cyrilzakka/clinical-trials huggingface dataset:
Effect of Applying Cognitive Defusion Techniques on Mindful Awareness, Cognitive Fusion and Believability of Delusions Among Clients With Schizophrenia

Schizophrenia causes hallucinations, delusions, and disorganized thinking, resulting in decreased functioning and lifelong therapy.Delusion believability is the degree of belief in the truth of one's subjective experiences as representations of reality. It was unpleasant, typically accompanied by a suspicious, strange tension. Delusional belief is seen as a means of resolving tension and conflict in cognition and experience. Previous studies have shown that cognitive defusion strategies help people become more aware of their surroundings, accept their thoughts and feelings, and become more psychologically adjustable. defusion is crucial in reducing medication-resistant psychotic symptoms such delusions in schizophrenia patients. Therefore, this study aimed to investigate the effects of cognitive defusion techniques on psychological flexibility, mindful awareness, cognitive fusion, and believability of delusions among clients with schizophrenia.

Research Hypothesizes

* Clients who participated in cognitive defusion techniques had more psychological flexibility and mindful awareness than the control group.
* Clients who participated in cognitive defusion techniques had less cognitive fusion and delusional believability than the control group.


Eligibility Criteria:
Inclusion Criteria:

* Male clients diagnosed with schizophrenia according to the DSM-V
* Diagnosed with schizophrenia With no comorbidity.
* Able to communicate coherently and relevantly.
* Able to read and write.
* Willing to participate in the study
* Duration of illness not exceeding 10 years.

Exclusion Criteria:

• Any client in an acute phase or have any neurological disorder that may affect cognitive function were excluded from a study.
NIR-Guided Sentinel Lymph Node Mapping in Melanoma

This study will try to define an appropriate dose of the investigational drug indocyanine green (ICG) in combination with near infrared (NIR) imaging to use for future studies.

ICG is a dye which has been in use since the 50s, and is approved for testing liver function and measuring blood flow from the heart. It has been used in studies to map lymphatic pathways in lung and breast cancer and information from those studies suggest it may help identify lymph nodes associated with melanoma. ICG can be detected within the body using near-infrared light cameras.

In this study the investigators are looking at how easily ICG can get to the first lymph node (sentinel lymph node \[SLN\]) associated with melanoma, whether the investigators can see the path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it does provide a small amount of radiation. This study will compare the investigators results to the standard procedure.

At the time of surgery, you will undergo a lymphoscintigraphic procedure which is standard of care for patients with melanoma. You will also receive a dose of ICG mixed with human serum albumin. This will be administered in four small injections immediately around your tumor or the tumor scar if it has already been removed. Pictures of the ICG solution will be taken with the NIR camera and the progression of the dye along the lymphatic channel from your tumor to the SLN will be monitored.

As each lymph node is removed, pictures will be taken to see if the ICG dye has entered and colored that node. We will compare this technique with the results from the lymphoscintigraphy to measure accuracy.

Patients will be followed for at least one hour post injection for adverse events. The patient will then be taken off of the study. The results from each intervention will subsequently analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed melanoma and an appropriate surgical candidate for a sentinel lymph node biopsy
* Stage of disease conducive to sentinel lymph node biopsy as determined by oncologic surgeon
* Receiving a planned lymphoscintigraphy procedure

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy
* Pregnant or breast-feeding
Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis

The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.


Eligibility Criteria:
Key Inclusion Criteria:

* HIV-infected individuals must have positive serologies with viral load suppressed below 400 copies/mL
* HCV-infected individuals must have:

  * Chronic HCV infection with HCV RNA ≥ 2000 IU/ml AND at least 1 of the following:
  * Been null responder to previous pegylated interferon and ribavirin therapy OR
  * Failed to achieve sustained virologic response (SVR) on a regimen containing a direct-acting antiviral (DAA) in addition to pegylated interferon and ribavirin OR
  * Are unwilling to receive or have contraindications to interferon therapy for HCV
* HIV/HCV co-infected individuals must have:

  * Positive HIV serologies with viral load suppressed below 400 copies/mL
  * Chronic HCV infection with HCV RNA ≥ 2000 IU/ml AND at least 1 of the following:
  * Been null responder to previous pegylated interferon and ribavirin therapy OR
  * Failed to achieve SVR on a regimen containing a direct-acting antiviral (DAA) in addition to pegylated interferon and ribavirin OR
  * Are unwilling to receive or have contraindications to interferon therapy for HCV
* Willing to allow blood and tissue samples to be stored for future use to study HIV infection, immune function, liver disease and additional mechanisms involved in liver fibrosis among patients with HIV and/or HCV, which may not be related directly to the specific objectives of this study protocol
* Have a primary care physician

Key Exclusion Criteria:

