Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effect of renal impairment on the pharmacokinetics of jnj-64041575 in adult participants with various degrees of renal function

Conditions: Renal Insufficiency

Summary: the primary purpose of this study is to evaluate the pharmacokinetic (pk) and systemic exposure of jnj-63549109 and jnj-64167896 after a single oral dose of jnj-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease \[esrd\] with or without hemodialysis) compared to adult participants with normal renal function.


Eligibility criteria:
inclusion criteria: * participant must have a body mass index (bmi: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening * contraceptive use by female participants, male participants and their female partners should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria in the protocol participants with normal renal function (group 1): -participant must have an estimated glomerular filtration rate (egfr) \>= 90 milliliter per minute (ml/min) participants with renal impairment (groups 2 to 4): - the following classifications of renal function are used: mild renal impairment (egfr greater than or equal to \[\>=\] 60 to less than \[\ = 30 to \ =15 to \<30 ml/min) participants with end-stage renal disease (esrd) with or without hemodialysis (group 5): * participant must have an egfr \<15 ml/min if not on hemodialysis * participant on hemodialysis treatment must have been on the same hemodialysis regimen for at least 3 months before screening exclusion criteria: all participants (groups 1 to 5): * participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (example, crohn's disease), with the exception of renal impairment * participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs * participant has known allergies, hypersensitivity, or intolerance to jnj-64041575 or its excipients * participants with evidence of an active infection * participant is a woman who is pregnant or breastfeeding
a study to evaluate the safety and efficacy of omiganan (cls001) topical gel versus vehicle in female subjects with moderate to severe acne vulgaris

Conditions: Acne Vulgaris

Summary: the primary objective of this study is to evaluate the safety and efficacy of omiganan (cls001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.


Eligibility criteria:
inclusion criteria: * non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris * subjects with an investigator's global assessment (iga) of inflammatory lesions of acne vulgaris of moderate (3) or severe (4) at baseline. * subjects with ≥ 30 facial inflammatory lesions exclusion criteria: * subjects with \ 75 facial non-inflammatory lesions * subjects with \> 3 facial nodular or cystic lesions at baseline * standard exclusion criteria
anti-adhesion effect of guardix-sgⓡ in gastric cancer surgery

Conditions: Adhesive Intestinal Obstruction

Summary: this study is to evaluate the efficacy of guardix-sgⓡ for patients with gastrectomy in korea and the investigators hypothesized applying of adhesive preventing agent would reduce incidence of adhesive obstruction after gastrectomy.

adhesive bowel obstruction is relatively often complication in patients after abdominal surgery gastric cancer is the most frequent cancer in korea. the incidence of adhesive bowel obstruction would be increased in patients with gastric cancer, especially associated radical lymphadenectomy. the causes of postoperative adhesive obstruction include adhesion of the wound, adhesion of small intestine to small intestine, adhesion of the small intestine to other abdominal organs, and internal hernia. several studies reported efficacy of adhesive preventing agent after colorectal resection. gastrectomy is associated with a high risk (incidence, 11.7%-38.5%) of bowel obstruction. to date, however, no randomized study has shown that guardix-sgⓡ reduces the rate of small bowel obstruction after gastrectomy with radical lymphadenectomy for gastric cancer.

Eligibility criteria:
inclusion criteria: * patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy * informed consents exclusion criteria: * pregnant * ascites * liver dysfunction * renal failure * past history of abdominal operation or small bowel obstruction
bikini scarless laparoscopic cholecystectomy for morbid obesity as a day case.

