Kornimate/medical-research-clean huggingface dataset:
impact of a telephone-based support intervention on the long-term well-being of women undergoing termination of pregnancy for fetal anomaly

Conditions: Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly

Summary: this study focuses on women undergoing termination of pregnancy for fetal anomalies (topfa). psychological consequences of such terminations may be even greater than those associated with spontaneous losses of pregnancy because of shame and guilt which can result in social isolation. currently, there is little support for women after they have left hospital. in this study, 50 topfa women will be randomly assigned to an intervention group and 50 to a control group. by completing four questionnaires at the time of induction of labour, total sample will be assessed for depression, stress and "hardiness"; they will be reassessed at 3, 6, and 12 months. total sample will be interviewed by phone at 6 and 12 months. we hope to determine whether a telephone-based intervention (a biweekly supportive call) can decrease the emotional distress experienced by women undergoing termination of pregnancy.

we hypothesize that: 1)women in the intervention group will show lower rates of depression and stress and a significant increase in hardiness over time at 6 and 12 months post-termination compared with the control group; 2) women who score low on hardiness initially will experience more psychological distress at 6 and 12 months than subjects who score higher initially, irrespective of group; 3) women who have anxious/avoidant attachment styles will not show an improvement in psychological distress over time, irrespective of group.

Eligibility criteria:
inclusion criteria: * women over 18 years of age undergoing termination of pregnancy for fetal anomaly at mount sinai hospital, toronto * fluent in oral and written english * able to understand the nature of the study * can provide informed consent * can be reached by telephone exclusion criteria: -women who are currently seeing a therapist or undergoing psychiatric care, and women who do not meet all of the inclusion criteria

Keywords: termination fetal anomaly psychological sequelae pregnancy termination for anomalies supportive follow-up pregnancy termination anomalies
a study to assess hemoglobin level depending on the comorbidity index in chronic kidney disease (ckd) participants not in dialysis treated with methoxy polyethylene glycol-epoetin beta (comete)

Conditions: Renal Anemia of Chronic Kidney Disease

Summary: this prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (mircera). data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta treatment.


Eligibility criteria:
inclusion criteria: * participants with chronic kidney disease not on dialysis * treatment-naïve for erythropoiesis-stimulating agents (esas), not having received esas in the 6 months prior to inclusion in this study * hemoglobin level less then (\<)10 grams per deciliter (g/dl) at inclusion * participants for whom the treating physician has decided to initiate treatment with methoxy polyethylene glycol-epoetin beta for medical reasons prior to study start exclusion criteria: * functional renal transplant * current participation in a clinical trial in anemia due to chronic kidney disease
function, locomotion, measurement and inflammation

Conditions: Ankylosing Spondylitis

Summary: folomi is a pilot study in which the investigators will seek to determine if gait spatio-temporal and kinematic parameters can explain the evolution of a functional score, the bath ankylosing spondylitis functional index (basfi), at 18 months. the secondary objectives are: (1) to study the relationship between gait parameters measured at t0 and the basfi at t0, (2) to study the relationship between gait parameters at t0 and the basdai at t0, (3) to assess general state of health of the patients and its evolution by appreciating: level of physical activity, state of fatigue, diurnal sleepiness and quality of life, and (4) to compare spatio-temporal gait parameters between patients and healthy controls.

this longitudinal cohort study is aiming to follow 60 persons with ankylosing spondylitis during 18 months. assessments will be conducted at baseline and every 6 months. an healthy control group of 30 persons will be included and age and sex matched to the first 30 patients.

Eligibility criteria:
inclusion criteria: * ankylosing spondylitis or axial spondyloarthritis patient * patient able to walk at least 180 meters without technical help * stable treatment for 3 months * affiliated to a social security system exclusion criteria: * concomitant musculo-skeletal disease * cardio-respiratory disease with an impact on locomotion * hips, ankle or knee arthroplasty (scheduled or done within 18 months) * no french understanding * central or peripheric neurologic disease * other disease with impact on posture, locomotion or prehension * quickly evolutive disease (less than 12 month life expectancy) * chemotherapy or radiotherapy ongoing * patient who live more than 50 km away from grenoble hospital * willing of pregnancy within 18 months * people protected by law (article l1121.5 of public health code)

Keywords: ankylosing spondylitis gait basfi basdai 6mwt
the effect of renastart formula supplementation in children with acute kidney injury in maintaining normal serum electrolytes levels

Conditions: Acute Kidney Injury

Summary: this clinical trial will evaluate renastart formula effectiveness in children with acute kidney injury (aki) and acute on top of chronic kidney disease (ckd), in maintaining normal serum electrolytes levels without using electrolyte binders,24 patients will be recruited from pediatric nephrology unit (pnu), children's hospital, ain shams university, they will be assigned randomly in to two arms, arm 1 including patients who will be treated by electrolytes binders, arm 2 including patients who will be treated by renastart formula, after initial assessment serum electrolyte evaluation will be followed up monthly for 3 months.


