Kornimate/medical-research-clean huggingface dataset:
sirolimus in the treatment of refractory/relapsed waiha

Conditions: Warm Autoimmune Hemolytic Anemia

Summary: autoimmune hemolytic anemia (aiha) is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies. glucocorticoid (combined with rituximab) is the first-line treatment. however, the recurrence rate is very high and some patients may not respond to steroids. second-line therapies include cyclosporine a (csa), cyclophosphamide, rituximab, azathioprine, and even splenectomy. our previous study of sirolimus in refractory/relapsed aiha and es found an effective rate of 80%. therefore, the investigators plan to explore the efficacy and safety of sirolimus in the treatment of refractory/relapsed waiha.

based on the optimal autoantibody-rbc reactivity temperatures, aiha is classified into warm type, cold type, and mixed type. aiha can be further classified into primary or secondary in nature. glucocorticoid (combined with rituximab) is the first-line treatment. however, the recurrence rate is very high and some patients may not respond to steroids. second-line therapies include cyclosporine a (csa), cyclophosphamide, rituximab, azathioprine, and even splenectomy. the refractory/relapsed waiha patients have increased cardiovascular events, increased opportunities for infections, decreased quality of life, and even death. a prospective multi-institutional trial in autoimmune cytopenia found that 8 of 10 patients with aiha and evans syndrome respond to sirolimus. our previous study of sirolimus in refractory/relapsed aiha and es also found an effective rate of approximately 80%. since sirolimus is cheap and accessible, our findings may reduce the economic burden of patients and be a guide on the selection of second-line treatment drugs in refractory/relapsed waiha and evans syndrome.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old. 2. diagnosed as primary warm autoimmune hemolytic anemia or evans syndrome (primary or secondary). there is no treatment indication of other systemic involvement in the original disease if secondary. 3. no response to glucocorticoid therapy or recurrence. 4. baseline liver (alt, ast) was less than 2 times the normal value. 5. no active infection; not pregnant or breastfeeding. 6. agree to sign the consent form. exclusion criteria: 1. patients with connective tissue disease or other organs involvement 2. infection or bleeding that cannot be controlled by standard treatment. 3. active hiv, hcv or hbv infection or cirrhosis or portal hypertension. 4. progressed uncontrolled malignant tumors and lymphoma 5. cirrhosis or portal hypertension. 6. pregnant or breastfeeding.

Keywords: warm autoimmune hemolytic anemia evans syndrome refractory/relapsed sirolimus efficacy
a study to assess the safety and efficacy of ruxolitinib cream in participants with genital vitiligo

Conditions: Nonsegmental Vitiligo With Genital Involvement

Summary: an open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (bid) to all depigmented areas (up to 10% bsa) for up to 48 weeks. participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of nonsegmental vitiligo with genital involvement * at least ≥ 0.25% bsa of nonsegmental vitiligo in the genital area. * pigmented hair within some of the genital vitiligo areas. * at least 1 genital target lesion that is ≥ 0.1% bsa that has a pigmented hair within it. * vitiligo on areas of the body besides the genitals. * total body vitiligo area not exceeding 10% bsa. * willing to have genital photography conducted. * must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted. exclusion criteria: * other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders. * prior or current use of depigmentation treatments (eg, monobenzone). * active or recurrent genital warts or herpes. * male participants with partners with known current/active cervical intraepithelial neoplasia or anal intraepithelial neoplasia. * an active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum). * had ≥ 3 laser hair removal treatments in an area to be treated for vitiligo. * any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study or interpretation of study data. * clinical laboratory test results outside of protocol defined ranges * pregnant or lactating participants, or those considering pregnancy during the period of their study participation.

Keywords: vitiligo genital vitiligo incb18424 ruxolitinib cream
a study of ly317615 in patients with brain tumors

Conditions: Malignant Glioma

Summary: 1. the safety of ly317615 and any side effects that might be associated with the drug. 2. whether ly317615, can help patients with brain tumors.


Eligibility criteria:
inclusion criteria: * you must be at least 18 years old * you must have been diagnosed with a recurrent brain tumor by mri or ct scan * you must be able to swallow the ly317615 tablets exclusion criteria: * you are a woman who is pregnant or breastfeeding * in view of your doctor, you have significant heart, liver, kidney, or psychiatric disease
"nava-pav" study: a cross-over comparative study of 2 advanced modes

Conditions: Critical Illness; Mechanical Ventilation; Intensive Care; Ventilation Weaning

Summary: neurally adjusted ventilatory assist (nava) and proportional assist ventilatory plus (pav +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for nava and to patients efforts for pav +. the goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between nava and pav+.

twenty patients will be enrolled. they will be ventilated with pav+ and nava for one day, each in a randomized crossover order. the oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.

