Kornimate/medical-research-clean huggingface dataset:
long-term follow-up of children for a 2-year period to confirm the safety and immunogenicity of gsk 257049 vaccine

Conditions: Malaria

Summary: the rts,s/as02a vaccine (or gsk 257049 vaccine), gsk biologicals' candidate plasmodium falciparum (p. falciparum) malaria vaccine is being developed for the routine immunization of infants and children living in malaria endemic areas. the vaccine would offer protection against malaria disease due to the parasite p. falciparum. the vaccine would also provide protection against infection with hepatitis b virus (hbv). this phase iib trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. in this study, the children from mozambique (nct= nct00197041) are followed-up to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after dose 1. this protocol posting deals with objectives \& outcome measures of the extension phase at year 2. during this extension study, no new subjects will be recruited and no vaccine will be administered. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * completion of visit 7, month 21 of 104297 (nct= nct00197041). * written informed consent obtained from the parent(s) or guardian(s) of the subject exclusion criteria: * planned use of any investigational or non-registered drug or vaccine during the study period. * simultaneous participation in any other clinical trial
retrospective cervical cancer oligo states (recurrence, metastasis) multicentre outcomes study

Conditions: Cancer, Cervical; Recurrence; Metastasis

Summary: this multi centric international retrospective study aims to register patients with oligo metastatic and oligo recurrent cervical cancer. the study will register patients in planned period with an aim to analyse clinical outcomes with or without use of radiation in this setting.

detailed clinical protocol can be obtained by contacting the principal investigator.

Eligibility criteria:
inclusion criteria: 1. cervical cancer with (induced) oligo-metastatic and/or oligo-recurrent cervix cancer whether treated or not treated with radiation. these patients may have received previous treatment within or outside approved clinical trials/studies. 2. patients with poly-metastatic disease with good response to systemic chemotherapy and treated with radiation to recurrence or metastatic site. 3. patients treated with radical doses at the time of first diagnosis of oligo-metastasis/oligo-recurrence and present with further oligo-progression. 4. patients with oligo-metastasis or oligo-recurrence treated with other locally directed therapies (like surgery, ablation, etc.) are also permitted. exclusion criteria: 1. gynecological cancer other than cervical cancer 2. persistent poly-metastatic disease post systemic treatment 3. receiving investigational new drugs at the time of relapse as part of other ongoing trials 4. no clinical follow up after treatment

Keywords: reirradiation oligorecurrence oligometastasis
randomized trial on the effect of topical phenytoin on healing after fistulotomy

Conditions: Anal Fistula

Summary: patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.

patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment. healing of the wound after fistulotomy will be observed every week and the duration till complete healing will be recorded. the two groups will be compared regarding the mean duration till complete healing and postoperative complications.

Eligibility criteria:
inclusion criteria: * patients of both genders aging between 18-65 years with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers) exclusion criteria: * patients with high trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary, or recurrent anal fistulas. * patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases. * patients under chronic corticosteriod or immunosuppressive therapy.
a six month randomized controlled clinical trial of lung flute in patients with chronic obstructive pulmonary disease

Conditions: COPD

Summary: this is a 26 week randomized controlled study. the study consists of, in order, an enrollment visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. there will also be telephonic assessments at 8 weeks and 20 weeks. clinic visits will involve comprehensive assessments of the patients lung condition, including post-bronchodilator spirometry, shuttle walk distance, bode index, health status (sgrq) and symptoms (ccq). sputum and serum samples will also be collected at these visits for microbiological and inflammation analysis. sputum will be obtained with the lung flute as an induction device and pulse oximetry will be assessed prior to and after use of the lung flute. clinic and telephonic visits will collect information regarding compliance with the use of the lung flute, adverse events and exacerbation history.


