cyrilzakka/clinical-trials huggingface dataset:
Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS

A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein.

If the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed.

The aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.

This single-center observational study will record and compare Midline and PICC line catheter-related bloodstream infections in the first 30 days after placement, catheter-related bloodstream infections being defined as clinical signs associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.

Catheter indications, insertion conditions, incidence of haemorrhagic and thrombotic complications during the first 30 days will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Major ≥ 18 years old
* opposition formulated

Exclusion Criteria:

* Refusal of participation
* Patients under legal protection (guardianship, curatorship, etc.)
A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants

The purpose of this clinical trial is to learn about the interaction of sisunatovir with four medications (midazolam, itraconazole, rifampicin, and verapamil). These medications are known to have specific effects on enzymes and proteins that could influence drug absorption.

This study will be conducted in 4 Cohorts:

* Cohort 1 will receive midazolam and sisunatovir or placebo,
* Cohort 2 will receive Itraconazole and sisunatovir,
* Cohort 3 will receive verapamil and sisunatovir,
* Cohort 4 will receive rifampicin and sisunatovir. A placebo looks like sisunatovir but does not contain any active medicine in it.

This study is looking for health adult participants that meet the following criteria:

1. Caucasians age 18 to 45 years
2. All fertile participants must agree to the use of highly effective contraception
3. Body mass index (BMI) of 18-25.0 kg/m2
4. Male and female participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests.

This study consists of 2 parts, Part A and Part B. Part A will enroll up to 104 participants. The design of Part B will be determined after the completion of Part A.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 years, inclusive
* Willing to comply with protocol defined contraception requirements
* In good health with no history of major medical conditions
* A body mass index (BMI) of 18 - 25 kg/m2

Exclusion Criteria:

* Evidence of any clinically significant or currently active major medical condition
* Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
* Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products
The CARDIO-TTRansform Scintigraphy Sub-study

The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.

Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optional scintigraphy scans.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have been properly randomized into the ION-682884-CS2 study (NCT04136171) and should have had a baseline scintigraphy scan (99mTc-DPD, 99mTc- PYP, and 99mTc-HMDP) within 12 months prior to screening for ION-682884-CS2 with planar and SPECT or SPECT/CT images that can be read by the central reader.

Exclusion criteria:

* Must not meet any of the exclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
* Must not have weight or body girth that exceeds the limits of the equipment specifications.
* Should not have any previously reported hypersensitivity reaction to Technetium-99m.
Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients

The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.

To compare the treatment effects of risperidone and quetiapine on cognitive function, using measures commonly believed to be affected by sedation and at doses typically used in clinical settings in stable bipolar I outpatients.One-half of patients are randomized to treatment sequence risperidone-quetiapine (R-Q), and the other one-half to quetiapine-risperidone (Q-R). Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing. After a 6 - 14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing.

Those randomized to Q-R receive the same treatments, but in reverse order. Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing. After a 6-14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing. Those randomized to Q-R receive the same treatments, but in reverse order.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with bipolar I disorder in partial or full remission and deemed clinically stable

Exclusion Criteria:

* Current use of benzodiazepines, prescription or herbal sleep agents
* Use of antihistamines
* Use of antipsychotic medications in the past 6 months
* Pregnant/breastfeeding females
* Females not using contraception
* Illicit drug users
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry

The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check.


Eligibility Criteria:
Inclusion Criteria:

* Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)

Exclusion Criteria:

* N/A
Does Atrial Fibrillation (AF) Termination Without Additional Ablation Influence Outcome?

This prospective study aims to investigate if termination of atrial fibrillation (AF) after pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in long-standing persistent (LSP) AF, is enough to ensure long-term success.

Background: AF is a heterogeneous arrhythmia. At its simplest, it is triggered by rapidly firing foci around pulmonary veins (PV) and can be cured by isolation of PV alone. Evidences suggest that when high frequency of atrial activation is maintained for relatively longer period (as in persistent or long-standing AF), ion channel remodeling changes the electrophysiologic substrate and lead to AF permanence. Therefore, PVAI alone, as anticipated, demonstrates to have limited success rate in persistent and LSP AF and additional ablations beyond PVAI involving substrate modification are advocated by many experts in electrophysiology. However, there is yet no consensus on the ablation strategy for long-standing AF. It is still not clear whether AF termination during ablation could be considered as an ablation endpoint or not, as earlier studies have reported results that are at variance with each other. Some studies have suggested that termination of AF during ablation is associated with reduced recurrence of arrhythmia while others detected no association of AF termination with long-term maintenance of sinus rhythm (SR) in persistent or LSP-AF.Therefore this study aims to examine ablation outcomes in LSP-AF patients with AF termination with or without additional ablation of extra-PV triggers.

