Kornimate/medical-research-clean huggingface dataset:
sleep respiratory disorders evaluation in sickle cell disease children

Conditions: Sickle Cell Disease; Respiration Disorders

Summary: in sickle cell disease children, sleep respiratory abnormalities are risk factors for vaso-occlusive complications, as well as cerebral vasculopathy. a 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems frequency and etiology, as well as their influence on sickle cell disease complications.

* inclusion visit with physical examination. a 2.9 ml blood sample will be necessary, if not done within the framework of care within 6 months for: cbc (cell blood count), reticulocytes counts (1.2 ml of blood), liver enzymes, electrolytes, urea, creatininemia (1,2 ml of blood) and fetal hemoglobin (0.5 ml of blood). - a complete standardized examination including nasopharynx endoscopy, if not yet done in usual care, to identified upper airway obstruction * a standardized pneumology evaluation to identified obstructive lung symptomatology * an ambulatory polysomnography will be performed within days following inclusion, during sleep and will allow electroencephalogram recording, oculomotricity, muscles (mentalis muscles and tibialis anterior) movements, electrocardiogram and respiratory activity recording. the steering committee will classify the children in three populations based on their exam results: * group 1: no abnormality in polysomnography * group 2: obstructive sleep-related disorder * group 3: isolated sleep hypoxemia for group3, patients will have a new ambulatory polysomnography.

Eligibility criteria:
inclusion criteria: * sickle cell disease children with either sickle cell anemia, compound heterozygozity sb0-thalassemia, or sdpunjab, * no prior transfusion program within 3 months, * no prior treatment with hydroxycarbamide within 3 months, * aged 2 to 6 years, * parents or tutors signed informed consent, * prior physical examination, * social security insurance. exclusion criteria: * encephalopathy * other disease that could interfere with protocol exams realization * nitrous oxide analgesia contre-indication * conventional hospitalization in the past 3 weeks

Keywords: sickle cell disease respiration disorders polysomnography
a study of dex-methylphenidate extended release in children (6-12 years) with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 6-12 years, inclusive. * subjects meeting the dsm-iv criteria for adhd of any type, as established by the k-sads-pl (kiddie schedule for affective disorders and schizophrenia-present and lifetime version). if a dsm-iv-defined adhd diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study. * subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to screening visit (concerta® 36 mg and 54 mg is allowable) exclusion criteria: * parent or guardian unable or unwilling to complete the conner's adhd/dsm-iv scale for parents (cads-p) and the daily diary card * diagnosed with a tic disorder or tourette's syndrome * history of seizure disorder * the presence of a known medical condition that would preclude the use of methylphenidate. a history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease * alt, ast, ggpt or serum creatinine greater then 2x the uln at screening * a history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe conduct disorder or severe oppositional defiant disorder) * subjects who have participated in an investigational trial within the past 4 weeks (28 days) are excluded * subjects who are currently taking antidepressants or other psychotropic medication * subjects who have initiated psychotherapy during the three months prior to randomization * subjects with a positive urine drug screen * subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate other protocol defined inclusion/exclusion criteria may apply

Keywords: adhd children laboratory classroom attention deficit hyperactivity disorder
sodium pertechnetate (99tc) injection generator: 99mtc from neutron-activation 99mo v 99mtc from fission 99mo

Conditions: Cancer of Bone

Summary: a non-fission sourced, solvent generator produced 99mtc intravenous injection, as 99mtc -mdp, is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology using the same oncologic indications as nuclear reactor sourced 99mtc, as 99mtc-mdp.

this clinical trial will be a comparison of diagnostic and imaging equivalency of 99mtc pertechnetate intravenous injection (labeled with commercial mdp kits) produced by a non-fission sourced/solvent generator and a nuclear reactor/column sourced generator. each oncologic participant acts as their own control to reduce error variance. condition intervention phase oncologic indication for which a bone scan would normally be indicated. participant having recently had a bone scan using technetium (99mtc) medronate injection usp labeled with 99mtc derived from fission-sourced 99mo. drug: technetium (99mtc) medronate injection usp labeled with 99mtc derived from neutron-activation-produced 99mo. phase 3

