cyrilzakka/clinical-trials huggingface dataset:
Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With MCO PES-PVP (Theranova) Membrane

The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).

The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, β2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.

Eligibility Criteria:
Inclusion Criteria:

* patient on chronic hemodialysis
* age 18 years old or more
* being able to give an informed consent to participate in the survey

Exclusion Criteria:

* on therapeutic anticoagulation
* citrate or heparin contraindicated
* citrate or heparin intolerance
* acute renal failure
A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor

The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.

In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Have a viral load of 1000 or more copies/ml within 3 weeks before randomization. Have a CD4 cell count of 50 or more cells/mm3 within 3 weeks prior to randomization.
* Are at least 16 years old (or the minimum age by local requirements).
* Have had more than 16 weeks of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and/or nucleoside reverse transcriptase inhibitor (NRTI).
* Use effective barrier method of contraception.
* Give written informed consent.
* Are available for follow-up for at least 52 weeks.

Exclusion Criteria

Patients may not be eligible for this study if they:

* Have used a protease inhibitor (PI) treatment for more than 7 days or within 30 days prior to screening.
* Have a newly-diagnosed HIV-related infection or any medical condition requiring relatively short but intense therapy at the time of enrollment.
* Have hepatitis in the 30 days before the study. Patients with long-term hepatitis are eligible if their liver function meets certain requirements.
* Are unable to demonstrate responsiveness to a provided NRTI.
* Have had previous or expect a need for therapy with agents that may cause damage to nerve tissue, the pancreas, the liver, bone marrow, or cells within 3 months of study start.
* Use too much alcohol or drugs to be able to follow the study therapy; or if they use enough to increase the risk of developing pancreatitis or chemical hepatitis.
* Have severe diarrhea within 30 days prior to study entry.
* Are pregnant or breast-feeding.
* Have a history of hemophilia.
* Have history or signs of bilateral peripheral neuropathy.
* Have cardiomyopathy.
* Have certain heart problems.
* Cannot tolerate oral medication.
* Have any other problems that would interfere with the study.
Physician Reasoning on Management Cases With Large Language Models

This study will evaluate the effect of providing access to GPT-4, a large language model, compared to traditional management decision support tools on performance on case-based management reasoning tasks.

Artificial intelligence (AI) technologies, specifically advanced large language models like OpenAI's ChatGPT, have the potential to improve medical decision-making. Although ChatGPT-4 was not developed for its use in medical-specific applications, it has demonstrated promise in various healthcare contexts, including medical note-writing, addressing patient inquiries, and facilitating medical consultation. However, little is known about how ChatGPT augments the clinical reasoning abilities of clinicians.

Clinical reasoning is a complex process involving pattern recognition, knowledge application, and probabilistic reasoning. Integrating AI tools like ChatGPT-4 into physician workflows could potentially help reduce clinician workload and decrease the likelihood of mismanagement. However, ChatGPT-4 was not developed for clinical reasoning nor has it been validated for this purpose. Further, it may be subject to disinformation, including convincing confabulations that may mislead clinicians. If clinicians misuse this tool, it may not improve reasoning and could even cause harm. Therefore, it is important to study how clinicians use large language models to augment clinical reasoning prior to routine incorporation into patient care.

In this study, participants will be randomized to answer clinical management cases with or without access to ChatGPT-4. Each case has multiple components, and the participants will be asked to discuss their reasoning for each component. Answers will be graded by independent reviewers blinded to treatment assignment. A grading rubric was developed for each case by a panel of 4-7 expert discussants. Discussants independently developed a rubric for each case, and then any discrepancies were resolved through multiple rounds of discussions.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be licensed physicians and have completed at least post-graduate year 2 (PGY2) of medical training.
* Training in Internal medicine, family medicine, or emergency medicine.

Exclusion Criteria:

* Not currently practicing clinically.
N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI

The goal of the project is to improve the care of Veterans with mild traumatic brain injury (mTBI) and unhealthy alcohol use.

