Kornimate/medical-research-clean huggingface dataset:
study of mk-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors (mk-4464-001)

Conditions: Advanced/Metastatic Solid Tumors; Neoplasms

Summary: the purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of mk-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.


Eligibility criteria:
inclusion criteria: the key inclusion criteria include but are not limited to the following: * have a histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit * must submit a baseline tumor sample for analysis * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance scale * human immunodeficiency virus (hiv) infected participants must have well controlled hiv on antiretroviral therapy (art) * participants who are hbsag positive are eligible if they have received hbv antiviral therapy for at least 4 weeks, and have undetectable hbv viral load before randomization. exclusion criteria: the key exclusion criteria include but are not limited to the following: * has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention or has not recovered to ctcae grade 1 or better from any aes that were due to cancer therapeutics administered more than 4 weeks earlier * has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * has clinically active central nervous system (cns) metastases and/or carcinomatous meningitis * has an active infection requiring therapy * history of an allogenic stem cell transplant or a solid organ transplant * has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * has an active autoimmune disease that has required systemic treatment in the past 2 years * hiv-infected participants with a history of kaposi's sarcoma and/or multicentric castleman's disease * has known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the study * has not fully recovered from any effects of major surgery without significant detectable infection * has received radiation therapy to the lung that is \>30 gray (gy) within 6 months of the first dose of study treatment * received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * is currently participating and receiving study intervention in a study of an investigational agent or has participated and received study intervention in a study of an investigational agent or has used an investigational device within 28 days
carpal tunnel syndrome, right/left judgement

Conditions: Carpal Tunnel Syndrome

Summary: the discrimination of the right/left side of the body is related to the integrity of the motor and somatosensory areas at the cortical and subcortical levels. although some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies. in this study, the effect on right/left side discrimination will be investigated even in cases with carpal tunnel syndrome. additionally, the investigators aimed to assess the relationship between right/left discrimination and symptom severity.

the left/right discrimination is a motor imagery task that involves viewing images of a body part and determining whether each image belongs to the left or right side of the body or if it rotates towards it. some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies, such as carpal tunnel syndrome. in this study, the relationship between right/left decision accuracy will be compared with control subjects. the investigators will assess the relationship between right/left judgment and symptom severity, two-point discrimination, and handgrip force. the hypothesis of the study are: 1. the right/left discrimination accuracy is less than the control subjects. 2. right/left discrimination is in relationship with symptom severity, two-point discrimination, and handgrip force.

Eligibility criteria:
inclusion criteria: * participants with a duration of symptoms associated with unilateral cts of at least 3 months * participants with clinically and nerve conduction study confirmed carpal tunnel syndrome * all participants will be right-hand dominance and diagnosed with carpal tunnel syndrome on the same side * participants with moca score minimum 26. exclusion criteria: * severe visual impairment that may prevent performing the test * polyneuropathy * cervical spine surgery history * presence of abnormal cervical spine, shoulder, and elbow joint examination findings * patients with any history of surgery for the upper extremity * congenital/developmental upper extremity malformations * central nervous system disease * antihistaminic, gabapentinoids, antiepileptics, methylphenidate, modafinil, neuroleptics use

Keywords: carpal tunnel syndrome, body schema
a pharmacokinetic study of ckd-501 in patients with impaired hepatic function

Conditions: Liver Dysfunction

Summary: the purpose of this study is to evaluate pharmacokinetics of ckd-501 in patients with impaired hepatic function compared with normal hepatic function.

a phase 1, non-randomized, open, parallel-group study.