* Cause of liver fibrosis other than HCV or long-term antiretroviral therapy (ART) treatment for HIV
* Currently being treated for HCV
* Evidence of active Hepatitis A, B or D infections
* History or evidence of hepatocellular carcinoma
* Unwillingness to undergo a liver biopsy pre-treatment and post-treatment, or to undergo all other protocol required tests/procedures or return to the site for required visits
* Presence of contraindications to magnetic resonance imaging (e.g., presence of any metal in the body, cardiac or neural pacemaker, aneurysm clip, cochlear implant, claustrophobia)
German Corneal Cross Linking Register

Corneal Cross Linking is new treatment modality for patients with keratoconus. A keratoconus is characterized by progressive bulging and thinning of the eye's cornea. Keratoconus is a potentially severely sight impairing condition that may necessitate corneal transplantation in the progressive state.

Corneal Cross Linking is designed to

* increase the cornea's mechanical stability
* to stop progression of bulging and thinning of the cornea
* to prevent the need for corneal transplantation

Corneal Cross Linking is performed by

1. Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea
2. Illuminating the cornea with UV-light

This register of Corneal Cross Linking procedures performed in Germany serves to

* gather long-term results
* detect rare complications and side-effects
* evaluate the efficacy in a large number of patients


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany

Exclusion Criteria:

* Non-ectatic conditions
Fluoride Concentration in Inter-proximal Fluid From Dental Sealants

The hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. To validate this hypothesis a randomized clinical trial was designed and performed in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing fluoride and RB sealants without fluoride content.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are: year of birth between 2000 and 2002, informed consent signed by parents/guardians, presence of at least two permanent first molars completely erupted.

Exclusion Criteria:

* The exclusion criteria are: demineralized lesions and hypomineralized permanent molar, carious lesions or presence of filling on the occlusal surface of the first permanent molar, fixed orthodontic treatment.
Intermittent Fasting and Metabolic Dysfunction Associated Fatty Liver Disease

Previous studies have investigated the effect of different dietary patterns on metabolic dysfunction-associated fatty liver disease (MAFLD), for which lifestyle modification remains the primary treatment. The present study sought to determine the effect of intermittent fasting on anthropometric measurements, fibroblast growth factor (FGF)-21, and autophagy markers including autophagy-related protein (ATG)-5 and BECLIN-1 levels, as well as on hepatic steatosis and fibrosis levels in overweight or obese patients with MAFLD to elucidate the efficacy of intermittent fasting in the management of MAFLD. The study included 48 patients diagnosed with MAFLD. Patients were randomly assigned into two groups: 22 received a dietary treatment involving 22-25 kcal/kg/day of energy for 8 weeks (energy-restricted diet group), and 26 followed the same dietary intervention and a 16:8 pattern (energy + time-restricted diet group). The patients were assessed for various parameters at baseline (T0) and at the end of the week 8 (T8). The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. Serum levels of FGF-21, BECLIN-1, and ATG-5 were determined using enzyme-linked immunosorbent assay.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MAFLD
* Aged 18-65 years
* BMI ≥ 25 kg/m²
* A stable body weight (\<5 kg weight loss or gain) over the last 3 months preceding the start of the study
* Signed the informed consent form.

Exclusion Criteria:

* An average daily alcohol consumption \>20 g for females and \>30 g for males
* Pregnant or lactating women
* Patients with ischemic heart disease or heart failure, chronic inflammatory diseases, chronic viral infections, cancer, moderate-to-severe kidney disease, uncontrolled hypertension, and eating disorders
* Those with a history of bariatric surgery
* Those on insulin due to increased risk of hypoglycemia.
Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension: Prevalence and Quality of Life

The purpose of this study is to determine the prevalence of pulmonary hypertension (PH) among patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and to assess the quality of life in those patients with concomitant PH compared to COPD patients without PH and those only suffering from pulmonary arterial hypertension (PAH) respectively.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Known or newly diagnosed COPD or PAH
* Written informed consent
* Present long-term oxygen treatment is no exclusion criterion

Exclusion Criteria:

* Age \< 18 years
* Right-heart catheterization not reasonable
* Pregnancy, Lactation
* Life expectancy \<12 months due to any diseases aside from COPD
* Any medical, psychological or other condition, which limits the patient's ability to provide informed consent
* No written informed consent provided
* Current participation in another clinical trial
Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure

The purpose of this current study is to evaluate whether the size of the endotracheal tube (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be inherent risks associated with the use of a cuffed endotracheal tube that is less than the appropriate size. The investigators believe that the size of the tube chosen has an impact on the characteristics of the inflated cuff and hence the intracuff pressure and the sealing pressure are variable.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring intubation with an ETT for a surgical procedure.
* Children ages 4 to 8 years old.
* Surgical procedure lasting less than 60 minutes.

