cyrilzakka/clinical-trials huggingface dataset:
Microcirculation in Continuous Venovenous Hemofiltration Patients on the Intensive Care Unit

In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number, the microvascular flow index (MFI).

Before deciding to threat a patient actively with CVVH, a target balance will be agreed for the next 12 hours. Then the ultrafiltration rate for the zero balance is calculated. From there, the ultrafiltration rate progressively increased to 50 ml per hour, up to a maximum ultrafiltration rate of 300 ml per hour.

After each increase of the ultrafiltration rate, the sublingual microcirculation is assessed by SDF.

After obtaining the desired ultrafiltration rate, the microcirculation will again be assessed before and after the patient is temporarily placed in Trendelenburg position. This could possibly show that underfill has the greatest influence on the microcirculation, and not other factors like a rising hematocrit.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 jaar
* informed consent

Exclusion Criteria:

* age \< 18 jaar
* oral surgery
Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes

Type 1 diabetes mellitus is the most common chronic metabolic disorder in children. Diabetic children who take proper nutrition and good care attain normal growth status. Factors affecting growth in diabetic patients include gender, age at diagnosis, duration of disease, glycemic control, and puberty status. Moreover, diabetes mellitus has negative impact on vestibular system, affect proprioception and lower limb muscle fatigue resulting in reduced balance.

Limited literature is available regarding the relation between anthropometric measurements and balance in children with diabetes mellitus. Therefore, the current study will be conducted to investigate the relation between anthropometric measurements (weight, height and body mass index) and balance in children with diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as controlled T1DM.
* Age ranges from 7 to 11 years.
* From both sexes.
* Duration of the disease 3 to \< 5 years.
* Same socioeconomic level.

Exclusion Criteria:

* Other hormonal diseases (hypothyroidism or hyperthyroidism).
* Hereditary sensory and autonomic neuropathy
* Significant visual disorders.
* Subjects participating in regular sports activities.
* History of fracture or surgery in the lower extremities in the past 12 months.
Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa

Sickle cell anemia (SCA) is among the world's most common and devastating blood disorders, affecting more than 300,000 newborns per year. Most infants with SCA are born in the low-resource settings of sub- Saharan Africa, where an estimated 50-90% will die before 5 years of age due to lack of early diagnosis and appropriate care. Hydroxyurea is a safe and effective once-daily oral medication that has become the standard of care for the treatment of children with SCA in high-resource settings. There is now a growing body of evidence to support the safety and clinical benefits of hydroxyurea for the treatment of SCA in sub-Saharan Africa. The requirement for frequent laboratory monitoring, uncertainties about appropriate, most effective dosing, and the concern for hematologic laboratory toxicities, however, will continue to limit widespread hydroxyurea utilization and real-world effectiveness. The investigators have recently developed and prospectively evaluated an individualized, pharmacokinetics-guided hydroxyurea dosing strategy for children with SCA that has demonstrated optimal clinical and laboratory benefits with minimal toxicity. In this research study, the investigators aim to extend this precision medicine approach to Africa.

The Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa (PUSHUP) trial is a prospective, randomized clinical trial of hydroxyurea for 400 children with SCA in Luanda, Angola. The study will prospectively evaluate the safety and efficacy of hydroxyurea with limited laboratory monitoring and will bring precision medicine to children with SCA using several novel features including measurement of hydroxyurea using a battery-powered HPLC machine and individualized dose calculations using an automated computer-based algorithm. The objective of this study is to establish evidence-based guidelines for hydroxyurea in sub-Saharan Africa, including appropriate dosing and laboratory monitoring strategy with the goal of allowing for widespread use of hydroxyurea across sub-Saharan Africa, regardless of clinical or laboratory resources.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sickle cell anemia (HbSS or HbS/B0-thalassemia)
* Age 6 months- 12 years of age at enrollment
* Parent or guardian willing and able to provide written or informed consent
* Weight ≥ 7.5 kg (temporary exclusion)

Exclusion Criteria:

