Kornimate/medical-research-clean huggingface dataset:
study of the fetal and maternal microbiota in preganant women with fetal defect growth

Conditions: Intrauterine Growth Restriction

Summary: it is an observational and prospective study that will include consecutively 63 controls (fetuses with estimated fetal weight above the 10th centile) and 63 fetuses with defects in fetal growth (estimated fetal weight below the 10th percentile) during the third trimester (32-26 weeks) with gestational age at birth equal or over 37 weeks. investigators will collect: (1) obstetric and nutritional questionnaires, (2) maternal samples between 32-36 weeks (feces), (3) intrapartum samples (maternal blood, cord blood and placenta) and (4) postpartum samples (meconic and newborn feces at 6 weeks of life)

it is an observational and prospective study to determine the influence of the gastrointestinal microbiome on the intrauterine growth restriction (iugr). for this purpose, investigators are planning to recruit 63 women with a diagnoses of iugr and 63 pregnant women with a normal intrauterine growth. samples will be taken during third trimester (fecal and blood maternal sample), intrapartum (maternal blood, umbilical cord blood and placenta tissue sample) and post partum samples (meconic and newborn fecal samples at 6 weeks of life). also, obstetric and nutritional information will be registered by means of specific questionnaires. fecal samples will be use to study the gastrointestinal microbiome by next generation sequencing techniques, whereas inflammatory biomarkers will be determine in plasma samples.

Eligibility criteria:
inclusion criteria: * intrauterine growth restriction (32-36 weeks) * vaginal delivery * delivery at 37 weeks exclusion criteria: * alcohol, tabacco or other drugs consumption during pregnancy * antibiotic use before recruitment (3 months) or during pregnancy until delivery * gestational diabetes * fetuses anormalities

Keywords: intrauterine growth restriction gastrointestinal microbiome inflammatory biomarkers
development of human laboratory study model of cocaine relapse prevention. - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to assess the development of human laboratory study model of cocaine relapse prevention.

the primary objective of this study will be to develop experimental procedures and parameters demonstrating arousal and craving responses to cocaine-related environmental cues as a model for future testing of the relapse prevention medication treatment of cocaine addiction.

Eligibility criteria:
inclusion criteria: * cocaine dependent, non treatment seeking individuals exclusion criteria: please contact site directly for details.
patient-centered anticoagulation self-monitoring in minority patients

Conditions: Thromboembolism; Blood Coagulation Disorders; Cardiovascular Disease; Vascular Disease

Summary: the purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population.

despite favorable results and enhanced patient convenience, the adoption of patient self-monitoring for anticoagulation therapy has been limited primarily to non-minority and higher socioeconomic status individuals. while effectiveness has been studied, the factors influencing the adoption of self-monitoring of anticoagulation in minorities with the most barriers to accessing quality care in specialized clinics, are not known. hypothesis: patient centered education and training intervention for minority patients will result in effective adoption of self-monitoring of anticoagulation therapy, resulting in anticoagulation control of comparable quality to that seen in specialized anticoagulation clinic-based monitoring. the research objective of this proposal will be accomplished through 3 specific aims: 1. identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population. 2. adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring. 3. demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.

Eligibility criteria:
inclusion criteria: * \> 21 years of age * african american or hispanic * english speaking * has been on warfarin therapy \> 3 months * plan to be on warfarin therapy \> 12 months * willing ( or caregiver be willing) to do self-monitoring * willing to be randomized exclusion criteria: * lack of access to a telephone * moderate to severe dementia (if lacks caregiver) * severe hearing impairment ( if lacks caregiver) * blindness ( if lacks caregiver) * life expectancy \< 6 months * antiphospholipid antibody syndrome

Keywords: anticoagulation anticoagulation management self-testing self-management warfarin thromboembolism blood coagulation disorders health disparities minorities african american hispanic cardiovascular disease models of anticoagulation care tele-health home self-testing
efficacy and safety of increased dose of ta-650 (infliximab) in patients with crohn's disease (cd)

Conditions: Crohn's Disease

Summary: the purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg ta-650 every 8 weeks to patients with crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of remicade every 8 weeks.


