Kornimate/medical-research-clean huggingface dataset:
descartes-11 consolidation treatment in patients with high-risk multiple myeloma who have residual disease after induction therapy

Conditions: Multiple Myeloma

Summary: to assess minimal residual disease (mrd)-negative complete response (scr) rate after consolidation treatment with descartes-11 in patients with high-risk myeloma who have residual disease following induction therapy.


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older at the time of enrollment * high-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs). exclusion criteria: * patients who are pregnant or lactating. * patients who have any active and uncontrolled infection. no blood cultures are necessary unless clinically indicated.
multifocal vs monofocal iol in congenital cataract surgery

Conditions: Cataract Congenital

Summary: the aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal iols.

purpose: to assess the impact on visual development of multifocal versus monofocal intraocular lenses (iols) implantation in children following congenital cataract surgery. design: retrospective interventional consecutive case series. methods: we reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of iol under one year of age. corrected distance visual acuity (cdva), refractive error and ocular motility disorders were evaluated after a follow-up greater than 4 years.

Eligibility criteria:
inclusion criteria: * unilateral congenital cataract * bilateral congenital cataract exclusion criteria: * other ocular pathologies (such as glaucoma, microphthalmia, micro - or megalocornea, persistent fetal vasculature, retinal congenital disease, corneal scar, traumatic cataracts) * systemic diseases (such as chromosomal abnormalities, prematurity or mental retardation)
a clinical trial in higher risk geriatric patients undergoing ohsp

Conditions: Heart Disease

Summary: to provide information on parameters needed to design a subsequent phase iii confirmatory trial and to assess the safety and efficacy of the acute use of cmi x-11s in high-risk geriatric patients undergoing open-heart surgical procedures (ohsp) requiring cardio-pulmonary bypass.


Eligibility criteria:
inclusion criteria: * requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass: * either: * age ≥ 70 to \<80 with a parsonnet mortality risk score of ≥13 (poor risk); or * age ≥ 80

Keywords: ohsp high risk geriatrics
technology assisted programs that promote mental health for teenagers

Conditions: Depression

Summary: the mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (bits) for the prevention of depression in adolescents. the investigators define bits as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

the mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (bits) for the prevention of depression in adolescents. the investigators define bits as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

Eligibility criteria:
inclusion criteria: * has a score of 12-39 (males) / 15-39 (females) on the center for epidemiologic studies depression scale (ces-d) or reported past month use of marijuana, cigarettes, alcohol or other substances on the center for disease control youth risk behavior survey (yrbs). * is familiar with the use of computers and the internet, as well as mobile phones * is able to speak and read english * is between 14-19 years of age exclusion criteria: * is currently taking an antidepressant medication or has taken one in the previous 3 months * has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the internet or mobile phone * is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. inclusion of participants with symptoms of anxiety disorders, eating disorders and substance abuse disorders will be made on a case-by-case basis. * is severely suicidal (has ideation, plan, and intent in the past 12 months) .

Keywords: depression prevention technology assisted adolescents peer networked
safety and immunogenicity of one dose of novartis' meningococcal acwy-crm vaccine and glaxosmithkline biologicals' meningococcal acwy-tt vaccine in healthy toddlers

Conditions: Meningococcal Disease

Summary: evaluate the immune response and reactogenicity of one dose of meningococcal acwy-cross reactive material (crm) and meningococcal acwy-tetanus toxoid (tt) in 12-15 months old healthy toddlers.


