Kornimate/medical-research-clean huggingface dataset:
effect of sleep debt on neurophysiological responses to heat exposure

Conditions: Heat; Excess; Sleep Disorder

Summary: many people are required to work in stressful situations combining sleep debt and hot environmental conditions. if the effect of sleep debt on cognitive performance is proven, this effect could be increased, during heat exposure, through the deleterious effects of sleep debt on thermoregulatory abilities. these alterations may favour the occurrence of accidents. the changes in cognitive performance induced by hyperthermia are also poorly characterised and often not dissociated from the effects of dehydration. little is known about the effects of the combination of sleep debt and heat exposure on mental performance. describing and understanding the alterations induced by this combined situation could provide a better understanding of the mechanisms explaining the deterioration of performance in hot conditions and promote the development of appropriate countermeasures.


Eligibility criteria:
inclusion criteria: * 18 to 35 years old * body mass index between 18 and 27 kg/m2 * body weight ≥ 54 kg exclusion criteria: * presence or history of medical pathology (cardiological, renal, hepatic, cutaneous, intestinal, neurological...) * presence of a significant deviation from the normal values observed on the electrocardiogram * history of heat stroke * known intolerance to heat (e.g. migraine sufferers) * presence of a contraindication to blood sampling, notably low venous capital, belonephobia * inability to ingest a capsule or refusal of the rectal probe * habitual consumption of caffeine \> 500 mg per day * alcohol consumption greater than the equivalent of 3 glasses of wine per week * consumption of narcotics * smoking \> 0.5 packet of cigarettes per day * undergoing habitual medication * pregnant or breastfeeding woman
olaparib real-world utilization and clinical outcomes in france, italy, and the uk

Conditions: Ovary Cancer

Summary: this is a retrospective observational medical records review study of brca mutated advanced (figo stage iii-iv) ovarian cancer patients who received first dose maintenance olaparib in 1l setting in france, italy and the uk. physicians who treated ovarian cancer patients with olaparib in 1l setting will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws

primary objective(s) 1. to estimate progression-free survival (pfs) in patients with brca-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting. 2. to describe olaparib treatment patterns (dosage; frequency of: dosage changes, dose interruptions, treatment cessation) in patients with brca-mutated advanced ovarian cancer treated in real-world first line maintenance setting. secondary objective(s) 1. to estimate overall survival (os) in patients with brca-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting. 2. to describe reasons for olaparib dosage changes, dose interruptions and treatment cessation in patients with brca-mutated advanced ovarian cancer treated in real-world first line maintenance setting 3. to describe surgical and chemotherapy outcomes (pr/cr) in patients with brca-mutated advanced ovarian cancer before initiation of real-world first line maintenance olaparib tablets 4. to describe response rate (rr) to olaparib tablets in patients with brca-mutated ovarian cancer with partial response to real-world first line chemotherapy. 5. to describe treatment patterns and clinical outcomes in patients with brca-mutated advanced ovarian cancer who progressed during olaparib real-world first line maintenance therapy (including frequency of treatment interruptions, dosage reductions and treatment discontinuations and reasons associated with patterns) 6. to estimate second progression-free survival (pfs2) in patients with brca-mutated ovarian cancer who progress while on olaparib real-world first line maintenance therapy. 7. to describe healthcare resource utilisation in patients with brca-mutated advanced ovarian cancer treated with olaparib in real-world first line setting

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed, histologically confirmed, advanced (figo stage iii - iv) epithelial ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer who have completed first line platinum-based chemotherapy, in pr/cr and treated with at least one dose of olaparib in first line maintenance setting * patients aged ≥18 years old * ability and/or willingness to provide a signed informed consent form (where required) exclusion criteria: * withdrawal of informed consent (where consent required) * concurrent participation in any clinical study with an investigational product at the time of olaparib initiation

Keywords: ovary cancer ovarian neoplasm brca mutated advanced (figo stage iii-iv) ovarian cancer
clinical comparison of toric contact lenses fit characteristics

Conditions: Astigmatism; Refractive Errors

Summary: the purpose of this study is to compare the fit characteristics between four alcon commercially available toric contact lenses.

subjects will be expected to attend 3 visits including the screening visit. the total duration of a subject's participation in the study will be approximately 19 days.

