Kornimate/medical-research-clean huggingface dataset:
effects of a fasting mimicking diet on sperm quality

Conditions: Sub Fertility, Male; Fertility Disorders; Sperm Count, Low

Summary: this study investigates the effect of repetitive cycles of a fasting mimicking diet (3x5 days in six months) on sperm quality in men

this 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in male infertility due to reduced sperm quality according to who5-criteria. the participants will be randomized in two groups. the intervention group follows a regime of a periodic fasting mimicking diet (3x5 days in six months, every 6-8 weeks, accompanied via a mobile application), whereas the patients on the waiting list continue their normal diet. spermiograms are taken about every 2 months following the who-5 criteria. in addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.

Eligibility criteria:
inclusion criteria: * men aged between 18 and 60 years * unfulfilled desire to have a child \> 1 year * reduced sperm quality (proven via spermiogram according tho who-5 criteria) * informed consent * 20 kg/m² \<= bmi \<= 35 kg/m² exclusion criteria: * no sufficient communication possible * severely impairing cognitive illness * serious mental illness * patients with anatomical/organic damage of reproductive organs * eating disorders in the medical history * serious internal diseases * lack of internet access * no consent to randomisation * participation in other studies

Keywords: fasting natural therapies fasting mimicking diet caloric restriction dietary restriction dietary intervention lifestyle modification spermiogram sperm motility liquefaction time sperm morphology total sperm count sperm density
role of medical treatment in endometriosis patients undergoing icsi

Conditions: Endometriosis

Summary: the aim of this study to assess the effect of medical treatment prior to stimulation on fertility (icsi) outcome in cases with endometriosis associated infertility.

patients complaining of infertility due to endometriosis diagnosed by ultrasound or laparoscopic surgery will be randomly allocated to three groups : group a: will receive cocps for 3-6 months prior to starting ivf / icsi cycle. group b: will receive dienogest for 3-6 months prior to starting ivf / icsi cycle. group c: will be subjected to direct icsi /ivf cycle. then all patients will be subjected to ovarian stimulation regimen using gnrh agonist down-regulation gonadotropin stimulation-the "long" protocol. during the ovarian stimulation, the woman's response is monitored with serum estradiol levels and vaginal ultrasound examinations. the estradiol level is used to determine the dose of gonadotropins and whether under- or overstimulation occurs. the goal of the ovarian hyperstimulation is to develop at least three mature follicles that are 17 mm in diameter or larger. once this is achieved, fsh and other medications are discontinued, and a single injection of hcg is given to mature the eggs to allow fertilization. the hcg administration will also cause ovulation, but this does not occur until 40 hours or later after the injection. therefore, it is standard that the hcg injection is administered 36 hours before the scheduled egg retrieval such that this will allow adequate maturation of the eggs and yet there would be little risk of ovulation. then the process will be continued through oocyte retrieval, oocyte maturation , fertilization by icsi. each group will be followed up to detect the number of oocyte yield, fertilization rate and availability of good quality embryos and then according to the results the effect of medical treatment prior to stimulation will be assessed.

Eligibility criteria:
inclusion criteria: * presence of endometrioma on ultrasound. * history of ovarian cystectomy either open or via laparoscopic surgery. * presence of endometriotic foci in the pelvis during laparoscopic surgery. * patients coming for the first icsi / ivf cycle. exclusion criteria: * age above 40 years * cases with endometrioma on ultrasound more than 3 cm size. * prior failed icsi / ivf. * known poor responders or poor ovarian reserve, defined as afc\<5 or amh \< 0.5 . * patients with previous uterine surgery. * patients diagnosed to have uterine abnormalities

Keywords: oocyte yield, fertilisation rate
face masks for preventing influenza transmission

Conditions: Influenza Human

Summary: this work aims to measure the effectiveness of face mask worn by a patient with flu to avoid transmission to other persons in the household.

background. non pharmaceutical interventions, and in particular the wearing of face masks, could play a role in controlling the transmission of influenza in the early stages of the epidemic. in the french pandemic plan, surgical masks are recommended in contagious patients in wards. the effectiveness of such masks in preventing transmission of influenza a virus is unknown. our project aims to assess the preventive efficacy and tolerance of surgical mask. the primary objective is to measure the decrease of the number of secondary cases of flu in households where the index case will wear a surgical mask during its period of infectiousness (5 days), compared to households where the index case will not be subject to this intervention. secondary objectives are: (1) to study the feasibility and tolerance of wearing a mask continuously during the period of viral shedding; (2) virological description of infection spreading among household contacts based on virological collections.

