Kornimate/medical-research-clean huggingface dataset:
low-dose s-ketamine in women with prenatal depression

Conditions: Prenatal Depression; Ketamine; Postpartum Depression

Summary: prenatal depression is an important risk factor of postpartum depression. low-dose ketamine has been used for depression treatment. as a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. we speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.

studies have shown that prenatal depression symptoms are important predictors of postpartum depression. screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. ketamine is an nmda-receptor antagonist. in recent years, many studies confirmed that ketamine has a significant antidepressant effect. as a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. in clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. we speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. evidence is lacking in this regard.

Eligibility criteria:
inclusion criteria: 1. maternal age ≥18 years; 2. prenatal edinburgh postnatal depression scale score ≥10 points. exclusion criteria: 1. a clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties; 2. severe pregnancy complications, such as severe preeclampsia, placental implantation, hellp (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption; 3. american society of anesthesiologists classification ≥iii; 4. presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (new york heart association classification ≥iii), and hyperthyroidism.

Keywords: prenatal depression s-ketamine postpartum depression
neoadjuvant short-course radiotherapy with or without chemotherapy and ak112 in locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: this phase ii multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (scrt) sequentially combined with ak112 (envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (larc). the study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.

the study is designed as a two-arm, randomized, open-label, prospective trial. patients with locally advanced rectal adenocarcinoma will be randomly assigned to one of two treatment groups: arm a: scrt followed by chemotherapy (capeox) combined with ak112. arm b: scrt followed by ak112 alone. primary and secondary outcome measures include complete response rate (cr), safety, pathological and radiological response rates, and biomarkers associated with treatment response. the trial will enroll 100 participants across multiple centers over three years.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. age 18-80 years, male or female. 3. histologically confirmed rectal adenocarcinoma. 4. clinical baseline stage t3-4nxm0 or txn1-2m0 by mri assessment. 5. able to swallow tablets. 6. ecog performance status of 0-1. 7. no prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy. 9.fit for surgery with no contraindications. 10.normal organ function. 11.tumor ≤12 cm from the anal verge exclusion criteria: 1. allergy to monoclonal antibodies, ak112 components, or capeox regimen. 2. previous or current use of immune checkpoint inhibitors or immune-related 3.treatments. 4.active autoimmune diseases or history of significant autoimmune conditions. 5.immunodeficiency disorders or history of organ/bone marrow transplantation. 6.uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent mi). 7.severe infection within 4 weeks or active pulmonary infections. 8.active hepatitis b or c infection. 9.diagnosis of other malignancies within 5 years (except low-risk cancers). 10.pregnant or breastfeeding women.

Keywords: rectal cancer neoadjuvant ivonescimab immunotherapy
macugen observational study

Conditions: Vascular Endothelial Growth Factor; Macular Degeneration

Summary: the objective of this observational study is to evaluate the effectiveness and safety of macugen for treatment of wet age-related macular degeneration (amd) in indian patients.prospective, observational, non-interventional study. the period of observation for the study will be 1 year

to be eligible for enrollment in this study, patients must receive the first injection of macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (amd). the decision to prescribe macugen will necessarily precede and will be independent of the decision to enroll patient into the study. if both eyes of a patient receive injection macugen, only one eye will be included in the study. if both eyes receive first injection macugen after initiation of the study, only the first treated eye will be included in the analysis. if one eye has already received macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis. the study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on august 30, 2010. there were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility criteria:
inclusion criteria: * to be eligible for enrollment in this study, patients must receive the first injection of macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (amd). exclusion criteria: * active or suspected ocular or periocular infection. * known hypersensitivity to pegaptanib sodium or any other excipient in this product.

Keywords: pegaptanib macular degeneration vascular endothelial growth factor
caspofungin for the treatment of non-blood candida infections (0991-045)

Conditions: Candidiasis

Summary: candida is the most common fungal pathogen identified in hospitalized patients. this study will seek to enroll adult patients (18 years of age or older) with invasive candida infections (involving deep tissues and organs). the study will not enroll patients whose only site of candida infection was the bloodstream. patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. the dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.


Eligibility criteria:
inclusion criteria: * all patients must have at least 1 positive culture for candida species obtained from an otherwise sterile, non-blood body site within 96 hours of the study entry. * the patient must also have clinical evidence of candida infection (e.g., oral temperature \>100 degrees fahrenheit, signs of inflammation from infected site, systolic blood pressure \<90) within 96 hours of study entry. * the patient must be at least 18 years old, and if a woman of child bearing potential, must have a negative serum or urine pregnancy test sensitive to 25 iu hcg prior to enrollment. exclusion criteria: * patients whose only site of candida infection was the bloodstream.
a study of ly900014 compared to insulin lispro (humalog) in adults with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to see if ly900014 compared to insulin lispro (humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (t2d).


