Kornimate/medical-research-clean huggingface dataset:
studying genes in tissue samples from younger and adolescent patients with soft tissue sarcomas

Conditions: Childhood Alveolar Soft-part Sarcoma; Childhood Angiosarcoma; Childhood Desmoplastic Small Round Cell Tumor; Childhood Epithelioid Sarcoma; Childhood Fibrosarcoma; Childhood Leiomyosarcoma; Childhood Liposarcoma; Childhood Malignant Mesenchymoma; Childhood Neurofibrosarcoma; Childhood Synovial Sarcoma; Chordoma; Desmoid Tumor; Metastatic Childhood Soft Tissue Sarcoma; Nonmetastatic Childhood Soft Tissue Sarcoma; Recurrent Childhood Soft Tissue Sarcoma

Summary: this research trial studies genes in tissue samples from younger and adolescent patients with soft tissue sarcomas. studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors find better ways to treat cancer

study subtype: ancillary/correlative observational study model: cohort time perspective: retrospective biospecimen retention: samples with dna biospecimen description: tissue study population description: existing nrsts samples from the cog d9902/arst0332 studies sampling method: non-probability sample objectives: i. to determine the frequency with which actionable mutations are found in archived non-rhabdomyosarcoma soft tissue sarcoma (nrsts) tumor specimens using mass spectrometry (ms) analysis of tumor-derived deoxyribonucleic acid (dna). outline: archived dna tissue samples are analyzed for frequency of genetic mutations, including single nucleotide polymorphisms (snps), single nucleotide variants (snvs), and small deletions and/or insertions, by polymerase chain reaction (pcr) and mass spectometry (sequenom massarray). results are then analyzed to determine whether specific mutations correlate with patient or disease features such as tumor stage, histological grade, or outcome.

Eligibility criteria:
inclusion criteria: * archived non-rhabdomyosarcoma soft tissue sarcoma (nrsts) tumor-derived dna * synovial sarcoma, malignant peripheral nerve sheath tumor (mpnst), soft tissue sarcoma not otherwise specified (nos), or other less common pediatric nrsts * formalin-fixed, paraffin-embedded (ffpe) tissue from patients enrolled on: * cog-d9902 soft tissue sarcoma (sts) biology and banking protocol * cog-arst0332 a risk-based treatment for pediatric nrsts study * see disease characteristics
role of exenatide in nash-a pilot study

Conditions: Nonalcoholic Fatty Liver Disease

Summary: we hypothesize that exenatide (byetta), a glp-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven nash.

eight adult patients with known type 2 dm(diabetic) and biopsy-proven nafld were treated with 5-10 mcg subcutaneous exenatide for 28 weeks. liver histology was assessed using the nafld activity score (nas) prior to therapy and after 28 weeks of therapy. we used the following criteria to define our primary outcome: (i) no worsening of fibrosis score, (ii) improved score by at least one point in hepatocyte ballooning, (iii) either (a) improvement in nas by 2 or more points spread across at least two of the three nas components, or (b) post-treatment nas equal or greater than 3.

Eligibility criteria:
inclusion criteria: * well documented nash based on clinical and histological criteria. liver biopsy must have been obtained within 12-months prior to initiation of the study. * subjects must have known diabetes (either diet controlled or only on metformin or sulfonylureas such as glyburide or glipizide). * subjects must be 18 year or older. exclusion criteria: * co-existing etiologies for chronic liver disease (hepatitis b or c, autoimmune or hemochromatosis, etc.). * clinical or histological evidence of cirrhosis. * alanine aminotransferase or aspartate aminotransferase \> 300 iu/l. * uncontrolled diabetes (hemoglobin a1c greater than or equal to 9%). * insulin or tzd dependant dm. * known human immunodeficiency virus infection. * current or history of significant alcohol consumption within past 5 years. significant alcohol consumption is defined as \>20 grm/day in females and \>30 grms/day in males or if alcohol consumption cannot satisfactorily be quantified. * serum creatinine of greater than or equal to 2 mg/dl. * active, serious medical disease (cardiac, renal, pulmonary, dermatologic, psychiatric illness) with likely life expectancy less 5 years. * current or previous malignancy with expected life expectancy less than 5-years (other than basal cell cancer of the skin). * use of drugs historically associated with nash. * histological evidence of malignancy, 4+ iron deposition, or any other type of liver disease. * active substance abuse, such as alcohol,inhaled or injection drugs with the previous one year. * known intolerance or allergy to exenatide (byetta). * history of neuroglycopenia. * women of childbearing potential must have had a negative pregnancy test prior to starting the study and should be willing to avoid pregnancy during the study period. * women must not be nursing.

