Kornimate/medical-research-clean huggingface dataset:
impact of achilles tendon rupture on the achilles tendon and calf muscles

Conditions: Achilles Tendon Rupture

Summary: the aim of this study is to measure the recovery following achilles tendon rupture. the investigators will use an ultrasound scan to look at the achilles tendon, they will complete calf strength tests and use questionnaires to measure how individuals are managing in everyday life. the investigators will take these measurements when participants first arrive to the achilles tendon rupture clinic, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year.

this study will measure the recovery of participants following achilles tendon rupture. measurements will be completed following achilles tendon rupture, after 8 weeks, 10 weeks, 4 months, 6 months and 1 year. the measurements include an ultrasound tissue characterisation scan, isometric (static) strength test and heel raise test. in addition questionnaires will be completed by participants at each time point. questionnaires include the achilles tendon rupture score, hospital anxiety and depression scale, eq5d (a health related quality of life measure), international physical activity questionnaire, tampa scale for kinesiophobia and the pain catastrophising scale.

Eligibility criteria:
inclusion criteria: * able to provide informed consent * 16 years of age or above exclusion criteria: * inability to provide informed consent due to cognitive impairment * inability to provide informed consent as unable to understand sufficient english
immunogenicity and safety of a 1-dose regimen of a zoster vaccine versus different 2-dose regimens in participants ≥ 70 years of age. (v211-043)

Conditions: Prevention of : Herpes-Zoster

Summary: primary objective: immunogenicity to demonstrate that a second dose of zostavax® elicits higher varicella-zoster virus (vzv) antibody titres than a first dose of zostavax® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination secondary objectives immunogenicity * to summarise the vzv antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of zostavax®. * to compare the vzv antibody titres at 12 months after completion of a 1-dose regimen with the vzv antibody titres at 12 months after completion of each 2-doses regimen of zostavax® * to summarise the vzv antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of zostavax®


Eligibility criteria:
inclusion criteria: 1. age ≥ 70 years 2. varicella history-positive or residence for \> 30 years in a country with endemic vzv infection 3. signed informed consent form prior to any study procedure exclusion criteria: 1. febrile illness within the last 72 hours before the first vaccination 2. prior herpes-zoster episode clinically diagnosed by a physician 3. prior receipt of varicella or zoster vaccine 4. exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination 5. significant underlying illness preventing completion of the study vaccination schedules, 6. known active tuberculosis, 7. immune deficiency disorder, including active neoplastic disease within the prior 5 years, 8. immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause, 9. receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination, 10. receipt of any other live vaccine within the 4 weeks prior to the first vaccination, 11. receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination, 12. concomitant use of non-topical antiviral therapy
efficacy of nyaditum resae(r) against active tb in georgia

Conditions: Close Contacts of Active Tuberculosis

Summary: the use of a supplement food like "nyaditum resae" is a reliable opportunity to stop the progression towards active tb through the most updated knowledge of this disease:the induction of tolerance. in order to demonstrate the percentage of efficacy of this approach, different studies must be run to elucidate the percentage of protection in different setting all over the world. the strategy is to establish its efficacy through a simple clinical trial, aimed just to know the incidence of tb in placebo and nr treated contacts of active tb cases.

evaluation of a supplement food "nyaditum resae" in the uincidence of tb. this is a ranzomized doube-blind controlled clinical trial to evaluate the efficacy and safety of a supplememt food in comparison to placebo in tb.

Eligibility criteria:
inclusion criteria: 1. have completed the written informed consent process prior to undergoing any screening evaluations. 2. have ability to complete follow-up period as required by the protocol. 3. willing to allow the investigators to discuss the subject's medical history with the subject's health care provider. 4. close contact of an active tb case not eligible for chemoprophylaxis. exclusion criteria: 1. investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol. 2. any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results on the effects of the vaccine. 3. being eligible for chemoprophylaxis (children of \<5 years old and hiv-positive adults) 4. pregnancy or lactation 5. hypersensitivity to mannitol 6. suffering active tb

Keywords: tuberculosis latent tuberculosis infection food supplement mycobacterium manresensis nyaditum resae efficacy trial
the efficacy and safety study of car-t cells for functional cure in hiv-1/aids patients

