Kornimate/medical-research-clean huggingface dataset:
the effect of prebiotics on gastrointestinal functioning and metabolism

Conditions: Change of Transit or Circulation; Obesity

Summary: the study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.

a human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.

Eligibility criteria:
inclusion criteria: * overweight to obese men and women (bmi ≥ 25 kg/m2 \<35 kg/m2) * aged 20-50 years * caucasian * normal fasting glucose (\<6.1 mmol/l.) * normal blood pressure (systolic blood pressure 100-140 mmhg, diastolic blood pressure 60-90 mmhg) * weight stable in last 3 months (±2 kg) * a low defecation frequency, \<4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires). * a slow whole gut transit (\>35h) exclusion criteria: * woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test) or (post)-menopausal * regular smokers * people with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training) * diabetes mellitus (defined as fpg ≥ 7.0 mmol/l and or 2h pg ≥ 11.1 mmol/l) * gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on alat and creatinine levels, respectively) disease with a life expectation shorter than 5 years * following a hypocaloric diet * gluten intolerance * regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study * more than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as 1. straining in \>1/4 defecations; 2. lumpy or hard stools in \>1/4 defecations; 3. sensation of incomplete evacuation in \>1/4 defecations; 4. sensation of anorectal obstruction/blockade in \>1/4 defecations 5. manual maneuvers to facilitate \>1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or 6. \<3 defecations/week * current use of medication interfering with study intervention or interfering with study endpoints/hypotheses * not to be able to understand the study information * blood donation 2 months prior to the study and during the study * participation in other studies
ketone esters for optimization of cognitive performance in hypoxia

Conditions: Hypoxia; Ketosis

Summary: this study will investigate the effects of ketone ester drinks on cognitive performance in hypoxia.

in the setting of altitude-induced hypoxia, cognitive capacity degrades and can compromise both individual and team performance. this degradation is linked to falling brain energy (atp) levels and an increased reliance on anaerobic energy production from glucose. ketone bodies are the evolutionary alternative substrate to glucose for brain metabolic requirements; previous studies have shown that the presence of elevated ketone bodies (ketosis) maintains brain atp levels and reduce cerebral anaerobic glycolysis during hypoxia. ketosis can be achieved when fasting or following a ketogenic diet; however, these approaches are impractical. exogenous ketone ester supplementation allows for rapid (\< 30 mins) and significant elevation of blood ketone levels without the need to maintain a diet or fast. hvmn, in collaboration with researchers at ihmc, proposes a study to investigate the effects of consuming an fda-approved ketone ester 'food' on cognitive performance in the setting of hypoxia. for the proposed 4-arm within-subject study, participants will complete a cognitive performance test battery under the conditions of normoxia and then hypoxia following consumption of a ketone ester drink or a placebo drink (n.b for each study drink cognitive performance in both hypoxia and normoxia will be assessed in one visit): visit a: arm1: normoxia + placebo arm 2: hypoxia + placebo visit b: arm 3: normoxia + ketone ester arm 4: hypoxia + ketone ester the investigators hypothesize that ketone ester supplementation will attenuate hypoxia-induced deterioration of operator cognitive performance.

Eligibility criteria:
inclusion criteria: \* pass medical examination on enrollment. exclusion criteria: \* active smoker, substance abuse.
repeated muscle vibration in acute stroke

Conditions: Acute Stroke

Summary: prospective randomized double-blind sham-controlled study aimed to investigate the effects of repeated muscle vibration (rmv) on motor recovery in acute stroke patients, treated within 72 hours from symptoms onset

