Kornimate/medical-research-clean huggingface dataset:
an open-label, randomized, prospective study of the effectiveness, safety, and clinical outcomes of stapled anastomoses versus hand-sutured anastomoses in patients undergoing gastrointestinal end to end or side to side anastomoses

Conditions: Gastrointestinal Disease; Colorectal Disease

Summary: this study is being conducted to compare surgical and patient outcomes across stapled (group ii) versus hand-sutured (group i) groups.


Eligibility criteria:
inclusion criteria:a. * able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document * 18 years to 75 years (inclusive) * admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis * willing to adhere to standard postoperative care, including ventilator support if required * female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilization, with appropriate documentation) * if female subject is capable of child bearing, must use an acceptable method of birth control (hormonal or iud) for at least 3 months prior to surgery and continue use throughout the study; maintained normal menstrual pattern for the past three months and has a negative urine pregnancy test prior to day of surgical procedure * absence of medical history of psychiatric disorders that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations. exclusion criteria: * women of childbearing potential who are pregnant at the time of screening or at the time of surgery * subject is on treatment with corticosteroid maintenance therapy (equivalent to \> 10mg/day of prednisone), immunosuppressive or chemotherapeutic agents within 14 days prior to enrollment; or likely to receive one of these drugs during study period * subject has connective tissue disease, renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis as evidenced by serum creatinine of \> 3mg/dl * subject has liver failure as evidenced by cp category c * immunocompromised subjects (hematological malignancies, history of bone marrow transplantation, splenectomized subjects, genetic disorders such as lupus, severe combined immunodeficiency, etc.) or a positive hiv test result * subject has extensive disseminated malignancy and unlikely to survive for more than 3 months based on investigator judgment * any subject that the investigator determines is not likely to be compliant during the study period * subjects determined or suspected to engage in substance abuse, or any subject who is currently, or has in the past 6 months, undergone substance abuse therapy * the investigator feels that the primary anastomosis is not feasible due to local conditions of the bowel or subject has unstable hemodynamic status requiring stoma * participation in any other investigational device or drug study (non survey based trial) within 30 days of enrollment.

Keywords: stapling hand sutured anastamosis colorectal disease
a phase i clinical trial to evaluate the safety and immunogenicity of 200 mcg of gp120 (cho) biocine in mf59 emulsion versus the emulsion control: three injections at 0, 1, and 6 months

Conditions: HIV Infections

Summary: to evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in mf59 emulsion without mtp-pe at 0, 1 and 6 months. preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol veu 007a indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol veu 007a indicate that a gp120 dose of potentially greater immunogenicity may be of interest. ten healthy volunteers receive 200 mcg gp120 in mf59 emulsion, and four volunteers receive placebo consisting of mf59 emulsion in pbs vehicle. injections are given at months 0, 1, and 6. patients are followed for 12 months following the third injection.

Eligibility criteria:
inclusion criteria subjects must have: * normal history and physical exam. * negative elisa for hiv. * normal cell-mediated immune responses using merieux skin test. * normal urinalysis. exclusion criteria co-existing condition: subjects with the following conditions are excluded: * evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements. * positive syphilis serology. if serology is documented as a false positive or is due to a remote (\> 6 months) treated infection, subject is eligible. * circulating hepatitis b surface antigen. subjects with the following prior conditions are excluded: * history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. * history of anaphylaxis or other adverse reactions to vaccines. prior medication: excluded: * prior hiv vaccines. * immunoglobulins or vaccines within the past 3 months. * experimental agents within the past 30 days. prior treatment: excluded: * blood transfusions or cryoprecipitates within the past 3 months. identifiable high-risk behavior for hiv infection, including: * any history of intravenous (iv) drug use within the past year. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. * more than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Keywords: vaccines, synthetic hiv envelope protein gp120 aids vaccines hiv seronegativity hiv preventive vaccine
a study to evaluate lu af90103 in healthy men

Conditions: Healthy

Summary: the purpose of this study is to investigate the safety and tolerability of lu af90103 and what the body does to lu af90103 after single doses of the drug administered directly into a vein.

this study is the first-in-human (fih) study with lu af90103. the study is divided in two parts, part a and part b. part a is an interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of lu af90103 in healthy men. part b is an interventional, randomized, double-blind, cross-over study to investigate the safety profile after administration of lu af90103 as an infusion at two different rates to healthy young men. the dosage in part b is guided by the cohorts in part a and is a repetition of one of the doses from part a. the total study duration per participant from baseline to the end of follow-up will be maximum 11 days in part a and 16 days in part b.

