Kornimate/medical-research-clean huggingface dataset:
human upper extremity allotransplantation: f/u protocol

Conditions: Amputation, Traumatic; Wounds and Injury; Hand Injuries

Summary: upper extremity allotransplantation is a new procedure which is becoming more common in the united states. ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. for these reasons, the johns hopkins hand/arm transplantation team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.


Eligibility criteria:
inclusion criteria: * males and females 5 or more years post-unilateral or bilateral upper limb transplantation. * completes the protocol informed consent form. * consents to sample collection and storage (biopsies). * usa citizen or equivalent. * patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime. exclusion criteria: * candidate has not received an upper extremity allotransplant. * any reason the study team thinks would cause the participant to be noncompliant or would put the patient at unacceptable risk if enrolled.

Keywords: hand transplant composite tissue allograft (cta) vascularized composite allotransplantation (vca) amputation upper limb immunosuppression
sirolimus with corticosteroid therapy for rapid recurrences of coronary unexplained in-stent restenosis

Conditions: In-stent Restenosis Lesion; Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Summary: this study aims to evaluate, through a multicenter, prospective, double-blind, randomized, placebo-controlled clinical trial, whether immunosuppressive therapy improves target lesion-related cardiovascular outcomes compared to placebo treatment in patients with rapid recurrence of coronary unexplained in-stent restenosis (recur).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. able to understand the trial design and sign an informed consent form 3. patients meeting the recur definition 4. satisfactory results from revascularization within the past two weeks 5. receiving standard secondary prevention medication for coronary heart disease with treatment targets achieved exclusion criteria: pregnant women, individuals known to be allergic to the study drug, those currently participating in other interventional clinical trials, or participants deemed unsuitable for this study based on the investigator's judgment.
dual sstr2 and integrin αvβ3 targeting pet/ct imaging

Conditions: Lung Cancer; Neuroendocrine Neoplasm

Summary: this is an open-label positron emission tomography/computed tomography (pet/ct) study to investigate the diagnostic performance and evaluate the efficacy of 68ga-nota-3ptate-rgd in lung cancer patients and neuroendocrine neoplam patients. a single dose of 111-185 mega-becquerel (mbq) 68ga-nota-3p-tate-rgd will be injected intravenously. visual and semiquantitative method will be used to assess the pet/ct images.

the number of somatostatin receptors may be greatly up-regulated in the cells of a variety of tumor including carcinoids, gastrinomas, paragangliomas, small cell lung cancer and non-small cell lung cancer. octreotide is an eight amino acid cyclic peptide that preserves a four amino acid motif (phe-trp-lys-thr) that is critical for the biological activity of somatostatin (sstr). on the other hand, the rgd moiety binds with integrin αvβ3, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human tumor. to target both receptors, a heterodimeric peptide tate-rgd was synthesized from tate and rgd through a glutamate linker and then labeled with 68ga. an open-label whole-body pet/ ct study was designed to investigate the safety and dosimetry of 68ga-nota-3ptate-rgd and diagnostic performance of 68ga-nota-3ptate-rgd pet/ct in evaluation of lung cancer and neuroendocrine neoplams.

Eligibility criteria:
inclusion criteria: * neoplasm identified by x-ray, ultrasound or mri as lung cancer or neuroendocrine tumors * to provide basic information and sign the written informed consent. exclusion criteria: * consisted of conditions of mental illness; * severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μμ) or any hepatic enzyme level 5 times or more than normal upper limit; * severe allergy or hypersensitivity to iv radiographic contrast * claustrophobia to accept the pet/ct scanning * pregnancy or breast feeding

Keywords: tate-rgd sstr2 integrin αvβ3
fibroscan study in hcc

Conditions: Confirmed Diagnosis of Hepatocellular Carcinoma; Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery; Child's A to C Cirrhosis

Summary: in patients with hcc undergoing therapy 1. we aim to determine the prognostic significance of liver stiffness in patients with hcc 2. we aim to determine the rate and severity of complications of treatment and its association with liver stiffness in patients with hcc


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hcc * patients who are scheduled to undergo therapy, either tace systemic therapy or surgery 1. for tace cohort, patients undergoing first cycle tace are eligible. 2. for systemic therapy cohort, patients undergoing first-line systemic therapy are eligible. 3. for surgery cohort, patient undergoing surgery are eligible. * prior surgery or loco-ablative therapy (e.g. radiofrequency ablation, microwave, percutaneous ethanol injection) is allowed * child's a to child's c liver function exclusion criteria: * ecog performance status \> 2 * poorly controlled ascites
covid-19 infection in patients infected with hiv and/or on prep

