Kornimate/medical-research-clean huggingface dataset:
the immune reactivity of biofilms in vaginal mesh erosion.

Conditions: Uterine Prolapse; Urinary Incontinence; Fecal Incontinence

Summary: aging, birth trauma and extensive pelvic surgery are the causes known to cause advanced pelvic organ prolaspe, fecal as well as urinary incontinence. surgical treatment is the last resort to manage the above-mentioned clinical manifestations of pelvic floor disorders except the subject is too frail to receive operation. in order to improve the outcome of reconstructive pelvic surgery, reinforcement with synthetic mesh or biological material is the modern trend in pelvic repair. unfortunately no prosthesis including synthetic or biological is ideal because vaginal erosion with mesh extrusion which is the subject of this protocol and other complications were reported continuously. as per the literature, the rate for mesh vaginal extrusion ranged between 2.4 and 17% when polypropylene which is the most popular synthetic material used for the mid-urethral sling or pelvic reconstructive surgery to date. the causes of this complication are still controversial which include rejection, poor quality of tissue, surgical artifact, material of mesh and etc. a prospective controlled study for the investigation of the cause for mesh vaginal erosion was conducted and the results revealed evidences of immune reactivity after mesh implantation, albeit the evidence was not solid (am j obstet gynecol 2004; 191(6): 1868-1874 ). as per the pilot study initially done by us to determine the biofilm-related-infection, we have found bacterial biofilm could adhere to surfaces and interfaces, i.e. bacteria located in the cells just beneath the contacting surfaces in the electron microscopic (em) analysis. in addition, soon after bacteria infection, proteins in biofilm undergo conformational changes, making them immunogenic and triggers a typical inflammatory response leading to activation of the complement system. thus, we plan to use cd (clusters of differentiation) antigens - 4, 8, 20, 25, 40, 68 and quantitative analysis of foxp3 to determine the function of regulatory t cells in the immune response. in addition, bacterial culture and em analysis of the excised mesh with surrounding vagina tissue will be performed for further analysis of biofilms.


Eligibility criteria:
inclusion criteria: * study arm: subjects present with mesh erosion in vaginal after placement of polypropylene mesh for either urinary stress incontinence or pelvic organ prolapse. * control arm: subjects present with symptomatic vaginal prolapse but without mesh erosion after placement of polypropylene mesh for either urinary stress incontinence or pelvic organ prolapse. exclusion criteria: * study arm: the eligible subjects with fasting sugar level ≥ 180mg/dl, post prandial sugar level ≥ 230mg/dl. * control arm: polypropylene mesh placement less than 6 months.

Keywords: biofilm-infection-related immune hyperreactivity mesh extrusion mid-urethral sling determine the immune reactivity of biofilms in mesh erosion
new clinical applications for internet-based cognitive behavior therapy for insomnia and depression

Conditions: Insomnia; Major Depression; Minor Depression

Summary: this study includes two sub-trials. both are included in this singe registration since they have parallel inclusion of participants and have been approved by the swedish ethics board together in one application. trial 1 includes patients with both insomnia and major or minor depression. participants are randomized to either a combined therapist guided internet-cbt for insomnia and depression, or to internet-cbt for depression with an addition of a placebo intervention for insomnia. the primary purpose is to evaluate changes in insomnia and depression severity for the combination treatment compared to the depression treatment, after treatment and at 6 and 36 months follow up. a secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. recruitment is done in the stockholm county through mass media and the internet psychiatry clinic's regular patient recruitment. trial 2 includes patients with insomnia who do not meet criteria for major or minor depression. all participants start therapist guided internet-cbt for insomnia. after 4 weeks patients that are judged to be at risk of treatment failure are randomized to either continued treatment or treatment with added support intended to enhance outcome. the primary purpose is to evaluate change in insomnia severity for participants who get added support, compared to continued treatment with regular support level. a secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. recruitment is done in the stockholm county through mass media and the internet psychiatry clinic's regular patient recruitment. note: the first participants in trial 1 will be regarded as pilots, due to problems with the experimental treatment: technical issues as well as problems with the design of treatment modules. these problems were corrected when discovered. 12 participants in the experimental arm were affected by these errors. the pilot participants will not be included in the main analyses of data. this was decided upon on 31st of october 2014.