Eligibility criteria:
inclusion criteria: * the participant is ≥18 and ≤45 years of age at the screening visit for cohorts a1 to a6 (excluding cohort a2b) or ≥55 to ≤65 for participants in the csf sampling cohorts a2b and a7. * the participant has body mass index (bmi) ≥18.5 kilograms (kg)/square meter (m\^2) and ≤30 kg/m\^2 and body weight ≥60 kilograms (kg) at the screening visit and at the baseline visit. * the participant has a normal resting electroencephalogram (eeg) at screening. * the participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ecg), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests. exclusion criteria: * the participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. other inclusion and exclusion criteria may apply.
expanded indications in the pediatric bonebridge population

Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed

Summary: this study will assess safety and efficacy of the med-el bonebridge bone conduction implant in children under 12 years old with conductive or mixed hearing loss.

this prospective multicenter ide study will include 36 children implanted with the med-el bonebridge system at six academic medical centers across the us.

Eligibility criteria:
inclusion criteria: * under 12 years of age * unaided bone-conduction thresholds at 0.5, 1, 2, and 4 khz better than or equal to 45 db hl in the ear to be implanted * sufficient air-bone gap (abg) at in the ear to be implanted * hrct scan that confirms sufficient bone quantity and quality to recess and fix the bci in the ear to be implanted * developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (srt) in quiet with english spondees * prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons * parental commitment to comply with all study procedures exclusion criteria: * children under 3 years (36 months) of age * chronic or non-revisable vestibular or balance disorders * abnormally progressive hearing loss * prior use of a hearing implant in the ear to be implanted * current/ongoing use of a hearing implant in the contralateral/non-implant ear * evidence that hearing loss is retrocochlear in origin * medical condition that contraindicates implant surgery or anesthesia * skin or scalp condition precluding use of external audio processor
an evaluation of integration success and maintenance of short implants in maxillas needing sinus augmentation

Conditions: Tooth Disease; Partial Edentulism

Summary: this prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. the resources utilized during treatment will be assessed. study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.

in this randomized study, patients needing restorations in the posterior maxilla will be randomly assigned to the short implant group (test) or the standard length and augmentation group (control). all implants will be placed using a two-stage approach with healing abutments placed at three months and temporary prosthesis at four months following implant and/ or sinus augmentation surgery. time, materials, and efforts associated with treating test and control cases will be documented to allow an assessment of the costs incurred with each approach.

Eligibility criteria:
inclusion criteria: * patients of either sex and any race greater than 18 years of age * patients with partial edentulism in the posterior maxilla requiring a unilateral implant-supported maxillary prosthesis * patients with a residual alveolar floor of the sinus between 4 and 6 mm in height, as assessed on intraoral radiographs, and able to receive at least a 4mm wide implant * patients must be physically able to tolerate conventional surgical and restorative procedures exclusion criteria: * patients with active infection or severe inflammation in the areas intended for implant placement * patients with a \> 10 cigarettes per day smoking habit * patients with uncontrolled diabetes or metabolic bone disease * patient with a history of therapeutic radiation to the head * patients who are known to be pregnant * patients with para-functional habits with evidence of severe bruxing or clenching * patients not able to commit to a 3 year follow-up program

Keywords: dental implants nanotite certain implant osseotite multicenter randomized clinical study partial edentulism crestal bone level short fixed bridge cost analysis
a pilot study to explore the role of gut flora in fatty liver

Conditions: Fatty Liver

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding fatty liver.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding fatty liver.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients of any age (interest is given to children to compare with mothers) 3. diagnosis of fatty liver exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
study evaluating the association of antibiotic measures and control of bacterial resistance

Conditions: Bacterial Infections

Summary: assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of bacteria.

primarily, this study is designed to assess the efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of extended-spectrum betalactamases (esbls) producing e.coli or k pneumoniae, s aureus methicillin resistant (mrsa) and enterococcus vancomycin resistant (vre). secondly, this study plans to determine the acquisition rate of esbl producing e coli or k pneumoniae, methicillin resistant s aureus (mrsa) and vancomycin resistant enterococcus spp (vre), both pre- and post-intervention.

Eligibility criteria:
all patients admitted in icu will be enrolled (who qualify for treatment).

Keywords: antibiotic bacterial resistance
benefits of the hiresolution bionic ear system in adults with asymmetric hearing loss

Conditions: Hearing Loss; Ear Diseases; Hearing Disorders; Otorhinolaryngologic Diseases; Asymmetrical Hearing Loss; Single-Sided Deafness

Summary: the purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).


Eligibility criteria:
inclusion criteria: general requirements: * ability to provide informed consent * 18 years of age or older * english language proficiency * willingness to participate in all scheduled procedures outlined in the study investigational plan * willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study ear to be implanted: * severe-to-profound sensorineural hearing loss (\> 70 db hl) as defined by the pure tone average for 500, 1000, 2000 and 4000 hz * cnc word recognition score ≤30% (tested in subject's everyday listening condition for that ear) * duration of severe-to-profound sensorineural hearing loss (≥ 70 db hl) \>3 months and ≤10 years in the ear to be implanted only contralateral (non-implanted) ear: * up to a moderate sensorineural hearing loss (\<70 db hl) as defined by the pure tone average for 500, 1000, 2000 and 4000 hz * cnc word recognition score \>30% (tested in subject's everyday listening condition for that ear) exclusion criteria: * previous experience with a cochlear implant * cochlear malformation or obstruction (i.e. ossification) that would preclude full insertion of electrode array in the ear to be implanted * medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator * diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear * active middle-ear disease/infection in the ear to be implanted * unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator * unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator

Keywords: cochlear implant hires™ 90k advantage implant hifocus™ mid-scala electrode hifocus™ 1j electrode hifocus helix™ electrode cochlear implantation listening benefits adults cochlear implant benefit electrical stimulation hires™ ultra implant with hifocus™ mid-scala electrode
td-1607 sad study in healthy subjects

Conditions: Serious Infections Due to Known or Suspected Gram-positive Pathogens

Summary: td-1607, administered intravenously as single doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.