This is a pilot controlled clinical trial that aims to assess the efficacy of N-acetylcysteine (NAC) to reduce alcohol use and improve brain injury symptoms in Veterans with mTBI who consume alcohol at hazardous or harmful levels.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female veterans
2. Ages 18-65 (inclusive)
3. A history of mTBI as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (\>6 months from injury).
4. Current (past month \[30 days\]) Hazardous or Harmful Alcohol Use: Hazardous use is drinking that meets NIAAA criteria: Current (past 30 day) weekly drinking, consisting of an average of 15 standard drinks/week for men or 8 standard drinks/week for women. Harmful use is drinking behavior that meets DSM-5 criteria mild AUD.
5. Participants must express a desire to reduce or stop alcohol use.
6. Female subjects that must have a negative urine pregnancy test and must be either postmenopausal one year or practicing an effective birth control method.

Exclusion Criteria:

1. Unstable psychotic or bipolar disorders, dementia, or other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician.
2. Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
3. Female patients who are pregnant or nursing.
4. Concurrent participation in another alcohol treatment study, or in any research study involving medications.
5. Requiring acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD).
6. NAC use in the past week prior to study entry.
7. Use of AUD treatment medications (disulfiram, naltrexone, or acamprosate) within the past week.
8. Participants who are legally mandated to participate in an alcohol treatment program.
9. Participants who have had a suicide attempt in the past 3 months or suicidal ideation, with intent, in the 30 days prior to enrollment.
10. Participants who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the NAC package insert.
11. Participants with known hypersensitivity to acetylcysteine
Establishment of an ex Vivo Tumor Collection of Triple-negative Breast Cancers in Order to Validate the Interest of Innovative Therapies and the Search for Predictive Biomarkers of Response to Treatment

Initially described in 2009 on LGR5 positive stem cells from intestine, organoids correspond to a 3D cell culture that preserves the organization and part of the initial function of the organ from which the cells were derived. They use the proliferation and differentiation properties of stem cells cultured in a three-dimensional matrix.

These principles have been adapted to many human organs, including the breast. These culture conditions have thus allowed the establishment of cancer organoid lines that have the advantages of rapid amplification, a high rate of establishment success and unlimited proliferation potential. They are transfectable and cryopreservable. They are very close morphologically and genetically to the tumor from which they derive. Very recently, the in vivo response of orthotopic xenograft models of breast cancer organoids has been correlated to the in vitro response of these same organoids. In addition, the in vitro response of various of these models to PARP inhibitors was linked to the presence of the BRCA1/2 mutant signature, highlighting the potential of these models to predict patient response to these treatments.

Furthermore, one study demonstrated the value of using organoids derived from metastatic gastrointestinal tumors to predict patient response to cancer treatments (100% sensitivity, 93% specificity, 88% positive predictive value, and 100% negative predictive value.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient with early stage (I-III) triple negative breast cancer who needs to have clips placed before neoadjuvant chemotherapy
* Patient affiliated to a social security system
* Proficiency in French language,
* Patient having signed the consent to participate in the study.

Exclusion Criteria:

* Pregnant women
* Persons deprived of liberty or under guardianship (including curatorship)
* History of any other clinically active malignancy in the last 5 years prior to inclusion
Exercise Training in Women With Heart Disease

Coronary heart disease (CHD) is a leading cause of premature death in Canadian women. Women who suffer an acute coronary event are more likely than men to be physically inactive, have lower exercise capacity, and die in the next year. The standard cardiac rehabilitation (CR) programs do not meet women's needs. There is a need to address these issues to increase participation in CR. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) on exercise capacity and quality of life in women with CHD. Positive results of this study will fill the gap in knowledge in exercise training, levels of motivation, self-efficacy and enjoyment following HIIT vs. MICE in women with CHD.


Eligibility Criteria:
Inclusion Criteria:

* Women with CHD (e.g. CABG or PCI at least 4 weeks but less than 12 weeks post event or procedure; acute myocardial infarction; or, stable angina with corroborating evidence of CHD);
* Patient is able to perform a symptom-limited CPET (this is needed to determine peak HR for the exercise training prescription); and,
* Patient is able to read and understand English or French.

