Kornimate/medical-research-clean huggingface dataset:
ami construction in lower extremity residual limbs

Conditions: Amputation

Summary: this study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy

the hypothesis of this research protocol is that we will be able to modify the residual limbs of patients who have already undergone lower extremity amputations so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses, diminish/eliminate phantom limb pain, restore proprioception and regenerate lost muscle mass. the specific aims of the project are as follows: 1. to develop a standardized operative technique for both above knee (ak) and below knee (bk) amputation revision procedures that includes amis to restore musculotendinous proprioceptive capabilities 2. to assess the capacity for these actuators to provide enhanced motor control and sensory feedback, as well as ablate phantom limb symptomatology and augment residual limb muscle mass 3. to determine the reinnervation time course and longevity of these biological constructs 4. to validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to bka and aka 5. to develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

Eligibility criteria:
inclusion criteria: * between the ages of 18-65 * has already undergone a standard aka or bka procedure * suffers from symptoms such as: * intractable pain * deterioration of skin on or around stump * suffering from other sources of discomfort arising from stump * intact inherent wound healing * adequate communication skills * high motivation exclusion criteria: * inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary) * individuals with impaired wound healing * individuals suffering from extensive peripheral neuropathies * active smokers * individuals with a history of poor compliance * women who are pregnant or plan to become pregnant before surgical intervention

Keywords: amputation residual limb pain phantom pain residual limb atrophy prosthesis control
shr-a1921 for injection in patients with platinum-resistant recurrent epithelial ovarian cancer

Conditions: Ovarian Cancer

Summary: this study is a randomized, open-label, controlled, phase iii study to evaluate the efficacy and safety of shr-a1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and written informed consent. 2. 18 years and older, female. 3. pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 4. patients must have platinum-resistant disease 5. be able to provide fresh or archived tumour tissue. 6. at least one measurable lesion according to recist v1.1. 7. eastern cooperative oncology group (ecog) score: 0-1. 8. with a life expectancy ≥ 12 weeks. 9. adequate bone marrow reserve and organ function. 10. contraception is required during the trial. exclusion criteria: 1. uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 2. previous or co-existing malignancies. 3. current or history of ild. 4. clinical symptoms or diseases of the heart that are not well controlled. 5. arterial/venous thrombosis events occurred before the first dose. 6. grade ≥2 bleeding events of ctcae occurred before the first dose. 7. gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose. 8. patients with intestinal obstruction or parenteral nutrition before the first dose. 9. serious infection before the first dose. 10. active hepatitis b or active hepatitis c. 11. received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment. 12. treated with top1 inhibitors or adcs with top1 inhibitors as payload. 13. unresolved ctcae ≥grade 2 toxicities from previous anticancer therapy. 14. history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of shr-a1921. 15. other inappropriate situation considered by the investigator.
liposomal bupivacaine with dexamethasone for foot surgery

Conditions: Foot Surgery; Ankle Surgery; Post Operative Pain; Popliteal Nerve Block

Summary: this study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. it will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. we will compare liposomal bupivacaine (exparel) and liposomal bupivacaine (exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.


Eligibility criteria:
inclusion criteria: * participants with foot and ankle procedures at jefferson surgery center, navy yard * participants with foot and ankle orthopedic procedures requiring a preoperative nerve block * age 18 and older * english speaking * ability to complete surveys by phone or in person * ability to provide informed consent exclusion criteria: * revision foot and ankle cases * allergies to study medications * non-english speakers * known alcohol or narcotic abuse history * existing contract with a pain specialist due to underlying preoperative pain syndrome * preoperative opioid use within the 3 months prior to surgery * participants who are pregnant, plan to become pregnant, or are breastfeeding.
long-term study to evaluate the safety of dutogliptin/phx1149t in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Type 2 Diabetes

Summary: the purpose of this study is to demonstrate that dutogliptin/phx1149t is safe and tolerable.

in this study, open-label dutogliptin/phx1149t will be offered to subjects who complete a phase 3 core protocol and wish to continue treatment with dutogliptin. this will allow for the collection of long-term safety data and will also demonstrate long-term effects on hba1c and fasting blood glucose.

