Kornimate/medical-research-clean huggingface dataset:
liner ablation using contact-force in atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: linear ablation is frequently used in the procedure for persistent atrial fibrillation. however, it has a limitation because of technical difficulty. incomplete block is common and an important cause of atrial tachycardia. the association between contact force values and successful linear block has not been revealed yet. we aim to the effectiveness and safety of linear ablation by using cf sensing catheter.

catheter ablation is currently accepted as a treatment option for symptomatic atrial fibrillation. linear ablation is frequently used in the procedure for persistent atrial fibrillation. multiple studies have shown benefit of linear ablation. however, it has a limitation because of technical difficulty. incomplete block is common and an important cause of atrial tachycardia. contact-force (cf) monitoring during procedure has recently been available. this technology appears to significantly decrease procedure time and short term reconnection incidence in pulmonary vein (pv) isolation. it also helped to resolve the cause of pv reconnection. some reports demonstrated that the association between reconnection and lower cf value. linear ablation has more variation to interrupt block and reconnection was more often than pv isolation. the association between cf values and successful linear block has not been revealed yet. in addition, the investigators aim to the effectiveness and safety of linear ablation by using cf sensing catheter.

Eligibility criteria:
inclusion criteria: * patients age is18 years or greater * patients with persistent af (af episode lasting \> 7 days) * patients with symptomatic af that is refractory to at least one antiarrhythmic medication * patients with recurrent or sustained arrhythmia after pulmonary vein isolation * patients undergoing a first-time ablation procedure for af * at least one episode of af must have been documented by ecg, holter, loop recorder, telemetry, trans telephonic monitoring (ttm), or implantable device within last 2 years of enrollment in this investigation * patients must be able and willing to provide written informed consent to participate in this investigation exclusion criteria: * patients with long-standing persistent af; * long-standing persistent af will be defined as a sustained episode lasting more than 3 years. * patients for whom cardioversion or sinus rhythm will never be attempted/pursued; * patients with af felt to be secondary to an obvious reversible cause * patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor; * patients with left atrial size ≥ 60 mm (2d echocardiography, parasternal long axis view) * moderate to severe valvular disease * reduced left ventricular function (ejection fraction \<40%) * patients who are pregnant. pregnancy will be assessed by patients informing the physicians.

Keywords: persistent atrial fibrillation linear ablation catheter ablation contact force
circulating tumor cells (ctc) in cancer

Conditions: Cancer

Summary: this observational study with circulating tumor cells (ctc) count, isolation and analysis at several time points during disease progression is to investigate the role and biology of ctcs and clusters of ctcs in different cancer types. it also evaluates the role of ctcs as biomarkers, and aims at the identification of key signaling networks that are active in ctcs.


Eligibility criteria:
inclusion criteria: * adult cancer patients * all patients with histology-based proved diagnosis of cancer, all stages and subtypes can be included. precancerous lesions cannot be included. * all patients with the diagnosis of a solid tumor including adenocarcinoma, squamous cell carcinoma, neuroendocrine carcinoma, sarcoma * written pathology report must be available. * written informed consent. exclusion criteria: * no written informed consent. * no proved diagnosis of malignancy by pathology report. * patients with the diagnosis of blood cancer

Keywords: circulating tumor cells (ctcs) ctc clusters molecular analysis of ctcs ctc culture overall survival (os) progression free survival (pfs)
cognitive disability and quality of life of patients suffering from multiple sclerosis and treatment with immunosuppressant

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: multiple sclerosis is the first cause of neurological handicap in france. the importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. immunosuppressants represent new treatments in multiple sclerosis (ms) but imply a lot of constraints. this study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

multiple sclerosis is the first cause of neurological handicap in france. the importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. immunosuppressants represent new treatments in ms but imply a lot of constraints. this study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of relapsing ms since at least 6 months and less than 10 years * neurological state stable since at least 1 month * moderate handicap (edss ≤ 5,5) exclusion criteria: * secondary progressive ms * patient having an attack * patient having experienced en ms relapse or recovered systemic corticosteroid in the previous 1 month * depressive patient

Keywords: immunosuppressant quality of life cognitive function relapsing multiple sclerosis
vibratory stimulation for the treatment of chronic pain

