cyrilzakka/clinical-trials huggingface dataset:
Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler

This study will evaluate the perception of the physicians and the patients about the approved adjustable dosing of Symbicort® 160/4,5. Symbicort maintenance dose will be adjusted up and down within the approved dose range of 1x2 - 4x2 inhalations per day, to the level of asthma symptoms. Patients and physicians perception of this new dosing schedule will be evaluated by means of questionnaires completion and direct questioning.


Eligibility Criteria:
Inclusion Criteria:

* Minimum of 6 months history of asthma and treatment with an inhaled corticosteroids for at least 3 months prior to visit 1 and/or a history of short term variation in airway function and asthma symptoms responding promptly to convent
* Patients where use of a combination (inhaled corticosteroid and long acting beta2-agonist is appropriate, i.e. not controlled on inhaled corticosteroids alone).

Exclusion Criteria:

* Asthma exacerbation requiring oral corticosteroid treatment in the four weeks prior to visit 1
* Upper Respiratory Tract Infection in the previous four weeks
* Severe cardiovascular disease or other significant concomitant disease, which may interfere with the conduct of the study.
* Women enrolled in the trial should not be planning pregnancy and should be taking adequate contraceptive measures where appropriate.
* Previous enrollment in a clinical study
* Known or suspected hypersensitivity to budesonide, formoterol or inhaled lactose
Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan

Thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a continuous barbed suture (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.

Inclusion criteria were female gender; 25 to 50 years of age; history of at least one pregnancy; body mass index (BMI) between 18 and 30 kg/m2; desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries; deformities of the skin and subcutaneous tissues in the abdominal region; and musculoaponeurotic defect.

Non-inclusion criteria were smoking habit; abdominal wall scar (except for a Pfannenstiel scar related to a Cesarean section); abdominal wall hérnias; history of deep-vein thrombosis; chronic obstructive pulmonary disease; câncer; hypertension; diabetes or other chronic systemic diseases; and use of corticosteroids. Patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study.

Primary outcome: Get a technique that provides a safe correction with lasting results and in every segment of time.

Secondary clinical outcome: confirms the plication of a single layer as positive in women patients at two years of surgery compared to two planes.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age: 25 to 50 years of age
* History of at least one pregnancy
* Body mass index (BMI) between 18 and 30 kg/m2
* Desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries
* Deformities of the skin and subcutaneous tissues in the abdominal region
* Musculoaponeurotic defect

Exclusion Criteria:

* Smoking habit;
* Abdominal wall scar (except for a Pfannenstiel scar related to a Cesarean section);
* Abdominal wall hérnias;
* History of deep-vein thrombosis;
* Chronic obstructive pulmonary disease;
* Câncer;
* Hypertension;
* Diabetes or other chronic systemic diseases;
* Use of corticosteroids.
* Patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study
Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)

This observational study is proposed to evaluate if the trend in the levels of cf-DNA evaluated on a sample of peripheral blood may be related to different clinical behaviors of the disease monitored by radiological investigations conducted.

Demetri and colleagues presented, at the AACR and ASCO Annual Meeting 2013, an exploratory analysis to assess GIST genotypes on patients in the GRID study. Mutations in the KIT gene were detected in 58 percent of the blood samples compared with 66 percent of the tumor tissue samples (31). However, when focusing their analysis on secondary KIT mutations, which are the mutations that drive resistance to targeted therapies like imatinib and sunitinib, the researchers found mutations in 47 percent of blood samples compared with only 12 percent of tissue samples. In addition, nearly half of blood samples in which secondary KIT mutations were found, harbored multiple secondary mutations. Therefore, cf-DNA may become an efficient marker of mutational GIST status and disease itself.

On this basis, this trial aims to evaluate whether tumor DNA carrying mutations (for KIT, PDGFRα, BRAF, RAS, SDH) can be detected and quantified in the plasma of patients with GISTs, either with active disease or during follow-up, and whether detection can be correlated with the disease status.

