Kornimate/medical-research-clean huggingface dataset:
effect of lumbar spinal fusion predicted by physiotherapists

Conditions: Low Back Pain

Summary: the main purpose of this study is to investigate if improvements in patient self-reported pain, symptoms, function and quality of life 12 months after lumbar spinal fusion among patients that have good projected prognosis differ from those among patients with a poor projected prognosis. the secondary purpose is to explore the underlying factors of the physiotherapists projected prognosis to identify objective and possible modifiable candidate prognostic factors for recovery.

background: over recent decades, an increasing number of patients with chronic low back pain (clbp) undergo surgical lumbar spinal fusion (lsf). for many of the patients lsf is their last resort in the hope of a better life with less pain, disability and use of medication. unfortunately, several reports show, that the pain level remains the same after lsf for many patients, and that consumption of medication remains unchanged in almost 50 % of the patients. knowing that characteristics such as maladaptive coping strategies, fear avoidance beliefs and pain catastrophizing seem to be predictive of worse outcome in pain, function and quality of life after surgery. it is important to assess how these individual factors in the postsurgical rehabilitation can be addressed. the single physiotherapists have an essential role in mobilizing the lsf patient post-operatively. in clinical practice it is not enough for the physiotherapists to use their biomechanical understanding of lsf material and heeling processes, it is also essential to use a so-called "silent knowledge" of experience and personal interaction with the patient. it remains unknown if this "silent knowledge" is a reliable predictor of the outcome of lsf surgery. if the physiotherapist can predict the outcome, it is important to explore which factors the physiotherapist rely their prognosis upon in order to identify objective and possible modifiable candidate prognostic factors for recovery. the aim of this study is to assess if physiotherapists attending inpatients at public back surgery hospitals can predict the future course (post hospitalisation) of recovery of patients undergoing lsf. the study will also break down the physiotherapists' "silent knowledge" in an attempt to identify objective (and hopefully modifiable) candidate prognostic markers of recovery.

Eligibility criteria:
inclusion criteria: * received primary lsf surgery for treatment of clbp * degenerative lumbar disease with or without lumbar spondylolisthesis grades 1 to 2 * fusion of a maximum of 3 adjacent vertebrae * above 18 years of age * competence in the danish language * has an email address exclusion criteria: * prior lsf surgery * cognitive impairments that preclude reliable answers to patient reported outcome questionnaire
effects of different doses of epinephrine on biomarkers of nervous system ischemia-reperfusion injury in patients with stanford type a dissection

Conditions: Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion Injury

Summary: aortic dissection is the most common aortic disease leading to death. among them, patients with stanford type a dissection (taad) are prone to dissection rupture in the early stage, and their condition deteriorates rapidly. they need immediate surgical treatment after admission.in this study, the detection data of biomarkers of nervous system ischemia / reperfusion (i/r)injury in patients with stanford type a dissection were retrospectively analyzed, and the effects of different doses of adrenaline on biomarkers of nervous system i/r injury were evaluated by statistical methods.the information of 132 patients with stanford type a aortic dissection who underwent sun's operation in the department of cardiovascular surgery of the first medical center of the pla general hospital from january 2012 to january 2019 was retrospectively analyzed.


Eligibility criteria:
inclusion criteria: * the patient's age was 18-75 years old; taad was diagnosed by aortic cta before operation; sun's operation was performed within two weeks of onset; deep hypothermic circulatory arrest (dhca) and selective unilateral cerebral perfusion via right axillary artery were used for brain protection; adrenaline was used after operation exclusion criteria: * nervous system disease and mental system disease before operation; recent acute coronary syndrome; recent cardiac arrest; recent poor perfusion of visceral or peripheral organs; recent hypoxemia; previous history of cardiac surgery; intraoperative death and death within 48 hours after operation; neurological or psychiatric symptoms occurred within 48 hours after operation; adrenaline was not used after operation
follow-up study to evaluate the long-term efficacy of the hpv vaccine (580299) in healthy young adult women in brazil

Conditions: Infections, Papillomavirus

Summary: infection with human papillomavirus (hpv) has been clearly established as the central cause of cervical cancer. this phase iib study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 hpv vaccine (cervarixtm) in a brazilian cohort of women vaccinated in the phase iib, blinded, primary study 580299/001 (nct00689741) and having participated in follow-up study 580299/007 (nct00120848). only subjects who participated in the primary \& follow-up study will be enrolled in this long-term follow-up study. subjects were aged 15-25 years at the time of entry into the primary study. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

in this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * subjects who participated in study 580299-007. * written informed consent obtained from the subject prior to enrollment. exclusion criteria: * use or planned use of any investigational or non-registered product other than the study vaccine. * decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator. * administration or planned administration of any other hpv vaccine, other than the vaccine administered in study 580299-001.
real-world registry study on patient satisfaction with transloc 3d si joint fusion

Conditions: Sacroiliac Joint Dysfunction; Sacroiliac; Fusion

Summary: this is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post si fusion with the transloc 3d si fusion system.


