Kornimate/medical-research-clean huggingface dataset:
the effect of the usage of squeezable vs standard bottles after cleft palate surgery on the feeding process of infants

Conditions: Bottle Feeding

Summary: this study aims to examine the effect of the usage of squeezable bottles and standard bottles on the feeding process of infants with clp after cleft palate surgery.

infants with cleft palate commonly have feeding difficulties due to incomplete development of orofacial structures. it has been reported that 67% of infants with cleft palate have feeding difficulties and 86% cannot be breastfed. feeding difficulties in an infants with a cleft palate can lead to poor weight gain and growth retardation. therefore, it is essential to provide nutritional interventions for these infants. this study was designed as a randomized controlled prospective study and was planned to be carried out in the surgical inpatient wards of a private hospital in istanbul. following the diagnosis of cleft lip and palate given to their infants, the families of infants with clp apply to aesthetic, plastic and reconstructive surgery department. in conclusion of the consultations performed in polyclinics, surgery dates are scheduled by the specialist and hospitalization is performed on surgery service ward. operations of the patients take approximately 3 to 4 hours. following the operation, for follow-up purposes the patients are taken to recovery unit and are observed for 30 to 45 minutes before infants get transferred to surgical service. following the completion of patients' observations in surgical service and their transition to full oral feeding, the patients are planned for discharge. the infants continue to be provided with hydration by intravenous infusion until their complete transition to full oral feeding. i̇nfants with clp are provided with different nutrition methods before and after surgery. since the literature also lacks a single or appropriate method that can remove nutrition issues of the babies with clp, the same nutrition protocol is maintained with an approach in context of resuming the on-going nutrition method after surgery, just like the method previously used before the surgery. in this study, the patients who use standard bottle before surgery will be included to control group, those who use squeezable bottle will be included to experimental group and participants both will be fed with same methods after surgery.

Eligibility criteria:
inclusion criteria: * infants between ≥ 6 to 12 ≤ months, * infants with lip, cleft palate and isolated cleft palate anomaly, * infants who are being fed using squeezable bottle or standard bottle, * infants not having any congenital anomalies or chronic diseases other than clp, * infants with clp who will undergo clp surgery, * infants who will undergo cleft palate surgery exclusion criteria: * infants having congenital anomalies or chronic diseases apart from clp * infants who are being fed with a different method rather than using squeezable nipple bottle or standard bottle.

Keywords: infant cleft lip and palate feeding
quality of life and treatment satisfaction in β-thalassemia patients receiving deferasirox

Conditions: β-thalassemia

Summary: regular blood transfusions are essential for the management of haematological conditions such as β-thalassemia major. as a result, however, patients with these conditions are susceptible to the development of transfusion-dependent iron overload (hemosiderosis or secondary iron overload

in the absence of a naturally occurring physiological mechanism for the removal of excess iron in the body, life-long treatment and adherence to iron chelation therapy (ict) are necessary to prevent the morbidity and mortality that may result if excess iron is allowed to . deferasirox (dfo),is the oldest available form of ict used by patients with transfusion-dependent disorders. improvements in ict administration convenience and tolerability are expected to improve patient's satisfaction with ict and health related quality of life (hrqol), thus promoting adherence to ict regimens and potentially reducing iron overload-related morbidity/mortality and associated healthcare costs

Eligibility criteria:
inclusion criteria: 1 - age more than 16 years 2-transfusion related iron over load (serum ferritin more than 1000 ng/ml) 3-patients on oral iron chelation (deferasirox ) for one year or more exclusion 1. primary haemochromatosis 2. thalassemia minor patients 3. preseance of systemic disease that prevent patient from treatment ,
chronic thalidomide administration in patients undergoing chemoembolization for unresectable hepatocellular cancer

Conditions: Liver Cancer

Summary: this is a clinical trial to test the safety and efficacy of the drug thalidomide in combination with a procedure called chemoembolization in patients with inoperable liver cancer. chemoembolization is the process by which chemotherapy is instilled directly into the blood vessels feeding the tumor, so that the blood vessels feeding the tumor may be blocked. chemoembolization consists of two separate procedures. it will be done by infusing chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by infusing collagen to cut off the blood supply to the tumor. a catheter will be inserted at various times to allow for these infusions. the objectives are to investigate the feasibility and potential activity of chronic administration of thalidomide in patients with unresectable hepatocellular cancer who receive chemoembolization to predominant tumor masses. the toxicity of thalidomide in these patients will be evaluated. overall safety will also be assessed. serum levels of angiogenic cytokines such as vegf, bfgf, and tnf-a, that are believed to have a role in hepatocellular carcinoma, will be collected.


