Kornimate/medical-research-clean huggingface dataset:
validity, reliability and responsiveness of king's sarcoidosis questionnaire in a danish population

Conditions: Sarcoidosis

Summary: the king's sarcoidosis questionnaire (ksq) is a brief questionnaire assessing health status in patients with sarcoidosis. the ksq was previously validated in english german and dutch. ksq will be translated into danish and validated in a danish sarcoidosis population.

ksq will be linguistic validated according to existing guidelines. consecutive patients with sarcoidosis will complete ksq and other health questionnaires at baseline, after two weeks and 12 months. concurrent validity, reliability, and responsiveness will be assessed.

Eligibility criteria:
inclusion criteria: * diagnosed with sarcoidosis * signed informed consent exclusion criteria: * inability or unwillingness to adhere to the study * inability to give informed consent
evaluation of gut microbiome in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the research will focus on the possible connection between prostate cancer, and various species of bacteria in the large intestine. in consecutive patients, referred to prostate biopsies, rectal swabs will be taken before the biopsies and before antibiotic treatment. the gut flora will be examined and characterized by a microbiome analysis tool. negative patients will serve as internal control. the investigators will look for association between prostate cancer of various grades and the presence of specific enteropathogens in the rectal flora of the participants.

prostate cancer is the no. 1 cancer among men. risk factors include afro-american origin, prostate cancer in a first degree relatives and the presence of brca2 genetic mutations. no specific association has been described yet between prostate cancer and specific gut bacteria. the gi tract is the home of billions of bacteria. the microbiome functions as a separate organ and contains 10 times the amount of genes compared to the human genome. the microbiome has crucial impact on the human metabolism, inflammatory processes and filtration of gi content. all of these effects may contribute to the exposure of the human body to various carcinogens and inflammatory factors, leading eventually to the development of cancer in remote organs. the purpose of this research is to try and identify specific species that might be related to the development of prostate cancer.

Eligibility criteria:
inclusion criteria: * male gender * age above 45 * referred for prostate biopsy exclusion criteria: * age below 45 * antimicrobial therapy in the 7 days prior to biopsy * previous prostate or pelvic irradiation * patients who suffer from inflammatory bowel disease * systemic chemotherapy for any reason in the 3 months prior to the biopsy.

Keywords: microbiome prostate cancer sequencing
abdominoperineal extra-elevators rectal resection for cancer: prone position vs. supine position

Conditions: Rectal Cancer; Abdominoperineal Resection

Summary: prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the miles operation in patients with advanced rectal cancer. primary objective: - pathological circumferential resection margin secondary objectives: * 5 year oncological outcomes * morbimortality rates * surgical specimen quality * perineal hernia incidence


Eligibility criteria:
inclusion criteria: * patients with primary low lying rectal cancer involving or threatening anal sphincter complex as seen in mri exclusion criteria: * american society of anaesthesiologists classification of physical health (asa) iv patients * locally palliative purpose of the operation * age \< 18 years * preoperative indication for pelvic exenteration * pregnancy * lack of patients consent

Keywords: inferior rectal cancer abdominoperineal resection miles operation supine miles operation prone miles operation total mesorectal excision circumferential radial margin
evaluation of efficacy and safety parameters of different antibiotics regimens for management of empyema

Conditions: Empyema, Pleural

Summary: to evaluate the impact of using different antibiotic regimens including single and combined agents as the empirical therapy and evaluate the clinical outcomes regarding safety, efficacy, and pharmacodynamics parameters.


Eligibility criteria:
inclusion criteria: confirmed diagnosis of empyema: patients with a clinical and radiological diagnosis of exclusion criteria: 1 - hypersensitivity or allergy to the selected antibiotic: patients with a known history of hypersensitivity or allergic reactions to used antibiotics. 2- pregnancy and lactation
fecal microbiota transplant for improvement of metabolism

Conditions: Obesity

Summary: the purpose of this study is to study the impact of gut bacteria on weight. fecal microbiota transplantation (fmt) transfers intestinal bacteria by a "stool transplant" from a healthy, lean person to a person with obesity.

multiple lines of evidence suggest that gut microbiota play an important role in regulating human metabolism. in this study, subjects will receive fmt capsules from lean metabolically healthy donors to study effects on body weight and insulin sensitivity. subjects who participate will be randomized 1:1 to receive either active fmt capsules or placebo capsules. subjects and providers will be blinded to treatment assignment. the study will last for 24 weeks. subjects will be asked to come to mgh for a baseline visit at week 0, return for 6 weekly visits and come back at week 12. major study outcomes include change in weight, insulin sensitivity, and body composition. fecal samples will also be collected for intestinal microbiome analysis.

