Kornimate/medical-research-clean huggingface dataset:
a pilot trial of the reach out, stay strong, essentials for mothers of newborns (rose) postpartum depression prevention intervention in pregnant patients admitted to strong hospital

Conditions: Postpartum Depression; Postpartum Anxiety

Summary: this study is a pilot, single-center, randomized controlled trial. it will 1. determine feasibility and acceptability of an evidence-based intervention for prevention of postpartum depression with antepartum patients on a high-risk obstetric unit, 2. determine what adaptations may be needed for an inpatient population 3. determine what retention strategies are most successful and acceptable for this patient population 4. estimate the effect size of an intervention for in-hospital distress, anxiety and depression 5. estimate the effect size of an intervention to reduce the risk of a post-partum depression diagnosis or depressive symptoms.


Eligibility criteria:
inclusion criteria: * viable pregnancy between 20 weeks 0 days and 35 weeks 0 days gestation at the time of enrollment * anticipated admission to the hospital for \>5 days due to pregnancy complication requiring hospital observation * age \> 18 years * planned hospitalization at strong memorial hospital through the duration of antepartum course * planned delivery at strong memorial hospital exclusion criteria: * fetal demise in utero * inability to give informed consent secondary to intellectual capacity * english is not primary language used to communicate * currently incarcerated * age \< 18 years * planned antepartum hospitalization at another institution * planned delivery at another institution * actively suicidal or in need of acute psychiatric care
the severe soft tissue bleeding study

Conditions: Soft Tissue Bleeding

Summary: the objective of this study is to evaluate the safety and hemostatic effectiveness of the fibrin pad (fp) versus standard of care treatment (soc) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.


Eligibility criteria:
inclusion criteria: * subjects \>= 18 years of age, requiring elective, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures; * presence of an appropriate severe bleeding soft tissue target bleeding site (tbs) as identified intra-operatively by the surgeon; * subjects must be willing to participate in the study, and provide written informed consent. exclusion criteria: * subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure; * bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the fp to blood flow and pressure during healing and absorption of the product; * subject with tbs within an actively infected field; * bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine; * subjects with known intolerance to blood products or to one of the components of the study product; * subjects unwilling to receive blood products; * subjects with known immunodeficiency diseases (including known hiv); * subjects who are known, current alcohol and / or drug abusers; * subjects who have participated in another investigational drug or device research study within 30 days of enrollment; * female subjects who are pregnant or nursing.

Keywords: hemostasis
spectral-domain optical coherence tomography of the eye

Conditions: Cornea; Retina; Refractive Surgery; Macular Edema; Diabetes; Diabetic Macular Edema

Summary: an increasing number of clinical studies on sd-oct of ocular pathologies and potential new clinical applications has recently been published in the peer-reviewed literature. however, the successful use of sd-oct in routine clinical use depends upon the diagnostic sensitivity, biometric accuracy and reliability of the sd-oct machines. this prospective, comparative, observational study aims to evaluate the imaging quality and diagnostic performance of two commercially available sd-oct machines for both the anterior and posterior segment of the eye.


Eligibility criteria:
inclusion criteria: * age 21 and older * normal eyes or * eyes with corneal disease: subjects that have any of the following conditions 1. corneal dystrophy or degeneration 2. corneal scarring 3. corneal ulcer 4. corneal injury 5. keratoconus 6. patients who had undergone corneal surgery 7. patients with other corneal disease or - eyes with retinal disease: subjects that have any of the following conditions: 1. diabetic macular edema 2. cystoid macular edema 3. age related macular degeneration 4. retinal vascular disorders (e.g. retinal artery occlusion) 5. epiretinal membrane 6. choroidal nevus 7. macular hole 8. patients who had undergone retinal surgery 9. patients with other retinal disease or * eyes with glaucoma * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant. and - written informed consent prior to recruitment exclusion criteria: any of the following will exclude a subject from the study: * patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus) * pregnancy (pregnancy test will be taken in women of reproductive age before enrolment into the trial)
radiography protocol in the acute phase after proximal femur internal fixation- self assessment and recommendations

Conditions: Pertrochanteric Fracture

Summary: there is no standardized protocol regarding the post-operative radiographic follow up of patients that sustain pertrochanteric hip fractures and are treated with closed reduction and internal fixation. the policy in the investigator's institution as in other hospitals is to conduct a radiogram of the operated hip during the first days following operation after the patient bore weight on the fixated femur. the investigator's goal is to asses the added value of this policy and to offer recommendations regarding this specific followup component.

