Kornimate/medical-research-clean huggingface dataset:
use of a smartphone© application to study autism spectrum disorders (asd)

Conditions: Autism Spectrum Disorders

Summary: this is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period to explore via a specific smartphone© application the evolution of a child's behavior over 6 months and the (psychological and social) effects of these changes on the family.

this is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period to assess the feasibility of using a smartphone© application designed for parents of patients with asd and to longitudinally collect data on the quality of life and anxiety of parents of children with asd and the children's functional symptoms over multiple weeks under natural conditions. population: the investigators propose to study individuals diagnosed with asd based on national health authority (has) recommendations (on adi-r diagnoses) from 3-16 years of age in the pays de la loire region. the investigators propose to include 100 families. the study is exploratory in nature; thus, randomizing patients is unnecessary. the investigators will include the first 100 families agreeing to participate in the study and meeting the inclusion criteria. all participants will be recruited from the department of child and adolescent psychiatry of university hospital of nantes and from the regional center for autism (cra des pays de la loire). method: at the inclusion visit, parents will receive a code to download the app from the "application store" of their choice (depending on their smartphone©) and sign an informed consent form. all type 1 data from the inclusion visit will be stored in an electronic database and in the smartphone© application (during the setup process). this initial evaluation by the investigator will include the following type 1 data: * sibling rank and marital status, * lifestyle: rural or urban; single or multiple occupants of the chid's bedroom and housing type and surface, * educational and teaching load and conditions (special education, inclusive education, partial or full time, etc.), and * the therapeutic management (speech therapy, psychomotor therapy, etc.). type 2 data will be stored in the electronic database only: * age at diagnosis, * current drug treatments (name, starting date and dose), * comorbidities (associated epilepsy, mental retardation and organic pathology), * medical and psychiatric family antecedent (atcd), * original scores on the autism diagnostic interview-revised (adi-r) and autism diagnostic observation schedule (ados) at the time of diagnosis, and * scores on the french version of the childhood autism rating scale (cars) (http://www.autisme.qc.ca) at baseline and at the end of the study.

Eligibility criteria:
inclusion criteria: * having a child with an asd diagnosis based on the international classification of diseases (icd) 10 criteria. * having at least one smartphone© (ios apple or android). * signing the consent form for participation. exclusion criteria: * having several children with an asd diagnosis. * having children living in more than two areas
effects of single dose tadalafil on urethral and anal closure function

Conditions: Urinary Incontinence,Stress; Fecal Incontinence

Summary: the purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence.


Eligibility criteria:
inclusion criteria: * signed informed consent form * normal weight (body weight 50 kg or more, body mass index 18-5-30 kg/m2) * sexual abstinence or use of safe contraceptive methods i.e. intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections), or surgically sterilized partner throughout the course of the study and until six days after the study has ended for the subject. women who are postmenopausal (defined as no menstrual periods for 12 months or more prior to enrolment) can be included without use of contraceptive methods. * presentation of a negative urine human chorionic gonadotropin (hcg) urine pregnancy test prior to dosing (on both study days) exclusion criteria: * history of clinically significant urinary incontinence. * current acute or chronic condition, unless considered clinically irrelevant and stable by the investigator. * average systolic blood pressure \ 140 mmhg and/or average diastolic blood pressure \ 90 mmhg (average of three measurements performed at screening). * average pulse \ 100 beats/minute (average of three measurements performed at screening). * pregnancy within 6 months before screening and throughout the study period. * breastfeeding throughout the study period and 6 days after study day 2. * any systemic drug use within 2 weeks before first study drug administration (prescription drugs, over-the-counter drugs, herbal drugs and illicit drugs), except for occasional use of paracetamol (up to 4 g/day), hormonal contraceptives and hormone replacement therapy. * smoking or other regular use of any form of nicotine product during the study period and the previous 3 months. * alcohol consume 24 hours prior to dosing. * current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
effect of soluble dietary fiber on bacterial translocation in crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the effect of soluble dietary fiber on bacterial translocation and mucosal immunology in patients with crohn's disease.

