Kornimate/medical-research-clean huggingface dataset:
high-dose chemotherapy with autologous stem cell rescue in pediatric high-risk brain tumors

Conditions: Brain Tumor

Summary: * study no.: kspno-s-081 reduced-dose craniospinal radiotherapy followed by high-dose chemotherapy and autologous stem cell rescue in children with newly diagnosed high-risk brain tumor * study no.: kspno-s-082 high-dose chemotherapy and autologous stem cell rescue in infants and young children with newly diagnosed high-risk brain tumor to avoid or reduce craniospinal radiation * study no.: kspno-s-083 high-dose chemotherapy and autologous stem cell rescue in children with recurrent brain tumor or non-germinomatous germ cell tumor with inadequate response to conventional treatment

although significant progress has been made in the treatment of brain tumors, the prognosis remains dismal in patients with relapsed tumor. the outlook for infants and young children is also poor, primarily because of the limited use of radiotherapy, although a recent report suggested that vigorous combination chemotherapy alone improved the survival of young children without macroscopic metastases at diagnosis. the prognosis is also not satisfactory when a large residual tumor remains after surgery or when leptomeningeal seeding is present at diagnosis. given the above situation, we plan to explore the possible efficacy of high-dose chemotherapy and autologous stem cell rescue in patients with high-risk embryonal tumors, relapsed brain tumors and in infants and young children with brain tumors.high-dose chemotherapy and autologous stem cell rescue has improved the survival of children with high-risk solid tumors. this treatment strategy is based on the hypothesis that a dose escalation might improve the survival of children with high-risk solid tumors.many investigators demonstrated that further dose escalation using sequential high-dose chemotherapy and autologous stem cell rescue might result in additional improvements in the survival of patients with high-risk tumors. as embryonal brain tumors are a chemosensitive tumors, a strategy using high-dose chemotherapy might be effective in the treatment of high-risk embryonal brain tumors and relapsed brain tumors. in addition, it might defer or eliminate irradiation in infants and young children with brain tumors

Eligibility criteria:
inclusion criteria: * kspno-s-081: newly diagnosed embryonal brain tumor, age \>= 3 years * kspno-s-082: all high-grade or malignant brain tumor, age \<3 years * kspno-s-083: recurrent embryonal brain tumors, recurrent cns germ cell tumor exclusion criteria: * patients with severe comorbid organ dysfunction (nci grade \> 2 organ toxicity) prior to high-dose chemotherapy * patients with progressed tumor prior to high-dose chemotherapy * patients whose parents do not want to undergo high-dose chemotherapy and autologous stem cell rescue

Keywords: brain tumor high-dose chemotherapy autologous stem cell transplantation infant
effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at mulago hospital

Conditions: Compare Blood Age for Transfusion

Summary: in resolving lactic acidosis among children with severe malarial anemia, there is no difference between those transfused with blood of longer storage compared to shorter storage age

objective of the study is to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anemia. methods: children aged 6 - 59 months admitted to acu with severe malarial anemia (hb \ 5 mmol /l), will be randomly assigned to receive either blood of shorter storage age (\<10 days) or longer storage age (21 -35 days) by gravity infusion as is the routine practice. 37 patients will be enrolled in each study arm. physiological measurements namely blood lactate, oxygen saturation, hemoglobin, blood pressure, respiratory rate and pulse rate will be taken at baseline, during and after transfusion. the two groups will be compared. the primary outcome variable will be the proportion of children whose lactic acidosis resolves after 4 hrs of transfusion. 24hr mortality will be our secondary outcome.

Eligibility criteria:
inclusion criteria:children aged 6 - 59 months admitted at acute care unit - mulago hospital with; 1. a positive b/s for malaria 2. severe anemia ( hb ≤ 5 g/dl) and 3. lactic acidosis (blood lactate ≥ 5 mmol/l) 4. written informed consent from the caretaker. exclusion criteria: 1. children undergoing transfusion with blood products other than packed cells. 2. children with known or concurrent cardiac disease.

Keywords: blood storage age transfusion lactic acidosis
haemodynamics variations of transcutaneous oxygen in patient with areterio-venous leg ulcers under venous compression

Conditions: Leg Ulcer; Compression; Vein

Summary: arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap. the management of leg ulcers is not clear and can be venous compression or surgery. the aim of the study is to evaluate the variation of the transcutaneous oxygen with compression. the second aim is to see how tolerate is the compression and the quality of life.