Conditions: HIV; Pre-exposure Prophylaxis

Summary: the sars-cov-2 epidemic was declared as a global pandemic by the who on march 12, 2020. france is affected with approximately 120,000 biologically confirmed cases, as of april 30, 2020, a figure probably very underestimated. its distribution in different populations, in particular immunocompromised, has not yet been measured. the in vitro efficacy of lopinavir coupled with ritonavir, an hiv protease inhibitor, on sars-cov, responsible for sars has been discussed and this therapeutic combination is currently being evaluated in patients infected with covid-19. the possible protective role of treatment with lopinavir / ritonavir or another hiv protease inhibitor has not been studied. in addition, patients receiving hiv pre-exposure prophylaxis (prep) share certain epidemiological and behavioral characteristics with hiv-infected patients. the objective was to carry out an epidemiological study aimed at determining the attack rate of covid-19 infection in patients infected with hiv and or on prep and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising lopinavir / ritonavir or another inhibitor of the hiv protease. cross-referencing of virology laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.


Eligibility criteria:
inclusion criteria: * hiv patients in hospices civils de lyon * on-prep patients in hospices civils de lyon exclusion criteria: -
pep buddy impact on breathing, exercise, and sleep quality in copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (copd), which is associated with lung dynamic hyperinflation (dh). there was evidence that positive expiratory pressure (pep), which less costly devices could offer, could reduce dh. a positive expiratory pressure device improved copd-related symptoms in more than 70% of patients with copd. pep buddy is an adjunct to current copd therapies, such as inhalers and pulmonary rehabilitation. it provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life.

pep devices have been wildly used to reduce breathing frequency and expiratory flow limitation, change breathing patterns, improve gas exchange, as well as result in less airway collapse and air-trapping in patients with copd. increasing copd disease severity promotes a negative impact on exercise tolerance and magnifies the level of disability. physical activity programs appear to safely ameliorate these copd consequences, conferring beneficial effects on dyspnea and health-related quality of life. the combination of pep during aerobic exercise helps to get the most benefits from the exercise for a longer time and little dyspnea and fatigue.

Eligibility criteria:
inclusion criteria: * • all gender copd patients * age will be 55-65 years. * moderate to severe copd patients * emphysema on ct scan (hu ≥ - 900) * their fev1 will be less than 80% predicted * class ii obesity (bmi of 35 to \< 40) * medically stable * greater than 10 pack-year smoking history exclusion criteria: * • very severe copd - lung cancer * lung resection - lung fibrosis * heart failure - cognitive disorders that affect the device application * musculoskeletal or neurological disorders that interfere with an exercise program * requiring invasive or non-invasive positive pressure ventilation * inability to speak in complete sentences due to breathlessness * suspected elevated intracranial pressure - hemodynamic instability * recent facial, oral, or skull surgery * active hemoptysis (more than two tablespoons of frank blood per day) * pneumothorax - failure to comply with the research protocol. * uncontrolled hypertension, or other concomitant respiratory diseases * participate in any research or pulmonary rehabilitation program during the period of this study. * imaging changes of lung disease such as occupancy, exudation, and interstitial changes on ct scan

Keywords: chronic obstructive pulmonary disease quality of life sleep quality positive expiratory pressure exercise dyspnea
rct study on granulocyte colony-stimulating factor(g-csf) treatment of hepatic failure

Conditions: Liver Failure; Hepatitis B; Alcoholic Liver Disease

Summary: this study evaluates the granulocyte colony-stimulating factor (g-csf) in the treatment of acute on chronic liver failure in adult. half participants will receive g-csf and standard treatment in combination, while half participants will receive standard treatment.

granulocyte colony-stimulating factor (g-csf) can be used to mobilize stem cells to the periphery and the liver tissue in patients with advanced liver disease, and could promote hepatic regeneration. moreover, g-csf was reported to protect patients from sepsis by restoring the function of both neutrophils and monocytes. therefore, g-csf therapy may be beneficial for liver regeneration in patients with aclf induced by different causes. standard therapy for the treatment of aclf includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. hbv associated aclf patients receive entecavir at the same time