Exclusion Criteria:

* Patient is currently participating in routine exercise training (\>2x/week) (this may reduce the impact of the program on outcomes);
* Patient has: a ventricular ejection fraction \<45%; unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy (this may interfere with the ability to engage in MICE or HIIT);
* Patient has unmanaged psychiatric illness (e.g. active psychosis, suicidal ideation) or cognitive impairment (this may confound improvements in physical and health outcomes);
* Patient does not have internet connection;
* Patient is unable to provide written informed consent; or
* Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks.
* Patient is unwilling to be randomized to HIIT or MICE
Follow Ups of Parents With Infants With Cleft Lip and Palate

In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents of infants with CLP need information and support, especially with feeding immediately after birth. These needs are often not met. The purpose of this study is to investigate the effect of systematic follow ups of parents with infants with CLP performed by a special trained nurse. Parental information needs, parental coping and stress and infant growth and feeding will be explored and compared to a control group receiving standard care. 26 parents (mothers and fathers) or more shall be included in each group according to specific criteria. The control should be examined first. Both groups will answer questionnaires 3 times during the child's first year.


Eligibility Criteria:
Inclusion Criteria:

* Parents of infants with cleft lip and palate (CLP); cleft lip, cleft palate or cleft lip and palate
* Birthplace in south-east region of Norway
* Scandinavian speaking parents

Exclusion Criteria:

* Parents of infants with CLP who are referred to the hospital after the first measure point
* Birthplace outside south-east region of Norway
* Non-scandinavian speaking parents
Negative Pressure Wound Therapy in Traumatic Skin Loss

Assessment of the effectiveness of negative pressure wound therapy on post-traumatic wounds, as regard to :

* The period of granulation tissue formation.
* The infection rate in NPWT in comparison to conventional dressing.
* The rate of graft take after NPWT.
* The length of hospital stay.

Over the last 15 years, negative-pressure wound therapy "NPWT" has become commonly used for treatment of a wide variety of complex wounds. Many clinicians have noted a dramatic response when negative-pressure wound therapy technology has been used, prompting a number of scientific investigations related to its mechanism of action and clinical trials determining its efficacy.

NPWT is a modality that has shown great promise and delivered significantly better results in the clinical care of acute as well as chronic wounds. It is designed to seal the wound site using foam dressing linked to an electronic pump, which applies a pressure ranging from -75 to -150 mmHg. As a matter of fact, NPWT's impact on wound healing appears to be the consequence of multiple effects, each contributing to the overall positive influence on wound healing. Current research indicates that there are four primary NPWT mechanisms of action: Macrodeformation, Microdeformation, Fluid removal and Environmental control of the wound.

Even if the role of NPWT in promoting wound healing has been largely accepted, there is a lack of evidence (few high-level clinical studies) regarding its effectiveness and further research is needed to better understand the mechanisms of action.

Traumatic wounds vary from abrasions and minor skin incisions or tears to wounds with extensive tissue damage or loss and damage to bone and internal organs. Delayed wound healing particularly in difficult wounds is a major concern, It leads to pain, morbidity, prolonged treatment, and require major reconstructive surgery which imposes enormous social and financial burden.

Eligibility Criteria:
Inclusion Criteria:

* No age preference.
* No gender preference.
* Acute traumatic wounds.
* Admitted to the hospital.

Exclusion Criteria:

* Exposed Vessels, Nerves \& Organs.
* Active bleeding.
* Ischemic limb.
* Opening into body cavity.
* Vulnerable body organs.
* Necrotic tissue with eschar present.
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.


Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of metastatic melanoma (stage IV)
* progressive disease after first-line chemotherapy or immuno-chemotherapy
* Karnofsky-index \> 60%
* informed consent

Exclusion Criteria:

* Uvea melanoma
* another primary malignancy except basal cell carcinoma or cervical carcinoma in situ
* severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)
Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor

Retrospective, single-centre study. Review of patients aged 85 and over who underwent total hip replacement between June 2015 and February 2022.

This is a femoral stem survival study with calculation of the complication rate in this population.

The study does not focus on total hip replacements in the context of trauma. The secondary endpoint was the search for complication risk factors.