Eligibility criteria:
inclusion criteria: •infants and children with aki and acute on top of ckd suffering from hyperkalemia and/or hyperphosphatemia at pediatric nephrology unit (pnu), children's hospital, ain shams university hospitals. exclusion criteria: * patients are on dialysis. * pediatric patients with coexisting another medical problems and different risk factors which can affect serum electrolytes such as: constipation, high volume blood transfusion and diabetes medications disrupt potassium balance e.g., acei, arbs and diuretics.
creatine supplementation in chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome

Summary: this study evaluates the effectiveness of medium-term supplementation with creatine to improve clinical outcomes in well-defined adult cfs population. half of the participants will receive creatine while the other half will receive placebo.

chronic fatigue syndrome (cfs) is a debilitating and complex condition characterized by profound fatigue of unknown cause, which is permanent and limits the person's functional capacity, producing various degrees of disability. it seems that inadequate or impaired energy provision through cellular metabolism may contribute to the pathogenic initiation and maintenance of cfs. a variety of dietary interventions have been used in the management of cfs, yet no therapeutic modality demonstrated overall positive results in terms of effectiveness. previous studies have evaluated the effects of essential fatty acids, vitamins, minerals and/or enzymes, with findings that do not support the use of a broad-spectrum nutritional supplement in treating cfs-related symptoms. considering the fact that patients with cfs have lower levels of high-energy compounds (e.g. phosphocreatine, adenosine triphosphate), effective dietary treatment of cfs should be focused on providing compounds that facilitates cellular bioenergetics. besides other candidate agents, creatine (cr) could be of particular interest since it occurs naturally in the human body. placebo-controlled, randomized, double-blind, cross-over clinical trial examining the effectiveness of cr for the treatment of cfs will be organized according to the consolidated standards of reporting trials (consort) guidelines.

Eligibility criteria:
inclusion criteria: * older than 18 years * fulfilled cdc criteria for cfs exclusion criteria: * psychiatric co-morbidity * use of dietary supplement within 4-weeks prior to the study commencing * pregnancy
irinotecan plus radiation therapy followed by chemotherapy in treating patients with glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. irinotecan may make the tumor cells more sensitive to radiation therapy. purpose: this phase i/ii trial is studying the side effects of irinotecan given together with radiation therapy followed by irinotecan and carmustine and to see how well it works in treating patients with newly-diagnosed glioblastoma multiforme.

objectives: * determine the safety of adjuvant irinotecan when administered concurrently with radiotherapy in patients with newly diagnosed glioblastoma multiforme. * determine survival of patients treated with this regimen followed by irinotecan and carmustine. * assess the toxic effects of this regimen in these patients. * determine whether the dose of irinotecan chosen produces radiosensitizing plasma concentrations of sn-38 in these patients. * assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of irinotecan in these patients treated with this regimen. outline: this is a pilot, dose-escalation study of irinotecan. patients are stratified according to receipt of concurrent enzyme-inducing anticonvulsants (eiacs) (yes vs no). * phase i (closed to accrual as of 3/5/2005): patients receive carmustine iv over 2 hours on day 1 of courses 2-5 and irinotecan iv over 90 minutes (beginning immediately after carmustine infusion) on days 1, 8, 22, and 29 of courses 1-5. patients also undergo radiotherapy 5 days a week for 6 weeks concurrently with course 1 only. treatment repeats every 6 weeks for 5 courses in the absence of unacceptable toxicity. cohorts of 6 patients receive escalating doses of irinotecan until the recommended dose for phase ii is determined. the recommended dose for phase ii is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.