Eligibility criteria:
inclusion criteria: patient seeking medical advice for: * for symptoms less than 48 hours, combining fever\> = 37.8 ° c and a cough, * during the period of a seasonal influenza epidemic (as defined by the sentinel network) * older than 5 years * and living in a household size between 3 to 8.. * the patient is the first case in the household (index patient). the patient has a positive rapid influenza a test. * informed consent. * affiliation to the social security. exclusion criteria: * when concomitant influenza cases are known in other householders * when the patient is suffering from asthma or copd (ongoing treatment): * hospitalization. * treatment by a neuraminidase inhibitor.

Keywords: influenza, human masks disease transmission, horizontal
cilostazol following peripheral endovascular procedures

Conditions: Peripheral Arterial Disease

Summary: to compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral angioplasty or stenting or both for the management of peripheral arterial disease.

this is a multi-center, randomized, single-blinded, phase iii, controlled trial investigating the safety and effectiveness of dual antiplatelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral, infrainguinal angioplasty or stenting or both for the management of peripheral arterial disease (intermittent claudication or critical limb ischemia). the study will include in total 200 patients randomized on a 1:1 basis to receive either dual antiplatelet therapy for 6 months cilostazol 100 mg once daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily for 12 months. the study's primary endpoint will be the composite of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, major amputation, target limb open surgical or endovascular revascularization). additional therapy with clopidogrel 75mg daily will be added in either group for one month in case of stent placement. secondary endpoints will include quality of life assessment using dedicated questionnaires, drug- and procedure-related complication rates, target-limb revascularization rates, clinical improvement (abi and rutherford-becker classification changes). clinical follow up will be performed at 1, 6 and 12 months and will include physical examination, abi measurements, rutherford-becker classification. maximum follow up period will be 2 years after the index procedure.

Eligibility criteria:
inclusion criteria: * scheduled infrainguinal (femoropopliteal or infrapopliteal or both) angioplasty and/or stenting. * surgical or endovascular treatment of inflow iliac artery significant stenosis if deemed necessary. * symptomatic severe intermittent claudication (rutherford-becker 3) or critical limb ischemia (rutherford-becker 4-6). * informed consent signed exclusion criteria: * any contraindication to aspirin or cilostazol intake * no pedal arch outflow * sole iliac artery treatment * standard contraindications to angioplasty * acute or sub-acute limb ischemia
diet / gut microbiome interaction and influence on inflammatory disease in hiv patients

Conditions: HIV

Summary: the primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in antiretroviral therapy (art)-treated hiv-infected participants and human immunodeficiency virus (hiv)-negative controls in the united states.

this is a randomized clinical trial. fifty (50) antiretroviral therapy (art)-treated human immunodeficiency virus (hiv) positive participants, 24 hiv negative controls matched for age and sex, and 24 hiv negative controls from a population at high risk for contracting hiv will be recruited into 3 cohorts. all participants will undergo a 4 week diet modification and will be randomly assigned to receive either an agrarian diet or a western-type diet. for the first 2 weeks, food will be provided to the participant, followed by an additional 2 weeks where participants will be provided a diet menu with recipes to prepare themselves. there will be 4 study visits and participation will last for up to 2 months.

Eligibility criteria:
inclusion criteria: * hiv-infected cohort (cohort a) * documentation of hiv-1 infection defined as a positive antibody test or plasma hiv-1 rna (ribosomal ribonucleic acid). * treated with art (minimum of three antiretroviral drugs in regimen) for at least 12 months with no changes in antiretroviral drugs over the past 6 months * plasma hiv-1 rna ≤ 50 copies/ml in the preceding 6 months. * hiv-negative cohorts (cohort b and c) * documentation of a negative hiv-1 antibody test * all cohorts * age 18 to 65 years * body mass index between 21-29 kg/m2 (non-obese) * stable weight for at least 3 months (≤15% change in body weight) * negative pregnancy test (if female) exclusion criteria: * use of systemic (oral or parenteral) antibiotics within two months prior to study entry * active chronic infection such as hepatitis b or c or an active malignancy that requires systemic chemotherapy.