Eligibility criteria:
inclusion criteria: * estimated remaining duration of mechanical ventilation for more than two days * patient alert and calm * surrogate decision maker's consent exclusion criteria: * clinical contraindication for the use of nava: contraindications for an eadi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery) * clinical instability for any reason * contraindications for continuing intensive care treatment * patient under tutelage * age \< 18 years * pregnancy * no french health insurance

Keywords: sleep pattern mechanical ventilation weaning intensive care nava (neurally adjusted ventilatory assist) pav+ (proportional assist ventilation plus)
local 5-fluorouracil injection for the treatment of chalazia: a prospective, comparative study

Conditions: Chalazion

Summary: local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection of triamcinolone (steroid) and incision and curettage for treatment of chalazia.

this is a prospective randomized interventional study comparing four current standard-of-care treatments for chalazia: incision and curettage, local injection of triamcinolone, local injection of 5-fu, and local injection of combination triamcinolone/5-fu.

Eligibility criteria:
inclusion criteria: * single or multiple chalazia in a single eyelid exclusion criteria: * chalazia present for less than one month and no previous injection or incision and curettage

Keywords: size pain resolution complications swelling
hybrid type-1 effectiveness-implementation trial of motivation matters!

Conditions: HIV Antiretroviral Therapy (ART) Adherence

Summary: the goal of this clinical trial is to learn if an interactive mhealth intervention will be effective in helping hiv-positive women in high-burden settings who are initiating antiretroviral therapy (art) take their art regularly as prescribed, effectively reducing their viral load. the main question it aims to answer is: - compared to standard of care, will motivation matters! (mm!) be significantly more effective at achieving undetectable viral load in women with hiv by month six. researchers will compare the undetectable hiv viral load in women who receive individualized text messages (intervention group) in addition to standard care to those who receive standard care alone (control group). participants in the intervention group will receive three messages per week in month one, then two messages per week for the six-month intervention period. participants will be asked to send a brief, standardized reply to each message, indicating that they are doing well or that they have a question or problem. regardless of study arm, women will receive art and counseling consistent with kenyan guidelines.


Eligibility criteria:
inclusion criteria: * age \>18 * transactional sex in past 12 months * hiv-positive * not currently on art * enrolled in one of the sex workers outreach program clinics * has access to mobile phone * willing to receive study text messages * able to read or have someone else read exclusion criteria: * plans to move away in next 6 months * undetectable viral load at baseline * pregnant
comparison of pupilometer and ultrasound of optic nerve sheath diameter in estimating intracranial pressure (icp)

Conditions: Intracranial Hemorrhages; Brain Injuries; Subarachnoid Hemorrhage; Ischemic Stroke; Stroke

Summary: the purpose of this investigator-initiated study is to compare the use of pupilometer and ultrasound assessment of optic nerve sheath diameter in predicting the icp and to see if there is a value that could be used to indicate elevated icp with either modality as these numbers are inconsistent throughout the literature. patients that have either an external ventricular drain (evd) or bolt placed will be enrolled in the study. after the evd and bolt are placed the patient will undergo pupilometer examination (standard of care) followed by ultrasound assessment of the optic nerve sheath diameter (onsd). the three values will be recorded. the same patient may have multiple readings performed if there is a change in icp either spontaneously or due to intervention.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old * intracranial pathology requiring either evd or bolt placement for icp measurement exclusion criteria: * known disorder of lens or orbit including but not limited to glaucoma, cataract, blindness, lens implants. * patients unable to close eyelids as this would increase risk of corneal abrasion from ultrasound probe.

Keywords: external ventricular drain (evd) placement of bolt
ivl for stent underexpantsion

Conditions: In Stent Restenosis; Coronary Artery Calcification; Intravascular Lithotripsy

Summary: the ivl-dragon registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with ivl in high-volume pci centers. the primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to \<30% with no evidence of in-hospital device-oriented composite end point (doce) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).