there is no consensus regarding the proper radiographic protocol following closed reduction and internal fixation of pertrochanteric femoral fractures. despite its' questionable necessity and significant economic burden, many medical centers practice a policy of imaging internally fixated proximal femurs after the patients bore weight on them. the investigator's goal is to assess the added value of the postoperative imaging study described. materials and methods: we will conduct a prospective study. all patients who will be treated with closed reduction and internal fixation of ao31a fractures will be enrolled. two sets of imaging studies will be assessed- the intra-operative ap and axial fluoroscopy studies and the radiograms that are taken following bearing weight on the operated hip. three decision steps will take place regarding weight bearing limitations and a necessity for re-operation- (1) immediately after the operation; (2) a day after the operation; (3) following weight bearing according to a new radiogram. objective measurements will be taken for each hip on both imaging modalities- neck-shaft angle, neck length and tip-apex distance.

Eligibility criteria:
inclusion criteria: * pertrochanteric femur fracture, classified as ao-31-a * go through a closed reduction and internal fixation operation at the investigator's institution exclusion criteria: * patients that due to clinical findings or other necessities go through specific followup radiography imaging protocols * fluoroscopy imaging studies were not saved

Keywords: pertrochanteric radiography
pain after breast surgery

Conditions: Breast Cancer; Surgery

Summary: this is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer.


Eligibility criteria:
inclusion criteria: * english speaking undergoing elective breast cancer surgery exclusion criteria: * patients with recurrent cancer, metastasis, and previous breast surgery
dyspnea neuroscience education on patients with chronic obstructive pulmonary disease

Conditions: Dyspnea

Summary: the principal aim of this study was to adapt pain neuroscience education to dyspnea, dyspnea neuroscience education (dne), and measure its effect on dyspnea perception, physica l activity level, disability, quality of life and ventilatory and functional capacity through a randomized controlled trial. the secondary objectives were to evaluate its feasibility and its effect on emotional state (anxiety and depression), medical atten dance, number of exacerbations and the willingness to exercise.


Eligibility criteria:
inclusion criteria: * diagnostic of copd by a physician or pneumologist * stage 1, 2 or 3 on the gold classification * gold stage and fev1 assessed by a physician in the last three months * access to a computer and internet exclusion criteria: * cognitive impairment (moca-s score \< 21) * depression disorder (phq-9 score ≥11) * generalized anxiety disorder (gad-7 score ≥10) * instable comorbidities preventing physical activities * had a surgery in the past three months * had an exacerbation in the past three months * currently quitting tobacco * use of oxygenation

Keywords: education neuroscience education
a study of the selective pkc-β inhibitor ms- 553

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Aggressive Lymphoma

Summary: a phase i/ii dose-escalation and expansion study of the selective pkc-β inhibitor ms-553 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma


Eligibility criteria:
inclusion criteria: to be eligible for inclusion in the primary escalation and expansion cohort 1 in this study, patients must meet all of the following criteria: 1. age 18 years or older 2. diagnosis of chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll): 1. history of histologically documented cll or sll that meets iwcll diagnostic criteria according to the 2008 guidelines, and 2. indication for treatment as defined by the 2008 iwcll guidelines, or the need for disease reduction prior to allogeneic transplantation exclusion criteria: patients who meet any of the following criteria are not eligible for the primary escalation and expansion cohorts of this study: 1. current or past transformation of cll/sll to prolymphocytic leukemia (pll), non-hodgkin lymphoma, or hodgkin lymphoma aggressive lymphoma outlined in the inclusion criteria for the optional cohort. 2. active and uncontrolled autoimmune cytopenia(s) 3. any of the following prior therapies within 14 days prior to cycle 1, day 1: 1. major surgery 2. corticosteroids greater than 20 mg / day prednisone (or equivalent), unless used by inhalation or topical route, or unless necessary for premedication before iodinated contrast dye, or for autoimmune hemolytic anemia 3. cytotoxic chemotherapy or biologic therapy, excepting bcr pathway kinase inhibitors for which no wash out is required (but must be stopped before cycle 1 day 1)
study of the effects of bronchoalveolar lavage liquid in the ards on the functioning of the neutrophil polynuclear system

Conditions: ARDS, Human

Summary: firstly, the study assesses the effect of bronchoalveolar lavage fluid (bal) from patients in (acute respiratory distress syndrome (ards) on the life span of pnns and on the phagocytosis of apoptotic cells by macrophages and polynuclear neutrophil (pnn). then, the effect of an antibody directed against "high-mobility group box 1" protein (hmgb1) and the effect of metformin on efferocytosis are studied.

