Kornimate/medical-research-clean huggingface dataset:
irreversible electroporation(ire) for unresectable gallbladder neoplasms

Conditions: Gallbladder Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable gallbladder neoplasms.

by enrolling patients with unresectable gallbladder neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable gallbladder neoplasms.

Eligibility criteria:
inclusion criteria: * gallbladder neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable gallbladder neoplasms
cc-11050 trial in nepalese patients with erythema nodosum leprosum

Conditions: Erythema Nodosum Leprosum; Leprosy

Summary: this study will be a single center, phase 2, open-label trial to evaluate the safety and efficacy of 200mg cc-11050 administered twice daily taken with food for patients with moderate to severe enl. the study will be performed in two steps: 1) to evaluate immediate effect in safety and efficacy of drug in 10 males with new or new recurrent episode enl and, if found to be safe and effective by the dsmb and 2) if allowed by the dsmb, and approved by relevant study stakeholders, an additional 40 enl patients will be enrolled for up to 52 weeks of treatment. a safety analysis will be conducted on all patients who have received at least one dose of study drug, and will include the frequency of all adverse events and laboratory abnormalities as well as frequency of dose interruptions, dose reductions and treatment discontinuation.


Eligibility criteria:
inclusion criteria: study participants must satisfy the following criteria to be enrolled in the study: 1. must be 18 -65 years old, weight \> 35kg for women and \>40kg for men at the time of signing the informed consent. 2. understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. 3. have signs or symptoms of new or new episode enl. in step one, participants must be male. in step 2, participants can be either male or female. 4. able to adhere to the study schedule and other protocol requirements. exclusion criteria: the presence of any of the following will exclude a participant from enrollment: 1. any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study. 2. patients on continuous rifampicin will be excluded, however, if rifampicin is given only once a month as part of a multi-drug regimen, a minimum of 2-week washout period is required prior to administration of cc-11050 3. any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he were to participate in the study. 4. any condition that confounds the ability to interpret data from the study (ie, hiv, chronic hepb, chronic hepc or tb patients under active treatment). resolved tb patients will not be excluded from the study. 5. stable and well managed patients with diabetes and hypertension will not be excluded from the study. 6. use of systemic corticosteroid or immunosuppressant therapy within 7 days of study medication initiation 7. pregnant or nursing females.
chronic nonspecific neck pain and central nervous system focused treatment program

Conditions: Neck Pain; Chronic Pain Syndrome; Rehabilitation

Summary: neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. pharmacological and non-medical treatments such as physiotherapy are applied in its treatment. patients with chronic nonspecific neck pain (cnsp) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. however, it is also reported that chronic pain occurs as a result of neuroplasticity, that is, the brain learning pain through the central synthesis mechanism in the central nervous system. for this reason, although the importance of central nervous system-oriented therapies is increasing day by day, this system-oriented therapies are still ignored in clinics. therefore, in this master's thesis study, it is aimed to investigate the effects of central nervous system-focused therapies (pain neuroscience education, breathing exercises and relaxation exercises with guided imagery) on pain, range of motion, functional status, pain-related fear, anxiety, depression and quality of life in addition to traditional physiotherapy applied to patients with cnsp.


Eligibility criteria:
inclusion criteria: * being diagnosed with nonspecific neck pain by a doctor, * to be between the ages of 18-65, * having neck pain for more than 3 months * no previous neck or shoulder surgery, * no shoulder pain due to any cause, * a tumour or inflammatory disease underlying the neck pain not to be found, * a clinically underlying stenosis or discogenic problem not to be present. * negative results from the following clinical examination tests; * spurling test, * lhermitte test, * cervical distraction test, * adson test, exclusion criteria: * not meeting the inclusion criteria, * positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb * systemic rheumatological or metabolic diseases or cancer * refusal to participate in the study, * failure to complete treatment, * having any neurological problem * severe psychological illnesses
a multinational study comparing the long-term efficacy and safety of two medicines, solifenacin succinate and mirabegron taken together, or separately, in subjects with symptoms of overactive bladder

Conditions: Urinary Bladder Overactive; Overactive Bladder; Urgency Incontinence; Urinary Bladder Diseases\Urologic Diseases

Summary: the purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.


Eligibility criteria:
inclusion criteria: main inclusion at screening (visit 1): * subject had completed study 178-cl-101 or study 905-ec-012 (this inclusion criterion would no longer apply once the recruitment for study 178-cl-101 and study 905-ec-012 had been completed. in that case the subject had to have symptoms of "wet" oab (urinary frequency and urgency with incontinence) for at least 3 months); * subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; main inclusion at randomization (visit 2): * subject had a micturition frequency of on average ≥ 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition). * subject had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period. * subject had experienced on average at least 1 urgency episode (grade 3 or 4 on patient perception of intensity of urgency scale \[ppius\]) per 24-hour period during the 7-day micturition diary period. exclusion criteria: main exclusion at screening (visit 1): * subject had clinically significant bladder outflow obstruction at risk of urinary retention; * subject had significant pvr volume (\> 150 ml); * subject had significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor; * subject has an indwelling catheter or practices intermittent self-catheterization; * subject had evidence of a uti (urine culture containing \> 100,000 cfu/ml), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs; * subject had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin; main exclusion at randomization (visit 2): * subject had evidence of a urinary tract infection (uti) (urine culture containing \> 100,000 cfu/ml) as assessed in the screening visit (v1) samples. the subject could be rescreened after successful treatment of the uti (confirmed by a dipstick negative for nitrite). * subject had an average total daily urine volume \> 3000 ml as recorded in the micturition diary period.

