Kornimate/medical-research-clean huggingface dataset:
the nocebo effect: a prospective study of informed consent as a factor in the prevalence of ssri's side effects

Conditions: Depression

Summary: in this study we invetigate the influence of the nocebo effect (as part of obtaining informed consent) on the prevalence of side-effects. the study is prospective, focusing on the connection between what the physicians says to the patient about side-effects to the frequency of these side effects during treatment period. we also inquire whether informing the patient about the existence of the nocebo effect influences the extent of phenomena.

in this study the investigators wish to inquire whether the nature of the explenation given to the patient as part of informed consent has an effect on the prevalence of side-effects. the study will take place in the out-patient clinic at the shalvata mental health center. three arms are included: 1. 50 patients started on ssri's will be updated about its common side effects 2. 50 patients started on ssri's will be updated about its common side effects and will receive an explenation on the nocebo effect 3. 50 patients started on ssri's will receive an explenation on the nocebo effect, but will not be updated about common side-effects. nonetheless, they will be informed of severe side-effects. following the prescription of an ssri the subjects will we enter the follow-up phase of the study. they will attend two follow-up meetings: 3 days after the initiation point and one month after the starting point. during each meeting they will be asked to fill the antidepressant side-effect checklist (asec)and the general health questionnaire (ghq).

Eligibility criteria:
inclusion criteria: 1. age 18-60 2. started on an ssri exclusion criteria: * psychotic spectrum disorder * suicidality * sensitivity to ssri * has taken the prescribed ssri in the past

Keywords: nocebo side-effects ssri informed consent
intrathecal tetanus immunoglobulin to treat tetanus

Conditions: Tetanus

Summary: to establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus

the investigators will conduct a randomised partially-blinded controlled 2x2 factorial trial. first, adults admitted to the intensive care unit at the hospital for tropical diseases ho chi minh city will be randomized to receive either human (3000 iu) or equine (21,000 units) intramuscular antitoxin. second, participants will be randomized to receive either standard treatment with intramuscular antitoxin alone or with the addition of 500 iu intrathecal human antitoxin. patients with prior antitoxin treatment and those with contra-indications to lumbar puncture or antitoxin treatment will be excluded. all patients will receive other standard tetanus treatment as deemed necessary by the attending physicians. spasms will be treated with benzodiazepines as first-line therapy. patients with spasms not controlled with benzodiazepines will receive tracheostomy, paralysis, magnesium sulphate and mechanical ventilation. heart rate, bp, temperature and daily drug use will be recorded throughout the icu stay. patients will be followed following discharge from hospital until 240 days for disability/ death.

Eligibility criteria:
inclusion criteria: * all adult patients (≥16 years old) with a clinical diagnosis of generalized tetanus admitted to the intensive care unit (icu) at the hospital for tropical diseases, ho chi minh city, vietnam exclusion criteria: * prior administration of antitoxin during this episode * contra-indication to use of human or equine antitoxin * contra-indication to lumbar puncture * already receiving mechanical ventilation or expected to require this before intrathecal injection can be given * pregnancy * informed consent not obtained

Keywords: tetanus
acute pain trajectories and persistent pain after breast cancer surgery

Conditions: Breast Neoplasms

Summary: persistent pain after breast cancer surgery (ppbcs) is a significant clinical problem, affecting between 25 and 50% of patients. several factors are associated with the development of ppbcs, including acute postoperative pain. the analysis of pain trajectories through mixed model modeling is an alternative to static pain measures, improving precision and providing information on the time course of pain resolution. our aim was to investigate if the characteristics of pain trajectories during the first postoperative week are correlated with the persistence of pain 3 months after breast cancer surgery.


Eligibility criteria:
inclusion criteria: * scheduled for breast cancer surgery * general anesthesia exclusion criteria: * previous breast surgery * reconstructive surgery scheduled during follow-up * day-surgery patients * inability to understand the questionnaires
safety and pharmacokinetic evaluation of nitrite for prevention of cerebral vasospasm

Conditions: Subarachnoid Hemorrhage

Summary: the purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.

intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a primate model of subarachnoid hemorrhage (sah). this was a phase iia dose escalation study of sodium nitrite to determine its safety in patients with aneurysmal sah and to establish its pharmacokinetics during a 14 day infusion. sodium nitrite was delivered intravenously for 14 days in 18 patients with sah from a ruptured cerebral aneurysm using a dose escalation scheme in three cohorts of 6 patients each (3 nitrite, 3 saline), with a maximum dose of 64 nmol/min/kg. sodium nitrite blood levels were frequently sampled and measured using mass spectroscopy and blood methemoglobin levels were continuously monitored using a pulse oximeter.

