Kornimate/medical-research-clean huggingface dataset:
evaluation of effectiveness of combined intra-articular and intra-osseus injection vs a single intra-articular injection of bone marrow concentrate

Conditions: Osteoarthritis, Knee

Summary: osteoarthritis (oa) is one of the most common diseases resulting in large burdens on society. among the emerging treatments, bone marrow concentrate (bmc) intra-articular injections are a promising regenerative approach. however, they offer only a temporary benefit since they target synovial and chondral tissues but fail to address the osteochondral interface, which plays a key role in the onset and progression of joint degeneration. this project will investigate the efficacy of combined bmc injections, targeting both intra-articular tissues and subchondral bone, to treat oa in a randomized controlled trial (rct).

the main aim is to evaluate in a rct the potential of a new combined bmc treatment for oa, through the use of scores for the clinical outcome, the study of imaging and biological samples for tissue regeneration and systemic effects, and the identification of bmc and patient characteristics predictive of better results. all patients will undergo an arthroscopic procedure to debride degenerated tissues (this can offer a temporary benefit but not long lasting results) before bmc intra-articular injection. half patients will receive also the injection of bmc at the subchondral level (bone samples obtained to allow bmc placement will be sent to the lab). the same minimally invasive incisions will be used for all patients, ensuring patient blinding. evaluations, performed by medical staff not involved in the treatment to ensure double blinding, will document subjective clinical improvement, functional measurements, biomarker study, and imaging with the use of modern 3tmri and qct technology. bmc characterization and patient features will be analysed to identify factors predictive of a better outcome.

Eligibility criteria:
inclusion criteria: 1. male or female patients, aged between 40 and 70; 2. arthrosis of the medial compartment (grade 2-3 according to the kellgren-lawrence score\> 4 months); 3. failure after at least 6 months of conservative treatment (drug therapy with nsaids and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, prp); 4. patients' ability and consent to participate in clinical and radiological follow-up; 5. signature of informed consent. exclusion criteria: 1. patients with trauma in the 6 months prior to surgery; 2. patients with maligncy; 3. patients suffering from rheumatic diseases; 4. patients suffering from non-compensated diabetes; 5. patients suffering from uncompensated thyroid metabolic disorders; 6. patients abusing alcoholic beverages, drugs or drugs; 7. patients with axial deviations\> 5 °; 8. body mass index\> 35; 9. patients treated with joint infiltrations in the previous 6 months; 10. patients treated with surgery at the same knee in the previous 12 months.

Keywords: bone marrow comcentrate intra-articular intra-osseus
the efficacy of single coil defibrillation leads for internal cardioversion of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.

this study seeks to compare the efficacy of single coil defibrillation leads for the internal cardioversion of atrial fibrillation as compared with cardioversion by external defibrillation pads. it is known that dual coil leads are effective for atrial cardioversion, but the presence of the svc defibrillation coil allows for selection of shock vector that more reliably incorporates the majority of atrial tissue compared to a single right ventricular lead. for a variety of reasons single coil defibrillation leads are now implanted in the majority of patients requiring placement of implantable cardiac defibrillators, and many of these patient's will later develop atrial fibrillation and potentially require cardioversion. currently, there is no clear consensus on how to approach cardioversion in these patient's and both external and internal methods are used. internal cardioversion may be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion. external cardioversion may carry a small risk of damaged to the cied. the investigator's goal is to identify patient's referred for cardioversion for atrial fibrillation who also have an implanted cardiac defibrillator with a single coil defibrillation lead and randomize them to either external or internal cardioversion.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age * persistent atrial fibrillation and have been recommended by your primary cardiologist to undergo cardioversion * have an implantable cardiac defibrillator exclusion criteria: * over the age of 99 * pregnant * prisoner

Keywords: atrial fibrillation implantable cardiac defibrillator cardioversion
sahastara remedy extract capsule in primary osteoarthritis of clinical trial phase ii

Conditions: Osteoarthritis

Summary: to study efficacy and safety of sahastara 95% ethanolic extract capsules compared to treatment primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (phase ii).

sample size 66 volunteers the patients were divided randomly into 2 treatment groups. the patients in group 1 received the sht extract 300 mg/day (1 capsule of 100 mg sht extract three times daily before meals). the patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). in addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of gastrointestinal adverse effects.