ards (acute respiratory distress syndrome) is a syndrome that causes significant mortality and morbidity. this syndrome is characterized by an alveolitis with polynuclear neutrophil (pnn). pnns play an important role in the persistence and in injuries induced by ards. several animal studies have shown that lesional edema can be increased by two important mechanisms: the increase in the lifespan of pnns in the lung and the decrease in the phagocytosis capacities of apoptotic cells (efferocytosis) by macrophages and pnns. however, confirmation of these data in humans does not exist, and knowledge of the mechanisms that may increase lung damage during ards will limit it and thus reduce the mechanical ventilation time of these patients as well as the mortality associated with ards. " high-mobility group box 1 " (hmgb1) protein may be involved in reducing efferocytosis capacity. similarly, activation of amp-activated protein kinase (ampk) could restore the clearance capacity of apoptotic cells in macrophages and pnns.

Eligibility criteria:
inclusion criteria: * ards group : inpatients hospitalized in medical intensive care with an ards defined according to the berlin criteria and requiring an bal(for diagnostic purpose in suspicion of pneumopathy acquired under mechanical ventilation). * control group : the control population is made up with patients with a bal considered normal (endoscopy patients from the pneumology department). the normality of the bal is defined by a normocellular wash with cellularity: \< 150,000 to 200,000 cells/ml cell composition (formula): macrophages: 80-90%, lymphocytes 5 to 10% (\< 20%), neutrophils: \< 5%, eosinophils: \< 2%. exclusion criteria: * age \< 18 years; * pregnant women ; * persons deprived of their liberty by judicial or administrative decision; * persons legally incapable; * persons not affiliated to a social security system; * previously immunocompromised patients (hiv infection, hematopathy, organ transplantation, immunosuppression); * patients who do not require a lung sample.

Keywords: bronchoalveolar lavage
study of sanguinate™ versus hydroxyurea in sickle cell disease (scd) patients

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to compare the safety of sanguinate™ versus hydroxyurea in patients suffering from sickle cell disease.


Eligibility criteria:
inclusion criteria: * patients with homozygous (hbss) sickle cell anemia; * hb levels: \>6g/dl - \<10g/dl; * age : \>18 years old; * frequency of er hospitalizations \< 6x/yr for scd pain events documented "medical history". exclusion criteria: * patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks; * allergic to hydroxyurea; * history of clinical significant disease, as determined by the investigator; * history of allergy or major allergic reaction considered to be clinically significant by the investigator; * screening assessments considered to be abnormal by the investigator; * patient has sever pulmonary hypertension (index \>3 meters per sec); * donated blood within 60 days of screening or otherwise experienced blood loss of \>250 ml within the same period; * intending to begin new concomitant drug therapy or over-the-counter medication anytime from scree4nin to the time of administration of study drug;

Keywords: sanguinate
effects of high-intensity noninvasive positive pressure ventilation in aecopd

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Summary: this study aims to investigate the effects of high-intensity noninvasive positive pressure ventilation (nppv), as compared with low-intensity nppv, on hypercapnia, consciousness, inspiratory muscle effort, dyspnea, nppv tolerance, inflammatory response, adverse events and other outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: 1. diagnosis of copd according to the criteria of the global initiative for chronic obstructive lung disease in 2019 2. presence of acute exacerbation 3. arterial ph \ 45 mmhg on room air or supplemental oxygen 4. paco2 \>45 mmhg following low-intensity nppv of ≥6 hours exclusion criteria: 1. age \<18 years 2. excessive amount of respiratory secretions or weak cough 3. upper airway obstruction 4. recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery 5. potential risk factors for restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, and severe abdominal distention) 6. active upper gastrointestinal bleeding 7. cardiac or respiratory arrest 8. arterial oxygen tension/fraction of inspired oxygen \<100 mmhg 9. pneumothorax 10. severe ventricular arrhythmia or myocardial ischemia 11. severe hemodynamic instability despite fluid repletion and use of vasoactive agents 12. severe metabolic acidosis 13. refusal to receive nppv 14. endotracheal intubation already performed before icu admission
comparison of bisoprolol with metoprolol succinate sustained-release on heart rate and blood pressure in hypertensive patients

Conditions: Hypertension

Summary: this is a multicentre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (sr) tablet in subjects with mild to moderate primary hypertension.

