Kornimate/medical-research-clean huggingface dataset:
progesterone for prevention of preterm birth in women with short cervix: randomized controlled trial

Conditions: Preterm Birth; Pregnancy Trimester, Second

Summary: the aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.

background the results of randomized studies have shown that the prophylactic use of progesterone in women who previously delivered prematurely reduces the risk of recurrence. asymptomatic women found to have a short cervix (\< 15 mm) at mid-gestation are at greatly increased risk for spontaneous early preterm delivery and it is uncertain whether in such women the risk is reduced by progesterone. methods cervical length was measured by transvaginal sonography at 22 (range 20-25) weeks in 24,620 pregnant women attending for routine antenatal care. the cervix was 15 mm or less in 413 (1.7%), and 250 (60.5%) of these women participated in a randomized study of vaginal progesterone (200 mg per night) vs identical-looking placebo, between 24 and 34 weeks. primary outcome was the frequency of spontaneous delivery before 34 weeks (238 days) of pregnancy. analysis was performed according to the intention-to-treat principle.

Eligibility criteria:
inclusion criteria: * all women with singleton or twin pregnancies attending for routine ultrasound examination at 20-25 weeks of gestation with a short cervical length (\<15 mm). exclusion criteria: * women with major fetal abnormalities, * painful regular uterine contractions, or history of ruptured membranes or cervical cerclage in-situ were excluded from screening.

Keywords: preterm delivery, short cervix, progesterone
texting atopic dermatitis patients to optimize learning and easi scores

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to determine if sending text messages with treatment reminders and facts regarding atopic dermatitis (ad) to caretakers of children with ad will have a positive effect on the disease severity.

atopic dermatitis (ad) is a common, chronic, and debilitating disease that tends to present in children under age 2 and has a waxing and waning course. poor adherence to treatment is the primary preventable contributor towards adverse outcomes such as infection, hospitalization, permanent disfigurement, and disruptions in normal childhood psychological development. the burden of care for these patients often falls upon parents, who may have difficulty incorporating the necessary daily treatments into the family's lifestyle. thus, investigating ways of improving adherence could have a significant impact on a patient's long term prognosis and the family's ability to understand and adjust to the demands of ad.text message reminders with embedded health literacy information have been shown to improve vaccination rates in children and caregivers have reported increased satisfaction with this means of communication. this study aims to assess whether text message reminders with information about ad are an effective way to improve treatment adherence and provide disease specific information to caregivers of children with ad. the measure of ad severity will be the eczema area and severity index (easi) score. health literacy with regard to ad will be assessed via in-office survey.this study will involve children age 0-6 with newly diagnosed ad and their primary caregivers. the subjects will be randomized to standard care or text message reminder group. all study participants will be asked to complete a survey after their initial evaluation and after their follow up visit on the same day they are in the office. the text message group will receive text messages with information and treatment reminders. all participants will receive the standard of care with regard to ad. if this study demonstrates that text message reminders can improve easi scores in ad patients it could lead to a significant change in how these patients are managed. fewer complications from episodic flares, infections, and other sequelae may lessen the burden of this disease for both patients and their caregivers. text messaging is an inexpensive, noninvasive, and broadly applicable tool that is worth studying for the purpose of improving treatment adherence and disease literacy.

Eligibility criteria:
inclusion criteria: * new clinical diagnosis of atopic dermatitis * new patient to columbia university medical center, department of dermatology * caregiver has mobile that can send/receive text messages exclusion criteria: * age over 7 years * caregiver is not fluent english speaker * those patients in which a definitive diagnosis of atopic dermatitis cannot be made * any individual who declines participation

Keywords: atopic dermatitis text messages health literacy
clinical study to investigate safety and efficacy of gsk933776 in adult patients with geographic atrophy secondary to age-related macular degeneration

Conditions: Atrophy, Geographic

Summary: the purpose of this study is to determine the safety and efficacy of gsk933776 in the treatment of geographic atrophy secondary to age-related macular degeneration.

this is a phase 2a proof of concept study designed to evaluate the safety and efficacy of gsk933776 for the treatment of geographic atrophy secondary to age-related macular degeneration. this is a placebo-controlled parallel-group study that is double masked.

