Kornimate/medical-research-clean huggingface dataset:
dose study of antithymocyteglobulin in haploidentical allogeneic stem cell transplantation

Conditions: Hematopoietic Stem Cell Transplantation

Summary: the purpose of this study is to compare the incidences of gvhd in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (atg) for acute graft-versus-host disease(agvhd) prophylaxis. the investigators' first objective was to investigate the optimal dose of atg for agvhd.

graft-versus-host diseases (gvhd) remains a major cause of morbility and mortality after allogeneic hematopoietic stem cell transplantation (hsct) with grafts from an hla-mismatched family donor. antithymocyteglobulin (atg) has been widely used to prevent acute gvhd (agvhd) in haploidentical hsct. notwithstanding, immunosuppressive effect of atg, which may also increase the risk of opportunistic infections, necessitates the use of the lowest possible dose. till now, the optimal dose of atg is not known. here, the investigators compared the outcome of patients receiving haploidentical hsct treated with two different doses of atg.

Eligibility criteria:
inclusion criteria: * haploidentical hematopoietic stem cell transplant recipient * subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: haploidentical hematopoietic stem cell transplantation antithymocyte globulin acute graft-versus-host disease antithymocyte globulin
green banana peel extract for melasma treatment

Conditions: Melasma

Summary: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.

objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. methods: it will be a clinical, interventional, longitudinal study, random sampling, sample will have 60 patients divided into two groups. in the control group, spf 30 sunscreen plus pharmaceutical formulation without green banana peel extract will be used, and in the study group, in addition to spf 30 sunscreen, pharmaceutical formulation containing green banana peel extract will be used. patients will undergo treatment for 90 days, evaluated every 30 days through clinical evaluation and melasqol.

Eligibility criteria:
inclusion criteria: * female patients with melasma. * patients aged 18 years or over and 60 years or less. * patients who agree to participate in the study. - exclusion criteria: * patients who have other types of facial hyperchromia. * patients who give up, for any reason, to continue treatment. * patients who have any type of allergic reaction to the product.

Keywords: melasma banana skin sunscreen
review of kidney biopsies of dent disease patients

Conditions: Dent Disease

Summary: this study is being done to obtain pathology reports from all patients in the dent disease registry who have had a kidney biopsy. the investigator will collect the biopsy slides and reports in an attempt to determine if they have any common findings.

if the patient agrees to be in the study, the patient will be asked to participate in the following: * sign a consent form indicating the patient's willingness to participate. * provide a signed medical release form allowing the investigator to request your official kidney biopsy reports, and also allowing the investigator to request the original slides for review. at the end of the study, all slides will be returned to the referring facility. * the investigator will also review your medical record

Eligibility criteria:
inclusion criteria: * all patients in the dent disease registry with a previous renal biopsy. exclusion criteria: * none.

Keywords: dent dents dent disease renal biopsy kidney biopsy clinical biopsy
effects of lutein in retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: phase i/ii double-masked, randomized, placebo-controlled, cross-over trial to determine effects of lutein on vision in retinitis pigmentosa, including safety and effective dosage assessment

retinitis pigmentosa (rp) is a group of congenital retinal degenerations affecting over 100,000 individuals in the us, characterized by nightblindness, gradual loss of peripheral vision, and eventually total vision loss. despite surgical and medical efforts it has not been possible to slow down, let alone reverse, the process of photoreceptor degeneration in rp. however, a recent patient-initiated pilot study demonstrated that rp patients may respond to a nutrition supplement (lutein) with a modest, but statistically significant gain in visual acuity and central visual field area; demonstration of these effects relied critically on frequent home vision tests using a letter chart on the screen of a personal computer and a wall chart to measure the central visual field. supporting the reliability of the data was a highly significant correlation between eye color and vision changes; eye color has earlier been shown to influence macular pigment changes following lutein supplementation. at this state, a study of long-term lutein benefits would be costly and, without placebo-controlled pilot data, premature. we are proposing to prepare for a long-term clinical trial through an exploratory study, investigating the effects of lutein and creating pc-based home vision tests. in the initial 6 months of the study, we will develop and adapt standard clinical vision tests for use on a personal computer, and recruit two study groups: 1) 42 rp patients to study the effects of lutein on vision, using placebo and 20 dosages in a randomized, double-masked crossover design (latin square, 2x16 weeks), testing for possible adverse effects through serum hepatic panels every 4-6 weeks, and measuring compliance through baseline and end-value serum carotenoid tests and frequent macular pigment density tests; 2) 31 other volunteers (10 normally signed, 21 rp patients) who, along with the first group, will monitor their vision every 1-2 weeks at home using the pc-based tests. results will be validated against those obtained with standards tests during multiple visits to our center. the results and tools produced by this study will enable a long-term lutein supplementation trial with vision as its principal outcome measure, and the study can serve as a model for other supplement trials. moreover, by virtue of the pc-based home vision tests developed as part of this study, such future trials may, under proper safeguards, enroll remote participants who would download test software, perform frequent outcome tests at home, submit test results via e-mail, and be examined periodically by local physicians to detect potential adverse effects.