Eligibility criteria:
inclusion criteria: * clinical level of insomnia (more than 10 on isi) * meets criteria for insomnia according to dsm-iv-tr * enough language skills * only trial 1: meets criteria for major or minor depressive disorder according to dsm-iv-tr (for minor depression a madrs-s-level of \>19 is required). exclusion criteria: * sleep disorders requiring other treatment * alcohol/drugs abuse * started to use or changed the dose of antidepressant drug during the last 2 months * somatic or psychiatric conditions requiring acute care * working night shifts * only trial 2: meets criteria for major or minor depressive disorder according to dsm-iv-tr (for minor depression a madrs-s-level of \>19 is required for exclusion).

Keywords: cognitive behavior therapy internet treatment self-help treatment insomnia depression icbt cbt-i cbt-d
social media on prescription for colorectal cancer patients

Conditions: Colorectal Cancer

Summary: the overall aim with this study is to get a deeper understanding of the potential benefits with a health platform for patients diagnosed with colorectal cancer.

this is a prospective randomized parallel group design. consecutive patients will be recruited from participating hospitals and randomized to either "prescribed participation" or just receiving information about the platform but with no prescription. all patients are also receiving standard care. after treatment all patients will receive information about the platform and the aim with the platform. a short demonstration of the platform will also be provided. the platform will contain general information on "life after cancer treatment". it will be a forum to discuss with fellow-patients, both experienced and newly treated and it is also possible to address questions to health professionals. after the demonstration an information about the study will be given and patients will be asked to participate. if accepted a consent form will be presented and signed by the patients. all patients will be given an alias - a username, to be used at the platform which gives the patients confidentiality. however, as this is a research project they will be informed that their clinical data will be extracted from their patient charts. the alias will in a separate file be connected with their personal identification number. the patients randomized to intervention (prescribed participation) will be offered to contact a research nurse or researcher if they have any practical questions regarding the use of the platform. all patients will be asked to answer a questionnaire at baseline, 3, 6 and 12 months after surgery. patients will be answering the questionnaires electronically on the platform or in a paper version sent by ordinary mail.

Eligibility criteria:
inclusion criteria: * colorectal cancer diagnosis within 1 year * must be able to speak and read the swedish language * must be able to use the health platform exclusion criteria: -inability to speak and read the swedish language
the effects of intradialytic exercise in hemodiafiltration patients

Conditions: End Stage Renal Disease; Hemodialysis; Sedentary Lifestyle

Summary: low physical activity is associated with in hemodialysis and hemodiafiltration (hdf) patients. previous studies showed the benefits of intradialytic exercise for improvement of physical fitness and hemodialysis adequacy. however, the effect of intradialytic exercise on physical activity has not been explored. this current open-labelled randomized controlled trial is conducted in hdf patients to determine the effect of intradialytic exercise program for 6 months on daily physical activity measured by tri-axial accelerometer (wearable device).

the study is an open-labelled randomized controlled trial which compare the changes of daily physical activity measured by tri-axial accelerometer (wearable device) between the hdf patients in intradialytic exercise group and control during the 6-month period. after inclusion in to the study, all of the participants will be evaluated before randomized. the investigators will prescribe the exercise program for each participant in the exercise group. the exercise program use intradialytic cycling which will be gradually increased to at least 30 minutes with moderate intensity. the participants in control group will receive dialysis as usual without intradialytic exercise prescription. the participants will go on the program for at least 6-months period. in each session, any adverse event or side effect will be reported.

Eligibility criteria:
inclusion criteria: * dialysis vintage more than 3 months * sedentary or light physical activity exclusion criteria: * recent myocardial infarction (\<12 months) * recent ischemic stroke (\<12months) * uncontrolled comorbidities (diabetes/hypertension/heart failure/heart disease/respiratory disease) * life expectancy \< 12 months * active musculoskeletal problem e.g.) rheumatoid arthritis, spondyloarthropathy, osteoarthritis, fracture
dermacyd femina (lactic acid) - photo dermatological evaluation of the irritation and sensitivity potential.

Conditions: Hygiene

Summary: to prove the absence of photo irritation and photo sensitivity potential of the product dermacyd femina.


