cyrilzakka/clinical-trials huggingface dataset:
Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.

Cell Free Circulating Nucleic Acids as New Tumor Diagnostics From Human Plasma Samples.

Cell free circulating free nucleic acids is new substrates for laboratory diagnostics in a number of medical areas including oncology, transfusion medicine, gynecology/obstetrics, inflammatory and autoimmune diseases etc.There are various qualities of cell free nucleic acids. In oncology, it has been shown that the early detection of cell free nucleic acids originating from the tumour preceeds the diagnostic detection of clinical relapse as done by imaging techniques or clinical symptoms by 6-8- months.

Exosomes are small, lipid bilayer membrane vesicles (30-100 nm) that are released from all cell types into the extracellular space. These tiny membrane vesicles transmit EV-mediated signals by proteins, lipids, nucleic acids and sugars, and the unique molecular pattern of this package direct the type of extracellular signal to be transmitted to target cells. Interest in exosomes range from their mode of action and various functions in the body to more practical applications such as development of biomarkers based on analysis of their RNA and protein content and their use in clinical diagnostics. It was proposed that micro RNAs are transferred through exosomes to recipient cells and can there mediate repression of their mRNA targets.

The use of highly expensive targeted therapies (e.g. tyrosine kinase inhibitors or PARP inhibitors) may become obsolete during therapy due to changes in the mutational molecular profile of the malignant tumour. Indeed, if early detection of cell free nucleic acids suggest therapy failure, new stratification of the patient and changed therapy modalities may be possible in the future, thus helping to prolong overall survival of tumour patients.

Aims of the Research:

* To isolate exosomes as a stable source of cell free nucleic acids.
* To perform protein profiling on the isolated exosomes.
* To isolate nucleic acids from exosomes for analysis.
* To define and develop standards and protocols for cell free nucleic acids analysis particularly regarding epigenetic alterations with emphasis on DNA methylation.
* Optimizing of pre-analytical process to improve the pre-analytical aspects of assays.
* To test the stability of methylated compared to non-methylated circulating DNA under various pre-analytical conditions.

Eligibility Criteria:
Inclusion Criteria:

* patients with Melanoma

Exclusion Criteria:

* patients with other types of malignancies
Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality

This study will investigate the accuracy of implant navigation for spinal instrumentation. The tested technique is based on commercially available AR-glasses and a specially developed software component

The experimental intervention consists of using the AR-glasses and a specially developed software as a navigation aid in surgery. The surgical technique for the intervention group corresponds to the established standard method. It is identical to the control intervention except for the step where pedicle screws or rod implants are instrumented.

The surgeon wears the hardware component during the entire surgery. He proceeds conventionally up to the point where navigation of pedicle screws and rod implants with is required.

Eligibility Criteria:
Inclusion Criteria:

* Indication for surgical instrumentation of the spine (Os Sacrum, L1-L5, Th1-Th12) without or with correction of a malposition.
* Anatomical adaptation of the rod implant necessary.
* The trial participant is able to give his/her consent.
* Signed written declaration of consent after oral and written explanation.
* Male and female patients aged 18 years and older.
* Indication for a preoperative CT scan of the lumbar spine
* Existence of a preoperative planning, which was created on the basis of 3D CT imaging

Exclusion Criteria:

* Pregnant or breastfeeding women
* Emergency situations
* Other known clinically significant concomitant diseases (e.g. infections, tumors, co-existing arthrosis).
* Known or suspected incompliance with the protocol, such as drug or alcohol abuse.
* Inability of the patient to follow the study procedures, e.g., due to language problems, mental illness, dementia, etc.
* There is no conventional surgical treatment that can be used if the MP cannot be used intraoperatively.
Mitochondrial Dysfunction and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program.