Eligibility Criteria:
Inclusion Criteria:

* receive total hip arthroplasty with uncemented stem fully hydroxyapatites coated

Exclusion Criteria:

* trauma context
* less than 3 month follow up
* Any surgery of the hip as medical history
Closed Incision Disposable Negative Pressure Wound Therapy in Immediate Postmastectomy Breast Reconstruction

The study aimed to assess the impact of the use of closed incision negative pressure wound therapy (ciNPWT) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic ciNPWT application.

Breast cancer excluding skin cancer is the most commonly diagnosed cancer after lung cancer among women. In recent years, the incidence rate of breast cancer has been rising by 0,3% annually. Screening tests are designed to diagnose breast cancer in possible early stadium of disease. Rapid diagnosis and efficacy of neoadjuvant and adjuvant therapies influence on immediate breast reconstructions after skin (SSM) and nipple-sparing mastectomies (NSM). The prophylactic methods of reducing a higher wound healing complication rate after neoadjuvant and adjuvant therapies are crucial.

The study aimed to assess the impact of the use of closed incision negative pressure wound therapy (ciNPWT) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic ciNPWT application.

The analysis included data from anamnesis, details of performed surgical procedure, measurements of skin surface temperature with Skin-Thermometer® probe, measurements of skin elasticity with Cutometer® probe, and scar assessments according to POSAS v2.0 questionnaire for patient and observer.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* indications for immediate breast reconstruction

Exclusion Criteria:

* pregnancy or lactation,
* use of steroids, use of immune modulators known to affect wound healing;
* tattoos in the area of the incision;
* breast skin conditions such as cutis laxa;
Body-oriented Interventions on Preschoolers' Social-emotional Competence

Experimental study with 4 groups (3 experimental and 1 control). Examine the effects of 3 body-oriented intervention programs on preschoolers' social-emotional competence.

Intervention programs focused on relaxation, loose parts play and combined loose parts play and relaxation, for 12 weeks with 2 30-min sessions per week.

To examine the chronic effects of the intervention programs, instruments were collected at baseline (pretest) and at the end of the 12-week period (post-test). To measure the acute effects, salivary cortisol was measured at the beginning and end of the 1st and the 24th sessions.

Eligibility Criteria:
Inclusion Criteria:

* participants' age between 3 and 6 years
* do not have participated in a similar intervention program within the last 6 months
* do not have a physical condition that can affect the participation in the program.

Exclusion Criteria:

* participants' age less than 3 and under 6 years
* have participated in a similar intervention program within the last 6 months
* have a physical condition that can affect the participation in the program.
PRecIsion Medicine in CardiomyopathY

This is a retrospective cohort study of pediatric hypertrophic cardiomyopathy (HCM) patients using chart and registry review methodology. The studies objective is to develop and validate a sudden cardiac death (SCD) risk calculator that is age-appropriate for children with HCM that includes clinical and genetic factors.


Eligibility Criteria:
Inclusion Criteria:

* phenotype-positive patients diagnosed with hypertrophic cardiomyopathy
* phenotype-negative, genotype positive patients considered at risk for developing hypertrophic cardiomyopathy

Exclusion Criteria:

* Neuromuscular, metabolic, syndromic (other than Noonan Syndrome and related RAS-opathies) or endocrine (including infants of diabetic mothers) causes of HCM
* (Other treatable causes of left ventricular hypertrophy (systemic hypertension, anatomic defects causing left ventricular outflow tract obstruction e.g. aortic stenosis, subAS, subaortic membrane, coarctation)
Exercise and Acarbose in Type 2 Diabetes

The purpose of this study is to investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Our hypothesis is that the combination therapy will be superior to monotherapy with exercise or Acarbose.


Eligibility Criteria:
Inclusion Criteria: Men and women, diagnosis of type 2 diabetes established since at least three months, treatment with diet or maximum one oral anti-diabetic drug, GHb \< 8.5 %, age 45 - 60 years, BMI 25 - 30 kg/m2, no participation in any regular exercise program.

-

Exclusion Criteria: Unable to perform exercise, significant GI-disease, severe heart-disease, renal failure

-