Kornimate/medical-research-clean huggingface dataset:
effect of dhea on patients with poor ovarian responds

Conditions: Subfertility

Summary: the purpose of this study is to investigate the effect of dhea for treatment of subfertile patients with poor ovarian reserve and post-treatment evaluation of ivf outcome.

the aim of this randomized controlled study is to compare the effect of dhea and placebo on live birth rate in poor ovarian responders. consecutive infertile women attending the subfertility clinic for ivf treatment will be approached. those fulfilling the selection criteria would be recruited and a written consent will be obtained after detailed explanation and counseling. baseline assessment will be performed at early follicular phase (day 2 or 3) at recruitment. patient characteristics including age, body mass index (bmi), and smoking status would be recorded and blood test including follicular stimulating hormone (fsh), estradiol (e2), testosterone and anti-müllerian hormone (amh) would be checked. pelvic scan will be performed to assess the total antral follicle count (afc) and total ovarian volume. subjects will be randomized divided into two groups: 1. dhea group: subjects will take dhea (vitacost) 25mg three times a day for 12 weeks prior to the start of ivf treatment. 2. placebo group: subjects will take placebo three times a day for 12 weeks prior to the start of ivf treatment. ultrasound assessment will be repeated in follicular phase (d2 or 3) of every month or cycle followed by a ivf treatment using antagonist protocol based on our standard departmental regimen. cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for hormonal profiles.

Eligibility criteria:
inclusion criteria: * indicated for ivf treatment according to our standard department protocol * age \< 42 * regular menstrual cycles (21-35 days) poor ovarian responders are defined according to the bologna criteria fulfilling 2 out of 3 of the following: * advanced maternal age (≥40) or any other genetic or acquired risk factor for por * previous poor ovarian response (por) (≤3 oocytes with a conventional stimulation protocol using at least 150iu gonadotrophins per day) * abnormal ovarian reserve test (i.e. afc \< 5-7 or amh \< 0.5-1.1ng/ml). alternatively, two episodes of por after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ort. exclusion criteria: * previous chemotherapy or pelvic irradiation * polycystic ovarian syndrome or polycystic ovaries * on hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or dhea)

Keywords: dhea live birth rate poor ovarian responder
deciphering the interactions between food intake, sleepiness, and nighttime sleep quality in patients with type 1 narcolepsy and idiopathic hypersomnia

Conditions: Narcolepsy Type 1; Idiopathic Hypersomnia

Summary: links between sleep and food intake are manyfold. in healthy individuals, sleep deprivation promotes obesity by stimulating food intake of high glycemic index (gi) foods. conversely, high gi foods induce sleepiness. obesity is observed in 30-50% of patients with narcolepsy type 1 (nt1). its determinism may involve transient changes in basal metabolism at the early stage of the disease, eating disorders, disrupted nighttime sleep and sleepiness. in contrast, patients suffering from idiopathic hypersomnia (ih), whose nocturnal sleep is generally long and of good quality, rarely present with obesity. by studying the relationships between diet, body composition and sleep patterns in these two populations and in healthy controls, the narcofood study aims to provide a better understanding of the determinants of obesity in narcolepsy and, more generally, of the effects of food intake on sleepiness. patients will be recruited at the lyon and clermont-ferrand sleep centers and controls at the lyon neuroscience research center. data from clinical evaluation (including body mass index and body composition), and questionnaires (sleep quality, insomnia, sleepiness, anxiety and depression, impulsivity, eating behaviors) will be collected. during 4 days, at home, the following parameters will be explored : 1) eating behaviors (meals' photos) and sugar consumption (freestylepro sensor measuring interstitial glucose) 2) sleep/wake rhythm (diary and actigraphy) 3) nocturnal sleep parameters (somfit device) 4) sleepiness (karolinska sleepiness scale and eeg markers of sleepiness with the somfit device) before and after meals. the hypothesis is that increased sleepiness would favor food intake of high gi foods, which would worsen sleepiness in all 3 groups, with a more pronounced effect in nt1. compared to ih patients and controls, nt1 patients may present more snacking of high gi foods, especially at night if sleep is disrupted, and this would be correlated with body composition. the findings will help to better understand the mechanisms of obesity in narcolepsy and may lay the ground for the development of new therapeutic strategies in disorders of hypersomnolence, targeting dietary behaviors.