Eligibility criteria:
a. inclusion criteria \[the subjects with impaired hepatic function\] 1. the subjects who are 19 to 64 years old 2. the subjects with stable hepatic disease and impaired hepatic function as child-pugh a or b 3. body weight ≥ 55kg 4. if females, negative for pregnancy test at the screening and pre dose of day 1 5. the subjects who agreed with performing contraception during the study 6. the subjects who agreed with written informed consent \[the subjects with normal hepatic function\] 1. the subjects who are 19 to 64 years old 2. the subjects who are matched impaired hepatic function by gender, age(± 5years) and body weight(± 10kg) 3. if females, negative for pregnancy test at the screening and pre dose of day 1 4. the subjects who agreed with performing contraception during the study 5. the subjects who agreed with written informed consent b. exclusion criteria \[the subjects with impaired hepatic function\] 1. the subjects with impaired hepatic function as child-pugh c 2. the subjects had a portosystemic shunt surgery 3. the subjects had a liver transplantation or unsuitable for the study by the investigator's judgement(for examples, hepatic encephalopathy grade 3 or 4, stroke, heart failure, cancer etc.) but the subject is eligible to participate if had not chemotherapy or radiofrequency ablation therapy within 6months) 4. the subjects have a gastrointestinal disease or surgery which can be effected in absorption of investigational product 5. the subjects who took drugs or medicine which can be effected in metabolism of cytochrome p450 within 14days prior to day 1 6. positive for anti-hiv ab or venereal disease research laboratory etc. \[the subjects with normal hepatic function\] 1. the subjects with liver disease or abnormal laboratory test(asparate transaminase \>1.25 fold of upper normal limit, alanine transaminase\>1.25 fold of upper normal limit, total bilirubin \>1.5 fold of upper normal limit) 2. the subjects have a gastrointestinal disease or surgery which can be effected in absorption of investigational product 3. estimated glomerular filtration rate \< 60 ml/min/1.73m2 by modification of diet in renal disease formula 4. positive for hbsag, anti-hepatitis c virus ab, anti-hiv ab or venereal disease research laboratory 5. the subjects with high blood pressure or low blood pressure(systolic blood pressure \>150mmhg or \ 90mmhg or \<60mmhg) 6. the subjects who took drugs or medicine which can be effected in metabolism of cytochrome p450 within 14days prior to day 1 etc.

Keywords: ckd-501
telehealth follow-up in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Treatment Compliance

Summary: the main objective of the present project is to test the effect of a customized patient-reported-outcome (pro)-based telehealth follow-up compared to a conventional pre-scheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in patients with ra

rheumatoid arthritis (ra) is a chronic inflammatory joint disease with a high burden both for the patient and society. outcomes for the individuals living with ra have been improved and the majority of ra patients are now in remission or low disease activity status. ra patients continue to be followed up by pre-scheduled visits, which may compromise accessibility for the sickest and thus, quality of care. the introduction of patient-initiated follow-up leads to a reduction in the use of outpatient clinic services without compromising outcomes. self-monitoring and remote patient monitoring are facilitated by electronic innovative health tools. among ra patients with low disease activity or remission, a patient-reported outcome-based telehealth follow-up for tight control of disease activity in ra can achieve similar disease control as conventional outpatient follow-up and is likely to reduce the costs. thus, the main objective of the present project is to test the effect of a customized pro-based telehealth follow-up compared to a conventional prescheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in norwegian ra patients.

Eligibility criteria:
inclusion criteria: 1. \>18 years 2. fulfilling the european league against rheumatism (eular) / american college of rheumatology (acr) 2010 classification criteria for ra 3. being in remission (rapid 3 score \<=3) 4. able to use the electronic app 5. able to give informed consent exclusion criteria: 1. \<18 years 2. severe cognitive failure
discovisc versus duovisc, healon5 and amvisc plus

Conditions: Cataract

Summary: a comparison of the ability of discovisc to that of other ophthalmic viscosurgical devices (ovds) (duovisc, healon5 or amvisc plus) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.


Eligibility criteria:
inclusion criteria: * operable cataracts in at least one eye exclusion criteria: * endothelial cell count (ecc) ≤1500cells/mm2 * intraocular pressure (iop) \> 21mm hg * previous ocular inflammation * systemic or ocular conditions affecting corneal endothelium

Keywords: discovisc ophthalmic viscosurgical device
a pharmacokinetic study of cefepime after administration into dialysate in patients with continuous ambulatory peritoneal dialysis (capd) peritonitis

Conditions: Peritonitis

Summary: cefepime is a broad-spectrum antibiotic used in treating capd peritonitis. however, medical knowledge has been lacking with regard to its pharmacokinetic profile after it has been administered intraperitoneally. the current study aims at determining the drug level at different time after the drug has been added into the peritoneal fluid in patients with capd peritonitis. the results of this study will finally leads to rational prescription of this drug at correct dosages.