Eligibility Criteria:
* Male or female patients aged \>= 18 years
* Histologically confirmed diagnosis of GIST of any anatomical location either by biopsy or surgical specimen
* Available archival tumor tissue
* Signed informed consent form

Exclusion Criteria:

* Impossibility to ensure adequate clinical and serum sample follow-up
* Serious psychiatric disease that precludes informed consent or limits compliance
Complete Penile and Testicular Self-amputation: a Very Rare Case

The study is a case report on penile and testicular self-amputation. We didn't assign a drug of intervention. We tried to describe about this rare phenomenon by observation of the presentation and outcome.

We describe a very rare case of bilateral testicular and penile self-amputation by a psychiatric patient who came to our hospital after he amputated his penis and both of his testis. He was operated to replant his severed organs, but because of multiple reasons the replantation failed after 9 days of surgery. This kind of case is very rare, and it is our aim to disseminate the information about the case to physicians for better management in the future.

Eligibility Criteria:
Inclusion Criteria: Patient with Penile and testicular self-amputation -

Exclusion Criteria: Patients with out Penile and testicular self-amputation

-
Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery

The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to determine whether treatment with sitagliptin is effective in maintaining blood sugar control in patients with type 2 diabetes (T2D).

The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) and the need for continuous intravenous insulin infusion (CII) in the intensive care unit (ICU) in patients with type 2 diabetes (T2D) undergoing coronary artery bypass graft (CABG) surgery. In addition, the study seeks to determine whether treatment with sitagliptin is effective in maintaining glycemic control and in preventing the need for subcutaneous (SC) insulin therapy in patients with T2D during the transition from intensive care unit (ICU) to regular floor in cardiac surgery patients with T2D.

Eligibility Criteria:
Inclusion Criteria:

* The ability to provide informed consent
* Ages 18 to 80 years old
* Male or female
* Scheduled to undergo cardiac surgery
* Type 2 Diabetes treated with diet, oral agents,

Exclusion Criteria:

* Severely impaired kidney function (glomeruler filtration rate (GFR ) less than 30 ml/min)
* Clinically significant liver failure
* Imminent risk of death (brain death or cardiac standstill)
* Gastrointestinal obstruction or adynamic ileus
* Expected to require gastrointestinal suction
* Clinically relevant pancreatic or gallbladder disease
* Using oral or injectable corticosteroid
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Female subjects are pregnant or breast feeding at time of enrollment into the study
Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death

OBJECTIVES: I. Describe the psychosocial response of parents and caretakers who learn cardiopulmonary resuscitation (CPR) techniques for infants at high risk for respiratory or cardiac arrest.

II. Compare the effect of 4 methods of CPR instruction on psychosocial response.

III. Evaluate a psychological intervention based on social support theory designed to offset the potential adverse psychological outcomes of CPR instruction.

IV. Evaluate a self-paced CPR learning module using the principles of adult learning theory.

V. Document the level of CPR knowledge and skill retention over time. VI. Document the frequency of CPR and its outcome following a witnessed respiratory or cardiac arrest.

PROTOCOL OUTLINE: Parents of high-risk infants are randomly assigned to 1 of 4 groups; groups are alternated at each site and the sequence of groups at each site is randomly assigned.

The first group receives a 90-minute, 1-person cardiopulmonary resuscitation (CPR) and obstructed airways management instruction.

The second group receives the same instruction plus a 1-hour social support discussion. Ongoing support is provided with weekly phone calls to assess caretaker status and answer questions regarding the infant's health.

The third group learns CPR using a self-paced multimedia learning module. The control group receives the standard CPR instruction at hospital discharge. Participants are followed at 2 weeks, then at 3 and 6 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Population Characteristics-- Parent or caretaker with infant at risk for sudden death, i.e.: Birth weight less than 2500 g Abnormal pneumogram Bronchopulmonary dysplasia Respiratory distress syndrome Primary pulmonary hypertension Congenital cardiac abnormality Home oxygen requirement Asphyxia or hypoxia Apnea of infancy Documented episode of apnea or bradycardia Sibling of sudden infant death syndrome victim Substance-abusing mother Literate in Spanish or English No history of mental illness No contraindication to cardiopulmonary resuscitation instruction, e.g., arthritis or orthopedic injury No cardiopulmonary resuscitation instruction within 2 years
Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis

The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent has been obtained from the patient or his/her legally acceptable representative
* Severe sepsis
* Disseminated intravascular coagulation
Children's Antibiotic Resistant Infections in Low Income Countries

The main challenge of the ChARLI program is to assess the clinical burden of severe neonatal and childhood bacterial infections in low-income countries,in particular those caused by antibiotic resistant bacteria. This program will address both healthcare associated, as well as community acquired infections. Beside its main challenge, the ChARLI program will also allow the assessment of the economic burden of these infections, the improvement of their medical care and then ultimately help to set public health interventions and guide public health measures necessary to combat bacterial infections and bacterial resistance in children. It will also lead to set up more basic research investigation to better understand how pathogenic and epidemic may be the resistant clones in these countries and to experiment innovative strategies devoted to prevent these infections.

In order to achieve these objectives, an international paediatric cohort will be created, and monitored a platform. This will be done first within the Institut Pasteur International Network (IPIN) and possibly extended in some others low income countries where the IPIN has no center. This constituted initiative will represent the first international pediatric program of its size to be located in low-income countries and specifically focusing severe bacterial infections and bacterial resistance to antibiotics


Eligibility Criteria:
Inclusion Criteria:

* Neonate born to parents living in the study zone of a participating country
* Parents of the neonate not intending to move away from the study zone during the follow-up period
* Legal guardians of the neonate informed about the way in which the study is to be carried out and about the collection of biological samples
* Legal guardians of the neonate having no objection to the collection of biological samples
* Authorisation from at least one of the legal guardians of the child, in the form of a signed informed consent form.

Exclusion Criteria:

* Stillborn neonate
* Parents of the neonate living outside the study zone of a participating country
* Neonate born to parents planning to move away from the study zone of a participating country during the follow-up period
* At least one of the legal guardians of the neonate not informed about the study or about the collection of biological samples
* At least one of the legal guardians of the neonate opposed to the collection of biological samples.
* Neonate already participating in another biomedical study.
The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12

In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.

During a 12 week period subjects will consume

* bread fortified with folic acid and vitamin B12 or
* placebo bread (not fortified)

Bread consumption has to be at least 3 slices per day, fortification level is 100mcg folic acid and 6mcg vitamin B12 per 3 slices.

We will study the effect of this fortification strategy on markers of folate and vitamin B12 status.

Eligibility Criteria:
Inclusion Criteria:

* age 50-75y

Exclusion Criteria:

* consumption of \< 3 slices of bread/day
* use of B-vitamins in the period three months prior to the study
* treatment with B12-injections in the last 5y
* illness or use of medication interfering with folate or vitamin B12 metabolism
The Effect of Education Given to Patients with Atrial Fibrillation on Anxiety Levels

This study aims to evaluate the effect of a structured training program on state anxiety levels in patients diagnosed with Atrial Fibrillation (AF). AF is a chronic heart rhythm disorder that negatively affects patients' quality of life with both physical and psychological symptoms. Lack of information and uncertainty in AF patients cause increased anxiety levels, making compliance with treatment difficult. This study aims to determine whether an educational intervention for AF patients can reduce their anxiety levels and increase their awareness of the disease. This is a randomized controlled trial. A two-session individual training program containing detailed information about AF will be applied to the training group and no training will be given to the control group. Data will be collected through a personal information form and the Situationality Anxiety Inventory (STAI).

Hypotheses of the Research H0: Training regarding Atrial Fibrillation has no effect on the anxiety level of patients.

H1: Education regarding Atrial Fibrillation reduces the anxiety level of patients.


Eligibility Criteria:
Inclusion criteria:

* Newly diagnosed with AF,
* Able to speak and understand Turkish,
* Does not have a physical or psychological disorder that would cause communication problems,
* Patients between the ages of 18 and 65 who are oriented to place and time, -Agreeing to participate in the study

Exclusion criteria:

\* Using any psychotropic medication (antidepressant, anxiolytic, antipsychotic)
Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

In this research study we want to learn more about the character of neutrophils that are present in the blood of children with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in organs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood of children with sepsis so that they can work to develop therapies to prevent these cells from being harmful.


