Kornimate/medical-research-clean huggingface dataset:
expression of mir-204 and consequences on capillarization in limb muscles of patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: limb muscle dysfunction, characterized by loss of capillaries, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (copd) leading to poor functional status and premature mortality. one prevailing hypothesis stipulates that modification in the expression of mir-204 leads to change the regulation of angiogenesis in vastus lateralis of patients with copd when compared to controls.

the investigators objective is to investigate the impact of copd on key signaling pathways involved in the muscle angiogenesis. mild to severe copd patients and healthy controls will be recruited. all of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity and body composition. blood sampling and biopsy of the quadriceps will be done. key proteins and micrornas of signaling intramuscular pathways involved in angiogenesis will be measured in the quadriceps.

Eligibility criteria:
inclusion criteria: * copd (fev1/fvc \< 0.70) * healthy subjects: no evidence of airways obstruction (fev1/fvc \> 0.70 and fev1 \> 0.80 predicted) * smoking history \> 10 pack-years * ex-smoker \>6 months exclusion criteria: * chronic hypoxemia and/or hypercapnia (pao2 \ 45 mmhg) * recent exacerbation or oral corticosteroids (\< 2 months) * recent cancer (\< 3 years) * diabetes * myopathy, neuromuscular, neurological or articular diseases * kidney disease * other respiratory diseases * unstable cardiac disease * physical activity score \> 9 in the voorips questionnaire * bmi \> 30

Keywords: micrornas angiogenesis skeletal muscle copd
novel synthetic t2w mr imaging and spin parameter mapping techniques for screening prostate cancer

Conditions: Prostate Adenocarcinoma; Prostate Carcinoma

Summary: this clinical trial studies examines a 3d magnetic resonance imaging (mri) compared to standard mri imaging techniques in screening patients with prostate cancer. diagnostic procedures, such as mri, may help find and diagnose prostate cancer. computer systems that allow doctors to create a 3-dimensional (3-d) picture of the tumor may help in planning.

primary objective: i. to determine whether the image quality of the novel 3-dimensional (3d) t2-weighted imaging (t2w) synthetic imaging technique without endorectal coil is comparable to the 2-dimensional (2d) t2w imaging technique without endorectal coil. secondary objective: i. to evaluate the qualitative diagnostic quality of the t2w images provided by the novel 3d technique, as determined by subjective scoring by experienced readers. exploratory objective: i. to investigate the feasibility of novel 3d synthetic imaging and multi-spin parameter mapping technique of prostate for the detection of clinically significant prostate cancer (cspca). outline: patients undergo 3d mri imaging over 15 minutes with standard of care mri or at a separate time.

Eligibility criteria:
inclusion criteria: * male, age \>= 18 * untreated, biopsy-proven with intermediate and high-risk adenocarcinoma of the prostate * patient is being considered for curative-intent treatment with radical prostatectomy * patient has provided written informed consent for participation in this trial * patient should be eligible for scanning on a 3t magnet exclusion criteria: * low-risk adenocarcinoma of prostate * any prior therapy for prostate cancer * a history of other active malignancy within the last 2 years * prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components * cardiac pacemaker * orthopedic hardware in the pelvis and spine * claustrophobia
first correct study of minimal residual disease (mrd) detection in colorectal cancer

Conditions: Colorectal Cancer

Summary: the correct - mrd i study will prospectively enroll patients who have undergone complete surgical resection for stage ii or iii colorectal cancer. patients will be followed for up to 5 years for recurrence.


Eligibility criteria:
inclusion criteria: subject is/has: 1. 18 years of age or older. 2. diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous,or neuroendocrine features are not eligible). 3. post complete surgical resection of crc, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met: 1. in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and 2. histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells. i. patients with t4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension form the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized. 4. pathologic stage ii or iii crc. 5. ecog performance status ≤ 2 (0, 1 or 2). 6. able to understand and provide written informed consent. 7. willing and able to comply with the study requirements, which includes the collection of approximately 35ml of blood for each research blood draw. exclusion criteria: subject is/has: 1. initiated adjuvant therapy for current crc diagnosis (note: neoadjuvant therapy acceptable). 2. known pregnancy or breastfeeding at time of enrollment. 3. prior history of any invasive cancer (including crc) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment. 4. prior transplant history: 1. prior allogeneic hematopoietic stem cell transplant at any time. 2. prior solid organ transplant within the last 2 years prior to enrollment. 5. multiple cancer diagnoses: synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.

Keywords: colorectal ctdna
a study in ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancers, and squamous cell carcinoma of the head and neck

Conditions: Ovarian Cancer; Non Small Cell Lung Cancer; Prostate Cancer; Colorectal Cancer; Gastric Cancer; Esophageal Cancer; Cancer of Head and Neck

Summary: the purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered ly2523355.


