Kornimate/medical-research-clean huggingface dataset:
observational study to assess long-term follow-up of breast augmentation subjects

Conditions: Postoperative Pain

Summary: a history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of sky0402 and its relation to the silicon shell.

this was an observational, multicenter study conducted to investigate the long term follow-up of subjects who had been exposed to study drug (either sky0402, bupivacaine hcl, or both) in prior sky0402 breast augmentation studies. specifically, the protocol was designed to elicit any changes in the response of the silicone shell of the implant after exposure to study drug.

Eligibility criteria:
inclusion criteria: * participated in either pacira sky0402-c-210 or pacira simple breast augmentation 315 and received a dose of sky0402, bupivacaine hcl, or both * able and willing to comply with all study visits and procedures. * able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments. * able and willing to provide written informed consent exclusion criteria: * did not receive study drug in either pacira sky0402-c-210 or simple breast augmentation 315. * has a clinically significant systemic or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments.

Keywords: augmentation mammoplasty breast augmentation postoperative pain analgesia
molecular epidemiology of biliary tree cancers

Conditions: Cholangiocarcinoma; Malignant Digestive System Neoplasm

Summary: this study is to learn if certain risk factors (environmental, viral, behavioral, medical, and dietary), tumor markers, and genetic changes can predict the development and outcome of biliary tree cancers. establishing biomarkers models from patients may help doctors to further understand how biliary tree cancer is affected by different treatments, and why some people's cancer responds differently than others.

primary objectives: i. to identify significant factors that may contribute to the etiology of biliary tree cancer. ii. to identify novel genetic loci that predispose to gallbladder cancers (gbc) and cholangiocarcinoma (cgc) diagnosis. exploratory and correlative objectives: i. to use the collected blood and tissue materials for exploratory analysis to identify markers that predict prognosis of biliary tree cancers. ii. to correlate the identified markers with results of specific aim i and ii to test the interaction between the identified markers with environmental and genetic factors. outline: participants complete a questionnaire over 20 minutes. participants also undergo collection of blood and leftover tissue samples.

Eligibility criteria:
inclusion criteria: * pathologically or radiologically confirmed diagnosis of cgc or gbc * with or without prior radiation or chemotherapy * all united states of america (usa) and non usa residents * no age, gender, or racial restriction * healthy control with no current or history of cancer * healthy controls are usa and non usa residents * healthy controls are matched to the cases in age (5 years), gender, and race * healthy controls are friends and spouses of patients with other than gastro-intestinal (gi) cancers * chronic liver disease (cld) controls with no current or history of cancer * cld controls are usa and non usa residents * cld controls are frequency matched to cgc cases by age (5 years), gender, and race * cld controls are patients are diagnosed with or without liver biopsy (core or fine needle aspiration) * cld controls must not have evidence liver cancer diagnosis by computed tomography (ct) or magnetic resonance imaging (mri) exclusion criteria: * none
uc-mscs in the treatment of severe and critical covid-19 patients

Conditions: Mesenchymal Stem Cell; COVID-19 Pneumonia

Summary: the goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (uc-mscs) in the treatment of severe and critical covid-19 patients. the main questions it aims to answer are: 1. the efficacy of uc-mscs in the treatment of severe and critical covid-19 patients. 2. the safety of uc-mscs in the treatment of severe and critical covid-19 patients. 3. the potential immune mechanisms of uc-mscs in the treatment of severe and critical covid-19 patients. participants will receive standard therapy, paxlovid treatment or the uc-mscs treatment. for the standard treatment, it will be conducted according the 9th edition of chinese guidelines for covid-19 infection. for uc-mscs treatment, participants will be given uc-mscs instillation at the first and fourth day after assignment. blood examples will be taken at indicated time for arterial blood gas analysis and other tests. and participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.


