Kornimate/medical-research-clean huggingface dataset:
impact of the platelet level in patients treated for glioblastoma with temozolomid

Conditions: Glioblastoma

Summary: the purpose of glioplak is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. the studied parameter is the variation in platelet count during the radio-chemotherapy phase. the main objective is to identify early in stupp protocol a group of patients having high risk to undergo thrombocytopenia in maintenance phase of temozolomide. with this result an algorithm of platelet monitoring for patients treated with stupp protocol wil be proposed.

glioblastoma is the most common primitive cerebral tumor. currently its optimal treatment is based on a multidisciplinary approach combining an initial surgical resection, if feasible, then stupp protocol. stupp protocol consists of two phases: first phase involves external radiotherapy with concomitant oral temozolomide at a dose of 75mg/m2 per day for about six weeks. after 4 weeks of therapy break, maintenance phase begins with temozolomide alone, for a period of 6 cycles (1 cycle = 5 days over 28). the dose of temozolomide is 150mg/m2 on the first cycle followed by 200 mg/m2. one major limiting toxicity of temozolomide is hematologic, especially thrombocytopenia. they occur in around 15 and 20% of patients in maintenance phase. thrombocytopenia has an impact on the schedule of stupp protocol such as dose reduction or even early discontinuation. currently no predictive marker of thrombocytopenia in the maintenance phase was identified. such marker could be of major interest to adapt biological and clinical follow-up by patient in maintenance phase. we conduct a retrospective analysis on a cohort of patients suffering from glioblastoma and treated with stupp protocol. we found that a decrease in platelet count during the radio-chemotherapy phase could be highly predictive of protocol changes in maintenance phase of temozolomide due to thrombocytopenia. the main objective of glioplak is to prospectively confirm the predictive value of this test and to evaluate the prognostic impact of the occurrence of thrombocytopenia \<100,000/mm3. secondary objective of glioplak are to describe all limiting toxicities in maintenance phase, to constitute a prospective biological collection and to collect biological samples to perform pharmacological analysis (pharmacogenomics and pharmacokinetics parameters).

Eligibility criteria:
inclusion criteria: * age superior to 18 years * inform consent form signed * newly diagnosed (histologically) glioblastoma * stupp protocol treatment * with social insurance exclusion criteria: * not inform consent form signed * participation to another clinical trial * other cancer * background of hematological pathology * patient under guardianship, curatorship

Keywords: stupp protocol, glioblastoma, thrombocytopenia
the prisice clinical trial (pre-implantation screening and investigation on the cryopreservation of embryos)

Conditions: Infertility

Summary: the trial objective is to determine whether the deferred transfer of embryos following cryopreservation at the blastocyst stage following pre-implantation genetic screening (pgs-fet) improves live birthrates compared to both the deferred transfer of cryopreserved embryos without pgs (fet) and immediate transfer at the conclusion of a "fresh" in vitro fertilization (ivf) cycle (fresh). additionally, whether "freeze-only" (fet) improves live birth rates compared to "fresh" will be determined.

this will be a multi-center, prospective randomized clinical trial comparing three standards of care: group 1: pgs-fet group: deferred transfer of day 5/6/7 (blastocyst stage) embryos cryopreserved following trophectoderm biopsy group 2: "freeze-only" (fet) group: deferred transfer of frozen/thawed embryos without biopsy group 3: "fresh" et group: immediate transfer of "fresh" embryos in the stimulation cycle. 1539 eligible couples will be recruited to participate. couples will be randomized at retrieval to undergo cryopreservation with deferred embryo transfer, with or without pgs, or fresh embryo transfer during the cycle of egg retrieval. number of embryos to transfer will be based on clinical estimation of embryo quality and will not exceed asrm guidelines for embryo transfer number including newly revised guidelines. we are aware that the number of embryos transferred, to maintain enrollment, may not be equivalent, with likely more embryos transferred in patients not having pgs. the primary outcome of live birth/retrieval, with a secondary outcome of healthy singleton birth, may reflect the true benefit of pgs.