Eligibility criteria:
inclusion criteria: * bmi ≥30 kg/m2 * because of frequent study mandated visits, only subjects living within reasonable driving distance of massachusetts general hospital may be enrolled exclusion criteria: * pregnant women * use of diabetic medications or weight loss medications in the preceding 1 year * significant gastrointestinal disorders * significant food allergies * immunosuppressed patients
a study to compare the efficacy and safety of bms-986365 versus the investigator's choice of therapy in participants with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the purpose of this study is to compare the efficacy and safety of bms-986365 versus the investigator's choice of therapy in participants with metastatic castration-resistant prostate cancer.

the primary objective of this clinical trial is to assess the radiographic progression free survival (rpfs) of bms-986365 versus investigator's choice comprising docetaxel + prednisone/prednisolone or abiraterone + prednisone/prednisolone or enzalutamide. in part 1, participants will be randomized 1:1:1 to one of the two bms-986365 dose levels, or to the active comparator arm (investigator's choice). in part 2 of the study, participants will be randomized 1:1 between bms-986365 selected dose, or to the active comparator arm (investigator's choice).

Eligibility criteria:
inclusion criteria * participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features. * participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (ct/mri). * participants must be asymptomatic or mildly symptomatic from prostate cancer with score on brief pain inventory - short form (bpi-sf) that must be \< 4. * participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide). exclusion criteria * participants must not have impaired cardiac function or clinically significant cardiac disease. * participants must not have any brain metastasis. * participants must not have any liver metastasis. * participants with superscan on technetium-99m (tc-99m) radionuclide bone scans. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: prostate cancer protein degrader protein degradation androgen receptor castrate resistant prostate cancer castration resistant prostate cancer hormone resistant metastatic hormone resistant prostate cancer metastatic castrate resistant prostate cancer metastatic castration resistant prostate cancer bms-986365 cc-94676 ca071-1000 ca0711000 recharge abiraterone docetaxel enzalutamide
preparing for international prevention trials involving hiv-infected individuals in care settings

Conditions: HIV

Summary: the purpose of this study is to conduct preparatory research needed to design a behavioral intervention to decrease sexual transmission risk behaviors in hiv-infected individuals in care and to determine whether a similar intervention structure can be used across various sexual risk groups and cultural settings.


Eligibility criteria:
inclusion criteria: * men and women at least 18 years of age (note: pregnant and breast feeding women are allowed to enroll into the study) * documented evidence of hiv infection (hiv diagnosis performed outside of the trial is acceptable so long as local/country guidelines were followed in the testing) * receiving hiv/aids care (defined as at least two visits within 9 months of enrollment) in a formal health care setting (clinic or hospital) * reported history of sexual risk behavior in the previous 12 months, including: acquisition of a sexually transmitted infection, vaginal or anal intercourse without a condom, difficulty negotiating condom use, or non-disclosure of hiv status to an hiv-uninfected partner or partner of unknown hiv serostatus. * note: for the msm population, we will enroll men who have sex with men, regardless of whether or not they also have sex with women exclusion criteria: * anyone currently enrolled in another study that involves protocolized hiv risk reduction counseling (e.g. actg 5175 or hptn 052) or any other prevention study * anyone having unprotected (i.e. without a condom) sex for the expressed purpose of conceiving * planning to relocate out of the area in the next year * any condition that, in the opinion of the investigator of record or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
exploring the effect of colonic j-pouch in anorectal preservation surgery for ultra-low rectal cancer.

Conditions: Rectum Cancer; Faecal Incontinence; Faecal Incontinence with Faecal Urgency; Low Anterior Resection Syndrome; Leakage, Anastomotic

Summary: the occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. the practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. the objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.