Eligibility criteria:
inclusion criteria: * adult patients ≥55 years of age inclusive * evidence of amd confirmed by the presence of at least 1 druse ≥125 μm diameter * well-demarcated ga due to amd of total area 1.9-17 mm2 measured in the study eye * best-corrected visual acuity score of ≥ 35 letters (approximately 20/200 snellen va equivalent or better) in the study eye exclusion criteria: * additional eye disease in the study eye that could compromise assessment of best-corrected visual acuity or imaging of the posterior pole * history of cnv secondary to amd in the study eye * any previous treatment for amd in the study eye, approved or investigational, with the exception of dietary supplements * risk of cerebrovascular disease, cerebral hemorrhage or stroke * history of systemic autoimmune disease * use of platelet anti-aggregants or anti-coagulants (aspirin up to 325 mg/day is allowable, or in subjects allergic or intolerable to aspirin, clopidogrel up to 75 mg/day is allowable) * use of chronic corticosteroids * uncontrolled hypertension in spite of antihypertensive medications * renal or hepatic insufficiency or clinically significant anemia * more than moderate mri white matter changes

Keywords: age-related macular degeneration geographic atrophy dry amd
effectiveness of transcranial direct current stimulation in chronic pain related to lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: transcranial direct current stimulation (tdcs) is a promising non-invasive brain stimulation technique in chronic pain. there is no study investigating the effectiveness of tdcs in radiating chronic lower extremity pain related to lumbar spinal stenosis (lss). the aim of this study is to investigate the effects of tdcs on pain, walking capacity, functional status and quality of life in patients with chronic pain related to lss. 32 patients diagnosed with chronic pain related to lss will be enrolled in this prospective, randomized, double blind, placebo-controlled study according to inclusion/exclusion criteria. patients in active group will receive 10 sessions of anodal tdcs delivered over primary motor cortex (m1) with a constant current of 2 miliampers for 20 minutes. patients will be evaluated at baseline, on day 1, 5 and 10 (after the session) and 5 days, 1 month and 3 months after treatment.


Eligibility criteria:
inclusion criteria: * magnetic resonance imaging evidence of narrowing of the central canal, lateral recess, and/or foramen. * persistent leg pain for at least 3 months * an average pain intensity score (during walking) of at least 4 out of 10 on the visual analog scale at screening and randomisation * persistent neurogenic claudication for at least 3 months * stable pharmacological treatment for pain and sleep disorders for at least 1 month before the study and throughout the trial * if present, coexisting low back pain intensity should be less than leg pain intensity. exclusion criteria: * patients with other neurological or psychiatric disorders including ongoing major depression (beck depression score\>14) * uncontrolled/unstable endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal disease * inflammatory diseases, cancer * severe hip and/or knee osteoarthritis that affects treadmill walking test * absolute/relative contraindications of tdcs (past head trauma resulting with loss of consciousness, epilepsy, past neurosurgical intervention, intracranial hypertension, implanted devices, migraine, chronic-severe headache episodes, a history of side effects with non-invasive brain stimulation techniques, skin diseases, pregnancy)

Keywords: transcranial direct current stimulation non-invasive brain stimulation neuromodulation chronic pain neurogenic claudication
tracheal intubation vs. bag-valve-mask ventilation in patients with out-of-hospital cardiac arrest _ caam study

Conditions: Out-of-hospital Cardiac Arrest

Summary: the aim of this study is to improve the management of patients in cardiac arrest, and this by comparing two initial airway management methods: tracheal intubation and bag-valve-mask ventilation. the survival rate at 28-day with favorable neurological function will be compared in the tracheal intubation group versus the bag-valve-mask group

it is a multicenter prospective non-inferiority open randomized controlled trial in patients with out-of-hospital cardiac arrest carried out in physician-staffed emergency medical services. the investigators hypothesis is that basic airway management (i.e. bag-valve-mask ventilation) is safe and may avoid the deleterious effects of tracheal intubation including interruption of chest compressions. on medical team's arrival at the scene and after verification of participant's eligibility, patients will be enrolled in the study and randomly assigned to either initial bag-valve-mask ventilation or tracheal intubation. after the hospital admission, all patients will be intubated whatever the initial airway management.