Keywords: non-alcoholic steatohepatitis nash
the effect of methylphenidate treatment in familial attention deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit/Hyperactivity Disorder Combined Type; ADHD Predominantly Inattentive Type; ADHD Predominantly Hyperactivity Type; ADHD-not Other Specified

Summary: the purpose of this study is to investigate the familial response to methylphenidate treatment (ritalin ir) in two aspects: adhd symptom's improvement and side-effects development.

attention deficit/hyperactivity disorder (adhd) is very prevalent and tends to continue from childhood to adult life. it's heritability is 76%. it was found that there is a greater adhd prevalence in first-degree families of adhd subjects- 4-6 times more than the general population. pharmacological treatment is the first line treatment today in adhd, in children and adults, and methylphenidate (specially ritalin ir) is the first medication given for the disorder. the study includes couples of first-degree family members, both diagnosed with adhd. subjects will receive ritalin ir for 4 weeks and undergo several psychiatric and cognitive questionnaires at each time of the follow-up meeting (a total of 3).

Eligibility criteria:
inclusion criteria: * couples of first-degree family members, both diagnosed with adhd (any type or adhd-nos) and need medical treatment. exclusion criteria: * subjects who receive other psychiatric medications: antipsychotic medications, antidepressants medications, anti-anxiety medications or mood stabilizers. * people who suffer from psychotic disorder, bipolar disorder or other severe psychiatric disorders which are not stabilized. * alcohol/drugs addicted. * people with chronic neurologic diseases. * people with autism or mental retardation. * people with congenital heart defect. * people with hypertension/tachycardia (\>100 bpm). * pregnancy or breast feed women.

Keywords: attention deficit hyperactivity disorder (adhd) methylphenidate- ritalin ir (immediate release)
weight loss & comorbidity resolution with lagb alone vs. lagb with gastric plication

Conditions: Morbid Obesity

Summary: the purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (aka: lap-band surgery, lagb) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. we anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.

laparoscopic adjustable gastric banding when combined with gastric plication will provide lasting weight loss benefits to patients. we are projecting that the percent of excess body weight loss (% ewl) will be greater in study subjects when compared with our control group with lagb alone. furthermore, it is anticipated that the % ewl in study subjects will be similar to patients who have laparoscopic roux-en-y gastric bypass.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 35 * meet asmbs and nih criteria for weight loss surgery * asa class i - iii * agree to refrain from any type of weight-loss drug (prescription or otc)or elective procedure that would affect body weight for the duration of the trial. * english speaking \& comprehension * normal mental caliber. exclusion criteria: * pregnancy, liver failure or kidney failure * women of childbearing potential lactating at the time of initial consult or at the time of surgery * any condition which precludes compliance with the study * history or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the director of bariatric surgery.

Keywords: morbid obesity weight loss surgery laparoscopic adjustable gastric band laparoscopic gastric plication imbrication
growth differentiation factor 15 in icu acquired muscle weakness

Conditions: Muscle Weakness

Summary: intensive care unit -acquired weakness (icu- aw) is a common consequence linked to a worse outcome as evidenced by prolonged mechanical ventilation, longer icu stays, greater mortality rates and a lower quality of life for survivors, so early detection and treatment of icu-aw are critical. however, there is no "gold standard" currently available for assessing and diagnosing icu-aw. it's crucial to develop diagnostic methods that enable for early detection and risk stratification in all critically ill patients, such as: gdf-15 (growth differentiation factor-15) is thought to be a mediator of muscle atrophy because its level increases in the muscular atrophy as a result, measuring gdf-15 seems promise for diagnosing muscle atrophy.