Eligibility criteria:
inclusion criteria: * age eighteen or more * leg arteio-venous ulcers exclusion criteria: * age under eighteen, * index pressure in the ankle under 0.5
sleep treatment for addiction recovery

Conditions: Insomnia; Alcohol Use Disorder; Substance Use Disorders

Summary: project star aims to examine the feasibility, acceptability, and initial efficacy of a cbt-i supplement to outpatient alcohol and substance use treatment.

among those who receive treatment for alcohol use disorder (aud), one in three relapses to problematic drinking within one year of treatment. thus, additional treatment strategies are needed. notably, up to 74% of individuals seeking treatment for aud report co-occurring symptoms of insomnia, while 85% of those seeking sud treatment report insomnia symptoms. given the negative impact of insomnia on attention and emotion regulation, insomnia symptoms may decrease patients' abilities to attend to treatment for substance use and manage negative emotions that lead to craving and relapse. this project aims to examine the feasibility, acceptability, and initial efficacy of a cbt-i supplement to substance use treatment. forty adults who meet diagnostic criteria for aud or sud and insomnia disorder will receive cognitive behavioral therapy for insomnia (cbt-i). in order to generate hypotheses regarding the efficacy of cbt-i for individuals who are and are not engaged in substance use treatment, we aim to recruit 20 participants who are engaged in substance use treatment through the community at baseline and 20 participants who are not. outcomes will be assessed at the end of the active intervention period (6 weeks) and at 6 weeks post-intervention

Eligibility criteria:
inclusion criteria: * participation in alcohol or substance use treatment in the columbia, mo area * dsm-5 criteria for moderate to severe alcohol use disorder of substance use disorder * dsm-5 episodic criterion (duration at least 1 month) for insomnia disorder exclusion criteria: * unable to provide informed consent * cognitive impairment * continuous sobriety for 2+ months at baseline * untreated sleep disorder requiring more than behavioral treatment for insomnia * severe psychiatric disorder that requires immediate clinical attention * initiation of a sleep medication in the past six (6) weeks

Keywords: sleep alcohol drinking insomnia outpatient inpatient drug use
cerebrospinal acid-base in pregnant and non-pregnant fertile women

Conditions: Acid-Base Imbalance; Respiratory Alkalosis; Cerebrospinal Fluid; Pregnancy

Summary: the third trimester of pregnancy is typically characterized by the development of a marked respiratory alkalosis. the possible role of pregnancy-induced variations of cerebrospinal fluid (csf) acid-base characteristics on the development of hypocapnic alkalosis is still unknown. aim of this study is to characterize, according to stewart's approach, the acid-base equilibrium of csf and arterial plasma of pregnant women and compare the results with data obtained from fertile, non-pregnant women.

the reduction in plasma pco2 correlates with gestational age and was shown to be associated to plasma progesterone concentrations. we hypothesize that pregnancy-related haemodilution, inducing a reduction in csf strong ion difference (sid), might have a role in the development of pregnancy-related hypocapnic alkalosis. samples of csf and arterial plasma of pregnant women with gestational age \> 35 weeks undergoing spinal anesthesia for elective caesarean section will be analyzed for blood gases, ph, electrolytes, osmolality, albumin and haemoglobin concentration. in addition plasma copeptin levels will be analyzed. the same measurements will be performed in fertile, non-pregnant women undergoing spinal anesthesia for elective surgery.

Eligibility criteria:
inclusion criteria: * pregnancy with gestational age \> 35 weeks * scheduled elective cesarean section under spinal anesthesia exclusion criteria: * known respiratory or neurologic disease * multiple pregnancies
ibi310 in combination with sintilimab in patients with dna mismatch repair deficient (dmmr)/microsatellite instability high (msi-h) locally-advanced or metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the main purpose of this study is to assess the efficacy and safety of ibi310 in combination with sintilimab in patients with microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) locally advance or metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal adenocarcinoma 2. imaging confirmed locally-advanced or metastatic colorectal cancer 3. measurable disease by ct or mri 4. msi-h confirmed by central lab 5. eastern cooperative oncology group (ecog) performance status 0 to 1 exclusion criteria: 1. prior treatment with an anti-programmed death receptor (pd)-1, anti-pd-l1, anti-pd-l2, anti-cytotoxic t-cell lymphoma-4 antigen (ctla-4) antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways 2. subjects with active,known or suspected autoimmune disease 3. subjects with a history of primary immune deficiency 4. subjects with severe infectious diseases
sensorimotor control in people with and without neck pain

Conditions: Movement Disorders; Neck Pain

Summary: this is a descriptive, observational, longitudinal, prospective study consecutively enrolling patients with non-specific neck pain and age-matched asymptomatic participants. the investigators will register sensorimotor control variables, including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns. these variables will be recorded by means of inertial measurement unit (imu) sensors during the following tests consecutively performed in two measuring sessions separated by 12 months: (a) kinematics of planar movements, (b) kinematics of the craniocervical flexion movement, (c) kinematics during functional tasks and (d) kinematics of task-oriented neck movements in response to visual targets.


