cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus

This study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to extraction of data according to the protocol)
* Male or female patients at least 18 years of age at time of informed consent
* Diagnosis of T2DM (type 2 diabetes mellitus)
* Xultophy® initiation prescribed at least 6 months before inclusion in this study (i.e., date of signed informed consent). Patients may or may not be continuing Xultophy® at study inclusion
* Minimum available data:a.) At the time of Xultophy® prescription: HbA1c value (or if unavailable, the most recent HbA1c value within 6 months before the first Xultophy® prescription);b.) At 6 months plus/minus 45 days after first Xultophy® prescription: HbA1c value

Exclusion Criteria:

* Type 1 diabetes
* Previous participation in this study. Participation is defined as having provided informed consent
* Participation in a clinical trial within 6 months before or 12 months after the first Xultophy® prescription (Participation in a non-interventional study is not an exclusion criteria)
* Mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation
Pounds Off Digitally (POD): The Use of Podcasting and Mobile Media to Promote Weight Loss

Overweight and obesity play a role in both cancer incidence and survival rates. Many people have found attending weight loss support groups to be time-intensive. Past research has shown electronic media, particularly the Web, to be effective in producing weight loss. The Web, however, lacks portability, which prevents people from accessing the information when it is convenient for them. Providing weight loss information via podcasting (audio files that may be listened to on portable audio players) may allow people to receive weight loss tips anywhere. A previous research study showed that podcasts emphasizing healthy eating and exercise can help people lose weight. This study was short-term and did not include additional social support. The purpose of this research project is to assess the effectiveness of a weight loss intervention delivered through podcasts as compared to the same podcast with added mobile media such as self-monitoring software (such as a pedometer) and support delivered via a social networking site. For this research study, the investigators will conduct a 6-month study in 104 overweight adults to determine if a podcast plus mobile media support leads to greater weight loss than a podcast alone.


Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 18-60 years old
* be a non-smoker
* live in the Chapel Hill, NC area
* be able to attend monitoring visits at baseline, 3-months, and 6-months
* have access to the Internet and a computer
* have access to an Internet-capable mobile device (such as an iPhone, iPod Touch, or Blackberry) and an MP3 player (this may be the same device)
* have access to a scale for self-monitoring weight
* be willing to be randomized to either group
* be free of psychiatric diseases, drug or alcohol dependency, or uncontrolled thyroid conditions
* be free of major health conditions, such as heart conditions, diabetes, and past incidence of stroke
* have MD consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues.
* able to prepare all their own meals (i.e. not living on-campus)

Exclusion Criteria:

* should not be pregnant, anticipating on becoming pregnant in the next 7 months, or currently breastfeeding
* be free of an eating disorder as screened by the Eating disorder Screen for Primary care \[ESP\].
* no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
* have not participated in previous podcasting weight loss research
Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood

The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration.

There are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention.

Data from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease.

Most studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life.

The investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood.


Eligibility Criteria:
Inclusion Criteria:

* congenital heart disease,
* patients having had surgery during childhood,
* patients followed within the CHU Brugmann Hospital.

Exclusion Criteria:

* None.
Duble Lumen Intubation

Intrabronal intubation is one of the basic methods of airway protection during cardiac surgery. The use of double-lumen tubes in the implementation of a standard method based on macintosh laryngoscope may cause the prolongation of the procedure especially in the case of difficult airways. The aim of the study was to match the effectiveness of endotracheal intubation using a standard Macontosh laryngskop and a normal double-lumen tube versus the ETView DL tube.


Eligibility Criteria:
Inclusion Criteria:

* anesthesiologist or a person in the course of specialization
* consent voluntary participation in the study

Exclusion Criteria:

* refusal to participate in the study
Web-based Insulin Titration - An Efficacy Study

The main objective of the study is to determine whether an intensive web-based titration system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective in improving glycaemic control in patients with diabetes mellitus type 2 using a basal insulin, compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 80 years
* Type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months
* Once daily basal insulin therapy usage
* No restriction on HbA1c or FPG
* BMI \< 40 kg/m2
* Ability to read and understand the Dutch language
* Familiarity with the Internet and use of a mobile phone
* Ability and willingness to adhere to the protocol
* Ability and willingness to use a web-based insulin self-titration system
* Confirmed written consent

Exclusion Criteria:

* Type 1 diabetes
* Use of systemic corticosteroid in the last three months
* Recurrent severe hypoglycaemia or hypoglycaemic unawareness
* Active proliferative diabetic retinopathy
* Any clinically significant disease or disorder
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Working in night shifts
Behavioral Activation Plus Savoring for University Students

The current investigation aims to examine whether a brief, two-session, virtual behavioral activation plus savoring intervention will increase daily positive emotion in university students.

Experiences of positive emotions are often unchanged following standard psychotherapy. To address this, the current investigation aims to enhance traditional brief behavioral activation with savoring, an emotion regulation strategy specifically targeting positive emotion, or affect, for university students endorsing low levels of the symptom. Individuals will be randomized to either a two-session behavioral activation plus savoring intervention or two sessions of empathic listening. Daily levels of positive emotions will be assessed throughout the study and for one week prior to and completing the intervention.

