years or older. patients assessed to require mechanical ventilation. control group: age- and sex-matched critically ill patients not requiring mechanical ventilation. availability of both chest x-ray and arterial blood gas (abg) analysis at the time of evaluation. exclusion criteria: patients with missing or incomplete data (e.g., absent chest x-ray or abg results). patients with chronic lung diseases unrelated to the current admission (e.g., copd, pulmonary fibrosis). pregnant females.

Keywords: mechanical ventilation respiratory failure critical illness artificial intelligence chest x-ray arterial blood gas
a feasibility study with iressa in resistant cytokeratin-positive tumor cells circulating in the blood of women with breast cancer

Conditions: Breast Cancer

Summary: based on preclinical data, zd1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. therefore it could be very important and clinically relevant to know if zd1839 is capable of eliminating occult tumour cells circulating in the blood of breast cancer patients


Eligibility criteria:
inclusion criteria: * provision of written informed consent * histologically or cytologically confirmed breast cancer * metastatic breast cancer (stage iiib and iv) * patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. there should be at least one month between end of chemotherapy treatment and trial entry. * er+ve patients should have received adjuvant hormonal treatment * detection of ck-19 mrna positive cells in the blood by real time pcr despite the previous administration of chemotherapy and if appropriate hormonal therapy * aged 18 years and over * paraffin-embedded tissue available for tumour histology (egfr testing, er, pgr, her-2-neu testing) * eastern cooperative oncology group (ecog) performance status (ps) of 0 to 2 * patients willing to undergo regular detection of circulating occult tumour cells in the blood by immunocytochemistry and/or rt-pcr * life expectancy of at least 12 weeks exclusion criteria: * any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies) * known severe hypersensitivity to zd1839 or any of the excipients of this product * any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) * other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * any unresolved chronic toxicity greater than common toxicity criteria (ctc) grade 2 from previous anticancer therapy (except alopecia) * serum bilirubin greater than 1.5 times the upper limit of reference range (ulrr) * as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * alanine amino transferase (alt) or aspartate amino transferase (ast) greater than 3 times the ulrr. * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study * pregnancy or breast feeding (women of child-bearing potential). women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy * concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or st john's wort * treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment

Keywords: breast cancer iressa circulating tumor cells
clinical investigation of wireless transmission of invasive blood pressure signal

Conditions: Multiple Trauma; Shock; Atrial Fibrillation; Perioperative/Postoperative Complications

Summary: the purpose of this study is to determine whether wireless transmission of invasive arterial blood pressure signal (by hmw 10 wireless system) from patient to patient's bedside monitor is feasible, safe and as accurate as conventional cable connection.

the technology for invasive arterial blood pressure measurement in emergency room, operating theater, recovery room and intensive care unit is well established and uses pressure sensor connected via cable to patient's bedside monitor. the wireless sensors result in reduction of wires attached to the patient and may enhance nursing, treatment and transportation of patients in aforementioned setting. the hmw 10 wireless system was developed and incorporates wireless transmission of patient's signal. the purpose of the study was to measure the quality of data transmitted through the hmw 10 wireless system, and to demonstrate that the quality of the data meets the requirements of european directive 93/42/eec (medical device directive - mdd) and en/iec 60601-1 and en/iec 60601-2-34.

Eligibility criteria:
inclusion criteria: * icu patients requiring invasive blood pressure monitoring exclusion criteria: * frequent blood sampling through arterial cannula (more than 3 times a day)

Keywords: invasive blood pressure monitoring intensive care unit wireless technology
safety and efficacy of insulin detemir in combination with oad in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (oads) versus insulin nph combined with oral anti-diabetic drugs (oads) in type 2 mellitus not well controlled on current therapy on blood glucose control.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 months since diagnosis * insulin naive subjects * oad treatment for at least 4 months alone or combined with no more than two oads * body mass index (bmi) below 35.0 kg/m2 * hba1c between 7.5-10.0% * able and willing to use twice a day injections for the entire trial period exclusion criteria: * current or previous treatment with thiazolidiones within the last 6 months * oad treatment with three or more oads within the last 6 months * acute insulin treatment for longer than 7 days in a row within the last 6 months * secondary diabetes * known maturity onset of diabetes of young (mody) * known or suspected allergy to trial product or related products
far infrared radiation treatment for bipolar condition

Conditions: Bipolar Disorder

Summary: a preliminary study to determine the possibility of using far infrared radiation for the treatment of the bipolar condition

a 2000 study in the american journal of psychiatry reported that, "in those with bipolar, two major areas of the brain contain 30 percent more cells that send signals to other brain cells". this fact explains why famous people with the bipolar condition like astronaut buzz aldrin, financier robert campeau, british prime minister winston churchill, composer mozart, scientist isaac newton, physician sigmund freud and media giant \& entrepreneur ted turner, excelled in life due to the additional brain power! the excessive brain power, however, had to be controlled occasionally with mood stabilizers. mood stabilizers include a number of anticonvulsants and lithium. these medications, however, have adverse side effects on the kidneys. the proposed evaluation does not have any adverse health effects.

Eligibility criteria:
inclusion criteria: * persons with bipolar condition, depression, anxiety, stress and insomnia exclusion criteria: * persons with severe mental illness that are confined to mental hospitals etc. as defined by the usa diagnostic and statistical manual of mental disorders (dsm) are excluded from this clinical trial.

Keywords: affective psychosis, bipolar depression, bipolar mania manic disorder manic state manic-depressive psychosis psychoses, manic-depressive psychosis, manic-depressive
randomized controlled trial comparing co2 vs. air in colonoscopy in sedated patients

Conditions: Pain, Satisfaction

Summary: co2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. there is limited data, that co2 is similar effective in sedated patients. furthermore it had not been investigated if patient's compliance for participating in cancer screening could be improved by using co2. the aim of the study is to assess postoperative pain and satisfaction after colonoscopy by comparing c02 with air.


Eligibility criteria:
inclusion criteria: * all patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation * between 18 and 90 years exclusion criteria: * copd * dementia

Keywords: co2 pain colonoscopy cancer screening