after obtaining the approval of research ethical committee of faculty of medicine, minia university, written informed consent will be obtained from all participants or their legal representatives prior to study inclusion, this prospective cross sectional non randomized observational study will be conducted in intensive care unit minia university hospital, on conscious non-mechanically ventilated patients with expected icu stay 7 days or more during the period from january 2022 to december 2022. based on inclusion and exclusion criteria, patients who met eligibility criteria, the prognosis and outcome of patients developing icu-aw will be observed. parameters will be assessed: 1. medical history, age, gender, weight, bmi and apache ii score ("acute physiology and chronic health evaluation ii") which is a severity-of-disease classification system one of several icu scoring systems will be assessed in the day of admission. 2. sofa score ("sequential organ failure assessment ") which will be assessed every day. 3. routine lab investigations other than these in sofa score as (urea, albumin, hb, tlc, pt, ptt, rbg.....ect). 4. urea:creatinine ratio: urea and creatinine will be measured daily as a part of sofa score and urea to creat will be calculated. 5. plasma growth differentiation 15 (gdf15) on 1, 4 and 7 days. 6. ultrasound measurement of rectus femoris cross-sectional area (rfcsa) on 1, 4, 7, 10 and then every 3days according to patients stay in icu. 7. muscle strength assessment using the medical research council (mrc) score on 1, 4 and 7 days where patients will be divided into an icu-aw group and a non icu-aw group according to their mrc-score on the 7th day. 8. length of hospital and icu stay. 9. long term out come after 3 months survival, physical activity and return to work

Eligibility criteria:
inclusion criteria: * age more than 18 conscious patients patients with expected icu stay more than 7 days exclusion criteria: - unconscious patients spinal cord injury limb fracture or amputations history of cognitive dysfunction severe oedema end stage kidney disease

Keywords: gdf15 muscle weakness icu
the experiences of parents learning physiotherapy techniques for their child

Conditions: Developmental Disabilities

Summary: the experiences of learning from paediatric physiotherapists were explored through unstructured interviews applying colazzi's method to interpret the data. in this hermeneutic phenomenological study, six parents responsible for a physiotherapy home programme for their child were selected through convenience sampling. the purpose of this study was to obtain rich and valid information that could be analysed. the phenomenon of their learning experiences was formed and explored, its implications discussed and inferences made in light of current physiotherapy service delivery.


Eligibility criteria:
inclusion criteria: * parent/main carer of a child with a long term physical condition receiving physiotherapy in the united kingdom for at least six months. exclusion criteria: * parents experiencing physiotherapy outside uk practice. * parents to whom english is not their first language. * parents under 16 years of age

Keywords: children with physical disabilities home activity programs home programmes learning therapeutic relationship phenomenology physiotherapy clinicians who teach parent perspective parent-professional relationships parents/carers long term physiotherapy needs
organ preservation in locally advanced rectal cancer

Conditions: LOCALLY ADVANCED RECTAL CANCER

Summary: pronar trial aims to assess if treatment with organ preservation in stage ii and iii rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment. the main objective of this project is to implement the organ preservation strategy in the treatment of rectal cancer in our environment within a clinical study that allows the analysis of its results in terms of survival. the secondary objective is to assess local relapse, distant relapse and quality of life.

after pathology confirmed rectal cancer patients with stage ii and iii (mri, ct and endoscopy) will be identified in the first visit to medical oncology department. patients will receive the most appropriate neoadjuvant treatment according to clinical guidelines. response to neoadjuvant treatment will be assessed by mri. those patients with a complete response in mri, confirmed by endoscopy, will be offered a "watch and wait" strategy. patients with a complete response in mri, with an almost complete response in endoscopy, will be offered transanal endoscopic microsurgery. all patients with complete or near complete response will sign an informed consent before study entry. radical surgery will be performed in patients without complete or almost complete response criteria after neoadjuvant treatment. patients in organ preserving strategy will be subjected to a more intensive follow up schedule, including mri and endoscopy, compared to patients with radical surgery. as the complete histopathologic response rate after neoadjuvant treatment in locally advanced rectal cancer is approximately 15-20%, considering that approximately 40 patients with locally advanced rectal cancer are diagnosed annually in our setting, approximately 6-8 patients per year could be potentially recruited for this project, until reaching an initial sample of 30 patients for evaluation. the following results will be analyzed: * percentage of complete and almost complete responses. * percentage of watch and wait and transanal endoscopic microsurgery. * disease free survival. * overall survival. * local relapse rate. * distant relapse rate. * treatment and outcomes of relapses. * colostomy free survival. * quality of life. all data will be obtained from patient's medical records

Eligibility criteria:
inclusion criteria: * patients with confirmed histopathological diagnosis of rectal adenocarcinoma. * patients treated with neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy. * patients with evidence of complete or near complete response criteria after completion of neoadjuvant treatment (approximately 8 weeks later). response criteria should be based on digital rectal examination, flexible rectoscopy and mri. exclusion criteria: * evidence of distant metastases.

