Kornimate/medical-research-clean huggingface dataset:
relative bioavailability of two formulations of moroctocog alfa (af-cc)

Conditions: Hemophilia A

Summary: this study is being conducted to compare how moroctocog alfa (af-cc) acts in the body when administered as 2 different dose presentations. the first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.

this study is being conducted in order to satisfy a post-approval ema commitment to compare the pharmacokinetics of the 2 dose presentations used in this study.

Eligibility criteria:
inclusion criteria: * male patients at least 18 years old with severe or moderately severe hemophilia a (facto viii concentration less than or equal to 2%). * negative test for facto viii inhibitor. * if applicable, hiv or hepatitis treatment is stable at the time of enrollment. * ability to abstain from use of fviii products for 72 hours at a time. exclusion criteria: * history of any positive test result for factor viii inhibitor. * presence of any bleeding disorder in addition to hemophilia a. * body weight less than 50 kg. * history of alcoholism. * treatment with investigational drug or device within 30 days prior to the screening visit.

Keywords: hemophilia a moroctocog alfa (af-cc) refacto af dual-chamber syringe bioavailability
study of xl999 in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of xl999 when given weekly to patients with metastatic colorectal cancer (crc). xl999 is a small molecule inhibitor of multiple kinases including vegfr, pdgfr, fgfr, flt-3, and src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.


Eligibility criteria:
inclusion criteria: * males and females with histologically confirmed metastatic colorectal cancer * measurable disease according to response criteria for solid tumors (recist) * at least 1 prior therapeutic regimen (chemotherapy or biologic) * ecog performance status of 0 or 1 * life expectancy ≥3 months * adequate organ and marrow function * no other malignancies within 5 years * signed informed consent exclusion criteria: * radiation to ≥25% of bone marrow within 30 days of xl999 treatment * treatment with systemic anticancer therapy within 30 days of xl999 treatment * subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered \>30 days prior to study enrollment * history of or known brain metastases, current spinal cord compression, or carcinomatous meningitis * uncontrolled and/or intercurrent illness * pregnant or breastfeeding females * known hiv

Keywords: colon cancer
standard versus fanning techniques for endoscopic ultrasound-fine needle aspiration (eus-fna)

Conditions: Pancreatic Tumors

Summary: endoscopic ultrasound (eus)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. eus-guided biopsies yield a definitive diagnosis in greater than 80% of cases. in 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. one of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. the fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. the diagnostic performance of both these techniques has not been compared in a randomized fashion.

fanning technique: fine needle aspiration (fna) performed in multiple directions within a mass. standard technique: fna performed in unidirectional fashion.

Eligibility criteria:
inclusion criteria: * age \> 19 years * solid pancreatic mass lesions exclusion criteria: * age \< 19 years * coagulopathy * unable to consent
proliferative effects of erythropoietin on human endometrium

Conditions: Anemia; Endometrial Diseases

Summary: the purpose of this study to assess the proliferative effects of erythropoetin on human endometrium tissue by measuring the endometrial thickness, uterine artery and subendometrial blood flow in postmenopausal women.

20 postmenopausal women who are planned to treat with erythropoietin alpha for their renal conditions will be included to the study. sample size was calculated with proper power analysis with accepting the difference of 1 mm in endometrial thickness as a significant change. after the informed consent, endometrial thickness (mm), uterine artery and subendometrial blood flow by doppler ultrasonography (ri, s/d) will be measured. same measurements will be repeated on the 3rd day and 30th day. patients' age, bmi, co-morbidities, administered erythropoietin doses will be noted. no adverse effect is expected with regard to the ultrasonographic examination. date of the patients who do not attend for the appointments for repetitive examinations and uninterpretable doppler variables due to the atrophic uterus will be noted as the missing data and will be excluded from the study. proper statistical analysis will be done.

Eligibility criteria:
inclusion criteria: * clinically condition with need for erythropoietin treatment such as anemia due to the renal failure or the need for hemodialysis. * must be in postmenopausal period exclusion criteria: * patients with any type of malignancy * existence of any intracavitary mass which may affect endometrial thickness or blood flow such as endometrial polyps, myomas, intracavitary fluid etc. * intrauterine device * being on hormon replacement therapy * hysterectomized patients

Keywords: erythropoietin endometrium doppler ultrasonography
homemade versus commercialized single-access port devices in single-incision laparoscopic appendectomy

Conditions: Minimally Invasive Surgical Procedures

Summary: homemade and commercialized single-assess port devices are two kinds of port devices commonly used for single-incision laparoscopic appendectomy. this study aimed to compare these two port devices in terms of short-term surgical outcomes and medical costs.

the advantages of homemade port devices include accessibility of the composites and lower equipment costs to the patients; however, the potential disadvantage is the easy leakage of co2, ballooning of the surgical glove, and device instability, leading to difficult maneuverability. on the other hand, commercialized port devices have relatively easy maneuverability, flexibility for instrument changes, and port stability for long-duration surgery ; however, their higher equipment cost is a disadvantage.