Hypothesis: AF termination does not eliminate the need for additional ablations in achieving long-term ablation success in LSP-AF.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. LSP-AF patients experiencing AF termination during ablation
3. Ability to understand and provide signed informed consent

Exclusion Criteria:

1. Previous left atrial catheter ablation or MAZE procedure in left atrium
2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Transfer Learning of a Neural Network for Robotic Surgical Assessment

The goal of this observational study is to explore how pretrained artificial intelligence (AI) models, trained on preclinical data, can improve the accuracy of action recognition and skills assessment in robot-assisted surgery (RAS) in urological patients by the use of transfer learning. The main questions it aims to answer are:

* Can pretrained AI models accurately assess action recognition and skills assessment in clinical surgeries?
* How do different training approaches of transfer learning affect the performance of the AI models? A baseline model developed from scratch using clinical data will be compared to pretrained models that are (1) directly applied to clinical data (2) fine-tuned by training only some layers of the AI model, and (3) fully retrained to see if these approaches improve performance.

Participants who are robot surgeons will:

* Undergo RAS procedures on patients, with no intervention, where video data will be collected for later action recognition and skills assessment.
* Contribute to model training and evaluation through clinical dataset integration.


Eligibility Criteria:
Inclusion Criteria:

* Robot surgeons who are experienced with more than 100 cases.
* Robot surgical fellows with less than 100 cases.
* Robot surgeons who worked at the urological department of Aalborg University Hospital.
Nitrous Oxide for Major Depressive Disorder

This study aims at investigating the persistence of antidepressant effect of Nitrous Oxide (N2O) for Treatment-Resistant Depression(TRD). The investigators also aim to assess the effect of N2O on the electroencephalograph, multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in patients with TRD. The investigators further aim to identify the predictors of N2O's antidepressant effeect using the above techniques.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years, both sexes), with ICD-10 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview
* Moderate to severe depression, as defined by a pretreatment score \>17 on the HDRS-17 scale
* TRD was defined as having had at least two adequate dose-duration, antidepressant medication failures in the current episode and a lifetime failure of at least three antidepressant medication trials.
* Informed consent to participate in this study

Exclusion Criteria:

* A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
* Active or recent (\<12 months) substance abuse or dependence; excluding nicotine
* Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease
* Acute severe suicidal ideation
* Acute psychosis
* Received ECT treatment within 6 months
* History of NMDA-antagonists (e.g., ketamine) intake
* Pregnancy or breastfeeding
* Any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin B12).
Neuromuscular Electrical Stimulation in Fibromyalgia

Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the American College of Rheumatology (ACR) 1990 criteria. Neuromuscular electrical stimulation (NMES) stimulates nerve fibers providing innervation in healthy muscle and muscle fibers in denervated muscle to produce contraction. All patients will be taught neck normal joint motion exercises, upper trapezius stretching exercise and posture exercises. Patients included in the study will be randomly distributed equally between the two groups. In addition to the study group, NMES will be applied to the upper trapezius muscle for 30 minutes 5 days a week for 4 weeks. Pain, disability and sleep quality of all patients will be evaluated.

Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the 1990 criteria of the American College of Rheumatology (ACR) (1). Pain and other symptoms associated with fibromyalgia interfere with daily functions, work and social activities, leading to a decrease in quality of life. Neuromuscular electrical stimulation (NMES) stimulates nerve fibers that provide innervation in healthy muscle and muscle fibers in denervated muscle to produce contraction. Studies on TENS current in patients with FM have shown that pain decreases and functional status improves. However, although muscle weakness has been described in patients with FM, there are no studies on the effects of NMES application. All patients will be taught neck normal joint motion exercises, upper trapezius stretching exercise and posture exercises. Patients included in the study will be randomly distributed equally between the two groups. In addition to the study group, NMES will be applied to the upper trapezius muscle for 30 minutes 5 days a week for 4 weeks. Pain, disability and sleep quality of all patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were aged between 18-65 years,
* Patients who got diagnosed with Fibromyalgia Syndrome

Exclusion Criteria:

* Patients who had regular exercise habits, malignancy, pregnancy, incorporation
* Patients who had changes of medical treatment in last 3 months
* Patients who had dysfunction that can prevent physical activity
Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.

PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.

OBJECTIVES:

Primary

* Identify factors predictive of treatment failure in patients with solid tumors treated with epoetin beta while undergoing chemotherapy.

Secondary

* Evaluate the impact of achieving target hemoglobin levels (i.e., hemoglobin \> 11 g/dL) after 8 weeks of treatment with epoetin beta.
* Evaluate changes in hemoglobin levels from baseline to after 8 weeks of treatment with epoetin beta.
* Evaluate the tolerability of epoetin beta in these patients.
* Evaluate the quality of life of these patients.

OUTLINE: This is a multicenter study.

Patients receive epoetin beta subcutaneously once a week for ≥ 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete a quality-of-life questionnaire (FACT-An) at baseline and after 8 weeks of treatment.