Eligibility criteria:
key inclusion criteria: * successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. * able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability). * best corrected visual acuity (bcva) better than or equal to 0.10 (logmar) in each eye. * willing to stop wearing habitual contact lenses during in-office visits. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * current spherical, monovision or multifocal lens wearer. * protocol-specified biomicroscopy findings at screening. * current or history of herpetic keratitis in either eye. * participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses
trauma informed guilt reduction therapy

Conditions: Guilt; Shame; Post-traumatic Stress Disorders

Summary: the goal of this project is to determine if a 6-session psychotherapy intervention will help veterans feel less deployment-related guilt and less distress related to their guilt. half of the participants will receive the guilt focused intervention and half will receive a supportive intervention. a supplemental pilot study added in fy2021 will examine the intervention for pandemic-related guilt events.


Eligibility criteria:
inclusion criteria: * participant served in oef/oif/ond, has post-traumatic guilt related to deployment event (for pandemic supplement in 2021, has guilt related to pandemic event) exclusion criteria: * moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania
a pilot study of chemo-prevention of green tea in women with ductal carcinoma in situ

Conditions: Ductal Carcinoma in Situ

Summary: the purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (dcis).

many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. some studies have found that asian women who drink many cups of green tea have lower rates of breast cancer. green tea may have an effect on proliferative and inflammatory pathways. women with ductal carcinoma in situ (dcis) have been found to have inflammation in the breast tissue surrounding dcis lesions. inflammatory pathways are being studied for a possible link to cancer. this study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.

Eligibility criteria:
inclusion criteria: * histologically confirmed dcis by breast core biopsy with a corresponding lesion on breast mri of at least 1-cm3 in volume. * patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis. * age \>18 years. * ecog performance status \ 60%) * life expectancy of greater than 12 months. * normal organ and marrow function as defined below: * leukocytes \>3,000/mcl * absolute neutrophil count \>1,500/mcl * platelets \>100,000/mcl * total bilirubin within normal institutional limits * ast(sgot) \& alt(sgpt)within normal institutional limits * creatinine \ 60 ml/min/1.73 m2 * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * pregnancy * patients who have undergone prior excisional biopsy for dcis. * patients who are unable to undergo mri due to claustrophobia or other reason. * patients with ipsilateral treatment for dcis or breast cancer within 12 months prior to entering this study. * patients receiving any other chemotherapy or investigational agents. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea. * uncontrolled concurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Keywords: dcis
to evaluate the effectiveness and safety of yvoire y-solution 720 injected into the mid-face

Conditions: Volume Defects in the Mid-face

Summary: to evaluate the effectiveness and safety of yvoire y-solution 720 injected into the mid-face


Eligibility criteria:
inclusion criteria: * male or female adults 18 to 65 years of age (inclusive) * 3 (moderate) or 4 (severe) on mfvda-srs * sign the written informed consent form exclusion criteria: * have streptococcal disease or bleeding disorder * have an active or infective skin disease, scars, or tumor on mid-face * have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases * have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment * have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months * have a medical history of hypertrophic cicatrix or keloid * have radiation therapy experience on mid-face * have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or streptococcal protein
the effects of yoga on quality of life among a population of ovarian/ fallopian tube/ primary peritoneal cancer patients receiving chemotherapy: a feasibility study

Conditions: Ovarian Cancer

Summary: this is a pilot study to establish the feasibility of an eight-week yoga intervention and to estimate the effect size on qol in female patients with ovarian, fallopian tube and primary peritoneal malignancies receiving chemotherapy for the treatment of primary or recurrent cancer.