Eligibility criteria:
inclusion criteria: * participants must have t2d based on the disease diagnostic criteria world health organization (who) classification. * participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily. * participants must be treated no more than 3 oral anti-hyperglycemic medications (oams). * participants must have a hba1c ≥7.0% and ≤11.0%. * participants must have body mass index (bmi) of ≤35.0 kilograms per meter squared (kg/m2). exclusion criteria: * participants must not have been diagnosed, at any time, with type 1 diabetes (t1d) or latent autoimmune diabetes in adults. * participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening. * participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening. * participants must not have used thiazolidinediones, glucagon-like peptide 1 (glp-1) receptor agonist, or pramlintide within 90 days prior to screening.
observational study to evaluate the safety of levemir® in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe, north america and asia. the aim of this observational study is to evaluate the safety and effectiveness while using levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice. data from the nn304-3573 study (nct00740519) will be pooled with data from this study and reported together in the final study report for this study.


Eligibility criteria:
inclusion criteria: * after the participating physician's decision has been made to initiate once-daily levemir® therapy, any patient with type 2 diabetes who is currently treated with diet, exercise and one or more oads can be offered to participate exclusion criteria: * current treatment with insulin * known or suspected allergy to levemir® or excipients * children below the age of 6 years * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)
effectiveness of child intubation

Conditions: Cardiac Arrest

Summary: we hypothesized that the intubrite video laryngoscope system vls 6600 is beneficial for intubation of pediatric manikins while performing cpr. in the current study, we compared effectiveness of the intubrite and mil laryngoscopes in child resuscitation with and without cc.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * minimum 1 year of work experience in emergency medicine * experienced emergency medical personnel (physicians, nurses, paramedics) exclusion criteria: * not meet the above criteria * wrist or low back diseases

Keywords: intubation
upper extremity home exercises in patients with scleroderma

Conditions: Scleroderma; System; Sclerosis

Summary: hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. the vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. literature indicate that more work is needed to continue to develop and evaluate rehabilitation interventions in this population. this study is a randomized controlled study examining the effects of 8 weeks of upper extremity home exercises on grip strength, normal joint movement, activity performance and functionality in patients with scleroderma. in our study, it is aimed to contribute to the standardization of upper extremity exercise protocols for scleroderma patients, to increase the quality of life of patients and to increase their independence in daily living activities.

the primary aim of the study is to examine the effects of upper extremity exercises on joint range of motion, grip strength, activity performance and functionality in patients with scleroderma, and thus contribute to the standardization of exercise protocols for the upper extremity in patients with scleroderma. the secondary aim of the study is to ensure the independence of scleroderma patients in their daily living activities and to increase their quality of life. at least 46 scleroderma patients meeting the inclusion criteria will be included in the study. demographic information form, canadian activity performance measurement (copm), arm, shoulder and hand problems questionnaire (dash), chronic rheumatological influence of the hands assessment and measurement score questionnaire (sacrah), duruöz hand index (dhi) will be applied to the patients, upper extremity joint range of motion will be applied, gross and fine grip strength measurements will be made. after the initial evaluation, patients will be randomized to intervention and control groups. upper extremity home exercises including stretching and strengthening will be taught to the intervention group, and they will be asked to do it 5 days a week for 8 weeks. for eight weeks, the patients will be supported by the phone by the physiotherapist and it will be checked whether they do the exercises. the control group will be trained on the principles of joint protection. at the end of eight weeks, patients will have their final evaluation and analysis.

Eligibility criteria:
inclusion criteria: * having a diagnosis of ssc according to 2013 acr/eular criteria * having upper extremity/hand involvement * voluntary and consent to participate in the study exclusion criteria: * having a known diagnosis of additional rheumatological disease * diagnosis of any known non-rheumatic disease * existence of deformity that prevents doing the exercises * presence of active digital ulcer being involved in another rehabilitation program * having cognitive disorder * failure to give consent to participate in the study

Keywords: scleroderma upper extremity exercises home exercises grip strength
standardization of laparoscopic surgery for right hemi colon cancer (slrc)

Conditions: Overall Survival; Postoperative Complications; Metastasis; Stage, Colon Cancer

Summary: to standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (cme) could improve disease-free survival in patients with right colon cancer, compared with d3 radical operation in laparoscopic colectomy.


Eligibility criteria:
inclusion criteria: 1. patients suitable for curative surgery 18-75years old 2. qualitative diagnosis: a pathological diagnosis of adenocarcinoma; 3. localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon; 4. enhanced ct scan of chest, abdominal and pelvic cavity: assessment of tumor stage is t stage 1-4 and n stage 0-2; there is no distant metastasis. 5. informed consent exclusion criteria: 1. simultaneous or simultaneous multiple primary colorectal cancer; 2. preoperative imaging examination results show: (1) tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform r0 resection; 3. history of any other malignant tumor in recent 5 years; 4. patients need emergency operation; 5. not suitable for laparoscopic surgery; 6. women during pregnancy or breast feeding period; 7. informed consent refusal

Keywords: cme right hemi colon cancer d3 laparoscopy
routine health care of patients with fshd

Conditions: Primary Disease Fascioscapulohumeral Dystrophy (FSHD)