Eligibility Criteria:
Inclusion Criteria:

* University student
* Own a smartphone
* Positive affect score less than 32 on the Positive and Negative Affect Schedule, Short Form (PANAS-SF)
Optimal Timing for Repair of Right-to-Left Shunt Lesions

The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects.

The secondary aim being define the criteria for failing medical therapy.

In the past, children with right-to-left shunt lesions such as Tetralogy of Fallot defects were palliated with a systemic to pulmonary artery shunt. This prevented cyanosis while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia.

Study Design and Methodology:

Retrospective chart review - approximately 75 patients

Preoperative data:

Diagnosis

Operative data:

Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared

Postoperative data:

Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications

Eligibility Criteria:
Inclusion Criteria:

* patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect

Exclusion Criteria:

* those who do not meet inclusion criteria
Novel Testing Procedures

The purpose of this study is to evaluate a novel screening test to detect patients with primary immunodeficiencies(PIDs). The investigators plan to use information gained from this study in order to advance the field of clinical immunology, thus improving the diagnosis, treatment, and well-being of future patients. The purpose of this study is to determine if this screening test is able to detect patients with immune problems, and the investigators will test patients with known PIDs to determine if the test is accurate

The investigators hypothesize that detecting serum immunoglobulins from dried blood spots will be effective in detecting patients with known primary immunodeficiencies. If our hypothesis is confirmed, it opens the possibility of using point of care testing to screen for primary immune deficiencies.

Age of study subjects will range from 1 year to 80 years of age, and will be recruited form the Immunodeficiency clinic at the Medical College of Wisconsin/Children's Hospital of Wisconsin (MCW/CHW). Any subject having testing done to evaluate the immune system is eligible for this study. This will include patients with known PIDs as well as patients evaluated for a suspected immunodeficiency. It is anticipated that 150 subjects will be analyzed over a two year period.

After consent is obtained, blood will be obtained. The total amount of blood to drawn in one day will not exceed 1.5 mL (1/3 tsp) per pound of body weight. All samples will be collected at the same time as routine blood draws as ordered by your physician.

Subject samples will be de-identified by the Principal Investigator (PI) and given a serial number. The PI will retain a secured log of the serial numbers and basic identifiers (name, Date of Birth (DOB0, sex, preliminary diagnosis, and test results), and the subject samples will be stored in a secured freezer. Only the PI will have access to the secured log book. All study test results will be kept on compact discs, or similar computer storage devices, in a secured area that will only be accessible by the PI. Study test results will not kept on computers accessible by other individuals. The samples will not be sold to any third party. The results of this research will not be conveyed to any third party. If the subject withdraws or is withdrawn from the study all identifiable biological samples from that subject will be discarded. The sample will not be available for any other type of testing outside of this study.

Eligibility Criteria:
Inclusion Criteria:

* Any subject having testing done to evaluate the immune system is eligible for this study.

Exclusion Criteria:

* Inability or unwillingness on the part of the parents or individual to provide clinical or family history, or refusal to allow blood sampling.
A Study of ApricityRx™ for Management of IR-AEs in Patients on Immuno-Oncology Therapy

Study of ApricityRx™ for Management of IR-AEs for patients on I-O therapy. Patients currently receiving immunotherapy will be asked to consent to participate in ApricityRx software platform mobile telephone application to report symptoms, view educational content in video form about IO and irAEs and communicate with site study team.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed cancer diagnosis
* Prescribed treatment with immune-checkpoint inhibitor
* Age ≥ 18 years
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Uncomfortable with or unwilling to use digital or mobile technology
* Lack of a smart phone with compatible operating systems: iOS version 10 and above, or Android 6.0 Marshmallow
* Presence of any medical, psychological or social condition that, in the opinion of the investigator, would preclude participation in this study.
Safety and Efficacy of Extracorporeal Cytokine Hemoadsorption in Septic Shock in Critically Ill Cirrhotics

Patients with septic shock would be screened. Following this, patients meeting the inclusion and exclusion criteria will be screened and randomized to the two treatment groups. Standard criteria will be considered to define refractoriness to fluids. In all patients, baseline endotoxin activity assay and blood and urine sample will be stored for looking at the effect of therapy on these factors. Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP\>=65 mm of Hg and having a serum lactate \>2 mmol/L despite adequate volume resuscitation. Patients assigned to the treatment arm and who do not already have access for dialysis will have a standard hemodialysis catheter inserted in one of the femoral veins by the physician. Hemoperfusion will be carried out for one session within 12 hours for all randomized patient using the adsorption columns for Jianfan Biotechnology Co., Zhuhai, China). The hemoperfusion apparatus will be connected in front of the hemodialyzer in series. The procedure would be done for 2 hours without use of heparin with use of normal saline for pipeline flushing. In patients who also require hemodialysis the dialysis would subsequently be continued. Subsequent sessions of therapy would be done for patients (if required).