Eligibility criteria:
inclusion criteria: * population aged between 18 and 65 years old exclusion criteria: * visual impairment not corrected by the use of glasses/contact lenses * migraine headache * complex regional syndrome * previous surgeries in the neck and/or head region * sensory and/or vestibular alterations, (f) otogenic or idiopathic vertigo/dizziness * presence of tumors in the craniocervical region * previous fracture in the head or neck region * osseous deformities in the thoracic, cervical or cranial region
doac versus vka after cardiac surgery

Conditions: Anticoagulant-induced Bleeding

Summary: postoperative management of oral anticoagulation is a frequent preoccupation in cardiac surgery, concerning about half of patients. vitamin k antagonists are often recommended but their management is not easy due to the high dose-response patient variability. pharmacologically more stable, direct oral anticoagulants have similar efficiency in preventing thromboembolic complications while they decrease the risk of bleeding in certain patient populations. the objective of study is to assess the safety and efficacy of direct oral anticoagulants in the postoperative period of cardiac surgical procedures.

this study will be composed by 2 groups of 103 participants, patients undergoing cardiac surgery and needing oral anticoagulation in the early postoperative period. the control group will receive vitamin k antagonist and the study group will receive direct oral anticoagulant. the investigators will call back each participants at 3 months to report the ischemic and bleeding complications during this period and evaluated the quality of life of the oral anticoagulation.

Eligibility criteria:
inclusion criteria: * cardiac surgery, with or without cardiopulmonary bypass * indication of postoperative oral anticoagulation: preoperative (atrial fibrillation/flutter of idiopathic venous thromboembolism disease), intraoperative (bioprosthetic mitral valve replacement/mitral valve repair or bioprosthetic tricuspid valve repair), postoperative (de novo persistent more than 24 hours or recurrent atrial fibrillation/flutter, venous thromboembolism) exclusion criteria: * mechanical valvular prostheses or ventricular assist devices * morbidly obesity (body mass index ≥ 40 kg/m²), prior biliopancreatic diversion or sleeve gastrectomy * perioperative dysphagia needing naso-enteric tube or jejunostomy * antiretroviral of antifungal oral therapy * perioperative recent (less than 2 weeks) stroke * perioperative severe renal failure (clearance of creatinine under 30 ml/min or dialysis) * perioperative severe hepatic failure (elevated alanine aminotransferase more than 3 times the superior limit of normal range or cirrhosis) * perioperative recent (less than 3 months) heparin-induced thrombocytopenia

Keywords: direct oral anticoagulant vitamin k antagonist cardiac surgery perioperative care
rio trial - reopro and peripheral arterial intervention to improve clinical outcome in patients with peripheral arterial disease

Conditions: Arterial Occlusive Diseases

Summary: the rio study is a randomized, double blinded german- swiss- austria multi-centre trial on the efficacy and safety of reopro together with interventional recanalization of tasc d lesions in the sfa and popliteal artery.

purpose: the rio trial is designed to test the efficacy of gp iib/iiia blockade on subacute reocclusions in patients with interventional recanalization of chronic occlusions in the superficial femoral and popliteal artery. methods: a total of 420 patients will be randomly assigned to reopro or placebo. patients will be eligible for randomisation with occlusions longer than 5 cm. doppler ultrasound follow-up will be at 30 days, and after 6, and 12 months.

Eligibility criteria:
inclusion criteria: * patients with a history of peripheral artery disease with superficial femoral or popliteal artery occlusion, which mandates pta or stent administration as first treatment modality. the history of peripheral artery occlusion has to be at least 6 weeks, and the target vessel occlusion has to be more than 5 centimeters in length. * age between 18 and 90 years exclusion criteria: * acute limb ischemia * subacute ischemia with requires thrombolysis as first treatment modality * active bleeding or known bleeding diathesis * known severe hepatic or renal disorder (liver cirrhosis, stage b, c or serum creatinine \> 2.5 mg%) * hyperthyreosis * diabetes mellitus treated with metformin * known heparin induced thrombocytopenia (hit, type 2) * female sex with childbearing potential * major surgery or trauma in past 6 weeks * history of stroke within the previous 2 years, or any stroke with a residual neurological deficit, or other cns abnormality (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm) * gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks * administration of oral anticoagulants within the previous 7 days unless prothrombin time is \< 1.2 times control (or international normalized ratio \[inr\] \<1.4), or ongoing treatment with oral anticoagulants * history of bleeding diathesis of platelet count \< 100,000/mm3 * arteriovenous malformations or aneurysms * severe uncontrolled hypertension (treated sys. bp \> 200 mm hg, diast. bp \> 100 mm hg) * hypertensive or diabetic retinopathy * vasculitis * known autoimmune disorders * patient with aspirin intolerance * contraindication or known allergic reactions to abciximab or murine proteins * co-existent condition associated with a limited life expectancy (e.g., advanced cancer, end-stage congestive heart failure) * participation in another clinical research study involving the evaluation of another investigational drug or device within 7 days prior to enrollment * patient who has previously received a gp iib/iiia antagonist