Eligibility criteria:
inclusion criteria: * age 18 year or older * confirmed implant of the transloc 3d fusion system * did not have transloc device removed or another manufacturer device implanted post transloc * does not have other manufacturer's titanium or metal implant * patient may be included with prior allograft implant * willing to participate and give written consent * must have or planned ct post ≥1 year per standard of care exclusion criteria: * patient is younger than 18 years * patient is unable to sign the informed consent * implant of other manufacturer's titanium or alternative metal implant * revision with another manufacturer's implant * fracture or unresolved trauma of implant side after implantation of transloc * patient unwilling to participate in patient satisfaction survey * patient has not returned for standard of care follow-up
cohort comparison of dental nerve block with other forms of analgesia in alleviating the pain of toothache

Conditions: Tooth Pain

Summary: toothache is a common source of pain for emergency department patients. there are several common ways to control the pain of toothache. but we do not know if any one of them is more effective than another. it is also possible that how we take care of your pain in the emergency department will influence the level of pain you experience one or two days from now. this study seeks to answer these questions.


Eligibility criteria:
inclusion criteria: * \> 18 years, pain in any tooth exclusion criteria: * duration of pain \> 96 hours * oral trauma within 96 hours of presentation * facial or neck swelling * pericoronitis * visual impairment to less than finger counting within three feet
clinical and radiographic assessment of a novel wedge shape implant placed in edentulous narrow ridges

Conditions: Surgical Technique; Implant Surface

Summary: the aim is to clinically and radiographically assess a novel wedge implant placed in narrow ridges. * 60 wedge implants (rex implants, columbus, oh, usa) will be placed using piezosurgery® following either a bone consumption (n=30) or bone expansion technique (n=30). each group (bone consumption and bone expansion) will be divided into 2 surface treatments: machined transcortical portion (n=15) and roughened transcortical portion (n=15). * record the time needed to place each implant. * isq will be evaluated at day 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement. * periapical radiographs will be performed at implant placement, loading. and 1, 3, and 5 years after loading to assess marginal bone stability. * buccal bone height and lingual and buccal bone thickness will be recorded post-intervention, at the time of functional loading, and at 12, 36, and 60 months after loading with cbct. * digital impressions will be taken post-operatively, at loading and at 12 months after loading to monitor gingival profile.


Eligibility criteria:
inclusion criteria: 1. partially or totally edentulous patients presenting indications for a prosthetic rehabilitation supported by the upper or lower jaw implants on the basis of an accurate diagnosis and treatment planning; 2. the bone crest must be completely healed (at least six months after the loss of teeth); 3. the residual bone crest must have a width between 3 and 5 mm; 4. presence of at least 10 mm of bone height available for implant placement; 5) patient age \> 18 years; 6) the patient must not wear any type of removable dentures on the treated area; 7) the patient must be capable of following the study protocol; and 8) written informed consent must be provided exclusion criteria: 1. acute myocardial infarction within the last two months; 2. uncontrolled coagulation disorders; 3. uncontrolled diabetes (hba1c\> 7.5); 4. radiation therapy to the head \\ neck region in the last 24 months; 5. immunocompromised patients, hiv positive or receiving chemotherapy in the last five years; 6. past or present treatment with intravenous bisphosphonates; 7. psychological or psychiatric problems; 8. abuse of alcohol or drugs;
a phase iia study of khk4563

Conditions: Uncontrolled and Suspected Eosinophilic Asthma

Summary: this is a double-blind, placebo-controlled dose-ranging study of khk4563 to evaluate the effect of multiple-dose subcutaneous administration of khk4563 on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.