Eligibility criteria:
inclusion criteria: 1. healthy children between 12 months and 15 months old inclusive who were born with an estimated gestational age ≥ 37 weeks. 2. parent(s)/legal guardian(s) had given written informed consent after the nature of the study had been explained according to local regulatory requirements. 3. parents/legal guardian available for all the visits and would comply with the requirements of the protocol (e.g., completion of the diary cards, availability for study visits / safety phone calls). 4. in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. exclusion criteria: 1. previous confirmed or suspected disease caused by n. meningitidis. 2. previously exposed to clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization, i.e. possible meningococcal disease. 3. previously immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). 4. received within 90 days prior to enrollment or were expected to receive during the study period any investigational or non-registered product (drug or vaccine). 5. received or planning to receive any vaccines within 14 days before and 30 days after administration of the study vaccine (exceptions: injectable influenza vaccine could be administered up to 14 days prior to study vaccination and at least 14 days after study vaccination). 6. major congenital defect or a serious chronic disease. 7. history of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine components including diphtheria toxoid (crm197) or tetanus toxoid (tt) and latex. 8. required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (for corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day. inhaled and topical steroids were allowed). 9. receipt of immunoglobulins and/or any blood products within six months prior to study vaccination or who had administration planned during the study period. 10. any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 11. any bleeding disorder which was considered as a contraindication to intramuscular injection. 12. moderate or severe acute infection and/or fever (defined as temperature ≥ 38°c) within 3 days prior to enrollment. 13. systemic antibiotic treatment within 7 days prior to enrollment.

Keywords: meningococcal disease children vaccination
injectable platelet rich fibrin with non surgical periodontal therapy

Conditions: CHRONIC PERIODONTITIS

Summary: clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-prf ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid. 120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). equal number of patients will receive subgingival application of i-prf, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.

the aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-prf and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. patients were randomly allocated in three groups. group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. clinical parameters will be evaluated: plaque index (pi), gingival index (gi), bleeding on probing (bop), probing depth (pd), clinical attachment level (cal), gingival recession (gr). clinical measurements will be performed at baseline, 1 month and at 3 months.

Eligibility criteria:
inclusion criteria: * patients are in general good health. * patients having minimum of 20 permanent teeth. * they have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months. * presence of periodontal pockets (≥5 mm) and clinicala ttachment level \> 5 mm. exclusion criteria: * immunosuppressive systemic diseases (like cancer, aids, diabetes etc.) * clotting and hematological disorders * patients with grade iii mobility. * patients with smoking and alcohol consuming habit. * pregnant and lactating female. * medications influence on the gingival and periodontal tissues (like calcium channel blockers, or long-term steroid use) * the teeth with poor filling and ill fitted restorations
efficacy and safety of celecoxib versus ibuprofen in the treatment of osteoarthritis of the knee (europe)

Conditions: Osteoarthritis, Knee

Summary: to compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (oa) of the knee.


Eligibility criteria:
inclusion criteria: inclusion criteria: * aged \>=40 years old * diagnosed with oa of the knee according to the american college of rheumatology and oa in flare state at baseline visit * functional capacity class of i-iii exclusion criteria: exclusion criteria: * inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) * acute joint trauma at index joint within the past 3 months with active symptoms * score of \>=20 on phq-9 or score of \>=1 on phq-9 item i * use of mobility assisting device for \<6 weeks or use of walker
a bioelectric dressing for post de-roofing treatment of hs

Conditions: Hidradenitis Suppurativa

Summary: the primary purpose of this study is to test if the use of a bioelectric dressing can improve healing after a surgical procedure called de-roofing.


Eligibility criteria:
inclusion criteria: * adults 18 years old and older. * have diagnosis of hs confirmed by a dermatologist * have at least two ancillary tunnels in separate anatomical sites * able to provide informed consent exclusion criteria: * individuals who are not yet adults * subject is allergic to any of the materials and dressings involved in the procedures * women known to be pregnant * prisoners * subjects, who in the opinion of the pi, cannot comply with hope application of the treatment
adjunctive pregnenolone in post-traumatic stress disorder (ptsd) and depression in operations enduring freedom and iraqi freedom (oef/oif) veterans

Conditions: Post-traumatic Stress Disorder; Major Depressive Disorder

Summary: this study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in ptsd and depression in oef/oif veterans.

ptsd and depression are critical areas of immediate impact to operation enduring freedom and operation iraqi freedom (oef/oif) veterans. current treatments for ptsd (which frequently co-occurs with depression) remain limited, with many patients remaining symptomatic despite single or combination administration of ssris, mood stabilizers, antipsychotics and sedatives/hypnotics. in addition, many patients treated for depression remain symptomatic. new interventions are thus urgently needed in ptsd with co-occurring depression to ensure optimal functional outcomes for our service members and their families.