Eligibility criteria:
inclusion criteria: * the age ranges from 18 to 75 (inclusive), regardless of gender. * patients diagnosed with severe and critical covid-19 pneumonia within one week, according to the chinese diagnostic criteria for covid-19 pneumonia in the diagnosis and treatment plan for covid-19 pneumonia (tentative ninth edition). * 20kg/m2≤body mass index（bmi）≤30 kg/m2. * volunteer to participate in this clinical study and sign the written informed consent. exclusion criteria: * those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. * t lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), hiv positive. * highly allergic or have a history of severe allergy, especially interleukin-2 allergy. * pregnant and lactating women. * patients with severe autoimmune disease history; allergies to all biological reagents in this treatment, such as interleukin-2. * patients with serious complications, including chronic cardiac insufficiency (nyha cardiac function grading assessment of cardiac function grade iii - iv), chronic renal insufficiency (ckd stage 3 and above); chronic liver insufficiency (child-pugh score\>7); patients with malignant tumors. * patients with pulmonary embolism or acute coronary syndrome. * patients with severe organ dysfunction caused by other diseases. * there are other situations that the researcher thinks are not suitable to participate in this clinical study.

Keywords: covid-19 pneumonia umbilical cord mesenchymal stem cells
ketoconazole contributes to cryptorchidism outcome via modulating macrophage trem2

Conditions: Cryptorchidism

Summary: reduced hormone insulin-like 3, exclusively secreted by leydig cells, has been identified as the recognized mechanism for cryptorchidism. testicular macrophages residing in the testicular interstitium were thought to play a vital role in maintaining hormone secretion of leydig cells. however, the contribution of macrophages to cryptorchidism remained poorly understood. here, after 14 days of ketoconazole treatment, levels of both trem2 and insulin-like 3 significantly decrease in human embryonic testes compared to the untreated control group. conversely, 14 days of luteinizing hormone stimulation lead to elevated levels of trem2 and insulin-like 3 in the testes compared to the untreated control group. additionally, researchers find a positive correlation between trem2 and insulin-like 3 expression in a human ex vivo tissue culture model. in summary, the study will propose trem2 as a novel target for maintaining normal testicular descent by regulating the testicular immune microenvironment.


Eligibility criteria:
inclusion criteria: * 1. termination of pregnancy is not related to the health of the fetus. * 2. the fetus is intact in development and free of malformations and abnormalities. * 3. estimation of gestational age based on parietal-rump length must be between 8 and 13 weeks of gestation. exclusion criteria: * 1. the termination of pregnancy is related to the health of the fetus * 2. the fetus is not intact in development. * 3. the fetus has malformations, abnormalities * 4. estimation of gestational age based on parietal-rump length must not be within 8-13 weeks of gestation.

Keywords: cryptorchidism testicular macrophages leydig cells immune micro-environment
safety & efficacy of pilocarpine ophthalmic spray for temporary improvement of near vision in presbyopic adults

Conditions: Presbyopia

Summary: volunteer participants are evaluated for eligibility during a screening visit; those meeting study inclusion/exclusion criteria are scheduled for 2 treatment visits. at each treatment visit, 1 of the 2 study treatments is self-administered to both eyes. afterwards, efficacy and safety assessments are performed over a 3-hour period.


Eligibility criteria:
primary inclusion criteria: * poor near vision impacting daily living that requires near correction * best-corrected distance visual acuity (bcdva) of 0.0 logmar or better * manifest refraction spherical equivalent ≥ -2.00 diopters (d) and ≤ +2.00 d * monocular dcnva between 0.4 and 0.7 logmar, inclusive * in need of near addition power \< +2.00 d to achieve bcnva of 0.0 logmar primary exclusion criteria: * diagnosis of glaucoma or ocular hypertension * narrow iridocorneal angles * history of intraocular surgery, refractive surgery, laser treatment, or iris surgery * clinically significant abnormality of cornea, lens, retina, ciliary body, or iris * presence/history of a severe/serious ocular condition or any other unstable medical condition * presence or history of manifest strabismus, amblyopia, or nystagmus * current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears * clinically significant external ocular inflammation within 30 days of screening visit * current use or history of rigid gas permeable (rgp) contact lens use within 30 days of screening visit * known pilocarpine allergy or contraindication to use of pilocarpine * presence or history of congenital heart anomaly, valve disease, or other cardiac disease * disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the optejet
eeg brain-machine interface control of an upper-limb robotic exoskeleton for robot-assisted rehabilitation after stroke