Eligibility criteria:
inclusion criteria : * patients with nt1 or ih (icsd-3-tr) or healthy controls without sleep disorder * familiar use of a smartphone exclusion criteria : * untreated moderate or severe sleep apnea syndrome; * cognitive disorders incompatible with the protocol; * unstable treatment or treatment with sodium oxybate; * unstable medical or psychiatric pathology; * shift work; * pregnancy or breastfeeding; * diabetes

Keywords: narcolepsy type 1 idiopathic hypersomnia obesity food intake disrupted nighttime sleep
naltrexone treatment for alcoholic women

Conditions: Alcoholism; Eating Disorder

Summary: this study will assess naltrexone's effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women. alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment. each group will receive behavioral therapy for 12 weeks, with followup 6 months after treatment.

background: despite important gender differences in drinking patterns, physiological effects of alcohol, and co-occurring psychiatric conditions, relatively little is known about the efficacy of naltrexone for the treatment of alcohol dependence in women. this study investigated the safety and efficacy of naltrexone in combination with cognitive behavioral coping skills therapy (cbcst) in a sample of alcohol-dependent women, some with comorbid eating pathology. methods: one hundred three women meeting dsm-iv criteria for alcohol dependence (29 with comorbid eating disturbances) were randomized to receive either naltrexone or placebo for 12 weeks in addition to weekly group cbcst.

Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence. abstinent from alcohol for a period of at least 5 days. * able to read english and complete study evaluations. * a stable residence and a telephone to ensure that subjects can be located during the study. exclusion criteria: * meets criteria for dependence on another psychoactive substance besides alcohol or nicotine. * regular use of psychoactive drugs except antidepressants. * current use of disulfiram (antabuse). * psychotic or otherwise severely psychiatrically disabled. * significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac pathology. * abstinent longer than 30 days prior to admission to program. * hepatocellular disease or elevated bilirubin levels. * individuals with present history of opiate abuse or who require the use of opioid analgesics. * women who are pregnant, nursing, or not using a reliable method of birth control. * women who are significantly overweight or significantly underweight.
neurophysiological molecular and developmental analysis of the glutamate synapse in autism

Conditions: Autism

Summary: neurophysiological, molecular and developmental analysis of the glutamate synapse in autism

analysis about 50 genes in glutamate synapse

Eligibility criteria:
inclusion criteria: * have a pervasive developmental disorder exclusion criteria: * n/a
ability to awaken in nonmonosymptomatic enuresis

Conditions: Enuresis, Nocturnal, 2 (Disorder)

Summary: to evaluate the effect of controlling lower urinary tract symptoms (luts) with anticholinergics on improving the ability to awaken (aa) in children with nonmonosymptomatic enuresis and evaluate the potential implication of improved aa for treatment response prediction.

nocturnal enuresis is associated with three main etiologies, including nocturnal polyuria secondary to abnormal anti-diuretic hormone levels, low bladder capacity related to lower urinary tract dysfunction, and sleep disorders causing problems in arousal. among them, the association between enuresis and lower urinary tract symptoms (luts) has gained importance. if these two conditions coexist, the diagnosis is nonmonosymptomatic enuresis (nme). the reported prevalence of luts among enuretic patients ranges widely from 21% to 99%. moreover, it was reported that spontaneous resolution can be prolonged, and some cases of nme are likely to become refractory if treated like monosymptomatic enuresis (me) cases. a possible explanation for this may be the presence of bladder dysfunction that is not addressed properly by the standard treatment of me. however, this explanation is only speculative. by showing a paradoxical increase in light sleep and higher cortical arousal index in enuretic children with reduced bladder capacity, one of the reason for impaired ability to awaken (aa) in enuretic patients may lie in the chronic stimulation of the bladder. this kind of bladder dysfunction leading to an abnormal bladder-brain dialogue has been further elaborated by an experiment showing brain dysfunction in the ventrolateral periaqueductal gray matter as a result of the experimental reduction of the bladder capacity. if this is true for enuretic children, we may be able to improve arousal (improved aa) by increasing their bladder capacity. based on this hypothesis, the present study aimed to evaluate to the effects of anticholinergic therapy with standard urotherapy on improvement of aa and show the effect of improved aa on treatment response in children with nme.

Eligibility criteria:
inclusion criteria: * primary nonmonosymptomatic enuresis who received initial anticholinergic therapy exclusion criteria: * any urological abnormalities including neuropathic bladder

Keywords: anticholinergics awakener
subacromial injection with corticosteroid versus nonsteroidal anti-inflammatory drugs (nsaid) in shoulder impingement syndrome

Conditions: Subacromial Impingement Syndrome; Subacromial Bursitis

Summary: injection with corticosteroid is one of the most common non-operative interventions in the treatment of subacromial impingement; however, its use is limited by its potential side effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). the objective of this study was to compare the efficacy of subacromial injection of triamcinolone compared to injection of ketorolac. thirty-two patients diagnosed with external shoulder impingement syndrome were included in this double-blinded randomized controlled clinical trial. each patient was randomized into the steroid group or nsaid group.

after a single injection into the subacromial space, the patients were instructed to perform home physical therapy and follow-up in four weeks. each patient was evaluated in terms of arc of motion, visual analog scale and the ucla shoulder rating scale. the outcome measures were taken at the preinjection state, immediately post injection, and at 4 weeks follow-up.