Eligibility criteria:
inclusion criteria: * diagnosis of ptsd, * diagnosis of mdd, * age 18-55, * no change in psychotropic medication for \>=4 weeks, * no anticipated need to to alter psychotropic medication for duration of study exclusion criteria: * unstable medical/neurological illness, * diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, * cognitive disorder, * substance dependence, * positive urine drug screen at screening, * use of hormonal supplementation, * pregnancy/lactation, * female patients who are sexually active and not using acceptable non-hormonal birth control, * initiation/change of psychotherapy within 3 months of randomization, * recent/current electroconvulsive therapy, * regular use of opiates/barbiturates/benzodiazepines

Keywords: ptsd depression neurosteroids
impact of introduction of phid-cv for nunavik children, quebec, canada

Conditions: Acute Upper Respiratory Infection; Acute Lower Respiratory Tract Infection; Otitis Media (OM); Invasive Pneumococcal Disease, Protection Against

Summary: the objective of this study is to document the residual burden of acute upper respiratory infections (auris), acute lower respiratory infections (alris), otitis media (oms) and auditory functional and anatomical abnormalities in children under the age of 5 years in nunavik who will be exposed to phid-cv in combination with pcv-7 or pcv-13. the comparison groups will be the cohorts of children who received no pcv vaccine (those born in 1994-1996) and those exposed to pcv-7 exclusively (those born in 2003-2007).

around 1420 children born between 2006 and 2010 had been eligible to routine immunization program with pneumococcal vaccines. the objective of this study is to document the residual burden of acute upper respiratory infections (auris), acute lower respiratory infections (alris), otitis media (oms) and auditory functional and anatomical abnormalities in children under the age of 5 years in nunavik who will be exposed to phid-cv in combination with pcv-7 or pcv-13. the comparison groups will be the cohorts of children who received no pcv vaccine (those born in 1994-1996) and those exposed to pcv-7 exclusively (those born in 2003-2007). the specific objectives are to measure in children under the age of 5 years in nunavik and born in the period 2009 to 2010: 1. the incidence of invasive pneumococcal disease(ipd), auris, alris and oms; 2. the frequency of antibiotic treatments due to these diseases; 3. the frequency of hospitalizations and transfers to the south on account of alris; 4. the frequency of tympanotomies and ventilation tube insertions; 5. the prevalence of anatomical and functional lesions of the middle ear at the age of 5 years (the main issue). the main research hypothesis is that the incidence of auris, alris and oms and the prevalence of sequelae from om decreased after the implementation of phid-cv in 2009, as compared with previous cohorts of children who were not exposed to this new vaccine.

Eligibility criteria:
inclusion criteria: * born between 2006 and 2010 * resident in nunavik (province of quebec, canada) exclusion criteria: • not applicable

Keywords: streptococcus pneumoniae pneumococcal conjugate vaccines immunization otitis media
intravenous nalbuphine for prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section: a double-blind, randomized controlled trial.

Conditions: Intrathecal Morphine; Caesarean Section; Postoperative Nausea and Vomiting; Neuraxial Opioid

Summary: we study efficacy of iv nalbuphine in prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section.

iv nalbuphine has been proved to help prevent intrathecal morphine-induced pruritus in some studies but results in nausea vomiting prevention have not been well studied. in thailand, most caesarean section is done under spinal anesthesia with intrathecal morphine, proving that iv nalbuphine is effective would be beneficial for our population. this study aims to see whether 4 mg of nalbuphine is effective in reducing incidence of intrathecal morphine-related nausea vomiting in parturient who underwent c-section under spinal anesthesia with 0.2 mg of intrathecal morphine.

Eligibility criteria:
inclusion criteria: * elective cesarean section under spinal anesthesia * age \> 18 years exclusion criteria: * patients with known allergy to medications used in this study (nalbuphine, bupivacaine or morphine) * patient with medical conditions which spinal anesthesia is contraindicated ie. heart diseases, renal or hepatic impairment, obesity \>=100 kilograms * patients with history of postoperative nausea and vomiting (ponv) or motion sickness who may have preexisting risk factors for ponv * patient with known history of drug abuse * unwilling to participate in the study

Keywords: postoperative nausea and vomiting intrathecal morphine caesarean section neuraxial opioid
a prospective observational study of perioperative lumbar puncture pressure and shunt valve pressure management in patients with communicating hydrocephalus undergoing lumboperitoneal shunt surgery

