cyrilzakka/clinical-trials huggingface dataset:
informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia

The study is designed as a multicenter, prospective, observational registry of CLL/SLL patients who are initiating approved oral kinase inhibitors, BCL-2 inhibitors or other approved anti-CLL therapies/regimens. The study will characterize treatment patterns and their association with patient characteristics, healthcare resource utilization, and clinical outcomes, as well as patient-reported outcome (PRO) measures.

This multicenter, prospective, observational registry of CLL patients is designed to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors and other approved anti-CLL therapies/ regimens. The registry will provide information on regimens used to treat first-line and later lines of CLL as well as the sequencing of treatment regimens. The registry will also evaluate the association of these treatment patterns with patient characteristics, healthcare resource utilization, and functional outcomes including patient-reported HRQoL. These data will provide information to physicians that may help guide clinical practice and appropriate use of therapies, and will also provide information on HRQoL and healthcare resource utilization that will be of interest to healthcare decision makers.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
* Initiating anti-CLL/SLL treatment regimen (excluding clinical trials) within ±45 days of enrollment
* Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records if patient has received prior line(s) of treatment (i.e. NOT treatment naïve)
* Willing and able to provide informed consent
* Willing and able to complete PRO instrument
* Willing and able to provide information on patient survey questionnaire
* Willing and able to provide a blood sample at time of enrollment prior to receiving treatment, as possible

Exclusion Criteria:

* Diagnosis of B-cell malignancies other than CLL/SLL
* Estimated life expectancy \<6 months
* Currently receiving treatment in an interventional clinical trial at time of entry into this study \* Note- Exceptions: 1) Patients may enroll in interventional clinical trials for indications other than CLL/SLL, 2) The interventional clinical trial treatment is not the treatment used for meeting Inclusion Criteria #2 (or "Index Treatment"), 3) Patients may enroll in an interventional clinical trial indicated for CLL/SLL as later line of treatment after discontinuing the Index Treatment
The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children

Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004).

Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* 12-15 years
* IsoBMI\>30

Exclusion Criteria:

* Chronical diseases
* Chronical medication
Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy (CP) Forms

In recent years Ferrari et al. proposed a new classification of manipulation in children with spastic hemiplegia which describes five different classes by analyzing and integrating the kinematic patterns of the hand and its functional use.

The investigators believe that this classification provides the clinician with clinically meaningful information, by identifying the useful strategies spontaneously adopted by the children during manipulation tasks.

The aim of this study is to determine the criterion validity of the new classification of the pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne Assessment of Unilateral Upper Limb Function.


Eligibility Criteria:
Inclusion criteria:

* clinical and instrumental (TC or RMN) diagnosis of child hemiplegia
* age \> 5 years

Exclusion criteria:

* acquired hemiplegia at the age \> 3 years
* anti-spastic drug inoculations or functional surgery on the plegic UE 6 months prior to the video recordings
* severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV
* pharmaco-resistant epilepsy
* behavioural disorders
Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery

This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.

Adverse neurological events include perioperative neurocognitive disorders and stroke and remain one of the major risks after cardiac surgery. A lack of a comprehensive knowledge of their causes and neuroprotective strategies has hindered the development of strategies to effectively reduce these complications. Against this background, this research project will take three approaches. First, non-invasive, personalised cerebral autoregulation-oriented blood pressure monitoring aims to reduce complications by uncovering blood pressure targets tailored to individual characteristics. In parallel, establishing biological associations between adverse neurological outcomes, brain injury biomarkers and genetic studies are complementary strategies that make a move to a proactive patient-tailored paradigm, ultimately understanding the mechanisms and improving patient outcomes, patient safety and quality of life.

Therefore, this international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of MAP outside of an individual's CA limits using NIRS and TCD are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults, defined by the duration and magnitude spent outside of an individual's CA limits based on NIRS and/or TCD, have an increased incidence of postoperative delirium (POD), stroke or cognitive decline. Biological associations between adverse neurological outcomes, the role of brain injury serum biomarkers will be explored. Genetic studies will be conducted on participants who give written informed consent for these further investigations.

Eligibility Criteria:
Inclusion Criteria:

* Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

* Surgery requiring moderate or deep hypothermic circulatory arrest;
* Heart and/or lung transplantation;
* Urgent (\< 24 hours) and emergency surgery;
* Inability to follow procedures or insufficient knowledge in English, German or French;
* Inability to give consent.

Participants from the University Hospital Basel who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.
Hand Grip Strength in Athletic and Non-Athletic Girls at Different Phases of Menstrual Cycle

The study was designed as an observational study

The study was designed as an observational case-control study

Eligibility Criteria:
Inclusion Criteria:

- 1. The participant had regular menstrual cycles, which were confirmed by using a calendar for three consecutive menstrual cycles, 2. The participant ages ranged from 16 to 22 years old, 3. The body mass index (BMI) ranged from 18.5 to 25 kg/m2. 4. For athletic group, they had participated in basketball and tennis teams for 3 to 4 years.