Keywords: peripheral vascular disease intervention restenosis age above 18 years
a multi-omics study of vasospastic angina

Conditions: Vasospastic Angina

Summary: this is a observational study to identify the key factor associated with vasospastic angina and to explore the prognosis of the participants. the study will recruit 400 patients with vasospastic angina, 400 healthy controls and 400 patients with acute myocardial infarction. next generation sequencing, metabolome and proteomics will be performed in these participants.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosed as vasospastic angina exclusion criteria: * participate in any drug clinical trials within 3 months * patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years * serious neurological disease (alzheimer's disease, parkinson syndrome, progressive lower limbs or deaf patients) * previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix)
brain gaba levels and treatment response in major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study will evaluate changes in brain gamma-aminobutyric acid (gaba) levels due to treatment with escitalopram in people with major depressive disorder.

major depressive disorder (mdd) is a severe form of depression. mdd can significantly interfere with an individual's thoughts, behavior, mood, and physical health. people who suffer from mdd often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. in addition, they often experience sleep disruption, loss of appetite, and chronic pain. the purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers. specifically, we want to see if symptoms of depression are related to a decrease in a brain chemical called gaba. we measure the concentration of gaba using a brain-scanning device called "magnetic resonance spectroscopy" (or "mrs"), which is a type of mri. the study lasts for 14 weeks and involves 8 visits to our mgh clinic in boston. the first visit is the screening visit, which can last up to 3 hours. the rest of the visits are about a half hour long and take place every other week. in addition to these 8 visits, there are also 2 visits to mclean hospital brain imaging center for the mrs scans. the first scan takes place within a few days after the screening visit, and the second scan will be at the end of the 14 weeks. each scan visit lasts between an hour and a half and two hours. subjects are reimbursed $50 per mrs scan and $25 per visit to mclean to cover travel costs. all subjects in this study will receive escitalopram (or lexapro), which is an antidepressant medication approved by the food and drug administration. subjects start at 10 mg daily of the escitalopram, but may be increased up to 30 mg if the study doctor thinks it is appropriate.

Eligibility criteria:
inclusion criteria: * meet diagnostic criteria for current major depressive disorder * men or women aged 18-65 * medication-free for one week prior to the start of the study * agrees to use an effective form of contraception throughout the study exclusion criteria: * anyone who is suicidal * pregnant or breastfeeding women * anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease * anyone with a history of seizure disorder or hypothyroidism * anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months) * anyone with a history of intolerance or multiple adverse drug reactions or allergy to (es)citalopram. * patients who are currently taking medications active on gaba, including benzodiazepines.

Keywords: depression biology
post market clinical follow-up study protocol for profemur® gladiator ha coated modular femoral stems

Conditions: Joint Disease

Summary: microport orthopedics (mpo) is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of its total hip arthroplasty (tha) and resurfacing components marketed in the european union (eu). these types of studies are required by regulatory authorities for all tha and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the eu. this study has been designed in accordance with the medial device directives (meddev) 2.12/2 rev 2.


Eligibility criteria:
inclusion criteria: * subject has undergone primary tha for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia; * inflammatory degenerative joint disease such as rheumatoid arthritis; or * correction of functional deformity * subject is implanted with the specified combination of components * subject is willing and able to complete required study visits or assessments previously implanted bilateral subjects can have both thas enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the inclusion/exclusion criteria are satisfied, 3) enrollment does not exceed the subject count specified in the investigator agreement, and 4) the subject agrees to a second informed consent document specific to the second tha. prospective enrollment of a previously unimplanted hip is not permitted in this study. exclusion criteria: * subjects skeletally immature (less than 21 years of age) at time of primary tha surgery * subjects currently enrolled in another clinical study which could affect the endpoints of this protocol * subjects unwilling to sign the informed consent document * subjects with substance abuse issues * subjects who are incarcerated

Keywords: osteoarthritis avascular necrosis ankylosis protrusio acetabuli painful hip dysplasia rheumatoid arthritis correction of functional deformity revision procedures
the best parameter of bladder diary correlates with the volume at strong desire to void of filling cystometry

Conditions: Bladder Diary; Urodynamic Studies

Summary: to identify the bladder diary parameters that are best correlated to vsd.

to identify the bladder diary parameters that are best correlated to vsd.

Eligibility criteria:
inclusion criteria: * female patients with lower urinary tract symptoms who had underwent urodynamic studies exclusion criteria: * patients without data of bladder diary

Keywords: bladder capacity; bladder diary; bladder oversensitivity; lower urinary tract symptoms