cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System

A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for transapical TAVI
* Patient ≥ 70 years of age
* Patient able to give informed written consent
* Patient able to attend follow up examinations

Exclusion Criteria:

* Scheduled concomitant non-TAVI cardiac procedure
* Patient with Left Ventricular Ejection Fraction (LVEF) \< 30% at time of enrollment
* Patient with known apical infarcted area
* Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
* Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
* Patient with contra-indications to transapical TAVI
* Patient's inability to tolerate or comply with normal post-surgical drug regimen
* Patient's inability to comply with required follow-ups, including echocardiography
* Patient participation in other clinical trials within previous month
Campath Maintenance in Chronic Lymphocytic Leukemia

This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.

This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2

Exclusion Criteria:

* Treatment failure in more than 3 prior regimens
* Active secondary malignancy
* Central nervous system involvement with CLL
* History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy
* History of HIV positivity
* Hepatitis C virus (HCV) positivity based upon core antigen testing
* Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents
* Pregnancy or lactation
* Other severe, concurrent diseases or mental disorders
Comprehensive Oral Intervention in Patients With AMI

The investigators performed a randomized controlled trial with investigator-masked design enrolling subjects with acute myocardial infarction.

The purpose of this study is to find a treatment strategy to reduce the risk of recurrence of myocardial infarction through oral hygiene improvement.

Subjects were divided into a treatment group and a control group. Both sides receive basic periodontal examinations, but the treatment group receives active dental procedure such as scaling and root planing. Both groups also receive post-myocardial infarction management.

As part of a pilot study, this study used the primary outcome measure for changes in surrogate markers rather than clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18
* Patients diagnosed with type 1 or 2 MI according to the Fourth Universal Definition of Myocardial Infarction (2018) criteria
* Patients with baseline hsCRP (high-sensitivity C-reactive protein) elevated above 1.0 mg / dL

Exclusion Criteria:

1. clinical exclusion criteria

   * Inability to provide informed consent
   * Patients who are predicted to have low compliance
   * Those whose life expectancy is less than 3 months due to cardiovascular disease or other reasons
   * Those who are considered to be too poor condition to perform dental treatment or have a high risk of bleeding
   * Those who need active dental treatment such as extraction
   * Patients suspected of having active infection
   * Those who are taking long-term systemic antibiotics or receiving immunosuppressive treatment
2. periodontal exclusion criteria

   * Fully edentulous (Except for fixed implant restorations)
   * If more than 15 teeth and implants do not exist
   * If the last dental visit experience is less than 6 months
   * If periodontal treatment is not possible by the researcher
Cesarean Section Study

Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures
* healthy newborns
* born by Cesarean section
* singleton birth
* Age at enrollment in the study \< 24h
* birth weight ≥ 2500g and ≤ 4300g
* gestational age ≥ 37 weeks and ≤ 42 weeks

Exclusion Criteria:

* congenital diseases or malformations that may inhibit growth
* prenatal and/or postnatal diseases
* parents are expected to have difficulty complying with the feeding regime
* planned re-admittance to the hospital in the first 14 days of life
* antibiotic treatment at the time of enrollment in the study
"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"

The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized patients and that the stimulation can generate a diaphragmatic contraction that generates significant breath volume - a Controlled Own Breath (COB).

Also of interest is the reproducibility of the generated diaphragmatic movements and the reliability of different feedback signals for detecting the generated diaphragmatic contraction. This applies to inspiration and expiration detection for subsequent synchronization mechanisms of the magnetic stimulator for patient-initiated breathing as well as to contraction intensity. Further, the characterization of the position finding process is of great importance, so that technical developments can further simplify the process of coil positioning in the future. The possible occurrence of discomfort and pain sensation will also be investigated in awake healthy volunteers. Different stimulation protocols will be used.

Finally, it will be investigated whether an adjusted coil position still triggers reproducible diaphragmatic contractions after removal and repositioning in the same configuration. The knowledge gained will be used to further develop the technique and to prepare a study in critically ill, ventilated patients where the diaphragmatic muscle is to be treated preventively by stimulating the phrenic nerve, in order to prevent atrophy of the muscle.