Eligibility criteria:
inclusion criteria: * the patients were diagnosed as acute appendicitis and undergoing single-incision laparoscopic appendectomy exclusion criteria: * the patient was not diagnosed as acute appendicitis based on surgical finding or pathological findings * the patients underwent surgery other than single-incision laparoscopic surgery

Keywords: single-incision laparoscopic appendectomy single-access port device
multispectral optoacoustic tomography in head and neck squamous cell cancer

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this research is to assess the safety and evaluate the potential of the multispectral optoacoustic tomography (msot) device to more precisely identify and assess the neck lymph nodes which might be affected in patients with metastatic head and neck squamous cell carcinomas.

this is a 2-arm investigational device study designed to provide safety information regarding the use of the acuity msot device in the clinical setting, and to determine the ability of msot imaging data to correlate with clinical findings identified via pathology. imaging with the msot device is expected to obtain information about the number, size, and appearance of the lymph nodes in the neck. the device will be used to obtain images of the tumor or lymph node margins for investigational use only to compare to clinical pathology and patient's medical records. all images will be obtained pre-surgery for arm 1 patients (undergoing surgery for their cancer) and before, during and after radiotherapy in arm 2 patients (undergoing radiotherapy treatment for their cancer). the temperature of the patient's skin will also be measured prior to and after each msot scan. once radiotherapy treatment has completed, images using the msot device will be obtained every 6 months for 2 years to assess for radiation induced fibrosis. msot scans will be for research only and no treatment decisions will be based on the msot images obtained.

Eligibility criteria:
inclusion criteria: * clinically confirmed node positive head and neck squamous cell cancer * written informed consent signed and dated by the patient prior to the performance of the msot * at least 18 years-of-age at the time of signature of the informed consent form (icf) * patients planned for curative intent therapy * patient available for the study duration * patients of childbearing potential must have a negative pregnancy test prior to the study entry. * patients of childbearing potential must use an effective form of contraceptive as per the protocol. exclusion criteria: * history of previous head and neck radiotherapy * intent of treatment palliative * women who are pregnant * patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of the investigational regimen should be included. * psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Keywords: imaging device
a trial to improve quality of life with stereotactic body radiotherapy for patients with painful bone metastases

Conditions: Metastasis to Bone; Radiotherapy; Neoplasm Metastasis

Summary: this is a phase iii randomized-controlled, single-blind study comparing the standard schedule for antalgic radiotherapy of a single fraction of 8.0 gy delivered through three-dimensional conformal radiotherapy (3d-crt) to a single fraction of 20.0 gy delivered through stereotactic body radiotherapy (sbrt). the primary aim of this trial is to double the complete response rate. secondary aims are to compare general response rates, duration of pain response, acute and late toxicity, hrqol through patient-reported outcome measures (proms), pain flare, and re-irradiation need.


Eligibility criteria:
inclusion criteria: * histologically confirmed malignancy. * pain score ≥ 2 on a scale from 0 to 10. * radiological or (bone) scintigraphic evidence of bone metastasis at the site of pain. * lesions ≤ 5cm in largest diameter. * per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below. * no more than 3 painful lesions needing treatment. * life expectancy estimated at \> 3 months. * patients who have received the information sheet and signed the informed consent form. * patients must be willing to comply with scheduled visits, treatment plan, and other study procedures. * patients with a public and/or private health insurance coverage. exclusion criteria: * myeloma. * bone metastasis in previously irradiated sites. * previous radioisotope treatment for bone metastases. * complicated bone metastasis, i.e. impending and/or existing pathological fracture, spinal cord compression or cauda equina compression \[16\]. * patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potential hampering compliance with the study. * individual deprived of liberty or placed under guardianship.

Keywords: stereotactic body radiotherapy spinal metastases bone metastases
a study to evaluate the safety and efficacy of gr2002 injection in patients with atopic dermatitis.