Eligibility criteria:
inclusion criteria: * no pregnancy * no serious medical condition evaluated by physical examination and laboratory results in 1 month before study * no supplementary food and/or vitamin during the study able to follow suggestion during the study exclusion criteria: * uncontrolled hypertension (bp\>140/90 mm.hg.) bmi \> 30 * have serious medical condition including severe peptic ulcer, congestive heart disease, liver and renal dysfunction. * on during use medicine including rifampicin, phenytoin, propranolol, theophylline

Keywords: sahastara osteoarthritis herbal medicine
quality of life in patients with multiple myeloma

Conditions: Multiple Myeloma; Quality of Life

Summary: the purpose of this study is to determine clinically important difference and response shift in quality of life in patients with multiple myeloma.

multiple myeloma is a plasma cell tumor with an annual incidence of 6 pr. 100 000. in the absence of curative treatment, the aim of the therapy is not only to induce an objective response and a prolongation of survival but also to improve the patients quality of life. this project will raise two problems which make qol-data hard to interpret 1. in a clinical trial where many patients are included, statistically significant differences are obtained. however, there is widespread agreement that p-values do not indicate whether a particular finding has clinical significance because statistical significance does not necessarily equate to a meaningful difference or change in qol. a crucial task for clinicians in interpreting trial-based qol results is to determine if the observed change is clinically important to the patient. 2. when measuring changes in qol in a pretest-posttest design,response shift can affect results. patients with advanced disease can report surprisingly good qol.including response shift into quality of life research would allow a better understanding of changes in the qol that patients report.

Eligibility criteria:
inclusion criteria: * multiple myeloma * age \> 18 years * informed consent exclusion criteria: * terminal illness with life expectancy less than 3 months * unable to fill in a questionnaire in norwegian

Keywords: multiple myeloma quality of life response shift clinically important difference
randomized phase iii-study in stage iiib and iv non-small-cell lung cancer. sequential single-agent vs. double-agent vs. triple-agent therapy.

Conditions: Non-Small-Cell Lung Carcinoma

Summary: this study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer. it claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.


Eligibility criteria:
inclusion criteria: 1. histological verified non-small cell lung cancer. cytological diagnosis is accepted for doubtless results. 2. present stage iiib with malignant pleural effusion or stage iv disease. tumor dissemination should not be irradiable in one field 3. age between 18 and 75 years 4. karnofsky index 70 - 100% 5. measurable or evaluable tumor parameter 6. no prior chemotherapy for nsclc 7. sufficient hematological parameter before start of therapy (leucocytes \> 3.500/µl and platelets \> 100.000/µl). 8. sufficient liver function (bilirubin \< 1,6mg/dl) 9. sufficient renal function (creatinine \ 60ml/min) 10. minimal estimated life expectancy \> 3 months 11. written informed consent for study attendance 12. patient accessibility for therapy and follow up 13. no attendance to an other study exclusion criteria: 1. small-cell lung cancer oder tumors with small-cell fractions 2. local advanced irradiable stage iii 3. previous chemotherapy because of other diseases, not longer than 3 years ago 4. simultaneous radiation of all present tumor manifestations 5. simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma 6. respiratory insufficiency 7. heart insufficiency nyha iii and iv 8. peripheral arteriosclerosis stage iii and iv 9. neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol 10. pregnancy, breastfeeding or not ensured contraception 11. hiv-infection 12. active hepatitis b and c 13. manifest infectious diseases before start of therapy 14. minimal estimated life expectancy \< 3 months 15. no written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol
effects of a stretching protocol in patients with hip osteoarthritis