Keywords: solifenacin succinate mirabegron urinary incontinence combination therapy urgency nocturia overactive bladder
the effect of forced air warming during cesarean section on postoperative infectious morbidity

Conditions: Cesarean Section

Summary: the purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.

given the physiologic and experimental evidence regarding temperature regulation; it remains convincing that forced air warming is protective against the development of ssi. we will set out to prospectively study the effect of forced air warming on patients undergoing cesarean section.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years old) female subjects who will undergo cesarean delivery regardless of indication. * subjects who have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. * patients scheduled to receive prophylactic antibiotic therapy. exclusion criteria: * patients who are undergoing a true emergent cesarean section that does not allow placement of the warming devices. * patients undergoing general anesthesia.

Keywords: forced-air warming bair hugger cesarean section postoperative infection surgical site infections
pembrolizumab (mk-3475) plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin for first-line advanced and/or unresectable biliary tract carcinoma (btc) (mk-3475-966/keynote-966)-china extension study

Conditions: Biliary Tract Carcinoma

Summary: in this china extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in chinese adults with advanced and/or unresectable biliary tract carcinoma. the primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (os).

the china extension study will include participants previously enrolled in china in the global study for mk-3475-966 (nct04003636) plus those enrolled during the china extension enrollment period. a total of approximately 158 chinese participants will be enrolled.

Eligibility criteria:
inclusion criteria * has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer) * has measurable disease based on response evaluation criteria in solid tumors (recist 1.1), as determined by the site investigator * participants with a history of hepatitis b or hepatitis c can be enrolled if they meet study criteria * is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion * has a life expectancy of greater than 3 months * has adequate organ function exclusion criteria * has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer) * has ampullary cancer * has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms * has received prior therapy with an anti-programmed cell death 1 (anti-pd-1), anti- programmed cell death ligand 1 or 2 (anti-pd-l1, anti-pd-l2) agent or with an agent directed to another stimulatory or coinhibitory t-cell receptor (e.g., cytotoxic t-lymphocyte-associated protein 4 \[ctla-4\], ox-40, cd137) * has a known history of, or any evidence of, central nervous system (cns) metastases and/or carcinomatous meningitis, as assessed by local site investigator * has had an allogenic tissue/solid organ transplant

Keywords: programmed cell death 1 (pd-1) pembrolizumab cholangiocarcinoma gallbladder cancer checkpoint inhibitor immunotherapy biliary keytruda bile duct cancer
ivus guided pci for ckd to reduce ci-aki

Conditions: Coronary Artery Disease; Chronic Kidney Diseases

Summary: patients with chronic kidney disease are most vulnerable to contrast induced nephropathy after percutaneous coronary intervention, intravascular ultrasound guidance can be used to safely guide the procedure to reduce the contrast usage, this randomized trial is design to test the hypothesis that ivus based ultra-low contrast pci is feasible and can reduce the contrast induced nephropathy.

prospective, open-label, randomized(1:1), multi-center trial of 320 patients allocated to one of the treatment arms(ivus-guided ultra-low contrast pci or angiography-guided pci). the study population will be composed of patients with renal dysfunction referring for pci on one to more coronary artery. target lesion must be assessable with ivus. egfr will be re-evaluated 48 hours after the procedure. and at 1 month, 3 month, 6 month, 12 month. as well as follow-up for other clinical outcomes unless contra-indicated all patients will receive intravenous hydration 12 hours before and after the procedure. saline infusion at a dose of 1ml/kg/hour. if with reduced ejection fraction or overt heart failure reduce the saline infusion to 0.5ml/kg/hour. the use of sodium bicarbonate and diuretic will be left at the discretion of the operator all procedure will be performed using non-ionic, low osmolar or iso-osmolar, iodine-based contrast media the study groups will be compared according to the intention-to-treat principle. categorial variables will be compared by fisher's exact test and continuous variables by students t test. time-dependent events will be estimated by the kaplan-meier method and compared by hazards cox model or log-rank test.