Keywords: organ preservation watch and wait transanal endoscopic microsurgery
identifying predictors of poor health-related quality-of-life among pediatric hematopoietic stem cell donors

Conditions: Quality of Life

Summary: to compare donors to their non-donor counterparts and healthy controls as well as to generate trajectory classes based on longitudinal patterns of donor hrqol and identify predictors of poor donor hrqol.

there is limited data to show the effects that donation has on pediatric donors to their siblings. there is widespread agreement that it is critical to investigate the medical and psychosocial aspects of sibling pediatric hsc donation for multiple reasons including (a) the vulnerability of the pediatric population undergoing donation, (b) increasing use of pediatric hsc donation as a therapeutic option, (c) evidence that \~20% of pediatric hsc donors experience clinically important hrqol deficits, and (d) the impact that improved understanding of factors predicting poor hrqol will have on our ability to develop guidelines and/or interventions for assisting at-risk donors/families. the proposed study will help to compare donors to their non-donor counterparts and healthy controls as well as to generate trajectory classes based on longitudinal patterns of donor hrqol and identify predictors of poor donor hrqol.

Eligibility criteria:
inclusion criteria: * participants must fall into one of the following categories: * donor between the age of 5 and 17 who is donating to a sibling * parent/caregiver of study participating donor * recipient sibling aged 5 to 17 of study participating donor * any of the donor's non-donor/non-recipient siblings between 5 and 17 * any child between 5 and 17 with a brother or sister (also between 5 and 17) receiving a transplant from an unrelated source * be willing and able to provide signed informed consent: * adults must give consent for their children's and, if applicable, their own participation * assent will be obtained in accordance with guidelines at the participant's transplant institution * be willing and able to respond to psychological assessment questions * must be the donor's first donation * recipient must consent to the cibmtr research database exclusion criteria: * for families with pediatric donors aged 5 to 17, at minimum, the donor child and/or one parent must consent/assent to participation. if that minimum is not met, the family will be excluded * donor or non-donor siblings who do not live in the same household as the recipient at lease half of the time * unable to consent/assent or complete a phone interview in english * parents may consent/assent in spanish * no access to a telephone
assess safety and efficacy of vilaprisan in subjects with uterine fibroids

Conditions: Uterine Fibroids

Summary: the study was performed to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids compared to standard of care


Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosis of uterine fibroid(s) documented by ultrasound at screening and/or during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence * at least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain * good general health * normal or clinically insignificant cervical smear * an endometrial biopsy performed during the screening period, without significant histological disorder * use of an acceptable nonhormonal method of contraception starting at visit 1 until the end of the study exclusion criteria: * pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * hypersensitivity to any ingredient of the study drug * any condition requiring immediate blood transfusion * any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug * any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results * abuse of alcohol, drugs, or medicines (eg, laxatives) * use of other treatments that might interfere with the conduct of the study or the interpretation of the results * undiagnosed abnormal genital bleeding

Keywords: uterine fibroid
an extension to the b1451006 protocol to evaluate the safety and efficacy of dimebon in subjects with moderate-to-severe alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of dimebon in subjects with moderate-to-severe alzheimer's disease.

this study was terminated on may 7, 2010 due to modification of the dimebon development plan, following the lack of demonstration of efficacy in the completed dim14 (connection) study. the study was not terminated due to any safety findings. dimebon has been well-tolerated in clinical trials. demonstration of efficacy for dimebon in alzheimer's disease is pending completion of the ongoing dim18 (concert) study.

Eligibility criteria:
inclusion criteria: * successful completion of 6 months treatment in the previous b1451006 phase 3 dimebon study exclusion criteria: * any major medical illness or unstable medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the ability to interpret study safety data

Keywords: delirium dementia amnestic cognitive disorders mental disorders nervous system diseases central nervous system diseases
effects of the combination of l-arabinose and indigestible dextrin on obesity

Conditions: Obesity

Summary: this study aims to investigate the effect of supplement containing l-arabinose and indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat mass, and serum biochemical parameters in overweight subjects.


Eligibility criteria:
inclusion criteria: * healthy as based on medical history and physical examination * bmi between 25 and 30 kg/m2 * willing not to serve as blood donor during the study * informed consent signed exclusion criteria: * female subjects who are pregnant or nursing a child * participation in any clinical trial up to 90 days before day 01 of this study * renal or hepatic dysfunction * heart disease * under medication * subjects who are taking functional food designed for weight loss or serum lipid reduction