the primary objective of this study was to determine the feasibility of implementing a yoga program among gynecologic cancer patients receiving chemotherapy. the investigators concluded that it is not feasible due to the lack of participation and difficulty in recruiting patients. of 25 consented patients, 16 agreed to participate in the control arm, 9 agreed to participate in the yoga classes. three (3) of those 9 changed their minds and withdrew consent. of the 6 remaining patients, only 3 attended at least 1 of the 8 classes.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of epithelial ovarian/fallopian tube/primary peritoneal cancer * participant must be age 18 or older * participants must be 6 weeks post-surgery * participant must be currently receiving chemotherapy or beginning a regimen within the next four weeks * participant must be willing to attend the intervention sessions * all subjects must have given signed, informed consent prior to registration in the study. exclusion criteria: * participant has practiced yoga more than 4 times in the last year * participant has a surgical procedure scheduled during the 8 weeks that they would be part of the intervention * participant has an ecog performance status less than or equal to two

Keywords: women yoga ovarian cancer lifestyle
a model for the early diagnosis of colorectal cancer by the detection of 5-hydroxymethylcytosine (5-hmc) in plasma cell-free dna

Conditions: Colorectal Cancer

Summary: in this study, the investigators establish a model for the early diagnosis of colorectal cancer based on detection of 5-hydroxymethylcytosine (5-hmc) in training group and validate the effectiveness of the model using a validation group.

many kinds of cancers are associated with changes in epigenetics, including 5-methylcytosine (5-mc) and 5-hydroxymethylcytosine (5-hmc). this changes may help diagnose cancer. the new detection method for 5-hmc can meet the requirements of liquid biopsy. the traditional diagnostic methods for colorectal cancer is colonoscopy and pathology which are inconvenient and unpleasant, and sometimes, it is difficult for the very patients to get tissues or get enough tissues. in addition, other screening methods for colorectal cancer,such as guaiac-based fecal occult blood testing and a blood test for methylated sept9 dna, have the shortcomings of relatively low sensitivity and specificity. as a result, it is imperative to find a new detection method for early diagnosis of colorectal cancer with high the advantages of high sensitivity and specificity, minimally invasive and convenient. the aim of this research study is to establish a model for the early diagnosis of colorectal cancer by the detection of 5-hmc in plasma cell-free dna. patients who are diagnosed with colorectal cancer by colonoscopy and pathology and not received any anti-tumor therapy (arm a) will be eligible for inclusion as well as healthy individuals with normal colonoscopy (arm b). then, 5-hmc in plasma cell-free dna will be detected and compared between the two arms of patients (training group) to establish a model to diagnosis other people (validation group) who may suffer from colorectal cancer.

Eligibility criteria:
inclusion criteria: arm a * histologically proven colorectal adenocarcinoma * no other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri * eastern cooperative oncology group score 0-2 * informed consent arm b * healthy people with normal colonoscopy * no other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri * eastern cooperative oncology group score 0-2 * informed consent exclusion criteria: arm a * patients received chemoradiotherapy or other anti-tumor therapy before being enrolled * patients and/or family members can not understand and accept this study * familial adenomatosis polyposis, lynch syndrome, acute inflammatory bowel disease * pregnancy or lactation * unsuitable to take part in the clinical trial judged by doctors arm b * pregnancy or lactation * unsuitable to take part in the clinical trial judged by doctors

Keywords: colorectal cancer early diagnosis 5-hydroxymethylcytosine
risk factors of anxiety and depression in patients with herpes zoster neuralgia

Conditions: Herpes Zoster

Summary: the goal of this observational study is to explore risk factors of anxiety and depression in patients with herpes zoster neuralgia, and the changes of certain serum biomarkers and functional brain magnetic resonance images of these patients.

patients with herpes zoster neuralgia will be recruited and take hospital anxiety depression rating scale (hospital anxiety and 'scale, hads) evaluation. according to the hads scores, patients will be divided into depression group and no depression, or anxiety group and no anxiety group. the clinical data the of two groups will be collected and statistically analyzed to explore the risk factors of anxiety and depression, including the changes of serum biomarkers and functional brain magnetic resonance imaging in patients with herpes zoster neuralgia accompanying anxiety or depression.