bacterial translocation (bt) is a proposed mechanism of cd. microorganisms can be cultured from 18-48% of draining mesenteric lymph nodes from cd patients. a breakdown in barrier function in "late stage" cd has been observed in patients requiring surgery. in addition, it was found that bt influences the response to biological therapy and clinical relapse in cd. therefore, reducing bt may be of therapeutic importance in treatment for cd. the role of soluble dietary fiber in crohn's disease (cd) is still inconclusive. population based studies have shown that long-term intake of dietary fiber is associated with lower risk of cd. however, meta-analysis did not show benefit in inducing or maintaining remission. in addition, the possible mechanism of dietary fiber on cd is still unclear. the rationale relates to the beneficial effects of fiber may be due to the production of the fiber metabolites short-chain fatty acids (scfas), particularly butyrate. dietary substrates may modify the commensal microbiota or their metabolites or enhance epithelial barrier function. recently, it was found that dietary fiber metabolites scfa is regulatory of mucosal regulatory t cells. the current study is to examine the impact of dietary fiber on bacterial translocation,intestinal luminal microbiology, and mucosal immunology in cd patients.

Eligibility criteria:
inclusion criteria: * patients aged \>=17 years with diagnosis of cd for at least 3 months defined by histology or radiology * ileocolonic non-penetrating disease * moderate active cd with cdai 250-450 * crp level over normal range * stable cd therapy with a total steroid dose not exceeding 10mg prednisolone or equivalent for 4 weeks exclusion criteria: * infection with enteric pathogen * usage of probiotics, antibiotics, or prebiotics within the last month * change in dose of oral steroids or 5-asa within the last 4 weeks or aza or mtx in the last 3 months * dose of steroids exceeds 10 mg prednisolone per day or equivalent * infusion of ifx or any alternative biological therapy within the last 3 months * use of rectal 5-asa or steroids within the last 2 weeks. * imminent need for surgery or presence of severe disease (cdai \>450) * pregnancy or lactation * short bowel syndrome or subtotal/total colectomy * pure anal disease and previous proctocolectomy * significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator * history of cancer with a disease-free state of less than two years * patients with penetrating disease or small bowel lesion only.

Keywords: dietary fiber
comparison of real-time continuous glucose monitoring with self-monitoring of blood glucose in young adults with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the main objective of this study is to determine whether real-time continuous glucose monitoring (cgm) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (smbg) in young adults with type 1 diabetes.

this is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded cgm, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time cgm or smbg in random order. subjects will wear a blinded cgm for a 3-week period during the control phase. a total of up to 40 subjects (aiming for 30 completed subjects) aged 16 to 24 years with t1d will be recruited through diabetes clinics and other established methods in participating centres. subjects who drop out of the study within the first 2 weeks of the first intervention period will be replaced. subjects will receive appropriate training in the use of real-time cgm. subjects will have regular contact with the study team during the study. the primary outcome is time spent in target range between 3.9 and 10.0 mmol/l as recorded by cgm. secondary outcomes are the hba1c, time spent with glucose levels above and below target, as recorded by cgm, and other cgm-based metrics. measures of subject's responses in terms of daily diabetes management, diabetes distress and diabetes technology use and acceptance will also be evaluated in this study.

Eligibility criteria:
inclusion criteria: 1. age between 16 - 24 years old (inclusive) 2. type 1 diabetes, as defined by who for at least 1 year or is confirmed c-peptide negative 3. hba1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment 4. treated with insulin pump or mdi 5. has a smart phone compatible with dexcom g5 or similar 6. willingness to wear study devices 7. willing to follow study specific instructions 8. literate in english exclusion criteria: 1. non-type 1 diabetes mellitus including those secondary to chronic disease 2. any other physical or psychological disease likely to interfere with the normal conduct of the study 3. untreated celiac disease or hypothyroidism 4. current or planned users of real-time or flash (libre) glucose monitoring sensors 5. current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, metformin, sglt2 inhibitors, glp-1 agonists, non-selective beta-blockers and mao inhibitors etc. 6. regular use of acetaminophen 7. medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement 8. serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor) 9. lack of reliable telephone facility for contact 10. known or suspected allergy against insulin 11. severe visual impairment 12. severe hearing impairment 13. subject not proficient in english
patients with interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: prospective monocentric collection of data from adult patients with interstitial lung disease (ild), to provide real-world data on current patient management at the ild clinic.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * diagnosis of ild, according to international guidelines. exclusion criteria: * inability to give informed consent.
the pk/pd, efficacy, safety and tolerability study of shr3824 in combination with metformin in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of 3 different doses of shr3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of type 2 diabetes mellitus; * hemoglobin a1c levels \>=7.5% and \<=10.5%; * body mass index (bmi) 25 to 45 kg/m2; * patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day. exclusion criteria: * type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, cushing's syndrome, etc.); * past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage iii or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy); * systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period; * history of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period; * past or current history of malignant tumor; * past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms; * pregnant women, lactating mothers, or women of childbearing potential; * any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
telemental health and cognitive processing therapy for female veterans with military-related ptsd