Eligibility criteria:
inclusion criteria: * oncology out-patients in whom an acceptable quality standard-of-care technetium (99mtc) medronate bone scan has been ordered or obtained within the last 28 days. * if female of child-bearing potential is outside of the window of 10 days since the last menstrual period, a negative serum pregnancy test is required. * age greater than or equal to 18 years. exclusion criteria: * oncology out-patients in whom an acceptable quality standard-of-care technetium (99mtc) medronate bone scan has been ordered or obtained within the last 28 days. * if female of child-bearing potential is outside of the window of 10 days since the last menstrual period, a negative serum pregnancy test is required. * age greater than or equal to 18 years. * identified interval events which have occurred after the standard of care bone scan but prior to the administration of non-fission sourced technetium (99mtc) medronate which could influence or change bone scan uptake (e.g. skeletal trauma, orthopedic surgery, bone infection, or interval therapy (i.e. radiation therapy, non-maintenance chemotherapy). -

Keywords: 99mtc pertechnetate sodium pertechnetate technetium molybdenum mdp neutron activation
bone marrow cells with core decompression for avn treatment

Conditions: Avascular Necrosis of the Femoral Head

Summary: avascular necrosis of the femoral head (avn) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. this is a single armed study to be done from july 2023 till january 2024, the total number of patients anticipated is 10, total joints treated around 20, the procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.

avascular necrosis of the femoral head (avn) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. early stage avn can be managed by various techniques, the results have been disappointing, total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. this procedure is usually a high risk procedure under general anesthesia ,with the newer treatment modalities include using high stem cell concentration in the vicinity of the necrosed tissue with core decompression to prevent disease progression. this study is a single armed study to be done from july 2023 to january 2024, the total number of patients is 10, etiology include corticosteroids use, systemic lupus erythematosus mostly related to steroid use in covid 19 epidemic,. the age of the patients range from 25-55 years. the procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.

Eligibility criteria:
inclusion criteria: 1. avascular hip necrosis irrespective of stage. 2. age from 25-55 years. - exclusion criteria: 1. history of bleeding tendency. 2. history of malignant disease. 3. critically ill patient. -

Keywords: avascular necrosis of the femoral head core decompression bone marrow cells local anesthesia
urinary incontinence in women from amapa

Conditions: Urinary Incontinence

Summary: the investigators aim to study the prevalence of urinary incontinence in women who live in the riverside community in the state of amapa (the bailique island) and compare it to the prevalence of urinary incontinence in women who live in the urban region -macapa-the capital city of the amapa state - brazil.

the study aims to compare urinary complaints of women belonging to two different groups: women who live in a riverside area of the amapa state-the bailique island, which is about 12 hours by boat from the state capital city and compare them to those of the women who live in the urban region -macapa (the capital city of the amapa state). the main goals are: to describe the clinical features of the women in the study, assess probable risk factors concerning the urinary incontinence, make physical gynecological exam as well as urodynamic studies in the patients who have urinary complaints and use a life quality questionnaire with those patients (kings health questionnaire). cross and prevalence study, followed by case series. cohort study between the two populations. the riverside group with 120 interviews and the urban group with 260 interviews, where the sample calculation was based on the population of each region and the incidence of urinary incontinence checked through a pilot study. after reading and signing an informed consent, interviews with women aged 20 years or over and non-pregnant are hold so as to identify those who have complaints about urinary incontinence, socio-economic data and risk factors. in patients who complain about urinary incontinence, gynecological exams are performed in order to assess genital prolapse and urodynamic studies are made as to confirm urinary incontinence and life quality questionnaire. all the data will be encoded in the database and analyzed through statistics programs and a comparison between the two groups (urban and riverside) will be made.