Eligibility criteria:
inclusion criteria: * ruptured cerebral aneurysm exclusion criteria: * pregnancy, sickle cell disease, g6pd deficiency, anticoagulant therapy

Keywords: cerebral aneurysm subarachnoid hemorrhage nitrite
a placebo-controlled trial of chronic total occlusion percutaneous coronary intervention for the relief of stable angina

Conditions: Stable Angina; Chronic Total Occlusion of Coronary Artery

Summary: orbita-cto pilot is a double blinded randomised placebo-controlled trial comparing the effects of chronic total occlusion percutaneous coronary intervention versus placebo on symptoms of angina in patients with background optimal medical therapy.


Eligibility criteria:
inclusion criteria: orbita cto will enrol patients who meet all 5 of the following criteria: 1. accepted for cto pci procedure by a specialist cto operator. 2. patients with symptoms related to a single vessel cto (≥3 months duration, or probable cto where duration is unknown) in a vessel of at least 2.5mm diameter without angiographically significant (lms ≥50%, lad/cx/rca/graft ≥70%, ≥2mm diameter) coronary artery stenosis in remaining non-cto vessels. symptoms are: a) typical exertional angina defined as: i) constricting discomfort in the front of the chest or in the neck, jaw, shoulder or arm ii) precipitated by physical exertion iii) relieved by rest or nitrates within 5 minutes b) angina symptoms at rest (including decubitus angina and post-prandial angina). c) shortness of breath on exertion considered to be angina equivalent. 3. clinical evidence of ischaemia in cto territory on dobutamine stress echocardiography, nuclear myocardial perfusion scan, stress perfusion cmr or pet). 4. evidence of viability: if left ventricular angiogram or echocardiogram demonstrates lv impairment or rwma then viability must be demonstrated. 5. j-cto score ≤ 3. exclusion criteria: 1. acute coronary syndrome within 4 weeks. 2. pci to non-cto lesion in prior 4 weeks as part of acs or elective pci. 3. non-revascularised clinically important non-cto vessel. 4. proven ischaemia (invasive or non-invasive) in non-culprit territory. 5. contraindications to pci or drug-eluting stent (des) implantation. 6. inability to tolerate or contraindication to dapt. 7. severe valvular heart disease. 8. severe chronic pulmonary disease (fev1 \<30% of predicted value). 9. severe musculoskeletal disease resulting in immobility. 10. life expectancy \<2years. 11. pregnancy. 12. age \<18years. 13. inability to consent.

Keywords: angina chronic total occlusion angioplasty
study of pemetrexed plus cisplatin in advanced gastric cancer

Conditions: Neoplasm, Gastric

Summary: this is a multicenter, single arm, open-label phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. the treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.


Eligibility criteria:
inclusion criteria: * histological proven diagnosis of adenocarcinoma of the stomach * stage iv disease not amenable to curative surgery. * disease status must be that of measurable disease as defined by response evaluation criteria in solid tumors (recist) criteria. * performance status of 0 or 1 on eastern cooperative oncology group (ecog) scale. * adequate organ functions exclusion criteria: * prior palliative chemotherapy for advanced gastric cancer. * pregnancy and breast feeding. * known or suspected brain metastasis and secondary primary malignancy * inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a 5-day period. * inability or unwillingness to take folic acid or vitamin b12 supplementation. * concurrent administration of any other tumor therapy.
a study of the safety and tolerability of v419 in healthy infants at 2,4, 6 and 12 to 14 months of age (v419-003)

Conditions: Bacterial Infections; Virus Diseases

Summary: the purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 formulations of the hr5i vaccine (haemophilus influenzae type b conjugate, recombinant hepatitis b surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus types 1, 2, and 3). the primary hypothesis is that at least 1 of the 3 formulations of hr5i administered as a primary series at 2, 4, and 6 months of age will be acceptable (similar to targeted rates) with respect to postdose 3 antibody responses to all antigens.

participants will be randomized into 4 arms: ar51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (prp) conjugated to tetanus toxoid (prp-t) and 10 mcg of hepatitis b surface antigen (hbsag) pr51 (3, 10): arm receiving vaccine formulation containing 3 mcg of polyribosylribitol phosphate conjugated to the outer membrane protein complex of neisseria meningitides (prp-ompc) and 10 mcg of hbsag pr51 (6, 10): arm receiving vaccine formulation containing 6 mcg of prp-ompc and 10 mcg of hbsag pentacel™ + recombivax hb™: open-label control group receiving pentacel™ (licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to haemophilus influenzae type b) and recombivax hb™ (licensed vaccine for hepatitis)