Eligibility criteria:
inclusion criteria: 1. male or female subjects between and including the ages of 30 and 80 years. females of childbearing potential may be included provided they are not pregnant or are not nursing. 2. subjects with a diagnosis of moderate to very severe chronic obstructive pulmonary disease as defined by the global initiative for copd (gold, 2008 update) and who meet the following criteria for stage ll - iv disease: a) subjects must have a post-bronchodilator fev1/fev ratio \<70% and fev1 of \<80% of the predicted value for age, height, and sex using the nhanes iii standards (hankinson, 1999). 3. subjects must have a smoking history of at least 10 pack-years. 4. subjects must have stable disease for at least 1 month prior to enrollment with no changes in the maintenance treatment for copd in this period. - exclusion criteria: 1. history of an exacerbation or other significant disease instability during the month preceding enrollment. 2. a primary diagnosis of asthma or bronchiectasis. 3. inability to vibrate the reed of the lung flute® consistently because of severely expiratory flow rate. 4. subject with any evidence of significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct of the study or safety of the subject. 5. pregnant or nursing females or females intending to become pregnant during the course of the study. 6. use of any investigational drug within one month or 6 half-lives (which-ever is greater) of the enrollment visit. 7. inability to comprehend or willingness to follow the study requirements including attendance at out-patient clinic visit and participation in testing as called for by the protocol. 8. patients currently using the lung flute. -
adjunctive mild hypothermia therapy to primary percutaneous coronary intervention in patients with acute myocardial infarction complicated with shock: a feasibility study

Conditions: Myocardial Infarction Complicated With Cardiogenic Shock

Summary: the purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (th) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock


Eligibility criteria:
inclusion criteria: * recent myocardial infarction: 24 hours of start pain * pump failure cardiogenic shock (defined as persistent hypotension, systolic bp \< 90 mmhg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs * candidate for immediate percutaneous reperfusion * maximal care support: mechanical ventilation, intraaortic balloon contrapulsation exclusion criteria: * cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute vsd, tamponade * pregnant women * absence of maximal support care
evolution of thromboelastography during tranexamic acid treatment

Conditions: Hematological Malignancies Treated With Intensive Chemotherapy

Summary: patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. the aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies.

patients with hematological malignancies often develop low platelet counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). the last studies have showed that many patients continue to experience bleeding, despite the use of platelet transfusions. tranexamic acid is an antifibrinolytic agent. it reduces the breakdown of clots formed. this treatment is widely used in medicine (e.g. emergency, surgery, post-partum) and decreases blood loss and the use of red cell transfusions. the purpose of this study is to test different doses of tranexamic acid (full dose: 3g/day and half dose (1.5g/day) and to study its effect by thromboelastography, with the aim to determine the optimal posology for further clinical studies.

Eligibility criteria:
inclusion criteria: * patient affiliated to a social security regimen or beneficiary of the same * signed written informed consent form * confirmed diagnosis of a hematological malignancy and undergoing intensive chemotherapy * expected to experience hypoproliferative thrombocytopenia resulting in a platelet count of ≤10 g/l for ≥ 5 days exclusion criteria: * pregnant women * patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent * refractoriness to platelet transfusion or requirement for a specific type of platelet transfusion (abo-compatible, plasma-free) * ongoing anticoagulant therapy or antiplatelet therapy at the time of enrolment * treatment with any pro-coagulant agent within 48 hours of enrolment, or enrolment in other trials involving platelet transfusions, platelet growth factors, or presentation of a known hypercoagulable state * diagnosis of arterial or venous thromboembolic disease within the previous year * patient experiencing a bleeding event who grade ≥ 2 within 7 days before inclusion * contra-indications to tranexamic acid (allergy, history of seizures, creatinine clearance \< 30 ml/min) * refusing participation

Keywords: tranexamic acid bleeding hematological malignancies thrombocytopenia
improving functional capacity in fontan patients through inspiratory muscle training

Conditions: Congenital Heart Disease; Single Ventricle

Summary: mechanisms that typically result in increased cardiac output, such as inotropic support, increased heart rate, and decreased afterload, have a blunted effect in fontan circulation. the "thoracic pump" is a contributor to venous return that has been largely unexplored in patients with fontan physiology. inspiratory muscle training can improve the performance of competitive athletes across a range of sports and can improve quality of life and functional capacity in heart failure patients, presumably by reducing inspiratory muscle fatigue and possibly by improving peripheral blood flow during exercise. one could surmise that the effects of these changes would be particularly important in the fontan population. the investigators propose to study the effects of inspiratory muscle training on exercise and pulmonary function parameters in a cohort of adult fontan patients. the investigators hypothesize that a 12-week program of inspiratory muscle training with an inspiratory impedance threshold device will improve inspiratory muscle strength and endurance, and that this will translate into improved exercise performance in patients with fontan physiology.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * fontan physiology * undergoing cardiopulmonary stress testing * able to complete a previous cardiopulmonary stress test in the preceding 24 months * ability to comply with the inspiratory muscle training protocol * ability to return for repeat stress testing and pulmonary function testing 12 weeks after enrollment * ability to provide informed consent exclusion criteria: * status post cardiac transplantation * current pregnancy or plans to become pregnant within the next 3 months (for females of childbearing potential) * active respiratory infection * active cigarette smoker * baseline oxygen saturation \<90% at the previous clinic visit or exercise test * forced expired volume in 1 s and/or vital capacity \<60% of predicted at the previous exercise test * cardiac surgery or catheter-based procedure in the preceding 18 months or planned surgery or catheter-based procedure within the next 3 months
right ventricular resynchronization therapy

