cyrilzakka/clinical-trials huggingface dataset:
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD

The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a vulnerable and challenging period of time for patients and providers. Suboptimal control of blood pressure is known to be common in patients with the advanced stages of CKD, and may contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and mortality. This proposal is a pilot randomized controlled trial designed to test whether intensive home blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.

The transition from advanced chronic kidney disease (CKD), when estimated glomerular filtration rate (eGFR) is \<=30 mL/min/1.73m2, to end-stage renal disease (ESRD) represents a vulnerable period, when multiple physiologic and psychosocial changes occur as patients prepare for either dialysis or kidney transplant. This study is a pilot randomized controlled trial to test the safety and feasibility of studying strict versus usual BP control in a population of patients with advanced CKD (eGFR \<=30 mL/min/1.73m2), including those with diabetes. For this pilot study, we will randomize 120 patients with advanced CKD who have elevated BP to either a home SBP target of \<120 mm Hg (intervention group) versus usual care (130-140 mmHg).

Eligibility Criteria:
Inclusion Criteria:

Adults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have

1. at least two eGFR in the last three months that are \<=30 mL/min/1.73m2 or
2. prior diagnosis of CKD (per electronic chart review) and at least one eGFR \<=30 mL/min/1.73m2
3. history of hypertension
4. mid-arm circumference between 22-37cm (BP cuff size limitation) and be able to provide consent to participate in our study.

Exclusion criteria

Those who:

* are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents
* are marginally housed, due to concerns regarding routine follow-up
* are actively participating in a different interventional trial that may affect blood pressure
* are unwilling to consent to participate
* institutionalized individuals or prisoners
* are actively abusing illicit drugs or alcohol
* have a history of poor or doubtful compliance (e.g., frequently missed appointments)
* have office SBP \>170 mmHg
* are already taking \>5 anti-hypertensive medications (any classes, including diuretics) have cognitive impairment prohibiting participation in the study.
Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm

The primary objectives of the study are

* to assess the contribution of alteration of each known gene on non-syndromic TAA.
* to map and identify unknown gene involved in the non-syndromic TAA.

The secondary objectives of the study are

* to study the correlation of phenotype-genotype, in particular, to compare the aortic phenotype of non-syndromic TAA patients and TAA syndromic patients.
* to develop national standardized strategies of genetic diagnosis and of clinical management using genetic data.

Eligibility Criteria:
Inclusion Criteria:

For all:

* Aged \> 18 years.
* Written informed consent obtained.
* People with health insurance.

For individual:

* people ≥ 45 years, thoracic aortic aneurysm without syndrome,
* or people \> 45 years with familial TAA.

For family:

* At least 2 members of family in 2 generations have TAA without syndrome and at least 2 patients of TAA will undergo blood collection.
* All people in family will undergo blood collection, each member should declare at first his (her) status (with or without TAA, unknown), the relationship (direct relative family or family in-law), no limit of age. For the children, only those with TAA will perform blood collection for the study.

Exclusion Criteria:

* Thoracic aortic aneurysm with different syndromes (Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome, Turner syndrome, Noonan syndrome).
* Arterial hypertension.
Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies

Fresh breast core biopsies suspicious for breast cancer that are usually taken during clinical breast assessments will be imaged via confocal microscopy.

The device so called HistologTM Scanner is based on confocal fluorescence and displays microscopic histology images superficial layers of fresh tissue.

After the imaging procedure the fresh breast tissue specimen will be followed according to the gold standard workflow (H\&E-stained images).

Subsequently, two pathologists will analyze the HistologTM Scanner obtained-images and H\&E-stained images for potential breast cancer structures.

A comparison of both analyses for cancer visualization will be performed to evaluate the feasibility of using confocal microscopy for breast cancer detection.

During clinical breast assessments physicians may detect diagnostic findings suspicious for breast cancer. In such situations a biopsy has to be taken to confirm the diagnosis histologically. Once informed consent will be obtained, the physician will collect a biopsy sample using the standard procedure with US- or MG-guided Biospy. Immediately prior to gold standard pathology workflow (formalin fixation), HistologTM Scanner will be used to image the fresh biopsy specimens. The HistologTM Scanner (v1.0, SamanTree Medical SA, Lausanne, Switzerland, CE marking) is based on confocal fluorescence and displays microscopic histology images of superficial layers of fresh tissue after nuclear staining with Acridine Orange (30 seconds) and rinsing in saline solution.

Finally, the specimen will be processed following the gold standard workflow (H\&E-stained images).

Two independent pathologists will assess the HistologTM Scanner- and H\&E-stained images subsequently according to the B-classification (categories B1-B5; "0" was defined as "no diagnosis possible") and determine the correspondence of the results.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patient ≥18 years old.
* Patient presenting with suspected breast carcinoma.
* Patient eligible for biopsy sampling.
* Patient must sign a written informed consent prior to research project entry.

