Kornimate/medical-research-clean huggingface dataset:
ifx-hu2.0 as an adjunctive therapy to pembrolizumab in advanced or metastatic merkel cell carcinoma (mcc)

Conditions: Advanced Or Metastatic Merkel Cell Carcinoma

Summary: this phase 1, multicenter, open-label trial will assess the safety and feasibility of ifx-hu2.0 as adjunctive therapy to pembrolizumab in adult patients (≥18 years) with non-cutaneous merkel cell carcinoma. nine subjects will receive ifx-hu2.0 as a visceral lesion injection in a single lesion followed by pembrolizumab.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. 2. life expectancy equal to or greater than six months. 3. eastern cooperative oncology group (ecog) performance status ≤ 2. 4. active disease measurable by ct or mri, measurable lesions are lesions that can be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded). 5. must be recurrent and/or unresectable stage iii or stage iv american joint committee on cancer (ajcc) (8th edition) and have histologically confirmed merkel cell carcinoma a. must have at least one visceral injectable lesion equal to or greater than 3 mm 6. subject should be cpi naïve i.e., no prior therapy with cpi including but not limited to pembrolizumab, avelumab, ipilimumab, nivolumab. 7. tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. if archival tissue is not available, then a new biopsy should be performed. 8. adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol. exclusion criteria 1. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements. 2. subjects with active brain metastases, with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids. 3. subjects with recurrent resectable mcc 4. subjects who have received prior systemic chemotherapy 5. pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study. 6. active, known, or suspected autoimmune disease. potential subjects with type i diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. low grade autoimmune toxicity is not an exclusion under this criterion. 7. a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of ifx-hu2.0 administration. inhaled or topical steroids are permitted in the absence of active autoimmune disease.

Keywords: metastatic advanced merkel cell carcinoma
magnetically controlled capsule endoscopy first vs. standard algorithm in patients with melena

Conditions: Melena

Summary: mce first algorithm is not inferior to standard of care algorithm in terms of further bleeding in hemodynamically stable patients with acute overt and non-hematochezia gi bleeding.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * presenting to the outpatient department or emergency department with melena (without hematemesis) within the previous 48 hours * hemodynamically stable (blood pressure \> 100/60 mmhg and heart rate \< 100 bpm) at presentation * no endoscopy performed after the new onset of melena exclusion criteria: * presenting with hematochezia and/or hematemesis within the previous 48 hours of presentation * hemodynamically stable after initial volume resuscitation * drop of hemoglobin level ≥ 2 g/dl/day, and/or need of transfusion ≥ 2 units of packed red blood cells per day * contraindications of ce (e.g. dysphagia, zenker's diverticulum, esophageal stricture, known or suspected gastric or small bowel obstruction or perforation, gastroparesis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation, etc.) * presence of internal cardiac defibrillator (icd), pacemaker and/or other implanted electronic devices (cochlea, drug infusion pump, nerve stimulator, etc.) or magnetic metal foreign bodies; possibility of requiring an mri examination prior to capsule excretion * patients who cannot undergo surgery in the event of capsule retention * pregnant and/or lactating women * patients with altered mental status (such as hepatic encephalopathy) * patients moribund from terminal malignant diseases or other end-stage illnesses with a limited life expectancy * unable to consent

Keywords: magnetically controlled capsule endoscopy detection algorithm
modification of coronary calcium with laser based intravascular lithotripsy for coronary artery disease (fracture)

Conditions: Coronary Artery Disease; Coronary Artery Calcification

Summary: the fracture trial is a prospective, non-randomized, single-arm, multicenter, interventional study in us and international centers.

the fracture trial is a prospective, non-randomized, single-arm, multicenter, interventional study in us and international centers with the bolt intravascular lithotripsy system that was designed to percutaneous transluminal angioplasty by utilizing delivery of ivl to disrupt calcium prior to full balloon dilatation at low pressures.