Eligibility criteria:
* 18 years and older * histologically confirmed newly diagnosed grade iv astrocytoma or gliosarcoma * no oligodendrogliomas/oligoastrocytomas * study entry must occur within 8 weeks after surgery * performance status - ecog 0-2 * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 130,000/mm\^3 * bilirubin ≤ 1.5 times upper limit of normal (uln) * sgot ≤ 2 times uln * creatinine ≤ 0.5 mg/dl above uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no uncontrolled infection * no other concurrent malignant disease except superficial skin cancers * no other major medical problems * no prior chemotherapy * no prior radiotherapy for any tumor

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
the role of genetic factors in the development of bronchial asthma in the kazakh population

Conditions: Bronchial Asthma; Genome Wide Association Studies

Summary: to research for a genetic marker of bronchial asthma, a single nucleotide polymorphism (snp) analysis of dna obtained from the peripheral blood of patients with bronchial asthma and normal control will be performed.

unrelated kazaks subjects who have bronchial asthma were recruited in the current study. genotyping for various snp associated due to the linkage disequilibrium patterns is to be performed. genotypes would be statistically compared between patients with bronchial asthma and normal control subjects free of bronchial asthma

Eligibility criteria:
inclusion criteria: * persons with bronchial asthma confirmed by a doctor; * the age of the patients is from 5 to 60 years; * persons of kazakh nationality, whose paternal and maternal grandparents are kazakhs. * persons who are able and willing to provide written informed consent; * persons capable and willing to comply with the research protocol; exclusion criteria: * persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent; * pregnant or lactating women; * tuberculosis of any localization in the active phase and in history; * severe and decompensated diseases of the liver and kidneys, cardiovascular system; * severe and decompensated course of endocrine diseases; * autoimmune diseases; * systemic diseases; * oncological diseases;

Keywords: bronchial asthma genome wide association studies
randomized study of positron emission tomography - computed tomography (pet/ct) in pre-operative staging of lung cancer

Conditions: Non-Small Cell Lung Cancer; Thoracotomy

Summary: patients with possible operable non-small cell lung cancer are randomised to conventional staging, or conventional staging and pet/ct. according to, patients with operable tumor will be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be compared with the two groups in order to asses the possible benefit of pet/ct.

patients with possible operable nsclc after staging with ct are randomised to pet-ct with fdg or not, prior to mediastinoscopy. all patients are referred to mediastinoscopy unless a positive fdg uptake results in a positive biopsy suggesting stage iv disease. biopsies are performed according to the following criteria: 1. lymph nodes are numbered according the mountain classification, and abnormal lesions must be confirmed histologically, by mediastinoscopy or thoracotomy. 2. pet-positive lesions in the liver must be biopsied unless ultrasound or mri unequivocally indicate the lesions are benign cysts or haemangioma. 3. pet-negative adrenal lesions are accepted without biopsy if ct scan indicate the lesion is a benign adenoma. 4. pet-positive bone lesions must be evaluated by plain x-ray, ct, mri, or bone scintigraphy. in case of equivocal findings a biopsy must be performed. 5. pet-positive brain lesions must be confirmed by ct or mri. number of patients: patients with clinically operable nsclc after ct-staging are included. all patients must have mediastinoscopy performed. all patients referred to mediastinoscopy can be randomised after informed consent. a total of 430 consecutive, non-selected patients are planned. it is anticipated that approximately 60% of the referred patients with clinical stage i-iiia nsclc will undergo thoracotomy, and a risk of type i and ii error of 5% and 10%, respectively, is accepted. thus a total of 215 patients are randomised in each arm in order to observe an absolute difference of 15% in the number of thoracotomies. this number seems to be sufficient to evaluate differences in the secondary endpoints. after inclusion of a total of 220 patients, corresponding to 110 pet-scans, an interim analyses are performed. in case of a highly significant difference in the number of thoracotomies (p \< 0,001) the study will be closed.

Eligibility criteria:
inclusion criteria: 1. clinically operable nsclc after ct 2. fit for thoracotomy and lobectomy or pneumectomy after lung function tests 3. ct-scan of thorax, including liver and adrenals with no signs of distant metastases. 4. no medical condition contraindication surgery. 5. age 18-80 6. no claustrophobia. 7. negative pregnancy test. 8. no diabetes mellitus. 9. signed informed consent. exclusion criteria: 1. radiologically m1 disease. 2. pregnancy 3. known claustrophobia. 4. estimated fev1 \< 30% of expected after surgery. 5. diabetes mellitus.