Eligibility Criteria:
Inclusion criteria Patients will be eligible for enrollment as septic patients if they

* Are \< 18 years old
* Meet the definition of sepsis described in the study design section above. Patients will be eligible for enrollment as control patients if they
* Are \< 18 years old
* Are scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure.

Exclusion criteria Patients will be ineligible for enrollment in either control or sepsis group if any of the followings is present or anticipated

* Congenital cardiac disease
* On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases
Sustainable Hypertension Management in Primary Health Care in Sweden

New sustainable models of patient-focused and team-based care for patients with hypertension should be developed to achieve health improvements and cost-efficiency.

The aim of this project is to evaluate new ways of sustainable hypertension (HT) management in primary care, starting with a pilot study at 2 Primary Health Care Centres (PHCCs).

At intervention PHCCs cardiovascular risk is assessed with SCORE2 for all hypertension patients. The staff receives education on HT treatment and an easy-to-follow treatment protocol. Non-physicians lead patient education on HT in groups. Patients receive a home blood pressure (BP) monitor and communicate digitally with the assigned nurse on medication update, blood and urinary tests and follow up. The nurse consults with the physician if needed. Regular face to face visits with the physician are only scheduled for patients with high cardiovascular risk or end organ damage, otherwise for all patients if needed.

At the control PHCs hypertension care continues as usual. All participants will be asked to complete questionnaires after 6 and 24 months.

Outcomes are feasibility for the pilot study and the proportion of patients reaching BP target plus change in systolic BP, cardiovascular risk factors, patients´ and staff´s grade of satisfaction and knowledge, and health care costs for the main study, compared between intervention and control PHCCS. Results will help to establish sustainable models of treating HT patients in Primary Care.


Eligibility Criteria:
Inclusion Criteria:

- Adult patients with hypertension

Exclusion Criteria:

* secondary hypertension according to the medical records at the Primary Health Care Center
* terminal illness
* pregnancy-induced hypertension
* cognitive impairment
* impaired vision (not able to read measurements for the home BP measurements or communicate via "1177 direct" digitally)
* psychotic disorder
An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis

This is a study of a new oral drug used for the treatment of psoriasis. All subjects will get active medication, there is no placebo arm.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential (at least 2 years post-menopausal or undergone successful surgical sterilization at least 1 year before inclusion)
* Presence of moderate to severe plaque psoriasis with a PASI of at least 5

Exclusion Criteria:

* Pustular, guttate or other non-plaque forms of psoriasis or psoriatic arthritis
* Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
* History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
* Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc \>470 ms in females or \>450 ms in males
* Use of vitamin A (\>1000 µg/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroidal anti-inflammatory drugs, non-potassium-sparing diuretics
* Previous use of any systemic immunomodulatory therapy (biologicals) or psoriasis vaccine
* Use of other systemic therapy for psoriasis (e.g. PUVA, systemic steroids, cyclosporin A, methotrexate, retinoids) within four weeks prior to Visit 2
* Use of UV therapy or excessive UV exposure or topical therapy for psoriasis other than bland emollients within two weeks prior to Visit 2
Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients


Eligibility Criteria:
Inclusion Criteria:

1. Patients with age greater than 18 years old.
2. Patients with Ham-D score at least 18 with item 1 depressed mood scored 2 or greater are eligible.

Exclusion Criteria:

1. Patients with bipolar I or bipolar II disorder; eating disorders, personality disorders, and mental retardation, current diagnosis anxiety disorders (except for specific phobia), mental disorder due to general medical condition; met criteria for substance dependence or abuse in the previous three months; have a concurrent medical illness or history of seizures that would contraindicate use of the study medication and are receiving Electroconvulsive therapy (ECT).
2. Pregnant women or women not using medically accepted means of birth control are excluded.
3. Persons who score greater than 2 on the suicide item of the Ham-D, or who are judged to have significant suicidal ideation or potential in the view of an investigator, are excluded.
4. Patients who are required to be free of all psychotropic except for escitalopram and anti-inflammatory medications for at least four weeks before study entry.