Eligibility criteria:
inclusion criteria: * completion of all required visits of a qualifying phase 3 core protocol (e.g., visit 8/day 196 of phx1149-prot301) * current treatment of type 2 diabetes mellitus as in phx1149-prot301 exclusion criteria: * except for type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat * any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Keywords: diabetes dpp4 inhibitor dutogliptin phx1149
shr-a1904 compared with investigator's choice of therapy in claudin18.2 positive patitens with second-line advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

Conditions: Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Summary: the study evaluated the overall survival (os) of shr-a1904 versus investigator-selected treatment in second-line cldn18.2-positive advanced gc/gejc patients


Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years old (including boundary values) 2. volunteer to participate in this clinical study and sign informed consent; 3. ecog score 0-1; 4. expected survival ≥3 months; 5. gastric or gastroesophageal junction adenocarcinoma; 6. positive cldn18.2 expression in tumor tissue; 7. there is at least one measurable or evaluable lesion that meets the recist 1.1 criteria; 8. adequate bone marrow and organ function. exclusion criteria: 1. received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study 2. her2 posotive (ihc 3+ or ihc 2+/ish +); 3. toxicities caused by previous anticancer therapy were not recovered to ctcae 5.0 grade≤1; 4. individuals with leptomeningeal metastasis or active brain metastases; 5. individuals with a history of gi perforation or fistula, unstable gi bleeding; 6. individuals with a history of severe cardiovascular and cerebrovascular diseases; 7. the researcher determined that there are other situations that are not suitable for participation.
covid-19: sars-cov-2 specific memory b and t-cd4+ cells

Conditions: COVID-19; SARS-CoV-2 Infection

Summary: the current pandemic caused by the newly identified coronavirus responsible for covid-19 is a major threat to our populations and societies. hypothesis/objective the acquisition of protective immunity at the level of the individual, either through vaccination or natural resolution of the infection, progressively leads at the level of the population to the reduction of the fraction of the population that can be productively infected and transmit the virus, hence, leading to the diminution of the rate of transmission, a phenomenon called herd immunity. herd immunity was proposed as a strategy to control the infection. however, it remains difficult to model group immunity given the limited knowledge of the interaction between the host immune system with the virus, whose capacity to evolve in face of a neutralizing response is also not known. it is therefore important to acquire a better knowledge of the immunological memory that ensures the resolution of covid-19 after sars-cov2 infection. method to study single-cell b and t memory cells specific for the anti-sars-cov-2 response and characterize somatic mutations of immunoglobulin genes and tcr, in hospitalized and symptomatic patients and in patients cured of sars-cov-2.


Eligibility criteria:
inclusion criteria: * patients who have recovered from cov-2-sars * adult patient (≥ 18 years old) with a positive sars-cov-2 pcr. * adult patient (≥ 18 years old) who has recovered from sars-cov-2 i.e. has been free of clinical symptoms for more than 15 days and has not been hospitalized and for less than 6 weeks. * patient affiliated to a social security scheme. patients hospitalized for sars-cov-2 * adult patient (≥ 18 years old) with a positive sars-cov-2 pcr. * adult patient (≥ 18 years old) with clinical symptoms for more than 3 days and hospitalized. exclusion criteria: * refusal of the patient to participate in the study. * patient under guardianship / curatorship

Keywords: covid-19 immunity
the effect of mirror therapy with virtual reality application on motor-sense acquisition and quality of live in home care of stroke patients