this is a prospective randomized double-blind sham-controlled study. after enrollment (t-0), patients are randomly placed into the vibration group (vg) or the control group (cg), by using a computer-generated randomization list. vg patients receive rmv treatment while those of cg receive the sham one. both treatments are carried out during the 1st, 2nd and 3rd day after enrollment. physiokinesitherapy (pt) is carried out in all patients every day, starting soon after t-0 clinical evaluation. patients are re-evaluated after 4 ± 1 days (t-1), at the end of treatment. upon admission, all participants' demographic details and medical history are recorded. all patients undergo a clinical examination, performed at all time-points by an experienced investigator, blinded to group assignment and different from the recruiting one. clinical evaluation consists of stroke severity evaluation, by means of nih stroke scale; motor and functional limbs abilities are evaluated by using both the fugl-meyer scale and the motricity index; post-stroke spasticity is assessed with ashworth scale, modified by bohannon and smith. all participants undergo a daily rehabilitation program. the physical therapist is instructed about duration, frequency, and content of therapy in order to ensure uniformity in treatment procedures, and blinded to patients' treatment allocation. low-amplitude rmv (frequency 100 hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (cro®system, nemocosrl). the rmv treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (for each treated limb), interspersed with a 5-minute break. during the rmv, subjects are required to make a voluntary isometric contraction of the treated muscle. otherwise, the cg participants undergo the sham rmv by positioning the vibrator close to the tendon but without touching the skin. in this condition, patients are only subject to the faint buzzing sound of the vibrator

Eligibility criteria:
inclusion criteria: * age \>18, * first ever stroke detected by magnetic resonance imaging (mri) or computer tomography (ct) scan * ischemic or hemorrhagic stroke within 72 hours from symptom onset * motor deficit of the upper and/or lower limb; * ability to perform at least a minimal isometric voluntary contraction of the affected limb exclusion criteria: * tia, or rapidly improving stroke * cerebral venous thrombosis * patients presenting with aphasia, neglect, or apraxia

Keywords: repetitive muscle vibration (rmv) acute stroke motor recovery nonpharmacological therapy bedside intervention
the alama project: autism outcomes and neurobehavioral markers in young children born to mothers with hiv in kenya

Conditions: Autism

Summary: the study will use a non-invasive remote eye-tracking system (eyelink portable duo) to acquire a short series of eye-tracking measures to determine whether these can predict autism diagnoses in both children exposed to hiv and uninfected (cheu) and children not exposed to hiv and uninfected (chuu).

the study will use a non-invasive remote eye-tracking system (eyelink portable duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism outcomes. investigators will recruit children enrolled in the tabiri study during or following their 24-month visit. the tabiri study is comparing neurodevelopmental (nd) outcomes between 24-month-old cheu and chuu.

Eligibility criteria:
inclusion criteria: * children enrolled in the tabiri study (r01hd104552) * cheu or chuu * children ages 24-72 months * caregivers of children must speak kiswahili (local language) or english. exclusion criteria: * there will be no specific exclusion criteria. we anticipate that a small number of cheu and chuu will develop hiv prior to enrollment in the current study; these children will be included and will follow all general study procedures.

Keywords: autism hiv eye tracker
pfc sigma fixed and mobile knee study

Conditions: Osteoarthritis, Knee

Summary: the primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the p.f.c. sigma and p.f.c. sigma rotating platform total knee systems in clinical practice.

the secondary objectives of this investigation are:to evaluate the performance of the p.f.c. sigma and p.f.c. sigma rotating platform total knee systems in clinical practice. to evaluate the impact of patellar resurfacing on the performance of the p.f.c. sigma and the p.f.c. sigma rotating platform total knee systems. to evaluate the impact of posterior cruciate ligament (pcl) sacrifice or retention on the performance of the p.f.c. sigma and the p.f.c. sigma rotating platform total knee systems.

Eligibility criteria:
inclusion criteria: 1. male or female subjects may be recruited to the evaluation. 2. age - there are no restrictions relating to age of the patient. the patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation. 3. subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. 4. subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. 5. subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis. 6. patients who in the opinion of the clinical investigator are considered to be suitable for treatment with a fixed or mobile bearing knee system and who are suitable for patella resurfacing. exclusion criteria: 1. patients who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. 2. patients who require revision total knee arthroplasty surgery. 3. patients with any tibial deformity requiring tibial component augmentation. 4. patients whom, in the opinion of the clinical investigator, require a constrained prosthesis. 5. patients with rheumatoid arthritis. 6. patients with a pathology which, in the opinion of the clinical investigator, will adversely affect healing. 7. patients with other disorders which, in the opinion of the clinical investigator, will / could impair rehabilitation. 8. contra-indications for use of the device, as detailed in the package insert. 9. women who are pregnant. 10. subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. 11. subjects who are currently involved in another clinical study with an investigational product. 12. subjects who are currently involved in any injury litigation claims.
study of the neurobiology of tourette syndrome and related disorders