Eligibility criteria:
inclusion criteria: * diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck * have measurable disease defined by response evaluation criteria in solid tumors (recist) 1.1 guidelines (except prostate cancer participants) * have an eastern cooperative oncology group (ecog) performance status of 0 to 1 * are willing to follow study procedures for the duration of the study * are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment exclusion criteria: * have a serious preexisting medical condition that would preclude participation in the study * are pregnant or lactating * have received treatment within 28 days of first dose of ly2523355 with a drug that has not received regulatory approval for any indication * have symptomatic, untreated, or uncontrolled central nervous system (cns) metastases * have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy * have qtc interval greater than 470 millisecond (msec) or intraventricular conduction delay (ivcd) with qrs greater than 120 msec on screening electrocardiogram (ecg) * have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (hiv) or viral (a, b, c) hepatitis * participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
longitudinal strain in addition to visual assessment of wall motion for ruling in ischemia in the emergency room

Conditions: Chest Pain

Summary: to assess the utility of technician-based analysis of echocardiograms with longitudinal strain for ruling-in ischemic chest pain in the emergency room, compared to emergency room (er) physician opinion and expert echocardiographer analysis of wall motion, both the latter blinded to any relevant clinical data .


Eligibility criteria:
inclusion criteria: * chest pain * no indication of acute myocardial infarction exclusion criteria: * patients admitted for acute myocardial infarction * patients with known coronary artery disease
study to assess change in disease activity and adverse events of rinvoq in adult participants with ankylosing spondylitis in the real-world japan

Conditions: Ankylosing Spondylitis

Summary: axial spondyloarthritis (axspa), which encompasses radiographic axspa (r-axspa, also known as ankylosing spondylitis \[as\]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. this study will assess how effective rinvoq is in treating axspa. rinvoq is an approved drug for treating axspa. approximately 100 adult participants who are prescribed rinvoq by their physician in accordance with local label will be enrolled in japan. participants will receive rinvoq as prescribed by their physician according to their routine clinical practice and local label. participants will be followed for up to 52 weeks. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * participant with clinical diagnosis of ankylosing spondylitis (as) and meeting the modified new york criteria for as. * participant who is administered the first dose of rinvoq for as. exclusion criteria: * participant with prior treatment by jak inhibitors. * participant currently participating in another clinical study except non-interventional study. * participant for whom upadacitinib is contraindicated. * participants who are not registered within 14 days after initiation of rinvoq treatment for as.

Keywords: ankylosing spondylitis rinvoq
patients with human papillomavirus-associated head and neck cancer for the discovery of predictive biomarkers to guide clinical intervention

Conditions: Squamous Cell Carcinoma of Oropharynx

Summary: prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx opscc for detection of hpv-dna/rna and immuno-phenotypic analysis of t cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response

the study involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx opscc for detection of hpv-dna/rna and immuno-phenotypic analysis of t cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response. radiological images will be collected during diagnosis, treatment and the care path, with exploratory and research purposes only, without the results modifying the care path and the diagnostic-therapeutic process of the patients participants. molecular analyzes and/or material extraction will not be conducted genomic/protein of any kind. the objective is to observe the kinetics of the levels of hpv-dna circulating in the blood patients with oropharynx cancers hpv related to the diagnosis and during the care pathway patient. the blood of hpv-negative patients will be tested to confirm that there are no copies of circulating hpv-dna. the aim is to collect the information necessary to improve understanding and managing hpv-associated opscc.

Eligibility criteria:
inclusion criteria: * squamous cell carcinomas of the oropharynx (opscc) candidates for surgical * age \> 18 years * ecog performance status \<_ 2 * signature of informed consent (to participate in the study and data processing) exclusion criteria: * presence of distant metastases at the time of diagnosis * previous head and neck cancer

Keywords: carcinoma of the oropharynx squamous cell carcinoma of the oropharynx head and neck
safety and tolerability extension trial for patients with chronic idiopathic constipation

Conditions: Chronic Idiopathic Constipation

Summary: safety and tolerability extension trial for patients with chronic idiopathic constipation (cic)

this was a phase 3 multicenter, open-label, safety and tolerability extension trial of 10 mg elobixibat daily, with possibility for dose adjustment to 5 mg daily, for 52-week treatment period in patients with cic. a dose adjustment to 5 mg/day was allowed for the remainder of the trial if a patient reported unacceptable treatment-related diarrhoea that occurred within the first four weeks of treatment. the trial enrolled patients from two lead-in, double-blind efficacy trials (trial codes nct01827592 and nct01833065).

