Kornimate/medical-research-clean huggingface dataset:
ctdna to predict response to chemo-immunotherapy and detect minimal residual disease in non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine if a blood test called circulating tumor dna (ctdna) can be used to predict how well patients will respond to treatment and if there is any cancer left after surgery. the investigators will also study if a drug called pembrolizumab can help prevent the cancer from coming back in patients who are ctdna-positive or who have evidence of cancer after treatment and surgery.


Eligibility criteria:
inclusion criteria: 1. eligible participants must be males or females ≥18 years of age on day of signing the informed consent form. 2. eastern cooperative oncology group (ecog) performance status (ps) 0-1 3. participants with histologically confirmed stage ib (≥4 cm), ii, or iiib (n2) nsclc (as per the 8th american joint committee on cancer (ajcc)) who are considered resectable by a multidisciplinary team and who are going to be treated with neoadjuvant treatment including chemotherapy, immunotherapy, and in some cases radiation before surgery 4. measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1) 5. participants must have tumor tissue available for programmed cell death ligand 1 (pd-l1) immunohistochemical (ihc) testing performed by a third-party analyzing lab during the screening period: 1. either a formalin-fixed, paraffin-embedded (ffpe) tissue block or unstained tumor tissue sections, with an associated pathology report, must be submitted for biomarker evaluation prior to randomization. the tumor tissue sample may be fresh or archival if obtained within 6 months prior to enrollment 2. tissue must be a core needle biopsy, excisional or incisional biopsy. fine needle biopsies obtained by endobronchial ultrasound (ebus) are not considered adequate for biomarker review and randomization. core needle biopsies obtained by ebus are acceptable for randomization. exclusion criteria: 1. presence of locally advanced, unresectable, or metastatic disease. mediastinal lymph node samples at levels 4 (bilaterally) and 7 are required for clinical staging to assess nodal involvement in participants with mediastinal adenopathy on positron emission tomography-computed tomography scan (pet/ct). 2. participants with known epidermal growth factor receptor (egfr) mutations or anaplastic lymphoma kinase (alk) translocation 3. previous exposure to anti-cancer therapy, including chemotherapy, radiotherapy or immunotherapy, and previous exposure to immunosuppressive drugs within 3 weeks before neoadjuvant treatment 4. participants with impaired decision-making capacity .
photocil (topical) for the treatment of atopic dermatitis

Conditions: Atopic Dermatitis

Summary: photocil is a topical drug (cream) that selectively delivers narrow band - ultraviolet b (nb-uvb) therapy when exposed to sunlight. photocil is intended to help protect users from non-therapeutic ultraviolet b (uvb) radiation while selectively passing wavelengths of light in the nb-uvb range with peak transmission of 308nm. the aim of the study is to assess the safety and efficacy of photocil in the treatment of atopic dermatitis.

nb-uvb phototherapy is a common treatment for patients with atopic dermatitis, and has been reported to be safe and effective in numerous clinical trials. clinical trials have reported achievement of atopic dermatitis area severity index (adasi)-75 in 50-70% of patients after 4-6 weeks of nb-uvb treatment. many drawbacks limit patients compliance, access, and acceptance of traditional nb-uvb phototherapy. the strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback. in order to address the drawbacks of phototherapy, we developed a novel topical cream - photocil - that selectively delivers nb-uvb therapy when exposed to sunlight. when used with natural sunlight, photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.

Eligibility criteria:
inclusion criteria: * diagnosed with atopic dermatitis confirmed by a dermatologist * atopic dermatitis lesions affecting at a minimum 5% of the facial, legs, or arms surface area * age: 18 to 65 * participants able to give informed consent exclusion criteria: * subject did not respond to prior phototherapy treatment * subject completed phototherapy for same lesion(s) in last 6 months * subject has previous history of skin cancer * subject has previous history of photosensitivity * subject has a history of herpes (hsv i or ii) outbreaks * subject has previous history of autoimmune disease may be excluded at investigator's discretion * subject is currently taking of immunosuppressive or photosensitizing drugs * subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. these patients may be excluded at investigator's discretion * subject is pregnant or lactating women
clinical and economic impact of upfront plerixafor in autologous transplantation

Conditions: Non-Hodgkin's Lymphoma; Multiple Myeloma

Summary: this protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. there is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.