Eligibility criteria:
inclusion criteria: * age 18 years or older; * patient with out-of-hospital cardiac arrest on medical team's arrival * resuscitation attempted * medical insurance exclusion criteria: * massive suspected aspiration * presence of do-not-resuscitate order * pregnancy * prisoners

Keywords: out-of-hospital cardiac arrest bag-valve-mask ventilation tracheal intubation
the women's healthy lifestyle study

Conditions: Breast Cancer

Summary: this study aims to determine if a motivational interviewing counseling style can help women eat a healthy diet and exercise during breast cancer treatment and beyond.

women receiving chemotherapy for early stage breast cancer often gain weight and body fat, and this contributes to the health burden that cancer survivors face. weight gain is a concern not only for overall health status, but also as a possible factor for risk of cancer recurrence. unfortunately achieving weight loss, after a gain has occurred, is difficult, and there are no satisfactory methods for maintenance of weight loss. this study proposes to design and test a novel telephone-based intervention for preventing weight gain during treatment for breast cancer in a pilot, randomized study. the 12-month intervention will target maintenance of current weight and prevention of body fat gain using counseling for moderate exercise and a low-fat, high fruit-vegetable diet. the counseling approach will be based on motivational interviewing techniques and will be delivered through telephone appointments. motivational interviewing is a client-centered type of counseling that elicits active participation of the patient. by taking a more active role, patients may be more likely to follow through with the recommended lifestyle changes. study endpoints will include blood markers of dietary compliance, pedometer steps, self-monitoring logs, questionnaires (including quality of life) and anthropometric measures (including body fat by dexa). an important goal of the study is to establish recruitment methods and demonstrate recruitment rates in newly diagnosed stage i-iiia breast cancer patients. the study data also will demonstrate implementation of the counseling approach and provide a basis for sample size estimates for a larger trial. this type of intervention, namely a combination of exercise and diet, has been indicated to have good potential for prevention of recurrence. it is therefore necessary to develop effective methods for eliciting these behaviors.

Eligibility criteria:
inclusion criteria: * adult female, age 18 and older * stage i, ii, or iiia breast cancer * scheduled for chemotherapy and completed no more than two weeks of chemotherapy * body mass index 25-45 kg/m2 * stable body weight within 5 pounds in the past 2 months * physician approval for participating in a weight control program * willing and able to follow advice for exercise and diet quality exclusion criteria: * previous invasive cancers, excluding basal cell carcinoma, in the past 10 years * following a medically-prescribed diet * currently participating in a formal weight loss program * medical conditions that preclude safe exercise

Keywords: chemotherapy exercise diet fruit vegetables low-fat
the impact of donor covid-19 infection status on the recipient in allo-hsct

Conditions: COVID-19; Hematopoietic Stem Cell Transplantation

Summary: this study was conducted to observe whether covid-19 can be transmitted through stem cell transplantation and whether covid-19-positive donors have an effect on early hematopoietic reconstitution and immune reconstitution in the recipients.