Conditions: Cholecystitis, Chronic

Summary: background: bikini line laparoscopic cholecystectomy is a safe method, used as a scarless cosmetic port technique for gall bladder diseases in morbid obese patients as a day case. objectives: the aim of this study was to investigate the safety and efficacy of an elective bikini line laparoscopic cholecystectomy in the morbid obese patients with chronic calcular cholecystitis, and review our experience with bikini line laparoscopic cholecystectomy as minimal invasive scarless technique. we issued a modifications in order to minimize the number of ports (brief ports) and modify port sites, using the bikini line laparoscopic cholecystectomy as a cosmetic and hidden scar laparoscopy for obese patients concerned with aesthetic results and body image. aiming at faster recovery, decrease pain and improve cosmoses. bikini line laparoscopic cholecystectomy is technically safe and effective day surgery procedure for chronic cholecystitis patients with higher patient satisfaction regarding pain and cosmoses. obesity, intended as bmi 40, does not have any obstacle on the technical feasibility of bllc.

thoroughly, bllc is a novel technique aimed at solving the issue of cosmoses that is always presented as a main complaint from morbid obese patients. the main concern to use brief ports laparoscopy or hidden scar laparoscopy to reduce incisions and change sites. the study designed to identify superiority of technique regarding success as a day case surgery, better cosmoses and lesser pain. we tried to wear off the port sites scar and kept our stabs in the suprapubic bikin line. we kept camera port in the navel's natural scar and used the other ports in lower abdominal crease at bikini line. cosmosis has been and still the reason among patient population to accept the laparoscopic surgery, many synonyms can be applied here, as cosmotic,hidden scar, scarless, non-visualized or scarless bikini cholecystectomy. bllc is performed under general anesthesia. patient placed in the supine position with patient's legs apart and arms are rolled in, patient strapped to table at the mid-thigh. surgeon stood between patient's legs, the camera man stood on the right side of patient, monitor placed near patient head to the right side. three ports were used, 12 mm visiport (....) umbilical, with a 30 degree camera used, 5mm in bikini line at right mid-clavicular line and third port 5mm in bikini line at left mid-clavicular line (figure) patient kept in reverse trendlenburg position with maximum degree 20. but to lesser degree than done in classic lc,

Eligibility criteria:
inclusion criteria: * morbid obese patients with bmi ≤30 kg/m2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, asa 1-3. exclusion criteria: * acute calcular cholecystitis, bmi ≥45, asa 4 or higher, length of stay more than 1 day. patients required additional trocars for patient safety, readmission,

Keywords: scarless cholecystectomy breif port cholecystectomy
optimized diffusion-weighted imaging for the evaluation of post-treatment squamous cell carcinoma in the neck: comparative study with fdg pet/ct

Conditions: Squamous Cell Carcinoma

Summary: the investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (scc) of the neck using an innovative optimized diffusion-weighted imaging (dwi) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.


Eligibility criteria:
inclusion criteria: * histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of t3 or t4 squamous cell carcinoma of the head and neck * must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck * at least 18 years of age * patient must be able to understand and willing to sign a written informed consent document. exclusion criteria: * contraindications to mri, including: * mri-incompatible implantable devices * severe claustrophobia; and * pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test
a study of the efficacy and safety of pregabalin for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. if this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.


Eligibility criteria:
inclusion criteria: * patients who met the american college of rheumatology (acr) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) * patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the visual analogue scale (vas) of the sf-mpq at screening (visit 1) and randomization (visit 2) exclusion criteria: * patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia * patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders * patients with severe depression
studying tissue samples from women with breast cancer who were treated on clinical trial ncctg-n9831

Conditions: Breast Cancer

Summary: this research study is looking at tissue samples from women with breast cancer who were treated on clinical trial ncctg-n9831. studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

primary objectives: i. to determine the association between the primary breast tumor protein expression of myc, igf-1r, and pten and disease-free survival (dfs) in patients randomized on clinical trial ncctg-n9831. ii. to determine the association between the primary breast tumor amplification status of myc and top2a and dfs in patients randomized on ncctg-n9831. iii. to determine the association between the primary breast tumor mutation status of pik3 and dfs in patients randomized on ncctg-n9831. secondary objectives: i. to determine the association between the primary breast tumor marker protein expression/amplification/mutation status of the aforementioned markers and overall survival in patients randomized on ncctg-n9831. ii. to investigate the predictive potential of multiple marker analyses on dfs and overall survival using multivariate analysis. iii. to determine the correlation between the protein expression and amplification status of myc in patients randomized on ncctg-n9831. iv. to determine the correlation between marker protein expression/amplification/mutation status and known clinicopathological characteristics of the tumors.

