Kornimate/medical-research-clean huggingface dataset:
longitudinal ctdna surveillance for older women with er+ breast cancer who omit surgery

Conditions: Breast Cancer

Summary: this prospective study recruits patients with er+/her2-, non-metastatic breast cancer who omit upfront surgery in favor of primary endocrine therapy for sample collection and prospective circulating tumor dna (ctdna) measurement to guide disease surveillance.

age is one of the most important risk factors for the development of breast cancer. nearly a third of all breast cancer cases occur in older women (aged ≥ 70 years), with most cases being estrogen receptor-positive (er+). such tumours are unlikely to be the ultimate cause of death for older women, particularly when considering other comorbidities. our group has recently shown that risk of breast cancer-related mortality is only around 3% for older women who forego upfront surgery and instead treated with primary endocrine monotherapy. however, with omission of surgery, surveillance for tumor growth or treatment failure is important but requires patients (and their caregivers) to have regular imaging and to see their oncology team every 3 months, which can be quite burdensome. thus, this study employs a ctdna surveillance scheme to monitor for potential tumor growth. partnering with natera, this study uses a bespoke, tumor-specific ctdna assay (signatera) to monitor for changes in ctdna dynamics while the patient is on endocrine therapy. this study is for patients who choose not to undergo primary surgical intervention and are managed medically on primary endocrine therapy (any endocrine therapy permitted). patients will undergo signatera testing at the time of regularly scheduled clinic follow-up visits and/or at the time of surveillance imaging, which will occur every 3-6 months. patients will also be asked to complete regular surveys while participating in the study.

Eligibility criteria:
inclusion criteria: * early-stage (stages i-iii) breast cancer * estrogen receptor positive (er+) and/or progesterone receptor positive (pr+) and her2 receptor negative * able to provide blood samples * decision made by treating physician and patient to forego upfront surgery in favor of medical management with endocrine therapy * non-metastatic disease at diagnosis (patients need not have staging scans; patients at higher risk for de novo stage iv disease should not have any symptoms concerning for metastatic disease) * patients may be taking any endocrine therapy * patients may be taking any cdk4/6 inhibitor as deemed necessary by their treating physician * any ecog performance status allowed * if patients have synchronous bilateral er+ breast cancer, tissue from both sites should be submitted to natera to perform ctdna testing * patients with multifocal/multicentric tumors are eligible and the largest focus of cancer should be submitted for testing exclusion criteria: * under 70 years of age * breast cancer that is not estrogen receptor positive (er+) or progesterone receptor (pr+) * unable to provide blood samples or insufficient tumor tissue for signatera testing

Keywords: estrogen receptor positive (er+) progesterone receptor (pr+) early-stage breast cancer
evaluation of intra axial brain masses based on magnetic resonance in adults

Conditions: Brain Tumor

Summary: although the magnetic resonance imaging with contrast is the gold standard for diagnosis of intra axial brain masses. the conventional magnetic resonance imaging appearances of intra axial brain masses can be non-specific and even the use of contrast agent is of limited benefit. contrast enhancement reflects only disruption of blood brain barrier. one third of high-grade malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement. reliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade from low grade tumor, is difficult with conventional magnetic resonance imaging


Eligibility criteria:
1. inclusion criteria: \* an intra axial space occupying lesion/lesions detected on conventional structural imaging 2. exclusion criteria: * mri contraindications (as pace maker or claustrophobia). * contrast hypersensitivity * impaired renal function. * pediatric age group
does an occupational therapy program enhance mental health outcomes for veterans who scuba dive

Conditions: Post Traumatic Stress Disorder; Depression; Anxiety; Stress, Psychological

Summary: the purpose of the study is to investigate whether an occupational therapy program could enhance mental health outcomes for veterans who scuba dive. scuba diving requires modified breathing techniques and has been found to provide calming effects to individuals who engage in this activity. occupational therapy interventions such as mindfulness, journaling, and deep breathing techniques can also provide similar calming effects. therefore, this study will explore whether occupational therapy can provide additional benefits to overall mental health of veterans who scuba dive.