Eligibility criteria:
inclusion criteria: * scheduled to undergo in vitro fertilization for treatment of infertility (1st or 2nd "fresh" attempt); subject can have had no more than one prior failed "fresh" ivf cycle * couple able to participate in a research project * able to understand study requirements * willing to sign informed consent * able to return for required follow-up * access to telephone * ability to read and write * normal uterine cavity evaluation within one year of enrollment exclusion criteria: * medical conditions which may complicate treatment * no plans to undergo embryo transfer * medical contraindication to the transfer of more than a single embryo (i.e. congenital uterine anomaly). * concurrent participation in any other interventional trial * recurrent pregnancy loss * known chromosomal abnormality (e.g. translocation) * pre-implantation genetic diagnosis requiring blastocyst biopsy
simultaneous fluoroscopic and manometric measures of the oropharyngeal phase of deglutition

Conditions: Dysphagia

Summary: to validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry.

the specific aim of this study is to validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry. combined videofluoroscopic swallowing studies with pharyngeal manometry are commonly used in the evaluation of dysphagia. however, no published study has compared the results of simultaneous pharyngeal manometry with objective timing and displacement measures on videofluoroscopy. these objective measures, such as the pharyngeal constriction ratio, were developed here at ucd and are not yet routinely used by other practitioners. a secondary aim of this study will be to corroborate recent data in the literature suggesting that the presence of feeding tube through the upper esophageal sphincter does not affect the oropharyngeal phase of deglutition. this topic is currently under hot debate in the speech language pathology realm and has important implications for the evaluation of hospitalized patients with dysphagia.

Eligibility criteria:
inclusion criteria: * undergone pharyngeal manometry with simultaneous videofluoroscopy during the period 1/1/06 to 4/30/07 exclusion criteria: * those who do not meet the inclusion criteria; pregnancy

Keywords: pharyngeal manometry videofluoroscopy
the effect of sitting position on the labor process

Conditions: Healthy; Bleeding; Pain

Summary: this study was conducted to determine the effect of sitting position on the labor process. the randomized controlled experimental study was conducted in the delivery room of sivas numune hospital.


Eligibility criteria:
1. inclusion criteria: * age range: 19-35 * 38-42 weeks of pregnancy * no health problems that would prevent the use of sitting position * -amniotic membranes not ruptured * having a singleton pregnancy * fetus in vertex position * labor occurs with normal spontaneous vaginal delivery * no diagnosed chronic physical disease * no diagnosed psychiatric disease * no risky pregnancy, risky delivery and newborn/fetus * no communication problems * voluntarily participating in the research 2. exclusion criteria: * only women who gave birth at sivas sample hospital were included in the study * women who gave birth more than two times were not included in the study

Keywords: bleeding pregnant labor duration pain sitting position
ethnic differences in iron absorption (fegenes)

Conditions: Anemia, Iron Deficiency; Iron Overload

Summary: this study aims to; 1) investigate population differences in iron absorption between east asians and northern europeans; 2) assess population differences in hormonal and biochemical determinants of fe absorption between east asians and northern europeans; and 3) to investigate genetic contributions to fe absorption, fe status and fe regulatory hormones between east asians and northern europeans.

detailed description: this study will utilize a multidisciplinary approach to identify genetic variation in genes that control iron utilization in order to shed light on the genetic basis of population differences in iron status and disease susceptibility with a long-term goal of informing population-specific dietary iron intake recommendations to minimize the risk of chronic diseases. to evaluate iron utilization, we will employ an in vivo, functional approach using an oral stable iron isotope method. each participant will have genetic ancestry and genotyping evaluated using the illumina global diversity array-8. study participants (n=504, aged 18-50 y) will consume 57fe (as ferrous sulfate) in the fasted state and will then ingest a standardized breakfast and lunch meal. two weeks after iron dosing, a blood sample will be collected from each participant and the amount of 57fe incorporated into red blood cells will be measured using magnetic sector thermal ionization mass spectrometry. this project will fundamentally advance our understanding of ethnic differences in nutrient metabolism and iron status. it will also provide information to assist with the long-term goal of reducing the public health burden of fe-related diseases.