Eligibility criteria:
inclusion criteria: 1. a confirmed diagnosis of intestinal cancer, with the lower edge of the tumour \&lt;5 cm from the anus or \&lt;3 cm from the dentate line, and treated with anus-preserving surgery; 2. no distant metastasis; 3. age \&gt;18 years old; 4. voluntary enrollment in the study and signing of an informed consent. exclusion criteria: 1. a combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (asa ≥ grade 4); 2. preoperative anal stenosis and anal nonfunction; 3. temporary stoma diversion.
evaluation of post infectious inflammatory reaction (piir) concerning children after streptococcus pneumoniae, streptococcus pyogenes and neisseria meningococcus invasive infection

Conditions: Streptococcus Pneumonia; Streptococcus Pyogenes Infection; Neisseria Meningitides Meningitis

Summary: as covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. some of them are delayed and provide post infectious inflammatory reaction (piir), they are challenging for diagnosis and for management. clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. except for rheumatic disease for group a streptococcus (gas) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and piir have probably a suboptimal management. in this context the investigators aim to explore piir in the 3 most frequent bacterial invasive infection in france, by a retrospective monocentric study. the investigators include all children betwwen 2012 and 2018 hospitalized for infections by streptococcus pneumoniae (sp), neisseria meningitidis (nm), and gas invasive infections.


Eligibility criteria:
inclusion criteria: * less than 18 years of age * fever associated with gas, nm, or sp invasive infection exclusion criteria: * age \> 18 years * impossibility to obtain the consent of parents / legal representatives.

Keywords: post-infectious inflammatory reactions neisseria meningitis
short term follow-up of patient implanted with the metatarso-phalangeal prosthesis metis®

Conditions: Hallux Rigidus; Hallux Limitus; Hallux Valgus; Osteoarthritis; Rheumatoid Arthritis - Ankle and/or Foot

Summary: the great toe is vital for normal, pain free ambulation. decreased function associated with osteoarthritis of the first matatarsal phalangeal joint (mtp i) often called hallux rigidis or hallux limitus leading to a painful great toe. patients experience pain during ambulation especially during the push-off phase of gait. when surgery is indicated four techniques are used for hallux rigidis; cheilectomie, resection arthroplasty, arthrodesis and implant surgery (1). endoprostetic implants are relatively new. silicone implants like the arthroplasty developed by swanson (2) resulted in foreign body reactions and periarticular bone loss. subsequent implants, in particular the metallic hemi arthroplasty with or without polyethylene articulations, have been more successful (3). still, implants are prone to wear of the material and show higher rates of loosening and infection compared to other techniques (4;5). in the last decades several new implants are described using two non cemented pressfit components, of titanium alloy or ceramic (6-9). between 2001 and 2004 the investigators developed a new concept with instrumentation for exact alignment to prevent for wear with loosening of the implant on the long term. the implant has bone-conserving characteristics to enable arthrodesis as a salvage procedure. it is a completely modular two-component press fit titanium alloy implant with polyethylene insert that can be used as either for hemi-, total- or revision arthroplasty. the purpose of this study is to have an overview of clinical status of the patient implanted with the metis® prosthesis at short term (2 years of follow-up). the objective of this study is to evaluate the safety and efficacy of the metatarso-phalangeal prosthesis metis® at short term follow up.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * have willingness to give his/her data transfer authorisation; * has an indication of: hallux rigidus, hallux limitus with degenerative joint disease, painful hallux valgus, osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, for which surgeon has recommended that a metis® prosthesis be implanted exclusion criteria: * active infection or inflammation; * excessive bone loss, bone deficiency or rapid joint destruction; * suspected or documented metal allergy or intolerance; * metatarsal head or phalangeal avascular necrosis; * joint instability involving soft and fibrous tissue deficiency; * severe metatarso-phalangeal axis deviation (hallux valgus angle \> 20°); * prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol; * a previous joint replacement.
comparison of 5g-mobile stroke unit with standard ems for acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: while mobile stroke units (msus) are considered as a relatively new model for acute stroke treatment, 5g mobile stroke units (5g msus) have already come into service for stroke treatment in some parts of china. since limited evidence has been found to suggest their advantages over conventional emergency medical services (ems), well-conducted clinical studies are required to further assess their effectiveness and safety. this study aims to evaluate whether 5g msus outperform standard management (sm) by ems in terms of functional outcomes of acute ischemic stroke (ais) patients within 4.5 hours after symptom onset in urban and rural areas of china.

