Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of smart101 in pediatric and adult patients with hematological malignancies after t cell depleted allo-hsct

Conditions: Hematological Malignancies

Summary: the purpose of this study is to evaluate the safety and the efficacy of smart101 (human t lymphoid progenitor (htlp)) injection to accelerate immune reconstitution after t cell depleted allogeneic hematopoietic stem cell transplantation (hsct) in adult and pediatric patients with hematological malignancies.


Eligibility criteria:
inclusion criteria: group a (adults): 1. adult patients affected by: * acute leukemia (aml, all) defined as: * acute myeloid leukemia (aml): * high risk aml in cr1; any adverse genetic abnormality, secondary or therapy related aml excluding good risk genetic abnormalities * chemo-refractory relapse (mrd+) * ≥ cr2 * acute lymphoblastic leukemia (all): * chemo-refractory relapse (mrd+) * high risk all in cr1; philadelphia (like) or any poor risk feature * ≥ cr2 * acute leukemia of ambiguous lineage: * ≥ cr1 with a minimal residual disease (mrd) \<5% (flow cytometry, molecular and/or cytogenetics accepted) * myelodysplastic syndrome (mds) with least one of the following: * revised international prognostic scoring system risk score of intermediate or higher at the time of transplant evaluation. * life-threatening cytopenia. * karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of tp53, or complex or monosomal karyotype. * therapy related disease or disease evolving from other malignant processes. 2. patient eligible for a t-depleted allogeneic hsct 3. age ≥ 18y and clinical condition compatible with allogeneic stem cell transplantation 4. karnofsky index ≥ 70% prior to conditioning regimen 5. patients with normal organ function prior to conditioning regimen group b (pediatrics): 1. pediatric patients affected by acute leukemia defined as: * acute myeloid leukemia (aml): * high risk aml in cr1; any adverse genetic abnormality, secondary or therapy related aml excluding good risk genetic abnormalities, * chemo-refractory relapse (mrd+) * ≥ cr2 * acute lymphoblastic leukemia (all): * chemo-refractory relapse (mrd+) * high risk all in cr1; philadelphia (like) or any poor risk feature * ≥ cr2 * acute leukemia of ambiguous lineage: * ≥ cr1 with a minimal residual disease (mrd) \<5% (flow cytometry, molecular and/or cytogenetics accepted) 2. patient eligible for a t-depleted allogeneic hsct 3. age \< 18y at the time of inclusion 4. absence of a matched sibling donor (msd) 5. lansky ≥ 70% / karnofsky performance status ≥ 70% prior to conditioning regimen 6. patients with normal organ function prior to conditioning regimen exclusion criteria: groups a and b: 1. use of an hla matched cord blood (8/8 allele matched) or haploidentical donor 2. prior therapy with allogeneic stem cell transplantation 3. treatment with another cellular therapy within one month before inclusion
lactate compared to creatine kinase as diagnostic marker in generalized epileptic seizure

Conditions: Seizure; Syncope

Summary: the investigators compared the feasibility of serum creatine kinase and serum lactate concentration as diagnostic markers to distinguish between generalized tonic-clonic seizures (gtcs) and syncopes in clinical settings that require fast-action treatment, such as in the emergency departments.

the patients of this prospective study were selected from a sample of patients who were admitted to the emergency room of the university hospital rwth aachen with an unclear impairment of consciousness. only patients who later on were diagnosed as having experienced a gtcs or a syncope and whose serum lactate concentrations had been measured within 2 hours after the event were enrolled in the study. the investigators compared the specificity and sensitivity of the serum lactate concentrations at admission with the ck concentration at admission and the ck follow-up taken 10 to 48 hours after the event. the values at admission were compared between patients from whom a blood sample was collected within 60 minutes after the event, and those from whom a blood sample was collected within 61-120 minutes after the event. the comparison of initial lactate concentrations at admission with ck levels 10 - 48 hours later could only be performed on part of the patient collective because the other patients were already discharged at this time-point and could therefore not be included. the initial blood samples were taken at patient arrival in the emergency room. the follow up was performed during the inpatient stay. serum lactate and ck concentrations between patient groups were statistically compared with a mann-whitney-u test. we defined cut-off values and their sensitivity and specificity by receiver operating characteristic (roc) analysis.