Eligibility criteria:
inclusion criteria: * healthy adults * age between 18- 50y * non-smoking * not taking vitamin or mineral supplements. * females: premenopausal and not pregnant or lactating * no preexisting medical complications (such as eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) * body mass index (bmi) between 18 - 30 kg/m2. exclusion criteria: * bmi \ 30 kg/m2, * age \ 50y, * not of northern european or east asian ancestry * smoking * pregnancy, lactating * have gastrointestinal disorders/malabsorption diseases/hemoglobinopathies/dietary restrictions/steroid use/ medication use of medications known to impact iron status, iron utilization or inflammatory status * take vitamin and mineral supplementations

Keywords: iron absorption genetics
role of hypofractionated radiotherapy with concurrent gemcitabine in treatment of urinary bladder carcinoma

Conditions: Urinary Bladder Cancer

Summary: estimate the response to modified hypofractionated radiotherapy concurrent with gemcitabine in urinary bladder cancer patients . estimate local control, relapse free survival, overall survival and bladder preservation rate. evaluate the toxicity of a modified hypofractionated chemoradiotherapy protocol for patients with invasive bladder cancer.


Eligibility criteria:
inclusion criteria: - pathologically confirmation of transitional cell carcinoma . non metastatic invasive bladder cancer (tnm0) any age group ≥ 18 years. non pregnant female patients. exclusion criteria: - other pathology than transitional cell carcinoma metastatic patient age less than 18 years
the outcomes of ultrasound-guided thermal ablation for benign thyroid nodules

Conditions: Thyroid Nodules

Summary: 1. to evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules; 2. to develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules


Eligibility criteria:
inclusion criteria: * \[1\]confirmation of benign nodule status on two separate fine- needle aspiration (fna) or core-needle biopsy (cnb) \[2\]no suspicious malignant features on ultrasound examination \[3\]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation \[4\]refusal or ineligibility for surgery \[5\]follow-up time ≥6months exclusion criteria: 1. follicular neoplasm or malignancy findings on biopsy 2. nodules with benign result on biopsy had suspicious of malignancy in us, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications 3. patients with cystic nodules 4. patients with contra-lateral vocal cord par- alysis 5. previous radiation to the head and neck 6. ; follow- up time less than 6 months
data analysis for drug repurposing for effective alzheimer's medicines (dream)- semaglutide v dpp4 inhibitors

Conditions: Diabetes

Summary: this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

this is a non-randomized, non-interventional study that is part of the dream study of brigham and women's hospital. dream is led by dr. madhav thambisetty, md, phd, chief of the clinical and translational neuroscience section, laboratory of behavioral neuroscience, national institute on aging (nia) intramural research program. this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility criteria:
please see https://drive.google.com/drive/folders/1vrjpaaelxfybba5gv6pwb_ijsimyij4n?usp=share_link or appendix a(https://drive.google.com/drive/folders/1ogkqlxsji9uwrdd3kbaux_8adngosnzy?usp=sharing) for full code and algorithm definitions. medicare timeframe: 2008 to 2019 (end of data availability). inclusion criteria: * 1. aged \>/= 65 years on the index date * 2. enrollment in medicare part a, b, and d with no hmo coverage for 365 days prior to and including cohort entry date * 3. diagnosis code for type 2 diabetes measured 365 days prior to drug initiation exclusion criteria: * 1. prior history of dementia measured anytime prior to cohort entry date * 2. prior history of nursing home admission in the 365 days prior to the cohort entry date * 3. prior use of any glp receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or dpp4 inhibitors * 4. prior use of semaglutide or dpp4 inhibitors concomitantly on index date
safety and efficacy of inhaled cannabis for the uncontrolled pain relief in patients with advanced cancer

Conditions: Cancer Pain; Quality of Life; Pain, Acute; Cannabis Use

Summary: this phase 2 multicenter clinical trial assess the safety and efficacy of inhaled ppp001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. this is a 4-week treatment period study followed by an open label period of 1 year.

this is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled ppp001 on uncontrolled cancer pain in patients with symptoms related to advanced incurable cancer.