Conditions: Tourette Syndrome; Obsessive Compulsive Disorder

Summary: objectives: i. investigate the pathobiology of tourette syndrome and related disorders by measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients with tourette syndrome, obsessive compulsive disorder, and/or chronic tics. ii. determine the pattern of familial aggregation of tourette syndrome and obsessive compulsive disorder by systematic assessment of all first-degree family members of patients selected for cerebrospinal fluid studies. iii. establish the neurochemical and neuropeptide profile associated with the range of expression of the putative tourette gene expression in adult and adolescent patients.

protocol outline: all patients are screened with a complete physical and neurologic exam, and a semi-structured interview. patients then receive a comprehensive assessment of systemic disease. patients and first-degree family members also participate in a genetic study. any patient who experiences an unusual exacerbation of symptoms or significant side effects is removed from the study.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnostic and statistical manual of mental disorders iv lifetime diagnosis of 1 or more of the following: * tourette syndrome (ts) * obsessive compulsive disorder * chronic tics severely affected adolescents with a score of 3 or greater on the ts-clinical global impression scale eligible --prior/concurrent therapy-- at least 1 month since any medication --patient characteristics-- other: * in good physical health * no alcohol or substance abuse * no intelligence quotient below 80 * negative pregnancy test required of fertile women

Keywords: tourette syndrome anxiety disorder disease-related problem/condition neurologic and psychiatric disorders obsessive compulsive disorder oncologic disorders rare disease
the rolandic epilepsy/eses/landau-kleffner syndrome and correlation with language impairment study

Conditions: Rolandic Epilepsy; Nocturnal Frontal Lobe Epilepsy; Landau-Kleffner Syndrome; Electrical Status Epilepticus During Slow Wave Sleep

Summary: in clinical practice language impairment is frequently reported in association with nocturnal epileptiform activity. there is a spectrum of epileptic conditions that are characterized by nocturnal epileptiform activity. from mild to severe this spectrum involves: rolandic epilepsy (re), nocturnal frontal lobe epilepsy (nfle), landau-kleffner syndrome (lks) and electrical status epilepticus during slow wave sleep (eses). the exact characteristic of the relationship between nocturnal epileptiform activity and language impairment is yet to be explored. the investigators suggest that nocturnal epileptiform eeg discharges and nocturnal epileptic seizures during development will cause diseased neuronal networks that involve language. the diseased neuronal networks are less efficient compared with normal neuronal networks. objective: identification of a diseased neuronal network characteristic in children with nocturnal epileptiform activity, which can explain language impairment in these children. for this the investigators will use functional magnetic resonance imaging (mri) to analyse brain activity and diffusion weighted mri to investigate white matter connectivity.


Eligibility criteria:
inclusion criteria: * aged between 6-18 * diagnosis of rolandic epilepsy (or other childhood epilepsies as listed in study population description) exclusion criteria: * structural brain lesions which might influence cognition

Keywords: language problems childhood epilepsy bening (rolandic) epilepsy (of childhood) with centro temporal spikes brain maturation structral connectivity functional connectivity
study of regn1193 in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of regn1193 in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. metformin monotherapy at a dose of ≥1000 mg/day (up to the maximum daily dose of 2550 mg per day) for ≥8 weeks prior to randomization 2. hemoglobin a1c value of ≥7.0% to ≤10.0% 3. fasting plasma glucose value ≥130 mg/dl and ≤240 mg/dl exclusion criteria: 1. type 1 diabetes mellitus 2. use of insulin or oral or injectable antihyperglycemic medications during the 8 weeks prior to randomization 3. a severe hypoglycemic event in the 6 months prior to randomization note: the eligibility criteria listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
risk assessment model of trastuzumab-related cardiotoxicity in breast cancer patients

Conditions: Cardiac Toxicity; Antitumor Drugs; Breast Cancer

Summary: according to the existing clinical data in our hospital, retrospective study was conducted to screen the risk factors with predictive value for trc(trastuzumab-related cardiotoxicity) risk, and to construct the risk prediction model for trc.

the breast cancer patients with cardiotoxicity caused by trastuzumab were selected as the case group, and the breast cancer patients without cardiotoxicity were selected as the control group. the clinical baseline data, echocardiographic parameters and serum markers of the case group and the control group were compared to find out the risk factors that may have predictive value for the risk of trc. the target factors were analyzed by univariate analysis and multivariate logistic regression analysis, and the trc risk prediction model was established.