Keywords: gut microbiota composition
neck liposuction for the treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: liposuction, one of the most common cosmetic procedures performed in the united states, is a surgical technique used to reduce localized areas of excess subcutaneous fat. the neck is a common area of treatment, where liposuction reduces fat volume and neck size. we hypothesize that suctioned removal of fat of the neck will reduce the severity of obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * age 18-60 years of age * subjects must have documented mild to moderate obstructive sleep apnea(osa) syndrome within the last year from the northwestern university sleep clinic * subjects must qualify as "very sleepy" on the epworth sleepiness scale * females must have neck circumference of 16.0 cm or greater, and males must have neck circumference of 17.0 cm or greater * subjects must be a good candidates for neck liposuction as determined by the study physician * subjects must be in good health and is able to undergo the liposuction procedure exclusion criteria: * pregnant or lactating female * subjects who are unable to understand the protocol or to give informed consent * subjects dependent on blood thinners * subjects with bleeding diathesis * subjects with a history of poor wound healing, skin fragility, poor skin elasticity, or hypertrophic or keloidal scarring * subjects with a history of excessive surgeries on the neck in the area to be treated * subjects who are allergic to lidocaine or who have previously had an adverse reaction to epinephrine * subjects with non-apnea sleep disorders such as restless leg syndrome, insomnia, circadian rhythm disorders * subjects with chronic obstructive pulmonary disease * subjects with craniofacial abnormalities * subjects with hypoventilation * subjects with large tonsils/adenoids or an abnormal airway exam as determined by the study physician * subjects with an anatomical nasal obstruction * subjects who have a large tongue * subjects with severe cardiopulmonary risks as determined by the study physician * subjects who cannot complete an mri * subjects who intend to pursue other treatments for osa during the duration of this study * any previous and/or pending procedures at the treatment area or that may likely affect the treatment area * pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment * subjects with a body mass index \>35kg/m2 * subjects treated with continuous positive airway pressure (cpap) within one month of study enrollment
validation of a record-based frailty assessment according to the multidimensional prognostic index

Conditions: Frail Elderly Syndrome

Summary: background various phenotype and cumulative frailty assessment tools have been developed and compared in research. for use in an in-hospital setting, a cumulative and graded frailty assessment method is preferred in order to identify subgroups of patients at risk of adverse events during discharge and transition to primary care. comprehensive geriatric assessment (cga) is the gold standard to assess frailty. most medical wards have limited access to specialized geriatric team support capable of performing cga. thus in these wards there is a need for a cga based instrument to identify the frail patients and to quantify the level of frailty. the multidimensional prognostic index (mpi) is based on cga and is a comprehensive cumulative deficit frailty assessment tool validated in a danish geriatric department. mpi is fully applicable in the everyday clinical work and supplies useful information to clinicians. it can predict readmission and death, and it is well-suited to assess the degree of frailty. enabling identification of patients at risk of adverse events facilitates targeting of the interventions in order to improve patient outcomes. the mpi is a bedside assessment. however, in observational record-based research the patient is not accessible for the researcher. to assess and identify hospitalized frail patients retrospectively for clinical research, a valid record-based frailty assessment method is needed. the aim of this study is to compare the accuracy of a record-based mpi assessment with a bedside performed mpi assessment in order to use the record-based mpi when access to bedside mpi is impossible.


Eligibility criteria:
inclusion criteria: * acutely admitted to one of the two medical departments listed below * aged 75 years or older * living within the municipality of aarhus exclusion criteria: * included in any other kind of follow-up schemes * already included in this study * declared terminally ill or undergoing palliative care at admission * admitted from one specific temporary nursing home with geriatric medical assistance (vikærgården) * discharge or transfer to another department, including hospice * the patient does not want to participate in the mpi-screening process

Keywords: multidimensional prognostic index frailty geriatric elderly aged +75 comprehensive geriatric assessment
efficacy of vr educational program on empathy and attitudes toward dementia in caregivers

Conditions: Dementia; Caregiver Burden

Summary: this study aims to evaluate the effect of vr educational program on improving attitude and empathy toward dementia among caregivers. we plan to recruit around 600 participants and randomly assign them to either a control group or an experimental group. the experimental group will participate in a dementia educational program combining vr lasting approximately 2-3 hours. data would be collected from related questionnaires to investigate whether combining vr with dementia education can effectively improve participants' empathy and attitude toward dementia.

this study aims to evaluate the effect of vr educational program on improving attitude and empathy toward dementia among caregivers. we plan to recruit around 600 participants and randomly assign them to either a control group or an experimental group. the control group will receive traditional education on dementia which is primarily taught by instructors. the experimental group will participate in a dementia educational program combining vr lasting approximately 2-3 hours. the virtual reality educational modules predominantly offer first-person narratives that delineate various symptoms associated with dementia. before, immediately after, and 4 weeks after the traditional and vr educational program, all participants will be asked to complete questionnaires about dementia empathy and attitude to explore whether combining vr with dementia education can effectively improve participants' empathy and attitude toward dementia.