Eligibility criteria:
inclusion criteria: 1. shoulder pain characteristic of subacromial impingement syndrome with passive and/or active abduction in the 60-120 arc of motion (positive impingement sign) 2. diagnosis of subacromial bursitis based on tenderness to palpation anterior/lateral to the acromion. pain may be exacerbated with the shoulder held in internal rotation (positive hawkins test) exclusion criteria: 1. age \<18 years 2. symptoms less than one month 3. previous shoulder injections within the past 3 months 4. evidence of os-acromiale or other confounding shoulder pathology on plain radiographs 5. evidence of shoulder osteoarthritis 6. full thickness rotator cuff tear evidenced by mri, cuff weakness after lidocaine injection, or positive drop-arm sign 7. systemic inflammatory condition 8. pending litigation or work-related claims related to the shoulder 9. previous shoulder surgery on the affected shoulder 10. evidence of local infection 11. evidence of adhesive capsulitis 12. previous history of gastrointestinal ulcers or bleeding disorders 13. evidence of shoulder instability

Keywords: pain relief hypermobility, joint increased strength increased patient satisfaction
tolvaptan phase 3 efficacy and safety study in autosomal dominant polycystic kidney disease (adpkd)

Conditions: Polycystic Kidney Disease, Autosomal Dominant

Summary: this study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with adpkd.

this study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total kidney volume increase, while impacting the onset, severity, and progression of other important consequences of adpkd. during the 3-week titration phase, tolvaptan or placebo was titrated in weekly intervals from lowest to highest tolerated levels given in split-dose regimens of 45/15 mg, 60/30 mg and 90/30 mg orally upon awakening and approximately 9 hours later. as soon as a subject could not tolerate a given dose, the titration phase was over and the maintenance phase began at the dose level tolerated. the maintenance phase lasted to month 36. subjects were able to titrate down at any point during the study. subjects were able to titrate up during the maintenance phase with medical monitor approval.

Eligibility criteria:
inclusion criteria: * legal adult age and able to give informed consent. * adult subjects with a diagnosis of adpkd. a diagnosis of adpkd (age 18 or 20-50) required several cysts in each kidney (3 if by sonography, 5 if by ct or mri) in those with a family history of adpkd and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there was no family history. * willingness to comply with reproductive precautions, if female. * estimated creatinine clearance ≥ 60 ml/min. estimated from serum creatinine during screening using cockcroft-gault with correction for gender and race, where possible. * rapidly progressive kidney growth (total volume ≥ 750 cc) by magnetic resonance imaging (mri) at randomization. exclusion criteria: * prior exposure to tolvaptan or other experimental pkd therapies. * currently taking medication for purpose of affecting pkd cysts. * women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods. * in the opinion of the study investigator or sponsor may present a safety risk or confound study objectives. * patients who are unlikely to adequately comply with study procedures. * patients having contraindications to mri. * patients taking medications or having any illnesses likely to affect adpkd outcomes.

Keywords: adpkd polycystic kidney adpkd (autosomal dominant polycystic kidney disease)
dyadic psychological stress among lung cancer patient-caregiver dyads

Conditions: Lung Cancers; Lung Cancer Patients

Summary: a lung cancer diagnosis has a huge impact on the psychological well-being of both patients and family caregivers. however, the current psychological stress status among dyads remains unclear. the investigators aimed to determine the prevalence of anxiety and depression and identify the factors that influence patients with lung cancer and their caregivers. the investigators will conduct a cross-sectional study of 254 dyads of lung cancer patients and family caregivers from four tertiary hospitals in hunan province, china from january 2021 to june 2021. besides, the investigators used several instruments to collect data on depression, anxiety, illness perception, mindfulness, self-compassion, and dyadic coping. the independent samples t-test, analysis of one-way variance, spearman's correlation analysis, and multiple linear regression analysis were employed. the results will recommend oncology nurses promptly screen high-risk patient-caregiver dyads who may suffer from severe psychological stress and provide them with targeted psychosocial interventions.


Eligibility criteria:
inclusion criteria: * as for patients: aged≥18 years; hospitalized patients with lung cancer diagnosed by pathological section or cytology; and relatively stable condition, conscious, and able to express their willingness correctly. * as for caregivers: aged ≥18 years; a primary caregiver with a cumulative caregiving time of more than 33 hours; and a family member of the patient with lung cancer, such as spouse, children, parents, or other relatives. exclusion criteria: * as for patients: people with a combination of other cancers or serious life-threatening diseases; the presence of audiological disorders or previous mental or cognitive disorders, such as anxiety disorder, or depression disorder; and receiving mental disorder treatments. * as for caregivers: formal caregivers with employment relationships, such as nannies; the presence of audiological disorders or previous mental disorders or cognitive disorders, such as anxiety disorder, depression disorder; and receiving mental disorder treatments.
evaluation of cpp-acp prophylactic effect on enamel surface during orthodontic treatment

Conditions: White Spot Lesion; Enamel Hypomineralization

Summary: this study is aiming in preventing the formation of wsl associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying cpp-acp on the enamel surface once every 2 weeks for 3 months.

cpp-acp will be applied on premolars to be extracted in orthodontic patients whose treatment plan indicates extraction of at least 2 premolaes of the maxillary arch. application will continue on one premolar either the right or left one once every 2 weeks for the first 3 months of the treatment.