Eligibility criteria:
inclusion criteria: * healthy infants 2 months of age who have not received prior vaccinations for haemophilus influenzae type b (hib), hepatitis b, diptheria/pertussis/tetanus (dpt), or polio exclusion criteria: * hiv infection in participant (child/mother) * documented hbsag seropositivity in the participant (child or mother) * history of invasive hib disease, hepatitis b, diphtheria, tetanus, pertussis, or poliovirus infection * history of seizure disorder * underlying medical conditions such as inborn errors of metabolism, failure to thrive, or any major congenital abnormalities requiring surgery * prior or anticipated receipt of immune globulin, blood, or blood products * known hypersensitivity to any component of the investigational or marketed vaccines being administered in this protocol * any history or condition that would exclude the participant from receiving any vaccine administered under this protocol based on the contraindications that appear in the package circulars for each component of these vaccines * any condition that, in the opinion of the investigator, is not stable or may interfere with the evaluation of the study objectives
performance of flexible self-adherent absorbent dressing coated with a soft silicone layer after hip -,knee- arthroplasty,primary spine surgery in comparison to a standard wound dressing

Conditions: Hip-arthroplasty; Knee-arthroplasty; Spine Surgery

Summary: male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. individual trial duration will be for 7 days (follow-up). two hundred subjects will be included in the trial, i.e. 100 subjects per arm. the treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).

at the baseline visit: * subject demographic details * inclusion and exclusion criteria * vital signs * medical and surgical history * skin status at incision site * mobilisation (subject mobility, mobilisation in bed and chair) * medication * ae/ade/ sae/sade/dd * informed consent * randomization at visit 2: * type of surgery * length of incision * intraoperative antibiotic given * length of anesthesia at each visit from visit 3: * surgical incision condition (condition under the dressing, condition outside the dressing, exudates amount, exudates nature, wound odour, dressing capacity of handling blood, signs of systemic infection, systemic antibiotic given for the systematic infection, blistering, skin stripping * skin status at incision site (type of skin, skin temperature, skin perspiration, oedema, tissue consistency, sensation) * mobilisation (subject mobility, mobilisation in bed and chair) * dressing change (application and removal) * drainage (drainage used, application of the drainage) * compression medication (pain medication and systematic antibiotic treatment) * photo (photo before and after dressing removal and if signs of infection) * investigator/nurse evaluation (ease of application of the dressing, size of the dressing, shape of the dressing, visibility beneath the dressing, notice any pain at dressing change, ease of removal of the dressing, overall experience) * patient evaluation (the patient's overall experience of the dressing, comfort when wearing the dressing). * contentious pain - measured by visual analog scale (vas) prüfplan: close 2.0f 28.10.2013 5(40) * product application (time application start, time application ended, staff involved, material) * ae/ade/sae/sade/dd

Eligibility criteria:
inclusion criteria: 1. age ≥18years 2. have an expected total length of stay of 4 or more days 3. undergoing elective primary arthroplasty of the hip or knee or spinal surgery 4. undergoing hip surgery with a standard access 5. give their written informed consent to participate exclusion criteria: 1. dressing size does not fit the incision area 2. known allergy/hypersensitivity to any of the components of the dressing 3. multi-trauma 4. undergoing arthroplasty due to tumor 5. fractures 6. wound at the surgical site prior to surgery 7. neurological deficit of operated side (hemiplegia, etc.) 8. subject has documented skin disease at time of enrolment, as judged by the investigator
correlation of neck circumference with difficult mask ventilation and difficult laryngoscopy in morbidly obese patients

Conditions: Morbid Obesity

Summary: the aim of this study is to determine the correlation of neck circumference with difficult mask ventilation and laryngoscopy in morbidly obese patients.

patients' mallampati score, upper lip bite test, neck mobility, teeth abnormalities were evaluated preoperatively. mouth opening, sternomental and thyromental distances, neck circumference, thoracic circumference, breast circumference , belly circumference and hip circumference were measured preoperatively. after anesthesia induciton with propofol and rocuronium, patients' mask ventilation difficulty was evaluated as defined below: v1- ventilated by single anesthesist easily; v2- ventilated by single anesthesist with oral airway; v3- ventilated by two anesthesists; v4- unable to mask ventilate. v3 and v4 was defined as difficult mask ventilation. laringoscopy was performed with macintosh laryngoscop and cormack lehane (cl) score was evaluated. cl score iii and iv were defined as difficult laryngoscopy.