Eligibility criteria:
inclusion criteria: * stent underexpansion treated with intravascular lithotripsy (ivl) exclusion criteria: * no
evaluation of a range of dermo-cosmetic products to treat skin and nail toxicity linked to bispecific anti-gprc5d bispecific antibodies in multiple myeloma patients". myeloma". descriptive pilot study

Conditions: Myeloma Multiple

Summary: the aim of this study is to assess the efficacy of range of dermo-cosmetic products (hand/feet serum, nail strengthening solution nail strengthening solution, dissolving oil and gloves/slippers) based on natural products and designed for cancer patients)on bispecific ac-induced skin and nail toxicity in mm patients treated with anti-cd3xgprc5d bispecific antibodies. the effects of supportive care products will be studied as a preventive measure in patients starting treatment with bispecific ac and as a curative measure in patients undergoing treatment. patients will be able to apply the products directly at home according to the study schedule, and a skin and nail toxicity skin and nail toxicity will be performed each time the patient comes for administration of bispecific ac. follow-up will be for a total of 6 months (or less if progression occurs earlier), and patients will be asked to complete a quality-of-life questionnaire at protocol inclusion and after 1 month and 6 months of supportive care.


Eligibility criteria:
inclusion criteria: 1. mm patient. 2. patient starting anti-gprc5d bispecific ac therapy or patient undergoing anti-gprc5d bispecific ac therapy with nci-nctcae v5.0 grade ≥2 skin and nail toxicity. 3. patient with written consent. exclusion criteria: 1. patients treated or considering treatment with dermatological drugs (dermocorticoids) normally used for hand-foot syndrome or dermo-cosmetic products (serum or reparative solutions) other than those tested. 2. patients with atomic dermatitis (eczema) 3. patients allergic to one or more components of the products tested. 4. pregnant or breast-feeding women. 5. patients who are minors or under legal protection (guardianship or safeguard of justice). 6. patient not affiliated to a social security scheme.
gene expression profiling in patients with invasive bladder cancer receiving methotrexate, vinblastine, doxorubicin, and cisplatin

Conditions: Bladder Cancer

Summary: rationale: drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) may kill more tumor cells. evaluating blood or tissue samples from patients with cancer may help doctors learn more about changes that occur in dna, identify biomarkers related to cancer, and predict how well patients will respond to combination chemotherapy. purpose: this phase ii trial is studying gene expression profiling to see how well it works in predicting response to treatment in patients with invasive bladder cancer receiving methotrexate, vinblastine, doxorubicin, and cisplatin.

objectives: primary * analyze the correlation between gene expression profile and the effect of chemotherapy and detect the significant cluster of genes useful to predict chemosensitivity. * confirm the reduction in original tumor size in patients with invasive bladder cancer treated with methotrexate, vinblastine, doxorubicin hydrochloride, and cisplatin. secondary * determine the safety of this regimen in these patients. * determine the overall survival rate in patients treated with this regimen. * assess the reduction in size of metastatic lesions in patients treated with this regimen. outline: this is a multicenter study. patients receive methotrexate on days 1, 15, and 22, vinblastine on days 2, 15, and 22, doxorubicin hydrochloride and cisplatin on day 2. treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. patient samples will be collected for gene expression profiling. after completion of study treatment, patients are followed for 3 years.

Eligibility criteria:
disease characteristics: * diagnosis of invasive bladder cancer * must be confirmed by chest and abdominal ct scan or pelvic mri scan and transurethral biopsy (with definitive muscle invasion \> t2) within 4 weeks prior to registration patient characteristics: * ecog performance status 0-1 * wbc ≥ 3,000/mm\^3 * neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * total bilirubin ≤ 1.5 mg/dl * serum creatinine ≤ 1.5 mg/dl * ast and alt ≤ 2.5 x upper limit of normal * not pregnant * no liver cirrhosis * no ischemic cardiovascular disease or arrhythmia for which treatment is necessary * no cardiac infarction within the past 6 months * no interstitial pneumonia, pulmonary fibrosis, or any other diseases by which oxygen inhalation therapy is needed * no active cancerous lesion other than upper urinary tract tumor * no high fever or any other infectious symptom * no uncontrolled hypertension or diabetes mellitus prior concurrent therapy: * no prior systemic chemotherapy

Keywords: recurrent bladder cancer stage ii bladder cancer stage iii bladder cancer stage iv bladder cancer
computer aided diagnostic tool on computed tomography images for diagnosis of retroperitoneal tumor in children

Conditions: Wilms' Tumor; Neuroblastoma; Teratoma; Lymphoma; Sarcoma; Germ Cell Tumor

Summary: the aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for retroperitoneal tumor using machine learning and deep learning techniques on computed tomography images in children.