5. For non-athletic group, they had a sedentary life without any sport activities.

Exclusion Criteria:

* Participants were excluded from the study if they had:

  1. Irregular menstrual cycle
  2. Pelvic inflammatory diseases, pelvic infection or gynecological diseases.
  3. Any musculoskeletal disorders of Upper extremity or surgery, cardiovascular, pulmonary, neurological or systemic conditions.
  4. Receiving contraceptives or any hormonal therapy.
Rapid Clamp Release Post Trans-radial Cardiac Catheterization

The purpose of the study is to compare different short durations of radial clamp application following an angiogram via a trans-radial approach.

This is a single-center, prospective, randomized study that will enroll patients that are referred for an angiogram and will compare 3 different durations of radial clamp applications. Patients will be randomly assigned to either 10, 20 or 30-minute clamp applications. The clamps will be gradually released at the end of the assigned durations and participants will be assessed for the radial artery occlusion, hematoma, and other bleeding events.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic catheterization
2. 5 F slender sheath
3. Normal ulno-palmar circulation

Exclusion Criteria:

1. Abnormal ulno-palmar circulation type D
2. Ad hoc percutaneous coronary intervention
3. Heparin or other anticoagulation
Combined Effect of tDCS and Motor or Cognitive Activity in Patients With Alzheimer's Disease

The goal of this clinical trial is to evaluate the effectiveness of combining tDCS with motor or cognitive activities on cognitive functions in patients with AD. Second aim is to investigate if tDCS has a different impact if it is combined with motor or cognitive activities.


Eligibility Criteria:
Inclusion Criteria:

* Mini Mental State Examination (MMSE) major or equal to 15;
* good level of compliance;
* acetylcholinesterase inhibitor treatment (e.g., donepezil, rivastigmine);
* no modifications of medication during the last four months.

Exclusion Criteria:

* behavioral disorders (e.g., aggressiveness);
* alcohol abuse;
* orthopedic pathology with risk of falls to the ground;
* respiratory pathology;
* severe auditory or visual deficits uncorrected;
* history of epileptic fits;
* anti-epileptic medication;
* metallic body implants; pacemaker;
* psychiatric, neurologic, systemic or metabolic disorders.
WeCanManage. An mHealth Self-management Tool

Examine the Feasibility, Acceptability, User Satisfaction, and Response Patterns and Preliminary Efficacy on Targeted Patient Reported Outcomes. Using a pre-post, single arm feasibility design with cancer survivors with disabilities

Examine the Feasibility, Acceptability, User Satisfaction, and Response Patterns and Preliminary Efficacy on Targeted Patient Reported Outcomes. Using a pre-post, single arm feasibility design with cancer survivors with disabilities, we will collect data on the WeCanManage app delivered self-management intervention's feasibility, acceptability, user satisfaction as well as response patterns and preliminary efficacy on targeted patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

Usability Testing of the WeCanManage High Fidelity Prototype

* Age 18 or older
* Diagnosis of breast cancer, head and neck cancer or sarcoma
* Completion of active treatment
* Self-identify as a person with a disability according to the Americans with Disabilities .Act and the American Community Survey 6-disability questions
* Able to understand and communicate in English
* Medically stable enough to participate in two data collection sessions totaling 2 hours

Evaluation of the WeCanManage App

* Age 18 or older
* Diagnosis of breast cancer, head and neck cancer or sarcoma
* Completion of primary (i.e. surgery, chemotherapy, and/or radiation); may still be under-going endocrine or hormone therapies
* Self-identify as experiencing disabling after-effects of cancer and its treatment according to the Americans with Disabilities Act and the American Community Survey 6-disability questions
* Able to read, understand and communicate in English
* Ownership of a smartphone, tablet, or personal computer.
* Internet access

Exclusion Criteria:

Usability Testing of the WeCanManage High Fidelity Prototype

* No diagnosis of breast cancer, head and neck cancer or sarcoma
* In active treatment
* Does not self-identify as a person with a disability according to the Americans with Disabilities Act and the American Community Survey 6-disability questions
* Not able to understand and communicate in English
* Not medically stable enough to participate in two data collection sessions totaling 2 hours

Evaluation of the WeCanManage App

* Age 17 or younger
* No diagnosis of breast cancer, head and neck cancer or sarcoma
* In active treatment
* Does not self-identify as experiencing long-term effects of cancer and its treatment according to the Americans with Disabilities Act and the American Community Survey 6-disability questions
* Not able to read, understand, and communicate in English
* Does not have access to internet enabled smartphone, tablet, or personal computer
* Does not have access to the internet
OC000459 Bronchial Allergen Challenge

OC0000459 reduces inflammation in the tissues in response to allergic stimuli in patients with asthma. This clinical trial, in mildly asthmatic patients, studies the effects of OC000459 and placebo on the asthmatic response to two known stimulants of the asthmatic response in the lungs, namely cat hair, pollen or house dust mite and methacholine.


