cyrilzakka/clinical-trials huggingface dataset:
Observational Registry for Basal Insulin Treatment Study (ORBIT)

The scientific use of basal insulin is of great help to individuals and the government. However, there are few studies to investigate the real world use, effect, safety and influence factors of basal insulin in China. This study is to evaluate the use of first basal insulin in China patients with type 2 diabetes with inadequate glycemic control on oral antidiabetic agents (OADs) from the naturalistic clinical practice.

This is a 6-month multicentre, observational, prospective, registry study. About 200 hospitals from different parts of China will take part in this study, and about 20,000 patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with OADs and willing to accept basal insulin (BI) treatment will be consecutively enrolled during a 12 months period.

The study participants will include at baseline (0 month), 3 month and end point (6 month) to collect the study information. The project will probably last for about 18 months.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Type 2 diabetic patients
* Taking OADs before inclusion
* Recently tested HbA1c \>=7% at the same site within 3 months
* Being suggested by physician to start basal insulin (BI) treatment
* Willing to start and having been prescribed BI treatment
* Willing to join the registry study and sign the informed consent

Exclusion Criteria:

* Diagnosed with type 1 diabetes
* Received any type of insulin in the last 2 years (except for the intermittent use of insulin of less than 1 month each time)
* With any severe health problem, or any other situation judged by the investigator, that is difficult for the 6 months follow-up
* Current or planned pregnant, lactating women
* Involved in other clinical trial simultaneously or at most 1 month before
Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version

Although eating disorders often occur during or after puberty, it is likely that critical antecedent conditions can be established before adolescence. The Eating Disorder Examination has been adapted for children and is described by Bryant - Waugh, Cooper, Taylor and Lask (1996). The EDE is considered the gold standard of measures of eating disorder psychopathology (Wilson, 1993), and this adaptation, which allows its use with a younger age group, is a potentially important addition to the assessment of eating disorders in children. The latest version of EDE, the l7th edition, has now surpassed its predecessors.

The aim of the study is to evaluate the psychometric properties of the Child vers ion EDE (chEDE) translated into Italian, in a sample of patients with eating disorder


Eligibility Criteria:
Inclusion Criteria:

* Subjects meet a diagnosis of nutrition and eating disorder, specifically anorexia nervosa, bulimia nervosa, binge eating disorder, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders DSM-5
* or (for control group) Exclusion of a current or past eating disorder by performing pre-testing (KL subscales - SADS) and BMI 17.5
* Signed informed consent

Exclusion Criteria:

* Schizophrenia or other psychotic disorders;
* Substance misuse in place
* Medical complications that have the potential to hinder interpretation of results ( e.g., a medical illness that induces weight loss)
* Presence of physical treatments (including medications) that have the potential to hinder interpretation of results (e.g., chemotherapy for cancer)
* or (for control group) Presence of a current or past eating disorder and/or Ongoing eating disorder therapy
The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients

Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.

Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.

The patients were randomly divided into two groups:

Usual care : patients will receive standard clinical care by the primary physicians AKI alert : an AKI alert will be sent to the doctor in charge. The team of kidney experts would give a suggestion if the doctor in charge need a renal consultation.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult patients with an Alert for AKI(based on KDIGO guidelines)

Exclusion Criteria:

* Patients already having eGFR\<15ml/min/1.73m2 or receiving renal replacement therapy for AKI at the time of alert.
* Patients already having a AKI before admission.
Fecal Calprotectin Level in Patients With Nosocomial Diarrhea

Nosocomial diarrhea is a common problem.There are multiple ethiologies of nosocomial diarrhea in which can be divided into inflammatory and non inflammatory diarrhea. Fecal calprotectin is a good marker to identify inflammatory diarrhea in outpatient setting; for example, differentiating inflammatory bowel disease and irritable bowel syndrome. Its performance in inpatient setting has not been well established. This study aim to determine the efficacy of fecal calprotectin in distinguishing inflammatory nosocomial diarrhea from non-inflammatory nosocomial diarrhea.

This is a prospective, cross-sectional, and observational study. The patients with nosocomial diarrhea whose stool samples are sent for stool examination and Clostridium difficile toxin by their treating physicians will be recruited. Their leftover stool samples will be kept at - 80 c and will be measured for calprotectin level at the end of study. The patients will be treated by their treating physicians. They will be classified into 2 groups - inflammatory and non-inflammatory diarrhea.

