Kornimate/medical-research-clean huggingface dataset:
comparison of barbed and conventional sutures in adhesion formation following cesarean section

Conditions: Cesarean Section

Summary: the aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with more postoperative adhesions compared with conventional sutures or not.

the aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with an increase in the rate of postoperative adhesions compared with conventional sutures or not. primigravida patients undergoing transverse lower segment cesarean section will be included in the study.cesarean section incision will be closed with double layers of continuous barbed or conventional sutures.patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Eligibility criteria:
inclusion criteria: * primigravida patients undergoing transverse lower segment cesarean section exclusion criteria: * previous laparotomies * postoperative fever * patients with preterm pregnancies or in labor

Keywords: barbed sutures,cesarean section, adhesions
deep neuromuscular block with low pressure pneumoperitoneum in laparoscopic abdominal surgeries

Conditions: Deep Neuromuscular Block; Low Pressure; Pneumoperitoneum; Laparoscopic Abdominal Surgeries

Summary: the aim of this study is to evaluate the effect of deep neuromuscular block on postoperative pain, duration of surgery, quality of surgical field, length of recovery room stays, total amount of rescue analgesic, postoperative nausea/vomiting, and length of hospital stay.

acute-pain management in surgery patients is accompanied by an array of negative consequences, including increased morbidity, impaired physical function, and quality of life, slowed recovery, prolonged opioid use during and after hospitalization, and increased cost of care. reducing pneumo-peritoneum (pp) is one technique for reducing postoperative pain. the effect of low pp on postoperative pain remains a controversial topic with other studies reporting no difference in postoperative pain levels between the two pressures. deep neuromuscular block (dnmb) in abdominal surgeries is associated with various advantages, such as lower abdominal pressure, lower pain and rescue opioid consumption, as well as less bleeding. dnmb may facilitate the use of reduced insufflation pressure without compromising the surgical field of vision. however, its usage is limited due to a lack of predictable and rapid recovery with conventional nmb antagonists (neostigmine) or spontaneous recovery

Eligibility criteria:
inclusion criteria: * age 18 to 65 years old. * both sexes. * american society of anesthesiologists (asa) physical status i-iii. * patients scheduled for laparoscopic abdominal surgery. exclusion criteria: * known allergies to cis-atracurium or neostigmine. * contraindications to the use of neostigmine, such as bronchial asthma, glaucoma, myocardial ischemia, and epilepsy. * history of neuromuscular, renal, or hepatic disease; previous abdominal surgery. * treatment with drugs known to affect neuromuscular function. * preoperative hyperalgesia. * peripheral neuropathy is caused by diabetes. * history of chronic analgesics treatment, drug, or alcohol abuse. * body mass index (bmi) \> 35 kg/m2.
riociguat in patients with chronic thromboembolic pulmonary hypertension (cteph)

Conditions: Hypertension, Pulmonary

Summary: the aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (cteph) and who are not satisfactorily treated and cannot participate in any other cteph trial. in the us the study runs as an expanded access program under 21 cfr 312.320.


Eligibility criteria:
inclusion criteria: - male and female patients with cteph either inoperable or with persistent or recurrent ph after surgery exclusion criteria: * all types of pulmonary hypertension other than dana point classification group 4 * operable patients listed for pea (pulmonary endarterectomy)

Keywords: chronic thromboembolic pulmonary hypertension
lung cancer and idiopathic pulmonary fibrosis : pathological and molecular characterization

Conditions: Lung Cancer and Idiopathic Pulmonary Fibrosis

Summary: retrospective inclusion of lung cancers developed in a context of idiopathic pulmonary fibrosis, diagnosed and / or treated in participating centers. the cases are recovered retrospectively from the records of the pulmonology and pathology departments of our various partners.

primary objective: characterize altered molecular pathways in lung cancer in patients with ipf versus lung cancer in non-ipf patients. secondary objectives: identify specific therapeutic targets describe a cohort of lung cancers on ipf (clinical / radiological and pathological data) to study the relationship between neoplastic / preneoplastic lesions and pulmonary parenchyma reshaped by fibrosis.

