Kornimate/medical-research-clean huggingface dataset:
psychobiotics and mental health in obese women on a weight-loss diet

Conditions: Obesity; Mental Health; Probiotic

Summary: the aim of this study was to evaluate the effect of psychobiotic supplementation containing lactobacillus helveticus r0052, bifidobacterium bifidum r0071 and bifidobacterium longum r0175 strains on mental health, quality of life, anthropometric measurements and some biochemical parameters in obese women. in the randomized double-blind placebo-controlled study, 28 obese female participants (14 psychobiotic, 14 placebo) will be given psychobiotic supplement/placebo together with a weight loss diet once a day every day for 4 weeks. before and after the intervention, anthropometric measurements, blood samples and 24-hour retrospective 3-day food consumption records of the participants will be taken. in addition, the depression anxiety stress scale (dass-21) will be administered to measure mental health, the sf-36 quality of life scale to determine quality of life, and the international physical activity questionnaire (ipaq) to determine physical activity levels. psychobiotics, which have entered our lives in recent years, have many beneficial effects on mental health through gut microbiota. however, while the effects of psychobiotics on mental health have been studied, their effects on obesity have not been investigated much. this study is unique in that it is the first study to investigate the effect of psychobiotic use on mental health in obese individuals. however, obesity is known to be an inflammatory disease and there is no study in the literature that includes the systemic immune inflammation index (sii) as a biomarker. sii is effective in evaluating the inflammatory and immune response in the body and determining prognosis; it adds value to clinical practice with early diagnosis of diseases, treatment follow-up and a wide range of uses.


Eligibility criteria:
inclusion criteria: * healthy adults aged ≥ 18-65 years * bmi ≥30 kg/m2 * willingness to volunteer * able to give written consent exclusion criteria: * co-administration of probiotics. however, subjects will be eligible to participate after a four (4) week washout period. * pregnant or planning to become pregnant within the next two (2) months. * positive pregnancy test in women of childbearing potential. * use of antibiotic medication (e.g. neomycin, rifaximin) within the last 1 month. if this is the case, the participant will be eligible to participate four (4) weeks after completion of antibiotic treatment (washout period). * individuals with physician-diagnosed psychiatric and neurological conditions. * individuals with irritable bowel syndrome or gastrointestinal disorders. * people with immune disorders or possible immunodeficiency states (e.g. due to surgery). * use of anti-inflammatory drugs * use of corticosteroids * people who are allergic to milk, corn starch or soya. * foreign nationality.
quality of life in women with x-linked adrenoleukodystrophy

Conditions: X-linked Adrenoleukodystrophy

Summary: x-linked adrenoleukodystrophy (x-ald) is a hereditary white matter disorder caused by mutations in the abcd1 gene leading to disturbances in the metabolism of fatty acids. this results in an accumulation of very long chain fatty acids (vlcfa) in the cells of the body causing damage to the central nervous system (white matter of the brain and spinal cord). the most common adult-onset x-ald phenotype is adrenomyeloneuropathy (amn), a slowly progressive myelopathic variant with demyelination of the long tracts in the spinal cord, clinically manifested as slowly progressive spastic paraparesis, sensory ataxia, bladder and sexual dysfunction. although this rare disease is inherited x-linked, previous research revealed that up to 80% of heterozygous women develop amn symptoms during their lifetime. the primary objectives of this study are 1) to assess the prevalence of symptomatic courses in female carriers of x-ald and 2) to determine the impact of amn symptoms on the quality of life of affected women in various areas (including everyday life, work, social network, sleep quality, sexuality, mood). participants are asked to fill in self-report questionnaires, which are available in english, german, french, spanish, and italian, and are provided electronically on the online platform leuconnect (https://www.leuconnect.com) launched by european leukodystrophies association (ela) international (https://elainternational.eu/).


Eligibility criteria:
inclusion criteria: * informed consent obtained from the participant * females ≥18 years at the time of consent, with proven x-ald as defined by 1. elevated vlcfa values, or 2. mutation in abcd1 gene exclusion criteria: * no informed consent and assent * current pregnancy

Keywords: adrenoleukodystrophy adrenomyeloneuropathy brain diseases, metabolic, inborn central nervous system diseases demyelinating diseases white matter disorder genetic diseases, x-linked peroxisomal disorders metabolic diseases female carrier adrenoleukodystrophy, women heterozygous carrier quality of life
pharmacological manipulation of intrahepatic arterial blood flow in hcc

