Kornimate/medical-research-clean huggingface dataset:
radiofrequency ablation (rfa) in breast tumors

Conditions: Breast Cancer Female

Summary: to validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.

a prospective, phase ii-iii study, which will include a series of cases of 30 patients. the hospitals involved will be bellvitge university hospital and hospital del mar. efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure. patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.

Eligibility criteria:
inclusion criteria: * infiltrating ductal carcinoma according the biopsy of the breast, * tumor visible by ultrasound, smaller than 2 cm, * located \> 1 cm from the chest wall and the skin. exclusion criteria: * personal antecedents of breast cancer * multifocality or intraductal carcinoma * lobular infiltrating carcinoma * neoadjuvant therapy

Keywords: radiofrequency early stage
computed optical margin assessment for breast cancer surgery, phase i (part b)

Conditions: Breast Cancer

Summary: this intraoperative study is a prospective study analyzing specimens from fifty subjects. patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. the study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.


Eligibility criteria:
inclusion criteria: 1. women 18 years of age or older 2. signed informed consent form 3. women who have been histologically diagnosed with carcinoma of the breast prior to surgery 4. patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure exclusion criteria: 1. multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. neoadjuvant systemic therapy 3. all t4 tumors 4. previous radiation in the operated breast 5. prior surgical procedure in the same quadrant 6. implants in the operated breast 7. pregnancy 8. lactation 9. participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Keywords: lumpectomy breast cancer optical coherence tomography tumor margin imaging
safety and efficacy of meloxicam compared to other nonsteroidal antiinflammatory drugs (nsaids) in an observational cohort study of patients with rheumatoid arthritis, osteoarthritis, lumbago, scapulohumeral periarthritis, neck, shoulder and arm syndrome

Conditions: Arthritis, Rheumatoid

Summary: study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of nsaid in the routine daily therapeutic situation.


Eligibility criteria:
inclusion criteria: * patients with indications according to the package insert of the prescribed nsaid exclusion criteria: * there is no exclusion criterion, because this post marketing study is an observational study
human dopamine transported imaging in cocaine abuse: 2 - 2

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to determine the density of da transporters during prolonged cocaine abuse and during withdrawal from cocaine use. this aim will test the hypothesis that da transporters are altered by cocaine abuse and reestablished during withdrawal.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence
process validation in dermatology: assessing wound creation methods and treatment efficacy

Conditions: Validation of the Process of Wound Creation and Evaluation

Summary: the primary objective of this study is to validate controlled methods of wound, including 1%w/v sls, 3%w/v sls, and 24-24 times tape stripping, on the forearms of subjects. the study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters.


Eligibility criteria:
inclusion criteria: 1. the subject is aged between 18 and 55 years (both inclusive) at the time of informed consent. 2. the subject is a healthy adult male, or a non-pregnant, non-lactating, healthy adult female. 3. no previous history of adverse skin conditions, and not under any medication likely to interfere with the results. 4. the subject, if female, has a self-reported negative urine pregnancy test. 5. the subject is in a good general health as determined from recent medical history. 6. the subject has willingness and ability to adhere to study directions, and agrees not to use any other skin creams, lotions, serums, etc. at the application sites, except for the specified test products, and return for all specified visits. 7. the subject possesses the ability to comprehend and provide written informed consent for participation in the study. exclusion criteria: 1. the subject is currently pregnant/lactating or is planning to become pregnant during the study period. 2. the subject has a history of allergies or specific allergic reactions upon using dermatological/cosmetic products. 3. the subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment. 4. the subject suffers from any active clinically significant disease or any condition that according to the investigator's discretion warrants exclusion from the study. 5. the subject is taking or has taken a medication which, in the investigator's judgment, makes the subject ineligible or places the subject at undue risk.
denct shoulder bone quality evaluation