Eligibility criteria:
inclusion criteria: * women aged 20 or over * living either in the urban area or in the riverside exclusion criteria: * women under 20 and * pregnant

Keywords: urinary incontinence riverside women amapa
lipoprotein metabolism in normal volunteers and patients with high levels of lipoproteins

Conditions: Hypolipoproteinemia; Hypercholesterolemia; Dyslipidemia; Hyperlipidemia

Summary: researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. this study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis). patients participating in this study will receive injections of lipoproteins or apolipoproteins (the protein component of lipoproteins) that have been isolated and purified. these lipoproteins will be labeled with small amounts of radioactive material and sterilized before they are injected into the patient. patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. in addition, patient will be required to follow a specially formulated diet. patients will be weighed throughout the course of the study.

we propose to investigate human in vivo lipoprotein metabolism using radiolabeled apolipoproteins on plasma lipoproteins. paired kinetic studies using dual-labeled iodinated lipoproteins and apolipoproteins are performed in healthy volunteer controls with normal lipids and subjects with dyslipidemia under controlled metabolic conditions. studies are designed to formulate metabolic pathways in patients with undefined genetic disorders of lipid metabolism as well as in healthy volunteers to provide original insights into normal and pathologic metabolic pathways. all kinetic data is computer analyzed to provide quantitative data and facilitate direct comparison of multiple studies.

Eligibility criteria:
* inclusion criteria: subjects with new and undefined dyslipidemia-particularly familial disorders with extreme phenotypes. healthy normal volunteers - (18 years old or older) controls to investigate the formation of hdl for prebeta hdl. euthyroid. exclusion criteria: healthy control volunteers are initially screened for secondary causes of hyperlipidemia and are excluded if they have any clinically significant laboratory abnormality (i.e., liver disease, disease, kidney disease, endocrine disease,), chronic medical problems (i.e., hypertension, migraines, inflammatory bowel, hepatitis, hiv) or require any chronic medications (i.e., acne, asthma). the healthy control volunteers weight must fall within the current guidelines for ideal body weight. pregnant women. unwilling to follow metabolic diet. allergic to iodine. unable to sign consent form.

Keywords: metabolism hdl cholesterol ldl hypoalphalipoproteinemia natural history
diagnostic study to identify sentinel lymph nodes in women with stage i or stage ii breast cancer

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors. purpose: diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage i or stage ii breast cancer.

objectives: i. determine whether the concept of a sentinel lymph node within the axillary nodal basin is valid in staging breast cancer. ii. determine the sensitivity of combined methods of identification of sentinel lymph nodes by patent blue v dye and gamma probe detection in these women. outline: patients receive patent blue v dye injection peritumorally prior to surgery. preoperative lymphoscintigraphy is performed using technetium tc 99 sulfur rhenium colloid injected around the tumor associated with intraoperative gamma probe detection. nonpalpable tumors receive a localized injection using stereotactic injection techniques. patients then undergo standard axillary (level i and ii) lymph node dissection. projected accrual: a total of 200 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: histologically or cytologically proven stage i or iia invasive breast cancer t0, t1, or t2 (no greater than 3 cm), n0 noninflammatory nonmetastatic no ductal carcinoma in situ eligible for breast-conserving surgery hormone receptor status: positive or negative patient characteristics: age: any age sex: female menopausal status: pre- and postmenopausal performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant no allergy or sensitivity to radiopharmaceuticals or patent blue v dye prior concurrent therapy: biologic therapy: no prior biologic therapy chemotherapy: no prior neoadjuvant chemotherapy endocrine therapy: no prior endocrine therapy radiotherapy: no prior neoadjuvant radiotherapy surgery: no prior breast surgical biopsy or axillary surgery

Keywords: stage i breast cancer stage ii breast cancer
hydrocortisone for prevention of septic shock

Conditions: Severe Sepsis

Summary: severe sepsis is a disease with a high mortality. development of shock is a most serious complication and increases the risk of death considerably. application of low dose hydrocortisone is currently recommended only in patients after severe septic shock has been established. hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse shock, however, the preventive application has not been investigated in a larger study. the study investigates whether low dose hydrocortisone prevents the development of shock in patients with severe sepsis. it is postulated that shock prevention may also affect morbidity and mortality.


