cyrilzakka/clinical-trials huggingface dataset:
Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes

The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.


Eligibility Criteria:
Major Inclusion Criteria:

* Have type 2 diabetes mellitus (World Health Organization \[WHO\] Classification of Diabetes)
* Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m\^2)
* Have Glycated Hemoglobin A1c (HbA1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry
* Current U-100 insulin/analogue users on \>200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization
* Have a history of stable body weight for at least 3 months prior to study entry
* Concomitant medications may include metformin (MET), dipeptidyl peptidase-4 (DPP-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (SUs)/glinides (repaglinide or nateglinide). Participant's oral antihyperglycemic drug (OAD) dose(s) must have been stable for ≥3 months

Major Exclusion Criteria:

* Have type 1 diabetes mellitus or other types of diabetes mellitus apart from type 2 diabetes mellitus
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range
* Have chronic kidney disease stage 4 and higher or history of renal transplantation
* Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to study entry
* Have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry
* Have received U-500R in the 3 months prior to study entry
* Have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia
* Are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry
* Have an irregular sleep/wake cycle
* Have used rosiglitazone, once- or twice-daily glucagon-like peptide-1 (GLP-1) receptor agents, pramlintide, or other injectable or oral antihyperglycemic therapy not listed in the inclusion criteria in the 3 months prior to study entry. Participants may not have used once-weekly GLP-1 receptor agents in the 4 months prior to study entry
* Have used any weight loss drugs in the 3 months prior to study entry
* Have a history of bariatric surgery
* Have a history of malignancy other than basal cell or squamous cell skin cancer
* Have New York Heart Association (NYHA) Class III or IV per NYHA Cardiac Disease Functional Classification
* Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable
Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men

The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV) types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.

The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, MCM proteins, high-risk HPV types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.

Eligibility Criteria:
Inclusion Criteria:

* MSM with HIV negative
* MSM with HIV positive
Collaborative Care for Infants at Risk

This study evaluates the feasibility, acceptability, and impact of a collaborative care practice for infants investigated by state Child Protective Services (CPS) for suspected maltreatment. Recognizing the vulnerability of infants referred into CPS in the first year of life, as well as the frequent contact of infants with health care providers in the first year of life, the investigators will conduct a RCT to measure the impact of a collaborative practice model linking CPS caseworkers with primary health care providers during an investigation for suspected infant maltreatment. With this trial, the investigators will ask (3a) Can a collaborative practice model improve parent-reported infant health-related quality of life 6 months following child welfare involvement for suspected infant maltreatment? and (3b) Does a collaborative practice model impact repeat child welfare involvement for suspected child maltreatment over 6 months?


Eligibility Criteria:
Inclusion Criteria:

* Less than 12 months of age at referral
* Involved in a child welfare investigation for suspected maltreatment
* Investigation occurring in Utah DCFS Salt Lake Valley or Western regions

Exclusion Criteria:

For the primary and selected secondary outcomes,

* Caregiver with primary spoken language other than English or Spanish,
* CPS caseworkers not yet randomized to a practice arm
* Infants in out-of-home placement at the time of referral or case closure,
* Infants suffering fatal maltreatment
* Prior investigation of an infant in a household during study timeframe (e.g., twins, infant siblings, and repeat referrals will be excluded).

For other secondary outcomes related to CPS outcomes, language exclusion will not be considered.
Predictive Model on the Effect of Lifestyles in the Management of T2D

This study aims to produce new evidence on the positive effects of physical activity and certain individual lifestyles in the control of type 2 diabetic disease. The goal is to build and evaluate the effectiveness of a new parsimonious risk prediction model based on the use of classical variables (blood exams), already used in other models for predicting the risk related to the disease, together with measures obtained from the use of wearable devices (steps count, sleep hours, heart rate).