Eligibility criteria:
inclusion criteria: * has completed double-blind treatment in either of the lead-in efficacy trials, 000079 or 000080. * the patient reports having understood and has signed the informed consent form (icf) and is willing to comply with all trial visits and assessments. * the patient agrees to refrain from making any new, major lifestyle changes that may affect cic symptoms (i.e., starting a new diet, changing an exercise plan) from the time of signing the icf through to the last trial visit. exclusion criteria: * the patient has been withdrawn/discontinued from the 000079 or 000080 trials. * the patient is not willing to abide by the restrictions for intake of prohibited medication. * women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who have a positive urine pregnancy test at visit 1, or who do not agree to use one of the following methods of birth control from the day of signing the icf until 30 days after the final dose of trial drug are excluded: 1. transdermal patch 2. established use of oral, injected or implanted hormonal methods of contraception 3. placement of an intrauterine device (iud) or intrauterine system (ius). 4. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. 5. male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). 6. true sexual abstinence: when this is in line with the preferred and usual lifestyle of the patient. * the patients is considered by the investigator to be unsuitable to participate in the trial for any other reason.
prospective post-market data collection on patients with knee oa and treated with nstride aps

Conditions: Osteoarthritis, Knee

Summary: this study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nstride autologous protein solution. this study will also allow for the documentation of the same parameters following multiple injections of autologous protein solution to treat knee osteoarthritis.

clinical trials have, in general, formally demonstrated the effectiveness and safety of various autologous therapies for the treatment of knee oa. differences in the processing of autologous therapies can yield substantial differences in the resulting output. it appears that the safety of autologous therapies is roughly equivalent across different processing methods. however, making generalizations regarding the effectiveness across these autologous therapies is more complicated. thus, each autologous therapy requires independent efficacy evaluation. nstride aps has been shown to decrease pain, increase function and have a favorable safety profile in a small pilot trial. however, demonstration of the treatment effects in a more heterogeneous population is lacking. further, neither the effect time course nor the utility of multiple injections has been documented. this study will allow for low burden, efficient data collection in a larger heterogeneous population of persons suffering from knee oa. the study will document the treatment effects and timeline of treatment effects for nstride aps following single or repeated injections.

Eligibility criteria:
inclusion criteria: * oa of one or both knees as diagnosed by the treating physician * at least 18 years of age * willing and able to comply with the study procedures * signed informed consent form exclusion criteria: * any systemic inflammatory condition ( e.g., rheumatoid arthritis) * active malignancy at time of injection * pregnant at time of injection * lactating at the time of injection * knee joint infections or skin diseases or infections in the area of the injection site. * leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment * participating in another device or drug study

Keywords: autologous protein solution osteoarthritis intra-articular injection
vitamin d as an adjunctive treatment in patients with non-cystic fibrosis bronchiectasis

Conditions: Bronchiectasis

Summary: this study evaluates vitamin d as an adjunctive treatment in patients with non-cystic fibrosis bronchiectasis, which are combined with vitamin d deficiency. half of participants will receive vitamin d supplementation, while the other half will receive placebo.

to define the therapeutic effect of vitamin d in the treatment of non-cystic fibrosis bronchiectasis by means of a prospective randomized placebo-controlled double blind study with a follow-up of at least one year. to explore whether correction of vitamin d deficiency by the oral supplementation of vitamin d triggers the vitamin d receptors-mediated cathelicidin pathway and increases local or systemic concentrations of the natural antimicrobial polypeptide cathelicidin with enhanced eradication of bacteria.

Eligibility criteria:
inclusion criteria: * diagnosis of non-cystic fibrosis bronchiectasis by high resolution ct * age 18 years or older * vitamin d deficiency \[25(oh)d\<20 ng/ml\] * informed consent exclusion criteria: * current active allergic bronchopulmonary or tuberculosis * diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, human immunodeficiency virus infection, liver failure, renal failure or malignancy * taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone * taking dietary supplement or topical preparation containing vitamin d up to 2 months before first dose * treatment with any investigational medical product or device up to 4 months before first dose * breastfeeding, pregnant or planning a pregnancy * baseline corrected serum calcium \> 2.65 mmol/l * baseline serum creatinine \> 125 micromol/l

Keywords: vitamin d
hinting task for huntington's disease

Conditions: Huntington Disease

Summary: huntington's disease (hd) is an autosomal dominant neurodegenerative disorder, characterized by movement disorders, behavioural disorders and cognitive decline. especially the behavioural and cognitive symptoms of the disease lead to significant disability and burden for patients as well as caregivers. one of the cognitive domains affected by hd is social cognition. social cognition is the ability to perceive, interpret and respond correctly to social information. aspects of social cognition are emotion recognition, perspective taking (theory of mind), and emapathy. social cognition problems can be related to behavioural problems, but to be able to study this relationship, it is important to be able to reliable measure social cognition impairments. there are a few social cognition tests available, but often they are not normd and validated for use in a dutch neurological population. there is a lack of sensitive, simple, tests for measuring theory of mind in patients with hd. a promising test, that already has been proven valid in a psychiatric population, is the hinting task. the hinting task measures theory of mind through indirect speech, the hinting task is a social cognition test, where hints are implicitly given in speech, which resembles what patients and caregivers frequently report as difficult in hd. the hinting task has already been translated into dutch and is already being used in clinical parctice, but its sensitivity has not been studied yet in a neurological population. the aim of this study is to assess if the hinting task is sensitive in patients with hd and to relate the hinting task to other (social) cognitive measures, demographical characteristics and disease characteristics.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of huntington's disease via cag-repeat length analysis * between 18 and 74 years of age * dutch speaking exclusion criteria: * presence of serious psychiatric disorders or other neurological comorbidities

Keywords: social cognition theory of mind hinting task huntington cag repeat