Eligibility criteria:
inclusion criteria: patients with generalized tonic-clonic seizures and syncopes and whose blood samples were taken within 2 hours after the event 18 years or older observed seizure time of the event before admission was known diagnosis of an epileptic seizure or syncope had been entered in the final discharge report exclusion criteria: prisoner age \< 18 years old competing explanations for serum lactate or ck elevation e.g. shock or trauma lack of capacity for consent

Keywords: seizure lactate creatine kinase
the use of self-reported symptoms as a proxy for acute organophosphate poisoning among nepali farmers

Conditions: Organophosphate Poisoning

Summary: the purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and pche activity in response to occupational acute organophosphate exposure among farmers in nepal.


Eligibility criteria:
inclusion criteria: * male * minimum age 18 years * hand pressured backpack sprayer usage * used to spray with moderately to extremely hazardous pesticides according to the world health organization's (who) pesticide hazard classification exclusion criteria: * usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho) * unwilling to stay pesticide-free seven days prior to each of the two spray sessions * medical conditions interfering with pche activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)
investigation of the strategy of preventing post-operative opioid-induced hyperalgesia

Conditions: Opioid-Induced Disorders

Summary: the concept of enhanced recovery after surgery(eras) has been prevalent in recent years. in the eras guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. propofol-remifentanil based total intravenous anesthesia (tiva) can provide quicker emergence and decreased post-operative nausea and vomiting. however, the prescription of opioid (especially remifentanil) may induce opioid-induced hyperalgesia (oih) and increase the requirement of analgesics. previous studies provided some strategies to prevent oih. the purpose of this study is to investigate the effect of adding remifentanil(1 mcg/kg) after emergence and endotracheal extubation in breast cancer females receiving breast surgery under propofol-remifentanil based tiva for the prevention of oih.

1. after obtaining informed consent, patients will be randomized into two groups. 2. all patients receive remifentanil-propofol based tiva and bispectral index (bis) monitor during breast surgery. in the end of surgery, intravenous nsaid(keto) 30mg and local anestehsia (marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain. 3. group r(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube 4. group n(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube 5. in post-anesthesia room: record the numerical rating scale (nrs); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting 6. in ward: record the numerical rating scale (nrs) and total analgesics consumption

Eligibility criteria:
inclusion criteria: * subject's asa (american society of anesthesiologists) physical status classification: i (a normal healthy patient)\~iii(a patient with severe systemic disease) * subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(tiva) exclusion criteria: * subject's asa (american society of anesthesiologists) physical status classification \>3 * subject doesn't receive total-intravenous anesthesia(tiva) during surgery * subject has psychiatric disease * allergic to opioid or propofol * history of alcoholism * history of drug abuse

Keywords: opioid-induced hyperalgesia, remifentanil
effects of oral administration of antrodia cinnamomea products for clinical symptoms in spinocerebellar ataxia patients

Conditions: Spinocerebellar Ataxia

Summary: this study aims to assess the effect of antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. to investigate the advancements in neurodegenerative diseases.

this study aims to assess the effect of antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients: a randomized, double-blind, placebo-controlled crossover design, and parallel clinical investigation.

Eligibility criteria:
inclusion criteria: 1. adults aged 30 to 70 years, whose native language is chinese. 2. patients diagnosed with spinocerebellar ataxia. 3. subjects with a score below 30 on the scale for the assessment and rating of ataxia (sara scale). 4. individuals who can read and write in chinese and communicate in chinese. 5. agree to participate in the study. exclusion criteria: 1. patients with severe systemic diseases, such as heart or respiratory failure, liver or kidney failure, severe brain injury, prolonged bed rest, or incurable malignancies. 2. pregnant women and breastfeeding mothers. 3. patients who have taken antrodia cinnamomea products within the last 6 months prior to the trial. 4. patients with other factors that prevent them from continuing to participate in this study.