Conditions: HIV Infected Individuals; HIV

Summary: autologous car-t cell therapy in hiv-1/aids patients


Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years; 2. confirmed diagnosis of hiv-1 infection, with regular antiviral therapy ≥24 months prior to enrollment and sustained hiv-rna levels \<50 copies/ml for the 12 months preceding enrollment; 3. cd4+ t-cell count \>350/μl within 30 days prior to enrollment; 4. female participants of childbearing potential (including those ≤50 years old who are amenorrheic) must have a negative urine pregnancy test; from the screening period until the end of the study, participants should have no plans for conception and must voluntarily adopt effective contraceptive measures; 5. willingness to provide true identity information and comply with follow-up requirements; 6. ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements. exclusion criteria: 1. women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception. 2. coinfection with other viruses or infections, including hiv-2, hav, hbv, hcv, hdv, hev, ebv, cmv, or syphilis. 3. history of aids-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma). 4. autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., crohn's disease, rheumatoid arthritis, systemic lupus erythematosus). 5. severe non-aids-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies. 6. central nervous system (cns) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the cns. 7. suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders. 8. abnormal laboratory results within 14 days prior to enrollment meeting any of the following: hemoglobin \ 110 μmol/l inr \>1.5 or ptt \>45 seconds alt or ast \>2.5 × upper limit of normal (uln) total bilirubin \>1.5 × uln 9. current participation in another clinical trial that may conflict with the current protocol or outcome assessments. 10. any other condition deemed inappropriate for participation by the investigator.

Keywords: car-t hiv autologous
influence of the coloring of a complex form on anxiety associated with care.

Conditions: Anxiety

Summary: evaluate the contribution of a coloring-type artistic task of a complex form in the reduction of anxiety related to care and pathology by a self-questionnaire "state-trait anxiety inventory" and a self-questionnaire on the experience of the activity, in 3 different medical situations: in day hospitalization service in psychiatry, in hemodialysis service and in an ambulatory consultation waiting room.

evaluate the contribution of a coloring-type artistic task of a complex form in the reduction of anxiety related to care and pathology by a self-questionnaire "state-trait anxiety inventory" and a self-questionnaire on the experience of the activity, in 3 different medical situations.

Eligibility criteria:
inclusion criteria: psychiatric day hospital group: * men or women over the age of 18 and under the age of 65. * admitted to psychiatric day hospital for at least 10 consecutive days of care. * person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator. * patient with stabilized schizophrenia (f20.0). hemodialysis service group: * men or women over the age of 18 and under the age of 65. * person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator. * person having had at least 6 hemodialysis sessions. * valid dominant arm (allowing coloring - no fistula). * person currently on dialysis treatment. group ambulatory consultation waiting room: * men or women over the age of 18 and under the age of 65. * person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator. * consultant a practitioner at the hospital. exclusion criteria: * person with advanced cognitive impairment that alters the questionnaire response or coloring as assessed by the investigator. * opposition of the volunteer. * no affiliation to a social security scheme (beneficiary or beneficiary).

Keywords: stai questionnaire ectm2-qa
preoperative intervention to reduce delirium after cardiac surgery

Conditions: Cardiac Surgery

Summary: this research is designed for experimental quantitative research and is conducted by simple random sampling. both the control group and the experimental group provided preoperative routine nursing treatment and preoperative medical teaching manuals. the latter adds cognitive therapy and gamification evaluation. both groups used cam-icu to assess the occurrence and duration of postoperative delirium, and drs-r-98 was used to assess the severity of delirium. after collection, use spss 22.0 statistical software package for analysis and processing. the expected result is that the incidence of delirium, the duration of delirium, and the severity of delirium in the experimental group were significantly lower than those in the control group.

this study is an experimental quantitative research design. both the control group and the experimental group provide routine nursing treatment and preoperative medical teaching manuals before surgery. the latter adds cognitive therapy and gamification evaluation of "postoperative care and environmental image data explanation". the two groups used cam-icu to assess the occurrence and duration of delirium after surgery, and drs-r-98 was used to assess the severity of delirium. from 2021 to 2022, a simple random sampling method is adopted for patients undergoing cardiac surgery in the intensive care unit of a medical center in central taiwan, and a lottery is drawn on the first day of each month to determine the belong to which group in the current month. there were 55 persons in each group, and all subjects had no cognitive impairment. after the collected, it was analyzed and processed with spss 22.0 statistical package software. expected results: the incidence of delirium, the duration of delirium, and the severity of delirium in the experimental group were significantly lower than the control group.

