Kornimate/medical-research-clean huggingface dataset:
assessment of anxiety in patients treated by smur toulouse and receiving meopa as part of their care

Conditions: Pain; Anxiety

Summary: the emergency setting, frequently associated with pain and the feeling of loss of control, can cause anxiety in patients. reaction anxiety may be an appropriate response to an emergency; nevertheless, attention must be paid to the evaluation and management of the latter especially as anxiety and pain are closely linked.

there is a definite interest in the management of patients' pre-hospital anxiety. the literature reports a strong association between anxiety, post-traumatic stress and chronic pain. a study conducted at samu 31 also found that anxiety on arrival at the emergency department was a negative factor in the treatment of pain. anxiety can reduce the pain threshold and promote hyperalgesia. the management of patient anxiety in pre-hospital offers interesting results in terms of analgesia and satisfaction of users of care and should not be neglected. meopa has recently been available in smur vehicles (emergency and resuscitation mobile service) at samu 31 (urgent medical assistance service); its availability can lead teams to change their practices. more and more emphasis is placed on the importance of positive communication and comfort for which meopa, with its conscious sedating effect, could be a facilitating factor. the aim of our study is to evaluate the level of anxiety of patients treated by smur teams in toulouse and receiving meopa following the usual indications for pain-induced pain or pain alleviation. this is a pilot study, which focuses on the assessment of anxiety in patients treated in pre-hospital care by smur toulouse and receiving meopa as part of their care. no data exists in the literature on this subject. this descriptive study based on qualitative data collected by the fas1 scale will provide us with the first data on this population. it does not change the usual management of the patient since only patients who must receive meopa following the usual indications for pain relief or pain-induced care will be included in the study

Eligibility criteria:
inclusion criteria: * patient over 18 * patient supported by a smur team from toulouse * patient receiving meopa during pre-hospital care (in the usual indications for pain relief or pain-induced care) * patient having given his non-opposition to participate in the study exclusion criteria: * any patient with a contraindication to meopa: * patient requiring pure oxygen ventilation * intracranial hypertension * any alteration of the state of consciousness preventing the patient's cooperation * traumatic brain injury * pneumothorax * emphysema bubbles * gas embolism * diving accident * abdominal gas distension * patient who received an ophthalmic gas for ocular surgery less than three months old * known and unsubstituted vitamin b12 deficiency * patient under legal protection * refusal of the patient to participate in the study * barrier of the language or alteration of the communication * patient in vital distress

Keywords: emergency
effekt taiwan- efficacy and safety of long-term treatment with kogenate® fs in taiwan

Conditions: Hemophilia A

Summary: the aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of kogenate bayer/fs in treatment of patients with haemophilia a under daily-life treatment conditions.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of hemophilia a, independent of age, treated with kogenate fs as their only source of fviii, decision taken by the investigator to administer kogenate fs. for pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Keywords: octocog alfa hemophilia a
one vs. three hyperbaric oxygen treatments for acute carbon monoxide poisoning

Conditions: Carbon Monoxide Poisoning

Summary: this randomized trial will investigate important clinical outcomes of patients with acute carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen treatments.

all patients presenting with acute carbon monoxide poisoning will receive one hyperbaric oxygen treatment (barring contraindications for hyperbaric oxygen therapy). after this treatment, eligible patients who provide consent will be randomly allocated to receive two sham sessions, or two additional hyperbaric oxygen sessions administered in a double-blind fashion. outcome measures will be administered at 6 weeks and 6 months.

Eligibility criteria:
inclusion criteria: * symptomatic co poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, or loss of consciousness). * carboxyhemoglobin (cohb) levels \> 10% or confirmation of poisoning with ambient levels \> 50 ppm in a patient with symptoms compatible with co poisoning and no other reasonable explanation for their signs and symptoms. * less than 24 hours from removal from the source of co exposure and study enrollment. * accidental poisoning exclusion criteria: * pregnancy * age \ 79 years * complication during first hyperbaric oxygen session precluding subsequent hyperbaric oxygen. * intentional co poisoning * unable to obtain informed consent * moribund patient * concomitant smoke inhalation with cyanide poisoning * bleomycin use within two weeks of study enrollment * intracardiac defibrillator that cannot be deactivated * non-english speaking * unlikely to return at 6 weeks * history of central nervous system (cns) disease (i.e., alzheimer's, parkinson's, dementia, demyelinating disease (ms), etc.) * history of prior brain injury (i.e., stroke, traumatic brain injury) * presence of chronic debilitating disease likely to result in death within 12 months (i.e., kidney failure on dialysis, heart failure) * subject has a significant medical condition or conditions that would interfere with the treatment, safety, or compliance with the protocol. * intubated subjects * subjects requiring greater than 50% oxygen by non-rebreather facemask or exhibiting evidence of respiratory compromise or heart failure * subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. the investigator and the sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria.

