Kornimate/medical-research-clean huggingface dataset:
noninvasive prenatal diagnosis: using fetal cells from maternal blood

Conditions: Chromosome Disorders

Summary: this purpose of this study is to develop noninvasive methods of prenatal diagnosis. fetal cells can be found in maternal blood. this study is designed to isolate these fetal cells from a sample of the pregnant woman's blood and use those cells to test for fetal chromosome abnormalities.

fetal cells can be recovered from maternal blood, suggesting that noninvasive prenatal diagnosis is possible. however, recovery and analysis of fetal cells from maternal blood is complex and sensitivity is low because of the rarity of these cells in the maternal circulation. this study was designed to develop a noninvasive, safe, relatively inexpensive, and accurate technique for the prenatal diagnosis of genetic disorders in the first trimester. the study included a systematic evaluation of variables involved in separating and enriching fetal cells isolated from maternal blood through fluorescence activated cell sorting (facs) and magnetic activated cell sorting (macs) followed by fluorescent in situ hybridization (fish) with chromosome-specific dna probes. the results of these tests were compared to those obtained from amniocentesis or chorionic villus sampling (cvs) on the same women. no clinical decision was made based on the results of the experimental diagnostic/screening technique. even if the biological risks associated with reproductive genetic technologies are reduced, it is possible that other risks (or benefits) are associated with the procedures. some of these factors may be: increased or diminished maternal anxiety, increased adjustment or maladaption to the pregnancy, increased feelings of coercion to undertake the procedure, and increased or decreased comfort with reproductive decision-making. the study also assessed whether there were any nonbiological or psychological effects on the women undergoing prenatal diagnostic testing. after the first five years of the study, preliminary analysis of the data showed that the sensitivity of aneuploidy detection using fetal cell analysis from maternal blood is comparable to single marker prenatal serum screening, but technological advances are needed before fetal cell analysis has clinical application as part of a multiple maker method for noninvasive prenatal screening. target cell recovery and fetal cell detection were better using macs than with facs. the detection rate of finding at least one aneuploid cell in cases of fetal aneuploidy was 74.4%.

Eligibility criteria:
inclusion criteria * pregnant * abnormal serum marker profile (alpha-fetoprotein, hcg, estriol) * ultrasound abnormalities of the fetus * any high risk indicator for aneuploidy as determined by physician

Keywords: fetal cells prenatal diagnosis cytogenetic disorders chromosomal disorders single gene mutation detection abnormal serum marker profile fluorescence activated cell sorting (facs) magnetic activated cell sorting (macs) fluorescence in situ hybridization (fish) chromosomal disorders of the fetus single gene defects of the fetus
a clinical study on efficacy & safety profile of propionyl-l-carnitine tablets for peripheral arterial diseases

Conditions: Peripheral Arterial Disease

Summary: the main objective of this study is to evaluate the effectiveness and safety of the propionyl-l-carnitine hydrochloride tablets among chinese population in comparison with the placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with oral supplementation of 2g daily for a 4 months continuous administration.

this is a randomized, multi-centre, double-blind and placebo controlled clinical study. propionyl-l-carnitine (plc) is a kind of natural derivative of l-carnitine (lc) and is produced in the body and concentrated by 90% in the skeletal muscle and myocardium via an enzyme-mediated reaction involving propionyl-coa and lc. for oral adminsitration, plc shows that the decrease of the leg muscle carnitine of the pad patient appears to correlate with poor exercise performance. it has recently been shown that the severity of the impairment in walking distance is correlated with the impairment in carntine metabolism at the muscle level. 2g daily of plc supplementation can significantly improve the walking ability in patients with ic with a maximum walking capacity between 50 and 250 meters on the treadmill.

Eligibility criteria:
inclusion criteria: * the variability between the two standardized claudication tests during the wash-out period must be \<20%, as assessed by the formular: (highest mwd-lowest mwd)/(lowest mwdxx100%) * at the last visit during the wash-out period, the abi at rest must be ,0.9 exclusion criteria: * with rest pain, ulceration, and/or gangrene * pad of a non-atherosclerotic nature * aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 6 months; any above ankle level amputation. any type of major surgery during the last three months. * except pad, any concomitant disease that can limit patients' performance in the treadmill exercise. * with angina (at rest or activity) or any symptom which is sufficiently severe to discontinue the treadmill exercises. * myocardial infarction within 6 months * severe cerebral dysfunction * type i diabetes (stable type ii diabetes can also be included) * alcohol or drug abused history within 3 months * medium or severe anaemia (hb,90g/l) * platelets \<100 x 10 9/l * bleeding diathesis * renal insufficiency or hepatic function laboratory test result\>1.5 normal value * treatment with lc or carnitien derivatives in the past 3 months * pregnancy, lactation, fertility without adequate protest against pregnancy * reject to sign the informed consent form