severe acute respiratory syndrome coronavirus 2 (sars-cov-2) induced covid-19 infections are showing an explosive increase in china starting in late 2022. sars-cov-2 infections are characterized by an initial viral replication followed by an inflammatory phase with lymphocyte depletion in severe patients. past studies have shown that sars-cov -2 is detectable in the blood of 8%-15% of patients and that viremia occurs in the first 2-3 days after the onset of symptoms. ebmt, wmda and other organizations have suggested that covid-19 positive donors must be excluded or delayed from donation for safety reasons. however, there have not been any reports of transmission from donor to recipient in blood product transfusion or cell therapy. in the only reported cases of allogeneic hsct from sars-cov-2 positive donors, there was also no evidence of recipient infection from the graft. in the current situation where the vast majority of people are infected with covid-19 in the short term, many patients, such as those with leukemia, are in urgent need of transplantation due to the aggressive， hard-to-control，underlying disease. the investigators established this observational clinical trial to investigate whether covid-19 is transmitted through stem cells and whether covid-19 positive donors have an impact on early hematopoietic reconstitution and immune reconstitution in recipients.

Eligibility criteria:
inclusion criteria: 1. age between 16 and 65 years old. 2. history of hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma). 3. allogeneic hematopoietic stem cell transplantation perform during the covid19 pandemic. exclusion criteria: hematological diseases, other than hematological malignancies.
evaluating the usefulness of 18f-alf-fapi pet/ ct in orbital neoplasms

Conditions: Orbital Neoplasms

Summary: to evaluate the potential usefulness of 18f-alf-fapi positron emission tomography/computed tomography (pet/ct) for the diagnosis of primary and metastatic lesions in orbital neoplasms, and compared with 18f-fdg pet/ct.

subjects with orbital neoplasms underwent contemporaneous 18f-alf-fapi and 18f-fdg pet/ct for initial assessment. tumor uptake was quantified by the maximum standard uptake value (suvmax). the numbers of metastatic lesions of 18f-fdg and 18f-alf-fapi pet/ct were recorded by visual interpretation. the sensitivity, specificity, and accuracy of 18f-alf-fapi, 18f-fdg pet/ct were calculated and compared to evaluate the diagnostic accuracy.

Eligibility criteria:
inclusion criteria: 1. patients with suspected or newly diagnosed orbital neoplasms (supporting evidence may include mri, ct and pathology report); 2. patients who had scheduled both 18f-fdg and 18f-alf-fapi pet/ct scans; 3. patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee. exclusion criteria: 1. patients with pregnancy; 2. breastfeeding; 3. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
durability of three monthly loading doses with faricimab in treatment-naïve neovascular age-related macular degeneration

Conditions: Neovascular Age-Related Macular Degeneration (nAMD); Treatment-naïve

Summary: neovascular age-related macular degeneration (namd) is a one of the leading causes of irreversible vision loss among the elderly in developed countries. the implementation of anti-vegf therapies in the last decades has significantly improved amd management. faricimab (vabysmo®), a bispecific antibody targeting both vascular endothelial growth factor a (vegf-a) and angiopoietin-2 (ang-2), offers enhanced disease control by both inhibiting angiogenesis and stabilizing blood vessels to prevent inflammation and leakage. faricimab is thought to potentially reduce the frequency of injections compared to therapies targeting only vegf-a. a key aspect of evaluating its efficacy is understanding the interval before the need for subsequent injections following the initial loading dose. treatment with intravitreal anti-vegf injections would typically start with three injections administered at four-weekly intervals, however faricimab is recommended to be started with four loading injections. our department routinely initiates anti-vegf therapy with 3 loading doses and then follows an observe-and-plan regimen. this routine was continued with faricimab injections as well despite the manufacturer's recommendation of 4 monthly loading doses. determining the optimal interval for reinjection is crucial for reducing treatment burden and improving patient quality of life. this study aims to assess the durability of a loading dose of 3 faricimab injections, the need for a follow-up checkup at 4 weeks post-loading and functional outcomes post-loading in treatment-naive patients with neovascular age-related macular degeneration (namd),


Eligibility criteria:
inclusion criteria * age of 50 years or older * treatment-naïve patients diagnosed with namd who have received a loading dose with intravitreal faricimab * follow-up data available until the next subsequent faricimab injection after the loading dose, or if no injections were indicated following the loading dose, follow-up data for at least 4 months exclusion criteria * history of previous anti-vegf treatment. * neovascular conditions other than amd (e.g., choroidal neovascularization due to other causes) or co-existence of other retinal disease in the study eye * intraocular surgery in the study eye during the loading dose or prior to the first follow-up visit after the loading dose.