Eligibility criteria:
inclusion criteria: * patients with crohn's disease * patients who have relapsed with symptoms associated with crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg remicade every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician exclusion criteria: * severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery * the presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed * a history of a serious infusion reaction to remicade * pregnant, lactating, and probably pregnant women * patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent * patients judged to be inadequate to participate in this study by their physician

Keywords: infliximab remicade crohn's disease
high volume injection in mid portion achilles tendinopathy

Conditions: Mid-Portion Achilles Tendinopathy

Summary: this prospective randomised clinical trial aims to evaluate the effectiveness of treatment for mid-portion achilles tendinopathy in a real-world clinical setting, minimising the excessive control typically associated with explanatory studies. the primary focus is to assess the mechanical effects of high-volume image-guided injection in combination with rehabilitation exercises over three months. additionally, the study will determine the overall clinical improvement in participants. the main questions it aims to answer are: is high-volume image-guided injection treatment superior to the usual care in treating mid-portion achilles tendinopathy? do mechanical and morphological properties of the tendon change after the treatment?

the objectives of this trial are to * evaluate the effectiveness of high-volume image-guided injection combined with rehabilitation exercises in improving symptoms and functionality in patients with mid-portion achilles tendinopathy. * measure changes in the mechanical properties of the achilles tendon, including dynamic stiffness, as well as morphological characteristics such as thickness, cross-sectional area, and neovascularisation following treatment. * assess patient-reported outcomes related to pain, disability and function using validated questionnaires * explore participants' experiences and perceptions regarding their symptoms and the trial itself.

Eligibility criteria:
inclusion criteria: * participants with mid-portion achilles tendon pain in one or both legs. in bilateral symptoms, the most symptomatic leg will be considered for assessing the intervention or standard progressive rehabilitation exercise programme. * participants with chronic achilles tendinopathy for more than three months who had previously undergone physiotherapy and exercise rehabilitation but experienced no improvement or continued to suffer from severe pain. * having one or more ultrasonography characteristics of mid-portion tendinopathy including thickened tendon, neovascularisation, hypoechogenic areas or loss of fibrillar homogeneity. exclusion criteria: * history of previous achilles tendon rupture or surgically repaired tendons. * presentation of insertional achilles tendinopathy or concurrent pain at both the insertional and mid-portion of the achilles tendon at the start of the study. * presence of neurological or metabolic conditions known to affect tendon health

Keywords: achilles tendinopathy high volume saline injection mechanical properties free tendon
preoperative marking of the oral resection margin in esophageal cancer with a surgical fiducial marker - first experiences

Conditions: Esophagus Cancer, Adenocarcinoma

Summary: this study aims to evaluate if bioxmark™, a surgical marker, may efficiently and safely be used to preoperatively mark the proximal and distal resection line 5 cm proximal and distal to the tumor margin of gastroesophageal-junction adenocarcinoma (gej ac). furthermore, to determine if placing the resection margin according to the resection margin defined by bioxmark™ is superior to the current standard of a proximal resection line estimation by the individual surgeon based on the intraoperative findings.