Keywords: plc for treatment of peripheral arterial diseases
dialysate sodium concentration and blood pressure in chronic hemodialysis patients

Conditions: Hypertension

Summary: while hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. it is associated with higher cardiovascular morbidity and mortality in this group of patients. altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management. however, the ideal dialysate sodium concentration remains a topic for discussion. randomised and prospective single dialysis centre study is presented. the participants are randomly divided into 3 groups and will go through 3 periods of 2 months. a "low-to-high" dialysate sodium concentration group will start the study with 138 mmol/l in the first period, continue with 140 mmol/l in the second period and finish with 142 mmol/l. in the "high-to-low" group, the participants will go through the opposite design (reduction from 142 mmol/l to 138 mmol/l over 3 periods). one group will continue with 140 mmol/l throughout the study. systolic and diastolic bp values before and after dialysis sessions, interdialytic weight gain, ultrafiltration, serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * patients with end-stage renal disease hemodialysis for at least 3 months exclusion criteria: * non-cooperation * active cancer * hospitalization during the course of the study
non-vaccination factors against hepatitis b virus in drug users

Conditions: Adult Patients Drug Users; Substituted / Weaned or Not

Summary: hepatitis b is one of the major public health problems in the world. according to world health organization (who) data, about 2 billion people have been in contact with the hepatitis b virus (hbv), and 257 million have chronic hbv infection. although france is a low endemic country, with just over 280,000 people with chronic infection, hepatitis b remains a public health problem due to its morbidity and mortality. drug users are a population at risk by their consumption practices (injection or sniffing), but also by other high-risk behaviours, particularly sexual behaviours. prevention therefore involves securing consumption practices (sterile and single-use equipment) and protection of sexual intercourse, but also by vaccination (protecting more than 90%). since 1982, has has recommended to systematically vaccinate drug users. however, according to the marmottan study published in 2003, immunization coverage among drug addicts was already insufficient in 1999 (45.3%) and decreased again in 2000 and 2001 (15.6 and 21.7%). this decrease can be explained by the controversy around the potential link, now refuted, between vaccine against hbv and demyelination, which has stopped the mass vaccination campaign launched by the french health authorities in 1995. a study conducted between 2009 and 2012 on injecting drug users in alsace, estimated vaccination coverage at 28%. the hypothesize is that despite the recommendations in a population at high risk of contamination, and a balance of benefits and risks in favor of vaccination, vaccination coverage against the hepatitis b virus remains insufficient among drug users because of poor vaccination acquaintance, and hepatitis b in general, in this population. principal objective of this study is to identify non-vaccination factors against hepatitis b virus among drug users consulting at the croix-rousse csapa.


Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years) * patients with an addiction with product, substituted / weaned or not * patients consulting at the csapa of the croix-rousse hospital exclusion criteria: * patients with an addiction without a product * patients who have never snorted or injected psychoactive product * patients protected by the law * patient refusing to participate to the study
detection of clinical-functional changes following exercise therapy and neuroscience education in institutionalised and community-dwelling older adults diagnosed with sarcopenia

Conditions: Resistance Training; Aged; Nursing Homes; Sarcopenia

Summary: nowadays, ageing is an important aspect to consider from a social, healthcare and economic perspective. for this reason, it is necessary to focus on all the elements which can help staying healthy and active in old age. physical activity and exercise are one of these, and more specifically resistance training.

recently, it is been evidenced that physical activity and exercise are an important coping strategy to get what is called "active ageing". however, it is still under discussion some key aspect, like the training type or the optimal dose, among others. there is a modality of resistance training which it has not been sufficiently studied in old age population: the high intensity interval training. it has been demonstrated in other population (like cardiovascular patients or cancer survivor patients) that this modality of training can improve a lots their physical condition. furthermore, it produces a higher adhesion to the training program, because it does not require so long time like another type of training. for this reason, the aim of this investigation is to assess how implement this modality of training on elderly people with sarcopenia.