Eligibility criteria:
inclusion criteria: 1. age from 17ys to 70ys; 2. fale or femal; 3. aclf, as deﬁned by the asian pacific association for the study of the liver working party, is an acute hepatic insult manifested as jaundice (serum bilirubin ≥ 5 mg/dl) and coagulopathy\[international normalized ratio (inr) ≥ 1.5 or prothrombin activity\< 40%\], with complications of ascites and/or encephalopathy within 4 wk in patients previously diagnosed or undiagnosed with chronic hbv associated liver disease and alcoholic liver exclusion criteria: 1. super-infection or co-infection with hepatitis a, c, d, e,epstein-barr virus, cytomegalovirus, or human immunodeficiency virus; 2. a previous course immuno-modulator or cytotoxic/immunosuppressive therapy for chronic hepatitis within the prior 12 mo; 3. hepato-cellular carcinoma diagnosed by computed tomography or magnetic resonance imaging; 4. co-existence of any other serious medical illnesses or other liver diseases such as autoimmune hepatitis, drug-induced liver injury or wilson's disease; 5. any concurrent evidence of sepsis; 6. malignant jaundice induced by obstructive jaundice and hemolytic jaundice; 7. prolonged prothrombin time due to blood system disease.
delta multihole tt study

Conditions: Hip Osteoarthritis; Arthroplasty Complications; Hip Dysplasia

Summary: a retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with delta multihole tt cup.


Eligibility criteria:
iinclusion criteria as per delta multihole tt indications for use: age ≥ 18 years * non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis; * signed informed consent * hip dislocation using protruded liners, spacers; * rheumatoid arthritis; * post-traumatic arthritis; * correction of functional deformity in case of acetabulum verticalization, anteversion, and retroversion; * fractures of femoral neck; if used in combination with spacers and hemispheric modules, other indications are: * revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure; * clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results; * where bone stock is of poor quality or is inadequate for other reconstruction techniques as indicated by deficiencies of the acetabulum. exclusion criteria as per delta multihole tt contraindications for use: * local or systemic infections; * septicaemia; * persistent acute or chronic osteomyelitis; * confirmed nerve or muscle lesion compromising hip joint function; * vascular or nerve diseases affecting the concerned limb; * poor bone stock compromising the stability of the implant; * metabolic disorders which may impair fixation and stability of the implant; * any concomitant disease and dependence that might affect the implanted prosthesis; * metal hypersensitivity to implant materials. additional exclusion criteria: • female patients who are pregnant, nursing, or planning a pregnancy.

Keywords: total hip arthroplasty hip arthroplasty revision complex primary arthroplasty trabecular titanium
a phase 2 trial of rituximab and corticosteroid therapy for newly diagnosed chronic graft versus host disease

Conditions: Graft vs Host Disease

Summary: the addition of rituximab to prednisone for the initial treatment of chronic gvhd will increase the overall response rate, enable a more rapid and effective steroid taper.

to determine the efficacy of rituximab as first line of treatment of chronic gvhd. efficacy will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months without clinical or gvhd relapse/ recurrence.

Eligibility criteria:
inclusion criteria: * children and adults with a new diagnosis of chronic gvhd- that requires systemic immunosuppressive treatment to a dose of 1mg/kg/day prednisone and who have undergone any type of donor hematopoietic cell graft or conditioning regimen. * stable doses of other immunosuppressive medications (e.g. calcineurin inhibitors, mycophenolate mofetil) for 2 weeks prior to enrollment. in addition, these other immunosuppressive medications should not be dose increased. * men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. * all subjects must provide written informed consent. exclusion criteria: * known life-threatening hypersensitivity to rituximab or other anti-b cell antibody. * treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment. persistent prednisone treatment of acute gvhd that is less than 1mg/kg is allowed. * active, uncontrolled infection- cmv reactivation is excluded (i.e. pneumonitis, colitis). peripheral blood cmv reactivation is allowed as long as it is not associated with cmv disease and is responding to therapy. * known hepatitis b surface ag positive * active malignant disease relapse. * pregnancy * lactating * inability to comply with the rituximab treatment regimen.
s1p1 receptor subtype (s1pr1) axis in patients with interstitial cystitis (ic) pain

Conditions: Interstitial Cystitis

Summary: for each patient in the study, blood, and pain scores will be collected to look for markers for pain, at the start of treatment and 6 months after surgery of treatment.

the study is investigator-initiated, prospective, study. there will be no change in care. patients who have had a diagnosis of ic made by cystoscopy and hydrodistension and still have pain will be recruited for this study. patients will have blood samples taken at the visit they sign the consent form and 6 months later. the study staff will call and remind the patient of their 6 month visit.