Keywords: neuroinflammatory diseases nervous system diseases spinocerebellar ataxia antrodia cinnamomea
histrelin subcutaneous implant in children with central precocious puberty

Conditions: Central Precocious Puberty

Summary: the purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.

thirty-two (32) patients will receive a histrelin subdermal implant under the anesthesia deemed appropriate by the administering physician. ten-twelve (10-12) sites will enroll 2-3 patients per site. it is anticipated that half the patients will be receiving gnrh analog treatment and the other half will be treatment naïve. all patients will undergo selective pk sampling post-implantation to assess histrelin profile. at 12 months, provided that the patient continues to meet the safety and efficacy parameters, the original implant will be removed and the patient can receive a new implant. at 13 months, patients who receive new implants will be evaluated at the study site and administratively transferred to the initial extension study. at month 24), the implants inserted at month 12 will be removed. at this time, patients who have completed the initial extension study and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, third) implant and to enter an additional 12-month extended access phase at the discretion of the investigator. at month 36, the implants inserted at month 24 for the extended access phase will be removed. at this time, patients who have completed the extended access phase and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, fourth) implant and to enter the long term extended access phase (referred to as the implant treatment phase) at the discretion of the investigator. the purpose of this phase is to provide patients with the opportunity to continue to receive a new implant at the end of each 12-month period until the patient no longer requires hormone suppression. once implant therapy is discontinued, all patients are eligible to enter the long term follow up phase (post implant phase) of the study.

Eligibility criteria:
inclusion criteria: * pre-treated or treatment naive patients with gonadotropin-dependent precocious puberty * pre-treatment pubertal type response of lh to a stndard gnrh stimulation test before initiation of treatment exclusion criteria: * children who are less than 2 years of age at enrollment * children whose chronological age is greater than 8 years (naive) and 10 years (pre-treated) for girls or 9 years (naive) and 11 years (pre-treated) for boys at the onset of the study

Keywords: puberty precocious puberty early puberty early onset puberty histrelin histrelin subcutaneous implant implant therapy
effect of hiv/std risk reduction program on south african adolescents

Conditions: HIV Infections; Sexually Transmitted Disease

Summary: this study will evaluate the effect of an hiv/std risk-reduction program on the sexual behavior of south african adolescents.

hiv is a virus that can lead to acquired immunodeficiency syndrome (aids), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. hiv is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. south africa has been one of the countries in which the aids pandemic has had an especially devastating effect. new cases of hiv infection in south africa have been occurring at a high rate in people 15 to 24 years of age. there is no vaccine or cure for hiv yet, making disease prevention methods imperative. an important part of the prevention process is early education on hiv to reduce sexual-risk behavior and to promote safe sexual practices. this study will evaluate the effect of an hiv/std risk-reduction program on the sexual behavior of south african adolescents. in this single-blind study, participants will include sixth grade students from 18 south african schools that meet study criteria. the participants will be randomly divided into 2 structurally similar treatment groups. one group will take part in hiv/std risk-reduction sessions, while the other group will take part in health promotion sessions. there will be 12 total sessions, each lasting 1 hour. the participants in the hiv/std risk-reduction group will be taught to practice abstinence and condom use through interactive activities, comic workbooks, and take-home assignments. through similar methods, the participants in the health promotion group will be taught about general health problems, such as heart disease, diabetes, alcohol and drug abuse, and certain cancers. participants will also be taught healthful behaviors to help prevent these health problems. all participants will provide self-reports of sexual behavior and precautionary methods used in sexual intercourse immediately before the first and after the last treatment sessions. follow-up evaluations will occur at months 3, 6, 12, 42, and 54 months post-treatment. stds will be assessed 42 and 54 months post-treatment

Eligibility criteria:
inclusion criteria: * schools, with grade 6 learners, that served the general population of learners, not just those with learning disabilities * grade 6 learners at participating schools with signed parent/guardian consent forms exclusion criteria: * schools exclusively serving children with learning disabilities

Keywords: human immunodeficiency virus south africa intervention studies sexual behavior adolescents std hiv seronegativity
strawberry consumption in overweight and obese individuals

Conditions: Obesity; Metabolic Syndrome

Summary: our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.

the current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. participants will participate in a double blind, placebo-controlled, randomized crossover trial. following a 10-day run-in where no berries are consumed, participants will be randomized via latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.