this multicenter, prospective, open-label, blinded endpoint , week-wise randomized, controlled trial will allocate patients to one of two study arms for the analyses：one group will receive pre-hospital diagnosis and treatment in a 5g msu followed by transfer to a comprehensive stroke center (csc) emergency department (ed) for further management; the other group will undergo standard pre-hospital triage with subsequent transport by ems to a csc ed for evaluation and treatment. the main criteria to enroll a patient into the study include: a. history and physical/neurological examination consistent with acute stroke, b. age≥18, c. last seen normal within 4hr 30 min of symptom onset, d. pre-stroke modified rankin scale ≤3 (being able to ambulate), e. no recombinant tissue plasminogen activator（rt-pa）or tenecteplase（tnk）exclusions per guidelines, prior to ct scan or baseline labs and f. informed consent obtained from patient (if competent) or legal representative. the primary outcome was the distribution of modified rankin scale (mrs) scores (a disability score ranging from 0, no neurological deficits, to 6, death) at 3 months. it is hypothesized that the 5g msu pathway, compared to ems, can enable earlier evaluation and treatment of ais patients within 4.5 hours of onset, thereby improving functional outcomes three months after stroke while ensuring safety. the successful completion of this project will provide data on important outcomes and costs associated with the use of 5g msu vs sm in china that will help determine the value of integrating 5g msus into the pre-hospital environment in this country.

Eligibility criteria:
inclusion criteria: 1. history and physical/neurological examination consistent with acute stroke. 2. age≥18. 3. last seen normal within 4hr 30 min of symptom onset. 4. pre-stroke modified rankin scale ≤3（being able to ambulate）. 5. no rt-pa/tnk exclusions per guidelines, prior to ct scan or baseline labs. 6. informed consent obtained from patient (if competent) or legal representative. exclusion criteria: 1. malignant or other severe primary disease with life expectancy \<1 year. 2. participation in other interventional randomized clinical trials within 3 months before enrollment.
reconstruction of the medial patellofemoral ligament - a randomised controlled trial comparing two surgery technics

Conditions: Knee Stability; Patella Luxation

Summary: the purpose of this present study is to determine which surgery technic provides the best clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors and screw fixation in medial femoral condyle.


Eligibility criteria:
inclusion criteria: * patella luxation, more than 2 times exclusion criteria: * cartilage damage (grad 3)
exercise-induced epigenetic modifications in obese aging women

Conditions: Metabolic Syndrome

Summary: our greatest public health challenge is obesity and the co-morbidities of metabolic syndrome (mets). age is an established risk factor for mets and specific to women, data indicates that the prevalence of mets increases substantially with the menopausal transition with postmenopausal women having a 60% increased risk of mets. menopause also contributes to reductions in strength, physical function and often psychological well-being (e.g. fatigue). obese individuals also have: a) impaired immune function and chronic inflammatory responses associated with changes in the white blood cell population in blood and fat tissues; and, b) increased secretion of and signaling by proteins in their fat cells. weight loss, which requires an energy deficit through increased physical activity and/or caloric restriction (ex+cr), reduces risk for mets in older sedentary obese women by reducing insulin resistance and chronic systemic inflammation. science and clinical practice will be advanced by examining the molecular mechanisms by which ex+cr affects risk for mets in older women. the primary aim is to determine if cd4+ t cells will report the differential epigenetic reprogramming of relevant gene expression associated with metabolic indices resulting from ex+cr induced weight loss in older women known to be at risk for mets. this pilot data will be used to generate an nih proposal of the same topic. a secondary aim is to assess the impact of weight loss on physical function and psychological well-being which will provide pilot data for an additional grant proposal regarding weight management in postmenopausal women.


Eligibility criteria:
inclusion criteria: 1. volunteer for the study 2. age between 50 and 64 years 3. self-identified as white or caucasian 4. postmenopausal 5. sedentary (less than 1 hour each week of planned physical activity and sedentary job) 6. bmi range \>/= 25 kg/m2 7. waist circumference \>88cm 8. weight stable (within 2 kg) for 6 months 9. all allowable medications stable for 3 months 10. live independently 11. willing and able to obtain transportation to and from lab sessions 12. obtains physician clearance to participate in the study exclusion criteria: 1. tobacco use 2. normal weight (bmi \< 25 kg/m2) 3. males 4. dietary restrictions that do not allow for the consumption of beef, as required by our dietary protocol 5. weight loss surgery and/or weight loss medications usage 6. mini-mental state exam score \< 25 7. recent or history of unstable cvd 8. cancer treatment within the last 5 years or active cancer 9. history of lung disease or copd or severe asthma 10. history or severe arthritis or other medical condition that precludes ability to exercise to level needed by study. 11. current diagnosis or history of balance disorders 12. history of mental disorders, dementia, clinical depression or other disorders that preclude adherence to protocols. 13. current weight of 350 pounds or greater, due to weight restrictions on equipment.

Keywords: epigenetics obesity overweight high protein diet exercise post menopausal women