Eligibility criteria:
inclusion criteria: 1. age more than 18 years old 2. diagnosed as herpes zoster neuralgia 3. signing informed consent exclusion criteria: 1. unable to complete the scale assessment 2. history of mental illness

Keywords: anxiety depression herpes zoster neuralgia
milking the umbilical cord for extreme preterm infants

Conditions: Infant, Extremely Premature

Summary: milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). in this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. the data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months. the hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.

eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.

Eligibility criteria:
inclusion criteria: * pregnant women/child pairs with infants born at an estimated gestation age between 24 0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or ultrasound * informed consent obtained by the pregnant women prior to delivery of the infant. exclusion criteria: * pregnancy with a multiple gestation * infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities * infants with hydrops fetalis

Keywords: umbilical cord milking extremely low birth weight infant (elbw)
a nordic phase ii study of ptcl based on dose-intensive induction and high-dose consolidation with asct

Conditions: Peripheral T-Cell Lymphoma

Summary: this is a phase ii prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral t-cell lymphoma. the treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. there will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.


Eligibility criteria:
inclusion criteria: * previously untreated patients with newly diagnosed peripheral t-cell lymphoma of all stages. however, patients with nodal stage ia non-bulky disease (\<10cm) can be treated individually at the discretion of the responsible physician. * following histologic subtypes (who classification) are eligible for inclusion in the study: peripheral t-cell lymphomas, unspecified angioimmunoblastic t-cell lymphoma nk/t nasal-type t-cell lymphoma enteropathy-type t-cell lymphoma primary systemic, alk-negative anaplastic large cell lymphoma (t-or null phenotype) hepatosplenic t-cell lymphoma subcutaneous panniculitis-like t-cell lymphoma nb: patients should not enter the treatment program before confirmation of the histo-pathological diagnosis by the referral center pathologist * age 18-60 years. patients in the age range 61-67 years may be included in this protocol at discretion of the treating physician. * formed consent based on oral and written patient information (appendix i) exclusion criteria: * primary cutaneous t-or null-cell anaplastic large-cell lymphoma * alk-positive, primary systemic t-or null-cell anaplastic large-cell lymphoma * who performance status grade 4 (appendix ii) * patients with severe cardiac (i.e. severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%), pulmonary, neurologic, psychiatric, renal, hepatic or metabolic disease. * pregnancy. n.b: women of childbearing potential should be strongly advised to apply appropriate contraceptive precautions during the entire treatment period. * patients with concomitant malignancies except for non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * patients with seropositivity for the human immunodeficiency virus. * patients with other active and therapeutically uncontrolled infection. * psychological, familial, social or other condition/-s potentially hampering compliance and follow-up.
characterization of t-cell repertoire in patients with acute myeloid leukemia undergoing donor stem cell transplant

Conditions: Acute Myeloid Leukemia

Summary: this research trial studies characterization of t-cell repertoire through next-generation sequencing in patients with acute myeloid leukemia undergoing stem cell transplant. characterizing t-cell repertoire may help to understand if immune system plays a significant role in high risk patients with acute myeloid leukemia.

primary objectives: i. characterize the t cell receptor (tcr) repertoire in acute myeloid leukemia (aml) patients before and after receiving hematologic stem cell transplantation (hsct). ii. identify molecular changes (germline variants and somatic mutations) that contribute to shaping the tcr repertoire. outline: patents undergo collection of blood samples before, on day 100, and 1 year after hsct. donors undergo collection of blood at the time of hsct for ribonucleic acid (rna)-based next generation sequencing of tcra and tcrb genes.

Eligibility criteria:
inclusion criteria: * diagnosis of aml scheduled to undergo hsct at university of southern california (usc) exclusion criteria: * inability to provide consent because of severe mental disorders * donor unwilling to provide consent