Kornimate/medical-research-clean huggingface dataset:
study of botox injections to assess change in disease activity and adverse events in adult female participants with interstitial cystitis/bladder pain syndrome (ic/bps)

Conditions: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Summary: interstitial cystitis/bladder pain syndrome (ic/bps) is a chronic and debilitating urological complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon bladder filling, and often accompanied by lower urinary tract symptoms (luts). this study will assess how safe and effective botox (onabotulinumtoxina) is in treating ic/bps. adverse events and change in disease symptoms will be evaluated. botox (onabotulinumtoxina) is an investigational drug being developed for the treatment of interstitial cystitis/bladder pain syndrome (ic/bps). study doctors randomly assign the participants to 1 of 2 groups, called treatment arms, to receive botox or placebo. there is a 1 in 2 chance that participants will be assigned to placebo. approximately 80 female participants, aged 18 to 75 years, with a diagnosis of ic/bps will be enrolled in approximately 40 sites in the united states and canada. participants will receive botox or placebo injected into the bladder on day 1 and will be followed for at least 12 weeks in treatment 1. eligible participants may request additional dose of botox between weeks 12 and 24, and will be followed for 12 weeks in treatment period 2. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: - presence of interstitial cystitis/bladder pain syndrome (ic/bps) symptoms for at least 6 months, diagnosed by the investigator as ic/bps, and confirmed dominant bladder derived pain. exclusion criteria: - history or current diagnosis of hunner lesions.

Keywords: interstitial cystitis/bladder pain syndrome (ic/bps) botox botulinum toxin type a onabotulinumtoxina
surveillance and follow-up for latent tuberculosis infection and risk of developing active tuberculosis in patients receiving long-term dialysis

Conditions: To Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release Assy

Summary: to follow-up the latent tuberculosis infection and the risk of developing active tuberculosis in patients receiving long-term dialysis

tuberculosis (tb) remains an important infectious disease worldwide. taiwan is still an edemic area. in 2008, there is an incidence of 62 persons having tb per 100,000 population. to control tb, we should prevent further tb transmission via early diagnosis and treatment of latent tb. in screening the risk population for tb, patients with renal failure acquiring long-term dialysis, in addition to close contacts, have higher incidence and mortality than general population. moreover, the risk for active tb in dialysis patients is ten to 25 times larger. in taiwan, the dialysis group is important because it has higher prevalence (2228 per in per million people by 2009 annual report of united states renal data system) than other countries in the world. in particular, the dialysis patients usually has an extrapulmonary presentation for their tb, so diagnosis is always delay. hence, we should detect latent tb in those dialysis patients for monitor them from active tuberculosis. currently, interferon-gamma release assays (igras) are used for finding out those with latent tb and have been proven useful for those being immunocompromised, and having bcg vaccination. for dialysis patients, igras have been tested and been considered better than skin tuberculin test. however, previous studied rarely observed the patients receiving peritoneal dialysis. besides, those cross-sectional studies used the indirect evidence for diagnosis and lacked longitudinal follow-up. we thus conducted this study for observing the prevalence of latent tb in those receiving hemodialysis or peritoneal dialysis by using igras. we also kept one-year follow-up for the primary outcome of active tb occurrence.

Eligibility criteria:
inclusion criteria: * age equal to or more than 18-years old * having received dialysis more than 3 months exclusion criteria: * positive hiv test * liver cirrhosis, child-pugh class c * receiving long-term systemic corticosteroid use * receiving chemotherapy within recent three months * life span is less than one year * being suspected to have active tuberculosis

Keywords: latent tuberculosis, renal failure, dialysis, interferon-gamma release assay
a single-arm safety study of transplantation using umbilical cord blood and human placental-derived stem cells from partially matched related donors in persons with certain malignant blood diseases and non-malignant disorders

Conditions: Hematologic Malignancies

Summary: to investigate the safety of partially matched related human placental-derived stem cells (hpdsc) administered in conjunction with umbilical cord blood (ucb) stem cells from the same donor in subjects with various malignant or nonmalignant disorders potentially curable with stem cell transplantation and to assess potential restoration of normal hematopoiesis and immune function in subjects with these disorders