Eligibility criteria:
inclusion criteria: * patients with multiple myeloma or non-hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization. * karnofsky performance status ≥ 70. * age ≥ 18 * less than 30% involvement of marrow with disease. exclusion criteria: * \> 30% marrow involvement with disease * age \< 18. * pregnant women.

Keywords: autologous transplantation peripheral stem cell mobilization
two-dose methotrexate for ectopic pregnancy

Conditions: Ectopic Pregnancy

Summary: this study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.

the regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". the "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ectopic pregnancy via * d\&e without products of conception identified on frozen pathology or * vabra without products of conception identified with pathologic evaluation or * ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole * the subject is hemodynamically stable without signs of hemoperitoneum * laparoscopy has not been performed * the subject is able to return for frequent follow-up care * normal renal and liver function have been documented within 2 days * normal white blood count and platelet count have been documented as per laboratory standard * normal chest x-ray was obtained if the subject has a history of pulmonary disease * no history of allergy or sensitivity to methotrexate or any component of its formulation exclusion criteria: * breastfeeding * laboratory evidence of immunodeficiency * alcoholism or chronic liver disease * the concomitant use of non-steroidal anti-inflammatory drugs * blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia * active pulmonary disease * hepatic, renal, or hematological dysfunction * adnexal mass \> or = 3.5 cm * presence of fetal cardiac motion * active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction * subjects unable or unwilling to comply with study procedures or illiterate

Keywords: ectopic pregnancy methotrexate
the effects of kinesio® tape on neck pain and disability

Conditions: Neck Pain

Summary: this study is a within-subjects design; therefore, the participant will serve as their own control. participants will be included in the study if they have neck pain or disability defined by a score of more than 14 on the neck disability index. they will be excluded if they have any diagnosed disc pathology. a mask-associated pain questionnaire will be completed by the participants prior to the study to determine their perceived effect of mask-wearing on neck pain. this questionnaire is adapted from the happe study on mask-associated headache pain. a baseline pain rating will be recorded a numerical pain scale. next, active cervical range of motion will be measured, three times in each direction to be averaged. a pain rating will be recorded for pain during cervical motion. kinesio® tape will be applied to activate the cervical extensor muscles. the participant will sit with the tape on for 20 minutes, then active cervical range of motion and pain will be recored again.


Eligibility criteria:
inclusion criteria: * neck disability index score of more than 14 exclusion criteria: * cervical disc pathology or injury * previous neck surgery * prior history of general medical conditions involving joints, muscles, bones or connective tissue such as fibromyalgia, osteoporosis, etc. * an ndi score of less than 14 or more than 24 * reported allergies to kinesio® tex tape or any other adhesive material * any contraindications for the usage of kinesio® tape
safety and efficacy of apixaban in very old geriatric subjects (> 80 years) with atrial fibrillation in a prospective real world study;

Conditions: Nonvalvular Atrial Fibrillation

Summary: the main objective of this study is to realize an observational "real life" study conducted in french geriatric settings, to assess safety and efficacy in ≥ 80 year-old patients with nonvalvular atrial fibrillation (af) newly treated with apixaban. moreover, in this geriatric population the adequacy of apixaban dosage and events (bleeding and stroke) will be assessed.

it is a muliticentric, observational, prospective study. this study will be conducted in about 40 geriatric settings in france. the planned duration of the inclusion period is 27 months in each center. the follow-up period starts from inclusion up to one year after inclusion with phone contact or unscheduled visit at 3, 6, 9 and 12 months. during this follow-up, participants physicians will record patients' data during visit directly from the patients or their physicians or their families and by phone. the following data will be colllected: * at m0 : socio-demographics, clinical and biological data; embolic risk and emorrhagic risk scores,cognitive function, number of falls, blood pressure, nutritional assessment, athonomy, comorbidities, data on anticoagulant therapy, treatment discontinuation and clinical evaluation. * at m3, m6, m9 and m12: • number of falls, all treatment schedule, record of major bleeding events, record of any other bleeding events, record of other serious events, record of other non-major events, treatment discontinuation, and social and medical environment. * only m6 and m12: renal function (both cockcroft-gault, chronic kidney disease, epidemiology collaboration "ckd epi" and the four variable modification of diet in renal disease equation "mdrd")