Conditions: Right Ventricular Failure; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Hypertension

Summary: the purpose of this study is to determine whether cardiac resynchronization therapy with the use of an implanted electronic pacemaker reduces morbidity associated with chronic thromboembolic pulmonary hypertension

rationale: the clinical severity of right ventricular disease is largely determined by right-to-left ventricular dyssynchrony, i.e., delay of electrical activity between the right and left ventricles. moreover, in patients with chronic thromboembolic pulmonary hypertension (cteph), we found that acute correction of this dyssynchrony by temporary pacing (prior to pulmonary endarterectomy, presently the therapy of choice for cteph) results in significant improvement in cardiac output. in this study, we aim to establish whether chronic pacing with the use of implanted pacemakers confers long-lasting improvements in cardiac output and functional class. objective: to study whether chronic pacing with implanted pacemakers confers long-lasting improvements in cardiac output and functional class in severely symptomatic cteph patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed. study design: chronic intervention study, double-blinded, randomized, cross-over. study population: adult cteph patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed. intervention (if applicable): chronic right ventricular resynchronization therapy (rvrt), i.e., chronic right atrial, right ventricular, and left ventricular pacing with the use of implanted pacemakers. main study parameters/endpoints: (duration of) improvements (in l/min) in cardiac output as measured using doppler echocardiography, and functional class as measured using 6-minute walking distance (6-mwd), right and left ventricular dimensions and ejection fractions (99mtechnetium scintigraphy), biomarkers for heart failure (serum nt-probnp levels), and quality of life (sf-36) questionnaire. design: randomized, double-blind, cross-over study with 2 arms of 10 patients each (arms 1 and 2). in arm 1, rvrt is switched on immediately after pacemaker implant, is switched of in week 5, and switched on at the start of week 6 until study end (32 weeks). in arm 2, rvrt is switched at the start of week 5 after pacemaker implant until study end (32 weeks). at various follow-up visits at weeks 1, 4, 5, 6, 8, 12, 16, the main study parameters/endpoints (see previous paragraph) will be assessed.

Eligibility criteria:
inclusion criteria: adult patients with chronic thromboembolic pulmonary hypertension (cteph) who are ineligible for pulmonary endarterectomy, and those in whom pulmonary endarterectomy has failed exclusion criteria: none

Keywords: right ventricular failure pacemaker cardiac resynchronization therapy pulmonary hypertension
a randomised controlled trial of the use of topical metronidazole (10%) to reduce pain after haemorrhoidectomy

Conditions: Haemorrhoidectomy

Summary: the purpose of this study is to determine whether metronidazole 10% ointment , applied topically three times a day in and around the anus, on the reduction of pain following haemorrhoidectomy.


Eligibility criteria:
inclusion criteria: * have grade 3 or 4 haemorrhoids (external disease with or without significant internal component) * be scheduled for diathermy haemorroidectomy with ≥2 quadrant involvement * be medically fit for surgery * subjects must be aged 18 years or over and of the legal age of consent. * if female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study. * must have provided written informed consent to participate. exclusion criteria: * they have had surgery to the anus or rectum in the past 8 weeks * suffer from a chronic pain syndrome which requires regular narcotic analgesia * have anal fissures * have diagnosed crohn's disease * allergic to metronidazole * are taking any prohibited medication. * deemed mentally incompetent * considered by their physician unlikely to be able to comply with the protocol. * taken part in an experimental drug study in the preceding three months.
axial alignment in patients operated using the visionaire patient matched cutting blocks

