Kornimate/medical-research-clean huggingface dataset:
treatment of orthostatic hypotension in sci

Conditions: Hypotension

Summary: the purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with sci.


Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury * at least 12 months post injury * injury level of c1-t6 * ais a, b or c * non-ambulatory * non-ventilator exclusion criteria: * active psychiatric disorder * stroke or cerebrovascular disease * alzheimer's disease or dementia * unmanaged cardiac arrhythmias * concurrent systemic, hepatic, or renal disease * suspected or diagnosed malignancy * neurological disease other than sci * self-reported history of three or more symptomatic episodes of ad per day
the effect of schumann resonance on preterm newborns

Conditions: Extremely Low Birth Weight

Summary: body weight gain is crucial for preterm newborns, especially those with a low birth weight. owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (elf-emfs) are a promising medium of alternative and complementary therapy.

sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal intensive care unit of the chung shan medical university hospital and randomly assigned to one of two groups: the experimental group (n = 31) or the control group (n = 30). both groups received the same medical care, but the experimental group was exposed to elf-emfs until discharge.

Eligibility criteria:
inclusion criteria: * gestational age (ga) between 32 and 35 weeks * neonatal therapeutic intervention scoring system (ntiss) score \<9 exclusion criteria: * (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an ntiss score\>9
misoprostol as first aid measure to address excessive postpartum bleeding

Conditions: Postpartum Hemorrhage

Summary: the overall study purpose is to evaluate the safety, feasibility and acceptability of advance distribution of misoprostol to be used as 'first aid treatment' administered by the woman herself or her family to help treat excessive bleeding in home births.

this is a quasi-experimental, pre-post intervention study that will be conducted over a period of 12 months and will span two phases: phase 1 (baseline) (6 months): data on deliveries will be collected for pregnant women who deliver during this phase. data will also be collected on the treatment administered in any pph cases. women will be counseled on and also receive educational materials on how to identify excessive bleeding and the importance of seeking care at a facility if excessive bleeding occurs. phase 2 (misoprostol) (6 months): during this phase, the study will pilot the first aid concept. women will be provided with a single dose of 800 mcg sublingual misoprostol (200 mcg x 4 tablets) during their third trimester to use in the event of excessive postpartum bleeding, as well as the educational materials and counseling provided during the phase 1. the misoprostol is intended to serve as a first aid treatment measure and although seeking additional care is challenging in this setting, women and families will be advised to have a plan ready to seek immediate care at a health facility as soon as they take the misoprostol. during both study phases, data will be collected on maternal, clinical, and neonatal outcomes for all deliveries that occur in the study area. if women receive any care related to their delivery, data collectors will document this information.

Eligibility criteria:
inclusion criteria: * pregnant women living in sample districts exclusion criteria: * unable to provide informed consent
the effect of sertindole on sensory gating and cognition in schizophrenic patients

Conditions: Schizophrenia

Summary: this study aims to investigate whether the atypical antipsychotic and mixed 5-ht2/d2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. this goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (ppi) and p50 suppression of auditory evoked potentials in schizophrenic patients. these effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.


Eligibility criteria:
inclusion criteria: * schizophrenia according to dsm iv * selected and treated in respect of the spc (20 mg serdolect max. and population at risk will be excluded) exclusion criteria: * dsm iv axis i disorders other than schizophrenia: substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) dsm iv diagnosis according to dia-x of a major affective, anxiety disorder, eating-disorder. * dsm iv axis ii disorders: lifetime dsm iv diagnosis of personality disorder. * ecg: qtc-interval \>450 msec. * systolic blood pressure \<100 mmhg * bradycardia (hf \< 50/min) und arrhythmias * hypokalemia or hypomagnesemia

Keywords: schizophrenia ppi p50 cantab sensory gating schizophrenic patients according to dsm-iv
adore: efficacy of doravirine in adults living with hiv experiencing virological failure on first-line efavirenz-based antiretroviral therapy with nnrti resistance

Conditions: HIV-1-infection

Summary: this is a pilot study investigating the efficacy of doravirine (dor) in combination with lamivudine (3tc) and tenofovir disoproxil fumarate (tdf) administered over 48 weeks in adults living with hiv-1 experiencing virological failure on first-line efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance

this is a single-arm, phase 3 pilot study investigating the efficacy of doravirine (dor) in combination with lamivudine (3tc) and tenofovir disoproxil fumarate (tdf) administered over 48 weeks in adults living with hiv-1 experiencing virological failure on first-line efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance. approximately 25 male and female participants 18 years and older infected with hiv-1 and experiencing virological failure on efavirenz-based art will be administered a once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (dor/3tc/tdf). the study includes screening and baseline visits, 4 study visits from week 4 to week 36, and an end of study visit at week 48.