Eligibility criteria:
inclusion criteria: * phototype skin ii and iii; * integral skin test in the region; exclusion criteria: * lactation or gestation; * use of anti-inflammatory and/or immuno-suppression drugs 15 days before the selection; * diseases which can cause immunity decrease, such as hiv, diabetes; * use of drug photosensitizer; * history of sensitivity or irritation for topic products; * active cutaneous disease which can change the study results; * history or photodermatosis active; * family or personal antecedent of cutaneous photoinduced neoplasias; * presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium; * intense solar exposure in the study area; * use of new drugs or cosmetics during the study; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
transnasal insufflation (tni) and chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to determine wether transnasal insufflation as an alternate form of breathing support for copd patients will lead to improvement of their medical condition.

chronic obstructive pulmonary disease (copd) is a slowly proceeding lung disease which basic pathophysiologic mechanisms are only partly understood so far and which is difficult to access with a pharmacological or sundry approach besides smoking cessation. average life expectancy is clearly limited especially in advanced stages with respiratory insufficiency . based on different smaller surveys long-term oxygen treatment is classified to be the routine in copd treatment when patients develop hypoxemia. the primary application of non-invasive ventilation routine is the treatment for copd patients with acute respiratory decompensation and developing hypoxemia and respiratory acidosis, because it reduces the acute mortality as various prospective randomized studies showed. on the other side there are no distinct informations and data about the initiation of a nocturnal positive pressure breathing therapy when chronic hypercapnia appear in progression of copd. nocturnal positive pressure therapy appliqued with a mask can be assumed to be the routine treatment for neuromuscular and restrictive thorax diseases, because nocturnal ventilation results in a distinct increase of life expectancy. in contrast data about positive pressure therapy at copd are inconsistent and initiation of nocturnal breathing therapy is practised in many places, but is scientifically not confirmed yet. it is known from various other studies with other patient collectives with nocturnal positive pressure therapy, like patients with obstructive sleep apnoea syndrome, that only 50 to 70% of those patients are using their therapy constantly. daily practice shows that patients with chronic hypercapnia based on copd are even harder to accustom oneself to a nocturnal breathing therapy than patients with restrictive lung diseases or patients with obstructive sleep apnoea syndrome. reasons for that are not known, but maybe the significant lung distension or increased appearance of depressive or anxiety disorders of copd patients are responsible for that. perhaps patients do not feel a subjective improvement of their medical condition and don't accept a tight closing mask at nights. as a result an alternate form of breathing support would be desirable.

Eligibility criteria:
inclusion criteria: * copd gold iv * pco2 \> 50 mmhg * competent patients * stable respiratory situation exclusion criteria: * serious acute diseases * hypercapnic decompensation ph \< 7,30

Keywords: copd tni paco2
allogenic cord blood transfusion in patients with autism

Conditions: Autism Spectrum Disorder; Autism

Summary: autism is one of those disorders in autism spectrum disorders (asd), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress. the possible reason for asd is neural hypoperfusion and immune deregulation. the human umbilical cord blood mononuclear cells (hucb-mncs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. in this study, the safety and efficacy of hucb-mncs infusion will be evaluated in patients with autism.

autism spectrum disorders (asd) are heterogeneous neuro-developed disorders. autism is the most common disorder of the diseases characterized by dysfunctions in response social interaction and communication, as well as the presence of repetitive and stereotyped behaviors. recent reports of a sharp increase in the number of children with autism. the exact etiology of autism remains unclear. compliance, the definition of effective treatments for autism is particularly difficult. although it has been understood, it can be a question of immune dysregulation. examination of the inflammatory cytokines, dysfunction of the immune system and the immune system. the human umbilical cord blood mononuclear cells (hucb-mncs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. the our study suggest that infusion of cord blood mononuclear cells will affect autism.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis: autistic type disorder (asd). * systemic speech underdevelopment * the presence of attention deficit hyperactivity disorder as a comorbid state * cognitive impairment exclusion criteria: * organic pathology of the brain according to ct, mri * the presence of the following diseases in history: heart failure in the stage of decompensation, stroke in history less than 1 year ago, blood diseases; * decompensation of chronic and endocrinological diseases; * acute respiratory viral and bacterial infections, period less than 1 month after the acute phase. * hiv infection, hepatitis b and c. * oncological diseases, chemotherapy in the anamnesis; * tuberculosis. * severe form of intellectual disability. * cerebral palsy. * epilepsy.

Keywords: autism, asd, cord blood
a pilot clinical study to evaluate the safety and efficacy of marketed oxalate strips compared to a marketed safety pen

Conditions: Dentin Sensitivity

Summary: this pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * sign an informed consent form and be given a copy * be in good general health as determined by the investigator/designee * agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study * agree to not participate in any other oral care study for the duration of this study * agree to return for scheduled visits and follow all study procedures * have dentinal hypersensitivity with at least one tooth with a schiff sensitivity score of at least 1 in response to the cold water challenge exclusion criteria: * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession * active treatment for periodontitis * any diseases or conditions that might interfere with the subject safely completing the study * inability to undergo study procedures * fixed facial orthodontic appliances * a history of kidney stones * self-reported pregnancy or nursing * known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