Conditions: Osteoarthritis Shoulder; Rotator Cuff Tears

Summary: the objective of the study is to evaluate the preoperative bone quality assessment based on ct to later establish a scale for the decision of stemless shoulder arthroplasty.

the primary endpoint is the collection of the preoperative ct scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. therefore, this study is not centered around a specific device and any primary shoulder arthroplasty system from zimmer biomet including anatomical, hemi, or reverse, stemmed or stemless configurations can be used for the target population. the indications of this study are the shoulder joint diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with tsa/rsa. the subjects should be also met the inclusion/exclusion criteria. the safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

Eligibility criteria:
inclusion criteria: * patient must be older than 18 years and skeletally mature. * patient must undergo the sha, tsa, or rsa according to the instructions for use (ifu). * patient must be anatomically and structurally suited to receive shoulder arthroplasty implants. * patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or more of the following: * non-inflammatory degenerative joint disease including osteoarthritis. * avascular necrosis of the humeral head. * autoimmune disease including rheumatoid arthritis. * irreparable rotator cuff tears. * correction of functional deformity. * patient must be able and willing to sign the irb/ec approved informed consent. * patient must be able to undergo a preoperative ct scan * patient must be willing to share their ct images with sponsor exclusion criteria: * patient is a candidate for shoulder arthroplasty due to one or more of the following: * fractures of the proximal humerus, where other methods of treatment are deemed inadequate. * revision tsa/rsa after the prior tsa/rsa. * patient has experienced the traumatic fractures to the implant site. * patient is unwilling or unable to give consent * patient has any condition which would in the judgement of the investigator, place the patient at undue risk or interfere with the study, e.g., any neuromuscular disease compromising the affected limb. * patient is known to be pregnant or breastfeeding. * patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non- compliant). * patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions. * patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. * patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
pt003 mdi dose confirmation study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary objective of this study is to demonstrate efficacy of pt003 mdi relative to its individual components (pt001 mdi and pt005 mdi) in patients with moderate to severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
key inclusion criteria: * signed written informed consent * 40 - 80 years of age * clinical history of copd with airflow limitation that is not fully reversible * females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods * current/former smokers with at least a 10 pack-year history of cigarette smoking * a measured post- bronchodilator fev1/fvc ratio of \< or = 0.70 * a measured post- bronchodilator fev1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * able to change copd treatment as required by protocol key exclusion criteria: * women who are pregnant or lactating * primary diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * active pulmonary diseases * prior lung volume reduction surgery * abnormal chest x-ray (or ct scan) not due to the presence of copd * hospitalized due to poorly controlled copd within 3 months of screening * clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ecg, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * cancer that has not been in complete remission for at least 5 years * treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives other inclusion/exclusion criteria as defined in the protocol

Keywords: copd
cold induced futile cycles in white adipose tissue

Conditions: Metabolism Disorder

Summary: investigation of futile cycles in white adipose tissue under cold conditions for thermogenesis using two substitutes for glucose metabolism (18f-fdg and 13c-glucose).