Eligibility criteria:
inclusion criteria: * adults living with hiv-1, 18 years and older * viral load 5000 - 60 000 copies/ml on first-line efavirenz-based antiretroviral therapy * hiv genotype resistance test with first generation nnrti resistance (e.g. k103n, y181c, etc as listed in the protocol) * cd4 \> 200 cells/ul * creatinine clearance \> 50 ml/min * body mass ≥ 35 kg. exclusion criteria: * resistance to tdf on genotype (k65r) * "significant resistance" to doravirine, denoted by a stanford score ≥ 15 on genotype * virologic failure on any other regimen * women who are pregnant at the time of the screening or enrolment visits * active tuberculosis and/or are on anti-tuberculous therapy at the time of the screening or enrolment visits * taking and cannot discontinue prohibited concomitant medications listed in protocol at least two weeks prior to the enrolment visit and for the duration of the study period.

Keywords: virological failure, first-line antiretroviral therapy doravirine delstrigo
study of anti-glycan antibodies stability in saint-etienne ibd cohort

Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease

Summary: prognostic factors in inflammatory bowel diseases (ibd) are currently mainly based on clinical factors (disease extension, perianal involvement, need for surgery, use of immunomodulators...). all of immunological markers (or serological) of ibd have a diagnostic role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have been considered as predictors of ibd course in adults. among the most used, anti-neutrophil cytoplasm antibodies (anca) and anti-saccaromyces cerevisiae antibodies (asca) allow the distinction between ulcerative colitis (anca+/asca-) and crohn's disease (anca-/asca+), and their combined use has a sensitivity and a specificity of about 85%. however, 10 other antibodies have been identified and recently evaluated individually in ibd and especially in pediatric crohn's disease: anti-ompc, anti-i2, anti-flagellins, anti-glycan (anti-laminaribioside carbohydrate antibodies (alca), anti-mannobioside carbohydrate antibodies (amca), anti-chitobioside carbohydrate antibody (acca), anti-chitin and anti-laminarin), anti-goblet cells and anti-c.albicans specific mannans antibodies. these complementary tests improve the reliability of the diagnosis. in a previous cross-sectional work on a cohort of 195 ibd patients, the investigator showed a prognostic role of some of anti-glycan abs and especially a correlation with a pejorative form of the disease both in crohn's disease than in ulcerative colitis (uc) and a prediction of corticodependency in ibd.

there is few data on the stability of these antibodies, most of the studies are cross-sectional. there are conflicting results among scarce longitudinal data. one study reported a negativation of anti-glycan antibodies in some cases but not of asca or anca. on the cohort of 195 patients included in the first study, the investigator would like to assess at 3 years the immunological profiles of these patients and thus to compare them. in case of modification of the serological status for some antibodies, the search for associated factors (clinical, biological or therapeutic) will be performed. in case of sero-negativation of anti-glycan antibodies, this could be linked with a decrease or a normalization of the increased intestinal permeability in ibd. indeed, in this subgroup of patients, we will test this hypothesis by analyzing intestinal permeability in anti-glycan positive group on the 2 samples and in the group with a sero-negativation on the second sample.

Eligibility criteria:
inclusion criteria: * patients included in previous study (aol 2010) and followed in our department, accepting blood sampling and stool analysis * written consent of the patient exclusion criteria: * patient who decline to participate to the study * patient in the incapacity to give consent * patient deprived of their liberty by a judicial or administrative decision

Keywords: crohn's disease ulcerative colitis inflammatory bowel disease anti-glycan antibodies antibodies stability mucosal healing predictive markers
postural stability and ankle mobility in haglund syndrome

Conditions: Haglund Deformity

Summary: the purpose of the study is to find out the impact of haglund syndrome on ankle plantarflexion and dorsiflexion rom, dynamic postural stability and fall risk.

this study will be delimited to: * total sample size is fifty participants, twenty five patient of symptomatic haglund syndrome of both gender and twenty five healthy volunteers of matched age, sex and body mass index without any musculoskeletal complaints of the lower limbs. * biodex balance system will be used to determine postural stability. * ankle plantarflexion and dorsiflexion range of motion will be measured using an electrogoniometer. * age of the patients 25-56 * bmi of (18.5 to 24.9) participants: fifty volunteers from both genders will participate in the study. they will be assigned from outpatient clinic of faculty of physical therapy, deraya university. they will be interviewed and divided to twenty five patient of haglund syndrome as (patient group) after being diagnosed and referred by orthopedic surgeon and twenty five healthy volunteers as (control group) based on the following inclusion and exclusion criteria:

Eligibility criteria:
inclusion criteria: * for patient group: * patient referred from orthopedic surgeon with diagnoses as haglund syndrome according to the following signs and symptoms * calcaneal prominence diagnosed on lateral weight bearing radiograph with bony prominence superior to parallel pitch lines or posterior calcaneal angle greater than 75 degrees * pain medially at insertion of tendo-achilles * palpation of hard, bony prominence * pain upon rising out of bed * both unilateral and bilateral cases, and in consideration of dealing with bilateral cases the tested limb will be the most painful limb. * age of 25-56 years * both males and females. * bmi of (18.5 to 24.9) for control group: healthy volunteers of matched age, sex and body mass index without any musculoskeletal complaints of the lower limbs and will be included in the control group in this study . exclusion criteria: * musculoskeletal disorders except haglund syndrome * cognitive disorder, visual impairment that affected their daily living and any further medical condition that would prohibit them from participating safely in the chosen balance measures * sensory loss at foot or ankle and with a systemic inﬂammatory disease, such as diabetes mellitus, peripheral neuropathy, rheumatoid arthritis and ankylosing spondylitis, who had undergone corticosteroid injections or physical therapy in the last three months * patients with vestibular or neurological disorders * any other cause of posterior heel pain.
comparative study of two embryo culture systems

Conditions: Infertility

Summary: the centre for medically-assisted procreation (map) of dijon chu has two high-technology embryo culture systems, with incubation characteristics that are potentially superior to those provided by classical culture systems. indeed, these two systems, available in only two map centres in france, make it possible to maintain a stable temperature and gaseous environment during the in-vitro development of the embryos. it is necessary to observe the development of the embryos to determine which embryos have the highest implantation potential. these observations are done from time to time by microscope for one system and continuously using an incorporated video camera for the other (cinematographic study). the map centre in dijon wishes to compare the interest of these two systems.


Eligibility criteria:
inclusion criteria: * persons who have provided oral consent * attempt at in vitro fertilization with icsi (intracytoplasmic sperm injection) * at least 6 mature ovocytes to microinject exclusion criteria: * persons not covered by national health insurance * attempt at in vitro fertilization (ivf) * fewer than 6 mature ovocytes * decision to transfer at the zygote stage during the multidisciplinary meeting * attempts made in a context of viral risk (both systems are in a virus risk-free zone) * attempts with surgically-harvested spermatozoa

Keywords: in vitro fertilization with icsi
acupuncture for the treatment of phantom limb and residual limb pain after amputation

Conditions: Phantom Limb; Residual Limb Pain; Traumatic Amputation; Amputation

Summary: the purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.

the purpose of this pilot study is to identify the optimum combination of acupuncture points and treatment sequence in the treatment of post amputation limb pain in terms of the change in phantom limb pain (plp) and/or residual limb pain (rlp) as measured by the visual analogue scale (vas) and the mcgill short form pain questionnaire (sf-mpq). further, any side effects associated with the acupuncture treatment regimens, time requirements, and patient compliance with the treatment regimens will be estimated. study participants will be randomized to one of three acupuncture treatments: chinese scalp acupuncture, french auricular acupuncture, or a combination of both.

Eligibility criteria:
inclusion criteria: * amputees with traumatic/surgical amputation of a limb (greater than fingers or toes) secondary to trauma or peripheral vascular disease * amputees who have been cleared to begin prosthetic fitting * phantom and/or residual limb pain reported must be \>/= 3/10 * active duty military or dependent eligible for military benefit \>/=18 years old exclusion criteria: * congenital limb absence * pregnancy * any skin changes on the ear or scalp that would preclude placement of acupuncture needles * patients intubated and unable to give consent * patients with traumatic brain injury (tbi) diagnosed as greater than mild

Keywords: acupuncture phantom limb pain residual limb pain amputation amputee traumatic surgical traumatic amputation upper extremity traumatic amputation lower extremity surgical amputation upper extremity surgical amputation lower extremity
colon cancer prognosis after radical surgery

Conditions: Colon Cancer

Summary: 1. radical surgery. it is supposed to improve prognosis of colon cancer. a surrogate measure of achievement of radical surgery is the number of lymph nodes removed with the specimen. 2. markers. there may be variables that may make patient assessment more sound. the project is including investigation of such markers (genes, old age, comorbidity, and others). 3. laparoscopic resections. this is being used more and more in cancer surgery but the feasibility of this approach remains to be proven compared with conventional open surgery. the project compares these according to 1) and 2). 4. morbidity and mortality must be surveilled to keep at a minimum. many patients have comorbidity and are old to make this factor extra important, including perioperative care. 5. proper treatment of colon metastases may prolong life. treatment of lung-metastases will be studied in particular.