* Splenomegaly with evidence of hypersplenism as defined by platelet count \<150,000, hemoglobin \<5 g/dL or absolute neutrophil count \<1.0 x10\^9/L
* Hydroxyurea use within the past 6 months
* Blood transfusion within the past 6 months (temporary exclusion)
* Pregnancy
* Pre-existing severe hematologic toxicity, as defined by platelet count \<80,000, hemoglobin \<4 regardless of ANC; hemoglobin \<6 AND ARC \<100; hemoglobin \<7 AND ARC \<80 x10\^9/L (temporary exclusion)
Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory

Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. However, AZA/VEN is also associated with an increased hematological toxicity compared to azacytidine alone. In this context, alternative AZA/VEN regimens emerged progressively based on each physician experience and local procedures. Moreover, AZA/VEN is also recognized as a valuable therapeutic option in relapse/refractory settings. In this multicentric study, the investigators aimed to evaluate the efficacy and safety of various AZA/VEN regimen in frontline and relapse/refractory (R/R) patients diagnosed with AML in real life setting.

The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers (Saint-Etienne, Clermont-Ferrand, Lyon (Hopital Lyon Sud, Centre Léon Bérard), Vichy, Annecy, Chambery, Valence, Bourgoin-Jallieu, Grenoble, Roanne) in Auvergne Rhône Alpes (AURA) region, between January 2019 and December 2023. Composite complete remission was defined as in VIALE-A trial. Measurable residual disease (MRD) negativity was defined as ≤ 10-3 by flow cytometry (on bone marrow) and/or ≤ 10-4 for NPM1 by RT-qPCR.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or MRD relapse.
* receiving AZA/VEN combination regimen

Exclusion Criteria:

* Another VEN combination chemotherapy
* AZA/VEN initiation prior January 2019 and after December 2023
* Opposition to the study
Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors

This study investigates the clinical course of CDK4/6 inhibitor treated patients in the real-world setting among patients with breast cancer. CDK4/6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy, from patients with breast cancer that has spread to the other places in the body (metastatic) may help doctors learn more about cancer and the development of drug resistance in patients, and predict how well patients will respond to treatment.

PRIMARY OBJECTIVES:

I. Delineate clinical features of disease progression and responses to subsequent therapy following progression on ciclib-based therapy.

II. Define pharmacogenomics relationships that could provide a more precise approach to drug dosing.

III. Interrogate biomarkers related to response and acquired resistance in standard clinical practice.

IV. Develop patient-derived models from resistant disease to functionally assess the mechanisms occurring with resistance.

V. Elucidate the socio-demographic features related to the use of ciclibs clinically in the Roswell Park catchment area.

OUTLINE:

Patients electronic medical records are reviewed to capture clinical information, and patients undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples for diagnosis/treatment decision, biomarker assessments, and description of mechanisms of resistance/response related to ciclib-therapy.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with ER+/HER2- metastatic breast cancer or HR+/HER2-node positive, high risk early breast cancer who are being or have been treated with ciclib-based therapies are eligible for inclusion in this study

  * This includes patients receiving standard of care therapy for ER+/HER2- metastatic breast cancer, as well as those who would be eligible to participate in a non-interventional study while on a clinical study open at Roswell Park or St. Vincent's Hospital
  * Screening will occur in breast oncology clinic, by review of patient medical records for the pending, ongoing, or past treatment with ciclib-based therapy
* Participant must understand the prospective nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form

Exclusion Criteria:

* Pregnant of nursing female subjects
* Unwilling or unable to follow protocol requirements
German Lactat Clearance in Severe Sepsis

The aim of this study is to investigate if there is a correlation between lactate clearance and the course at patients with severe sepsis and septic shock at german intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe sepsis or septic shock
* signed informed consent

Exclusion Criteria:

* severe sepsis or septic schock within 4 weeks before inclusion of study
* shock of other genesis
* persons being accomondated in an institution because of court or official order
* persons being interdependet to the investigator
* employees of the investigator
Trans-parenchymal Compressing Suture in Major Liver Resection

Non-anatomical liver resection with appropriate resection margin was regarded as a potential curative treatment for selected major hepatic carcinoma due to preserving maximal normal liver, especially in cirrhotic patients. But occurrence of cutting surface related complications become a main challenge.

