cyrilzakka/clinical-trials huggingface dataset:
Cohort Event Monitoring Study of Pyramax®

The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes. The study is to assess the safety of Pyramax, particularly in patients with underlying liver function abnormalities, in patients who have co-morbid conditions, such as HIV, and also in very small children (\<1 year of age).

This is a non-comparative Cohort Event Monitoring study. The study will assess the safety of Pyramax in terms of the evaluation and identification of the hepatic safety events in a sub group of patients enrolled with liver function tests (LFT)s \>2x upper limit of normal (ULN) from blood taken immediately prior to treatment without any clinical signs or symptoms of hepatotoxicity and with signs and symptoms of uncomplicated malaria confirmed by a Rapid Diagnostic Test (RDT) or microscopy (thick blood smear). The study will compare the clinical hepatic safety of Pyramax between a cohort of patients enrolled with LFTs \>2xULN and a cohort of patients enrolled with normal LFTs matched for demographic characteristics.

An estimated 8,572 malaria episodes are to be recruited to provide 120 malaria episodes in patients with baseline raised LFTs \>2xULN for follow up of liver function. A cohort of at least 2% of children who are \<1 year of age will be included for monitoring of liver function.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies and in line with WHO recommendations:

  * Fever or history of fever in the previous 24 h and/or the presence of anaemia, for which pallor of the palms appears to be the most reliable sign in young children.
  * Confirmation of malaria by a parasitological diagnosis (RDT or Microscopy (thick blood smear). analysis).
* Weight ≥5 kg - \< 20 kg (granules); ≥20 kg (tablets).
* Ability to take an oral medication.
* Ability and willingness to participate based on signed informed consent (a parent or a guardian has to sign for children below 18 years old) and on signed assent form for minors that could be required per national regulations in each participating country.
* The patient has to comply with all scheduled follow-up visits.

Exclusion Criteria:

* Patients with clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage 3 or 4).
* Known allergy to artemisinin and/or to pyronaridine.
* Known pregnancy.
* Lactating women should be excluded if other anti-malarial treatments are available.
* Complicated malaria as per WHO definition (Annex 2)
* Patients that the investigator considers would be at particular risk if receiving an anti-malarial or if participating in the study.
* Patients having been treated with Pyramax in the previous 28 days.
Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing

The method to analyze the microsatellite instability (MSI) status by next-generation sequencing (NGS) has been established to assess the deficiency of DNA mismatch repair (MMR) system. The aim of our study is to evaluate the feasibility and reliability of this NGS method by testing the circulating tumor DNA (ctDNA) in blood sample of advanced colorectal cancer patients. If the result is positive, the MSI status could be easily learned without the acquisition of tissue samples.


Eligibility Criteria:
Inclusion Criteria:

* a biopsy proven histological diagnosis of colorectal carcinoma
* MSI status of tissue sample known by IHC or PCR method
* willing to participate and informed consent signed

Exclusion Criteria:

* history of other malignant tumors
* patients with inflammatory bowel disease
* patients with familial adenomatous polyposis
* patients treated by surgery or adjuvant treatment
* pregnant or lactating women
Adverse Plaque Characteristics in CCTA and TVC Imaging

The present study is intended to assess the vulnerability of plaques seen on CCTA by means of TVC Imaging System and to make comparisons between plaques with adverse plaque characteristics and ones without adverse plaque characteristics in terms of plaque volume and lipid core contents.

This study is to be conducted in two phases - Phases 1 and 2. In Phase 1, the vulnerability of plaques seen on CCTA will be assessed with TVC Imaging System, and the plaque volume and lipid core contents of plaques with versus without adverse plaque characteristics will be compared. For the purpose of this study, the study of this phase will be a cross-sectional study in which the shapes of vulnerable plaques seen on CCTA will be compared to their vulnerability visualized by the TVC Imaging System.