Conditions: Chronic Pain; Pelvic Pain; Functional Abdominal Pain Syndrome; Low Back Pain; Migraine

Summary: the purpose of this study is to perform a first in man study with vcr stimulation of the belly and back for patients with chronic pain conditions including pelvic pain, functional abdominal pain, or low back pain. this study will also examine vcr stimulation of the temporal region for patients with migraine with or without aura. additional goals of the study will be to determine the safety, tolerability, and acceptability of vcr stimulation for the treatment of these pain conditions.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old. * diagnosis of either chronic pelvic pain, functional abdominal pain, axial low back pain, or migraine with or without aura of at least 3 months duration. * english speaking * ability and willingness to complete questionnaires and in-person assessments * current average daily pain score of greater than or equal to 4 on the numeric rating scale of pain (0-10 scale) * for patients with migraine diagnosis they must report at least 2 headaches in the baseline headache diary in the 30 days preceding randomization. exclusion criteria: * any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status) * any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression * any suicidality as assessed by answer of greater than 0 on question 9 the phq-9 assessing suicidal thoughts. * any current illicit drug or alcohol abuse. * any history of recurrent or unprovoked seizures. * participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. * pregnancy, breast-feeding or lack of reliable contraception * changes in pain medications in the previous 4 weeks * implanted electrical stimulation device. * skin infection over stimulation sites. * any pain interventions in the preceding 6 weeks (epidural steroid injection, sympathetic block, peripheral nerve block, lumbar medial branch blocks) any botulinum toxin injection in the previous 3 months * for patients with migraine diagnosis additional exclusion criteria include receipt of preventive anti-migraine treatment in the past 3 months, failure on greater than or equal to 3 well-conducted preventive drug trials, concurrent medication overuse headache diagnosis, and concurrent frequent/chronic tension type headache. 4. frequent/chronic tension type headache
a study of mm-121 in combination with paclitaxel in patients with advanced gynecologic and breast cancers

Conditions: Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,; Primary Peritoneal Cancer or Endometrial Cancer; Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer

Summary: this study was a phase 1 and pharmacologic open-labeled dose-escalation trial of mm-121 in combination with paclitaxel using a "3+3" design.

successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 1 dose was identified. once the maximum tolerated dose was identified, an expansion cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints.

Eligibility criteria:
inclusion criteria: * cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or endometrial cancer; or, cytological or histological confirmation of locally advanced /metastatic her2 non-overexpressing breast cancer * eighteen years of age or above * candidates for chemotherapy * able to understand and sign an informed consent (or have a legal representative who is able to do so) * measurable disease according to recist v1.1 * ecog performance score (ps) of ≤ 2 * willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of mm-121 exclusion criteria: * prior radiation therapy to \>25% of bone marrow-bearing areas * evidence of any other active malignancy * active infection or fever\> 38.5°c during screening visits or on the first scheduled day of dosing * symptomatic cns disease * known hypersensitivity to any of the components of mm-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies * received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state * pregnant or breast feeding

Keywords: ovarian cancer her-2 negative breast cancer breast cancer fallopian tube cancer
monoclonal antibody-based multipurpose microbicides

Conditions: HIV; Sexually Transmitted Infections (STI)

Summary: the purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. the investigators will ask women to help design the best strategy for applying a vaginal product using a specific kind of applicator. the investigators want to identify designs that women think would be easy to prepare and insert. women's thoughts and opinions will help researchers develop new products called microbicides that may protect against hiv and other sexually transmitted diseases, that are easy to use, and that will be acceptable to women who use them. if researchers can make products that are easy to use and that women like to use, the products will be used more often, and more infections will be prevented. women who enroll in the project will either participate in a focus group with approximately 3-7 other women or a one-on-one cognitive interview. all participants will complete a brief questionnaire. some women may enroll in both stages. each focus group will take approximately 1.5-2.5 hours. group leaders will talk to women about their experiences using vaginal products and will provide participants with study products to look at and touch. all participants will be asked to come up with ideas of how to make the products easy to use and acceptable to women who use them. group leaders will encourage discussion about the different designs. after this, group leaders will talk about a specific type of microbicide and ask women about their opinions. in particular, researchers and participants will talk about the language that would be best understood by women who would use these products or be in studies to evaluate them. each cognitive interview will take approximately 1.5-2.5 hours. each participant will be asked about different product designs and application instructions, and will be asked her thoughts, opinions, and potential concerns about each. she will also evaluate sample language that will be used to help women understand the products and how to use them.