Exclusion Criteria:

* Patient previously treated for breast carcinoma.
* Patient has undergone previous neo-adjuvant treatment.
* Patient is not willing to participate in the research project.
* Patient is not capable of consenting.
* Patient is younger than 18 years old
* Patient is male
Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis

The purpose of the current study is to analyze and compare the lower-limb joint motions and muscle activation patterns during activities of daily living as well as self reported health related functional outcomes for patients with osteoarthritis of the knee undergoing one of two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).

Inclusion:

40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.

Patients who do not meet any exclusion criteria.

Exclusion:

Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.

Exclusion for patient group

1. Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
2. Patients with any other joint replacement in the ipsilateral and contralateral limb.
3. Patients with evidence of active infection.
4. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
5. Patients with neuropathic joints.
6. Patients requiring structural bone grafts.
7. Patients with a documented allergy to cobalt chromium molybdenum.
8. Patient with a BMI larger than 30 kg/m2.

Eligibility Criteria:
Inclusion Criteria:

* 40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.Patients who do not meet any exclusion criteria.

Exclusion Criteria:

* Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.

Exclusion for patient group

1. Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
2. Patients with any other joint replacement in the ipsilateral and contralateral limb.
3. Patients with evidence of active infection.
4. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
5. Patients with neuropathic joints.
6. Patients requiring structural bone grafts.
7. Patients with a documented allergy to cobalt chromium molybdenum.
8. Patient with a BMI larger than 30 kg/m2.
An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's Lymphoma

This prospective observational study will evaluate the safety and efficacy of first-line rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma. Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of 3 years or until disease progression occurs.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of follicular non-Hodgkin's lymphoma
* Complete or partial response to first-line induction therapy with chemotherapy with rituximab
* Participants about to receive first-line rituximab maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label

Exclusion Criteria:

* Pregnant or lactating women
* Receipt of an investigational drug within 30 days prior to initiation of observational drug
* Any medical or psychological alteration that, to criterion of the investigator, can jeopardize the capacity of the participant to grant informed consent
* Central nervous system involvement
* Hepatitis B or C virus infection or human immunodeficiency virus infection
Support, Health, and Fibromyalgia

This study tests the effects of social support and education on the health and well-being of people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization. We randomly assigned the study participants to one of three groups. People in the social support group met with others who suffer from FMS for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The social support and education group also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS. Members of this group learned about the disease and ways they can manage it themselves. The third group participated only in the five assessment periods. The study lasted 4 years.

Next to osteoarthritis, FMS is the most common arthritis-related disease. Symptoms include musculoskeletal pain, fatigue, headaches, irritable bowel syndrome, morning stiffness, and sleep disturbances. Fluctuating severity, pain, and frustration with the difficulty of diagnosis and treatment lead patients to continually seek help from health care professionals. There is no known cause or cure for this disease.

This study tests the effects of social support and education on the health and well-being of people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization. To be eligible, people had to meet the American College of Rheumatology guidelines for FMS. After we confirmed the diagnosis, we assigned those who agreed to participate to one of three groups. The first group (social support) met with others who suffer from FMS for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The second group (social support and education) also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS, and its members learned about the disease and self-management techniques. The third group (control) participated only in the five assessment periods. We assessed people in all three groups before we assigned them to a group, after the intervention, and at yearly follow-ups. The study duration was 4 years.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of fibromyalgia documented in medical records and confirmed using The American College of Rheumatology criteria for classification of FMS: (1) A history of widespread pain (pain on both sides of the body, above and below the waist, and present for at least 3 months). (2) Pain in 11 or more of 18 tender-point sites.
* Patient willing to attend 10 weekly meetings and 10 monthly meetings.

Exclusion Criteria:

* Patients who do not meet ACR criteria for FMS described above.
* Patients who cannot attend meetings once a week for 10 weeks and once a month for 10 months were excluded.
Investigation of the Usability of Neutrocheck Amongst Healthy Volunteers and Healthcare Professionals.

This study proposes to assess the usability of the Neutrocheck device and test kit amongst healthy volunteers and healthcare professionals (HCPs).

Neutrocheck is a portable, single-use diagnostic test intended to aid the diagnosis of neutropenia, febrile neutropenia and neutropenic sepsis using a finger prick blood sample.

Neutropenia is when the number of infection-fighting neutrophil cells in the blood are lower than normal. It can be caused by treatments such as chemotherapy or by certain medical conditions. Neutropenic sepsis is a life-threatening medical emergency that occurs when patients with neutropenia develop an infection. There is currently no way to test for neutropenic sepsis outside of hospitals. Neutrocheck is being developed for use as a self-test by patients at home alongside remote consultation with a HCP or at point-of-care by a HCP. This will allow rapid identification of patients requiring urgent intravenous antibiotics and medical assessment. In cases where Neutrocheck has eliminated the possibility of neutropenic sepsis, patients can avoid unnecessary and stressful hospital visits and valuable hospital resources will be saved.

Participants in this study will be invited to use the Neutrocheck test kit in a setting similar to a home environment to carry out a test, whilst being observed by a study moderator.