Eligibility criteria:
inclusion criteria: * male or female patients aged 80 years and older. * patients with non-valvular atrial fibrillation (documented on electrocardiography or other medical evidence like medical chart, hospital discharge note, physician's letter within 3 years before enrollment). * followed in geriatric settings (office consultation, acute care, rehabilitation settings and nursing homes). * newly treated (less than 6 months) with apixaban (5mg twice daily (or 2.5 mg twice daily for patients with 2 of the following criteria : age \> 80 years, creatinine \> 133 μmol/l, weight \< 60 kg) exclusion criteria: * patient refusing to participate. * participation to a clinical trial. * contraindication to use of apixaban as described in the summary of product characteristics .

Keywords: nonvalvular atrial fibrillation apixaban. bleeding
[68ga]ga-p17-079 in the diagnosis and treatment of metastatic prostate cancer

Conditions: Metastatic Prostate Cancer (mPC)

Summary: preclinical studies have confirmed that \[68ga\]ga-p17-079 in both mouse prostate tumors and osseogenic metastases has high uptake and prolonged retention, which enables \[68ga\]ga-p17-079 to be fully absorbed by the lesions, and it is possible to detect bone metastases, prostate cancer primary sites, lymph node metastases and organ metastases at the same time in a single examination. it is a potential "killing two birds with one stone" imaging agent. at this stage, the clinical study of \[68ga\]ga-p17-079 in the diagnosis and treatment of metastatic prostate cancer as a self-made preparation is planned to be carried out in our hospital to further verify its clinical application value.


Eligibility criteria:
inclusion criteria: * male aged 18-85 years, expected survival ≥12 weeks. * patients who have not undergone chemoradiotherapy, feasible surgery or biopsy to obtain a pathological diagnosis or are highly suspected of malignancy according to clinical diagnostic criteria. * at least one measurable target lesion was present according to recist1.1 criteria. * obtain written informed consent and be able to follow up exclusion criteria: * severe abnormal liver and kidney function * fertile subjects will need to use effective contraception during the study * unable to lie flat for half an hour * refused to join this clinical investigator * suffering from claustrophobia or other mental illness * other conditions deemed unsuitable for participation in the trial
study to assess the safety and efficacy of fx006 administered to patients with greater trochanteric bursitis

Conditions: Trochanteric Bursitis

Summary: the purpose of this study is to determine the safety and efficacy of fx006 in bursal injections and to assess the patient's impression to change in their chronic pain, following treatment.


Eligibility criteria:
inclusion criteria: * written consent to participate in the study * symptoms consistent with greater trochanteric bursitis for greater than or equal to 3 months prior to screening (patient reported is acceptable) * pain in hip for greater than 15 days over the last month (as reported by the patient). * hip bursitis as determined by clinical examination and clinical features. where magnetic resonance imaging (mri) data is available, it will be used to confirm the bursitis diagnosis. also, pain relief in subjects that have been treated with bursal injections containing an anesthetic (such as ropivacaine) is in itself indicative of bursitis. * body mass index (bmi) less than or equal to 40 kg/m2 * ambulatory and in good general health * willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions. * willing to abstain from use of protocol-restricted medications during the study exclusion criteria: * hip arthroplasty * hip osteoarthritis, iliopsoas bursitis, reactive arthritis,rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease * history of local infection around the bursa. * lack of pain relief with the intrabursal treatments containing an anesthetic * intra-bursal treatment of any bursa with any of the following agents within three (3) months of screening: any corticosteroid preparation (investigational or marketed, including fx006); and/or six (6) months for any biologic agent (e.g., platelet rich plasma (prp) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed). * parenteral or oral corticosteroids (investigational or marketed) within 3 months of screening * inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of screening. * females who are pregnant or nursing or plan to become pregnant during the study; women who plan to conceive

