Kornimate/medical-research-clean huggingface dataset:
assessment of histologic prognostic factors in peritoneal malignant mesothelioma

Conditions: Peritoneal Malignant Mesothelioma

Summary: malignant peritoneal mesothelioma is a rare neoplasm. the most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. its prognosis is improved by the use of a locoregional treatment combining extensive cytoreductive surgery (crs) and hyperthermic intraperitoneal chemotherapy (hipec), which increases survival up to 50 months. histology is one of the most important prognostic variable that, forms the basis for treatment decisions. however, the prognostic of the epithelioid type varies greatly due to its tumor heterogeneity. it is therefore necessary to find prognostic factors of malignant epithelioid peritoneal mesothelioma in order to better define the therapeutic strategy. among histological factors, solid growth, tumor necrosis, nuclear atypia, and mitotic count were found to be independent prognostic factors in epithelioid malignant pleural mesothelioma. however, in epithelioid malignant peritoneal mesothelioma (empm), these factors were studied in small and heterogeneous series in terms of histological growth and definitions used for histological factors. the present large study was conducted to investigate the prognostic impact of several histologic factors in empm. their prognosis impacts were assessed using overall survival (os) and progression-free survival (pfs) in empm.


Eligibility criteria:
inclusion criteria: * - peritoneal malignant mesothelioma exclusion criteria: * opposition to reuse personnal data

Keywords: prognostic factors peritoneal malignant mesothelioma mesothelioma
optimizing perioperative analgesia to lower pain following cleft palate surgery

Conditions: Cleft Palate; Pain; Postoperative Care; Perioperative Care; Children

Summary: the purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following cleft palate surgery in infants and young children.

this is a single center, randomized, double blind, parallel-group dose escalation investigation in infants and children undergoing cleft palate surgery which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as perioperative analgesics. surgical and anesthesia care, except for opioid management, are not altered for study purposes. subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. exploratory data will be collected for up to 30 days post-operatively.

Eligibility criteria:
inclusion criteria: * age 6 months to 4 years of age * primary cleft palate repair * signed informed consent by parent or legal guardian exclusion criteria: * history of chronic kidney or liver disease * planned admission to the pediatric intensive care unit (picu) * additional procedures under general anesthesia for which opioids would be prescribed * any patient ineligible for study participation at the discretion of the investigators

Keywords: cleft palate surgery perioperative pain management analgesia methadone
a test and treat strategy in new hiv diagnosis.

Conditions: HIV-1-infection

Summary: this is an open-label, single arm, single-centre prospective study to evaluate the feasibility, efficacy and safety of a once daily fixed dose combination regimen, biktarvy, as a rapid treatment strategy in newly hiv diagnosed patients that come for the first time to the hospital clínic hiv unit patients with confirmed hiv-1 diagnosis who wish to start arv treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir alafenamide 25 mg within the first week since the hiv-1 confirmation during 48 weeks.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old. 2. having confirmed hiv-1 positive test. 3. patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months). 4. clinically stable patients, in the opinion of the investigator, at the time of inclusion. 5. women of child-bearing potential\* must have a negative pregnancy test in urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. highly effective contraceptive methods will include: hormonal contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized partner or sexual abstinence. 6. written informed consent. exclusion criteria: 1. pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period. 2. suspicion of an active opportunistic infection that defers initiating antiretroviral treatment \> 7 days since hiv confirmation. 3. known hypersensitivity or intolerance of any of the components of biktarvy®. 4. patients on treatment with any prohibited medication (see section 5.2: concomitant, nonpermitted and permitted medication). 5. any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.
effect of shorten gonadotropin-releasing hormone agonist therapy on the outcome of in vitro fertilization-embryo transfer in patients with endometriosis

Conditions: Clinical Pregnancy Rate

Summary: gonadotropin-releasing hormone analogue (gnrh-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. since endometriosis is an estrogen-dependent disease, the use of long-acting gnrh-a can control the growth of endometriosis by inhibiting ovary function.some scholars have found that, for adenomyosis patients who received a super long protocol (pretreatment of long-acting gnrh-a for 1-2 months) in ivf treatment, the pregnancy outcome is comparable to that of the controls with normal uterus. thus, the aim of this study is to compare the clinical pregnancy rate in patients treated with gnrh-a for 1, or 2 months.