Eligibility criteria:
inclusion criteria: * lung carcinoma * idiopathic pulmonary fibrosis exclusion criteria: - no tumor sample available

Keywords: lung cancer; idiopathic pulmonary fibrosis
efficacy of laser therapy for periodontitis

Conditions: Periodontal Disease

Summary: the aim of this study is to evaluate the efficacy of diode laser in addition to periodontal treatment in periodontitis patients and to investigate their effects on gingival crevicular fluid (gcf) cytokine levels before and after treatment, among some yemeni individuals in sana'a city.

this study aims to compare the clinical and immunological effects of traditional mechanical debridement alone versus combined treatment with diode laser (high and low power). the clinical parameters include plaque index (pi), gingival index (gi), periodontal pocket depth (ppd), and clinical attachment loss (cal). immunological parameters include il-1β, il-6, il-8, and tnf-α levels in gcf. participants will be selected from the yemeni population residing in sana'a city. the study will include a control group receiving conventional therapy and two test groups receiving diode laser therapy with high and low intensity settings, respectively. measurements will be recorded at baseline (t0), one month after treatment (t1), and three months post-treatment (t2). the goal is to determine whether adjunctive diode laser therapy provides additional clinical and immunological benefits compared to conventional treatment alone.

Eligibility criteria:
inclusion criteria: only patients meeting the following criteria will be enrolled into the study: * patient with generalized periodontitis (bop and ppd ≥ 4 mm). * age group of 25-58 years old of periodontitis patients with at least 20 teeth present. exclusion criteria: * smoker and qat chewer patients. * pregnant and lactating women. * patients take medications which might influence the periodontal tissue state. * patients having systemic health disorders which affect the periodontium by history. * patients who received periodontal treatment or antibiotic therapy 3 months before the study. vi. patient wearing intra-oral appliance or with dental prosthesis. : -

Keywords: periodontal disease diode laser non-surgical periodontal therapy gingival crevicular fluid il-1b il-6 il-8 tnf laser dentistry periodontitis yemen
predictive values of serum adiponectin levels in aneurysmal subarachnoid hemorrhage.

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the purpose of this study is to evaluate the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage patients.

adiponectin (apn) is an abundant protein hormone derived from adipose tissue. it has been suggested to exert anti-inflammatory, antiatherogenic, and vascular protective. subarachnoid hemorrhage (sah) comprises about 5% of all strokes with high mortality and permanent disability rates. although many patients survive from the initial hemorrhage or rebleeding, they suffered from long-term delayed neurological deficits (dnds), including stroke, delayed cerebral ischemia, cognitive and neuropsychological abnormalities that seriously impact overall function and quality of life. ruptured cerebral aneurysms are the most common cause of sah. there is growing evidence supporting apn act as a predictive factor for sah. the observational study will focus on the predictive value of serum adiponectin levels in aneurysmal subarachnoid hemorrhage (asah).

Eligibility criteria:
inclusion criteria: * age\>18yrs and age\<90yrs * it shows subarachnoid hemorrhage (sah) based on computed tomography (ct) scan on admission * aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (cta), magnetic resonance angiography (mra) or digital subtraction angiography (dsa) * sah grade is assessed by hunt \& hess classification * informed consented exclusion criteria: * traumatic subarachnoid hemorrhage * patients with cerebral herniation or highly possible to occur within 2 days from sah * length of hospital stay is expected to be less than 5 days * duration from onset to admission is more than 48 hours * disturbance of communication or poor compliance to blood collection, imaging examination and follow-up

Keywords: subarachnoid hemorrhage, aneurysmal predictive adiponectin
a study of the relative bioavailability of a new formulation of bcx4161 and the effect of food on bcx4161

Conditions: Hereditary Angioedema

Summary: the purpose of the study is to compare how the body takes up and then eliminates the study drug bcx4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule. this study will also evaluate whether food has any effect on how the body takes up bcx4161.


Eligibility criteria:
key inclusion criteria: * written informed consent * body mass index 19 to 32 kg/m2 and a weight of at least 50 kg * abide by study restrictions * attend all study visits * acceptable birth control measures key exclusion criteria: * clinically significant medical history, current medical or psychiatric condition, ecg finding, or laboratory/urinalysis abnormality * activated partial thromboplastin time or prothrombin time outside of normal laboratory limits * pregnant or nursing * recent history of alcohol abuse or positive drugs of abuse screen * current smokers * donation or loss of greater than 400 ml of blood within 3 months

Keywords: bcx4161 biocryst hereditary angioedema relative bioavailability kallikrein inhibitor
effect of strength training for chronic low back pain patients (irma20)

Conditions: Musculoskeletal Pain; Low Back Pain

Summary: low back pain (lbp) is common in the population and has great socioeconomic consequences for societies across europe and the united states. about a third of working-age adults have frequent lbp, and for about 10% the pain becomes chronic with consequences for work and leisure activities. a cochrane review from april 2017 concluded that physical exercise is an intervention with few adverse events and positive outcomes on pain and function in adults with chronic pain. however, when scrutinizing the specific studies of the review there are large differences in adherence to the exercise interventions and consequently in the results obtained. thus, there is a need for simple exercises that the patients can easily adhere to.