In Phase 2, the patients with multi-vessel (polyvascular) disease of those participating in Phase 1 will be included, and the study of this phase will be a longitudinal study in which serial TVC imaging will be performed for non-target vessels, and any differences in changes of plaque vulnerability when treated with moderate-dose versus high-dose statin will be comparatively analyzed. The purpose of the present study is to determine whether there are any significant differences in changes of plaque volume and stability when treated with high-dose versus moderate-dose statin.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20 years of older
2. Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia
3. Patients with signed informed consent
4. Confirmed coronary artery disease in computed tomography

Exclusion Criteria:

1. The past history of coronary artery disease (e.g., myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), etc.)
2. Less than 2-year life expectancy due to non-cardiac disease
3. If the subject cannot voluntarily agree in writing to participate in this study
4. If the subject is currently participating in any other study with another investigational drug or medical device
5. Allergic reaction to iodinated contrast media
6. Significant renal dysfunction (Serum creatinine \> 1.5 mg/dl) 7 Heart rate ≥ 80 beats per minute even after treatment with a heart rate lowering medication which disable to take CCTA

8. Contraindications of either β blockers or nitroglycerin 9. The past history of complex congenital heart disease 10. Pregnant women or women with potential childbearing 11. Body mass index (BMI) exceeding 35 12. Irregular heartbeats which disable to take CCTA 13. Contraindications of statin due to hypersensitivity, past history of serious complication such as myopathy or increased liver enzyme more than 3 times of normal upper limit
Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment

Osteopathic medicine is based on a diagnostic and therapeutic system to treat tissue mobility/ motility dysfunctions in general, using different approaches (depending on the target tissue) known as osteopathic manipulative treatment.

Among all the available techniques those ones addressed to the cranial field are most questioned because of the lack of scientific evidence; but the compression of the 4th ventricle technique has been largely studied in clinical trials. Studies have shown that the technique may affect both central and autonomous nervous system, modulating some reflexes (Traube-Hering baro signal), and modifying brain cortex electrical activity through central sensitization in subjects with chronic low back pain.

Thus, investigators hypothesize that the compression of the 4th ventricle may modulate peak alpha frequency (electroencephalographic assessment) and promote physical relaxation in subjects in vigil.

A randomized controlled crossover trial with blinded assessor was designed to test the hypothesis. A total of 81 participants will be assigned to three treatment conditions, with seven days of washout: compression of the 4th ventricle group; sham compression of the 4th ventricle group; control group (no intervention).

All participants will be recruited at the Outpatient Rehabilitation Service of the University Hospital of Brasília - University of Brasília (Brazil).

Eligibility Criteria:
Inclusion Criteria:

* Participants over 18 years old with self-reported nonspecific chronic low back pain will be recruited

Exclusion Criteria:

* Participants suffering from secondary chronic low back pain,
* fever, chills, sweating, weight loss, asthenia, anorexia;
* cardiovascular and respiratory symptoms such as chest pain, dyspnea and cough;
* headache, dizziness, lightheadedness, fainting, tremors, dysarthria and aphasia;
* participants who underwent surgery on the spine;
* diagnosis of any neurological, cardiac, respiratory and rheumatic disease;
* regular use of drugs with effects on the central nervous system.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) : Predictive Marker and Mechanism

Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%. The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°). However, the cellular mechanisms involved are not fully understood, but they include cell death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of this study are to validate these findings in tissue samples of patients with ovarian PC. We will constitute a bank of isolated tumor samples before and after HIPEC and measure postoperative HSP90 serum levels in order to establish if they are predictive of a response. HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden therapeutic possibilities including the use of new immunotherapy. The multimodal approach could improve the efficacy of HIPEC with a minimal systemic toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Females over 18 years.
* Indication of Hyperthermic Intra Peritoneal Chemotherapy (HIPEC) for peritoneal carcinomatosis from ovarian origin
* Obtaining written informed consent and signed for participation in the study and conservation of samples taken.
* Affiliation to a social security scheme.

Non-inclusion criteria

* Major patients protected by law or deprived of liberty.
* Patients pregnant women in labor or breastfeeding.
* Refusal of participation
* Another cause of peritoneal carcinomatosis

Exclusion Criteria:

* consent withdrawn
The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

Psoriasis (Ps) and psoriatic arthritis (PsA) are associated with increased risk of metabolic syndrome (MetS), body fatness and cardiovascular risk. Additionally, oxidative stress and inflammation are also contributing mechanisms on Ps and PsA. However, little is known about the influence of diet and micronutrients on the main outcomes of these diseases. The aim of the investigators is to evaluate the effectiveness of an intervention diet program on disease activity, metabolic profile and oxidative stress inpatients with Psoriasis and Psoriatic Arthritis.