Eligibility criteria:
key inclusion criteria: * subject is ≥18 years of age; * subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for percutaneous coronary intervention (pci); * for patients with unstable ischemic heart disease, a local site-based biomarker (preferably troponin or hs-troponin) must be less than or equal to the upper limit of lab normal (uln) within 12 hours prior to the study procedure; * for patients with stable ischemic heart disease, ck-mb will be drawn at the time of the study procedure from the side port of the sheath; results need not be analyzed prior to enrollment, but must be less than or equal to the upper limit of lab normal (uln); * single de novo target lesion stenosis of protected lmca, or lad, rca, or lcx (or of their branches) with: * stenosis of ≥70% and \<l00%; or * stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or ifr \<0.90, or ivus or oct minimum lumen area ≤4.0 mm2; * evidence of calcification at the target lesion site by * angiography, with fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, or * intravascular ultrasound (ivus) or optical coherence tomography (oct), with presence of ≥270 degrees of calcium on at least 1 cross section; * ability to pass a 0.014" guidewire across the lesion. key exclusion criteria: * subject experienced an acute mi (stemi or non-stemi) within 30 days prior to index procedure; * new york heart association (nyha) class iii or iv heart failure at time of index procedure; * prospective need for hemodynamic support, i.e., iabp or impella; * chronic kidney disease with serum creatinine \>2.5 mg/dl, egfr \<30 ml/min/1.73m2, or on chronic dialysis; * unprotected left main diameter stenosis \>50%; * target vessel is excessively tortuous defined as the presence of two or more bends \>90º or three or more bends \>75º; * target lesion is an ostial location (lad, lcx, or rca, within 5 mm of ostium) or an unprotected left main lesion; * chronic total occlusion; * target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft;

Keywords: cad
study evaluating the safety and efficacy of jwcar029 in adult subjects with relapsed and refractory b-cell non-hodgkin lymphoma

Conditions: Non Hodgkin Lymphoma

Summary: this is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous cd19-targeted chimeric antigen receptor (cd19 car) t cells in adult subjects with relapsed and refractory b-cell non-hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * subjects must meet all of the following criteria to be enrolled in this study: 1. age ≥ 18 years at the time of consent 2. signed written informed consent obtained prior to any study procedures 3. relapsed or refractory b-cell nhl. 4. pet-positive disease by lugano classification 5. archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. if a subject has never had a complete response, a sample from the most recent biopsy is acceptable. 6. eastern cooperative oncology group (ecog) performance status of 0 or 1. 7. adequate bone marrow, renal, hepatic, pulmonary and cardiac function 8. adequate vascular access for leukapheresis procedure 9. subjects who have received previous cd19-targeted therapy must have cd19-positive lymphoma confirmed on a biopsy since completing the prior cd19-targeted therapy 10. subjects must agree to use appropriate contraception. exclusion criteria: * subjects who meet any of the following criteria will be excluded from participation in this study: 1. subjects with central nervous system (cns)-only involvement by malignancy (note: subjects with secondary cns involvement are allowed on study) 2. history of another primary malignancy that has not been in remission for at least 2 years. 3. treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis 4. active hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) infection at the time of screening 5. subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or jwcar029 administration 6. presence of acute or chronic graft-versus-host disease (gvhd) 7. history of cardiovascular disease 8. history or presence of clinically relevant cns pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 9. pregnant or nursing women. 10. prior car t-cell or other genetically-modified t-cell therapy, with the exception of prior jwcar029 treatment in this protocol for subjects receiving retreatment

Keywords: non hodgkin lymphoma cd19-targeted chimeric antigen receptor jwcar029
a comparison of symbicort® pmdi 2 x 160/4.5 μg bid and 2 x 80/4.5 μg bid with formoterol turbuhaler® 2 x 4.5 μg bid and placebo in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to compare symbicort in a pressurized metered-dose inhaler (pmdi) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of copd with symptoms for more than 2 years. * smoking history of 10 or more pack years * a history of at least one copd exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit. exclusion criteria: * a history of asthma * patients taking oral steroids * any significant disease or disorder that may jeopardize the safety of the patient
t2d pilot study for patients with uncontrolled type 2 diabetes

Conditions: Diabetes Mellitus; Health Behavior; Diabetes Mellitus, Type 2; Group Meetings