Eligibility criteria:
inclusion criteria: - age over 18 years coronary artery disease referred for percutaneous intervention, with stent, drug coated bloon, or bioresorbable stent, of one or more epicardial vessel. target lesion must be assessable by ivus at baseline and during the procedure. 60ml/min/1.73m2\ =15ml/min/1.73m2 consent can be obtained and comply with all study procedures. exclusion criteria: - use of \>50ml of iodinated agent\<72 hours planned used of iodinated contrast within 72 hours after the index procedure use of other nephrotoxic agents\<7 days known allergy to contrast agents unstable or unknown renal function prior to pci life expectancy less than 1 year

Keywords: ckd ivus cad pci
livewell: adapted dbt skills training for metastatic lung cancer

Conditions: Cancer Metastatic to Lung

Summary: patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. most metavivors will ultimately die of cancer and must navigate the duality of living while dying. unsurprisingly, metavivors endorse high psychological distress (e.g., anxiety, depression, illness non-acceptance), high symptom burden (e.g., fatigue, dyspnea, pain), and poor quality of life. psychosocial interventions can improve outcomes, but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease. dialectical behavioral therapy (dbt) skills training is an evidence-based treatment that teaches patients transdiagnostic, easy-to-use skills to both accept things as they are (mindfulness, distress tolerance) and change things within their control (emotion regulation, interpersonal effectiveness) to better navigate life challenges. however, dbt skills training has rarely been applied in patients with chronic illness. the investigators adapted dbt skills training (e.g., intervention dose, delivery, content) for patients living with metastatic lung cancer to create livewell, an 8-session skills training protocol delivered one-on-one via videoconference. building on preliminary data and aligned with the orbit model for behavioral intervention development, the first phase of this study (k99, aim 1, 1 year) aims to iteratively refine livewell using 1) qualitative exit interview data from a proof-of-concept study, 2) an advisory board of interested parties, 3) the dynamic sustainability framework from implementation science, and 4) user testing (n= up to 10). the k99 phase will produce a standardized protocol and procedures for the second, independent phase of the study (r00) which will be registered separately. if successful, livewell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.


Eligibility criteria:
inclusion criteria: 1. be diagnosed with metastatic (ajcc stage iv) non-small cell lung cancer 2. be undergoing lung cancer treatment with non-curative intent 3. endorse \>=3 out of 10 on the nccn distress thermometer over the past week 4. be \> 18 years of age 5. be able to understand, speak, and read english, and 5) be able to provide informed consent exclusion criteria: 1. reported or suspected cognitive impairment 2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist 3. expected survival \<6 months
intubated icu patients

Conditions: Patients Requiring Endotracheal Intubation

Summary: the purpose of this research study is to determine how cell changes during endotracheal intubation and artificial lung ventilation affect lung inflammation. patients will undergo placement of an endotracheal tube (ett) as standard of care. tracheal (windpipe) lavage will be obtained each day for up to 72 hours. lung samples or fiberoptic (lung) samples will be collected at the same time intervals when possible and if they are done as standard of care. blood samples will be obtained simultaneous with the collection of the trachael (windpipe) specimens.


Eligibility criteria:
inclusion criteria 1. ages 18 to 85 2. required to have endotracheal intubation 3. admitted to an intensive care unit exclusion criteria 1. on immunosuppressive medications 2. previous tracheal surgery 3. on azithromycin 4. pregnancy 5. cancer

Keywords: endotracheal intubation airway inflammation
a trial of vitamin b12 in septic shock

Conditions: Septic Shock

Summary: this study will randomize 20 septic shock patients to receive either a single 5 gram dose of iv vitamin b12 (cyanokit® meridian medical technologies, columbia, md) versus placebo in addition to standard of care to test the feasibility of completing clinical and laboratory protocols.

following informed consent from patient's legally authorized representative, patients will be randomized to hydroxocobalamin or saline. patients will have blood samples drawn up to 3 hours pre-dose and 3 hours post-dose to measure for hydrogen sulfide levels. patients will also be followed for 3 hours after study drug infusion to monitor and record vasopressor dependence in norepinephrine-equivalent dose. patients will then be followed through their medical record for 28 days to determine persistent organ dysfunction syndrome (pods).

Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age * admitted to the medical intensive care unit (micu) service at froedtert hospital * diagnosis of septic shock, as defined by sepsis-3 criteria exclusion criteria: * history of calcium oxaluria
vanguard rocc post market surveillance

Conditions: Osteoarthritis, Knee; Rheumatoid Arthritis; Traumatic Arthritis; Posttraumatic Deformity; Varus Deformity; Valgus Deformity; Osteotomy; Arthrodesis

Summary: the objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the vanguard rocc knee prosthesis. patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.

the vanguard rotating platform knee prosthesis (vanguard rocc) was launched in march 2009. therefore there is a need to show the safety and performance of the vanguard rocc at long term. a maximum of 10 sites will be involved in this study. this number of clinical centers will permit assessment of consistency among a multitude of investigators.

Eligibility criteria:
inclusion criteria: inclusion criteria should be in accordance with indications for use for vanguard-rocc® knee system specifically: * painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * correction of varus, valgus, or posttraumatic deformity. * correction or revision of unsuccessful osteotomy, or arthrodesis. additional inclusion criteria include: * male or female. * 18 years of age or older * subjects willing to return for follow-up evaluations exclusion criteria: exclusion criteria should be in accordance with absolute and relative contraindications for use for vanguard-rocc knee system: absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement. relative contraindications include: * uncooperative patient or patient with neurologic disorders who are incapable of following directions, * osteoporosis, * metabolic disorders which may impair bone formation, * osteomalacia, * distant foci of infections which may spread to the implant site, * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, * vascular insufficiency, muscular atrophy, neuromuscular disease, * incomplete or deficient soft tissue surrounding the knee.