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, placebo-controlled phase ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of gr2002 injection in patients with moderate to severe atopic dermatitis. the dosing period was 12 weeks and followed up to 20 weeks.


Eligibility criteria:
main inclusion criteria: 1. patients need to meet williams diagnostic criteria, have had ad for at least 1 year, and:easi ≥16, iga score ≥3, and ad involvement of ≥10% of bsa; 2. inadequate response or intolerance to prior topical glucocorticoid (tcs) therapy for the treatment of ad; 3. voluntary informed consent. main exclusion criteria: 1. current malignancy or history of malignancy; 2. history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation; 3. subjects may have active mycobacterium tuberculosis infection; 4. systemic anti-infective therapy required for chronic or acute active infection within 4 weeks prior to the baseline visit; 5. history of known or suspected immunosuppression; 6. presence of skin comorbidities that may interfere with evaluation; 7. suspected or confirmed allergy to the test drug (including excipients, similar drugs); 8. history of alcohol or drug abuse within 3 months prior to screening； 9. pregnant or lactating women who need to breastfeed； 10. major surgery planned during the trial； 11. the elution cycle of the drug of interest is not met at the baseline； 12. subjects of childbearing potential and partners refusing to use highly effective contraception.

Keywords: tslp
leg length and quality of life after total hip arthroplasty

Conditions: Total Hip Arthroplasty

Summary: this study used 3d reconstructions from the eos biplanar radiographic imaging system to perform leg length measurements before and after tha (total hip arthroplasty) on all included tha patients from 2015 to evaluate surgeon performance in restoring lower limb length after tha and the relationships between the quality of life, estimated by the hoos score (hip disability and osteoarthritis outcome score), and the anatomy of the new hip in standing position.

the study was conducted in patients who underwent a total hip arthroplasty in lariboisiere hospital, paris, france, during the year 2015. this retrospective study used 3d reconstructions from the eos biplanar radiographic imaging system (eos imaging, paris, france) to perform leg length measurements before and after tha on all included tha patients from 2015 to evaluate surgeon performance in restoring lower limb length after tha. included patients either had hip osteoarthritis or femoral head osteonecrosis. patients were excluded if they were undergoing revision surgery, or had a contralateral tha or total knee. the performance of the surgeons was judged using the cumulative sum control chart (cusum) method. our objective was to study surgeon performance, measured by their ability to restore the initial preoperative length of the operated leg or to equalize the length of the two legs, and evaluate the relationships between the quality of life, estimated by the hoos score, and the anatomy of the new hip in standing position using the eos imaging system.

Eligibility criteria:
inclusion criteria: * unilateral total hip replacement for osteoarthritis or avascular necrosis healthy contralateral hip * age over 18 years * informed consent to participate in the study * radiographs obtained after total hip replacement using the eos imaging system, filled hoos form * clinical follow-up of 12 months at least exclusion criteria: * past history of contralateral hip replacement * ipsi or contralateral knee replacement * hip arthroplasty performed using a kerboull cross * post-operative complications such as infection

Keywords: eos total hip arthroplasty performance of surgeons leg length discrepancy hoos
easivent study comparing intellivent-asv vs non automated ventilation in adult icu patients

Conditions: Acute Respiratory Failure; Coma; Acute Respiratory Distress Syndrome (ARDS); Chronic Obstructive Pulmonary Disease (COPD); Obesity

Summary: the purpose of the study is to assess the safety and efficacy of intellivent-asv (adaptive support ventilation) in adult icu patients comparing to non automated ventilation.

easivent is a prospective, multicenter, randomized (1:1), controlled study. this study is single-blind because only the subject will be unaware of the ventilation modality administered. the reference treatment used for comparison is a combination of controlled modes for passive subjects (volume control or pressure control) and assisted/spontaneous modes for active subjects (synchronized intermittent mechanical ventilation or pressure support)