Eligibility Criteria:
Inclusion Criteria:

* Persons aged \> 18 years
* Applicable for Group 2: planned for elective surgery
* No relevant pre-existing conditions - corresponding to American Society of Anesthesiologists (ASA) level of I-II.
* Written informed consent by the patient for participation in the study given

Exclusion Criteria:

* chronic lung diseases (bronchial asthma, COPD)
* known diaphragmatic weakness
* known neurological conditions with motor muscle weakness
* known paralysis of the phrenic nerve
* conditions that limit the mobility of the diaphragm (high intra-abdominal pressure, ascites, BMI \>30)
* not able to read and understand the national language German
* skin lesions, infections or strictures in the neck area
* persons with Implanted cardiac support systems (pacemaker, implanted defibrillator)
* persons with implanted medical pumps
* pregnant women
* persons deprived of liberty by administrative or judicial decision or under legal guardianship.
* Participation in another clinical trial
* Applicable for group 2 (intubated and mechanically ventilated) patients: Exclusion criteria at the time of stimulation:

  * Unstable patient after induction of anesthesia and intubation
Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis

The purpose of ths study is to evaluate changes in life quality of patients affected by rhinoconjuntivitis with or without asthma after immunotherapy treatment. It is an observational, prospective and comparative study before-after immunotherapy treatment with a one year follow-up.


Eligibility Criteria:
Based on Routine Clinical Practice

Inclusion criteria:

* Patients affected by allergic rhinoconjunctivitis sensityzed to one or several aeroallergens.Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013)
* Patients older than 12 years old
* Patients being subsidiaries of receiving allergen immunotherapy treatment
* Patients who obtained a prick test result ≥ 3 mm diameter to any aeroallergen. Positive and negative control of the test should give consistent results.
* Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to any aeroallergen.

Exclusion criteria (based on routine clinical practice):

* Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1\< 70% even if the are pharmacologically controlled .
* Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator seems relevant so as to interfere with the treatment.
* Patients with a previous history of anaphylaxis
* Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
* Female patients who are pregnant or breast-feeding
Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM

To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* hyperlipidemia controlled by medication
* hypertension controlled by medication
* type 2 diabetes controlled by medication
* minimum 3 years since onset of all three conditions
* sedentary lifestyle

Exclusion Criteria:

* regular smoking
* regular alcohol consumption
* family history of premature coronary heart disease
* hypothyroidism
* renal, hepatic or gastrointestinal disease
Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

This clinical study was a prospective, single-center, single-arm exploratory study. Subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform 5G remote gastrectomy on subjects using the Toumai endoscopic surgery system, and explore and evaluate the safety and efficacy of this clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old ≤ actual age ≤80 years old.
2. Patients requiring gastrointestinal endoscopic surgery.
3. Willing to cooperate with and complete the study follow-up and related examinations.
4. Voluntarily participate in the study and sign the informed consent in person.

Exclusion Criteria:

1. Have serious cardiovascular or circulatory disease and cannot tolerate surgery.
2. Participated in other clinical trials within the last 3 months.
3. Inability to understand trial requirements, or inability to complete the study follow-up plan.
4. Researchers believe that there are other circumstances that are not suitable for inclusion.
Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in Peru

This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 1 year
* Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause
* Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear
* An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old)
* Willingness to come to the health facility for the following 28 days

Exclusion Criteria:

* Signs or symptoms of severe malaria
* Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition)
* History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin
* Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines.
COntrolled MAp Trauma Brain Injury (COMAT Study)

The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)

In head trauma patients, the maintenance of MAP within a very narrow range is desired to avoid secondary ischemic diseases. However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust vasopressor infusion and/or fluid administration. Using a novel automated system can overcome this issue and may lead to more time in MAP target than the traditional management.

All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP.

The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated

Exclusion Criteria:

* Glasgow score \>8
* Bilateral mydriasis at the initial management
Cohort Study on the Effects of Aging in Acquired Brain Injury Patients

A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating.

In the Netherlands an estimated 650.000 people live with the daily consequences of an Acquired Brain Injury (ABI). A substantial amount of these patients acquired their brain injury (traumatic brain injury, subarachnoid hemorrhage or cerebrovascular accident) at a relatively young age: between 18 and 50 years old. The chain-of-care for ABI aims for recovery in the subacute phase, usually within a period of one year after injury. After an adaptation period, the patients reach a new balance, with stabilization of complaints and reintegration, sometimes with the necessity of modifications. The group of patients who acquired a brain injury at a young age, have to face the effects of aging like decreased cognitive functions, which can cause the participation level to drop. This is called the ABI-effect in the current study. At this moment, insufficient information is available about the functioning of people who suffered ABI multiple years ago and have established a new balance, and now make the transition to an older phase of live.

Primary objective:

Explore the prevalence of the ABI-effect, by mapping the participation level.

Secondary objective:

Substantiate the occurence of the ABI-effect, by mapping cognitive functions of patients and compare these to healthy controls.

Tertiary objective:

Gain insight in the need of care for patients, to enhance regular care after ABI.