the retroperitoneal space extends from the lumbar region to the pelvic region and houses vital structures such as the kidney, the ureter, the adrenal glands, the pancreas, the aorta and its branches, the inferior vena cava and its tributaries, lymph nodes, and loose connective tissue meshwork along with fat. this space thus allows the silent growth of primary and metastatic tumors, such that clinical features appear often too late. the therapeutic regimen differs on various types of retroperitoneal tumor in children. it is damaging for pediatric patients to acquire histological specimens through invasive procedures. hence, an urgent evaluation is absolutely necessary for preoperative diagnosis in such cases via noninvasive approaches. this study is a retrospective-prospective design by west china hospital, sichuan university, including clinical data and radiological images. a retrospective database was enrolled for patients with definite histological diagnosis and available computed tomography images from june 2010 and december 2020. the investigators have constructed deep learning and machine learning radiomics diagnostic models on this retrospective cohort and validated it internally. a prospective cohort would recruit infantile patients diagnosed as retroperitoneal tumor since january 2021. the proposed deep learning model would also be validated in this prospective cohort externally. the aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for retroperitoneal tumor using machine learning and deep learning techniques on computed tomography images in children.

Eligibility criteria:
inclusion criteria: * age up to 18 years old * receiving no treatment before diagnosis * with written informed consent exclusion criteria: * clinical data missing * unavailable computed tomography images * without written informed consent
mitochondrial energy metabolism in obese women

Conditions: Metabolism Disorder; Mitochondrial Alteration; Physical Activity; Obesity

Summary: considering that the failure of the treatment of obesity is justified by the multifactorial pathophysiology of this morbidity, the present project has the following hypotheses: 1. the occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ; 2. the unbalance is therapeutically modified through physical training ; 3. obesity courses with the break-down in energy metabolism mitochondrial disease associated with systemic inflammatory characteristics that can be corrected through a combined long-term physical training program. this study have as objective : to analyse changes in mitochondrial function, inflammatory profile, oxidative stress and energy metabolism caused by concurrent physical training in obese women.

specific objectives: body composition by deuterium oxide; metabolic rate of resting and oxidation of substrates by indirect calorimetry; proinflammatory cytokines anti-inflammatory cytokines oxidative stress: malondialdehyde, superoxide dismutase, glutathione-peroxidase; fatty acids: ceramide and palmitate; mitochondrial respiration and citrate synthase enzyme; quantify and qualify: mitochondrial number, endoplasmic reticulum structure, adipose cell size; gene expression, quantify by microscopy and analyze the protein by western blot. the study began with 20 women, however, there was withdrawal of 6, ending with 14 women.

Eligibility criteria:
inclusion criteria: * this study included women with obesity (bmi of 30 to 40 kg / m²), sedentary, with no associated comorbidity, convenience sample exclusion criteria: * women who have undergone bariatric surgery, menopause, cancer or any metabolic disease, smokers, alcoholics, who are in use of drugs that act directly on the metabolism and that have medical impediment to the practice of physical exercise.
genetic study of patients with primary ciliary dyskinesia

Conditions: Primary Ciliary Dyskinesia

Summary: objectives: i. characterize the clinical presentation of patients with primary ciliary dyskinesia. ii. identify the genetic mutations associated with this disease.

protocol outline: participants undergo a scrape biopsy acquisition of nasal cells for ciliary studies, a chest radiograph, sinus radiographs, lung function tests, sputum cultures, nitric oxide measurement, and an ear, nose and throat evaluation to screen for primary ciliary dyskinesia (pcd). blood collection and/or a buccal scrape is also performed for genetic studies. genetic studies include molecular linkage analyses, genetic mapping, and gene mutation identification based on large deletions. microsatellite markers are used to identify polymorphism. genetic counseling is provided to all participants.

Eligibility criteria:
* histologically or cytologically confirmed primary ciliary dyskinesia (pcd) * family members of patients with pcd

Keywords: cardiovascular and respiratory diseases genetic diseases and dysmorphic syndromes primary ciliary dyskinesia rare disease
expanded access to epcoritamab

Conditions: Lymphoma

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to epcoritamab prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: - the participant must not be eligible for an epcoritamab clinical trial.

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme
help in the emergency room to detect organ dysfunction

Conditions: Sepsis; Critical Illness

Summary: the purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including heparin binding protein (hbp), procalcitonin (pct), c-reactive protein (crp), white cell count (wcc) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness the hbp assay is an enzyme-linked immunosorbent assay (elisa) for the quantitative determination of heparin binding protein in human plasma.


Eligibility criteria:
inclusion criteria: i) ≥18 years of age ii) 1 or more of the following criteria: saturation\ 25/min, altered mental awareness, heart rate \>120/min, systolic blood pressure \<100 mm hg. iv) informed consent. exclusion criteria: none