Eligibility criteria:
inclusion criteria: * weight greater than 40 kg * under invasive ventilation * expected to be mechanically ventilated after enrollment for at least 24 hours * agrees to not participate in other interventional research studies involving mechanical ventilation for the duration of study * signature of the informed consent by the patient or his/her next-of-kin according to country or state regulation. exclusion criteria: * fulfilling weaning criteria according to the weaning procedure of the icu * need for "rescue therapy" (e.g: ecmo) * brain death status * respiratory drive disorder (cheyne-stokes breathing) * arterial hypoxia due to a non-pulmonary condition (right-to-left shunting due to congenital disease, hepato-pulmonary syndrome, ) * broncho-pleural fistula * chronic or acute dyshemoglobinemia: eg.: acute co poisoning * chronic respiratory failure requiring long term invasive ventilation; * moribund patient * patient under guardianship, deprived of liberties * any other condition, that in the opinion of the ior/designee, would preclude informed consent (by the spouse/next of kin), make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. * low quality index on the spo2 (oxygen saturation measured by pulse oximetry) measurement * patients already enrolled in the present study in a previous episode of acute respiratory failure * high paco2 - etco2 gap (\> 2.6 kpa or 19.5 mmhg) for \> 3 hours * patient tracheostomized at the time of inclusion * patient ventilated with helium
the 90% effective sedation dose of midazolam

Conditions: Gastro-Esophageal Reflux Disease With Ulceration

Summary: there are no clear conclusive clinical reports defining the adequate effective dose of midazolam in patients undergoing day-case esophageal-gastro-duodenoscopy (egd). defining such dosage will facilitate practitioners who are not anesthesia professionals to administer sedative drugs to establish a satisfactory level of moderate sedation. our first aim is to determine the effective dose for 90% of patients (ed 90) of midazolam undergoing day-case egd.

midazolam is widely used in conscious sedation during esophageal-gastro-duodenoscopy (egd) to increase patient's tolerance and cooperation. its short duration, cardiorespiratory stability, anxiolytic and amnestic properties makes it the drug of choice for moderate sedation in day case short procedure 1. therefore, moderate sedation during digestive endoscopy can be administered by endoscopist in safe monitored area while a qualified nurse monitors the level of consciousness and vital sings. the endoscopist's privileges to administer deeper alternative drug, i.e. propofol, might not be provided easily in many centers especially outside the hospital due to certain limitations. however, the patient's and endoscopist's satisfaction might not be achieved easily with the administration of midazolam for moderate sedation. inappropriate dose will fail to produce amnesia or may cause respiratory side effect and delayed recovery and discharge. therefore, there are no clear conclusive clinical reports defining the adequate effective dose of midazolam in patients undergoing day case egd. this is obvious from different dosage used in various studies. in addition, midazolam dosage in adult is rarely based on the body weight during our daily clinical practice. defining such dosage will facilitate practitioners who are not anesthesia professionals to administer sedative drugs to establish satisfactory level of moderate sedation. our first aim is to determine the effective dose for 90% of patients (ed 90) of midazolam undergoing day case egd.

Eligibility criteria:
inclusion criteria: * asa 1\&2 exclusion criteria: 1. patients with hypersensitivity to midazolam, 2. age less than 18, 3. obstructive sleep apnea 4. known or suspected memory impairment, 5. patients with psychiatric disorders, 6. visual or hearing impairment and pregnancy
endoluminal and needlescopic assisted repair of rectal prolapse

Conditions: Rectal Prolapse

Summary: the purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using co2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. further, investigators will evaluate the short and long-term clinical outcomes after this novel approach to treating rectal prolapse.

.aims/objective the purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using co2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. further, we will evaluate the short and long-term clinical outcomes after this new procedure. primary outcomes 1. feasibility: successful completion of endoluminal rectal prolapse repair with needlescopic assistance 2. safety: measured by the incidence of the intraoperative complications (bowel perforation, organ injury and bleeding requiring blood transfusion) 3. sedation and local anesthesia feasibility: surgery completed without patient intubation 4. clinical outcomes: rectal prolapse recurrence within 30 days, length of hospital stay and postsurgical complications 5. long term clinical outcomes: rectal prolapse recurrence methods design: a prospective pilot study with 10 patients who will be undergoing combined needlescopic and endoluminal (colonoscopic) surgery under sedation and local anesthesia for rectal prolapse repair with the colon and rectal surgeons at wcmc. data will be collected prospectively before, during, and after surgery. settings: colon and rectal surgery at wcmc-nyph population: patients male and female above 75 years of age, with rectal prolapse will be invited to participate in the study after surgery is deemed necessary for standard treatment of their medical conditions.

Eligibility criteria:
inclusion criteria: * age, 75 years and older, male and female * bmi above 18 and ≤30 * asa class 1-3 * willing to participate in the study exclusion criteria: * asa class 4-5 * previous abdominal surgeries including abdominal wall repair with mesh