cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Serum Mucoprotein 3 (MUC3) Protein Levels in Gestational Hypertensive Disease

Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20 gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010- January 2011.

Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20 gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010- January 2011. This is the first study measuring levels of serum mucoprotein three in gestational hypertensive disease. MUC3 levels showed a distinctive increase in hypertensive diseases of pregnancy compared with the pregnant control group. As a result, it is found that plasma mucoprotein 3 levels increase as the severity of hypertensive diseases of pregnancy increases; and plasma mucoprotein 3 could be a precursor for the evaluation of the severity of the disease.

Eligibility Criteria:
Inclusion Criteria:

* To accept the consent to participate in the research and sign the form,
* According to ACOG 2002, pregnancy meets the criteria of hypertensive diseases \[1\], The diagnosis of HELLP syndrome was made according to the criteria described by Sibai. These; abnormal peripheral smear, schistocyte in the peripheral smear, lactate dehydrogenase \> 600 U / L, hemolysis, total bilirubin\> 1.2 mg / dl, AST\> 70 U / L, platelet count \<100,000mm3.
* When the demographic characteristics and CVs of all cases were questioned in the initial evaluation, not having chronic inflammation or acute infection, not having any systemic disease, recurrent pregnancy loss, thrombophilia, antiphospholipid antibody syndrome,
* Not smoking, No history of cancer, No multiple pregnancies
* Not using antihypertensive, anticoagulant, NSAID, corticosteroid or antiplatelet and antiepileptic drugs

Exclusion Criteria:

* using antihypertensive, anticoagulant, NSAID, corticosteroid or antiplatelet and antiepileptic drugs
* smoking,history of cancer, multiple pregnancies
ERP Plus Improv Group Therapy for OCD (IMPROVE Study)

The goal of this study is to pilot test a novel group therapy intervention for adults with OCD.

The intervention will incorporate exposure and response prevention (ERP) with improvisational comedy ("improv") activities. ERP is the gold-standard treatment for OCD. Improv comedy is a type of theater in which actors perform without a script. This study aims to evaluate whether the intervention is helpful for reducing OCD symptoms and intolerance of uncertainty (a mechanism maintaining OCD). It will also explore whether the intervention is feasible and acceptable.

During the group therapy sessions, participants will engage with improv comedy exercises that have been adapted to function as exposures for different types of OCD. Participants will:

* attend an ERP + improv group therapy intervention (90-minute sessions for 12 weeks)
* complete homework in-between sessions
* answer questions
* complete questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Ability to speak and understand English
* Clinical diagnosis of obsessive-compulsive disorder (OCD)

Exclusion Criteria:

* Current active suicidality
* Medical or psychiatric illness that could interfere with study participation
Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.

Prospective, clinical-interventionist, randomized, and double-blind study. Patients with group 2 pulmonary hypertension will be included and subjected to cardiac surgery with extracorporeal circulation. Mean pulmonary artery pressure and the doses of dobutamine and sodium nitroprusside will be assessed four times: before (T0) administration of 2 μg/kg of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after extracorporeal circulation (T2), and 10 minutes after the injection of protamine (T3).

Eligibility Criteria:
Inclusion Criteria:

* Signing an informed consent form,
* Aged 18 to 80 years
* Pulmonary hypertension due to left heart disease,
* Physical status 2 or 3 according to the classification system of the American Society of Anesthesiologists,
* Subjected to cardiac circulation with extracorporeal circulation
Efficacy of Amniotic Membrane Over Pancreatic Anastomosis After Pancreaticoduodenenctomy to Preventing Pancreatic Fistula

Post-operative pancreatic fistula (POPF) after pancreatic resection is a potentially life-threatening complication occuring in up to 27% of patients undergoing a pancreatic resection. Despite several strategies have been proposed further improvements are needed. Many studies suggest that amniotic membrane(AM) implantation is effective in tissue regeneration and prevention of fluid leakage at many surgical sites. However,the implantation of AM has never been used in pancreatic surgery.

After having completed the first case of implantation of AM we proceed with this pilot study to determine in 20 consecutive patients undergone to pancreaticoduodenectomy (PD) with high risk of POPF, the efficacy of AM in reducing this event and the related morbidity.

Twenty consecutive patients candidated to PD regardless the diagnosis will be enrolled if presenting an high Fistula Risk Score. Enrollement will be done in O.R. after frozen section of the pancreas. The AM is provided by Fondazione Banca dei Tessuti di Treviso Onlus. The placenta is sourced from donors undergoing caesarean sections and processed shortly after retrieval, donors are evaluated according to Italian requirements. The AM is carefully detached from the chorion and rinsed with sterile saline solution, flattened on a nitrocellulose membrane filter (Merck Millipore), with its stromal side facing down, in contact with the filter. The AM is then immersed in a cocktail of antibiotics then cut into patches and immersed in cryopreservant solution. Cryopreservation was achieved using a programmable cryogenic freezer (Planer KryoSave Integra, 750-30), which triggers a controlled cooling rate. The AM patches were stored in vapor-phase liquid nitrogen. Thirty minutes before its use, the AM was defrozen and washed with saline. A 10x15cm MA patch was placed around the pancreatic anastomoses starting from the posterior surface. The caudal and the cranial flap were overlapped on the anterior surface to wrap the anastomosis. The membrane was than fixed with 4-0 Monocryl sutures at the jejunal surface and at the peri-pancreatic tissue. Then an end-to-side bilio-enteric anastomosis was carried out. The reconstruction was completed by an end-to-side antecolic duodenojejunostomy. At the end of the procedure, two drains were placed ventral and dorsal to the PJ, without friction with the AM.