Training protocol used is based on recommendations (Nici et al., 2006) and was previously used in our group (Varray et al., 1991; Vallet et al., 1997). A minimum of 20 sessions in 4-6 weeks were proposed. The exercise intensity of exercise corresponds to target heart rate at ventilatory threshold measured during incremental exercise test. Training at this intensity allowed us to individualize effort for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary mild to severe COPD patients

Exclusion Criteria:

* Neuromuscular disease
* Chronic heart failure
* Renal diseases
* Liver diseases
* Obesity
Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans

The aim of the study is to investigate whether the food matrix has an influence on the prebiotic efficacy (bifidobacteria growth) of chicory-derived Orafti® inulin in healthy adult volunteers. The main question it aims to answer is:

Does the food matrix influence the prebiotic effect of chicory-derived inulin in terms of stimulation of bifidobacteria in the gut microbiota Participants will receive one of three food items containing inulin or pure inulin dissolved in water daily for 10 days. The food items or pure inulin powder will deliver 10 g/d inulin split into two dosages of 5 g/d. They will provide stool samples before and at the end of the intake period. They will record any gastrointestinal sensations and bowel habits in a diary. Urinary samples will be collected at baseline and end of intervention for analysis of metabolites with Nuclear Magnetic resonance (NMR).


Eligibility Criteria:
Inclusion Criteria:

* Volunteer is healthy at the time of pre-examination
* Volunteer is aged ≥ 18 to ≤ 65 years at the time of pre-examination
* Volunteer's BMI is ≥ 18,5 and ≤ 29,9
* Volunteer follows an average Western European diet
* Volunteer has a stool frequency of at least 3 bowel movements per week
* Volunteer is able and willing to comply with the study instructions
* Volunteer is suitable for participation in the study according to the investigator/study personnel
* Written informed consent is given by volunteer

Exclusion Criteria:

* No command of any local language
* Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment
* Food allergies or intolerances
* Vegetarians, vegans and/or extreme diets including high protein/fibre, ketogenic, intermittent fasting and/or carnivore
* Using drugs (e.g. antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function (8 weeks before intervention)
* Use of laxatives and labelled pre- and probiotics in the previous 4 weeks before the beginning of intervention
* Clinically significant diabetes
* Volunteers currently involved or will be involved in another clinical or food study
* History of drug (pharmaceutical or recreational) or alcohol abuse.
* Has received bowel preparation for investigative procedures in the 4 weeks prior to the study
* Has undergone surgical resection of any part of the bowel.
* If participants are pregnant or are lactating
Preconception Carrier Screening at the Erasmus MC

Rationale A recent advisory report by the 'Health Council' has recommended that all prospective parents should have the opportunity to undergo preconception carrier screening. Consequently,there will no longer be any prerequisites for referring a couple. It is expected that there will be an increase in the number of prospective parents seeking counseling for preconception carrier screening. This is anticipated to result in an increase in the number of referrals, leading to several points of attention.

Objective(s) The aim of the research is to gather insights, perspectives, and experiences from healthcare professionals and prospective parents in order to design a care pathway for offering preconception carrier screening at Erasmus MC and the Rotterdam region. This will also include examining the role that nurse practitioners can play in this offering.

Study type Exploratory research. Study population Healthcare professionals involved in preconception carrier screening and potential prospective parents who might want to undergo preconception carrier screening in the future. Methods Semi-structured interviews and focus groups will be used to explore topics which will be audio recorded and transcribed verbatim. The results will be analyzed by two to three researchers independently following the principles of grounded theory.

Burden and risks There are no risks associated with this research. For the interviewees and participants of the focus groups there is the burden of time investment. Recruitment and consent Health care professionals and potential prospective parents will be asked for participation in the study by the treating physician. If they consent to be approached, they will be informed about the study and contacted by the researcher. If willing to participate, an appointment for the interview/focus group is scheduled. Before the start of the interview/focus group, signed informed consent will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Health care professionals working with potential prospective parents.
* Potential prospective parents who might want to undergo preconception carrier screening in the future.

Exclusion Criteria:

* (Dutch) language proficiency not sufficient.
Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.

The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter \> 4 mm with erythema)

Eligibility Criteria:
Inclusion Criteria:

* history of allergy symptoms during previous birch pollen season
* positive skin prick test to birch pollen extract

Exclusion Criteria:

* pregnancy
* uncontrolled asthma
* other significant clinical conditions or immune disorders
* subjects taking antihistamines or drugs with antihistamine activity
Ramipril for the Treatment of Oligospermia

This is a randomized controlled trial to evaluate the effect of ramipril in stimulating and promoting sperm production in men with low sperm count. Ramipril is an Angiotensin Converting Enzyme Inhibitor (ACEI) currently used to treat high blood pressure. However, previous studies have shown that this class of medications can improve sperm parameters. The purpose of this study is to evaluate the efficacy of ramipril compared to placebo (Substance That is not known to have treatment effect), in improving sperm density in infertile men with documented low sperm count. This study will help us identify subjects that might benefit from treatment with this medication, and the effect it will have on sperm count, shape, and motility.