Eligibility criteria:
inclusion criteria: * patients with unresectable hepatocellular carcinoma. * mri of liver must show discrete tumor nodules. lesions on angiography must be hypervascular. * patient must have the following minimum labs: anc\> 1200/mm3; hemoglobin \> 8 mg/dl; platelets \> 50,000 mm3; hepatic transaminases \< 5x normal; bilirubin \< 3.0 mg/dl; and creatinine \< 1.5 mg/dl. * ecog performance status \> 2. * no history of prior chemotherapy or biologic therapy for hepatocellular carcinoma. * no other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix. * patients must not be pregnant or lactating. * sexually active men and women of childbearing age must use adequate contraception. all patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide
evaluation of the fluorescent green of indocyanine in the detection of sentinel lymph node in endometrial cancer

Conditions: Cancer of the Endometrium

Summary: selective lymphadenectomy sentinel (lss). this technique is already well established in breast cancer and melanoma and more recently in vulvar and cervical cancer. compared to lymphadenectomy, it has several theoretical advantages: * this is a sensitive technique with a detection rate of\> 90% and a false negative rate of \<5%. * the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin antibodies, serial sections) are more sensitive than the standard histological analysis of lymphadenectomy, which allows an improvement in the detection of metastases (micro-metastases, isolated tumor cells). in the senti-endo study, it was possible to detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in 15% of intermediate-risk patients. * it avoids short-term and long-term operative and post-operative morbidity of lymphadenectomy. early studies of lss in endometrial cancer demonstrated superior efficacy of the colorimetric method coupled with the technetium 99m isotopic method with an overall detection rate of 78% \[95% ci: 73-84\]. the fluorescent green of indocyanine appears to give better results with an overall detection rate of 94% and a bilateral detection rate of 80%. it seemed useful to take stock of this technique using this new dye.


Eligibility criteria:
inclusion criteria: * major patient, without guardianship or curatorship. * patient with endometrial cancer confirmed by biopsy. * invasive cancer stage figo i at intermediate risk and high risk and ii according to the figo classification. * need for surgical staging. * performing an endovaginal ultrasound or a pelvic mri in preoperative, if contraindication to mri, performing a ct scan. * subject affiliated to a social health insurance scheme. * speaking and reading french. * subject having dated and signed informed consent. exclusion criteria: * pregnancy in progress. * figo iii and iv stage diagnosed preoperatively or intraoperatively. * cure or pre-surgery that may alter the uterine lymphatic drainage (conization, myomectomy). * mri or ct scan of suspected lymph nodes.
prevalence of latent tuberculosis (tb) infection diagnosed by interferon-gamma release assay and tuberculin skin tests in patients with old healed tb

Conditions: Tuberculosis

Summary: we easily regard nodules and fibrosis in upper lobes of lung as tb sequelae. the aim of this study is to confirm the prevalence of latent tb infection diagnosed by interferon-gamma release assay and tuberculin skin tests in patients with old healed tb.


Eligibility criteria:
inclusion criteria: * age \> 20 years * patients with tb sequelae in their cxr exclusion criteria: * patients on immune-suppressants

Keywords: people who have fibrosis or nodules in their upper lobe of the lung
stent for life observatory

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Summary: observatory multicenter, prospective, to support the acute phase of acute coronary syndromes with st segment elevation st (myocardial infarction).


Eligibility criteria:
inclusion criteria: * any patient with a myocardial infarction less than 48 hours during the november 2010 is eligible and should be considered for inclusion in the study. * every patient who agreed to participate in the study exclusion criteria: * patients with myocardial infarction after a coronary revascularization, or after cardiac surgery or extra heartbeat. * patient denying that his personal data are subject to treatment automated
broad spectrum hpv (human papillomavirus) vaccine in 16 to 26 year old women (v505-001)

Conditions: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection

Summary: the purpose of this study is to evaluate the safety and immunogenicity of v505 in comparison to gardasil (tm)


Eligibility criteria:
inclusion criteria: * female between 16 to 26 years old * has never had pap testing or have only had normal pap test results * lifetime history of 0 to 4 sexual partners exclusion criteria: * history of an abnormal cervical biopsy result; history of a positive test for hpv; history of external genital/vaginal warts; currently a user of any illegal drugs or an alcohol abuser * history of severe allergic reaction that required medical attention * are pregnant * received a marketed hpv vaccine * currently enrolled in a clinical trial * currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)
further study of afgen1 clinical performance

Conditions: Atrial Fibrillation; Afib; ECG

Summary: afgen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ecg is needed to identify episodes of afib. the purpose of this study is to establish further evidence for the clinical performance of afgen1 on human participants.