Summary: the primary objective of the study is to evaluate implementation and determine the effectiveness of a telehealth personal health planning program for individuals with uncontrolled type 2 diabetes mellitus. for this study, participants will be randomized into either the telehealth program or the standard of care group. the personal health planning (php) type 2 diabetes program is a virtual, 8 session/16- week behavioral health program. the program includes development of a personal health plan supported by a patient-provider health risk assessment; group session structure supplemented by educational, on-demand video sessions; lessons, discussions, and activities based on understanding behavioral modification, health engagement, and diabetes distress; goal progress tracking; social support; mindful awareness practices; 3 and 6-month post program sessions and qualitative health evaluations via surveys and a one-on-one consultation with a personal health coach. those in the control group will receive usual care by the participants personal care team. all participants will come to the duke research at pickett road facility for a pre and post-program fasting a1c and lipid panel blood draw (if required).


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosis * 18 and over * 2 a1c results in last 18 months * a1c of 8-12 * access to a electronic device with internet * duke patient exclusion criteria: * type 1 diabetes * pregnant * blind * deaf * cognitive impairment
evaluating different low-level laser therapies to treat neck pain in air force pilots and flight crew

Conditions: Neck Pain

Summary: determine the most effective and efficient treatment protocols for treating neck pain with lllt.

the purpose of this study is to identify what are the most effective low level laser therapy (lllt) dosimetry parameters when treating pilots and navigators complaining of flight related neck pain.

Eligibility criteria:
\*\*patients must be able to get care at nellis air force base (a military installation) in order to participate in this study\*\* inclusion criteria: * active duty us air force pilots or onboard navigators, aged 18- 62 years of age * maintain operational flight status at enrollment or within the last 6 months * history of neck pain for a period of more than two months * score on the neck disability index ranging from 15-24 * no physiotherapy or local injection in 3 months before starting the study exclusion criteria: * pregnant * major surgery or trauma in the previous 3 months * unstable cervical spine * cervical radiculopathy * rheumatoid arthritis * open wound over neck * pace-maker or defibrillator implantation * overt neuropathic pain or radiation pain * inability to express pain or quality of life. * history of neurological disorders * medical diagnosis of fibromyalgia; systemic disease
short-term effects of intravitreal bevacizumab and triamcinolone in patients with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: diabetic macular edema is a common complication of ocular diabetes mellitus and can cause blindness. hypoxygenation of the retina stimulates tissue mediators, especially different subtypes of vascular endothelial growth factor (vegf). vegf is responsible for proliferation, extension and increased permeability of the vessels. the aim of our study was to examine the short-term effect of intravitreal bevacizumab (avastin® 1.25 mg in 0.05 ml) and triamcinolone on visual acuity and central retinal thickness in patients with clinically significant diabetic macular edema (csme).


Eligibility criteria:
inclusion criteria: * clinical significant macular edema exclusion criteria: * retinal thickness \< 250 µm

Keywords: diabetic macular edema oct
sintilimab ± ibi305 plus chemotherapy (pemetrexed + cisplatin) for egfrm + locally advanced or metastasis non-squamous nsclc patients after egfr-tki treatment failure

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: the anti-tumor activity of anti-pd-1 therapy and vegf inhibitor in tki-resistant egfr-mutated non-squamous nsclc chinese patients will be investigated in this clinical trial.


Eligibility criteria:
main inclusion criteria: 1. signed written informed consent before any trial-related processes; 2. age ≥ 18 years and \<75 years male or females; 3. has a histologically or cytologically confirmed stage iiib/iiic (american joint committee on cancer \[ajcc\] 8th edition) nsclc that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous nsclc; 4. patients with egfr mutation confirmed by tumor histology or cytology or hematology prior to egfr-tki treatment 5. egfr-tki resistance, confirmed by recist 1.1 6. the investigator confirms at least one measurable lesion according to recist 1.1. a measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed; the eastern cancer cooperative group (ecog) performance score of 0 or 1; exclusion criteria: 1. squamous cell \> 10%. if small cell types are present, the subject is not eligible for inclusion.; 2. has previously received systemic anti-tumor treatment other than egfr-tki for or advanced non-squamous nsclc (including cytotoxic chemotherapy for radiotherapy, do not include other systemic treatment for other cured tumors); 3. has previously received the following therapies: anti-pd-1, anti-pd-l1 or anti-pd-l2 drugs or any other stimulatory or inhibitory agents of t cell receptors (eg ctla-4, ox-40, cd137); 4. has received egfr-tki treatment within 2 weeks; 5. diagnosed of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs. 6. history of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs; 7. symptomatic central nervous system metastases (cns) metastasis and/or cancerous meningitis. hemoptysis within 3 months, 8. full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;
myorelaxant effect of cannabis cream topical skin application in patients with tmd