Conditions: Osteoarthritis of the Knee

Summary: - title: patient-matched instrumentation vs. standard instrumentation: a randomized clinical trial comparing postoperative axial alignment and component position * short title: visionaire alignment * methodology: monocentric, single blinded, randomized controlled trial * study duration: november 2010 to july 2014 * study centres: leicester general hospital, united kingdom (uk)

malalignment is one of the main reasons for knee arthroplasty revision. with the use of patient matched cutting block we expect better axial alignment of the components. research objectives: * the primary research objective is to evaluate the axial alignment and component position in tka with use of smith \& nephew's visionaire patient matched technology and to compare with the alignment when standard instrumentation. * secondary research objectives include assessing the safety and effectiveness of the visionaire patient matched technology as compared to commonly accepted standard instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint. - outcome measures: * implant alignment and component position by means of ct-scans * knee society score * euroqol-5 dimensions (eq-5d) * knee injury and osteoarthritis outcome score (koos) * oxford knee score * knee-related adverse events * standard and full leg x-ray * number of subjects: 70 (2\*35) * enrollment time: 18 months * diagnosis and main inclusion criteria: patients with osteoarthritis of the knee requiring total knee arthroplasty * study product, dose, route, regimen: visionaire patient matched technology versus the commonly accepted standard instrumentation for the genesis ii total knee arthroplasty implant

Eligibility criteria:
inclusion criteria: * indication for tka, axial alignment between 10 degrees valgus and 20 degrees varus, bmi \<36, patient must be amendable for both genesis ii total knee and visioniare cutting blocks exclusion criteria: * insufficient femoral or tibia bone stock, inflammatory arthritis (e.g. rheumatoid arthritis), patient is immunosuppressed, has an active infection (local or systemic), patient has physical, emotional or neurological conditions that would compromise the patients compliance with rehabilitation and follow up.

Keywords: randomized controlled trial total knee arthroplasty patient matched cutting blocks
cabg reveal: atrial fibrillation after coronary artery bypass graft

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is an abnormal heart rhythm that can occur after coronary heart bypass graft operations. how often this happens and what other problems occur for a person after these operations needs to be better understood. this study uses a device called the reveal xt, a small device that records heart rhythms to track a patient's heart rhythms after the bypass surgery. the device is implanted at the time the bypass graft is made. the information that is gathered for this study will help physicians to provide better treatment and follow-up of the patients under their care.

we will utilize the reveal xt implantable loop recorder (ilr) in order to monitor the incidence of af in our post-cabg patients. the reveal xt has been shown to be superior in comparison to the more commonly used sporadic ecgs.6 unfortunately, the occurrences of arrhythmias tend to be "unpredictable" and often paroxysmal. observers are unlikely to have the opportunity to record ecgs at the time of event until it is too late. the ability of the reveal xt to continuously record ecgs over long periods of time has made it a superior and powerful diagnostic tool in patients with arrhythmias and arrhythmia related complications. this was evident in the large multicenter picture study whereby a large number of diagnostic tests were undertaken in patients with unexplained syncope without providing conclusive data, but in the same study with the reveal ilr, the mechanism of syncope in the vast majority of these patients were established often at first onset of an arrhythmia.7 "the equivalent efficacy", if not superiority, of reveal ilrs above conventional ecgs and holter-monitors in detecting af was established in the "xpect" trial.8 its sensitivity in detecting events not seen with ecgs and holter monitoring post cox maze procedure (surgical procedure for af) and post ablations for paroxysmal af and persistent af is well established.

Eligibility criteria:
inclusion criteria: * 60 years of age or older * presenting for elective coronary artery bypass graft at saint thomas west hospital exclusion criteria: * patients \<60 years of age * prior cardiac surgery * emergent surgery * need for concomitant cardiac surgery other than pfo closure * prior history of af or atrial flutter * prior atrial ablation * prior cardioversion * patients with prior permanent pacemaker * ejection fraction \<35% * prior history of thyroid disease * prior history of a cardiomyopathy * patients without telephonic access
nitrous oxide on acute postoperative pain and opioid consumption and chronic pain after inguinal hernia repair surgery

Conditions: Inguinal Hernia Repair; Post Operative Pain

Summary: to compare postoperative pain, opioid consumption and chronic pain in patients undergoing to hernia repair surgery after receiving nitrous oxide or oxygen during the general anesthesia.

the study is prospective and double blind. in the clinic, patients undergoing inguinal hernia surgery that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups. in the first group of patients will receive nitrous oxide and in the second group of patients will receive oxygen during the general anesthesia.

Eligibility criteria:
inclusion criteria: * 18 to 65 years old at time of the first procedure * american society of anesthesiologists physical status i or ii * inguinal hernia repair surgery undergoing the general anesthesia exclusion criteria: * neuropathic disease * chronic opioid users * contraindication for nitrous oxide receive * consent will not be obtained patient * psychiatric disorders * current or recent drug abuse (within past 6 months).