Scientific literature has shown that the use of wearable devices can improve the control of type 2 diabetes mellitus. The aim of the study is to develop a statistical model for the control of type 2 diabetes mellitus (DMT2) based on the use of "conventional" clinical parameters and the use of "unconventional" data from wearable devices. The medical outcome variable that will be used to measure diabetes control and model performance will be the Glycated Hemoglobin (HbA1c). The participant will receive a Samsung smartwatch (Galaxy Watch 3) and a Samsung smartphone (A51), (the latter only in case the participant is not in possession of a compatible smartphone) which he/she must wear during his daily activities and also during the night to measure daily activity, sleep hours and heart rate. Casa Sollievo della Sofferenza Hospital previoulsy developted the ENFORCE calculator, an inexpensive and parsimonious prediction model of 2-year all cause mortality in real life patients with T2D. In this study the investigators aim to elaborate a standardized validated risk scores similar to what has been done for ENFORCE.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 years old
* Affected by Type 2 Diabetes and monitored by Casa Sollievo della Sofferenza Hospital
* Basic skills in using a smartphone and its apps
* Available to use the device and its applications
* Ability to understand the informed consent

Exclusion Criteria:

* Inability to understand the informed consent
* Low life expectancy
* Type 1 Diabetes
* Secondary Diabetes
Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium (COVID-19)

This protocol focuses on the seroprevalence in primary care health care providers (PHCPs) in Belgium.

PHCPs manage the vast majority of COVID-19 and other patients and therefore are essential to organize health care efficiently. Currently however, evidence is lacking on

1. how many PHCPs get infected or diseased in Belgium,
2. the rate at which this happens,
3. their clinical spectrum,
4. their risk factors,
5. the effectiveness of the measures to prevent this from happening and
6. the accuracy of the immunological serology-based point-of-care test in a primary care setting.

This study will be set up as a prospective cohort study. All Belgian GPs in clinical practice will be invited to register online for participation in this national epidemiological study and will be asked to invite the other PHCPs in their practice to do the same. A model and demography-informed sample of registered GPs and other PHCPs will be selected. These participants will be asked at each testing point to perform a capillary blood sample antibody point of care test (OrientGene®) and complete an online questionnaire. All data analysis will be performed and reported after each relevant testing period and at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Any Belgian general practitioner (GP) (including those in professional training) currently working in primary care and any other primary health care providers (PHCPs) from the same GP practice who physically manage (examine, test, treat) patients/clients (frontline PHCP), are able to comply with the study protocol and provided informed consent to participate in the study. Also PHCPs having been diagnosed with COVID-19 are included.

Exclusion Criteria:

* Staff hired on a temporary (interim) basis will be excluded as follow-up over time will be compromised.
* Administrative staff or technical staff without any contact with patients/clients will also be excluded.
* PHCPs who were not active during the inclusion period will automatically be excluded.
Software-delivered CBT-I for Insomnia Disorder

The goal of this prospective multicenter clinical trial is to evaluate the efficacy and safety of software-delivered cognitive behavioral therapy for insomnia (CBT-I) in Chinese patients with insomnia disorder (ID). The main questions it aims to answer are: (1) whether the software-delivered CBT-I is more effective than an online patient education (online-PE) at improving insomnia. (2) whether the software-delivered CBT-I is safe for treatment of insomnia symptoms.

Participants will be randomized to receive (1) a software-delivered CBT-I using automated software called 'resleep' (one kind of digital device expected to treat insomnia targeted for Chinese patients); (2) online patient education (online-PE) about sleep.

Researchers will compare the efficacy of a software-delivered CBT-I program and an online sleep education control at improving insomnia symptoms and other psychological outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years old, no gender limitation;
* Own a mobile-phone, access the Internet, and be skilled in using software;
* Meet the diagnostic criteria of insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
* Insomnia symptoms appear at least 3 nights per week and last for at least 3 months;
* ISI scores ≥ 12 ;
* Volunteer to participate in this experiment and sign a written informed consent.

