Kornimate/medical-research-clean huggingface dataset:
effect of protein supplementation on craving in subjects hospitalised for addiction treatment

Conditions: Addiction

Summary: moncentric pilot study conducted in the addictology department of the pau hospital, designed to demonstrate the benefit of protein supplementation on craving in patients with a substance use disorder at the start of their treatment for addiction. this study will be conducted according a crossover design with a one-week phase with protein supplementation (p) and a one-week phase without protein supplementation (sp).

addiction is a chronic psychiatric disorder characterised by the loss of control over the use of rewarding substances or behaviours, despite the accumulated damage. craving, defined as an irrepressible, obsessive craving, is a key early symptom of addiction. protein supplementation could reduce this craving. nutritional abnormalities aggravate addictions but no study have directly assessed the impact of protein supplementation on craving. evidence suggests that protein supplementation reduces cravings for sugary and hyperpalatable foods, which could extend to rewarding substances. the hypothesis is that this supplementation reduces the intensity, duration and frequency of craving in withdrawal patients by influencing dopaminergic reward circuits. protein supplementation takes the form of a powder sachet mixed with yoghurt or compote. it will be given twice a day, at the same time (8am and 4pm). patients will be enrolled at the admission to the addiction unit. they will be assessed psychologically, addictologically and nutritionally for one week and then will be randomised. patients will be asked to assess their cravings, dietary needs, consumption of addictive substances and palatable foods.

Eligibility criteria:
inclusion criteria: * male and female * aged 18 and over * admitted for complex care in the addictology department * person affiliated to or benefiting from a social security scheme * free, informed and written consent signed by the participant and the investigator exclusion criteria: * allergy to milk protein * admitted to hospital for less than 3 weeks * severe somatic or psychiatric pathology incompatible with understanding assessment tools * difficulty understanding and/or writing french * presumed non-compliant in completing the patient diary * person participating in another research study with an exclusion period still in progress * person under legal protection (guardianship, curatorship)

Keywords: addiction craving protein supplementation
topical il-1-ra for treatment of posterior blepharitis

Conditions: Posterior Blepharitis

Summary: the purpose of this study is to determine the effectiveness and safety of topical interleukin-1-receptor antagonist in treatment of signs and symptoms of posterior blepharitis.


Eligibility criteria:
inclusion criteria: * a diagnosis of posterior blepharitis * a negative urine pregnancy test result for women of childbearing potential * women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation * normal lid position and closure * ability to understand and provide informed consent to participate in this study * willingness to follow study instructions and likely to complete all required visits. exclusion criteria: * history of stevens-johnson syndrome or ocular pemphigoid * history of eyelid surgery * intra-ocular surgery or ocular laser surgery within 3 months * history of microbial keratitis, including herpes * active ocular allergies * corneal epithelial defect \> 1mm2 * use of topical steroids or restasis within the past 2 weeks * use of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month * use of isotretinoin (accutane) within the past 6 months * have had any previous treatment with anakinra (kineret®) or any therapeutic agent targeted at il-1 blockade * pregnant or lactating women * signs of current infection, including fever and current treatment with antibiotics * liver, renal, or hematologic disease * the use of any other investigational drug
a study of suzetrigine (suz) spray-dried dispersion (ssd) in healthy adult panelists

Conditions: Pain

Summary: the purpose of this study is to evaluate the sensory attributes (basic tastes, aroma, texture, mouthfeel) of suz sdd and assess the impact of the dose on the sensory attributes.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: - panelists are qualified based on training and experience. they will be required to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. key exclusion criteria: * history of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant * sensitivity to suz * pregnant, nursing, or planning to become pregnant during the study other protocol defined inclusion/exclusion criteria may apply.
sub-chronic effects of 5-hydroxytryptophan on mood and emotional processing in healthy volunteers

Conditions: Mood

Summary: 5-hydroxytryptophan (5-htp) is a nutritional supplement sold in many health food stores, and is taken in order to raise levels of serotonin in the brain. serotonin is a neurotransmitter that is involved in the regulation of mood. previous research has assessed the effects of raising serotonin levels using tryptophan (the precursor of 5-htp) and serotonergic antidepressants on emotional processing in healthy volunteers. however, to date there has been no human trial investigating the effects of 5-htp on emotional processing in healthy volunteers. thus, the current study aims to assess the effects of 5-htp, on emotional processing and mood in healthy volunteers.