Eligibility criteria:
inclusion criteria: 1. age 20 through 75 years at the time of week -3 visit. 2. written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 3. physician prescribed daily use of medium-dose or high-dose ics plus laba or any combination of sequential dosing of either medium-dose or high-dose ics/laba for at least 12 months prior to week -3 visit. dose must be stable for at least 30 days prior to week -3 visit. 4. at least 2, but not more than 6, documented asthma exacerbations in the 12 months prior to week -3 visit that required use of a systemic corticosteroid burst. exclusion criteria 1. any condition (eg, any eosinophilic lower respiratory disease other than asthma, churg-strauss syndrome, hypereosinophilic syndrome, eosinophilic bronchitis, eosinophilic pneumonia, chronic obstructive pulmonary disease (copd), bronchiectasis or cystic fibrosis (cf)) that, in the opinion of the investigator or medical expert, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. 2. any clinically relevant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study. 3. acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to week -3 visit or during the screening period.
a clinical trial to assess the safety and pk of omn6 in habp or vabp caused by acinetobacter baumannii complex

Conditions: Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia

Summary: this is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and pk study in patients with habp (hospital acquired bacterial pneumonia) or vabp (ventilator associated bacterial pneumonia) caused by abc to identify safe and well-tolerated doses and to assess the pk profile of omn6 in patients.


Eligibility criteria:
inclusion criteria: 1. a signed informed consent form. 2. male or female patients 18 years or older 3. a diagnosis of either a habp or a vabp 4. abc infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens 5. women of childbearing potential (wocbp) (i.e., not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. 6. acute physiology and chronic health evaluation ii (apache ii) score between 10 and 24 exclusion criteria: 1. moderate to severe reduction of renal function 2. liver dysfunction 3. evidence of septic shock 4. acute respiratory distress syndrome. 5. immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition). 6. history of any known hypersensitivity to colistin or to carbapenems 7. any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data

Keywords: habp vabp abc acinetobacter baumannii pneumonia
the safety and effectiveness of a type of interleukin-2 plus zidovudine plus thymosin in hiv-positive patients with and without symptoms of infection

Conditions: HIV Infections

Summary: to determine the safety of thymosin alpha 1 given twice weekly in a regimen of daily oral zidovudine (azt) and biweekly polyethylene glycolated interleukin-2 (peg il-2). to determine the effect of thymosin alpha 1 and peg il-2 in combination with azt on immunologic and pharmacokinetic markers. aids is characterized by diminished t helper cell number and function. thymosin alpha 1 appears to both increase il-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus, the drug may further enhance the cd4 t cell levels in patients receiving azt and peg il-2.

aids is characterized by diminished t helper cell number and function. thymosin alpha 1 appears to both increase il-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus, the drug may further enhance the cd4 t cell levels in patients receiving azt and peg il-2. patients are stabilized on oral azt daily for 8 weeks and then begin receiving bolus infusions of peg il-2 every other week for at least four doses. thymosin alpha 1 (given sc) is then added to this regimen twice weekly for 4 weeks. if no significant toxicity occurs, thymosin alpha 1 is increased to and administered along with scheduled doses of peg il-2 for an additional 8 weeks.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * prophylactic pentamidine for pneumocystis carinii. patients must have: * hiv seropositivity. * cd4 count \> 50 and \< 200 cells/mm3. * no active opportunistic infections. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or kaposi's sarcoma. * significant cardiac disease or cns lesions or other neurologic abnormalities. * score of \> 0.5 on actg aids dementia complex staging. * major organ allograft. * intolerance to azt at 500 mg/day. concurrent medication: excluded: * antihypertensive medication other than diuretics. * chemotherapy, hormonal therapy, or other immunotherapy. * other investigational drugs, agents, or devices. * beta-blockers. * non-topical steroids. concurrent treatment: excluded: * radiation therapy. prior medication: excluded: * known anti-hiv medication (other than azt) or known immunomodulators (e.g., systemic steroids, interferons, interleukins) or other chemotherapy within 30 days prior to study entry. prior treatment: excluded: * transfusion within 4 weeks prior to study entry. * radiation within 30 days prior to study entry. active substance abuse.

Keywords: t-lymphocytes polyethylene glycols interleukin-2 drug therapy, combination adjuvants, immunologic acquired immunodeficiency syndrome zidovudine thymosin alpha(1)
safety and efficacy of encapsulated allogeneic mps-1 therapy

Conditions: MPS I; MPS1-S; MPS1-HS

Summary: sig-005-121 is a fih, phase 1/2, multi-centre, open-label, sequential dose-escalating study to assess the safety, tolerability, and preliminary efficacy of sig-005 in adults with mps-1. the study will evaluate up to three ascending dose levels of sig-005 in male and female patients with attenuated mps-1 (scheie or hurler-scheie), 18 years of age or greater, who received enzyme replacement therapy (ert) for a minimum of 12 months prior to the study entry. each cohort will include 3 patients.