Exclusion Criteria:

* Patients undergoing a surgical procedure that is anticipated to last longer than 60 minutes.
* Patients that are known or anticipated to have a difficult airway.
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions

Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who are suffering with back and/or leg pain are potential candidates for an ALIF procedure.

Purpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made

To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made.

This study is part of a larger Continuous Quality Improvement initiative at the Columbia Orthopaedic Group. The purpose of this effort is to improve surgical and non-surgical outcomes by using rigorous statistical analysis of our outcomes to guide our treatment decisions. Through an iterative feedback process we hope to optimize patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Standard of care

Exclusion Criteria:

* Standard of care
Regulation of Sterol Homeostasis

The purpose of this study is to determine how people with high triglycerides metabolize and absorb bile acids, compounds made in the body from cholesterol.

This project has two objectives: A) To define the mechanism of impaired bile acid absorption in hypertriglyceridemia (specifically we will determine if the active or passive component of absorption is abnormal) and B) to determine the contribution of an alternative pathway of bile acid synthesis which begins with 27-hydroxylation of cholesterol. Because 27-hydroxylase is present in endothelial cells as well as liver, this pathway may play a role in removal of cholesterol from incipient atherosclerotic plaque.


Eligibility Criteria:
Hypertriglyceridemia and normal controls with normal lipids
Glucagon Like Peptides Receptors Expression in the Stomach of Diabetes Type 2

Glucagon like peptides receptors expression in the stomach of diabetes type 2 Glucagon like peptides (GLP-1, GLP-2), are hormones secreted by L cells located along the gastrointestinal tract. These hormones are secreted after meals and have some roles in regulating the digestion process, absorption, and sending signals to the brain that regulate food consumption. GLP peptides affect peripheral targets and have an important homeostatic role. GLP-1 decreases the circulatory glucose level and GLP-2 has trophic effects which enable adequate intestine growth.

We aimed in our study to investigate the GLP-1 and GLP-2 receptor expression in different zones of the stomach in diabetes type 2 patients. If there are differences, it might explain the pathological gastric emptying in these patients.

Understanding the function of these peptides may lead to new therapeutic options for diabetic patients with delayed gastric emptying.

Methods: 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included in the study and 20 controls aged 18-70 years. Patients with neurological disease will be excluded. During esophagogastroduodenoscopy 3 biopsies will be taken from the antrum, corpus and cardia. The biopsies will be stored in -70. After RNA extraction the GLP receptors expression will established by real time PCR method. Patients with different expression compared to control will undergo isotopic scan for gastric emptying.


Eligibility Criteria:
Inclusion Criteria:

* 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included in the study and 20 controls aged 18-70 years

Exclusion Criteria:

* Patients with neurological disease will be excluded
Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)

The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

* Highly active RMS as defined by:
* One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs)
* Two or more relapses in the previous year, whether on DMD treatment or not.
* Expanded Disability Status Scale (EDSS) score less than equals to (\<=) 5.0.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab.
* Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
* Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
* Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
* History of tuberculosis , presence of active tuberculosis, or latent tuberculosis
* Evidence or suspect of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
* Active malignancy or history of malignancy.
* Other protocol defined exclusion criteria could apply.
Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis

Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion.

second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol

A patient with a brain metastasis may have the choice between surgery and focal radiosurgery of the surgical site and only hypofractionned radiosurgery on the lesion.

No previous study has focused on quality of life regarding these two treatments options.

Eligibility Criteria:
Inclusion Criteria:

* eligible for both treatments options OMS status \<3 primary cancer with no evolution brain metastasis \< 3cm ou giving symtoms patient with informed consent patient affilated to french social security

Exclusion Criteria:

* OMS \> 3 More than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients

In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis.

Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients.

The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT.

In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different.

In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment.

This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients.

The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.

The treatment of co-infected patients with normal ALT would be very important because the evolution of cirrhosis in this patients is quicker and frequently than mono-infected patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Hepatitis C co infected with stable HIV-1 and normal ALT (CASE) or elevated levels of ALT (CONTROL)
* CD4 \> 200 cel/mL
* Stable anti-retroviral treatment for HIV during at least, the 6 previous months to the inclusion
* Negative contraception test
* Informed consent signed

Exclusion Criteria:

* Pregnancy
* Any previous treatment for CHC
* Any experimental treatment in the 6 previous weeks to the inclusion
* Cirrhosis grade B or C (Child-Pugh)
* Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, ...
* Hepatic cancer
* Neutrophils \< 1500 cel/mL, Platelets \< 70000 cel/mL, Hemoglobin \< 11 g/dL (men) or \< 12 g/dL (women) previous to inclusion
* Severe psychiatric illness background
* Serum creatinin \> 1,5 times the upper normal limit
* Background of Pulmonary or Cardiovascular disease