Eligibility criteria:
inclusion criteria: * bmi \>= 40 * american society of anesthesiologists (asa) physical status i-iii * patients applied for elective surgery exclusion criteria: * bmi \< 40 * maxillofacial tumor or fracture * mass at the neck * mass in the thorax or mediastina * scar at the neck area * previous radiotherapy history to neck area * history of cervical vertebra operations * cervical vertebra structure abnormality

Keywords: morbid obesity neck circumference difficult mask ventilation difficult laryngoscopy
effects of herbal mouth rinse for chronic periodontitis

Conditions: Chronic Periodontitis

Summary: this double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (srp+placebo), positive control (srp+0.12% chx), and test group (srp+1% mtc mouth rinse). mouth rinsing (adjunctive therapy) was continued for 1 month while clinical parameters \[plaque index (pi), gingival index (gi), sulcus bleeding index (sbi), probing pocket depth (ppd), clinical attachment level (cal), gingival recession (gr), stain index (si)\] were evaluated at base line, 1 month, and 3 months. cfu was also evaluating at above said time periods.

this double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (srp+placebo), positive control (srp+0.12% chx), and test group (srp+1% mtc mouth rinse). mouth rinsing (adjunctive therapy) was continued for 1 month.the primary outcome of this study was cal, while ppd was the secondary outcome measure. a single clinician (aa) who was blinded to the groups assigned to the individuals, recorded all the parameters i.e. pi, gi, sbi, ppd, cal, gr, si at base line (prior to the treatment), 1 and 3 months after therapy. ppd, cal and gr were recorded at the six sites per tooth in every tooth, except third molar, with a manual unc-15 periodontal probe (hu-friedy, leinmen, germany) to the nearest millimeter. for recording of parameters at different time periods patients were instructed to refrain from any oral hygiene procedure for 8 hours prior to the evaluation. staining of the six maxillary anterior teeth was assessed using the lobene index. cfus of p. ginigvalis, t. forsythia, and t. denticola were evaluated at baseline , 1 months, 3 months.

Eligibility criteria:
inclusion criteria: * systemically healthy individuals of \> 30 years of age with previously untreated generalized chronic periodontitis (defined by armitage in 1999), * having minimum 15 teeth, * minimum of six teeth with at least one interproximal site with ppd between 5-7mm, * cal between 5-10 mm, at least 30% of the sites with ppd and cal ≥ 5 mm * presence of bleeding on probing (bop). exclusion criteria: * was any systemic disease, * use of any medication in the previous 6 months, * subjects wearing partial removal prosthesis or orthodontic appliance, * allergy to ingredient used in the study, alcoholics, smokers or tobacoo users in any form, mentally retarded individual, pregnant or lactating females.
automated microscopy evaluation study

Conditions: Malaria

Summary: since the introduction of giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. however, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise. to address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features. in this study, a prospective evaluation of milab™ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (rdt) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at poc.


Eligibility criteria:
inclusion criteria: * aged 5 years or older * malaria status (positive or negative) established by microscopy at the health facility, where the patient is presenting * freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17) * willing to provide finger prick blood sample at enrollment exclusion criteria: * having received antimalarial treatment during the preceding four-week period * presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by who guidelines
activity, balance and copd (abcopd)

Conditions: COPD

Summary: this research project incorporates a series of studies to investigate the relationship between physical performance (e.g. tests of strength, balance and walking distance) and physical activity (activity measured in day to day life) in people with copd and other chronic lung diseases.

the research project incorporates the following components: study 1) a prospective, observational study, to assess the relationship between a comprehensive set of measures of walking ability, strength and balance, and daily physical activity in people with chronic lung disease. patients will attend a single assessment session to evaluate physical capacity. they will also wear a physical activity monitor for a week following completing these tests to assess physical activity and aspects of physical performance. participants will also be invited to return two months later to provide evidence about the repeatability of measurements. study 2) a parallel study comparing assessment of performance during six-minute walk tests by an observer to a semi-automated assessment using an activity monitor worn by the patient. this will involve a single visit and be carried out during walking tests carried out as part of routine clinical care. study 3) a qualitative study to investigate experiences and perceptions of participants of dance groups for people with chronic lung disease, as a novel form of physical activity. this will be used to inform the design of subsequent trials of dance interventions for chronic lung disease.

Eligibility criteria:
inclusion criteria: * adults with stable chronic lung disease * able to understand instructions. * age and sex matched healthy controls. exclusion criteria: * for the main study, the presence of other comorbidities causing a significant reduction in mobility (for example stroke with neurological deficits, severe arthritis, significant peripheral neuropathy, significant visual impairment, dementia etc.). * exacerbation of lung disease within the last 2 months.

Keywords: copd