Eligibility criteria:
inclusion criteria: * 18 to 95 years of age * participation in waves project for at least 3 months * completion of 3 open water dives * proficient in written and verbal english exclusion criteria: * younger than 18 years of age or older than 95 years of age * not a member of waves project within 3 months of study recruitment * has not completed 3 open water dives * not proficient in written and verbal english

Keywords: post traumatic stress disorder, depression, anxiety, stress, scuba, occupational therapy
role of dynamic ultrasound in assessment of shoulder impingement syndrome

Conditions: Shoulder Impingement Syndrome

Summary: this study aims to evaluate the effectiveness of dynamic high-resolution ultrasonography in identifying various abnormalities of the shoulder impingement syndrome, especially the subacromial type, and to determine the added value of dynamic ultrasonography compared to static examination of such cases. furthermore, we will compare these findings to mri, which we regard as the standard in our cases.

patients with shoulder impingement syndrome often experience pain primarily in the anterior and lateral areas of the acromion, which can radiate to the lateral aspect of the mid-arm. this pain typically worsens at night and when lying on the affected side. additionally, some patients may experience stiffness and weakness due to the pain. when assessing a patient with signs of impingement, it is essential to evaluate the condition of the rotator cuff and the extent of any tears. this information allows surgeons to create an effective strategy for ongoing patient management. ultrasound (us) and magnetic resonance imaging (mri) are effective tools for diagnosing rotator cuff disorders, especially when it comes to detecting full-thickness rotator cuff tears, due to their high sensitivity. however, their overall sensitivity for identifying partial rotator cuff tears and tendinopathy is lower. impingement-related conditions, such as bursitis and changes or ruptures in tendons, can be visualized using a linear sonography. ultrasound (us) offers several advantages over mri. one key benefit is that ultrasonography is a dynamic form of imaging, while mri provides static images. us is also portable, better tolerated by patients, and allows for direct interaction with patients; this enables patients to point to the symptomatic area, which can enhance diagnostic accuracy. additionally, ultrasound is less time-consuming, more cost-effective, and more readily available in secondary and tertiary care settings compared to mri.

Eligibility criteria:
inclusion criteria: * male and female patients present with shoulder pain with positive clinical tests suggestive of shoulder impingement syndrome exclusion criteria: * history of shoulder surgery, instability disorders, shoulder girdle fracture, radiation therapy to the shoulder, neoplastic lesions, and congenital anomalies of the shoulder. patients having contraindications to perform mri (patients with electrically, magnetically, or mechanically activated implants, pacemakers, cochlear implants, or any metallic orthopedic implants) and claustrophobic patients).
vaginal microbiota, and sti/hiv risk among adolescent girls and young women

Conditions: Microbial Colonization

Summary: the investigators are doing a study on the bacteria that normally live in the vagina and what effect, if any, depo-provera has on the bacteria. women 13-24 years of age, who are hiv negative, being seen in a clinic for birth control or sexually transmitted disease (std) check-up, or have a child and are planning to receive a depo-provera shot for contraception or have declined the use of hormonal contraception may join.

the investigators are doing a study on the bacteria that normally live in the vagina and what effect, if any, depo-provera has on the bacteria. women 13-24 years of age, who are hiv negative, being seen in a clinic for birth control or std check-up, or have a child and are planning to receive a depo-provera shot for contraception or have declined the use of hormonal contraception may join.