Conditions: Stroke Syndrome

Summary: : aim: stroke is increasing day by day in our country as in the world. early rehabilitation after stroke accelerates motor-sensory gains of individuals. this also increases the quality of life. although there are studies on post-stroke rehabilitation in our country, rehabilitation applications with virtual reality application are very limited. for this reason, the research was carried out to determine the effect of home therapy with virtual reality application on motor-sensory gains and quality of life after stroke. material and method: the research was conducted as a randomized controlled experimental study. the universe of the research; between december 2021 and may 2022, individuals who met the criteria for inclusion in the study who applied for home care to erzurum atatürk university health application and research center physical therapy unit with the diagnosis of loss of movement in the upper extremity after stroke were formed. the sample size for the research was determined by power analysis. in the power analysis, it was determined that a total of 52 people should be reached in order to reach the 95% confidence level at the 0.05 significance level and 80% power at the p\<0.05 significance level. considering that there may be data losses in the study, it was decided to reach 60 people, 15% more than the sample. "descriptive feature form", "brunnstrom staging" and "sf-36 quality of life scale" were used to collect data.in the analysis of data; percentile distribution, chi-square, fisher-freeman- halton exact test, t-test in independent groups, repeated measures anova test, friedman test, one way anova test, kruskall wallis test, and post hoc analyzes (bonferroni, games howell, dunn) were used.


Eligibility criteria:
inclusion criteria: * being literate, * be over 18 years old, * having sufficient communication skills to be able to answer verbal and written questions and follow instructions, * to have applied to benefit from home care services, * having been diagnosed with stroke and being at least 6 days old, * not having advanced vision problems, * not having a vertigo problem * not being diagnosed with epilepsy * in brunnstrom staging, upper extremity stage 2 and above exclusion criteria: * to reside outside the borders of erzurum province * be under the age of 18 * in brunnstrom staging, the upper extremity is below stage 2

Keywords: stroke home care mirror therapy virtual reality nursing
efficacy of brief acceptance and commitment therapy (act) for perinatal anxiety

Conditions: Post Partum Depression; Perinatal Depression; Post Partum Anxiety; Perinatal Anxiety

Summary: this protocol will test the hypothesis that acceptance and commitment therapy (act) is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. participants should expect their participation in the study to last 9-12 months.

the study's major theme is "to examine the efficacy of a brief acceptance and commitment therapy (act) intervention in treating perinatal anxiety symptoms, as compared to a supportive control condition." the perinatal and postpartum periods are known to be a vulnerable time for the development of mental health symptomatology, with approximately 7% of women developing postpartum depression in the first three months following childbirth. one known predictor of postpartum depression is perinatal anxiety and distress. the impact of postpartum depression extends beyond the mother, whose distress and daily functioning are affected, with adverse effects on infant development and care. the need for interventions and preventive interventions has been widely indicated for over two decades. this protocol will describe two conditions, the effects of which will be contrasted to determine the efficacy of act in treating anxiety and depressive symptoms among perinatal women. the act condition will be compared to a supportive psychoeducation intervention. the effects of the intervention will be determined in terms of self-report measures (anxiety and depressive symptoms, flexibility, mindfulness, social satisfaction) and diagnostic interviews (depression, anxiety). the impact of trauma history and psychodiagnostic history will be examined as moderating factors and/or covariates in the examination of the intervention's efficacy. this protocol will test the hypothesis that act is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. second, the investigators will examine the intergenerational impact of the intervention on the offspring via offspring birth outcomes, as reported in the electronic medical record. finally, the investigators will explore mediators and moderators of the treatment outcomes. this work will advance the understanding of the impact of brief interventions on perinatal well-being and improve the ability to disseminate empirically supported interventions for pregnant mothers.

Eligibility criteria:
inclusion criteria: 1. adult women (ages 18-45) who are between 18-26 weeks pregnant 2. fluency in english 3. ability to give informed consent and comply with study procedures (including phone and internet access) 4. elevated gad-7 score (10+) 5. women must be receiving prenatal care 6. singleton pregnancy exclusion criteria: 1. prisoners 2. inability to give informed consent and comply with study procedures 3. past/current mania, past/current psychoses (assessed with psychosis screening questionnaire) 4. no therapy appointments in last 60 days (not currently in psychotherapy).