The inflammatory diarrhea will be defined if 1) positive for C. difficile toxin or 2) stool WBC more than 5/HPF or 3) inflammatory mucosa or ulceration noted on colonoscopy.

The noninflammatory diarrhea will be defined if 1)negative for C. difficile toxin and 2) no WBC on stool examination and 3) dramatic response to diet adjustment or 4) no mucosal inflammation or ulceration if colonoscopy is performed

The patients who do not respond to diet modification, but do not undergo colonoscopy will be excluded because the definite diagnosis cannot be made.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 hear
* Diarrhea more than 3 time per day after admitted in hospital more than 72 hours

Exclusion Criteria:

* intraabdominal pressure more than 12 mmHg
* patient on chemotherapy with neutropenia ,ANC less than 1,000/mm3
* patients whose definite diagnosis cannot be obtained
Helping Hands: Promoting Hand Hygiene in Hospital Nurses

Hand hygiene prescriptions are the most important measure in the prevention of hospital acquired infections. Yet compliance rates are generally below 50% of all opportunities for hand hygiene adherence. This study will test the short- and long term effects of two strategies for promoting hand hygiene in hospital nurses


Eligibility Criteria:
Inclusion Criteria:

* Hand hygiene opportunities at the point of patient care

Exclusion Criteria:

* Hand hygiene opportunities not concerning patient care like personal hygiene
Effect of Omega 3 Fats on Sperm Quality and Sexual Function

This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. It will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic acid.

Infertile men commonly have difficulty timing sexual relations around the time of ovulation. There is a high incidence of abnormal sperm morphology in infertile men. Omega 3 fats are known to increase the production of nitric oxide, which is the mediator of the male response, and folic acid is an important cofactor in the production of nitric oxide. Omega 3 fats are also important in the structure and function of cell membranes. There is a high incidence of deficient intake of omega 3 fats and folic acid in the U.S. population. Both folic acid and omega 3 fats are available as nutritional supplements and the doses used in this study are doses commonly recommended as nutritional supplements.

Comparison: Omega 3 fats plus folic acid will be compared with placebo plus folic acid in men age 35 to 55 attempting pregnancy with normal or mildly impaired semen quality. They will fill out dietary questionaires, questionaires regarding sexual function, and will have measurements of serum nitrates, blood pressure, and semen quality before and during use of these nutritional supplements. In men continuing on both omega 3 fats and folic acid, we will compare the effects of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo on their sexual function.

Eligibility Criteria:
Inclusion Criteria:

* infertile men
* age 35 to 55
* expressing difficulty timing relations to their partner's ovulation

Exclusion Criteria:

* hypertension, heart disease or other systemic diseases
* fatty fish intake more than twice per week
* marked semen abnormalities (less than 10 million sperm per ml, less than 20 % A plus B motility, more than 1 million WBC per HPF)
* use of anticoagulants
* must be willing to not take PDE 5 inhibitors during the study
* use of other supplements is prohibited during the study
Implantation Of Vaginal Construct For Patients With Vaginal Aplasia

In this Phase 1, single site, clinical trial, Vulvar/vaginal Smooth muscle cells (SMC) and Epithelial Cells (EPC) are isolated from autologous patient's biopsy

The cells are expanded in vitro and seeded on scaffold and matured - The final Tissue Engineered Vagina (TEV) is implanted into the native vaginal site

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital Mullerian duct anomaly that includes absence or obliteration of all or part of the vagina, as confirmed on pelvic MRI
* Females between the ages of 15 and 45 years
* Patients with stable medical comorbidities
* Patients that are willing to comply with all study instructions and are willing to return for study follow-up visits

Exclusion Criteria:

* Patients with a history of surgery in the target area more recent than the last 6 months
* Patients with an active vaginal area infection or urinary infection as evidenced by clinical exam or culture result
* Patients with a history of keloid scarring
* Patients who are currently taking anti-platelet medications or blood thinners
* Patients with a history of clotting disorder
* Patients with autoimmune disease or immune disorder
* Patients requiring concomitant use of or treatment with immunosuppressive agents
* Patients with a history of systemic conditions, including but not limited to HIV, thrombocytopenia, uncontrolled diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study
* Patients with evidence or diagnosis of any primary coagulation disorder (including concomitant anticoagulation therapy at enrollment)
* Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study
* Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
* Patients who are current tobacco users
* Patients with alcohol/drug abuse problems
* Patients with any systemic disease
* Patients with any psychiatric disorders
* Inability to participate in all necessary study activities due to physical or mental limitations.
* Any circumstance in which the investigator deems participation in the study is not in the subject's best interest
* The following vital sign cut-off values, laboratory cut-off values and ECG reading will be monitored as the exclusion criteria in the biopsy visit and again before the implantation surgery BP systolic \>160 or \<90 millimeters of mercury (mmHg) or diastolic \>100 or\<60 millimeters of mercury (mmHg) Pulse \<60 or \>105bpm Respiratory Rate \< 9 and \>20 Temp \> 100.4 degrees Fahrenheit Liver enzymes \>2 times the upper limit of normal (ULN) Abnormal bilirubin unless subject has Gilbert's glomerular filtration rate (eGFR) \< 60 mL/min/ 1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) HbA1C \> 8% Hb \<10 mg/dL Platelet Count \<100,000 O2 saturation \<95%
* If a vital sign or lab value results in exclusion, the subject could be rescreened later
PET/MR for Rectal Cancer Treatment Monitoring and Surveillance

The goal of pilot study is to assess the feasibility of FDG-PET/MRI for monitoring rectal cancer disease status in the setting of rectal cancer non-operative management (NOM). Data from this study will be used to guide the design of future clinical trials involving FDG-PET/MRI for rectal cancer NOM.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Biopsy-proven rectal adenocarcinoma of the rectum with clinically suspected or previously known stage I-IIIB (cT1-4, N0-2, M0) disease
* Anticipated or prior chemoradiation as part of an NOM treatment strategy
* Ability to understand and willingness to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Prior surgical resection of rectal cancer (endoscopic or TME)
* Contraindication to MRI
* Comorbidities that would limit patient's ability to cooperate with a PET/MRI examination (e.g. dementia, inability to follow commands, claustrophobia, tremors, requirement for oxygen by nasal cannula, etc...).
* Implanted devices or materials that may interfere with MRI imaging or create significant artifact
* Pregnancy
* Contraindication to gadolinium contrast or FDG
* End-stage renal disease
Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes

In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT.

Cardiovascular disease (CVD) is number one killer in the Netherlands. Insulin resistance and dyslipideima are the main causes of CVD. Recently, we have shown that there is an acute leukocyte activation after an oral glucose tolerance test (OGTT) in patients with newly-diagnosed diabets mellitus type 2 (T2DM). Leukocyte activation is an important and obligatory aspect in the process of atherosclerosis. Complement system is another important inflammatory component in atherosclerosis, which becomes activated in the postprandial phase.

In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Aged 45-65 years
* BMI \< 35 kg/m2

Exclusion Criteria:

* Emotionally and intellectually not capable to decide about participation in the study and the consequences of participation. Subjects who are not able to understand the patient information
* Diabetes mellitus treated with oral antidiabetic medicine
* Type 1 diabetes mellitus
* Peripheral artery and/or coronary disease
* Untreated hypertension
* Alcohol use \> 2 units/day
* Aberrations in kidney, liver and thyroid function
* Use of any experimental medication within 6 months of the study
* The use of immunosuppressive drugs
18850 - Human Photoallergy Test

To evaluate the potential of a test material to produce a photoallergic response.


Eligibility Criteria:
Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator.

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products.
* subjects who are employees of the CRO and/or Bayer or is a household member of an employee
Mechanical Treatment Peri-Implant Mucositis