Eligibility criteria:
staccato loxapine in agitated patients with schizophrenia

Conditions: Patients With Schizophrenia and Acute Agitation

Summary: phase 3 safety and efficacy study of staccato loxapine in the treatment of acute agitation in schizophrenic patients

this is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of staccato loxapine, 5 and 10 mg. patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. the primary endpoint is the change from baseline in the panss (positive and negative symptom scale) excited component (also known as pec) score, performed at 2 hours after the first dose.

Eligibility criteria:
inclusion criteria: * male and female adult patients with schizophrenia and acute agitation exclusion criteria: * agitation caused primarily by acute intoxication * history of drug or alcohol dependence * treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration

Keywords: schizophrenia, agitation, inhaled loxapine, adasuve
predicting if the blood pressure will drop after spinal anesthesia using ultrasound of the neck

Conditions: Spinal Anesthesia-induced Hypotension

Summary: after a spinal injection, blood pressure might drop for a short time, similar to what happens with general anesthesia. this drop can be different for each person. an anesthesiologist will use medicine to bring the blood pressure back to normal. if this drop could be predicted in advance, it would help the anesthesiologist treat it faster, making the procedure even safer and preventing side effects like dizziness or nausea.


Eligibility criteria:
inclusion criteria: * adult patients of either sex who are scheduled for elective surgery under spinal anesthesia, * who fasted for 6 hours or more exclusion criteria: * age \<18 years old * no informed consent for study participation * contra-indication for spinal anesthesia * emergency surgery * known poor left or right ventricular function / heart failure * moderate to severe valvular disease * atrial fibrillation * pacemaker rhythm * carotid artery stenosis \> 50% * history of cerebrovascular accident (cva) or transient ischemic attack (tia) * history of cerebral trauma * pregnancy * neck complaints * morbid obesity (bmi \> 40 kg/m2)

Keywords: spinal anesthesia-induced hypotension carotid doppler ultrasound common carotid artery corrected carotid flow time peak velocity variation
the role of meat-borne carcinogens in pancreatic cancer

Conditions: Pancreas Cancer

Summary: we propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. these subjects will ingest a very low dose of radiolabeled phip, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to dna in the pancreas.

pancreatic cancer is rapidly fatal in most cases and little is known about its causes. identifying and modifying risk factors can reduce mortality through prevention. carcinogens that form in meat cooked at high temperatures may be modifiable risk factors for pancreatic cancer, but direct evidence is needed to demonstrate involvement in pancreas tissue. we propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. these subjects will ingest a very low dose of radiolabeled phip, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to dna in the pancreas. we hypothesize that the meat-derived carcinogen will bind to dna in the pancreas. the amount of phip ingested is equivalent to the amount in two very well-done barbecued chicken breasts and the dose of radioactivity is comparable to a typical chest x-ray. this research can increase understanding of pancreatic carcinogenesis, facilitating the design of prevention strategies.

Eligibility criteria:
inclusion criteria: * at least 18 years old. * adequate hepatic function within 4 weeks of study enrollment defined as bilirubin ≤ 2 mg/dl and alt, ast, and alkaline phosphatase ≤ 2 times the upper limit of normal. * females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (i.e., a hormonal contraceptive. intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 4 months after phip administration. * voluntary written informed consent (phip consent and caffeine assay consent) before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care. exclusion criteria: * ca-19-9 equal to or above 400. * tumor size \>3.5 cm. * fluid in the abdomen (ascites). * conditions present, which, in the opinion of the surgeon, could make resection difficult, e.g., extensive vascular involvement. * pregnant or lactating (for women). * uncontrolled cardiovascular disease; e.g. hypertension, angina, etc. * patients who are intolerant of a 200 mg dose of caffeine or who otherwise do not wish to participate in the caffeine assay when consent is sought for the primary consent will be considered refusers and will not be enrolled in the study.