Eligibility criteria:
inclusion criteria: * age 13-24 * female sex * seeking contraceptive/ sti services or has had a child or is legally married * has had consensual vaginal sex * two years have passed since menses started * hiv negative by self-report * willing to refrain from using douches, washes, or other similar feminine hygiene products. (tampons are allowed) * planning to receive the depo-provera shot, -or- have regular menstrual cycles with at least 21 - 45 days between menses and plans to use no hormonal birth control. exclusion criteria: * any other immunodeficiency (e.g. organ transplant recipient) * recently pregnant (within 4 weeks), currently pregnant, or planning to become pregnant within the next 12 months * currently breastfeeding * hysterectomy or a known genital tract anomaly * amenorrhea (except if caused by contraceptive method like the implant) * antibiotic or antifungal use within past 30 days
measurement of relaxin peptide in multiple sclerosis (ms)

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this study will evaluate relaxin (rlx) levels in patients with multiple sclerosis.

the goal of this study is to obtain baseline information on serum and cerebrospinal fluid (csf) relaxin levels in patients with ms, as well as to further study rxfp-1 receptor binding affinity for rlx in patients with active and clinically stable ms.

Eligibility criteria:
inclusion criteria: * subjects with suspected ms, who have had a clinical attack within the last 12 weeks, have at least one gadolinium-enhancing lesion on brain or spinal cord mri taken within the prior 4 weeks, and for which they have not received any immunomodulating or immunosuppressant medication. * subjects with clinically stable definite ms, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on mri in the prior 4 weeks. these subjects will fulfill the revised (2010) mcdonald's criteria for the diagnosis of ms. * subjects without evidence of inflammatory systemic or inflammatory central nervous system disease, who require csf removal for some other cause, such treatment of benign intracranial hypertension or as part of the procedure for insertion of an intrathecal medication delivery system. exclusion criteria: - pregnancy

Keywords: multiple sclerosis ms relaxin
effect of liraglutide compared to glimepiride on appetite in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and oceania. the aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * diet-treated subjects and/or subjects with type 2 diabetes in oad (oral anti-diabetic drug) mono-therapy * hba1c for diet-treated subjects: hba1c between 6.5-10.0% (both inclusive) and for oad treated subjects: hba1c between 6.5-9.5% (both inclusive) * body mass index (bmi) between 27-40 kg/m\^2 (both inclusive) * subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight) * euthyroid subjects * subjects should be unrestrained eaters exclusion criteria: * recurrent severe hypoglycaemia * impaired liver function * impaired renal function * cardiac problems * uncontrolled treated/untreated hypertension * known or suspected allergy to trial products or related products * use of any drug (except for oads), which in the investigator's opinion could interfere with the subject's glucose level or body weight * active hepatitis b and/or active hepatitis c * positive hiv (human immunodeficiency virus) antibodies * known or suspected abuse of alcohol or narcotics * habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the investigator
sal067 treatment in patients with type 2 diabetes who are not controlled with diet and exercise

Conditions: Diabetes Mellitus, Type 2

Summary: this is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of sal067 in treatment-naive t2dm patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

all eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the sal067 group (12 mg once daily) or alogliptin group (25 mg once daily) or placebo group at a 2:1:1 ratio. after 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. subjects in the placebo group were to be switched to sal067 (12 mg once daily) treatment, while patients in the sal067 and alogliptin groups continued the same treatment until the end of the whole 52 weeks.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the world health organization (who) in 1999; 2. men or women aged 18 to 75 years old at the day of signing the informed consent; 3. body mass index: bmi 19kg/m2 to 35kg/m2, \[bmi=weight (kg)/height 2 (m2)\]; 4. glycated hemoglobin (hba1c): screening period: hba1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: hba1c 7.0% to 10.0% (central laboratory test) measurement); 5. screening period and random time fasting blood glucose \<=13.9mmol/l; exclusion criteria: 1. drug compliance during the introduction period \ 120%; 2. use other hypoglycemic drugs other than test drugs during the introduction period; 3. the patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, dpp4 drugs, metformin; 4. before screening, have any of the following endocrine-related medical history or evidence: * diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by cushing's syndrome or acromegaly; * diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lactic acidosis and other acute complications of diabetes within 6 months before screening; * severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia; 5. before screening, there is a history or evidence of any of the following diseases: * unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of); * decompensated heart failure before screening (new york heart association nyha heart function grades iii and iv, persistent and clinically significant arrhythmia; * a history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis;
effect of spiriva on the activities of daily living score recommended in austrian copd guidelines

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary goal of this post marketing surveillance (pms) study is to document the efficacy of tiotropium (spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (copd) guidelines for monitoring the course of the disease.