Conditions: Stroke; Hemiparesis

Summary: the goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. moreover, another goal is to understand how physical rehabilitation assisted by robotic device combined with electroencephalograph (eeg) can benefit adults who have had stroke to improve functions of their weaker arm. the proposed smart co-robot training system (neuroexo) is based on a physical upper-limb robotic exoskeleton commanded by a non-invasive brain machine interface (bmi) based on scalp eeg to actively include the participant in the control loop . the study will demonstrate that the neuroexo smart co-robot arm training system is feasible and effective in improving arm motor functions in the stroke population for their use at home.the neuroexo study holds the promise to be cost-effective patient-centered neurorehabilitation system for improving arm functions after stroke.

this study has two phases: the first phase will consist of baseline recordings for system calibration and training sessions to be conducted in a clinical setting. the second phase will consist of neuroexo bmi-exo neurotherapy to be conducted at the participant's home. throughout the study and after completion of the study, movement and brain activity will be analyzed to assess function of the affected upper extremity and changes in brain activity associated with the neurotherapy.

Eligibility criteria:
inclusion criteria: * subjects between the ages of 20-65, male or female, * mild-to- moderate unilateral stroke confirmed by brain ct or mri scan and manifested by a glasgow coma scale (gcs) score between 15 and 9 documented within 6 months, * the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study, * anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more. * patients are required to have a mmse\>=24 to rule out those with cognitive impairments. * patients will have to have normal/near normal strength in one upper/lower extremity and appreciable weakness in the other upper/lower extremity. exclusion criteria: * history of traumatic brain injury prior to the current episode, * severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by mmse\>=24 specified in inclusion criteria). * women and minorities will be recruited as long as they meet the inclusion criteria.
ketotifen/naphazoline ophthalmic solution in the conjunctival allergen challenge model of allergic conjunctivitis.

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (cac)-induced allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months. * calculated best-corrected visual acuity of 0.7 logmar or better in each eye as measured using the etdrs chart. * positive bilateral conjunctival allergen challenge(cac)reaction within 10 minutes of instillation of the last titration of allergen at visit 1. * positive bilateral cac reaction in at least 2 out of 3 time points at visit 2. exclusion criteria: * known contraindications or sensitivities to the study medication or its components. * any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters. * use of disallowed medications during the period indicated prior to study enrollment or during the study.
rtms in treatment of obsessive compulsive disorder (ocd)

Conditions: Obsessive Compulsive Disorder

Summary: low frequency (1hz) rtms applied bilaterally and simultaneously over sma for 6 weeks in addition to the standard treatment regimen for ocd, will lead to significant improvement in patients' symptoms. the clinical improvement detected by ybocs, cgi and sf-36 qols scores will be statistically significant in active treatment group compared to sham (placebo) treatment group.


Eligibility criteria:
inclusion criteria: * signed patient informed consent; * primary obsessive compulsive disorder; * ybocs score at least 20; * males/females 18-65yrs; * treated with adequate dose of ssri at least 8 weeks at some stage of illness; * currently using adequate, stable dose of ssri at least 4 weeks but not responding. exclusion criteria: * schizophrenia, other psychotic disorders, bipolar i, current major depressive disorder (hdrs(17)\>18, substance/alcohol dependence within last 6 months; * severe axis ii; * suicidal score\>=6 on mini; * metallic implant in cranium; * severe/unstable medical conditions; * not responding to ect or had tms in last 6 months; * history epilepsy; * neurological disorder leading to increased intracranial pressure; * severe cardiac disorder/intracardiac lines, pacemakers;
the effect of care bundle in preventing pressure ulcers caused by medical devices in the pediatric intensive care unit

Conditions: Pressure Ulcer; Nursing Caries; Device Induced Injury

Summary: with the development of technology in medicine, more medical instruments are used in the treatment of diseases. although the use of these instruments provides great benefits for the patients, it can also cause some complications.one of the most important of these complications is pressure ulcer.some care and evaluation are needed to prevent these complications.this study aims to prevent pressure ulcers with a care package for patients with high risk scores.

a care package will be created with the delphi method to prevent pressure ulcers caused by medical devices.experimental and control groups will be formed by randomized control method.the care package created for 14 days will be applied to the experimental group. standard care will be applied to the control group.as a result, the rates of medical device-induced pressure ulcers in both groups will be compared.children between the ages of 1 and 10 years and treated in the pediatric intensive care unit will be included in the study.patients with any skin-related disease will not be included in the study.