Summary: on the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with fshd, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with fshd.the result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with fshd and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. since then, patients with fshd who attend consultation at montpellier hospital are systematically supplemented with antioxidants according their own blood tests.

this study will assess course of patients with fshd in accordance with usual care performed within the department of clinical physiology at the university hospital of montpellier. this prospective longitudinal study include an initial assessment. then the follow up of patients will be monitored at 12 months and annually. the eventual objective will be to develop a fshd disease cohort in care at the montpellier hospital. a statistical analysis will be performed at 3-years follow-up

Eligibility criteria:
inclusion criteria: * molecular and clinical diagnosis for fshd * patients, men and women aged \> 7 years, exclusion criteria: * pregnant women * inability to understand the nature and goals of the study and / or communication difficulties with the investigator * major protected by law (guardianship, curatorship or under judicial protection)

Keywords: fshd usual care performed at montpellier hospital muscle function antioxidants oxidative stress quality of life physical activities, development of food-based dietary guidelines co-morbidity
detour i clinical study for percutaneous femoropopliteal bypass

Conditions: Peripheral Arterial Disease

Summary: to assess the safety and performance of the pq bypass system to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the pq bypass systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * age 18 or older * rutherford classification of 3-5 * patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 fr. introducer sheath * femoro-popliteal lesions ≥10 cm in length considered to be: * chronic total occlusion (100% stenosis) * diffuse stenosis (\>50% stenosis) with moderate to heavy calcification * in-stent restenosis (\>50% stenosis) * proximal and distal target vessels are 5.4-7.0 mm in diameter * orifice and proximal 1 cm of sfa is patent * patent popliteal artery 3 cm proximal to tibial plateau * at least 1 patent tibial artery to the foot * patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein * subject has \> one year life expectancy exclusion criteria: * bypass length required \> 30 cm * history of deep vein thrombosis * has a known hypersensitivities, allergies or contraindications to: nitinol, ptfe; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment; * has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months * pregnant or nursing * untreated flow-limiting aortoiliac occlusive disease * has renal failure (egfr \< 30ml/min) * major distal amputation (above the transmetatarsal) in the study or non-study limb * patient has had a revascularization procedure on the target limb within 30 days * patient has a planned amputation of the target limb * previous bypass surgery on the target limb * patient is participating in another clinical study for which follow-up is currently on going. * patient has a condition that in the view of the investigator precludes participation in this study
the impact of pdd during turb for nmibc

Conditions: Bladder Cancer

Summary: the goal of this clinical trial is to learn if photodynamic diagnosis (pdd) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (hexvix 85mg/50ml) is more sensitive than the standard white light tecnique in detection of malignant bladder tumour. patients will be randomised to: * transurethral resection of the bladder (turb) with a standard white light tecnique * turb with the pdd tecnique using the study drug hexvix

non-muscle invasive pt1 high-grade (hg) bladder cancer (nimbc) represents a challenge for the urologists due to its aggressive behavior, with a marked tendency to recur after transurethral resection of the bladder (turb) and even progress to muscle-invasive disease. to limit the risk of upstaging and to provide more clinical information indispensable for the decision-making process, international guidelines strongly recommend a re-turb to be performed within 2-6 weeks from the first resection in all pt1hg tumors. however, not all the published literature agrees on the value of re-turb wich is also an invasive and morbid procedure, requires a general or locoregional anesthesia and, like all surgical procedure, it is not free of risks and complications. there is, therefore, an unmet need for improving the quality and completeness of turb which may have an impact on the necessity of re-turb. it has been confirmed that fluorescence-guided biopsy and resection (photodynamic diagnosis-pdd) are more sensitive than conventional procedures for the detection of malignant tumours, particularly for cis. pdd is performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (hexvix 85mg/50ml).to date, no randomized controlled trials (rcts) have been conducted aiming to compare the completeness of turb with pdd compared to turb with standard white light (wl).

Eligibility criteria:
inclusion criteria: * voluntarily signed informed consent per good clinical practice and national regulations * age ≥ 18 years * patient planned for turb for \>1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. the cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-turb. exclusion criteria: * patients with history of recurrent nmibc * patients with visible incomplete resection during primary turb * patients with metastatic disease or with a preoperative ct scan highly suspected for mibc

Keywords: turb re-turb photodynamic diagnosis-pdd hexvix
supported treadmill ambulation training after spinal cord injury

Conditions: Spinal Cord Injury

Summary: this is a randomized, controlled trial to compare supported treadmill ambulation training (stat) to conventional gait training for improving gait speed, gait endurance, gait efficiency and muscle function in sci subjects injured more than six months prior to start of training. each subject will receive twelve weeks of either cgt or stat, given as 20 minutes of training within a one-hour period per day, five days per week. these subjects will be studied baseline, 4,8 and 12 weeks of training, and three months after the end of training with a battery of tests designed to evaluate the subjects' gait and muscle function.


Eligibility criteria:
spinal cord injury

Keywords: spinal cord injury, ambulation, treadmill