Keywords: hip bursitis hip pain
early post-operative enteral feeding in patients with advanced epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Summary: ovarian cancer patients are often at risk of malnutrition because of weight loss, lack of appetite and reduced food intake. being malnourished can contribute to the incidence and severity of cancer treatment side effects and increase the risk of infection. currently patients with advanced ovarian cancer do not receive early nutrition using a feeding tube. the purpose of this study is to compare enteral nutrition along with standard post-surgery care against current standard post-operative care alone. this study will see if early nutrition using a feeding tube has an impact on length of hospital admission, recovery from surgery, complications from surgery, nutritional status and ultimately a reduction in treatment costs in people with advanced epithelial ovarian cancer (eoc). primary peritoneal cancer (ppc) or fallopian tube cancer. nutritional support has been shown to ; * prevent and treat under-nutrition, * enhance anti-tumour treatment effects, * reduce adverse effects of anti-tumour therapies, * improve quality of life.


Eligibility criteria:
inclusion criteria: * patients requiring planned primary surgery for suspected or histologically proven advanced ovarian, primary peritoneal cancer or fallopian tube cancer. * signs of moderate or severe malnutrition - patient generated subjective global assessment (pg-sga) category b or c and/or a total numerical score of 4 or more in the pg-sga * medically fit for primary surgery * signed written informed consent * females aged 18 years or older exclusion criteria: * other histological type than ovarian cancer, peritoneal cancer or fallopian tube cancer * recurrent ovarian cancer, peritoneal or fallopian tube cancer * pre-existing contraindications to enteral nutrition such as ileus, gastrointestinal ischemia, bilious or persistent vomiting, or mechanical obstruction * positive urine pregnancy test * unfit for surgery; serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * participation in other clinical trials that may have an impact on the outcomes of this trial.

Keywords: enteral nutrition ovarian cancer peritoneal cancer fallopian tube cancer malnutrition surgery gynecological cancer suspected advanced epithelial ovarian cancer
functional and anatomical visual investigations in patients with early forms of age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: age-related macular degeneration (amd) is the leading cause of visual impairment in industrialized countries. anatomical examination findings at the early and intermediate stages of amd are not sufficient to determine any functional alterations at these stages (e.g., alterations in microperimetry, multifocal electroretinogram (mferg) and contrast sensitivity). identifying early functional markers of the disease is a necessary first step in the development and clinical validation of treatments to slow progression to advanced disease.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * corrected visual acuity 10/10 in each eye * presence of retinal alteration(s) compatible with early (presence of macular drusen \ 125 μm or pigmentary abnormalities) amd in at least one of the two eyes : * conventional "soft" or "hard" drusen * cuticular drusen * reticulated pseudo-drusen exclusion criteria: * presence of geographic atrophy, even incipient, in one or both eyes * presence of patent or latent neovascularization visible on oct b-scan or oct-a in one or both eyes * compatibility of retinal signs with a "probable" differential diagnosis (bestrophinopathies, familial drusen, fundus flavimaculatus, fundus albipunctatus, hypovitaminosis a) in one or both eyes. * oculomotor pathology that may prevent proper performance of functional tests: nystagmus, oculomotor paralysis, in one or both eyes * neurological/neurodegenerative pathology that may prevent adequate performance of functional tests: advanced parkinsonian syndromes, benson's disease, alzheimer's disease with visuomotor apraxia * other ophthalmological pathology that may affect anatomical and functional measurements: hypertonia / glaucoma or other optic neuropathy, media disorder causing reduced visual acuity, refraction \ +6.00d * other medical conditions preventing examinations or imaging (tremors, etc.)
efficacy and safety of spc1001 in patients with essential hypertension

Conditions: Hypertension, Essential; Cardiovascular Diseases; Cardiology

Summary: - objective: this study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (spc1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. additionally, it seeks to confirm the contribution of each component at low doses. - inclusion criteria: men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria. - exclusion criteria: patients whose blood pressure measured at the screening and randomization visits meets the criteria of mssbp ≥180 mmhg or msdbp ≥110 mmhg, among other conditions. - methods: this study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration. screening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. these participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.


Eligibility criteria:
inclusion criteria: * men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria. exclusion criteria: * patients whose blood pressure measured at the screening and randomization visits meets the criteria of mssbp ≥180 mmhg or msdbp ≥110 mmhg, among other conditions.

Keywords: blood pressure low-dose combination therapy candesartan amlodipine indapamide