Eligibility criteria:
inclusion criteria * diagnosed with breast cancer and treated on clinical trial ncctg-n9831 \* randomized to treatment * her-2 positive disease * whole tissue blocks and/or tissue microarray sections available * hormone receptor status: \* er/pr status known * any menopausal status

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer her2-positive breast cancer
improved patient recovery after anesthesia

Conditions: Recovery From Anesthesia

Summary: the proposed study will measure the incidence of adverse events and the decrease in time to meet discharge criteria from the post anesthesia care unit when hypercapnic and hyperpnoea are used during emergence.

hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. the benefits of accelerating patient recovery in the operating room may extend to the post anesthesia care unit if the patient is more alert and easier to care for when they arrive in the unit. respiratory patterns and gas levels - including co2, o2, and anesthetic vapor - will be measured in order to better understand a patient's respiratory status during recovery. in feb 2009 we finished our first study (irb 26111) and submitted a publication. the journal reviewers identified a serious limitation: we could not report whether the treated patients recovered from anesthesia faster because the treatment (inspired co2) caused them to breath more vigorously or because the treatment caused the anesthetic vapors to be cleared more rapidly from the brain. our new application uses essentially the same study protocol as the former study but adds chest bands to measure the patient's rate of breathing and expired gas monitoring to measure the rate at which the vapors are removed.

Eligibility criteria:
inclusion criteria: * adult asa class i-iii subjects of both genders scheduled to undergo eye surgery at the moran hospital. exclusion criteria: * a history of renal or hepatic disease, chronic alcohol or drug abuse, disabling neuropsychiatric disorder, hypersensitivity, or unusual response to other halogenated anesthetics, pulmonary hypertension, increased intracranial pressure, seizure disorder, or personal/familial history of malignant hyperthermia, and current smokers. * subjects will also be excluded if they are currently being treated with known hepatic enzyme-inducing drugs (e.g., phenobarbital, dilantin, or isoniazid) or with drugs known to alter anesthetic requirements (e.g., opiates, clonidine, alpha2 agonists, alcohol, anticonvulsants, antidepressants, barbiturates, benzodiazepines or other tranquilizers). * subjects will also be excluded if they have intolerance to non-steroidal anti-inflammatories. * in addition subjects who have received general anesthesia within the previous 7 days, received any investigational drug within the previous 28 days, or participated in a previous isoflurane or desflurane study will be excluded. * female subjects can be neither pregnant nor breast feeding. * subjects with significant restrictive lung disease will also be excluded. * subjects passing these criteria will be further evaluated with a medical history including medications, abbreviated physical examination, clinical laboratory tests (urine drug test), and a urine or serum human chorionic gonadotropin pregnancy test for women with childbearing potential.
a phase ia/ib clinical trial of ibi360 monotherapy or in combination with sintilimab and (or) chemotherapy in advanced or metastatic solid tumors

Conditions: Advanced Solid Tumor

Summary: this is an open label phase ia/ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of ibi360 monotherapy in advanced or metastatic solid tumors

phase ia is dose escalation and dose expansion study of ibi360 monotherapy and ibi360 in combination with sintilimab in advanced or metastatic solid tumors; phase ib is an multi-cohort trial of pancreatic carcinoma, her2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efsficacy of ibi360 in combination with sintilimab and (or) chemotherapy or ibi360 monotherapy.

Eligibility criteria:
inclusion criteria: 1. provide signed informed consent; 2. male or female aged at 18-75 (inclusive) years; 3. expected survival ≥12 weeks; 4. ecog ps score 0 or 1; 5. provide archival or fresh tissues for cldn18.2 expression analysis; 6. adequate laboratory parameters; 7. suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows: ia: the subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments. ib: pancreatic carcinoma, her2 negative gastric adenocarcinoma, advanced or metastatic solid tumors exclusion criteria: 1. the subjects who received the treatment with cldn18.2 monoclonal antibody or cldn-18.2 cart; 2. the subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug; 3. any toxicity due to previous anti-tumor therapy that has not yet resolved to nci ctcae v5.0 grade 0 or 1 prior to the first dose of study treatment; 4. the subjects with history of hypersensitivity to the study drug; 5. the subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment; 6. the subjects with symptomatic central nervous system (cns) metastasis or carcinomatous meningitis; 7. the subjects with pyloric obstruction; 8. the subjects with active or poorly controlled serious infections