thermogenesis is defined as a process, which generates heat by the depletion of energy-rich molecules. evolutionary, it is an essential process that allows the survival at lower temperatures. since the discovery of brown adipose tissue (bat) it is believed that this part of the adipose tissue can dissipate energy for heat thanks to the uncoupling protein 1 (ucp1). since energy expenditure is increased as a consequence of thermogenesis, pharmacological induction of this pathway presents an interesting therapeutic target to counter obesity. however, recent investigations indicate that white adipose tissue (wat) is much more versatile and probably essentially indispensable for thermogenesis. to investigate the mechanism of this futile cycle in wat we plan to investigate the glucose metabolism in 24 healthy volunteers with 2 exams (one with and one without external cooling) with two substitutes for glucose. we will use 18f-fdg to quantify the glucose influx into wat using dynamic pet/ct scans and 13c-glucose to analyze the downstream metabolites.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * healthy participants, as determined by screening assessments and principal investigator's judgment * health status is defined by the absence of evidence of any active or chronic disease following a medical and surgical history, basic physical examination and blood test exclusion criteria: * any clinically relevant history or the presence of e.g. respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, metabolic disease, etc. * intake of the following medications: insulin, oral antidiabetic drugs, glp-1-agonists, corticosteroids, sympathomimetic and sympatholytic drug, beta-blocker, statins. * bmi \> 35 kg/m2 * resting pulse rate \> 70 bpm, resting blood pressure \> 130/90 mmhg. * serum creatinine \> 145 µmol/l * asat\> 75 u/l and alat \> 75 u/l * γ gt \> 100 ui/l and total bilirubin \> 30 µmol/l * glucose \> 7.1 mmol/l * hba1c \> 46 mmol/mol (\>6.4%) * intake of anticoagulants or inhibitors of platelet aggregation (e.g. aspirin, clopidogrel). * known tendency to form keloids (hypertrophic scar tissue) * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * participation in another study with investigational drug within the 30 days preceding and during the present study * participation in another study involving ionizing radiation in the same year * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: glucose metablism futil cycles fdg pet/ct
a phase ii study to evaluate gfh375 in patients with kras g12d mutant metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: this is a multicenter, open-label, phase ii study to explore the efficacy, safety/tolerability and pharmacokinetics (pk) of gfh375 in in patients with previously treated kras g12d mutant metastatic pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. male or female ≥ 18 years old and ≤75 years old. 3. with histologically or cytologically confirmed metastatic pancreatic cancer harboring kras g12d mutation 4. be able to provide tumor tissue samples that meet the requirements 5. have at least one measurable lesion according to recist1.1 6. ecog performance status of 0-1. 7. with a life expectancy of ≥12 weeks. 8. adequate laboratory parameters during the screening period. exclusion criteria: 1. active brain metastases. 2. prior treatment with a kras g12d inhibitor or a pan-ras/kras inhibitor. 3. with poorly controlled or severe cardiovascular disease. 4. subjects with active hepatitis b or active hepatitis c. 5. known allergy to the study drug or its components. 6. pregnant or lactating women.
clinical characteristics of coronavirus disease 2019 (covid-19) in pregnancy

Conditions: Infection Viral

Summary: the novel coronavirus (2019-ncov), also known as wuhan coronavirus, causes the 2019-ncov acute respiratory disease.

coronaviruses (covs) are the largest group of viruses belonging to the nidovirales order. they are enveloped, non-segmented positive-sense rna viruses. coronavirus are believed to cause a significant proportion of all common colds in adults and children. the novel coronavirus (2019-ncov), also known as wuhan coronavirus, causes the 2019-ncov acute respiratory disease. the initial cases of 2019-ncov occurred in wuahn, china in december 2019. a recent review evaluated the potential impact of 2019-ncov in pregnancy. the authors reported published data on covs in pregnant women, including 2019-ncov, severe acute respiratory syndrome (sars-cov) and middle east respiratory syndrome (mers-cov). the review included 12 women with sars-cov,4 11 women mers-cov,5 and 9 women with 2019-n-cov6 in pregnancy. no cases of vertical trasmission were reported, but the authors showed an high rate of preterm birth (45.8%), cesarean delivery (70.8%), maternal admission to intensive care unit (icu) (63.3%), and maternal death (18.8%). the aim of this study was to evaluate the pregnancy and perinatal outcomes of pregnant women with 2019-n-cov. this was a multicenter, retrospective, cohort study. clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-cov data on recent exposure history, clinical symptoms or signs, laboratory findings, and maternal and perinatal outcomes were collected. all medical recors were sent to the coordinator center. data were entered into a computerized database and cross-checked. if the core data were missing, requests for clarification were sent to the coordinators.