Keywords: heterocyclic amines phip meat pancreas neoplasms
online adaptive radiation therapy for rectal cancer

Conditions: Rectal Cancer

Summary: in the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (art) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.


Eligibility criteria:
inclusion criteria: 1. ≥18 years old; 2. diagnose with rectal cancer; 3. t3-t4 or n+, and no distant metastasis 4. neoadjuvant chemoradiotherapy intended; 5. surgery is expected after neoadjuvant therapy; 6. ecog score 0-2, expected to lie in the treatment bed for at least half an hour; exclusion criteria: 1. with contraindications to rectal mri; 2. received surgery, radiotherapy or chemotherapy for rectal cancer; 3. history of pelvic radiotherapy.

Keywords: rectal cancer adaptive radiation therapy
melatonin for sleep in ms

Conditions: Multiple Sclerosis

Summary: many people with ms report sleep disturbances. however, objective data on sleep quality in ms, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. altered melatonin regulation and signaling has been implicated in ms, through observations including (1) ms risk associated with shift work, (2) contribution of melatonin to seasonal risk of ms relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration. to the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in ms. to test this, we are conducting a randomized controlled pilot trial.


Eligibility criteria:
inclusion criteria: * adults aged 20-70 with a diagnosis of ms by 2010 mcdonald criteria or cis (clinically isolated syndrome), who report sleep disturbance as measured by a score \>=5 on the pittsburgh sleep quality index, or more specific insomnia symptoms (a score of \>14 on the insomnia severity index) over the past month. * participants must be able to read and write english exclusion criteria: * individuals with nocturnal asthma, use of melatonin or another sleep agent in the past 2 weeks, women attempting conception, relapse or steroids or infusible disease modifying therapies (dmts) in prior month. * non-english speaking individuals * individuals with hypertension, impaired liver function, or seizure disorder * individuals with untreated depression, as determined by a score greater than or equal to 8 points on the hads (hospital anxiety and depression scale)

Keywords: sleep melatonin sleep disturbance
fresh intravenous blood samples for tbi diagnostic assay development with philips point of care system

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (glasgow coma scale score 13-15) from subjects over the age of 18, to help verify that both uch-l1 and gfap can be detected with the philips minicare poc diagnostic test platform.


Eligibility criteria:
inclusion criteria: * the subject is at least 18 years of age at screening. * the subject has presented to a health care facility or emergency department with a suspected traumatically induced head injury, as a result of insult to the head from an external force. * the subject has a glasgow coma scale score of 13-15 at the time of informed consent. * the venous blood sample is collected no later than 12 hours from the time of head injury. * the subject is competent and willing to undergo the informed consent process exclusion criteria: * participating in any other interventional, therapeutic clinical study (an observational study would be acceptable). * time of suspected head injury cannot be determined. * venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., iv drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)). * blood transfusion after head injury, and prior to study blood draw * blood donation within 1 week of study enrollment. * the subject is a female who is pregnant or lactating. * the subject is otherwise determined by the principal investigator to be an unsuitable candidate for participation

Keywords: traumatic brain injury head injury
double-blind study of timunox (thymopentin) in asymptomatic hiv-infected patients receiving either mono (azt or ddi) or combination (azt / ddi or azt / ddc) anti-retroviral therapy

Conditions: HIV Infections

Summary: to confirm results from a previous study in which the combination of thymopentin plus zidovudine ( azt ), an antiretroviral agent, slowed disease progression in hiv-infected asymptomatic patients. to evaluate the efficacy and safety of thymopentin in hiv-infected asymptomatic patients receiving either monotherapy with azt, didanosine ( ddi ), or stavudine ( d4t ), or combination antiretroviral therapy with azt / ddi or azt / zalcitabine ( ddc ).


Eligibility criteria:
inclusion criteria patients must have: * asymptomatic hiv infection. * cd4 count 100-400 cells/mm3. * no hiv-associated neurologic abnormalities or constitutional symptoms. * no oral hairy leukoplakia. * at least 6 months of prior azt. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * abnormal chest x-ray, consistent with active opportunistic infection. * hypersensitivity to thymopentin. * significant chronic underlying medical illness. * grade 2 or worse peripheral neuropathy. concurrent medication: excluded: * hiv vaccines. * investigational or non-fda approved medication. * immunomodulatory therapies. * experimental therapies. * any antiretroviral therapy other than azt, ddi, ddc, d4t, or 3tc. patients with the following prior conditions are excluded: * herpes zoster (within the past year). * recurrent (\> one episode) oral candidiasis (confirmed). * vulvovaginal candidiasis (persistent, frequent, or poorly responsive to therapy). * bacillary angiomatosis. * listeriosis. * idiopathic thrombocytopenia purpura. prior medication: excluded at any time prior to study entry: more than one dose of thymopentin. excluded within 30 days prior to study entry: * hiv vaccines. * investigational or non-fda approved medication. * immunomodulatory therapies. * experimental therapies. * any antiretroviral therapy other than azt, ddi, ddc, d4t, or 3tc. required: * prior azt (\>= 300 mg/day) for at least 6 months; on current regimen (any combination of approved nucleoside analogues) for at least 4 weeks. significant active alcohol or drug abuse.