Conditions: Hip Osteoarthritis

Summary: hip osteoarthritis (oa) is one of the most prevalent chronic disease in the world. clinical guidelines recommend non-pharmacological conservative treatments for the management of oa. hip flexors seems to play an important role in the development of hip oa but there is no published studies evaluating the results of a stretching protocol of hip flexors in hip oa patients. the objective of this trial is to evaluate if a stretching protocol of hip flexors is more effective in symptoms, functional capacity , range of motion, strength, muscular length, pain threshold and anxiety and depression compared to control. for this purpose the investigators conduct a single-group, pretest-posttest clinical trial.the investigators included patients diagnosed of hip osteoarthritis grade i-iii by scale of kellgren and lawrence. the variables are measured at the beginning and at the end of treatment of the control phase, and at the end of the stretching protocol phase.


Eligibility criteria:
inclusion criteria: * diagnosed medically with a x-ray test * american college of rheumatology criteria exclusion criteria: * secondary osteoarthritis by a traumatism, paget disease, inflammatory or metabolic disease, congenital diseases etc. * vascular or neurological disease. * musculoskeletal pathologies in lumbar spine, pelvis or lower limbs * grade iv in kellgren and laurence scale

Keywords: hip osteoarthritis manual therapy physiotherapy
volume versus pressure ventilation on lung atelectasis

Conditions: Cardiac Congenital Defects

Summary: this prospective randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with lma (laryngeal mask airway) under volume versus pressure controlled modes of ventilation.

the initial us scanning will be done prior to the induction of anesthesia. induction of anesthesia using 4% sevoflurane. adequate size lma will be inserted after adequate depth of anesthesia adjusted. group a (n=25): will receive pressure-controlled ventilation (pcv). group b (n=25): will receive volume-controlled ventilation (vcv). us scanning and arterial blood gases at the following: * t1(after maintenance of anesthesia). * t2 (one minute after applying groin bandage and before extubation). * t3 (10 minutes after extubation and resumption of adequate regular breathing). * t4 (30 min post extubation).

Eligibility criteria:
inclusion criteria: pediatric patients undergoing cardiac catheterization procedures. age from 2 years to 6 years of both sexes. exclusion criteria: * lung score at different times. * age \&lt;2 years and \&gt;6 years. * preoperative mechanical ventilation. * heart failure (any inotropic support infusion). * patients with any lung diseases( acute respiratory disease, pulmonary or lung * diseases). * lung consolidation score ≥ 2 before insertion of lma. * any contraindication for lma insertion (risk for aspiration, and/or airway * obstruction below the larynx.) * procedures exceeding 120 mins duration.

Keywords: pediatric cardiac catheterization lung ultrasound score lung atelectasis lma
standalone omni surgical system for open-angle glaucoma

Conditions: Open Angle Glaucoma

Summary: the emergence of minimally invasive glaucoma surgeries (migs) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (iop). the omni™ surgical system (sight sciences, menlo park, ca, usa) is a promising migs procedure. it combines two procedures known as trabeculotomy and viscodilation of schlemm's canal in one hand held device without the need for additional incisions or extra instrumentation. the device recently received fda approval in the united states for certain indications in ophthalmic surgery. to date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and iop.

the emergence of minimally invasive glaucoma surgeries (migs) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (iop).1 the omni™ surgical system (sight sciences, menlo park, ca, usa) is a promising procedure which targets the conventional outflow pathway.2 this device treats the trabecular meshwork, schlemm's canal and the distal collector channels, all conventional pathway points of aqueous outflow resistance. its designed microcatheter allows for cannulation of schlemm's canal, dilation using the controlled delivery of viscoelastic as well as a trabeculotomy by stripping the trabecular meshwork will retracting the catheter.3 goniotomy-assisted transluminal trabeculotomy (gatt) has shown promising results in using an ab interno approach to cleave the trabecular meshwork.4 alternatively, viscodilation alone has also shown an iop lowering effect. 5 the omni surgical system combines both procedures in one hand held device without the need for additional incisions or extra instrumentation. the device recently received fda approval in the united states for delivery of small amounts of viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures.6 to date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and iop.