the primary purpose of this study is to demonstrate the ecg signal acquired by the afgen1 device is of adequate quality and is suitable to support its intended use for the detection of afib. this will be evaluated by comparing the ecg data acquired by afgen1 to that acquired by an fda cleared 12-lead ecg device using a bland-altman analysis of the r-r intervals and r amplitude measurements and eigenvector magnitudes derived from principal component analyses of simultaneously captured waveforms measured by both devices by both devices. the ecg waveforms from both devices will also be adjudicated by 2 independent cardiologists. the study will also seek to demonstrate that there is no degradation in the quality of the ecg signal it acquires when the device is placed in an anticipated misplacement position to that directed by the instructions for use of the device. finally the study will seek to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ansi aami ec12-1 . another purpose of the study is to collect extended 5 minute ecg recordings by the subject periodically triggering the device while wearing the device for 7 (+3) days. this data will be used for product development purposes.

Eligibility criteria:
inclusion criteria: 1. 18+ willing to sign the consent form exclusion criteria: 1. implanted pacemakers 2. implanted cardioverter defibrillators 3. implanted cardiac resynchronization devices 4. potential life-threatening arrythmias 5. physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study 6. open wounds, abraded or irritated skin at the application site 7. planned to undergo a mri during the course of the study duration 8. known or suspected to be pregnant 9. student or employee of trivirum

Keywords: ecg signal quality
efficacy and safety of pramipexole compared to placebo in the treatment of restless legs syndrome (rls)

Conditions: Restless Legs Syndrome

Summary: a 12 week clinical trial was conducted in the united states in order to compare pramipexole (mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.


Eligibility criteria:
potential impact of neuroimmune and autophagic alterations on the progression and severity of human atherosclerotic process

Conditions: Carotid Atherosclerosis

Summary: the hypothesis of this study is that neural regulations of the atherosclerotic plaque, identified in the murine model of atherosclerosis, could also exist in human pathology. the dysregulation status of the autonomic nervous system is typical of several cardiovascular diseases, but the role it exerts in the modulation of important mechanisms at the basis of the atherosclerotic process progression has not been investigated yet. the main aim of this study will be to investigate, in the atherosclerotic plaque, the alterations of inflammatory and immune processes, the neural modulations and the presence of dysregulations of the autophagic process. the investigators will also associate the potential presence of neural modulations of the plaque to its stability/instability, from a clinical-translational point of view. finally, the investigators aim at providing a solid basis for the development of novel therapeutic strategies, which could reduce the elevated health and welfare costs for the clinical management of cardiovascular pathologies such as atherosclerosis.


Eligibility criteria:
inclusion criteria: * age ≥ 45 and ≤ 90 years; * patients with severe (70-99%) carotid stenosis, diagnosed with color doppler echography or angio-mri or angiography; * written informed consent. exclusion criteria: * carotid stenosis \<70% at carotid bifurcation or diagnosed with color doppler echography or angio-mri or angiography; * severe neoplasia; * participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.

Keywords: atherosclerotic plaque autonomic nervous system immune system autophagy
gsk372475 bioequivalence study

Conditions: Healthy Subjects; Depressive Disorder

Summary: the study is to show the new salt formulation of gsk372475 is equivalent to the old salt formulation of gsk372475.


Eligibility criteria:
inclusion criteria: * healthy males/females aged 18-45 years * non-smokers * bmi 19-30 kg.m2 * qtc\<450msec exclusion criteria: * use of oral contraception * positive breath alcohol and drug screen * regular alcohol consumption * current psychiatric illness or within 1 year. * history of gi, hepatic or renal disease * uncontrolled hypertension

Keywords: healthy bioequivalence
living in a precarious situation with an autistic child: what are the issues at stake for support in care

Conditions: Autistic Disorder

Summary: study the specificities of families in a precarious situation with a child with autism spectrum disorders (asd) in terms of housing, in order to better support them in the various social spaces and improve collaboration between professionals and parents

identify the living conditions related to the housing of children with autism spectrum disorders (asd) treated at the léo kanner center (clk), psychopathology department of the saint-étienne university hospital. the aim is to describe through the trajectories of children with asd and their families, their living conditions, and through interviews with professionals who support them, how the specificities related to precarious situations are identified and taken into account. a qualitative survey, carried out by sociological interviews with families whose children are followed at the léo kanner center (clk) and the professionals who care for them, would make it possible to collect data on the development of a young child with autism in his home and more generally in his habitat. the purpose of this study is to study the specificities of families in a precarious situation with a child with autism spectrum disorders (asd) in terms of housing, in order to better support them in different social spaces and improve collaboration between professionals and parents. the project aims to bring children with autism spectrum disorders (asd) into a dynamic of access to human rights. he suggests three levers to achieve this: rely on a precise inventory of needs; work towards a transformation of representations; streamline access to healthcare and common law services.