Eligibility criteria:
inclusion criteria: women who: * are between the ages of 18 and 45 at prescreening * report vaginal sex with a man in the past 12 months at prescreening * report negative pregnancy status and no intention to become pregnant during the course of the study * report negative or unknown hiv status, and * are willing and able to provide informed consent. exclusion criteria: women who: * self-report being pregnant, or intention to become pregnant during the course of the study * self-report being hiv-positive * self-report an allergy or sensitivity to vaginal contraceptive film (vcf), nonoxynol-9 (n9), or product(s) containing n9 * are unable or unwilling to give informed consent, or * have any condition that, in the opinion of the project leader or principle investigator, would compromise the participant's ability to participate in the study.

Keywords: hiv/sti prevention microbicides, topical
achieving tuberculosis (tb) control in zambia

Conditions: Tuberculosis

Summary: to achieve tb control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. systematic community case finding with highly sensitive screening and diagnostic tools are needed. at the facility level, the index of suspicion for tb by health care workers needs to be raised to ensure that all those that need tb screening are appropriately screened.

the purpose of this study is to initiate sustained, active health facility and community-based case finding interventions to achieve improved tb case detection in high burden settings (zambia) and contribute to tb control. the interventions are expected to increase the impact of xpert on tb case finding, thus increase tb case detection through scaling up of a combination of community level and facility level tb case finding interventions. the study will generate evidence on the added value of using chest x-ray (cxr) screening at community level, whilst also comparing the performance of cxr with computer assisted diagnosis (cad) and c-reactive protein (crp) and symptoms as screening tools in terms sensitivity, specificity and cost effectiveness. symptom screen alone has been shown to be suboptimal for screening as it misses a significant percentage of tb due to atypical presentation of tb in hiv-infected populations.

Eligibility criteria:
inclusion criteria: - program implementation: inclusion criteria: * any adult or child with tb symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats) * ability to produce sputum * verbal consent of parent or guardian if \< 18 years old operations research: inclusion criteria * adults (18 years and older) * tb symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats) * ability to provide a sputum sample * willing to provide written informed consent * willing to undergo full clinical evaluation * willing to undergo a cxr
oral sedation in vitreoretinal surgery

Conditions: Macular Holes; Intraocular Lens Opacification; Vitrectomy; Vitreous Hemorrhage; Retinal Detachment; Epiretinal Membrane; Vitreous Detachment; Intraocular Lens Dislocation

Summary: the purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.

after being informed about the study and potential risks, and providing written informed consent, a total of 40 patients will undergo vitreoretinal surgery with oral triazolam and 40 patients will undergo vitreoretinal surgery with intravenous sedation. the iv sedative will be determined by the anesthesiologist or certified registered nurse anesthetist but limited to midazolam, propofol, and fentanyl. the study will be a prospective, cross-sectional study with a 1:1 randomized procedure and unmasked.

Eligibility criteria:
inclusion criteria: * undergoing vitreoretinal surgery for a variety of indications including, but not limited to, epiretinal membrane (erm), macular hole, vitreous opacities, vitreous hemorrhage, aphakia, dislocated or displaced intraocular or crystalline lens, silicone removal, endolaser, and retinal detachment. * american society of anesthesiologists rating of i-iii exclusion criteria: * undergoing vitreoretinal surgery requiring general anesthesia * allergy or hypersensitivity to benzodiazepines * pregnant or nursing females * previous delirium after anesthesia * current use of drug or alcohol on the day of surgery * currently on medications inhibiting cytochrome p450 * failed anesthesia clearance * reported anxiety or a history of anxiolytic use * vitreoretinal surgery performed within the last 3 months of the current procedure * impaired renal or liver function

Keywords: sedation during vitreoretinal surgery oral sedation anesthesia in vitreoretinal surgery oral triazolam
a phase 1 study of orca-q in recipients undergoing allogeneic transplantation for hematologic malignancies

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes; Mixed Phenotype Acute Leukemia; Myelofibrosis; Chronic Myeloid Leukemia

Summary: this study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("orcagraft"/"orca-q") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.