Conditions: Hepatocellular Carcinoma

Summary: dr rajan is investigating a new method to improve local treatment of liver cancer. there is evidence that a drug, norepinephrine (ne), has the ability to shrink down normal liver blood vessels, but leave tumor vessels wide open. in patients with primary liver cancer, ne will be injected directly in the artery that nourishes the liver and the tumor. real time blood flow will be measured using an advanced ct scanner to demonstrate the ne effect on blood vessels. if dr rajan's hypothesis is confirmed, this drug has great potential to benefit patients during local delivery of chemotherapy in the liver artery, diverting it away from normal liver and towards the tumor, resulting in less complications and improved tumor kill.

this study aims to evaluate the blood flow modifications in liver following injection of norepinephrine in the hepatic artery. these blood flow variations have never been dynamically evaluated before. if indeed blood flow modulation in liver is favorable, the use of norepinephrine prior to localized chemotherapy has great potential to enhance treatment and diminish side effects. patients with hepatocellular carcinoma, a primary liver cancer, will be selected for this study. included patients will have a trans-arterial chemoembolization (tace) procedure scheduled as treatment for their cancer. during their procedure, they will be brought to an advanced ct-scanner. ct perfusion imaging will be performed prior, and after the injection of the study drug in the liver artery. patient's treatment will then be completed. perfusion color maps will illustrate blood flow. perfusion values will be correlated to see how the drug modulates blood flow in tumor and in normal liver.

Eligibility criteria:
inclusion criteria: * biopsy proven hcc\< or confident diagnosis of hcc on multi-phasic ct or mri * selection criteria for chemoembolization must be met, including adequate coagulation profile and serum creatinine, patent portal vein, no severe contrast allergy, cirrhosis child a or b. * 5 or less untreated nodular hepatic tumors within the lobe to undergo chemoembolization. larger nodule must be equal or over 3 cm. * patient must be able to provide written, informed consent. exclusion criteria: * symptoms or history of ischemic cardiac disease or arrhythmia * uncontrolled hypertension * pregnancy or desire to get pregnant * severe copd, fevs lower than 30% * prior documented hypersensitivity to norepinephrine * patients receiving mao inhibitors, or anti-depressants of the triptyline or imipramine types

Keywords: tace ct perfusion liver blood flow
metabolism characteristics in the children with narcolepsy

Conditions: Narcolepsy

Summary: a significant weight gain and obesity are observed for most patients with narcolepsy, mainly at the beginning of the disease and narcolepsy in young children. there is no specific study on the population and the consequences of overweight in the lives of these long-term patients. narcoleptic patients gain weight significantly at the onset of their illness. it is also known that weight gain is not related to the treatment of narcolepsy. the etiology of obesity in narcoleptic patients is not established. several assumptions were made (physical activity, leptin diet, metabolism). the reason and the pathophysiology of overweight and obesity in this population therefore remain unclear. in this study, potential change in the total metabolism (24h) for narcoleptic children that could explain their tendency to obesity will be assessed ?


Eligibility criteria:
inclusion criteria: narcoleptic patients * girl or boy age\> 6 years \<18 years; * narcoleptic: defined by the icsd diagnostic criteria 2 (international classification of sleep disorders) * beginning of the troubles there more than 6 months * parental consent and agreement of the child. hypersomnic patients * girl or boy age\> 6 years \<18 years; * hypersomnic : defined by the icsd diagnostic criteria 2 (international classification of sleep disorders) * beginning of the troubles there more than 6 months * parental consent and agreement of the child. exclusion criteria: narcoleptic patients * secondary narcolepsy; * narcolepsy already treated with psychostimulant or anticataplectic; * restless legs; * sleep apnea syndrome; * obesity known outside narcolepsy cause; * absence of parental consent. hypersomnic patients * symptomatic or secondary hypersomnia; * hypersomnia already treated psychostimulant or anticataplectic; restless legs; * sleep apnea syndrome; * pathology neurological, psychiatric, endocrine or concurrent; * lack of parental consent

Keywords: narcolepsy metabolism
molecular diagnosis on circulating tumor dna of non-small cell lung cancer

Conditions: Stage IIIb and IV Non Small Cell Lung Cancer

Summary: the purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor dna (ctdna) for treatment, diagnosis and monitoring disease progression of non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * signed written informed consent * male or female aged \>= 18 years * stage iiib and iv non small cell lung cancer histologically confirmed exclusion criteria: * tissue and plasma samples can not be provided for mutation analysis * unwilling or unable to provide informed consent * any serious medical condition that would interfere with the subject's safety
a prospective randomized trial of capecitabine treatment in patients with hnscc

Conditions: Head and Neck Neoplasms

Summary: this prospective randomized controlled clinical trial will be performed in patients with locally advanced squamous cell carcinoma of the head and neck. the objectives of the trial are to compare the efficacy and safety of capecitabine treatment with placebo as adjuvant therapy to patients who have received radiotherapy.