Eligibility criteria:
inclusion criteria: * pregnant women with laboratory-confirmed 2019-n-cov
evaluation of effectivity of erector spina plane block with different levels

Conditions: Postoperative Pain

Summary: in last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. laparoscopic cholecystectomy is one of the most commonly performed surgical operations. in this study, the investigators will evaluate the effectiveness of erector spina plan block with different injection levels for postoperative analgesia on patients undergoing laparoscopic cholecystectomy surgery.

three groups were planned for this study.randomization was planned with the closed envelope method. i̇n the first group, the esp(erector spinae plane) block procedure will be applied from the t7 level bilaterally and in the second group it will be applied from the t9 level bilaterally. esp block procedure will not be applied in the third group and this group will be considered as the control group. a comparison of nrs (numeric rating scale) and morphine consumption will be planned for all groups of patients at 1-th, 4-th, 8-th.,12-th and,24-th postoperative hours.

Eligibility criteria:
inclusion criteria: * asa 1-2 elective cholecystectomy surgery * 18-65 years old patients exclusion criteria: * asa 3-4 patients * patient refusal * several lung and heart disease * contraindications to regional anesthesia * bmi̇ \> 35 patients * known allergy to local anesthetics * bleeding diathesis * use of any anti-coagulants * severe kidney or liver disease * patient with psychiatric disorders

Keywords: postoperative pain erector spinae plane blok laparoscopic cholecystectomy
once-daily fluorometholone vs twice-daily cyclosporine in dry eye disease

Conditions: Dry Eye Disease (DED)

Summary: this study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment in dry eye disease.


Eligibility criteria:
inclusion criteria: 1. participants aged 18 years or older 2. complaint of dry eye symptoms for 6 months or longer at screening 3. ocular surface disease index (osdi) score of 33 or higher 4. tear film breakup time of 7 seconds or less exclusion criteria: 1. abnormal lid anatomy or active blepharitis 2. severe systemic autoimmune diseases 3. received permanent lacrimal plug within 3 months 4. ded secondary to alkali burns, cicatricial pemphigoid, or stevens-johnson syndrome 5. ocular/periocular malignancy 6. active ocular allergies or allergy to the study drug or its components 7. active infection 8. intraocular surgery or ocular laser surgery within 6 months 9. uncontrolled systemic disease or history of herpetic keratitis 10. contact lens user 11. intraocular pressure \>25mmhg 12. pregnancy or current breast-feeding.
the effects of extracorporeal shock wave therapy in patients with coccydynia: a randomized controlled trial

Conditions: Coccydynia

Summary: the purpose of this study is to evaluate the effects of extracorporeal shock wave therapy (eswt) on the outcomes of coccydynia.

coccydynia is pain in the coccygeal region, and usually treated conservatively. extracorporeal shock wave therapy (eswt) was incorporated as non-invasive treatment of many musculoskeletal conditions. however, the effects of eswt on coccydynia are less discussed. the purpose of this study is to evaluate the effects of eswt on the outcomes of coccydynia. patients were allocated to eswt (n=20) or physical modality (sit) group (n=21) randomly, and received total treatment duration of 4 weeks. the visual analog scale (vas), oswestry disability index (odi), and self-reported satisfaction score were used to assess treatment effects. the vas and odi scores were significantly decreased after treatment in both groups, and the decrease in the vas score was significantly greater in the eswt group. the mean proportional changes in the odi scores were greater in the eswt group than in the sit group, but the between-group difference was not statistically significant. the patients in the eswt group had significantly higher subjective satisfaction scores than sit group. the investigators concluded that eswt is more effective and satisfactory in improving discomfort and disability caused by coccydynia than the use of physical modalities. thus, eswt is recommended as an optimal treatment option for patients with coccydynia.

Eligibility criteria:
inclusion criteria: * first-time diagnosed with coccydynia * history of direct traumatic events to the buttocks, such as falls or slipping exclusion criteria: * tumors of the cauda equina * pelvic surgery * herniation of the lumbosacral disc * internal procidentia * genitourinary or gastrointestinal complaints * psychogenic factors

Keywords: coccydynia extracorporeal shock wave therapy disability