Eligibility criteria:
inclusion criteria: * age \>= 18 years \& has been put on capd for \>= 4 weeks before entering into the study exclusion criteria: * known hypersensitivity to cefepime or other cephalosporin; capd peritonitis \<= 28 days before being enrolled into the study * antibiotic treatment within 1 week prior to entry into the study * severe exit site or tunnel infection on the day of presentation * any conditions that prompt early removal of tenckhoff catheter irrespective of clinical response to antibiotic treatment * abdominal malignancy; any surgical causes of peritonitis * suspected or known fungal or tuberculous peritonitis * history of dementia or known mental incompetency

Keywords: capd peritonitis peritoneal dialysis, continuous ambulatory
longitudinal investigation of cancer-related fatigue and its treatment (lift project)

Conditions: Cancer-related Fatigue

Summary: the lift project aims to thoroughly investigate the current status of health care in germany regarding cancer-related fatigue from the institutional, professionals' and patients' perspective.

the lift project aims to thoroughly investigate the current status of health care in germany regarding fatigue from the institutional, professionals', and patients' perspective. with a multimodal approach including a comprehensive assessment of fatigue management and support offered by different institutions (uncertified hospitals, uncertified oncological practices, counselling units, certified cancer centers; n=350), a survey and qualitative interviews among practicing physicians ("niedergelassene ärzte"), hospital physicians, practicing psychotherapists with psycho-oncological focus, psycho-oncologists at hospitals, nurses at certified cancer centers and nurses at other hospitals (n=420), and a longitudinal clinical study among cancer patients (n=1400) as well as two focus groups with patient representatives (each n=6), the characteristics, patterns, and potential effects or shortcomings of the current fatigue management will be investigated. furthermore, factors associated with patients' and health care professionals' knowledge about fatigue will be examined. concerning the longitudinal clinical study assessing the patients' perspective, online or paper-based questionnaires on socio-demographic, clinical and patient reported outcomes will be sent to the patients 6,9,12 and 24 months after diagnosis. moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. tumor and cancer therapy data will be extracted from the epidemiological cancer registry. the results of the lift project shall provide a basis to identify and overcome shortcomings in the actual fatigue management in germany, and, to eventually ameliorate this severe burden in cancer patients and survivors.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * newly diagnosed with a primary tumor of one of the following malignant neoplasms: colon (c18), rectum (c19-20), liver (c22), pancreas (c25), lung (c33-34), malignant melanoma (c43), breast (c50, only female), cervix (c53), endometrium (c54.1), ovaries (c56), prostate (c61), kidney (c64), bladder (c67), thyroid gland (c73), non-hodgkin lymphoma (c82-88), leukemia (c91-c95) * having received or receiving at enrolment at least one of the following treatments: chemotherapy, radiotherapy, hormone therapy, targeted or immune therapy * able to understand and follow the study protocol exclusion criteria: * carcinoma in situ * any additional malignant or unclear neoplasm before or since time of diagnosis of the considered primary tumor, except unspecified neoplasm of skin (c44)
study dosed with (123i-mibg) for identifying subjects with heart failure who will experience an adverse cardiac event

Conditions: Congestive Heart Failure

Summary: the study was designed to study the utility of meta-iodobenzylguanidine (123i-mibg) imaging to identify those participants with heart failure who would experience an adverse cardiac event during 24 months of follow-up from the administration date of 123i-mibg in previous studies mbg311 or mbg312.


Eligibility criteria:
inclusion criteria: * the subject was a heart failure subject who signed informed consent for mbg311, mbg312, or mbg312c. * the subject was administered 123i-mibg in mbg311, mbg312, or mbg312c. * the subject completed the late planar imaging assessments (at a minimum) required by the protocols for mbg311, mbg312, or mbg312c. * the subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur. exclusion criteria: * the subject withdrew or was withdrawn from mbg311, mbg312, or mbg312c. * the subject was considered lost-to-follow-up (6 months without contact) in mbg311, mbg312, or mbg312c.

Keywords: heart failure mibg 123i-mibg
ep-catheter guided cs-lead implantation

Conditions: Heart Failure; Reduced Left Ventricular Ejection Fraction; Left Bundle Branch Block

Summary: in patients undergoing crt device implantation a lead positioning in the coronary sinus is required. even this part of the surgical procedure is challenging. in this study we compared retrospectively to methods of cs-lead implantation: conventional vs. ep-catheter guided.


Eligibility criteria:
inclusion criteria: * crt implantation due to heart failure * full documented data exclusion criteria: * previous pacemaker/icd/crt implantation

Keywords: heart failure cardiac resynchronization therapy coronary sinus lead
a study to evaluate safety, tolerability and efficacy of eribulin mesylate in treating adult females with locally advanced or metastatic breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.