Eligibility criteria:
inclusion criteria: 1. histologically type： squamous cell carcinoma 2. head and neck squamous cell carcinoma (hnscc), tumor staged as iii to ivb (according to the 8th ajcc edition). 3. eastern cooperative oncology group (ecog) performance status 0 or 1 4. age between 18 and 65 years old 5. prior treatment with chemo-radiotherapy (crt) based platinum drugs. 6. adequate marrow: wbc count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl. 7. normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) ≤ 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln, and bilirubin ≤ 1.5uln. 8. adequate renal function: creatinine clearance ≥60 ml/min. 9. patients must be informed of the investigational nature of this study and give written informed consent. exclusion criteria: 1. nasopharyngeal carcinoma and/or salivary gland carcinoma. 2. any other malignancy (except for primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) 3. currently recurrent of metastatic disease 4. received research drug in 4 weeks 5. prior treatment with epidermal growth factor receptor (egfr)-targeted small molecules, egfr-targeted antibodies, and/or any investigational agents for hnscc 6. severe hematological abnormality and intolerance to chemotherapy 7. evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. 8. pregnancy or breast feeding 9. patients who cannot obey to completion of the study

Keywords: head and neck neoplasms;capecitabine
a study to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy

Conditions: Epilepsy

Summary: the purpose of this dose optimization study is to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive or have failed one anti-epileptic drug (aed) treatment in monotherapy.

this is an open label (all people know the identity of the intervention), dose optimization trial to assess the tolerability and efficacy of topiramate as monotherapy in recently (within 5 years) diagnosed patients with epilepsy. treatment naive patients (patients who have never received the treatment before) and patients who failed on their first aed in monotherapy are allowed. failure is defined as a lack of efficacy and/or tolerability of that aed and the reason for failure is recorded by the physician. a lack of efficacy is characterized when the patient has been treated with aed at target dose but the patient still has seizure. topiramate will first be titrated up to an initial target dose that will be reached after 4-6 weeks. further dose titration is guided by the clinical response of the individual patient, but the dose may not exceed a maximum of 400mg/day \[9mg/kg/day for children\]. if the patient uses an aed at entry, the aed will be fully tapered off over a period of 3 weeks, starting at the beginning of week 2, in order to have all patients on topiramate monotherapy at visit 3. tapering the aed off may, however, extend this 3-week period if clinically indicated. visits will be performed at baseline and after 2, 4, 8, 12, 16 weeks. the total duration for each patient in the study will be 4 months.

Eligibility criteria:
inclusion criteria: * has been diagnosed with epilepsy within the past 5 years with primary generalized tonic-clonic (pgtc) seizures as well as partial onset seizures with or without secondary generalization * therapy naive, or being treated with their first anti-epileptic drug (aed) in monotherapy that fails in efficacy, tolerability, or both, and not in need of a combination aed therapy * informed assent in children at least 7 years and older exclusion criteria: * have pseudoseizures or the treatable cause of the seizures (eg, metabolic disorder, toxic exposure, active infection or neoplasia) * has any clinically relevant progressive or serious illness (eg, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbance) * pregnant or breast-feeding * has a history or suspicion of alcohol or drug abuse * must have on current treatment with furosemide, hydrochlorothiazide, monoamine oxidase inhibitors

Keywords: epilepsy seizures topiramate anti-epileptic drug nervous disorder
nivolumab plus chemoradiotherapy in patients with muscle-invasive bladder cancer (mibc) not undergoing cystectomy

Conditions: Bladder Cancer

Summary: the purpose of this study is to investigate the effect synchronous use of nivolumab in addition to chemoradiotherapy in patients withnon-metastatic mibc who are not candidates for radical cystectomy

the initial hypothesis is that addition of nivolumab will increase 2-year locoregional control rate from 55% (control arm) to 75% (immunotherapy arm) there is a 24 month accrual period during which 78 patients will be randomized in a control group (standard chemo-radiotherapy) and the treatment group (chemo-radiotherapy + nivolumab) the primary objective would be to compare locoregional control rate at 2-years between patients with mibc receiving or not receiving nivolumab in addition to chemoradiotherapy. the secondary objectives are 1. to study the safety of the addition of nivolumab to chemoradiotherapy in patients with mibc 2. to compare 2-year bladder cancer failure-free (bcff) rates, defined as distant metastasis free survival (mfs) and/or locoregional failure (defined as in primary objective) 3. to compare median overall survival (os) in patients with mibc receiving or not receiving nivolumab in addition to chemoradiotherapy 4. assess the effect of combined treatment on the quality of life correlative studies of outcomes with pd-l1expression and with lymphocytic populations in the environment of the tumor