Eligibility criteria:
inclusion criteria: * first ivf cycle; * with normal ovarian reserve(fsh(10miu/ml； antral follicle count )3) * with normal uterine exclusion criteria: * pre-implantation genetic diagnosis cycles; * oocyte donation cycles

Keywords: endometriosis long term gnrh-a
effects of movement representation techniques with sensorimotor training for rotator cuff related shoulder pain

Conditions: Rotator Cuff Related Shoulder Pain

Summary: the aim of this study is to evaluate the efficacy of 12 weeks of sensorimotor training with movement representation techniques for reducing pain intensity in people with rotator cuff related shoulder pain, relative to standard care. besides, the secondary aim of this study is to explore the mechanisms underlying the effects of central mechanism treatment in people with rotator cuff related shoulder pain. a total of 122 older adults aged 50 or above with the presence of shoulder pain for more than three months will be recruited and randomized into 12-weeks of movement representation techniques with sensorimotor training vs. standard care. shoulder pain and disability index (spadi), changes in primary motor cortex (m1) using brain mri, changes in subacromial space using ultrasound imaging, widespread pain index (wpi), pain catastrophising scale (pcs), and fear-avoidance beliefs questionnaires (fabq) will be assessed at baseline and 12-week post intervention.


Eligibility criteria:
inclusion criteria: * aged 50 or above * presence of shoulder pain for more than three months * clinical test showed 3/5 positive tests (painful arc, resisted external rotation, neer test, kennedy-hawkins test, and jobe test), and the intensity of pain being provoked should be ≥ 3/10 on an 11-point numeric pain rating scale (nprs) * structural changes of rotator cuff tendons using mri or ultrasound imaging exclusion criteria: * history of trauma * shoulder fracture, glenohumeral osteoarthritis, or arthritis in the acromioclavicular joint * clinically suspected labrum lesion * previous shoulder surgery or dislocation * clinical signs of anterior shoulder instability * clinical signs of frozen shoulders * previous clinical treatment or corticosteroid injection for a shoulder injury within the last 12 months * symptoms referred from or related to the spine; and (9) other competing diagnoses (i.e., rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, or psychiatric illness).
clinical trial to evaluate the pk and safety of bcd-201 and keytruda® in patients with advanced malignancies

Conditions: Melanoma; Non Small Cell Lung Cancer

Summary: clinical study bcd-201-1 is a double-blind randomized study of the pharmacokinetics (pk), pharmacodynamics (pd), safety, and immunogenicity of bcd-201 versus keytruda following intravenous administration to subjects with advanced unresectable, metastatic, or recurrent melanoma and nsclc. the study aimed to establish the equivalence of pk and similarity of the safety, immunogenicity, and pd profiles of bcd-201 and keytruda.


Eligibility criteria:
inclusion criteria: * signed informed consent; * body weight 60 to 90 kg; * histologically confirmed melanoma or nsclc (patients with nsclc are eligible to participate if high tumor pd-l1 expression \[≥50%\] is confirmed by local or central laboratory results); * ecog score 0-1; * laboratory test results consistent with adequate functioning of systems and organs; * willingness of males and females of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and within 6 months after the administration of the last product dose exclusion criteria: * indications for radical therapy (surgery, radiation therapy); * previous systemic anti-tumor therapy for advanced unresectable, recurrent or metastatic melanoma or nsclc (history of neoadjuvant or adjuvant therapy is acceptable provided that the treatment was completed at least 6 weeks prior to randomization); * active metastases in the central nervous system and/or carcinomatous meningitis; * patients with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing the informed consent and during the screening period; * for patients with nsclc: presence of activating egfr mutations/alk translocations; * concomitant diseases and/or conditions that significantly increase the risk of aes during the study; * active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders \[vitiligo, alopecia, or psoriasis\] not requiring systemic therapy are eligible to participate); * the need for therapy with glucocorticoids or any other drugs with immunosuppressive effects within 14 days prior to randomization; * history of (non-infectious) pneumonitis requiring glucocorticoid therapy or pneumonitis at the time of screening; * hypersensitivity or allergy to any of the pembrolizumab product components; * pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.
influence of osmotic stimulation of vasopressin on autonomic function

Conditions: Water Stress; Body Water Dehydration

Summary: the regulation of total body water that defines human hydration status is a complex and dynamic process. current methods of assessing hydration status (e.g. hematologic and urinary analyses) lack the ability to track changes in hydration status in real-time due to whole-body homeostatic physiologic processes required to maintain central pressure and cardiovascular function. this project will address this problem by assessing the relationship between autonomic function (measured using heart rate variability), a brain-derived process that regulates cardiovascular function, and changes in the hydration-mediated hormone vasopressin.