In order to better manage the cutting surface after liver resection, we further applied trans-parenchymal compressing suture to "not good" cutting surface in hope of decreasing cutting surface related complication. A majority of studies investigating cutting surface management are limited to non-surgical treatments, such as the application of hemostasis agents including fibrin sealants, oxidized cellulose, and absorbable gelatin sponge13-15 . But there is no consensus regarding the necessity of the hemostatic agent application to the liver cutting surface. Up to date, few studies investigate surgical suture management of the cutting surface in liver resection.

Eligibility Criteria:
Inclusion Criteria:

1. tumor size more than 5cm
2. non-anatomical liver resection;

Exclusion Criteria:

1. intravascular infiltration with tumor embolus;
2. previous liver surgical treatment (e.g. microwave ablation; preoperative transcatheter arterial chemoembolization (TACE);
3. other concomitant extrahepatic procedures (e.g. splenectomy).
4. exposed Glisson Shealth, main hepatic veins or (and) retro-hepatic inferior vena cava.
Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.

Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2

Exclusion Criteria:

* abnormality of upper airway gastroesophageal disease risk of aspiration BMI \> 35
Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE (OSAS)

The purpose of this study is to determine the possible effects of uvulopalatopharngoplasty (UPPP) -which is a a therapy used on patients with Obstructive sleep apnea syndrome (OSAS- on oxidative damage.

Obstructive sleep apnea syndrome (OSAS) is a sydrome which has characteristic upper way obstruction and a decrease in blood oxygen saturation as sleeping. uvulopalatopharngoplasty (UPPP)is one of the surgical approaches applied to the patients with OSAS, since the oxidative damage markers have been found high in patients with OSAS. Although antioxidant levels were higher in patients with OSAS than those in normal population, there is report about the effect of UPPP on antioxidant status in patients with OSAS. We performed this study to confirm whether is there a We performed the present study to confirm whether there is a relationship between the OSAS and oxidative damage before and after UPPP.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS)

Exclusion Criteria:

* Anormal nasopharyngeal computed tomography, chronic diseases such as diabetes mellitus, hypertension etc.
Use of Acupuncture for Dental Pain: Testing a Model

This study is testing the safety and effectiveness of acupuncture in controlling pain related to the removal of partially impacted mandibular third molars. Acupuncture is the Chinese art of healing by inserting needles into the skin.

Participants ages 18 - 40 are given an initial x-ray to determine if one lower molar is partially bony impacted. Eligible participants will then undergo standard oral surgery to remove the impacted molar. A local anesthetic will be used prior to surgery. Directly after surgery the participant will be assigned to one of three groups. Participants will not be able to select which group they are assigned. Participants will receive either real or sham (fake) acupuncture as a treatment for post-extraction pain. After the initial acupuncture treatment, participants are required to remain for six hours at the dental site to be monitored. If a participants discomfort is measured as moderate or higher then a second acupuncture treatment will be administered. All participants will be administered questionnaires during the day of surgery. Participants will also be required to complete two diaries during the seven days following surgery. On the seventh day, participants return to have stitches removed and hand in completed diaries.


Eligibility Criteria:
Inclusion Criteria:

* At least one lower mandibular molar with partial bony impaction
* General good health
* Minimum body weight of 99 lbs.
* Able to read and write in English
Exercise in Patients With a Biventricular Pacemaker

The investigators will evaluate the effects of an exercise program (walking on a treadmill) on the physical performance, the cardiorespiratory function, the proclivity to heart arrhythmias and the quality of life of patients with severely impaired left ventricular function and a bi-ventricular resynchronization pacemaker.