Eligibility criteria:
inclusion criteria: 1. participants with locally advanced or metastatic breast cancer. 2. participants must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. prior therapy should have included an anthracycline and a taxane unless participants who are not suitable for these treatments. 3. participants must have documented disease progression within or on 6 months from their last anti-cancer therapy. 4. eastern cooperative oncology group (ecog) performance status less than or equal to (\<=) 2. 5. participants must have normal organ and marrow function as defined below: * absolute neutrophil count greater than (\>) 1,500 per microliter (/mcl) * hemoglobin \>10.0 gram per deciliter (g/dl) * platelets \>100,000/mcl * serum total bilirubin less than (\<) 1.5\*upper limit of normal (uln) * serum aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\]) and alanine aminotransferase (alt) (serum glutamic pyruvic transaminase \[sgpt\]) \<3\*uln or \<5\*uln in the presence of liver metastases * serum creatinine \<1.5 mg/dl. 6. females in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study. exclusion criteria: 1. hypersensitivity to the active substance or any of the excipients. 2. participants who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start. 3. participants receiving any other investigational agents. 4. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition. 5. participants requiring concurrent anti-cancer therapy during the study period. 6. participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting study treatment.

Keywords: e7389 tumors, breast breast cancer breast carcinoma neoplasms, breast
multicenter study to evaluate the analgesic efficacy of xp21l in subjects with pain following bunionectomy surgery

Conditions: Pain, Postoperative

Summary: a multicenter study to evaluate the analgesic efficacy of xp21l in subjects with pain following bunionectomy surgery.


Eligibility criteria:
inclusion criteria: * 18-65 years of age * have undergone bunionectomy surgery * have achieved adequate post-surgical pain exclusion criteria: * confounding medical conditions which preclude study participation * participated in a study of another investigational drug or device within 30 days prior to randomization

Keywords: bunionectomy bunion surgery post-operative pain
two approaches to routine hiv testing in a hospital emergency department

Conditions: HIV Infections

Summary: this study will compare the effectiveness of two different approaches to providing routine hiv counseling, testing, and referral services in an urban hospital emergency department setting.

about 25% of hiv infected people do not know that they are infected. these people lack medical care that could prolong their lives and access to counseling services that could prevent further spread of hiv. with so many people unaware of their hiv status, there is a clear need for more readily available hiv counseling, testing, and referral services throughout the united states. the centers for disease control and prevention (cdc) recommends routine hiv testing in u.s. hospitals in which hiv infected patients make up at least 1% of the total patient population for that hospital. however, routine hiv testing in such hospitals is rarely carried out, which might be because the cdc has not specified who should perform routine hiv testing. the purpose of this study is to compare the effectiveness of two different approaches to providing routine hiv counseling, testing, and referral services in an urban hospital emergency department setting. one approach will be led by an hiv counselor, and the other approach will be led by an emergency department staff member. for both approaches, the study will evaluate to what extent patients accept hiv testing, how well follow-up care is established, and the cost-effectiveness of the approach. participants in this study will include adults who visit brigham and women's hospital emergency department in boston, massachusetts. participants will be randomly assigned to a counselor versus provider and will be asked to fill out a questionnaire while waiting in the emergency room. the questionnaire will be anonymous. participants will then be offered an oral rapid hiv test. test results will be available in about 20 minutes and will be provided to participants by either their assigned hiv counselor. participants who test positive for hiv will be offered a more definitive blood test to confirm hiv infection. the blood test results will be available 2 weeks from testing, and participants must return to the hospital to get their test results. participants who test positive for hiv will be offered counseling support and referral services by either their assigned hiv counselor or emergency department staff member. follow-up care appointments will also be initiated at this time. for participants who test positive for hiv, the study will last about 6 months. there will be no follow-up visits for participants who do not test positive for hiv during their emergency room visit.

Eligibility criteria:
inclusion criteria: * waiting to receive care in the brigham and women's hospital emergency room * english- or spanish-speaking * enters the emergency room when an hiv counselor is available exclusion criteria: * an estimated severity index score of 1 or 2 who have mechanical ventilation or are not deemed alert, awake, and oriented to person, place and time by the triage nurse * hiv infected

Keywords: hiv testing hiv seronegativity