the serotonin precursor 5-htp is sold as a nutritional supplement and has been used to offset low mood for over 30 years due to its ability to raise levels of neural serotonin. however, evidence for the efficiency of 5-htp is limited and the mechanism of action of 5-htp in offsetting low mood has not been well-characterised. the current study assessed the ability of 5-htp to induce biases for positive emotional material in healthy volunteers, similar to those induced by serotonergic antidepressants and the nutritional supplement tryptophan. the effects of 5-htp on subjective mood and depressive symptoms were also assessed. participants were randomised to receive either 150mg of 5-htp or placebo daily for 14 days. depressive symptoms and subjective mood were assessed pre- and post-intervention. emotional processing was assessed on the 15th day using a battery of emotionally valenced cognitive tasks.

Eligibility criteria:
inclusion criteria: * male/female * healthy * aged 18-65 * not taking any herbal or prescription medications (excluding contraceptive pill) * free from depressive illness or mood disorder for the last 6 months * free of physical illness exclusion criteria: * physically ill * history of medical illness * current or previous (6 month) history of psychiatric disorder * pregnant/breastfeeding * allergy or hypersensitivity to any of the ingredients contained in the investigational product * taking any medication (excluding contraceptive pill)

Keywords: 5-hydroxytryptophan mood emotional processing emotional cognition nutritional supplement low mood
protective ventilation with carbon dioxide (co2) -removal technique in patients with adult respiratory distress syndrome (ards)

Conditions: Adult Respiratory Distress Syndrome

Summary: 30% of ards patients ventilated according to nih protocol presents morphological (ct) and functional (stress index\>1) conditions of hyperinflation even with plateau pressure (pplat) \< 30 cmh2o; values of pplat lower than 26 cmh2o were associated with more a condition of more protective ventilation. in patients at risk of hyperinflation, use of alternative techniques such as co2-removal my allow the reduction of tidal volume (vt) and pplat.

aim of the study was to verify the efficacy of co2-removal technique in reducing vt and consequently pplat to obtain a stress index value equal to 1.

Eligibility criteria:
inclusion criteria: * ards patients with pplat \>= 26 during nih protective ventilation protocol exclusion criteria: * age \< 18 years * brain injury and patients with intracranial pressure \> 20 mmhg * pregnancy * immunodepressed patients * patients already enrolled in other trials * renal replacement therapy * bmi \> 40 * contraindication anticoagulation treatment * morphological abnormalities of femoral veins * nyha iii-iv * burns bsa\>30% * hepatic failure (grade c child)

Keywords: respiratory insufficiency co2 removal protective ventilation ards
predictive efficacy of ratio of median frequency to spectral edge frequency used in the depth of anaesthesia monitoring on post-operative cognitive functions

Conditions: Postoperative Delirium; Cognitive Impairment

Summary: the primary objective of this observational study is to evaluate the effectiveness of preoperative anaesthesia depth monitoring parameters in predicting postoperative cognitive functions in non-cardiac adult patients. participants will preoperatively perform cognitive tests such as the nursing delirium screening scale(nu-desc) and 4 'a's test(4at) to assess baseline cognitive performance. the same tests will be repeated twice daily until the postoperative 3rd day or discharge.

the primary objective of this observational study is to evaluate the effectiveness of preoperative anaesthesia depth monitoring parameters such as bispectral index(bis), spectral edge frequency(sef) and median frequency(mf) in predicting postoperative cognitive functions in non-cardiac adult patients. participants will preoperatively perform cognitive tests such as the nursing delirium screening scale(nu-desc) and 4 'a's test(4at) to assess baseline cognitive performance. intraoperative haemodynamic and bis parameters will be collected via manual data entry into printed forms. also, a two-channel electroencephalogram(eeg) and bis parameters(bis number, sef, mf) will be collected digitally. the cognitive tests will be repeated twice daily until the postoperative 3rd day or discharge. parameters such as mean intraoperative mf value and the ratio of mf over sef will be compared against postoperative cognitive test scores.