Eligibility criteria:
key inclusion criteria: 1. age ≥ 18 and ≤ 65 years at the time of enrollment 2. diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (mds), myelofibrosis, or chronic myeloid leukemia 3. planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (hct) 4. matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor 5. estimated glomerular filtration rate (egfr) \> 50 ml/minute 6. cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (muga) 7. diffusing capacity of the lung for carbon monoxide (dlco) (adjusted for hemoglobin) ≥ 50% 8. total bilirubin \< 1.5 times upper limit of normal (uln) (\< 3 times if attributed to gilbert's syndrome) and alt/ast \< 3 times uln key exclusion criteria: 1. prior allogeneic hct 2. currently receiving corticosteroids or other immunosuppressive therapy. topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed. 3. planned donor lymphocyte infusion (dli) 4. positive anti-donor hla antibodies against a mismatched allele in the selected donor 5. karnofsky performance score \< 70% (appendix 12.7) 6. hematopoietic cell transplantation-specific comorbidity index (hct-ci) \> 4 (appendix 12.8) 7. uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment 8. seropositive for hiv-1 or -2, htlv-1 or -2 9. any uncontrolled autoimmune disease requiring active immunosuppressive treatment 10. concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected 11. history of idiopathic or secondary myelofibrosis 12. women who are pregnant or breastfeeding
epidemiologic study of diabetes and cancer risk

Conditions: Diabetes Mellitus, Type 2, Cancer

Summary: the purpose of this study was to evaluate whether treatment with pioglitazone is associated with risk of incident cancer at the 10 most common sites in a cohort of participants with recognized diabetes along with the assessment of association between diabetes severity and cancer risk.

the study enroll a large population of approximately 252467 participants. this epidemiology study of diabetes and cancer risk is an expansion study which would include estimation of cancer rate among kpnc members with or without diabetes and the relative risks of cancers associated with a diagnosis of diabetes. the study included diabetes participants who were kpnc members between 1997 and 2011. it also included a subset of participants who took the 1996/7 diabetes survey and member health survey (mhs) in 1993, 1999, 2001 or 2003. this multi-center trial was conducted in the united states of america. the overall time to participate in this study was approximately 15.5 years. the participants were followed-up from january 1, 1997 up to december 31, 2011.

Eligibility criteria:
inclusion criteria: 1. has been in the kpnc diabetes registry diabetes mellitus (dm) registry, aged 40 years or older and are members of kpnc as of january 1, 1997 and had no prior diagnosis of the cancer of interest.

Keywords: drug therapy
application of digital techniques in intraoral condylectomy via coronoid process resection

Conditions: Surgical Approach & Incisions

Summary: this study will apply the digital techniques to do the condylectomy through an intraoral approach without needing to do the intraoral vertical ramus osteotomy (ivro). this new surgical technique will greatly maintain the tmj anatomy structure, reduce the risk and increase the precision of the operation procedure.

in this study we will use the digital techniques such as pre-surgical visual treatment planning, real time surgical navigation system, endoscope techniques, to do the intraoral condylectomy via coronoid process resection. after the condyle lesion resection, the coronoid process will be reimplanted and fixed by stainless steel wire. by using these techniques we can safely and precisely cut proper size and position of the condyle lesion as we pre-surgically designed, and at the same time greatly maintain the temporomandibular joint anatomy structure. since we don't need to do the mandible vertical ramus osteotomy, and no conventional extraoral incision will be needed, the surgical injury will be minimized and the tmj function will recover soon postoperatively. additionally, the intraoral approach can avoid the risk of facial nerve injury, salivary fistula and skin scar, so it has better aesthetic results than the preauricular approach and the submandibular approach.

Eligibility criteria:
inclusion criteria: * patients with mandible condylar hyperplasia or osteoma who need to do the condylectomy to prevent the active growth of the affected mandible condyle and the consequence progressive facial asymmetry * usually the patients have tmj functional disorder; and the spect shows difference greater than 20% (pixel count) between the affected side and the contralateral normal side. exclusion criteria: * patients with contradictions to do the operation procedure and general anesthesia, patients refuse to accept the condylectomy, or patients can't afford the extra cost for the application of digital techniques are excluded from this study

Keywords: condylectomy tmj function intraoral approach