Eligibility criteria:
inclusion criteria: * non-specific chronic low back pain patient (more than 3 months) at the hospital arnau de vilanova exclusion criteria: * spine surgery * neurologic or psyquiatric disorders * low back traumastism * recent participation in a similar training program
gene therapy for pleural malignancies

Conditions: Pleural Mesothelioma; Metastatic Pleural Effusions

Summary: this phase i study will evaluate the safety of two doses of bg00001 at different doses and intervals. eligible subjects will have: * malignant pleural mesothelioma, or * pleural effusions who have progressed through at least one prior therapy or have refused therapy bg00001 is given twice through a catheter in the pleural space.

ad.hifn-β (bg00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hifn-β) gene. this phase i study is designed to evaluate the safety and maximum tolerated dose (mtd) of two doses of intrapleural (ip) ad.hifn-β in subjects with pleural malignancies either metastatic or pleural mesothelioma. five dose levels will be studied: * dose levels 1, 2, and 3 will be given on days 1 and 15 * dose levels 4 and 5 will be given on days 1 and 8

Eligibility criteria:
inclusion criteria: * must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma * must have evaluable disease * must have ecog performance status of 2 * must have pleural space involved with tumor accessible for pleural catheter * must have fev1 \> 1 liter or 40% of predicted value * must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with bg00001 * concurrent tarceva is allowed if patients has been on a stable dose for at least three months and has not had serious adverse events * patients on stable dose of hormone may continue use of hormone * patients on stable dose of tarceva for 3 months and without complications may remain on tarceva exclusion criteria: * malignant pleural effusions secondary to lymphoma * rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation * untreated brain metastases * use of concurrent systemic steroids or immunosuppressants

Keywords: gene therapy immunotherapy
multicentre registry of ccta, ivus and oct

Conditions: Coronary Artery Disease

Summary: the invictus registry will compare the diagnostic performance of coronary computed tomography angiography (ccta) versus intravascular imaging by intravenous ultrasound (ivus) or optical coherence tomography (oct) for the measurement of minimum lumen area, the identification of stenosis severity, burden, morphology and vulnerability of coronary atherosclerosis.

clinical significance: coronary computed tomographic angiography (ccta) is a robust non-invasive modality to evaluate the presence, extent and severity of coronary artery disease (cad). for a plaque assessment, previous studies demonstrated that ccta provides a high correlation with intravascular imaging by intravenous ultrasound (ivus) in assessing coronary plaque characteristics stenosis severity and volume. high risk (vulnerable) plaque characteristics (positive remodeling, low attenuation plaque, spotty calcifications) are recognized to be more prone to rupture with increased rates of short-term cardiovascular disease events. although several studies similarly demonstrated the good concordance between ccta and ivus or optical coherence tomography (oct) in assessing high risk plaque features, patient numbers in these prior studies were limited to fully understand the effect of ccta for the assessment of coronary atherosclerotic plaque features. the research is a multi-center, registry enrolling patients with single/multi vessel atherosclerotic coronary artery disease. the study will be conducted in up to 15 medical centers in japan. in each patient, a ccta, ivus), and/ or oct will be performed, to provide a total of 1,300 vessels from 1,000 patients. thus, the full cohort (prospective plus retrospective patients) will provide a total of 2,000 vessels as basis for a diagnostic performance comparison between ccta and ivus or oct. accrual is expected to take 24 months.