Eligibility Criteria:
Inclusion Criteria:

- Critically ill cirrhotics with early onset septic shock (\<24 hours) with norepinephrine of more than 10 ug/min and lactate \>4 mmol/L.

Exclusion Criteria:

* Patients with age less than 18 years
* Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
* Severe coagulopathy platelets \<20,000 and INR \>5
* Active Bleed (Mucosal or variceal)
* Pregnancy
* Chronic kidney disease
* Extremely moribund patients with an expected life expectancy of less than 24 hours
* Failure to give informed consent from family members.
* Hemodynamic instability requiring very high dose of vasopressors, late presentation or spontaneous reversal of shock
* Patient enrolled in other clinical trials
Evaluation of Laparoscopic Internal Retractor Device

The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic cholelithiasis
* Age 18-60
* ASA 1-2
* Able to sign an informed consent

Exclusion Criteria:

* ASA 3 or more
* Acute cholecystitis
* Choledocholithiasis
* Coagulation disorders
* Patients on blood thinners
* Use of Steroids
SUPPORT-D Intervention for Persons With Alzheimer's Disease and Their Caregivers

The purpose of this research is pilot test a nurse led intervention previously used in patients with pulmonary fibrosis and their caregivers in a new population (persons living with Mild Cognitive Impairment or Alzheimer's disease and their caregivers. The researchers hypothesize improving advanced care planning in this population will result in enhanced quality of life over illness trajectory and improve safety for community dwelling PWD/CG dyads. Findings from this study will inform additional necessary adaptations required prior to conducting larger scale powered randomized control trial.


Eligibility Criteria:
Inclusion Criteria:

The participants in this study include persons with Alzheimer's disease (PWD) and their caregivers (CG.

* Persons with Alzheimer's Disease (investigators anticipate cognitive impairment within this group)
* 18 years old or older
* Diagnosis of Alzheimer's Disease or suspected Alzheimer's disease (FAST score \< 4)
* Able to read and speak English (intervention in English)

Caregivers (CG)

* \> 18 years old
* Non-paid (eliminates professional caregivers)
* Provides care to someone living with Alzheimer's Disease or suspected Alzheimer's disease (self-report)
* Able to read and speak English (written materials in English)
* No diagnosis of cognitive impairment

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery

To determine the effect of post-operative abdominal binder usage on total narcotic usage after undergoing surgery. To determine if abdominal binder usage results in decreased visual analog scale (VAS) pain scores and shorter time to first ambulation post operatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older.
* Willing and able to provide informed consent.
* Patients must be undergoing scheduled pelvic surgery.
* Patients must be admitted overnight (at least one night) after surgery.

Exclusion Criteria:

* Patients who are younger than 18 years old.
* Patients who are unable or unwilling to provide informed consent.
* Patients who are illiterate.
* Patients who are non-English speaking or reading.
* Patients who are unwilling to be contacted by phone after surgery.
* Patients who are undergoing pelvic surgery that does not warrant observation or admission after surgery for at least one night.
* Patients who are having surgery for any other indication other than pelvic surgery.
* Patients with a chronic pain syndrome (as evidenced by daily intake of opioids).
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China

This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab.

All patients will be followed up for 52 weeks no matter they adhere to secukinumab or they have shifted to other treatment plans. Data will be collected in conjunction with routine care visits, most likely happen at week 0, 4, 12, 16, 24, 36, 52. No extra study visits, examinations, laboratory tests or procedures will be mandated. If visits happen at other time points (not within the window period), then they will be counted as unscheduled visits.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years;
* Diagnosis of clinically moderate to severe plaque-psoriasis;
* Initiating treatment with secukinumab during the identification period or within 30 days prior to the index date;
* Patient agrees to sign the informed consent

Exclusion Criteria:

- Participation in any dermatology or rheumatology clinical trial, concurrent or within the last 30 days of the secukinumab initiating date
Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .

Materials and Methods: This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period.

Oral glucose tolerance test will examined before and 6 months post-treatment during the trial.

Eligibility Criteria:
Inclusion Criteria:

1.Newly diagnosed insulin resistance or glucose intolerance .

2.20 to 70 years of age.

3.BMI≥28kg/m2，or BMI\>25kg/m2 beside waistline≥80cm（female)，≥90cm(male).

Exclusion Criteria:

1. Under Diabetes Mellitus treatment.
2. Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors .
3. Active heart failure.
4. Unwilling or unable to sign inform consents.
NSAID Treatment of Patients With Osteoarthritis

The study investigates associations between pre treatment pain intensity and central pain mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Knee Ostoarthritis

Exclusion Criteria:

* Current ulcer diagnosed by endoscope
* Asthma or other allergic reaction to NSIADs
* Kidney disease
* Myocardial infarction within the last six months
* Severe hyper tension (systolic ≥180mmHg, diastolic ≥110mmHg)
* Severe thrombocytopenia (thrombocyst count \<50x10\^9/l)
* Insufficience lever or kidney function