1. radical surgery. a detailed description of procedures for each location of tumor in the large intestine is used. by following a given procedure for each location in the large intestine, the number of lymph nodes can be analyzed for each location to find out if this differs and if prognosis is affected by lymph node numbers according to tumor site. 2. markers. different variables are examined for use in clinical judgment to make treatment better as well as genetic experimental analyses for comparison with clinical outcome to better understanding of clinical behavior. 3. laparoscopic resections. the technical challenge of laparoscopic approach has been compared with conventional surgery without any difference being observed in trials. however, it should be compared with radical open surgery to compare best achievements by using number of lymph nodes as well as outcome measures in the short and long term (mortality). 4. comorbidity, old age itself, type of surgery and perioperative care according to the so called fast track surgery may all play a part in reducing perioperative morbidity and mortality. a maximum 3% mortality should be aimed for. 5. colon cancer usually metastasize to the liver and lungs. surgical treatment of liver metastases has been extensively studied and the prognosis has improved. lung metastases has not been given similar attention but the prognosis of those operated may be good and equal that after liver surgery. the need for pulmonary resection and factors associated with metastases and lung metastases in particular will be studied.

Eligibility criteria:
inclusion criteria: * malignant tumor (adenocarcinoma) of the large intestine (colon) * willingness to participate exclusion criteria: * no radical resection (r0) possible * unwilling to participate or medically unfit to undergo follow-up

Keywords: colon cancer open surgery resection laparoscopic surgery resection morbidity mortality metastases oncology freedom of malignant disease recurrence safety of intervention open and laparoscopic examination of adverse markers development of metastases in lungs and other organs
collaborative wilms tumour africa project

Conditions: Wilms Tumour

Summary: significant progress has been made in the treatment of wilms tumor in high income countries, where survival is now around 85% - 90%. survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment. a comprehensive treatment guideline was introduced in malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. survival has increased to around 50%; 95% of children completed their treatment. a multi-disciplinary group of african clinicians and 'state of the art' experts produced a consensus treatment guideline for children with wilms tumor in sub-saharan africa. this guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year. the hypothesis is that 2 year event free survival will be 50%, with \<10% failure to complete treatment and \<10% treatment related mortality. other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.

patients are treated according to standard care. data are documented on presentation at diagnosis, response of the tumor, findings at surgery and pathology, treatment given and outcome of the patients.

Eligibility criteria:
inclusion criteria: * age \< 18 years * diagnosis wilms tumour exclusion criteria: \* none

Keywords: wilms tumour childhood cancer africa
use of a vibrotactile sensory prosthesis in patients with postural imbalance and spatial disorientation

Conditions: Vestibular Diseases; Peripheral Neuropathies; Proprioceptive Disorders; Hemispatial Neglect

Summary: the investigators propose to explore the hypothesis that vibrotactile channels for indicating spatial orientation can be exploited as a sensory prosthesis. the specific research applications will be used for guiding visual orientation, to provide alternative feedback to vision and vestibular signals for controlling balance, and for directional and lateralisation cueing in patients with neglect syndromes. the programme will study whether vibrotactile feedback improves performance and also if it speeds rehabilitation when used as an adjunct to conventional therapy.


Eligibility criteria:
inclusion criteria: * sensory impairments * unsteadiness exclusion criteria: * high strokes

Keywords: hemineglects
effect of the pneumoperitoneum on dynamic variables delta pp and pvi during trendelenburg position.

Conditions: Surgery

Summary: arterial pulse pressure variation induced by mechanical ventilation (δpp) is considered one of the best parameter to predict fluid responsiveness in patients under general anaesthesia. pleth variability index (pvi) has been proposed as a less invasive alternative. however, the pneumoperitoneum has been recently seen suggested as a limitation to their interpretation. the aim of this observational study is to compare changes in δpp and pvi related to autotransfusion associated with a trendelenburg manoeuver before and during laparoscopy in patients undergoing elective surgery.


Eligibility criteria:
* american society of anesthesiologists (asa) score i-ii * scheduled for elective abdominal laparoscopic surgery * with written informed consent * more than 18 years * body mass index \< 40 kg.m-2 * no supraventricular arrhythmias * no heart failure with ejection fraction \<25 % * no peripheral vascular * no severe respiratory disease * no end stage renal failure (creatinine clearance \<30ml/min).