Conditions: Posttraumatic Stress Disorder

Summary: the immediate objective of this project is to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention to female rural veterans, reservists, national guardsmen, and civilians suffering with ptsd. this study is an expansion, seeking to add a treatment arm of women, to an already cdmrp-funded study that completed in july 2014 treating male combat veterans with military-related ptsd. the long-term objective of this project is to disseminate an empirically sound tmh ptsd protocol for male and female veterans, reserve and guard that will extend the use of cpt to remote rural sites. it is hypothesized that using vtc, will be as effective as the in-person mode of service delivery for providing cpt.

this expansion is a 4-year rct, plus a 1 year no-cost extension, which provides a direct comparison of the vtc and in-person modalities using rigorous methodology and a sophisticated analysis of treatment equivalency in clinical and process outcome domains. outcome domains include clinical and process outcomes. approximately 154 female veterans, reservists, national guardsmen, or civilians with ptsd have been recruited from multiple va clinical sites and community health centers (for n=110 completers). consistent with the male combat veterans cpt study, prospective participants received a comprehensive assessment battery at baseline to determine eligibility. the exclusion criteria selected are consistent with large ptsd randomized clinical trials as well as research using the cpt protocol with military populations with ptsd. the treatment is delivered up to twice a week for up to 12 weeks by a doctoral level psychologist. quality control procedures have been incorporated into the study's design to ensure integrity, fidelity and standard administration of the cpt intervention across both conditions. it is expected that the results from this project can be applied to other va and military locations, where similar specialized ptsd clinical services are needed but unavailable due to geographic barriers.

Eligibility criteria:
inclusion criteria: * diagnosis of current ptsd established by the clinician-administered ptsd scale (caps) and * a stable psychotropic medication regimen for a minimum of 45 days prior to study entry for those taking such medications. exclusion criteria: * significant cognitive impairment or history of organic mental disorder, * active psychotic symptoms/disorder, * active homicidal or suicidal ideation, * current substance dependence, and * unwillingness to refrain from substance abuse during treatment.
a study of mk-6913 for the treatment of hot flashes in postmenopausal women (6913-004)

Conditions: Moderate to Severe Vasomotor Symptoms in Postmenopausal; Women

Summary: this study will assess the safety, tolerability, and efficacy of mk-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. the primary study hypothesis is that one or more doses of mk-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of treatment.


Eligibility criteria:
inclusion criteria: * woman with at least 50 moderate to very severe hot flash episodes per week * postmenopausal * between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy * not receiving hormone therapy * has had both a normal mammogram and a normal pap test in the past 6 months * generally healthy exclusion criteria: * a history of cancer, except for certain skin cancers * undiagnosed vaginal bleeding or any uterine endometrial disorder * currently uses tobacco products, or has used them in the last 6 months * has human immunodeficiency virus (hiv)
relationship between social status and use of healthcare services during the confinement period linked to the covid-19 epidemic

Conditions: Covid-19

Summary: epidemics have always affected the most disadvantaged social categories more intensely. this social inequality is expressed in the use of care and emergencies: greater frequency but also greater seriousness. our hypothesis is that, during a period of confinement, the most disadvantaged populations are more affected by the covid-19 infection than the rest of the population. the number of remedies is greater, as is the severity of the forms of infection.