Eligibility criteria:
inclusion criteria: 1. over 20 years; 2. speak chinese; 3. take care of people with dementia currently. exclusion criteria: 1. those who are unable to use vr devices due to certain physical or mental situations; 2. those who have fear/disgust for vr devices; 3. those who feel dizzy after using vr devices; 4. the individual with dementia is currently residing in a care facility.
optimized therapy in severe traumatic brain injured patients

Conditions: Traumatic Brain Injury; Coma

Summary: severe traumatic brain injury is associated with life-threatening and incapacitating secondary injury. contemporary therapeutic interventions are aimed at preventing and treating secondary damage. in this context, improved cerebral metabolism is an important target in modern neurointensive care. the main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide restores disturbed brain metabolism following severe traumatic brain injury.

patients suffering from severe traumatic brain injury and requiring multimodal neuromonitoring during pharmacological coma will receive alanyl-glutamine dipeptide (dipeptiven) as part of standard clinical nutrition. in two groups of patients the influence of different duration of infusion (group 1: 24 hours; group 2: 5 days) will be investigated. for this, pharmacokinetic and pharmacodynamic parameters in plasma and brain are determined. increased plasma glutamine and alanine in arterial and jugular venous plasma and in cerebral microdialysates are to reflect efficacy of dipeptiven infusion. plasma glutamate levels as well as changes in cerebral glutamate, lactate, lactate/pyruvate ratio, intracranial pressure, bispectral index electroencephalography will be measured to exclude potential adverse effects

Eligibility criteria:
inclusion criteria: * severe traumatic brain injury * prolonged pharmacologic coma * multimodal neuromonitoring (microdialysis, ptio2) * enteral nutrition exclusion criteria: * patients anticipated to decease within 48 hours * abdominal injury * mass transfusion * renal impairment * hepatic impairment * barbiturate coma * parenteral nutrition * weight below 50 kg * weight above 100 kg

Keywords: traumatic brain injury glutamine microdialysis metabolism
targeting leukotrienes in kidney disease

Conditions: Diabetic Kidney Disease

Summary: diabetic kidney disease (dkd) is associated with significant morbidity and mortality. identifying new treatments for dkd to be used alone or in combination with other therapies is a high priority. inflammation plays a key role in dkd and targeting pro-inflammatory lipid mediators called leukotrienes may represent a promising therapy for dkd. the current proposal will investigate whether montelukast, a leukotriene antagonist, reduces proteinuria and improves vascular function and arterial stiffness in patients with dkd.


Eligibility criteria:
inclusion criteria: * ckd stage 3 * urine albumin to creatinine ratio 200-5000 mg/g * blood pressure \<140/90 mmhg * use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks * history of diabetes type 1 or 2 * bmi \<40 kg/m2 * stable antihypertensive regimen for at least one month prior to enrollment * stable diabetes regimen for at least one month prior to enrollment * sedentary or recreationally active (\<2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements) * able to provide consent exclusion criteria: * significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * uncontrolled hypertension * factors judged to limit adherence to interventions (e.g. history of medication noncompliance, noncompliance with follow up visits, significant cognitive impairment, etc.) * anticipated initiation of dialysis or kidney transplantation within 3 months * current participation in another research study * pregnancy or planning to become pregnant or currently breastfeeding * allergy to aspirin * severe hepatic impairment (child-pugh class c) * history of major psychiatric disorder * use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction) * current use of sglt2 inhibitor * current use of phenobarbital, rifampin or carbamazepine.
study to assess the safety, tolerability, pharmacokinetic (pk) and pharmacodynamic (pd) effects of evp-6308 and the potential of evp-6308 to affect the pk properties of the antipsychotic regimen in subjects with schizophrenia currently receiving stable treatment with up to 2 atypical antipsychotics

Conditions: Schizophrenia

Summary: this is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of evp-6308 administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic regimen.


Eligibility criteria:
inclusion criteria: • diagnosed with schizophrenia, male or female subjects, 18 to 60 years of age exclusion criteria: * clinically significant abnormalities on physical examination, medical history, ecg, vital signs, laboratory values, or unstable medical or psychiatric illness * any disorder that may interfere with drug absorption * clinically significant allergy or sensitivity to medications positive test for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen, or hepatitis c antibody * pregnant or breast feeding

Keywords: phosphodiesterase 10 inhibitor
liberate international

Conditions: Stress Urinary Incontinence

Summary: this is a prospective, randomized, double-blind, sham-controlled clinical study. the study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.

approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed.

Eligibility criteria:
key inclusion criteria: * signed and dated icf * pre-menopausal females * documented diagnosis of sui exclusion criteria: * pregnant or planning to become pregnant within the year * undergone other sui treatments (excluding kegels)

Keywords: incontinence urine urinary pee leak sui