in denmark, the national guidelines for gej ac surgery are an r0 resection with a minimum 5 cm proximal and distal resection margin, measured in vivo. during the operation, the primary surgeon sets the resection margin according to the guidelines, with 5 cm on either side. the danish national guidelines are clear, but the literature behind them is not, and the recommendations for resection margins vary worldwide. with the lack of a strong literature-backed guideline and a surgical approach that is heavily dependent on the individual surgeon's estimate, the risk of a microscopic positive resection margin (r1 resection) increases. both problems, namely resectability at the definitive surgery and the incidence of microscopic positive resection margins after resection, may be improved by preoperatively marking the tumor margins in vivo. this could be achieved with an endoscopically placed surgical marker. one such surgical marker is bioxmark™, a liquid injectable and adherent fiducial marker that has shown promising results for image-guided adaptive radiotherapy in lung, bladder, and esophageal cancer. bioxmark™ is implanted during endoscopy and has appropriate visibility with good positional stability on ct, cbct, and mri. furthermore, no adverse reactions or events have been reported yet. the study will be performed as a feasibility study of bioxmark™ at the department of surgery \& transplantation, centre of cancer and organ diseases. the investigators plan to include 10 patients who are scheduled to undergo curatively intended surgery for gej ac. the patients will be drawn from the existing operating program.

Eligibility criteria:
inclusion criteria: * patients referred with gastroesophageal adenocarcinoma to the department of surgery \& transplantation, centre of cancer and organ diseases, rigshospitalet, and who are candidates for curatively intended surgery. exclusion criteria: * patients under the age of 18. * patients diagnosed with disseminated disease during surgery. * patients with impaired cognitive ability, making obtainment of informed consent impossible
diabetic macular edema treated with ozurdex (dmeo)

Conditions: Diabetic Macular Edema

Summary: to measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema

patients with diabetic macular edema (dme) are increasingly being treated with molecules targeting vascular endothelial factor (vegf). one potential advantage of a dexamethasone implant over specific vegf antagonists is that steroids suppress production of multiple pro-permeability factors. our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-vegf agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.

Eligibility criteria:
inclusion criteria: * • signed informed consent and authorization of use and disclosure of protected health information * age more than or equal to 18 years * diagnosis of diabetic macular edema * intraretinal or subretinal fluid in the macula determined by spectralis oct * best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (snellen equivalents using the etdrs protocol at a distance of 4 meters) * in the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from dme and not from other obvious causes of decreased vision * persistent or recurrent edema despite prolonged treatment with an anti-vefg agent exclusion criteria: * • scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye * intraocular surgery in the study eye within 3 months of study entry * use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry * previous use of an anti-vegf drug within 1 month of study entry * yttrium-aluminum-garnet (yag) laser capsulotomy within 1 month of study entry * any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated. * inability to comply with study or follow up procedures * history of glaucoma. (patients who have undergone filtration surgery may be included) * patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. * aphakic eyes with rupture of the posterior lens capsule. * eyes with aciol and rupture of the posterior lens capsule. * patients with hypersensitivity to dexamethasone or to any other components of the product
signet ring cell carcinoma in esophageal adenocarcinoma

Conditions: Adenocarcinoma; Esophageal Cancer

Summary: there has been much controversy surrounding the biologic behavior and prognosis of esophageal signet ring cell (srcs) containing carcinomas. to clarify the biologic behavior of srcs, the investigators compared the clinicopathologic features and prognosis of srcs with other adenocarcinomas (adc) of the esophagus and gastroesophageal junction (gej).

adenocarcinoma (adc) of the esophagus and gastroesophageal junction (gej) is an aggressive neoplasm and has a poor prognosis. surgical based treatment has been the treatment of choice for localized esophageal adenocarcinoma. signet-ring cell carcinoma is a unique histologic subtype of adenocarcinoma characterized by abundant intracellular mucin accumulation and a compressed nucleus displaced toward one extremity of the cell (the so-called signet-ring cell (src)). according to the world health organisation (who), a true signet-ring cell carcinoma (srcca) is defined as an adenocarcinoma in which the predominant component (more than 50% of the tumor) consists of isolated or small groups of src in the stroma. if the tumor contains less than 50% of those cells, it is generally considered as an adenocarcinoma (adc).