Conditions: Temporomandibular Disorder; Myofascial Pain; Cannabis; Electromyography

Summary: evaluation of myorelaxant effect of cannabis cream.compared to placebo cream in topical skin application in patients with tmd

cannabis sativa has a very wide application in various fields of medicine. in patients with temporomandibular disorder, especially with myofascial pain of masticatory muscles there is a special need to seek an effective pain therapy and muscle relaxing methods. patients with tmd suffer from chronic pain and depression, cannabis topical skin application therapy seems promising in that field. patients attending the department of tmd in zabrze, polska were randomly divided into two groups: experimental and placebo. semg activity values were compared during 14 days therapy with cream. positive results were obtained confirming the efficacy of the cannabis cream used in the study, compared to placebo.

Eligibility criteria:
the inclusion criteria were as follows: 1. patient agreement to participate into the research study 2. age ≥22 and ≤ 27 3. good general health, 4. temporomandibular disorder-positive rdc/tmd examination for group ia and ib 5. presence of all teeth (with the exception of the third molars) the exclusion criteria were: 1. cannabis cream/ placebo cream allergy 2. hypersensitivity to substances to be used in the study 3. skin wounds with skin surface discontinuation 4. addiction to cannabis 5. patients being treated with analgesic drugs and/or drugs that affect muscle function 6. fixed or removable dental prosthesis 7. disease or autoimmune disorder associated with generalized muscular tension

Keywords: temporomandibular disorder cannabis electromyography masticatory muscles topical application
evaluation of the protective role of the l-dopa against age related macular degeneration in parkinson's patients

Conditions: Macular Degeneration, Senile

Summary: age related macular degeneration (armd) is a major and irreversible cause of blindness among the elderly. the sub-retinal space, located between the retinal pigmentary epithelium (rpe) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. a recent epidemiologic study in the us, unpublished yet, has shown that patients treated with the l-dopa, developed only later an armd when compared to the untreated patients. the l-dopa is an endogenous ligand of the gpr43 receptor, located on the rpe's cell's apical pole. this receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the l-dopa, by stimulating this receptor, decreases significantly the rpe's exosome release. the contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors. the aim of this study is to validate the hypothesis stating that he l-dopa would play a protective role against age related macular degeneration.


Eligibility criteria:
inclusion criteria: * patients aged of 70 years old and more * parkinson's disease exclusion criteria: * opposition to participate in this trial * patient under a measure of legal protection * absence of affiliation to social security or universal health coverage (cmu)

Keywords: senile macular degeneration parkinson's disease
real world observational study of naloxegol for patients with cancer pain diagnosed with oic.

Conditions: Opioid Induced Constipation

Summary: this is a single-arm, open label, multinational, multicentre, prospective, real world observational study of naloxegol in adult subjects with opioid induced constipation (oic) in patients receiving naloxegol in routine clinical practice. subjects who are receiving naloxegol (prescribed by their physician according to the smpc, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

the objective of this study is to assess the safety and efficacy of naloxegol in a real world setting in cancer patients. the primary safety end point is the incidence of adverse events leading to study discontinuation. the primary efficacy end point is the response rate assessed in the 4 week observation period. response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline.

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study * patient with opioid-induced constipation * patient in whom the clinician plans treatment with naloxegol according to routine clinical practice (naloxegol smpc recommends that all currently used maintenance laxative therapy should be halted) * signing of the informed consent exclusion criteria: - patients with colorectal cancer

Keywords: opioid induced constipation naloxegol peripherally acting mu-opioids receptor antagonist (pamora)