Keywords: carbon monoxide poisoning hyperbaric oxygen therapy randomized controlled trial clinical investigation
assessment of kan-101 in celiac disease (aced)

Conditions: Celiac Disease

Summary: a safety study of kan-101 in patients with celiac disease. the study has two parts: 1. part a - first in human study in which patients receive a single dose of kan-101 2. part b - patients will receive three doses of either kan-101 or placebo

study kan-101-01 is a phase 1, fih study designed to evaluate the safety and tolerability of kan-101 in patients with celiac disease on a gluten free diet (gfd). an overview of the two parts and proposed dose groups is given below: 1. part a (sad): patients will receive a single dose of kan-101. 2. part b (mad): patients will receive three doses of either kan-101 or placebo.

Eligibility criteria:
key inclusion criteria: 1. adults aged 18 to 70 years inclusive 2. diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase iga antibody and/or deamidated gliadin peptide igg) and intestinal histology consistent with ≥ marsh type ii or with evidence of villous atrophy 3. has hla-dq2.5 genotype (hla-dqa1\*05 and hla-dqb1\*02) (homozygotes or heterozygotes) 4. has followed a gfd for \> 12 months immediately prior to study entry 5. negative or weak positive for ttg-iga and negative or weak positive for dgp-iga/igg during screening 6. male or female. females of childbearing potential must use at least 2 acceptable birth control methods 7. capable of understanding and complying with protocol requirements 8. patient understands and has signed the informed consent form key exclusion criteria: 1. refractory celiac disease 2. selective iga deficiency 3. positive for hla-dq8 (dqa1\*03, dqb1\*0302) 4. previous treatment with tolerance-inducing therapies for celiac disease 5. known wheat allergy 6. part b only: history of hyperacute or prolonged symptoms following gluten exposure 7. uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the investigator, preclude participation 8. history of dermatitis herpetiformis 9. pregnant or breastfeeding

Keywords: phase 1 double blind multicenter
the effects of thrust joint manipulation on the resting and contracting thickness of transversus abdominis in subjects with low back pain

Conditions: Low Back Pain

Summary: the primary aim of this study is to examine how different physical therapy interventions affect the resting state and contraction state of a certain abdominal muscle in patients with low back pain.

patients with low back pain (lbp) will undergo ultrasound imaging of the transversus abdominis to measure the muscle thickness at rest and at the contracted state prior to intervention and again immediately after intervention. in this randomized controlled trial, patients will be randomized into one of two groups. one group will receive the intervention of thrust joint manipulation of the lumbar spine and the other group will receive the intervention of non-thrust joint manipulation of the lumbar spine.

Eligibility criteria:
inclusion criteria: * adults between 18-70 years of age with primary symptom of lbp, with or without referral into lower extremity. * subjects must be able to read and write in english. exclusion criteria: * presence of serious pathology. * diagnosis of spinal stenosis or symptoms in both lower legs (changes in sensation, muscle weakness). * any history of low back surgery, rheumatoid arthritis, osteoporosis, osteopenia, scoliosis, or ankylosing spondylitis. * pregnancy * pending legal action. * prior surgery to the lumbar spine or fractures of the lumbar spine.

Keywords: thrust joint manipulation non-thrust joint manipulation transversus abdominis
extension study of ns-065/ncnp-01 in boys with duchenne muscular dystrophy (dmd)

Conditions: Duchenne Muscular Dystrophy

Summary: this is an open-label, extension study of ns-065/ncnp-01 administered intravenously once weekly for an additional 192 weeks to boys with dmd who complete study ns-065/ncnp-01-201.

this is a phase ii, multicenter, open-label, extension study of ns-065/ncnp-01 administered intravenously once weekly for an additional 192 weeks to boys with dmd who complete study ns-065/ncnp-01-201. this study will evaluate the safety, tolerability, and clinical efficacy of ns-065/ncnp-01 at dose levels of up to 80 mg/kg/week administered by weekly iv infusion over an additional treatment period of 192 weeks or until enrollment in a separate long-term follow up program of ns-065/ncnp-01, whichever is earlier. patients who complete the phase ii dose-finding study ns-065/ncnp-01-201 are eligible to enroll.