Keywords: advanced solid tumor
measurement of nk cell activity in whole blood in subjects being screened for colorectal cancer using colonoscopy

Conditions: Natural Killer Cell Cytokine Production

Summary: this study will look at measuring the activity of natural killer (nk) cells using the in vitro diagnostic device nk vue in subjects being screened for colorectal cancer using colonoscopy. the nk vue diagnostic test for natural killer cell activity uses the principle of stimulation of whole blood with a proprietary cytokine followed by the quantitative detection of interferon gamma using an immunoassay. nk vue is intended to be used for the monitoring of the immune status of individuals. measurement of nk cell activity could be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where nk cell activity has been shown to be reduced, such as colorectal cancer.


Eligibility criteria:
inclusion criteria: * subjects undergoing colonoscopy at the hospital * subjects who have adequately prepared for their colonoscopies as per their doctor's directions * subjects whose colonoscopy preparation has been deemed to be excellent or sufficient during the colonoscopy procedure * subjects who provide informed consent to participate in the trial * subjects \>40 years of age exclusion criteria: * lack of understanding and/or participation due to illiteracy * history of active viral or bacterial infection * history of prescription use of immunosuppressive drugs within the last six months * history of anticancer treatments including surgery or chemotherapy * history of autoimmune disorders (rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease including crohn's disease, type i diabetes, guillain-barré syndrome) * known hiv, hepatitis b, or hepatitis c infection * currently participating (or participated within the previous 120 days) in an investigational therapeutic or device study * female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods.

Keywords: colorectal cancer natural killer cell activity screening nk cells
safety and preliminary efficacy of vg801 in patients with abca4 mutation-associated retinal dystrophy (stargardt disease)

Conditions: Retinal Dystrophy Due to Biallelic ABCA4 Mutations; Stargardt Disease 1

Summary: this is a single-arm, open-label, non-randomized, single dose-escalation, first-in-human (fih) clinical trial to evaluate the safety and preliminary efficacy of vg801 for treatment of patients with retinal dystrophy (stargardt disease) due to biallelic abca4 mutations.


Eligibility criteria:
inclusion criteria: to be eligible for study entry, subjects must satisfy all the following criteria: 1. written informed consent. 2. subjects aged ≥ 6 years. 3. clinical diagnosis of a macular lesion phenotypically consistent with a recessive hereditary macular dystrophy (stargardt disease). 4. confirmed molecular diagnosis of abca4 mutations (homozygotes or compound heterozygotes). 5. poor vision in the study eye. exclusion criteria: subjects will be excluded from the study if one or more of the following statements are applicable to either eye: 1. pre-existing eye conditions such as uveitis, glaucoma, or diabetic retinopathy or implantation of a medical device in the vitreous cavity or subretinal space. 2. systemic diseases that would preclude the planned surgery or interfere with the interpretation of study results. 3. history of intraocular surgery within the previous 6 months. 4. previous participation in a gene therapy trial. 5. participation in a clinical trial (investigational drug or medical device) within the previous 6 months. 6. any other eye disease that may affect the outcome of the study (e.g., ocular opacities, advanced cataracts, amblyopia, etc.).

Keywords: abca4 mutation gene therapy eye disease stargardt disease retinal disease retinal degeneration vg801
clinical survey of oticon medical ponto bhx implant

Conditions: Hearing Impaired (Partially); Hearing Impairment, Conductive; Deafness Unilateral

Summary: investigation of stability of the bhx implant in adult patients indicated and counselled for a bone anchored hearing aid system. patients are followed according to clinical practice for a total of 12 months in the study. stability of the implant is evaluated by implant stability quotient.


Eligibility criteria:
inclusion criteria: * patients eligible for treatment with a bone anchored hearing aid * 18 years or older exclusion criteria: * inability to participate in follow-up * diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.