Approximately half of all infertility problems are caused by male factors. These men account for 17% of patients at the primary health care level that seek help for infertility. Oligospermia (Low sperm count) of unknown cause occurs in up to 60% of men with unexplained infertility. Certain group of patients with oligospermia can father children, but those with infertility have long posed a major therapeutic challenge. A variety of empirical non-specific treatments have been used, in attempt to improve their semen characteristics and fertility. In the past, androgens were suggested as a treatment; however, exogenous testosterone was found to exert negative feedback on the pituitary-gonadal axis and thereby suppresses Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) secretion then adversely affects sperm production. Other treatment modalities like clomiphene citrate, tamoxifen, recombinant FSH, zinc, selenium, and L-carnitine have been tried with minimal success. In the present study we are proposing the use of an angiotensin converting enzyme inhibitor (ACEI) for the treatment of oligospermia. A recently published pilot study showed that the use of lisinopril improved sperm quantity and quality in oligospermic men. ACEI are inexpensive, safe, widely available, and, if effective in improving sperm production and quality, could avert couples from undergoing invasive procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Male partner of a couple presenting for infertility.
2. Moderate abnormalities of semen parameters (Mean sperm density \<20 million, but ≥ 3 million/ml), and/or motility \< 50%, and/or \< 4% abnormal morphology on at least two separate occasions.
3. Age 18-45 years.
4. Normal renal function defined as Glomerular filtration rate \> 90

Exclusion Criteria:

1. Patients that are currently taking thiazide, cyclosporin, lithium, and allopurinol or the use of these medications in the last 2 weeks.
2. The frequent use of NSAIDS (3 or more times a week).
3. Vasectomy reversal.
4. Regular use of tobacco products.
5. Mean white blood cell count \>1 million/ml in the ejaculate.
6. Inability or unwillingness to participate in evaluations required by the study.
7. Potassium \> 5.0.
8. Systolic blood pressure \< 90 mmHg.
9. Currently use of ACEI
Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on PTSD

Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on posttraumatic stress disorder after discharge from ICU.

Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have less posttraumatic stress disorder after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Endotracheally intubated
* Expected time on ventilator \> 24 hours
* Age ≥ 18 years
* Informed consent

Exclusion Criteria:

* Severe head trauma where therapeutic coma is indicated
* Therapeutic hypothermia where therapeutic coma is indicated
* Status epilepticus where therapeutic coma is indicated
* Patient has participated in the study before
* Patient is transferred from another ICU with length of stay \> 48 hours
* Patient is comatose at admission
* PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation
* Patient does not speak Danish, swedish or norwegian at a reasonable level
A Study on Evaluation of Mental Health Index of Patients With Psychiatric Disorders

Psychiatric patients under the mental impaired influences, their living function were disabled, and their social lives were handicapped consequently. Idea psychiatric treatment is to control the psychiatric symptoms in a better way, to develop efficient psychiatric adjustment, to manage living stress into a lower level, to gradually develop the meaning and value of the patients' lives, and to obtain the satisfaction and happiness in life for them. In order to investigate the satisfaction for psychiatric patients under the current treatment and to evaluate their psychiatric health, it is necessary to measure the mental health status for the psychiatric patients, and to ensure the ideological status of psychiatric treatment. If there is a mental health measurement for the psychiatric patients, we may precisely identify the mental health levels of the patients and their mental disturbances degrees. Accordingly, we may develop efficient procedure to manage the mental health for the psychiatric patients, and to achieve the goal for the idea psychiatric treatment.

In this study, we established the mental health assessment data sheet according to the clinical experiences. It includes mental health index data sheet, mental-and-physical stress response data sheet, mental sustentation data sheet, and supplemented with a general living satisfaction assessment data sheet. We will evaluate the reliability and validity of this study to ensure the usability of these data sheet in clinics. We will also recruit the continuous treated and mentally stabilized patients as subjects. After obtaining their written informed consents, we will go through these mental health assessments to discover the mental health status of these psychiatric patients, and use it as a reference to develop idea psychiatric treatment. We will use ICC test for the repeated measurement validity, Pearson r correlation coefficient within our data analyses to evaluate the validity of the same measurement, and independent t-test to assess the differences between the patient group and the society group (from previously established data files). This study result may evaluate the possible deficits existing in the traditional psychiatric treatment and may be used as a reference for the development of idea psychiatric medicine.