Eligibility criteria:
inclusion criteria * patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma. * an iop of 10-40 mmhg on maximum tolerated medical therapy who are either progressing, above iop target, or poorly adherent or tolerant to medical therapy. * phakic or pseudophakic eyes and previous laser trabeculoplasty will be included. exclusion criteria: * other forms of glaucoma, * prior incisional glaucoma surgery, * prior corneal graft (pkp, dalk, dsaek, dmek), * shafer angle grading \<2 in 2 or more quadrants.
ultrasound guided erector spinae block for postoperative analgesia in thoracotomy patients

Conditions: Postoperative Pain

Summary: aim of this study is to assess and compare between the efficacy of the new u/s guided erector spinae plane block (esp) and the conventional methods of systemic analgesics in adult patients scheduled for elective thoracotomy surgery.

thoracotomy is considered the most painful of surgical procedures and providing effective analgesia is the onus for all anesthetists. ineffective pain relief impedes deep breathing, coughing, and remobilization culminating in atelectasis and pneumonia.the erector spinae plane (esp) block is a newly-described technique for treating thoracic pain, and has several advantages that make it an attractive alternative to these more invasive procedures.ultrasound guided erector spinae (esp) block is a regional anesthesia technique, recently described by (forero; et al.) for use in thoracic neuropathic pain. esp block is reported to lead to analgesic effect on somatic and visceral pain by effecting the ventral rami and rami communicantes that include sympathetic nerve fibers, as la spreads through the paravertebral space . when performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.esp block leads to effective postoperative analgesia when performed at t 4-5 level for breast and thoracic surgery. the esp block , will be performed as follow:the patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the t5 spinous process. three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . a total of 20 ml of 0.25% bupivacaine will be injected here.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years * american society of anesthesiologists physical status i or iv scheduled for elective thoracotomy exclusion criteria: * refusal of the patient to provide written consent * history of relevant drug allergy * age less than 18 * obesity bmi \> 40 kg/m2 * infection of the skin at the site of needle puncture area * coagulopathy * pregnant females
efficacy of biphasic insulin aspart 30 in type 2 diabetics failing on oads

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (oads) with or without basal insulin therapy.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus for at least 12 months * hba1c: 7.5-10.0% * an antidiabetic regimen that has been stable for at least 3 months * able and willing to perform smbg testing as per protocol exclusion criteria: * use of any insulin preparations other than nph or glargine within the past 6 months * pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods) * known or suspected allergy to trial product or agents related to trial product
clinical investigation of the medtronic entrust™ implantable cardioverter defibrillator (icd), model d153atg

Conditions: Ventricular Arrhythmias

Summary: people who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (icd). an icd is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. the purpose of this study was to evaluate the safety and efficacy of the entrust icd device. a feature of this device allows it to send small, painless electrical impulses (anti-tachycardia pacing or atp) to the heart instead of shocking it out of a rhythm that is too fast. stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest. this device also allows the heart to beat on its own when it can and helping it (by pacing, or sending it electrical signals) when it needs help. this feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation (having too rapid of heart beats in the atrium). this study is now complete and the device has since been approved by the fda.


Eligibility criteria:
inclusion criteria: subjects with failure but no symptoms (nyha class i) or subjects with mild heart failure that only sometimes interferes with daily activities (nyha class ii) subjects who have, or are risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (icd) subjects who have, or are at risk of developing, rapid beats in the upper chambers of the heart (atrial tachyarrhythmias) exclusion criteria: subjects with rapid heart beats in their ventricles (lower chambers of the heart) associated only with reversible causes subjects with mechanical tricuspid heart valves (a structure in the heart, located between the right atrium and right ventricle, which allows blood to flow down from the atrium into the ventricle.)

Keywords: implantable cardioverter defibrillator, anti-tachycardia pacing (atp)