Eligibility criteria:
inclusion criteria: * severe crowding * increased overjet * protruded maxillary base * sound maxillary premolars * medically free * molar classification class ii * canine classification class ii exclusion criteria: * spacing of teeth * decreased overjet * molar classification iii medically compromised patients * pregnant females * carious premolars * hypoplasia

Keywords: wsl cpp-acp
combination treatment for moderate to severe acne

Conditions: Acne

Summary: to determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne

a phase iv, open-label study evaluating the treatment for combination acne therapy.

Eligibility criteria:
inclusion criteria: * moderate to severe acne, iga = 3 or 4 (investigator global assessment) exclusion criteria: * pregnancy and allergies

Keywords: acne
intermittent preventive treatment for malaria in patient with sickle cell disease

Conditions: Malaria; Sickle Cell Crisis

Summary: malaria prophylaxis is recommended for sickle cell disease patients. in nigeria, daily proguanil or weekly pyrimethamine are the most commonly prescribed regimens, but the current policy is not effective due to poor compliance and drug resistance. intermittent treatment with a long acting drug regimen administered under supervision at clinic visits may be more effective. the aim of this trial is to compare the tolerability and acceptability of supervised bimonthly treatment with either sulfadoxine-pyrimethamine plus amodiaquine (sp+aq) or mefloquine plus artesunate (mq+as), with the daily proguanil. two hundred and seventy patients with sickle cell disease attending the paediatric sickle cell disease clinic in ilorin hospital who meet the eligibility criteria and have parental consent, will be randomized to one of three prophylactic regimens: daily proguanil, bimonthly sulfadoxine-pyrimethamine plus amodiaquine, or bimonthly mefloquine plus artesunate. patients will be asked to return to clinic every two months and whenever they are sick. at enrollment, the study paediatrician will conduct a physical examination of the child, and collect a venous blood sample for a complete blood cell count and biochemical screen, determination of g6pd genotype, preparation of blood smears for malaria microscopy and a blood spot for determination of molecular markers of resistance. four days after each clinic visit, patients will be interviewed (by phone and, for a subset, at home or in the clinic) to ask about compliance and adverse events. participants will be followed for one year. the parents or carer will be encouraged to bring their child to the outpatient department clinic if the child becomes unwell. the primary outcome of the trial is tolerability, secondary outcomes are adherence to the regimen, and incidence of malaria and the number of hospitalizations over 12 months. if the bimonthly regimens are well tolerated and the preliminary data from this study are promising, a larger multicentre trial will be required to determine efficacy.


Eligibility criteria:
inclusion criteria: * age 6months or older and \>=5kg * sickle cell clinic attendant * both males and females * agree to abide by the study protocol * give informed consent and assent * not acutely sick at the time of recruitment * not having additional chronic disease * hb genotype of ss and sc confirmed by electrophoresis exclusion criteria: * known allergy to any of the antimalarial drugs use in the trial, * severe illnesses requiring urgent admission, * treatment with sulfadoxine-pyrimethamine or mefloquine in the previous 2wks * patients on cotrimoxazole prophylaxis

Keywords: sickle cell disease malaria intermittent preventive treatment (ipt) prophylaxis
hygieacare prep vs split-dose peg prep prior to colonoscopy

Conditions: Colonoscopy

Summary: the purpose of this study is to compare the level of cleanliness using the hygieacare prep vs the standard of care split-dose peg prep used prior to colonoscopy.

the level of cleanliness will be recorded using the boston bowel prep score (bbps) by an endoscopist who is blind to the randomized preparation.

Eligibility criteria:
inclusion criteria: 1. patient referred to colonoscopy 2. patient with high probability for poor prep due to one or more of the following: 1. chronic constipation (rome iii functional constipation criteria) 2. gastroparesis 3. immobilization 4. diabetes 5. history of poor prep exclusion criteria: 1. patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study. 2. patient is currently taking narcotics. 3. patient has any of the contraindications listed below: 1. cardiac: congestive heart failure (nyha class iii or iv or ef \< 50%) 2. gi: intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery 3. gu: renal insufficiency (cc \< 60 ml/min/173m2), cirrhosis with ascites 4. abdominal surgery within the last 6 months 5. pregnancy

Keywords: colon polyps cancer screening