Eligibility criteria:
inclusion criteria: 1. completed study ns-065/ncnp-01-201 through week 25. 2. willing and able to comply with scheduled visits, investigational product administration plan, and study procedures. 3. stable dose of glucocorticoid (gc), and is expected to remain on the stable dose for the duration of the study. exclusion criteria: 1. serious or severe adverse event in study ns-065/ncnp-01-201 that precludes safe use of ns-065/ncnp-01. 2. patient had a treatment which was made for the purpose of dystrophin or its related protein induction after completion of study ns-065/ncnp-01-201. 3. patient took any other investigational drugs after completion of study ns-065/ncnp-01-201. 4. patient was judged by the investigator and/or the sponsor that it was not appropriate to participate in the extension study for other reasons.
outcomes and patient satisfaction after colpocleisis for pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to evaluate the long-term success rate of the colpocleisis procedure and its effect on quality of life in women who have this surgery. we want to see if women who have this surgery have problems with recurrent pelvic organ prolapse, urinary incontinence, or bowel problems after the surgery. we also want to see how the surgery affects women's sexuality.


Eligibility criteria:
inclusion criteria: * women who underwent either total colpectomy with colpocleisis or partial colpectomy with lefort-type colpocleisis performed by the urogynecology service between 1/2000 and 12/2007 at strong memorial hospital exclusion criteria: * women who are not undergone colpocleisis or colpectomy

Keywords: colpocleisis
study of opioid rotation versus opioid escalation in patients with moderate to severe cancer pain

Conditions: Cancer; Pain

Summary: although opioid rotation is well known treatment modality in reducing pain and opioid-induced neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid escalation is more effective in controlling significant pain in cancer patients under opioid medication. - the purpose of this study is to determine effective therapy out of opioid rotation and opioid dose escalation in patients with moderate to severe cancer pain who have been already treated with strong opioid.


Eligibility criteria:
inclusion criteria: * age \> 18 years * patients who are being treated with one of strong opioids including oral oxycodone, oral hydromorphone, or fentanyl patch with range from 60 mg to 200 mg of oral morphine equivalent daily dose (medd) * moderate to severe cancer pain (numeric rating scale more than 3) at screening * patients without uncontrolled adverse effects associated with currently applied opioid exclusion criteria: * previous opioid rotation * unable to take oral medication * life expectancy less than a month * newly started chemotherapy and/or radiotherapy within past 2 weeks of screening * serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase \> 2.5 times of upper normal limit * serum total bilirubin or creatinine \> 1.5 times of upper normal limit

Keywords: significant cancer pain at least numeric rating scale 4
hong kong and taiwan hm3 pms

Conditions: Advanced Heart Failure

Summary: hong kong and taiwan hm3 pms is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the hm3 lvas as a treatment for advanced heart failure. the pms will enroll approximately 30 patients, that meet the hm3 commercially approved labelling indications, from approximately 4 sites in hong kong and taiwan. pms participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.


Eligibility criteria:
inclusion criteria: - all patients at the participating sites that are determined to meet the hm3 commercially approved labelling indication and have a planned hm3 implant are eligible to participate in this pms. assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient. exclusion criteria: none

Keywords: heartmate 3 left ventricular assist device abt-cip-10382
nonoperative management protocol in patients with blunt splenic injuries

Conditions: Blunt Injuries

Summary: this study was designed to explore the adverse events and associated risk factors before and after protocol-based nom of bsi over a 12-year period in our institution.

the nonoperative management (nom) protocol with angioembolization (ae) presents a trend in dealing with trauma patients with blunt splenic injury (bsi). this study was designed to explore the adverse events and associated risk factors before and after protocol-based nom of bsi over a 12-year period.

Eligibility criteria:
inclusion criteria: * adult trauma patients with blunt splenic injury who were admitted from 2005 to 2016. exclusion criteria: * patients younger than 16 years * patients who died in the emergency department
ascorbic acid, corticosteroids, and thiamine in sepsis (acts) trial

Conditions: Sepsis; Septic Shock; Metabolic Disturbance

Summary: in this study, we aim to determine whether the combination of ascorbic acid (vitamin c), thiamine (vitamin b1), and corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.

sepsis and septic shock are common and highly morbid clinical conditions without any specific therapy aside from antibiotics. a recent quasi-experimental study (marik et. al., pmid 27940189) demonstrated a remarkable benefit when the combination of ascorbic acid (vitamin c), corticosteroids, and thiamine (vitamin b1) were given to patients with sepsis. in particular, patients who received this combination of medications required a shorter amount of time on vasopressors, suffered less organ failure, and had improved mortality. vitamin c has long been suggested for treatment of patients with severe infection as it exerts significant anti-oxidant effects and reduces endothelial permeability. corticosteroids, a mainstay of therapy for refractory shock in sepsis, have also been shown to enhance the beneficial cellular effects of vitamin c. finally, thiamine has been shown to be an effective mitochondrial resuscitator in sepsis, especially for the \~30% of septic shock patients who present with thiamine deficiency (donnino et. al, pmid 26771781). in this study, we aim to reproduce the findings of marik et. al. using a more rigorous study design (i.e. a blinded, randomized clinical trial) and focus on the important clinical outcomes of organ failure and death.