Eligibility criteria:
inclusion criteria: * expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery. * no cognitive impairment before surgery. exclusion criteria: * diagnosed with aortic dissection. * previously admitted to the intensive care unit.

Keywords: delirium after cardiac surgery cognitive therapy gamification
a study of ly2875358 in participants with non-small cell lung cancer with activating epidermal growth factor receptor mutations

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the primary purpose of this study is to compare the efficacy of the study drug ly2875358, given together with erlotinib, against erlotinib, alone. participants will have non-small cell lung cancer (nsclc) that has advanced to stage iv. participants should not have been treated with drugs for stage iv nsclc, previously. all participants will get erlotinib alone, for approximately 8 weeks. participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive ly2875358 plus erlotinib or erlotinib alone. participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of metastatic stage iv nsclc * have at least 1 measurable lesion whose presence is assessable using standard techniques by response evaluation criteria in solid tumors (recist version 1.1) * have molecular evidence of an epidermal growth factor receptor mutation (egfrmt) known to be associated with egfr tyrosine kinase inhibitor (tki) drug sensitivity (g719x, exon 19 deletion, l858r, l861q) * eastern cooperative oncology group (ecog) performance status of ≤ 2 * haven't received any prior systemic chemotherapy for stage iv nsclc (unless received as neoadjuvant or adjuvant therapy for early-stage nsclc disease and completed therapy at least 6 months prior to enrollment) * availability of adequate tumor material (block or slides) exclusion criteria: * are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device * have previously completed or withdrawn from this study or any other study investigating ly2875358 * have a serious concomitant systemic disorder or significant cardiac disease * have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently * have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study * have major surgery less than 2 weeks prior to the initiation of study treatment therapy * pregnant or lactating women
feasibility study to assess the early use of porcine cross-linked collagen paste in cryptoglandular anorectal fistulas

Conditions: Anorectal Abscess; Fistula in Ano

Summary: this study is designed to assess the effectiveness of porcine cross-linked collagen paste for the treatment of patients with ano-rectal abscess with underlying cryptoglandular fistula in ano.

most anal fistulae are thought to arise as a result of the infection of anal glands. this infection frequently presents as an anorectal abscess which requires drainage of the abscess under a general anaesthetic. abscess and fistula should be considered as the acute and chronic phase of the same anorectal infection.the abscess represents the acute inflammatory event, whereas the fistula is representative of the chronic process. at the time of drainage of the anorectal abscess, the underlying fistulas frequently go undetected. as a result, patients present with a fistula in ano several months later. in this study, the investigators aim to identify the underlying fistula in patients with a perianal abscess with the help of an mri scan done in the acute setting. participants with a confirmed fistula on the mri scan have their abscess treated as per convention. however, a repeat examination under anaesthetic is performed 7-'10 days later when the fistula tract is identified and treated with injection of the porcine collagen paste into the fistula tract. participants are followed up clinically and radiologically to assess the effectiveness of the intervention.

Eligibility criteria:
* inclusion criteria: o clinical diagnosis of cryptoglandular fistula in ano. * exclusion criteria: * insulin dependent diabetes * thyroid disease * fistula secondary to crohn's disease/ulcerative colitis * clinical or radiological evidence of secondary tracts. * complex fistula tracts on mri scan such as horseshoe fistula, anorectal-vaginal fistula * patients refusing informed consent for admission to the study. * previous fistulotomy/fistulectomy * pregnancy * patients unable to consent * patients not suitable for mri scan those with- cochlear implant, permanent pacemaker, implanted metal work, aneurysm clips, claustrophobia, metallic foreign body
ultrasound-assisted paravertebral block v. traditional paravertebral block for pain control

Conditions: Paravertebral Peripheral Nerve Block; Acute Pain Management

Summary: the overall purpose of this research study is to compare the effectiveness of ultrasound assisted paravertebral block placement versus traditional "blind" technique for postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery.

the purpose of this project is to determine if there is a difference between paravertebral block performed with ultrasound assistance and paravertebral block performed with traditional technique in terms of twenty - four hour hydromorphone (dilaudid) consumption and visual analogue pain scores at rest or with deep breathing at twenty - four hours. this study will determine if ultrasound technique used for placement of paravertebral catheter facilitates safety of paravertebral catheterization and improves therapeutic effect of paravertebral blockade for pain control after thoracotomy. the investigators will also examine if ultrasound assisted paravertebral blockade improves pulmonary status in post-thoracotomy patient.