Eligibility criteria:
inclusion criteria: * male or female aged 18 or over * calling center 15 from march 17 at noon and until the end of the confinement period (may 31, 2020) for one of the following reasons that may be related to covid-19: cough, fever, rhinitis, diarrhea, pain thoracic, odynophagia, diarrhea, anosmia, ageusia, whose calling address belongs to bas-rhin or * supported (consultation or hospitalization) at the hus for a covid-19 infection and included in the covid-hus base and residing in the bas-rhin. exclusion criteria: * patient under the protection of justice * patient under guardianship, curatorship * patient taken care of at the screening center

Keywords: covid-19 coronavirus sars-cov-2
efficacy of buccal pad of fat, advanced platelet rich fibrin, fibrin glue and oxidized cellulose plug in management of oro-antral communication, comparative clinical study

Conditions: Healthy Volunteers Only

Summary: evaluation of the efficacy of different treatment protocols in the management of oro-antral communications.

the current study was carried on 24 patients suffering from oro-antral communications. all patients were divided into 4 equal groups.

Eligibility criteria:
inclusion criteria: * patients suffering from oroantral communications * patients suffering from oroantral fistula. * the diameter of the opening ranged from 4-9 mm, * communication resulted from recent extraction, * foreign body; or * cyst enucleation exclusion criteria: patients suffering from any systemic diseases were excluded from the study. * diabetes, * autoimmune diseases, * cancers, * nephropathy, * coagulation disorders

Keywords: benacel; bone regeneration; platelet rich growth factor; oro-antral communication buccal pad of fat fibrin glue
a study of ly3435151 in participants with solid tumors

Conditions: Solid Tumor; Triple-negative Breast Cancer; Gastric Adenocarcinoma; Head and Neck Squamous Cell Carcinoma; Cervical Carcinoma; High Grade Serous Ovarian Carcinoma; Hepatocellular Carcinoma; Undifferentiated Pleomorphic Sarcoma; Leiomyosarcoma

Summary: the reason for this study is to see if the study drug ly3435151 is safe in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * participant must have certain types of cancer, which your study doctor will discuss with you * participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you * participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. for certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for phase 1b) * participant must agree to use birth control * participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you exclusion criteria: * participant must not have a history of tuberculosis, uncontrolled hiv or uncontrolled hepatitis b or c virus infection * participant must not have an autoimmune disease, which your study doctor will discuss with you * participant must not use corticosteroids, which your study doctor will discuss with you * participant must not have heart disease, crohn's disease or brain cancer * participant must not be pregnant or breastfeeding

Keywords: immunotherapy cd226 agonist
toward zero prescribed opioids for outpatient general surgery

Conditions: Opioid Misuse and Addiction; Pain

Summary: investigators have created an opioid reduction "package" which includes patient education, non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions provided at discharge in an attempt to reduce the number of opioid consumption after outpatient general surgery.

between november 2019 and july 2021, patients undergoing elective inguinal hernia repair (ihr) or cholecystectomy were enrolled in the study. patients were divided into three cohorts: control, opioid sparing (os), or zero-opioid (zo). control patients did not have any intervention; os patients had an opioid reduction intervention protocol applied (patient education and perioperative multimodal analgesia) and were provided an opioid prescription at discharge; the zo had the same protocol, however patients were not provided opioid prescriptions at discharge. two weeks after discharge patients were interviewed to record opioid consumption, pain scores, and level of satisfaction since discharge.

Eligibility criteria:
inclusion criteria: * opioid naïve patients * age \> 18 * being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy exclusion criteria: * urgent/emergent status * previous cholecystostomy tube placement
a study of repeat-dose subcutaneous darbepoetin alfa in subjects with congestive heart failure and anemia, and a single dose in healthy age- and sex-matched control subjects

Conditions: Anemia; Congestive Heart Failure

Summary: the purpose of this study is to evaluate the single dose pharmacokinetics (pk) of subcutaneous (sc) darbepoetin alfa in subjects with congestive heart failure (chf) and anemia.


Eligibility criteria:
inclusion criteria: - symptomatic chf despite optimized therapy for at least the previous 3 months (treatment included a diuretic, angiotensin converting enzyme \[ace\] inhibitor, and/or an a2 antagonist, unless not tolerated) - hemoglobin greater than or equal to 12.5 g/dl at the time of screening

Keywords: heart failure