Eligibility Criteria:
Inclusion Criteria:

* Left ventricular failure
* Resynchronization therapy with a biventricular pacemaker
* Ability to understand written German

Exclusion Criteria:

* Age over 75 years
* Severe cardiac arrhythmia
* All conditions which can be aggravated by an exercise program
Flavonoid Supplementation and Endothelial Function

Flavonoids are one of the many classes of natural chemicals found in a variety of foods. People with the highest flavonoid blood levels have the lowest rates of coronary heart disease. This is considered one of the reasons why high fruit and vegetable consumption is associated with lower rates of heart disease, although it is not known if taking a flavonoid supplement provides the same protection as eating fruits and vegetables.

The purpose of this study is to determine if a particular flavonoid supplement, called Isotonix OPC-3, taken on a daily basis, will improve the function of arterial vessels. Arteries normally constrict after eating a high-fat meal. This study will examine the potential of the OPC-3 to lessen this constriction response. Approximately 25 people will be involved in this research project and participation will last for 10 weeks.

We propose to use a supplement made by NutraMetrix (called OPC-3), consisting of oligomeric proanthocyanidins derived from grape seed, pine bark, bilberry, citrus and red wine extracts, to determine effects on endothelial function, lipoproteins and inflammation. The primary outcome measure will be endothelial function as assessed by digital response to hyperemia using peripheral arterial tonometry, measured both in the fasting state and after a single standardized high-fat meal, when transient dysfunction is expected to occur. Secondary outcome measures will be the lipid profile, hs-CRP, and Lp-PLA2. The recruitment population will be healthy volunteers. The design will be a randomized, placebo-controlled, double-blind, cross-over trial lasting 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age or older
* no pregnant potential

Exclusion Criteria:

* History of coronary artery disease
* History of cerebrovascular disease
* History of heart failure
* Diabetes
* Renal impairment
* Uncontrolled hypertension
* Untreated or clinically evident thyroid disease
* Currently taking medications or supplements with known or potential lipid-altering effects including: phytosterols, statins, cholestin, niacin, fibrates, psyllium fiber, bile acid sequestrants, diabetic medications, and weight control medications such as orlistat
* Pregnancy or breastfeeding
* Tobacco use - Participants will be excluded with a history of smoking anytime in the past 6 months.
* Inappropriate for participation in a study, if in the opinion of the investigator it is questionable whether the participant will be able to comply with all aspects of the protocol (e.g. inadequate cognitive skills, possible drug abuse or dependence, suspected psychiatric problems, etc.)
Computer-based Training (Retraining) for People With Gambling Problems

The study examines the efficacy and acceptance of a computer-based training program for individuals with problematic or pathological gambling behavior. The study intends to investigate the extent to which the computer-based training program leads to a significant reduction in pathological gambling (primary outcome) when compared to a control group. The study design is a randomized-controlled trial with one intervention group and one wait-list control group.

The study examines the efficacy of a computer-based training program for individuals with problematic and pathological gambling behavior. The main objective of the study is to investigate the extent to which the online program leads to a significant reduction in pathological gambling. The primary outcome is the Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsory Scale (PG-YBOCS total score) as a measure of the severity of pathological gambling symptoms. Secondary outcomes are further measures of gambling-related symptoms, such as the South Oaks Gambling Screen (SOGS), as well as rates of depression, measured with the Patient Health Questionnaire - 9 items depression module (PHQ-9), and rates of impulsivity, measured with the impulsivity subscale of the Eysenck's Impulsivity Inventory (I-7). The training is expected to lead to a significant reduction in problematic/pathological gambling behavior (PG-YBOCS) and all secondary outcomes when compared to a control group. The study design is a randomized-controlled trial with one intervention group and one wait-list control group and two assessment times (pre and post). The intervention group receives the download link for the training program directly following the baseline survey and can use the training over a period of 8 weeks, whereas the wait-list control group receives access to the training after completion of the post-survey.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* access to internet
* sufficient command of the German language
* willingness to participate in two short (25-30 minutes) online surveys
* willingness to use the online program over a period of 8 weeks (participants who do not use the program are also included in the analysis)
* willingness to leave an (anonymous) email-address
* subjective need for treatment

Exclusion Criteria:

* presence of a lifetime diagnosis of schizophrenia or bipolar disorder
* acute suicidal tendency (assessed with item 9 of the PHQ-9, ≥3)