cyrilzakka/clinical-trials huggingface dataset:
Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Eligibility Criteria:
Inclusion Criteria:

1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:

   1. Cohort A: prostate cancer
   2. Cohort B: urothelial carcinoma
   3. Cohort C: renal cell carcinoma
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Age ≥18 years at time of consent.
5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
7. ≤ 5 progressing or new metastatic lesions.
8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.

Exclusion Criteria:

1. Medical comorbidities precluding locally ablative therapies.
2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
3. Progressing intracranial lesions.
The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children

This study employs a cross-sectional design to profile the gut microbiome and urine metabolome in overweight/obese children with type 1 diabetes (T1D).

The investigators will obtain stool and urine samples from subjects aged 7-17 years in 4 groups:

* Group 1: Obese or overweight children within 3 years of diagnosis of T1D
* Group 2: Normal weight children within 3 years of diagnosis of T1D
* Group 3: Obese or overweight children without T1D
* Group 4: Normal weight children without T1D

Type 1 diabetes will be defined according to American Diabetes Association criteria along with the presence of pancreatic autoantibodies (GAD65, ICA512, or insulin autoantibodies). Obese and overweight status will be defined by BMI \>85th percentile for age and gender according to CDC criteria.

All subjects will provide one-time stool and first morning urine sample. Overweight or obese subjects will additionally have a point of care blood glucose and hemoglobin A1c measurement to ensure that they do not have diabetes.

The investigators will perform 16S rRNA sequencing of stool bacteria and mass spectrometry measurement of urine metabolites.

Eligibility Criteria:
Inclusion Criteria:

* Age 7 to 17 years
* Diagnosis of diabetes will be defined by current American Diabetes Association criteria ° (fasting glucose \> 126 mg/dl, 2 hour OGTT glucose \> 200 mg/dl; random glucose \> 200 with symptoms of hyperglycemia; or HbA1c \> 6.5%)
* Diabetes duration \< 3 years
* Presence of pancreatic autoimmunity (GAD65, ICA512, or insulin autoantibody positivity)
* Adult caregiver willing to actively support study participation
* Signed parental informed consent form and minor child informed assent form

Exclusion Criteria:

* Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation
Safety and Immunogenicity of Sars-cov-2 Vaccine in Patients With Rheumatic Diseases

The purpose of this study was to preliminarily evaluate the immunogenicity of sars-cov-2 vaccine in patients with rheumatic diseases. The clinical information collection and blood sample testing of 100 healthy people and 200 patients with rheumatic diseases will be completed in Yunnan Traditional Chinese medicine hospital.

Research methods and procedures: clinical information collection and blood sample detection were carried out in healthy people and patients with rheumatic diseases, including systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic sclerosis (SSC), idiopathic inflammatory myopathy (IIM), systemic vasculitis and spinal arthritis

Rheumatic diseases (RDS) are a large class of systemic diseases caused by genetic background, environment and physics, infection, metabolism, endocrine, immune response and other reasons, mainly involving joints and surrounding tissues. The diseases covered include systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), rheumatoid arthritis (RA) Sjogren's syndrome (SS), systemic sclerosis (SSC), idiopathic inflammatory myopathy (IIM), systemic vasculitis, spinal arthritis, etc. Patients with rheumatic diseases have an increased risk of infection due to autoimmune dysfunction and long-term use of hormones and immunosuppressants.

The incidence rate of coronary heart disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2) in 2019 has resulted in high incidence and mortality worldwide. Although the epidemic prevention measures such as keeping distance and quarantine isolation have effectively improved and limited the epidemic scope and the number of infected people, the groups with low immunity are still the susceptible groups of sars-cov-2.

Vaccination is very important to suppress the epidemic and reduce the overall mortality. It can protect people from sars-cov-2 infection and the deterioration of covid-192, and has good safety. However, there are not enough reports on the safety and immunogenicity of sars-cov-2 vaccine in patients with rheumatic diseases. Studies have reported that the immunogenicity of sars-cov-2 vaccine is reduced in immunocompromised patients, including the use of immunosuppressive drugs.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria of rheumatic diseases in western medicine;

  * 18-70 years old, male or female;

    * The patient voluntarily participated in this clinical study, has been informed of relevant matters, and signed the informed consent form

Exclusion Criteria:

It does not meet the diagnostic criteria of rheumatic diseases in western medicine
Cell-mediated Immunity for Prevention of CMV Disease

An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV assay. Investigators will include kidney and liver transplant recipients. Patients will be randomized during the first month post transplant.

In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis will depend on the result of the assay:

* T-Track positive (patient at lower risk): discontinuation of the antiviral drug
* T-Track negative (patient at higher risk): continuation of the antiviral drug until the maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a standard fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin treated-patients and 6 months for D+/R- patients). Measurement of CMV CMI by both T-Track® CMV and the Quantiferon-CMV® assays will be done at the same time points of the interventional arm, but the result will not be known by the investigators.

