Kornimate/medical-research-clean huggingface dataset:
lentiviral (lv) gene therapy for adenosine deaminase (ada) deficiency

Conditions: Adenosine Deaminase Deficiency; Severe Combined Immunodeficiencies (SCID)

Summary: this is a historically controlled, non-randomized phase i/ii clinical trial to assess the safety and efficacy of autologous transplantation of cd34+ hematopoietic stem/progenitor cells (hspcs), obtained from infants affected by ada-scid, following transduction of the hspcs with a lentiviral vector (lv) carrying the human ada complementary dna (cdna) under the control of the elongation factor 1 alpha shortened (efs) promoter. subjects treated in the trial receive the infusion of autologous, transduced cells following marrow cytoreduction with busulfan. the outcomes are compared to those observed in a historical control group of patients who received an allogeneic hematopoietic stem cell transplant (hsct). this phase i/ii clinical trial will be performed at great ormond street hospital (gosh), london, united kingdom.


Eligibility criteria:
gene therapy (on trial) inclusion criteria: 1. diagnosis of ada-scid confirmed by dna sequencing or by confirmed absence of \<3% of ada enzymatic activity in peripheral blood (or for neonates) in umbilical cord blood erythrocytes and/or leukocytes or in cultured fetal cells derived from either chorionic villus biopsy or amniocentesis, prior to institution of polyethylene glycol-modified ada (peg-ada) replacement therapy 2. patients who lack a fully human leukocyte antigen (hla)-matched family donor 3. patients (male or female) \ 10 % naïve t cells (cd4+45ra+27+ cells) 4. parental/guardian signed informed consent exclusion criteria: 1. cytogenetic abnormalities on peripheral blood 2. evidence of active malignant disease 3. known sensitivity to busulfan 4. if applicable, confirmed pregnancy (to be tested in patients above 12 years old) gene therapy (cup) a group of patients were treated under cup (gosh special license) either because the study was not yet open and patients needed urgent treatment, or because they were outside of the inclusion/exclusion criteria or received investigational medicinal product (imp) followed a different process (ie, received in two infusions). patients followed the same protocol steps and study visits. historical control group inclusion criteria: 1. diagnosis of ada-scid confirmed by dna sequencing or by confirmed absence of \<3% of ada enzymatic activity in peripheral blood or (for neonates) in umbilical cord blood erythrocytes and/or leucocytes or in cultured foetal cells derived from either chorionic villus biopsy or amniocentesis, prior to institution of peg-ada replacement therapy 2. patients (male or female) between 0-18 years at time of treatment 3. patient treated with allogeneic haematopoietic stem cell transplantation since 2000

Keywords: gene therapy hematopoietic stem and progenitor cells lentiviral vector ada-scid
antiretroviral therapy intensification with raltegravir or addition of hyper-immune bovine colostrum in hiv-1 infected patients with suboptimal cd4+ t cell response

Conditions: HIV Infections

Summary: a research study to measure the effect on cd4 counts of adding to current anti-retroviral regimen raltegravir with or without hyper-immune bovine colostrum.

the primary objective of this study is to measure the effect on cd4+ t cell outcome as measured by the mean time weighted cd4+ t cell count change over 24 weeks of two interventions: (i) cart intensification with raltegravir and (ii) cart combined with hyper-immune bovine colostrum in hiv-1 infected individuals who have failed to achieve a cd4+ t cell count greater than 350 cells/µl despite persistent hiv plasma viraemia below 50 copies/ml on cart. eligible patients will be randomised to one of four arms. i. raltegravir + hyper-immune bovine colostrum placebo ii. raltegravir placebo + hyper-immune bovine colostrum iii. raltegravir + hyper-immune bovine colostrum iv. raltegravir placebo + hyper-immune bovine colostrum placebo

Eligibility criteria:
inclusion criteria: * documented hiv-1 infection * age \>18 years * signed informed consent * receiving combination art (cart) for at least 12 months with a stable cart regimen for a minimum of 6 months. a formulation change or modification of dosage schedule is acceptable (for example ritonavir - boosted lopinavir capsules for tablets, abacavir (abc) or tenofovir (tdf) and lamivudine (3tc) or emtricitabine (ftc) as single agents for abc/3tc or tdf/ftc fixed dose combinations) * two consecutive plasma hiv rna viral load measurements \ 50 (or \>400) copies/ml will not exclude the patient provided the viral load result \>50 (or 400) copies/ml on therapy follows a previous result \ 50 (or 400) copies/ml reading in the absence of a change to any component of the art regimen. * cd4+ t cell count \<350 cells/µl throughout the 6 months preceding the screening visit with \<50 cells/µl increase in the last 12 months exclusion criteria: * receiving a cart regimen containing an integrase inhibitor * anticipated change of cart in the 24 weeks following randomisation * participating in study with an investigational compound or device within 30 days of signing informed consent * use of immune modulating therapies or immunosuppressive medications within 60 days prior to study entry. patients using inhaled or nasal steroids are not excluded * pregnant or breastfeeding woman * cow's milk allergy * concurrent treatment with phenobarbitol, phenytoin or rifampicin. * a known cause of impaired cd4+ t cell gain: for example, patients with splenomegaly or individuals whose current cart regimen contains both tenofovir and didanosine