Eligibility criteria:
inclusion criteria: * patients with suspected chronic obstructive pulmonary disease (copd) * 3 or more positive answers in copd questionnaire * age over 40 years exclusion criteria: * patients with any conditions listed in special precautions, drug interactions, and contraindication of spiriva in the summary of product characteristics * patient treated with spiriva in the past year * patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of spiriva patient with known narrow-angle glaucoma patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction patient with known moderate to severe renal impairment (i.e.,creatinine clearance\<=50ml/min) pregnant or nursing women patient with any significant disease other than copd which would exclude him/her from participating in the study patients with any conditions listed in special precautions, drug interactions, and contraindication of spiriva in austrian summary of product characteristics
a study of lifileucel (tumor-infiltrating lymphocytes) in adults with advanced endometrial cancer.

Conditions: Endometrial Cancer

Summary: the purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.

the study will enroll participants with advanced endometrial cancer who previously received treatment with platinum-based chemotherapy and an anti-programmed cell death protein-1 (pd-1)/programmed death ligand 1 (pd-l1) agent in a recurrent or advanced setting, either sequentially or in combination.

Eligibility criteria:
inclusion criteria: 1. participants must have a histologically confirmed diagnosis of endometrial carcinoma. all histologies, including carcinosarcoma, will be allowed. uterine sarcoma will not be allowed. 2. participants who have received the following previous therapy: * up to 3 lines of systemic therapy with no more than 1 line of chemotherapy for recurrent, metastatic, or primary unresectable disease. prior hormonal therapy is allowed and do not count as prior lines of therapy. * participants have progressed on or after platinum-based chemotherapy and anti-pd-1/pd-l1 therapy. platinum-based chemotherapy and anti-pd-1/pd-l1 therapy may have been given together or in separate lines of therapy. * participants must have documented radiographic disease progression during or after the last line of therapy. 3. participants who have an eastern cooperative oncology group (ecog) performance status of 0 or 1 and estimated life expectancy of \>6 months. 4. participants having at least one resectable lesion and at least one measurable lesion, following resection of the lesion for til generation. 5. participants who have adequate organ function, including adequate cardiopulmonary function. 6. participants of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after the last dose of study intervention. 7. participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor. exclusion criteria: 1. participants who have symptomatic untreated brain metastases. 2. participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years. 3. participants who require systemic steroid therapy \> 10 mg/day prednisone or another steroid equivalent dose. 4. participants who have any form of primary immunodeficiency. 5. participants who have another primary malignancy within the previous 3 years. 6. participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the nmald.

Keywords: tumor infiltrating lymphocytes til endometrial cancer endometrial cell therapy cellular immunotherapy il-2 non-myeloablative lymphodepletion (nmald)
pet/mri and biomarkers in bladder cancer

Conditions: Bladder Cancer

Summary: muscle invasive bladder cancer is an aggressive malignancy. currently the investigators lack accurate imaging technologies in clinical staging and estimation of response to neoadjuvant chemotherapy as well as prognostic biomarkers. in the current study novel imaging modality (mri/pet) is utilized to stage bladder cancer prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. also prognostic biomarkers are studied from tur-bt tissues, blood and urine to estimate response to neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * invasive or locally advanced bladder cancer based on cystoscopic evaluation * age: 18 to 85 years old * language spoken: finnish or swedish * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethical committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * prior medical history: patient must have no history of serious cardiovascular, liver or kidney disease * infections: patient must not have an uncontrolled serious infection * contraindications for mri (cardiac pacemaker, intracranial clips etc) * patient refusing radical cystectomy or chemotherapy * intravesical bacillus calmette-guerin instillations within 6 months

Keywords: bladder cancer neoadjuvant chemotherapy radical cystectomy lymphadenectomy biomarker