Conditions: Hydrocephalus, Communicating

Summary: target population: patients 18 years of age or older who require surgical treatment with lumboperitoneal shunt surgery for traffic hydrocephalus estimated sample size: 30 cases. study design: this study is a multicenter prospective observational study, with lumbar puncture pressure measurement before and during surgery, and shunt valve setting pressure set according to the requirements of clinical practice in the hospital where it is performed, and the collection of relevant data, including preoperative lumbar puncture pressure, intraoperative lumbar puncture pressure after anesthesia, shunt valve initial pressure, shunt valve pressure at 6 months pressure, length of the intravertebral shunt, and length of the intraperitoneal shunt. complications, shunt effects, and the number of shunt valve adjustments during the 6-month period were also observed and recorded.


Eligibility criteria:
inclusion criteria: 1. age of 18 years or older; 2. confirmed diagnosis of communicating hydrocephalus; 3. signed informed consent for surgery and informed consent for research. exclusion criteria: 1. pregnant women; 2. inappropriate for lumboperitoneal shunt surgery despite the diagnosis of communicating hydrocephalus.
a trial of stress reduction in the secondary prevention of coronary heart disease in blacks

Conditions: Coronary Artery Disease

Summary: the overall hypothesis of this study is that a cardiac rehabilitation program with meditation will be more effective than cardiac rehabilitation alone in improving blood flow through the diseased coronary arteries in african americans. for this purpose, 56 african american men and women with coronary heart disease will be randomly assigned either to standard cardiac rehabilitation plus the transcendental meditation program or to standard cardiac rehabilitation alone. the treatment period will be 12 weeks in length.

the overall objective of this study is to conduct a randomized controlled trial to determine the efficacy of cardiac rehabilitation with and without a structured, standardized, and validated stress reduction component in the secondary prevention of coronary heart disease (chd) in african americans. in this phase ii trial, 56 african american men and women with established chd will be randomly allocated either to standard cardiac rehabilitation with formal stress reduction training using the transcendental meditation program or to standard cardiac rehabilitation alone. the intervention period will be 12 weeks. at baseline and posttest, subjects will be tested by quantitative positron emission tomography (pet) for myocardial perfusion and ischemia. secondary outcomes comprise physiological, behavioral and psychosocial risk factors for chd. the field site will be columbia university medical center and the coordinating center will be mumri-center for natural medicine and prevention.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age: no limitations 3. chd documented by medical history of at least one of the following: a.acute myocardial infarction (mi) within the preceding 12 months b.coronary artery bypass surgery (cabg) c. percutaneous coronary intervention (pci, ptca)d. chronic stable angina 4. written informed consent exclusion criteria: 1. noncardiac life threatening illness 2. severe cognitive impairment or physical disability 3. history of major psychiatric disorder, i.e. psychosis, dementia, or substance abuse disorder within the past year. 4. left ventricular ejection fraction less than 40% 5. conditions that may be a contraindications to pet perfusion imaging with adenosine stress testing, including unstable angina or myocardial infarction in the past week, aortic stenosis, uncontrolled hypertension, uncontrolled atrial or ventricular arrhythmias, second-degree or higher atrio-ventricular block in the absence of a functioning pacemaker, baseline hypotension (systolic blood pressure \< 90 mm hg), severe obstructive lung disease or decompensated heart failure.

Keywords: transcendental meditation cardiac rehabilitation
blood samples to evaluate biomarkers of donor chimerism

Conditions: Leukemia; Hodgkins Disease; Non-hodgkins Lymphoma; Myelodysplastic Syndrome

Summary: we are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. we will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.


Eligibility criteria:
inclusion criteria: * diagnosed with a hematologic disease or malignancy * scheduled to receive nonablative conditioning with fludarabine and total body irradiation * donor is well-matched by high resolution dna techniques. * scheduled to receive postgrafting immunosuppression of oral mmf (cellcept) and an oral calcineurin inhibitor. * age \>18 years at the time of enrollment. exclusion criteria: -diagnosed with an immunodeficiency disorder

Keywords: hematopoietic stem cell transplantation fludarabine mycophenolate mofetil mycophenolic acid biomarkers