Keywords: thymopentin zalcitabine didanosine drug therapy, combination zidovudine stavudine
local and peripheral immune responsive landscape induced by local cryoablation in patients with lung adenocarcinoma

Conditions: Lung Adenocarcinoma; Local Cryoablation

Summary: the goal of this observational study is to learn about local and peripheral immune and metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. the main question it aims to answer are: * local and peripheral immune changes in patients with lung adenocarcinoma undergoing cryoablation. * local and peripheral metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. peripheral blood, biopsy tissues of patients will be collected at the baseline and after cryoablation. single-cell sequencing, single-cell immune bank, metabolomics and spatial metabolomics will be used to explore the local and peripheral immune changes and metabolites changes in patients with lung adenocarcinoma before and after cryoablation.


Eligibility criteria:
inclusion criteria: 1. primary or metastatic lung cancer with definite pathological diagnosis. 2. patients are not suitable for thoracotomy due to serious lung or systemic disease. 3. peripheral lung cancer involves pleura and chest wall, which cannot be completely removed by surgical resection. 4. there are indications for surgical resection, but the patient refuses surgery. 5. single tumor, maximum diameter ≤5cm; or the number of tumors ≤3, the maximum diameter ≤3cm. 6. ecog-ps score≤2. 7. patients with an expected survival of more than three months. 8. patients have not participated in other clinical validation within 3 months. 9. subjects voluntarily sign informed consent. exclusion criteria: 1. serious heart and brain disease or other mental illness. 2. severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis. 3. patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder, and multiple pulmonary bulla. 4. a history of immunodeficiency, including a positive hiv test (enzyme-linked immunoassay and western spot assay). 5. patients treated with chemotherapy, radiotherapy, interventional therapy, ablative therapy or surgery within 30 days before surgical treatment. 6. there is a serious bleeding tendency, platelets less than 50×109 /l and coagulation function is seriously disturbed. 7. coagulation index (pt, tt, aptt) \> 2.5 times the upper limit of normal. 8. ablation of ipsilateral malignant pleural effusion is not well controlled. 9. poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorders. 10. patients with extensive extrapulmonary metastasis are not suitable for ablative therapy. 11. people who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs. 12. pregnant or breastfeeding women. 13. patients who cannot evaluate the efficacy. 14. other conditions determined by the investigators to be unsuitable for inclusion, such as inability to tolerate cryoablation surgery, difficulty in follow-up, and other serious diseases.

Keywords: lung adenocarcinoma local cryoablation immune landscape metabolic changes
exercise and respiratory therapy in patients with rheumatoid arthritis / collagenosis and pulmonary hypertension

Conditions: Pulmonary Hypertension; Connective Tissue Disease

Summary: in patients with rheumatic disease exercise training is a well established element of therapy. in contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. this study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.


Eligibility criteria:
inclusion criteria: 1. informed consent 2. men and women 18 - 80 years 3. diagnosed rheumatic disease: rheumatoid arthritis, collagenosis (systemic lupus erythematodes, systemic sclerosis, sjögren-syndrome, sharp-syndrome, crest-syndrome, mixed connective tissue disease) 4. symptomatic pah (who- functional class ii-iv) invasively diagnosed by right heart catheterisation * mean pulmonary artery pressure (mpap) \> 25 mmhg * pulmonary capillary wedge pressure (pcwp) \> 15 mmhg * pulmonary vascular resistance (pvr) at baseline \>320 dyn.sec/cm5 patients under optimized medical treatment since at least 2 ½ months exclusion criteria: 1. other forms of pah. 2. pregnancy or lactation 3. change in medication during the last 2 ½ months 4. patients with signs of right heart decompensation 5. severe impairment of walking 6. unclear diagnosis 7. no invasive diagnosis of ph 8. acute illness, infection, fever 9. severe lung disease with fev1 \<50% and tlc\< 70% below reference