Eligibility criteria:
inclusion criteria: * 1. american society of anesthesiologists (asa) i-iii subjects * 2. ages 18-75 years * 3. bmi \< 40 * 4. scheduled for elective thoracic surgery at university of pittsburgh medical center (upmc) passavant and shadyside hospitals in pittsburgh, pennsylvania * 5. patients willing and able to provide informed consent exclusion criteria: * 1) age younger than 18 years or older than 75 years * (2) any contraindication to the placement of unilateral thoracic paravertebral catheter, including local infection, hypocoagulable state. * (3) american society of anesthesiologists physical status iv or greater * (4) chronic painful conditions * (5) preoperative opioid use * (6) coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively * (7) allergy to lidocaine, ropivacaine or bupivacaine * (8) personal or family history of malignant hyperthermia * (9) serum creatinine greater than 1.4 g/dl * (10) pregnancy or lactating.the pregnancy status will be determined by history and prior pregnancy testing when appropriate * (11) having an altered mental status (not oriented to place, person, or time) or emergency surgery * (12) comorbid conditions such as sepsis, unstable angina, congestive heart failure, moderate to severe valvular heart disease, severe chronic obstructive pulmonary disease (copd) * (13) patient's inability to provide adequate informed consent * (14) patient refusal to nerve blocks and/or participation in the study * (15) respiratory support via ventilator post * (16) non english speaking * (17) allergy to contrast of iodine * (18) emergency surgery or any other non-elective procedure * (19) unstable vertebral and transverse process fractures

Keywords: peripheral nerve block ultrasound guidance postoperative pain management post status thoracotomy postoperative pain management post status vats
oa for breast cancer nac response

Conditions: Breast Cancer

Summary: this is an early research and development study. the objective of this study is to determine the feasibility of the imagio oa/us breast imaging system to detect complete breast cancer pathologic response to neoadjuvant therapy as assessed by functional optoacoustic features, vascular features and relative degrees of oxygenation/deoxygenation

the use of neoadjuvant systemic therapy in the treatment of breast cancer patients is increasing beyond the scope of locally advanced disease. imaging provides important information in assessing response to therapy as a complement to conventional tumor measurements via physical examination. tumor response to neoadjuvant therapy can also provide prognostic information. as stated in the background section, the attainment of pcr after completion of neoadjuvant therapy and surgical resection is associated with improved disease-free survival \[1-3\]. this correlation is especially strong for triple-receptor negative (er, pr negative and her-2 non amplified), and her-2 positive breast cancer. studies of neoadjuvant therapy have used a variety of methods for assessing tumor response. currently, there are no established clinical practice guidelines for how best to assess tumor response to neoadjuvant therapy. typically, patients undergo conventional breast imaging (mammography and us) and physical examination, and dce-mri in selected cases. the imagio oa/us technology is an alternative imaging technology that demonstrates both gray scale ultrasound morphologic information, including size measurements, and functional information that includes presence or absence of tumor angiogenesis, degree of angiogenesis, and relative degrees of oxygenation and deoxygenation of hemoglobin.

Eligibility criteria:
inclusion criteria: 1. 18 years and older male or female patients; 2. ipsilateral intact biopsy-proven invasive breast cancer clinical t1-t4 (by standard of care imaging), including primary or recurrent disease. 3. patient eligible to receive neoadjuvant chemotherapy exclusion criteria: 1. known stage iv disease (breast or other cancer); 2. have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule); 3. patient has received chemotherapy for any type of cancer within 90 days from date of baseline imagio oa/us exam; 4. is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline; 5. is currently undergoing phototherapy; 6. has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus); 7. is undergoing treatment for a photosensitive disease and is experiencing photosensitivity; 8. pregnancy; 9. patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening visit that may have an impact on clinical outcomes.