Eligibility Criteria:
Inclusion Criteria:

* Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
* FEV1 \>65% of predicted on at least two occasions at screening.
* At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
* No steroid usage in the past 12 weeks.
* Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
* Non smokers for a minimum of 6 months; less than 10 pack year history.

Exclusion Criteria:

* Respiratory tract pathology other than allergic asthma.
* Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
* Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
Analysis of Gene Expression in Femoroacetabular Impingement (FAI)

Femoral acetabular impingement (FAI) is a common disease of the hip joint. In this study, whole-genome sequencing was used to further explore the pathogenesis of this disease.

Femoral acetabular impingement (FAI) is a group of chronic hip pain caused by the impact between the proximal femur and the edge of the acetabulum due to the anatomical abnormality of the hip joint, which damages the labrum and adjacent cartilage, and causes limited hip movement, especially limited flexion and internal rotation. However, the specific etiology of FAI is still unknown at present. The application of genome-wide, exon and transcription research methods to the study of hip impaction syndrome can uncover key differentially expressed genes and provide a theoretical basis for the study of FAI.

Eligibility Criteria:
Inclusion Criteria:

* The patient underwent preoperative imaging and was diagnosed with FAI. The patient complained of pain in the hip, hip, or thigh, and had a positive hip flexion impact test.

Exclusion Criteria:

* Patients with hip surgery history, hip osteoarthritis, necrosis of the femoral head, hip infection, hip dysplasia and other hip diseases.
Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

The objective of the study is as follows:

1. To know the antibody level during different interval after received 1 dose varicella vaccine.
2. To know safety and effectiveness of received 2 doses varicella vaccine with different interval.
3. To know safety and effectiveness of received varicella vaccine and MMR at the same time.

To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.

All blood specimens will be tested by a third-party detection institution.


Eligibility Criteria:
Inclusion Criteria:

* Aged 1 to 7
* Without a previous history of varicella
* With an axillary temperature ≤37.5℃ at the time of vaccination
* Appropriate varicella vaccination history
* With guardian signing the informed consent and available for clinical observation

Exclusion Criteria:

* Hypersensitive to any active substance of the vaccine including excipients and antibiotics
* With acute illness, severe or acute attack of chronic illness or fever
* With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs
* Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease
* With a family or personal history of seizure, chronic illness, epilepsy or allergy
* With unknown immunization history or unable to follow the immunization schedule of EPI
* Received any vaccine within 4 weeks or willing to receive any vaccine in 1 month
* With hemorrhagic tendency or prolonged period of bleeding
* Received whole blood, plasma or immunoglobulin within 5 months
* Received systemic antibiotics or antiviral treatment for acute illness within 7 days
* With an axillary temperature ≥38℃ within 3 days
* Participating in another clinical trial
* Any situation that might influence the consequence of the clinical trial
Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation

Based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. population size is 207. The participants will be randomized to the linear ablation group and PVI ablation group with a 2:1 ratio. the follow-up period is 12 months. The primary outcome is freedom from atrial fibrillation, the secondary outcome is complications related to ablation.

Pulmonary vein isolation is recommended as the cornerstone of catheter ablation of atrial fibrillation by current guidelines, However, meta-analysis suggests that the success rate of continuous pulmonary vein isolation for persistent atrial fibrillation is only 43%. Therefore, in addition to pulmonary vein isolation, further research on substrate modification in the treatment of atrial fibrillation is particularly important.

Based on our previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from persistent atrial fibrillation and referred to catheter ablation therapy.
* patients agreeing to be enrolled， with the informed consent signed

Exclusion Criteria:

1. Sinus rhythm at the time of recruitment;
2. Age less than 18 years old or older than 75 years;
3. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm;
4. History of previous radiofrequency ablation of atrial fibrillation or surgical ablation History;
5. Left atrial thrombus recorded by ultrasound or CT;
6. Combined with severe lung disease;
7. Previous history of cardiac surgery;
8. Patients with hyperthyroidism, atrial septal defect, mitral stenosis, or severe coronary heart disease requiring further treatment
Applying Speed of Processing Training to Individuals With Traumatic Brain Injury

This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with TBI with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the TBI population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in TBI could have a profound impact on the population and society as a whole.


Eligibility Criteria:
Inclusion Criteria:

* fluent in English
* processing speed impairment (based on evaluation).

Exclusion Criteria:

* currently taking steroids and /or benzodiazepines
* prior stroke or neurological disease
* history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
* significant alcohol or drug abuse history