Eligibility criteria:
inclusion criteria: * males and females between the ages of 18 - 35 exclusion criteria: * 1) evidence of clinically relevant diseases that may alter body water regulation (e.g., diabetes, kidney disease, metabolic disorders, cardiovascular disease, and other potential fluid balance covariates such as habitual use of non-steroidal anti-inflammatory drugs or serotonin reuptake inhibitors, 2) previous surgery on the digestive tract that may impair the body's ability to normally regulate body water, 3) regular drug treatment within the previous 15 days, 4) actively attempting to gain or lose body weight, 5) for female participants, testing will take place during the early follicular phase of their menstrual cycle (days 1-8) to maintain consistency in the hydration status measures as total body water fluctuates over the course of the menstrual cycle. females who are currently using contraceptives (e.g., iud) that limit the number of menstrual cycles occurring in a given year will be excluded from this study to ensure accuracy in the testing periods for this study.

Keywords: vasopressin heart rate variability cardiovascular function autonomic function
intraperitoneal infusion of ex vivo-cultured allogeneic nk cells in recurrent ovarian carcinoma patients

Conditions: Recurrent Ovarian Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Primary Peritoneal Carcinoma

Summary: this study investigates an innovative treatment for recurrent ovarian cancer exploiting ex vivo-generated allogeneic natural killer (nk) cells with or without preceding non-myeloablative conditioning chemotherapy.

this study investigates an innovative treatment for recurrent ovarian cancer exploiting ex vivo-generated allogeneic natural killer (nk) cells with or without preceding non-myeloablative conditioning chemotherapy. this study is a phase i safety and feasibility study in a series of 12 patients who are suffering from recurrent ovarian, fallopian tube or primary peritoneal cancer. prior to nk cell infusion, a laparoscopy is performed to place a catheter in the peritoneal cavity. the first cohort of three patients will receive an intraperitoneal infusion of allogeneic ucb-nk cells generated ex vivo from cd34+ hematopoietic progenitor cells obtained from an allogeneic ucb unit without a preparative regimen. in the second group of three patients the same ucb-nk cell dosage will be given with a preparative regimen of four days non-myeloablative immunosuppressive conditioning regimen with cyclophosphamide and fludarabine (cyflu). if no severe toxicity is seen in these 6 patients, an extension cohort of 6 patients will be included to answer the secondary objective.

Eligibility criteria:
inclusion criteria: * patients suffering from their second recurrence of ovarian, fallopian tube or primary peritoneal cancer, with an elevated serum level of ca-125 on two successive time points with 28 days in between, reaching a value of more than 2 times nadir and above 35 u/ml without gastrointestinal symptoms. * able to undergo laparoscopic ip port placement and ip treatment administration * adequate organ function * age 18 years or older * age under 76 years. * karnofsky performance status \>70% (see appendix 2) * life expectancy \> 6 months * at least 28 days after last anti cancer treatment, before start of preparative regimen * written informed consent * availability of a partially hla-matched ucb unit exclusion criteria: * patients on immunosuppressive drugs * patients with active infections (viral, bacterial or fungal) that requires specific therapy. acute anti-infectious therapy must have been completed within 14 days prior to study treatment * laparoscopic adhesion score \>4 out of 9. * severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease (appendix 4) * severe pulmonary dysfunction (ctcae iii-iv) (appendix 4) * severe renal dysfunction (mdrd\<50) (appendix 4) * severe hepatic dysfunction (serum bilirubin or transaminases \> 3 times normal level) (appendix 4) * severe neurological or psychiatric disease
the efficacy of 5-fluorouracil/mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Lung Metastasis

Summary: the aim of this study is to evaluate the efficacy of 5-fluorouracil + mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.

extrahepatic metastasis of hepatocellular carcinoma has recently been paradoxically increasing due to increased survival with effective locoregional therapies. sorafenib is the first systemic agent that has demonstrated a significant survival benefit in patients with advanced hcc; however, the modest improvement of 3 months is far from satisfactory. there is no convincing evidence, to date, that systemic chemotherapy when tumor progresses after sorafenib therapy improves overall survival. the combination of anticancer agents is important to achieve favourable clinical results. for patients with metastatic liver cancer or hcc, some studies have discussed the effectiveness of 5-fluorouracil/mitomycin(fm). however, few studies have examined the actual fm regimen for hcc. the aim of this study is to evaluate the efficacy of 5-fluorouracil/mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.