Eligibility criteria:
inclusion criteria: * overweight or obese by bmi (25.0-34.9kg/m2), * borderline-high ldl-cholesterol (130-159mg/dl), * normal or elevated blood pressure ((≤129mmhg/≤80mmhg) exclusion criteria: * known allergy or intolerance to strawberries * taking any medications for chronic diseases including anti-inflammatory, anti-hypertensive, lipid-lowering, glucose-controlling, or steroidal medications * taking any supplements that might affect outcomes of the study including anti-oxidant or fish-oil supplements * having anemia or any liver, thyroid, renal conditions * current smoker or user of tobacco products, or use within the past three months * consuming alcohol (\>1-2 drinks/day) on a regular basis * currently pregnant or lactating * having elevated blood pressure ≥130mmhg/≥80mmhg * presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions * total cholesterol ≥240mg/dl * hemoglobin normal range values for males (between 13.0-17.5g/dl) and females (between 12.5-15.5g/dl)
assessing the time demands of cancer

Conditions: Metastatic Breast Cancer; Ovarian Cancer

Summary: a total of 80 individuals receiving treatment for metastatic breast or advanced stage ovarian cancer will be asked to complete a baseline survey and install the mobile app on their smartphone; carry the smartphone for 28 consecutive days while outside the home; keep smartphone location and motion services active; confirm and correct (if needed) smartphone-detected activities and trips; use the app interface to provide additional information on activities and trips related to cancer treatment tasks; complete daily surveys regarding well-being; and at the end of the 28 day period, complete an online survey.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosed with advanced stage (iii, iv) ovarian (ovarian, fallopian tube or prmary peritoneal) or metastatic breast cancer \[do not need to be newly diagnosed\] * currently receiving any type of therapy for their cancer \[can be front-line, maintenance therapy, or treatment for recurrence\] * able to complete study tasks in english * able to provide voluntary informed consent * own an android or ios smartphone on which the operating system is version 9.0 or higher for android or 10.0 higher for ios; or willing to use a researcher-provided smartphone exclusion criteria: * those who are currently incarcerated * have opted out of research contact

Keywords: ovarian cancer metastatic breast cancer time use quality of life cancer survivorship
investigation of the psychosocial factors responsible for the late recourse to hiv testing within msm

Conditions: AIDS; HIV Seropositivity

Summary: the present study will try to investigate and analyze the psycho-social hindrances and levers concerning the recourse to late hiv testing among the msm population. this study is divided in two parts. the first one will consist of individual and groups interviews. then, depending on the items that will rise from the first part of the study, groups interview will take place based on theses items. finally, a questionnaire build from the collected information will be sent to msm community in order to obtain quantitative results.

the late recourse to hiv testing, among the population in general way and among msm population in a more specific way, participates in the dissemination of the hiv epidemic. actually, there is no cure for hiv infection, but treatments that reduce viral charge to undetectable level exists. when diagnosed and treated earlier, seropositive people will be less communicating the virus because of the reduction of their viral charge. this study aims to uncover the reasons behind the late recourse to hiv testing in msm population facing a high risk of contamination. the study hypothesis, is that late recourse to hiv testing is probably related to social and economics factors like age, social standing, accessibility to the diagnosis or even to a traditional beliefs or a fear of stigma etc. to shed the light on these factors, the main objectives of the investigator will try to investigate and analyze the psycho-social hindrances and levers through a quantitative and qualitative approach. this plurality of approaches is a part of a methodological triangulation method described by kalampalikis \& apostolidis, 2016. people among msm community having had a late or very late hiv test (as defined by biological parameters :cd4≤200/mm3 or having been diagnosed with aids), will be recruited in this study. during the first phase of the study, the eligible population will participate to individual or group interview . this qualitative part of the project will allow the set up of a questionnaire that will be diffused widely to the msm community to have quantitative results.

Eligibility criteria:
inclusion criteria: * hiv-positive * self-reported homo-or bisexual contamination mode * tcd4 + / mm3 200 200 lymphocyte count or have an aids classifying event * diagnosis of hiv positive for at least two months and for a maximum of 24 months exclusion criteria: * primary infection

Keywords: msm population hindrances hiv screening late recourse hiv test healt social psychology