Eligibility Criteria:
Inclusion Criteria:

* Current age range between 50-67 years \[Rationale: having an age that enables the patient to experience the effects of aging with a low risk of neurodegenerative disease\]
* Able to complete questionnaires independently

Additionally, patients must also meet the following criteria:

* Age of acquiring the ABI ≧ 25 years \[Rationale: the brain is supposed to be fully developed at a maximum capacity
* ABI must be ≧ 5 years ago\] \[Rationale :time period regarded sufficient to have achieved a stable level of cognitive functioning and participation after an ABI\]
* ABI diagnosis at hospital admission with abnormalities at the brain-CT or MRI
* Independent regarding Activities of Daily Living
* Not living in a long-term care facility

Exclusion Criteria:

* Psychiatric disease (for which participant is currently treated)
* Accompanying disease with reduced life expectancy
* Neurological disease (including recurrent ABI for patients)
* Language barriers prohibiting and completion of Dutch questionnaires
* Alcohol or drug abuse
* Suspected neurodegenerative disease
Telomere Length in Relation to Acute Stress Response in Critical Care Patients

the investigators studied the impact of severe stress (in this case any event or illness leading to a necessity of critical care) on telomere length.

Telomeres length analysis were determined from 2 blood samples, the initial sample drawn in the first 72 hours after hospitalization and the second after not \< 5 or \> 14 days. For patients discharged before day 5, a repeat sample was drawn and analyzed on the discharge day. The blood sample processing was as follows: 5 ml of blood was collected and the red blood cells (RBC) were lysed using the RBC lysis solution (Biological Industries, Beit Haemek, Israel). Isolation of genomic DNA was performed by using the DNA isolation kit for mammalian blood (Roche, Mannheim, Germany). Briefly, DNA was isolated by the salting out procedure, washed and precipitated by isopropanol. The DNA was resuspended in polymerase chain reaction (PCR) grade water. The DNA concentration was measured by using the NanoDrop device (Thermo Fisher, USA).

DNA samples were analyzed for telomere length according to the method of Cawthon (2009) \[20\] with slight modifications. Each DNA sample was analyzed by two sets of primers detailed below, one for telomere length analysis and one for a reference gene analysis (human hemoglobin). The primers were diluted to 100µM in PCR grade water and then to 10µM. DNA samples were diluted to 2.5 ng/µl in PCR grade water. The primers sequences are shown below:

telc: TGTTAGGTATCCCTATCCCTATCCCTATCCCTATCCCTAACA telg: ACACTAAGGTTTGGGTTTGGGTTTGGGTTTGGGTTAGTGT hbgd:_GCCCGGCCCGCCGCGCCCGTCCCGCCGGAGGAGAAGTCTGCCGTT hbgu: GGCGGCGGGCGGCGCGGGCTGGGCGGCTTCATCCACGTTCACCTTG

Reaction PCR were processed as follows:

50°C for 2 min, 95°C for 5 min, a single cycle of 94°C for 15 sec, 49°C for 15 sec; 40 cycles of: 94°C for 15sec, 62°C for 10 sec and a final stage of: 74°C for 15 sec. All reactions were performed using the Step One device (ABI, USA).

Eligibility Criteria:
Inclusion Criteria:

* • Patients hospitalized up to 72 hours prior to admission to the ICU

  * Predicted ICU stay is at least 5 days

Exclusion Criteria:

* • Pregnancy and lactation
Study of microRNAs in the Evolution of Carotid Plaque. Physiopathological and Therapeutic Interest

Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world

Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world. The constitution of the atheroma plaque is linked to the deregulation of several biological phenomena, including angiogenesis, adipogenesis, inflammatory response, lipid metabolism and oxidative stress. In addition to its anatomical and physiological characteristics, the notion of plate stability is of paramount importance for clinical implications. This stability depends largely on the biological composition of the plate. A vulnerable or unstable plaque often has a large lipid body consisting of foam cells (macrophages laden with oxidized LDL) with a thin fibrous screed consisting of smooth muscle cells (CML), collagen fibers and extracellular matrix. This plaque is also made up of numerous inflammatory cells including macrophages, rich vascularization and intraplate hemorrhage. Although the cell composition of the unstable plate is still relatively established, its molecular analysis remains little known.

The benefit of carotid surgery in asymptomatic patients with stenosis greater than 70% is increasingly controversial given the moderate risk of spontaneous stroke under optimal medical treatment. This annual average risk is less than 5%. Thus, the discovery of an original and innovative biomarker, predictive of plate rupture, would define the patients most at risk, who benefit most from this surgery.

Eligibility Criteria:
Inclusion Criteria:

* Any adult with a carotid thrombo endarterectomy,
* affiliated to a social security scheme,
* informed of the study and not opposed to it.

Exclusion Criteria:

* Any person benefiting from an iterative carotid surgery,
* or refusing to participate in the study,
* or not being able to express its consent.