Exclusion Criteria:

* Generalized Anxiety Disorder Scale-7 (GAD-7) scores ≥ 15;
* Patients Health Questionnaire-9 (PHQ-9) scores ≥ 20;
* Current thoughts of suicide or self-injury (defined as PHQ-9 9th item score ≥ 1);
* Confirmed physical diseases that may affect sleep, such as congestive heart failure, chronic obstructive pulmonary disease acute phase, cardiovascular and cerebrovascular disease acute phase, etc.
* Current diagnosed neurological or mental illness (major depressive disorder, bipolar disorder, epilepsy, schizophrenia, etc.) that may affect sleep;
* Diagnoses of other untreated sleep disorders, such as obstructive sleep apnea, restless leg syndrome (RLS);
* Usual bedtime (when the subject attempts to fall asleep) is earlier than 8 p.m. or later than 2 a.m., or usual waking (arising) time is earlier than 4 a.m. or later than 10 a.m.
* Alcohol or drug abusers (other than nicotine dependence) in the past year;
* Pregnant or lactating women;
* Undergoing systematic psychotherapy within the past 3 months;
* Undergoing other cognitive behavioral therapy for sleep disorders;
* Unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month);
* Night shift workers, travelers across time zones;
* Subjects who have not responded to previous CBT-I;
* Other conditions deemed unsuitable for clinical trials by the investigator.
Persona of Central Serous Chorioretinopathy

Purpose: Central serous retinopathy (CSCR) is characterized by macular detachment due to thickened choroid mostly affecting young men under perceived stress. While most previous studies in CSCR have been retrospective and have focused on a single facet of the patient's personality, the investigators conducted a prospective intercontinental controlled study to analyze the multifaceted personality profile in CSCR.

Design: Prospective interview. Participants and Controls: Subjects with CSCR consented to participate in a questionnaire. Controls not having retinal disease were recruited from the same clinic.

Main Outcome Measures: The main parameters registered were presence of stress, daily number of cups caffeine intake, personality traits (Type A; obsessive-compulsive; aggressive).

Methods: The interview consisted of a 60-item questionnaire. Recruitment of participants was from January 2015 to February 2016. Controls were matched for age, gender and race. Statistical analyses were done using univariate and multivariate analysis.

Central serous chorioretinopathy (CSCR) characterized by serous macular detachment is the fourth most common retinal disease after age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. In a population-based retrospective cohort and case control study in Olmsted county, Minnesota, USA, Kitzmann et al4 reported a mean age-adjusted incidence of 9.9 (95% confidence interval \[CI\] 7.4-12.4) per 100, 000 in men, and 1.7 (95% CI 0.7-2.7) in women. The mean age of onset of CSCR appears between 41 and 45 years5. The disease affects various racial groups5-8 and occasionally can be familial9. The pathogenesis remains poorly understood and currently the exudation is thought to result from hyper-permeable choroid secondary to venous stasis, ischemia, or inflammation2. Because of lack of proper animal models and lack of definite cure, clinical research has focused on risk factors such as stress, corticosteroid intake, and type A personality. Different hospital-based studies yielded different risk factors. Epidemiologic studies failed to ascertain many of these risk factors. Due to different methodology (retrospective vs. prospective case-control studies; selection of controls; questionnaire vs. interview by physician assistant vs. interview by physician) and focus on single risk factors in the literature, the investigators designed a study that targets a vast number of known or potential risk factors in various collaborative centers and compare it to results reported in the literature.

Eligibility Criteria:
Inclusion Criteria:

* clinical evidence by fluorescein angiography and OCT of CSCR disease
* willingness to undergo long interview
* ability to sign an informed consent

Exclusion Criteria:

* severe systemic hypertension
* eclampsia
Study of Brain Tumors (Tectal Tumors) Using Magnetic Resonance Imaging

Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of 10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often incidentally diagnosed in the imaging work-up of children with hydrocephalus. Tectal tumors in children comprise a subcategory of brainstem tumors with unique clinical, imaging, and spectroscopic features. There is debate whether they truly represent brainstem tumors or whether they are a site of benign cellular overgrowth. The majority of these tumors are pathologically benign and show no or minimal growth. Not all tectal plate tumors, however, have this typically benign course. Some can manifest a more aggressive behavior. There have been reports in the past attempting to analyze the histology and behavior of these tumors. None of the prior series looking at these tumors have included Magnetic Resonance Spectroscopy (MRS) analysis.