Eligibility criteria:
inclusion criteria: * severe sepsis according to accp/ccm criteria * onset of severe sepsis \< 48 hours * informed consent * effective contraception in fertile women exclusion criteria: * septic shock * known hypersensitivity to hydrocortisone and additives * glucocorticoid history which warrants continuation of glucocorticoid administration * other indication for systemic glucocorticoid therapy * dnr-order * moribund patient * pregnancy * breast feeding women * age \< 18 years * other interventional study * relationship to investigator

Keywords: sepsis septic shock glucocorticoids hydrocortisone
identification of proteostasis-related biomarkers in alzheimer´s dementia

Conditions: Alzheimer Disease

Summary: at the time of biomarker-substantiated diagnosis for a given ad patient it remains unclear to what extent the disease will devastate cognitive abilities within the next years. this is not only unsatisfying for the patient and the attending physician but also a major problem in the context of clinical trials that aim to establish new therapeutic agents. in clinical trials it is critically important to foresee as precisely as possible the course of the disease. the overall aim of the subproject is to identify a panel of csf biomarkers to further improve specificity of diagnosis ("disease markers"), to measure disease activity and to predict ad progression ("stage and progression markers").

within the last years, protein analyses of aβ-species in the cerebrospinal fluid (csf) and amyloid-imaging using f18-based pet-tracers have become a part of the diagnostic repertoire in specialized memory clinics allowing a neurobiological, biomarker-based validation of alzheimer´s disease (ad) diagnosis. this has led to a substantial increase in the specificity of the diagnostic procedure. however, the problem remains that the diverse factors, which influence disease progression are largely unknown, while tools for diagnosis have improved substantially. we will identify patients for participation in a long-term clinical follow up study. biomaterial (csf, blood) will be obtained at baseline and subjected to a detailed protein analysis. in a subset of patients, a lumbar puncture will be repeated to compare baseline and follow up csf. within this study, a panel of proteins, comprising aβ- and tau-species as well as inflammation, glial and synaptic markers, potentially involved in disease progression will be measured in biomaterial from baseline and from follow up assessment. clinical data will be correlated with the panel of disease and progression markers.

Eligibility criteria:
inclusion criteria: diagnosis of alzheimer´s disease exclusion criteria: other neurological or psychiatric diseases stroke

Keywords: biomarker
allogeneic γ9δ2 t cells treatment of recurrent hematologic tumors

Conditions: Hematologic Diseases

Summary: this is an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 t cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation.

to evaluate the safety and in vivo dynamics of allogeneic γ9δ2 t cell in the treatment of recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation patients, and to explore the appropriate therapeutic dose.

Eligibility criteria:
inclusion criteria: 1. age 12-65 (inclusive)； 2. patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation； 3. basically normal liver and kidney function (as demonstrated by the following laboratory tests prior to initial γ9δ2 t cell therapy) * alanine transaminase/aspartate transaminase \< 2.5×uln； * serum creatinine \< 1.5×uln； * total bilirubin level \< 1.5×uln； 4. no obvious hereditary disease; 5. normal cardiac function, cardiac ejection index above 55%; 6. women of reproductive age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative, and use contraception during the clinical trial period and within 3 months after the last cell transfusion; 7. sign informed consent. exclusion criteria: 1. patients with simple extramedullary recurrence; 2. pregnant and lactating women; 3. organ failure; * heart: ⅲ level and ⅳ level; * liver: reach the grade c child - turcotte liver function; * kidney, renal failure and uremia period; * lung: symptoms of severe respiratory failure; * brain: consciousness disorder. 4. patients with a history of solid organ transplantation; 5. uncontrollable infectious diseases or other serious diseases, including but not limited to infections (such as hiv positive), congestive heart failure, unstable angina, arrhythmia, psychosis, or restricted social circumstances or those that the attending physician considers to pose unpredictable risks; 6. patients with systemic autoimmune diseases or primary immunodeficiency; 7. patients with allergic constitution; 8. use of systemic steroid drugs; 9. chronic diseases requiring the use of immunological agents or hormone herapy; 10. prior treatment with any other immune cells; 11. participated in similar clinical trials within 30 days; 12. received radiation therapy within 4 weeks from the time of enrollment; 13. researchers don't think clinical trials are appropriate for other reasons.

Keywords: recurrent hematologic tumors allogenic γδt cell