After discontinuation of prophylaxis, patients in both arms will be followed for the development of CMV replication at each visit using the local PCR assay and antiviral therapy will be administered in case of CMV infection according to local guidelines.

The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV replication during the first 12 months post transplant AND the duration of antiviral prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Kidney or liver transplantation
* Scheduled to receive CMV antiviral prophylaxis:
* CMV D+/R- patients
* Patients receiving lymphocyte-depleting antibodies (thymoglobulin® or ATG®)

Exclusion Criteria:

* Unable to provide informed consent
* Unable or unwilling to comply with study protocol
Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced Renal Cell Carcinoma

Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE Renal Cell Carcinoma population

The PRO Kidney project will recruit a representative cohort of patients with advanced renal cell carcinoma (RCC) treated with systemic antiproliferative therapies such as TKIs, mTOR inhibitors, cytokines, antiVEGF or immune therapy. The aim of this study is to collect data on the effectiveness and patients´quality of life on preference in the real life setting.

Patient Reported Outcomes ( PRO) are assessed by a questionnaire consisting Functional Assessment of Cancer Therapy ( FACT) Kidney Syndrome Index 19 (FKSI 19) completed by four questions assessing ailments about changes in skin of hands/feet, taste, color of hair and mouth scores.

13 Questions about Fatigue assessed with the Functional Assessment of Chronic IIlness Disease.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed renal cell carcinoma
* Start of the first line systemic treatment
* Ability to read and understand German
* Written informed consent

Exclusion Criteria:

* None
Surgical Pain Control With Ropivacaine by Atomized Delivery

The purpose of this trial is to determine the effect of spraying a local anesthetic called Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a local anesthetic used to block pain in the body. There are studies showing that Ropivacaine decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder removal but has not been tried in robotic pelvic surgery.

Practice guidelines from the American Society of Anesthesiologists peri-operative techniques for pain management have remained essentially unchanged over the last 10 years (3). Current acute pain-management strategies include 1.) Epidural or intrathecal opioids 2.) Patient-controlled devices delivering systemic opioids and 3.) Regional techniques such as peripheral nerve blocks and post-incisional infiltration with local anesthetics.

The use of epidural and systemic opioids results in significant side-effects such as post-operative nausea and ileus which often lead to increased hospital stay. The literature supporting the benefit of preincisional infiltration with anesthetics remains equivocal.

A recently published study describes the use of intraperitoneal Ropivacaine (2mh/kg) during laparoscopic appendectomy(4). The study was a randomized, double-blinded, placebo-controlled study using Ropivacaine (vs placebo) injected through the laparoscopic ports prior to the start of the appendectomy in 63 patients(4).

Patients treated with Ropivacaine had a significant decrease in visual analog pain scores post-operatively and had decreased narcotic use during their hospital stay compared to placebo. There were no side-effects found with the one-time use of the Ropivacaine.

The results of the above study and review of an additional 24 randomized controlled trials conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port placement and the operative procedures vary significantly. Hence this study was undertaken to investigate the role of intraperitoneal Ropivacaine as an adjuvant to muscle relaxants and narcotics at the time of pelvic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Consent to undergo robotic assisted gynecologic or urologic surgery
* Between the ages of 18 and 75
* Able to consent, fill out study documents, and complete all study procedures and follow-up visits

Exclusion Criteria:

* Patients with an allergy to local anesthetics
* Patients with severe underlying cardiovascular, renal or hepatic disease
* Pregnant patients
Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX \[Leucovorin + Fluorouracil (5-FU) + Oxaliplatin\]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.

Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.

Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)
* Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

* Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens
* Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens
* For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting
Comparison of Home-based Video, Paper/Print Checklist and Professional Home Assessment in Detection of Fall Hazards at Home

The purpose of this study is to assess the feasibility and potential impact of video analysis of footage taken with a GoPro camera video in comparison to a homeowner checklist or gold standard home assessment as a means of detecting home fall hazards.

Investigators hypothesize that the assessment of homes for fall hazards with a GoPro camera will be better than a homeowner paper checklist in hazard identification.

80 community-dwelling adults (50-75 years of age) will be recruited from clinics and the community through posters and advertising (n = 40 in the Healthy Group; n = 40 in the Distal Radius Fracture (DRF) Group (adults with 3-12 months post-DRF)).

Participants will be randomly allocated to a homeowner paper checklist or a GoPro video assessment and then cross-over to the opposite intervention.

To assess accuracy, a gold standard home assessment will be completed by a trained evaluator, after the homeowner checklist and GoPro video assessment.