Eligibility criteria:
inclusion criteria: * able and willing to provide informed consent * male or female aged 18 or older * diagnosis of attenuated mps-1 (hurler-scheie or scheie) * alpha-l-iduronidase enzyme activity level of less than 10% of the lower limit of the normal range * prior treatment with ert * willing to transition from ert to sig-005 * female patients of childbearing potential with negative pregnancy test * use of highly effective method of contraception if applicable exclusion criteria: * a diagnosis of severe mps-1 * previous haematopoietic stem cell transplantation (hsct) * history of elevated total (igg) anti-idua antibody * use of assistive respiratory devices * unable to walk independently * history of allergic reaction or anaphylaxis to recombinant hidua * body mass index (bmi) ≥35 * history of abdominal adhesions, medical history of crohn's disease, inflammatory bowel disease or any disease that increases the risk of post-operative abdominal adhesions * significant underlying disease or comorbidities that are a contraindication for general anaesthesia or laparoscopic procedure * pregnant or lactating patients * prior administration of a gene therapy product * participation in another investigational medicine or device study * abnormal laboratory values as defined in the protocol * active alcoholism or drug addiction during the 12 months before the screening visit * active malignancy or history of malignancy in the 5 years prior to study entry * recent covid-19 infection: within 60 days of recovery from infection * vaccination(s) within the last 60 days (including vaccines for sars-cov-2/covid- 19)
is it safe to advance a guidewire through a previously placed double j stent?

Conditions: Kidney Stone; Ureter Obstruction; Stent Complication

Summary: in this prospective randomized controlled study, it is aimed to investigate the effects of guidewire advanced through a previously placed double j stent on postoperative complications, operation time and efficacy.


Eligibility criteria:
inclusion criteria: * double j stent placed at least 2 weeks ago exclusion criteria: * active urinary tract infection

Keywords: double j stent guidewire infection
assessment of left ventricular torsion by echocardiography study

Conditions: Hypertrophic Cardiomyopathy

Summary: the purpose of this study is to learn about the twisting or wringing motion of the heartbeat called left ventricular torsion (lv torsion) which can be seen on ultrasound.

this study is designed to characterize the myocardial torsional behavior in patients with a variety of cardiac pathologies. simple and inexpensive methods for measurement of lv torsion could facilitate more widespread investigation of lv torsion, which might reveal significant relationships between torsional alterations and clinical outcomes and eventually lead to routine clinical application. recently, doppler tissue imaging (dti) has been shown to accurately reflect myocardial velocity24,25 with better temporal resolution than mri.26 investigators hypothesize therefore that dti might be used for quantification of lv rotation and torsion of the human heart. the purpose of the present study was to examine the accuracy of a novel method with dti for quantifying the lv torsion in humans and tagged mri as the reference standard.

Eligibility criteria:
inclusion criteria: * male and female patients age 18 to 70 years * patients with hypertrophic cardiomyopathy * patients with the ability to exercise using a supine bicycle * ability to provide informed consent exclusion criteria: * aortic valve stenosis classified as moderate to severe * severe left ventricular obstruction at rest (high gradients \> 4m/second) * uncontrolled arrhythmias including atrial fibrillation, atrial flutter, frequent premature ventricular ectopic beats * history of sustained ventricular tachyarrhythmia at any time

Keywords: hcm hocm hypertrophic cardiomyopathy tissue doppler echocardiography myocardial torsion
music therapy is associated with decreased pain and agitation in intubated icu patients

Conditions: Music Therapy for Pain and Sedation

Summary: the study is designed to analyze the use of music therapy to decrease pain and agitation in intubated icu patients.

this is a randomized, prospective single-blinded placebo-controlled study of consecutive intubated icu patients requiring anxiolytics and analgesic medications. patients will be randomized into two groups: one group will receive music (music), whereas the other group (control) will wear headphones, but hear an audio loop of recorded icu sounds (vent alarms, ambient noise, talking, etc). the two groups will then be analyzed for sedation and analgesia requirements; ramsay sedation score, icp in brain injured patients, ventilator days, icu length of stay, hospital length of stay, mean arterial blood pressure (map).

Eligibility criteria:
inclusion criteria: * between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics exclusion criteria: * hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)

Keywords: pain, agitation, music