Eligibility criteria:
inclusion criteria: * signed informed consent, inclusive of release of medical information, and health insurance portability and accountability act (hipaa) documentation * age 18 years or older * known or suspected coronary artery disease and subsequently indicated for coronary artery angiography exclusion criteria: * individuals unable to provide informed consent * acute st elevation myocardial infarction * pregnant woman * angiographically visible thrombus at the site of the lesion interrogated by ivus or oct * patients with lesions required balloon angioplasty before oct and/or ivus

Keywords: cad
community-engaged hypertension prevention program in black men

Conditions: Hypertension

Summary: the clip program will train community health workers (chws) to screen and identify black men with elevated blood pressure (bp) or stage 1 hypertension (htn), initiate lifestyle counseling; and link them to primary care and social services.

the study will consist of: 1. an implementation phase that will use a cluster randomized cluster trial of 20 barbershops among black men with elevated bp or stage 1 htn, to compare the effect of the barbershop-based facilitation (bf) strategy (n=10 barbershops; n=210 participants) vs. self-directed control (i.e. receipt of information for implementation of clip without the bf strategy; n=10 barbershops; n=210 participants), on bp reduction, htn prevention, linkage to care, and adoption of clip at 12 months 2. a post-implementation phase that will use reach effectiveness adoption implementation and maintenance (re-aim) to evaluate the effect of the bf strategy versus self-directed control on sustainability of clip 6 months after completion of the trial; and cost-effectiveness over a 10-year time horizon.

Eligibility criteria:
inclusion criteria: 1. 18 years of age as of date of data extraction 2. repeat customer within the last 3 months 3. self-identify as black 4. self-identify as male 5. have elevated blood pressure (pb) (120-129/\<80 millimeters of mercury (mm hg)) or untreated stage 1 hypertension (htn) (130-139/80-89 mm hg) (defined by american heart association's 2017 htn clinical guidelines) exclusion criteria: 1. age \<18 years 2. prescribed antihypertensive medication 3. diagnosis of end-stage renal disease (esrd) 4. condition which interferes with outcome measurement (e.g., dialysis) 5. serious medical condition which either limits life expectancy or requires active management (e.g., cancer) 6. cognitive impairment or other condition preventing participation in the intervention 7. upper arm circumference \>50 cm (maximum limit of the extra-large bp cuff) 8. active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days) 9. pregnant or planning pregnancy in the next 24 months 10. currently nursing a child 11. current participation in another research study focused on reducing bp 12. unwillingness to provide informed consent

Keywords: barbershop-based facilitation blood pressure
treatment of postpartum haemorrhage (pph) using misoprostol in home births

Conditions: Postpartum Haemorrhage

Summary: a double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the chitral district, in the khyber pakhtunkhwa province in pakistan.

a double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the chitral district, in the khyber pakhtunkhwa province in pakistan. the purpose of the study is to assess the overall clinical and programmatic effectiveness of traditional birth attendants (tbas) administering 800 mcg sublingual misoprostol to treat postpartum haemorrhage (pph) at the community level. the study will recruit pregnant women who deliver at home. all women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). women diagnosed with pph will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. in this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the lady health visitor/ community health nurse.

Eligibility criteria:
inclusion criteria: * women who deliver at home with a study tba present. * women must be willing and able to provide informed consent * women must agree to participate in a follow up interview * women must agree to have pre and post-partum haemoglobin taken exclusion criteria: * if the woman does not meet any of the above outlined inclusion criteria

Keywords: postpartum haemorrhage misoprostol treatment prophylaxis home births
effect of sensory adapted dental environment on dental anxiety of children with intellectual and developmental disabilities

Conditions: Developmental Disability; Intellectual Disability; Dental Anxiety

Summary: children with intellectual/developmental disabilities (id/dd) will experience less dental anxiety and cooperate better in a sensory adapted dental environment (modified visual, sensory, and somatosensory stimuli in a regular dental setting) than in a regular dental environment (rde).

the aim of this pilot study is to determine the effect of sensory adapted dental environment (sade) on reducing dental anxiety of children with intellectual and/or developmental disabilities (id/dd). with the growing number of children diagnosed with id/dd and their inclusion in the community, there are more opportunities for dentists to encounter this population for their routine oral health care. if improvement in dental anxiety and behavior is evident from the study, as other pilot studies have suggested, it can be applied as one of clinical tools for treating children with id/dds. furthermore, utilization of a sade in clinical training of pediatric dentists or general dentists can improve clinicians' comfort level in managing behavior of individuals with id/dd. this will encourage more clinicians to provide care and address the unmet oral health needs of this vulnerable population.

Eligibility criteria:
inclusion criteria: * children with intellectual and/or developmental disabilities exclusion criteria: * no specific diagnosis * parents/guardians have limited english proficiency

Keywords: sensory adapted environment pediatric dentistry oral health developmental disability intellectual disability dental anxiety autism spectrum