Eligibility criteria:
inclusion criteria: * patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (rfa, pei, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver ct or liver mri) after the locoregional therapy * patients who have measurable lung metastasis * patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib * patients who have risk factors of hepatocellular carcinoma (chronic hepatitis b, chronic hepatitis c, liver cirrhosis) * age : 18 years to 80 years * ecog performance status of 0 to 2 * child-pugh class a,b (child-pugh score 5-9) * adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * wbc count \> 1,000/mm3 * absolute neutrophil count \> 500/mm3 * hb \> 7.0 g/dl * platelet count \> 50,000 /mm3 * bilirubin \< 3 mg/dl * adequate clotting function: inr \< 2.3 or \< 6sec exclusion criteria: * child-pugh score \> 10 * ecog performance status \> 3 * history of organ allograft * patients with uncontrolled co-morbidity which needs treatment * patients who have received prior systemic chemotherapy except sorafenib

Keywords: hepatocellular carcinoma lung metastasis 5-fluorouracil/mitomycin
a study investigating the influence of hepatic insufficiency on the pharmacokinetics of vaniprevir (mk-7009-005)

Conditions: Hepatitis C

Summary: this was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (mk-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. the primary hypothesis is that the area under the curve (auc) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.


Eligibility criteria:
inclusion criteria: hepatic participants: * females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study * apart from hepatic insufficiency, is in good general health * has a diagnosis of chronic stable hepatic insufficiency * score on the child-pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7 to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency). moderate and severe participants must have had a 50% score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the prestudy visit. healthy matched participants: * females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study * is in good health exclusion criteria: * female is pregnant, lactating, expecting to become pregnant or donate eggs * has a history of stroke or seizures * has a history of cancer * is unable to refrain from the use of any prescription or non-prescription medication * consumes excessive amounts of alcohol or caffeinated beverages daily * has had surgery, donated blood or participated in another investigational study with in the last 4 weeks * is a regular user or past abuser of any illicit drug including alcohol
a phase ii study to evaluate the efficacy of thromboview® in the detection of pulmonary emboli

Conditions: Acute Pulmonary Embolism

Summary: the aim of the study is to determine the diagnostic accuracy of 99mtc thromboview® spect imaging for the detection of acute pulmonary embolism (pe) in patients for whom there is a moderate to high clinical suspicion for pe.


Eligibility criteria:
inclusion criteria: 1. written consent by the subject to participate in the study. 2. moderate to high pre-test probability of acute pulmonary embolism. 3. positive d-dimer. 4. onset of pe symptoms occurring within the last seven days. 5. aged 18 years or older. 6. women of childbearing potential must have a negative serum pregnancy test (β-hcg) result at the time of enrollment into the study. both male and female participants must agree to use effective contraception for the first 30 days after administration of 99mtc thromboview®. exclusion criteria: 1. the subject is unwilling or unable to provide written informed consent. 2. allergy or other contraindication to intravenous iodinated contrast media. 3. prior exposure to murine, chimeric or humanized antibodies. 4. illicit intravenous drug use in the past 12 months. 5. administration of therapeutic radioiodine in the past 6 months. 6. life expectancy less than 90 days. 7. previous participation in the current study. 8. current enrollment in a clinical trial involving any other investigational agent. 9. subject is unsuitable for spect scanning at the study investigator's discretion (e.g. residual detectable radioactivity within the lungs due to prior imaging studies or treatment, preceding planned administration of 99mtc thromboview®). 10. inability to perform ctpa or 99mtc thromboview imaging, for any reason. 11. renal dysfunction: calculated creatinine clearance \< 30 ml/min. 12. hepatic dysfunction: serum transaminases ≥ 3 x upper limit of normal range. 13. hepatic dysfunction: subject has history of chronic or currently active liver disease. 14. current pregnancy or lactation or conception intended within three months of enrollment. 15. subject is unsuitable for the study at the study investigator's discretion. -

Keywords: pulmonary embolism pe