Keywords: pregnancy mental health
ventricular matrix remodeling: correlates and prognosis

Conditions: Heart Diseases; Heart Failure, Congestive; Cardiovascular Diseases; Heart Failure

Summary: to assess the diagnostic and prognostic usefulness of serum markers of left ventricular remodeling for predicting congestive heart failure.

background: recent studies have established that cardiac extracellular matrix (ecm) remodeling is a major determinant of pathologic left ventricular hypertrophy (lvh) and progressive left ventricular dilatation, and as a result, contributes to the development of left ventricular dysfunction and overt congestive heart failure (chf). the recent development of reliable serologic assays for procollagen peptides, metalloproteinases (mmp) and their tissue inhibitors (timp), and cytokines permits the in vivo assessment of lv ecm remodeling, and raises the possibility of expanding the utility of these markers 'from the bench to the bedside.' prior studies of ecm biomarkers in congestive heart failure have been limited to cross-sectional investigations of small samples of highly selected patients with advanced disease. the fundamental question whether serum markers of ecm remodeling are important correlates of left ventricular dilatation or left ventricular hypertrophy, or are independent predictors of incident congestive heart failure in the community remains unanswered. design narrative: the aims of the study are to: determine the relationships between serum markers of ecm remodeling and traditional congestive heart failure risk factors; analyze the cross-sectional relations between markers of ecm remodeling and echocardiographic left ventricular hypertrophy and left ventricular dilatation, doppler indices of left ventricular filling and serum natriuretic peptides; investigate prospectively the relationships between ecm remodeling markers and progressive left ventricular dilatation and left ventricular hypertrophy and congestive heart failure incidence, adjusting for standard risk factors. stored samples from the framingham offspring and omni cohorts will be used. participants at the extremes of the joint distributions of left ventricular wall thickness and left ventricular internal dimension from echocardiograms performed at earlier framingham exams will be sampled.

Eligibility criteria:
no eligibility criteria
the safety, completion rate and prevention effect by rifamycin-containing regimens for latent tuberculosis infection in patients with kidney transplantation: a prospective intervention pilot study

Conditions: Pulmonology

Summary: tuberculosis (tb) remains the leading infectious disease worldwide and kidney transplant recipients (ktr) is high risk population needing prevention from reactivation, which cause high mortality. in fact, its latent tuberculosis infection (ltbi) is increasing after transplantation and has been identified as a risk factor for tb. however, the suitable regimen for ltbi treatment in ktrs remains unclear. currently, three-month rifamycin-containing regimens, such as weekly rifapentine and isoniazid (3hp) or daily rifampicin and isoniazid (3hp), are common because its non-inferiority to nine-month of daily isoniazid (9h) and high completion rate by its short course in tb contacts. however, ktrs have many differences from general population, like use of immune-suppressants and possible residual renal insufficiency, so that to prescribe rifamycin-containing ltbi treatment regimens may have many concerns. one biggest concern is that drug-drug interaction between rifamycin and immunosuppressants. in addition, there is no study before in investigating the use of rifamycin-containing regimen in the population of ktrs (only study for kidney transplant candidates).

tuberculosis (tb) remains the leading infectious disease worldwide and kidney transplant recipients (ktr) is high risk population needing prevention from reactivation, which cause high mortality. in fact, its latent tuberculosis infection (ltbi) is increasing after transplantation and has been identified as a risk factor for tb. however, the suitable regimen for ltbi treatment in ktrs remains unclear. currently, three-month rifamycin-containing regimens, such as weekly rifapentine and isoniazid (3hp) or daily rifampicin and isoniazid (3hp), are common because its non-inferiority to nine-month of daily isoniazid (9h) and high completion rate by its short course in tb contacts. however, ktrs have many differences from general population, like use of immune-suppressants and possible residual renal insufficiency, so that to prescribe rifamycin-containing ltbi treatment regimens may have many concerns. one biggest concern is that drug-drug interaction between rifamycin and immunosuppressants. in addition, there is no study before in investigating the use of rifamycin-containing regimen in the population of ktrs (only study for kidney transplant candidates). therefore, we conducted this project aiming to monitor the safe issues (adverse events and drug-drug interaction), completion rate, and prevention effect in the population of ktrs.

Eligibility criteria:
inclusion criteria: 1. received kidney transplant, and 2. will receive interferon-gamma release assay (igra) for ltbi, and 3. if igra was positive, participants agree to receive ltbi treatment exclusion criteria: 1. age \< 20 years old 2. pregnancy 3. suspicious active tuberculosis

Keywords: latent tuberculosis infection,mycobacterium tuberculosis