Eligibility criteria:
inclusion criteria: * suitable ucb collected from partially or fully hla matched related donor * subject requires umbilical cord transplantation exclusion criteria: * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * major anticipated illness or organ failure incompatible with survival from stem cell transplant

Keywords: myelodysplastic syndrome (mds) acute myelogenous leukemia (aml) acute lymphocytic leukemia (all) sickle cell disease (scd) beta thalassemia inborn errors of metabolism severe combined immunodeficiency disease (scid)
low-dose endotoxemia and the acute phase response

Conditions: Endotoxemia; Sepsis

Summary: the purpuse of this study is to examine the acute phase respons when different doses of e. coli endotoxin is injected in healty volunters.


Eligibility criteria:
inclusion criteria: healty volunteers - exclusion criteria: infection 14 days prior to the trial regular medication present and /or former heart disease -
predictors for low rates of surgical resection in elderly patients with resectable pancreatic ductal adenocarcinoma

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: more and more older adults are diagnosed with pancreatic ductal adenocarcinoma (pdac), but the rate of surgical resection in patients with resectable tumour is still low. clinical workers need to take more attention to oncologic care in this group. it's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection.

the incidence of pancreatic ductal adenocarcinoma (pdac) in the elderly has been on the rise, but the elderly were always neglected in clinical oncology care. pancreatic ductal adenocarcinoma is a lethal disease, and the most effective treatment for curing it remains the radical resection. unfortunately, there are many a study had reported that the rate of radical surgery of patients with pdac has been low in the past decade. in order for more elderly pancreatic cancer patients to undergo surgical resection, investigators extracted the data of elderly patients with pdac from seer program and investigated predictive factors associated with surgical resection abandonment. in this study, investigators extracted data of patients older than 75 years diagnosed with t1-t3 stage pdac to investigate rate of radical surgery. and researchers used univariate and multivariate logistic regression model to explore potential factors associated with patients and surgeon chose to abandon surgical resection.

Eligibility criteria:
inclusion criteria: 1. patients older than 75 years old and were diagnosed with pancreatic ductal adenocarcinoma by positive histology. 2. patients were diagnosed with t1 through t3, m0 tumor based on criteria of tnm stage. exclusion criteria: 1. patients were diagnosed by death certificate. 2. patients died before radical surgery. 3. patients with important data missing, such as t-stage, surgical resection status, surgery procedures and complete survival time.

Keywords: pancreatic ductal adenocarcinoma elderly treatment abandonment relative weight analysis
a clinical trial to determine the effects of 40 mg doxycycline versus a placebo control for the treatment of rosacea

Conditions: Rosacea

Summary: the objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.


Eligibility criteria:
main inclusion criteria: * healthy patients with rosacea * males and females ≥18 years of age * 10 to 40 papules and pustules and ≤2 nodules * score of 2 to 4 on the iga * presence of telangiectasia * moderate to severe erythema main exclusion criteria: * use of topical acne treatments or topical or systemic antibiotics * use of systemic retinoids within 90 days of baseline * use of an investigational drug within 90 days of baseline * pregnant or nursing women * women of childbearing potential not using an adequate form of contraception * change in method of contraception within 4 months of baseline * known hypersensitivity to tetracyclines * surgeries that bypass or exclude the duodenum or achlorhydria

Keywords: rosacea acne rosacea
assert-iq implantable cardiac monitor (icm) post market study

Conditions: Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent; Cardiac Arrhythmia; Ablation

Summary: this is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the assert-iqtm implantable cardiac monitor (icm) device.

the study's intent is to generate long-term real-world data on the safety, performance, and clinical benefits of the assert-iqtm icm device system. this clinical investigation is sponsored by abbott medical.