The Neutrocheck devices used in the study will be for investigational use only. This study will not be testing the accuracy of the Neutrocheck result, rather if Neutrocheck can be used safely and in a user-friendly way. Results will not be considered valid. Planned study duration is 2 months. This approach will enable us to complete the current phase of development and advance to a clinical validation study of Neutrocheck, assessing the diagnostic accuracy of Neutrocheck amongst users including those at risk of neutropenia and neutropenic sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent to participate
* Age 18 years or over

Exclusion Criteria:

* Known HIV or active Hep B or Hep C infection
* Phobia of needles or blood
* Currently undergoing immunosuppressive medical treatment or have received immunosuppressive treatment in the previous 3 months.
Evaluation of Atelectasis Formation with Electrical Impedance Tomography During Anesthesia for MRI in Children

This study investigates under controlled conditions the variation of poorly ventilated lung units (silent spaces) in children between 1 and 6 years of age measured by electrical impedance tomography during intravenous anaesthesia in a day-hospital setting and before discharge to help further raise safety standards in paediatric anaesthesia

Eligible, children, with parental written informed consent, scheduled for a cerebral magnetic resonance image (MRI) will receive an intravenous anaesthesia using a Propofol infusion of 10 mg/kg/h. At the Bern Children's Hospital all children will be premedicated with Midazolam rectal/oral 0.5 mg/kg or Dexmedetomidine nasal 2 mcg/kg 20 minutes before the beginning of the procedure Eligible children will be prepared for procedure according to the local SOPs of the paediatric anaesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP. An iv-line for drugs injection will be placed.

Induction of anaesthesia: after iv-line placement a bolus of Propofol of 2 mg/kg followed by a continuous infusion of 10 mg/kg/h will be applied. Administration of low-flow oxygen for all children (0.3 l/kg/min) via Microstream® Smart CapnoLine® paediatric cannula (Philips Healthcare, Amsterdam, Netherlands). This cannula allows to measure the etCO2.

In case of extremely agitated child an inhalative induction may be performed. This technique represent the actual standard of care and is not associated with increased risks because of the study.

Before induction of the anaesthesia, before the radiological procedure when the induction is terminated, after the termination of the radiological procedure, before transport to the Post anaesthesia Care Unite (PACU), and before the discharge from the PACU after 2 hours of monitoring ventilation distribution changes by thoracic electrical impedance tomography are measured (each measurement will last 1 min).

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 to 3,
* 1 to 6 years of age with legal guardians providing written informed consent.

Exclusion Criteria:

* Exclusion criteria are necessity to intubate the child,
* contraindication for propofol administration,
* congenital heart or lung disease with oxygen
* dependency and high aspiration risk (requiring rapid sequence induction intubation).
A Multisensory Music Intervention for Children With Reading Disorders (RitMoZ)

With this study, we wish to test how effective/ beneficial music activities can be for children with dyslexia.

Studies have shown that music in the form of training (i.e., intervention) is able to facilitate linguistic processes (e.g., phonological encoding/decoding, categorical perception) and cognitive functions (e.g., working memory) in children that have dyslexia or reading difficulties. In addition to this, music trainings with a focus on entrainment can improve phonological as well as reading skills.

In line with the above, we have designed and developed a music training programme. This programme, which is called RitMoZ Training (i.e., from Ritmus és Mozgás és Zene: meaning Rhythm and Movement and Music in Hungarian language), is designed for (Hungarian) children who have dyslexia or reading difficulties.

In order to assess the efficacy of the music training, we are going to conduct a randomized controlled trial which consists of a pre-training phase, a training phase and a post-training phase.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of reading disorder
* Hungarian as native language

Exclusion Criteria:

* comorbidities (e.g., Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD))
* sensory impairment (e.g., hearing loss, low vision)
* cognitive impairment (e.g., panic disorder, low IQ)
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil

A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE\<10%) metastatic HER2-Low breast cancer.

Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 18 years old;
* Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer;
* Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line;
* Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months.

Exclusion Criteria:

* Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms);
* Have other active neoplasms (except from non-melanoma skin tumors);
* Have serious or active non-oncology lung diseases;
* Have other primary and concurrent breast tumor with differing receptor profiles.
Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.

100 Patients ages 40-95 with lumbar stenosis to be decompressed are randomized to undergo the procedure with either general anesthesia or local anesthetic with MAC.

Participants will be randomized to either group 1 General anesthesia or group 2 Local + MAC anesthetic group.

Group 1: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing.

Group 2: Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed

Eligibility Criteria:
Inclusion Criteria:

Patients with lumbar stenosis to be decompressed over 1-3 segments

* Ages 40-95
* Appropriate for general anesthesia

Exclusion Criteria:

* Planned significant nerve root retraction
* Previous fusion operation
* Unable to comply with follow up
* Patients with daily morphine equivalents or more 100mg
* Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components.
* Patients with allergies to eggs, egg products, soybeans or soy products.