primary objectives: to demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior in mean ambulatory dbp as compared with metoprolol sr in the last 4 hours after 12-week active treatment in subjects with mild to moderate essential hypertension (eh). secondary objectives: 1. to compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several parameters at different times (example: blood pressure, heart rate, their variability, etc...) after 12-week treatment from baseline among subjects with mild to moderate eh 2. to evaluate safety of the two drugs 3. to evaluate the treatment compliance of the two drugs

Eligibility criteria:
inclusion criteria: 1. subjects aged: \>=18 years and =\<70 years old 2. eh who are suitable for mono-therapy, either mild to moderate eh patients who have not been treated with anti-hypertension drugs, or mild eh subjects who have taken anti-hypertension drug. 3. clinic resting heart rate \>=70 beats per minute (bpm) 4. patients who have signed informed consent exclusion criteria: 1. subjects with contraindications according to the china summary of product characteristics (smpcs) of both bisoprolol and metoprolol sr, such as acute heart failure, second or third degree atrioventricular block (without a pacemaker), sick sinus syndrome, symptomatic bradycardia or symptomatic hypotension, severe bronchial asthma or severe chronic obstructive pulmonary disease, metabolic acidosis, etc. 2. moderate eh patients who have used anti-hypertension drugs 3. secondary hypertension 4. subjects with history of coronary heart disease 5. chronic or acute heart failure 6. cerebrovascular events within 6 months before screening 7. impaired hepatic or renal function (according to local lab standard) 8. other protocol defined exclusion criteria could apply

Keywords: bisoprolol hypertension blood pressure heart rate
transversus abdominis plane block versus external oblique intercostal plane block for postoperative analgesia in pediatrics undergoing open nephrectomy

Conditions: Transversus Abdominis Plane Block; External Oblique Intercostal Plane Block; Postoperative Analgesia; Pediatrics; Open Nephrectomy

Summary: the aim of this study is to compare the ultrasound guided tap block and eoip block for postoperative analgesia in pediatrics undergoing open nephrectomy.

nephrectomy in children may also be for malignant conditions of the kidney and adrenal glands. the major indications for nephrectomy vary in different parts of the world and in different age groups and sexes with some recording more benign conditions and others more of malignancies ultrasound-guided transversus abdominis plane (tap) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. the purpose is to provide analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall. external oblique intercostal plane block (eoipb) has been reported by elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. in comparison to quadratus lumborum block (qlb) and erector spinae plane block (espb) , the advantage of eoipb is that it may be performed with the patient supine. furthermore, in comparison to serratus intercostal plane block (sipb), it generates more extensive analgesic effects throughout the whole midline of the abdomen .

Eligibility criteria:
inclusion criteria: * age ≤ 18 years. * both sexes. * american society of anesthesiology (asa) physical status i-iii. * scheduled for open nephrectomy. exclusion criteria: * abnormal blood coagulation. * scar, infection, and tumor of puncture site. * history or family history of high malignant fever. * severe cardiovascular problems.
long-standing persistant atrial fibrillation-pulmonary vein isolation with or without ablation

Conditions: Atrial Fibrillation; Tachycardia

Summary: the chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (pvi) as compared to pvi alone in patients with long-standing persistent af.


Eligibility criteria:
inclusion criteria: * long standing persistent atrial fibrillation \> 6 months and \< 5 years exclusion criteria: * renal failure * left atrial size \>55 mm
a study to assess the pharmacokinetics, immunogenicity and safety of escalating doses of bms-188667 given as a single intravenous infusion to patients with psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the purpose of this protocol is to determine the single-dose pharmacokinetics and immunogicity of bms-188667 administered as a 1 hour intravenous infusion with extended pharmacokinetic sampling. safety of all subjects will be assessed in a double blind fashion through the inclusion of placebo controls at each dose level.


Eligibility criteria:
inclusion criteria: * subjects required to have a know diagnosis of psoriasis vulgaris involving 5-49% of total body surface area (bsa) for at least six months prior to randomization. * subjects clinically insignificant abnormal laboratory or ecg test results who were otherwise healthy and met all remaining eligibility criteria. exclusion criteria: * evidence of active bacterial or viral infections at the time of enrollment, including any history of or clinical evidence of infection with human immunodeficiency virus (hiv) hepatitis b or hepatitis c. * any underlying metabolic, hematologic, pulmonary, cardiac, renal hepatic, infectious, psychiatric or gastrointestional condition, which in the opinion of the investigator, placed the subject at unacceptable risk from participation in a study with potentially immunosuppresive therapy.