Keywords: hiv antiretroviral therapy intensification suboptimal cd4+ t cell response virological suppression bovine colostrum raltegravir
early warning scores in pregnant woman

Conditions: Pregnancy Complications

Summary: our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section. this prospective study included 304 patients undergoing cesarean section at suleyman demirel university between april 2022 and april 2023. physiological parameters were assessed in all 304 pregnant women before the operation. maternal early warning scores, including modified early obstetric warning score (meows), maternal early warning score (mewc), and maternal early warning triggers (mewt), were calculated for each patient. patients triggering the system were classified as group 1 (risky patients), while those not triggering the system were classified as group 2 (risk-free patients).

Eligibility criteria:
inclusion criteria: * all patients who are pregnant and undergo cesarean section exclusion criteria: * none

Keywords: early warning scores meows mewc mewt pregnant women maternal morbidity
a study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of asc47 in healthy and obese subjects

Conditions: Chronic Weight Management

Summary: this will be a phase i, randomized, double-blind, placebo-controlled, single dose escalation study. this study will be conducted in three periods: the screening period, the treatment period, and the follow-up period. this study aims to evaluate the pharmacokinetics and target engagement of asc47 in healthy and obese subjects.


Eligibility criteria:
key inclusion criteria: * subject have provided informed consent before initiation of any study-specific procedures * healthy male subjects or female subjects, between 18 and 55 years of age (inclusive). * females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible. * in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ecg, vital signs measurements, and other screening procedures, eg. key exclusion criteria: * have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator. * have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders. * have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia. * have a history of febrile illness within 14 days prior to screening. * have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 years. * have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of investigational product.

Keywords: asc47
the association between sensory block level, oxygen therapy, and ori in varicose vein patients undergoing spinal anesthesia (ori: oxygen reserve index)

Conditions: Hyperoxia; Hypoxia

Summary: the assessment of peripheral capillary oxygen saturation (spo2) by pulse oximetry has become standard in perioperative care for the detection of hypoxaemia. the oxygen reserve index (ori) can provide an early warning of deteriorating oxygenation long before a change in spo2 occurs, reflect the response to oxygen administration, facilitate oxygen titration and prevent unwanted hyperoxia. the combination of ori with pulse oximetry can help to accurately adjust inhaled oxygen concentration and prevent hypo- and hyperoxaemia. in spinal anaesthesia, neuraxial blockade can cause paralysis of accessory respiratory muscles and theoretically lead to bronchospasm. therefore, in this study, the investigators planned to perform oxygen saturation monitoring using two modalities. the investigators wanted to investigate the correlation between ori, spo2, oxygen therapy and the degree of sensory block.

the assessment of peripheral capillary oxygen saturation (spo2) by pulse oximetry has become standard in perioperative care for the detection of hypoxaemia. the oxygen reserve index (ori) can provide an early warning of deteriorating oxygenation long before a change in spo2 occurs, reflect the response to oxygen administration, facilitate oxygen titration and prevent unwanted hyperoxia. the combination of ori with pulse oximetry can help to accurately adjust inhaled oxygen concentration and prevent hypo- and hyperoxaemia. in spinal anaesthesia, neuraxial blockade can cause paralysis of accessory respiratory muscles and theoretically lead to bronchospasm. the respiratory effects of neuraxial blockade up to mid-thoracic level are minimal in patients without lung disease. while the intercostal muscles may be paralysed by thoracic block, diaphragmatic function is preserved. therefore, in this study, the investigators planned to perform oxygen saturation monitoring using two modalities. the investigators wanted to investigate the correlation between ori, spo2, oxygen therapy and the degree of sensory block.