Eligibility criteria:
inclusion criteria: patients must meet all study inclusion criteria to participate in the study. 1. have an approved indication and are scheduled to receive an assert-iqtm icm device prior to enrollment in the study. 2. diagnosed with symptomatic, drug-refractory paroxysmal or persistent af prior to enrollment in the study and scheduled to undergo a first-time atrial fibrillation ablation. 3. have a cellular phone or the ability or willing to use a mobile transmitter that is compatible with the mymerlin™ app and able to communicate with the assert-iqtm icm device. if a subject doesn't have a cell phone or loses their cell phone, then the site can provide a mobile transmitter to the subject. the study will not provide cell phones. 4. are 18 years of age or older, or of legal age to give informed consent specific to state and national law. 5. have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. exclusion criteria: if any study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure). 1. subject is currently participating in another clinical investigation that could confound the results of this study, without documented pre-approval from abbott. 2. subject is implanted with a cardiac implantable electronic device (cied) with pacing capability. 3. have a life expectancy of less than 1 year due to any condition.

Keywords: atrial fibrillation holter monitor cardiac arrhythmia arrhythmia risk syncope shortness of breath dizziness palpitations tachycardia sinus pauses holter ecg recorder
comparison of strategies for vascular access closure after transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis

Summary: the access-tavi trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. the objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.

detailed information is provided elsewhere.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years and able to give consent * patients with an indication for tf-tavi as judged by the local multi-disciplinary heart team * feasibility of transfemoral access route using commercially available transcatheter heart valves and delivery systems * written informed consent exclusion criteria: * vascular access site anatomy not suitable for percutaneous vascular closure device * vascular access site complications prior to the tavi procedure * known allergy or hypersensitivity to any component of the vcd * active bleeding or bleeding diathesis * absence of computed tomographic data of the access site before the procedure * systemic infection or local infection at or near the access site * limited long-term prognosis due to other comorbid conditions * patient cannot adhere to or complete the trial protocol for any reason * pregnancy * participation in any other interventional trial * patients with mechanical heart valves in mitral position * patients with elevated international normalized ratio (inr) due to oral anticoagulation therapy requiring reversal of vitamin k antagonists prior to tavi using prothrombin complex concentrate

Keywords: aortic valve stenosis transcatheter aortic valve implantation (tavi) vascular closure device
decoding presymptomatic white matter changes in huntington disease

Conditions: Huntington Disease; White Matter Alterations

Summary: win-hd is a monocentric longitudinal study comparing premanifest huntingtin (htt) mutation carriers and non htt mutation carriers to determine that white-matter atrophy occurs far earlier than clinical onset in hd using diffusion-weighted nuclear magnetic resonance (n spectroscopy (dws) and diffusion tensor imaging (dti). the investigators will recruit up to 20 premanifest htt mutation carriers (15 completed) and up to 20 non htt mutation carriers (15 completed). it is important to have those 2 populations in order to compare our results and determine if there are significant white-matter changes far from the onset of hd. therefore, non htt mutation carriers will be age and gender matched to premanifest htt mutation carriers. in order to test the hypothesis, the study has 2 visits with a year interval. this study is based on 4 principal criteria: 1. imaging criteria 2. clinical and neurological criteria 3. psychological criteria 4. behavioral criteria


Eligibility criteria:
inclusion criteria: * for presymptomatic individuals: * genetic test available with cag (cytosine-adenine-guanine) repeat length \> 36 in htt gene * uhdrs score \<5 * burden score \<250 * for controls: - genetic test available with cag repeat length ≤ 36 in htt gene * common inclusion criteria for presymptomatic individuals and controls (age-matched and gender-matched with presymptomatic individuals and but without any familial relationship): * at least 18 years of age * capacity to consent * signature of the informed consent * covered by social security * ability to undergo mri scanning non-inclusion criteria: * under the age of 18 years of age * contra-indications to mri examination (metallic implant, pacemaker, artificial heart valve, brain vascular malformation, aneurysm clips, exposed by metallic fragments, artificial implants, peripheral or neuronal stimulator, insulin pump, intravenous catheter, epilepsy, person with an history of seizure, metallic contraceptive device, permanent eyelid make up, claustrophobia,...) * unwillingness to be informed in case of abnormal mri (with a significant medical anomaly) * history of severe head injury * history of neurological disorder or presence of neurological disorder * participation in a drug trial or exclusion period of another study * pregnancy or breastfeeding * inability to understand information about the protocol * person deprived of their liberty by judicial or administrative decision * person under legal protection (legal guardianship, tutelage or maintenance of justice) * person without any protection and unable to consent
health advocate for liver transplant - pilot

Conditions: Liver Transplant; Complications; Pediatric ALL

Summary: the health advocate for liver transplant (heal-tx) pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a health advocate onto the transplant team. across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. in this pilot, the investigators will adapt this intervention for pediatric liver transplant patients and measure acceptability and feasibility according to re-aim.