In the postoperative period will be evaluated: morbidity according to Clavien Dindo classification with attention to clinical relevant pancreatic fistula, bleeding, need of reintervention, surgical site infection, multi drug resistant infection and mortality. Costs and postoperative staying will be monitored as well.

Student t test, Mann Whitney and Chi square will be used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* Undergone to Pancreatico-duodenectomy with high FRS (\>=5)
* Adeguate consent

Exclusion Criteria:

* Total pancreatectomy
* Pancreatic anastomosis different from pancreo-jejunal anastomosis
Long-term Follow-up of HIV Infected Patients Identified During Early Infection

This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP).

AIEDRP was established to develop and evaluate data from studies of patients with acute or recent HIV infection. Long-term effects of antiretroviral therapies raise questions regarding the value and necessity of therapeutic interventions during acute and early HIV infection. Conventional randomized clinical trials are generally designed with finite endpoints; most patients who reach an endpoint or complete a protocol are no longer followed. As a result, long-term virologic, immunologic, and clinical outcome data are not available. This is particularly true for participants who fail therapy, require changes in treatment, or develop a treatment-limiting toxicity in a time-limited study.

This database study will establish a cohort of HIV infected individuals who are participating in HIV studies at AIEDRP sites and of HIV infected individuals who have chosen to defer therapy but agree to be followed by this study. The study will facilitate longitudinal and prospectively planned meta-analyses or cross-protocol analyses of AIEDRP studies by developing data collection guidelines, defining common research goals, and creating data templates. The primary aim is to determine the long-term virologic, immunologic, and clinical outcomes and complications for patients who were diagnosed during acute or early HIV infection.

Participants in this study will be followed for at least 5 years. Study visits will occur at Weeks 2, 4, and 12, and then every 12 weeks thereafter, through Week 96. After 2 years, study visits will occur every 24 weeks until the end of the study. Participants who start antiretroviral therapy at or after Week 2 will restart the study visit schedule. Study visits will include a medical interview, adherence questionnaire, and blood tests. Duplicate tests performed as part of another study will not be performed if the results of those tests are available.

Eligibility Criteria:
Inclusion Criteria

* Documented acute or recent HIV infection
* Willing to allow study investigators access to and use of participant's medical information from other AIEDRP clinical trials
* Parent or guardian willing to provide informed consent, if applicable
* If enrolled at an AIDS Clinical Trial Group (ACTG) site, must also be participating in one of the following clinical trials: AIN501/ACTG A5216, AIN503/ACTG A5217, or AIN504/ACTG A5218

Exclusion Criteria

* More than 7 days of antiretroviral therapy prior to study entry without adequate documentation of pretreatment viral load and CD4 count. Individuals who have failed postexposure prophylaxis with antiretroviral treatment are not excluded from enrollment.
* Any factor that, in the opinion of the study official, may interfere with study participation
Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers

This study aims to assess if an educational programme combining approaches of self-management, health promotion, and e-learning will improve self-efficacy and other key health and mental health outcomes for people with mild to moderate dementia.

It is currently estimated that 47 million people are living with dementia today and this number is expected to double in the next 20 years. Unfortunately, there has been limited advancement in medical treatments for dementia and new cost-effective approaches are needed. The utility of self-management has been proven to be of benefit in certain chronic diseases, however, very little work has been undertaken regarding self-management in people with dementia.The SHAPE self-management group therapy aims to significantly improve self-efficacy in people with mild to moderate dementia and to improve key health and mental health outcomes, carer stress and knowledge of dementia.SHAPE comprises a 10 week online course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the disease process and the development of healthy behaviours in a supportive learning environment to prevent problems that are common in the later stages of the disease. E-learning resources will be provided for carers (study supporters) which covers the similar and complimentary material discussed in the group sessions for the participant with dementia.