Keywords: nsclc pet/ct surgery fdg staging
historical data analysis of hematological remission and survival in adults with r/r acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: a retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory b-precursor acute lymphoblastic leukemia patients.

a retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory b-precursor acute lymphoblastic leukemia. data are aggregated across multiple countries and study sites in the eu and us

Eligibility criteria:
inclusion criteria: * adult patients with relapsed / refractory b-precursor acute lymphoblastic leukemia * age 15 or older at time of de novo (initial) diagnosis of acute lymphoblastic leukemia * initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later * no cns involvement at relapse * no isolated extramedullary relapse * other inclusion criteria may apply
prevalence of human papillomavirus in men living in the northern plains

Conditions: Human Papillomavirus Infection

Summary: hpv infection is associated with cervical and other anogenital cancers. hpv may also be associated with the development of prostate cancer. the purpose of the study is to determine the prevalence of hpv infection in men living in south dakota.


Eligibility criteria:
inclusion criteria: * male * ages 18-65 * living in south dakota (aka northern plains) exclusion criteria: -
endoscopic assessment of polyp histology

Conditions: Colonic Polyps

Summary: polyps found during screening colonoscopy have to be removed or at least biopsied. attempts to save costs include endoscopic assessment of polyps with regards to differential diagnoses between adenomas (which have to be removed) and hyperplastic polyps (could be left in place or removed and not examined histologically). such a concept would only be feasible if endoscopy can make the differential diagnosis with high accuracy. such high accuracy rates - between 80% and 95% - have been reported from reference centers with specific scientific interest. the investigators want to test whether these results a) can be reproduced in the private practice setting performing large-volume screening colonoscopies and b) whether latest generation endoscopes provide benefit in terms of better accuracy.

patients undergoing screening colonoscopy will be randomized to the use of two different colonoscopes, namely the latest generation (pentax iscan, hi line) versus the previous generation (classic line). on withdrawal, all polyps found will be diagnosed according to their pit pattern (classification scheme mit example images provided) and a differential diagnosis made during the live examination. pit patterns i/ii will be classified as hyperplastic polyps, patterns iii-v as adenomas (in a subgroup iv and v will be classified as pre-/malignant). all polyps will be photographed from near distance to allow for later blinded review which will be done on patients with only one polyp (to avoid mix-up of polyps) by 3 examiners and 2 independent hospital experts.

Eligibility criteria:
inclusion criteria: * all patients undergoing screening colonoscopy exclusion criteria: * missing consent * no screening colonoscopy (diagnostic colonoscopy because of symptoms)

Keywords: screening colonoscopy adenoma hyperplastic polyp differential diagnosis
periprosthetic distal femur fracture

Conditions: Periprosthetic Fractures; Distal Femur Fractures

Summary: a periprosthetic distal femur fracture is a fracture close to a knee implant. this type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture. our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. one treatment consists of open surgery and the placement of a plate and screws along the side of the femur. the other consists of implanting an intramedullary nail in the femur. the goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.


Eligibility criteria:
inclusion criteria: age 18 years and older displaced periprosthetic fracture of the distal femur fracture amenable to both treatment groups, in the opinion of the investigator knee prosthesis is well-fixed and non-stemmed open box femoral component provision of written informed consent exclusion criteria: presence of an active infection around the fracture (soft tissue or bone) open fracture injury severity score (iss) \> 15 or any associated major injuries of the lower extremities medical contraindication to surgery pregnant women likely problems, in the judgment of the investigators, with maintaining follow-up
respiratory biofeedback device and reduction of dental anxiety associated with local anesthesia in children

Conditions: Anxiety

Summary: the aim of the study was to investigate the effect of a respiratory biofeedback device (resperate tm) in reduction of preoperative anxiety in children undergoing dental procedures under local anesthesia.

the study was a randomized controlled clinical trial. a total of 110 anxious pediatric dental patients, of age range 7-12 years, were selected from the pediatric dentistry and dental public health department, faculty of dentistry, alexandria university, egypt, after securing parental informed consents. children were chosen according to the faces version of modified child dental anxiety scale scoring 26 or more. the participants will be randomly allocated into 2 groups: group i: study group and group ii: control group. the patients of group i (study group) will undergo a session of biofeedback regulation by using "resperatetm" as an anxiety reducing method. group ii patients will be managed by a routine behavioral management technique "tell,show,do". local anesthesia injection will be administered to the child, after which heart rate measurement and salivary sample for salivary amylase analysis will be repeated.

Eligibility criteria:
inclusion criteria: * normal healthy children (physical status asa i \& ii). * scoring 26 or more on faces version of modified child dental anxiety scale (mcdasf). * dental procedure requiring local anesthesia. * completion of a parental consent to participate in the study. exclusion criteria: * children on anxiolytic medication or using any medication directly related to emotional or cognitive function. * children with special needs. * children on medications that specifically agonize or antagonize alpha- or beta-adrenergic processes.