Keywords: neovascular age-related macular degeneration anti-vegf faricimab loading dose
clinical study of donor ebv-ctl infusion in patients with caebv and ebv-hlh after allo-hsct

Conditions: Chronic Active Epstein-Barr Virus Infection; Virus-Associated Hemophagocytic Syndrome

Summary: to evaluate the efficacy and safety of donor ebv-specific t lymphocytes (ebv-ctl) infusion in patients with chronic active epstein-barr virus infection (caebv) and ebv-associated hemophagocytic lymphohistiocytosis (ebv-hlh) after allogeneic hematopoietic stem cell transplantation (allo-hsct)

evaluate the efficacy and safety of donor ebv-specific t lymphocytes (ebv-ctl) infusion in patients with chronic active epstein-barr virus infection (caebv) and ebv-associated hemophagocytic lymphohistiocytosis (ebv-hlh) after allogeneic hematopoietic stem cell transplantation (allo-hsct)

Eligibility criteria:
inclusion criteria: 1. patients with caebv or ebv-hlh who were eligible for allogeneic hematopoietic stem cell transplantation agreed to regular monitoring of ebv-dna after transplantation. 2. age ≤65 years old, ecog score 0-2. 3. organ function: cardiac ef≥40%, creatinine clearance ≥50%, aminotransferase (alt/ast) \< 200u/l. 4. the estimated survival time is more than 3 months. 5) have donors who meet the requirements of allogeneic hematopoietic stem cell transplantation donors， and the donor agreed to collect lymphocytes to prepare ebv-ctl exclusion criteria: 1. the patient or donor had a new york heart association (nyha) score of grade ii or higher (including grade ii). or a definite diagnosis of cirrhosis. 2. there are active infections other than ebv that have not yet been controlled. 3. the donor has a blood-borne infectious disease (e.g. hiv, hepatitis b, hepatitis c, syphilis, etc.). the patient was positive for hbv-dna or hcv-rna. 4. active major hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.). 5. the donor refused to collect lymphocytes to prepare ebv-ctl cells, or the number of ebv-ctl cells prepared from the donor did not meet the infusion requirements. 6. at the same time participate in other clinical studies.
constitution of a clinico-radiological database and a biobank for patients with lacunar infarcts

Conditions: Lacunar Strokes

Summary: the aim of this study is to determine in patients with a recent lacunar strokes (\<15 days), the natural history of cognitive disturbances and disability.

this bi-centric cohort study aims at determining in patients with recent lacunar strokes (\<15 days), the main clinical, radiological, or genetic predictive markers of recurrent stroke, cognitive impairment, dementia, depression gait disturbances and disability.

Eligibility criteria:
inclusion criteria: * age 18 years and above * history of recent (less than 15 days) neurological deficit related to a small subcortical infarct (evidenced by medical history or physical examination) * diagnosis of recent small subcortical infarct on mri (hyperintensity on diffusion-weighted imaging showing an infarction in the territory of one perforating artery) presumably responsible for the corresponding neurological deficit * lesion diameter mess than 20 mm * ability to comply with scheduled follow-up and annual neurological evaluation * affiliation to the national french health insurance (sécurité sociale) * signature of informed consent exclusion criteria: * prior diagnosis of dementia according to dsm iv criteria * prior severe disability with rankin scale ≥ 4 * serious concomitant systemic disorder that can compromise the follow-up study; * leukoencephalopathy of non-vascular origin; * severe psychiatric disorder; * inability to obtain an informed signed consent from the patient or his/her family; * medical contraindication or refusal to undergo cerebral magnetic resonance scanning (mri).

Keywords: small subcortical infarct cerebrovascular disorders neurocognitive and cardiovascular disorders disability dementia stroke