This trial uses 2:1 randomisation and will assess the clinical and cost effectiveness of SHAPE. Participants will be randomised to participate in the SHAPE intervention or continue with usual care. To assess the effectiveness of SHAPE at improving self-efficacy and secondary outcomes a battery of questionnaires will be administered to the participants and study supporters at baseline, after SHAPE participants have completed the intervention, and 9 months after randomisation. The answers to these questionnaires will be assessed and the results compared between the two groups of participants.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia according to the ICD-10 classification or the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or V
* 65 years of age or older
* Mild to moderate dementia, as associated with tMMSE ≥15
* Ability to read and write
* Hearing and vision that are sufficiently good to work in a group setting
* Capacity to give consent for participation in the study
* Proficient in the language in which the intervention is provided
* Care partner willing to participate

Exclusion Criteria:

* A diagnosis of alcohol or drug abuse
* Lewy body dementias, Fronto-temporal lobar degeneration or Semantic dementia
* A limited life expectancy due to any terminal disease or other serious illness, other than dementia
* Chemotherapy or radiation treatment ongoing at enrolment
* Currently participating in health promotion or self-management group
A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain

The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have experienced rapid and significant body weight gain.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of greater than or equal to (\>=) 18 kilogram per meter square (kg/m\^2) at time of starting an integrase (INI)-based regimen plus Tenofovir Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen
* Documented human immunodeficiency virus (HIV)-1 infection
* Currently being treated with a stable ARV regimen consisting of an INI combined with TAF/FTC for \>=6 consecutive months preceding the screening visit and experienced a \>=10 percent (%) increase in body weight within a 36-month time period prior to screening and while on the current INI + TAF/FTC ARV regimen
* Documented evidence of being virologically suppressed while on the current stable INI+TAF/FTC ARV regimen prior to screening
* At least one plasma HIV-1 RNA measurement less than (\<) 50 copies/milliliter (mL) occurring between 12 and 2 months prior to the screening visit while on the stable INI+ TAF/FTC ARV regimen and have HIV-1 RNA \<50 copies/ mL at the screening visit

Exclusion Criteria:

* Known history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
* Known allergies, hypersensitivity, or intolerance to D/C/F/TAF fixed-dose combination (FDC) tablet or its excipients
* Active hepatitis B (HBV) or hepatitis C virus (HCV) infection
* Uncontrolled diabetes that will require treatment with insulin during the study period
* Evidence of Child Pugh Class C based on clinical laboratory testing and clinical evaluation
* History of failure on darunavir (DRV) treatment or known documented history of \>=1 DRV resistance-associated mutations (RAM)
* Screening hepatic transaminases \>5x the upper limit of the normal range
* Screening creatinine based estimated glomerular filtration rate (eGFRcr) \<30 ml/min according to the Cockcroft-Gault formula for creatinine clearance
* Participants initiating or discontinuing concomitant medications associated with significant changes in weight within the last 90 days
The Dual Factor Model of Mental Health in Inpatients

The Dual Factor Model of mental health (DFM; Greensporn \& Saklofske, 2001) postulates that mental health consists of two at least partially unrelated factors, the experience or absence of psycho-pathological symptoms (i.e. depressive symptoms) and the experience or absence of positive mental health (i.e. life satisfaction, meaningfulness). Both factors contribute to an individual's well-being and mental health.The DFM has been used as a framework to describe and evaluate participants' mental health in different settings in cross-sectional and longitudinal designs mostly outside of clinical settings. Psychological Interventions, such as cognitive-behavioral therapy are widely studied concerning their reduction of psycho-pathological symptoms. However, little is known about the effect of psychological interventions on the second factor (positive mental health) of the DFM. This is especially important, because the latter has been shown to contribute significantly to subjective well-being and to reduce the risk of suicidal intentions and behavior.

Primary, the authors aim to investigate the DFM in an inpatient sample over the course of time (pre-treatment, post-treatment, 6 and 12 months after discharge). Secondly, they aim to investigate the relationship between positive mental health and suicidal ideation over the course of time.

Participants will be divided into four groups according to the DFM over the course of time:

1. unhappy: high psychopathology and low positive mental health; depression and/or anxiety scores above published cut -offs and positive mental health scores under published cut offs.
2. symptomatic but content: high psychopathology and high positive mental health; depression and/or anxiety scores above published cut -offs and normal to high positive mental health scores
3. vulnerable: low psychopathology and low positive mental health; depression and/or anxiety scores under published cut -offs and positive mental health scores under published cut offs
4. Complete mental health: low psychopathology and high positive mental health; depression and/or anxiety scores under published cut -offs normal to high positive mental health scores.

The authors will then depict the movements of patients through these groups graphically and use regression analyses to check for differences according to age, diagnosis and gender.

Towards the second aim they will use regression analyses to investigate the protective effect of positive mental health on suicidal ideation or behavior.

Eligibility Criteria:
Inclusion Criteria:

-inpatients at the Stiilachaus Privatklinik

Exclusion Criteria:

-None
Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis

This study is to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥ 18 years.
2. Patients with Stage 1 NK defined by the Mackie criteria

Exclusion Criteria:

1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
2. Have current or history of conditions that may confound the study data including but not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD), neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome.
3. History of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the subject's participation in the trial) or chronic conjunctivitis and/or keratitis other than dry eye disease.
4. Patients with severe vision loss with no potential for visual improvement in the study eye, in the opinion of the investigator, or if the subject is deemed legally blind.
5. Ocular surgery or elective ocular surgery expected during participation in the trial.
6. Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.