Eligibility Criteria:
Inclusion Criteria:

* patients with psoriatic arthritis, according to the Classification Criteria of Psoriatic Arthritis (CASPAR)

Exclusion Criteria:

* lack of written informed consent;
* age \< 18 years old;
* history of gastrointestinal, endocrine, pulmonary, kidney, hepatic, and neuromuscular diseases, as well as HIV-positive;
* pregnant or breast-feeding women;
* previous history of cancer;
* use of steroids, protein supplements, vitamins, multivitamins, or antioxidants.
* Specific medications to PsA and physical activity were required to be stable for the last 3 months to be included in the study
Haemolytic Uraemic Syndrome in Childhood: Clinical, Cognitive and Psychological Aspects

The purpose of this study is to investigate the clinical, cognitive outcome and psychosocial outcome of haemolytic uraemic syndrome in childhood.

The haemolytic uraemic syndrome (HUS) is the leading cause of acute renal failure in childhood. The more common typical HUS is mostly caused by Shigatoxin-producing enterohaemorrhagic Escherichia coli (EHEC). The rarer atypical HUS is mainly caused by different genetic abnormalities in complement regulatory proteins.

About 50 till 60 percent of all patients with HUS develop a severe acute renal failure and require dialysis. Resulting from new diagnostic and therapeutic approaches the survival rate increased during the last years. Despite this, there are only few data concerning long-term prognosis, cognitive and motoric development, as well as psychological coping and health-related quality of life of affected children and their parents.

The main purposes of this study are: the evaluation of the long-term renal function of pediatric HUS-patients; the evaluation of the dialysis method in the acute phase of the disease and its impact on the duration of the renal-placement-therapy, as well as the long-term renal function; the evaluation of the intellectual and motoric performance of affected children and the evaluation of the health-related quality of life and psychological processing of the patients themselves and their parents.

All cases of HUS treated at the University Children's Hospital Zurich between 1995 and 2012 will be analyzed retrospectively. In the course of a routine-follow-up-examination the clinical data of patients up to the age of 17 years will be actualized and completed. The results of clinical and paraclinical investigations related to renal function will be evaluated to describe the clinical features of haemolytic uraemic syndrome in childhood.

Intellectual performance will be analyzed with the Wechsler-Intelligence Scale for Children-IV (WISC-IV) and motoric performance with the Zurich Neuromotor Assessment in children at the age from 6 to 16 years.

The health-related quality-of-life of all parents and affected children from the age of 7 years will be assessed by different generic quality-of-life-instruments.

Eligibility Criteria:
Inclusion Criteria:

* children and youth from 2 months to 17 years who had suffered from haemolytic uraemic syndrome
* willingness and ability to participate in the study
* freely signed informed consent

Exclusion Criteria:

* missing written informed consent
* children who do not fulfil the age criterion
Phase 1 Study With Sorafenib and Sirolimus

The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological or cytological confirmed advanced solid tumor, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a combination of sorafenib and sirolimus (especially metastic RCC, malignant melanoma, HCC, NSCLC, pancreatic cancer, hormone refractory prostate cancer).
* Men or women of at least 18 years
* Patients who have an ECOG status of 0 or 1
* Patients who have a life expectancy of at least 12 weeks
* Adequate bone marrow, liver and renal function
* Negative pregnancy test for female patients of childbearing potential
* Women and men enrolled into this trial must use adequate birth control measures during the course of the trial.
* Signed informed consent

Exclusion Criteria:

* History of serious cardiac disease
* Active clinically serious bacterial, viral or fungal infections (\> grade 2).
* Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
* Clinically symptomatic brain or meningeal metastasis.
* Patients with seizure disorders requiring medication (such as steroids or antiepileptics).
* Patients with evidence or history of bleeding diathesis.
* Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.
* Concomitant treatment with strong CYP3A4 inductors (such as rifampicin, St. John´s Wort) or CYP3A4 inhibitors (such as ketoconazole, voriconazole, itraconazole, diltiazem, verapamil, erythromycin). Moderate or weak CYP3A4 modifiers should be used concomitantly only after careful assessment of risk-benefit ratio. Concomitant use of carbamazepine, phenobarbital, phenytoin or chronic use of dexamethasone is excluded
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Our hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.

Inclusion Criteria:

Duodenal or ampullary adenoma greater than or equal to 10mm. Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection.

Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female

Exclusion criteria:

Duodenal or ampullary adenoma \<10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide Informed Consent Less than 18 years old Allergy to Octreotide

Eligibility Criteria:
Inclusion Criteria:

Duodenal or ampullary adenoma greater than or equal to 10mm Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female

Exclusion Criteria:

Duodenal or ampullary adenoma \<10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide informed consent Less than 18 years old Allergy to Octreotide
The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students

Purpose: The study was conducted to examine the effect of web-based progressive muscle relaxation exercise on the perceived stress and anxiety level of nursing students who were in clinical practice for the first time.