Eligibility criteria:
inclusion criteria: * families having their child followed in the child psychiatry service of the léo kanner center (clk), * children followed for autism spectrum disorders (asd), * families who received informed information about the study and who co-signed a consent to participate in the study with the investigator. exclusion criteria: * opinion of the child's referring physician contraindicating inclusion * refusal of one of the legal guardians to participate in the study

Keywords: precarious support care professional interview family interview
influence of an anti-gravity treadmill on functional outcome in non-operatively treated pelvic fractures - a pilot study

Conditions: Weight-bearing; Rehabilitation

Summary: non-operative treatment of pelvic fractures is possible. immobilisation implies different adjustment processes. patients with pelvic ring fractures and partial weight bearing have to obtain theses. the aim of this pilot study was to prove the additional effect of the anti-gravity treadmill in patients with non-operatively treated pelvic fractures.

we prospectively included patients with non-operatively treated pelvic fractures as the intervention group (ig) and healthy volunteers of different age, sex and body mass index (bmi) as the reference group (rg). patients of the ig participated in a training session every three days with an anti-gravity treadmill (picture 1, alterg®, www.alterg.com) for a total of 40 days in addition to physiotherapy, lymph drainage massage and manual therapy. patients were evaluated on three successive dates: baseline (s1), after mobilization without crutches with full weight-bearing (20 days, s2) and after 40 days (s3)

Eligibility criteria:
inclusion criteria: * patients with non-operatively treated pelvic fractures exclusion criteria: * pregnancy, neuromuscular disorders, preexisting muscle atrophy
efficacy and safety study of mci-196 in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the objective of this study is to evaluate the efficacy of mci-196 in patients with type 2 diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. and in addition, the changes in lipid-related parameters are examined.


Eligibility criteria:
inclusion criteria: * patients whose fasting blood glucose levels during the observation period are between 130mg/dl and 200mg/dl. * patients whose hba1c is 7.0% or above during the observation period. exclusion criteria: * patients with serious cardiac, hepatic or renal complications. * patients with serious diabetic complications. * patients with complete biliary obstruction or ileus. * pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.

Keywords: type 2 diabetes anion-exchange resin
efficacy and safety of inotersen in familial amyloid polyneuropathy

Conditions: FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis

Summary: the purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with familial amyloid polyneuropathy (fap).

fap is a rare, hereditary disease caused by mutations in the transthyretin (ttr) protein. ttr is made by the liver and secreted into the blood. ttr mutations cause it to misfold and deposit in multiple organs causing fap. inotersen (also known as isis 420915) is an antisense drug that was designed to decrease the amount of mutant and normal ttr made by the liver. it is predicted that decreasing the amount of ttr protein would result in a decrease in the formation of ttr deposits, and thus slow or stop disease progression. the purpose of this study is to determine if inotersen can slow or stop the nerve damage caused by ttr deposits. this study will enroll late stage 1 and early stage 2 fap participants. participants will receive either inotersen or placebo for 65 weeks.

Eligibility criteria:
inclusion criteria: * stage 1 and stage 2 fap participants with the following: 1. nis score within protocol criteria 2. documented transthyretin variant by genotyping 3. documented amyloid deposit by biopsy * females of child-bearing potential must use appropriate contraception and be non-pregnant and non-lactating. males engaging in relations of child-bearing potential are to use appropriate contraception exclusion criteria: * low retinol level at screen * karnofsky performance status ≤50 * poor renal function * known type 1 or type 2 diabetes mellitus * other causes of sensorimotor or autonomic neuropathy (for example, autoimmune disease) * if previously treated with vyndaqel®, will need to have discontinued treatment for 2 weeks prior to study day 1. if previously treated with diflunisal, will need to have discontinued treatment for 3 days prior to study day 1 * previous treatment with any oligonucleotide or sirna within 12 months of screening * prior liver transplant or anticipated liver transplant within 1 year of screening * new york heart association (nyha) functional classification of ≥3 * acute coronary syndrome or major surgery within 3 months of screening * known primary or leptomeningeal amyloidosis * anticipated survival less than 2 years * any other conditions in the opinion of the investigator which interfere with the participant participating in or completing the study

Keywords: fap familial amyloid polyneuropathy ttr transthyretin amyloidosis