Eligibility criteria:
inclusion criteria: * older adults aged 55 years or older. * living in an institutionalised setting or community-dwelling older adults living in the province of badajoz or cáceres. * voluntarily participating in the study. * who had a diagnosis of sarcopenia/fragility in the last year. * submit a prescription from the centre's medical practitioner to participate in the study as physiotherapy intervention would be appropriate and potentially beneficial. exclusion criteria: * patients with cognitive impairment (score ≥24 in the validated spanish version for general older adults of the mini-mental status examination). * unable to tolerate moderate physical activity due to cardiovascular or respiratory disease. * with balance disorders other than those caused by ageing such as dizziness or vestibular disorders requiring the ingestion of medication with a potential effect on balance, as well as balance disorders secondary to the ingestion of any medication or other medical causes. * at high risk of falling (≥ 51 points on the morse scale). * at high risk of falling (≥ 51 points on the morse scale). * at high risk of falling (≥ 51 points on the morse scale).
an observational study of patients with chronic hepatitis b (chb) infection

Conditions: Hepatitis B; Hepatitis; Liver Diseases

Summary: the target-hbv study engages an observational research design to conduct a comprehensive review of outcomes for patients with chb infection. the initial phase of the study that enrolled patients treated with tenofovir alafenamide (taf) was successfully completed. the current protocol (amendment 1) describes the second phase of the study that will engage research activities for patients being managed for chb in usual clinical practice in the us and canada. the study addresses important clinical questions regarding the management of chb by collecting and analyzing data from patients at academic and community medical centers. target-hbv creates a robust database of real-world data regarding the natural history, management, and health outcomes related to antiviral treatments used in clinical practice.


Eligibility criteria:
inclusion 1. male or female patients, age ≥18 years 2. being managed for chronic hepatitis b (chb), including patients who have achieved functional cure and patients with concurrent delta hepatitis exclusion 1. inability to provide written informed consent 2. known history of human immunodeficiency virus (hiv) 3. history of liver transplantation
respiratory mechanics assessment at different head of the bed elevations in mechanically ventilated patients

Conditions: Respiratory Failure; Pulmonary Disease

Summary: the effects of different degrees of head-of-bed elevation on respiratory mechanics are poorly explored in the literature, and no study has investigated such effects using electrical impedance tomography, esophageal and gastric balloons to identify the ideal angle for optimizing respiratory mechanics. the hypothesis is that there is a optimal degree for the respiratory mechanics.

respiratory mechanics and regional ventilation will be monitored using electrical impedance tomography (enlight 2100, timpel medical®, brazil) . esophageal and gastric pressures will be obtained through esophageal and gastric balloon catheters (nutrivent®) (validation concerning to modified baydur maneuver - slope delta esophageal pressure/delta airway pressure (0,8-1,2). we are using the hardware pneumodrive (biônica, recife, brazil) to record and store the esophageal, gastric and airway pressures, these data will be analyzed using labview 7.1 (pneumobench). initially, patients will be positioned at 0 degrees of head-of-bed elevation, and after stabilization of the plethysmogram, data from electrical impedance tomography, hemodynamics, and arterial blood gas will be collected (arterial blood will be drawn by a nurse or physician). sequentially and in the same manner, the bed will be adjusted to 10, 20, 30, and 40 degrees (the same data will be collected, except for the arterial blood sample, which will only be collected at the 40-degree elevation). then, an alveolar recruitment maneuver will be performed, followed by a peep titration with 10-degree of head-of-bed elevation.

Eligibility criteria:
inclusion criteria: * patients under invasive mechanical ventilation, intubated due to respiratory failure exclusion criteria: * hemodynamics instability, contraindication for monitoring with esophageal and gastric catheters, and electrical impedance tomography, no authorization of medical team of the intensive care unit, and contraindication for lung recruitment maneuver

Keywords: respiratory failure pulmonary disease intensive care respiratory mechanics
endurance exercise & virtual reality for optimizing cortical excitability and neuroplasticity in pd

Conditions: Parkinson Disease

Summary: this study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (vr)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with parkinson's disease (pd). this study will utilize two groups - one group will receive the exercise and vr, while the other group will receive stretching exercise and vr over eight weeks. the study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment).

this study will enroll individuals diagnosed with parkinson's disease who will be randomly assigned to 2 groups: 1) high intensity endurance exercise and virtual reality (experimental) or 2) stretching and virtual reality (control) for eight weeks (three sessions, thrice weekly). outcomes will include balance and gait measures, blood-based biomarkers, neuroplasticity measures (assessed by transcranial magnetic stimulation), spinal reflex excitability (measured by h reflex) and quality of life.

Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic pd (ages 18 -85) in hoehn and yahr stages 2 - 3. 2. subjects need to demonstrate a score of equal to or greater than 23 on the mini mental state examination. 3. subjects who have a score of ≤21.5 on the mini balance evaluations systems test (minibestest). exclusion criteria: 1. subjects with a history of other neurological diseases (i.e., stroke, multiple sclerosis). 2. subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis, severe arthritis affecting their lower extremity joints. 3. subjects with a history of pd-specific surgical procedures such as deep brain stimulation etc. 4. subjects with a history of head injury. 5. subjects with a history of seizures or epilepsy. 6. subjects who are currently pregnant. 7. individuals who use of medications that could alter corticomotor excitability or increase risk of seizure. 8. individuals with skull abnormalities, fractures or unexplained, recurring headaches.