This two-arm, single-blinded, monocentric, controlled, randomised clinical study is designed to examine the effect of professional submucosal treatment by means of ultrasonics with plastic tip (test group), as compared to no professional submucosal instrumentation (control group), in the treatment of peri-implant mucositis (PIM). Both groups will have oral hygiene instruction/reinforcement (OHI) at baseline and repeated at 3 months. In the study, 50 participants will be enrolled (25 per group), with each patient contributing one implant with PIM. Peri-implant sulcus fluid (PISF) samples will be obtained at baseline, 3- and 6-months to analyse the change of relevant biomarkers over the course of PIM treatment. Intraoral scans will be performed at baseline, 3- and 6-months to analyse potential soft-tissue volumetric changes according to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 20 years
* Subject must have one implant presenting PIM as defined according to the World Workshop 2017 criteria (presence of BoP and/or suppuration (SoP), without bone loss exceeding 0.5 mm beyond crestal bone level changes resulting from initial remodeling, regardless of PPD. In absence of baseline radiographs (i.e., 0-1 year after loading) a bone level of \<2mm from the top of the intraosseous part of the implant is considered as the reference threshold)
* Cleansable prosthesis (an interproximal brush must be able to pass from side to side at interproximal aspects tangential to the peri-implant sulcus, and a brush has to be able to reach the buccal and palatal/lingual sulcus).
* No evidence of occlusal overload
* No cement remnants identified on radiographs or clinically
* Implant-supported fixed restoration inserted at least 6 months before patient enrolment and not interfering with assessment of clinical parameters at more than 3/6 sites
* Periodontally healthy subjects or treated periodontitis (no residual site with PPD ≥ 5 mm)
* Full-mouth plaque (FMPS) and bleeding (FMBS) score ≤ 20%¬¬¬¬¬¬¬ at screening visit
* Non-smokers or light-smokers (\<10 cigarettes per day)
* Competent to give consent

Exclusion Criteria:

* Previous radiotherapy, current use of chemotherapy, systemic long-term corticosteroid treatment
* Hematologic disorders
* Pregnant subjects
* Patients classified as \> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
* No systemic antibiotic treatment within 3 months prior to intervention
Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility

The aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies.

The natural aging process involves several body changes that can affect to the mobility of subjects. Among them, those that affect the joints may have the greatest impact on mobility. With age, there is a progressive loss of the cartilage that covers the joints, as well as the synovial fluid, which in turn increases the stiffness of the ligaments and tendons that allow joint mobility, which implies a reduction in muscle tone and bone strength. This joint degeneration produces pain and discomfort, which leads to stiffness and restriction of movement. Therefore, and as a consequence of this loss of mobility, subjects decrease their physical performance, which can affect their mood and vitality. All of these may lead to a loss of quality of life and to an increase of the risk of future adverse health events, such as disability, institutionalization, hospitalization and the need for home medical care.

For all these reasons, and considering the increase in the ageing population worldwide, it seems relevant to develop new strategies to improve joint mobility, physical performance and vitality that are safe for the consumer, affordable and not associated with undesirable side effects. In this regard, natural plant extracts have been widely used as a traditional remedy to reduce joint pain, reduce fatigue and improve mood and physical performance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women that have joint discomfort (WOMAC score \>20)

Exclusion Criteria:

* Consumption of pharmacological treatments on an ongoing basis that may affect joint mobility (chondroprotectors, corticoids and/or interarticular therapy or infiltrations).
* Having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative osteoarthritis made by a rheumatologist/traumatologist
* Consuming nutritional supplements containing antioxidant substances
* Consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or scheduled basis and will continue to do so during the study, even if they do not have pain.
* Being unable to perform the physical tests required in the study.
* Have an allergy to some component of the study product.
Soft Tissue Physical Properties in Long-Distance Runners

The aim of this study is to investigate in greater depth the effects of different running forms on soft tissue physical properties in long-distance runners and the relationship of this to injury risk. By doing so, the study seeks to provide new insights into the pathophysiology of running injuries and develop more effective injury prevention strategies.

This study is expected to reveal the effects of different running forms on soft tissue physical properties in long-distance runners and the relationship of these effects to injury risk.

Running analysis will be conducted by recording 30-second videos of participants during their runs, and tests will be performed using the MyotonePro device on predetermined areas. Before the evaluations, all participants will be informed about the study's objectives and their verbal informed consent will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* individuals who have been regularly running long distances for at least 1 year,
* between the ages of 25 and 35,
* classified as amateur athletes

Exclusion Criteria:

* Having undergone orthopedic surgery involving the lower extremity
Nursing-Home Residents Given Bread Fortified With Vitamin D3

Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3.

Objective: We wanted to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vitamin D3.

Methods: In a single-arm design, 45 nursing-home residents consumed one bun/d that had been fortified with 125 mcg (5,000 IU) of vitamin D3 and 320 mg elemental calcium.

Eligibility Criteria:
Inclusion Criteria:

* Healthy seniors in an institution in Romania

Exclusion Criteria:

* Known hypercalcemic or hypercalciuric disease