Keywords: sensitivity
progestin-induced endometrial shedding in pcos (the pies in pcos study)

Conditions: Polycystic Ovary Syndrome; Infertility

Summary: progestin-induced endometrial shedding (pies) followed by clomiphene citrate is fertility treatment of choice in anovulatory women with polycystic ovary syndrome (pcos). however, some preliminary data suggest that skipping pies could result in a higher live birth rate. the investigators are performing the first randomized controlled trial to find out if skipping the use of progestin during fertility treatment of anovulatory pcos women is associated with improved pregnancy and live birth rates compared to the traditional approach of using progestin prior to use of clomiphene citrate.

this is a prospective randomized trial of clomiphene citrate (cc) preceded by progestin-induced endometrial shedding (pies) vs cc without pies in the treatment of infertility in patients with pcos, for up to 5 treatment cycles. participants will be randomized to receive either progestin followed by cc starting on day 3 of the induced menses, or cc without induced menses. study participants will be monitored at regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal parameters. the maximum dose of cc will not exceed 750 mg/cycle. treatment will not exceed 5 ovulatory cycles. participants who are resistant to 150 mg of cc will exit the study. 170 anovulatory pcos women actively seeking pregnancy, aged 18 through 40 years will be enrolled and randomized in a 1:1 treatment ratio into the two study arms. anovulation will be the only infertility factor in all patients.

Eligibility criteria:
inclusion * women aged 18 - 40, desiring pregnancy * established diagnosis of pcos confirmed by the rotterdam criteria * oligo or anovulatory, with menstrual cycles \> 35 days apart or less than 9 menstrual cycles per year * normal vaginal ultrasound with endometrial stripe \< 12 mm * normal thyroid stimulating hormone (tsh) within past one year * normal prolactin (prl) within past one year * for women with previous successful clomid treatment, a washout period of at least 2 months is required exclusion * regular menstrual cycles occurring less than 35 days apart * evidence of other infertility factors such as endometriosis, tubal factor or male infertility * prior unsuccessful clomiphene citrate ovulation cycles * abnormal vaginal ultrasound findings such as endometrial polyps, submucous myomas, synechiae * uterine anomaly such as unicornuate or bicornuate uterus * presence of hydrosalpinx * evidence of active endocrinopathy, such as thyroid disorder or hyperprolactinemia * partner with abnormal semen analysis (count \< 15 million sperm /ml)

Keywords: pcos polycystic ovary syndrome infertility anovulation clomiphene citrate clomid progestin provera progesterone endometrial shedding
covid-19: laser interferometry for rapid single coronavirus detection

Conditions: Diagnoses Disease; Coronavirus

Summary: using laser light to detect covid 19 virus particles in deep throat swab / nasal swab samples.

the investigators will develop novel primers to detect single virus particles in patient samples. the method involves the absorption of light by single virus particles giving a specific pattern. the investigators will develop the device to create a microdroplet of carrier fluid that is run through the trial device. the investigators will develop novel binding receptors for preferential capture of coronavirus. the investigators will review the results of the novel test against the standard diagnostic test and identify virus particles in test negative subjects. the investigators will isolate the viral rna in test negative subjects and perform sequencing to find novel mutations that are not detected by the current test.

Eligibility criteria:
inclusion criteria: * clinical suspicion of coronavirus or staff member having a coronavirus test exclusion criteria: * unable to give written informed consent
development of a developmental prognostic tool for the premature child based on automated spontaneous motor analysis

Conditions: Premature Birth

Summary: prematurity is a major risk factor for poor neurodevelopmental outcomes. the clinical and neuroradiological evaluations proposed during the neonatal period to assess the developmental prognosis of children born prematurely are not sensitive and nor specific. the analysis of spontaneous motor activity by prechtl's method has a better predictive value but is currently unfeasible in clinical routine. the study's principal objective is to describe the standardized values of complexity, variability, and fluidity of general movements.


Eligibility criteria:
inclusion criteria: * birth before 33 week of amenorrhea; * hospitalization in the neonatal department of the saint-étienne university hospital * patient affiliated or entitled to a social security scheme; * authorization to shoot the holders of parental authority; * consent to participate in the study by the holders of parental authority exclusion criteria: * need for ventilatory support; * difficulty of thermal regulation contraindicating the use of a heating cradle; * refusal of authorization to shoot by holders of parental authority; * refusal of participation in the study of holders of parental authority.

Keywords: premature children motor skill developmental prognostic prognostic tool