Eligibility criteria:
inclusion criteria: 1. written informed consent, 2. adult male and female patients at least 18 years of age, 3. subject agreed to follow the protocol, 4. advanced cancer for which there is no known curative therapy as per investigator's judgement, 5. patients experiencing at least 2 symptoms related to cancer \> 4 on esas-r-cs nrs including pain symptom, 6. life expectancy six weeks or longer with pps \> 50% and pap score group a (30-day survival probability \>70%), 7. no cognitive impairment according to mini-cog©, 8. the patient is able to perform deep inhalations with fev1 more than 60%, 9. ability to read and respond to questions in english, 10. a female volunteer must meet one of the following criteria: if of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose, if of non-childbearing potential - should be surgically sterile or in a menopausal state, 11. a male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.
stepped care for weight loss maintenance

Conditions: Obesity

Summary: this study is a 3-group, parallel design, randomized controlled trial (rct) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. 16-week run-in (phase 1). to qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. this loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet. 52-week randomized trial of 3 weight loss maintenance strategies (phase 2): participants who have achieved ≥ 5% weight loss during phase 1 will be randomly assigned to 1 of 3 groups: 1. participants in the usual care group will be emailed monthly educational modules with information on maintaining weight loss. 2. participants in the self group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance. 3. participants in the step group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. after 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. participants who maintain weight loss will stay at the same step.


Eligibility criteria:
inclusion criteria: * bmi\>/=30 kg/m2 or \>/=27 kg/m2 with an obesity-related complication * age 18-70 years * completion of baseline assessment tasks * ability to engage in physical activity * own a smartphone capable of receiving text-messages and syncing to weight scales and physical activity trackers * home wireless access exclusion criteria: * serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program * pregnant or planning pregnancy in the next 1.5 years * weight\>440 lbs * planned move out of the area in the next 1.5 years * recently began a course of or changed the dosage of medication that can cause significant change in weight * history of bariatric surgery * weight loss of \>5% in the previous 6 months * household member already participating in study

Keywords: obesity weight loss
a study to evaluate long-term outcomes following treatment with abt-450/ritonavir/abt-267 (abt-450/r/abt-267) and abt-333 with or without ribavirin (rbv) in adults with genotype 1 chronic hepatitis c virus (hcv) infection

Conditions: Chronic Hepatitis C Virus (HCV) Infection Genotype 1

Summary: the purpose of this study was to evaluate the effect of treatment with abt-450 co-formulated with ritonavir and abt-267 (abt-450/r/abt-267) and abt-333; 3-daa regimen, with or without ribavirin (rbv) in adults with chronic hepatitis c virus genotype 1 (hcv gt1) infection.

this study (topaz-ii; m14-222), was a phase 3b, open-label, multicenter study conducted in the united states which, together with its companion study topaz-i (m14-423; nct02219490) conducted outside of the united states, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic hcv gt1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (ifn/rbv) treatment- experienced. in both studies, participants were treated with the 3-daa regimen with or without rbv. this study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for hcv gt1a-infected subjects without cirrhosis and for hcv gt1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for gt1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.

Eligibility criteria:
inclusion criteria: 1. females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control 2. chronic hepatitis c, genotype 1-infection (hcv rna level greater than 1,000 iu/ml at screening) 3. hcv genotype 1 infection per screening laboratory result exclusion criteria: 1. use of contraindicated medications within 2 weeks of dosing 2. abnormal laboratory tests 3. positive hepatitis b surface antigen and anti-human immunodeficiency virus antibody 4. history of solid organ transplant, clinical evidence of child-pugh b or c classification or clinical history of liver decompensation 5. presence of hepatocellular carcinoma at screening

Keywords: hepatitis c genotype 1 compensated cirrhosis cirrhosis naïve hepatitis c hepatitis c virus treatment-experienced relapser null responder non responder
social determinants of health in diabetes outcomes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a cross-sectional study of six hundred adults with type 2 diabetes, (300 white and 300 african-american) who will be recruited from two primary care sites to determine how social determinants of health impact diabetes outcomes. the first aim is to investigate the role of psychosocial factors and ses on diabetes care processes and outcomes. the second aim is to investigate the influence of community and neighborhood characteristics on diabetes care processes and outcomes. finally, we will examine the contribution of social determinants of health to ethnic differences in diabetes care processes and outcomes. clinical and metabolic measures will be abstracted from the electronic medical records. outcome variables include hemoglobin a1c, blood pressure, ldl-cholesterol and quality of life.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * able to communicate in english exclusion criteria: * mental confusion on interview suggesting significant dementia * alcohol or drug abuse/dependency * active psychosis or acute mental disorder