Eligibility criteria:
inclusion criteria: - asa i-ii exclusion criteria: * chronic obstructive pulmonary disease (copd) * smoking history of \>30 pack-years * cancer patients * interstitial lung disease patients * patients with body mass index (bmi) \>30 kg/m² * patient refusal of spinal anesthesia * refusal to participate in the study

Keywords: hyperoxia hypoxia oxygen therapy spinal anaesthesia
individualized blood pressure management in patients undergoing cardiac surgery

Conditions: Cardiac Surgery

Summary: this pilot randomized-controlled study will determine the feasibility of large study comparing individualized versus standard blood pressure (bp) management in patients undergoing cardiac surgery under cardiopulmonary bypass (cpb). our hypothesis is that maintaining higher bp levels based on preoperative measurements will reduce the incidence of major complications (composite outcome).

adequate hemodynamic control is a cornerstone in management in patients undergoing different types of surgery. among all perioperative risk factors, the association between perioperative hypotension and adverse clinical outcomes in noncardiac and cardiac surgery patients is well defined. numerous factors are responsible for development of perioperative hypotension. they include but not limited to perioperative use of renin-angiotensin-aldosterone system and calcium channel blockers, hypovolemia, hemodilution, bleeding and inflammatory response syndrome. to date, several evidence has been accumulated indicating that intraoperational hypertension can be hazardous. it was shown that even short durations (1 to 5 min) of an intraoperative mean arterial pressure \< 55 mmhg were associated with myocardial injuries and acute kidney injury (aki). results of recent large retrospective cohort study conducted in adult patients who underwent cardiac surgery requiring cpb showed that postoperative stroke was strongly associated with sustained mean arterial pressure of less than 64 mmhg during cardiopulmonary bypass. in patients undergoing cabg the overall incidence of combined cardiac and neurologic complications was significantly lower in the group where map during cpb was relatively high (80-110 mmhg) than in the low pressure group (map 50-60 mmhg) (p = 0.026). for each of the individual outcomes the trend favored the high pressure group. therefore, map may be an important intraoperative therapeutic hemodynamic target to reduce the incidence of complications in patients undergoing cpb.

Eligibility criteria:
inclusion criteria: * ≥18 years old * signed informed consent * elective cardiac surgery under cpb (cabg or valve surgery) exclusion criteria: * unstable coronary artery disease: recent (\ 70%) left main coronary artery stenosis * uncontrolled hypertension preoperatively (sbp \> 160 mm hg) * critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or intraaortic balloon pumping, preoperative severe acute renal failure (anuria or oliguria \<10ml/hr) * planned surgery on aorta * emergency surgery * pregnancy * current enrollment into another randomized controlled trial (in the last 30 days) * previous enrollment and randomization into current study * glomerular filtration rate ≤59 ml/min/1.73m2 (chronic kidney disease epidemiology collaboration (ckd-epi) equation)

Keywords: hypotension intraoperative blood pressure cardiopulmonary bypass myocardial infarction acute kidney injury
intensive unimanual (cimt) and bimanual training (habit) in children with hemiplegia

Conditions: Cerebral Palsy; Hemiplegia; Children

Summary: a randomized control trial examining the relationship between changes in hand function and brain plasticity following intensive therapy. two treatment approaches are used: constraint-induced movement therapy (cimt) or hand-arm bimanual intensive therapy (habit). the protocols have been developed at tc columbia university to be child friendly and draw upon our extensive experience with constraint-induced movement therapy in children with cerebral palsy. our center has been providing interventions camps for children with cerebral palsy since 1998. the interventions are performed in a 15 day day-camp setting with several children and at least one interventionist per child. the aim of the intervention is to improve the use of the affected hand and quality of overall movement in a fun, social setting. participation is free. please check out our website for more information: http://www.tc.edu/centers/cit/

constraint-induced movement therapy and bimanual training are motor-learning based approaches to engage children in fun activities. this study looks at what areas of the brain are responsible for recovery after intensive training. we are trying to understand how the brain responds to movement training and hope that in the future we can develop new treatments for hemiplegia based on what we learn about the brain in this study. to study the areas of the brain we will use magnetic resonance imaging (mri) to take pictures of the brain and transcranial magnetic stimulation (tms) to determine parts of the brain involved in using the hand. tms uses a brief magnetic field over the scalp by using a wand that looks like a figure 8. the wand can make brief magnetic fields over a series of spots on your child's head to activate the brain cells under the wand. non-invasive, single pulse tms will be used in this study, which is considered minimal risk and tolerable to children. if your child has a recurrent history of seizures after two years of age, he/she might not qualify.