Eligibility criteria:
inclusion criteria: * 18-70 years of age * patients must be able to provide written informed consent. * diagnosis of interstitial cystitis documented by provider exclusion criteria: * age \ 70 years of age * pregnant
a parallel group phase ii study of kct-0809 in patients with dry eye syndromes

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate the efficacy and safety of kct-0809 compared to placebo in patients with dry eye syndromes.


Eligibility criteria:
inclusion criteria: * corneal and conjunctival damage * insufficiency of lacrimal secretion * ocular symptom exclusion criteria: * severe ophthalmic disorder * punctual plugs or surgery for occlusion of the lacrimal puncta

Keywords: dry eye syndromes corneal diseases conjunctival diseases
spray skin treats for pediatric burns

Conditions: Pediatric Burn

Summary: the treatment of burns in children remains a global challenge. at present, the clinical treatment plan is still waiting for further improvement. this study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application.

the treatment of burns in children remains a global challenge. children's burn wounds have many characteristics that are different from those of adults, such as easy deepening of the wound, uncooperation in dressing change, poor resistance and so on. at present, there are new dressing applications a nd surgery in clinical treatment, etc., but how to treat children to achieve better therapeutic effects still needs to be explored. this study intends to retrospectively analyze the experience of treating children burn in recent years and promote sharing and application.

Eligibility criteria:
inclusion criteria: * burn for any reasons * children exclusion criteria: * combined with mental illness * congenital immune disease * severe cardiopulmonary failure，etc

Keywords: pediatric burn spray skin skin graft
laser puncture and program of lifestyle modification in lupus females

Conditions: Systemic Lupus Erythematosus

Summary: serum lipid profile was significantly dysregulated in female systemic lupus erythematosus (sle) patients

the research will recruit 64 female systemic lupus erythematosus (sle) obese patients to divide them to two study groups equally. the study groups will receive, for 12 weeks, energy expenditure program (pilates exercise, managed 5 times per week, combined with low calorie diet for).one group only will receive an additional laser puncture (with 3-time per-week design). the following points will be directly contacted by laser, for two minutes: gb34\&28, st25\&36\&40, sp6, and cv4\&9\&12.

Eligibility criteria:
inclusion criteria: * obese female participants * lupus females exclusion criteria: * pregnant lupus female * lactating lupus females * neurologic or articular disorders * another autoimmune conditions
an assessment of an attenuated live listeria vaccine in cin 2+

Conditions: Cervical Intraepithelial Neoplasia

Summary: cervical cancer is associated with human papilloma virus. about 57% of cervical cancer is the result of infection by human papilloma virus strain 16 (hpv-16). hpv is a very common virus that can affect the cells of the cervix. e7 is a substance that is made by the hpv virus which causes cervical cancer. the purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called lovaxin c against e7. the vaccine is designed to cause the immune system to react against the e7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.

worldwide, many women carry hpv and cervical cancer is the leading cancer killer of women under the age of 50. although its consequences are considerably less severe in the us, it leads to considerable morbidity. many published clinical trials describe the immunotherapeutic treatment of early stage, pre-invasive, cervical cancer. it is widely recognized that immunotherapies are most effective in early stage disease because the immune system is least debilitated and disease burden is lowest. invasive cervical cancer is preceded by a long, slowly progressive, pre-invasive phase termed cervical intraepithelial neoplasia (cin), which allows for this therapeutic approach. an ideal therapy would result in the remission of cin 2/3 without damage to cervical tissue. a national institute of cancer panel charged with achieving consensus on this issue concluded that a non-surgical medical treatment for this indication would be valuable the primary objectives of this trial are to test three doses of lovaxin c to determine if vaccination with lovaxin c in women with cin 2/3 for whom surgery is indicated can safely reverse the disease compared to placebo treated control patients. an earlier phase 1/2 trial of lovaxin-c in late stage metastatic cervical cancer used a regimen of two doses given with a 28-day interval. that regimen was shown to be safe and to generate reduction in tumor burdens in some patients. in this trial we will treat earlier stage disease in healthier patients with better immune systems, will use the same and lower doses as given before, but add an additional dosing to the regimen by administering the lowest dose that we assessed previously and by adding a third vaccination to the prior regimen. unlike the phase 1 trial in which 2 doses were given with a 3 week separation, dosing in the proposed trial will be separated by 4-week intervals.

Eligibility criteria:
inclusion criteria: * histologically confirmed cin 2/3 that requires surgical intervention exclusion criteria: * previous history of listeriosis * steroid use * antibiotic use * negative anergy panel * hiv positive * pregnant or actively trying during the treatment period * intercurrent disease

Keywords: cervical intraepithelial neoplasia stage 2/3