Eligibility criteria:
inclusion criteria: 1. patients under 18 years if age that have undergone liver transplantation. 2. subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures. 3. subject and/or parent/ legal guardian is willing to be contacted in the future by study staff. 4. patient and/or caregiver felt to be a good fit for this pilot by transplant team. exclusion criteria: * caregiver unwilling or unable to complete the survey. * child is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances. * non-english, non-spanish speakers. * non-us residents. * greater than 18 years of age at the time of enrollment.

Keywords: health advocate patient navigator
autologous bone marrow mononuclear stem cell for children suffering from liver cirrhosis due to biliary atresia

Conditions: Liver Cirrhosis, Biliary

Summary: the aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation for children suffering from liver cirrhosis due to biliary atresia

this study is ferformed to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation in the management of liver cirrhosis due to biliary atresia after kasai's operation of 20 patients at vinmec research institute of stem cell and gene technology, hanoi, vietnam from january 2017 to december 2018

Eligibility criteria:
inclusion criteria: * children were diagnosed with liver cirrhosis due to biliary atresia after kasai's operation * from 5 months to 2 years old * weight ≥ 6 kg * patients with manifestation of cirrhosis after kasai's operation: hepatomegaly, congestive splenomegaly, elevated liver enzymes, esophageal varices (based on endoscopic diagnosis), cirrhosis (based on liver biopsy) exclusion criteria: * under 1 year old patients * epilepsy * coagulation disorders * allergy to anesthetic agents * severe health conditions such as cancer, failure of heart, lung, liver or kidney * active infections * severe psychiatric disorders

Keywords: autologous bone marrow transplantation biliary atresia kasai's operation liver cirrhosis
effect of the 3 wishes program on bereaved families' end-of-life care perceptions

Conditions: End of Life; Death

Summary: dying in the intensive care unit (icu) can be a source of trauma for patients and their families. the 3 wishes program is a palliative care initiative in which healthcare workers fulfills small wishes to provide a personalized, humanizing experience at the end of life (eol) for dying patient and their families. the investigators' objective is to assess families' ratings of eol care for icu decedents who received the 3wp as part of their eol care versus usual care.

this is a quality improvement study to evaluate the effect of the 3 wishes program (3wp) on end-of-life (eol) care in the adult icus of a two-hospital academic healthcare system. at this health system, patients were invited to participate in the 3wp once a decision to withdraw life support was made or the health care team agreed that the patient's probability of dying in the hospital or on discharge to hospice was \>95%. as a quality improvement measure, 3wp initiation was up to the discretion of the clinical team. patients and/or families provide verbal consent. hcws, mostly nurses, asked how they might bring comfort to a dying patient and their family in the final hours or days of life. wishes can also be suggested by the clinical team. a modified bereaved family survey (bfs), a cover letter and a self-addressed stamped envelope were mailed to the next of kin three months after the patient's death. surveys had no identifying information and were tracked using a unique code. no incentive was offered. two weeks following the initial mailing, non-responders received up to three telephone calls (at least one attempt after 5pm and maximum two voice messages) to request the return of the survey or to complete it by telephone, if preferred. bfs results were compared between patients who received the 3wp and those who did not. demographics and clinical characteristics were abstracted and included in multivariate models.

Eligibility criteria:
inclusion criteria: * for participation in the 3wp, if there was a decision to withdraw life support or the health care team agreed that the patient's probability of dying in the hospital or on discharge to hospice was \>95% * for surveys, next of kin/surrogate of a patient who died in the icu during the study period * for surveys, speaks english exclusion criteria: * \<21 years old * does not speak english

Keywords: end of life palliative care intensive care unit