It is interesting that according to where tumors occur in the brainstem usually indicates what their histology and behavior is. Although not absolute, we know that tumors can have a very poor prognosis versus an extremely good prognosis depending on their location in the brainstem. Yet there are always the cases that do not act in the typical fashion and this is where MRS can prove helpful.

This study is being done to look at a region of the brain, called the tectal plate, in children. This part of the brain can be involved by tumors. Because of the location of the tectal plate, it is usually very difficult and risky to get a biopsy (tissue sample) from this area. Magnetic Resonance Spectroscopy (MRS) is a non-invasive imaging technique that can look at the chemical make up of the brain. MRS may allow us to better understand the nature and behavior of these tumors. However, in order to understand disease in this area, we need to look at the normal chemical make up of the brain in children without tectal plate tumors. Healthy patients are being asked to participate as a normal volunteer. We anticipate having a total of 10 to 12 normal volunteers in the MRS study.


Eligibility Criteria:
Inclusion Criteria:

* patients who are already scheduled for a brain MRI at Children's Healthcare of Atlanta at Scottish Rite for reasons other than tectal plate glioma evaluation

Exclusion Criteria:

* patients with tectal plate glioma
Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans

Cannabis is widely used worldwide and is associated with negative outcomes including cannabis use disorder (CanUD), psychosis, and cognitive impairment amongst others. Given the legalization of "recreational" and "medical" cannabis globally, the increasing availability of cannabis, the higher potency of cannabis, the availability of highly potent cannabinoid products, the commercialization of cannabis, and the rising rates of cannabis use, it is critical to understand how genetic factors influence 1) an individual's vulnerability for addiction and psychosis, 2) the response to cannabinoids, 3) the response to novel treatments for CanUD. CanUD is strongly genetically influenced; the investigators published the first CanUD genomewide association study (GWAS) with genomewide-significant results; however, the precise nature of the contribution of genetic factors in the development of CanUD is still not clear. Cannabis exposure has also been linked to a number of psychosis outcomes including schizophrenia (SCZ). SCZ is highly heritable and population-based and genetics studies both support a bidirectional genetic relationship between SCZ and CanUD. However, the precise contribution of genetic factors in the development of psychosis outcomes related to cannabis are not clear.


Eligibility Criteria:
Inclusion Criteria:

-Ages 21-60 years old

Exclusion Criteria:

* Major or unstable medical conditions based on history, the Structured Clinical Interview for DSM-5, collateral information, physical and laboratory examinations, ECG, and vital signs.
* Cannabis naïve individuals
* Positive pregnancy test
Difference Between Pressing and Vacuum Techniques in Fabrication of Orthodontic Aligners in Cases With Crowding: A Cross-sectional Study

This cross sectional study is aiming to compare 2 methods of clear aligner fabrication.


Eligibility Criteria:
Inclusion Criteria:

* Maxillary arch with crowding.
* Full permanent dentition.

Exclusion Criteria:

* Missing teeth.
* Dental restorations.
Diabetes Coaching Study

The purpose of the study is to compare the effect of telemedical coaching versus telemedical control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical activity and quality of life in type 2 diabetes patients with poor glycaemic control.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* hemoglobin A1c (HbA1c) \>7.5%
* at leat two different antidiabetic drugs
* body mass index \>27kg/m2

Exclusion Criteria:

* acute infections
* diagnosed chronic diseases other than type 2 diabetes and hypertension, e.g. cancer, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, (macro-) nephropathy, kidney insufficiency with glomerular filtration rate (eGFR) \< 30ml / min / 1.73 m2
* acute chemotherapy or chronic cortisol treatment
* smoking cessation for less than 3 months and or planned smoking cessation during study
* known intolerance of any ingredient of Almased (especially soy protein)
* pregnancy or breast feeding, lack of contraception (women)
* other study participation in the last 6 months prior to study start