Eligibility criteria:
inclusion criteria: adult patients (aged over 18 years), patients undergoing elective surgeries, patients consenting to participate in the study. exclusion criteria: pediatric patients (aged under 18 years), patients undergoing emergency surgeries, patients requiring or anticipated to require postoperative intensive care for more than one day, patients undergoing cardiac surgeries, patients undergoing intracranial surgeries, patients are undergoing endoscopic sinus or brain surgeries, patients with pacemakers or implantable cardioverter-defibrillators (icds), patients diagnosed with dementia (including alzheimer's disease, lewy body dementia, etc.), patients with chronic opioid or benzodiazepine use, patients with contraindications to propofol, remifentanil, or fentanyl, pregnant or breastfeeding women, patients are not willing to participate in the study.

Keywords: bispectral index median frequency spectral edge frequency post operative cognitive dysfunction cognition
pharmacokinetics study of xg005 capsule

Conditions: Pain

Summary: this was a phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the pk, safety, and tolerability of single ascending doses of xg005 (period 1) and the naproxen and pregabalin combination (period 2), in 5 dose groups each with 10 subjects.

period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to xg005 and 2 subjects (1:1 allocation ratio by gender) to placebo. subjects were enrolled sequentially into a total of 5 ascending dose levels pending safety review, and pk review where possible, of period 1 of the prior dose level. sentinel dose participants (1 for xg005 and 1 for placebo) were included as the first dose administered at each dose level in period 1. in period 2, all subjects in the last three xg005 dose groups received approximate molar equivalents of naproxen and pregabalin corresponding to xg005 doses after a 7-day washout period. period 2 was open-label with 10 subjects per group. pk blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.

Eligibility criteria:
inclusion criteria: * bmi range of 18-30 kg/m2 * medically healthy subjects * creatinine clearance ≥ 80 ml/min exclusion criteria: * history or presence of significant diseases * history or presence of alcoholism or drug abuse * consumption of alcohol 48 hours prior each dose * hypersensitivity or idiosyncratic reaction to the study drug * abnormal diet (for whatever reason) during the 30 days prior to the first dosing; * donation (standard donation amount or more) of blood or blood products * plasma donation within 7 days prior to the study; * participation in another clinical trial within 30 days prior to the first dose; * female subjects who are pregnant or lactating; * hemoglobin \< 120 g/l
leap2 on postprandial glucose metabolism and food intake

Conditions: Obesity

Summary: the study aim to delineate the effects of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (leap-2) on postprandial glucose metabolism and food intake in healthy volunteers. the overall objective is to investigate the physiological importance of leap-2 in healthy subjects.

in a recent study, the molecular phenotype of enteroendocrine cells in the small intestine before and after roux-en-y gastric bypass (rygb) surgery in obese individuals was examined. enteroendocrine cells were identified and isolated from intestinal biopsies and analysed for differentially expressed genes by illumina high throughput rna-sequencing. it was discovered that the gene encoding liver-enriched antimicrobial peptide 2 (leap-2), a naturally occurring peptide in humans, was significantly upregulated compared to baseline expression. interestingly, leap-2 was recently shown to antagonize ghrelin function in response to feeding in mice. moreover, the mature murine leap-2 peptide is identical in mice and humans. thus, leap-2 has been identified as an endogenous peptide that may be able to alter feeding behaviour and maintenance of glucose levels during calorie restriction. the study hypothesis is that leap-2 alters postprandial glucose metabolism and decreases appetite as well as food intake in relation to a liquid mixed meal and a standardised ad libitum meal compared with saline (placebo) in healthy subjects.

Eligibility criteria:
inclusion criteria: * caucasian men * age between 18 and 25 years * body mass index between 20-35 kg/m2 * informed consent exclusion criteria: * anaemia (haemoglobin below normal range) * alanine aminotransferase (alat) and/or aspartate aminotransferase (asat) \>2 times normal values) or history of hepatobiliary and/or gastrointestinal disorder(s) * nephropathy (serum creatinine above normal range and/or albuminuria) * allergy or intolerance to ingredients included in the standardised meals * first-degree relatives with diabetes and/or glycated haemoglobin (hba1c) \>48 mmol/mol * regular tobacco smoking or use of other nicotine-containing products * any ongoing medication that the investigator evaluates would interfere with trial participation. * any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses
effect of motivational therapy on schizophrenia with cannabis misuse

Conditions: Schizophrenia; Cannabis Dependence, Continuous

Summary: schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. we are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.

schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. we are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia. 330 patients with schizophrenia and cannabis abuse or dependence (according to dsm-iv criteria) are randomly assigned to 4 motivational interview during one month or usual intensive treatment. treatment is conducted in outpatient which are evaluated at the inclusion and at 6 month with time-line follow bach for the consumption, panss score, number of relapse...). a outcome measure was urinalysis results providing an objective measure of cannabis use throughout the six month of the trial.