Eligibility criteria:
inclusion criteria: - adenocarcinoma r0 resection primary surgery exclusion criteria: - other histology r1 or r2 resection neoadjuvant therapy

Keywords: esophagectomy signet ring cells
state of play of non-tuberculous mycobacteria in alsace

Conditions: Non-Tuberculous Mycobacteria

Summary: non-tuberculous mycobacteriosis (ntm) are infectious diseases caused by mycobacteria that are not part of the tuberculosis complex. more than 190 species have been identified to date. as an environmental reservoir, it most often affects the lungs, skin and soft tissues, lymph nodes, but it can affect all organs. varying in virulence depending on the species, most infections do not cause illness. there is currently no coordinated care pathway for this pathology in alsace. the means necessary to set up such a structure requires knowing the importance of the disease.

the aim of the study is to determine the incidence of non-tuberculous mycobacterial infections in the alsace region, the proportion of cases in which the infection causes illness, and its evolution over time.

Eligibility criteria:
inclusion criteria: * adult subject (≥ 18 years old) * in whom a biological sample is culture positive for a non-tuberculous mycobacterium * born in france and domiciled in alsace (i.e. whose home postal code begins with 67 or 68) * not opposing the reuse of its data for scientific research purposes exclusion criteria: * subject having expressed opposition to participating in the study * not domiciled in alsace * born abroad * isolation of a mycobacterium from the tuberculosis complex and mycobacterium gordonae

Keywords: non-tuberculous mycobacteria
wound assessment using spectral imaging eu/uk

Conditions: Diabetes; Diabetic Foot; Diabetic Foot Ulcer

Summary: during the observational, non-interventional study, at baseline study visit (bsv) subjects will be screened and consented. eligible subjects will undergo imaging with the deepview device. pre- and post-debridement images will be obtained (if debridement performed per soc), as well as reviewing medical history and physical assessments. additional study visits (svs) will be performed when patient returns to the clinic for routine clinic visit for up to 12 weeks or wound closure. during these visits deepview imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.


Eligibility criteria:
inclusion criteria: * at least 18 years old. * subject has an ulcer, or a slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of diabetes. * the target ulcer will be the largest ulcer if two or more eligible dfus are present and will be the only one evaluated in the study. * the target ulcer is planned to undergo standard wound care (swc) therapy (see 8.6 standard wound care (swc) therapy). * subject understands and is willing to participate in the clinical study and can comply with required visits. exclusion criteria: * target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes. * target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. * eligible dfu has associated untreated acute osteomyelitis or active infection * subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), or cytotoxic chemotherapy. * subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.
thoracoscopy in patients with stage iiia non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment. purpose: diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage iiia non-small cell lung cancer.

outline: the purpose of this study is to test the usefulness and safety of restaging the patient's cancer by a procedure called a thoracoscopy. restaging is a process by which physicians measure the response of the patient to treatment. the primary and secondary objectives are described below. objectives: primary objective: 1. evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or evaluate for other conditions which render patients unresectable (pleural carcinomatosis or t4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant therapy for stage iiia n2 non-small cell lung cancer. secondary objectives: 1. evaluate the safety (morbidity and mortality) of pre-resectional, thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for stage iii (n2) nsclc. 2. assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy.

Eligibility criteria:
1. histologic documentation: all patients must have histologic documentation of stage iiia non-small cell lung cancer on the basis of involved n2 nodes from a documented mediastinoscopy performed prior to induction therapy. previously treated relapsed patients are not eligible. 2. prior treatment: greater than or equal to 2 cycles of chemotherapy with or without radiotherapy (greater than or equal to 40 gy) or radiotherapy alone (greater than or equal to 40 gy) must be completed within 60 days of registration. 3. no distant metastatic disease or local disease progression. patients with responding or stable local disease are eligible. those with local disease progression defined as a 25% increase in local tumor size or the appearance of new areas of malignant disease are ineligible. 4. no previous intrapleural surgery on the ipsilateral side. 5. ecog performance status: 0-2

Keywords: stage iiia non-small cell lung cancer