Eligibility criteria:
inclusion criteria: 1. female patients diagnosed with her2-positive breast cancer treated in our hospital. 2. surgical treatment combined with chemotherapy or radiotherapy was completed according to nccn guidelines, and trastuzumab standard treatment was received for at least half a year. (3) cardiac function (including echocardiography or biomarkers) was assessed at least once within 3 months before trastuzumab treatment, and at least once during or after treatment was performed for heart-related tests. (4) complete case data. exclusion criteria: 1. patients who have not been properly treated with trastuzumab or have been treated for less than half a year; 2. patients who did not receive cardiac function assessment before trastuzumab treatment, during or after treatment; 3. patients whose case data were missing or lost to follow-up.

Keywords: cardiac toxicity antitumor drugs breast cancer trastuzumab
neutral endopeptidase for early detection of acute kidney injury after cardiac surgery

Conditions: Acute Kidney Injury

Summary: the investigators want to investigate if the urinary biomarker neprilysin can identify cardiac surgical patients suffering from postoperative aki within 24 hours.

acute kidney injury (aki) is a common complication following cardiac surgery and significantly increases morbidity, duration of hospital stay, and mortality. the diagnosis of aki relies on changes in serum creatinine (scr) from a baseline value or decreases in urine output. nevertheless changes of scr to diagnose aki are only reliable after a minimum of 48 hours. neutral endopeptidase, also called neprilysin (nep) represents a single-pass membrane glycoprotein with zinc-dependent endopeptidase activity and a short cytosolic tail and is found in epithelia, fibroblasts, and neutrophils and in soluble form in the circulation, urine, and cerebrospinal fluid. beside the focus of interest in cardiovascular medicine for its role in heart failure, where the inhibition of nep by the administration of sacubitril/valsartan may achieve an improvement in patients with chronic heart failure and reduced ejection fraction, there is also thought to be a link to renal damage. nep is expressed in the brush border of proximal tubular cells, which is first shed in renal damage and therefore it is a marker for tubular damage when it is measurable in urine in this study the investigators want to investigate if nep is a marker for earlier detection of aki after elective cardiac surgery compared to the currently recommended kidney disease - improved global outcomes (kdigo) guidelines for acute kidney injury. also, the investigators want to investigate at predefined time points the occurrence and the progression of tubular damage during cardio-pulmonary bypass (cpb) in a closed-meshed nep detection.

Eligibility criteria:
inclusion criteria: - patients undergoing an elective cardiac surgical intervention exclusion criteria: * emergency procedures * heart transplantation * elective left ventricular assist device (lvad) implantation * pulmonary thrombendarterectomy * declined informed consent * age \< 18 years * pregnant woman * preoperative renal replacement therapy (rrt) * receiving medication containing sacubitril
scleroderma treatment with celution processed adrcs registry

Conditions: Scleroderma

Summary: this registry study will assess the safety and performance of the celution device in the processing of an autologous graft consisting of adipose derived regenerative cells (adrcs) in the treatment of hand scleroderma.

this registry study will assess the safety and performance of the celution system in preparation of adipose derived regenerative cells in the treatment of scleroderma affecting the hands. this will be a multi-center, multi-national study.

Eligibility criteria:
inclusion criteria: * diagnosis of scleroderma and presence of hand scleroderma * cochin score ≥ 20 units exclusion criteria: * body mass index \< 17 kg/m2 * infection in any finger * stable medications for the treatment of scleroderma for ≥ 1 month * pregnant or lactating status.

Keywords: scleroderma device adrcs adipose derived regenerative cells hand