Eligibility criteria:
inclusion criteria: * schizophrenia or schizo-affective disorder according to dsm-iv criteria * meeting dsm-iv criteria for actual cannabis abuse or dependance * in current and regular contact with mental health service * with an age at interview of 18 years or more * no evidence of organic brain disease or clinically significant concurrent medical illness or learning disability * written informed consent was obtained from all subjects (patients and parents). exclusion criteria: * not membership to a regime of social security or to a cmu

Keywords: schizophrenia cannabis misuse comorbidity motivational interview randomised open trial
aortic valve replacement with trifecta(tm)

Conditions: Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence; Aortic Valve Stenosis

Summary: to confirm the clinical safety and effectiveness of the trifecta valve.

the clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the trifecta valve.

Eligibility criteria:
inclusion criteria: * requires aortic valve replacement (heart surgery such as bypass is allowed at the same time). * legal age. * signed informed consent prior to surgery. * willing to complete all follow-up requirements. exclusion criteria: * pregnant or nursing women. * have already had a valve replaced other than the aortic valve. * needs another valve replaced. * cannot return for required follow-up visits. * have active endocarditis. * acute preoperative neurological event (such as a stroke). * renal dialysis. * history of substance abuse within one year, or a prison inmate. * participating in another study. * life expectancy less than two years.

Keywords: aortic valve heart valve tissue valve bioprosthesis valve disorder valve disease cardiac surgery aortic valve stenosis aortic valve regurgitation
the urinary microbiome in patients receiving intradetrusor botox injections

Conditions: Overactive Bladder

Summary: an altered urinary microbiome (um) may explain the symptoms in overactive bladder (oab) patients who were previously considered to have "idiopathic" oab. to date, most research on the relationship between oab and the um has focused on differentiating between the um of a normal bladder and that of an oab bladder. there is currently a paucity of data on the way that oab therapy impacts the um. one of the few studies to evaluate the um pre- and post-oab treatment focused on how management with solifenacin affected the um, but no studies have evaluated how intravesical onabotulinumtoxin a injections (ioi) affects the um. understanding ioi's impact on the um is particularly interesting because despite both anticholinergics and ioi exerting antimuscarinic affects on the bladder, ioi is often successful when anticholinergics are not. this raises the question of what other mechanisms of action ioi may have in the bladders of oab patients - one hypothesis is that it might stabilize the um in those select patients who suffer from oab due to an altered um. the primary objective of this study is therefore to determine the um profiles of oab patients before and after treatment with ioi.


Eligibility criteria:
inclusion criteria: - women undergoing intradetrusor botox injection with botox 100 u exclusion criteria: * current uti * history of recurrent uti * history of antibiotic exposure for any reason (including if response is "unknown") * antibiotic exposure for any reason other than post-procedure prophylaxis during the four-week follow-up period.

Keywords: overactive bladder urinary microbiome
the influence of the menstrual cycle on lithium and sertraline blood levels

Conditions: Bipolar Affective Disorders; Cyclothymic Disorder; Schizoaffective Disorder; Major Depressive Disorder; Dysthymic Disorder; Obsessive-Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Premenstrual Dysphoric Disorder; Social Anxiety Disorder

Summary: the aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. on each visit, they will fill out a depression, anxiety and mania rating scale. also at each visit a 20ml blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. the primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. the investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease.


Eligibility criteria:
inclusion criteria: * 18-40 year old female * women currently taking lithium or sertraline exclusion criteria: * currently pregnant or breastfeeding * concurrent use of any form of hormonal birth control, including oral contraceptive pills, norplant or depo-provera * hepatic or renal disease * irregular menstrual cycles.

Keywords: lithium sertraline