Upon completion of the data collection, the evaluator will conduct their assessment (gold standard); review the findings from the GoPro "playback" with the participant, and conduct a semi-structured interview on their prior awareness of fall hazards, perceptions about the different methods of detecting fall hazards in their home; and intentions to remediate identified hazards.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Group: community-dwelling adults
* DRF Group: adults with 3-12 months post DRF
* ability to read, understand and speak English

Exclusion Criteria:

* identified cognitive disorder
* major loss of vision or hearing
* other concurrent upper extremity injuries or neurological impairments
* any unhealed fractures
Comparison of Training in Virtual Environment With and Without Physiotherapeutic Intervention in Chronic Stroke Patients

The aim of this study is to compare the effects of balance training in a virtual environment with and without physiotherapeutic intervention on the motor function, balance and gait in chronic stroke patients.

It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group.

The aim of this study is to compare the effects of a balance training program in a virtual environment (using a gaming system with balance board device) with and without verbal/manual physiotherapeutic intervention, on the motor function, balance and gait in chronic stroke patients.

It is a prospective, single blinded, randomized clinical trial, performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.

Forty chronic stroke patients will be randomly in control and experimental group, 20 each one. Both groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups will perform more 30 minutes of balance training using eight Wii Fit games which stimulate motor and cognitive functions.

The main outcome measures will be: the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); Balance Evaluation Systems Test (BESTest) and 6- minute walk test (6MWT).

Eligibility Criteria:
Inclusion Criteria:

* hemiparetic status resulting from a single stroke at least 6 months earlier;
* the ability to walk 10 m independently with or without an assistive device;
* a Montreal Cognitive Assessment (MoCA) score of ≥ 20;
* the absence of a musculoskeletal condition that could potentially affect the ability to stand or walk safely;
* the absence of serious visual impairment or a hearing disorder;
* muscle strength ≥ 3 in lower limbs;
* ability to understand and follow simple instructions.

Exclusion Criteria:

* severe dementia or aphasia;
* hemispatial neglect, ataxia or any other cerebellar symptom;
* inability to stand without minimal assist;
* uncontrollable medical complications
* participation in other studies or rehabilitation programs
Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer

This study evaluates the genomic profiles of breast cancer in a prospective and population-based manner. In the first phase, breast tumors are analyzed by whole transcriptome RNA-sequencing. Gene expression profiles, mutational profiles, and transcript isoform-level data will be analyzed in the context of patient information, clinicopathological variables, and outcome, with the purpose to develop new molecular diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses will be performed in the future.

Breast cancer exhibits significant molecular, pathological, and clinical heterogeneity. Current patient and clinicopathological evaluation is imperfect for predicting outcome, which results in overtreatment for many patients, and for others, leads to death from recurrent disease. Therefore, additional criteria are needed to better personalize care and maximize treatment effectiveness and survival.

The Sweden Cancerome Analysis Network - Breast (SCAN-B) study was initiated in 2010 as a multicenter prospective population-based observational study with long-sighted aims to analyze breast cancers with next-generation genomic technologies for translational research and integrated with healthcare; decipher fundamental tumor biology from these analyses; utilize genomic data to develop and validate new clinically-actionable biomarker assays; and establish real-time clinical implementation of molecular diagnostic, prognostic, and predictive tests. In the first phase, we focus on molecular profiling by next-generation RNA-sequencing. Gene expression profiles, mutational profiles, and transcript isoform-level data will be analyzed in the context of patient information, clinicopathological variables, and outcome, with the purpose to develop new molecular diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses will be performed in the future.

As of February 2024, over 20,000 patients have enrolled in the study, representing approximately 85% of all eligible patients within the catchment region. Tissue and blood collection is integrated within healthcare routines and clinical information is provided from national quality registries.

As of Q4 2021, the SCAN-B RNA-seq analysis for molecular subtyping and risk-of-recurrence has been clinically implemented for all breast cancer patients in Skåne within the Center for Molecular Diagnostics, Laboratory Medicine, Medical Service, Region Skåne.

Eligibility Criteria:
Inclusion Criteria:

* suspicion or confirmed diagnosis of primary breast cancer
* signed informed consent

Exclusion Criteria:

* lack of signed informed consent
The Noninvasive Ventilation to COVID-19 Patients

Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.

Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.We wish to raise the success rate to COVID-19 patients with respiratory failure.More critically ill COVID-19 patients could avoid the intubtion.

Eligibility Criteria:
Inclusion Criteria:

1. Shortness of breath, RR\>30 times per minute;
2. At room air, SpO2 lower than 93%;
3. The partial pressure of Arterial blood oxygen (PaO2)/the fraction of inspired oxygen (FiO2) ≤ 300mmHg;
4. CT（computed tomography） chest imaging shows that lung damage develops significantly within 24 to 48 hours.

Exclusion Criteria:

1. Severe cardiovascular disease,
2. respiratory arrest,
3. cardiovascular instability (hypotension, arrhythmias, myocardial infarction),
4. change in mental status or patients who were uncooperative, high risk of aspiration, viscous or copious
5. secretions,
6. recent facial or gastroesophageal surgery,
7. craniofacial trauma, 8)fixed nasopharyngeal abnormalities,

9）burns, 10) extreme obesity.