Method: This randomized controlled study was conducted at a state university in Turkey. The sample of the study consisted of a total of 66 nursing students, 36 of whom were control and 30 interventions, who were educated in the 2021-2022 academic year, were in clinical practice for the first time and agreed to participate in the research. The intervention group was asked to perform a total of 36 sessions of progressive muscle relaxation exercise, 3 days a week for 12 weeks. Data; It was collected using the "Sociodemographic Characteristics Form", "State-Trait Anxiety Inventory (DSQ)" and "Perceived Stress Inventory (PSI)".


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Studying in the 2021-2022 academic year
* Being in 2nd grade
* Not going into clinical practice before

Exclusion Criteria:

* Being under the age of 18
* Not studying in the 2021-2022 academic year
* Being in 1st, 3rd or 4th grade
* Prior clinical practice
Prebiotics in Patients With Non-alcoholic Liver Disease

The purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS 75/25) is effective in treating patients with non-alcoholic liver disease.

The study will include 60 patients with Non-alcoholic fatty liver disease (NAFLD) which will randomize to two groups, receiving either ITF (Inulin/oligofructose-OFS 75/25) or maltodextrin (placebo).

The trial will last for 26 weeks: Stage 1-Run-in period: Subjects will be followed to ascertain weight maintenance. Stage 2- Randomized intervention period: Subjects will be assigned to receive 16 gram/day of ITF or maltodextrin. Both ITF and placebo will be provided in identical opaque packages and both subjects and researchers will be blinded to the content.

After signing informed (-2 week) consent, the following data will be collected: demographics, lifestyle habits including dietary questionnaires, and medical history. At week 0, week 12 and week 24 all the following tests will be performed: Vital Signs: blood pressure, anthropometric measurements, body composition determined by bioelectrical impedance analysis (BIA). Biochemical blood tests: liver function tests fasting glucose insulin \& lipid profile, CRP (an inflammation marker), SCFA, BCAA, and LBP and FGF 19. Fecal samples: fecal samples will be used for microbiota composition analysis, and BA analysis. Assessment of liver status At week 0 and 24 by using magnetic resonance spectroscopy (1H-MRS), SteatoTest and NashTest (FibroMax™) and by liver enzymes for evaluating steohepatitis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NAFLD based on fatty infiltration detection by ultrasonography and alanine aminotransferase levels of (ALT) ≥ 30 U/L male ≥ 19 U/L females.
* Over-weight (BMI ≥ 27 kg/m2) who fulfill the criteria of the National Cholesterol Education Program (NCEP) metabolic syndrome
* Willing to sign informed consent to participate in the study
* Patients without diabetes or with well-controlled diabetes (HbA1C \< 7.5%) who are treated by diet ± metformin

Exclusion Criteria:

* Pregnancy
* Uncontrolled diabetes
* Diabetic treatment other than metformin, unusual diets (vegetarian, vegan), usage of antibiotics, probiotics or prebiotics up to 6 months prior to study, alcohol abuse, presence of gastrointestinal or mental disorders, weight-loss treatment, bariatric surgery
* Serious medical conditions
* Evidence of another etiology for chronic liver disease such as: hepatitis B, hepatitis C, HIV, autoimmune diseases and metabolic diseases, medications with known hepatotoxicity.
Effects of Chlorhexidine Gluconate, Ozonated Water and Hypochlorous Acid Solutions Used in the Oral Care of Patients Supported by Mechanical Ventilation on the Integrity of the Oral Mucosa

The purpose of this clinical trial is to learn whether ozonated water and hypochlorous acid solution can restore the integrity of the oral mucosa. In addition, the investigators will learn about the safety of ozonated water and hypochlorous acid solution. The main questions that participants need to answer are:

What medical conditions do participants have while taking ozonated water and hypochlorous acid solution?

Investigators will compare ozonated water and hypochlorous acid solution with 0.12% chlorhexidine gluconate solution to see if it helps to restore the integrity of the oral mucosa.

Participants:

Participants will be asked to agree to receive oral care 4 times a day, every day for 1 week.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-65,
* Have been on mechanical ventilation for at least 24 hours,
* Have no intolerance or allergy to the solutions,
* Agree to participate in the study

Exclusion Criteria:

* Having a contraindication for oral care
* Not agreeing to participate in the study