Eligibility criteria:
inclusion criteria: * diagnosis of unilateral cerebral palsy exclusion criteria: * current medical illness unrelated to cp * seizure disorder * current use of medications know to lower the seizure threshold * metallic object(s) in body, other than dental fillings * pregnancy * claustrophobia

Keywords: pediatric habit cimt cerebral palsy hemiplegia children therapy
compound danshen dripping pill for diabetic microvascular angina

Conditions: Diabetic Microvascular Angina

Summary: to investigate the efficacy and safety of compound danshen dripping pill in patients with diabetic microvascular angina pectoris. long-term follow-up of 1 year will be performed to evaluate the effect of compound danshen dripping pill on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility criteria:
inclusion criteria: history of type 2 diabetes ≧5 years; repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; coronary normal or stenosis \<50%; ischemic depression in st segment during resting or exercise; coronary flow reserve (cfr) of the anterior descending coronary artery \< 2.0, or cfr ≧2.0 but acetylcholine activation test is positive; subjects or their guardians agreed to participate in this study. exclusion criteria: previous myocardial infarction or pci or cabg treatment; severe arrhythmia; refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm; familial hypercholesterolemia; takayasu arteritis, kawasaki disease or coronary artery malformation; pregnant or nursing, or having the intention to give birth within one year; hepatic or renal dysfunction; allergic to contrast agents or traditional chinese medicines; patients who participated in clinical research of other drugs within 3 months before being selected.
efficacy and safety of precut-emr for resecting of colonic polyp

Conditions: Colonic Polyps

Summary: this study was attempted to determine the efficacy and complication of precut emr comparing with convetional emr for resecting of 10 \~ 20 mm colon polyp through prospective, randomized controlled trial.

in general, a potential risk of advanced colorectal neoplasia is proportional with size. however, recent study report that occurence rate of advanced neoplasia in small polyp is 9 \~ 10 %. and, incidence of interval cancer after screening colonoscopy was reported as 10 \~ 27%. so we can suspect that complete resection of small polyp is important. previous study recommended that endoscopic submucosal dissection (esd) is a safe and effective procedure for treating colon polyp larger than 20 mm because of high complete resection rate and low recurrence rate. in contrast, endoscopic mucosal resection (emr) is more recommended for resecting colon polyp smaller than 20 mm because of technical ease and low rate of complication. however, complete resection rate of conventional emr is 60 \~ 70%. in case of incomplete resection, local recurrence rate is higher than complete resection. and in case of adenocarcinoma, specimen of piecemeal resection cannot be evaluated a depth of invasion and resection margin, and physician cannot decide a therapeutic plan. in precut-emr, mucosal resection is performed after pre-incision around a polyp. when precut emr of polyp \> 20 mm was performed in previous study, complete resection rate and en-bloc resection rate were higher and local recurrence rate was lower than conventional emr. but, there is no study of comparsion precut emr and conventional emr for resecting colon polyp \< 20 mm. this study was attempted to determine the efficacy and complication of precut emr comparing with convetional emr through prospective, randomized controlled trial.

Eligibility criteria:
inclusion criteria: * all patients older than 20 years old who had 10\~20 mm colon polyp and agreed to participate a research exclusion criteria: * medication history of antiplatelet agent within a week of procedure. * medical history of coagulopathy * more than american society of anesthesiology class iii * medical history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel disease, severe inflammatory disease. * pedunculated polyp and polyp with malignant potential.

Keywords: colonic polyps colonoscopy
the features behind the beneficial effects of interval-walking

Conditions: Diabetes Mellitus, Type 2

Summary: a single bout of interval-walking (iw) exercise is superior to energy-expenditure and time-duration matched continuous walking (cw) exercise upon improving glycemic control. the reason iw is superior is unknown. this study will look into whether it is the larger peak intensity during iw or if it is the alternating exercise pattern that is responsible for the larger improvements seen. subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. trials will be identical except the following interventions: 1. one hour of rest (con) 2. one hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; iw3) 3. one hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1 min of slow walking; iw1). after the interventions subjects will undergo a standardized mixed meal tolerance test, with consecutive measurements of blood glucose, insulin and c-peptide.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * body mass index \> 18 but \< 40 m2/kg * agreement to pause antidiabetic medication from 2 days before to after each trial exclusion criteria: * pregnancy * smoking * use of exogenous insulin * contraindication to increased levels of physical activity * evidence of thyroid, liver, lung, heart or kidney disease

Keywords: glycemic control exercise
knowledge of vital pulp therapy in permanent teeth after educational programme: a before and after study

Conditions: Pulp Disease, Dental; Knowledge

Summary: evaluating the extent of knowledge of vital pulp therapy in permanent dentition among a group of dental interns in egypt after educational programme.

evaluating the extent of knowledge of vital pulp therapy in permanent dentition using a survey among a group of dental interns in egypt after educational programme.

Eligibility criteria:
inclusion criteria: * dental interns enrolled in the pediatric dentistry department, cairo university . * candidates who are willing to participate exclusion criteria: * responses with incomplete information