Eligibility criteria:
inclusion criteria: 1. adult patient (age ≥ 18 years) 2. suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection 3. receiving vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin ii or vasopressin) exclusion criteria: 1. member of a protected population (pregnant, prisoner) 2. known kidney stones within the past 1 year (except for asymptomatic, incidentally noted stones on imaging) 3. end stage renal disease (esrd) requiring dialysis 4. known glucose-6-phosphate dehydrogenase deficiency 5. known hemachromatosis 6. comfort measures only status 7. anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician) 8. receiving supplemental thiamine in a dose greater than that contained in a multivitamin 9. clinical indication for steroids (e.g. chronic use) as determined by the clinical team providing this drug 10. clinical indication for thiamine as determined by the clinical team providing this drug 11. clinical indication for ascorbic acid as determined by the clinical team providing this drug 12. known allergy to vitamin c, hydrocortisone, or thiamine

Keywords: sepsis metabolic resuscitation
sevoflurane-remifentanil anaesthesia. the risk of post operative nausea

Conditions: Nausea; Vomiting

Summary: the purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.

propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion. propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post operative nausea and vomiting (ponv) as ponv is diminished. however, when remifentanil is used as adjuvant to sevoflurane, the total dose of the latter is reduced. therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total ponv during 24 hours. in the post anaesthesia care unit (pacu) and in the surgical ward nausea was scored on a visual analogue score. vomiting was registered.

Eligibility criteria:
inclusion criteria: * females younger than 50 years * asa i-ii * scheduled to gynaecological laparotomies or laparoscopies exclusion criteria: * medication known to act anti-emetic * asa status greater than ii * malignant hyperthermia * allergy to the drugs used.

Keywords: nausea vomiting post operative propofol remifentanil anaesthesia sevoflurane remifentanil anaesthesia
tucidinostat and nab-paclitaxel in advanced hr+/her2- breast cancer

Conditions: HR+/HER2- Breast Cancer

Summary: this study is looking to see whether the combination of tucidinostat and nab-paclitaxel is safe and effective in participants with advanced hr+/her2- breast cancer.


Eligibility criteria:
inclusion criteria: 1. age≥18 years, ≤75, female; 2. histologically confirmed hr positive and her2 negative postmenopausal metastatic breast cancer patients \[her2 negative is defined as immunohistochemistry(ihc) 0 or ihc 1+, and if the score of ihc is 2+, fluorescence in situ hybridization technology (fish) test must be negative, hr positve is defined as er or pr ≥1%\]; 3. primary endocrine resistance or at least experienced one line of endocrine therapy for recurrent or metastatic disease; 4. no more than 1 prior line of chemothrapy for recurrent or metastatic disease; 5. patients who have been exposed to taxanes in neoadjuvant or adjuvant setting will be allowed to enroll, if they have obtained benifits from neoadjuvant treatment or have progressed ≥ 12 months from completion of adjuvant treatment; 6. ecog performance status ≤ 1; 7. at least one measurable disease based on recist v1.1 8. adequate organ function; 9. life expectancy is more than 3 months; 10. willing and able to provide written informed consent. exclusion criteria: 1. prior exposed to histone deacetylase inhibitors, or received taxanes for metastatic disease; 2. known hypersensitivity to any formulation component of the study drug; 3. received chemotherapy, targeted therapy, chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 4 weeks before enrollment, or still within 5 half-lives of such drugs; 4. toxicities that did not recover to national cancer institute common adverse event terminology version 5.0 (ncictcaev5.0) grade 0 or 1 toxicity from prior antineoplastic therapy prior to the first dose of study treatment(alopecia, grade 2 fatigue, grade 2 anemia, non-clinically critical and asymptomatic laboratory abnormalities can be enrolled); 5. has known active central nervous system (cns) metastases and/or carcinomatous meningitis. 6. pregnant or lactating female. 7. any other conditions deemed inappropriate by the investigator to participate in this study.