Eligibility Criteria:
Inclusion criteria :

* Age \> 18 years
* Hemoglobin levels between \[ \> 9g/dl - \< 11 g/dl \] .
* Patient requiring erythropoietine beta treatment for a foreseeable duration of at least 8 weeks under the same chemotherapy protocol.
* Patient with cancer undergoing chemotherapy
* Patient without EPO within 6 months prior to current chemotherapy.
* WHO 2 performance status (Appendix 1).
* Patient information and signature of informed consent or legal representative

Exclusion criteria :

* Hemoglobin \< 9 g/dl or \> 11 g/dl
* Patient with cancer not treated with chemotherapy (targeted therapy, hormone therapy, etc...)
* Patient with cancer treated with concomitant radiation chemotherapy.
* Co-treated with Epo beta and scheduled transfusion prior to inclusion.
* Hypersensitivity to the active substance or one of the NeoRecormon excipients®
* Poorly controlled high blood pressure
* Pregnant woman, likely to be pregnant or breastfeeding,
* Persons deprived of liberty or under guardianship,
* Unable to undergo medical follow-up for geographic, social or psychological reasons.
Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage

This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute cerebral hemorrhage. The study is designed to look at both infection rate and overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility Criteria:
Inclusion Criteria:

* Occurrence of an acute cerebral hemorrhage (between 9 and 72 h after onset) with a score of at least 6 on the National Institute of Health Stroke Scale (NIHSS), and patient age of at least 18 years.
* Have no pneumonia according to modified criteria of the U.S. Centers for Disease Control and Prevention (CDC)
* Consistent with the Constipation of Phlegm-Heat Accumulation type by Traditional Chinese Medicine (TCM) standard
* Patients or their representatives voluntarily take part in this study and signed the informed consent

Exclusion Criteria:

* Cerebral infarction, transient ischemic attack(TIA)
* Subarachnoid hemorrhage
* Proven cerebral embolism caused by tumor, Brain Trauma, cerebral parasitic disease, dysbolismus, fibrillation atrial resulted from rheumatic heart disease, coronary heart disease, and other heart diseases
* Clinical signs of infection on admission
* Pregnant or breast-feeding
* Allergic to rhubarb
* Preceding or ongoing antibiotic therapy within the last 24 h
* Participation in another interventional trial
* Immunosuppressant treatment within the last 30 days
* Combining severe clinical conditions such as liver, kidney, Hematopoietic System, endocrine system or psychological diseases
Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults

To evaluate the effects of protein-enriched soup plus exercise on muscle mass and muscle strength.

Besides, the investigators use the valued-based healthcare standard set as well as the Center for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive Assessment , and Mini Nutritional Assessment as outcome measures and to use the trial in validate additional supplement protein-enriched soup plus exercise could improve the vitality and health of mid-aged and old adults.

With aging, functions of every organs become to decline. Muscle mass, is one of the decline. According to previous research, adults would lose 40% among from aged 20 to 70. If muscle mass decline combining with the decline of muscle strength is so called Sarcopenia.When muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In addition, activity and life quality are also responsible for falling, cognitive difficulty, disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia through this program and develop prevention strategy and model to mollify the the negative effect of rapid aging society.

Eligibility Criteria:
Inclusion Criteria:

1. People who aged 50-75 years
2. Patients with following characteristics:
3. feeling loss in activity
4. detecting decline in self's walking speed.
5. feeling tired of doing everything.
6. having fell in last year.
7. People willing to follow the program and cooperate with us for following tracking.
8. People who are neither vegan nor vegetarian
9. People agree and be able to sign the informed consent.
10. the protein of the daily meal are less than 1.0g/kg

Exclusion Criteria:

1. People cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is allergic to our diets.
2. People with any disease affecting their limbs, including:
3. having fracture on limbs in the past 6 months
4. having severe arthritis in the past 6 months
5. any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
6. People with intermittent limp caused by peripheral artery diseases
7. People with weak control of mental disorder
8. People with weak control of Cardiopulmonary disease
9. People with weak control of Malignant tumor
10. People with weak control of kidney diseases (eGFR \<60ml/min/1.73)
11. People with Visual impairment and Hearing disorder which cannot help to complete the program.
12. People who have underwent hormone treatment and planned to undergo hormone treatment during program session.
13. Any other condition that PI recognized as not suitable
The Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients

The aim of the study is to determine the percentage of cases of acute treatment with Allopurinol in gout patients who have been previously treated.


Eligibility Criteria:
Inclusion Criteria:

* Gout patients

Exclusion Criteria:

* Pregnant women
* Chronic renal failure
* Patients with Allopurinal hypersensitivity
rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A

A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.

A multicenter, international, non- interventional, retrospective and prospective medical chart review study. Data will be collected from medical records for patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI . The study will be descriptive in nature and report on baseline characteristics, treatment and outcomes for patients who have been, or who are currently, treated with rFVIIIFc for ITI.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI.
* Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, before any study-related data collection are undertaken. Assent should be obtained from paediatric patients according to local regulations.

Exclusion Criteria:

* Current participation in any investigational medicinal product trial.