Eligibility criteria:
inclusion criteria: * histologically proven, muscle-invasive carcinoma of the bladder, ct2-t4an0m0 * urothelial, squamous or glandular histology according to who 2016 classification (fig 1) * undergone a vigorous turb * not candidates for radical cystectomy. * ps:0-1 * age \>18 years old * adequate bone marrow function * adequate renal function exclusion criteria: key exclusion criteria * histology other than transitional-cell, squamous or adenocarcinoma * prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer cervix or breast. * previous systemic chemotherapy or prior biologic agents within 4 weeks, or intravesical bacillus calmette-guerin (bcg) within 6 weeks of the first dose of study treatment. * prior treatment with any pd-1 or pdl-1 inhibitor or anti ctla4 agent * previous pelvic radiation therapy. * patients with inherited syndromes associated with hypersensitivity to ionizing radiation * any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation * any history of inflammatory bowel disease and or history of abdominal fistula * previous allergy to any of the study drugs
feasibility study of a novel device for chronic wounds

Conditions: Ulcer; Wounds and Injuries

Summary: the purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.

this is an open label study

Eligibility criteria:
inclusion criteria:- venous stasis ulcer or other chronic wound on the lower extremity that is \>1.5cm and \<10cm at widest point * the wound must have at least 2 cm of intact epithelium surrounding it. * a wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved. * ulcer must not have healed for \>14 days under standard treatment. * chronic wound with prior graft placement will be allowed in the study. * patient is \>18 years old. * willing and able to sign informed consent. exclusion criteria:- active wound infection. * 3+ or greater pitting edema of lower extremity * history of malignancy at wound site. however, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study. * thick eschar at wound base after debridement. * wound location is not amenable to forming an airtight seal and placement of device. * ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, raynaud's syndrome. * current smoker (must have quit for \>3 weeks) * wound with exposed bone, blood vessels, tendon * significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone * fasting blood sugar \>200 by study personnel administered bedside fingerstick blood glucose * ankle brachial index less than lower limit of normal (\<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds). * pregnancy * incapable of giving informed consent * inability to comply with study procedures including lack of telephone access for week 8 telephone survey
effect of acupuncture and low caloric diet on primary hypothyroidism and irregular menstruation in infertile women

Conditions: Primary Hypothyroidism; Acupuncture; Irregular Menstruation; PCO

Summary: the goal of this randomize clinical trial is to compare in 60 infertile women with hypothyroidism. selected from national nutritional institute out clinic. the main question it aims to answer is: • there an effect of acupuncture and low caloric diet on primary hypothyroidism and irregular menstruation in infertile women. all participants were received• thyroxine tablets (levothyroxine) • a low caloric diet regime. researchers compared study group (30 infertile women with hypothyroidism) to see the effect of acupuncture sections on hypothyroidism.

each woman was instructed carefully about the assessment and treatment procedures and a consent form has been signed by each woman before starting of this study, * each patient in the study group was instructed about the beneficial effect of the acupuncture. * each woman in the study group assumed supine position for the points (du20, gb20, st9, li4, rn6, rn4, sp9, st36, sp6, ki3, lr2). and prone position for du14, bl15, bl20, bl23, du4 with uncovered treatment area, which was cleaned with alcohol and hair was removed. acupuncture was applied on a room temperature of 37. fine sterile needles used with a size 0.25x25mm. they were inserted to various depths (2-5 cm) at acupoints points on the body according to site and fat deposition. 16 needles were used in the treatment.

Eligibility criteria:
inclusion criteria: * sixty pcos women will be evaluated for presence of hirsutism, acne, irregular menses. they will be diagnosed for presence of cysts by ultrasonography apparatus. * they will complain from primary hypothyroidism. their thyroid-stimulating hormone (tsh) will be \>4.0mu/l and free tetraiodothyronine (ft4) will be \<0.8ng/dl. * their luteinizing hormone / follicle-stimulating hormone (lh/fsh) ratio will be \<1. * their age will range from 20-35 years old. * their body mass index (bmi) will be \> 25 kg/m2 and \< 39.9 kg/m2. exclusion criteria: * history of previous neurological disorders, previous thyroidectomy, and surgical removal of uterus. * presence of hemorrhage, carcinoma, metal implants and using of immune suppressant drugs. * presence of endometriosis, uterine fibroids, primary ovary insufficiency, fallopian tube damage or blockage, pelvic adhesion, autoimmune disorders, implantation failure, and infections.

Keywords: primary hypothyroidism acupuncture low caloric diet infertile women