Eligibility Criteria:
Inclusion Criteria:

* Psychiatric Disorders

Exclusion Criteria:

-
Dopaminergic, Functional, Structural, and Cognitive Disturbances in First-episode Schizophrenia

We wanted to compare dopamine D2 receptor activity, brain structure, brain function, sensory gating and cognition in neuroleptic-naive schizophrenic patients and matched healthy controls. Additionally, we wanted to examine the effects of 3 months of treatment with either low doses of a typical or an atypical antipsychotic compound on the same functions. The hypotheses were that schizophrenic patients suffered from disturbances in brain function and structure, information processing, and extrastriatal D2 receptor activity, and that these disturbances would be related to each other and to psychopathology. Additionally, we expected the atypical compound to have an effect on some of the disturbances in information processing, and that the atypical compound - in contrast to the typical drug - would show extrastriatal over striatal selectivity.

31 neuroleptic-naive schizophrenic patients and 25 matched controls were recruited from the greater Copenhagen area. The patients were randomized to treatment with either low doses of the typical antipsychotic compound, zuclopenthixol, or the atypical drug, risperidone. Patients and controls were examined at base-line and patients were re-examined after 3 months of treatment.The study has resulted in two finish Ph.D. theses (Torben Mackeprang and Birgitte Fagerlund).

The data has in part been published in:

Mackeprang T, Tjelle Kristiansen K, Glenthoj B. Prepulse inhibition of the startle response in drug-naïve, first-episode schizophrenic patients before and after 3 months of treatment with a typical or an atypical antipsychotic drug. Biological Psychiatry 2002; 52(9): 863-873.

and

Fagerlund B, Mackeprang T, Gade A, Hemmingsen R, Glenthoj BY. Effects of Low-Dose Risperidone and Low-Dose Zuclopenthixol on Cognitive Functions in First-Episode Drug-Naïve Schizophrenic Patients. CNS Spectr. 2004; 9: 364-74.

and

Glenthoj BY, Mackeprang T, Svarer C, Rasmussen H, Pinborg L, Friberg L, Baaré W, Hemmingsen R, Videbæk C. Frontal dopamine D2/3 receptor binding in drug-naïve first-episode schizophrenic patients correlates with positive psychotic symptoms and gender. Biological Psychiatry 2006; in press. Mar 30; \[Epub ahead of print\]. PMID: 16784819 \[PubMed - as supplied by publisher\].

We are at present conducting a five-year follow-up study of the same cohort of patients and controls and plan a ten-year follow-up as well. The follow-up studies focus on brain structure (MRI), brain function, information processing, and psychopathology. We will correlate changes in structure and function to treatment, but no interventions (pharmacological or otherwise) are planned.

Eligibility Criteria:
Inclusion Criteria:

* For patients: Clinical diagnosis of schizophrenia.
* The controls were matched to the patients.

Exclusion Criteria:

* Patients: Previous antipsychotic treatment, patients who were compulsorily hospitalised or deemed in acute need of medication, mental retardation
* Controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives, drug abuse, mental retardation
Using of Bone Marrow Stem Cell Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Reconstruction of Upper Jaw Bony Cystic Defects, Comparing with Platelet Rich Fibrin with Bone Graft

Will the use of bone marrow stem cells with platelet rich fibrin enhance and accelerate the bone regeneration in the upper jaw cystic defects ?

Reconstruction of critical size bone defect in maxillofacial surgery is a great challenge, current practice of bone reconstruction still having problems like delay in bone regeneration (up to 12 months) and bone graft failure and low availability of autogenous bone graft.

last decade stem cells therapy gained great interest, in many studies Bone marrow stem cells showed promising result in bone regeneration enhancing .

Platelet Rich Fibrin PRF also capability of enhancing bone and tissue regeneration by releasing of certain protein molecules call growth factors that initiate sequential biological events resulting in stem cells migration into the site of bone defect and differentiation to bone formation cells (osteoblast cells ).

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-50 years
* Patients with a critical size maxillary cyst. (\>3 cm)
* Patients that free of any significant medical conditions that could affect healing or outcomes.

Exclusion Criteria:

* Patients with large jaw cyst that endanger vital structures
* Patients with significant medical condition
* age under 18 years