Keywords: aerobic exercise virtual reality rehabilitation balance neurophysiology
melatonin cream against acute radiation dermatitis in patients with early breast cancer

Conditions: Radiation Dermatitis; Radiation Dermatitis Acute; Breast Cancer

Summary: the aim of the present randomized double-blinded placebo-controlled clinical trial is to investigate if melatonin can protect against acute radiation dermatitis in patients with early breast cancer receiving radiation therapy, and whether this has an impact on the patients' quality of life.

the study will be a randomized, placebo-controlled, double-blinded clinical pivotal trial. patients will be allocated in a ratio of 1:1 to the melatonin or placebo group. patients will be stratified according to the type of surgery (lumpectomy or mastectomy). randomization will be performed in blocks of randomized sizes. the study will be performed in the department of oncology, rigshospitalet, denmark. eligible patients with early breast cancer receive adjuvant radiation therapy over 15 to 30 daily fractions (5 fractions per week) of ionizing megavoltage photon radiation to a total of 40 - 60 gy within 3-5 weeks according to the guidelines of the danish breast cancer cooperative group. in this study, the patients will administer approximately 1 g of cream containing melatonin (25 mg/g) and dimethyl sulfoxide (dmso) (150 mg/g) or a placebo cream topically twice daily on the irradiated skin area. the patients are scheduled to do this every day from the first to the last fraction of radiation therapy, including the days where they do not receive radiation therapy. the investigators have chosen placebo as the comparator due to it being safe and the most reasonable method of evaluating any effects of the intervention. on days where the patients receive radiation, the melatonin/dmso or placebo cream will be applied no less than 2 hours prior to radiation. throughout the study, the patients will meet with an investigator once weekly who will monitor compliance and assess outcomes.

Eligibility criteria:
inclusion criteria: * diagnosed with early breast cancer * over 49 years old * have had radical tumor resection surgery * follows treatment regimens and follow-up at rigshospitalet * written informed consent after written and verbal information exclusion criteria: * inability to understand danish, written or spoken * mental illness (defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance) * previous therapy with ionizing radiation in the thoracic or neck area * use of bolus for radiation therapy (a bolus is a material which has dose absorption properties equivalent to tissue. it is placed on the irradiated area to alter dosing or target of the radiation therapy) * pregnancy

Keywords: melatonin
three way interaction between gabapentin, duloxetine, and donepezil in patients with diabetic neuropathy

Conditions: Diabetic Neuropathic Pain; Chronic Low Back Pain

Summary: the purpose of the study is to determine whether the combination of the the three drugs gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic neuropathy or patients with failed low back syndrome (chronic back pain).

neuropathic pain is a complex and likely heterogeneous disorder, and we recognize that clinically useful agents such as opioids, gabapentin, and antidepressants may be effective precisely because they have multiple mechanisms of action at multiple sites. this study, however, will not only provide important mechanistic information regarding one cascade which can be manipulated for analgesia, but will also provide much needed systematic and practical guidance for multi-drug therapy in patients with neuropathic pain. this study in patients with diabetic neuropathic pain and patients with failed low back syndrome, culminate in a quantitative description of interactions between activators of descending noradrenergic activity, norepinephrine transporter inhibitors, and cholinesterase inhibitors to exploit the plasticity of analgesia in chronic pain states. we will focus on practical applications, using clinically approved drugs, including gabapentin (neurontin®) to activate noradrenergic activity, duloxetine (cymbalta®) to inhibit the norepinephrine transporter, and donepezil (aricept®), approved for the treatment of alzheimer's dementia, but not previously tested to treat neuropathic pain, to inhibit cholinesterase. after the baseline measurements and physical examination patients will be trained to use a personal digital assistant (pda) to answer questions about their diabetic neuropathic pain or their chronic back pain. upon successful completion of these tasks the patients will be randomized to receive one of the drug choices or placebo (inactive pill). the study will last for a total of 16 weeks and includes 5 visits to the research center with each visit lasting approximately 2 hours.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetic neuropathy * age 18-80 * willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon entry into the study exclusion criteria: * pregnancy * allergy to study medications * uncontrolled narrow-angle glaucoma * currently being treatment with thioridazine (mellaril) * unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases * treatment with a monoamine oxidase inhibitor (maoi) within 14 days of randomization

Keywords: asymmetric diabetic proximal motor neuropathy diabetic autonomic neuropathy diabetic neuralgia diabetic neuropathy, painful neuralgia, diabetic low back pain, chronic