Eligibility criteria:
inclusion criteria: * subject is a healthy nonsmoking male or a female of non-child bearing potential and 18 to 50 years old, inclusive, at screening. females are considered to be of non-childbearing potential if they have had a hysterectomy or tubal ligation or are postmenopausal (amenorrheic for at least 2 years) with a follicle-stimulating hormone (fsh) level \>20 iu/l. * subject has a body mass index (bmi) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg exclusion criteria: * subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. * subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin), penicillin, or cephalosporin antibiotics. * subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to screening or is currently participating in another trial of an investigational drug (or medical device).

Keywords: gram-positive infections bacterial infections
digital media based physical therapy post distal radius fracture

Conditions: Distal Radius Fracture

Summary: this trial aims to develop and test the efficacy of a digital media based physical therapy protocol on patients after surgical fixation and non-operative treatment of distal radius fractures.it is hypothesized that there will not be a difference in outcomes for patients after surgical fixation of distal radius fractures with traditional physical therapy and digital media based therapy


Eligibility criteria:
inclusion criteria: * patients undergoing operative treatment for distal radius fractures. exclusion criteria: * poly-trauma patients with significant previous diagnosis of dementia, previous traumatic brain injury, or other reason for significant altered mental status that would interfere with their participation in therapist directed or digital based therapy will be excluded. * patients who present to oregon health \& science university for physical therapy who will be treated by a physician at another non oregon health \& science university facility will be excluded. * patients who are not proficient in the english language will be excluded.
a study to evaluate the efficacy and safety of orelabrutinib in adult patients with immune thrombocytopenia

Conditions: Primary Immune Thrombocytopenia

Summary: the study is designed to be a randomized, open, multi-center, phase iia/iib seamless adaptive trial. phase iia: the study consists of a screening period, a core treatment period, an open label extension period, and a safety follow-up period phase iib: at present, a preliminary exploratory study (i.e., phase iia study) will be conducted first. the design of the phase iib study (including the selection of populations) will be clarified after a relatively clear understanding of the therapeutic effect, value, risks and benefits of the btk inhibitor for itp is obtained.


Eligibility criteria:
inclusion criteria: 1. subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written icf before the study. 2. males or females aged from 18 to 80 years (including the marginal values). 3. with a body weight of ≥ 35 kg at screening. 4. diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) itp is met 5. patients who have failed at least 1 prior first-line standard therapy for itp, or who have failed to tolerate a standard therapy. 6. women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug. 7. the mean of two platelet counts is less than 30 × 109/l and no platelet count is greater than 35 × 109/l during the screening visit and/or before the first dose. exclusion criteria: 1. severe hemorrhage occurred within 4 weeks prior to screening. 2. subjects suffer from severe itp at screening 3. subjects have other diseases which mention in protocol 4. subjects develop intracranial hemorrhage within 6 months prior to screening. 5. active and uncontrollable infection 6. subjects have a history of coagulopathy other than itp 7. subjects with a history of malignancies. 8. history of major organ transplantation or hematopoietic stem cell/bone marrow transplantation. 9. subjects with a known history of hypersensitivity to the investigational drug as described in the protocol, or any ingredients. 10. subjects with a medication history and surgical history which mention in protocol 11. subjects do not meet the criterion of the laboratory test in protocol note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: persistent or chronic
preadmission skin wipe use for surgical site infection prophylaxis in adult orthopaedic surgery patients

Conditions: Surgical Site Infection

Summary: intervention: this study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus theraworx wipes, (3) shower plus chlorhexidine wipes study design: single center rct sample size: 500 patients, aged 18+ objectives: primary objectives: 1. monitor for safety and adverse effects. 2. evaluate for differences in peri-operative skin cultures between treatment groups; 3. compare surgical site infection rates between groups. secondary objectives: 1. assess for patient compliance for each different treatment arms. 2. measure patient satisfaction. 3. measure nurse satisfaction. 4. visual assessment of wound healing expected results: we expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.


Eligibility criteria:
inclusion criteria: * adult patient between ages 18-64 * scheduled and deemed healthy enough to undergo orthopaedic surgery * willing and able to comply with protocol exclusion criteria: * clinical signs of infection * contraindication to chg or theraworx * previous allergic reaction to chg or theraworx * surgeon's discretion