Eligibility criteria:
inclusion criteria: * being in the pediatric intensive care unit. * nasogastric tube, intubation tube and saturation probe attached. * voluntary consent of family to participate in the study exclusion criteria: * patients with skin disease * patients staying less than 14 days

Keywords: medical devices pressure ulcers care bundles
a study of atezolizumab in combination with bevacizumab in spanish patients with unresectable or unsuitable for locoregional treatments hepatocellular carcinoma not previously treated with systemic therapy

Conditions: Carcinoma, Hepatocellular

Summary: this is a phase iiib, one arm, multicenter, open-label study primarily designed to evaluate the safety of atezolizumab + bevacizumab in participants with unresectable or unsuitable for locoregional treatments for metastatic hcc not previously treated with systemic therapy. as part of its secondary objectives, this study is also designed to evaluate the efficacy of atezolizumab and bevacizumab in these participants.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic and/or unresectable hcc with diagnosis confirmed by histology or radiologically, following the aasld criteria * disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies * no prior systemic therapy (including systemic investigational agents) for hcc * at least one measurable (per recist 1.1) untreated lesion detected by ct scan * patients who received prior local therapy such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization (excluding transarterial radioembolization.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with recist version 1.1 exclusion criteria: * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan * known fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc * co-infection of hbv and hcv
validation of a vital signs monitoring wristband

Conditions: Coronary Artery Disease

Summary: today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home monitoring in the extra-mural setting. wearable devices on the wrist, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs. this study aims to validate the corsano cardiowatch 287-2 for the continuous monitoring of heart rate at ≤ 4 bpm root mean squared error (rmse); interbeat intervals at ≤ 50 ms rmse; breathing rate at ≤ 2 brpm rmse; and peripheral oxygen saturation at ≤ 3 percentage point rmse. also, this study aims to validate the corsano cardiowatch 287-2 for the measurement of non-invasive blood pressure according to iso 81060-2:2018.


Eligibility criteria:
inclusion criteria: * 18 years old; * undergoing invasive monitoring, like coronary angiography; * able to provide consent. exclusion criteria: patients * who cannot wear the corsano cardiowatch 287 due to reasons such as allergic reactions, wounds, amputations etc.; * unable or not willing to sign informed consent; * with significant mental or cognitive impairment; * who do not have a suitable entry site for the invasive arterial line * who do not comply to criteria established by iso 81060-2:2018.

Keywords: vital signs blood pressure oxygen saturation heart rate respiratory rate
bright light therapy as possible treatment option for ms-fatigue

Conditions: Multiple Sclerosis; Fatigue

Summary: this study aims to investigate the effect of a 2-week trial of bright light therapy (blt, 10.000 lx) on fatigue in multiple sclerosis (ms) patients. in this randomised placebo-controlled trial, the effect of bright light therapy will be compared to dim red light. ms-fatigue is quantified by patients using a visual analogue scale (vas) and activity levels, subjective and objective sleep parameters and daytime sleepiness are measured.

materials and methods: * visual analogue scale (4x/day for 6 weeks; measuring fatigue) * wrist actigraphy (6 weeks) * sleep diaries (6 weeks) * polysomnography (2x) * multiple sleep latency test (2x) * 4 subtests of the tap (testbatterie zur aufmerksamkeitsprüfung; alertness, vigilance, go/no-go, split attention) * questionnaires (fatigue severity scale, epworth sleepiness scale, pittsburgh sleep quality index, beck depression inventory, beck anxiety inventory, modified fatigue impact scale, morningness-eveningness questionnaire)

Eligibility criteria:
inclusion criteria: * ms patients who suffer from fatigue * age between 18 and 65 years old * fss score of 36 or greater * ess score of 12 or greater * meq score between 31 and 69 * bdi score lower than 19 * bai score lower than 27 * edss lower than 4 exclusion criteria: * sleep disorders (periodic limb movement disorders, obstructive or central sleep apnea, rem sleep behavior disorders) * change of antidepressive/fatigue influencing/sleep influencing/photosensizing/ms medication within the preceding 4 weeks * clinical ms-relapse within the preceding 4 weeks * consumption of alcohol: more than 1 glass per day * consumption of caffeine: more than 4 cups per day * current shift work * jet lag (travelled across two or more time zones within 90 days before study screening * retinopathy or other visual diseases/abnormalties * traumatic brain injury within the preceding 5 years * pregnant or lactating * participation in another clinical trial at the same time

Keywords: bright light therapy ms-fatigue